Beyond Air Inc (XAIR) 2025 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon, and welcome, everyone, to the Beyond Air financial results call for the fiscal quarter and year ended March 31, 2025. (Operator Instructions)

    下午好,歡迎大家參加 Beyond Air 2025 年 3 月 31 日止財政季度和年度財務業績電話會議。(操作員指示)

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

    現在我想將電話轉給 LifeSci Advisors 的 Corey Davis。請繼續。

  • Corey Davis - Investor Relations

    Corey Davis - Investor Relations

  • Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after the market closed, we issued a press release announcing the operational highlights and financial results for Beyond Air's fourth quarter of fiscal year 2025 ended March 31, 2025. A copy of this press release can be found on our website, beyondair.net, under the News & Events section.

    謝謝您,接線生。大家下午好,感謝大家的參與。今天,市場收盤後,我們發布了一份新聞稿,宣布了 Beyond Air 截至 2025 年 3 月 31 日的 2025 財年第四季度的營運亮點和財務業績。您可在我們的網站 beyondair.net 的「新聞與活動」部分找到此新聞稿的副本。

  • 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.

    在我們開始之前,我想提醒大家,我們將對未來的期望、計劃和前景發表評論和各種評論,這些評論和評論構成了 1995 年《私人證券訴訟改革法案》安全港條款規定的前瞻性陳述。

  • 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 SEC, including, without limitation, the company's most recent Form 10-K and Form 10-Q which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

    Beyond Air 警告稱,這些前瞻性陳述受風險和不確定性的影響,可能導致實際結果與預期結果有重大差異。我們鼓勵每個人都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 表和 10-Q 表,這些文件確定了可能導致實際結果或事件與前瞻性陳述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, beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, June 17, 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 beyondair.net 上提供音訊重播。此外,本次電話會議的內容包含時間敏感訊息,其準確性僅限於直播日期(2025 年 6 月 17 日)。Beyond Air 不承擔修改或更新任何聲明以反映本次電話會議召開日期之後的事件或情況的義務。

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

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

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Thanks, Corey, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We are quite pleased with the progress we've made over the past year. For the fiscal year ended March 31, 2025, we reported a 220% increase in revenue to $3.7 million compared with $1.2 million for the same period last year. All of this growth came from US sales, the majority coming from hospitals signed during the back half of the year.

    謝謝,科里,大家下午好。今天和我一起在場的是我們的財務長道格‧拉森 (Doug Larson)。我們對過去一年的進展感到非常滿意。截至 2025 年 3 月 31 日的財政年度,我們報告營收成長 220%,達到 370 萬美元,而去年同期為 120 萬美元。所有這些增長都來自美國的銷售,其中大部分來自下半年簽約的醫院。

  • As a result, we have tremendous revenue growth built in to kick off fiscal year 2026, along with several new growth drivers as I will discuss in a moment. With this in mind, we have decided to also announce that we are on track to report revenue of at least $1.7 million for the quarter ending in just two weeks on June 30, 2025, which translates to greater than a 45% sequential quarterly growth and greater than 145% year-over-year growth.

    因此,我們在 2026 財年開始時就實現了巨大的收入成長,同時也帶來了幾個新的成長動力,我稍後會討論。考慮到這一點,我們還決定宣布,我們預計在僅剩兩週的 2025 年 6 月 30 日結束的季度中實現至少 170 萬美元的收入,這意味著季度環比增長超過 45%,同比增長超過 145%。

  • In addition, we are providing revenue guidance of $12 million to $16 million for the full fiscal year ending March 31, 2026. This level of projected growth moving forward shows how we are overcoming the barriers to entry in the nitric oxide market and are well on our way to making LungFit PH the market leader. The more customers use LungFit PH, the more confidence grows in the product and our ability to provide top-tier service. This is an exciting time for our team and our shareholders.

    此外,我們也預計截至 2026 年 3 月 31 日的整個財年的收入將達到 1,200 萬至 1,600 萬美元。預計未來這一成長水準表明我們正在克服進入一氧化氮市場的障礙,並且正在順利使 LungFit PH 成為市場領導者。客戶使用 LungFit PH 越多,對產品和我們提供一流服務的能力的信心就越強。對於我們的團隊和股東來說,這是一個令人興奮的時刻。

  • Let me now dig a little deeper into the numbers for the fiscal fourth quarter of 2025 and growth drivers for fiscal 2026. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year 2025. During the fourth quarter, we saw three new hospital starts and three hospitals renew their contracts.

    現在,讓我更深入地探討 2025 財年第四季的數據以及 2026 財年的成長動力。商業團隊的努力使得整個2025財年新醫院合約源源不絕。第四季度,我們看到三家新醫院開業,三家醫院續約。

  • As I've mentioned recently, we have established a solid customer base across key target regions in the US. We are pleased and thankful that many of these customers have made themselves available as references for LungFit PH over recent months, which has proven to be a valuable tool when establishing new accounts.

    正如我最近提到的,我們已經在美國主要目標地區建立了穩固的客戶群。我們非常高興和感激,許多客戶在最近幾個月中都願意為 LungFit PH 提供參考,事實證明,LungFit PH 在建立新帳戶時是一個很有價值的工具。

  • Further to the customer reference approach, we have partnered with Vanderbilt University Medical Center, naming them as the first luminary site for LungFit PH. Through this program, we will work alongside the Vanderbilt team to further optimize LungFit products and explore new opportunities to enhance hospital-based nitric oxide therapy.

    除了客戶參考方法之外,我們還與范德比爾特大學醫學中心合作,將其命名為 LungFit PH 的第一個傑出站點。透過該計劃,我們將與范德比爾特團隊合作,進一步優化 LungFit 產品並探索增強醫院一氧化氮治療的新機會。

  • In addition, Vanderbilt has made themselves available to better showcase the full utility of LungFit PH technology to respiratory therapists, anesthesiologists, nurses and other relevant clinicians at hospitals considering adopting our cylinder-free nitric oxide delivery system. This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation in respiratory care.

    此外,范德比爾特大學也致力於向考慮採用我們的無氣瓶一氧化氮輸送系統的醫院的呼吸治療師、麻醉師、護理師和其他相關臨床醫生更好地展示 LungFit PH 技術的全部實用性。此次合作標誌著我們的核心使命——重新定義無罐一氧化氮輸送和推動呼吸護理領域的持續創新——的一個重要里程碑。

  • Now, I would like to update you on the status of LungFit PH II, our next-generation system. As announced yesterday, we have submitted a PMA supplement to FDA. LungFit PH II is smaller, lighter and designed for air and ground transportation while still delivering all the revolutionary features of the current FDA-approved system. Additional improvements include a more intuitive user interface, more functional backup system, adjustable volume and significantly less frequent maintenance.

    現在,我想向您介紹我們的下一代系統 LungFit PH II 的現狀。正如昨天宣布的那樣,我們已經向 FDA 提交了 PMA 補充文件。LungFit PH II 更小、更輕,專為空中和地面運輸而設計,同時仍具有當前 FDA 批准的系統的所有革命性功能。其他改進包括更直觀的用戶介面、功能更強大的備份系統、可調節的音量以及明顯更少的維護頻率。

  • All of these improvements were made with extensive input from our customers. We anticipate that the anticipated FDA approval of the second-generation system and subsequent introduction to the US market will have a major impact on our market share, total NO volume and logistics within the hospital.

    所有這些改進都是在我們廣泛聽取客戶意見的基礎上做出的。我們預計,FDA 批准第二代系統並隨後將其引入美國市場將對我們的市場份額、NO總量和醫院內的物流產生重大影響。

  • Looking outside the US, over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia and the Middle East. These activities have included securing key regulatory approvals, including CE Mark as well as signing distribution agreements across more than 2 dozen countries covering over 2 billion lives. Today, we announced that the team has recently signed several new international distribution partnerships for the following countries: India, Italy, Latvia, Lithuania, Estonia, Ukraine, Kuwait, Kazakhstan, Israel and Poland.

    放眼美國以外,在過去六個月中,我們迅速擴大了在歐洲、東南亞和中東的商業計劃。這些活動包括獲得 CE 標誌等關鍵監管部門的批准,以及簽署涵蓋 20 多個國家、覆蓋 20 多億人口的分銷協議。今天,我們宣布,團隊最近與以下國家簽署了幾項新的國際分銷合作夥伴關係:印度、義大利、拉脫維亞、立陶宛、愛沙尼亞、烏克蘭、科威特、哈薩克、以色列和波蘭。

  • As a reminder, because the LungFit system generates NO for room air, unlike other systems that require NO-filled cylinders, we are opening an enormous new opportunity in geographical areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to the logistical difficulties associated with cumbersome cylinder-based systems.

    提醒一下,由於 LungFit 系統為室內空氣產生 NO,與其他需要充滿 NO 的氣瓶的系統不同,我們在世界各地的地理區域開闢了巨大的新機遇,這些區域的醫院無法獲得一氧化氮供應或不使用一氧化氮,因為與笨重的基於氣瓶的系統相關的後勤困難。

  • I am pleased to report that we have already shipped more than a dozen units of LungFit PH to customers outside the US over the course of just the past few weeks. As a result, we plan to see a meaningful contribution from these activities reflected in our financial results starting in the back half of fiscal 2026 and beyond.

    我很高興地報告,在過去幾週內,我們已經向美國以外的客戶運送了十幾台 LungFit PH。因此,我們計劃從 2026 財年下半年開始,看到這些活動對我們的財務表現有有意義的貢獻。

  • Turning to Beyond Cancer, as previously reported, they received regulatory approval in Israel to begin a Phase Ib trial for a low-volume UNO or ultra-high concentration nitric oxide in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy. This remains an area of high unmet patient need. Timing for the initiation of this study is under review.

    談到 Beyond Cancer,正如先前報導的那樣,他們已獲得以色列監管部門的批准,開始對低容量 UNO 或超高濃度一氧化氮與抗 PD-1 療法聯合治療抗 PD-1 療法失敗的晚期癌症患者進行 Ib 期試驗。這仍然是患者需求尚未被滿足的領域。這項研究的啟動時間正在審查中。

  • On to NeuroNOS, our subsidiary focused on therapies for autism special disorders, we are pleased to announce recently that the US FDA granted Orphan Drug Designation to our lead investigational therapy, BA-102, which is being developed for the treatment of Phelan-McDermid syndrome, a syndrome associated with autism spectrum disorder.

    我們的子公司 NeuroNOS 專注於治療自閉症特殊障礙,我們很高興最近宣布,美國 FDA 授予我們的主要研究療法 BA-102 孤兒藥稱號,該療法正在開髮用於治療 Phelan-McDermid 綜合徵,這是一種與自閉症譜系障礙相關的綜合徵。

  • As many of you are aware, this designation provides key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees and access to FDA protocol assistance. NeuroNOS will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar 2026.

    眾所周知,這項頭銜提供了關鍵的發展激勵措施,包括批准後七年的市場獨佔權、合格臨床試驗的稅收抵免、免除 FDA 申請費以及獲得 FDA 協議援助。NeuroNOS 將於今年稍晚與 FDA 會面,了解人體研究的進展,我們預計人體研究將於 2026 年底開始。

  • The excitement around our autism program goes beyond our walls. This is evident by our ability to recruit leaders in the field to our Scientific Advisory Board. Just recently, we announced the appointment of Nobel Prize laureate, Professor Dan Shefman to the NeuroNOS SAB. We believe bringing in Professor Shefman to join Professor Roger from Stanford University on this board brings unparalleled scientific expertise to the NeuroNOS team.

    我們對自閉症計畫的熱情超越了我們的想像。我們有能力招募該領域的領導者加入我們的科學顧問委員會,這證明了這一點。就在最近,我們宣布任命諾貝爾獎得主丹·謝夫曼教授為 NeuroNOS SAB 成員。我們相信,引入謝夫曼教授與史丹佛大學的羅傑教授一起加入委員會將為 NeuroNOS 團隊帶來無與倫比的科學專業知識。

  • During the March quarter, NeuroNOS published a peer-reviewed journal article in Translational Psychiatry, which presented breakthrough research by its Chief Scientific Officer, Professor which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease. These new preclinical data further underscore the consistency and power of NeuroNOS's platform and offers new hope for the development of effective therapies for this devastating condition.

    在三月季度,NeuroNOS 在《轉化精神病學》雜誌上發表了一篇同行評審的期刊文章,該文章介紹了其首席科學官、教授的突破性研究,該研究提供了令人信服的證據,證明了阿茲海默症早期階段的一種新機制。這些新的臨床前數據進一步強調了 NeuroNOS 平台的一致性和強大功能,並為開發針對這種毀滅性疾病的有效療法帶來了新的希望。

  • Building on the excitement around the data and progress of its programs, NeuroNOS announced at the end of March that it completed a $2 million equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of NeuroNOS's small molecule drug designed as an injectable or oral treatment for children with autism.

    基於對其專案數據和進展的興奮,NeuroNOS 於 3 月底宣布,作為更大規模融資的一部分,它已從私人投資者那裡完成了 200 萬美元的股權融資。這項投資將加速 NeuroNOS 小分子藥物的臨床前開發,該藥物旨在作為自閉症兒童的注射或口服治療。

  • Turning to the corporate side. We're excited to announce today the appointment of Bob Goodman to our Board of Directors effective June 13, 2025. Bob is a seasoned healthcare executive and Board Director, who brings decades of commercial leadership experience from across the medical technology, pharmaceutical services and medical device industries. His career has included executive roles at BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher and Pfizer. Our Board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business.

    轉向公司方面。我們今天很高興地宣布,任命鮑勃古德曼 (Bob Goodman) 為我們董事會成員,該任命將於 2025 年 6 月 13 日起生效。鮑伯是一位經驗豐富的醫療保健高階主管和董事會董事,擁有數十年醫療技術、製藥服務和醫療器材行業的商業領導經驗。他的職業生涯包括在 BioTelemetry、飛利浦醫療保健、Cardiocore、賽默飛世爾和輝瑞擔任高階主管。我們的董事會和管理團隊期待與鮑伯合作,繼續在我們業務的商業方面營造積極的勢頭。

  • Before I conclude my comments today, I want to mention that our LungFit GO program is still moving along. We are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections. We plan to meet with FDA prior to year-end to discuss the clinical path forward.

    在我結束今天的評論之前,我想提一下,我們的 LungFit GO 計劃仍在進行中。我們致力於將這種療法推向市場,以改善肺部感染患者的生活。我們計劃在年底之前與 FDA 會面,討論未來的臨床進展。

  • We continue to make significant progress in executing against the strategies for each of our businesses. The past year showed just a glimpse of how LungFit PH will transform the global NO landscape for the better and give us a solid foundation from which to continue to build. Beyond Air team will continue to be diligent on its path to profitability and improving the lives of patients in need of the benefits of nitric oxide.

    我們在執行每項業務的策略方面繼續取得重大進展。過去的一年只是 LungFit PH 如何改善全球一氧化氮格局並為我們繼續建立奠定堅實基礎的一瞥。Beyond Air 團隊將繼續努力實現盈利,並改善需要一氧化氮益處的患者的生活。

  • 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 Doug Larson。

  • Douglas Larson - Chief Financial Officer

    Douglas Larson - Chief Financial Officer

  • Thanks, Steve, and good afternoon, everyone. Our financial results for the fourth quarter fiscal year 2025, which ended March 31, 2025, are as follows. Revenue for the fiscal year ended March 31, 2025, increased 220% to $3.7 million compared with $1.2 million for the fiscal year ended March 31, 2024. We're showing $1.7 million loss in gross profit for the fiscal year 2025 compared to $1.3 million for fiscal year 2024. Cost of revenue of $5.4 million were recognized in the fiscal year compared to $2.5 million in the fiscal year ended March 31, 2024. Cost of revenue exceeded revenue, primarily driven by the depreciation of LungFit devices and onetime upgrade costs to systems.

    謝謝,史蒂夫,大家下午好。截至 2025 年 3 月 31 日的 2025 財年第四季財務表現如下。截至 2025 年 3 月 31 日的財政年度的收入為 370 萬美元,而截至 2024 年 3 月 31 日的財政年度的收入為 120 萬美元,增長了 220%。我們預計 2025 財年的毛利損失為 170 萬美元,而 2024 財年的毛利損失為 130 萬美元。本財政年度確認的收入成本為 540 萬美元,而截至 2024 年 3 月 31 日的財政年度的收入成本為 250 萬美元。收入成本超過了收入,主要原因是 LungFit 設備的折舊和系統的一次性升級成本。

  • Research and development expenses were $16.9 million for fiscal year 2025 compared with $24.4 million for fiscal year ended March 31, 2024. The decrease of $7.5 million was primarily attributed to a decrease in salaries, stock-based compensation and, to a lesser extent, from clinical and preclinical study expenses.

    2025 財年的研發費用為 1,690 萬美元,而截至 2024 年 3 月 31 日的財年的研發費用為 2,440 萬美元。750 萬美元的減少主要歸因於薪資、股票薪資的減少,以及臨床和臨床前研究費用的減少(較小程度)。

  • SG&A expenses for the year ended March 31, 2025 and March 31, 2024, were $26 million and $37.3 million, respectively. The decrease of $11.3 million was attributed primarily to a reduction in salaries and stock-based compensation costs.

    截至 2025 年 3 月 31 日及 2024 年 3 月 31 日止年度的銷售、一般及行政費用分別為 2,600 萬美元及 3,730 萬美元。1,130 萬美元的減少主要歸因於工資和股票薪酬成本的減少。

  • Other expense was $3.9 million compared to $1.3 million a year ago. The increase in other expense of $2.6 million was mainly due to a noncash loss recorded upon the retirement of Avenue Capital debt. Net loss attributed to common stockholders of Beyond Air Inc was $46.6 million or a loss of $0.69 per share, basic and diluted. Our net loss for the fiscal year ended March 31, 2024, was $60.2 million or a loss of $1.82 per share, basic and diluted.

    其他支出為 390 萬美元,而去年同期為 130 萬美元。其他費用增加 260 萬美元,主要是由於 Avenue Capital 債務償還時所記錄的非現金損失。Beyond Air Inc 普通股股東的淨虧損為 4,660 萬美元,即每股虧損 0.69 美元(基本虧損和稀釋虧損)。截至 2024 年 3 月 31 日的財政年度,我們的淨虧損為 6,020 萬美元,即每股虧損 1.82 美元(基本虧損和稀釋虧損)。

  • Net cash burn for the year was $44.1 million, which is more than 28% lower than previous year. We've talked in previous quarters how we've been laser focused on fixed cost reduction in R&D and in our supply chain. Now that we're wrapping up spend on development of our next-generation LungFit device, we'll see further reduction in our cash burn in Q1 and again in Q2.

    全年淨現金消耗為 4,410 萬美元,比前一年下降 28% 以上。我們在前幾季討論如何專注於降低研發和供應鏈中的固定成本。現在,我們正在完成下一代 LungFit 設備的開發支出,我們將看到第一季和第二季的現金消耗進一步減少。

  • I would like to take a moment and expand a bit on our cost reduction efforts. Over the past 6 quarters, we've reduced operating expenses from north of $17 million to just above $7 million in the fourth quarter. This translates to a 58% reduction. We believe the trough in our operating expenses will either be in the coming June quarter or the September quarter.

    我想花一點時間來詳細闡述我們的成本削減措施。在過去的六個季度中,我們已將營運費用從 1,700 萬美元以上削減至第四季的 700 萬美元以上。這意味著減少了 58%。我們相信,我們的營運費用的低谷將出現在即將到來的六月季度或九月季度。

  • Please do not interpret that expenses will be moving up significantly in the December quarter. Expenses will move up in proportion to our commercial performance to maintain our excellence in service and take advantage of coming opportunities. As of March 31, 2025, the company had cash, cash equivalents and marketable securities of $6.9 million. Please note, this does not include the $1 million payment we received from Getz Healthcare nor the additional $2 million investment into our existing synthetic royalty debt structure, both of which we received after March 31, 2025.

    請不要將其解讀為 12 月季度的支出將大幅增加。費用將隨著我們的商業表現而增加,以保持我們卓越的服務並利用未來的機會。截至 2025 年 3 月 31 日,該公司擁有現金、現金等價物和有價證券為 690 萬美元。請注意,這不包括我們從 Getz Healthcare 收到的 100 萬美元付款,也不包括我們現有的合成特許權使用費債務結構的額外 200 萬美元投資,這兩項都是我們在 2025 年 3 月 31 日之後收到的。

  • We believe our cash, cash equivalents, marketable securities and existing financing vehicles will be sufficient to allow us to support our current operating plans well into calendar 2026 and potentially, profitability, provided we continue to hit internal revenue estimates and control costs at Beyond Air.

    我們相信,只要我們繼續達到 Beyond Air 的內部收入預期並控製成本,我們的現金、現金等價物、有價證券和現有融資工具將足以讓我們在 2026 年之前很好地支持我們目前的營運計劃,並有可能實現盈利。

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

    說完這些,我就把電話轉回給史蒂夫。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Thanks, Doug. We'll now take some questions. Operator?

    謝謝,道格。我們現在來回答一些問題。操作員?

  • Operator

    Operator

  • (Operator Instructions) Marie Thibault, BTIG.

    (操作員指示)Marie Thibault,BTIG。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Congrats on the progress here. I wanted to ask my first question here about LungFit 2.0. Great to see that get in. Wanted to understand if that system approval is being assumed in the fiscal year '26 guidance range that you've given us. And how we should think about the selling dynamics ahead of that potential approval? Is that something where hospitals see that coming approval and say, hey, I want to get exposure to LungFit before that comes out? Is it they wait a little bit as they're waiting for that next-gen system? Help us think about some of those dynamics.

    恭喜你在這裡的進展。我想在這裡問第一個關於 LungFit 2.0 的問題。很高興看到你來。想了解該系統批准是否在您向我們提供的 26 財年指導範圍內。在獲得批准之前,我們應該如何看待銷售動態?是不是醫院看到即將獲得的批准後會說,嘿,我想在 LungFit 上市之前先了解一下它?他們是不是在等待下一代系統?幫助我們思考其中的一些動態。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Thanks, Marie. Fiscal '26 guidance does not include the second-generation system at all. And to answer your other question, we don't promote the Gen 2, obviously, until we get approval, so people know it exists, obviously, and they do inquire. But I think it's -- the focus is on Gen 1. That's what we're promoting now and that's what we're marketing and pushing. And yeah, I mean, obviously, there are some hospitals that are interested in getting exposure to Gen 1 immediately. And then there are others who will choose to wait. So we've seen both at this point.

    謝謝,瑪麗。26財年指導意見根本不包括第二代系統。回答您的另一個問題,顯然,在獲得批准之前,我們不會推廣 Gen 2,所以人們顯然知道它的存在,並且他們會詢問。但我認為重點是第一代。這就是我們現在所推廣的,也是我們正在行銷和推動的。是的,我的意思是,顯然有些醫院有興趣立即接觸 Gen 1。還有一些人會選擇等待。我們現在看到了這兩種情況。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Okay. Very encouraging. Very helpful, Steve. Wanted to ask also about OUS. You've gotten several shipments out there, it sounds like, of units. What are we understanding about what some of those contracts look like? Is there any difference in how hospitals use this versus how they use it within US hospitals? Any trends or specific countries we should be looking towards or any other catalyst OUS? Just want to get a little closer to that market.

    好的。非常令人鼓舞。非常有幫助,史蒂夫。也想問一下有關 OUS 的問題。聽起來你已經收到幾批貨了。我們對其中一些合約有何理解?醫院的使用方式與美國醫院內部的使用方式有什麼不同嗎?我們應該關注哪些趨勢或特定國家,或其他催化劑 OUS?只是想離那個市場更近一點。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yeah. I think it's a little early for us to see any trends in actual hospitals outside the US. Right now, our shipments are initial shipments to distributors, and they're taking those and using them for demonstration to get interest to have hospital placements. And there's much more of a tender process outside the United States than in the US, so it takes a little bit longer to get into the hospitals.

    是的。我認為現在就看到美國以外實際醫院的趨勢還為時過早。目前,我們的貨物是首次發給分銷商,他們正在使用這些貨物進行演示,以引起醫院安置的興趣。而且美國以外的地區的招標過程比美國國內要複雜得多,因此進入醫院需要更長的時間。

  • So I think the back half of this fiscal year, we'll see a big upswing on the international side as we get hospital placements and we'll get some trends at that point. But our initial work in the market outside the US is showing consistency in terms of how they use nitric oxide. Outside the US, cardiac surgery is on label so they're definitely using it in that area. But again, it's similar to how it's used in the United States.

    因此,我認為在本財年的後半年,隨著我們獲得醫院安置,我們將看到國際方面的大幅上升,屆時我們將看到一些趨勢。但我們在美國以外市場的初步工作表明,他們在使用一氧化氮方面保持一致。在美國以外,心臟手術是可以接受的,所以他們肯定會在該地區使用它。但同樣,它與美國的使用方式類似。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Okay. Very helpful update.

    好的。非常有用的更新。

  • Operator

    Operator

  • Jason Wittes, ROTH Capital.

    羅仕資本(ROTH Capital)的 Jason Wittes。

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • Congrats on the progress here. On the PMA submission, do you have an expected time line for when we may see an approval for LungFit PH II?

    恭喜你在這裡的進展。關於 PMA 提交,您是否有預計何時可以看到 LungFit PH II 獲得批准的時間表?

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Jason, did you ask me when FDA is going to approve it?

    傑森,你問過我 FDA 什麼時候批准它嗎?

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • I just -- do you have an estimate is what I'm asking. And I guess I'd add to that, how should we think about a potential launch? I think you had indicated earlier that it's kind of a staged launch versus an immediate bolus type hit. I'm just curious about the dynamics around what we might expect when the FDA approves this device.

    我只是──我問的是,你有一個估計嗎?我想補充一點,我們應該如何考慮潛在的發布?我認為您之前已經指出過,這是一種分階段發射,而不是立即進行推注式打擊。我只是好奇當 FDA 批准該設備時我們可能會期待什麼動態。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Okay. So yeah, I'm going to stay away from the exact timing on an FDA approval. Everybody kind of knows what's going on at FDA right now. There's a little bit of an upheaval, so let's just kind of let things settle in. It will take a few months for us to interact with FDA and get a better understanding of their questions on our application. And perhaps I can give some more on timelines or better guidance on timing at that moment in time.

    好的。所以是的,我將避免關注 FDA 批准的具體時間。每個人都知道現在 FDA 正在發生什麼。發生了一些小動亂,所以我們就讓事情平息下來吧。我們需要幾個月的時間與 FDA 互動,以更好地了解他們對我們的申請的問題。也許我可以提供更多關於時間表的信息,或者在當時提供更好的時間指導。

  • But as for the launch for Gen 2, obviously, we're going to prep for that as we work with FDA. There's always a period where you need to build up inventory and you need to scale up your manufacturing. So it will take a couple of months, and then we will try to keep up with demand. That will probably be the challenge that we have post approval.

    但至於 Gen 2 的推出,顯然我們將與 FDA 合作做好準備。總有那麼一個時期,你需要增加庫存,擴大生產規模。所以這將需要幾個月的時間,然後我們會盡力滿足需求。這可能是我們在獲得批准後面臨的挑戰。

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • Okay. Totally appropriate answer, I get it. And then appreciate the guidance, which looks quite strong. We're at the low end. There's a big range there. I mean, what has to happen to get to the higher end of that range for the $12 million to $16 million that you're kind of hinting or pointing to for 2026?

    好的。完全恰當的答案,我明白了。然後感謝指導,它看起來很強大。我們處於低端。那裡的範圍很大。我的意思是,要達到您所暗示或指出的 2026 年 1200 萬美元至 1600 萬美元的較高水平,需要做些什麼呢?

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yeah. It's not really that big of a range. I mean, $4 million range. I guess it seems that way because it's a small $12 million to $16 million, it's not [100% to 104%] --

    是的。範圍其實並沒有那麼大。我的意思是,400萬美元左右。我想看起來是這樣,因為這只是 1200 萬到 1600 萬美元的小數目,但事實並非如此[100% 至 104%] --

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • Percentage wise, certainly, but right, go ahead.

    從百分比來看,確實如此,但正確,繼續吧。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • But I mean, you can get a couple of contracts that are a good size, and it can move you a few million dollars. We can get some approvals -- regulatory approvals overseas for some big countries and get some big orders in. So to us, it's not that big of a range because things can swing dramatically with some of the things that we have going on in the pipeline.

    但我的意思是,你可以獲得幾份規模很大的合同,這可以為你帶來幾百萬美元的收入。我們可以獲得一些批准——一些大國的海外監管部門的批准,並獲得一些大訂單。所以對我們來說,範圍並不是很大,因為隨著我們正在進行的一些事情,事情可能會發生巨大的變化。

  • So that's kind of how we view it. We look at it as we feel pretty comfortable getting to the low end of that. There are a couple of things in the works that could get us into the mid upper range of that. And if anything changes, we'll update you. I mean, I know the next call we have is in early August so there might not be any kind of change at that point. But certainly, by November, we'll have a good idea of how we're looking for getting into the range or perhaps maybe we get lucky. Maybe it will be at the high end or higher. We just don't know at this point. There's too many moving parts, and it's only June. So it's exciting for us.

    這就是我們的看法。我們對此感到很舒服,因為我們可以達到這個最低水平。正在進行的一些工作可以讓我們進入這個範圍的中高端。如果有任何變化,我們會及時通知您。我的意思是,我知道我們下一次通話是在八月初,所以到那時可能不會有任何變化。但可以肯定的是,到十一月,我們會對如何進入這個範圍有一個很好的想法,或者也許我們會很幸運。也許它會處於高端或更高。目前我們還不知道。有太多活動部件,而且現在才六月。這對我們來說是令人興奮的。

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • Got it. That's helpful. And then maybe just another clarification on -- did I hear correctly, so basically on the expense line, there'll be further reductions until expected through September and then you basically grow with revenues on the expense line? Is that the right way to think about modeling the P&L?

    知道了。這很有幫助。然後也許只是另一個澄清 - 我是否理解正確,所以基本上在費用線上,預計到 9 月份還會進一步減少,然後費用線上的收入基本上會增長?這是思考損益模型的正確方法嗎?

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yes, exactly.

    是的,確實如此。

  • Jason Wittes - Analyst

    Jason Wittes - Analyst

  • Okay. That's all I got. Congrats on the PMA submission.

    好的。這就是我所得到的全部。恭喜您提交 PMA。

  • Operator

    Operator

  • Justin Walsh, JonesTrading.

    賈斯汀·沃爾什(Justin Walsh),JonesTrading。

  • Justin Walsh - Analyst

    Justin Walsh - Analyst

  • Now you guys are supplying globally, I was wondering, I guess, the degree to which you're seeing impacts or worried about impacts from some of the emerging geopolitical questions. I mean, we have a moving target with US tariffs, and you mentioned that you're supplying to Ukraine and, of course, you have ties in Israel. So just curious how all of that is impacting things or not.

    現在你們正在向全球供應產品,我想知道,你們在多大程度上看到了一些新出現的地緣政治問題的影響或擔心這些問題的影響。我的意思是,我們對美國關稅的目標不斷變化,你提到你正在向烏克蘭供貨,當然,你與以色列也有聯繫。所以只是好奇這一切是否會產生影響。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • I don't think it's impacting us that much. I mean, we manufacture in the United States for LungFit, so the vast majority of our costs are in the US. We do source some parts from outside the US, but it's not a major impact if those tariffs and some of the big ones are going to stay in place. It's a low single-digit percentage impact on our cost of goods, so it's not a major impact on us.

    我認為這對我們的影響並不大。我的意思是,我們在美國為 LungFit 製造產品,所以我們的絕大部分成本都在美國。我們確實從美國以外採購一些零件,但如果這些關稅和一些高關稅繼續存在,就不會造成重大影響。這對我們的商品成本的影響只是一個低個位數百分比,所以對我們來說影響不大。

  • And on the reverse side, we haven't really seen anything about where we're shipping to in terms of tax on the other end at this point. And as for Israel and Ukraine, I mean, honestly, it wasn't -- Israel is great to be in. It's not a large country but it will impact our ex US sales. We're very happy to be there. But I don't think it's a major driver like France or Turkey or Australia, India. These are much bigger countries where we are.

    另一方面,目前我們還沒有真正看到有關我們運送到哪裡的另一端的稅收的任何資訊。至於以色列和烏克蘭,我的意思是,說實話,以色列不是一個好國家。雖然這個國家並不大,但它會影響我們在美國以外的銷售。我們很高興能來到這裡。但我不認為它像法國、土耳其、澳洲、印度那樣成為主要推動力。這些國家比我們所在的國家大得多。

  • And to be honest, we were very surprised and happy that the distributor that we're working with in Eastern Europe had Ukraine on their list. So we're very excited to be able to help the distributor there going to Ukraine, but we didn't -- that wouldn't have any expectations for. So that's just upside.

    說實話,我們非常驚訝和高興,我們在東歐合作的經銷商將烏克蘭列入了他們的名單。因此,我們很高興能夠幫助那裡的經銷商前往烏克蘭,但我們對此沒有任何期望。所以這只是好處而已。

  • Justin Walsh - Analyst

    Justin Walsh - Analyst

  • Great. And maybe just a follow-up on that. I'm curious if you're seeing more uptake in some of those geographies or where you think some of the markets might be a little bigger. I mean, obviously, you just mentioned a couple of them, but I'm wondering if you're, I don't know, really, I think you'll take off in India or somewhere in particular.

    偉大的。也許只是對此進行跟進。我很好奇,您是否看到其中一些地區的成長勢頭更強勁,或者您認為哪些地區的市場規模可能更大一些。我的意思是,顯然,你剛才提到了其中幾個,但我想知道你是否,我不知道,真的,我認為你會在印度或某個特定的地方起飛。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yeah. I mean, it depends. Like they're all different in terms of regulatory timing. So India, we have a partner but there's a regulatory process to go through. So the impact from India on this fiscal year will be minimal. And some of the other countries where -- like Australia, Thailand, France, Romania, Turkey, these places, the regulatory process is already done or a very short time. So we'll get some more impact from them.

    是的。我的意思是,這得看情況。就像它們在監管時間方面都是不同的。因此,我們在印度有一個合作夥伴,但還需要經過監管程序。因此印度對本財年的影響將微乎其微。而其他一些國家,如澳洲、泰國、法國、羅馬尼亞、土耳其,這些地方的監管過程已經完成或在很短的時間內完成。因此我們會從他們那裡獲得更多的影響。

  • But it's like I said earlier, on an earlier question, it's a little too early because there are tender processes in a lot of these countries, so it takes time to get in to some hospitals. So we're going to wait in the next three, four, five months to see how those go and how many we get and how quickly we get in. And every country is different, so this is new for us as a company. And new for this product, even our international team who has experience with this.

    但就像我之前在回答之前的問題時所說的那樣,現在還為時過早,因為許多國家都有招標程序,因此進入一些醫院需要時間。因此,我們將等待接下來的三、四、五個月,看看進展如何、我們能得到多少以及我們能多快進入。每個國家的情況都不同,所以這對我們公司來說是一個新鮮事。對於這款產品來說,即使是我們的國際團隊也對此產品有經驗。

  • This is a new product, right? I mean, no one's ever seen a noncylinder-based nitric oxide system outside the United States before and certainly not one that makes it from ambient air. So this is kind of new for everybody. And we have some distributors are extremely excited, jumped at the opportunity and it was a very quick process to sign them up.

    這是新產品吧?我的意思是,以前從來沒有人在美國以外見過非基於氣瓶的一氧化氮系統,當然也沒有人見過利用環境空氣製造的一氧化氮系統。所以這對每個人來說都是一種新鮮事。我們的一些分銷商非常興奮,抓住了這個機會,並且簽約過程非常快。

  • And others are a little kind of more skeptical, I think, because they can't believe what the machine does. So I think we're just in the early stages, and it's exciting. And I'll probably have a better idea maybe on the next call or the call after that of where we're going to move quickly and which country is going to move fastest. But right now, it's just kind of feeling it out, and we're excited to have this many partners in this many countries open to us at this moment in time.

    我認為其他人有點懷疑,因為他們不敢相信機器的功能。所以我認為我們還處於早期階段,這很令人興奮。也許在下次電話會議或再下次電話會議中,我會對哪裡的進展速度更快、哪個國家的進展速度最快有更好的想法。但現在,我們還只是在摸索,我們很高興此時此刻有這麼多國家的這麼多合作夥伴向我們開放。

  • Operator

    Operator

  • Yale Jen, Laidlaw & Company.

    耶魯仁萊德勞公司。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Congrats on the guidance as well as the performance. We just got about three here. The first one is that you suggested you will have more than $1.7 million for the next quarter or the current ongoing quarter actually and $12 million to $16 million for the fiscal '26. So what's the confidence you can provide that behind these forecasts or projections? And I have a follow-up.

    恭喜您的指導和表現。我們這裡剛好有三隻。第一個問題是,您建議下一季或當季的實際收入將超過 170 萬美元,而 26 財年的營收將達到 1,200 萬至 1,600 萬美元。那麼,您對這些預測或預期有何信心?我還有一個後續問題。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Thanks, Yale. I mean, we're pretty confident. We wouldn't have put it out if we weren't. I think the fact that the June quarter ends in two weeks, we're pretty confident it will be $1.7 million. There could be something that happens in the next two weeks to pump it up a bit. We can't really predict that, but we're highly confident in that number.

    謝謝,耶魯。我的意思是,我們非常有信心。如果我們不這樣做,我們就不會把它拿出來。我認為,由於六月季度還有兩週就結束,我們非常有信心這個數字將達到 170 萬美元。未來兩週可能會發生一些事情,讓情況稍微好轉。我們無法真正預測這一點,但我們對這個數字非常有信心。

  • And as for the fiscal year, we're pretty confident. I mean, we've got a lot in the hopper here especially on the international side. Even in the US, there's movement in some areas that we're excited to see and maybe happening a little bit sooner than we thought.

    至於財政年度,我們非常有信心。我的意思是,我們這裡有很多機會,特別是在國際方面。即使在美國,我們也很高興看到一些領域出現了一些變化,而且這些變化可能比我們想像的要快一些。

  • So I'll give you an example. We're very flexible with customers in how they want to structure their contracts. It's very easy with our system to be as flexible as they would like us to be. But one of the things we started offering earlier this year is the razor-razor blade model, so the purchase of our system and then the ongoing purchase of the consumables, which is mainly the filter. And we've gotten some good feedback over the last month or twi on that model.

    我給你舉個例子。我們對客戶如何制定合約結構非常靈活。我們的系統可以輕鬆實現他們所希望的靈活性。但我們今年稍早開始提供的產品之一是剃刀刀片模型,因此需要購買我們的系統,然後持續購買消耗品,主要是過濾器。在過去的一個或兩個月裡,我們收到了一些關於該模型的良好回饋。

  • So we may actually see some hospitals jumping at the opportunity for that rather than the more traditional nitric oxide model, which is how many hours do you use X amount? This is what your annual cost could be divided by 12 and you get paid that per month. That's really the main way it's done, but we're offering this other way of doing it with the purchase model. And we may see some of that in this fiscal year and that's exciting. And that gives us some confidence in our numbers because it wasn't something we were seeing six to nine months ago at all.

    因此,我們實際上可能會看到一些醫院抓住這個機會,而不是更傳統的一氧化氮模型,即您使用 X 量多少小時?將您的年度成本除以 12,然後您將每月獲得該金額的報酬。這確實是主要的實現方式,但我們提供了另一種方式,即購買模式。我們可能會在本財年看到一些這樣的情況,這是令人興奮的。這讓我們對數據更有信心,因為六到九個月前我們根本沒有看到這種情況。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great. That's very helpful and comforting. And also in the press release, you mentioned you have about 45 hospitals in the United States now either installed or actually as well as using the LungFit systems. So going towards, let's say, end of this year, fiscal year or maybe or calendar years of this -- end of this year, do you anticipate -- what might be the estimate or projection of the number of hospitals that you may have as well as maybe whether you would also see the volume increase per hospital?

    好的,太好了。這非常有幫助並且令人欣慰。另外,在新聞稿中,您提到目前美國大約有 45 家醫院安裝或正在使用 LungFit 系統。那麼,假設到今年年底、財政年度年底或日曆年年底,您預計到今年年底,您所在地區的醫院數量估計或預測是多少,以及每家醫院的數量是否也會增加?

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • I definitely see the volume increasing per hospital. We've been seeing that for the past 1.5 years. A lot of our hospitals are going over what their estimate was for the year. That's a good thing. We do offer a discounted hourly rate if they go over. So certainty of price is important for the customer.

    我確實看到每家醫院的業務量都在增加。過去一年半以來我們一直看到這種情況。我們的許多醫院正在審查今年的預算。這是一件好事。如果超出的話,我們確實會提供折扣小時費率。因此,價格的確定性對客戶來說很重要。

  • So I think that may continue. Hopefully, hospitals can get -- work with us and get a better handle on what they're going to use for the year so there's certainty in what they're spending. I don't want to speculate on the number of hospitals we're going to have at the end of the fiscal year. While it's important, not every hospital is created equal, so some hospitals are small in terms of their volume, and some are very large in terms of their volume. So we get that one hospital will be worth 10 in some cases.

    所以我認為這種情況可能會持續下去。希望醫院能與我們合作,更能掌握今年的資金使用情況,從而確定他們的支出。我不想猜測財政年度結束時我們將擁有多少家醫院。雖然這很重要,但並非每家醫院都是平等的,所以有些醫院的規模很小,有些醫院的規模很大。因此,在某些情況下,一家醫院的價值將達到 10 家。

  • So obviously, 45 is a great number. I certainly see it being significantly more than that number at the end of the fiscal year. But I'm not going to take a guess and try to triangulate that exact number right now, Yale, but thank you.

    顯然,45 是一個很大的數字。我確實看到財政年度結束時的數字會大大高於這個數字。但是我現在不會去猜測並嘗試三角測量這個確切的數字,耶魯,但還是謝謝你。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great. And maybe just squeezing one more question actually is a follow-up to the earlier one that for the PMA application. I know this is difficult to predict the time for a possible approval. But just let's assume or maybe if in the, quote unquote, normal circumstances, would this process maybe take a while, 12 months to 16 months or shorter? Just curious what would be the sort of reference point we can at least think about.

    好的,太好了。也許再問一個問題實際上是對先前關於 PMA 申請的問題的後續。我知道很難預測批准的時間。但是,讓我們假設一下,或者在正常情況下,這個過程可能需要一段時間,12 個月到 16 個月或更短?只是好奇我們至少可以考慮什麼樣的參考點。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yes. So there are statistics that FDA puts out about PMAs, and this is a PMA supplement. So FDA puts statistics out about how long these things take so you can see them online. I'd just caution you to take these averages because not every PMA is created equal. We are just a supplement.

    是的。因此,FDA 發布了有關 PMA 的統計數據,這是一種 PMA 補充劑。因此,FDA 公佈了這些事情需要多長時間的統計數據,以便您可以在線上查看。我只是要提醒您採用這些平均值,因為並非每個 PMA 都是平等的。我們只是補充。

  • We basically make nitric oxide the same way with our second-generation system as our first-generation system. A lot of the things that are equivalent, it's obviously smaller. It obviously has some enhanced features and it obviously is built to use for transport in ambulances and helicopters and airplanes. So there are some differences but from how it operates, it's really not that much different. So could we be quicker than the average that FDA puts out?

    我們第二代系統製造一氧化氮的方式與第一代系統基本相同。很多同等的東西,它明顯要小一些。它顯然具有一些增強的功能,而且顯然是為救護車、直升機和飛機運輸而設計的。因此存在一些差異,但從其運作方式來看,實際上並沒有太大的差異。那我們能比 FDA 公佈的平均速度更快嗎?

  • Probably. But again, if you look at FDA's guidelines, 180 days for a PMA supplement, and they normally do not hit the 180 days. And it's not that they can't hit their time lines. A lot of times, they have questions and that clock will stop while you're having discussions with FDA. So that's something that companies don't control. FDA does, and we're going to work with them to get this done as quickly as possible. But I just don't know what that time line will be at this point. We'll have a better handle once we start discussions with FDA in the next couple of months.

    大概。但是,如果你再看一下 FDA 的指導方針,PMA 補充劑的有效期為 180 天,而他們通常不會達到 180 天。這並不是說他們無法準時完成任務。很多時候,他們有疑問,當你與 FDA 討論時,時鐘就會停止。所以這是公司無法控制的事情。FDA 會這樣做,我們將與他們合作,盡快完成此事。但我現在還不知道時間線是怎麼樣的。一旦我們在接下來的幾個月內開始與 FDA 進行討論,我們就會得到更好的處理。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Great. That's a lot of great color on the story. And again, congrats.

    偉大的。這個故事有很多精彩的色彩。再次恭喜你。

  • Operator

    Operator

  • Jason Bednar, Piper Sandler.

    傑森貝德納、派珀桑德勒。

  • Joseph Downing - Analyst

    Joseph Downing - Analyst

  • This is Joe Downing on for Jason. Congrats on the PMA submission. Just wondering if there's any difference you can call out in the sales process with the 2.0 device versus the 1.0 device. And then just off of that, can you just remind us how much this LungFit 2.0 expands the market?

    喬唐寧 (Joe Downing) 代替傑森 (Jason)。恭喜您提交 PMA。我只是想知道 2.0 設備和 1.0 設備在銷售過程中是否有任何差異。然後,您能否提醒我們 LungFit 2.0 對市場擴展了多少?

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • So Joe, thanks for the questions. I mean, we're not trying to sell this Gen 2 or market the Gen 2 right now, so we're not going to comment on how the process is different because we don't have a process yet. We have to wait for approval on that. But as for how it opens the market, I mean, it vastly expands this market. It opens it up for us as a company to every hospital in the world that wants to use nitric oxide.

    喬,謝謝你的提問。我的意思是,我們現在還沒有嘗試銷售第二代產品或推銷第二代產品,所以我們不會評論這個過程有何不同,因為我們還沒有確定流程。我們必須等待批准。但至於它如何打開市場,我的意思是,它極大地擴展了這個市場。這為我們公司向世界上每家想要使用一氧化氮的醫院開放了市場。

  • We can get it anywhere. Our Gen 1 is already in remote locations treating patients, so the Gen 2, it will be even easier to do that. So this is something that will change the way people use nitric oxide in the hospital. I think that it will increase volumes overall and, again, reach hospitals that don't use nitric right now. So this is for us, I think, and for the industry, it's a game changer. It really is.

    我們可以在任何地方得到它。我們的 Gen 1 已經在偏遠地區為患者提供治療,因此 Gen 2 將會更容易做到這一點。因此這將改變人們在醫院使用一氧化氮的方式。我認為它將增加整體用量,並再次到達目前不使用一氧化氮的醫院。所以我認為這對我們以及整個產業來說都是一個改變遊戲規則的事件。確實如此。

  • Joseph Downing - Analyst

    Joseph Downing - Analyst

  • Great. Steve, appreciate that. And then just one last one on the competitive landscape. Your largest peer put out a new offering a number of months ago. Just wondering if you're seeing anything worth calling out with contract negotiations and hospitals as a result of that launch.

    偉大的。史蒂夫,非常感謝。最後再來談談競爭格局。您最大的同行幾個月前推出了新產品。我只是想知道,在此次發布之後,您是否看到了與合約談判和醫院有關的值得關注的事情。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Which one are you talking about?

    你在談論哪一個?

  • Joseph Downing - Analyst

    Joseph Downing - Analyst

  • Mallinckrodt.

    馬林克羅德。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • The Mallinckrodt offering?

    Mallinckrodt 提供的嗎?

  • Joseph Downing - Analyst

    Joseph Downing - Analyst

  • Yeah.

    是的。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • Yeah, we haven't seen a change. I mean, the contracts are usually one, three and five years in this market. We haven't really seen any change in that. So at least my team and I haven't really seen much change. Yes, they're out there with their new offering and they're marketing it, for sure. And I think the last time they spoke, they gave an idea of how many hospitals they were in or something that they were in hospitals. So you can take a look at what their transcript said. So yeah, it's another competitor. It's another cylinder-based system out there. That's the fourth cylinder-based system in the United States.

    是的,我們沒有看到改變。我的意思是,在這個市場上,合約通常為一年、三年和五年。我們確實沒有看到任何變化。所以至少我和我的團隊並沒有看到太大的改變。是的,他們確實推出了新產品,並且正在行銷。我認為他們上次發言時已經說明了他們駐紮在多少家醫院,或者他們在幾家醫院工作。所以你可以看看他們的記錄是怎麼說的。是的,這是另一個競爭對手。這是另一種基於圓柱的系統。這是美國第四個基於圓柱的系統。

  • Operator

    Operator

  • At this time, we are showing no further questions in queue. This does conclude 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。現在我想將電話轉回給史蒂夫·利西 (Steve Lisi) 來做最後發言。

  • Steven Lisi - Chairman of the Board, Chief Executive Officer

    Steven Lisi - Chairman of the Board, Chief Executive Officer

  • I'd just like to thank everybody for joining us today, and we'll talk to you in August. Thank you.

    我只想感謝大家今天的參加,我們將在八月與大家交談。謝謝。

  • Operator

    Operator

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

    今天的會議到此結束。現在您可以斷開線路。感謝您的參與。