Hyperfine Inc (HYPR) 2025 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Hyperfine Q1 '25 earnings call. (Operator Instructions)

    感謝您的支持。我叫凱特,今天我將擔任您的會議主持人。現在,我歡迎大家參加 Hyperfine 2025 年第一季財報電話會議。(操作員指示)

  • I would now like to turn the call over to Webb Campbell, Investor Relations. Please go ahead.

    現在我想將電話轉給投資者關係部門的韋伯坎貝爾 (Webb Campbell)。請繼續。

  • Webb Campbell - Investor Relations

    Webb Campbell - Investor Relations

  • Thank you for joining today's call. Earlier today, Hyperfine, Inc., released financial results for the quarter ended March 31, 2025. A copy of the press release is available on the company's website as well as sec.gov.

    感謝您參加今天的電話會議。今天早些時候,Hyperfine, Inc. 發布了截至 2025 年 3 月 31 日的季度財務業績。新聞稿副本可在該公司網站和 sec.gov 上查閱。

  • Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or projections of future events, results or performance are forward-looking statements.

    在我們開始之前,我想提醒您,管理層將在本次電話會議中發表聲明,其中包括聯邦證券法所定義的前瞻性聲明,這些聲明是根據 1995 年《私人證券訴訟改革法案》的安全港條款作出的。本次電話會議中包含的任何與未來事件、結果或表現的預期或預測相關的陳述均為前瞻性陳述。

  • All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance, expense management; expectations for hiring, training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

    所有前瞻性陳述,包括但不限於與我們的經營趨勢和未來財務表現、費用管理有關的陳述;對招聘、培訓和採用、組織成長、市場機會、商業和國際擴張、監管批准和產品開發的期望均基於當前估計和各種假設。這些聲明涉及重大風險和不確定性,可能導致實際結果或事件與這些前瞻性聲明預期或暗示的結果或事件有重大差異。

  • Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our latest periodic filings with the Securities and Exchange Commission.

    因此,您不應過度依賴這些聲明。有關與我們的業務相關的風險和不確定性的清單和說明,請參閱我們向美國證券交易委員會提交的最新定期文件中的風險因素部分。

  • This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 13, 2025. Hyperfine disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

    本次電話會議包含時間敏感訊息,僅截至今天(2025 年 5 月 13 日)的現場直播時準確。Hyperfine 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務,除非法律要求,無論是由於新資訊、未來事件或其他原因。

  • With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

    說完這些,我將把電話轉給總裁兼執行長瑪麗亞·塞恩斯 (Maria Sainz)。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Good afternoon, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale.

    下午好,感謝您加入我們。今天與我一起通話的是我們的首席行政官兼財務長 Brett Hale。

  • In the first quarter, we delivered revenue of $2.1 million with the sale of six systems, with a strong average selling price. We also reinforced our financial profile, taking steps to meaningfully reduce cash burn by completing a reorganization, and we further strengthened our balance sheet by raising $6 million through a registered direct offering to extend our cash runway to the end of 2026.

    第一季度,我們銷售了六套系統,實現了 210 萬美元的收入,平均售價很高。我們也加強了我們的財務狀況,採取措施透過完成重組來大幅減少現金消耗,並且我們透過註冊直接發行籌集 600 萬美元以將我們的現金流延長至 2026 年底,進一步加強了我們的資產負債表。

  • In the first quarter, we experienced some headwinds to revenue associated with the new political environment, which resulted in the loss of several deals at large academic institutions that were funded by grants.

    在第一季度,我們遇到了與新的政治環境相關的一些收入阻力,導致我們失去了由撥款資助的幾個大型學術機構的交易。

  • The first half of 2025 marks the end of a time in our company's commercial trajectory where our business relies primarily on US hospital deals. As we have previously indicated, hospitals have proven to have protracted sales cycles and high variability in deal timing. We are committed and excited about Hyperfine's future with diversified revenue across the three verticals of the hospital, the office setting, and international markets, and introducing our significantly improved product performance with our next-generation image quality. We still expect this catalyst to change the growth trajectory of Hyperfine starting in the second half of this year.

    2025 年上半年標誌著我們公司商業軌蹟的結束,我們的業務主要依賴美國醫院交易。正如我們之前指出的,事實證明醫院的銷售週期較長,交易時機變化很大。我們致力於 Hyperfine 的未來,並對未來充滿期待,該公司將在醫院、辦公環境和國際市場三個垂直領域實現多元化收入,並透過下一代影像品質推出性能顯著改進的產品。我們仍預期這項催化劑將從今年下半年開始改變 Hyperfine 的成長軌跡。

  • I will now provide an update on our diversified growth catalysts coming to fruition in 2025. As we progress into the second half of 2025, our business will be a diversified portfolio with hospital, office, and international verticals providing a platform for higher growth and less variability. We have continued to make solid progress toward launch readiness for the office business. Several of the office accounts in the pilot program are now IAC-accredited, have started to scan, and are going through the reimbursement process with CMS.

    我現在將介紹我們多元化成長催化劑在 2025 年取得成果的最新情況。隨著我們進入 2025 年下半年,我們的業務將實現多元化組合,醫院、辦公室和國際垂直行業將為更高的成長和更少的波動提供平台。我們在辦公業務的啟動準備方面繼續取得堅實進展。試點計畫中的幾個辦公室帳戶現已獲得 IAC 認證,開始掃描,並正在與 CMS 進行報銷流程。

  • Neuro PMR, our office clinical study, has begun enrollment, and the two participating office sites are demonstrating strong enthusiasm for the Soup system. Neuro PMR is a multi-center prospective observational study comparing AI-powered portable MRI and conventional high-field MRI with respect to pathology findings, clinical utility, and patient experience in the neurology office setting to assess different use cases for the soup system.

    我們的辦公室臨床研究 Neuro PMR 已經開始招募,兩個參與的辦公室站點對 Soup 系統表現出了強烈的熱情。Neuro PMR 是一項多中心前瞻性觀察研究,比較了人工智慧便攜式 MRI 和傳統高場 MRI 在病理學發現、臨床實用性和神經內科辦公室環境中的患者體驗,以評估湯系統的不同用例。

  • The study is being run by two private neurology practices, the Dent Neurologic Institute and Pepsis Neurology. The study has a target enrollment of 100 patients. Enrollment is progressing very well, and I am pleased to report that the study is about halfway enrolled, and we now expect the study to conclude ahead of our previous estimate by the end of the third quarter of 2025. Additionally, in the last couple of weeks, we have conducted training for our field teams on the office market opportunity.

    這項研究由兩家私人神經病學機構——登特神經病學研究所和百事神經病學研究所負責進行。研究的目標招募人數為 100 名患者。招募工作進展順利,我很高興地報告,這項研究的招募工作已完成一半左右,我們現在預計這項研究將在 2025 年第三季末提前完成,比我們之前估計的要早。此外,在過去的幾周里,我們對現場團隊進行了有關辦公市場機會的培訓。

  • On the technology front, we continue to improve the image quality of our unique AI-powered portable MRI to drive broad clinical utility and mainstream adoption. We expect to obtain clearance for our next-generation software in the first half of the year and expect the commercial rollout in the second half of the year.

    在技​​術方面,我們不斷提高獨特的人工智慧便攜式 MRI 的影像質量,以推動廣泛的臨床實用性和主流採用。我們預計將在今年上半年獲得下一代軟體的批准,並預計在下半年實現商業推廣。

  • Meanwhile, we continue to work towards the clearance and launch of another generation of soup system technology later this year. These releases will bring a step-function improvement in image quality, approaching the quality obtained from conventional 1.5 Tesla MRI systems, as noted by several key opinion leaders involved in our development process. We believe this level of image quality will make the adoption of portable brain MRI quicker for new users, enabling a shorter learning curve and accelerating market adoption of our technology.

    同時,我們將繼續致力於在今年稍後清理和推出另一代湯系統技術。這些版本將使影像質量實現階躍式提升,接近傳統 1.5 特斯拉 MRI 系統所獲得的質量,正如參與我們開發過程的幾位關鍵意見領袖所指出的那樣。我們相信,這種影像品質等級將使新用戶更快地採用便攜式腦部 MRI,從而縮短學習曲線並加速市場對我們技術的採用。

  • Our strategy for growth is based on site of care expansion. Our focus is on building an office business, expanding to multiple sites inside the hospital, and driving adoption in international markets. The neurology office setting is an incredibly compelling opportunity for the soup system. Neurologists directly impact 100 million patient lives in the United States. They order an average of 500 to 600 MRIs annually, and only a very small fraction of the private neurology practices staff MR imaging equipment on site.

    我們的成長策略是基於護理地點的擴張。我們的重點是建立辦公業務,擴展到醫院內的多個地點,並推動國際市場的應用。神經科辦公室環境對於湯系統來說是一個極具吸引力的機會。神經科醫師直接影響美國 1 億患者的生活。他們每年平均訂購 500 至 600 張 MRI,但只有極少數私人神經科診所在現場配備 MRI 影像設備。

  • We plan to launch in the office in mid-2025. And as highlighted previously, the team has made a lot of progress towards launch readiness by initiating pilot accounts, initiating the neuro PMR study, and most recently, training the field teams.

    我們計劃於 2025 年中期在辦公室推出。正如先前強調的那樣,該團隊透過啟動試點帳戶、啟動神經 PMR 研究以及最近培訓現場團隊,在啟動準備方面取得了巨大進展。

  • Now moving to the hospital opportunity. We have continued our expansion into the emergency department as an additional call point in the hospital, given the importance of time to scan and patient progress, and supported by the clinical work we have done in stroke. MRI availability for the triage of stroke patients in the ER is very limited, and patients and clinicians often endure long waits.

    現在有了搬到醫院的機會。考慮到掃描時間和患者病情進展的重要性,並得到我們在中風方面所做臨床工作的支持,我們繼續擴展到急診科,作為醫院的額外呼叫點。急診室中用於對中風患者進行分類的 MRI 非常有限,患者和臨床醫生經常需要長時間等待。

  • Data from Action PMR shows that AI-powered portable MRI in ischemic stroke triage can help address patients quickly and provide valuable clinical insights in this highly time-sensitive environment. Action PMR evaluating the use of the Soup system for ischemic stroke patients completed enrollment at 100 patients across four leading institutions globally. Data was presented most recently at the 2025 International Stroke Conference.

    Action PMR 的數據顯示,缺血性中風分流中的人工智慧便攜式 MRI 可以幫助快速處理患者,並在這種高度時間敏感的環境中提供寶貴的臨床見解。Action PMR 評估了 Soup 系統對缺血性中風患者的治療效果,已在全球四家領先機構招募了 100 名患者。數據最近在 2025 年國際中風會議上公佈。

  • To drive expansion into DER, we plan to support additional projects to generate clinical evidence that will demonstrate the clinical workflow and economic value of the use of the Swoop system in this new site of care. Besides selling on the clinical benefits of using the Swoop system in the hospital, we have focused our team on highlighting the potential favorable economic impact of using the Swoop system.

    為了推動向 DER 的擴展,我們計劃支持其他項目來產生臨床證據,以證明在這個新的護理站點使用 Swoop 系統的臨床工作流程和經濟價值。除了宣傳在醫院使用 Swoop 系統的臨床益處之外,我們的團隊還致力於強調使用 Swoop 系統可能帶來的有利經濟影響。

  • We have compiled data from key Swoop system accounts documenting incremental conventional scans enabled by the use of the Swoop system in critical care and cost savings in care associated with the use of the Swoop system, enabling faster decision-making and discharge as appropriate. This real-world data is another valuable tool our commercial teams are now using in their accounts. I am pleased to report we have seen an increase in multiple-unit deals in the hospital setting in our pipeline, illustrating the interest across several hospital call points.

    我們從關鍵的 Swoop 系統帳戶中收集了數據,記錄了在重症監護中使用 Swoop 系統實現的增量常規掃描以及與使用 Swoop 系統相關的護理成本節省,從而能夠更快地做出決策並酌情出院。這些真實世界的數據是我們的商業團隊現在在其帳戶中使用的另一個有價值的工具。我很高興地報告,我們看到醫院環境中的多單元交易有所增加,這表明多個醫院呼叫點對此感興趣。

  • Finally, turning to our international commercialization activities. We continue to see strong interest and healthy demand in our markets across Europe, the Middle East, and Asia. I'm also pleased to share that we continue to anticipate regulatory approval and market entrants in India in the second half of the year. As I said on our last call, 2025 will be a tale of two halves, with our first-half performance based on our legacy business with a heavy mix of hospital deals.

    最後,談談我們的國際商業化活動。我們繼續看到歐洲、中東和亞洲市場對我們的濃厚興趣和健康需求。我也很高興地告訴大家,我們將繼續期待今年下半年獲得印度監管部門的批准和市場進入者。正如我在上次電話會議上所說的那樣,2025 年將分為兩個半場,我們的上半年業績基於我們的傳統業務以及大量的醫院交易。

  • The second half of 2025 will be favorably impacted by the launch of two new AI-powered technology releases with significant improvements in image quality, the launch of our office business and the adoption from existing and new international markets, including India, driving healthy growth and diversification of our revenue in the second half of 2025 and beyond. I remain confident in the opportunity in front of us and the execution and capabilities of our team.

    2025 年下半年將受到兩款新型人工智慧技術的發布以及圖像品質顯著改善、辦公業務的推出和包括印度在內的現有和新國際市場的採用的積極影響,從而推動我們 2025 年下半年及以後收入的健康增長和多樣化。我對我們面前的機會以及我們團隊的執行和能力仍然充滿信心。

  • I will now turn over the call to Brett to review our Q1 performance and provide an update to 2025 guidance.

    現在我將把電話轉給布雷特,讓他回顧我們第一季的表現並提供 2025 年指引的更新。

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • Thank you, Maria. I will recap our financial results for the first quarter of 2025 before providing an update on our financial guidance.

    謝謝你,瑪麗亞。在提供我們的財務指導更新之前,我將回顧我們 2025 年第一季的財務表現。

  • Revenue for the first quarter of 2025 was $2.1 million. In the first quarter of 2025, we sold 6 units with a strong average selling price. During the first quarter, we continued to experience longer deal timing and processes for US hospitals and the loss of several deals due to significant reductions and cancellations of grant funding to academic institutions.

    2025 年第一季的營收為 210 萬美元。2025 年第一季度,我們賣出了 6 台,平均售價很高。在第一季度,我們繼續經歷美國醫院交易時間和流程的延長,並且由於對學術機構的資助大幅減少和取消而導致多筆交易的損失。

  • Our average selling price and pipeline remain strong, but US hospital critical care deal sales cycles continue to experience variability and are longer than in past quarters. Also, during the first quarter, a majority of our United States sales personnel were newly hired. These new members of our sales teams are gaining traction with customers while training to be prepared to build awareness and visibility of our next-generation imaging technology once cleared and launched.

    我們的平均售價和管道依然強勁,但美國醫院重症監護交易的銷售週期持續變化,並且比過去幾季更長。此外,在第一季度,我們大部分的美國銷售人員都是新聘用的。我們銷售團隊的這些新成員在接受培訓的同時,也逐漸吸引了客戶,為我們的下一代成像技術一旦獲批並推出就提高其知名度和可見度做好準備。

  • Gross profit for the first quarter of 2025 was $0.9 million, and gross margin for the first quarter of 2025 was 41.3%, representing a 20-basis-point improvement versus the prior-year period. We continue to drive healthy margins at our stage, and we believe we are well-positioned for meaningful margin expansion at scale. R&D expenses for the first quarter of 2025 were $5.0 million compared to $5.6 million in the first quarter of 2024.

    2025 年第一季的毛利為 90 萬美元,2025 年第一季的毛利率為 41.3%,比去年同期提高了 20 個基點。我們將繼續在現有階段保持健康的利潤率,並相信我們已做好準備,以實現利潤率的大規模有效擴張。2025 年第一季的研發費用為 500 萬美元,而 2024 年第一季為 560 萬美元。

  • Sales, general, and administrative expenses for the first quarter of 2025 were $6.7 million compared to $6.4 million in the first quarter of 2024. Net loss for the first quarter of 2025 was $9.4 million, equating to a net loss of $0.12 per share as compared to a net loss of $9.8 million or a net loss of $0.14 per share for the same period of the prior year.

    2025 年第一季的銷售、一般和行政費用為 670 萬美元,而 2024 年第一季為 640 萬美元。2025 年第一季淨虧損為 940 萬美元,相當於每股淨虧損 0.12 美元,去年同期淨虧損為 980 萬美元,即每股淨虧損 0.14 美元。

  • Our net cash burn, including financing in the first quarter of 2025, was $4.6 million. As of March 31, 2025, we have $33.1 million in cash and cash equivalents on our balance sheet, inclusive of $6 million registered direct financing in February. For the first quarter of 2025, our net cash burn, excluding financing, was $10.1 million, down 16% from $12.0 million in 2024. The first quarter is typically our highest cash burn quarter during the year due to several annual one-time costs. Reducing cash burn remains a significant focus for us, and we will continue to prioritize spending discipline and optimize our operating leverage in 2025.

    我們的淨現金消耗(包括 2025 年第一季的融資)為 460 萬美元。截至 2025 年 3 月 31 日,我們的資產負債表上有 3,310 萬美元的現金和現金等價物,其中包括 2 月份註冊的 600 萬美元直接融資。2025 年第一季度,我們的淨現金消耗(不含融資)為 1,010 萬美元,較 2024 年的 1,200 萬美元下降 16%。由於每年有幾項一次性成本,第一季通常是我們一年中現金消耗最高的季度。減少現金消耗仍然是我們關注的重點,我們將在 2025 年繼續優先考慮支出紀律並優化我們的營運槓桿。

  • Now turning to financial guidance, beginning with our revenue outlook. For the first half of 2025, we now expect revenue to be in the range of $5 million to $6 million. Our updated expectations for the first half revenue are a result of several US deals recently lost due to cancellations of grant funding to certain academic institutions by the federal government. We believe we'll be able to more precisely forecast our second-half revenue over the coming months as our growth catalysts play out.

    現在轉向財務指導,首先從我們的收入展望開始。對於 2025 年上半年,我們預計收入將在 500 萬至 600 萬美元之間。我們更新了對上半年收入的預期,這是因為美國聯邦政府取消了對某些學術機構的資助,導致最近失去了幾筆美國交易。我們相信,隨著成長催化劑的發揮,我們將能夠在未來幾個月更準確地預測下半年的收入。

  • And for the full year, we now expect revenue growth to be in the range of 10% to 20% over 2024. For the full-year 2025, we are also updating our gross margin outlook to 47% to 50% for the year, representing a 280 basis point increase in gross margin on a year-over-year basis at the midpoint. We expect the progression of gross margin percentage increase to closely follow our sales growth, and we expect second-half gross margin percentages to exceed the first half. We remain optimistic that we will surpass 50% gross margins comfortably and sustainably as we realize higher volume driven by our growth catalysts.

    就全年而言,我們預計 2024 年的營收成長率將在 10% 至 20% 之間。對於 2025 年全年,我們還將全年毛利率預期更新為 47% 至 50%,這意味著毛利率中位數年增 280 個基點。我們預計毛利率的成長將緊跟銷售額的成長,並且我們預計下半年的毛利率將超過上半年。我們仍然樂觀地認為,隨著我們在成長催化劑的推動下實現更高的銷量,我們的毛利率將輕鬆且可持續地超過 50%。

  • Lastly, we now expect total cash burn to be in the range of $25 million to $28 million for the full-year 2025, representing a 31% decline in cash burn on a year-over-year basis at the midpoint.

    最後,我們現在預計 2025 年全年總現金消耗將在 2,500 萬美元至 2,800 萬美元之間,這意味著現金消耗在中點同比下降 31%。

  • We have taken several steps to enhance our financial profile. We completed a restructuring in the first quarter to reduce operating costs, extend cash runway, and transition our organization from a development stage to a commercial-stage company. We also bolstered our balance sheet with a $6 million financing. We will execute upon our plan with strong spending discipline while maintaining appropriate investments in our growth catalyst. We continue to see a cash runway for the business to the end of 2026.

    我們已採取多項措施來改善我們的財務狀況。我們在第一季完成了重組,以降低營運成本,延長現金流,並將我們的組織從開發階段轉變為商業階段的公司。我們也透過 600 萬美元的融資增強了我們的資產負債表。我們將嚴格控制支出,執行我們的計劃,同時對我們的成長催化劑保持適當的投資。我們預計到 2026 年底,該業務仍將擁有充足的現金流。

  • Before turning the line back to Maria, I want to briefly touch upon the topics of tariffs. We have been closely monitoring recent government commentary and actions and the potential impact on our business. Our 2025 guidance assumes that our business will not be materially impacted by tariffs.

    在把話題轉回瑪麗亞之前,我想先簡單談談關稅問題。我們一直在密切關注最近的政府評論和行動及其對我們業務的潛在影響。我們的 2025 年指引假設我們的業務不會受到關稅的重大影響。

  • Additionally, at this time, we have sufficient inventory on hand to meet current demand. We will continue to follow the situation closely and provide updates to the market as needed.

    此外,目前我們有足夠的庫存來滿足當前的需求。我們將繼續密切關注局勢,並根據需要向市場提供最新資訊。

  • I would like to now turn the call back to Maria for closing comments.

    現在我想把電話轉回給瑪麗亞,請她做最後發言。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Thank you, Brett. As we get closer to mid-2025, my confidence in driving a new office business, expanding in the hospital, and into more international markets, and bringing forward the highest performing image quality in the Swoop system increases significantly. The team is laser-focused on our growth drivers and very excited about the future of our company.

    謝謝你,布雷特。隨著我們越來越接近 2025 年中期,我對推動新的辦公業務、在醫院和更多國際市場擴張以及在 Swoop 系統中實現最高性能影像品質的信心顯著增強。團隊高度關注我們的成長動力,並對我們公司的未來感到非常興奮。

  • With that, I want to thank you for your time and open up the line for questions.

    最後,我要感謝您抽出時間並開放提問熱線。

  • Operator

    Operator

  • (Operator Instructions) Frank Takkinen, Lake Street.

    (操作員指示)Frank Takkinen,湖街。

  • Frank Takkinen - Analyst

    Frank Takkinen - Analyst

  • I was hoping we could start with one on some of the pilot activities ongoing in the office setting. Most curious, I know you touched on it a little bit in your prepared remarks, but just most curious about initial feedback and whether or not this has resulted in you changing strategy, changing any timelines to go into these markets? And then I have one follow-up after that.

    我希望我們可以從辦公室環境中正在進行的一些試點活動開始。最令人好奇的是,我知道您在準備好的發言中稍微提到了這一點,但我最好奇的是最初的反饋,以及這是否導致您改變策略,改變進入這些市場的時間表?然後我還有一個後續行動。

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • Maria, do you want to take that?

    瑪麗亞,你想接受這個嗎?

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Sorry, I was talking to myself. I was on mute. Sorry, Frank. Thank you for the question. And I was saying that we have really taken a very methodical approach to working through the pilot phase and make sure that we follow very closely the accounts from how we have pitched to them their interest in the technology to then really understanding the deal cycle, making sure that we are ready to support them and chaperone any activities associated with accreditation and then even down to implementation.

    抱歉,我正在自言自語。我處於靜音狀態。對不起,弗蘭克。謝謝你的提問。我想說的是,我們在試點階段確實採取了非常有條理的方法,並確保我們密切關注客戶,從我們如何向他們推銷他們對這項技術的興趣,到真正了解交易週期,確保我們準備好支持他們,並陪同與認證相關的任何活動,甚至直到實施。

  • So we now have the pilot accounts gone through, and all of them are now accredited by IAC. They're all scanning. And they're all going through the CMS registration and the motion. And I would say in the training meeting that we had for our sales team, we had one of those pilot neurologists come to speak to them.

    現在我們已經審核了試點帳戶,並且所有帳戶都已獲得 IAC 的認可。他們都在掃描。他們都在經歷 CMS 註冊和動議。我想說,在我們為銷售團隊舉辦的培訓會議上,我們請了一位試驗神經病學家來與他們交談。

  • It is really encouraging to hear how they are thinking about this opportunity in terms of transforming their practice, being able to offer more, being able to be actually a more full-service supplier, and how easy they report feeling the technology is to operate and to bring on board.

    聽到他們如何看待這個機會,如何轉變實踐,如何提供更多服務,如何成為真正提供更全方位服務的供應商,以及他們如何感覺這項技術易於操作和採用,這確實令人鼓舞。

  • So I would say, if anything, we are feeling more bullish. I'm also incredibly encouraged by the two very large neurology practices that are participating in Neuro PMR. The rate at which they are enrolling patients is exceeding our expectations, which is a great testament to their enthusiasm.

    所以我想說,如果有的話,我們感覺更樂觀。我也對參與 Neuro PMR 的兩家大型神經病學診所感到非常鼓舞。他們招募患者的速度超出了我們的預期,這充分證明了他們的熱情。

  • And also, we are seeing a variety of cases that they are willing to use in triage in patients with the Swoop system. So I am feeling that it is really the right thing for us to diversify, and there's an opportunity there that is very substantial, and we're going to be moving into that launch phase here in the next several weeks as we hit the midpoint of the year with the field team now trained.

    而且,我們看到他們願意使用 Swoop 系統對患者進行分類的各種案例。因此,我覺得多元化對我們來說確實是正確的選擇,而且這是一個非常巨大的機會,隨著我們進入年中,現場團隊也已接受培訓,我們將在接下來的幾週內進入啟動階段。

  • Frank Takkinen - Analyst

    Frank Takkinen - Analyst

  • And then just for my follow-up, maybe a two-parter. First, on the grant-funded headwind in Q1, is this an instance where if some of those grants start to come back online that, that business could be recovered? Or are you guys thinking of that as lost business at this point?

    然後只是為了我的後續行動,也許是兩個部分。首先,關於第一季撥款資助的逆風,如果其中一些撥款開始恢復,那麼該業務是否可以恢復?還是你們現在認為這是業務損失?

  • And then, as a second part, just any update on initial receptivity with the international distributors would be great.

    然後,作為第二部分,只要提供有關國際分銷商初步接受度的任何更新就很好了。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Sure. So I think across academic institutions, the tone of clinicians around grant funding confidence is clearly very, very sobering. So we are not expecting that they come back, even though some of the institutions actually that we were affected by were on the front page of main news streams, and they have received some of it back. There is no appetite to do anything eagerly with any grant funding because there's no confidence whether that is going to stick, stay, or get retracted. It's just a very unsettling time in that respect.

    當然。因此,我認為在各個學術機構中,臨床醫生對資助資金信心的態度顯然非常非常令人擔憂。因此,我們並不指望他們會回來,儘管我們實際上受到影響的一些機構登上了主要新聞頭條,而且他們已經收回了部分損失。人們並不熱切地希望利用任何贈款資金來做任何事情,因為他們不確定這些資金是否會繼續存在、保留下來,還是會被撤回。從這個角度來說,這是一個非常令人不安的時期。

  • Definitely, we are moving away from betting on grant funding for deals that may have had that, and we are putting all of our efforts on other deals that don't have grant funding. It is not every deal in the hospital that has grant funding as the source of funding for the acquisition of the equipment. So I don't think we expect them to come back.

    毫無疑問,我們不再將賭注押在可能獲得贈款資助的交易上,而是將所有精力放在沒有贈款資助的其他交易上。並不是每筆醫院交易都以贈款資金作為購置設備的資金來源。所以我不認為我們會指望他們回來。

  • The question is, are we able here in the second quarter to deliver the quarter and then make anything up? Or is it going to be more challenging to find deals? As we say, most of it is hospital deals, and they have a long sales cycle. And then as it relates to international, we continue to see a lot of interest, and we are now seeing that a lot of the business internationally is very hospital-based.

    問題是,我們能否在第二季完成本季的業績並彌補任何損失?或者說尋找交易會變得更具挑戰性?正如我們所說,大多數是醫院交易,而且銷售週期很長。然後,就國際業務而言,我們繼續看到很多人感興趣,現在我們看到很多國際業務都是以醫院為基礎的。

  • So we are seeing our distributors work through the pipeline. We are seeing the implementations from last year start to generate clinical activity that is encouraging. So we're starting to go deeper in some countries with our distributors.

    因此,我們看到我們的分銷商正在透過管道開展工作。我們看到去年實施的措施開始產生令人鼓舞的臨床活動。因此,我們開始與一些國家的分銷商進行更深入的合作。

  • So we're looking at establishing centers of excellence. We're looking at establishing networks of users that can actually communicate and maybe not collaborate, but communicate as the pioneers on the use of swooping in different markets. And in our prepared remarks, we stated that we still feel like we will get India clearance and approval from the CDSCO, and we will do market entrants in the second half.

    因此我們正在考慮建立卓越中心。我們正在考慮建立用戶網絡,這些用戶實際上可以進行交流,也許不能進行協作,但可以作為在不同市場使用 Swooping 的先驅進行交流。在我們準備好的演講中,我們表示我們仍然覺得我們將獲得印度 CDSCO 的批准和認可,並且我們將在下半年進入印度市場。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    富國銀行的拉里·比格爾森。

  • Simran Kaur - Analyst

    Simran Kaur - Analyst

  • This is Simran on for Larry. Maybe just for guidance. If I do the math, you took the full-year '25 outlook down by about $1 million at the midpoint. It does imply slightly lower second-half sales than before at the midpoint. So I guess you laid out a number of growth catalysts that you expect to come online in the second half.

    這是 Simran 為 Larry 表演的。也許只是為了指導。如果我算一下,你把 25 年全年的預期中位數下調了約 100 萬美元。這確實意味著下半年的銷售額會比之前的中期銷售額略低。所以我想您已經列出了一些預計下半年會出現的成長催化劑。

  • So maybe what's changed in your second half guidance since you set your initial guidance in mid-March? And can you talk more broadly about your expectations for the selling cycle, the hospital selling cycle, and the capital environment for the remainder of the year?

    那麼,自從您在三月中旬設定初步指導以來,您的下半年指導有什麼變化嗎?您能否更廣泛地談談您對今年剩餘時間的銷售週期、醫院銷售週期和資本環境的預期?

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Brett, do you want to start?

    布雷特,你想開始嗎?

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • Yes. So I'll take that. So I think two things on revenue guidance. In the first half, we adjusted it to $5 million to $6 million. As Maria highlighted, predominantly, that's coming from the grant funding-related activities that we do not anticipate necessarily coming back.

    是的。所以我會接受。因此,我認為關於收入指導有兩點。上半年我們將其調整為500萬至600萬美元。正如瑪麗亞所強調的,這主要來自於與贈款資金相關的活動,我們預計這些活動不一定會回來。

  • So the first half, we adjusted, and then we also adjusted the full-year guidance, which also incorporates some of that grant funding-related revenue that we do not anticipate that we'll be capturing here for fiscal year '25. So no major changes in terms of our anticipation for second-half guidance, how we think about the prospects of the business, and the growth drivers will all be in place. But given what we saw in Q1 in terms of grant funding, we made adjustments to both the first half as well as the full year guidance.

    因此,我們對上半年進行了調整,然後也調整了全年指引,其中也納入了部分我們預計在 2025 財年不會實現的贈款相關收入。因此,我們對下半年業績指引的預期、對業務前景的看法以及成長動力都不會發生重大變化。但考慮到第一季的撥款情況,我們對上半年和全年的指導都做出了調整。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • And I think you had a question regarding the capital cycle. I think that's what I don't know, that we are seeing anything different than what we have been messaging for the last several quarters, which is that they are definitely getting longer. I think about 1.5 years ago or so, I was estimating our hospital deals were going to take us about nine months or so.

    我認為您對資本週期有疑問。我認為這就是我不知道的,我們看到的與過去幾季所傳達的訊息有什麼不同,那就是它們肯定變得更長了。我想大約一年半前,我估計我們的醫院交易大約需要九個月左右的時間。

  • I would say, often now, they are a year or 1.5 years in some instances. So we have a really robust pipeline of hospital deals, but they are going to take their time to happen. And I would say it's probably in that year to 1.5 years timeframe now, as we think about where that stands.

    我想說,現在通常情況下,需要一年或一年半的時間。因此,我們擁有非常強大的醫院交易管道,但它們需要時間才能實現。我想說,現在大概是一年到一年半的時間範圍內,我們正在考慮這件事的進展。

  • Simran Kaur - Analyst

    Simran Kaur - Analyst

  • And maybe just a follow-up on the in-office expansion. Have you talked about how many office sites of care are in the launch readiness phase? And can you elaborate on the economics of selling in the office versus the hospital setting in light of today's macroenvironment? I know on the previous call, you talked about flexible payment models here.

    或許只是辦公室內部擴張的後續行動。您是否談論過有多少護理辦公點處於啟動準備階段?您能否根據當今的宏觀環境,詳細說明在辦公室和醫院環境中銷售的經濟效益?我知道在之前的電話中,您談到了靈活的付款模式。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Yes. So we haven't mentioned how many accounts are in the pilot phase. I would say it's fair to say it's like a handful. And those are the ones that have gone through the motions definitely in the last several weeks, the accreditation, the starting to scan, and then the beginning of the process around reimbursement and CMS registration. Again, we have now gone through the drill of implementation.

    是的。所以我們還沒有提到試點階段有多少個帳戶。我想說,公平地說,這確實很難。這些都是在過去幾週內已經完成的程序,包括認證、開始掃描,然後是報銷和 CMS 註冊流程的開始。再次,我們現在已經完成了實施演練。

  • I would say, as simple as implementation, shipping a device and training on the device is a very, very different experience in the hospital than in the office. In the hospital, the moment we get a PO, usually, we ship the device, and the hospital has no problem storing a device and implementing it when their teams are already there, and all the connectivity has happened, and lots of those things.

    我想說,就像實施一樣簡單,運送設備和對設備的培訓在醫院和在辦公室的體驗是非常非常不同的。在醫院,我們一收到採購訂單,通常就會發送設備,當醫院的團隊已經到達時,醫院可以毫無問題地存儲設備並實施,並且所有的連接都已完成,還有很多這樣的事情。

  • With the office, they really pick a date. And at that date, everything needs to happen. You need to open the crate, you need to put the device into motion, you need to train the team, and it's sort of one and done. And sometimes we need to do it after hours or over the weekend because that is the plan that they have available.

    有了辦公室,他們才真正挑選日期。到那時,一切都需要發生。你需要打開箱子,你需要啟動設備,你需要訓練團隊,這一切都是一次性完成的。有時我們需要在下班後或週末進行這項工作,因為這是他們提供的計劃。

  • So again, it's been a handful of accounts with whom we've actually learned the whole drill from pitching a deal all the way to implementing and the different steps. In terms of pricing, I think we are continuing to talk about flexibility to accommodate. They definitely have an appetite to pay overtime rather than all at once. It depends on the size of the account.

    所以,我們實際上已經從少數幾個客戶身上學到了從推銷交易到實施交易的整個流程以及不同的步驟。在定價方面,我認為我們正在繼續討論靈活性。他們肯定願意支付加班費,而不是一次性支付全部工資。這取決於帳戶的大小。

  • I think we are doing an economic model to understand whether they are really ready for our device. A lot of it depends on the number of cases that they refer to. We talked about the fact that they do 500 on average, a neurology office refers about 500 to 600 patients a year for an MRI. So that definitely it falls right in when this makes sense at our price point. But we are seeing variability in the way we're potentially going to transact with the offices based on their size and their appetite to pay more upfront or pay more over time.

    我認為我們正在建立一個經濟模型來了解他們是否真的準備好使用我們的設備。這很大程度上取決於他們所提及的案件數量。我們談到這樣一個事實:神經科診所平均每年會做 500 例 MRI 檢查,大約有 500 到 600 名患者需要做 MRI 檢查。因此,當這個價格符合我們的預期時,它肯定是合適的。但我們發現,根據辦事處的規模以及他們願意預付更多費用還是分期支付更多費用,我們與辦事處進行交易的方式可能會有所不同。

  • Brett, feel free to add any other commentary here.

    布雷特,請隨意在這裡添加任何其他評論。

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • No, I think that's fair. I mean, there are over 2,000 neurology offices, and there obviously is a segmentation within that size. So there are some that are more sole proprietary that have a look and feel of what their business looks like, versus those that are more than 5 to 10 practitioners within a setting. So each one of those has a little bit different dynamics.

    不,我認為這很公平。我的意思是,有超過 2,000 個神經科診所,而且在這個規模內顯然存在細分。因此,有些公司是獨資經營,可以直觀地了解自己的業務是什麼樣的,而有些公司則擁有超過 5 到 10 名從業人員。因此,每一個都有一點不同的動態。

  • I would say health economics has been something that's been front and center, both in the office setting as well as what we're bringing to the hospital setting. So each one of those has a very compelling use case. We do allow for some degree of making sure that we can meet the practice where it makes sense for their business model.

    我想說,衛生經濟學一直是我們關注的焦點,無論是在辦公室環境或醫院環境。因此,每一個都有一個非常引人注目的用例。我們確實允許某種程度的確保我們能夠滿足適合其商業模式的實踐。

  • Operator

    Operator

  • Yuan Zhi, B. Riley Securities.

    袁志,B. Riley 證券。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Maria, maybe on the tariff because to tariffs, can you clarify if some of your international orders are delayed to a later time, or were they just canceled?

    瑪麗亞,也許關於關稅,因為對於關稅,你能否澄清一下你的一些國際訂單是否被推遲到以後的時間,或者它們是否被取消了?

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • Yes. So, I mean to date, we haven't had any impact of any tariff-related delays of any of our transactions with our third-party distributors to date. So that hasn't come to fruition. We're in the early stages, as you know, of international market development. But to date, no direct tariff impact.

    是的。所以,我的意思是到目前為止,我們與第三方分銷商的交易尚未受到任何與關稅相關的延遲的影響。所以這還沒有實現。如您所知,我們正處於國際市場開發的早期階段。但迄今為止,尚未受到直接的關稅影響。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Maybe a follow-up question there. So, for the 1Q 2025 product revenue, most of the products from the US market, with a very minor contribution from international? And any reason why?

    也許那裡有一個後續問題。那麼,對於 2025 年第一季的產品收入,大部分產品來自美國市場,來自國際市場的貢獻很小?有什麼原因嗎?

  • Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

    Brett Hale - Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary

  • So there's been a -- any individual quarter, there's been variability, as you know, in terms of our mix. So I guess, for the first quarter of 2025, I guess I would highlight that we sold six units. The effective ASP was $254,000, which was actually a very strong ASP. But any individual quarter, we can have variability in terms of what the demand is and what the sales are. So nothing specific to comment about the mix per se in Q1.

    所以,如你所知,就我們的組合而言,任何一個季度都會存在變化。因此,我想,對於 2025 年第一季度,我想強調的是,我們銷售了 6 台。有效 ASP 為 254,000 美元,這實際上是一個非常強勁的 ASP。但在任何一個季度,需求和銷售情況都會有所不同。因此,對於第一季的組合本身沒有什麼特別的評論。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • And maybe one last question from us. So now we are in May, what is your current visibility for the first half of 2025, and then for the full-year 2025? The other way to think about this is which bucket of orders you think is at risk, and which bucket of orders you think you have higher confidence in?

    我們還有最後一個問題。現在已經是五月了,您對 2025 年上半年以及 2025 年全年的預測如何?另一種思考方式是,您認為哪一類訂單有風險,以及您認為哪一類訂單更有信心?

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • I think as we think about I mean, as we think about the second half of this year, that's when we get into this more balanced portfolio of opportunities. And we have the hospital, we have international, we add to international India, and we have the office. So we are managing the pipeline across all of those buckets to have higher confidence as to how things are going to play out based on different sales cycles and time frames.

    我認為,當我們思考今年下半年時,我們就會進入更平衡的機會組合。我們有醫院,有國際業務,我們在印度也有國際業務,我們還有辦事處。因此,我們正在管理所有這些環節的管道,以便更有信心地了解事情將如何根據不同的銷售週期和時間框架進行。

  • So as I said, the pipeline is very robust. We have also now had a little more run time with the new team, which, as we said, was close to 50% of an upgrade at the beginning of the year, and we are very impressed by the pipelines that they are driving as well as new individuals as well as the legacy team.

    正如我所說,該管道非常強大。現在,我們與新團隊的合作時間也更長了,正如我們所說,新團隊在年初的規模已接近 50%,他們所推動的管道以及新員工和原有團隊都給我們留下了深刻的印象。

  • So I would say the pipeline looks very robust, and we're starting to build the pipeline for the office for the second half. Most of what is going to be driving the business in this second quarter, to round up the first half, is going to be the hospital. That's why there is definitely a significant ramp in total business between the two halves, the first and the second.

    所以我想說,管道看起來非常強勁,我們正開始為下半年的辦公室建造管道。推動第二季業務發展的主要因素將是醫院,以帶動上半年業務的發展。這就是為什麼第一季和第二季之間的整體業務量肯定會出現顯著的成長。

  • Operator

    Operator

  • (Operator Instructions) I will turn the call back over to Maria for closing remarks.

    (操作員指示)我將把電話轉回給瑪麗亞,請她做最後發言。

  • Maria Sainz - President, Chief Executive Officer, Director

    Maria Sainz - President, Chief Executive Officer, Director

  • Well, thank you very much for attending today's call and for your questions, and we look forward to updating you at the end of the second quarter. Take good care.

    好吧,非常感謝您參加今天的電話會議並提出您的問題,我們期待在第二季末向您通報最新情況。好好保重。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。