Nano-X Imaging Ltd (NNOX) 2024 Q3 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

  • Ladies and gentlemen, thank you for standing by. Welcome to Nano-X third quarter 2024 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded.

    女士們先生們,謝謝你們的支持。歡迎參加 Nano-X 2024 年第三季財報電話會議。(操作員指示)請注意,今天的會議正在錄製中。

  • I would like now to turn the conference over to Mike Cavanaugh, Investor Relations. Sir, please go ahead.

    我現在想把會議交給投資者關係部的 Mike Cavanaugh。先生,請繼續。

  • Mike Cavanaugh - Investor Relations

    Mike Cavanaugh - Investor Relations

  • Good morning, and thank you for joining us today. Earlier today, Nano-X Imaging Ltd released financial results for the quarter ended September 30, 2024. The release is currently available on the Investors section of the company's website. With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman; and Ran Daniel, Chief Financial Officer.

    早安,感謝您今天加入我們。今天早些時候,Nano-X Imaging Ltd 發布了截至 2024 年 9 月 30 日的季度財務表現。該新聞稿目前可在公司網站的投資者部分取得。今天與我在一起的有執行長兼代理董事長 Erez Meltzer;和財務長冉丹尼爾。

  • Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations and other matters. These statements are subject to risks, uncertainties and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date.

    在我們開始之前,我想提醒大家,管理層將在這次電話會議中發表聲明,其中包括有關公司財務業績、研發、製造和商業化活動、監管流程運營和其他事項的前瞻性聲明。這些陳述受到風險、不確定性和假設的影響,這些風險、不確定性和假設是基於管理層截至目前的當前預期,未來可能不會更新。因此,這些陳述不應被視為代表公司在任何後續日期的觀點。

  • Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP gross loss per share.

    可能導致這種差異的因素包括但不限於該公司向美國證券交易委員會提交的文件中所述的因素。我們也將參考某些非公認會計準則財務指標,為投資者提供更多資訊。我們的新聞稿中提供了非 GAAP 與 GAAP 指標的調整表,主要差異是非 GAAP 普通股淨虧損、非 GAAP 收入成本、非 GAAP 毛利、非 GAAP 毛利利潤率、非GAAP 研發費用、非GAAP 銷售和行銷費用、非GAAP 一般和管理費用以及非GAAP 每股毛虧損。

  • With that, I'd now like to turn the call over to Erez Meltzer.

    現在,我想將電話轉給 Erez Meltzer。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • Thank you for joining us today for our financial results call. I'm happy to share the progress we have made deploying our innovative Nano-X ARC technology as well as further progress with Nano-X AI and the other components of the full Nano-X solutions. Since its commercial deployment at the beginning of this year, there are now 47 units, almost 50 that are in various stages of shipments and deployments for both commercial and clinical use.

    感謝您今天參加我們的財務業績電話會議。我很高興與大家分享我們在部署創新 Nano-X ARC 技術方面取得的進展,以及 Nano-X AI 和完整 Nano-X 解決方案其他組件的進一步進展。自今年年初投入商業部署以來,目前已有 47 台,其中近 50 台處於商業和臨床使用的不同運輸和部署階段。

  • In the US, we are deployed across seven states. Our strategic growth plan is well underway and we are committed to accelerating our efforts to expand our footprint and enhance our technology. This is a multipronged effort, which includes doubling our pipeline, expanding our sales, service and support teams on the ground in the key US market to drive sales to raise awareness with imaging centers and hospitals as well as supporting our growing customer base and the installations and ongoing use of Nano-X solutions. Hand in hand with these efforts, we are also continuing to advance our regulatory efforts with the US FDA for additional clearances and securing the CE Mark in European Union, while also continue to generate trial data supporting the use of the Nano-X ARC.

    在美國,我們分佈在七個州。我們的策略性成長計劃正在順利進行,我們致力於加快努力擴大我們的足跡並增強我們的技術。這是一項多管齊下的努力,包括將我們的管道加倍,擴大我們在美國主要市場的銷售、服務和支援團隊,以推動銷售,提高成像中心和醫院的知名度,以及支持我們不斷增長的客戶群和安裝以及 Nano-X 解決方案的持續使用。在這些努力的同時,我們也繼續推動美國 FDA 的監管工作,以獲得更多許可並獲得歐盟的 CE 標誌,同時繼續產生支持 Nano-X ARC 使用的試驗數據。

  • The positive feedback from health care providers and patients alone reinforce our belief in the transformative potential of Nano-X ARC, we are confident that our continued focus on innovation and strategic partnership will drive significant value for our shareholders.

    僅來自醫療保健提供者和患者的正面回饋增強了我們對 Nano-X ARC 變革潛力的信念,我們相信,我們對創新和策略合作夥伴關係的持續關注將為我們的股東帶來巨大的價值。

  • We also signed several new deals for Nano-X AI solutions, including Oxford University Hospitals, NHA's Foundation Trust in the UK. I will share more detail on this and other agreements later in my remarks. But I will say that all of the Nano-X ARC are excited to partner with such prestigious institutions. We at Nano-X were also humbled and proud to have Nano-X AI selected for a special mention in Times Best Inventions of 2024 List. This annual list highlights groundbreaking products that are transforming industries and Nano-X AI is certainly beginning to change how we diagnose and manage population health.

    我們還簽署了幾項 Nano-X AI 解決方案的新協議,其中包括牛津大學醫院、英國 NHA 基金會信託基金。我將在稍後的發言中分享有關該協議和其他協議的更多細節。但我要說的是,Nano-X ARC 的所有成員都非常高興能與這些享有盛譽的機構合作。Nano-X 也對 Nano-X AI 入選《泰晤士報》2024 年最佳發明榜單特別提及感到謙卑和自豪。這份年度榜單重點介紹了正在改變行業的突破性產品,而 Nano-X AI 無疑正在開始改變我們診斷和管理人口健康的方式。

  • I'm also pleased to report that our USARAD business continued to produce meaningful revenue for our organization, generating $2.6 million in revenues, which is a quarterly record, and we anticipate its continued growth to complement our business lines. These milestones across all our business segments are a testament to our team's dedication and the growing demand for our cutting-edge medical imaging solutions globally.

    我還很高興地報告,我們的 USARAD 業務繼續為我們的組織帶來可觀的收入,創造了 260 萬美元的收入,這是季度記錄,我們預計其持續增長將補充我們的業務線。我們所有業務部門的這些里程碑證明了我們團隊的奉獻精神以及全球對我們尖端醫學影像解決方案不斷增長的需求。

  • As we look ahead, we remain confident about the opportunities that lie before us. Our mission to make advanced medical imaging accessible and affordable is more critical than ever, and we are poised to lead the industry with our pioneering solutions.

    展望未來,我們對擺在我們面前的機會仍然充滿信心。我們的使命是讓先進的醫學成像觸手可及且價格實惠,這項使命比以往任何時候都更加重要,我們準備透過我們的開創性解決方案引領業界。

  • Thank you for continued support and confidence in our vision. I look forward to discussing our financial performance and future plan in more detail. Now let's dive right into some details around our deployment of the Nano-X ARC in the US, a highly sophisticated and competitive market. I'm proud of our market penetration, a notable job demonstrating the benefits introducing the Nano-X ARC to imaging and medical centers in the US, which are by nature sophisticated buyers and are exposed to the latest technology the world has to offer.

    感謝您對我們願景的持續支持和信心。我期待更詳細地討論我們的財務表現和未來計劃。現在,讓我們深入了解我們在美國這個高度複雜且競爭激烈的市場中部署 Nano-X ARC 的一些細節。我對我們的市場滲透感到自豪,這是一項引人注目的工作,展示了將Nano-X ARC 引入美國成像和醫療中心的好處,這些中心本質上是成熟的買家,並且接觸到世界上提供的最新技術。

  • Our accelerating commercial traction demonstrates not only the skill and the tenacity of our sales team, but also the value that Nano-X ARC brings to health care providers, as our customer base increases, along with rising awareness of the Nano-X ARC within the medical community, we will add to our team accordingly as the result, during the quarter, we strengthened our sales team with representative as well as expanded our clinical team, along with enhancements to our operational team.

    我們不斷加速的商業吸引力不僅證明了我們銷售團隊的技能和堅韌,還證明了Nano-X ARC 為醫療保健提供者帶來的價值,因為我們的客戶群不斷增加,以及Nano-X ARC 在醫療保健領域的認知度不斷提高醫療界,我們將相應地增加我們的團隊,因此,在本季度,我們加強了我們的銷售團隊的代表,並擴大了我們的臨床團隊,同時增強了我們的運營團隊。

  • As we accelerate our US commercialization, we doubled our sales and service personnel in the US to support our expanding client base, along with various channel partners. Our team on the ground will be critical to our accelerated rollout, and we will steadily by carefully continue to add to this team. We have an internal target of 30 to 40 sales service marketing and support personnel in place by the end of 2025, in alignment with our commercial progress. Additionally, we are focusing on expanding our network of strategic collaborations and distributors.

    隨著我們加速美國商業化,我們在美國的銷售和服務人員數量增加了一倍,以支援我們不斷擴大的客戶群以及各種通路合作夥伴。我們的實地團隊對於我們的加速推出至關重要,我們將謹慎地繼續穩定地增加這個團隊的成員。我們的內部目標是到 2025 年底配備 30 至 40 名銷售服務行銷和支援人員,以與我們的商業進展保持一致。此外,我們也致力於擴大我們的策略合作和經銷商網絡。

  • I mentioned on our last call that we have engaged with three prominent imaging groups in the US. And during Q3, we continued to gain traction with additional imaging groups. Our sales team continues to actively engage imaging groups across the US. In consultative discussions demonstrating the added clinical utility to be gained by adding the Nano-X ARC to their practices. It is our aim as more stand-alone imaging groups adopt our technology that the Nano-X ARC eventually be viewed as a standard equipment alongside traditional x-ray and CT technologies.

    我在上次電話會議中提到,我們已經與美國三個著名的成像集團進行了接觸。在第三季度,我們繼續吸引更多成像組的注意。我們的銷售團隊繼續積極與美國各地的成像團隊合作。在諮詢討論中,展示了將 Nano-X ARC 添加到他們的實踐中可以獲得的額外臨床效用。我們的目標是,隨著越來越多的獨立成像團隊採用我們的技術,Nano-X ARC 最終被視為與傳統 X 光和 CT 技術並列的標準配備。

  • We are also working with multiple distributors in Europe charged with expanding our footprint in the EU. This is an important as we anticipate receiving the CE Mark designation for the Nano-X ARC in the coming months. To further assist our commercial core technology OEM rollout we have created the demo kits to more effectively educate potential buyers on the Nano-X value proposition. We have now shipped several demo kits to the prospective clients to more easily allow them to experience our unique technology.

    我們也與歐洲的多家經銷商合作,負責擴大我們在歐盟的足跡。這一點很重要,因為我們預計在未來幾個月內獲得 Nano-X ARC 的 CE 標誌指定。為了進一步協助我們的商業核心技術 OEM 推廣,我們創建了演示套件,以更有效地向潛在買家介紹 Nano-X 的價值主張。我們現在已經向潛在客戶提供了多個演示套件,以便他們更輕鬆地體驗我們獨特的技術。

  • Clearly, we have been ramping up our activity in the US, and we know we must continue with this momentum and drive even greater adoption going forward. While we view the key US market as a strategic priority, we continue to advance commercialization efforts in the rest of the world. In Mexico, where we have already made commercial inroads, we are waiting for the import license needed to deploy the Nano-X ARC.

    顯然,我們一直在加大在美國的活動力度,我們知道我們必須繼續保持這一勢頭,推動未來更廣泛的採用。雖然我們將美國市場視為戰略重點,但我們仍繼續推動在世界其他地區的商業化工作。在墨西哥,我們已經取得了商業進展,我們正在等待部署 Nano-X ARC 所需的進口許可證。

  • The system allocated for the Mexican market has been manufactured and tested and is today ready for shipment and our partner has already designated the first two sites for the Nano-X ARC in Mexico. In Chile, the Nano-X ARC is in registration process after a successful site visit in our demo center in the US. Also in Europe, we were excited to showcase the Nano-X ARC technology at Medica 2024 in Dusseldorf, Germany recently in November, Medica is one of the largest medical B2B trade fairs in the world. Our team was well prepared and did an excellent job raising awareness to the 3D digital tomography as a key tool in the future of medical imaging.

    分配給墨西哥市場的系統已經製造和測試,今天已準備好發貨,我們的合作夥伴已經為 Nano-X ARC 在墨西哥指定了前兩個地點。在智利,Nano-X ARC 在美國演示中心成功進行實地考察後正在進行註冊過程。同樣在歐洲,我們很高興在 11 月於德國杜塞爾多夫舉行的 Medica 2024 展會上展示 Nano-X ARC 技術,Medica 是世界上最大的醫療 B2B 貿易展之一。我們的團隊做好了充分準備,並出色地提高了人們對 3D 數位斷層掃描作為未來醫學影像關鍵工具的認識。

  • Turning to the regulatory front. We have maintained ongoing communication with both the US FDA and the European regulatory bodies. As you are aware, we have pending 510(k) applications to the FDA for the general use of Nano-X ARC, which could cover general use, including chest. We continue to work closely with the FDA and provide any supporting information as needed in a timely manner, including in recent weeks.

    轉向監管方面。我們與美國 FDA 和歐洲監管機構保持持續溝通。如您所知,我們正在向 FDA 提交關於 Nano-X ARC 一般用途的 510(k) 申請,該申請可能涵蓋一般用途,包括胸部。我們繼續與 FDA 密切合作,並及時提供所需的任何支持信息,包括最近幾週。

  • In the EU, we continue to work with our notified body in the process aimed to securing the CE Mark designation for the Nano-X ARC. Both new designations when secured would be, in our view, a considerable expansion for the Nano-X ARC technology and help to make it standard part of medical imaging equipment worldwide and results in a significant increase in our total addressable market. We are not able to comment specifically on timing, but we are doing everything we can to assist in both review processes and hope to receive the clearances in the coming months.

    在歐盟,我們繼續與我們的公告機構合作,旨在確保 Nano-X ARC 獲得 CE 標誌。我們認為,這兩個新名稱一旦獲得,將是 Nano-X ARC 技術的重大擴展,有助於使其成為全球醫學影像設備的標準組成部分,並導致我們整個潛在市場的顯著增長。我們無法具體評論時間,但我們正在盡一切努力協助審查流程,並希望在未來幾個月內獲得許可。

  • Turning to our clinical update in Beilinson Hospital more than 40 patients were already recruited for both the CHEST trial and the multisite trial. Together, with the staff, we have reviewed more than 25 of the patient's data sets, and the results are impressive, continued the trend we have published in a recent white paper from the first 12 patients.

    根據我們在 Beilinson 醫院的臨床最新情況,已有 40 多名患者被招募參加 CHEST 試驗和多中心試驗。我們與工作人員一起審查了超過 25 個患者的數據集,結果令人印象深刻,延續了我們在最近的白皮書中發布的前 12 名患者的趨勢。

  • In Ghana, the multicenter trial site is actively recruiting and the Nano-X ARC system is actively scanning patients, both for the clinical trial as well as part of the clinical practice. Furthermore, Nano-X is in active discussions with a prominent site in Europe for incorporation into the multi-site clinical trial. I'd like now to discuss the Nano-X AI business segment, which is generating revenues and is also gaining commercial tractions worldwide.

    在加納,多中心試驗中心正在積極招募患者,Nano-X ARC 系統正在積極掃描患者,既用於臨床試驗,也用於臨床實踐的一部分。此外,Nano-X 正在與歐洲的一個著名中心積極討論納入多中心臨床試驗。我現在想討論 Nano-X AI 業務部門,該部門正在產生收入,並且也在全球範圍內獲得商業吸引力。

  • As previously announced, during the quarter, we secured a new 510(k) clearances, from the US FDA for Nano-X AI Health CNG version 2.0, the upgraded version of Nano-X ARC solution, which has already shown clinical utility in several health care systems by identifying patients at high risk of coronary artery disease and enabling earlier intervention. The solution is also easy to use being seamlessly integrated with existing picture archiving and communication systems and electronic medical record systems.

    如同先前所宣布的,本季度我們獲得了美國FDA 的Nano-X AI Health CNG 2.0 版新的510(k) 許可,它是Nano-X ARC 解決方案的升級版本,已在多個領域顯示出臨床實用性。該解決方案還易於使用,可與現有的圖片存檔和通訊系統以及電子病歷系統無縫整合。

  • As we know, AI has been the forefront of the news worldwide for some time, highlighting its groundbreaking benefits to many industries, use case, much of which is largely hypothetical at this point. Conversely, the Nano-X AI application has been fully developed into a product tool with significant clinical utilities in many imaging and diagnostic users. Its advanced algorithm and robust data processing capabilities have been trained on thousands of images and enable health care providers to identify health problems in much earlier stage than was previously possible.

    眾所周知,人工智慧一段時間以來一直是全球新聞的前沿,強調了它對許多行業和用例的突破性好處,其中大部分目前還只是假設。相反,Nano-X AI應用已完全發展成為在許多成像和診斷用戶中具有重要臨床實用性的產品工具。其先進的演算法和強大的數據處理能力已經過數千張圖像的訓練,使醫療保健提供者能夠比以前更早地識別健康問題。

  • With that, let's look at some recent Nano-X AI being used in the rail world. Corewell, formerly Spectrum Health, one of the early US-based adopters of the Nano-X AI solution after two years of successful collaboration and having seen the clinical utility of the Nano-X AI Health CNG solution, the system will implement the health OT bone solution into its clinical system. The health host algorithm automatically detects vertebral compression fractures and low bone mineral density to help identify patients at risk of MSK disease with a focus on osteoporosis without a need for discrete imaging.

    接下來,讓我們來看看最近在鐵路領域使用的一些 Nano-X AI。Corewell(原 Spectrum Health)是美國 Nano-X AI 解決方案的早期採用者之一,經過兩年的成功合作,並看到 Nano-X AI Health CNG 解決方案的臨床實用性,該系統將實施健康 OT骨解決方案進入其臨床系統。健康主機演算法可自動檢測椎骨壓縮性骨折和低骨礦物質密度,以幫助識別有 MSK 疾病風險的患者,並專注於骨質疏鬆症,無需離散成像。

  • We are looking forward to another exciting and productive collaboration with Corewell and it is very gratifying to see sophisticated health systems validate the use of Nano-X AI solution. As previously reported, the UK National Health Services initiated the DAPT trial to evaluate the use of Nano-X AI bone solution. Through this study, the NHS discovered that it was able to identify 6 times as many patients with osteoporosis in routine scans as they were without Nano-X AI.

    我們期待與 Corewell 再次進行令人興奮且富有成效的合作,並且非常高興看到複雜的醫療系統驗證 Nano-X AI 解決方案的使用。如同先前所報導的,英國國家衛生服務部門啟動了 DAPT 試驗,以評估 Nano-X AI 骨骼解決方案的使用。透過這項研究,NHS 發現,在常規掃描中識別出的骨質疏鬆症患者數量是沒有使用 Nano-X AI 時的 6 倍。

  • Following on those powerful results, one of the national health services sites, Oxford University Hospitals NHS Foundation Trust decided to secure a three-year contract for the Health host bone solution. AdAPT will continue into Q1 2025, but it's already decided to secure the solution plus the new Real plus bone management tool for three years. This is the first time the Real plus bone management tool has been mentioned, and I'd like to take a few moments to describe this exciting new offering.

    繼這些強有力的成果之後,國家衛生服務網站之一的牛津大學醫院 NHS 基金會信託基金決定與 Health 宿主骨解決方案簽訂為期三年的合約。AdAPT 將持續到 2025 年第一季度,但它已經決定將該解決方案以及新的 Real plus 骨骼管理工具保留三年。這是 Real plus 骨骼管理工具第一次被提及,我想花一些時間來描述這個令人興奮的新產品。

  • We have developed this application for use either as a stand-alone applications or alongside the Health host solution, and it is specifically designed to support fracture liaison service clinics in managing the entire patient life cycle more effectively from initial detection, whether through AI or other diagnostic in real plus bone management tool will facilitate the comprehensive management of treatment and ongoing disease management, including follow-up exams, update letters, and medication management.

    我們開發了該應用程序,既可以作為獨立應用程序使用,也可以與健康主機解決方案一起使用,它是專門為支持骨折聯絡服務診所而設計的,無論是通過人工智能還是其他方式,從最初的檢測到更有效地管理整個患者生命週期。

  • These are the latest examples of prominent health systems, validating the utility of our Nano-X AI solution, and that is not just a concept, but a real value-add solution. We expect many more to come. In other AI business news, Dandelion Health extended its cooperation with Nano-X AI solution available on its clinical AI marketplace. Dandelion Health is a health care data platform that focuses on AI analytics, it offer life science companies, the ability to leverage Nano-X AI products to extract clinical insights from their multi-model, longer patient data sets of over 10 million patients.

    這些是著名衛生系統的最新範例,驗證了我們 Nano-X AI 解決方案的實用性,這不僅僅是一個概念,而是一個真正的增值解決方案。我們預計還會有更多的人加入。在其他人工智慧商業新聞中,Dandelion Health 擴大了與其臨床人工智慧市場上提供的 Nano-X 人工智慧解決方案的合作。Dandelion Health 是一個專注於人工智慧分析的醫療保健數據平台,它為生命科學公司提供利用 Nano-X 人工智慧產品從超過 1000 萬患者的多模型、更長的患者數據集中提取臨床見解的能力。

  • During the quarter, we also signed a new reseller agreement with Spanx Medical, Inc., a distributor of medical equipment based in Florida. Spanx will distribute the Nano-X AI solution in the large Florida market, and we look forward to a productive partnership. Looking to the future of Nano-X AI, the strong validation of these solutions by multiple health systems around the world drives us to develop additional algorithms that can identify more health problems.

    本季度,我們也與位於佛羅裡達州的醫療設備經銷商 Spanx Medical, Inc. 簽署了新的經銷商協議。Spanx 將在龐大的佛羅裡達市場分銷 Nano-X AI 解決方案,我們期待建立富有成效的合作夥伴關係。展望 Nano-X AI 的未來,這些解決方案得到了世界各地多個衛生系統的強大驗證,促使我們開發更多演算法來識別更多健康問題。

  • We are now working on a pulmonary solution, which is expected to be the first AI application designed specifically for the Nano-X ARC. The algorithm aims to automatically identified patients with pulmonary nodules with a goal of identifying chest diseases, essentially lung cancer through routine chest scans, the Nano-X team will provide timely updates on the development of these exciting new AI solutions as we advance its development.

    我們現在正在研究肺部解決方案,預計這將是第一個專門為 Nano-X ARC 設計的人工智慧應用程式。該演算法旨在自動識別患有肺結節的患者,目的是透過常規胸部掃描來識別胸部疾病,主要是肺癌,Nano-X 團隊將在我們推進這些令人興奮的新人工智慧解決方案的開發過程中及時提供有關其開發的最新資訊。

  • Turning to our OEM efforts, which will help to ensure we have the manufacturing capacity for our expected client base of the future. As mentioned in the past, we finalized the establishment of our technology development centers based in our headquarters. The primary purpose of the center is to consolidate our core assets and knowledge and to advance the development of the chips and the tubes and to lead our future road map.

    談到我們的 OEM 工作,這將有助於確保我們擁有滿足未來預期客戶群的製造能力。正如過去所提到的,我們最終確定了在總部設立技術開發中心。中心的主要目的是鞏固我們的核心資產和知識,推進晶片和管材的開發,引領我們未來的路線圖。

  • This center has eight R&D labs and is manned by a highly credentialed team of engineers and researchers who are also advancing now chip and tube technology from the robust technology patent library. The library includes dozens patents and families for Nano-X and Nano-X AI. The team at the center is tasked with the ongoing work on Nano-X future technology innovations as well as the development of our next products in our road map, and I know our future development is in a very capable hands.

    該中心擁有八個研發實驗室,由一支高素質的工程師和研究人員團隊管理,他們現在也利用強大的技術專利庫來推進晶片和管技術。該庫包含 Nano-X 和 Nano-X AI 的數十項專利和同族專利。中心的團隊負責 Nano-X 未來技術創新的持續工作以及我們路線圖中的下一個產品的開發,我知道我們未來的發展掌握在非常有能力的手中。

  • I'd now like to provide an update on our OEM partners who will play an important role in ensuring that we have the supply of systems to meet our accelerating growth trajectory over the coming years. There are many manufacturing agreements in place, as well as multiple development projects in motion at various stages and sites globally, an increased pipeline of potential leads, and I'd like to provide a high-level overview of some of these activities.

    現在我想介紹一下我們的 OEM 合作夥伴的最新情況,他們將在確保我們提供系統以滿足未來幾年加速成長軌跡方面發揮重要作用。目前已經簽訂了許多製造協議,並且在全球不同階段和地點開展了多個開發項目,增加了潛在線索的管道​​,我想對其中一些活動進行高級概述。

  • Nano-X has completed assembly of the first ARC tubes with Nano-X proprietary, and we have taken delivery of them at our manufacturing facility. We are now performing systems integration and pre-FDA submission testings on the tubes, which will be used in the Nano-X ARC. Nano-X is also engaged in development of a multisource modules utilizing mentioned Nano-X meters testing of this unit should commence in Q1 2025.

    Nano-X 已經完成了第一批採用 Nano-X 專有技術的 ARC 管的組裝,我們已在我們的製造工廠接收了它們。我們現在正在對管子進行系統整合和 FDA 提交前測試,這些管子將用於 Nano-X ARC。Nano-X 也致力於利用上述 Nano-X 儀表開發多源模組,該單元的測試應於 2025 年第一季開始。

  • As part of our efforts to raise awareness of Nano-X value and security applications such as screening Nano-X attended the International Security Expert in September in London, where over 300 international exhibitors showcased products and solutions from across the entire security spectrum. As a result of this event, we are following up on multiple opportunities to expand our penetration in the security vertical.

    為了提高人們對Nano-X 價值和安全應用(例如篩選)的認識,Nano-X 於9 月參加了在倫敦舉行的國際安全專家會議,其中300 多家國際參展商展示了整個安全領域的產品和解決方案。這項活動的結果是,我們正在抓住多個機會來擴大我們在安全垂直領域的滲透率。

  • A leading global medical and diagnostic solution provider is assembling the first prototype tubes utilizing the Nano-X meter. We are working closely with them and have delivered Nano-X ARC demo kit to serve a test bench for a prototype under development. We have been partnering with the US government security application projects to develop noninvasive screening applications. The team has successfully completed component build, assembly and testing. We have since received the follow on purchase order to finalize two unique tube designs for advancing prototyping, which are to be delivered in the first half of 2025.

    一家全球領先的醫療和診斷解決方案提供商正在利用 Nano-X 測量儀組裝第一批原型管。我們正在與他們密切合作,並提供了 Nano-X ARC 演示套件,為正在開發的原型提供測試台。我們一直與美國政府安全應用計畫合作開發非侵入性篩檢應用。團隊已成功完成組件建置、組裝和測試。此後,我們收到了後續採購訂單,以最終確定兩種獨特的管設計以推進原型設計,這些設計將於 2025 年上半年交付。

  • We also delivered in Q3 Nano-X demo it to Viewworks a global X-ray imaging solution provider for assessment of our technologies. Viewworks recently completed their assessment, issued their findings and have since requested to acquire Nano-X tubes towards specific application testing and development. We are pleased that our demo kit at increasing with our meter cube high-voltage power supply and software has already enabled multiple global solution providers to more easily experience our technology.

    我們也在第三季向全球 X 光成像解決方案供應商 Viewworks 提供了 Nano-X 演示,以評估我們的技術。Viewworks 最近完成了評估,發布了調查結果,並要求購買 Nano-X 管以進行特定應用測試和開發。我們很高興我們的演示套件與我們的儀表立方高壓電源和軟體一起增加,已經使多個全球解決方案提供者能夠更輕鬆地體驗我們的技術。

  • Additionally, the first tube utilizing CCM chips have been successfully built and the initial fab of production quality chips is scheduled to commence in Q1 2025. This is another example of the Nano-X team's dedication to secure new manufacturing agreements to ensure the supplier of Nano-X ARC system can meet our expected demand.

    此外,首個採用 CCM 晶片的管子已成功製造,最初的高品質晶片工廠計劃於 2025 年第一季啟動。這是 Nano-X 團隊致力於獲得新製造協議的另一個例子,以確保 Nano-X ARC 系統的供應商能夠滿足我們的預期需求。

  • That concludes my business update, and I would like now to turn the call over to Ran Daniel for a review of our financials. Ran?

    我的業務更新到此結束,現在我想將電話轉給 Ran Daniel,以審查我們的財務狀況。蘭?

  • Ran Daniel - Chief Financial Officer

    Ran Daniel - Chief Financial Officer

  • Thank you, Erez. We reported a GAAP net loss for the third quarter of 2024 of $13.6 million, which I will refer as to the reported period compared with a net loss of $21.4 million in the third quarter of 2023, which I'll refer as to the comparable period. The decrease was largely due to a decrease of $7.4 million in expenses related to impairment of goodwill, which were recorded in the comparable period and not in the reported period. .

    謝謝你,埃雷茲。我們報告的 2024 年第三季 GAAP 淨虧損為 1,360 萬美元,我將指的是報告期間,而 2023 年第三季的淨虧損為 2,140 萬美元,我將指的是可比期間。減少的主要原因是與商譽減損相關的費用減少了 740 萬美元,該費用記錄在可比較期間而非報告期間。。

  • Revenue for the reported period was $3.0 million, and gross loss was $2.8 million on a GAAP basis, compared to a revenue of $2.5 million and a gross loss of $1.7 million on a GAAP basis for the comparable period. Non-GAAP gross loss for the reported period was $0.2 million as compared to a non-GAAP gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 6% on a non-GAAP basis for the reported period as compared to a gross profit margin of 37% on a non-GAAP basis in the comparable period.

    報告期間的收入為 300 萬美元,以 GAAP 計算的毛虧損為 280 萬美元,而同期的收入為 250 萬美元,以 GAAP 計算的毛虧損為 170 萬美元。報告期間的非 GAAP 毛虧損為 20 萬美元,而可比期間的非 GAAP 毛利為 90 萬美元,這意味著報告期間的非 GAAP 毛損率約為 6%:相比之下,同期按非公認會計準則計算的毛利率為37%。

  • Revenue from the teleradiology services for the reported period was $2.6 million with a gross profit of $0.3 million on a GAAP basis in the reported period, which represents a gross profit margin of approximately 15% on a GAAP basis for the reported period. Non-GAAP gross profit of the company's teleradiology service for the reported period was $0.9 million, which represents a gross profit margin of approximately 35% on a non-GAAP basis.

    報告期間內,遠距放射服務收入為 260 萬美元,以 GAAP 基準計算,報告期間的毛利為 30 萬美元,以 GAAP 基準計算,報告期間的毛利率約為 15%。報告期間內,該公司遠距放射服務的非公認會計準則毛利為 90 萬美元,以非公認會計準則計算,毛利率約 35%。

  • Revenue from the teleradiology services for the comparable period was $2.2 million with a gross profit of $0.2 million on a GAAP basis, which represented gross profit margins of approximately 11% on a GAAP basis. Non-GAAP gross profits of the company's teleradiology services for the comparable period was $0.8 million, which represents a gross profit margin of approximately 36% on a non-GAAP basis. The increase in the company's revenue from the teleradiology services was mainly attributable to customer retention and increased volume of the company's reading services during the weak day shift.

    同期遠距放射服務收入為 220 萬美元,以 GAAP 計算毛利為 20 萬美元,以 GAAP 計算毛利率約為 11%。同期,該公司遠距放射服務的非 GAAP 毛利為 80 萬美元,以非 GAAP 計算,毛利率約為 36%。公司遠距放射服務收入的成長主要歸因於客戶保留以及公司在疲軟的白班期間閱片服務量的增加。

  • During the reported period, the company generated revenues through the sales of its AI solutions in the amount of $0.4 million as compared to a revenue of $0.1 million in the comparable period, the increase was mainly due to a completion of the project of the installations of our AI solution. During the reported period, the company generated revenue through the sales and deployment of its imaging systems, which amounted to $29,000 with a gross loss of $1.5 million on a GAAP and non-GAAP basis. Those revenue stems from the sales and deployment of the Nano-X ARC systems in the US and the sales of our 2D systems in the rest of the world.

    報告期內,公司透過銷售人工智慧解決方案實現營收40萬美元,而去年同期營收為10萬美元,成長主要是由於AI解決方案安裝專案完成所致。在報告期間內,該公司透過銷售和部署其成像系統獲得了 29,000 美元的收入,以 GAAP 和非 GAAP 計算,毛虧損為 150 萬美元。這些收入來自 Nano-X ARC 系統在美國的銷售和部署以及我們的 2D 系統在世界其他地區的銷售。

  • Research and development expenses net for the reported period were $4.7 million compared to $6.0 million in the comparable period. The decrease of $1.3 million was largely due to a decrease of $0.3 million in salaries and wages. Decrease of $0.4 million in share-based compensation and a decrease of $0.6 million in expenses that are related to other research and development activities. Sales and marketing expenses for the reported period were $0.9 million compared to $1.1 million in the comparable period.

    報告期間的研發費用淨額為 470 萬美元,去年同期為 600 萬美元。減少 130 萬美元主要是因為薪水和工資減少 30 萬美元。股票薪資減少 40 萬美元,與其他研發活動相關的費用減少 60 萬美元。報告期間的銷售和行銷費用為 90 萬美元,而去年同期的銷售和行銷費用為 110 萬美元。

  • General and administrative expenses for the reported period were $5.7 million as compared to $5.0 million in the comparable period. The increase of $0.7 million was mainly due to an increase of $0.5 million in share-based compensation, increase in our legal expenses in the amount of $0.5 million, which was offset by a decrease in the cost of our D&O liability insurance premium in the amount of $0.3 million.

    報告期間的一般及行政費用為 570 萬美元,而去年同期的一般及行政費用為 500 萬美元。增加 70 萬美元主要是由於股權激勵增加 50 萬美元、法律費用增加 50 萬美元,但 D&O 責任保險費成本減少 50 萬美元抵消了這一增加。

  • Our non-GAAP net loss attributable to our ordinary shares for the reported period was $8.7 million as compared to a non-GAAP net loss of $9.4 million in the comparable period. The decrease of $0.7 million was mainly due to a decrease in our non-GAAP operating expenses of $1.8 million, which was offset by a decrease of $1.1 million in our non-GAAP gross profit.

    報告期間內,我們的非 GAAP 普通股淨虧損為 870 萬美元,而同期的非 GAAP 淨虧損為 940 萬美元。減少 70 萬美元主要是因為我們的非 GAAP 營運費用減少 180 萬美元,但被我們的非 GAAP 毛利減少 110 萬美元所抵消。

  • Turning to our balance sheet. As of September 30, 2024, we had cash, cash equivalents, restricted deposits and marketable securities of approximately $57.1 million, and we had $3.4 million loan from a bank. We ended the third quarter of 2024 with a property and equipment net of $44.7 million. As of September 30, 2024, we had approximately 58.5 million shares outstanding.

    轉向我們的資產負債表。截至 2024 年 9 月 30 日,我們擁有約 5,710 萬美元的現金、現金等價物、限制性存款和有價證券,並從銀行獲得了 340 萬美元的貸款。截至 2024 年第三季末,我們的財產和設備淨值為 4,470 萬美元。截至 2024 年 9 月 30 日,我們擁有約 5,850 萬股已發行股票。

  • With that, I will hand the call back over to Erez.

    這樣,我會將電話轉回給埃雷茲。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • As we conclude our discussion today, I'm filled with confidence about the future of Nano-X, our initial deployment of the Nano-X ARC technology across multiple states in the US, along with our expanding footprint in international markets, as being a testament to our unwavering commitment to making advanced medical imaging accessible and affordable worldwide. The positive feedback from health care providers and patients reaffirm their transformative potential of our solution.

    當我們今天結束討論時,我對 Nano-X 的未來充滿信心,我們對 Nano-X ARC 技術在美國多個州的初步部署,以及我們在國際市場上不斷擴大的足跡,作為這證明了我們堅定不移地致力於讓先進的醫學成像在全球範圍內變得易於使用且價格實惠。醫療保健提供者和患者的正面回饋再次證實了我們解決方案的變革潛力。

  • Coupled with a robust infrastructure, we have established this past year we are well positioned to accelerate our progress in 2025. On the regulatory front, we are diligently working with the FDA and European Union bodies to secure the necessary approvals, which will further solidify our position in the market. Our ongoing trials and collaboration with leading health system demonstrates the clinical utility and the value of our AI solutions, paving the way for broader adoption of groundbreaking advancement to medical imaging. We take pride in our robust clinical performance. By prioritizing clinical needs and development efforts in close collaboration with the medical community, we ensure that our innovations are not only advanced but also deeply relevant to those we serve.

    加上強大的基礎設施,我們在過去的一年裡已經做好了充分準備,可以在 2025 年加快進展。在監管方面,我們正在與 FDA 和歐盟機構努力合作,以獲得必要的批准,這將進一步鞏固我們在市場上的地位。我們正在進行的試驗以及與領先的衛生系統的合作證明了我們的人工智慧解決方案的臨床實用性和價值,為更廣泛地採用醫學成像突破性進步鋪平了道路。我們為我們強大的臨床表現感到自豪。透過與醫學界密切合作,優先考慮臨床需求和開發工作,我們確保我們的創新不僅先進,而且與我們所服務的對象密切相關。

  • Our commitment to providing advanced diagnosis imaging capabilities continues to elevate market needs and utilization, setting new standards in the industry. Moreover, we're constantly working to improve and innovate with solutions designed to meet and exceed market expectations.

    我們致力於提供先進的診斷影像功能,不斷提高市場需求和利用率,樹立產業新標準。此外,我們不斷努力改進和創新解決方案,以滿足並超越市場期望。

  • Thank you for your continued support and confidence in our vision, together we will drive significant value for our stakeholders, and make a lasting positive impact on global health care. As always, we welcome your feedback and are happy to meet with the interested investors, please contact our Investor Relations partner at ICR and they will assist.

    感謝您對我們願景的持續支持和信心,我們將共同為利害關係人創造巨大價值,並對全球醫療保健產生持久的正面影響。一如既往,我們歡迎您提供回饋,並很高興與有興趣的投資者會面,請聯繫我們 ICR 的投資者關係合作夥伴,他們將提供協助。

  • With that, operator, let's now open the call for questions.

    接線員,現在讓我們開始提問。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Ross Osborn, Cantor Fitzgerald.

    羅斯·奧斯本,康托·菲茨杰拉德。

  • Ross Osborn - Analyst

    Ross Osborn - Analyst

  • Congrats on the progress. So starting off, how many systems did you deploy in the US during the quarter? and how many were operating. And as a follow-up, what types of imaging centers are adopting?

    祝賀取得的進展。那麼首先,本季您在美國部署了多少系統?以及有多少台正在運作。後續,影像中心採用何種類型?

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • I think it was mentioned altogether, the number was 47. The -- I would say, majority of the medical centers are imaging centers, small and medium. Another part are imaging medical imaging chains that we mentioned, and we added a few right now. And we have a few in hospitals or I would say, multifunctionality medical centers and some chiropractors clinics or orthopedic clinic, altogether in terms of the locations in the place, by far, our pipeline and deal flow is far bigger than what we have indicated, and we continue to work.

    我想這已經全部提到了,數字是 47。我想說的是,大多數醫療中心都是中小型影像中心。另一部分是我們提到的影像醫學影像鏈,我們現在添加了一些。我們在醫院裡有一些,或者我想說的是,多功能醫療中心和一些脊椎按摩師診所或骨科診所,就該地點的位置而言,到目前為止,我們的管道和交易流量遠遠大於我們所表示的,我們會繼續努力。

  • Ross Osborn - Analyst

    Ross Osborn - Analyst

  • Okay. And then looking at placements to date, how has average utilization trended in terms of scans per day or month for ARC?

    好的。然後查看迄今為止的展示位置,ARC 每天或每月掃描的平均利用率趨勢如何?

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • I think it's similar to what we reported last time that in the operating in the places which are operating, this is around the number that we've indicated in the past in working days, seven days -- seven scans per day.

    我認為這與我們上次報告的情況類似,在正在運營的地方的運營中,這大約是我們過去在工作日中表示的數字,即7天——每天7次掃描。

  • Ross Osborn - Analyst

    Ross Osborn - Analyst

  • Okay. And then lastly for us, I'll jump back in queue. You mentioned ongoing conversations with FDA, but could you parse out how those conversations are going? And any updates on ARC-X and then the label extension for full body?

    好的。最後,對我們來說,我會插回隊列。您提到了與 FDA 正在進行的對話,但您能分析一下這些對話的進展嗎?ARC-X 以及全身標籤擴充有什麼更新嗎?

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • As you know, Ross, we don't give any indication on something that is not in our hands. From our point of view and the best we can judge all the information, all the answers, all the questions were answered. From our point of view, the indication is positive. And from the FDA point of view, I don't see a reason why it will not be in the short future.

    如你所知,羅斯,對於不在我們手中的事情,我們不會給出任何指示。從我們的角度和最好的角度來判斷,所有的資訊、所有的答案、所有的問題都得到了解答。從我們的角度來看,這跡像是正面的。從 FDA 的角度來看,我看不出它不會在短期內出現的原因。

  • In terms of the ARC-X, this is something that we are going to submit in a few months, next early next year. And the ARC-X is anyhow scheduled to be deployed sometimes during the next year. I would say, probably second half, if everything goes well. But from the FDA point of view, right now, the process seems to be in line.

    就 ARC-X 而言,這是我們將在幾個月後,也就是明年初提交的東西。無論如何,ARC-X 計劃在明年進行部署。我想說,如果一切順利的話,可能是下半場。但從 FDA 的角度來看,目前流程似乎符合要求。

  • Operator

    Operator

  • Jeffrey Cohen, Ladenburg.

    傑弗裡·科恩,拉登堡。

  • Jeffrey Cohen - Analyst

    Jeffrey Cohen - Analyst

  • So a few questions from our end. Congrats on the progress. I know you called out, can you talk about Europe generally how that may play out throughout the first year or two of commercialization after a CE Mark. Are you anticipating that, that will also become 30 or 40 or 50 commercial folks on the ground across Europe? Or do you imagine that will be more clinical and related to agreements by country as far as distributors.

    我們最後提出幾個問題。祝賀取得的進展。我知道您大聲疾呼,您能否談談歐洲在獲得 CE 標誌後商業化的頭一兩年中可能會如何發揮作用。您是否預計歐洲各地將有 30、40 或 50 名商業人員?或者您認為這會更加臨床,並且與經銷商的國家協議相關。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • So if you remember from what we presented as a strategy for the company for sales and distribution. Europe main -- maybe with the exception of the UK, Europe will be based on distributors, we have already a few agreements with the distributors that were signed. The Medica actually indicated a very high interest from other countries, new distributors. And based on the -- right now, the current indication, I think that I don't want to give a number, but it will be hopefully similar to the one that we currently have, and we're going to deploy. We have already a few purchase orders which are concrete. And once we get the CE, I think we have already a plan or the action plan for the go-to-market is already in place, and we're going to start.

    因此,如果您還記得我們提出的公司銷售和分銷策略的話。歐洲主要—也許除了英國之外,歐洲將以經銷商為基礎,我們已經與經銷商簽署了一些協議。事實上,Medica 表示其他國家的新經銷商表現出非常高的興趣。根據目前的情況,我認為我不想給出一個數字,但希望它與我們目前擁有的、我們將要部署的數字類似。我們已經有一些特定的採購訂單。一旦我們獲得了 CE,我認為我們已經有了一個計劃或進入市場的行動計劃已經到位,我們就要開始了。

  • One of the things which is important with respect to the Europe, we have indicated that we are planning to do another clinical trial in a prominent institution in Europe, which will help us to get clinical samples and have a lot of clinical data to help us to work in Europe. But in terms of the salespeople, our channel management directors, the agreement with the distributors and the contract and the promotion and the marketing, we are already in place, and we are running fast forward. Bear in mind that another country that is related to Australia, which we have already an agreement over there.

    對於歐洲來說,重要的一件事是,我們已經表示,我們計劃在歐洲的一家著名機構進行另一項臨床試驗,這將幫助我們獲得臨床樣本,並有大量的臨床數據來幫助我們前往歐洲工作。但在銷售人員、我們的通路管理總監、與經銷商的協議和合約以及促銷和行銷方面,我們已經就位,並且正在快速前進。請記住,另一個與澳洲有關的國家,我們已經在那裡達成協議。

  • Jeffrey Cohen - Analyst

    Jeffrey Cohen - Analyst

  • Got it. And Eric, carried that over for a moment to APAC and LATAM as far as those territories and walk us through plans there and also talk about the regulatory and who's carrying that burden and where that's being pursued currently besides Mexico and Chile.

    知道了。艾瑞克(Eric)暫時將其轉移到亞太地區和拉丁美洲,直至這些地區,並向我們介紹了那裡的計劃,並討論了監管以及誰承擔了這一負擔,以及除墨西哥和智利外目前正在哪裡尋求這負擔。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • Okay. So LATAM is also going to be based on distributors, the process is already in place in these countries, in Mexico and Chile. So the request for the regulation approvals was already submitted and submitted by the distributors. They carry actually the process. We are in touch with them actually with Mexico, just now it's another call.

    好的。因此,拉丁美洲也將以經銷商為基礎,這項流程已經在墨西哥和智利這些國家實施。因此,監管批准請求已經由經銷商提交。他們實際上承擔了這個過程。我們實際上正在與墨西哥聯繫,只是現在是另一個電話。

  • And it's going to be similar in terms of the efforts that we do there. We have a channel manager that is responsible for this area. The beauty of what we can do is we bring people from Latin America to see the demos that we have in the US in order to take them all the way to Israel. So it's good for them to make a short trip and see the system operating, see the clinical value that we had discussed the economic value that we can contribute, et cetera.

    我們在那裡所做的努力也將是相似的。我們有一位通路經理負責這個領域。我們能做的事情的美妙之處在於,我們讓拉丁美洲的人們來觀看我們在美國進行的演示,然後將他們一路帶到以色列。因此,對他們來說,進行短途旅行並了解系統的運作情況、了解我們討論過的臨床價值、我們可以貢獻的經濟價值等等都是有好處的。

  • Jeffrey Cohen - Analyst

    Jeffrey Cohen - Analyst

  • Okay. That's helpful. And then lastly for us, a quick one. I didn't hear any mention about the Nano-X Connect. Was there any update there or any anticipation for that platform for 25?

    好的。這很有幫助。最後對我們來說,是一個快速的。我沒有聽到任何關於 Nano-X Connect 的提及。該平台是否有任何更新或對 25 月的預期?

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • The -- we'll probably have more clarity on 2025. But right now, I think the next one on the agenda will be Mexico. And that we're going to get orders once we get the approval. We have submitted already a request for regulation approvals in a few other countries for the Connect as well.

    到 2025 年,我們可能會更加清楚。但現在,我認為議程上的下一個將是墨西哥。一旦獲得批准,我們就會收到訂單。我們已經向其他一些國家提交了 Connect 監管批准請求。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Scott Henry, Alliance Global.

    斯科特亨利,全球聯盟。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • For starters, when we think about Europe and the rest of the world, how should we think of that opportunity relative to the US. I know you used to think of all of that comparable to the US as far as potential revenues. But I just wanted to get your thoughts on that.

    首先,當我們考慮歐洲和世界其他地區時,我們應該如何看待相對於美國的機會。我知道您曾經認為就潛在收入而言,所有這些都可以與美國相提並論。但我只是想聽聽你對此的想法。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • I cannot say that we don't have any internal thoughts about it, an indication, what's the split between the US and the rest of the world, and especially Europe. But I would say that I will be smarter to indicate or to give an answer to your question once we get the CE approval. And we know that we can move fast forward. In terms of strategy and the go-to-market, we have definitely -- as we have mentioned a few times last year in 2023, and in 2024, in the beginning when we started the deployment in the US, we have put the US as a priority, mainly because of the FDA approval and the fact that we can get easier access to customer and customer base and to generate big deal flow and the pipeline. And so right now, US would be a priority and Europe will follow after.

    我不能說我們對此沒有任何內部想法,這表明美國與世界其他國家,特別是歐洲之間存在分歧。但我想說,一旦我們獲得 CE 批准,我會更明智地指出或回答您的問題。我們知道我們可以快速前進。在策略和進入市場方面,我們確實——正如我們去年多次提到的,2023 年和 2024 年,當我們開始在美國部署時,我們已經把美國作為優先事項,主要是因為FDA 的批准以及我們可以更輕鬆地接觸客戶和客戶群並產生大筆交易流和管道的事實。因此,目前美國將是首要任務,歐洲將緊跟其後。

  • Ran Daniel - Chief Financial Officer

    Ran Daniel - Chief Financial Officer

  • But Scott, in terms of modeling, you should think about it like the way that we did with the US just we have learned more lessons from the past. So you can think about more efficient.

    但是史考特,在建模方面,你應該像我們對美國所做的那樣思考,只是我們從過去學到了更多。所以你可以考慮更有效率。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Okay. Great. And then I noticed revenues for AI solutions were higher than the trend line, is that a signal that AI solutions revenue should continue to be higher, and is there a little bit of seasonality? Because I know they were strong in third quarter of last year as well. Just trying to get a sense of that line.

    好的。偉大的。然後我注意到人工智慧解決方案的收入高於趨勢線,這是人工智慧解決方案收入應該繼續走高的信號嗎?因為我知道他們去年第三季也很強勁。只是想了解這條線。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • So the first question, I will start, then Ran will continue. The first question is yes. You can anticipate that the number will continue to grow. In terms of seasonality, usually relates to the budget-related decisions, especially in the US, in the public health market. But since part of it is in the UK, and it's not necessarily related to the US budget processes then I wouldn't say that it's a seasonality, there is seasonality impact on this. Ran, would you like to add anything else?

    那麼第一個問題,我開始,然後Ran繼續。第一個問題是肯定的。可以預見,這個數字將會繼續成長。就季節性而言,通常與預算相關的決策有關,尤其是在美國的公共衛生市場。但由於其中一部分是在英國,而且不一定與美國的預算流程相關,所以我不會說這是季節性的,對此有季節性影響。蘭,你還有什麼要補充的嗎?

  • Ran Daniel - Chief Financial Officer

    Ran Daniel - Chief Financial Officer

  • Yes. Thank you. So as we explained in the PR, this -- the increase in the revenue of the AI division was due to a completion of a project of where we installed our solution, as for what the second part of your question is, we do continue to build up our customer base and backlog, whether it's existing or expand the scope with existing customers. So it's not related to seasonality and there's no linear expansion over here, but you do, with this, we do see some expansion in the scope of the businesses the AI division.

    是的。謝謝。正如我們在 PR 中解釋的那樣,人工智慧部門收入的增加是由於我們安裝解決方案的項目的完成,至於你問題的第二部分是什麼,我們確實會繼續建立我們的客戶群和積壓訂單,無論是現有客戶還是擴大現有客戶的範圍。所以它與季節性無關,這裡沒有線性擴張,但你確實看到了人工智慧部門業務範圍的一些擴張。

  • Scott Henry - Analyst

    Scott Henry - Analyst

  • Thank you for the feedback. A final question, which is very much a big picture question. When we think about the revenue trajectory, when do you think we would start to see an inflection point? Would that be the expanded indication? And then obviously, we get Europe coming in. I mean are we thinking kind of middle of 2025, we should start to see kind of that hockey stick upward turn. Just trying to get your sense of when we should look for the inflection point.

    感謝您的回饋。最後一個問題,這是一個大問題。當我們考慮收​​入軌跡時,您認為我們什麼時候會開始看到轉折點?這會是擴展的指示嗎?顯然,我們讓歐洲加入進來。我的意思是,我們認為到 2025 年中期,我們應該開始看到曲棍球棒的向上轉變。只是想讓您了解我們何時應該尋找拐點。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • Ran?

    蘭?

  • Ran Daniel - Chief Financial Officer

    Ran Daniel - Chief Financial Officer

  • Yes. So without specifying any specific point of time, it's connected for various factors. Of course, first of all, and the clinical value of our devices, the commercialization -- it's -- of course, it's also related to expanding the fluencies for the general use in the US and the CE Mark, so it's really a combination of many things, which we hope that will come to fruition in the near future.

    是的。因此,在沒有指定任何特定時間點的情況下,它與多種因素有關。當然,首先,我們的設備的臨床價值,商業化——當然,它也與擴大美國通用性和CE標誌的流暢性有關,所以它實際上是一個組合我們希望在不久的將來能夠實現許多事情。

  • Erez Meltzer - Chief Executive Officer, Director

    Erez Meltzer - Chief Executive Officer, Director

  • I would actually look at it more -- not as an inflection point, but more of a kind of milestones that each one of them can make it be a game changer. So one will be the chest and the full body. Another one will be the CE later on, sometimes 2025, the FDA approval of the ARC-X, the ARC-X launch. So we have a lot of milestones along the way that each one of them will be a game changer. That's the way at least we see it internally. .

    實際上,我會更多地看待它——不是將其視為拐點,而是將其視為一種里程碑,其中每個里程碑都可以使其成為遊戲規則的改變者。所以其中一個就是胸部和全身。另一個是稍後,有時是 2025 年,FDA 批准 ARC-X,ARC-X 發布。因此,我們一路走來有很多里程碑,其中每一個都將成為遊戲規則的改變者。至少我們內部是這麼看的。。

  • Operator

    Operator

  • I am showing no further questions at this time, and I do want to thank you for participating today's call, and you may now disconnect.

    我目前沒有提出任何進一步的問題,我確實要感謝您參加今天的電話會議,您現在可以斷開連接。