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
Good day, and thank you for standing by. Welcome to the Nano-X second-quarter 2024 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
美好的一天,感謝您的支持。歡迎參加 Nano-X 2024 年第二季財報電話會議。(操作員指示)請注意,今天的會議正在錄製中。
I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor Relations. Please go ahead.
我現在想把會議交給今天的演講者,投資者關係部的 Mike Cavanaugh。請繼續。
Mike Cavanaugh - IR
Mike Cavanaugh - IR
Good morning, and thank you for joining us today. Earlier today, Nano-X Imaging Ltd., released financial results for the quarter ended June 30, 2024. The release is currently available on the Investors section of the company's website.
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 6 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。
With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman; and Ran Daniel, Chief Financial Officer.
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. 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.
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。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。
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 non-GAAP other expenses or income and non-GAAP gross loss per share.
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、非GAAP 研發費用、非GAAP 銷售和行銷費用、非GAAP 一般和管理費用、非GAAP 其他費用或收入以及非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. And as always, we appreciate your continued support of Nano-X and our mission.
感謝您今天加入我們。一如既往,我們感謝您對 Nano-X 和我們使命的持續支持。
2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts as we continue to expand our deployment in the US and the rest of the world. We are not only accelerating deployment of the Nanox.ARC system, but also expanding the footprint of the other value-added elements of the full Nanox solution, including Nanox.AI. As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing investments in the coming periods.
2024 年是商業強勁進展的時期,同時隨著我們繼續擴大在美國和世界其他地區的部署,我們的臨床工作也提高了我們產品的價值。我們不僅加速 Nanox.ARC 系統的部署,而且還擴大整個 Nanox 解決方案的其他增值元素的覆蓋範圍,包括 Nanox.AI。正如之前的電話會議中所提到的,我致力於提供有關我們在未來一段時間內正在進行的投資的進一步見解和詳細更新。
I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advancements, commercial deployments, Nanox.AI updates and an introduction to our new Nanox.ARC system, which we'll call Nanox.ARC X. After my prepared comments, I'll turn the call over to our CFO, Ran, who will review our Q2 financial results. I will then share a few closing thoughts before turning the call over to the Q&A session. We have a lot to discuss, so let's get started.
我將首先討論我們最近的成就,其中包括監管更新、臨床進展、商業部署、Nanox.AI 更新以及我們新的 Nanox.ARC 系統(我們將其稱為 Nanox.ARC X)的介紹。後,我會將電話轉給我們的財務長Ran,他將審查我們第二季的財務業績。然後,在將電話轉入問答環節之前,我將分享一些結束語。我們有很多事情要討論,所以讓我們開始吧。
Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510(k) submission to the FDA, which is intended to expand the indications for our current Nanox.ARC system in general tomosynthesis imaging. Once cleared, the submission will significantly expand the systems indication for use from the current MSK, for general use, including chest.
在概述我們的商業進展之前,我將首先介紹一些臨床和監管更新,我們相信這些更新將對我們的商業努力產生近期積極影響。我很高興與大家分享,就在上週,Nano-X 向 FDA 提交了一份新的 510(k) 申請,旨在擴大我們目前的 Nanox.ARC 系統在普通斷層合成成像中的適應症。一旦獲得批准,提交的內容將顯著擴展當前 MSK 的系統適應症,用於一般用途,包括胸部。
As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nanox.ARC for chest indications and was intended to support the submission. The submission will include some software updates and is accompanied by new clinical data for various body anatomies with and without pathologies. To be clear, it is worth noting that all card-installed Nanox.ARC systems are hardware ready and have the required capabilities to scan MSK, chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post FDA clearance, a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nanox.ARC units up to the new standards.
如您所知,我們最近進行的大部分臨床工作都集中在 Nanox.ARC 對胸部適應症的適用性上,旨在支持提交。提交的內容將包括一些軟體更新,並附有針對有或沒有病理的各種身體解剖結構的新臨床數據。需要明確的是,值得注意的是,所有安裝卡的 Nanox.ARC 系統均已準備好硬件,並具有掃描 MSK、胸部和腹部所需的功能,但需獲得 FDA 許可和必要的監管批准。這意味著在 FDA 批准後,只需進行可遠端完成的簡單軟體升級即可使目前部署的 Nanox.ARC 裝置達到新標準。
Additionally, after completing the technical stages, including obtaining the ISO 13485 certification from BSI and successfully passing the MDR audit. We are now in advanced stages with our Notified Body to secure the CE mark for the EU region. Rest assured, we will provide updates as soon as they are available.
此外,在完成技術階段後,包括獲得 BSI 的 ISO 13485 認證並成功通過 MDR 審核。我們現在正與我們的公告機構合作,以確保獲得歐盟地區的 CE 標誌。請放心,我們將在有更新後立即提供更新。
Turning now to our global deployment and commercial efforts which continued in the next second quarter, our team is diligently working with imaging centers, physicians and regulators to increase footprint of our Nanox.ARC technology. As of today's call, there are now dozens of units in various stages of shipment and deployment. The deployments in the US are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan.
現在轉向我們在下一個第二季度繼續進行的全球部署和商業努力,我們的團隊正在與成像中心、醫生和監管機構努力合作,以擴大我們 Nanox.ARC 技術的覆蓋範圍。截至今天的電話會議,目前已有數十台設備處於不同的運輸和部署階段。美國的部署分佈在七個州,最新的是特拉華州和加利福尼亞州,正在等待州政府的批准,隨著我們的商業團隊執行我們的部署和增長計劃,我們預計這一數字將會增加。
To give more color on our US deployment, I would like to add that during the second quarter, we have installed Nanox.ARC system in three prominent healthcare chains operating imaging facilities across the US, including one of the largest in the industry. Additionally, in the US, some of the deployed sites have received certification from the corresponding state regulatory body and have begun to scan patients. Others are in the process of obtaining approval.
為了讓我們在美國的部署更加豐富多彩,我想補充一點,在第二季度,我們在美國運營成像設施的三個著名醫療連鎖店安裝了 Nanox.ARC 系統,其中包括業內最大的醫療連鎖店之一。此外,在美國,一些部署的站點已獲得相應州監管機構的認證,並已開始對患者進行掃描。其他人正在獲得批准。
This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day. We recently received good indications for validation of the US CPT and reimbursement process as we received management care EOB. Since March 2024, we have been ramping up in the US with current targeted backlog of 50 favorable prospects and additional 44 leads in the pipeline.
這種商業掃描活動正在加速。例如,截至今天,其中一個網站每天顯示多達 14 次掃描。最近,當我們接受管理護理 EOB 時,我們收到了美國 CPT 和報銷流程驗證的良好跡象。自 2024 年 3 月以來,我們一直在美國加大力度,目前的目標是積壓 50 個有利的潛在客戶,並有 44 個潛在客戶正在籌備中。
With the main segments being outpatient imaging centers, medical imaging chains and orthopedic centers. We understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period, and we are very confident that this will continue to grow over time. We are also awaiting the import license to deploy the first Nanox.ARC in Mexico with the systems ready for shipment.
主要細分市場為門診影像中心、醫學影像連鎖店及骨科中心。我們知道並非所有這 94 個潛在客戶都會轉化,但我對我們的商業團隊在如此短的時間內取得的進展感到非常滿意,並且我們非常有信心隨著時間的推移,這將繼續增長。我們也正在等待進口許可證,以便在墨西哥部署第一個 Nanox.ARC,系統已準備好出貨。
Additionally, there are two units fully deployed in Israel, and another deployment is expected in the upcoming months for both clinical and commercial use. We're able to pursue this opportunity as we obtained AMAR approval several months ago. Importantly, the number of daily scans is accelerating. And in last July, we experienced an average of 6.67 scans globally for all deployed Nanox.ARC system, accomplishing both clinical work and commercial patient scans.
此外,還有兩個裝置已在以色列全面部署,預計未來幾個月還將部署另一個裝置,用於臨床和商業用途。幾個月前我們獲得了 AMAR 批准,因此我們能夠抓住這個機會。重要的是,每日掃描的數量正在加速。去年 7 月,我們對所有部署的 Nanox.ARC 系統在全球平均進行了 6.67 次掃描,完成了臨床工作和商業患者掃描。
I think it is interesting to learn that the global commercial and clinical scans by body part are distributed as follows: 31% chest; 25% hand; 14% leg; and 14% spine. But of course, these indications may vary from over time. For those of you that are interested, we also have some new clinical samples on our website, including chest pathology. To support our accelerating deployments effort, we continued to strengthen our team and infrastructure during the quarter, adding to our US sales and technical teams.
我認為有趣的是,全球商業和臨床掃描按身體部位分佈如下: 31% 胸部;31% 胸部; 25%手牌; 14% 腿部;和 14% 的脊椎。但當然,這些跡象可能會隨著時間的推移而改變。對於有興趣的人,我們的網站上還提供了一些新的臨床樣本,包括胸部病理學。為了支持我們加速部署工作,我們在本季繼續加強我們的團隊和基礎設施,增加了我們的美國銷售和技術團隊。
Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaboration in the country. Our mission is to provide healthcare practices with a transformative imaging advantage with a Nanox.ARC, an accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. We are working to accelerate a steady flow of referrals from healthcare providers for Nanox.ARC digital tomography imaging as part of their diagnostic workflow.
展望未來,Nano-X 致力於加速我們在該國的商業基礎設施和未來戰略合作的執行。我們的使命是透過 Nanox.ARC 為醫療保健實踐提供變革性成像優勢,這是一種經濟高效的解決方案,不僅提供先進的診斷成像功能,而且還提升整體患者護理水平。我們正在努力加速醫療保健提供者對 Nanox.ARC 數位斷層掃描成像的穩定轉診,作為其診斷工作流程的一部分。
We also continue to advance our other clinical efforts in multiple countries and locations, generating data, demonstrating the utility of the Nanox.ARC for a fuller, wider range of indications is a key initiative for Nano-X. The reason is simple, if we can show large volumes of data demonstrating the value-added utility of the Nanox.ARC, it will significantly boost our all important commercial efforts. For example, the Beilinson Hospital in Israel has been scanning patients for exactly this reason. And this trial has begun to generate data. There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies.
我們也持續推動在多個國家和地區的其他臨床工作,產生數據,證明 Nanox.ARC 在更全面、更廣泛的適應症方面的實用性是 Nano-X 的關鍵舉措。原因很簡單,如果我們能夠展示大量數據來證明 Nanox.ARC 的增值效用,它將顯著促進我們所有重要的商業努力。例如,以色列貝林森醫院正是因為這個原因對病人進行掃描。而這個試驗已經開始產生數據。作為本研究和多中心研究的一部分,我們的臨床中心已招募了數十名患者。
The previously announced multisite trial is now operational, and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multisite trial as the second participating site while already gaining clinical experience with the Nanox.ARC installed in scanning patients. The multisite trial held at Shamir Hospital has been completed and a company white paper published recently. The study concluded that the Nanox.ARC was a value-added tool in the hospital's clinical workflow, enabling quicker diagnosis when used as a supplemental tool to the standard x-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow.
先前宣布的多站點試驗現已投入運行,我們正在加快患者掃描活動。UGMC 正在為作為第二個參與點加入多站點試驗做最後的準備,同時已經獲得了在掃描患者中安裝 Nanox.ARC 的臨床經驗。在沙米爾醫院進行的多站點試驗已經完成,並於最近發布了公司白皮書。研究得出的結論是,Nanox.ARC 是醫院臨床工作流程中的增值工具,用作標準X 光系統的補充工具時,可以實現更快的診斷,與基於CT 的標準工作流程相比,實現更快的診斷時間。
Furthermore, all Nanox.ARC images were determined to be of high diagnostic quality, enabling optimal depiction of findings. Our technology can increase depiction of occult chest lesions, localized characterized and resolve questionable lesions even without prior audiologist experience cold cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose, cost and images per study should be further investigated. For more information, see more our white paper section on our website.
此外,所有 Nanox.ARC 影像均被確定為具有高診斷質量,從而能夠最佳地描述結果。我們的技術可以增加對隱匿性胸部病變的描述、局部特徵描述並解決可疑病變,即使沒有聽力學家先前的經驗,與 CXR 相比,冷陰極 PTS 可能具有更高的診斷準確性。其以每項研究的輻射劑量、成本和影像的一小部分消除 CT 需求的能力應進一步研究。欲了解更多信息,請參閱我們網站上的白皮書部分。
Turning to our AI business, just last month, we announced that our Nanox.AI cardiac solution called HealthCCSng was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI cardiac solution and esteemed healthcare systems, along with a continued validation through real-world studies of its potential to promote early detection, and preventive care of cardiovascular diseases.
談到我們的人工智慧業務,就在上個月,我們宣布我們名為 HealthCCSng 的 Nanox.AI 心臟解決方案在 2024 年心血管電腦斷層掃描學會 SCCT 年會上的多個科學演講中得到強調。我們對人工智慧心臟解決方案和受人尊敬的醫療保健系統的實施以及透過現實世界研究不斷驗證其促進心血管疾病早期檢測和預防性護理的潛力感到鼓舞。
Corewell Health, as previously reported that in the first full year of implemented HealthCCSng in its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years. At Beilinson Hospital in Israel, incidental coronary artery calcification on the CT scans of immune-mediated inflammatory disease patients identify and quantify by our AI cardiac solution was found in over 50% of scan patients and associated with all cause mortality and adverse cardiovascular outcome. Traditional cardiovascular risk scoring is difficult in these patients and Nanox.AI can be a valuable new tool in quantifying these risks.
Corewell Health先前曾報導稱,在其電子病歷系統中實施HealthCCSng的第一個全年,報告的患者數量比前兩年增加了13倍。在以色列Beilinson 醫院,免疫介導的發炎性疾病患者的CT 掃描中,超過50% 的掃描患者發現了偶然的冠狀動脈鈣化,並透過我們的AI 心臟解決方案進行了識別和量化,並且與全因死亡率和不良心血管結局相關。傳統的心血管風險評分對於這些患者來說很困難,而 Nanox.AI 可以成為量化這些風險的有價值的新工具。
After being installed and implemented at the Jefferson Einstein Hospital, HealthCCSng help identify 757 patients, aged 30 or above with CAC levels higher than 100 Agatston units. In a study conducted by Mass Gen Hospital and Brigham and Women's Hospital, HealthCCSng was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein A as part of the clinical care. A statistically significant correlation was founded between level of CAC and this lipoprotein A, the risk factor for coronary atherosclerosis suggesting that this approach may be used to identify at-risk patients. As a signed out, the lead author of this study, Brittany Weber was declared as Young Investigator Award Winner at the Annual Meeting as well.
在 Jefferson Einstein 醫院安裝和實施後,HealthCCSng 協助識別了 757 名年齡在 30 歲或以上、CAC 水準高於 100 Agatston 單位的患者。在 Mass Gen 醫院和布萊根婦女醫院進行的一項研究中,使用 HealthCCSng 分析了 260 名患者的非對比胸部 CT 掃描,作為臨床護理的一部分,這些患者進行了脂蛋白 A 測量。CAC 水平與脂蛋白 A(冠狀動脈粥樣硬化的危險因子)之間存在統計上顯著的相關性,表明這種方法可用於識別高風險患者。作為這項研究的主要作者,布列塔尼·韋伯 (Brittany Weber) 在年會上也被宣佈為青年研究員獎得主。
Nano-X is proud to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nanox.AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcome. Additionally, the previous agreements we signed for Nanox.AI with Covera Health and Dandelion Health are off to a great start, and the feedback has been very positive thus far.
Nano-X 很自豪能夠與充滿活力的臨床人才合作,他們正在做有價值的工作來支持Nanox.AI 解決方案的使用,以在護理連續過程的早期識別潛在的健康風險,並幫助推動更好的整體患者治療結果。此外,我們先前與 Covera Health 和 Dandelion Health 為 Nanox.AI 簽署的協議已經有了一個良好的開端,迄今為止的反饋非常積極。
We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solutions and ensuring they reach and benefit a wider audience. I think I can speak of all of us at Nano-X when I say there is a lot to be excited about.
我們不斷努力擴大我們的人工智慧足跡,讓更廣泛的客戶能夠使用它。我們持續的創新和開發工作的重點是增強我們的人工智慧解決方案,並確保它們惠及更廣泛的受眾並使其受益。當我說有很多值得興奮的事情時,我想我可以指的是 Nano-X 的所有人。
Looking ahead to the near future of Nano-X, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long term with the new technology needs to constantly refine their offering based on customer feedback, changes in technology and evolving use case. Nano-X is no different, and we are constantly working on product and technology future developments. I'm very pleased to share for the first time that we are developing another Nanox system called Nanox.ARC X, which we intend to submit, among others for FDA clearance.
展望 Nano-X 不久的將來,我們始終致力於改進並滿足市場需求。事實上,每家計劃利用新技術長期快速擴張的充滿活力的公司都需要根據客戶反饋、技術變化和不斷發展的用例不斷完善其產品。Nano-X 也不例外,我們不斷致力於產品和技術的未來發展。我很高興第一次與大家分享,我們正在開發另一個 Nanox 系統,名為 Nanox.ARC X,我們打算將系統提交給 FDA 批准。
Once cleared, it will be marketed along the current system, which will expand our current product offering. At the high level, the Nanox.ARC X is designed to meet market needs of our customers, including hospitals and imaging centers as well as our clinical partners who are using the Nanox.ARC to generate data for additional use cases. Listening to the clinical needs is an important step in the ongoing expansion of Nanox solution. Amongst the feature, I'm able to share at this time that Nanox.ARC X will have an even smaller footprint than existing Nanox.ARC systems, enhancing one of our key differentiators.
一旦獲得批准,它將沿著當前系統進行行銷,這將擴大我們目前的產品範圍。從高層次來看,Nanox.ARC X 旨在滿足我們客戶的市場需求,包括醫院和影像中心以及我們使用 Nanox.ARC 為其他用例產生資料的臨床合作夥伴。傾聽臨床需求是 Nanox 解決方案持續擴展的重要一步。在這些功能中,我現在可以分享的是,Nanox.ARC X 的佔地面積將比現有 Nanox.ARC 系統更小,從而增強了我們的關鍵優勢之一。
The new system will also be easy to deploy and use with an anticipated one-day setup time and plug-and-play functionality. There will also be image enhancement options in the new units, which are currently not available on existing Nanox.ARC systems and future synthetic 2D. Please note that we are planning to share more detail about the future Nanox.ARC system publicly during our next event, which will also be made available via our website. Stay tuned for further detail.
新系統也易於部署和使用,預計一天的安裝時間和即插即用功能。新裝置中還將提供影像增強選項,這些選項目前在現有的 Nanox.ARC 系統和未來的合成 2D 上不可用。請注意,我們計劃在下次活動期間公開分享有關未來 Nanox.ARC 系統的更多細節,這些細節也將透過我們的網站提供。請繼續關注更多詳情。
To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the US government entity towards completion of a novel tube design, utilizing our emitter and focused on the entity space. We are optimistic we will move towards prototyping tubes in the second half of this year. Regarding our teleradiology services, we are leveraging our USA RAD client based on a network of radiologists as a significant part of our US deployment plan.
為了談到我們的 OEM 工作,我可以報告說,我們與美國政府實體的開發計劃的第一階段正在順利進行,以利用我們的發射器並專注於實體空間來完成新穎的管設計。我們樂觀地認為,我們將在今年下半年轉向原型管。關於我們的遠端放射學服務,我們正在利用基於放射科醫生網路的 USA RAD 客戶端作為我們美國部署計劃的重要組成部分。
On the mass production front, we have finalized the second phase of our development with CSEM, resulting in a high-yield wafers in functional emitters. We are transitioning to the production readiness and confident we have secured a second source of supply for our novel emitters. Varex has completed their initial tubes prototype utilizing emitter for testing to be integrated into our new Nanox.ARC. I've covered a lot of ground today.
在量產方面,我們已經完成了 CSEM 開發的第二階段,從而生產了功能性發射器的高良率晶圓。我們正在過渡到生產準備階段,並相信我們已經為我們的新型發射器獲得了第二個供應來源。Varex 已經完成了利用發射器進行測試的初始管原型,並將其整合到我們的新 Nanox.ARC 中。今天我已經介紹了很多內容。
So with that, I'll hand the call over to Ran Daniel to review our financials. Ran?
因此,我會將電話轉交給 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.
謝謝你,埃雷茲。
We reported a GAAP net loss for the second quarter of 2024 of $13.6 million, which I will refer to as the reported period compared with a net loss of $17.4 million in the second quarter of 2023, which I'll refer to as the comparable period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses, and a decrease of $1.7 million in the general and administrative expenses, an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.
我們報告的 2024 年第二季 GAAP 淨虧損為 1,360 萬美元,我稱之為報告期間,而 2023 年第二季的淨虧損為 1,740 萬美元,我將其稱為可比期間。減少的主要原因是研發費用減少了 210 萬美元,一般和管理費用減少了 170 萬美元,公司財務收入增加了 50 萬美元,但增加了 1.2 美元,抵消了這一影響。 。
Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a GAAP basis, compared to a revenue of $2.6 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 $0.9 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 9% on a non-GAAP basis for the reported period as compared to a gross profit margin of 34% on a non-GAAP basis in the comparable period.
以 GAAP 計算,報告期間的收入為 270 萬美元,毛虧損為 290 萬美元,而同期以 GAAP 計算的收入為 260 萬美元,毛虧損為 170 萬美元。報告期間的非 GAAP 毛虧損為 90 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 9%:相比之下,同期按非公認會計準則計算的毛利率為34%。
Revenue from the teleradiology services for both the reported period and comparable period was $2.5 million with a gross profit of $0.4 million on a GAAP basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a GAAP basis for the reported and comparable periods. Non-GAAP gross profit of the company's teleradiology services for the reported and comparable periods was $0.9 million, which represents a gross profit margin of approximately 36% on a non-GAAP basis.
報告期間和可比較期間的遠距放射服務收入均為 250 萬美元,報告期間和可比較期間以 GAAP 基準計算的毛利為 40 萬美元,這意味著以 GAAP 基準計算的毛利率約為 15%。和可比期。報告期間內和可比較期間,該公司遠距放射學服務的非 GAAP 毛利為 90 萬美元,以非 GAAP 計算,毛利率約為 36%。
During the reported period, the company generated revenues through the sales of its AI solutions in the amount of $113,000 and as compared to revenue of $53,000 in the comparable period. During the reported period, the company generated revenues through the sales and deployment of its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a GAAP and non-GAAP basis. Those revenues stem from the sale and deployment of the Nanox.ARC systems in the US and the sales of our 2D systems in Africa.
在報告期間內,該公司透過銷售人工智慧解決方案產生的收入為 113,000 美元,而同期收入為 53,000 美元。在報告期間內,該公司透過銷售和部署其成像系統獲得了 68,000 美元的收入,以 GAAP 和非 GAAP 計算,毛虧損為 130 萬美元。這些收入來自 Nanox.ARC 系統在美國的銷售和部署以及我們在非洲的 2D 系統的銷售。
Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages, a decrease of $0.2 million in share-based compensation and a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities.
報告期間的研發費用為 480 萬美元,而去年同期的研發費用為 690 萬美元。減少 210 萬美元主要是因為薪水和工資減少 120 萬美元、股權激勵減少 20 萬美元以及與研發和監管活動相關的費用減少 70 萬美元。
Sales and marketing expenses for the reported and comparable periods were $0.8 million.
報告期間和可比較期間的銷售和行銷費用為 80 萬美元。
General and administrative expenses for the reported period were $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation, and the settlement of the class action and a decrease in the cost of directors and officers liability insurance premium in the amount of $0.4 million.
報告期間的一般及行政費用為 590 萬美元,而同期的一般及行政費用為 760 萬美元。減少 170 萬美元主要是由於我們的法律費用減少了 160 萬美元,這主要是由於 SEC 調查的最終完成、集體訴訟的和解以及董事和董事費用的減少官員責任保險費金額為 40 萬美元。
Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million as compared to a non-GAAP net loss of $9.9 million in the comparable period. The decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses of $2.2 million and an increase of $0.5 million in our non-GAAP interest income, 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 840 萬美元,而同期非 GAAP 淨虧損為 990 萬美元。減少 150 萬美元主要是由於非 GAAP 營運費用減少 220 萬美元以及非 GAAP 利息收入增加 50 萬美元,但被非 GAAP 毛利減少 110 萬美元所抵消。
Turning to our balance sheet, as of June 30, 2024, we had cash, cash equivalents, restricted deposits and marketable securities of approximately $64.2 million and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million. As of June 30, 2024, we had approximately 58.5 million shares outstanding.
轉向我們的資產負債表,截至 2024 年 6 月 30 日,我們擁有約 6,420 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 320 萬美元的貸款。截至 2024 年第二季度,我們的財產和設備淨值為 4,450 萬美元。截至 2024 年 6 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
Thank you, Ran.
謝謝你,蘭。
As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nanox.ARC system as well as integrating Nanox.AI solution into medical workflow. Our vision is to extend Nanox technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics. We deliver a seamless scan-to-diagnosis solution, leveraging AI for smarter more efficient healthcare with a focus on aligning innovation with clinical needs to enhance patient outcome globally.
進入 2024 年下半年,我們的團隊仍然專注於執行我們的成長策略,繼續將 Nanox.ARC 系統商業化,並將 Nanox.AI 解決方案整合到醫療工作流程中。我們的願景是將 Nanox 技術擴展到醫院內外,針對急診室和骨科診所等服務不足的領域。我們提供無縫的掃描到診斷解決方案,利用人工智慧實現更智慧、更有效率的醫療保健,重點是將創新與臨床需求結合起來,以提高全球患者的治療效果。
Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the US. Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC, an accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.
Nano-X 致力於加速我們在美國的商業基礎設施和未來策略合作的執行。我們的使命是透過 Nanox.ARC 為醫療保健實踐提供變革性成像優勢,這是一種經濟高效的解決方案,不僅提供先進的診斷成像功能,而且還提升整體患者護理水平。
Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers and shareholders for their support of Nano-X and our mission. As always, I'm available to meet with you and look forward to sharing the insights of Nanox.ARC X and the upcoming events.
在結束今天的演講之前,我要感謝我的同事、客戶和股東對 Nano-X 和我們使命的支持。一如既往,我可以與您會面,並期待分享 Nanox.ARC X 和即將舉行的活動的見解。
With that, operator, let's now open the call for questions. Operator, can you pause for a second? I'd like to make one more comment.
接線員,現在讓我們開始提問。接線員,您能暫停一下嗎?我想再發表一項評論。
So in addition to everything we said, I'm happy to announce that as just today, we received another FDA clearance for the HealthCCSng version 2.0, which is an upgraded version of advanced AI cardiac solution, empowering physicians in assessment of coronary artery calcium. The HealthCCSng version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium categorization of coronary calcium, CAC and generates an exact calcium score with corresponding CAC detection category in output. For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution. So thank you.
因此,除了我們所說的一切之外,我很高興地宣布,就在今天,我們的HealthCCSng 2.0 版再次獲得FDA 批准,這是先進人工智慧心臟解決方案的升級版本,使醫生能夠評估冠狀動脈鈣。HealthCCSng 2.0版是心臟解決方案的升級版,引入了冠狀動脈鈣CAC的額外零鈣分類,並在輸出中產生精確的鈣分數以及相應的CAC檢測類別。對我們來說,我們的人工智慧心臟解決方案獲得 FDA 的進一步監管驗證是非常高興的。所以謝謝你。
And with that, now we will open the call for questions.
現在我們將開始提問。
Operator
Operator
(Operator Instructions) Jeffrey Cohen, Ladenburg.
(操作員說明)Jeffrey Cohen,拉登堡。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
So I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke about 50 on sales and 34 on leads. Could you give us a sense of where these units are? I imagine they are mostly domestic US. And how that funnel looks for actually placements and training over the coming quarters?
所以我想知道,首先,當您談到銷售方面的 50 項和潛在客戶方面的 34 項時,您能否詳細介紹一下您的積壓工作以及想像。您能為我們介紹一下這些單位的位置嗎?我想他們大多是美國國內的。該管道如何尋找未來幾季的實際安置和培訓?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
Okay. So I think that we mentioned last time, the number of 20; right now, the number was growing to more than triple, as you can imagine, in various stages of deployment. We have a few dozens which are already deployed.
好的。所以我想我們上次提到的20個這個數字;現在,正如您可以想像的那樣,在不同的部署階段,這個數字已經增長到三倍以上。我們已經部署了幾十個。
A few that are waiting for approval, regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals. And we believe that the indication that we gave, which 50 of them are probably favorable to be installed and 44 in the leads in the beginning of the process, we are getting to the targeted that we wanted to be by the end of the year, and that's where we are.
有一些正在等待批准、監管和州批准,因為它們分佈在七個州,最後兩個州正在等待批准。我們相信,根據我們給出的指示,其中 50 個可能有利於安裝,44 個在流程開始時處於領先地位,我們正在實現我們希望在年底之前達到的目標,這就是我們現在的處境。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay, got it. And then congratulations on the news today for a calcium score. Could you talk a little bit about these other 510(k) indications? And for general tomo as well in addition to general testing. Could you talk about the codes associated with them as far as reimbursement at facilities?
好的,明白了。然後恭喜今天獲得鈣分數的消息。能談談其他 510(k) 適應症嗎?除了一般測試之外,也適用於一般 Tomo。能談談與設施報銷相關的代碼嗎?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
Okay. So with -- maybe I'll start with the end. With the reimbursement right now, what we speak about the reimbursement is based on the tomo CPT code, which is 76100. And this is the basis for the reimbursement of those that submitted their scans to -- for the reimbursement. We have received only already indications from more than -- from two, I think, that insurance insurers. And this continues to grow.
好的。所以——也許我會從結尾開始。現在報銷,我們所說的報銷是根據tomo CPT代碼,即76100。這是向那些提交掃描的人報銷的基礎——報銷。我們只收到了超過兩家保險保險公司的指示。而且這種情況還在持續成長。
The numbers that were received are in line of the model that we put together. So basically, right now, it seems that for the clinics and the sites that the system is installed, it's -- the model is profitable. With respect to the 510(k), so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar -- it's a line of what we have indicated in the past that we are going to submit this year the additional clinical indications, especially the chest. We decided that we're going to submit it for whole body, so including the chest, not only but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan the whole body and basically everything.
收到的數字與我們匯總的模型一致。所以基本上,現在看來,對於安裝該系統的診所和場所來說,該模型是有利可圖的。關於 510(k),除了我們今天收到的新的 CCS 或鈣評分之外,我們還提交了類似的內容——這是我們過去表示的一行內容,我們將要今年提交了額外的臨床適應症,尤其是胸部。我們決定提交整個身體,包括胸部,不僅如此,而且當我們獲得許可時,即使在美國,不僅在世界其他地方,我們也能夠掃描整個身體,基本上是一切。
Bear in mind that in the rest of the world and especially part of the others and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body, and we are using it to all the clinical indications, based on this indication I gave -- in this call today, I gave indication of the spread between the various body anatomies or body parts that were received and I gave the percentage that we have on a global basis. And you can see the chest is a major part of them.
請記住,在世界其他地方,尤其是其他部分地區,包括 CE 的提交,我們正在使用這樣一個事實:硬體是為整個身體做好準備的,我們將它用於所有臨床適應症,基於我給出的指示——在今天的電話會議中,我給出了收到的各種身體解剖結構或身體部位之間的傳播情況,並給出了我們在全球基礎上的百分比。而且你可以看到胸部是他們的主要部分。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
And then one more, if I may. Could you talk a little bit more about the ARC X platform and perhaps its form factor and differences versus the current platform and the intended commercial presence that you anticipate as compared to the current platform?
如果可以的話,再來一張。您能否多談談 ARC X 平台,或許還有它的外形尺寸以及與當前平台的差異,以及您預期與當前平台相比的預期商業存在?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
So first of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter. We are, of course, going to submit it to the FDA. And after the FDA clearance, it will be marketed as long -- along the current system, which will expand our current product offering.
首先,我們將在下一個季度末和下個季度初提供更多細節。當然,我們將把它提交給 FDA。在獲得 FDA 批准後,它將沿著當前系統進行長期銷售,這將擴大我們目前的產品範圍。
And we mentioned a few times in the past that the ARC or the first version, 2.2, is not the first product and definitely not the last and we have in line a real product road map for the future. ARC X is one of them. We will give more indications, but I think that. The idea is to make the ARC X available to more specific locations or sites that are more suitable for the spec of the system.
我們過去曾多次提到,ARC 或第一個版本 2.2 不是第一個產品,也絕對不是最後一個產品,我們已經為未來制定了真正的產品路線圖。ARC X 就是其中之一。我們會給出更多的指示,但我認為是這樣。其想法是使 ARC X 可用於更適合系統規格的更具體的位置或站點。
We are talking about footprint. We are talking about -- first of all, even for us, it's the cost of manufacturing, the return on investment, the features. And the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features, to be installed remotely. So we don't have to send technicians to do it. It's download from the network.
我們正在談論足跡。我們談論的是——首先,即使對我們來說,也是製造成本、投資回報和功能。它的美妙之處在於,每當我們要安裝它時,我們都會啟用軟體和功能附帶的所有功能,以進行遠端安裝。所以我們不用派技術人員去做。是從網路下載的。
Operator
Operator
Scott Henry, AGP.
斯科特·亨利,AGP。
Scott Henry - Analyst
Scott Henry - Analyst
Just a couple of questions. Congratulations on getting the 510(k) application in for the general use in chest indication. Could you give thoughts on what you would expect the review time line to be for that indication? What is it typically in this case? Just to get a sense of when we may get final approval.
只是幾個問題。恭喜您獲得 510(k) 應用程序,用於胸部指示的一般用途。您能否談談您對該適應症的預期審查時間表?這種情況通常是什麼情況?只是為了了解我們何時可以獲得最終批准。
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
First of all, I hope that I understand the question, so I'll give the answer and if not, you'll tell me. Bear in mind that up until now, all revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK -- MSK, spine, hand, leg, et cetera, and not chest. We all know that the chest is the most common use of x-ray and especially when we talk about the tomosynthesis.
首先,我希望我明白這個問題,所以我會給出答案,如果你不明白,你會告訴我。請記住,到目前為止,在美國安裝的數十個系統中進行的所有收入和掃描主要是 MSK——MSK、脊椎、手、腿等,而不是胸部。我們都知道胸部是 X 光最常見的用途,尤其是當我們談論斷層合成時。
So we expect that once we get the clearance, it will definitely increase the likelihood of sites and customers to take the ARC -- and more than that, that the -- in the sites that the system is going to be -- ARC is going to be installed, it will increase the number of scans per day because it will be used for other indications as stated. Is this what you asked or --
因此,我們預計,一旦獲得許可,肯定會增加網站和客戶採用 ARC 的可能性 - 更重要的是,在系統將要部署的網站中,ARC 將會運行安裝後,它將增加每天的掃描次數,因為它將用於所述的其他指示。這是你問的還是--
Scott Henry - Analyst
Scott Henry - Analyst
Well, that's very helpful. And I guess the question I additionally was hoping to get some sense on, how long do you expect the review period to be for that 510(k)?
嗯,這很有幫助。我想我還希望了解的問題是,您預計 510(k) 的審核期需要多長時間?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
I wish I could tell you. I do hope that it will be faster than the previous processes that other companies as well as us experience since COVID. But I think that the fact that the system itself is already cleared and it will enhance the process. But I cannot even guesstimate the time.
我希望我能告訴你。我確實希望它會比其他公司以及我們自新冠疫情以來所經歷的流程更快。但我認為系統本身已經被清除,並且它將增強這一過程。但我甚至無法猜測時間。
Scott Henry - Analyst
Scott Henry - Analyst
Okay. Well, that's helpful.
好的。嗯,這很有幫助。
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
I would say the following. I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will for some reason, to be longer. So I will be happy to announce that it's cleared once it's cleared, and everyone can imagine that the period that it will take.
我想說以下幾點。我不樂意猜測,因為我最不想要的就是我給出一個估計,然後由於某種原因,它會變得更長。所以我會很高興地宣布,一旦清除就清除了,大家可以想像一下需要多長時間。
Scott Henry - Analyst
Scott Henry - Analyst
Okay. I appreciate that feedback. Second question, you mentioned the installed Nanox.ARC systems in the three chains, medical, imaging, service providers in the US. Have you gotten any feedback from those three chains and how that's working out, and perhaps what kind of expansion opportunities there would be? It may be too early, but I just wanted to get a sense of how that was going so far.
好的。我很欣賞這樣的回饋。第二個問題,你提到美國醫療、影像、服務三大連鎖店安裝了Nanox.ARC系統。您是否從這三家連鎖店得到了任何回饋?現在可能還為時過早,但我只是想了解一下到目前為止的進展。
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
So especially for those of the people who are actually on the call here, in the beginning -- or I would say, at the end of 2023 and at the beginning, when we started the test or the pilot or the what we call the soft launch of the ARC in the US, we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains.
因此,特別是對於那些實際上在這裡打電話的人,在一開始 - 或者我會說,在 2023 年底和一開始,當我們開始測試或試點或我們所說的軟體時在美國推出ARC 時,我們說過我們將在第一季或第二季推出,我們將從每位客戶那裡獲得回饋,而不僅僅是從連鎖店獲得回饋。
But we are getting a lot of feedback from the customers, feedback on a clinical basis, on the maintenance, on the usage, on the pattern of the body parts, which -- and the anatomies that it's being used, the clinical use -- so far, and this is something that encouraged us to accelerate the installation and the deployment, we received a very good feedback. And I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.
但我們從客戶那裡得到了很多回饋,包括臨床基礎、維護、使用、身體部位的模式的回饋,以及正在使用的解剖結構、臨床使用——到目前為止,這鼓勵我們加快安裝和部署,我們收到了非常好的回饋。我認為我們看到的是這個系統正在取代 CT 的許多例子,在這些地方他們沒有考慮安裝或部署系統,但他們決定這樣做。
So overall, the feedback is very good. I would say that probably in the next few months, we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes. And we will always, as indicated, even in today's call, we will always implement them and improve our service and our products accordingly.
所以整體來說,回饋還是非常好的。我想說,可能在接下來的幾個月裡,我們將獲得對使用、流程、安裝和監管流程的更好的了解。正如所表明的那樣,即使在今天的電話會議中,我們也將始終執行它們並相應地改進我們的服務和產品。
Scott Henry - Analyst
Scott Henry - Analyst
Okay, great. Final question, when we're thinking about Q3 relative to Q2, should we expect any seasonality in the US? Is the summer months? Do they tend to be a little slower with a pickup in the fourth quarter? Just trying to get a sense of what kind of cadence we should expect through the year?
好的,太好了。最後一個問題,當我們考慮第三季相對於第二季的情況時,我們是否應該預期美國會出現季節性?是夏季嗎?他們在第四季的回升速度是否會慢一些?只是想了解今年我們該期待什麼樣的節奏?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
Frankly speaking, right now, we don't expect any seasonality, especially due to the fact that we are ramping up our installed base. So we will probably see anyhow better results. But right now, we are not planning or expecting to have any seasonality effect.
坦白說,目前我們預計不會出現任何季節性,特別是因為我們正在擴大我們的安裝基礎。所以我們可能會看到更好的結果。但目前,我們沒有計劃或預期會產生任何季節性影響。
Operator
Operator
(Operator Instructions) Ross Osborn, Cantor Fitzgerald.
(操作員指示)羅斯·奧斯本、坎托·菲茨杰拉德。
Ross Osborn - Analyst
Ross Osborn - Analyst
So starting off, it seems like you are at the point of inflection in terms of deployments. With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand?
因此,從一開始,您似乎正處於部署方面的轉折點。考慮到這一點,您能否介紹一下您目前的製造能力以及您的各種合約計劃的進展?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
So you're right about what you said. In terms of manufacturing, I would say the following. The chips, we have no problem. We have available chips right now. We were able, due to the results of the high-yield wafers that we get from CSEM. We have two suppliers, and I think that this is not an issue.
所以你說的都是對的。在製造方面,我想說以下幾點。晶片,我們沒有問題。我們現在有可用的晶片。由於我們從 CSEM 獲得高產晶圓的結果,我們能夠做到這一點。我們有兩個供應商,我認為這不是問題。
In terms of the tubes, we have already the tubes that are coming from Korea. We have the tubes that are coming from the plant in Europe. And last but not least, Varex has completed their initial tube prototype utilizing our emitter and this is for testing. So I hope that it will be integrated into our new Nanox.ARC system shortly, and it will be part of the available production.
就管材而言,我們已經擁有來自韓國的管材。我們的管子來自歐洲工廠。最後但並非最不重要的一點是,Varex 已經利用我們的發射器完成了他們的初始管原型,這是為了測試。所以我希望它很快就會整合到我們新的 Nanox.ARC 系統中,並且它將成為可用產品的一部分。
In terms of the production of the assembly of the system, we have made the preparations in the site in Israel, that's we're moving forward, and we've increased the capacity of the manufacturing to enable what is needed in the next few quarters. And the low-cost manufacturing arrangement that we have will enable us to ramp up next year even higher than what we are currently doing.
在系統組裝的生產方面,我們已經在以色列現場做好了準備,我們正在向前推進,我們已經提高了製造能力,以滿足未來幾個季度的需要。我們擁有的低成本製造安排將使我們明年的產量甚至比目前的產量還要高。
So right now, I would say that it seems to be in line with what is needed for the next few quarters. We are working on the next ramp up for 2025 to be announced later.
所以現在,我想說這似乎符合未來幾季的需求。我們正在努力在 2025 年進行下一次升級,稍後將宣布。
Ross Osborn - Analyst
Ross Osborn - Analyst
And then following up on my previous question. Would you remind us how large your US sales force is today? And then any plans for adding to the team?
然後跟進我之前的問題。您能提醒我們現在您的美國銷售團隊有多大嗎?那麼有加入團隊的計畫嗎?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
So right now, we actually work with -- I would say, it's about 10 people altogether. And if I add the independent agents, then I think that we are right now at around 15. We are expecting to grow them to the number of 30 in the foreseeable future.
所以現在,我們實際上與——我想說,總共大約有 10 個人。如果我加上獨立代理,那麼我認為我們現在大約有 15 個。我們預計在可預見的將來將其數量增加到 30 個。
Ross Osborn - Analyst
Ross Osborn - Analyst
Great. And then last one for us --
偉大的。然後是我們的最後一個--
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
What I said is that, that's what we anticipate for 2025 to be around 30 to 40.
我所說的是,我們預計 2025 年將達到 30 到 40 個左右。
Ross Osborn - Analyst
Ross Osborn - Analyst
Got it. And then lastly, just in anticipation of CE market approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting if you'll build out your own sales force or leverage a distributor there? And lastly, what the reimbursement environment looks like?
知道了。最後,在CE 市場批准的預期中,您能否向我們介紹一下您在歐洲和其他相關地區的商業化計劃,以及如果您要建立自己的銷售團隊或槓桿,您將瞄準哪種類型的醫療中心?最後,報銷環境是什麼樣的呢?
Erez Meltzer - Chief Executive Officer, Director
Erez Meltzer - Chief Executive Officer, Director
Okay. So with respect to the rest of the world, first of all, there are a few countries that you should remember, we have agreements that were signed in the past, and we are going to deploy them once the clearance in these countries are expected to be received. So I mentioned today one of them, Mexico is really coming very shortly. I will be there next month to visit the places that they are planning to install the ARC. So this is one. We were talking about another one or two countries in Latin America.
好的。所以對於世界其他地區,首先,有幾個國家你應該記住,我們過去簽署過協議,一旦這些國家的清關預計完成,我們就會部署它們。所以我今天提到其中之一,墨西哥真的很快就會到來。下個月我會去參觀他們計劃安裝 ARC 的地方。這是其中之一。我們正在談論拉丁美洲的另外一兩個國家。
In terms of Europe, we are waiting for the CE approval, as indicated previously. And we are really in the final process of the CE approval. Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them, each one of them. It's going to be the distributors that are going to do the work. If you remember, I mentioned about a year ago that right now only in the US, Israel, and the UK, we are planning to have our own people.
就歐洲而言,如前所述,我們正在等待 CE 批准。我們確實處於 CE 批准的最後過程。一旦我們獲得了CE,我們簽署的協議中的所有國家,例如澳洲、紐西蘭、西班牙,我們都會使用它們,每一個國家。這項工作將由經銷商來做。如果你還記得的話,我大約一年前提到過,目前只有美國、以色列和英國,我們計劃擁有自己的人民。
And in the rest of the world, we are planning to have distributors. We are right now already in the last quarter and this quarter in touch with these distributors in order to ensure that we have a plan. Our people visited already few locations in each one -- not in each one, but in most of these countries. Right now, we are talking in Europe and in Mexico. We are talking about medium to large medical centers.
在世界其他地區,我們計劃設立經銷商。我們現在已經在上個季度和本季與這些分銷商聯繫,以確保我們有一個計劃。我們的人員已經訪問了每個國家的少數地點——不是每個國家,而是大多數國家。現在,我們正在歐洲和墨西哥進行討論。我們談論的是大中型醫療中心。
Operator
Operator
And I'm currently showing no further questions at this time. This does conclude today's conference call. Thank you all for participating, and you may now disconnect.
目前我沒有提出任何進一步的問題。今天的電話會議到此結束。感謝大家的參與,現在您可以斷開連線了。