Nano-X Imaging Ltd (NNOX) 2023 Q2 法說會逐字稿

Good morning, and thank you for standing by. Welcome to the Nanox Second Quarter 2023 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded.

早上好，感謝您的支持。歡迎參加 Nanox 2023 年第二季度收益電話會議。 （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. Please go ahead.

我現在想將會議交給投資者關係部的邁克·卡瓦諾 (Mike Cavanaugh)。請繼續。

Good afternoon, and thank you for joining us today. Earlier today, Nanox Imaging Ltd. released financial results for the quarter ended June 30, 2023. The release is currently available on the Investors section of the company's site. Erez Meltzer, Chief Executive Officer; and Ran Daniel, Chief Financial Officer, will host this morning's call.

下午好，感謝您今天加入我們。今天早些時候，Nanox Imaging Ltd. 發布了截至 2023 年 6 月 30 日的季度財務業績。該新聞稿目前可在該公司網站的投資者部分查看。埃雷茲·梅爾策，首席執行官；首席財務官 Ran Daniel 將主持今天上午的電話會議。

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描述的因素。

Management will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of each non-GAAP financial measure to the nearest GAAP financial measure is provided in the company's press release filed today. The non-GAAP financial measures include 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 and non-GAAP gross loss per share.

管理層還將參考某些非公認會計準則財務指標，向投資者提供更多信息。該公司今天提交的新聞稿中提供了每項非公認會計原則財務指標與最接近的公認會計原則財務指標的調節表。非 GAAP 財務指標包括非 GAAP 普通股淨虧損、非 GAAP 收入成本、非 GAAP 毛利潤、非 GAAP 毛利率、非 GAAP 研發費用、非 GAAP 銷售額和營銷費用、非GAAP 一般和管理費用、非GAAP 其他費用以及非GAAP 每股毛虧損。

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

說到這裡，我想把電話轉給埃雷茲·梅爾策。

Thanks, Mike, and welcome all to the Nanox Second Quarter 2023 Earnings Conference Call. Throughout this quarter, we achieved significant advancements across multiple business segments. I would like to highlight that today's call will extend a bit beyond our typical duration as I aim to offer more comprehensive insights. I will delve into specifics, including our strategic approach to the U.S. market, the reinforcement of our manufacturing and supply chain and our regulatory process.

謝謝 Mike，並歡迎大家參加 Nanox 2023 年第二季度收益電話會議。整個季度，我們在多個業務領域取得了重大進展。我想強調的是，今天的電話會議將比我們通常的持續時間稍長一些，因為我的目的是提供更全面的見解。我將深入探討具體細節，包括我們針對美國市場的戰略方針、加強我們的製造和供應鏈以及我們的監管流程。

During the quarter, at June 30, 2023, we continue to advance our commercialization efforts outside the U.S. following FDA clearance to market the multi-source Nanox.ARC. With this clearance, we are now preparing to establish our foothold in the U.S. market, complemented by our ongoing commercialization initiatives outside the U.S. Today, we are excited to delve into our commercial efforts in both the U.S. and the non-U.S. markets.

截至 2023 年 6 月 30 日的本季度，在 FDA 批准多來源 Nanox.ARC 上市後，我們繼續推進在美國以外的商業化工作。有了這一許可，我們現在正準備在美國市場建立立足點，並輔之以我們在美國以外正在進行的商業化計劃。今天，我們很高興深入研究我們在美國和非美國市場的商業活動。

About the U.S. deployment and strategy. Obtaining the 510(k) clearance from the FDA for the multi-source Nanox.ARC has been a long-standing strategic goal for the company and enabled us to deploy the Nanox.ARC in the U.S. for the indication of use cleared by the FDA. As previously announced, we are in the process of establishing a U.S. demo as part of our strategic approach for our U.S. commercial activities. We have decided to shift this first unit and are now planning to install the unit in a clinical setting rather than a stand-alone commercial site. The system is planned to be installed in an East Coast facility and will expect to start to generate revenues alongside training and demonstrations.

關於美國的部署和戰略。獲得 FDA 對多來源 Nanox.ARC 的 510(k) 許可一直是該公司的長期戰略目標，這使我們能夠在美國部署 Nanox.ARC，用於 FDA 許可的使用適應症。正如之前所宣布的，我們正在建立美國演示，作為我們美國商業活動戰略方針的一部分。我們決定轉移第一個設備，現在計劃將該設備安裝在臨床環境中，而不是獨立的商業場所。該系統計劃安裝在東海岸的一個設施中，預計將在培訓和演示的同時開始產生收入。

We believe that this first site will serve a dual purpose: first, as a training and demonstration center for Nanox.ARC, which will provide potential buyers with live demonstration of the technology which we believe is essential for informed acquisitions purposes by health care practices, hospitals and health systems; secondly, we believe the clinical site can raise awareness of the Nanox.ARC among key opinion leaders, radiologists and hospital system personnel.

我們相信，第一個站點將具有雙重目的：首先，作為Nanox.ARC 的培訓和演示中心，它將為潛在買家提供該技術的現場演示，我們認為這對於醫療保健實踐的知情採購目的至關重要，醫院和衛生系統；其次，我們相信臨床站點可以提高關鍵意見領袖、放射科醫生和醫院系統人員對 Nanox.ARC 的認識。

The first Nanox.CLOUD system was shipped from Israel and arrived in the U.S. for installation in the clinical site, which we expect to open the clinical site during the fourth quarter of this year. Based on market analysis of the U.S. market of clinicians, imaging administrators and directors, stakeholders recognize the clinical benefits of the Nanox.ARC and it's more affordable approach to advanced imaging techniques. Furthermore, outpatient facilities such as skilled nursing facilities, freestanding emergency clinics and preliminary clinics showed interest in adopting the Nanox.ARC. Specifically, because such facilities typically do not have CT capabilities and we believe such facilities view the Nanox.ARC as a more affordable way to keep patients in-house for advanced imaging needs, combined with a 2-D X-ray. Outpatient facilities also expressed potential interest in our MSaaS business model, which we believe reduces the risk of an upfront purchase because the cost is based on equipment use. We believe that gathering further clinical evidence will strengthen the support of our technology.

第一個 Nanox.CLOUD 系統從以色列運抵美國並安裝在臨床現場，我們預計將在今年第四季度開放臨床現場。根據對美國市場的臨床醫生、影像管理員和主管的市場分析，利益相關者認識到 Nanox.ARC 的臨床優勢以及它是一種更實惠的先進影像技術方法。此外，熟練護理機構、獨立急診診所和初級診所等門診機構也對採用 Nanox.ARC 表現出了興趣。具體來說，因為此類設施通常不具備 CT 功能，而我們相信此類設施將 Nanox.ARC 視為一種更實惠的方式，可讓患者在內部滿足高級成像需求，並結合 2-D X 射線。門診機構也對我們的 MSaaS 業務模式表示了潛在興趣，我們認為這種模式可以降低預購風險，因為成本取決於設備的使用。我們相信，收集進一步的臨床證據將加強我們技術的支持。

Our U.S. go-to-market strategy is comprised of 3 primary components: customer targeting, building the sales team and using a hybrid business model. In terms of the customer targeting, we believe several factors impact willingness to adapt to our system, including the type of facility, the current imaging capabilities and imaging volumes and geographic locations, namely rural versus urban. Our aim is to strategically engage segments that show early adoption potential such as orthopedic clinics, skilled nursing facility, freestanding emergency departments and urgent care facilities. We intend to continue to build clinical evidence, particularly with the U.S. market, to support the adoption of our system as well as reimbursement mechanisms, specifically with commercial payers. We have strategically realigned our focus to enhance our presence in the U.S. market. Our initial efforts in commercialization and deployment within the U.S. will be concentrated on select states. This approach allows us to optimize customer service delivery and support in the near term.

我們的美國市場進入戰略由 3 個主要組成部分組成：客戶定位、建立銷售團隊和使用混合業務模式。在客戶定位方面，我們認為有幾個因素會影響適應我們系統的意願，包括設施類型、當前成像能力以及成像量和地理位置（即農村與城市）。我們的目標是戰略性地吸引具有早期採用潛力的細分市場，例如骨科診所、熟練護理設施、獨立急診室和緊急護理設施。我們打算繼續建立臨床證據，特別是在美國市場，以支持採用我們的系統以及報銷機制，特別是商業付款人。我們戰略性地重新調整了重點，以增強我們在美國市場的影響力。我們在美國商業化和部署方面的初步努力將集中在選定的州。這種方法使我們能夠在短期內優化客戶服務交付和支持。

To execute our strategy, we have allocated internal sales resources, and we are planning to leverage the USARAD network in order to accelerate our initial penetration in the market. Furthermore, we are in the process of enhancing a U.S.-based sales and service team that will seek to generate leads, close sales, manage relationships and provide services for the Nanox.ARC installed base. We are also in the process of engaging an independent service provider to provide service needs in remote geographies and to decrease equipment downtime. We expect that the other operating areas such as medical affairs, regulatory, billing, finance and contracting will be supported by the existing international Nanox organization.

為了執行我們的戰略，我們分配了內部銷售資源，併計劃利用 USARAD 網絡來加速我們對市場的初步滲透。此外，我們正在增強美國的銷售和服務團隊，該團隊將尋求開發潛在客戶、完成銷售、管理關係並為 Nanox.ARC 安裝基礎提供服務。我們還正在聘請獨立服務提供商來滿足偏遠地區的服務需求並減少設備停機時間。我們預計醫療事務、監管、計費、財務和合同等其他運營領域將得到現有國際 Nanox 組織的支持。

For our business model in the U.S., we intend to use a hybrid approach combining a usage-based MSaaS model with a CapEx model to help promote adoption based on different segments. We have designed a training program to promote the Nanox.ARC. We intend to use a combination of pilot size, training, sales and marketing efforts to help meet customer needs. These aspects of our business strategy will require us to hire additional experienced health care business development professionals who will be charged with raising awareness of the Nanox.ARC among physicians, hospitals, urgent care operators and large health systems throughout the USA.

對於我們在美國的業務模式，我們打算採用一種混合方法，將基於使用的 MSaaS 模型與資本支出模型相結合，以幫助促進基於不同細分市場的採用。我們設計了一個培訓計劃來推廣 Nanox.ARC。我們打算結合試點規模、培訓、銷售和營銷工作來幫助滿足客戶需求。我們業務戰略的這些方面將要求我們聘請更多經驗豐富的醫療保健業務開發專業人員，他們將負責提高全美國醫生、醫院、緊急護理操作人員和大型醫療系統對 Nanox.ARC 的認識。

To support these important efforts, I intend to increase my personal presence in the U.S. and make myself available of meeting -- for meetings with potential customers as well as investors who would like to have an in-depth conversation about our technology, commercial strategy and future strategic plans. We look forward to providing further details in the upcoming months.

為了支持這些重要的努力，我打算增加我在美國的個人存在，並讓自己能夠參加會議——與潛在客戶以及願意就我們的技術、商業戰略和技術進行深入對話的投資者進行會面。未來的戰略計劃。我們期待在未來幾個月內提供更多詳細信息。

With respect to the rest of the world deployment, turning to our commercialization efforts outside of the U.S. We continue to make significant progress in multiple countries, principally in Africa. As we have previously announced, we have an agreement with a distributor in Morocco and are working to accelerate deployments. We have deployed a Nanox.ARC system in a prominent hospital in Morocco that is a major health care provider in the southern region of the country. The distributor in Morocco received appropriate clearance to conduct certain scans with the Nanox.ARC. Subject to the clearance, the Nanox.ARC system has generated human images on incoming patients at the hospital, including chest. In Nigeria, we have installed an Nanox.ARC system, which we access will become operational upon receipt of the necessary regulatory approvals and certification that has been formally submitted to the local authorities, the NNRA, to facilitate clinical activities. We hope to begin generating human images in the very near future.

關於世界其他地區的部署，轉向我們在美國以外的商業化努力。我們繼續在多個國家（主要是非洲）取得重大進展。正如我們之前宣布的，我們與摩洛哥的一家分銷商達成協議，並正在努力加快部署。我們在摩洛哥的一家著名醫院部署了 Nanox.ARC 系統，該醫院是該國南部地區的主要醫療保健提供者。摩洛哥經銷商獲得了適當的許可，可以使用 Nanox.ARC 進行某些掃描。根據許可，Nanox.ARC 系統已生成醫院入院患者的人體圖像，包括胸部圖像。在尼日利亞，我們安裝了 Nanox.ARC 系統，在收到必要的監管批准和認證（已正式提交給地方當局 NNRA）後，我們將進入該系統，以促進臨床活動。我們希望在不久的將來開始生成人類圖像。

As previously reported, we have already placed a system in Ghana at the UGMC Hospital mainly for training purposes, Meantime, our distributor has submitted the specific Nanox.ARC device for approval to the Ghana Food and Drug Authority for commercial use. We anticipate receiving an initial response in the fourth quarter of 2023. And in addition, we have engaged a clinical research organization to potentially hold clinical trials in both Morocco and Ghana, subject to local regulatory approvals. In alignment with our global initiatives and as announced in the past, we established a partnership with BIO Ventures for Global Health, BVGH, a nonprofit organization dedicated to solving global health issues by forming connections between people, resources and ideals. We completed the first phase of this program and are excited to begin the second series in just a few weeks, which involves a series of export-led seminars to train Nigeria and other African health care professionals on imaging topics.

正如之前報導的，我們已經在加納的UGMC 醫院放置了一個系統，主要用於培訓目的，同時，我們的經銷商已向加納食品和藥物管理局提交了特定的Nanox.ARC 設備，以供批准用於商業用途。我們預計在 2023 年第四季度收到初步答复。此外，我們還聘請了一家臨床研究組織，有可能在摩洛哥和加納進行臨床試驗，但須獲得當地監管部門的批准。為了配合我們的全球舉措，正如過去所宣布的，我們與BIO Ventures for Global Health (BVGH) 建立了合作夥伴關係，BVGH 是一家非營利組織，致力於通過在人、資源和理想之間建立聯繫來解決全球健康問題。我們完成了該計劃的第一階段，並很高興在短短幾週內開始第二個系列，其中包括一系列出口主導的研討會，以培訓尼日利亞和其他非洲醫療保健專業人員進行影像主題培訓。

We also regularly host radiologists, distributors, representatives from hospital systems, investors and analysts at Nanox headquarter in Israel to discuss the Nanox.ARC system in detail and conduct live demonstration of the systems on site, providing firsthand insight into the capabilities of the Nanox.ARC. I'm happy to report that these meetings resulted in very positive feedback in writing. All of those efforts constitute just the beginning our goal to help people achieve better health outcomes. Lastly, on this front, as part of our global commercialization, we have started to generate initial revenues from the medical imaging equipment and MSaaS.

我們還定期在以色列 Nanox 總部接待放射科醫生、分銷商、醫院系統代表、投資者和分析師，詳細討論 Nanox.ARC 系統並在現場進行系統現場演示，提供對 Nanox 功能的第一手了解。弧。我很高興地向大家報告，這些會議產生了非常積極的書面反饋。所有這些努力只是我們幫助人們實現更好健康成果的目標的開始。最後，在這方面，作為我們全球商業化的一部分，我們已開始從醫療成像設備和 MSaaS 中產生初始收入。

With respect to the OEM. Before I provide an update on the manufacturing and production front, I'd like to share the news that we have entered an original equipment manufacturing, OEM, relationship with a U.S. government agency that we have signed and are working to develop. The government agency I referred to has procured Nanox MEMs systems for assessment. Their interest in our technology is for the purposes of developing next-generation security scanning and nondestructive testing applications. The project is scheduled to commence next month. As part of our OEM efforts, we have sent several demo units to industry partners, out of which a leading partner independently examined Nanox Cold cathode chip and reported a real technological break-through.

關於 OEM。在提供製造和生產方面的最新情況之前，我想先分享一下這樣的消息：我們已經與一家美國政府機構建立了原始設備製造、OEM 關係，我們已經簽署並正在努力發展這種關係。我提到的政府機構已採購 Nanox MEMs 系統進行評估。他們對我們的技術感興趣是為了開發下一代安全掃描和無損測試應用程序。該項目計劃於下個月啟動。作為 OEM 工作的一部分，我們已向行業合作夥伴發送了多個演示單元，其中一家領先的合作夥伴獨立檢查了 Nanox 冷陰極芯片，並報告了真正的技術突破。

With respect to the mass production, as we begin to deploy the Nanox.ARC and prepare for mass production, I would like to provide updates regarding research and development and manufacturing. We are currently using chips produced by our Korean fabrication facility in our Nanox.ARC system. However, to secure additional chips supply in anticipation of commercialization scale-up and acceleration of manufacturing activity, we recently entered into an agreement with CSEM, a chip maker located in Switzerland. We have proceeded to pay a phase 2 lab to fab development, which is expected to manufacture sample chips by the end of this year and provide production of chips in Q1 2024. For the commercial production of our digital X-ray tubes for use in Nanox.ARC, we plan to engage third-party manufacturers and suppliers based on, among other things, cost effectiveness. We are currently developing both ceramic and glass-based digital X-ray tubes for use in Nanox.ARC.

關於量產，隨著我們開始部署Nanox.ARC並準備量產，我想提供一下研發和製造方面的最新情況。我們目前在 Nanox.ARC 系統中使用韓國製造工廠生產的芯片。然而，為了確保商業化規模擴大和製造活動加速的額外芯片供應，我們最近與瑞士芯片製造商 CSEM 簽訂了一項協議。我們已開始支付第二階段實驗室開發費用，預計將在今年年底前製造樣品芯片，並在 2024 年第一季度提供芯片生產。用於 Nanox 中使用的數字 X 射線管的商業化生產.ARC，我們計劃基於成本效益等因素與第三方製造商和供應商合作。我們目前正在開髮用於 Nanox.ARC 的陶瓷和玻璃數字 X 射線管。

Our Korean facility is currently our primary manufacturer and supplier for our ceramic digital X-ray tubes, and we are working with a third party for the production of glass-based digital x-ray tubes. For example, we recently started testing glass-based digital X-ray tubes manufactured by CEI. The testing includes performance, integration and radiation testing. Furthermore, we are negotiating with additional third party to produce digital X-ray tubes. Along with our existing manufacturing facilities in Israel and Korea, we believe these developments further strengthens our future supplies of both chip and tubes, the 2 key components of the Nanox.ARC to support the scaled deployment of the Nanox.ARC units.

目前，我們的韓國工廠是陶瓷數字 X 射線管的主要製造商和供應商，我們正在與第三方合作生產玻璃數字 X 射線管。例如，我們最近開始測試 CEI 製造的玻璃數字 X 射線管。測試包括性能、集成和輻射測試。此外，我們正在與其他第三方談判生產數字 X 射線管。連同我們在以色列和韓國的現有製造設施，我們相信這些發展進一步加強了我們未來芯片和管材的供應，這是 Nanox.ARC 的兩個關鍵組件，可支持 Nanox.ARC 裝置的規模部署。

In an additional step towards optimizing our mass manufacturing capabilities, we have initiated collaboration with Skanray for Nanox.ARC systems assembly at scale. Skanray, a medical equipment manufacturer, meets central standard requirements and serve as a supplier for prominent global medical entities. It is also the parent company of CEI, our Italian provider of glass-based digital X-ray tubes. With robust technological manufacturing capabilities in India, we plan to leverage in the coming years of the Nanox.ARC deployment.

為了優化我們的大規模製造能力，我們已開始與 Skanray 合作進行 Nanox.ARC 系統大規模組裝。 Skanray 是一家醫療設備製造商，符合中央標準要求，是全球知名醫療實體的供應商。它也是 CEI 的母公司，CEI 是我們的意大利玻璃數字 X 射線管供應商。憑藉印度強大的技術製造能力，我們計劃在未來幾年利用 Nanox.ARC 部署。

Regarding regulatory, I'd like to now turn our attention to regulatory and clinical trials update. On April 28, 2023, we obtained a 510(k) clearance from the FDA to market the Nanox.ARC, including the Nanox.CLOUD, it's a company cloud-based infrastructure. The Nanox.ARC is a stationary X-ray system intends to produce tomographic images of the human MSK system adjunctive to conventional radiology on adult patients. The approved device is intended to be used in professional health care facilities for radiological environment such as hospital, clinics, imaging centers and other medical practices by trained radiographers, radiologists and physicians. This version of the Nanox.ARC has the required capabilities to scan MSK, chest and abdomen and to provide 2D X-ray images, conventional radiography subject to local regulatory approvals.

關於監管，我現在想將我們的注意力轉向監管和臨床試驗的更新。 2023 年 4 月 28 日，我們獲得了 FDA 的 510(k) 許可，可以銷售 Nanox.ARC，包括 Nanox.CLOUD，它是公司基於雲的基礎設施。 Nanox.ARC 是一種固定 X 射線系統，旨在生成人類 MSK 系統的斷層掃描圖像，輔助成人患者的常規放射學。批准的設備旨在由經過培訓的放射技師、放射科醫生和醫生在放射環境的專業醫療保健設施中使用，例如醫院、診所、成像中心和其他醫療實踐。此版本的 Nanox.ARC 具有掃描 MSK、胸部和腹部所需的功能，並提供 2D X 射線圖像、傳統放射線攝影（需獲得當地監管機構的批准）。

We are also continuing to pursue the CE mark in the European Union with our notified body, aiming to submit during Q3 of 2023. In Israel, we are pursuing the AMAR clearance, the Israeli medical device listing. The required technical file was completed and submitted in early July 2023, and we expect a decision in the few months.

我們還繼續與我們的公告機構一起在歐盟申請 CE 標誌，目標是在 2023 年第三季度提交。在以色列，我們正在尋求 AMAR 許可，即以色列醫療器械清單。所需的技術文件已於 2023 年 7 月上旬完成並提交，我們預計將在幾個月內做出決定。

Clinical. As previously discussed under our Helsinki permit, we started to collect clinical sample images of multiple human body anatomies with a Nanox.ARC system that was deployed in the Shamir Hospital in Israel. We have completed the first phase of clinical sampling and have begun the second phase. We are in the final stages of approval of additional clinical sites in Israel, and this additional trial aims to utilize the Nanox.ARC, subject to receiving the final approval from the Institution of IRB. This trial will aim to assess the diagnostic capabilities of Nanox.ARC in detecting chest and lung diseases. Installation of Nanox.ARC is expected to be completed within a month from its commencement, and the trial itself is scheduled to commence in the third quarter.

臨床。正如之前在赫爾辛基許可下所討論的，我們開始使用部署在以色列 Shamir 醫院的 Nanox.ARC 系統收集多個人體解剖結構的臨床樣本圖像。我們已經完成了第一階段的臨床採樣，並開始了第二階段的工作。我們正處於批准以色列其他臨床地點的最後階段，這項額外試驗旨在利用 Nanox.ARC，但需獲得 IRB 機構的最終批准。該試驗旨在評估 Nanox.ARC 在檢測胸部和肺部疾病方面的診斷能力。 Nanox.ARC 的安裝預計將在啟動後一個月內完成，試驗本身計劃於第三季度開始。

With respect to Nanox.AI, I'm excited to share the progress we have made in the ADOPT trial with the National Health Service in the U.K. To date, all 5 of the testing sites in the U.K. have signed the collaboration agreement, and in addition, 3 sites: Cambridge, South Hampton and Bradford, has begun sending images to the Nanox.CLOUD platform. And we expect 2 more sites in Nottingham and Cardiff to begin sending images very soon. Nanox.AI is currently engaged in showcasing the product across a range of platforms to 10 integrated delivery networks in both the United States and in other regions.

關於 Nanox.AI，我很高興與英國國家衛生服務中心分享我們在 ADOPT 試驗中取得的進展。迄今為止，英國所有 5 個測試站點均已簽署合作協議，並在此外，3個站點：劍橋、南漢普頓和布拉德福德，已開始向Nanox.CLOUD 平台發送圖像。我們預計諾丁漢和卡迪夫的另外 2 個站點很快就會開始發送圖像。 Nanox.AI 目前正在美國和其他地區的 10 個綜合交付網絡的一系列平台上展示該產品。

With that, I'd like to turn the call over to Ran Daniel, Chief Financial Officer, to review our financial results.

說到這裡，我想將電話轉給首席財務官 Ran Daniel，以審查我們的財務業績。

Thank you, Erez.

謝謝你，埃雷茲。

We reported a GAAP net loss for the second quarter of 2023 of $17.4 million compared with a net loss of $19.6 million in the second quarter of 2022. The decrease was largely due to a goodwill impairment of $14.3 million that was recorded in the comparable period and not in the 3 months ended June 30, 2023, which effect was offset in part by a decrease in the company's earn-out liabilities in the amount of $12.8 million in the second quarter of 2022 versus an increase of $0.1 million in the second quarter of 2023.

我們報告 2023 年第二季度的 GAAP 淨虧損為 1,740 萬美元，而 2022 年第二季度的淨虧損為 1,960 萬美元。這一下降主要是由於同期記錄的商譽減值為 1,430 萬美元，不是在截至2023 年6 月30 日的三個月內，該影響被公司2022 年第二季度的盈利負債減少1,280 萬美元而部分抵消，而2022 年第二季度則增加了10 萬美元。 2023 年。

Revenues for the second quarter of 2023 were $2.6 million and the gross loss was $1.7 million on a GAAP basis. Revenues from the teleradiology services for the same period was $2.5 million with a gross profit of $0.4 million on a GAAP basis and a gross profit of $0.9 million on a non-GAAP basis, which represents a gross profit margin of approximately 14% on a GAAP basis and 36% on a non-GAAP basis. The increase in the company's revenue in the second quarter of 2023 is mainly due to the increase in the number of radiologists that engaged in reading during the overnight and weekend shift. The decrease in the gross profit margin on a GAAP and a non-GAAP basis is mainly due to an increase in the cost of the company's radiology due to the incentive payments which the company pays to the radiologist to engage in reading during the overnight and weekend shift.

根據 GAAP 計算，2023 年第二季度的收入為 260 萬美元，毛虧損為 170 萬美元。同期遠程放射服務收入為 250 萬美元，按 GAAP 計算毛利潤為 40 萬美元，按非 GAAP 計算毛利潤為 90 萬美元，按 GAAP 計算毛利率約為 14%按非 GAAP 計算為 36%。該公司2023年第二季度營收的增長主要是由於在夜班和周末輪班期間從事閱片的放射科醫生數量增加。按公認會計原則和非公認會計原則計算的毛利率下降的主要原因是，公司向放射科醫生支付夜間和周末閱片獎勵，導致公司放射科成本增加。轉移。

Research and development expenses for the second quarter of 2023 were $6.9 million as compared to $6.5 million for the comparable period in 2022. The increase of $0.4 million in our research and development expenses was mainly due to an increase in the company's cost of labor in the amount of $0.7 million, mainly due to an increase in the headcount in connection with the development of the Nanox.ARC system, which was partially offset in part by a decrease in share-based compensation of $0.3 million, an increase in research and development grants that the company has received in the amount of $0.1 million.

2023 年第二季度的研發費用為 690 萬美元，而 2022 年同期為 650 萬美元。研發費用增加 40 萬美元主要是由於公司在 2022 年第二季度的勞動力成本增加。 70 萬美元，主要是由於與Nanox.ARC 系統開發相關的人員數量增加，但部分被股權激勵減少30 萬美元、研發補助金增加所部分抵消該公司已收到 10 萬美元。

Sales and marketing expense for the second quarter of 2023 were $0.8 million as compared to $1.1 million for the comparable period in 2022. General and administrative expenses for the second quarter of 2023 were $7.6 million as compared to $11.2 million for the comparable period in 2022. The decrease of $3.6 million in the general and administrative expenses mainly was due to a decrease in the company's cost of labor in the amount of $0.5 million due to a reduction in headcount as part of the company's plan to increase efficiencies. In addition, we had a decrease in our share-based compensation in the amount of $2.8 million and a decrease in the cost of directors and officers liability insurance premium in the amount of $0.3 million.

2023 年第二季度的銷售和營銷費用為 80 萬美元，而 2022 年同期為 110 萬美元。2023 年第二季度的一般和管理費用為 760 萬美元，而 2022 年同期為 1,120 萬美元。一般及管理費用減少360 萬美元，主要是由於公司提高效率計劃中減少員工人數，導致公司勞動力成本減少50 萬美元。此外，我們的股票薪酬減少了 280 萬美元，董事和高級管理人員責任保險費用減少了 30 萬美元。

During the second quarter of 2023, we had accrued $0.7 million for the future settlement expenses in connection with the SEC investigation. As previously disclosed, the company and Ran Poliakine, our Chairman of the Board of Directors, reached agreement in principle with the SEC staff to settle the SEC investigation. The agreements are subject to finalization, including any financial remedies, which the company estimates will be approximately of $0.7 million in civil penalties from the company. Final resolution of this matter is subject to the preparation and negotiation of the documentation satisfactory to all parties, including with respect to the company, approval by the company's Board of Directors, and in the case of the SEC, authorization by the commission as well as approval by a federal district court.

2023 年第二季度，我們已計提 70 萬美元，用於與 SEC 調查相關的未來和解費用。正如之前披露的，該公司和我們的董事會主席 Ran Poliakine 與 SEC 工作人員原則上達成了和解 SEC 調查的協議。這些協議有待最終確定，包括任何財務補救措施，該公司估計該公司將承擔約 70 萬美元的民事罰款。該事項的最終解決取決於各方滿意的文件的準備和談判，包括與公司有關的文件、公司董事會的批准，以及就 SEC 而言，需要獲得委員會的授權以及經聯邦地區法院批准。

As mentioned above, we incurred an expense of $0.1 million and change in contingent earnout ability in the 3 months ended June 30, 2023. During the second quarter of 2023, we entered into an amendment to the stock purchase agreement with their former stockholders of USARAD. Under this amendment, the company paid an aggregate amount of approximately of $0.3 million in cash and 45,392 ordinary shares to the former stockholders of USARAD in consideration for the achievement of certain milestones in connection with the first earn-out period as defined in the USARAD stock purchase agreement. In addition, we paid an aggregate of $0.5 million in cash and 210,000 ordinary shares to the former stockholders of USARAD as consideration for the remainder of the milestones and applicable earn-out under the USARAD stock purchase agreement.

如上所述，截至2023 年6 月30 日的3 個月中，我們發生了10 萬美元的費用以及或有盈利能力的變化。在2023 年第二季度，我們與USARAD 前股東簽訂了股票購買協議修正案。根據這項修正案，公司向 USARAD 前股東支付了總計約 30 萬美元的現金和 45,392 股普通股，作為實現 USARAD 股票中定義的第一個盈利期的某些里程碑的代價購買合同。此外，我們還向 USARAD 前股東支付了總計 50 萬美元的現金和 210,000 股普通股，作為 USARAD 股票購買協議下剩餘里程碑和適用盈利的對價。

Turning to our balance sheet. As of June 30, 2023, we had cash, cash equivalents, restricted cash and marketable securities of approximately $80.3 million and add $3.4 million loans from banks. We ended the quarter with a property and equipment of $45.2 million. As of June 30, 2023, we had approximately 55.5 million shares outstanding as compared to 52.1 million shares outstanding as of December 31, 2022. The increase was mainly due to the issuance of approximately 255,000 ordinary shares for the former stockholders of USARAD under the amendment to the USARAD stock purchase agreement as previously discussed.

轉向我們的資產負債表。截至 2023 年 6 月 30 日，我們擁有約 8030 萬美元的現金、現金等價物、限制性現金和有價證券，並增加了 340 萬美元的銀行貸款。本季度結束時，我們的財產和設備價值為 4520 萬美元。截至2023 年6 月30 日，我們擁有約5,550 萬股流通股，而截至2022 年12 月31 日，我們的流通股為5,210 萬股。增加的主要原因是根據修正案向USARAD 前股東發行了約255,000 股普通股之前討論過的 USARAD 股票購買協議。

On July 26, 2023, we raised $30 million in a registered direct offering by selling approximately 2.1 million shares and warrants to purchase up to 2.1 million shares. The net proceeds of the raise are intended to be used through further development restructuring and commercial deployment of our systems.

2023 年 7 月 26 日，我們通過出售約 210 萬股股票和購買最多 210 萬股股票的認股權證，通過註冊直接發行籌集了 3000 萬美元。此次籌集的淨收益擬用於我們系統的進一步開發重組和商業部署。

With that, I'll hand the call back over to Erez.

這樣，我會將電話轉回給埃雷茲。

Once again, I want to thank you all for being here today and for being with Nanox on our multiyear journey to make medical imaging more accessible around the world. We have made tremendous strides in realizing our vision this year, and I'm proud of what our team has done to bring our company to doorstep of commercializing the ARC system at scale.

我想再次感謝大家今天來到這裡，並與 Nanox 一起踏上我們多年的旅程，讓世界各地更容易獲得醫學成像。今年，我們在實現願景方面取得了巨大進步，我對我們的團隊為使我們公司實現 ARC 系統大規模商業化所做的努力感到自豪。

Before we end the call, I want to announce that we will be hosting an Investor Day to be held in New York City at the end of September or the beginning of October 2023. And if you would like to attend either in person or virtually, please contact our Investor Relations partner at ICR Westwicke. Have a great day.

在結束通話之前，我想宣布，我們將於 2023 年 9 月底或 10 月初在紐約舉辦投資者日活動。如果您想親自或虛擬參加，請聯繫我們 ICR Westwicke 的投資者關係合作夥伴。祝你有美好的一天。

Operator, please open the call for questions.

接線員，請打開電話提問。

(Operator Instructions) The first question will come from Ross Osborn with Cantor Fitzgerald.

（操作員說明）第一個問題將由羅斯·奧斯本和坎托·菲茨杰拉德提出。

Congrats on the progress. So starting off, would you discuss the level to which your system in Nigeria is operating in terms of scans per day?

祝賀取得的進展。那麼首先，您能否討論一下您在尼日利亞的系統在每天掃描方面的運行水平？

I think it was indicated that the one in Nigeria right now is operating without the approval of getting scans for patients or for human, and we're waiting for the final NNRA approval for the scans in human -- or to getting human images.

我認為有跡象表明，目前尼日利亞的一家醫院在未經批准對患者或人體進行掃描的情況下運行，我們正在等待 NNRA 對人體掃描或獲取人體圖像的最終批准。

Apologies, I may have missed it. So is Ghana operating on human scans or is that also waiting?

抱歉，我可能錯過了。那麼加納是在進行人體掃描還是也在等待？

Ghana is waiting for the final approval for commercial use.

加納正在等待商業用途的最終批准。

Okay. Understood. And then following on...

好的。明白了。然後接著...

The one in Morocco is operating with human scans with images, like it's in the full operation at the hospital.

摩洛哥的醫院正在使用人體掃描圖像進行手術，就像在醫院進行全面手術一樣。

Okay. Great. Would you be able to provide...

好的。偉大的。您能否提供...

With all the -- I beg your pardon?

與所有 - 我請你原諒？

Would you be able to provide the level to which it's operating in terms of scans per day?

您能否提供每天掃描的運行水平？

Right now, we don't disclose what's the number of scans per day. But I think that in the next call or probably even earlier, in the Investors Day, we will provide the initial indication for the scans per day in all the units that we have installed.

目前，我們不透露每天的掃描次數是多少。但我認為，在下一次電話會議中，甚至可能更早的投資者日，我們將提供我們已安裝的所有設備每天掃描的初步指示。

Okay. Understood. And then following up on this, when can we expect for you to deliver more systems to your commercialized operating countries? I believe Nigeria calls for 1,000, Ghana for 350 and Morocco for 270 systems.

好的。明白了。然後跟進這個問題，我們什麼時候可以期望你們向你們的商業化運營國家提供更多的系統？我相信尼日利亞需要 1,000 個系統，加納需要 350 個系統，摩洛哥需要 270 個系統。

First of all, as soon as we get the final approvals. But this basically will start in the next 2 quarters for sure.

首先，一旦我們獲得最終批准。但這基本上肯定會在未來兩個季度開始。

Okay. And then turning to the U.S., could you just walk us through the rationale for the delay in the training center operating? I believe it was previously calling for this summer.

好的。然後轉向美國，您能否向我們介紹一下培訓中心推遲運營的原因？我相信它之前是在今年夏天召喚的。

The one thing that we've had an early indication is that we're going to send the first systems. We are waiting for the approval of the demo center itself. But in the meanwhile, we have decided, as mentioned in the -- in my preliminary, the -- what I said actually earlier today, that we wanted to -- we preferred to have the first system to be installed in a clinical site and to make it commercial earlier than the original plan. Since we have already a few clinical locations or clinics that are willing to install the systems even before we have the full operating -- U.S. operation system -- U.S. operation, then we decided that the first system will be installed in the next few weeks in one of these locations and would start both, first of all, to generate -- to scan patients and to generate revenues.

我們有一個早期跡象，那就是我們將發送第一批系統。我們正在等待演示中心本身的批准。但與此同時，我們已經決定，正如我在初步報告中提到的，我今天早些時候實際上說過，我們希望我們更願意在臨床現場安裝第一個系統，並且使其比原計劃更早商業化。由於我們已經有一些臨床地點或診所願意在我們完全運營之前安裝這些系統——美國操作系統——美國運營，因此我們決定在接下來的幾週內安裝第一個系統這些地點之一，首先將啟動這兩項工作——掃描患者並產生收入。

Got it. And then last one for us and I'll jump back in the queue. Would you discuss the size of your U.S. contract you announced today? And just so we're on the same page, did the OEM sign on for your comprehensive system? Or are you now selling your chips on a stand-alone basis?

知道了。然後是我們的最後一個，我會跳回到隊列中。您能否討論一下您今天宣布的美國合同的規模？就這樣我們達成了共識，OEM 是否已登錄您的綜合系統？或者您現在正在單獨銷售您的芯片嗎？

You mean the OEM agreement?

你說的是OEM協議嗎？

Yes.

是的。

Okay. The OEM, we have a few OEM arrangements and collaboration. The one that was mentioned, it's for the chip only. The others are into either chip or chip and tube. In addition, we are in the process of having a full demo, not only the tube itself, that will be tested in the next, I would say, 6 months.

好的。 OEM方面，我們有一些OEM安排和合作。剛才提到的，僅適用於芯片。其他的要么是芯片，要么是芯片加管。此外，我們正在進行完整的演示，而不僅僅是電子管本身，我們將在接下來的 6 個月內對其進行測試。

Okay. And then are you able to disclose the size of the contract with the U.S. government agency?

好的。那麼你能透露一下與美國政府機構的合同規模嗎？

We are not allowed to.

我們不被允許這樣做。

The next question comes from Jeff Cohen with Ladenburg.

下一個問題來自拉登堡的傑夫科恩。

This is actually Destiny on for Jeff. I will start by kind of continuing on the last group of questions. I'm curious, how are you determining the initial physicians that will be welcomed into your demo sites? And is this going to be more of a group demonstration? Or is this going to be on a kind of one-to-one basis?

這實際上是傑夫的命運。我將從繼續最後一組問題開始。我很好奇，您如何確定將歡迎進入您的演示網站的初始醫生？這會更像是集體示威嗎？或者這將是一對一的基礎上？

First of all, right now, as we have shared, it's -- actually, it's a full range. So we have individuals that are coming to see the systems and will be coming to see the system. We have some delegations, one of them was even like 10 or 15 people. We are willing and will be willing to host any size of group that will be able to see what we do.

首先，正如我們所分享的，現在它是——實際上，它是一個全方位的。因此，我們有人會來查看該系統，也將會來查看該系統。我們有一些代表團，其中一個甚至有十、十五人左右。我們願意並將願意接待任何規模的團體來參觀我們的工作。

Got it. Okay. And there could be multiple people from a single site, I would assume. So that makes sense.

知道了。好的。我認為，一個站點可能有多個人。所以這是有道理的。

Absolutely.

絕對地。

Got it. Okay. And then you mentioned the sales team, a direct sales force in the U.S. I'm wondering about the size of that sales team, the timing of the onboarding of your initial sales reps and then how we should be thinking about the impact to sales and marketing expense going forward for modeling purposes.

知道了。好的。然後您提到了銷售團隊，這是美國的一支直接銷售隊伍。我想知道該銷售團隊的規模、初始銷售代表的入職時間，以及我們應該如何考慮對銷售和銷售的影響。用於建模目的的營銷費用。

Okay. Let's start with the first question. So as I've indicated, we are building the team as we speak. We mentioned in the past that we are in the final process of conclude and complete the full action plan or execution plan of the deployment in the U.S. Part of what -- of this, I've shared with earlier today. And the full, I would say, more detailed plan including numbers and further indications will be presented in the Investors Day that were planning to the end of September. By then, we are going to have probably most of the team already ready to do the work. We are planning the kickoff early October In the U.S. A few of the people have already engaged and working in the U.S. So I think that more of this, you will be able to hear -- we are talking, by the way, on the September 22 at Nasdaq to have the Investors Day that we're planning. And more details to come on this.

好的。我們先從第一個問題開始。正如我所指出的，我們正在組建團隊。我們過去提到過，我們正處於總結和完成在美國部署的完整行動計劃或執行計劃的最後階段。我今天早些時候已經分享了其中的一部分。我想說，完整的、更詳細的計劃，包括數字和進一步的指示，將在計劃於 9 月底舉行的投資者日上公佈。到那時，我們團隊的大部分成員可能已經準備好開展這項工作。我們計劃十月初在美國啟動。一些人已經在美國參與並工作了。所以我認為，您將能夠聽到更多內容 - 順便說一下，我們正在談論 9 月22 日在納斯達克舉行我們計劃的投資者日。更多細節即將公佈。

Excellent. Looking forward to that Investor Day. And then lastly for us, you're collecting a lot of clinical and some real-world data. I'm wondering if you'll create some kind of registry to kind of capture all of that.

出色的。期待投資者日的到來。最後，對於我們來說，您正在收集大量臨床數據和一些現實世界的數據。我想知道您是否會創建某種註冊表來捕獲所有這些。

The answer is yes. Part of it will be shown and presented in our website. Everything based on what is allowed, what we can, it will be based on regulation related to this disclosure. We are also in the process of preparing all the clinical data collected and prepare the paper that we're going to release. So this is actually, at the same time that we do all the commercial deployment, we're going to make a lot of efforts and emphasize the clinical side of what we are doing. I think that I've shared a little bit today that, as you know, in the U.S. we are allowed right now to do the MSK, but in the rest of the world we do chest, abdomen and other anatomies. So both in Israel and in Morocco, we have already tested and scanned humans in the other anatomies used. So basically, this is the plan that we move forward in order to enhance our ability to do the clinical -- to provide the clinical data and explore the opportunities for the future intended use.

答案是肯定的。其中一部分將在我們的網站上展示和呈現。一切都基於允許的、我們能做的，這將基於與此披露相關的法規。我們還正在準備收集到的所有臨床數據並準備我們將要發布的論文。所以實際上，在我們進行所有商業部署的同時，我們將做出大量努力並強調我們正在做的事情的臨床方面。我想我今天分享了一些內容，如您所知，在美國我們現在可以進行 MSK，但在世界其他地方我們可以進行胸部、腹部和其他解剖學檢查。因此，在以色列和摩洛哥，我們已經在使用的其他解剖結構中對人類進行了測試和掃描。基本上，這是我們推進的計劃，以增強我們的臨床能力——提供臨床數據並探索未來預期用途的機會。

Thank you. This is all the time we have for questions. Thank you for your participation in today's conference. You may disconnect. Have a great day.

謝謝。這是我們提問的所有時間。感謝您參加今天的會議。您可以斷開連接。祝你有美好的一天。