(NNOX) 2022 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the NANO-X IMAGING Second Quarter 2022 Earnings 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 IMAGING 2022 年第二季度財報電話會議。 （操作員說明）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, Managing Director of Investor Relations. Please go ahead.

我現在想把會議交給你今天的演講者，投資者關係董事總經理 Mike Cavanaugh。請繼續。

Good morning, and thank you for joining us today. Earlier today, NANO-X IMAGING, LTD. released its financial results for the quarter ended June 30, 2022. The release is currently available on the Investors section of the company's website. Erez Meltzer, Chief Executive Officer; and Ran Daniel, Chief Financial Officer, will host this morning's call.

早上好，感謝您今天加入我們。今天早些時候，NANO-X IMAGING, LTD.發布了截至 2022 年 6 月 30 日的季度財務業績。該新聞稿目前可在公司網站的“投資者”部分獲得。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.

在我們開始之前，我想提醒大家，管理層將在本次電話會議期間發表聲明，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今天的當前預期，未來可能不會更新。

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. 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 goodwill impairment, change an obligation in connection of a merger and acquisitions, stock-based compensation, amortization of intangible assets and class action litigation and SEC inquiry related expenses.

因此，不應依賴這些陳述來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公司提交給證券交易委員會的文件中描述的因素。我們還將參考某些非公認會計準則財務措施，以向投資者提供更多信息。我們的新聞稿提供了非公認會計原則與公認會計原則措施的對賬，主要區別是商譽減值、改變與併購相關的義務、基於股票的補償、無形資產攤銷和集體訴訟以及美國證券交易委員會查詢相關費用。

I'd now like to turn the call over to Erez Meltzer.

我現在想把電話轉給 Erez Meltzer。

Thank you, Mike, and thank you all for joining us on the call today. As always, we appreciate your continued support of Nanox.

謝謝你，邁克，感謝大家今天加入我們的電話會議。一如既往，我們感謝您對 Nanox 的持續支持。

As on our last call, I will give an overview of our recent achievements and share our outlook on the coming months before turning the call over to Ran Daniel, our Chief Financial Officer, to review our financial results. We will then open the call up to questions.

與上次電話會議一樣，我將概述我們最近的成就並分享我們對未來幾個月的展望，然後將電話轉給我們的首席財務官 Ran Daniel，以審查我們的財務業績。然後，我們將打開電話提問。

We have continued to make progress during the past quarter to advance the Nanox.ARC system towards commercialization, and we continue to proceed full force ahead to make headway in the FDA clearance process. On the call today, I will discuss the advances we have made since our last earnings call by breaking my comments into 3 distinct segments: regulatory; commercialization; and finally, AI and teleradiology.

在過去的一個季度中，我們繼續在推動 Nanox.ARC 系統商業化方面取得進展，我們將繼續全力以赴，在 FDA 批准程序中取得進展。在今天的電話會議上，我將討論自上次財報電話會議以來我們取得的進展，將我的評論分為三個不同的部分：監管；商業化；最後，人工智能和遠程放射學。

I will discuss what we have done in each of these segments, and how we have moved closer to our goal of system deployment at scale. Before I do that, I'll touch on our financial results at a high level but will leave most of the details to Ran's commentary later in the call.

我將討論我們在每個部分中所做的工作，以及我們如何更接近大規模系統部署的目標。在此之前，我將在高水平上談及我們的財務業績，但大部分細節將留給 Ran 稍後在電話會議中的評論。

Nanox generated top line revenue of $2.2 million in the second quarter of 2022 compared to $1.8 million in Q1 2022. As in previous quarter, all revenue was generated by Nanox teleradiology services business unit and by Nanox.AI, our deep learning machine analytics company. As most of you know, these business units began generating revenue since their acquisitions in November 2021. And it's gratifying to see our teleradiology services growing quarter-over-quarter. These revenues were relatively small at this time are important for 2 reasons: First, they help us to improve our cash flow and its management; and second, we believe they demonstrate that customers and other stakeholders such as hospitals and integrated health systems value these services, which in turn strengthens our belief that these applications and services will add value within our multi-source system when integrated with our proprietary imaging technology.

Nanox 在 2022 年第二季度的收入為 220 萬美元，而 2022 年第一季度為 180 萬美元。與上一季度一樣，所有收入均由 Nanox 遠程放射學服務業務部門和我們的深度學習機器分析公司 Nanox.AI 產生。正如你們大多數人所知，這些業務部門自 2021 年 11 月收購以來就開始產生收入。很高興看到我們的遠程放射服務季度環比增長。這些收入在這個時候相對較小很重要，原因有兩個：首先，它們有助於我們改善現金流及其管理；其次，我們相信他們證明了客戶和其他利益相關者（例如醫院和綜合醫療系統）重視這些服務，這反過來又加強了我們的信念，即當與我們的專有成像技術集成時，這些應用程序和服務將在我們的多源系統中增加價值.

I'm happy to report that during the second quarter of 2022, we signed 14 new client agreements for teleradiology services. Our clients in the teleradiology segment include hospitals, outpatient imaging centers, urgent cares, multi-specialty physician group, research facility and mental health facilities. We continue to see accelerated revenue growth in our teleradiology services driven by new client additions as well as organic growth from existing clients.

我很高興地報告，在 2022 年第二季度，我們簽署了 14 份新的遠程放射服務客戶協議。我們在遠程放射學領域的客戶包括醫院、門診影像中心、緊急護理、多專科醫師團隊、研究機構和心理健康機構。我們繼續看到我們的遠程放射學服務的收入加速增長，這得益於新客戶的增加以及現有客戶的有機增長。

The AI solution business continued to gain tractions, both in the U.S. and abroad. For example, Nanox had their first go live at 5 Northwell Health outpatient centers on July 26, followed by South Shore Hospital on August 8. Additional hospitals and outpatient sites throughout the system are anticipated to go live through the remainder of August and into September.

人工智能解決方案業務在美國和國外都繼續受到關注。例如，Nanox 於 7 月 26 日在 Northwell Health 的 5 個門診中心首次上線，隨後於 8 月 8 日在南岸醫院上線。整個系統的其他醫院和門診點預計將在 8 月剩餘時間和 9 月上線。

In addition, we previously reported a large strategic agreement with one of the leading IDNs in the Northwest of the U.S. to use our AI population health solution. We can now share that this customer is in Spectrum Health, an integrated health care network based in Michigan with 15 hospitals and health facilities.

此外，我們之前曾報導過與美國西北部領先的 IDN 之一達成一項大型戰略協議，以使用我們的 AI 人口健康解決方案。我們現在可以分享該客戶在 Spectrum Health 中，這是一個位於密歇根州的綜合醫療保健網絡，擁有 15 家醫院和醫療機構。

I'd now like to discuss our progress on the regulatory front. Beyond the beneficial revenue streams I just mentioned, we made further progress in our efforts to gain FDA clearance for the Nanox.ARC multisource system. Recently, we received feedback from the FDA on our Q-submission supplement that we previously submitted to the agency. The feedback we have received has been valuable, and it's helping us to optimize our 510(k) submission.

我現在想討論一下我們在監管方面的進展。除了我剛才提到的有益收入來源之外，我們在獲得 FDA 對 Nanox.ARC 多源系統的批准方面取得了進一步的進展。最近，我們收到了 FDA 關於我們之前提交給該機構的 Q 提交補充的反饋。我們收到的反饋很有價值，它幫助我們優化了我們的 510(k) 提交。

Subsequently, we are now preparing our 510(k) submission to the FDA for our multisource Nanox.ARC, which we expect will have the full power levels and indications that we believe will result in a successful deployment of the Nanox.ARC.

隨後，我們現在正在為我們的多源 Nanox.ARC 準備向 FDA 提交的 510(k)，我們預計它將具有我們認為將導致 Nanox.ARC 成功部署的全部功率水平和跡象。

In parallel, we are preparing for global deployment of our multisource Nanox.ARC, according to local regulations and subject to requisite approval in each market. Regarding regulatory efforts to obtain the CE mark for Nanox.ARC, we have submitted all necessary documentation to begin the process for CE marking. We look forward to providing additional updates as this process advances.

與此同時，我們正準備根據當地法規在全球部署我們的多源 Nanox.ARC，並在每個市場獲得必要的批准。關於為 Nanox.ARC 獲得 CE 標誌的監管工作，我們已提交所有必要的文件以開始 CE 標誌流程。隨著這一進程的推進，我們期待提供更多更新。

Moving on to commercialization. We have continued to progress toward commercialization of the multisource Nanox.ARC in several areas. I'm happy to announce that we have taken steps to advance deployment of the multisource Nanox.ARC in Nigeria. In April, we sent a preliminary deployment team to be on the ground there and are preparing to send our first commercial unit for demonstration and training purposes.

繼續商業化。我們在多個領域繼續朝著多源 Nanox.ARC 的商業化邁進。我很高興地宣布，我們已採取措施推進多源 Nanox.ARC 在尼日利亞的部署。 4 月，我們派出一個初步部署小組到那裡，並準備派出我們的第一個商業單位進行演示和培訓。

Our shipment plan to Nigeria is progressing hand-in-hand with the local regulation process. I also have the pleasure to announce another new agreement that we have signed recently with the distributor in Ghana, under which we agreed to deploy 350 units subject to local regulatory requirements, which brings our total contracted units to 6,850 worldwide. This is a great milestone for the company, and we are pushing forward on the development and the deployable system to fulfill these orders. We believe that once we begin to deploy the multisource Nanox.ARC in Nigeria and other early adoption area, health systems, hospitals and distributors will see the service that the Nanox.ARC provides and that we will then begin to fulfill the backlog of orders with buildup.

我們對尼日利亞的發貨計劃與當地監管程序同步推進。我還很高興地宣布，我們最近與加納的經銷商簽署了另一項新協議，根據該協議，我們同意根據當地監管要求部署 350 台設備，這使我們在全球範圍內的合同總數量達到 6,850 台。這對公司來說是一個偉大的里程碑，我們正在推進開發和可部署系統來完成這些訂單。我們相信，一旦我們開始在尼日利亞和其他早期採用地區部署多源 Nanox.ARC，衛生系統、醫院和分銷商將看到 Nanox.ARC 提供的服務，然後我們將開始履行積壓的訂單積聚。

In addition, we have an agreement in place with a nongovernmental organization, BIO Ventures for Global Health, known as BVGH for developing and implementing a medical imaging training initiative in Nigeria.

此外，我們與非政府組織 BIO Ventures for Global Health 簽訂了一項協議，該組織被稱為 BVGH，用於在尼日利亞開發和實施一項醫學成像培訓計劃。

BVGH is a Seattle-based nonprofit organization that strategically develops and manage programs across the for-profit and nonprofit sectors to accelerate research and development for poverty-related diseases, build biomedical R&D capacity in low and middle-income countries and improve cancer patient care in Africa. Some new book collaboration and developments.

BVGH 是一家總部位於西雅圖的非營利組織，戰略性地開發和管理營利性和非營利性部門的項目，以加速與貧困相關的疾病的研發，在低收入和中等收入國家建立生物醫學研發能力，並改善癌症患者的護理。非洲。一些新書的合作和發展。

Finally, I'd also like to take a minute to announce another milestone on the path to commercialization that we are excited about. We are in the process of establishing a technology development center based in Israel to develop the chips and the tubes that we'll need for the Nanox.ARC in the years to come. This center will complement our facilities in Korea and Japan.

最後，我還想花一點時間宣布我們對商業化道路上的另一個里程碑感到興奮。我們正在以色列建立一個技術開發中心，以開發我們未來幾年 Nanox.ARC 所需的芯片和管子。該中心將補充我們在韓國和日本的設施。

To close my remarks, I want to thank the Nanox team for all their hard work and progress achieved in this quarter. But most of all, I want to thank all our investors for their continued support for our mission to democratize health care by making imaging affordable and available anywhere in the world. We look forward to reporting more progress on our next earnings call.

最後，我要感謝 Nanox 團隊在本季度取得的所有辛勤工作和取得的進展。但最重要的是，我要感謝我們所有的投資者對我們的使命的持續支持，即通過使成像在世界任何地方都能負擔得起和可用來實現醫療保健民主化。我們期待在下一次財報電話會議上報告更多進展。

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

有了這個，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. First, I'm delighted to announce that we were added to the Russell 2000 and Russell 3000 Indices effective after the U.S. market opened on June 27 as part of the 2022 Russell Indices annual reconstitution. This is a great development for our company. As for our financial results, we reported a GAAP net loss for the second quarter of 2022 of $19.6 million compared to a net loss of $13.6 million in the second quarter of 2021, largely due to expenses related to the acquisition of the Nanox market platform in November 2021. The consolidation of Nanox.AI and USARAD with the company since the fourth quarter of 2021, an increase in our research and development expenses, goodwill impairment and increase in our general and administrative expenses which was mitigated by a decrease in our sales and marketing expenses and a decrease in our obligation in connection of merchants and acquisitions.

謝謝你，埃雷茲。首先，我很高興地宣布，作為 2022 年羅素指數年度重組的一部分，我們在 6 月 27 日美國市場開盤後加入羅素 2000 和羅素 3000 指數。這對我們公司來說是一個巨大的發展。至於我們的財務業績，我們報告 2022 年第二季度的 GAAP 淨虧損為 1960 萬美元，而 2021 年第二季度的淨虧損為 1360 萬美元，主要是由於與收購 Nanox 市場平台相關的費用2021 年 11 月。自 2021 年第四季度以來，Nanox.AI 和 USARAD 與公司合併，我們的研發費用增加、商譽減值以及我們的一般和管理費用增加，但我們的銷售額和營銷費用和減少我們與商家和收購有關的義務。

Our revenues for the second quarter of 2022 were $2.2 million, and gross loss was $1.8 million. Revenue from teleradiology services for the period was $2.1 million with a gross profit of $0.3 million on a GAAP basis and a gross profit of $0.9 million on a non-GAAP basis, which represents gross profit margins of approximately 43% on a non-GAAP basis. Revenue from licensings of AI solutions for the period was $0.1 million, with a gross loss of $2.1 million on a GAAP basis and a $0.1 million on a non-GAAP basis.

我們 2022 年第二季度的收入為 220 萬美元，總虧損為 180 萬美元。期內遠程放射服務收入為 210 萬美元，按公認會計原則計算的毛利潤為 30 萬美元，按非公認會計原則計算的毛利潤為 90 萬美元，按非公認會計原則計算的毛利率約為 43% .該期間人工智能解決方案許可收入為 10 萬美元，按公認會計原則計算的總虧損為 210 萬美元，按非公認會計準則計算的總虧損為 10 萬美元。

Research and development expenses for the second quarter of 2022 were $6.5 million compared to $4.3 million for the comparable period in 2021. The increase in our research and development expenses was mainly due to consolidation of Nanox.AI with the company since November 2021, increasing our share based compensation and the balance due to the development of the multisource Nanox.ARC system and the Nanox.CLOUD.

2022 年第二季度的研發費用為 650 萬美元，而 2021 年可比期間為 430 萬美元。我們的研發費用增加主要是由於自 2021 年 11 月以來 Nanox.AI 與公司合併，增加了我們的研發費用。由於多源 Nanox.ARC 系統和 Nanox.CLOUD 的開發，基於份額的補償和平衡。

Sales and marketing expenses for the second quarter of 2022 were $1.1 million compared to $1.8 million for the comparable period in 2021. The decrease was mainly due to a decrease of $0.6 million in our share base compensation.

2022 年第二季度的銷售和營銷費用為 110 萬美元，而 2021 年同期為 180 萬美元。減少的主要原因是我們的股票基礎薪酬減少了 60 萬美元。

General and administrative expenses for the second quarter of 2022 were $11.1 million compared to $7.4 million for the comparable period in 2021. The increase of $3.7 million was mainly due to the acquisitions of the Nanox markets platform in November 2021 and the consolidation of Nanox.AI and USARAD with the company since the fourth quarter of 2021, an increase in the company's headcount and the overall organization infrastructure and an increase in the company's legal fees due to the U.S. Securities Exchange Commission equally and the class action litigation as described in the company's Form 20-F for the year ended December 31, 2021, filed on May 2, 2022.

2022 年第二季度的一般和行政費用為 1110 萬美元，而 2021 年可比期間為 740 萬美元。增加 370 萬美元主要是由於 2021 年 11 月收購 Nanox 市場平台以及合併 Nanox.AI和 USARAD 自 2021 年第四季度以來與公司合作，公司員工人數和整體組織基礎設施增加，公司法律費用因美國證券交易委員會和公司表格中所述的集體訴訟而增加截至 2021 年 12 月 31 日止年度的 20-F，於 2022 年 5 月 2 日提交。

Change in obligation in connection of merger and acquisitions for the second quarter of 2022 was $2.6 million (sic) [$12.6 million] compared to none for the second quarter of 2021. The increase was mainly due to the change in the company's contingent and our stability. Goodwill impairment for the 3 months ended June 30, 2022, was $14.3 million due to the goodwill impairment in connection to the -- of the acquisition of Nanox.AI.

與 2022 年第二季度的併購相關的義務變化為 260 萬美元（原文如此）[1260 萬美元]，而 2021 年第二季度為無。增加的主要原因是公司的或有變化和我們的穩定性.由於與收購 Nanox.AI 相關的商譽減值，截至 2022 年 6 月 30 日止 3 個月的商譽減值為 1430 萬美元。

Our non-GAAP net loss for the second quarter of 2022 was $8.2 million compared to a non-GAAP net loss of $8.6 million for the same period in 2021. A reconciliation between GAAP net loss and non-GAAP net loss for the second quarter of 2022 and 2021 is provided in the financial results that are part of the press release we issued this morning.

我們 2022 年第二季度的非 GAAP 淨虧損為 820 萬美元，而 2021 年同期的非 GAAP 淨虧損為 860 萬美元。 2022 年和 2021 年在我們今天上午發布的新聞稿中的財務業績中提供。

The difference between GAAP and non-GAAP network is mainly due to goodwill impairment, change in obligation in connection of merger and acquisition, amortization of intangible assets, share-based compensation expenses, legal fees in connection with the class action litigation and the SEC inquiry and the secondary offering expenses.

GAAP 與非 GAAP 網絡之間的差異主要是由於商譽減值、與併購相關的義務變化、無形資產攤銷、股權激勵費用、與集體訴訟和 SEC 調查有關的法律費用以及二次發行費用。

Turning to our balance sheet. As of June 30, 2022, with cash, cash equivalents and marketable securities of approximately $126.7 million. We ended the quarter with a property and equipment net of $42.9 million compared to $37.4 million as of December 31, 2021. The net increase of $5.5 million during the first half of '22 is mainly due to the completion of the construction of the company's fabrication facility in South Korea and the purchase of machinery and equipment. As of June 30, 2022, we had intangible assets of $140.5 million as compared to $160.1 million as of December 31, 2021. The decrease is mainly due to the periodic amortization of intangible assets and impairment of the goodwill.

轉向我們的資產負債表。截至 2022 年 6 月 30 日，現金、現金等價物和有價證券約為 1.267 億美元。截至本季度末，我們的財產和設備淨額為 4290 萬美元，而截至 2021 年 12 月 31 日為 3740 萬美元。22 年上半年淨增加 550 萬美元，主要是由於完成了公司製造的建設在韓國設廠併購買機械設備。截至 2022 年 6 月 30 日，我們的無形資產為 1.405 億美元，而截至 2021 年 12 月 31 日為 1.601 億美元。減少的主要原因是無形資產的定期攤銷和商譽減值。

As of June 30, 2022, the company had approximately 52.2 million shares outstanding compared to 51.8 million shares outstanding as of December 31, 2021. The increase was mainly due to the exercise of 192,927 warrants and the exercise of 141,067 auctions, the company generated approximately $0.5 million in gross proceeds from the exercise of such options and formats. In addition, during the first half of 2022, the company issued 89,286 shares to the former equity holders of Nanox.AI due to the achievement of a milestone pursuant to the terms of the agreement and plan of merger dated August 9, 2021, as amended, among the company Nanox.AI and Perryllion, Ltd as a representative of Nanox.AI's equity holders.

截至 2022 年 6 月 30 日，公司流通股約為 5220 萬股，而截至 2021 年 12 月 31 日為 5180 萬股。增加的主要原因是行使 192,927 股認股權證和行使 141,067 次拍賣，公司產生約行使此類選項和格式的總收益為 50 萬美元。此外，在 2022 年上半年，由於根據 2021 年 8 月 9 日的協議和合併計劃的條款（經修訂）實現了里程碑，公司向 Nanox.AI 的前股東發行了 89,286 股股票，其中 Nanox.AI 公司和 Perryllion, Ltd 作為 Nanox.AI 的股東代表。

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

有了這個，我會把電話交給埃雷茲。

Thank you, Ran, for the financial update. And once again, thank you all for joining us today. I feel very good about Nanox results in the second quarter as CEO. But all of us recognize there is more to do. We hope to provide additional updates in the coming weeks and months.

謝謝你，冉，財務更新。再次感謝大家今天加入我們。作為 CEO，我對 Nanox 第二季度的業績感覺非常好。但我們所有人都認識到還有更多工作要做。我們希望在未來幾周和幾個月內提供更多更新。

I would also like to share with you all that the Nanox management team will have a non-deal road show with investors in late September. If you would like to schedule a meeting, please contact our Investor Relations partners at ICR.

我還想和大家分享一下，Nanox 管理團隊將在 9 月下旬與投資者進行非交易路演。如果您想安排會議，請聯繫我們在 ICR 的投資者關係合作夥伴。

With that, I'd like now to open the call for questions. Operator, please begin the Q&A session.

有了這個，我現在想打開提問電話。接線員，請開始問答環節。

(Operator Instructions) Our first question comes from Jeff Cohen with Ladenburg.

（操作員說明）我們的第一個問題來自 Jeff Cohen 和 Ladenburg。

A couple of questions for Erez. So could you talk about the technologies you're planning on opening to [Azure] capabilities that you anticipate there versus the current and anticipated capabilities in the facilities in Korea and Japan.

Erez 有幾個問題。那麼，您能否談談您計劃向 [Azure] 功能開放的技術與您在韓國和日本的設施中的當前和預期功能。

First of all, the -- it's going to be very similar, but we're going to strength the fact that we are willing to base our future on further advanced technologies. Right now, we have both centers in Japan and in Korea for the chips and the tubes. We thought that it would be appropriate that the core technology and knowledge will be developed very close to where we do the R&D, the product design, the road map, our future products, et cetera, and that Korea will be kind of more of manufacturing and supply for the chips and further development that will be on the engineering side.

首先，這將非常相似，但我們將加強這樣一個事實，即我們願意將我們的未來建立在更先進的技術上。目前，我們在日本和韓國都有芯片和管材中心。我們認為，核心技術和知識將在非常接近我們進行研發、產品設計、路線圖、我們未來產品等的地方開發是合適的，並且韓國將更像是製造業芯片供應和工程方面的進一步開發。

Okay. Got it. Could you talk about ARC manufacturing and number of ARCs, which have been manufactured and maybe anticipated number of ARCs manufactured by the end of the year and then tie that into your anticipated time line at the FDA as far as your project?

好的。知道了。您能否談談 ARC 的製造和 ARC 的數量，它們已經製造出來，並且可能在年底前預計製造的 ARC 數量，然後將其與您在 FDA 的預期時間線聯繫起來，就您的項目而言？

Okay. So first of all, we are accelerating the production, as mentioned. Obviously, we're not disconnected from the reality of the -- what's going on in the market in terms of the supply chain, in terms of the various components, which are part of this assembly. So we have actually -- part of the systems will be pushed to 2023 to hopefully, for the beginning. And this is with respect to the production. We are -- even before the end of the year, we are going to go even to the next step to further explore the discussion with the mass production. And I mean beyond the 1,000 units in 1 or 2 locations, which are not in Israel. We mentioned that the first 1,000 units will be assembled in Israel. And the -- and we hope that either Q4 or Q1 next year, we will have the arrangement for the assembly of the -- of all the systems following after the first 1,000 units.

好的。因此，首先，如前所述，我們正在加速生產。顯然，我們並沒有脫離現實——就供應鏈而言，市場上正在發生的事情，就作為該組件的一部分的各種組件而言。所以我們實際上 - 部分系統將被推到 2023 年，希望是開始的。這是關於生產的。我們是——甚至在今年年底之前，我們甚至會進入下一步，進一步探索與量產的討論。我的意思是超過 1 或 2 個地點的 1,000 個單位，這些地點不在以色列。我們提到前 1,000 台將在以色列組裝。而且 - 我們希望明年第四季度或第一季度，我們將安排在前 1,000 台之後的所有系統的組裝。

With respect to the question that you asked about the FDA. First of all, I was very happy with the meeting that was held last week, which was actually the last -- not the last, but the last meeting before the final preparation for the submission. I would say that the feedback that we received from the FDA was very helpful and meaningful for us. So as we say, we are in the final preparation for the formal submission and it's going to be aligned with our path moving forward.

關於你問的關於 FDA 的問題。首先，我對上週舉行的會議非常滿意，這實際上是最後一次——不是最後一次，而是最後一次準備提交之前的最後一次會議。我想說，我們從 FDA 收到的反饋對我們非常有幫助和意義。正如我們所說，我們正在為正式提交做最後準備，它將與我們前進的道路保持一致。

Right now, I would say that the idea to go to the pre-sub and to the submission and to take the advantage for, I would say, about 8 -- almost 8 months dialogue, continuous dialogue with the FDA and prudent self to be the right decision. And I think that all the feedback that we got and the cooperation that we are -- that we had with FDA and we continue to have with FDA will make it much easier for us to do it. So...

現在，我想說的是進行預申請和提交的想法，並利用大約 8 - 近 8 個月的對話，與 FDA 的持續對話和謹慎的自我正確的決定。我認為我們得到的所有反饋以及我們與 FDA 的合作以及我們繼續與 FDA 的合作將使我們更容易做到這一點。所以...

Got it. And then finally, talk about Ghana as far as manufacturing and delivering ARC units. How many would you expect to be delivered there in the coming quarter or 2?

知道了。最後，談談加納製造和交付 ARC 裝置的情況。您預計下一季度或第二季度將在那裡交付多少？

Right now, I would say that the -- we explained in the past that basically not all the countries that we're working in require the FDA regulation like we mentioned Nigeria, one of them and Ghana will be another one. We have another 2 that are not really related to the submission of the -- to the formal approval of the FDA.

現在，我想說的是——我們過去曾解釋說，基本上並非我們工作的所有國家都需要像我們提到的尼日利亞那樣的 FDA 監管，其中一個國家和加納將是另一個國家。我們還有另外兩個與提交 FDA 的正式批准無關。

Ghana has a special process that we are going through. They give us indications, but I wouldn't actually -- I feel I see it in my eyes, I wouldn't actually commit to -- we hope to have the approval to send the systems during the fourth quarter. And I would say the -- starting next year, it will be probably more a system that will be sent. Overall, the agreement is for 350 units.

加納有一個我們正在經歷的特殊過程。他們給了我們指示，但我實際上不會——我覺得我看到了它，我實際上不會承諾——我們希望在第四季度獲得批准發送系統。我想說的是——從明年開始，它可能會更多地發送一個系統。總體而言，該協議適用於 350 個單位。

Got it. And then one quick question for Ran. Would you expect any goodwill impairment in the back half of the year for Q3 or Q4?

知道了。然後給 Ran 一個簡短的問題。您預計第三季度或第四季度下半年會出現商譽減值嗎？

As we say in the PR, it really depends on the market parameter, the interest rate, there will be an increase or there will be any change in other capital market format. So we may have to do an impairment again. We have to test it at least and it also depends on our internal management estimate.

正如我們在公關中所說，這實際上取決於市場參數，利率，是否會增加或其他資本市場格式會發生任何變化。所以我們可能不得不再次進行減值。我們至少必須對其進行測試，這也取決於我們的內部管理估計。

Our next question comes from the line of Suraj Kalia with Oppenheimer.

我們的下一個問題來自 Suraj Kalia 與 Oppenheimer 的對話。

Erez, can you hear me all right?

埃雷茲，你能聽到我的聲音嗎？

Loud and clear.

響亮而清晰。

Hope everyone is safe and healthy. So Erez, just following up on Nanox.ARC, the multisource submission. Was a full power level ever in doubt, maybe I'm misreading from your comments on the feedback from the FDA. If I remember correctly last quarter, I think so you all had mentioned that from 40 to 120 kVp. It would cover the entire gamut. So maybe if you could kindly shed some additional light on your specific comments at the full power level feedback.

希望每個人都平安健康。所以 Erez，只是跟進 Nanox.ARC，多源提交。是否曾經懷疑過全功率水平，也許我誤讀了您對 FDA 反饋的評論。如果我上個季度沒記錯的話，我想你們都提到過從 40 到 120 kVp。它將涵蓋整個色域。因此，如果您可以在完整的功率級反饋中對您的具體評論提供一些額外的說明，也許可以。

First of all, I hope that I understand the question, but it was -- it has never been a doubt.

首先，我希望我能理解這個問題，但它是——從來沒有懷疑過。

Okay. Fair enough. So Ran, when -- are you at -- or can you give us a time frame as to when the multisource 510(k) will actually be filed? And when you are expecting clearance?

好的。很公平。所以 Ran，你什麼時候 - 你在 - 或者你能給我們一個時間框架，說明多源 510(k) 的實際提交時間？當您期待獲得許可時？

As you already know, I'm actually -- I can say or indicate or willing to commit only things which are 100% sure that there will be on the time to time actually committing. So right now, I think that I gave enough background and information about the time line. We are in the final preparation to the submission, and it will be done shortly. And I think that the -- this is, I would say, positively saying the feedback that we got from the FDA gave us the advantage to add a few things in the submission that will be done in the next few weeks that will be added to the system. So I hope that this submission will done shortly. And once it's submitted, I'm sure that you'll know about it.

正如您已經知道的那樣，我實際上——我可以說、表明或願意只承諾 100% 確定會不時實際承諾的事情。所以現在，我認為我提供了足夠的關於時間線的背景和信息。我們正在對提交進行最後的準備，很快就會完成。而且我認為 - 我會說，這是積極地說，我們從 FDA 獲得的反饋讓我們有優勢在提交中添加一些內容，這些內容將在接下來的幾週內完成，這些內容將添加到系統。所以我希望這個提交將很快完成。一旦提交，我相信你會知道的。

So you will file more than likely in Q4?

所以你很可能會在第四季度提交文件？

You said so. Basically, I'm always trying to do things earlier on all level and all fronts.

你是這麼說的。基本上，我總是試圖在各個層面和各個方面儘早做事。

As the CE mark, generally speaking, companies have voiced a lot of concern. Just the MDR process has become very cumbersome, CE processes overall become very cumbersome. And maybe I missed it in your prepared remarks, some of the updated time lines for CE mark for Nanox.ARC multisource?

作為CE標誌，一般來說，企業都表達了很多關注。只是MDR流程變得非常繁瑣，CE流程整體變得非常繁瑣。也許我在您準備好的評論中錯過了 Nanox.ARC 多源 CE 標誌的一些更新時間線？

First of all, we have already submitted all the necessary documentation for the registration with a notified body. We have selected the notified body. We gave them all the information. The -- when I was young, I learned that you have to do whenever you can, when you can control things. You have to be patient when you cannot, but you hope that you will have the wisdom to differentiate between them. This is basically right for the CE and for the FDA. We can control what we are doing, okay? We're not control. We are not managing the CE or the FDA, and we hope that the fact that they have a lot of overload in their systems and processes will not hurt us and will give us the privilege that the preparations that we have done during the last few months, will give the results sooner rather than later.

首先，我們已經向指定機構提交了註冊所需的所有必要文件。我們選擇了指定機構。我們給了他們所有的信息。 ——當我年輕的時候，我了解到你必須盡可能地去做，當你可以控制事情的時候。當你不能時，你必須要有耐心，但你希望你有智慧來區分它們。這對於 CE 和 FDA 來說基本上是正確的。我們可以控制自己在做什麼，好嗎？我們不受控制。我們不是在管理 CE 或 FDA，我們希望他們的系統和流程中有很多超負荷的事實不會傷害我們，並且會讓我們有特權，我們在過去幾個月所做的準備工作，遲早會給出結果。

Got it. Erez, 2 final questions, and I'll hop back in queue. So in terms of Ghana, what all validation testing has been done before you'll start shipping these units? And the second -- the last question from my side, Erez, is the 6,850 units that you referenced in terms of contractual amounts, if memory shows me right, a substantial portion of these are more than 3-year old contracts. I remember seeing these in 2019. Maybe if you could just talk to us about whether they are still valid? Or have there been any amendments? Any additional color there would be greatly appreciated.

知道了。 Erez，最後 2 個問題，我會跳回隊列。那麼就加納而言，在您開始運送這些設備之前，所有的驗證測試都完成了哪些？第二個 - 我的最後一個問題，Erez，是你提到的合同金額方面的 6,850 個單位，如果我沒記錯的話，其中很大一部分是超過 3 年的合同。我記得在 2019 年看到過這些。也許你可以和我們談談它們是否仍然有效？或者有沒有修改過？任何額外的顏色將不勝感激。

Okay. So first of all, I'm not sure about the first question about the validation. What exactly are you referring to with respect to the systems that we check. The answer is yes. So I would say, positive.

好的。所以首先，我不確定關於驗證的第一個問題。關於我們檢查的系統，您到底指的是什麼。答案是肯定的。所以我會說，積極的。

To the second question, with respect to the clearance in the region, are you referring to what kind of validation in terms of technology or in terms of regulation in Ghana?

關於第二個問題，關於該地區的清關，您是指加納在技術方面還是在監管方面進行什麼樣的驗證？

No, Erez. What I meant was before you launch any product commercially, you have to go through a slew of testing, performance testing, character...

不，埃雷茲。我的意思是在你將任何產品投入商業之前，你必須經過一系列的測試、性能測試、特性......

Yes, of course, Yes, yes. The answer is basically, yes. Not basically, the answer is yes.

是的，當然，是的，是的。答案基本上是，是的。基本上不是，答案是肯定的。

Our next question comes from the line of Rahul Rakhit with LifeSci Capital.

我們的下一個問題來自 LifeSci Capital 的 Rahul Rakhit。

So you mentioned that there are 2 other countries that don't necessarily require FDA clearance for deployment. Maybe if you talk about where you are in conversations in those geographies and provide any indication on timing there?

所以你提到有兩個其他國家不一定需要 FDA 批准才能部署。也許如果您談論您在這些地區的對話中的位置並提供有關那裡時間的任何指示？

The answer is no because since we have not announced it to the public. As soon as we are going to announce to the public, we'll actually share. My preference would be that only when we sign agreements, we let the market know that they were signed. In the past, you know that in the 20-F, there are a few countries which do not necessarily meet the FDA.

答案是否定的，因為我們還沒有向公眾宣布。一旦我們要向公眾宣布，我們就會真正分享。我的偏好是，只有當我們簽署協議時，我們才讓市場知道它們已經簽署。過去，你知道在 20-F 中，有幾個國家不一定符合 FDA。

Right. Right. Okay. That makes sense. And then really exciting to hear about some of these AI agreements that you guys announced. Maybe could you help us think about the broader revenue potential there, these obviously big health systems. What is integration like -- what does integration look like there? And ultimately, what is the broader revenue opportunity?

正確的。正確的。好的。那講得通。然後聽到你們宣布的一些人工智能協議真的很令人興奮。也許你能幫我們考慮一下那裡更廣泛的收入潛力，這些顯然是大型的衛生系統。什麼是集成——那裡的集成是什麼樣的？最終，更廣泛的收入機會是什麼？

So first of all, with respect to the integration, I think we mentioned it in the script in the 6(k) that these are -- we have already implemented in a few and installed the system over there. And we are -- and there is a time line right now in the next few months. I think the last one is going to be October or November, I think November, November will be the last one that we're going to install the system in all the hospitals that this specifically Northwell gave us to as part of the plan.

首先，關於集成，我認為我們在 6(k) 的腳本中提到了這些——我們已經在其中實施了一些並在那里安裝了系統。我們是——在接下來的幾個月裡，現在有一個時間表。我認為最後一個將是 10 月或 11 月，我認為 11 月和 11 月將是我們將在所有醫院安裝系統的最後一個，這是 Northwell 給我們的計劃的一部分。

In terms of IBM in general, our business model is basically that it can go -- and this is, by the way, unlike what used to be in the past and in the old -- what used to be Zebra Medical. Right now, it's everywhere between a few hundred thousand dollars to a few million dollars in scale.

總體而言，就 IBM 而言，我們的商業模式基本上是它可以走——順便說一句，這與過去和過去不同——過去是 Zebra Medical。現在，它的規模在幾十萬到幾百萬美元之間。

Got it. Okay. I appreciate that. And then just based on a lot of the Q&A so far, it sounds like the conversations with the FDA have been very fruitful. I know you don't want to lock in on a specific timing for the submission. But maybe can you help us understand what the impact of these conversations in the Q-submission has had on the actual timing of the decision. So once you do submit the 5(k) filing, how long do you expect it to take to actually obtain FDA clearance from there?

知道了。好的。我很感激。然後僅基於迄今為止的大量問答，聽起來與 FDA 的對話非常富有成果。我知道您不想鎖定提交的特定時間。但也許你能幫助我們了解 Q 提交中的這些對話對決定的實際時間有什麼影響。因此，一旦您提交了 5(k) 申請，您預計從那裡實際獲得 FDA 許可需要多長時間？

So basically, the one thing I would say, ideally, in a reasonable logical markets and time line, I would say the Q-submission would be probably (inaudible) for us, leads very helpful in the process, to accelerate the process. But right now, we know that the FDA -- based on the dialogue, we know that since we are working with them and cooperate with them. We know the overall that they have. And I hope that it will not -- that it will give us the -- I would say, the benefit or the I wouldn't say the privilege, but I would say the benefit of the process that we have done to make it sooner rather than later. And that's what I would mention. Overall, I think the process has a positive impact on the process, and I hope it will be the same on the clearance process.

所以基本上，我想說的一件事，理想情況下，在合理的邏輯市場和時間線上，我會說 Q 提交對我們來說可能（聽不清），在這個過程中非常有幫助，可以加速這個過程。但是現在，我們知道 FDA - 基於對話，我們知道，因為我們正在與他們合作並與他們合作。我們知道他們的整體情況。我希望它不會 - 它會給我們帶來 - 我會說的好處或我不會說的特權，但我會說我們已經完成的過程的好處，以使其更快而不是以後。這就是我要提到的。總的來說，我認為這個過程對過程有積極的影響，我希望在通關過程中也是如此。

That's all the time we have for questions today. I'd now like to turn the call back over to Erez Meltzer for closing remarks.

這就是我們今天的所有提問時間。我現在想將電話轉回給 Erez Meltzer 以完成結束語。

So -- sorry. So once again, I'd like to thank you all for being part of this call today, we'll see you shortly. For those of you who are in the U.S., sometimes in September -- at the end of September. And we're always with ICR are willing to address any question that will may come from investors or from any audience that the questions that are related to what we are doing and what we were doing so far. Thank you so much, and have a good day.

非常抱歉。因此，我要再次感謝大家參加今天的電話會議，我們很快再見。對於那些在美國的人，有時是在九月——九月底。我們始終與 ICR 合作，願意解決可能來自投資者或任何觀眾的任何問題，這些問題與我們正在做的事情以及我們迄今為止所做的事情有關。非常感謝，祝您有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。