[Report Overview and Business Update](index=1&type=section&id=1.%20Report%20Overview%20and%20Business%20Update) This section provides an overview of Nanox's Q4 2022 performance, highlighting key operational achievements, strategic partnerships, and the CEO's outlook on future system deployments and FDA progress [Q4 2022 Highlights and Recent Developments](index=1&type=section&id=1.1%20Q4%202022%20Highlights%20and%20Recent%20Developments) Nanox reported Q4 2022 revenue of $2.1 million, highlighting significant progress in the initial deployment of Nanox.ARC systems in Ghana and Nigeria, and expanding Nanox AI solution availability through a partnership with Nuance Precision Imaging Network 2022年第四季度及全年营收 | Period | Revenue (Millions USD) | | :----- | :--------------------- | | Q4 2022 | $2.1 | | Q3 2022 | $2.4 | | Q2 2022 | $2.2 | | Q1 2022 | $1.8 | | Full Year 2022 | $8.6 | - Nanox.ARC systems have been initially deployed for training and demonstration at the University of Ghana Medical Centre and shipped to Nigeria for regulatory review[4](index=4&type=chunk) - A partnership with Microsoft's Nuance Precision Imaging Network was established to offer Nanox AI solutions to thousands of healthcare facilities and providers through its marketplace[4](index=4&type=chunk) [CEO Statement](index=1&type=section&id=1.2%20CEO%20Statement) CEO Erez Meltzer expressed satisfaction with the company's progress in Nanox.ARC deployment, Nanox AI expansion, and FDA review, noting 2022 focused on FDA 510(k) submission, cost rationalization, and manufacturing infrastructure, with 2023 anticipated as a significant year for initial Nanox.ARC system shipments - The company achieved significant progress in the initial deployment of Nanox.ARC systems in Ghana and Nigeria, expanded Nanox AI solution availability through key commercial partnerships, and advanced the FDA review process for Nanox.ARC[3](index=3&type=chunk) - **2022** was a successful year for Nanox, focusing on FDA 510(k) submission, cost rationalization to extend cash runway, and strengthening manufacturing infrastructure[3](index=3&type=chunk) - **2023** is expected to be a highly impactful year, with the goal of announcing the first shipments of Nanox.ARC systems[3](index=3&type=chunk) [Financial Performance - Fourth Quarter 2022 (GAAP)](index=2&type=section&id=2.%20Financial%20Performance%20-%20Fourth%20Quarter%202022%20(GAAP)) This section details Nanox's GAAP financial results for Q4 2022, including a significant net loss driven by goodwill impairment, changes in revenue and gross profit, and shifts in various operating expense categories [Net Loss Analysis](index=2&type=section&id=2.1%20Net%20Loss%20Analysis) Nanox reported a net loss of $44.8 million in Q4 2022, a significant increase from $22.0 million in Q4 2021, primarily due to a $36.5 million goodwill impairment 净亏损 (2022年第四季度 vs. 2021年第四季度) | Period | Net Loss (Millions USD) | Change (YoY) | | :----- | :---------------------- | :----------- | | Q4 2022 | $44.8 | +$22.8M | | Q4 2021 | $22.0 | | - The increase in net loss was primarily attributable to a **$36.5 million goodwill impairment** recorded in Q4 2022[5](index=5&type=chunk) [Revenue and Gross Loss](index=2&type=section&id=2.2%20Revenue%20and%20Gross%20Loss) Q4 2022 revenue increased to $2.1 million (+$0.8 million YoY), driven by teleradiology services and AI solutions; GAAP gross loss increased to $1.7 million, while non-GAAP gross profit rose to $0.8 million, with teleradiology non-GAAP gross margin around 40% due to higher service rates 营收 (2022年第四季度 vs. 2021年第四季度) | Period | Revenue (Millions USD) | Change (YoY) | | :----- | :--------------------- | :----------- | | Q4 2022 | $2.1 | +$0.8M | | Q4 2021 | $1.3 | | - Q4 2022 revenue was primarily generated through **teleradiology services ($2.0 million)** and **AI solutions ($0.1 million)**[6](index=6&type=chunk) GAAP毛亏损 (2022年第四季度 vs. 2021年第四季度) | Period | GAAP Gross Loss (Millions USD) | Change (YoY) | | :----- | :----------------------------- | :----------- | | Q4 2022 | $1.7 | +$0.2M | | Q4 2021 | $1.5 | | 非GAAP毛利润 (2022年第四季度 vs. 2021年第四季度) | Period | Non-GAAP Gross Profit (Millions USD) | Change (YoY) | | :----- | :----------------------------------- | :----------- | | Q4 2022 | $0.8 | +$0.4M | | Q4 2021 | $0.4 | | - The non-GAAP gross margin for teleradiology services was approximately **40%** in Q4 2022, an increase from 39% in the prior year period, primarily due to higher teleradiology service rates[6](index=6&type=chunk) [Operating Expenses](index=2&type=section&id=2.3%20Operating%20Expenses) In Q4 2022, R&D expenses increased due to higher labor and system development costs, while sales and marketing, and general and administrative expenses decreased due to reduced labor, share-based compensation, and legal fees 运营费用概览 (2022年第四季度 vs. 2021年第四季度) | Expense Category | Q4 2022 (Millions USD) | Q4 2021 (Millions USD) | Change (YoY) | | :--------------- | :--------------------- | :--------------------- | :----------- | | R&D | $7.1 | $6.4 | +$0.7M | | S&M | $1.5 | $1.9 | -$0.4M | | G&A | $8.2 | $10.9 | -$2.7M | [Research and Development Expenses](index=2&type=section&id=2.3.1%20Research%20and%20Development%20Expenses) R&D expenses increased by $0.7 million, driven by higher labor costs and development for Nanox.ARC and Nanox.CLOUD systems - Research and development expenses increased by **$0.7 million**, primarily due to a **$0.2 million increase in labor costs** and a **$0.5 million increase in development costs** for the multi-source Nanox.ARC and Nanox.CLOUD systems[7](index=7&type=chunk) [Sales and Marketing Expenses](index=2&type=section&id=2.3.2%20Sales%20and%20Marketing%20Expenses) Sales and marketing expenses decreased by $0.4 million, primarily due to lower labor costs and share-based compensation - Sales and marketing expenses decreased by **$0.4 million**, mainly due to a **$0.1 million decrease in labor costs** and a **$0.2 million decrease in share-based compensation**[8](index=8&type=chunk) [General and Administrative Expenses](index=2&type=section&id=2.3.3%20General%20and%20Administrative%20Expenses) G&A expenses decreased by $2.7 million, mainly due to reductions in labor, share-based compensation, D&O insurance, professional services, and legal fees - General and administrative expenses decreased by **$2.7 million**, primarily due to a **$0.5 million decrease in labor costs**, a **$2.3 million decrease in share-based compensation**, a **$0.3 million decrease in D&O insurance premiums**, a **$0.4 million decrease in other professional services**, and a **$2.0 million decrease in legal fees** related to the SEC investigation and class action lawsuit[9](index=9&type=chunk) [Change in Contingent Earnout Liability](index=2&type=section&id=2.4%20Change%20in%20Contingent%20Earnout%20Liability) In Q4 2022, the company recognized $9.1 million in income from a decrease in contingent earnout liability, primarily due to a settlement agreement with former Nanox AI Ltd. shareholders - In Q4 2022, a **$9.1 million income** was generated from the change in contingent earnout liability, primarily due to a decrease in the company's contingent earnout liability[10](index=10&type=chunk) - The decrease in liability was mainly attributable to a settlement agreement with former shareholders of Nanox AI Ltd. (formerly Zebra Medical Vision Ltd.) regarding additional amounts potentially payable under the merger agreement[10](index=10&type=chunk) [Goodwill Impairment](index=2&type=section&id=2.5%20Goodwill%20Impairment) In Q4 2022, the company recorded a $36.5 million goodwill impairment related to the Nanox AI reporting unit, as its population health applications are taking longer than expected to generate substantial revenue and positive cash flow - The **goodwill impairment** in Q4 2022 amounted to **$36.5 million**, related to the Nanox AI reporting unit[11](index=11&type=chunk) - The impairment resulted from the annual impairment test, indicating that the Nanox AI reporting unit, particularly its population health applications, is taking longer than anticipated to generate substantial revenue, gross profit, and positive operating cash flows[11](index=11&type=chunk) [Financial Position and Non-GAAP Performance](index=4&type=section&id=3.%20Financial%20Position%20and%20Non-GAAP%20Performance) This section analyzes Nanox's financial position and non-GAAP performance, detailing liquidity, capital resources, changes in assets like property, equipment, intangible assets, and goodwill, alongside shifts in shareholders' equity [Non-GAAP Financial Performance Overview](index=4&type=section&id=3.1%20Non-GAAP%20Financial%20Performance%20Overview) In Q4 2022, Nanox's non-GAAP net loss narrowed to $9.9 million, and non-GAAP gross profit increased to $0.8 million, with differences from GAAP primarily due to adjustments for goodwill impairment, intangible asset amortization, share-based compensation, and legal fees 非GAAP净亏损 (2022年第四季度 vs. 2021年第四季度) | Period | Non-GAAP Net Loss (Millions USD) | Change (YoY) | | :----- | :------------------------------- | :----------- | | Q4 2022 | $9.9 | -$5.1M | | Q4 2021 | $15.0 | | 非GAAP毛利润 (2022年第四季度 vs. 2021年第四季度) | Period | Non-GAAP Gross Profit (Millions USD) | Change (YoY) | | :----- | :----------------------------------- | :----------- | | Q4 2022 | $0.8 | +$0.6M | | Q4 2021 | $0.2 | | - The differences between GAAP and non-GAAP financial measures are primarily attributable to adjustments for **goodwill impairment**, **intangible asset amortization**, **share-based compensation**, secondary offering expenses, changes in contingent earnout liability, and legal fees related to class action lawsuits and SEC investigations[14](index=14&type=chunk) [Liquidity and Capital Resources](index=4&type=section&id=3.2%20Liquidity%20and%20Capital%20Resources) As of Q4 2022, Nanox held $102.9 million in cash, cash equivalents, and marketable securities, a $53.7 million decrease YoY, mainly due to operating cash outflows and capital expenditures, while working capital increased to $65.4 million 现金、现金等价物和有价证券 (截至年末) | Period | Amount (Millions USD) | | :----- | :-------------------- | | Dec 31, 2022 | $102.9 | | Dec 31, 2021 | $156.6 | - As of December 31, 2022, the company's working capital was **$65.4 million** (current assets of $82.5 million and current liabilities of $17.1 million)[15](index=15&type=chunk) - For the twelve months ended December 31, 2022, the company's cash, cash equivalents, and marketable securities decreased by **$53.7 million**, primarily due to **negative cash flow from operating activities of $43.4 million** and **$7.2 million in purchases of property and equipment** for the Korean manufacturing facility and multi-source system[17](index=17&type=chunk) [Other Assets](index=4&type=section&id=3.3%20Other%20Assets) At year-end 2022, net property and equipment increased due to the completion of the Korean manufacturing facility and equipment purchases, while intangible assets and goodwill significantly decreased due to amortization and impairment [Property and Equipment, Net](index=4&type=section&id=3.3.1%20Property%20and%20Equipment,%20Net) Net property and equipment increased by $6.1 million, driven by the completion of the Korean manufacturing facility and equipment purchases 物业和设备净值 (截至年末) | Period | Amount (Millions USD) | Change (YoY) | | :----- | :-------------------- | :----------- | | Dec 31, 2022 | $43.5 | +$6.1M | | Dec 31, 2021 | $37.4 | | - The increase was primarily attributable to the completion of the company's manufacturing facility in South Korea and the purchase of machinery and equipment[18](index=18&type=chunk) [Intangible Assets and Goodwill](index=4&type=section&id=3.3.2%20Intangible%20Assets%20and%20Goodwill) Intangible assets and goodwill decreased by $61.5 million, primarily due to amortization and a significant goodwill impairment 无形资产和商誉 (截至年末) | Period | Amount (Millions USD) | Change (YoY) | | :----- | :-------------------- | :----------- | | Dec 31, 2022 | $98.6 | -$61.5M | | Dec 31, 2021 | $160.1 | | - The decrease was attributable to the **periodic amortization of intangible assets ($10.6 million)** and **goodwill impairment ($50.9 million)**[19](index=19&type=chunk) [Shareholders' Equity](index=4&type=section&id=3.4%20Shareholders'%20Equity) As of December 31, 2022, the number of outstanding shares increased to approximately 55.1 million, mainly due to common stock issued for Nanox.AI milestones, settlement agreements with former shareholders, and warrant and option exercises 已发行股份数量 (截至年末) | Period | Shares Outstanding (Millions) | Change (YoY) | | :----- | :---------------------------- | :----------- | | Dec 31, 2022 | 55.1 | +3.3M | | Dec 31, 2021 | 51.8 | | - The increase in shares was primarily due to the issuance of **89,286 ordinary shares** to former Nanox.AI shareholders for milestone achievement and an additional **2,648,424 ordinary shares** under a settlement agreement[20](index=20&type=chunk) - Additionally, **192,927 ordinary shares** were issued upon the exercise of warrants and **372,159 ordinary shares** upon the exercise of options, collectively generating approximately **$0.9 million in gross proceeds** for the company[20](index=20&type=chunk) [Conference Call and Webcast Details](index=4&type=section&id=4.%20Conference%20Call%20and%20Webcast%20Details) This section provides details for the conference call and webcast held by Nanox to discuss its financial results and business updates, including access information for interested parties [Conference Call and Webcast Details](index=4&type=section&id=4.1%20Conference%20Call%20and%20Webcast%20Details) Nanox held a conference call and webcast on Thursday, March 9, 2023, at 8:30 AM ET to discuss financial results and business updates, with investors able to participate via the company's website or by registering for dial-in details - The conference call and webcast were held on **Thursday, March 9, 2023, at 8:30 AM Eastern Time**[21](index=21&type=chunk) - Interested individuals could join the live webcast via the "Events & Presentations" section of the Nanox investor relations website or register online to receive dial-in numbers and a personalized PIN[22](index=22&type=chunk) - An archived webcast replay was made available after the event[22](index=22&type=chunk) [About Nanox](index=6&type=section&id=5.%20About%20Nanox) This section offers a company overview, highlighting Nanox's mission to enhance global diagnostic medicine accessibility and affordability through its proprietary X-ray technology and comprehensive imaging solutions [Company Overview](index=6&type=section&id=5.1%20Company%20Overview) Nanox is a medical imaging technology company dedicated to making diagnostic medicine globally accessible and affordable through its proprietary X-ray technology and solutions, aiming to improve early detection of diseases discoverable by X-ray medical imaging - Nanox is dedicated to applying its proprietary medical imaging technology and solutions to make diagnostic medicine globally accessible and affordable[23](index=23&type=chunk) - The company's vision is to increase the early detection rates of diseases discoverable by X-ray medical imaging to facilitate early prevention and treatment, improving health outcomes[23](index=23&type=chunk) - Nanox is developing an end-to-end imaging solution, including the Nanox.ARC system utilizing novel MEMs X-ray source technology and the Nanox.CLOUD companion cloud software integrating AI solutions and teleradiology services[23](index=23&type=chunk) [Forward-Looking Statements](index=7&type=section&id=6.%20Forward-Looking%20Statements) This section outlines the forward-looking statements disclaimer, emphasizing the inherent risks and uncertainties that could cause actual results to differ materially from expectations, and advises readers to review the company's Form 20-F for detailed risk factors [Forward-Looking Statements Disclaimer](index=7&type=section&id=6.1%20Forward-Looking%20Statements%20Disclaimer) This press release contains forward-looking statements subject to risks and uncertainties regarding R&D, manufacturing, commercialization, regulatory approvals, acquisition benefits, market acceptance, and global operations, with actual results potentially differing materially due to various factors, and readers are advised to consult the 'Risk Factors' section in the company's Form 20-F annual report - This press release may contain forward-looking statements subject to risks and uncertainties, concerning the company's research and development, manufacturing and commercialization activities, the benefits of acquisitions, and the company's business prospects[24](index=24&type=chunk) - Factors that could cause actual results to differ from expectations include the ability to complete the development of the Nanox System, the commercial viability of the technology, regulatory approvals, the realization of acquisition benefits, collaborations with third-party manufacturers and suppliers, market acceptance, changes in global operations, and risks related to the COVID-19 pandemic[24](index=24&type=chunk) - Readers should not place undue reliance on any forward-looking statements in this press release and should refer to the "Risk Factors" section in the company's Form 20-F annual report for additional risks and uncertainties[25](index=25&type=chunk) [Non-GAAP Financial Measures Disclosure](index=7&type=section&id=7.%20Non-GAAP%20Financial%20Measures%20Disclosure) This section clarifies the company's use of non-GAAP financial measures, explaining their purpose in assessing performance and identifying trends, while noting they are not GAAP-standardized and should not substitute for GAAP metrics [Explanation of Non-GAAP Measures](index=7&type=section&id=7.1%20Explanation%20of%20Non-GAAP%20Measures) This section explains the company's use of non-GAAP financial measures, such as non-GAAP net loss and gross profit, which are not standardized by GAAP but are used by management for performance evaluation, planning, and identifying operational trends, providing a clearer view of performance by adjusting for items like intangible asset amortization, share-based compensation, goodwill impairment, and legal fees, but should not replace GAAP measures or serve as liquidity indicators - This press release includes information regarding certain financial measures not prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, and non-GAAP gross profit[27](index=27&type=chunk) - These non-GAAP measures are adjusted to exclude items such as **intangible asset amortization**, **share-based compensation expenses**, secondary offering expenses, **goodwill impairment**, changes in contingent earnout liability, and legal fees related to class action lawsuits and SEC investigations[27](index=27&type=chunk) - The company's management and board of directors use these non-GAAP financial measures to evaluate the company's performance and believe they are useful to investors and analysts in identifying potential trends in ongoing operations, but they should not be considered a substitute for GAAP measures or as indicators of liquidity[27](index=27&type=chunk) [Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=8.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Nanox's unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, changes in shareholders' equity, and cash flow statements for the reported periods [Balance Sheets](index=8&type=section&id=8.1%20Balance%20Sheets) As of December 31, 2022, Nanox reported total assets of $253.9 million, total liabilities of $29.3 million, and shareholders' equity of $224.7 million, with total assets, liabilities, and shareholders' equity all decreasing compared to 2021 关键资产负债表数据 (单位：千美元) | Item | Dec 31, 2022 | Dec 31, 2021 | | :-------------------------------- | :----------- | :----------- | | **Assets** | | | | TOTAL CURRENT ASSETS | 82,461 | 94,857 | | TOTAL NON-CURRENT ASSETS | 171,472 | 268,313 | | **TOTAL ASSETS** | **253,933** | **363,170** | | **Liabilities** | | | | TOTAL CURRENT LIABILITIES | 17,074 | 52,751 | | TOTAL NON-CURRENT LIABILITIES | 12,179 | 18,271 | | **TOTAL LIABILITIES** | **29,253** | **71,022** | | **Shareholders' Equity** | | | | TOTAL SHAREHOLDERS' EQUITY | 224,680 | 292,148 | [Statements of Operations and Comprehensive Loss](index=10&type=section&id=8.2%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) In Q4 2022, Nanox reported $2.1 million in revenue, a gross loss of $1.7 million, an operating loss of $45.8 million, and a net loss of $44.8 million; for the full year, revenue was $8.6 million, with a net loss of $105.2 million and basic and diluted loss per share of $2.01 关键运营和综合亏损数据 (单位：千美元) | Item | 12 Months Ended Dec 31, 2022 | 12 Months Ended Dec 31, 2021 | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | | :-------------------------------- | :--------------------------- | :--------------------------- | :-------------------------- | :-------------------------- | | REVENUE | 8,578 | 1,304 | 2,132 | 1,304 | | GROSS LOSS | (6,880) | (1,512) | (1,747) | (1,512) | | TOTAL OPERATING EXPENSES | 102,830 | 60,046 | 44,009 | 20,403 | | OPERATING LOSS | (109,710) | (61,558) | (45,756) | (21,915) | | NET LOSS | (105,243) | (61,798) | (44,837) | (22,035) | | BASIC AND DILUTED LOSS PER SHARE | (2.01) | (1.28) | (0.86) | (0.44) | [Statements of Changes in Shareholders' Equity](index=11&type=section&id=8.3%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) As of December 31, 2022, the number of ordinary shares increased to 55,094,237, with total shareholders' equity at $224.7 million, primarily due to common stock issued for warrant and option exercises, contingent earnout liabilities, and settlement agreements with former Nanox AI Ltd. shareholders 股东权益变动概览 (单位：千美元) | Item | Dec 31, 2022 | Dec 31, 2021 | | :-------------------------------- | :----------- | :----------- | | Ordinary shares (Number of shares) | 55,094,237 | 51,791,441 | | Ordinary shares (Amount) | 158 | 149 | | Additional paid-in capital | 477,953 | 438,820 | | Accumulated deficit | (251,457) | (146,214) | | **Total Shareholders' Equity** | **224,680** | **292,148** | - Major changes in 2022 included the issuance of **192,927 ordinary shares** for warrant exercises, **372,159 ordinary shares** for option exercises, **89,286 ordinary shares** for contingent earnout liabilities, and **2,648,424 ordinary shares** under a settlement agreement with former Nanox AI Ltd. shareholders[34](index=34&type=chunk) [Statements of Cash Flows](index=13&type=section&id=8.4%20Statements%20of%20Cash%20Flows) In 2022, Nanox reported net cash outflow from operating activities of $43.4 million, net cash inflow from investing activities of $14.6 million, and net cash inflow from financing activities of $0.8 million, with total cash, cash equivalents, and restricted cash at year-end amounting to $38.5 million 现金流量概览 (单位：千美元) | Cash Flow Activity | 2022 | 2021 | 2020 | | :-------------------------------- | :----- | :------ | :------ | | Net cash used in operating activities | (43,385) | (38,061) | (21,609) | | Net cash provided by (used in) investing activities | 14,606 | (116,320) | (13,937) | | Net cash provided by financing activities | 804 | 7,379 | 240,991 | | NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (28,243) | (147,012) | 205,567 | | CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE YEAR | 38,529 | 66,772 | 213,784 | - Non-cash activities in 2022 included the issuance of **$0.953 million in ordinary shares** for contingent earnout liabilities and **$18.617 million in ordinary shares** under a settlement agreement with former Nanox AI Ltd. shareholders[42](index=42&type=chunk) [Unaudited Reconciliation of GAAP and Non-GAAP Results](index=15&type=section&id=9.%20Unaudited%20Reconciliation%20of%20GAAP%20and%20Non-GAAP%20Results) This section provides a detailed unaudited reconciliation of GAAP to non-GAAP financial results, adjusting for items like goodwill impairment, amortization, share-based compensation, and legal fees to present a clearer operational performance view [GAAP to Non-GAAP Reconciliation](index=15&type=section&id=9.1%20GAAP%20to%20Non-GAAP%20Reconciliation) This section provides detailed reconciliation tables between GAAP and non-GAAP financial measures, covering net loss, cost of revenue, gross profit, and operating expenses, with adjustments primarily for goodwill impairment, intangible asset amortization, share-based compensation, and legal fees, aiming to offer investors a clearer view of operational performance 非GAAP净亏损调节 (单位：千美元) | Item | 12 Months Ended Dec 31, 2022 | 12 Months Ended Dec 31, 2021 | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | | :-------------------------------- | :--------------------------- | :--------------------------- | :-------------------------- | :-------------------------- | | GAAP net loss | 105,243 | 61,798 | 44,837 | 22,035 | | Non-GAAP net loss | 37,781 | 39,123 | 9,932 | 14,969 | 非GAAP毛利润调节 (单位：千美元) | Item | 12 Months Ended Dec 31, 2022 | 12 Months Ended Dec 31, 2021 | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | | :-------------------------------- | :--------------------------- | :--------------------------- | :-------------------------- | :-------------------------- | | GAAP gross loss | 6,880 | 1,512 | 1,747 | 1,512 | | Non-GAAP gross profit | 3,442 | 242 | 826 | 242 | 非GAAP运营费用调节 (2022年第四季度 vs. 2021年第四季度，单位：千美元) | Item | GAAP 2022 | Non-GAAP 2022 | GAAP 2021 | Non-GAAP 2021 | | :-------------------------------- | :-------- | :------------ | :-------- | :------------ | | Research and development expenses | 7,095 | 6,168 | 6,362 | 5,371 | | Sales and marketing expenses | 1,494 | 1,066 | 1,940 | 1,367 | | General and administrative expenses | 8,185 | 4,675 | 10,919 | 7,172 |

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $19.1 million for Q3 2022, compared to a net loss of $13.5 million in Q3 2021, primarily due to the consolidation of Nanox.AI and USARAD, increased R&D expenses, and higher general and administrative expenses [13][17][18] - Revenues for Q3 2022 were $2.4 million, with a gross loss of $1.4 million, reflecting an increase in revenue from data monetization projects [14][18] - Non-GAAP net loss for Q3 2022 was $8.1 million, compared to a non-GAAP net loss of $8.4 million for the same period in 2021 [18] Business Line Data and Key Metrics Changes - Revenue from teleradiology services in Q3 2022 was $2.4 million, up from $2.2 million in Q2 2022, driven by new client additions and organic growth [10] - The company signed nine new client agreements for teleradiology services during Q3 2022, indicating growth in this segment [10][28] Market Data and Key Metrics Changes - The company has a total of 6,850 pre-ordered units globally, with plans to deploy the multi-source Nanox.ARC system in Nigeria and other early adopting countries [8] - The company received an import license for Nigeria and is preparing to ship the first system upon securing regulatory approval [8] Company Strategy and Development Direction - The company aims to begin deploying the multi-source Nanox.ARC system in 2022 and is actively pursuing CE Mark approval in the EU [8] - The strategy includes a stepwise approach to FDA submissions, utilizing Q submissions for ongoing dialogue with the FDA [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in Q3 2022 and the potential for future growth as regulatory approvals are secured [21] - The company is focused on making medical imaging accessible globally and is preparing for large-scale commercialization [11] Other Important Information - The company has engaged with VSI for CE Mark approval in the EU and is conducting clinical trials in Israel with expected results in Q4 2022 [9][58] - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities of approximately $117.1 million [19] Q&A Session Summary Question: Update on Nigeria and available units - Management confirmed that they are ready to ship units once regulatory approvals are obtained and are preparing for customer engagement and training in Nigeria [25][27] Question: Teleradiology account growth and utilization trends - The company added nine accounts this quarter, bringing the total to approximately 40 accounts, with a significant portion of revenue coming from a few key clients [28][29] Question: Goodwill impairment for the quarter - There was no impairment expense for Q3, but management indicated that they would continue to assess goodwill impairment based on changing discount rates [30][31] Question: FDA review status and expectations - Management refrained from predicting the timing of FDA responses but emphasized their efforts to enhance the likelihood of clearance [32][33] Question: Update on the Ghana contract - Management stated they are awaiting regulatory processes and will provide updates once approvals are secured [36] Question: Workflow for commercialization in Nigeria - The manufacturing and assembly processes involve collaboration between facilities in Korea and Israel, with training and installation conducted on-site in Nigeria [44][45] Question: Confidence in fulfilling pre-orders - Management expressed that confidence in contracts is contingent on regulatory approvals and ongoing dialogue with business entities [49][50] Question: Initial utilization levels at Northwell - Management noted ongoing discussions with Northwell and indicated potential for higher revenues from the partnership [52][56] Question: Clinical trials in Israel - The company received permits to conduct trials and anticipates generating images of multiple body organs in Q4 2022 [58]

Financial Data and Key Metrics Changes - Nano-X generated top line revenue of $2.2 million in Q2 2022, compared to $1.8 million in Q1 2022, indicating a quarter-over-quarter growth [10] - The GAAP net loss for Q2 2022 was $19.6 million, compared to a net loss of $13.6 million in Q2 2021, largely due to acquisition-related expenses and increased R&D costs [25] - Non-GAAP net loss for Q2 2022 was $8.2 million, compared to a non-GAAP net loss of $8.6 million for the same period in 2021 [31] Business Line Data and Key Metrics Changes - Revenue from teleradiology services was $2.1 million with a gross profit of $0.0 million on a GAAP basis, and $0.9 million on a non-GAAP basis, representing a gross profit margin of approximately 43% [26] - The AI solutions business generated $0.1 million in revenue with a gross loss of $2.1 million on a GAAP basis [26] - The company signed 14 new client agreements for teleradiology services during Q2 2022, indicating accelerated revenue growth [12] Market Data and Key Metrics Changes - The company is preparing for global deployment of the Nanox.ARC system, with significant progress in Nigeria and Ghana [18][19] - A strategic agreement was signed with Spectrum Health, an integrated healthcare network in Michigan, to use the AI population health solution [14] Company Strategy and Development Direction - The company aims to advance the Nanox.ARC system towards commercialization and is focused on obtaining FDA clearance [8] - A technology development center is being established in Israel to enhance R&D capabilities, complementing existing facilities in Korea and Japan [22] - The company is pushing forward with the deployment of the Nanox.ARC in Nigeria and has signed an agreement to deploy 350 units in Ghana [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the FDA clearance process and the potential for accelerated revenue growth from teleradiology services [15][12] - The management team acknowledged the challenges posed by supply chain issues but remains committed to advancing production and deployment timelines [42] Other Important Information - The company was added to the Russell 2000 and Russell 3000 indexes effective June 27, 2022, which is seen as a positive development [24] - Cash, cash equivalents, and marketable securities as of June 30, 2022, were approximately $126.7 million [33] Q&A Session Summary Question: Can you talk about the technology center in Israel and its capabilities? - The technology center will focus on advanced technologies and will complement existing facilities in Korea and Japan, which are more manufacturing-oriented [41] Question: What is the anticipated number of ARCs manufactured by the end of the year? - Production is being accelerated, with the first 1,000 units expected to be assembled in Israel, and further discussions on mass production are ongoing [42] Question: Will there be any goodwill impairment in Q3 or Q4? - Future goodwill impairment will depend on market parameters and internal management estimates [46] Question: What is the status of the CE Mark for Nanox.ARC? - All necessary documentation for CE marking has been submitted, and the company is hopeful for a timely process [57] Question: Can you provide an update on the AI agreements and their revenue potential? - The integration of AI solutions is ongoing, with revenue potential ranging from a few hundred thousand to several million dollars [66]

Financial Performance - The company generated $2.2 million in revenue for Q2 2022, up from $1.8 million in Q1 2022, representing a growth of over 15% in sales of radiology services [4]. - The company reported a net loss of $19.6 million for Q2 2022, compared to a net loss of $13.6 million in the same period last year [6]. - Revenue for the six months ended June 30, 2022, was $4,008 thousand, compared to $0 for the same period in 2021 [32]. - Gross loss for the six months ended June 30, 2022, was $(3,674) thousand, with a gross loss of $(1,755) thousand for the three months ended June 30, 2022 [32]. - Net loss for the six months ended June 30, 2022, was $(41,280) thousand, compared to $(26,294) thousand for the same period in 2021, representing a 57.1% increase in loss [32]. - The company reported a basic and diluted loss per share of $(0.79) for the six months ended June 30, 2022, compared to $(0.56) for the same period in 2021 [32]. - The company reported a basic and diluted loss per share of $0.38 for the six months ended June 30, 2022, compared to $0.33 for the same period in 2021 [44]. Expenses - Research and development expenses increased to $6.5 million in Q2 2022 from $4.3 million in the comparable period, primarily due to the consolidation of Nanox.AI [7]. - Total operating expenses for the six months ended June 30, 2022, were $40,451 thousand, an increase of 54.5% from $26,168 thousand in the same period of 2021 [32]. - Research and development expenses for the six months ended June 30, 2022, were $13,323 thousand, up from $7,052 thousand in the same period of 2021, reflecting an increase of 88.5% [32]. - GAAP research and development expenses for the six months ended June 30, 2022, were $13.32 million, compared to $7.05 million in 2021, representing an increase of 89% [45]. - The company incurred $11.53 million in share-based compensation for the six months ended June 30, 2022, compared to $9.53 million in 2021, a 21% increase [44]. Cash and Assets - The company ended Q2 2022 with cash, cash equivalents, and marketable securities totaling $126.7 million [14]. - Cash and cash equivalents decreased to $51,676 thousand as of June 30, 2022, from $66,645 thousand as of December 31, 2021 [28]. - Total assets decreased to $317,724 thousand as of June 30, 2022, from $363,170 thousand as of December 31, 2021 [28]. - The company had total current assets of $89.8 million and total current liabilities of $40.6 million, resulting in working capital of $49.2 million as of June 30, 2022 [14]. - Cash and cash equivalents at the end of the period were $51.80 million, down from $116.86 million at the end of the same period in 2021, a decrease of 56% [41]. Liabilities and Equity - The company reported a goodwill impairment of $14.3 million in Q2 2022 due to changes in management estimates [10]. - Total liabilities decreased to $55,448 thousand as of June 30, 2022, from $71,022 thousand as of December 31, 2021 [28]. - The company had a total shareholders' equity of $262,276 thousand as of June 30, 2022, down from $292,148 thousand as of December 31, 2021 [28]. - Non-GAAP net loss attributable to ordinary shareholders for the six months ended June 30, 2022, was $19.78 million, up from $15.73 million in 2021, indicating a 25% increase [44]. Financing and Investments - Cash used in operating activities for the six months ended June 30, 2022, was $22.28 million, compared to $11.75 million in 2021, reflecting a 90% increase in cash outflow [41]. - Net cash provided by financing activities was $14.08 million for the six months ended June 30, 2022, compared to $3.90 million in 2021, indicating a significant increase in financing [41]. - The company’s total cash outflow from investing activities was $6.77 million for the six months ended June 30, 2022, compared to $89.08 million in 2021, showing a significant reduction in investment cash outflow [41]. Strategic Initiatives - The company secured an agreement with BIO Ventures for Global Health to develop a medical imaging training initiative in Nigeria [4]. - The company plans to make a 510(k) submission to the FDA for the multi-source Nanox.ARC system [3]. - The company was added to the Russell 2000® and Russell 3000® Indexes effective June 27, 2022 [4]. - The company reported a change in contingent earnout liability of $12.26 million for the six months ended June 30, 2022, which was not present in the previous year [41].

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $21.7 million for Q1 2022, compared to a net loss of $12.7 million in Q1 2021 [21] - Revenue for Q1 2022 was $1.8 million, an increase from $1.3 million in Q4 2021, marking the first full quarter of revenue generation [8][21] - The non-GAAP net loss for Q1 2022 was $12.0 million, compared to a non-GAAP net loss of $7 million for the same period in 2021 [24] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q1 2022 was $1.7 million, with a gross profit of $0.1 million on a GAAP basis and $0.7 million on a non-GAAP basis, representing a gross profit margin of approximately 39% [21] - Revenue from licensing of AI applications was $0.1 million, with a gross loss of $2.0 million on a GAAP basis [21] Market Data and Key Metrics Changes - The company has established a network of over 300 independent radiologists and provides teleradiology services to over 500 imaging facilities, including hospitals [11] - The company is experiencing organic growth in its teleradiology business, with sales and marketing efforts yielding results since November 2021 [10] Company Strategy and Development Direction - The company aims to democratize healthcare globally through its innovative Nanox.ARC technology and the integration of acquired companies [11][12] - The company is focused on improving internal controls and investing in human capital and technological infrastructure [14] - The company is in discussions to secure CE Mark in the EU for the Nanox System, which is crucial for achieving a global footprint [17] Management's Comments on Operating Environment and Future Outlook - Management expressed satisfaction with the company's performance in Q1 2022, highlighting accelerating revenue growth and progress in FDA clearance processes [8][26] - The company anticipates that the increasing use of AI-enabled diagnostic equipment will shift healthcare from predictive to preventive, contributing to rising product demand [13] Other Important Information - The company commenced large-scale production of MEMs chips at a new semiconductor fabrication plant in South Korea [18] - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities of approximately $139.4 million [25] Q&A Session Summary Question: Timing of 510(k) submission and CE Mark - Management indicated that they are waiting for FDA feedback on their Q submission before proceeding with the 510(k) submission [33][40] Question: Validation testing by clients on multisource - Management stated that no implementation can occur until FDA approval is received, but trials will commence in countries with different regulations [37] Question: Regulatory processes in countries not requiring FDA approval - Management described these processes as simpler than FDA and CE, with expectations to receive approvals shortly [50] Question: Additional MSaaS agreements - Management confirmed ongoing negotiations for additional agreements, with some in advanced stages [53] Question: Employee count changes - Management reported a decrease in total employee count but plans to recruit more in line with their annual operating plan [48]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $61 million for the full year 2021, compared to a net loss of $43 million in 2020 [19] - For Q4 2021, the GAAP net loss was $22 million, compared to a net loss of $19 million for the same period in 2020 [19] - Revenue for the year ended December 31, 2021, was $1.3 million, with a gross loss of $1.5 million [19][20] - Non-GAAP net loss for the full year 2021 was $39.2 million, compared to $18.9 million in 2020 [25] Business Line Data and Key Metrics Changes - Revenue from radiology services for Q4 2021 was $1 million, with a gross profit of $0.0 million on a GAAP basis and a gross profit of $0.4 million on a non-GAAP basis, representing a gross profit margin of approximately 40% [20] - Revenue from licensing of AI applications for Q4 2021 was $0.3 million, with a gross loss of $1.5 million on a GAAP basis [21] Market Data and Key Metrics Changes - The company signed 11 MSaaS agreements for the global deployment of 6,500 units of the Nanox.ARC multi-source system across various territories, including Africa, Central America, and Europe [15] Company Strategy and Development Direction - The company aims to streamline commercialization through strategic acquisitions, including Zebra Medical Vision (now Nanox.AI), USARAD Holdings, and MDW LLC, to enhance healthcare access and affordability [9][10] - The leadership team of Nanox.AI has been strengthened with the appointment of Pini Ben Elazar as General Manager [12] - The company is focused on establishing production capabilities for the Nanox.ARC system and enhancing regulatory pathways [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing communication with the FDA regarding the Nanox.ARC system and expects thoughtful improvements based on FDA feedback [7][8] - The company anticipates being in full production of the Nanox.ARC system by mid-2022, which is crucial given current global chip supply shortages [17] Other Important Information - As of December 31, 2021, the company had cash equivalents and marketable securities of $156.6 million and $3.8 million in loans from banks [27] - The company ended the year with approximately 51.8 million shares outstanding, an increase from 46.1 million shares at the end of 2020, primarily due to acquisitions [28] Q&A Session Summary Question: What is the update expectation on approval or clearance for the multisource? - Management indicated that they do not expect the FDA response to take the full 75 days and are hopeful for a quicker response based on ongoing discussions [35][36] Question: What are the annualized revenue run rates and growth rates for Nanox.AI and USARAD segments for FY 2022? - Expected annual revenue for USARAD is around $8 million to $9 million, while for the AI segment, it is projected to be $3 million to $4 million [41] Question: What was the litigation expense in the fourth quarter? - The litigation expense related to the SEC probe and class action was $455,000 for the quarter [47] Question: Can you provide a sense of the size of the integrated healthcare organization? - The organization is among the top 25 in the U.S., indicating a significant size and influence in the healthcare sector [52] Question: What is the status of the production and delivery commitments for 2022? - Management confirmed that they have ordered necessary components for assembly and expect to produce hundreds of machines quarterly [48]

Revenue Performance - Revenue for Q4 2021 was $1.3 million, compared to $0 for Q4 2020, with a non-GAAP gross profit of $0.2 million[4] - The company reported a revenue of $1.304 million for the year ended December 31, 2021, compared to $0 for the previous two years[35] Net Loss and Expenses - The company reported a net loss of $22.0 million for Q4 2021, an increase from a net loss of $19.0 million in Q4 2020, primarily due to merger-related expenses[5] - The non-GAAP net loss applicable to ordinary shares for Q4 2021 was $15.0 million, compared to $8.4 million in Q4 2020[9] - The company reported a net loss of $61.798 million for 2021, compared to a net loss of $43.815 million in 2020, which is a 41% increase[35] - The non-GAAP net loss attributable to ordinary shares for 2021 was $39.124 million, compared to $18.902 million in 2020, reflecting a 106% increase[37] Research and Development - Research and development expenses for Q4 2021 were $6.4 million, up from $3.0 million in Q4 2020, driven by the merger and increased R&D headcount[6] - Research and development expenses rose to $17.122 million in 2021, up from $9.210 million in 2020, indicating a 85% increase[35] General and Administrative Expenses - General and administrative expenses increased to $10.9 million in Q4 2021 from $8.1 million in Q4 2020, largely due to merger-related costs and legal fees[8] Cash and Assets - The company had $88.7 million in cash and cash equivalents as of December 31, 2021, down from $213.5 million a year earlier[12] - Cash and cash equivalents decreased significantly to $66.645 million in 2021 from $213.468 million in 2020, a decline of 69%[33] - The company's total assets increased to $363.170 million in 2021 from $236.149 million in 2020, representing a growth of 54%[33] Liabilities - Total current assets were $94.9 million and total current liabilities were $52.8 million, resulting in working capital of $42.1 million[12] - The total liabilities rose to $71.022 million in 2021, compared to $5.403 million in 2020, marking a substantial increase[33] Shareholder Information - The weighted average number of ordinary shares increased to 48.216 million in 2021 from 35.654 million in 2020, a rise of 35%[37] Future Outlook - The American Medical Association issued a new CPT code for quantitative CT tissue characterization, effective July 2022, which may enhance future revenue opportunities[3] - The company is focused on the development and commercialization of its X-ray source technology and the Nanox.ARC, with expectations for future growth and market acceptance[25]

Nano-X Imaging Ltd. (NASDAQ:NNOX) Q3 2021 Earnings Conference Call November 17, 2021 ET Company Participants Ran Poliakine ??? Chairman of the Board and Chief Executive Officer Mike Cavanaugh ??? Investor Relations Erez Meltzer ??? Executive Board Member and incoming Chief Executive Officer Ran Daniel ??? Chief Financial Officer Conference Call Participants Jeffrey Cohen ??? Ladenburg Thalmann Suraj Kalia ??? Oppenheimer Ravi Misra ??? Berenberg Capital Rahul Rakhit ??? LifeSci Capital Operator Thank you fo ...

Exhibit 99.1 NANO-X IMAGING LTD The Communications Center Neve Ilan, Israel 9085000 Telephone: 972 2 5360360 NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on November 4, 2021 To our Shareholders: You are invited to attend the Annual Meeting of Shareholders of Nano-X Imaging Ltd ("we" or the "Company") to be held at the Company's offices at The Communications Center, Neve Ilan, Israel on November 4, 2021 at 15:00 Israeli time (9:00 am EST), and thereafter as it may be adjourned from time to tim ...