Recorded noted regulatory successes with FDA general use clearance and granting of CE Mark in the EU

Advanced commercialization globally, signing new customer and channel partner agreements for Nanox.ARC and Nanox AI

Management to host conference call and webcast Monday, March 31, 2025 at 8:30 AM ET

PETACH TIKVA, Israel, March 31, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the fourth quarter ended December 31, 2024, and provided a business update.

Recent Highlights:

• Generated $3.0 million in revenue in the fourth quarter of 2024, compared to $2.4 million in the fourth quarter of 2023.
  
• Regulatory achievements: FDA clearance of the Nanox.ARC for general use in December 2024, and a CE mark of the Nanox.ARC in February 2025 with no adjunctive requirements. The Company also submitted the Nanox.ARC X for 510 (k) FDA clearance.
  
• US commercialization advanced with a new Nanox.ARC channel partner agreement.
  
• During the first quarter of 2025, we signed two new Nanox.AI customers, Ezra AI Inc., a healthcare AI company revolutionizing consumers’ screening for early cancer detection, and another outpatient medical imaging provider.
  
• Recently engaged with two new distributors for the Nanox.ARC in Romania and Greece which will be the Company’s initial entry points into the EU.

“The fourth quarter capped off a dynamic year for Nanox, during which we accelerated our US commercialization effort of both the Nanox.ARC and Nanox.AI products, generated additional clinical evidence supporting the use of the Nanox.ARC system and technology, and successfully passed key regulatory hurdles among other achievements.” said Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman.

Mr. Meltzer continued, “We enter 2025 a portfolio of cutting-edge technologies and pursuing a vision to reimagine imaging. Our operational progress in 2024, coupled with a growing and innovative portfolio, leaves us confident that we are well-positioned to build our momentum and drive our new technologies into a medical imaging market that is ripe for new tools that improve accessibility, lower costs, and streamline the delivery of healthcare for providers and patients.”

Financial results for three months ended December 31, 2024

For the three months ended December 31, 2024 (the "reported period"), the Company reported a net loss of $14.1 million, compared to a net loss of $10.2 million for the three months ended December 31, 2023 (which is referred as the "comparable period"), representing an increase of $3.9 million. The increase was largely due to a one time income in the amount of $3.0 million that was recognized in the comparable period, related to compensation from its D&O insurance carrier under the settlement agreement in connection with the class action lawsuits against the Company.
The Company reported revenue of $3.0 million in the reported period, compared to $2.4 million in the comparable period. During the reported period, the Company generated revenue through teleradiology services, the sales of its imaging products and services, and its AI solutions.

The Company’s gross loss during the reported period totaled $2.9 million (gross loss margin of 96%) on a GAAP basis, as compared to $1.7 million (gross loss margin of 72%) in the comparable period. Non-GAAP gross loss for the reported period was $0.3 million (gross loss margin of approximately 9%), as compared to Non-GAAP gross profit of $0.9 million (gross profit margin of approximately 36%) in the comparable period.

The Company’s revenue from teleradiology services for the reported period was $2.8 million, compared to revenue of $2.3 million in the comparable period. The Company’s GAAP gross profit from teleradiology services for the reported period was $0.6 million (gross profit margin of approximately 21%), compared to $0.3 million (gross profit margin of approximately 14%) in the comparable period. Non-GAAP gross profit of the Company’s teleradiology services for the reported period was $1.1 million (gross profit margin of approximately 41%) compared to gross profit of $0.9 million (gross profit margin of approximately 38%) in the comparable period. The increase in the Company’s revenue and gross profit margins from teleradiology services was mainly attributable to customer retention, increased rates and increased volume of the Company’s reading services during the weekdays shifts.

During the reported period, the Company generated revenue through the sales and deployment of its imaging systems which amounted to $136 thousand for the reported period, with a gross loss of $1.5 million on a GAAP basis and $1.4 million on a non-GAAP basis compared to revenue of $17 thousand with a gross loss of $44 thousand on a GAAP and Non-GAAP basis in the comparable period. The revenue stems from the sale and deployment of our 2D systems and the sale of our OEM services in the U.S.

The Company’s revenue from its AI solutions for the reported period was $83 thousand with a gross loss of $2.0 million on a GAAP basis, compared to revenue of $84 thousand with a gross loss of $2.0 million in the comparable period. Non-GAAP gross profit of the Company’s AI solutions for the reported period was $6 thousand, compared to $21 thousand in the comparable period.

Research and development expenses, net, for the reported period were $5.4 million, compared to $6.8 million in the comparable period, reflecting a decrease of $1.4 million. The decrease was mainly due to a decrease of $0.2 million in salaries and wages, a decrease of $0.5 million in share-based compensation and $0.7 million in expenses related to our research and development activities.

Sales and marketing expenses for the reported period were $0.9 million compared to $1.0 million in the comparable period.

General and administrative expenses for the reported period were $5.8 million, compared to $3.8 million in the comparable period. The increase of $2.0 million was mainly due to an increase of $1.8 million in our legal expenses since the Company received $2 million from the Company’s directors’ and officers’ liability insurance carrier during the comparable period under the Company’s policy and the settlement agreement which reduced the Company’s legal expenses in the same amount during the comparable period. 

Non-GAAP net loss attributable to ordinary shares for the reported period was $10.0 million, compared to $10.4 million in the comparable period. The decrease of $0.4 million was mainly due to an increase of $0.5 million in financial income, net.

Non-GAAP gross loss for the reported period was $0.3 million, compared to a non-GAAP gross profit of $0.9 million in the comparable period. Non-GAAP research and development expenses, net for the reported period, were $5.0 million, compared to $5.9 million in the comparable period. Non-GAAP sales and marketing expenses for the reported period were $0.6 million, compared to $0.8 million in the comparable period. Non-GAAP general and administrative expenses for the reported period were $5.0 million, compared to $4.7 million in the comparable period.

The difference between the GAAP and non-GAAP financial measures above is mainly attributable to amortization of intangible assets, share-based compensation, change in contingent earnout liability, impairment of Goodwill, expenses related to an offering and legal fees and settlement expenses in connection with the class-action litigation and the SEC investigation. A reconciliation between GAAP and non-GAAP financial measures for the three- and twelve-month periods ended December 31, 2024, and 2023 is provided in the financial results that are part of this press release.

Liquidity and Capital Resources

As of December 31, 2024, the Company had total cash, cash equivalents, short-term and long-term deposits, restricted deposits and marketable securities of $83.5 million, compared to $82.8 million as of December 31, 2023. During the reported period the Company experienced negative cash flow from operations of $36.6 million and a positive cash flow from financing of $39.5 million.

Other Assets

As of December 31, 2024 the Company had property and equipment of $45.4 million, compared to $42.3 million as of December 31, 2023.

As of December 31, 2024, the Company had intangible assets of $70.0 million compared to $80.6 million as of December 31, 2023. The decrease was attributable to the periodic amortization of intangible assets in the amount of $10.6 million.

Shareholders’ Equity

As of December 31, 2024, the Company had approximately 63.8 million shares outstanding. As of December 31, 2023, the Company had approximately 57.8 million shares outstanding. During the fourth quarter of 2024, the Company sold approximately 5.0 million ordinary shares, which generated net proceeds of approximately $37.8 million, pursuant to the Company’s previously announced Controlled Equity OfferingSM Sales Agreement, dated as of June 7, 2024 with Cantor Fitzgerald & Co. and Mizuho Securities USA LLC relating to the issuance and sale from time to time of our ordinary shares, an aggregate offering price of up to $100 million from time to time through the Agents pursuant to the sales agreement. During 2024, 0.9 million options to purchase ordinary shares were exercised to ordinary shares in consideration of $1.7 million, including 0.7 million options to purchase ordinary shares that were exercised by the estate of the late Company’s Chairman of the Board in consideration of $1.6 million.

Conference Call and Webcast Details

Monday, March 31, 2025 @ 8:30am ET

Individuals interested in listening to the conference call may do so by joining the live webcast on the Investors section of the Nanox website under Events and Presentations. Alternatively, individuals can register online to receive a dial-in number and personalized PIN to participate in the call. An archived webcast of the event will be available for replay following the event.

About Nanox:

Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox’s vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI to enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI Ltd., a subsidiary of Nanox Imaging, an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages and stores data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – a proprietary decentralized marketplace through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts, and a comprehensive teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. For more information, please visit www.nanox.vision

Forward-Looking Statements

This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xii) potential litigation associated with our transactions.

For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations.

Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit (loss), non-GAAP gross profit (loss) margin, non-GAAP research and development expenses, net, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses (income) and non-GAAP basic and diluted loss per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, impairment of Goodwill, change in contingent earnout liability, expenses related to an offering, legal fees in connection with class-action litigation and the SEC investigation, accrual in connection with the settlement of the SEC investigation and class-action. The Company’s management and board of directors utilize these non-GAAP financial measures to evaluate the Company’s performance. The Company provides these non-GAAP measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, these non-GAAP measures should not be considered measures of the Company’s liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

The accompanying notes are an integral part of the unaudited condensed consolidated financial statements

UNAUDITED RECONCILIATION OF GAAP AND NON-GAAP RESULTS

(U.S. dollars in thousands (except per share data))

Use of Non-GAAP Financial Measures

The unaudited condensed consolidated financial information is prepared in conformity with GAAP. The Company uses information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit (loss), non-GAAP gross profit (loss) margin, non-GAAP research and development expenses, net, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses (income) and non-GAAP basic and diluted loss per share. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, impairment of Goodwill, change in contingent earnout liability, expenses related to an offering, legal fees in connection with class-action litigation and the SEC investigation, accrual in connection with the settlement of the SEC investigation and class-action. The Company believes that separate analysis and exclusion of the one-off or non-cash impact of the above reconciling items (as applicable) adds clarity to the constituent parts of its performance. The Company reviews these non-GAAP financial measures together with GAAP financial measures to obtain a better understanding of its operating performance. It uses the non-GAAP financial measures for planning, forecasting, and measuring results against the forecast. The Company believes that the non-GAAP financial measures are useful supplemental information for investors and analysts to assess its operating performance. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance.

Reconciliation of GAAP net loss attributable to ordinary shares to non-GAAP net loss attributable to ordinary shares and non-GAAP basic and diluted loss per share (U.S. dollars in thousands)

Reconciliation of GAAP cost of revenue to non-GAAP cost of revenue (U.S. dollars in thousands)

Reconciliation of GAAP gross loss to non-GAAP gross profit (U.S. dollars in thousands)

  
Reconciliation of GAAP gross loss margin to non-GAAP gross profit margin (in percentage of revenue)

Reconciliation of GAAP research and development, expenses, net, to non-GAAP research and development expenses, net (U.S. dollars in thousands)

Reconciliation of GAAP sales and marketing expenses to non-GAAP sales and marketing expenses (U.S. dollars in thousands)

Reconciliation of GAAP general and administrative expenses to non-GAAP general and administrative expenses (U.S. dollars in thousands)

Reconciliation of GAAP other expenses (income) to non-GAAP other expenses (U.S. dollars in thousands)

Contacts

Investor Contact
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@icrhealthcare.com

Media Contact
ICR Healthcare
NanoxPR@icrinc.com