Announced FDA 510(k) clearance for the single source Nanox Cart X-Ray System
Scaling up Company’s semiconductor fabrication plant in
Ended Q1 with cash and cash equivalents of
Management to host conference call and webcast today,
“We were very pleased in April to receive FDA clearance for our single source Nanox Cart X-Ray System, a critical achievement for our company, and an important reference point as we prepare to submit for approval of our multi-source device this year,” stated
Due to delays with the original third-party supplier of the second-generation high-power ceramic tube, which were compounded by the COVID-19 pandemic, Nanox is currently working with two alternative tube suppliers for the multi-source system.
As a result, while the Company does not expect to meet its previously announced milestone of shipment of 1,000 multi-source Nanox units by the first quarter of 2022, the Company believes that it will be able to gain ground during the year to reach the shipment milestone of 1,000 multi-source Nanox units during 2022, and possibly more, if the multi-source Nanox.ARC is cleared by the FDA and authorized by other similar regulatory agencies.
Nanox continues to expect submission of a 510(k) premarket notification to the FDA with respect to the multi-source Nanox.ARC and the Nanox.CLOUD during 2021 and deployment of an initial wave of approximately 15,000 Nanox.ARC units by the end of 2024.
“While we have experienced delays, compounded by the world pandemic, in the production of our second-generation high-power tube by a third-party manufacturer, which caused us to revisit certain timelines associated with the shipment of multi-source units, we believe that the manufacture and shipment of at least 1,000 multi-source systems will be accomplished in 2022,” added
“We continue to believe that our novel digital x-ray source incorporating our MEMs chip can be manufactured at a fraction of the cost of legacy analog x-ray source tubes. This, along with our innovative Medical Screening as a Service (MSaaS) business model of working with healthcare providers, will allow us to achieve our mission of democratizing medical imaging and making access to imaging more widely available to people who currently have limited or no access or experience long wait times. We have a growing, highly qualified management team and a strong balance sheet, and are working tirelessly toward this goal.”
“Our vision is to provide a worldwide end-to-end medical imaging solution, including remote services such as: image repository, radiologist matching, online and offline diagnostics review and annotation, connectivity to medical imaging AI systems, and billing and reporting. This will enable us to offer a more comprehensive and differentiated medical imaging solution to our customers,” stated
First Quarter 2021 and Recent Developments:
- Received FDA 510(k) clearance for its single-source Nanox Cart X-Ray System on
April 2, 2021 - Commenced technology transfer to Nanox’s wholly owned Korean subsidiary to enable production of the silicon MEMs chip that is integral to the Nanox digital X-ray source. The subsidiary is leveraging SK Telecom’s expertise in semiconductors under the joint collaboration between the two companies in establishing permanent chip facility.
- Appointed global medical business development and sales executive Moshe Shtengel as Chief Business Officer
Financial results for three months ended March 31, 2021
For the three months ended
Research and Development expenses for the first quarter 2021 were
Marketing expenses for the first quarter 2021 were
General and administrative expenses for the first quarter 2021 were
Net cash used in operating activities during the first quarter 2021 was
The Company ended the first quarter 2021 with cash and cash equivalents of
Non-GAAP net loss for the three months ended
A reconciliation between GAAP and non-GAAP metrics for the three-month period ended
As of
Conference call and webcast details
Investor domestic dial-in: 877-407-0789
Investor international dial-in: 201-689-8562
Conference ID: 13718794
Webcast link: http://public.viavid.com/index.php?id=144411
About Nanox:
Nanox, founded by the serial entrepreneur
Forward-Looking Statements:
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements contained in this press release that are not historical facts are forward-looking statements and 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. This includes any statements relating to the initiation, timing, progress and results of Nanox's research and development, manufacturing and commercialization activities with respect to its X-ray source technology and the Nanox.ARC.
Forward-looking statements are based on information Nanox 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:; Nanox's (i) ability to successfully demonstrate the feasibility of its technology for commercial applications; (ii)expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its X-ray source technology and the Nanox.ARC from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iii)ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; the market acceptance of the Nanox.ARC and the proposed pay-per-scan business model; (iv)expectations regarding collaborations with third-parties and their potential benefits; and Nanox's ability to conduct business globally; risks and business interruptions related to the COVID 19 pandemic, among others. 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
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
Non-GAAP net loss attributable to ordinary shares, non-GAAP research and development expenses, non-GAAP marketing expenses and non-GAAP general and administrative expenses each adjusts for stock-based compensation expenses.
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, non-GAAP net loss attributable to ordinary shares, non-GAAP research and development expenses, non-GAAP marketing expenses and non-GAAP general and administrative expenses 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, non-GAAP net loss attributable to ordinary shares, non-GAAP research and development expenses, non-GAAP marketing expenses and non-GAAP general and administrative expenses 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.
Contact:
Nanox Imaging
IR@nanox.vision
646-597-6989
bob@lifesciadvisors.com
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| March 31, 2021 | ||||
| Assets | ||||
| CURRENT ASSETS: | ||||
| Cash and cash equivalents | 219,293 | 213,468 | ||
| Prepaid expenses and other current assets | 2,920 | 6,325 | ||
| TOTAL CURRENT ASSETS | 222,213 | 219,793 | ||
| NON-CURRENT ASSETS: | ||||
| Restricted cash | 304 | 316 | ||
| Property and equipment, net | 19,639 | 14,020 | ||
| Operating lease right-of-use asset | 1,496 | 1,359 | ||
| Other non-current assets | 911 | 661 | ||
| TOTAL NON-CURRENT ASSETS | 22,350 | 16,356 | ||
| TOTAL ASSETS | 244,563 | 236,149 | ||
| Liabilities and Shareholders' Equity | ||||
| CURRENT LIABILITIES: | ||||
| Accounts payable | 454 | 435 | ||
| Accrued expenses and other liabilities | 17,237 | 3,526 | ||
| Current maturities of operating leases | 602 | 519 | ||
| TOTAL CURRENT LIABILITIES | 18,293 | 4,480 | ||
| NON-CURRENT LIABILITIES: | ||||
| Non-current operating leases | 927 | 923 | ||
| Other long-term liabilities | 65 | - | ||
| TOTAL NON-CURRENT LIABILITIES | 992 | 923 | ||
| TOTAL LIABILITIES | 19,285 | 5,403 | ||
| COMMITMENTS | ||||
| SHAREHOLDERS' EQUITY: | ||||
| Ordinary Shares, par value |
||||
| authorized at |
135 | 131 | ||
| Additional paid-in capital | 322,276 | 315,031 | ||
| Accumulated deficit | (97,133) | (84,416) | ||
| TOTAL SHAREHOLDERS' EQUITY | 225,278 | 230,746 | ||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 244,563 | 236,149 | ||
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended |
|||
| 2021 | 2020 | ||
| OPERATING EXPENSES: | |||
| Research and development | 2,709 | 2,366 | |
| Marketing | 1,748 | 973 | |
| General and administrative | 8,194 | 4,032 | |
| TOTAL OPERATING EXPENSES | 12,651 | 7,371 | |
| OPERATING LOSS | (12,651) | (7,371) | |
| FINANCIAL EXPENSES, net | 66 | 51 | |
| NET LOSS | (12,717) | (7,422) | |
| BASIC AND DILUTED LOSS PER SHARE | (0.27) | (0.26) | |
| BASIC AND FULLY DILUTED WEIGHTED AVERAGE OF THE NUMBER OF | |||
| ORDINARY SHARES (in thousands) | 46,839 | 28,924 | |
RECONCILIATION OF GAAP TO NON-GAAP METRICS
(U.S. dollars in thousands (except per share data))
(Unaudited)
| Three Months Ended |
||||
| 2021 | 2020 | |||
| ( |
||||
| Reconciliation of GAAP net loss attributable to ordinary shares to Non-GAAP net loss attributable to ordinary shares |
||||
| GAAP net loss attributable to ordinary shares | (12,717) | (7,422) | ||
| Non-GAAP adjustments: | ||||
| Secondary offering expenses | 981 | - | ||
| Class-action litigation expenses | 43 | - | ||
| Share-based compensation | 4,639 | 4,850 | ||
| Non-GAAP net loss attributable to ordinary shares | (7,054) | (2,572) | ||
| BASIC AND DILUTED LOSS PER SHARE | (0.15) | (0.09) | ||
| BASIC AND FULLY DILUTED WEIGHTED AVERAGE NUMBER OF | ||||
| ORDINARY SHARES (in thousands) | 46,839 | 28,924 | ||
| Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses ( |
||||
| GAAP research and development expenses | (2,709) | (2,366) | ||
| Non-GAAP adjustments: | ||||
| Share-based compensation | 630 | 1,677 | ||
| Non-GAAP research and development expenses | (2,079) | (689) | ||
| Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses ( |
||||
| GAAP general and administrative expenses | (8,194) | (4,032) | ||
| Non-GAAP adjustments: | ||||
| Secondary offering expenses | 981 | - | ||
| Class-action litigation expenses | 43 | - | ||
| Share-based compensation | 3,422 | 2,851 | ||
| Non-GAAP general and administrative expenses | (3,748) | (1,181) | ||
Source: Nano-X Imaging