Reports progress towards global supply chain development
Ended the third quarter of 2022 with cash, cash equivalents and marketable securities of
Management to host conference call and webcast
Third Quarter 2022 Highlights and Recent Developments:
- Generated
$2.4 million in revenue in the third quarter of 2022 compared to$2.2 million in the second quarter of 2022 and$1.8 million in the first quarter of 2022.
- Submitted a 510(k) premarket notification to the
U.S. Food and Drug Administration as part of the Company’s 510(k) application process for the multi-source Nanox.ARC system
- Received a
Helsinki permit to conduct clinical trials atShamir Hospital ,Israel using the multisource Nanox.ARC system, with a goal of generating sample images in the fourth quarter of 2022.
- Engaged a Notified Body to work with during the CE marking process.
“As we report third quarter results, I am proud of the Nanox team’s progress across multiple fronts. We continue to generate revenues from our AI and teleradiology businesses and advance toward the deployment of our Nanox.ARC multi-source imaging system,” said
Financial results for three months ended September 30, 2022
For the three months ended
For the three months ended
Research and development expenses for the three months ended
Sales and marketing expenses for the three months ended
General and administrative expenses for the three months ended
Change in obligation in connection of acquisitions was
Non-GAAP net loss applicable to ordinary shares for the three months ended
A reconciliation between GAAP and non-GAAP financial measures for the three-month periods ended
Liquidity and Capital Resources
The Company ended the third quarter of 2022 with total cash, cash equivalents and marketable securities of
As of
The decrease in the Company’s cash, cash equivalents and marketable securities of
Other Assets
As of
As of
Shareholders’ Equity
As of
Conference Call and Webcast Details
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 applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. The vision of Nanox is to increase the early detection of medical conditions that are discoverable by medical image technologies based on X-rays, which Nanox believes is key to increasing early prevention and treatment, improving health outcomes, and, ultimately, saving lives. Nanox is developing a holistic imaging solution, which includes the Nanox System, comprised of the Nanox.ARC using its novel MEMs X-ray source technology, and the Nanox.CLOUD, a companion cloud software, integrated with AI solutions and teleradiology services. 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 recent 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; and (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; and (x) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things.
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
Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this report 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
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(
2022 |
2021 |
||||||
Assets | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 40,331 | $ | 66,645 | |||
47,706 | 22,066 | ||||||
Accounts receivables net of allowance for credit losses of |
1,121 | 1,051 | |||||
Prepaid expenses | 103 | 3,129 | |||||
Other current assets | 1,349 | 1,966 | |||||
TOTAL CURRENT ASSETS | 90,610 | 94,857 | |||||
NON-CURRENT ASSETS: | |||||||
Restricted cash | 65 | 127 | |||||
Property and equipment, net | 44,079 | 37,435 | |||||
Operating lease right-of-use asset | 1,288 | 1,725 | |||||
29,023 | 67,845 | ||||||
Intangible Assets | 93,868 | 101,826 | |||||
43,960 | 58,298 | ||||||
Other non-current assets | 2,793 | 1,057 | |||||
TOTAL NON-CURRENT ASSETS | 215,076 | 268,313 | |||||
TOTAL ASSETS | 305,686 | 363,170 | |||||
Liabilities and Shareholders’ Equity | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | 5,588 | 3,134 | |||||
Accrued expenses | 2,628 | 3,611 | |||||
Loan from a |
145 | 145 | |||||
Deferred revenue | 626 | 247 | |||||
Contingent short term earnout liability | 30,654 | 42,471 | |||||
Current maturities of operating leases | 281 | 881 | |||||
Other current liabilities | 3,670 | 2,262 | |||||
TOTAL CURRENT LIABILITIES | 43,592 | 52,751 | |||||
NON-CURRENT LIABILITIES: | |||||||
Non-current operating lease liabilities | 1,008 | 950 | |||||
Long-term loan | 3,481 | 3,796 | |||||
Non-current deferred revenue | 6 | 415 | |||||
Contingent long-term earnout liability | 5,375 | 5,814 | |||||
Deferred tax liability | 4,338 | 7,063 | |||||
Other long-term liabilities | 54 | 233 | |||||
TOTAL NON-CURRENT LIABILITIES | 14,262 | 18,271 | |||||
TOTAL LIABILITIES | 57,854 | 71,022 | |||||
SHAREHOLDERS’ EQUITY: | |||||||
Ordinary Shares, par value |
150 | 149 | |||||
Additional paid-in capital | 456,761 | 438,820 | |||||
Accumulated other comprehensive deficit | (2,459 | ) | (607 | ) | |||
Accumulated deficit | (206,620 | ) | (146,214 | ) | |||
TOTAL SHAREHOLDERS’ EQUITY | 247,832 | 292,148 | |||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 305,686 | 363,170 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(
Nine Months Ended |
Three Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
REVENUE | 6,446 | - | 2,438 | - | |||||||||||
COST OF REVENUE | 11,579 | - | 3,897 | - | |||||||||||
GROSS LOSS | (5,133 | ) | - | (1,459 | ) | - | |||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | 19,412 | 10,760 | 6,089 | 3,708 | |||||||||||
Sales and marketing | 2,882 | 5,093 | 698 | 1,529 | |||||||||||
General and administrative | 33,069 | 23,790 | 10,630 | 8,238 | |||||||||||
14,338 | - | - | - | ||||||||||||
Change in obligation in connection of acquisitions | (11,303 | ) | - | 953 | - | ||||||||||
Other expense | 423 | - | - | - | |||||||||||
TOTAL OPERATING EXPENSES | 58,821 | 39,643 | 18,370 | 13,475 | |||||||||||
OPERATING LOSS | (63,954 | ) | (39,643 | ) | (19,829 | ) | (13,475 | ) | |||||||
FINANCIAL INCOME (EXPENSES), net | 902 | (120 | ) | 305 | 6 | ||||||||||
OPERATING LOSS BEFORE INCOME TAXES | (63,052 | ) | (39,763 | ) | (19,524 | ) | (13,469 | ) | |||||||
INCOME TAX BENEFIT | 2,646 | - | 398 | - | |||||||||||
NET LOSS | (60,406 | ) | (39,763 | ) | (19,126 | ) | (13,469 | ) | |||||||
BASIC AND DILUTED LOSS PER SHARE | (1.16 | ) | (0.84 | ) | (0.37 | ) | (0.28 | ) | |||||||
Weighted average number of basic and diluted shares of common stock outstanding (in thousands) | 52,180 | 47,486 | 52,276 | 47,851 | |||||||||||
Comprehensive Loss: | |||||||||||||||
Net Loss | (60,406 | ) | (39,763 | ) | (19,126 | ) | (13,469 | ) | |||||||
Other comprehensive loss: | |||||||||||||||
Unrealized loss from available- for-sale securities | (1,852 | ) | (190 | ) | (254 | ) | (74 | ) | |||||||
Total comprehensive loss | (62,258 | ) | (39,953 | ) | (19,380 | ) | (13,543 | ) |
UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(
Ordinary shares | Additional | Accumulated other |
|||||||||||||||||||||
Number of shares |
Amount | paid-in capital |
comprehensive deficit |
Accumulated deficit |
Total | ||||||||||||||||||
BALANCE AT |
51,791,441 | 149 | 438,820 | (607 | ) | (146,214 | ) | 292,148 | |||||||||||||||
Changes during the period: | |||||||||||||||||||||||
Issuance of ordinary shares upon exercise of options under the ESOP Plan | 192, 820 | * | 280 | - | - | 280 | |||||||||||||||||
Other comprehensive loss | - | - | - | (1,852 | ) | - | (1,852 | ) | |||||||||||||||
Issuance of ordinary shares upon achievement of a milestone | 89,286 | * | 953 | - | - | 953 | |||||||||||||||||
Issuance of ordinary shares upon exercise of warrants | 192,927 | 1 | 369 | - | - | 370 | |||||||||||||||||
Share-based compensation | - | - | 16,339 | - | - | 16,339 | |||||||||||||||||
Net loss for the period | - | - | - | - | (60,406 | ) | (60,406 | ) | |||||||||||||||
BALANCE AT |
52,266,474 | 150 | 456,761 | (2,459 | ) | (206,620 | ) | 247,832 |
* Less than
Ordinary shares | Additional | Accumulated other |
|||||||||||||||||||||
Number of shares |
Amount | paid-in capital |
comprehensive deficit |
Accumulated deficit |
Total | ||||||||||||||||||
BALANCE AT |
52,214,721 | 150 | 451,825 | (2,205 | ) | (187,494 | ) | 262,276 | |||||||||||||||
Changes during the period: | |||||||||||||||||||||||
Issuance of ordinary shares upon exercise of options under the ESOP Plan | 51,753 | - | 125 | - | - | 125 | |||||||||||||||||
Other comprehensive loss | - | - | - | (254 | ) | - | (254 | ) | |||||||||||||||
Share-based compensation | - | - | 4,811 | - | - | 4,811 | |||||||||||||||||
Net loss for the period | - | - | - | - | (19,126 | ) | (19,126 | ) | |||||||||||||||
BALANCE AT |
52,266,474 | 150 | 456,761 | (2,459 | ) | (206,620 | ) | 247,832 |
UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)
(
Ordinary shares | Additional | Accumulated other |
|||||||||||||||||||||
Number of shares |
Amount | paid-in capital |
comprehensive deficit |
Accumulated deficit |
Total | ||||||||||||||||||
BALANCE AT |
46,100,173 | 131 | 315,031 | - | (84,416 | ) | 230,746 | ||||||||||||||||
Changes during the period: | |||||||||||||||||||||||
Issuance of ordinary shares upon exercise of options under the ESOP Plan | 1,073,413 | 3 | 3,271 | - | - | 3,274 | |||||||||||||||||
Issuance of ordinary shares upon exercise of warrants | 704,133 | 2 | 118 | - | - | 120 | |||||||||||||||||
Share-based compensation | - | - | 13,963 | - | 13,963 | ||||||||||||||||||
Other comprehensive income | - | - | - | (190 | ) | - | (190 | ) | |||||||||||||||
Net loss for the period | - | - | - | - | (39,763 | ) | (39,763 | ) | |||||||||||||||
BALANCE AT |
47,877,719 | 136 | 332,383 | (190 | ) | (124,179 | ) | 208,150 |
* Less than
Ordinary shares | Additional | Accumulated other |
|||||||||||||||||||||
Number of shares |
Amount | paid-in capital |
comprehensive deficit |
Accumulated deficit |
Total | ||||||||||||||||||
BALANCE AT |
47,834,457 | 136 | 327,854 | (116 | ) | (110,710 | ) | 217,164 | |||||||||||||||
Changes during the period: | |||||||||||||||||||||||
Issuance of ordinary shares upon exercise of options under the ESOP Plan | 7,790 | * | 45 | - | - | 45 | |||||||||||||||||
Issuance of ordinary shares upon exercise of warrants | 35,472 | * | 47 | - | - | 47 | |||||||||||||||||
Share-based compensation | - | - | 4,437 | - | 4,437 | ||||||||||||||||||
Other comprehensive income | - | - | - | (74 | ) | - | (74 | ) | |||||||||||||||
Net loss for the period | - | - | - | - | (13,469 | ) | (13,469 | ) | |||||||||||||||
BALANCE AT |
47,877,719 | 136 | 332,383 | (190 | ) | (124,179 | ) | 208,150 |
* Less than
NANO-X IMAGING LTD.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(
Nine Months Ended |
|||||||
2022 | 2021 | ||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net loss for the period | (60,406 | ) | (39,763 | ) | |||
Adjustments required to reconcile net loss to net cash used in operating activities: | |||||||
Share-based compensation | 16,339 | 13,963 | |||||
Amortization of intangible assets | 7,958 | - | |||||
Impairment of goodwill | 14,338 | - | |||||
Depreciation | 626 | 390 | |||||
Interest income due to a long-term loan | (315 | ) | - | ||||
Deferred income taxes | (2,725 | ) | - | ||||
Interest income net of amortization of premium on marketable securities, net | (568 | ) | (117 | ) | |||
Impairment of property and equipment | 133 | 174 | |||||
Changes in Operating Assets and Liabilities: | |||||||
Accounts receivable | (70 | ) | - | ||||
Prepaid expenses and other current assets | 3,663 | 5,184 | |||||
Other non-current assets | (726 | ) | 155 | ||||
Accounts payable | 2,438 | 807 | |||||
Accrued expenses and other liabilities | 425 | 768 | |||||
Operating lease assets and liabilities | (105 | ) | (16 | ) | |||
Change in contingent earnout liability | (11,303 | ) | - | ||||
Deferred revenue | (30 | ) | - | ||||
Other long-term liabilities | (179 | ) | (298 | ) | |||
Net cash used in operating activities | (30,507 | ) | (18,753 | ) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Purchase of property and equipment | (7,387 | ) | (17,246 | ) | |||
Investment in marketable securities | - | (102,813 | ) | ||||
Proceeds from the sale of marketable securities | 11,898 | - | |||||
Cash paid in advance for business combinations | (3,750 | ) | |||||
Investment in equity securities | (1,010 | ) | - | ||||
Net cash provided by (used in) investing activities | 3,501 | (123,809 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Proceeds from long term loan | - | 2,954 | |||||
Proceeds from issuance of ordinary shares upon exercise of warrants | 370 | 120 | |||||
Proceeds from issuance of ordinary shares upon exercise of options | 260 | 3,261 | |||||
Net cash provided by financing activities | 630 | 6,335 | |||||
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (26,376 | ) | (136,227 | ) | |||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 66,772 | 213,784 | |||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | 40,396 | 77,557 | |||||
SUPPLEMENTARY INFORMATION ON ACTIVITIES NOT INVOLVING CASH FLOWS - | |||||||
Purchase of property and equipment, not yet paid | 16 | 60 | |||||
Operating lease liabilities arising from obtaining operating right-of use assets | - | 226 | |||||
Ordinary shares issued due to exercise of warrants and options | 20 | 13 |
UNAUDITED RECONCILIATION OF GAAP AND NON-GAAP RESULTS
(
Use of Non-GAAP Financial Measures
The unaudited condensed consolidated financial information is prepared in conformity with accounting principles generally accepted in
Nine Months Ended | Three Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
GAAP net loss attributable to ordinary shares | 60,406 | 39,763 | 19,126 | 13,469 | |||||||||||
Non-GAAP adjustments: | |||||||||||||||
Less: Class-action litigation and |
5,225 | 665 | 2,642 | 604 | |||||||||||
Less: Amortization of intangible assets | 7,958 | - | 2,654 | - | |||||||||||
Less: Impairment of goodwill | 14,338 | - | - | - | |||||||||||
Add: Change in obligation in connection of acquisitions | (11,303 | ) | - | 953 | - | ||||||||||
Less: Secondary offering expenses | - | 981 | - | - | |||||||||||
Less: Share-based compensation | 16,339 | 13,963 | 4,811 | 4,437 | |||||||||||
Non-GAAP net loss attributable to ordinary shares | 27,849 | 24,154 | 8,066 | 8,428 | |||||||||||
BASIC AND DILUTED LOSS PER SHARE | 0.53 | 0.51 | 0.15 | 0.18 | |||||||||||
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands) | 52,180 | 47,486 | 52,276 | 47,851 |
Reconciliation of GAAP cost of revenue to Non-GAAP cost of revenue (
GAAP cost of revenue | 11,579 | - | 3,897 | - | |||||||||||
Non-GAAP adjustments: | |||||||||||||||
Amortization of intangible assets | 7,668 | - | 2,557 | - | |||||||||||
Share-based compensation | 81 | - | 25 | - | |||||||||||
Non-GAAP cost of revenue | 3,830 | - | 1,315 | - |
Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses (
GAAP research and development expenses | 19,412 | 10,760 | 6,089 | 3,708 | |||||||||||
Non-GAAP adjustments: | |||||||||||||||
Share-based compensation | 3,879 | 2,257 | 1,093 | 702 | |||||||||||
Non-GAAP research and development expenses | 15,533 | 8,503 | 4,996 | 3,006 |
Reconciliation of GAAP sales and marketing expenses to Non-GAAP sales and marketing expenses (
GAAP sales and marketing expenses | 2,882 | 5,093 | 698 | 1,529 | |||||||||||
Non-GAAP adjustments: | |||||||||||||||
Amortization of intangible assets | 290 | - | 97 | - | |||||||||||
Share-based compensation | 663 | 1,933 | 229 | 525 | |||||||||||
Non-GAAP sales and marketing expenses | 1,929 | 3,160 | 372 | 1,004 |
Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses (
GAAP general and administrative expenses | 33,069 | 23,790 | 10,630 | 8,238 | |||||||||||
Non-GAAP adjustments: | |||||||||||||||
Class-action litigation and |
5,225 | 665 | 2,642 | 604 | |||||||||||
Secondary offering expenses | - | 981 | - | - | |||||||||||
Share-based compensation | 11,716 | 9,773 | 3,464 | 3,210 | |||||||||||
Non-GAAP general and administrative expenses | 16,128 | 12,371 | 4,524 | 4,424 |
Investors:
ICR Westwicke
IR@nanox.vision
Media:
ICR Westwicke
NanoxPR@icrinc.com
Source: NANO-X IMAGING LTD
Source: Nano-X Imaging LTD.