Announces entry into acquisition via merger agreement with Zebra Medical Vision LTD. and binding letter of intent with USARAD Holdings Inc. to create a globally connected end-to-end radiology solution and population health platform
Chairman and Chief Executive Officer,
Reports progress towards global supply chain development
Ended the second quarter with cash and marketable securities of $193.4 million
Management to host conference call and webcast today,
Management to host public streaming event on August 16, at 08:30AM ET
Nanox today announced entry into two agreements intended to create a globally connected, end-to-end radiology solution. The Company announced that it has entered into an agreement to acquire a leading medical artificial intelligence (AI) developer Zebra Medical Vision in an all-stock transaction for
“Expanding access to medical imaging via widespread deployment of the Nanox.ARC solves just one of the obstacles to achieving true population health management,” stated
“With regards to the ongoing development of the multi-source Nanox.ARC, as you may recall, one of the highlights since our last quarterly update was the FDA 510(k) submission for the first version of the multi-source Nanox.ARC. We are reiterating our goal of deploying 15,000 by the end of 2024.
“As we prepare to scale globally and ramp up our manufacturing capabilities, I have asked
“I would also like to welcome
Second Quarter 2021 and Recent Developments:
- Announced acquisition agreement with Zebra Medical Imaging and binding letter of intent with USARAD to create a globally connected end-to-end radiology solution for population health management.
- Executed MSaaS agreement with EiLEENO Pharma for the deployment of 1,000 Nanox.ARC units across
Nigeria. With this agreement, the Company now has contracts in place to deploy 6,150 Nanox.ARC units, plus agreements with USARAD and SK Telecom to deploy an additional 5,500 across the US, Koreaand Vietnam, pending local regulatory approvals and satisfactory completion of user acceptance tests.
- Submitted 510(k) application for the first version of its multi-source Nanox.ARC.
- Continued to progress 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 a permanent chip facility.
- Chairman and Chief Executive Officer,
Ran Poliakine, will continue his role as Executive Chairman; Erez Meltzer, current Board member, will become assume the role of CEO in January 2022.
Ran Danielto succeed Itzhak Maayanas Chief Financial Officer, and will join the Company on August 15. Mr. Maayanwill remain with the company as CFO through the end of September.
Financial results for three months ended
For the three months ended
Research and development expenses for the second quarter 2021 were
Marketing expenses for the second quarter 2021 were
General and administrative expenses for the second quarter 2021 were
The Company ended the second quarter 2021 with cash, cash equivalents and marketable securities of
Non-GAAP net loss for the three months ended
A reconciliation between GAAP and non-GAAP metrics for the three-month and six-month periods ended
Completion of the proposed Zebra-Med acquisition is subject to, among others, approval of the transaction by the equity holders of Zebra-Med. The acquisition of USARAD is subject to the completion of due diligence and to the negotiation of a definitive agreement. The definitive agreement with USARAD may not be entered into the terms or in the timeframe currently contemplated. Both acquisitions are subject to satisfaction of the conditions to closing in the definitive agreements, regulatory approvals, and other customary conditions. Therefore, neither of the proposed transactions may be consummated on a timely basis or at all.
Conference call and webcast details
Investor domestic dial-in: 855-327-6837
Investor international dial-in: 631-891-4304
Conference ID: 10015901
Webcast link: http://public.viavid.com/index.php?id=146006
Nanox, founded by the serial entrepreneur
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 potential acquisitions, 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: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the negotiations and any subsequent definitive agreements with respect to the proposed acquisitions, and the possibility that the terms and conditions set forth in any definitive agreements with respect to the proposed acquisitions may differ materially from the terms and conditions set forth in the term sheet, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed acquisitions and any definitive agreements with respect thereto, (3) the inability to complete the proposed transactions, including due to failure to obtain approval of the stockholders of Zebra Medical Vision or other conditions to closing, (4) the impact of the COVID-19 pandemic on the parties’ ability to negotiate and consummate the proposed acquisitions, (5) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed transactions, (6) the risk that the proposed transaction disrupts current plans and operations as a result of the announcement and consummation of the proposed transaction, (7) the ability to recognize the anticipated benefits of the proposed transactions, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably and retain its key employees, (8) costs related to the proposed transactions, (9) the demand for the combined company’s services together with the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors, (10) 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; (iv) the market acceptance of the Nanox.ARC and the proposed pay-per-scan business model; (v) expectations regarding collaborations with third-parties and their potential benefits; (vi) ability to conduct business globally, and (11) 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.
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||116,858||213,468|
|Prepaid expenses and other current assets||1,808||6,325|
|TOTAL CURRENT ASSETS||154,861||219,793|
|Property and equipment, net||26,183||14,020|
|Operating lease right-of-use asset||1,321||1,359|
|Other non-current assets||656||661|
|TOTAL NON-CURRENT ASSETS||68,526||16,356|
|Liabilities and Shareholders' Equity|
|Accrued expenses and other liabilities||4,262||3,526|
|Current maturities of operating leases||612||519|
|TOTAL CURRENT LIABILITIES||5,355||4,480|
|Non-current operating leases||774||923|
|Other long term liabilities||94||-|
|TOTAL NON-CURRENT LIABILITIES||868||923|
|COMMITMENTS AND CONTINGENCIES||-||-|
|Ordinary Shares, par value
|Additional paid-in capital||327,854||315,031|
|Accumulated other comprehensive income (deficit)||(116||)||-|
|TOTAL SHAREHOLDERS' EQUITY||217,164||230,746|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||223,387||236,149|
CONSOLIDATED STATEMENTS OF OPERATIONS
|Six Months Ended
||Three Months Ended
|Research and development||7,052||4,152||4,343||1,786|
|General and administrative||15,552||7,903||7,358||3,871|
|FINANCIAL EXPENSES (INCOME), NET||126||(14||)||60||(65||)|
|BASIC AND DILUTED LOSS PER SHARE||(0.56||)||(0.47||)||(0.28||)||(0.21||)|
|WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands)||47,300||29,273||47,756||29,268|
|Other comprehensive income:|
|Unrealized gain from available- for-sale securities||(116||)||-||(116||)||-|
|Total comprehensive loss||(26,410||)||(13,786||)||(13,693||)||(6,364||)|
|RECONCILIATION OF GAAP TO NON-GAAP METRICS
(U.S. dollars in thousands (except per share data))
|Three Months Ended
||Six Months Ended
|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||13,577||6,364||26,294||13,786|
|Secondary offering expenses||-||-||981||-|
|Non-GAAP net loss attributable to ordinary shares||8,618||2,867||15,672||5,439|
|BASIC AND DILUTED LOSS PER SHARE||0.18||0.1||0.33||0.19|
|WEIGHTED AVERAGE NUMBER OF||47,756||29,628||47,300||29,273|
|ORDINARY SHARES (in thousands)|
|Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses (
|GAAP research and development expenses||4,343||1,786||7,052||4,152|
|Non-GAAP research and development expenses||3,418||1,546||5,497||2,235|
|Reconciliation of GAAP marketing expenses to Non-GAAP marketing expenses (
|GAAP marketing expenses||1,816||772||3,564||1,745|
|Non-GAAP marketing expenses||995||450||2,156||1,101|
|Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses (
|GAAP general and administrative expenses||7,358||3,871||15,552||7,903|
|Class-action litigation expenses||18||-||61||-|
|Secondary offering expenses||-||-||981||-|
|Non-GAAP general and administrative expenses||4,145||936||7,893||2,117|
Source: Nano-X Imaging LTD.