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Nanox Announces First Quarter 2021 Results and Provides Business Update Announced FDA 510(k) clearance for the single source Nanox Cart X-Ray System Scaling up Company's semiconductor fabrication plant in South Korea End

Key Takeaway: Nanox Announces First Quarter 2021 Results and Provides Business Update Announced FDA 510(k) clearance for the single source Nanox Cart X-Ray System Scaling up Company's semiconductor fabrication plant in South Korea Ended Q1 with cash and cash equivalents of $219 Manageme

Full Press Release Details

Nanox Announces First Quarter 2021 Results and
Provides Business Update
Announced FDA 510(k) clearance for the single
source Nanox Cart X-Ray System
Scaling up Company's semiconductor fabrication
plant in South Korea
Ended Q1 with cash and cash equivalents of $219
Management to host conference call and webcast
today, May 11, at 8:30 AM ET
NEVE ILAN, Israel-May 11, 2021 -- NANO-X
IMAGING LTD (NASDAQ: NNOX) ("Nanox" or the "Company"), an innovative medical imaging technology
company, today announced results for the first quarter ended March 31, 2021 and provided a business update.
"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 Ran Poliakine, Chairman and Chief Executive Officer
of Nanox. "In addition, we are making solid progress, despite the impact of the pandemic, on the technology transfer of MEMs chip
technology to our interim clean-room facility in Korea and the construction of our new state-of-the-art fabrication facility."
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 Mr. Poliakine.
"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 Mr. Poliakine.
First Quarter 2021 and Recent Developments:
results for three months ended March 31, 2021
For the three months ended March 31, 2021, the
Company reported a net loss of $12.7 million, compared to a net loss of $7.4 million for the three-month period ended March 31, 2020.
Research and Development expenses for the first
quarter 2021 were $2.7 million, as compared to $2.4 million for the corresponding prior year period in 2020. The slight increase was due
to higher development costs related to the Nanox System, including increased R&D headcount, and costs related to the ongoing regulatory
approval process, offset by a decrease in share-based compensation.
Marketing expenses for the first quarter 2021
were $1.7 million, as compared to $1.0 million for the corresponding prior year period in 2020. These expenses increased due to higher
investments in brand awareness and product marketing capabilities as well as share-based compensation.
General and administrative expenses for the first
quarter 2021 were $8.2 million, as compared to $4.0 million for corresponding prior year period in 2020. The increase in general and administrative
expenses in the first quarter of 2021 as compared to the corresponding prior period was due to secondary offering expenses and share-based
Net cash used in operating activities during the
first quarter 2021 was $4.4 million.
The Company ended the first quarter 2021 with
cash and cash equivalents of $219.3 million, including $13.6 million cash in transit which was paid soon after the quarter ended.
Non-GAAP net loss for the three months ended March
31, 2021 was $7.1 million, as compared to $2.6 million for the corresponding prior year period in 2020. Non-GAAP research and development
expenses for the first quarter of 2021 were $2.1 million, as compared to $689 thousand for the corresponding prior year period in 2020.
Non-GAAP marketing expenses for first quarter 2021 were $1.2 million, as compared to $651 thousand for the corresponding prior year period
in 2020. Non-GAAP general and administrative expenses for the first quarter 2021 were $3.7 million, as compared to $1.2 million for the
corresponding period year period in 2020.
A reconciliation between GAAP and non-GAAP metrics
for the three-month period ended March 31, 2021 and March 31, 2020 is provided in the financial results that are part of this press release.
The difference between the GAAP and non-GAAP results for each of the metrics above is mainly attributable to secondary offering expenses
and share-based compensation.
As of March 31, 2021, the Company had approximately
47.6 million shares outstanding.
Conference call and webcast details
Tuesday, May 11, 2021 @ 8:30am ET
Investor domestic dial-in: 877-407-0789
Investor international dial-in: 201-689-8562
Conference ID: 13718794
Nanox, founded by the serial entrepreneur Ran
Poliakine, is an Israeli corporation that is developing a commercial-grade digital X-ray source designed to be used in real-world medical
imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans
to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service
for all. 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 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
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
Last updated: May 11, 2021