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Nano-X Imaging Ltd.
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Nano-X Imaging Ltd.
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3 company response(s)
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2023-01-05
Nano-X Imaging Ltd.
References: December 6, 2022
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Company responded
2023-02-01
Nano-X Imaging Ltd.
References: January 18, 2023 | January 5, 2023
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Company responded
2023-03-02
Nano-X Imaging Ltd.
References: February 1, 2023 | February 3, 2023
Nano-X Imaging Ltd.
Awaiting Response
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SEC wrote to company
2023-02-03
Nano-X Imaging Ltd.
References: February 1, 2023
Nano-X Imaging Ltd.
Awaiting Response
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2023-01-18
Nano-X Imaging Ltd.
References: January 5, 2023
Nano-X Imaging Ltd.
Response Received
2 company response(s)
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2021-02-08
Nano-X Imaging Ltd.
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2021-02-08
Nano-X Imaging Ltd.
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Nano-X Imaging Ltd.
Response Received
3 company response(s)
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SEC wrote to company
2020-08-11
Nano-X Imaging Ltd.
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2020-08-12
Nano-X Imaging Ltd.
References: August 11, 2020
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2020-08-18
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2020-08-18
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2020-02-28
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-26 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2026-03-23 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | 333-294302 | Read Filing View |
| 2023-03-09 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-03-02 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-02-01 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-01-18 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-01-05 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2022-12-06 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-02-08 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-02-08 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-01-21 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-18 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-18 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-12 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-11 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-02-28 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-01-28 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-01-02 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-23 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | 333-294302 | Read Filing View |
| 2023-03-09 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-01-18 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2022-12-06 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-01-21 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-11 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-02-28 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-01-28 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-01-02 | SEC Comment Letter | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-26 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-03-02 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-02-01 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2023-01-05 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-02-08 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2021-02-08 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-18 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-18 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
| 2020-08-12 | Company Response | Nano-X Imaging Ltd. | Israel | N/A | Read Filing View |
2026-03-26 - CORRESP - Nano-X Imaging Ltd.
CORRESP 1 filename1.htm NANO-X IMAGING LTD Ofer Tech Park 94 Shlomo Shmeltzer Road Petach Tikva Israel 4970602 March 26, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, NE Washington, D.C. 20549 Attn: Margaret Sawicki RE: Nano-X Imaging Ltd. (the " Company ") Registration Statement on Form F-3 File No. 333-294302 Dear Ms. Sawicki: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Company's Registration Statement on Form F-3 (File No. 333-294302) be accelerated by the Securities and Exchange Commission to 4:00 p.m. New York time on March 30, 2026, or as soon as practicable thereafter. We request that we be notified of such effectiveness by a telephone call to Michael J. Schwartz of Skadden, Arps, Slate, Meagher & Flom LLP at (212) 735-3694 and that such effectiveness also be confirmed in writing. Very truly yours, Nano-X Imaging Ltd. By: /s/ Erez Meltzer Erez Meltzer Chief Executive Officer cc: Michael J. Schwartz Skadden, Arps, Slate, Meagher & Flom LLP
2026-03-23 - UPLOAD - Nano-X Imaging Ltd. File: 333-294302
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 23, 2026 Erez Meltzer Chief Executive Officer Nano-X Imaging Ltd. Ofer Tech Park 94 Shlomo Shmeltzer Road Petach Tikva Israel 4970602 Re: Nano-X Imaging Ltd. Registration Statement on Form F-3 Filed March 13, 2026 File No. 333-294302 Dear Erez Meltzer: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Margaret Sawicki at 202-551-7153 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Michael J Schwartz, Esq. </TEXT> </DOCUMENT>
2023-03-09 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
March 9, 2023
Ran Daniel
Chief Financial Officer
Nano-X Imaging Ltd.
Communication Center
Neve Ilan , Israel 9085000
Re:Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December 31, 2021
Filed May 2, 2022
File No. 001-39461
Dear Ran Daniel:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2023-03-02 - CORRESP - Nano-X Imaging Ltd.
CORRESP
1
filename1.htm
March 2, 2023
BY E-MAIL AND BY EDGAR
Division of Corporation Finance
Office of Industrial Applications and Services
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn:
Tracey Houser
Terence O’Brien
Re: Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December
31, 2021
Filed May 2, 2022
Response Letter Dated February 1, 2023
File No. 001-39461
Dear Ms. Houser and Mr. O’Brien:
NANO-X IMAGING LTD (the “Company”)
hereby provides responses to the comments received from the staff (the “Staff”) of the United States Securities and
Exchange Commission (the “Commission”) set forth in the comment letter dated February 3, 2023 (the “Comment
Letter”) with respect to the above-referenced Form 20-F for the fiscal year ended December 31, 2021 (the “Form 20-F”)
filed with the Commission by the Company on May 2, 2022.
The headings and paragraph
numbers in this letter correspond to those contained in the Comment Letter and, to facilitate the Staff’s review, we have reproduced
the text of the Staff’s comments in bold below. Capitalized terms used but not defined herein have the meanings given to them in
the Form 20-F. All references to page numbers and captions (unless otherwise stated) under the header titled “Form 20-F for Fiscal
Year Ended December 31, 2021” correspond to the page numbers and captions in the Form 20-F.
Form 20-F for Fiscal Year Ended December 31, 2021
Item 5. Operating and Financial Review and Prospects
E. Critical Accounting Estimates, page 90
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
March 2, 2023
Page 2
1. We note your response to comment 2. Regarding the draft disclosures provided, please address the following:
● Clarify that the amount of goodwill assigned to the AI solutions
reporting unit at the interim testing date was $51.2 million and that $14.3 million was recognized as an impairment charge based on the
testing results.
● Expand your discussion of the discounted cash flow model used
to estimate the fair value of your AI solutions reporting unit to state when you have assumed that the business will be generating material
revenues, gross profit and positive operating cash flows to support the remaining $36.9 million of goodwill as of December 31, 2022.
Response
The
Company acknowledges the Staff’s comment. The Company confirms that it has performed an interim test of goodwill impairment
during the second quarter of fiscal year 2022, which resulted in the recognition of a $14.3 million goodwill impairment charge associated
with the AI solutions segment.
In the fourth quarter of 2022,
the Company performed its annual test of goodwill impairment and is currently in the process of determining its results. The Company expects
to record an additional material goodwill impairment charge. The impairment is a result of further revision of management estimates due
to the global economic slowdown and industry specific considerations which led the Company to re-assess the projected revenue, gross profit,
operating profit and cashflows of the AI solutions reporting unit and the estimated timeline for such unit to start generating substantial
revenues, gross profit, operating profit and positive cash flow.
The Company will include the
disclosures as required by ASC 350-20-50-2 in the financial statements included in its Annual Report on Form 20-F for the fiscal
year ended December 31, 2022, substantially similar to the disclosure below (which is marked against the suggested disclosure included
in our response letter dated February 1, 2023).
Goodwill
“We
determine the fair value of our reporting units using a discounted cash flow model, which utilizes key assumptions such as projected revenues,
cost of revenues and operating expenses. These assumptions were determined by management utilizing our internal operating plan, growth
rates for revenues and operating expenses and margin assumptions. An additional key assumption under this approach is the discount
rate, based on the weighted average cost of capital, which is adjusted for current risk-free rates of capital, current market interest
rates, and the evaluation of a risk premium relevant to the business segment.
If
our assumptions relative to revenue growth rates, cost of revenues and operating expenses were to change, our fair value calculation may
change, which could result in impairment. If our assumptions relative to the discount rate and the evaluation of risk premium growth rates
were to change, our fair value calculation may change, which could result in impairment. Management uses the income approach to determine
the fair value of the reporting units because it considers the anticipated future financial performance of the reporting units. Accordingly,
changes in the assumptions described above could have a material impact on our consolidated results of operations.
Our
goodwill is tested for impairment at least on an annual basis, on the last day of the fourth quarter of the fiscal year and whenever events
or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, we record charges
for impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value.
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
March 2, 2023
Page 3
Goodwill impairment assessments
for the year ended December 31, 2022
AI solutions reporting
unit
During
the second quarter and given of 2022, in light of triggering
events arising from the increase of the discount rate, the change of management
and changes in management estimates as a result of business specific considerations,
we performed a quantitative annual interim assessment
for goodwill impairment for our AI solutions reporting unit. The amount of goodwill assigned to the AI
solutions reporting unit on the interim testing date, which had not changed from the amount assigned to such unit on the acquisition
date, was $51.2 million. As a result of the impairment assessment, we concluded that the fair value
of the AI solutions reporting unit exceeded its carrying amount by approximately 11.61%,
with a carrying amount of goodwill impairment
charge assigned to this reporting unit
in an amount of $14.3 million. As a result, the remaining amount of goodwill assigned to the AI solutions
reporting unit at June 30, 2022 was $36.9 million.
We
also During the fourth quarter of 2022, we performed a quantitative annual assessment
for goodwill impairment and concluded that the fair value of the AI reporting unit exceeded its carrying amount by approximately [●]%,
with a carrying amount of goodwill impairment
charge assigned to this unit in an amount of $[●] million. As
a result, the remaining amount of goodwill assigned to the AI solutions reporting unit in
an amount of at December 31, 2022 was $[●] million.
When
evaluating the fair value of the AI solutions reporting unit under the income approach, we used a discounted cash flow model which utilized
Level 3 measures that represent unobservable inputs. Key assumptions used to determine the estimated fair value include: (a) internal
cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to sales and operating expenses;
(b) an estimated terminal value using a terminal year long-term future growth rate of
[●]% determined based on the growth prospects of the reporting unit; and (c) a discount
rate of [●]% which reflects the weighted-average
cost of capital adjusted for the relevant risk associated with the AI solutions reporting unit’s operations and the uncertainty
inherent in our internally developed forecasts.
Specifically,
as part of our interim impairment test, in making the assumptions mentioned in clauses (a) and (b) above, we considered (1) the efforts
and time required for the AI solutions reporting unit to achieve financial stability, (2) our estimate that it
would take approximately one year for such unit to generate any material revenue and two years to achieve profitability; and (3)
our estimate that it would take longer than we originally expected for such unit to generate material revenues, gross profit, and positive
operating cash flows, especially from its population health applications. For the assumption
mentioned in clause (b) above, we assumed a terminal year long-term future growth rate of 3.0% as
of June 30, 2022. For the assumption mentioned in clause (c) above, we assumed a
discount rate of 22.0%.
Actual
results may differ from those assumed in our valuation method. It is reasonably possible that our assumptions described above could change
in future periods. If any of these were to vary materially from our plans, we may record impairment of goodwill allocated to this reporting
unit in the future. A hypothetical decrease in the growth rate of [●]% or an increase of [●]% to the discount rate would have
reduced the fair value of AI Solutions reporting unit by approximately $[●] million and $[●] million, respectively.
Radiology
services reporting unit
We
performed a quantitative assessment for goodwill impairment for our teleradiology reporting unit and concluded that the fair value of
the radiology services reporting unit exceeded its carrying amount by approximately [●] %, with a carrying amount of goodwill assigned
to this reporting unit in an amount of $[●] million.
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
March 2, 2023
Page 4
When
evaluating the fair value of the radiology services reporting unit under the income approach, we used a discounted cash flow model which
utilized Level 3 measures that represent unobservable inputs. Key assumptions used to determine the estimated fair value include: (a)
internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to sales and operating
expenses; (b) an estimated terminal value using a terminal year long-term future growth rate of [●]% determined based on the growth
prospects of the reporting unit; and (c) a discount rate of [●]% which reflects the weighted-average cost of capital adjusted for
the relevant risk associated with the radiology services reporting unit’s operations and the uncertainty inherent in our internally
developed forecasts.
Actual
results may differ from those assumed in our valuation method. It is reasonably possible that our assumptions described above could change
in future periods. If any of these were to vary materially from our plans, we may record impairment of goodwill allocated to this reporting
unit in the future. A hypothetical decrease in the growth rate of [●] % or an increase of [●] % to the discount rate would
have reduced the fair value of the radiology services reporting unit by approximately $[●] million and $[●] million, respectively.
As of December 31, 2022,
the percentage by which the estimated fair value of our reporting units exceeds the carrying value was as the following:
Goodwill
from
acquisition of
Nanox AI
Unit #1
Goodwill
from
acquisition of
USARAD
Unit #2
Goodwill Assigned (in millions)
$
[●]
$
[●]
Fair Value/Carrying Amount
[●]
%
[●]
%
Goodwill impairment assessment for the
year ended December 31, 2021
As of December 31, 2021,
we evaluated that there was no notable change in qualitative factors due to the short period of time that had lapsed from the acquisition
date through December 31, 2021. Therefore, we did not determine that it was more likely that not that the fair value of each reporting
unit was less than its carrying amount. As such, we concluded that no further impairment testing
was required for either reporting unit as of December 31, 2021.”
* * * * *
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
March 2, 2023
Page 5
We hope that the foregoing
has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please
direct any questions or comments regarding the foregoing to me at (212) 982-0269.
Very truly yours,
/s/ Ran Daniel
Ran Daniel
Chief Financial Officer
cc: Michael Zeidel
Yossi Vebman
Skadden, Arps, Slate, Meagher & Flom LLP
2023-02-03 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
February 3, 2023
Ran Daniel
Chief Financial Officer
Nano-X Imaging Ltd.
Communication Center
Neve Ilan , Israel 9085000
Re:Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December 31, 2021
Filed May 2, 2022
Response Letter Dated February 1, 2023
File No. 001-39461
Dear Ran Daniel:
We have reviewed your February 1, 2023 response to our comment letter and have the
following comment. In our comment, we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional
comments. Unless we note otherwise, our reference to a prior comment are to comments in our
January 18, 2023 letter.
Form 20-F for Fiscal Year Ended December 31, 2021
Item 5. Operating and Financial Review and Prospects
E. Critical Accounting Estimates, page 90
1.We note your response to comment 2. Regarding the draft disclosures provided, please
address the following:
•Clarify that the amount of goodwill assigned to the AI solutions reporting unit at the
interim testing date was $51.2 million and that $14.3 million was recognized as an
impairment charged based on the testing results.
•Expand your discussion of the discounted cash flow model used to estimate the fair
value of your AI solutions reporting unit to state when you have assumed that the
business will be generating material revenues, gross profit and positive operating
FirstName LastNameRan Daniel
Comapany NameNano-X Imaging Ltd.
February 3, 2023 Page 2
FirstName LastName
Ran Daniel
Nano-X Imaging Ltd.
February 3, 2023
Page 2
cash flows to support the remaining $36.9 million of goodwill as of December 31,
2022.
You may contact Tracey Houser at 202-551-3736 or Terence O'Brien at 202-551-3355, if
you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2023-02-01 - CORRESP - Nano-X Imaging Ltd.
CORRESP
1
filename1.htm
February 1, 2023
BY E-MAIL AND BY EDGAR
Division of Corporation Finance
Office of Industrial Applications and Services
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn: Tracey Houser
Terence O’Brien
Re: Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December
31, 2021
Filed May 2, 2022
Response Letter Dated January 5, 2023
File No. 001-39461
Dear Ms. Houser and Mr. O’Brien:
NANO-X IMAGING LTD (the “Company”)
hereby provides responses to the comments received from the staff (the “Staff”) of the United States Securities and
Exchange Commission (the “Commission”) set forth in the comment letter dated January 18, 2023 (the “Comment
Letter”) with respect to the above-referenced Form 20-F for the fiscal year ended December 31, 2021 (the “Form 20-F”)
filed with the Commission by the Company on May 2, 2022.
The headings and paragraph numbers in this letter
correspond to those contained in the Comment Letter and, to facilitate the Staff’s review, we have reproduced the text of the Staff’s
comments in bold below. Capitalized terms used but not defined herein have the meanings given to them in the Form 20-F. All references
to page numbers and captions (unless otherwise stated) under the header titled “Form 20-F for Fiscal Year Ended December 31, 2021”
correspond to the page numbers and captions in the Form 20-F.
Form 20-F for Fiscal Year Ended December 31, 2021
Item 5. Operating and Financial Review and Prospects
E. Critical Accounting Estimates, page 90
1. We note your response and draft disclosures provided in response to comment 3. Please tell us your consideration of also providing
the requested disclosures for impairment of long-lived assets considering the significance of property and equipment and intangible assets
to your financial statements and also legal and other contingencies considering the three legal proceedings and the SEC investigation.
Response
The Company acknowledges the
Staff’s comment. The Company will prospectively include discussion and analysis of its critical accounting estimates in its
Annual Report on Form 20-F for the fiscal year ended December 31, 2022 that provides disclosures for impairment of long-lived
assets and legal and other contingencies substantially similar to the disclosure below:
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
February 1, 2023
Page 2
“Impairment
of Long-Lived Assets
Our long-lived assets,
such as property, plant and equipment and identifiable intangible assets, are reviewed for potential impairment whenever events
or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Impairment indicators which
could trigger an impairment may include, among others, any significant changes in the manner of our use of the assets or the strategy
of our overall business, certain reorganization initiatives, significant negative industry or economic trends or
when we conclude that it is more likely than not that an asset will be disposed of or sold.
The recoverability of assets
to be held and used is measured by a comparison of the carrying amount of an asset with the future undiscounted cash flows expected to
be generated by such assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by
which the carrying amount of the assets exceeds the fair value of the assets. Our identifiable intangible assets were recognized as part
of the business combinations we executed in 2021. Our identifiable intangible assets are comprised of developed technology, image big
data, market platform, radiologists’ relationships, trade names and customer relationships.
This measurement includes
significant estimates and assumptions inherent in the estimate of the fair value of identifiable intangible assets such as assumptions
associated with forecasting profitability, including operational margins and capital expenditures.
Newly acquired and recently
impaired long-lived assets are more vulnerable to impairment as the assets are recorded at fair value and are then subsequently measured
at the lower of fair value or carrying value annually or when triggering events are present. As such, immediately after acquisition or
impairment, even small declines in the outlook for these assets can negatively impact our ability to recover the carrying value and can
result in an impairment charge. Accordingly, changes in the assumptions described above could have a material impact on our consolidated
results of operations.
During the year ended December
31, 2021, we did not record any impairment charges related to our definite-life intangible assets.
During the years ended
December 31, 2022 and 2021, an impairment charge in the amount of $[●] thousand and $214 thousand was recorded for the years ended
December 31, 2022 and 2021, respectively in relation to our Property, Plant and Equipment. During the year ended December 31, 2019, we
did not record any impairment charges related to our Property, Plant and Equipment.
Legal and Other Contingencies
We are involved in claims
and other legal proceedings that arise from time to time in the ordinary course of business. We record accruals for these types of contingencies
to the extent that we conclude their occurrence is probable and that the related liabilities are estimable. When accruing these costs,
we recognize an accrual in the amount within a range of loss that is the best estimate within the range. When no amount within the
range is a better estimate than any other amount, we accrue the minimum amount within the range. We record anticipated recoveries under
existing insurance contracts that are virtually certain of occurring at the gross amount that is expected to be collected. Management
applies the guidance in ASC 450-20-25 when assessing losses resulting from contingencies. If the assessment of a contingency indicates
that it is probable that a material loss would be incurred and the amount of the liability can be estimated, then the Company records
an accrued expense in the Company’s consolidated financial statements based on its best estimate. Loss contingencies considered
by management to be remote are generally not disclosed unless material.
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
February 1, 2023
Page 3
We review the adequacy
of the accruals on a periodic basis and may determine to alter our reserves at any time in the future if we believe it would be appropriate
to do so. As such accruals are based on management’s judgment as to the probability of losses and, where applicable, actuarially
determined estimates, accruals may materially differ from actual verdicts, settlements or other agreements made with regards to such contingencies.
Litigation outcomes and contingencies are unpredictable and excessive verdicts can occur. Accordingly, management’s assessments
involve complex judgments concerning future events and often rely heavily on estimates and assumptions.
As of December 31, 2021,
we have not accrued any losses other than legal fees in connection with our legal proceedings, including two securities class action cases
and the SEC investigation. Given the status of the two securities class action cases and the SEC investigation, we cannot reasonably estimate
the possible loss or a range of possible loss from such cases or the SEC investigation due to the lack of specific damages claimed and
the unpredictable nature of future events. The Company did not accrue any liability in connection with the dismissed complaint brought
against the Company, its recently-formed Delaware subsidiary, and Nanox Gibraltar PLC.”
2. We note your response to comment 4. Please provide us with a draft of the disclosures that you intend to include in your fiscal year
2022 Form 20-F that provide the requested information regarding testing goodwill for impairment. In this regard, the related draft disclosures
provided in response to comment 3 do not provide any company-specific or quantitative information requested. We further note that you
performed an interim test of goodwill during the second quarter of fiscal year 2022, which resulted in the recognition of a $14.3 million
goodwill impairment charge associated with the AI Solutions segment.
Response
The Company is currently
completing the annual impairment test for the fiscal year ended December 31, 2022 and acknowledges the Staff’s comment. The
Company confirms that it has performed an interim test of goodwill impairment during the second quarter of fiscal year 2022, which resulted
in the recognition of a $14.3 million goodwill impairment charge associated with the AI solutions segment. The Company will include the
disclosures as required by ASC 350-20-50-2 in its financial statements for the fiscal year ended December 31, 2022.
The Company will prospectively
include a discussion and analysis of the quantitative impairment testing, if any, in its critical accounting estimates in its Annual Report
on Form 20-F for the fiscal year ended December 31, 2022, and going forward, substantially similar to the disclosure below:
Goodwill
“We
determine the fair value of our reporting units using a discounted cash flow model, which utilizes key assumptions such as projected revenues,
cost of revenues and operating expenses. These assumptions were determined by management utilizing our internal operating plan, growth
rates for revenues and operating expenses and margin assumptions. An additional key assumption under this approach is the discount
rate, based on the weighted average cost of capital, which is adjusted for current risk-free rates of capital, current market interest
rates, and the evaluation of a risk premium relevant to the business segment.
If
our assumptions relative to revenue growth rates, cost of revenues and operating expenses were to change, our fair value calculation may
change, which could result in impairment. If our assumptions relative to the discount rate and the evaluation of risk premium growth rates
were to change, our fair value calculation may change, which could result in impairment. Management uses the income approach to determine
the fair value of the reporting units because it considers the anticipated future financial performance of the reporting units. Accordingly,
changes in the assumptions described above could have a material impact on our consolidated results of operations.
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
February 1, 2023
Page 4
Our
goodwill is tested for impairment at least on an annual basis, on the last day of the fourth quarter of the fiscal year and whenever events
or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, we record charges
for impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value.
Goodwill impairment assessment for the
year ended December 31, 2022
AI solutions reporting
unit
During
the second quarter and given triggering events arising from the increase of the discount rate and changes in management estimates, we performed
a quantitative annual assessment for goodwill impairment for our AI solutions reporting unit and concluded that the fair value of the
AI reporting unit exceeded its carrying amount by approximately [●]%, with a carrying amount of goodwill assigned to this reporting
unit in an amount of $14.3 million.
We
also performed a quantitative annual assessment for goodwill impairment and concluded that the fair value of the AI reporting unit exceeded
its carrying amount by approximately [●]%, with a carrying amount of goodwill assigned to this reporting unit in an amount of $[●]
million.
When
evaluating the fair value of the AI solutions reporting unit under the income approach, we used a discounted cash flow model which utilized
Level 3 measures that represent unobservable inputs. Key assumptions used to determine the estimated fair value include: (a) internal
cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to sales and operating expenses;
(b) an estimated terminal value using a terminal year long-term future growth rate of [●]% determined based on the growth prospects
of the reporting unit; and (c) a discount rate of [●]% which reflects the weighted-average cost of capital adjusted for the relevant
risk associated with the AI solutions reporting unit’s operations and the uncertainty inherent in our internally developed forecasts.
Actual
results may differ from those assumed in our valuation method. It is reasonably possible that our assumptions described above could change
in future periods. If any of these were to vary materially from our plans, we may record impairment of goodwill allocated to this reporting
unit in the future. A hypothetical decrease in the growth rate of [●]% or an increase of [●]% to the discount rate would have
reduced the fair value of AI Solutions reporting unit by approximately $[●] million and $[●] million, respectively.
Radiology
services reporting unit
We
performed a quantitative assessment for goodwill impairment for our teleradiology reporting unit and concluded that the fair value of
the radiology services reporting unit exceeded its carrying amount by approximately [●]%, with a carrying amount of goodwill assigned
to this reporting unit in an amount of $[●] million.
Ms. Tracey Houser and Mr. Terrence O’Brien
Securities and Exchange Commission
February 1, 2023
Page 5
When
evaluating the fair value of the radiology services reporting unit under the income approach, we used a discounted cash flow model which
utilized Level 3 measures that represent unobservable inputs. Key assumptions used to determine the estimated fair value include: (a)
internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to sales and operating
expenses; (b) an estimated terminal value using a terminal year long-term future growth rate of [●]% determined based on the growth
prospects of the reporting unit; and (c) a discount rate of [●]% which reflects the weighted-average cost of capital adjusted for
the relevant risk associated with the radiology services reporting unit’s operations and the uncertainty inherent in our internally
developed forecasts.
Actual
results may differ from those assumed in our valuation method. It is reasonably possible that our assumptions described above could change
in future periods. If any of these were to vary materially from our plans, we may record impairment of goodwill allocated to this reporting
unit in the future. A hypothetical decrease in the growth rate of [●]% or an increase of [●]% to the discount rate would have
reduced the fair value of the radiology services reporting unit by approximately $[●] million and $[●] million, respectively.
As of December 31, 2022, the
percentage by which the estimated fair value of our reporting units exceed the carrying value was as the following:
Goodwill from acquisition of Nanox AI
Unit #1
Goodwill from acquisition of USARAD
Unit #2
Goodwill Assigned (in millions)
$
[●]
$
[●]
Fair Value/Carrying Amount
[●]
%
[●]
%
Goodwill impairment assessment
for the year ended December 31, 2021
As of December 31, 2021, we evaluated that there
was no notable change in qualitative factors due to the short period of time that had lapsed from the acquisition date through December
31, 2021. Therefore, we did not determine that it was more likely that not that the fair value of each reporting unit was less than its
carrying amount. As such, we concluded that no further impairment testing was required for either
reporting unit as of December 31, 2021.”
* * * *
2023-01-18 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
January 18, 2023
Ran Daniel
Chief Financial Officer
Nano-X Imaging Ltd.
Communication Center
Neve Ilan , Israel 9085000
Re:Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December 31, 2021
Filed May 2, 2022
Response Letter Dated January 5, 2023
File No. 001-39461
Dear Ran Daniel:
We have reviewed your January 5, 2023 response to our comment letter and have the
following comments. In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
January 5, 2023 letter.
Form 20-F for Fiscal Year Ended December 31, 2021
Item 5. Operating and Financial Review and Prospects
E. Critical Accounting Estimates, page 90
1.We note your response and draft disclosures provided in response to comment 3. Please
tell us your consideration of also providing the requested disclosures for impairment of
long-lived assets considering the significance of property and equipment and intangible
assets to your financial statements and also legal and other contingencies considering the
three legal proceedings and the SEC investigation.
2.We note your response to comment 4. Please provide us with a draft of the disclosures
that you intend to include in your fiscal year 2022 Form 20-F that provide the requested
FirstName LastNameRan Daniel
Comapany NameNano-X Imaging Ltd.
January 18, 2023 Page 2
FirstName LastName
Ran Daniel
Nano-X Imaging Ltd.
January 18, 2023
Page 2
information regarding testing goodwill for impairment. In this regard, the related draft
disclosures provided in response to comment 3 do not provide any company-specific or
quantitative information requested. We further note that you performed an interim test of
goodwill during the second quarter of fiscal year 2022, which resulted in the recognition
of a $14.3 million goodwill impairment charge associated with the AI Solutions segment.
You may contact Tracey Houser at 202-551-3736 or Terence O'Brien at 202-551-3355, if
you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2023-01-05 - CORRESP - Nano-X Imaging Ltd.
CORRESP 1 filename1.htm January 5, 2023 BY E-MAIL AND BY EDGAR Division of Corporation Finance Office of Industrial Applications and Services Securities and Exchange Commission 100 F St., N.E. Washington, D.C. 20549 Attn: Tracey Houser Terence O’Brien Re: Nano-X Imaging Ltd. Form 20-F for Fiscal Year Ended December 31, 2021 Filed May 2, 2022 Form 6-K Filed March 31, 2022 File No. 001-39461 Dear Ms. Houser and Mr. O’Brien: NANO-X IMAGING LTD (the “Company”) hereby provides responses to the comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) set forth in the comment letter dated December 6, 2022 (the “Comment Letter”) with respect to the above-referenced Form 20-F for the fiscal year ended December 31, 2021 (the “Form 20-F”) filed with the Commission by the Company on May 2, 2022 and Form 6-K (the “March 2022 Form 6-K”) filed with the Commission by the Company on March 31, 2022. The headings and paragraph numbers in this letter correspond to those contained in the Comment Letter and, to facilitate the Staff’s review, we have reproduced the text of the Staff’s comments in bold below. Capitalized terms used but not defined herein have the meanings given to them in the Form 20-F. All references to page numbers and captions (unless otherwise stated) under the header titled “Form 20-F for Fiscal Year Ended December 31, 2021” correspond to the page numbers and captions in the Form 20-F and all references to page numbers and captions (unless otherwise stated) under the header titled “Form 6-K Filed March 31, 2022” correspond to the page numbers and captions in the March 2022 Form 6-K. Ms. Tracey Houser and Mr. Terrence O’Brien Securities and Exchange Commission January 5, 2023 Page 2 Form 20-F for Fiscal Year Ended December 31, 2021 Item 5. Operating and Financial Review and Prospects A. Operating Results Results of Operations, page 82 1. Please expand your discussion and analysis of cost of revenue to explain why the amount recognized for the AI segment significantly exceeds the amount of revenue recognized. Response The Company acknowledges the Staff’s comment. The Company will prospectively include discussion and analysis of cost of revenue similar to the below, which relates to the year ended December 31, 2021, to explain why the amount recognized for the AI segment significantly exceeds the amount of revenue recognized in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, and any other future filings with the Commission, to the extent applicable. “The cost of revenue through the sale of AI solutions consisted mainly of Salaries and wages expense in the amount of $0.4 million and amortization of intangible assets of $1.4 million. The amortization of the intangible assets of developed technology and image big data is the periodic amortization expense with regard to the acquisition of the shares of Nanox AI Ltd since the date of acquisition through the year end. As a result, the cost of revenue recognized for the AI Solutions segment significantly exceeds the amount of revenue recognized”. 2. We note that you attribute the increase in general and administrative expenses to (a) the merger with Zebra and the acquisitions of USARAD and MDWEB and (b) increased headcount due to the expansion of your management team and overall organization infrastructure. When multiple factors impact the change in your results of operations, quantify the extent to which each factor impacted the corresponding line items. Refer to Item 303(b)(2) of Regulation S-K for guidance. Response The Company acknowledges the Staff’s comment. The Company will prospectively include discussion and analysis of the increase in general and administrative expenses similar to the below, which relates to the year ended December 31,2021, to quantify the extent to which each factor impacted the corresponding line items pursuant to Item 303(b)(2) of Regulation S-K for guidance in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, and any other future filings with the Commission, to the extent applicable. “The increase in general and administrative expenses was primarily attributable to an increase of approximately $3.9 million due to the merger with Nanox AI, and the acquisitions of USARAD and the assets of MDWEB, and an increase in the amount of approximately $1.9 million due to an increase in our headcount in connection with the expansion of our management team as part of our overall organization infrastructure.” Ms. Tracey Houser and Mr. Terrence O’Brien Securities and Exchange Commission January 5, 2023 Page 3 E. Critical Accounting Estimates, page 90 3. The disclosures you have provided for each of your identified critical estimates appear to provide investors with a discussion as to how you are accounting for these items in accordance with US GAAP and are similar to your significant accounting policies disclosures rather than providing investors with an understanding as to what the critical estimates being made are and how the uncertainty associated with those estimates may impact your consolidated financial statements. Please revise the disclosures for each of your critical estimates made in preparing your consolidated financial statements to comply with the guidance in Section 501.14 of the Financial Reporting Codification. Ensure your disclosures sufficiently explain to investors what each critical estimate is; the uncertainties associated with the critical estimates; the methods and assumptions used to make the critical estimates, including an explanation as to how you arrived at the assumptions used; the events or transactions that could materially impact the assumptions made; and how reasonably likely changes to those assumptions could impact your consolidated financial statements. Provide investors with quantified information to the extent meaningful and available. Response The Company acknowledges the Staff’s comment. The Company will prospectively include discussion and analysis of its critical accounting estimates in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, similar to the below: “We have provided a summary of our significant accounting policies, estimates and judgments in Note 2 to our consolidated financial statements. The following critical accounting estimates discussion pertains to accounting policies management believes are most critical to the portrayal of our historical financial condition and results of operations and that require significant, difficult, subjective or complex judgments. The Company regularly reviews its accounting estimates and assumptions to determine whether any should be disclosed as critical accounting estimates or whether sensitivities should be updated for those critical accounting estimates already disclosed. The preparation of financial statements in accordance with GAAP requires management to make certain estimates and assumptions based on our historical experience and on various other assumptions which we believe to be reasonable under the circumstances. Because of the uncertainty inherent in these matters, actual results could differ materially from the estimates we use in applying these policies. Goodwill We determine the fair value of our reporting units using a discounted cash flow model, which utilizes key assumptions such as projected revenues, cost of revenues and operating expenses. These assumptions were determined by management utilizing our internal operating plan, growth rates for revenues and operating expenses and margin assumptions. An additional key assumption under this approach is the discount rate, based on the weighted average cost of capital, which is adjusted for current risk-free rates of capital, current market interest rates, and the evaluation of a risk premium relevant to the business segment. If our assumptions relative to revenue growth rates, cost of revenues and operating expenses were to change, our fair value calculation may change, which could result in impairment. If our assumptions relative to the discount rate and the evaluation of risk premium growth rates were to change, our fair value calculation may change, which could result in impairment. Management uses the income approach to determine the fair value of the reporting units because it considers the anticipated future financial performance of the reporting units. Accordingly, changes in the assumptions described above could have a material impact on our consolidated results of operations. Our goodwill is tested for impairment at least on an annual basis, on the last day of the fourth quarter of the fiscal year and whenever events or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, we record charges for impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value. Ms. Tracey Houser and Mr. Terrence O’Brien Securities and Exchange Commission January 5, 2023 Page 4 Income Tax Valuation allowances are provided unless it is more likely than not that the deferred tax asset will be realized. In the determination of the appropriate valuation allowances, we consider future reversals of existing taxable temporary differences and the most recent projections of future business results that may enhance the likelihood of realization of a deferred tax asset. Assessments for the realization of deferred tax assets made at a given balance sheet date are subject to change in the future, particularly if earnings of a subsidiary are significantly higher or lower than expected, or if we take operational or tax positions that could impact the future taxable earnings of a subsidiary. Accordingly, changes in the assumptions described above could have a material impact on our consolidated results of operations.” Goodwill, page 91 4. We note that $51.2 million of the $58.3 million in goodwill as of December 31, 2021 was generated from the acquisition of Zebra Medical Vision Ltd. on November 4, 2021. We further note that the related segment, AI Solutions, has recognized minimal revenues and generated gross and operating losses. As such, please ensure your disclosures address each of the following: · The percentage by which the estimated fair value of your reporting units exceed the carrying value. · The methodologies used to estimate the fair value of the reporting units, including the material judgments, assumptions and estimates. · A discussion of the degree of uncertainty associated with the key assumptions and the potential impact changes in the key assumptions would have on your impairment analysis. · A discussion of the potential events and/or changes in circumstances that could reasonably be expected to occur and negatively affect the key assumptions and result in a material impairment charge. Refer to Item 303(b)(3) of Regulation S-K and Section 501.14 of the Financial Reporting Codification for guidance. Response The Company acknowledges the Staff’s comment. As of December 31, 2021, the Company performed a qualitative analysis whereby it assessed qualitative factors to determine whether it was necessary to perform the two-step quantitative goodwill impairment test. The Company evaluated the significance of the events and circumstances of the factors that may trigger a quantitative impairment as detailed in ASC 350-20-35-3C. As of December 31, 2021, the Company evaluated that there was no notable change in qualitative factors due to the short period of time that had lapsed from the acquisition date through December 31, 2021. Therefore, the Company did not determine that it was more likely that not that the fair value of each reporting unit was less than its carrying amount. As such, the Company concluded that no further impairment testing was required as of December 31, 2021. The Company will prospectively include a discussion and analysis of the quantitative impairment testing disclosures, if any, and a discussion of the potential events and/or changes in circumstances that could reasonably be expected to occur and negatively affect the key assumptions and result in a material impairment charge in its financial statements to be included in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022 and going forward. Ms. Tracey Houser and Mr. Terrence O’Brien Securities and Exchange Commission January 5, 2023 Page 5 Item 15. Controls and Procedures, page 129 5. We note your auditor has included the following material weakness, “did not design and maintain effective internal controls over certain information technology (“IT”) general controls for applications used in the preparation of the Company’s consolidated financial statements.” However, your disclosure of the material weaknesses did not include this item. Please advise. In this regard, we note one of your remediation efforts is to implement a new ERP system. Response The Company acknowledges the Staff’s comment and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, when describing the Company’s material weaknesses, if any, the Company will make a specific reference to IT general controls, including a description of the remediation efforts carried out by the Company. Note 2 - Significant Accounting Policies h. Intangible Assets, net Goodwill, page F-11 6. Please expand your accounting policy to disclose the date you are testing goodwill for impairment and to clarify the level at which you are testing goodwill for impairment (i.e., at the operating segment level or at a component of your operating segments level). Refer to ASC 350-20-35-28 and ASC 350-20-35-33 through 35-38 for guidance. Response The Company acknowledges the Staff’s comment and will prospectively include disclosure relating to its accounting policy to disclose the date it is testing goodwill for impairment and to clarify the level at which it is testing goodwill for impairment in its financial statements to be included in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, as follows: “Our goodwill is assigned to the reporting units of the AI Solutions segment (which was recorded in the acquisition of Nanox AI) and the Radiology Services segment (which was recorded in the acquisition of USARAD) and tested for impairment at least on an annual basis, on the last day of the fourth quarter of the fiscal year and whenever events or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable" l. Revenue Recognition, page F-13 7. Please expand your accounting policy to specifically address the following: · The disclosure requirements in ASC 606-10-50-12 and 50-18 through 50-19. In this regard, it is unclear when your performance obligations for your radiology services are satisfied and whether revenue is recognized over time or at a point in time; what the significant payment terms are; and the nature of the services you have promised to provide, including whether you are acting as the principal or agent in the transactions. Ms. Tracey Houser and Mr. Terrence O’Brien Securities and Exchange Commission January 5, 2023 Page 6 · The disclosure requirements in ASC 606-10-50-17 and 50-20 regarding the transaction price and whether there is any variable consideration. Response The Company acknowledges the Staff’s comment and will prospectively include disclosure in its financial statements to be included in its Annual Report on Form 20-F for the fiscal year ended December 31, 2022, substantially as follows: “The teleradiology services have one performance obligation where the Company acts as principal to its customers (imaging centers, hospitals, and other healthcare providers). Revenue is recognized at a point in time when such perf
2022-12-06 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
December 6, 2022
Ran Daniel
Chief Financial Officer
Nano-X Imaging Ltd.
Communication Center
Neve Ilan , Israel 9085000
Re:Nano-X Imaging Ltd.
Form 20-F for Fiscal Year Ended December 31, 2021
Filed May 2, 2022
Form 6-K Filed March 31, 2022
File No. 001-39461
Dear Ran Daniel:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 20-F for Fiscal Year Ended December 31, 2021
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Results of Operations, page 82
1.Please expand your discussion and analysis of cost of revenue to explain why the amount
recognized for the AI segment significantly exceeds the amount of revenue recognized.
2.We note that you attribute the increase in general and administrative expenses to (a) the
merger with Zebra and the acquisitions of USARAD and MDWEB and (b) increased
headcount due to the expansion of your management team and overall organization
infrastructure. When multiple factors impact the change in your results of operations,
quantify the extent to which each factor impacted the corresponding line items. Refer to
Item 303(b)(2) of Regulation S-K for guidance.
FirstName LastNameRan Daniel
Comapany NameNano-X Imaging Ltd.
December 6, 2022 Page 2
FirstName LastNameRan Daniel
Nano-X Imaging Ltd.
December 6, 2022
Page 2
E. Critical Accounting Estimates, page 90
3.The disclosures you have provided for each of your identified critical estimates appear to
provide investors with a discussion as to how you are accounting for these items in
accordance with US GAAP and are similar to your significant accounting policies
disclosures rather than providing investors with an understanding as to what the critical
estimates being made are and how the uncertainty associated with those estimates may
impact your consolidated financial statements. Please revise the disclosures for each of
your critical estimates made in preparing your consolidated financial statements to comply
with the guidance in Section 501.14 of the Financial Reporting Codification. Ensure your
disclosures sufficiently explain to investors what each critical estimate is; the uncertainties
associated with the critical estimates; the methods and assumptions used to make the
critical estimates, including an explanation as to how you arrived at the assumptions used;
the events or transactions that could materially impact the assumptions made; and how
reasonably likely changes to those assumptions could impact your consolidated financial
statements. Provide investors with quantified information to the extent meaningful and
available.
Goodwill, page 91
4.We note that $51.2 million of the $58.3 million in goodwill as of December 31, 2021 was
generated from the acquisition of Zebra Medical Vision Ltd. on November 4, 2021. We
further note that the related segment, AI Solutions, has recognized minimal revenues and
generated gross and operating losses. As such, please ensure your disclosures address
each of the following:
•The percentage by which the estimated fair value of your reporting units exceed the
carrying value.
•The methodologies used to estimate the fair value of the reporting units, including the
material judgments, assumptions and estimates.
•A discussion of the degree of uncertainty associated with the key assumptions and the
potential impact changes in the key assumptions would have on your impairment
analysis.
•A discussion of the potential events and/or changes in circumstances that could
reasonably be expected to occur and negatively affect the key assumptions and result
in a material impairment charge.
Refer to Item303(b)(3) of Regulation S-K and Section 501.14 of the Financial Reporting
Codification for guidance.
Item 15. Controls and Procedures, page 129
5.We note your auditor has included the following material weakness, “did not design and
maintain effective internal controls over certain information technology (“IT”) general
controls for applications used in the preparation of the Company’s consolidated financial
statements.” However, your disclosure of the material weaknesses did not include this
FirstName LastNameRan Daniel
Comapany NameNano-X Imaging Ltd.
December 6, 2022 Page 3
FirstName LastNameRan Daniel
Nano-X Imaging Ltd.
December 6, 2022
Page 3
item. Please advise. In this regard, we note one of your remediation efforts is to
implement a new ERP system.
Note 2 - Significant Accounting Policies
h. Intangible Assets, net
Goodwill, page F-11
6.Please expand your accounting policy to disclose the date you are testing goodwill for
impairment and to clarify the level at which you are testing goodwill for impairment (i.e.,
at the operating segment level or at a component of your operating segments level). Refer
to ASC 350-20-35-28 and ASC 350-20-35-33 through 35-38 for guidance.
l. Revenue Recognition, page F-13
7.Please expand your accounting policy to specifically address the following:
•The disclosure requirements in ASC 606-10-50-12 and 50-18 through 50-19. In this
regard, it is unclear when your performance obligations for your radiology services
are satisfied and whether revenue is recognized over time or at a point in time; what
the significant payment terms are; and the nature of the services you have promised
to provide, including whether you are acting as the principal or agent in the
transactions.
•The disclosure requirements in ASC 606-10-50-17 and 50-20 regarding the
transaction price and whether there is any variable consideration.
8.Please provide the disclosures regarding by ASC 606-10-50 for the revenues recognized
related to your AI Solutions, which represented approximately 23% of total revenue
recognized.
q. Fair value measurement, page F-15
9.Please provide the disclosures required by ASC 820-10-50-2 for your contingent short
term and long term earnout liabilities as of December 31, 2021.
Note 3 - Business Combination and Other Transaction, page F-18
10.Please expand your disclosures for the acquisition of Zebra Medical Vision Ltd. to
provide a discussion of the methodologies and material estimates and assumptions used to
estimate the fair value of the Image Big Data intangible asset in addition to the Developed
Technology intangible asset. Also provide a discussion of the facts and circumstances
that lead you to conclude both intangible assets have a useful life of 10 years.
Note 4 - Goodwill & Intangible Assets, Net, page F-23
11.Please expand your disclosures to provide the information required for your goodwill
activity and balances at the segment level in accordance with ASC 350-20-50-1.
FirstName LastNameRan Daniel
Comapany NameNano-X Imaging Ltd.
December 6, 2022 Page 4
FirstName LastName
Ran Daniel
Nano-X Imaging Ltd.
December 6, 2022
Page 4
Note 11 - Commitments and Contingencies, page F-30
12.We note your disclosures for three legal proceedings in addition to the SEC investigation.
Please expand your disclosures to state the amount or range of reasonably possible loss in
the aggregate, or that you are unable to reasonably estimate the amount or range. Please
note that ASC 450-20-50-4 does not require the amount or range of reasonably possible
loss to be estimated with precision or certainty.
Note 14 - Segments of Operations, page F-40
13.Please expand your disclosure to include the amount of total assets by reportable segment
in accordance with ASC 280-10-50-22. In this regard, we note that you disclose the
amount of depreciation and amortization expense by reportable segment.
Form 6-K Filed March 31, 2022
Exhibit 99.1, page 1
14.We note your presentation of non-GAAP financial measures without and/or prior to the
presentation of the most comparable US GAAP financial measure. Specifically, refer to
your presentation of (a) non-GAAP gross profit on page 1; and (b) non-GAAP cost of
revenue on page 2; (c) non-GAAP gross margin on page 2; and (d) non-GAAP basic and
diluted loss per share on page 9. Please comply with Item 10(e)(1)(i)(a) of Regulation S-
K and Question 102.10 of the Non-GAAP Compliance and Disclosure Interpretations by
presenting and/or discussing the most directly comparable US GAAP financial measure
with equal or greater prominence.
15.Please provide a reconciliation of non-GAAP gross profit/(loss) and non-GAAP gross
margin from US GAAP gross loss and US GAAP gross margin in accordance with Item
10(e)(1)(i)(b) of Regulation S-K.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Tracey Houser at 202-551-3736 or Terence O'Brien at 202-551-3355, if
you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2021-02-08 - CORRESP - Nano-X Imaging Ltd.
CORRESP
1
filename1.htm
February 8, 2021
VIA EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn: Kasey Robinson
Re:
NANO-X IMAGING LTD
Registration Statement on Form F-1
File No. 333-252860
Ladies and Gentlemen:
NANO-X IMAGING LTD, a company organized under the laws of the State of Israel (the “Company”), hereby requests, pursuant to Rule 461(a) of the General Rules and Regulations under the Securities Act of 1933, as amended,
that the effective date of the Company’s registration statement (the “Registration Statement”) on Form F-1 (File No. 333-252860) be accelerated by the Securities and Exchange Commission (the “Commission”) to 4:30 p.m., Eastern Daylight Time, on
February 10, 2021, or as soon thereafter as practicable.
We request that we be notified of such effectiveness by a telephone call to Andrea L. Nicolas of Skadden, Arps, Slate, Meagher & Flom LLP, the Company’s counsel, at (212) 735-3416 and that such effectiveness also be
confirmed in writing.
Very truly yours,
NANO-X IMAGING LTD
By: /s/ Itzhak Maayan
Name: Itzhak Maayan
Title: Chief Financial Officer
cc:
Andrea L. Nicolas, Skadden, Arps, Slate, Meagher & Flom LLP
Wesley C. Holmes, Latham & Watkins LLP
2021-02-08 - CORRESP - Nano-X Imaging Ltd.
CORRESP
1
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February 8, 2021
VIA EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn:
Kasey Robinson
Re:
NANO-X IMAGING LTD
Acceleration Request for Registration Statement on Form F-1
File No. 333-252860
Dear Ms. Kasey Robinson:
In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Cantor Fitzgerald & Co., as representative of the several underwriters, hereby join NANO-X
IMAGING LTD in requesting that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to February 10, 2021, at 4:30 p.m., Eastern Time, or as soon
thereafter as practicable.
Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the
requested effective time of the Registration Statement.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
[Signature Page Follows]
Very truly yours,
As representative of the several underwriters
CANTOR FITZGERALD & CO.
By:
/s/ Sage Kelly
Name:
Sage Kelly
Title:
Global Head of Investment Banking
2021-01-21 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
January 21, 2021
Ran Poliakine
Chief Executive Officer
Nano-X Imaging Ltd.
Communications Center
Neve Ilan, Israel 9085000
Re:Nano-X Imaging Ltd.
Draft Registration Statement on Form F-1
Submitted January 19, 2021
CIK No. 0001795251
Dear Mr. Poliakine:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Kasey Robinson at 202-551-5880 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrea L. Nicolás
2020-08-18 - CORRESP - Nano-X Imaging Ltd.
CORRESP
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August 18, 2020
VIA EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn:
Jason Drory
Mary Beth Breslin
Re:
NANO-X IMAGING LTD
Acceleration Request for Registration Statement on Form F-1
File No. 333-240209
Dear Mr. Drory and Ms. Breslin:
In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Cantor Fitzgerald & Co., as representative of the several underwriters, hereby join NANO-X
IMAGING LTD in requesting that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to August 20, 2020, at 4:30 p.m., Eastern Time, or as soon
thereafter as practicable.
Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the
requested effective time of the Registration Statement.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
[Signature Page Follows]
Very truly yours,
As representative of the several underwriters
CANTOR FITZGERALD & CO.
By:
/s/ Bala Murty
Name:
Bala Murty
Title:
COO, Investment Banking
2020-08-18 - CORRESP - Nano-X Imaging Ltd.
CORRESP
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August 18, 2020
VIA EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn:
Jason Drory
Mary Beth Breslin
Re:
NANO-X IMAGING LTD
Registration Statement on Form F-1
File No. 333-240209
Ladies and Gentlemen:
NANO-X IMAGING LTD, a company organized under the laws of the State of Israel (the “Company”), hereby requests, pursuant to Rule 461(a) of
the General Rules and Regulations under the Securities Act of 1933, as amended, that the effective date of the Company’s registration statement (the “Registration
Statement”) on Form F-1 (File No. 333-240209) be accelerated by the Securities and Exchange Commission (the “Commission”) to 4:30 p.m., Eastern Daylight Time, on August 20, 2020, or as soon thereafter as practicable.
We request that we be notified of such effectiveness by a telephone call to Andrea L. Nicolas of Skadden, Arps, Slate, Meagher & Flom
LLP, the Company’s counsel, at (212) 735-3416 and that such effectiveness also be confirmed in writing.
Very truly yours,
NANO-X IMAGING LTD
By:
/s/ Itzhak Maayan
Name:
Itzhak Maayan
Title:
Chief Financial Officer
cc:
Andrea L. Nicolas, Skadden, Arps, Slate, Meagher & Flom LLP
Wesley C. Holmes, Latham & Watkins LLP
2020-08-12 - CORRESP - Nano-X Imaging Ltd.
CORRESP
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[Letterhead of Skadden, Arps, Slate, Meagher & Flom LLP]
August 12, 2020
BY E-MAIL AND BY EDGAR
Division of Corporate Finance
Office of Life Sciences
Securities and Exchange Commission
100 F St., N.E.
Washington, D.C. 20549
Attn:
Jason Drory
Mary Beth Breslin
Re:
NANO-X IMAGING LTD
Registration Statement on Form F-1
Submitted July 30, 2020
CIK No. 0001795251
Dear Mr. Drory and Ms. Breslin:
On behalf of NANO-X IMAGING LTD, a company organized under the laws of the State of Israel (the “Company”), we respond to the comments of the staff (the “Staff”) of the Division of Corporation Finance of the Commission
contained in the Staff’s letter dated August 11, 2020 (the “Comment Letter”) in connection with the above-referenced Registration Statement (the “Registration Statement”).
Set forth below are the Company’s responses to the comments in the Comment Letter. For the convenience of the Staff, the Company has restated in this letter each of the comments in the Comment Letter and numbered each of
the responses to correspond to the numbers of the comments. Capitalized terms used but not defined herein have the meanings given to them in the Registration Statement. All references to page numbers and captions (other than those in the Staff’s
comments) correspond to the page numbers and captions in the Registration Statement.
Mr. Jason Drory and Ms. Mary Beth Breslin
Securities and Exchange Commission
August 12, 2020
Page 2
Form F-1 filed July 31, 2020
Our Strategy, page 3
1.
We note your updated disclosure that you have now “entered into collaboration agreements with cloud-based enterprises.” Please describe the material terms of these agreements. In addition, please file the
collaboration agreements as exhibits or tell us why you believe these agreements are not required to be filed. See Item 601(b)(10) of Regulation S-K.
Response
In response to the Staff’s comment, the Company respectfully advises the Staff that the collaboration agreements are entered into with the Company’s AI partners, the material terms of which are already disclosed under “Business—Commercial
Agreements—Collaboration Agreements—Collaboration Agreements with our AI Partners.” The Company will revise its disclosure on pages 3 and 81 of the Registration Statement to clarify that these collaboration agreements are entered into with its AI
partners instead of cloud-based enterprises.
The Company respectfully advises the Staff that these collaboration agreements with AI partners were entered into in the ordinary course of business and the Company is not substantially dependent on any of these agreements. As part of its business
plan, the Company expects the Nanox.CLOUD to be able to perform a wide range of functionalities, including connecting to multiple third-party AI diagnostics software. As a result, the Company has been routinely seeking collaboration arrangements with
AI partners mainly to commercialize medical AI solutions in connection with medical imaging scans. The net amounts payable to the Company under these collaboration agreements are expected to be insignificant to the Company’s future profitability. In
addition, the collaboration agreements do not fall under Item 601(b)(10)(ii)(B) of Regulation S-K as in the case of any license or other agreement to use a patent, formula or trade secret upon which the Company’s business depends to a material
extent. The Company’s business is mainly dependent on its proprietary digital X-ray source and the related medical imaging system, and the Company does not expect to rely on any license to be granted by the AI partners for the operation of its core
business. Because none of the collaboration agreements qualify under the definition of “material contract” provided under Item 601(b)(10) of Regulation S-K, they are not required to be filed as exhibits to the Registration Statement.
Collaboration Agreement with SK Telecom, page 93
2.
Please disclose the material terms of your material agreements, such as the expiration term and termination provisions of your collaboration agreement with SK Telecom. Please file the agreement as an exhibit or
tell us why you believe such agreement is not required to be filed. See Item 601(b)(10) of Regulation S-K.
Mr. Jason Drory and Ms. Mary Beth Breslin
Securities and Exchange Commission
August 12, 2020
Page 3
Response
In response to the Staff’s comment, the Company will revise its disclosure on page 129 of the Registration Statement to provide additional discourse of the material terms of the collaboration agreement with SK Telecom (the “SKT Collaboration
Agreement”).
The Company respectfully advises the Staff that, while the Company believes that the collaboration with SKT is important to the business of the Company, the SKT Collaboration Agreement itself is of immaterial significance to the Company. The
parties only agree to further explore and engage in good faith to develop a definitive agreement for the deployment of Nanox Systems in South Korea and Vietnam, and the Company agrees to use commercially reasonable efforts to establish a wholly-owned
subsidiary in South Korea with the support of SK Telecom. As a result, at this stage the SKT Collaboration Agreement only represents the parties’ mutual interests in exploring potential commercial collaboration opportunities in the future, and
neither the Company nor SK Telecom has any binding obligations under the agreement with respect to the deployment of Nanox Systems or the establishment of the Korean subsidiary until a definitive agreement is entered into by the parties.
Because the SKT Collaboration Agreement is immaterial to the Company, it is not required to be filed as exhibit to the Registration Statement under Item 601(b)(10) of Regulation S-K.
General
3.
On page 5 and page 77 you state you have not elected to opt out of the extended transition period under Section 107(b) of the JOBS Act. However, your risk factor disclosure on page 45 states that you have elected
to opt out of this provision. Please correct these apparent inconsistencies. If you elect to opt out of these provisions, please indicate as such on the cover page.
Response
In response to the Staff’s comment, the Company will revise its disclosure on page 45 of the Registration Statement to correct the inconsistencies.
Mr. Jason Drory and Ms. Mary Beth Breslin
Securities and Exchange Commission
August 12, 2020
Page 4
Please direct any questions regarding the Company’s responses or the Registration Statement to me at (212) 735-3416 or andrea.nicolas@skadden.com.
Very truly yours,
/s/ Andrea L. Nicolas
Andrea L. Nicolas, Esq.
cc:
Li Xiao
Kate Tillan
Securities and Exchange Commission
2020-08-11 - UPLOAD - Nano-X Imaging Ltd.
United States securities and exchange commission logo
August 11, 2020
Ran Poliakine
Chief Executive Officer
Nano-X Imaging Ltd.
Communications Center
Neve Ilan, Israel 9085000
Re:Nano-X Imaging Ltd.
Registration Statement on Form F-1
Filed July 31, 2020
File No. 333-240209
Dear Mr. Poliakine:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form F-1 filed July 31, 2020
Our Strategy, page 3
1.We note your updated disclosure that you have now "entered into collaboration
agreements with cloud-based enterprises." Please describe the material terms of these
agreements. In addition, please file the collaboration agreements as exhibits or tell us why
you believe these agreements are not required to be filed. See Item 601(b)(10) of
Regulation S-K.
Collaboration Agreement with SK Telecom, page 93
2.Please disclose the material terms of your material agreements, such as the expiration term
and termination provisions of your collaboration agreement with SK Telecom. Please file
the agreement as an exhibit or tell us why you believe such agreement is not required to be
FirstName LastNameRan Poliakine
Comapany NameNano-X Imaging Ltd.
August 11, 2020 Page 2
FirstName LastName
Ran Poliakine
Nano-X Imaging Ltd.
August 11, 2020
Page 2
filed. See Item 601(b)(10) of Regulation S-K.
General
3.On page 5 and page 77 you state you have not elected to opt out of the extended transition
period under Section 107(b) of the JOBS Act. However, your risk factor disclosure on
page 45 states that you have elected to opt out of this provision. Please correct these
apparent inconsistencies. If you elect to opt out of these provisions, please indicate as such
on the cover page.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Kate Tillan at 202-551-3604 or Li Xiao at 202-551-4391 if you have
questions regarding comments on the financial statements and related matters. Please contact
Jason L. Drory at 202-551-8342 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrea Nicolas, Esq.
2020-02-28 - UPLOAD - Nano-X Imaging Ltd.
February 27, 2020
Ron Poliakine
Chief Executive Officer
Nano-X Imaging Ltd.
Communications Center
Neve Ilan, Israel 9085000
Re:Nano-X Imaging Ltd.
Amendment No. 3 to Draft Registration Statement on Form F-1
Submitted February 18, 2020
CIK No. 0001795251
Dear Mr. Poliakine:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amended Draft Registration Statement submitted February 18, 2020
Collaboration Agreement with Intertrading Australia Ltd., page 88
1.We note you have entered into a Medical Screening as a Service Agreement with
Intertrading Australia Ltd. Please file this agreement as an exhibit to your filing or tell us
why you do not believe it is required to be filed. Please refer to Item 601(b)(10) of
Regulation S-K. Similarly address the agreement you entered into with USARAD.
Consolidated Financial Statements
Note 1. General, page F-7
2.You disclose on page F-7 that in November 2019, Nanox PLC transferred to Nanox IL an
amount of $7.2 million under the APA. You also disclose on page F-8 that the
FirstName LastNameRon Poliakine
Comapany NameNano-X Imaging Ltd.
February 27, 2020 Page 2
FirstName LastName
Ron Poliakine
Nano-X Imaging Ltd.
February 27, 2020
Page 2
consideration in the transaction (the "Related Party Liability") was recorded at the
beginning of the earliest period presented against a decrease in shareholders' equity and a
corresponding non-cash investing and financing activity of $10,276 thousand in your
statements of cash flow. Please tell us the nature of the consideration for $7.2 million and
why the transaction is not retrospectively applied to your 2018 financial statements.
Revise the disclosure as necessary.
Note 10. Related Parties, page F-21
3.You disclose that during the years ended December 31, 2019 and 2018, the total expenses
to Six-Eye were $679 thousand and $1,434 thousand, respectively. You also disclose that
the $3,684 thousand of proceeds from investors in 2018 were used to prepay expenses to
Six-Eye. Since the account has a zero balance as of December 31, 2019, please tell us
what happened to the remaining prepayment of $1,571 thousand (i.e., $3,684 thousand
less $679 thousand and $1,434 thousand) and revise the disclosure as necessary.
You may contact Li Xiao at 202-551-4391 or Kate Tillan at 202-551-3604 if you have
questions regarding comments on the financial statements and related matters. Please contact
Paul Fischer at 202-551-3415 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrea Nicolas, Esq.
2020-01-28 - UPLOAD - Nano-X Imaging Ltd.
January 27, 2020
Ron Poliakine
Chief Executive Officer
Nano-X Imaging Ltd.
Communications Center
Neve Ilan, Israel 9085000
Re:Nano-X Imaging Ltd.
Draft Registration Statement on Form F-1/A
Filed January 14, 2020
CIK No. 0001795251
Dear Mr. Poliakine:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amended Draft Registration Statement filed January 14, 2020
Financial Statements
Note 6. Shareholders' Equity, page F-13
1.In response to comment 14, we note that since the $3,684,000 raised from third-party
investors was sent directly to Six-Eye to pay for services, you concluded that the
transactions should be presented as a non-cash financing activity in the statement of cash
flows. Since the two transactions, the offering and the rendering of services, represent a
financing activity and an operating activity, respectively, and the two separate transactions
were with different parties, please further explain to us why you believe that these two
transactions should not be shown gross in the statement of cash flows instead of net. Refer
to ASC 230-10-45-7, 45-14, and 45-17 and 230-10-50-4.
FirstName LastNameRon Poliakine
Comapany NameNano-X Imaging Ltd.
January 27, 2020 Page 2
FirstName LastName
Ron Poliakine
Nano-X Imaging Ltd.
January 27, 2020
Page 2
Note 8. Related Parties, page F-16
2.Please disclose, similar to your response to comment 14, that the $3,684,000 raised from
third-party investors was sent directly to Six-Eye to pay for services provided during the
year ended December 31, 2018 and for services to be provided during the year ended
December 31, 2019.
You may contact Li Xiao at 202-551-4391 or Kate Tillan at 202-551-3604 if you have
questions regarding comments on the financial statements and related matters. Please contact
Paul Fischer at 202-551-3415 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrea Nicolas, Esq.
2020-01-02 - UPLOAD - Nano-X Imaging Ltd.
December 31, 2019
Ron Poliakine
Chief Executive Officer
Nano-X Imaging Ltd.
Communications Center
Neve Ilan, Israel 9085000
Re:Nano-X Imaging Ltd.
Draft Registration Statement on Form F-1
Submitted December 4, 2019
CIK No. 0001795251
Dear Mr. Poliakine:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1
Overview, page 1
1.Please revise paragraph four to briefly discuss the basis for the statement that you will be
able to market and deploy the Nanox System broadly across the globe "at a substantially
lower cost compared to currently available medical imaging systems, such as computed
tomography."
2.Please revise the second to the last sentence in paragraph five to indicate the basis for your
belief that neither your X-ray source nor the Nanox.Cloud will require regulatory approval
or clearance as individual products marketed independently from the Nanox.Arc. Please
also revise to address the apparent discrepancy between this statement and your statement
FirstName LastNameRon Poliakine
Comapany NameNano-X Imaging Ltd.
December 31, 2019 Page 2
FirstName LastNameRon Poliakine
Nano-X Imaging Ltd.
December 31, 2019
Page 2
in the first sentence that you expect to submit a 510(k) application with respect to the
Nanox.Arc and Nanox.Cloud for medical device clearance with the FDA at a future date.
3.Please also revise paragraph five to clarify, as you do at page 74, that to date you have not
obtained FDA feedback regarding the regulatory pathway you expect to pursue.
4.Please revise to make clear the basis for describing your system as potentially "first-of-its-
kind" when you also state that you expect to make no new claims as to the operation,
image quality or functionality of the Nanox.Arc compared to a predicate device and you
have not yet produced a prototype of the Nanox.Arc nor a beta version of the
Nanox.Cloud software.
Certain of our directors and/or officers may have interests that compete with ours., page 23
5.Please revise, as appropriate, to discuss any mechanism in place to resolve conflicts of
interest among the parties you have identified.
Use of Proceeds, page 53
6.Please revise paragraph two to indicate how much of the proceeds you intend to allocate
to each use you have identified. Also, please clarify whether you anticipate having
sufficient funds associated with obtaining regulatory clearance. If not, please indicate the
source of any additional funds needed to do so.
7.We note disclosure at page 110 under "Asset Purchase by the Company from Nanox
Gibraltar" that the consideration for assets transferred to the company will occur, among
other events, upon "the closing of the first underwritten public offering of the Company
pursuant to a registration statement under the Securities Act or the Israeli Securities Law."
To the extent that proceeds from the offering will be used as consideration for the assets
transferred, please revise to so indicate, including the amount to be allocated.
Business, page 68
8.Please describe the material terms of your collaboration agreement with Hadasit Medical
Research Services and Development Ltd., referenced in Note 10 on page F-18, including a
description of each party's rights and obligations, a quantification of any payment
obligations including milestones and range of royalty payments, the contract term and any
termination provisions. Please also file the agreement as an exhibit or provide us with an
analysis supporting a determination that you are not required to file it as an exhibit.
Intellectual Property, page 77
9.Please revise to identify the other jurisdictions where you have nine patents issued.
10.We note your reference to existing license agreements in sentence one of the first full risk
factor on page 28, but see no further discussion of these agreements, nor are they listed in
your exhibit index. Please revise or advise. Please also expand to describe the terms of the
FirstName LastNameRon Poliakine
Comapany NameNano-X Imaging Ltd.
December 31, 2019 Page 3
FirstName LastName
Ron Poliakine
Nano-X Imaging Ltd.
December 31, 2019
Page 3
right of first negotiation agreement with Fujifilm as noted on page 29 and file it as an
exhibit, or provide an analysis as to why you are not required to file it.
Note 1. General, page F-8
11.We note that the asset purchase agreement excluded the shares of Nanox Japan, Inc., a
wholly owned subsidiary of Nanox PLC (page 110) and you adjusted the financial
statements to reflect only the net assets that were transferred in the transaction. Since the
financial statements appear to include Nanox Japan, please explain to us the interests in
Nanox Japan that were transferred under the asset purchase agreement and are reflected in
the financial statements.
Note 2. Significant Accounting Policies, Functional Currency, page F-9
12.Please reconcile the disclosure on page 22 that a significant portion of your operating
expenses, including personnel and facilities related expenses, are incurred in NIS and Yen,
with your disclosure on page F-9 that a substantial portion of your operational costs are
denominated in U.S. dollars. Tell us how you considered ASC 830-10-45 in determining
that your functional currency is the U.S. dollar.
Note 4. Related Party Liability, page F-13
13.Please show us how you calculated the amount of the related party liability of $8,157,000.
Note 6. Shareholders' Equity, page F-13
14.Please tell us why you reflect the sale of 1,666,774 ordinary shares during the year ended
December 31, 2018, for an aggregate amount of $3,684,000, as a non-cash
financing activity in the statement of cash flows on page F-7.
15.We note that your pro forma presentations on pages 6, 8, 55, and 56 assume the issuance
of ordinary shares that will be issued upon the exercise of warrants held by certain of your
shareholders immediately prior to the closing of the offering. Please tell us where you
discuss these warrants in the financial statements and why you believe the warrants will
be exercised prior to the closing.
Note 8. Related Parties, page F-16
16.In Note 8(d), you disclose that the related party receivable of $1,694,000 includes funds
you received from Six-Eye from the sale of ordinary shares in 2018 less amounts payable
under your consulting agreement. Please tell us why you reflect the amounts net and
where you include the consulting services in the statements of operations. Ensure that you
include all of the disclosures required by ASC 850-10-50-1 in the financial statements.
FirstName LastNameRon Poliakine
Comapany NameNano-X Imaging Ltd.
December 31, 2019 Page 4
FirstName LastName
Ron Poliakine
Nano-X Imaging Ltd.
December 31, 2019
Page 4
General
17.Supplementally provide us with copies of all written communications, as defined in Rule
405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Li Xiao at 202-551-4391 or Kate Tillan at 202-551-3604 if you have
questions regarding comments on the financial statements and related matters. Please contact
Paul Fischer at 202-551-3415 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrea Nicolas