SEC Comment Letter for InMode Ltd. (INMD) (CIK 0001742692) (INMD) — Oct 25, 2018
InMode Ltd. (INMD) (CIK 0001742692)
Date: Oct. 25, 2018 · CIK: 0001742692 · Accession: 0000000000-18-033513
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October 25, 2018
Moshe Mizrahy
Chief Executive Officer
InMode Ltd.
Tavor Building, Sha’ar Yokneam
P.O. Box 533
Yokneam 2069200, Israel
Re:InMode Ltd.
Amendment No. 2 to
Draft Registration Statement on Form F-1
Submitted October 11, 2018
CIK No. 0001742692
Dear Mr. Mizrahy:
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.
Draft Form F-1 submitted October 11, 2018
Risk Factors, page 13
1.Please expand your response to prior comment 4 to provide us your analysis of the value
of your investment securities as a percentage of total assets (exclusive of Government
securities and cash items) on an unconsolidated basis as of the date of the latest balance
sheet that you have included in your registration statement. If you may be deemed an
investment company under section 3(a)(1)(C) of the Investment Company Act as of that
FirstName LastNameMoshe Mizrahy
Comapany NameInMode Ltd.
October 25, 2018 Page 2
FirstName LastNameMoshe Mizrahy
InMode Ltd.
October 25, 2018
Page 2
date, please add risk factor disclosure concerning the potential investment company
status. In the disclosure, include a description of why you may qualify as an investment
company and the consequences if you are deemed to be an investment company. If
appropriate, you may also include disclosure reflecting the substance of the last sentence
of your response to prior comment 4.
The use, misuse or off-label use of our products..., page 31
2.In an appropriate section of your prospectus, please address that part of prior comment 9
seeking clarification of the conditions and procedures for which you have received the
required regulatory clearances to market your products. Also, please expand your
response to tell us which "certain women's health conditions and procedures" were
addressed in the letter from the FDA and the nature of the "certain statements" that you
have modified.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
51
3.Please expand your response to prior comment 1 to tell us whether the products you
disclose have contributed equally to your business in each period presented, excluding the
disclosed effect of new products. It is unclear whether any disclosed product has
contributed disproportionately to your business or whether a product's significance to your
business has changed during the periods presented. In this regard, your revised disclosure
on page 85 appears to indicate that you have determined that amount of your business
involving the Fractora handpiece; please tell us the portion of your business derived from
that product.
Components of Our Results of Operations, page 52
4.Please expand your response to prior comment 14 to tell us the percentage of your
revenue derived from the United States in your fiscal year ended December 31, 2016.
5.Please expand your response to prior comment 15 to tell us the extent of your revenue
from consumables in 2016. Also please note that disclosure might be required before the
period mentioned in the last sentence of your response to prior comment 15.
Our Solution, page 71
6.We note your response to prior comment 18. Please balance your disclosure that you
believe the results are significant with the information in response 24 to your letter to us
dated September 7, 2018 indicating that the data does not provide you sufficient
quantitative data to determine statistical significance.
FirstName LastNameMoshe Mizrahy
Comapany NameInMode Ltd.
October 25, 2018 Page 3
FirstName LastName
Moshe Mizrahy
InMode Ltd.
October 25, 2018
Page 3
Joint Venture Equity Interest Conversion and Notice Rights, page 112
7.We note your response to prior comment 24. Please revise to disclose the redemption
feature and the specific terms that make the non-controlling interests redeemable, and
clarify who holds the option to redeem the interest.
Exhibits
8.Exhibit 10.12 appears to contemplate that the agreement will be followed be definitive
documents. Please file the definitive documents. Also please (1) file the attachment
missing from exhibit 10.12, and (2) tell us which exhibit represents the September 9, 2016
agreement mentioned in exhibit 10.14 and which section of which agreement addresses
the termination that you mention in response to prior comment 11.
You may contact Jeanne Bennett at 202-551-3606 or Brian Cascio, Accounting Branch
Chief, at 202-551-3676 if you have questions regarding comments on the financial statements
and related matters. Please contact Heather Percival at 202-551-3498 or Russell Mancuso,
Branch Chief, at 202-551-3617 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Brian D. Hirshberg