SEC Comment Letter for InMode Ltd. (INMD) (CIK 0001742692) (INMD) — Aug 21, 2018
InMode Ltd. (INMD) (CIK 0001742692)
Date: Aug. 21, 2018 · CIK: 0001742692 · Accession: 0000000000-18-025983
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August 21, 2018
Moshe Mizrahy
Chief Executive Officer
InMode Ltd.
Tavor Building, Sha’ar Yokneam
P.O. Box 533
Yokneam 2069200, Israel
Re:InMode Ltd.
Draft Registration Statement on Form F-1
Submitted July 25, 2018
CIK No. 0001742692
Dear Mr. Mizrahy:
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 Form F-1 submitted July 25, 2018
Strong brand recognition, page 4
1.Please reconcile your disclosure that your technology is not laser based with your
disclosure regarding laser applications like on pages 2 and 18. In this regard, tell us the
portion of your revenue from minimally-invasive products and the portion from non-
invasive products, and tell us about any trends you are experiencing regarding the
contribution to revenue of the products and handpieces that you mention on pages 72-74.
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Comapany NameInMode Ltd.
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InMode Ltd.
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Leverage our existing technology, page 5
2.We note your disclosure regarding three new product platforms. Please tell us the status
of development of the platforms, and the status of any required regulatory clearances.
Also provide us your analysis of how investors will be able to evaluate the significance of
the new product platforms from your existing disclosure.
Maintain a strong intellectual property and patent portfolio, page 5
3.Balance your disclosure here to highlight the "few" barriers to entry mentioned on page
80. Also highlight the patent litigation mentioned on page 79 in your "Risks Associated
with our Business" disclosure beginning on page 5.
Implications of Being an Emerging Growth Company, page 6
4.Reconcile your disclosure here that you have irrevocably elected to opt out of the
extended transition period under Section 107 of the JOBS Act with your disclosure on
page 60 that you have elected to utilize the exemption.
5.Please 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.
Risk Factors, page 12
6.Your disclosure on page 4 under the caption "Our Growth Strategy" suggests that you
might be marketing your products in countries other than those identified in your
disclosure on page 4 regarding where you are "permitted to sell [y]our products." If you
are marketing your product in jurisdictions in which you do not have required clearances,
please clearly disclose the related risks. In this regard, we also note your disclosure on
page 86 that you seek to obtain regulatory approvals related to use of radio frequency
energy; please tell us whether you have obtained all required approvals.
7.Please provide us your analysis of any risks created by the nature and amount of
marketable securities that you hold.
Product liability suits could be brought, page 19
8.If you currently do not have insurance or do not have insurance that you believe is
sufficient, please revise to clarify.
We are or may become subject to numerous foreign, federal, and state healthcare statutes and
regulations, page 22
9.We note your disclosure that you may be subject to transparency laws. Please clarify
whether you are subject to those laws. Also, please clarify why it is possible that
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Comapany NameInMode Ltd.
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authorities may conclude that your business practices do not comply with current laws as
you mention in the second paragraph of this risk factor.
If we are unable to protect our intellectual property rights, page 23
10.Revise your disclosure in the second paragraph of this risk factor to discuss the extent of
your business in jurisdictions in which you have not applied or obtained patent protection
so that an investor will understand the magnitude of the risk.
11.Please address existing patent litigation in a separately captioned risk factor. Disclose the
extent of your business that is derived from the intellectual property in dispute. Also,
provide us your analysis of whether the litigation amounts to an uncertainty that is
required to be addressed pursuant to Item 5.D of Form 20-F.
We may be subject to claims, page 27
12.Please expand your risk factor disclosure to highlight the related litigation you disclose on
page 88 and any material effects of the settlements.
We may be unable to obtain or maintain, page 32
13.Please clarify the date by which you must register your products with Israeli health
authorities. In an appropriate section of your prospectus, address the registration process.
As a "foreign private issuer," we are permitted, page 37
14.Please highlight how home country law differs from the requirements mentioned in this
risk factor. Also, highlight in the risk factor the quorum and director nomination issues
mentioned on page 91.
The tax benefits available, page 39
15.Please specify the material conditions to maintain the tax benefit that is the subject of this
risk factor.
Provisions of our amended and restated articles of association, page 40
16.Please clarify which material agreements require receipt of consents for change of control
transactions.
Market, Industry and Other Data, page 42
17.Please tell us whether you commissioned any data disclosed in your prospectus.
Components of Our Results of Operations, page 51
18.Please clarify the extent of your revenue from the United States.
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Comapany NameInMode Ltd.
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InMode Ltd.
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19.Please tell us the extent of revenue from consumables in each period presented. Also tell
us the percentage of revenue derived from service contracts and warranties in each period
presented.
Revenue, page 53
20.Revise to disclose the extent to which the changes in your revenues are attributable to
changes in prices. Separately discuss the extent to which changes in revenues are related
to new products. Also, please tell us the extent of your business derived from the long-
term financing that you mention on page 57 in each period presented.
Business, page 61
21.Please tell us the extent that clinical results differ from the "before-and-after" pictures that
you include in your prospectus, and whether those pictures represent typical results. Also,
where you refer to clinical studies like on page 2, please distinguish between completed
studies and studies that are not completed; tell us the extent of your involvement with the
studies.
Aesthetic Solutions Market Opportunity, page 62
22.Where you discuss global markets like here and on page 2, clarify the portion of such
markets that represent your market opportunity.
Our Solution, page 66
23.Revise to clarify how your products overcome the limitations and risks mentioned in the
previous section, and clarify which limitations and risks remain. For example, do your
products overcome the issue regarding multiple steps? In this regard, please tell us the
cost of your products relative to competitive non-invasive and minimally-invasive
products, and whether competitive non-invasive and minimally-invasive products provide
any of the benefits that you mention in this section.
24.We note your disclosure that many of your solutions are supported by clinical data.
Please clarify which solutions are supported by clinical data. Also, tell us whether the
clinical results that you cite in your prospectus are statistically significant, and
whether studies or users of your products have revealed any material negative results or
limitations of your products.
Intellectual Property, page 78
25.Revise to clarify the extent to which you are dependent on your issued patents. From the
fourth sentence of the second paragraph in this section, it is unclear the extent to which the
issued patents address the technology you describe. Separately address the extent of your
dependence on other intellectual property. See Item 4.B.6 of Form 20-F.
FirstName LastNameMoshe Mizrahy
Comapany NameInMode Ltd.
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FirstName LastNameMoshe Mizrahy
InMode Ltd.
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Page 5
Disclosure of Compensation of Executive Officers and Directors, page 97
26.We note your disclosure that you are required to disclose the annual compensation of your
five most highly compensated office holders on an individual basis. Please provide the
disclosure required by Item 6.B.1 of Form 20-F.
Relationship with Home Skinovations Ltd., page 106
27.Please tell us the nature of the aesthetic applications addressed by Home Skinovations
devices. Also tell us the nature of the software that you license from Home Skinovations,
and tell us about any roles that the individuals named in the first paragraph of this section
have with Home Skionovations.
Joint Venture Equity Interest Conversion Rights, page 106
28.Disclose the amount paid for the joint venture interests that may be converted into shares.
29.We note your disclosure on page 8 that you have excluded the shares issuable upon
conversion of the non-controlling equity interests, and your disclosure on page 33 that the
right to convert ends following this offering. Please tell us the basis for excluding the
shares and when you will know whether conversion will occur relative to the effective
date of this registration statement. Also, given your disclosure on page F-8 that the non-
controlling equity interests are redeemable, please disclose the redemption terms,
including who holds the option to redeem the interests. File the U.K. joint venture
agreement as an exhibit to your registration statement or advise.
Principal Shareholders, page 108
30.Please revise to disclose the natural person or persons who beneficially own the securities
held by the entities named in the table.
Transfer of Shares and Notices, page 112
31.Please tell us the nature of the exemptions and reliefs that you mention in this paragraph.
Taxation, page 118
32.We note your disclosure regarding stamp taxes and other charges on page 132. Please
provide information regarding the extent to which shareholders in the United States may
be subject to these taxes and charges. Also address the amount of the taxes and charges.
Other Relationships, page 132
33.We note your disclosure in the first paragraph of this section. Describe the nature and
terms of any material relationship between the company and any underwriter. See Item
9.B.10 of Form 20-F.
FirstName LastNameMoshe Mizrahy
Comapany NameInMode Ltd.
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FirstName LastName
Moshe Mizrahy
InMode Ltd.
August 21, 2018
Page 6
Exhibit Index, page II-5
34.Please file Dr. Kreindel's consent as required by Rule 438.
35.Please tell us why the subsidiary mentioned in the first sentence on page 90 is not
mentioned in exhibit 21.
36.Please file the attachments missing from exhibits 10.9 and 10.10. In this regard, it is
unclear why several attachments are missing from exhibit 10.11; please advise.
37.Given your disclosure on page 18 regarding risks related to four manufacturing
subcontractors and to sole-source suppliers, please tell us how you determined which
manufacturing and supply agreements to file as exhibits to your registration statement.
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