United States securities and exchange commission logo
January 25, 2022
Ori Gilboa
Chief Executive Officer
SaverOne 2014 Ltd.
Em Hamoshavot Rd. 94
Petah Tikvah, Israel
Re: SaverOne 2014 Ltd.
Draft Registration
Statement on Form F-1
Submitted December
28, 2021
CIK No. 0001894693
Dear Mr. Gilboa:
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
Prospectus Summary, page 1
1. Revise to clearly
explain the stage of development for each of your products and
solutions. With respect
to any products or solutions that are currently complete, disclose
the sales and marketing
efforts you have undertaken to date.
2. Please clarify when you
believe that you will first commercially offer your products and
specify the geographic
markets where you intend to concentrate your efforts. We note
your assertion that
certain SaverOne products are compliant with the National Highway
Traffic Safety
Administration (NHTSA) guidelines for solutions for distracted driving,
and such compliance
would give you an advance over competing solutions. The NHTSA
is a United States
federal agency, but we note that the vast majority of your pilot program
Ori Gilboa
SaverOne 2014 Ltd.
January 25, 2022
Page 2
partners and participants are located in Israel. Where appropriate,
describe your
operations or efforts to establish your products in the United States.
3. Please clarify that the NHTSA distracted driving guidelines and
studies do not constitute
U.S. law and compliance with their recommended features does not
necessarily result in
your solutions satisfying legal requirements or approval for
authorized use in the United
States. Please clarify whether you are required to obtain any licenses
or approvals in the
United States or other markets for which you intend to enter or test
your products.
Selected financial data, page 35
4. We note that for convenience to the reader, you applied a translation
rate of one US Dollar
per NIS 3.215 as of and for the year ended December 31, 2020 and of
one US Dollar per
NIS 3.26 as of and for the three months ended June 30, 2021. Please
revise to apply the
exchange rate as of the most recent balance sheet date included in the
filing to both
periods. Refer to Rule 3-20(b)(1) of Regulation S-X. Be advised that
the translation
should be made at the exchange rate on the balance sheet date or most
recent date
practicable, if materially different.
Results of Operations, page 38
5. We note your assertion that your results of operations have varied in
the past and can be
expected to vary in the future due to "numerous factors," and that you
believe that period-
to-period comparisons of operating results are "not necessarily
meaningful." Revise to
remove the implication that your disclosure of period-to-period
comparisons may not be
meaningful. Additionally, revise the discussion and analysis to
disclose all factors
affecting operating results for each period, including any trends or
changes necessary for
an understanding of the company s business as a whole.
Our Products, page 48
6. You indicate that your product does not require the cooperation of the
driver, will disable
various functions of their mobile phone, and will automatically send
text messages to any
callers while the driver is driving. Please clarify whether the driver
or their employer
must consent or register specific phones prior to your system being
able to access the
phone s functions. If not, please clarify the regulatory hurdles of
accessing a person s
mobile phone without their consent under privacy, telecommunication or
other laws.
7. Please clarify whether your system s ability to disable the functions
of a mobile phone
would be compliant with the Federal Communications Commission s
anti-jamming laws.
Further, clarify whether there is a risk that the system would disable
phones of the driver
and/or
FirstName the passengers
LastNameOri in times of emergencies.
Gilboa
Comapany
8. NameSaverOne
Please 2014needed
estimate the funds Ltd. to bring each of your SaverOne
Generations to market
Januaryunder the timetable
25, 2022 Page 2 described on page 49.
FirstName LastName
Ori Gilboa
FirstName LastNameOri Gilboa
SaverOne 2014 Ltd.
Comapany
January 25,NameSaverOne
2022 2014 Ltd.
January
Page 3 25, 2022 Page 3
FirstName LastName
Sales and Marketing, page 50
9. We note that you generate a modest amount of revenue through your
pilot programs and
that you have installed 550 SaverOne systems. Please describe the
economic terms
underlying your pilot program agreements. It is unclear whether your
pilot program
partners are receiving these systems for free, at cost, for
significantly discounted rates, or
at a price similar to market pricing. It is also unclear if you will
bear most of the
operating costs associated with the pilot program or if the costs will
be shared with the
participants. Further, clarify if the 1,500 orders constitute market
orders reflecting a fully
commercialized system or if the orders are part of the pilot program.
10. After your SaverOne systems are offered for commercial sale, please
clarify how you will
generate revenue from these systems. It is not clear if they will
involve a per-unit fee, a
usage fee, and/or subscription arrangements. We note references to
revenue sharing
programs in your financial statement footnotes. Please clarify how
these revenue sharing
arrangements would operate.
Intellectual Property, page 53
11. Please identify the Israeli patents that are subject to a patent
dispute by a third-party.
Further, please clarify the nature of the dispute and whether the
third-party objector offers
or is developing a competing product to the ones you are developing.
Manufacturing, page 53
12. Please describe the terms of your contract manufacturing agreement
with Flex Ltd. and
advise us whether it is a material agreement for which you are
substantially dependent.
Further, clarify whether these agreements would extend beyond the
pilot program phase of
SaverOne Generation 1.0.
Management , page 60
13. On page F-33, you refer to your CEO, Ori Gilboa, as being an
outsourced CEO pursuant
to a consulting agreement, yet working for a full-time equivalent.
Please clarify whether
Mr. Gilboa is still working under such an outsourced arrangement and
how this
arrangement differs from having him as an employee. To the extent that
Mr. Gilboa has
outside business interests that take up a material amount of his time,
please clarify.
Executive Compensation, page 63
14. Please advise us whether any of your executive employment or
consulting agreements are
material agreements pursuant to Item 601(b)(10) of Regulation S-K.
Principal Shareholders, page 69
15. Please disclose the natural person(s) that hold voting and/or
investment power of the
ordinary shares held by your principal shareholders that are entities.
Ori Gilboa
SaverOne 2014 Ltd.
January 25, 2022
Page 4
Report of Independent Registered Public Accounting Firm, page F-3
16. To the extent the financials were prepared in accordance with IFRS, it
should be clear
whether you prepared, and the auditors opined, on financials issued in
accordance with
IFRS as issued by the IASB. The auditors' report should explicitly state
that the financial
statements are in conformity with International Financial Reporting
Standards "as issued
by the IASB." Refer to Item 17(c) of Form 20-F.
Notes to the Financial Statements
Note 21 - Subsequent events, page F-48
17. Please revise your filing to disclose the date when the financial
statements were
authorized for issue and who gave that authorization. Refer to paragraph
17 of IAS 10.
General
18. Page 21 discloses that you have elected to delay the adoption of new or
revised accounting
standards as a result of your emerging growth company status. However,
page 42
discloses that you currently report and expect to continue to report your
financial results
under IFRS as issued by the IASB, so you will not be able to avail
yourselves of this
extended transition period. Please revise your disclosure on page 21 for
consistency.
You may contact Amanda Kim, Senior Staff Accountant, at (202) 551-3241
or Stephen
Krikorian, Accounting Branch Chief, at (202) 551-3488 if you have questions
regarding
comments on the financial statements and related matters. Please contact Edwin
Kim, Staff
Attorney, at (202) 551-3297 or Joshua Shainess, Legal Branch Chief, at (202)
551-7951 with any
other questions.
Sincerely,
FirstName LastNameOri Gilboa
Division of
Corporation Finance
Comapany NameSaverOne 2014 Ltd.
Office of
Technology
January 25, 2022 Page 4
cc: David Huberman, Esq.
FirstName LastName