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February 21, 2019
Erica J. Rogers
Chief Executive Officer
Silk Road Medical Inc
1213 Innsbruck Dr.
Sunnyvale, CA 94089
Re: Silk Road Medical Inc
Draft Registration Statement on Form S-1
Submitted December 19, 2018
CIK No. 0001397702
Dear Ms. Rogers:
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 S-1 submitted December 19, 2018
General
1. 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 communication.
2. We note that your existing officers, directors, and principal
stockholders currently own a
significant portion of your ordinary shares. Please clarify whether the
company will be a
"controlled company" under the definition of the applicable stock
exchange after the
offering and provide appropriate disclosure on the prospectus cover
page, prospectus
summary, and risk factors to the extent appropriate.
Erica J. Rogers
FirstNameMedical Inc
Silk Road LastNameErica J. Rogers
Comapany NameSilk Road Medical Inc
February 21, 2019
February 21, 2019 Page 2
Page 2
FirstName LastName
3. We note that you have submitted an application for confidential
treatment relating to
exhibits 10.6 through 10.9 that is currently pending. Please be
advised that we will not be
in a position to accelerate the effectiveness of your registration
statement until we have
completed processing your confidential treatment request.
Coverpage
4. On the back coverpage of the prospectus, please include the legend
pertaining to the
"Dealer prospectus delivery obligation", as required by Item 502 of
Regulation S-K.
Risk Factors
We have limited long-term data regarding the safety and effectiveness of our
products..., page 15
5. We note your disclosure that your "products enable TCAR... [to be]
safe and effective."
Because approval by the FDA and other comparable regulatory agencies
is dependent on
their making a determination according to criteria specified in agency
regulations that a
product is both safe and effective, please clarify the basis for this
statement.
Our amended and restated certificate of incorporation..., page 53
6. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any "derivative
action." Please disclose whether this provision applies solely to
state law claims. If it
does not apply solely to state law claims, then please note that
Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to
enforce any duty or
liability created by the Exchange Act or the rules and regulations
thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all
suits brought to enforce any duty or liability created by the
Securities Act or the rules and
regulations thereunder. If this provision applies to claims arising
under the Securities Act,
please disclosure that there is uncertainty as to whether a court
would enforce such
provision and to state that shareholders will not be deemed to have
waived the company's
compliance with the federal securities laws and the rules and
regulations thereunder. If
this provision is intended to apply solely to state law claims, please
also ensure that the
exclusive forum provision in the governing documents states this
clearly.
Intellectual Property, page 109
7. In accordance with Item 101(h)(4) of Regulation S-K, please identify
material patents and
the specific products, product groups and technologies to which such
patents relate. In
addition, please disclose the duration and jurisdiction for each
material patent.
Principal and Selling Stockholders, page 148
8. Please revise the table to include a column showing the amounts of
shares to be offered on
behalf of each selling stockholder pursuant to Item 507 of Regulation
S-K.
Erica J. Rogers
Silk Road Medical Inc
February 21, 2019
Page 3
Requirements for Advance Notification of Stockholder Nominations and Proposals,
page 153
9. We note your disclosure relating to provisions in your bylaws that will
specify certain
requirements regarding the form and content of a stockholder's notice.
Please elaborate on
all material requirements that a stockholder's notice must contain.
Item 15. Recent Sales of Unregistered Securities, page II-2
10. We note your recent sales of unregistered securities. Please name the
persons or identify
the class of persons to whom the securities were sold for every
transaction. Please see
Item 701 of Regulation S-K.
You may contact Gary Newberry, Staff Accountant, at (202) 551-3761 or
Kevin Kuhar,
Accounting Branch Chief, at (202) 551-3662 if you have questions regarding
comments on the
financial statements and related matters. Please contact Sergio Chinos, Staff
Attorney, at (202)
551-7844 or Kate McHale, Staff Attorney, at (202) 551-3464 with any other
questions.
Sincerely,
FirstName LastNameErica J. Rogers
Division of
Corporation Finance
Comapany NameSilk Road Medical Inc
Office of
Electronics and Machinery
February 21, 2019 Page 3
cc: Philip H. Oettinger
FirstName LastName