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United States securities and exchange commission logo
March 11, 2021
John T. Treace
Chief Executive Officer
Treace Medical Concepts, Inc.
203 Fort Wade Road, Suite 150
Ponte Vedra, Flordia 32081
Re: Treace Medical
Concepts, Inc.
Draft Registration
Statement on Form S-1
Submitted February
12, 2021
CIK No. 0001630627
Dear Mr. Treace:
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
Summary, page 1
1. Please disclose the
measure by which you determined you are the leading position in
your market. If your
statements are based on management s belief, please revise to
clarify.
2. On page 8, you address
other products you have commercialized to address ancillary
surgical procedures
performed routinely within a Lapiplasty surgical case. Please revise
the disclosure to
briefly describe these products and to briefly explain Akin osteotomies,
Weil osteotomies, and
intercuneiform stabilization. Generally in your disclosure define
any technical or
medical terms at their first use. We note the disclosure on page 95.
John T. Treace
Treace Medical Concepts, Inc.
March 11, 2021
Page 2
The terms of our credit agreements require us to meet certain operating and
financial
covenants..., page 16
3. Please specify the assets that are pledged as collateral under your
credit agreements and
discuss any material risks that you may face as a result thereof.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
65
4. Revise to quantify the salary reductions and other factors you
implemented in 2020 as a
result of COVID-19, disclosed on page 68, and clarify to what extent
the measures are
ongoing.
Our Market, page 87
5. Please revise the graphic on page 88 to include the current number
surgical bunion
procedures that are performed in the United States every year.
Royalty and License Agreements, page 102
6. Revise to disclose the material terms of the royalty and license
agreements with members
of your scientific advisory board disclosed here and on page 76 and
file the agreements as
exhibits pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K.
Intellectual Property, page 102
7. Revise your disclosure here or on page 26, as appropriate, to clarify
whether you own 21
or 22 patents issued in the United States. Revise to clarify the
jurisdictions in which you
have patents pending outside the United States. With respect to your
material patents,
please disclose the specific products, product groups and technologies
to which such
patents relate, the type of patent protection you have, the applicable
jurisdictions and
clarify whether there are any contested proceedings or third-party
claims.
8. With respect to the patent for which you have an exclusive license,
disclose the product to
which it relates, the type of patent protection, and disclose the
terms of your license. File
the agreement as required by Item 601(b)(10) of Regulation S-K or tell
us why you
believe it is not required to be filed.
Executive Compensation, page 126
9. Clarify whether you plan to enter into a change in control and severance
agreement or an
employment agreement with Mr. Treace or employment agreements with the
named
FirstName LastNameJohn T. Treace
executive officers prior to the offering. If not, add a risk factor to
address your lack of
Comapany NameTreace
agreements. Medical
We note Concepts,
it is to Inc. how many shares Mr. Treace
may sell shares
be determined
March in
11,the offering
2021 Page as
2 indicated in the principal and selling stockholders
table on page 141.
FirstName LastName
John T. Treace
FirstName LastNameJohn T. Treace
Treace Medical Concepts, Inc.
Comapany
March NameTreace Medical Concepts, Inc.
11, 2021
March3 11, 2021 Page 3
Page
FirstName LastName
Financial Statements
Note 2. Summary of Significant Accounting Policies
Revenue Recognition, page F-9
10. Please disclose the payment terms, the right of return, and any
warranties, included in
your customer contracts. In addition, disclose further detail
explaining why your refund
liability is zero. Refer to ASC 606-10-50-12 and 50-20.
Note 7. Commitments and Contingencies
License and Royalty Commitments, page F-17
11. Please expand your disclosure to provide all material terms of your
agreements, including
a range of royalties (e.g., low single digits or a range that does not
exceed 10%) and term
and termination provisions.
General
12. 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.
You may contact Michael Fay at (202) 551-3812 or Terence O'Brien at
(202) 551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at (202) 551-6902 or Christopher Edwards at (202) 551-6761
with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Brian Cuneo, Esq.