United States securities and exchange commission logo
September 7, 2021
Michael McGarrity
Chief Executive Officer and Director
MDxHealth SA
CAP Business Center
Zone Industrielle des Hauts -Sarts
4040 Herstal, Belgium
Re: MDxHealth SA
Draft Registration
Statement on Form F-1
Submitted August 9,
2021
CIK No. 0001872529
Dear Mr. McGarrity:
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 submitted August 9, 2021
Cover Page
1. We note that you intend
to disclose the last reported sale price of your ordinary shares on
Euronext Brussels on
the cover page, and your disclosure that the final offering price will
be determined through
negotiations with the underwriters by reference to the prevailing
market prices of your
ordinary shares on Euronext Brussels after taking into account
market conditions and
other factors. Please confirm that the U.S. IPO price will be
substantially similar
to the Euronext Brussels trading price, converted to U.S. dollars at
the most recent
exchange rate. If you intend to price the securities based on the Euronext
Brussels market price,
you may also disclose a percentage range based on that price (for
Michael McGarrity
FirstName
MDxHealthLastNameMichael McGarrity
SA
Comapany 7,
September NameMDxHealth
2021 SA
September
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example, 10% of the home market price) within which you intend to
price the securities.
Alternatively, if you expect that the U.S. IPO price will not be
substantially similar to the
Euronext Brussels trading price, please disclose on the cover page a
bona fide price range
for the offered securities. See Item 501(b)(3) of Regulation S-K.
Market and Industry Data, page iii
2. Your statements that (i) you have not independently verified the
market and industry data
obtained from third-party sources, (ii) you do not make any
representation or warranty as
to the accuracy or completeness of this information (even if you
believe it to be reliable),
and (iii) neither your internal research nor the definition of your
market and industry have
been verified by any independent source may imply an inappropriate
disclaimer of
responsibility with respect to the third party information and
internal research. Please
either delete these statements or specifically state that you are
liable for such information.
Prospectus Summary
Overview, page 1
3. Please revise this section to disclose (i) that your SelectMDx and
ConfirmMDx testing
services are not FDA approved, (ii) that you have chosen to
commercialize them as
laboratory developed tests following the CLIA certification and
inspection pathway and
(iii) the potential impact to your business should the FDA require
filings, clearance or
approval for your products or product candidates in the future.
4. Please make it clear in this section that your SelectMDx test is not
currently covered by
Medicare. Please also make it clear here and throughout the prospectus
where you
discuss Medicare coverage and reimbursement for SelectMDx that there
is no guarantee
that it will be covered or reimbursed by Medicare in the future.
Commercial Products, page 2
5. Please substantiate your statements that your SelectMDx test has a
best-in-class 95%
negative predictive value and that your ConfirmMDx test has a
best-in-class 96% negative
predictive value.
Market Opportunity, page 4
6. Please disclose any material assumptions and limitations associated
with your market
estimates.
Implications of Being an Emerging Growth Company, page 6
7. 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.
Michael McGarrity
MDxHealth SA
September 7, 2021
Page 3
Intellectual Property, page 60
8. Please disclose the expiration dates for your material owned or
licensed patents.
Collaboration and License Agreements, page 61
9. We note your disclosure that you have entered into numerous agreements
with universities
and companies for in-licensing intellectual property. With respect to
each material license
agreement, please revise to disclose in this section the nature and
scope of intellectual
property transferred, each parties rights and obligations, the
duration of the agreement,
the royalty term, the termination provisions, and the following
payment provisions:
Up-front or execution payments received or paid;
Aggregate amounts paid or received to date under the agreement;
Aggregate future potential milestone payments to be paid or
received;
Royalty rates or a royalty range;
Profit or revenue-sharing provisions; and
Minimum purchase requirements if the agreement involves
manufacturing.
Please also file these agreements as exhibits or tell us why you
believe that you are not
required to file them. Refer to Item 601(b)(10) of Regulation S-K.
Principal Shareholders, page 104
10. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by MVM Partners LLP and
Valiance Asset
Management Limited.
Use of Proceeds, page 107
11. Please revise the discussion to disclose the estimated net amount of
the proceeds broken
down into each principal intended use. If the anticipated proceeds
will not be sufficient to
fund all the proposed purposes, please disclose the order of priority
of such purposes. To
the extent material amounts of other funds are necessary to accomplish
the specified
purposes, state the amounts and sources of such other funds needed for
each specified
purpose. Refer to Item 3.C.1 of Form 20-F.
Consolidated Financial Statements
Note 14. Loans, Borrowings and lease liabilities, page F-30
12. On page 76, you discuss the Initial Convertible Loan, as well as, the
additional convertible
FirstName LastNameMichael McGarrity
loan amount as a result of your October 2020 and April 2021 loan
amendments. Please tell
Comapany NameMDxHealth
us, and SA how you have accounted for these convertible
loan balances.
revise if necessary,
Please
September cite the
7, 2021 accounting
Page 3 literature you relied upon in your
response.
FirstName LastName
Michael McGarrity
FirstName
MDxHealthLastNameMichael McGarrity
SA
Comapany 7,
September NameMDxHealth
2021 SA
September
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You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please
contact Ada Sarmento at 202-551-3798 or Jeffrey Gabor at 202-551-2544 with any
other
questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Roel Meers, Esq.