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United States securities and exchange commission logo
May 10, 2024
Doug Rice
Chief Financial Officer
MIMEDX GROUP, INC.
1775 West Oak Commons Court, NE
Marietta, GA 30062
Re: MIMEDX GROUP, INC.
10-K for the Fiscal
Year Ended December 31, 2023
Filed February 28,
2024
Form 10-Q for the
Quarterly Period Ended March 31, 2024
Filed April 30,
2024
File No. 001-35887
Dear Doug Rice:
We have limited our review of your filing to the financial
statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe a
comment applies to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to this letter, we may have additional comments.
Form 10-Q For the Quarterly Period Ended March 31, 2024
TELA and Regenity Agreements, page 17
1. You disclose the
Company entered into an Asset Purchase Agreement with TELA to
obtain exclusive rights
to sell and market a 510(k)-cleared collagen particulate xenograft
product in the United
States pursuant to a preexisting Manufacturing and Supply
Agreement between TELA
and Regenity, which retains all intellectual property rights and
regulatory clearances
related to the product. Simultaneously with entry into the TELA
APA, the Company
executed a new Manufacturing and Supply Agreement with Regenity,
replacing the previous
TELA-Regenity Supply Agreement. Please clarify for us, and in
future filings as
appropriate, your accounting and disclosure as it relates to the following:
Since you entered
into a new supply agreement that replaced the pre-existing supply
agreement, clarify
why you do not consider the $7.6 million as a transaction cost to
Doug Rice
FirstName LastNameDoug
MIMEDX GROUP, INC. Rice
Comapany
May NameMIMEDX GROUP, INC.
10, 2024
May 10,
Page 2 2024 Page 2
FirstName LastName
enter into the new agreement;
Clarify why you have not recorded the maximum profit share
amount, how you will
account for any future payments, and when you will record any
future amounts due;
Clarify the term of the TELA APA and your methodology for
amortizing the $7.6
million assigned cost; and
Clarify when you anticipate commercialization of the xenograft
product to commence
and whether you evaluated the recorded costs for recoverability
before recording
them as an asset.
Form 10-K For the fiscal year ended December 31, 2023
Financial Statements
13. Discontinued Operations, page 1
2. Please provide us your analysis of how you determined that your
disposal qualified as a
strategic shift, as outlined in ASC 205-20-45-1B and 1C, in support of
your discontinued
operations accounting. Please identify and evaluate all relevant facts
and circumstances.
As part of your analysis, describe how you determined your
Regenerative
Medicine segment to be important to your operations and strategy, and
a major part of
your entity.
3. In addition, we note research and development for your Regenerative
Medicine segment
was $14,993 and $11,480 for 2022 and 2021 per your prior year segment
footnote, and the
corresponding amounts in your Discontinued Operations footnote are
$10,128 and $7,412.
Please reconcile for us the difference between the amounts.
Note 14. Income Taxes, page 2
4. We note your change in the determination of the likelihood of the
realizability of certain
of the Company s deferred tax assets based on the disbanded
Regenerative Medicine
segment qualifying as a discontinued operation, in concert with the
Company s operating
results. We note, though, significant operating losses and losses from
continuing
operations before income tax provisions in 2022 and 2021 remain after
the application of
discontinued operations accounting. We also note a cumulative three
year loss from
continuing operations before income tax provision remains after the
application of
discontinued operations accounting. Please explain to us in further
detail how you
overcame this negative evidence to support your conclusion that a
valuation allowance is
not needed for most of your deferred tax asset and how your analysis
is consistent with
ASC 740-10-30-16 through 30-25.
In closing, we remind you that the company and its management are
responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review,
comments, action or
absence of action by the staff.
Doug Rice
MIMEDX GROUP, INC.
May 10, 2024
Page 3
Please contact Julie Sherman at 202-551-3640 or Michael Fay at
202-551-3812 with any
questions.
Sincerely,
FirstName LastNameDoug Rice
Division of
Corporation Finance
Comapany NameMIMEDX GROUP, INC.
Office of Industrial
Applications and
May 10, 2024 Page 3 Services
FirstName LastName