MIMEDX Provides AXIOFILL® Update & Reiterates 2023 Full Year Net Sales and Fourth Quarter Adjusted EBITDA Margin Outlook
December 29 2023 - 5:00PM
MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today
provided the following update regarding AXIOFILL and reiterated its
outlook for 2023 full year net sales growth and fourth quarter
adjusted EBITDA margin.
AXIOFILL Update
Following a routine inspection earlier in the year, the United
States Food and Drug Administration (“FDA”) took the position that
one of the Company’s recently-launched placental-derived tissue
products – AXIOFILL – does not meet the requirements as a Section
361 product and is therefore subject to enforcement as a Section
351 product. Specifically, FDA asserts that the production of
AXIOFILL involves more than “minimal manipulation.” The Company
does not agree with FDA’s position and has been actively engaged
with the agency through its “Request For Designation” (“RFD”)
process. However, on December 21, 2023, MIMEDX received a Warning
Letter from FDA reiterating the agency’s position on AXIOFILL. The
Warning Letter does not relate to any of the Company’s other
products, nor does it assert any product safety claims or adverse
events related to AXIOFILL. AXIOFILL has been on the market since
September 2022 and has a strong safety record.
The Company believes that AXIOFILL, which is expected to
generate less than 5% of MIMEDX’s total net sales anticipated for
2023, was developed and is manufactured to comply with the
requirements for a Human Cell, Tissue or Cellular or Tissue-based
Product (“HCT/P”) under Section 361 of the Public Health Service
Act. Specifically,
- AXIOFILL is composed solely of human
placental disc extracellular matrix (ECM)
- AXIOFILL is used to “replace or
supplement damaged or inadequate integumental tissue” which is
consistent with ECM homologous use.
AXIOFILL’s product characteristics can be reasonably considered
directly comparable to at least one other commercially available
HCT/P on the market that the FDA regulates under Section 361 and,
as a result, the Company believes FDA is not consistently applying
the rules for permitted use.
Joseph H. Capper, MIMEDX Chief Executive Officer commented, “In
the course of developing our products, we go to great lengths to
ensure that they comply with all relevant regulatory requirements.
We believe that AXIOFILL has been incorrectly characterized by the
agency, particularly in light of the existence of other Section 361
products currently available on the market. While AXIOFILL sales
are not material to our overall performance, we will, nonetheless,
continue to work with FDA and explore all available options to
ensure physicians and patients have continued access to this
incredibly safe and important product. Importantly, we are
permitted to continue selling the product until this matter has
been fully adjudicated.”
The Company will respond to the Warning Letter within the
required 15-day period. The Company is also currently engaged with
FDA in the RFD process regarding AXIOFILL. MIMEDX plans to provide
commentary about this matter during its upcoming fourth quarter and
year end 2023 conference call in late-February.
Mr. Capper concluded, “We remain on track to cap off a fantastic
year, with strong top line growth and profitability. As such, we
are also reiterating our expectations for full year 2023 net sales
in the high-teens and fourth quarter adjusted EBITDA margin above
20%. With clear strategic direction and excellent performance from
across the entire enterprise, 2023 has turned out to be quite the
turning point for MIMEDX. We plan to carry this momentum into 2024
and could not be more excited about the numerous prospects for our
growing Company.”
About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal.
With more than a decade of helping clinicians manage chronic and
other hard-to-heal wounds, MIMEDX is dedicated to providing a
leading portfolio of products for applications in the wound care,
burn, and surgical sectors of healthcare. The Company’s vision is
to be the leading global provider of healing solutions through
relentless innovation to restore quality of life. For additional
information, please visit www.mimedx.com.
Forward Looking Statements
This press release may contain statements which constitute
forward looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the future operating performance of MIMEDX and MIMEDX’s
pursuit of growth and innovation. Additional forward-looking
statements may be identified by words such as "believe," "expect,"
"may," "plan," “goal,” “outlook,” "potential," "will,"
"preliminary," and similar expressions, and are based on
management's current beliefs and expectations. Investors are
cautioned that any such forward looking statements are not
guarantees of future performance and involve risks and
uncertainties, and that actual results may differ materially from
those in the forward looking statements as a result of various
factors. Important factors that could cause such differences are
described in MIMEDX’s periodic filings with the Securities and
Exchange Commission. Any forward looking statements speak only as
of the date of this press release and MIMEDX assumes no obligation
to update any forward looking statement.
Contact:Matt NotarianniInvestor
Relations470-304-7291mnotarianni@mimedx.com
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