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MiMedx Group, Inc.

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FY2022 Annual Report · MiMedx Group, Inc.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K

☑ ANNUAL  REPORT  PURSUANT  TO  SECTION  13  OR  15(d)  OF  THE  SECURITIES  EXCHANGE  ACT  OF

1934
For the fiscal year ended December 31, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF

1934

For the transition period from __________to __________
Commission file number 001-35887

MIMEDX GROUP, INC.

(Exact name of registrant as specified in its charter)

Florida
(State or other jurisdiction of incorporation or organization)

26-2792552
(I.R.S. Employer Identification No.)

1775 West Oak Commons Court, NE, Marietta, GA
(Address of principal executive offices)

30062
(Zip Code)

(770) 651-9100
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: None.

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, par value $0.001 per share

MDXG

The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:
None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes o     No ☑
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes o No ☑
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☑     No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§223.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an
emerging  growth  company.  See  the  definitions  of  “large  accelerated  filer,”  “accelerated  filer,”  “smaller  reporting  company,”  and  “emerging  growth
company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer
Non-accelerated filer
Emerging growth company

Accelerated filer
Smaller reporting company

☐
☐
☐

☑
☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered accounting firm that prepared or its audit
report ☑

 
 
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the
filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received
by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☑
The aggregate market value of the registrant’s voting common equity held by non-affiliates of the registrant as of June 30, 2022 (the last business day of the
registrant’s most recently completed second quarter) was approximately $388.1 million based upon the last sale price ($3.47) of the shares as reported on
The Nasdaq Stock Market LLC on such date.

There were 114,083,096 shares of the registrant’s common stock, par value $0.001 per share, outstanding as of February 24, 2023.

Documents Incorporated By Reference

Portions of the proxy statement relating to the 2023 Annual Meeting of Shareholders, to be filed within 120 days after the end of the fiscal year to which
this report relates, are incorporated by reference in Part III of this Report.

Table of Contents

Item

Description

Page

Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.

Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.

Item 10.
Item 11.
Item 12.
Item 13.
Item 14.

Item 15.
Item 16.

Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures

Part I

Part II

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosures Regarding Foreign Jurisdictions that Prevent Inspections

Part III

Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services

Part IV

Exhibits, Financial Statement Schedules
Form 10-K Summary
Signatures

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47
47
47

47
50
50
64
F- 1
79
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80

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Explanatory Note and Important Cautionary Statement Regarding Forward-Looking Statements

PART I

As used herein, the terms “MIMEDX,” “the Company,” “we,” “our” and “us” refer to MiMedx Group, Inc., a Florida corporation, and its consolidated
subsidiaries as a combined entity, except where it is clear that the terms mean only MiMedx Group, Inc.

The following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this Annual Report. Certain
statements made in this Annual Report are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements relating to events or results that may occur in the
future are forward-looking statements, including, without limitation, statements regarding the following:

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our strategic focus and our current business priorities, and our ability to implement these priorities, including as a result of our no longer being
able to market our micronized products and certain other products;

our expectations regarding our ability to fund our ongoing operations and future operating costs and the sufficiency of our liquidity and existing
capital resources to implement our current business priorities;

the advantages of our products and development of new products;

our expectations regarding the size of potential markets for our products and any growth in such markets;

our expectations regarding the regulatory pathway for our products, including our existing and planned investigative new drug application and pre-
market approval requirements; current plans, designs, expected timelines, and expectations for success of our clinical trials; and our expectations
regarding timing and receipt of necessary regulatory approvals for certain of our products including Biological License Applications (“BLAs”);

our expectations regarding ongoing regulatory obligations and oversight and the changing nature thereof impacting our products, research and
clinical programs, and business, including those relating to patient privacy;

our expectations regarding our ability to procure sufficient supplies of human tissue to manufacture and process our existing and future products;

our expectations regarding our ability to manufacture certain of our products in compliance with Current Good Manufacturing Practices
(“CGMP”) in sufficient quantities to meet current and potential demand;

our expectations regarding costs relating to compliance with regulatory requirements, including those arising from our clinical trials, pursuit of
Investigational New Drug applications and BLAs, and CGMP compliance;

the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications
for our products.

our expectations regarding government and other third-party coverage and reimbursement for our products;

our expectations regarding future revenue growth;

our belief in the sufficiency of our intellectual property rights in our technology;

our expectations regarding future income tax liability;

our expectations regarding the outcome of pending litigation and investigations;

our  expectations  regarding  the  ongoing  and  future  effects  arising  from  the  investigation  conducted  by  the  Audit  Committee  (the  “Audit
Committee”) of our Board of Directors (the “Board”) that concluded in May 2019 relating to allegations regarding certain sales and distribution
practices  at  the  Company  and  certain  other  matters  (the  “Investigation”  or  the  “Audit  Committee  Investigation”),  the  restatement  of  our
consolidated  financial  statements  previously  filed  in  our  Annual  Report  for  the  year  ended  December  31,  2016,  as  well  as  selected  unaudited
condensed  consolidated  financial  data  as  of  and  for  the  years  ended  December  31,  2015  (Restated)  and  2014  (Restated),  which  reflected
adjustments to our previously filed consolidated financial statements as of and for the years ended December 31, 2015 and 2014 (collectively, the
“Restatement”), and related litigation;

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•

•

•

ongoing and future effects arising from the COVID-19 pandemic or other similar public health emergencies on our business, employees, suppliers
and other third parties with whom we do business, and our responses intended to mitigate such effects;

demographic and market trends; and

our ability to compete effectively.

Forward-looking  statements  generally  can  be  identified  by  words  such  as  “expect,”  “will,”  “change,”  “intend,”  “seek,”  “target,”  “future,”  “plan,”
“continue,”  “potential,”  “possible,”  “could,”  “estimate,”  “may,”  “anticipate,”  “to  be”  and  similar  expressions.  These  statements  are  based  on  numerous
assumptions and involve known and unknown risks, uncertainties and other factors that could significantly affect our operations and may cause our actual
actions, results, financial condition, performance or achievements to differ materially from any future actions, results, financial condition, performance or
achievements expressed or implied by any such forward-looking statements. Factors that may cause such a difference include, without limitation, those
discussed in Item 1A, Risk Factors in this Annual Report.

Unless  required  by  law,  the  Company  does  not  intend,  and  undertakes  no  obligation,  to  update  or  publicly  release  any  revision  to  any  forward-looking
statements,  whether  as  a  result  of  the  receipt  of  new  information,  the  occurrence  of  subsequent  events,  a  change  in  circumstances  or  otherwise.  Each
forward-looking statement contained in this Annual Report is specifically qualified in its entirety by the aforementioned factors. Readers are advised to
carefully read this Annual Report in conjunction with the important disclaimers set forth above prior to reaching any conclusions or making any investment
decisions and not to place undue reliance on forward-looking statements, which apply only as of the date of the filing of this Annual Report with the SEC.

Estimates and Projections

This discussion includes certain estimates, projections and other statistical data. These estimates and projections reflect management’s best estimates based
upon currently available information and certain assumptions we believe to be reasonable. These estimates are inherently uncertain, subject to risks and
uncertainties,  many  of  which  are  not  within  our  control,  have  not  been  reviewed  by  our  independent  auditors  and  may  be  revised  as  a  result  of
management’s further review. In addition, these estimates and projections are not a comprehensive statement of our financial results, and our actual results
may differ materially from these estimates and projections due to developments that may arise between now and the time the results are final. There can be
no assurance that the estimates will be realized, and our results may vary significantly from the estimates, including as a result of unexpected issues in our
business  and  operations.  Accordingly,  you  should  not  place  undue  reliance  on  such  information.  Projections,  assumptions  and  estimates  of  our  future
performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. See Item 1A,
Risk Factors for further information.

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Item 1. Business

Overview

MIMEDX is a pioneer and leader in placental biologics, developing and distributing placental tissue allografts with patent-protected, proprietary processes
for multiple sectors of healthcare. The Company is focused on addressing unmet clinical needs in the areas of Advanced Wound Care (“AWC”), Surgical
Recovery,  and  osteoarthritis.  We  derive  our  products  primarily  from  human  placental  tissues  and  process  these  tissues  using  our  proprietary  methods,
including the PURION  process. We employ Current Good Tissue Practices (“CGTP”), Current Good Manufacturing Practices (“CGMP”), and terminal
sterilization to produce our allografts. MIMEDX provides products primarily for use in the wound care, burn, and Surgical Recovery sectors of healthcare.
All of our products sold in the United States are regulated by the U.S. Food & Drug Administration (“FDA”), and to the extent we sell our products outside
the United States, by other regulatory agencies in such international markets.

®

At MIMEDX, our vision is to advance regenerative science and innovative biologics that restore quality of life. Our mission is to improve people’s health
and  lives  through  innovation  that  makes  healing  possible.  By  advancing  rigorous  science  and  increasing  access  to  evidence-based  regenerative
technologies, we elevate the standard of care. Our commitment to the highest quality standards maximizes our potential to reduce cost to the healthcare
system and restore quality of life. Character, Customer Orientation, Innovation, Collaboration and Stewardship are our core values.

MIMEDX is a leading supplier of human placental allografts, which are human tissues that are derived from one person (the donor) and used to produce
products  that  treat  another  person  (the  recipient).  MIMEDX  has  supplied  over  two  million  allografts,  through  direct  shipments.  Our  primary  platform
technologies  include  tissue  allografts  derived  from  human  placental  membrane  (EPIFIX®,  AMNIOFIX®,  and  AMNIOEFFECT®),  tissue  allografts
derived  from  human  umbilical  cord  (EPICORD®  and  AMNIOCORD®),  and  a  particulate  extracellular  matrix  derived  from  human  placental  disc
(AXIOFILL®).

EPIFIX and EPICORD products are marketed for external use, such as in Advanced Wound Care applications, while our AMNIOFIX, AMNIOEFFECT,
AXIOFILL,  and  AMNIOCORD  products  are  positioned  for  use  in  Surgical  Recovery  applications,  including  lower  extremity  repair,  plastic  surgery,
vascular surgery and multiple orthopedic repairs and reconstructions. We describe these in greater detail below under the heading “ - Our Product Portfolio
& Pipeline.”

2017  FDA  Guidance.  The  products  we  sell  are  regulated  by  the  FDA.  Generally,  our  products  are  regulated  as  Human  Cells,  Tissues  and  Cellular  and
Tissue  –  Based  Products  (“HCT/Ps”),  which  do  not  require  pre-market  clearance  or  approval  by  the  FDA  and  are  subject  solely  to  Section  361  of  the
Public Health Service Act (“Section 361”) and related regulations. However, in November 2017 the FDA published a series of related guidance documents,
including  one  entitled  “Regulatory  Considerations  for  Human  Cells,  Tissues,  and  Cellular  and  Tissue–Based  Products:  Minimal  Manipulation  and
Homologous  Use  –  Guidance  for  Industry  and  Food  and  Drug  Administration  Staff”  (collectively,  the  “Guidance”),  which  established  an  updated
framework for the FDA’s regulation of cellular and tissue-based products. Among other things, the Guidance clarified the FDA’s views about the criteria
that  differentiate  those  products  subject  to  regulation  solely  under  Section  361  (“Section  361  HCT/Ps”)  from  those  cellular  and  tissue-based  products
considered to be drugs, devices, and/or biological products (“Section 351 HCT/Ps”) subject to licensure under Section 351 of the Public Health Service
Act (“Section 351”) and related regulations.

Effect  of  Guidance  on  Our  Products.  Under  the  Guidance,  we  expect  that  the  FDA  will  continue  to  regulate  certain  of  our  placental  tissue  products
(EPIFIX, AMNIOFIX, EPICORD, AMNIOCORD, AMNIOBURN, AXIOFILL and AMNIOEFFECT) as Section 361 HCT/Ps so long as the claims we
make for them are consistent with the Section 361 framework. Beginning in May 2021, the FDA began regulating certain of our other products, including
our micronized dehydrated human amnion chorion membrane (“mDHACM”) products that we previously marketed in the United States as Section 351
HCT/Ps.

Enforcement Discretion. Under the Guidance, the FDA exercised enforcement discretion under limited conditions with respect to the Investigational New
Drug  (“IND”)  application  and  pre-market  approval  requirements  for  certain  HCT/Ps  through  May  31,  2021.  We  continued  to  market  our  micronized
products  (mDHACM)  and  our  particulate  product  (AMNIOFILL)  under  this  policy  of  enforcement  discretion  in  the  United  States  until  May  31,  2021,
while at the same time pursuing Biologics License Applications (“BLAs”)  for  certain  of  our  micronized  products  in  specific  clinical  applications.  After
May 31, 2021, we no longer sell our products that were impacted by enforcement discretion in the United States, and do not intend to sell such products in
the United States until the FDA grants pre-market approval. As a result, we will only be able to market such products for indications that have been cleared
or  approved  by  the  FDA.  Similarly,  we  are  engaged  with  the  FDA  regarding  the  classification  of  our  umbilical  cord  products,  EPICORD,  EPICORD
Expandable, and AMNIOCORD, which are tissue allografts derived from the structural, protective covering and extracellular matrix cushioning layers of
the umbilical cord. If the FDA makes a final determination that our umbilical cord-derived products do not meet the requirements for regulation solely
under Section 361, then, in order to continue to market the products, we would be required to obtain the appropriate FDA clearance or approval. In 2022,
revenues  from  US  sales  of  our  umbilical  cord-derived  products  were  $23.2  million.  See  discussion  below  in  Item  1A,  Risk  Factors  under  the  heading
“Certain of our products do not qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of the Public
Health Service Act, which has

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resulted in removal of the applicable products from the market, made the introduction of some new tissue products more expensive, significantly delayed the
expansion of our tissue product offerings and subjected us to additional post-market regulatory requirements. Additional regulatory requirements may be
imposed in the future.”
Our History

Our current business began on February 8, 2008 when Alynx, Co., our predecessor company, acquired MiMedx, Inc., a development-stage medical device
company,  the  assets  of  which  included  licenses  to  two  development-stage  medical  device  technology  platforms  which  we  do  not  currently  market.  On
March 31, 2008, Alynx, Co. merged into MiMedx Group, Inc., a Florida corporation and wholly-owned subsidiary that had been formed for purposes of the
merger,  with  MiMedx  Group,  Inc.  as  the  surviving  corporation  in  the  merger.  In  January  2011,  we  acquired  all  of  the  outstanding  equity  interests  of
Surgical Biologics, LLC (n/k/a MiMedx Tissue Services, LLC).

Current Business Priorities and Strategy

We combine a large donor network developed over multiple years that sources donated birth tissue from consenting mothers, with our proprietary tissue
manufacturing process and significant research and development expertise to develop innovative placental-derived products that address a wide range of
chronic and acute health conditions affecting large patient populations.

Our core business delivers innovative products that help clinicians treat patients suffering from acute and chronic non-healing wounds. These wounds can
be slow to respond or unresponsive to conventional treatments and may benefit from advanced treatments, such as our products, in order to support the
healing process. The costs associated with treatment and management of patients with acute and chronic wounds is also high, with some estimates of the
Medicare spend associated with such wounds approaching $100 billion annually.

The treatment of chronic wounds is often referred to as wound care. Chronic wounds are defined and characterized as those that do not progress through the
normal process of healing and remain open for over a month. Patients, typically in the elderly population, with conditions such as diabetes, obesity and
other comorbidities, are among those with the highest risk of developing chronic wounds, which include diabetic foot ulcers (“DFUs”), venous leg ulcers
1
(“VLUs”),  and  pressure  ulcers,  among  others.  Studies  estimate  that  in  2022  roughly  2.1%  of  the  U.S.  population  was  affected  by  chronic  wounds .
Complications from non-healing chronic wounds can result in significant, life-altering adverse outcomes, such as limb amputation. Today, up to one-fifth of
2
diabetic patients who develop a DFU will require some form of amputation . Further, patients who undergo a major lower extremity amputation have an
3
increased five-year mortality rate that is comparable to and in some cases higher than many forms of cancer .

Acute wounds are defined as those that are recent, are acquired from an incision or trauma and have yet to progress through the sequential stages of wound
healing.  Acute  wounds  can  be  caused  accidentally  or  they  can  arise  in  the  normal  course  of  a  wide-range  of  surgical  procedures.  When  acute  wounds
present in patients with similar comorbidities to those of chronic wound patients, the risk of a slow or ineffective healing wound increases, and the risk of a
surgical  site  infection  or  other  similar  complication  increases  for  the  patient.  We  refer  to  the  combination  of  a  wide  variety  of  surgical  procedures  on
patients with these comorbidities, who could thus see slow or ineffective healing, as the Surgical Recovery market.

Our strategy is to continue to deliver advanced products that serve patient needs within the Advanced Wound Care and Surgical Recovery markets and
increase access to our products through clinical data generation and physician education. We estimate that the combined U.S. wound and surgical market
for our products is currently $2.0 billion ($1.1 billion in wound; $0.9 billion in surgical) and is largely under-penetrated . We expect the U.S. wound and
5
surgical market will grow at an annual rate of 7-10% over the next 3 to 5 years .

4

The prevalence of both acute and chronic wounds has grown not only in the U.S. but also globally. While historically we have focused primarily on the
U.S. market, we are now in the process of expanding our footprint internationally, most notably with the recent launch of our EPIFIX product in Japan. In
2021,  we  secured  regulatory  approval  for  EPIFIX  in  Japan  followed  by  reimbursement  approval  in  2022.  We  also  announced  an  exclusive  distribution
agreement with Gunze Medical Limited (“Gunze Medical”),  a  subsidiary  of  Gunze  Limited,  for  sales  of  EPIFIX  in  the  Japanese  market,  and  expect  to
commence sales in the region in 2023. In Japan, EPIFIX is the first and currently the only amniotic tissue product approved for wound treatment across a
broad  range  of  conditions.  We  believe  our  first-mover  advantage,  favorable  reimbursement  rate,  and  strong  distribution  partner  set  us  up  for  long-term
success in this large and growing market.

1
 GlobalData: 2022 Wound Care Management- Tissue Engineered Skin Subs U.S. Updated May 2022
2
 Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092527/#CR1
3
Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease, https://www.ahajournals.org/doi/10.1161/ATVBAHA.120.314595
4
 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021
5
 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021

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Additionally, we have a regenerative medicine pipeline led by an injectable placental biologic product candidate, for which we are targeting an indication to
help decrease pain and improve function in patients suffering from knee osteoarthritis (“KOA”), also known as degenerative joint disease of the knee. KOA
is the most prevalent form of osteoarthritis and is a leading source of chronic pain and disability in the U.S. Our KOA program is in late-stage clinical trials
and we are working toward the filing of a BLA in order to obtain regulatory approval for this product and a subsequent commercial launch in the U.S.

By  incorporating  a  strategy  to  advance  the  scientific  and  therapeutic  potential  of  placental  tissue  and  rigorously  demonstrate  the  clinical  and  economic
effectiveness of our products, we believe we can differentiate the value of our portfolio and address multiple areas of significant unmet clinical need. We
have  focused  our  priorities  on  initiatives  across  our  organization  that  position  us  to  realize  our  commercial  ambitions  over  the  long-term  while  also
generating a profitable, cash flow positive business capable of self-funding our future growth objectives.

Business Segments

Beginning in the third quarter of 2022, the Company manages itself as two reportable segments: Wound & Surgical and Regenerative Medicine. Wound &
Surgical focuses on the Advanced Wound Care and Surgical Recovery markets through the sale of the Company’s existing product portfolio and product
development to serve these end markets. Its platform technologies include tissue allografts derived from human placental membrane (EPIFIX, AMNIOFIX,
and AMNIOEFFECT), tissue allografts derived from human umbilical cord (EPICORD and AMNIOCORD), and a particulate extracellular matrix derived
from human placental disc (AXIOFILL). This segment is also responsible for the international sales of the Company’s Section 351 products.

The  Regenerative  Medicine  business  focuses  solely  on  Regenerative  Medicine  technologies,  specifically  progressing  the  Company’s  placental  biologics
platform towards registration as an FDA-approved biological drug. mDHACM is the lead product candidate in its late-stage pipeline targeted at achieving
FDA approval for specific clinical indications, including degenerative musculoskeletal conditions, beginning with KOA.

Our Product Portfolio & Pipeline

We  sell  our  placenta-based  allograft  products  primarily  under  our  own  brands.  We  maintain  strict  controls  on  quality  at  each  step  of  the  manufacturing
process beginning at the time of procurement. Our Quality Management System is focused on compliance with the American Association of Tissue Banks’
(“AATB”) standards and the FDA’s CGTP and CGMP regulations.

EPIFIX

EPIFIX is a protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of chronic wounds,
including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers. EPIFIX is available in an assortment of sheet configurations and
sizes to accommodate various wounds.

MIMEDX also has a micronized version of this product that it no longer markets or sells in the United States, but does sell outside the United States. As
further discussed below under the heading “Government Regulation - 2017 FDA Guidance and Transition Policy for HCT/Ps,”  the  FDA  clarified  in  its
2017 guidance that it regards micronized amniotic membrane products as subject to FDA licensure as biological products under Section 351.

AMNIOFIX

AMNIOFIX  is  a  protective  barrier  allograft  comprised  of  dehydrated  human  amnion/chorion  membrane  that  may  be  used  in  Surgical  Recovery
applications. AMNIOFIX is available in an assortment of sheet configurations and sizes for internal use, including in the areas of lower extremity repair,
spine, orthopedic, sports medicine, gastrointestinal, urologic, and other general surgery applications.

mDHACM

mDHACM is a micronized form of AMNIOFIX, and supplied in powder form, reconstituted with 0.9% sterile saline for injection. This product is our lead
BLA  candidate.  We  completed  four  late-stage  randomized  controlled  studies  under  open  INDs,  evaluating  mDHACM  in  plantar  fasciitis,  Achilles
tendonitis and KOA. While the KOA Phase 2B trial did not meet its primary endpoints, we initiated a post-Phase 2B registrational clinical trial for KOA in
February 2023. For further details, see “-Clinical Trials” below.

AMNIOBURN

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AMNIOBURN is a protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of partial-
thickness and full-thickness burns.

EPICORD and AMNIOCORD

EPICORD  and  AMNIOCORD  are  dehydrated  human  umbilical  cord  allografts  that  may  be  used  to  provide  a  protective  environment  for  the  healing
process and are used in the areas of Advanced Wound Care and Surgical Recovery, respectively. These products are thicker than our amniotic membrane
allografts and can be applied in deeper wounds or in areas where suturing the allograft in place may be advantageous.

EPICORD Expandable is an allograft derived from the umbilical cord, and can expand to twice its size, conforming to uneven surfaces and deep wounds.
The thickness of the product allows for suturing as needed to keep the graft in place, and it provides healthcare professionals a new option to support the
Advanced Wound Care needs of their patients with larger, chronic, and hard-to-heal wounds.

AXIOFILL

The  Company  launched  AXIOFILL  during  the  third  quarter  of  2022.  AXIOFILL  is  an  extracellular  matrix  derived  from  human  placental  disc,  and  is
designed to provide a cost-effective human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries. Our
AXIOFILL product has seen initial adoption by clinicians primarily focused on Surgical Recovery applications.

AMNIOEFFECT

The  Company  also  launched  AMNIOEFFECT  during  the  third  quarter  of  2022.  AMNIOEFFECT  is  a  tri-layer  placental  tissue  allograft  that  contains
amnion, intermediate layer, and chorion membranes. This product is designed to meet the needs of surgeons performing procedures where a more robust
allograft with expansive size offerings is desired.

AMNIOFILL

The  Company  ceased  marketing  and  selling  AMNIOFILL  in  the  United  States  in  May  2021,  following  the  end  of  the  FDA’s  period  of  enforcement
discretion. We have not yet initiated any clinical trials in furtherance of any regulatory approvals for this product.

Antimicrobial Wound & Surgical Products

In  December  2022,  we  announced  an  in-licensing  and  distribution  agreement  with  Global  Health  Solutions,  Inc.  (d.b.a.  Turn  Therapeutics  or  “Turn”),
providing  us  with  worldwide  exclusive  rights  to  Turn’s  proprietary  antimicrobial  technology  platform,  PermaFusion®,  for  the  development  of  future
products focused on Advanced Wound Care and Surgical Recovery applications.

PermaFusion® is petrolatum-based, liquid-in-oil suspension technology that involves the creation of nanodroplets without binding agents or emulsifiers
and  also  includes  a  process  to  coat  materials  with  antimicrobial-infused  petrolatum.  Turn’s  intellectual  property  estate  includes  “mixing”  and  “coating”
intellectual  property  and  provides  protection  up  to  20  years.  MIMEDX  expects  this  technology  to  be  included  in  the  creation  of  a  number  of  new
antimicrobial products for the Wound & Surgical markets.

In addition to the exclusive license obtained to Turn’s intellectual property, MIMEDX will acquire the commercial rights to Turn’s FleX™ Antimicrobial
Collagen  Matrix  product,  contingent  upon  its  receipt  of  FDA  510(k)  clearance  and  other  conditions.  FleX™  is  a  bovine  collagen  powder  product  that
incorporates antimicrobial properties to aid in the management of partial and full thickness wounds.

Under the terms of the agreement, MIMEDX has exclusive rights to develop future products for the wound care, burn, and surgical fields using Turn’s
intellectual property. Turn received an upfront cash payment from MIMEDX and is entitled to future payments upon completion of regulatory and product
commercial milestones, along with royalties on the sales of products covered by the licensed intellectual property.

OEM Products

We sell a selection of allografts on an Original Equipment Manufacturer (“OEM”) basis pursuant to an agreement under which we have granted a third
party  an  exclusive  license  to  some  of  our  technology  for  use  in  dental  applications.  This  agreement  is  concluding  during  2023,  after  which  we  do  not
anticipate generating sales of our allograft products on an OEM basis.

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We continue to research new opportunities for amniotic and other placental tissue, and we have additional offerings in various stages of conceptualization
and development.

Placenta Donation Program

We  partner  with  physicians  and  hospitals  to  recover  donated  placental  tissue.  Through  our  donor  program,  a  mother  who  delivers  a  healthy  baby  via
Caesarean section can donate her placenta and umbilical cord tissue in lieu of having it discarded as medical waste. After consent for donation is obtained,
a  blood  sample  from  each  donor  is  tested  for  communicable  diseases,  and  the  donor  is  screened  for  risk  factors  in  order  to  determine  eligibility  in
compliance with federal regulations and AATB standards. We operate a licensed tissue bank that is registered as a tissue establishment with the FDA, and
we are an accredited member of the AATB. All donor records and test results are reviewed by our Medical Director and staff prior to the release of the
tissue for distribution.

We have developed a large, geographically diverse, network of hospitals across the United States that participate in our placenta donation program, and we
employ  a  dedicated  staff  that  work  with  these  hospitals.  We  also  utilize  third-party  providers  of  placenta  donations  on  an  as-  needed  basis  to  mitigate
business risk. We believe that we will be able to obtain an adequate supply of tissue to meet anticipated demand for the foreseeable future.

Processing (Manufacturing)

The Company has developed and patented a unique and proprietary technique (PURION) for processing allografts from the donated placental tissue. This
technique specifically focuses on preserving the tissue’s natural growth factor content and regulatory proteins, and maintaining the structure and collagen
matrix  of  the  tissue.  Our  patented  and  proprietary  processing  method  employs  aseptic  processing  techniques  in  addition  to  terminal  sterilization  for
increased product safety. Despite starting with similar placental tissues, all placental tissue products and processing methods are not the same – we believe
that our proprietary process preserves more of the natural beneficial characteristics of the tissue than the processes used by many of our competitors.

The PURION process produces an allograft that retains the tissue’s inherent biological properties and regulatory proteins (including cytokines, chemokines,
and growth factors) found in the placental tissue and produces an allograft that is safe and easy for healthcare providers to use. The allograft can be stored
at room temperature and has a five-year shelf life. Each sheet allograft incorporates specialized visual markings that assist the health care practitioner with
allograft placement and orientation.

To  ensure  the  safety  of  human  tissue  products,  the  FDA  enforces  CGTP  manufacturing  regulations.  We  believe  that  MIMEDX  has  developed  robust
systems  to  comply  with,  and  is  in  compliance  with,  these  regulations.  As  an  important  part  of  the  Company’s  product  safety  compliance,  MIMEDX
products are terminally sterilized to an internationally recognized industry standard in addition to having been processed via the PURION process.

Our facilities are subject to periodic unannounced inspections by regulatory authorities and may undergo compliance inspections conducted by the FDA
and corresponding state and foreign agencies. We are registered with the FDA as a tissue establishment and are subject to the FDA’s CGTP quality program
regulations,  state  regulations,  and  regulations  promulgated  by  various  regulatory  authorities  outside  the  United  States.  The  Company’s  September  2018
FDA inspection for compliance with CGTP regulations resulted in no observations and a no action indicated (“NAI”) rating, which is the most favorable
designation  the  FDA  provides  after  an  inspection.  In  December  2019,  the  FDA  conducted  CGMP  inspections  at  our  Marietta,  Georgia,  and  Kennesaw,
Georgia, processing facilities. The FDA issued a Form FDA 483 (“483”), which is a list of inspectional observations, at the conclusion of each inspection.
Specifically, the FDA issued a 483 consisting of nine observations at our Marietta, Georgia processing facility, and a 483 consisting of 14 observations at
our Kennesaw, Georgia processing facility. MIMEDX timely responded to the FDA regarding each observation, providing substantive responses to all of
the observations. The Company’s response included completed and planned actions to address each observation, and all of these remedial actions have been
completed.  The  FDA  classified  its  December  2019  inspection  of  our  Kennesaw,  Georgia  facility  as  voluntary  action  indicated  (“VAI”),  which  means
objectionable conditions or practices were found in their December 2019 inspection but the agency is not taking or recommending any administrative or
regulatory actions. The FDA also categorized its December 2019 inspection of our Marietta, Georgia facility as VAI. The Company believes it has made
progress in its CGMP compliance and continued to make quality improvements through its quality plan.

Intellectual Property

Our  intellectual  property  includes  owned  and  licensed  patents,  owned  and  licensed  patent  applications  and  patents  pending,  proprietary  manufacturing
processes and trade secrets, and trademarks associated with our technology. We believe that our patents, proprietary manufacturing processes, trade secrets,
trademarks, and technology licensing rights provide us with important competitive advantages.

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Patents and Patent Applications

Due to the substantial expertise and investment of time, effort and financial resources required to bring new regenerative biomaterial products and implants
to  the  market,  the  importance  of  obtaining  and  maintaining  patent  protection  for  significant  new  technologies,  products  and  processes  cannot  be
underestimated.  As  of  the  date  of  the  filing  of  this  Annual  Report,  in  addition  to  international  patents  and  patent  applications,  we  own  68  U.S.  patents
related to our amniotic tissue technology and products, and 30 additional patent applications covering aspects of this technology are pending at the United
States Patent and Trademark Office. The vast majority of our domestic patents covering our core amniotic tissue technology and products will not begin to
expire until August 2027. Globally, the Company has over 200 issued and pending patents.

Market Overview

Domestic sales currently account for substantially all of our revenue, and we are actively pursuing international expansion, primarily targeting Japan and
select countries in Europe, Asia Pacific, and the Middle East. In the United States, our primary areas of clinical use include Advanced Wound Care and
Surgical Recovery applications.

Advanced Wound Care

The Advanced Wound Care market is comprised of products such as medical devices, advanced dressings, xenografts, biological products, and HCT/Ps,
which are used as skin substitutes to treat severe wounds or chronic wounds that have not appropriately closed after four weeks of treatment with traditional
or standard of care dressings. Not included in Advanced Wound Care are traditional wound care dressings, such as bandages, gauzes and ointments, which
typically are used in the treatment of non-severe or non-chronic wounds.

In the United States, estimates indicate that in 2022 the prevalence of chronic wounds was 2.1% of the total U.S. population, or approximately 6.9 million
people suffering from chronic wounds. Of these chronic wounds, approximately 58% or 4.0 million are categorized as chronic leg ulcers (which include
DFUs  and  VLUs),  with  47%  treated  with  Advanced  Wound  Care  dressings  such  as  skin  substitutes .  MIMEDX  is  a  leader  in  the  cellular  tissue
products/skin  substitute  segment  of  the  Advanced  Wound  Care  category  and  the  amniotic  tissue  allograft  sub-category.  We  expect  these  markets  will
continue to grow due to certain demographic trends, including an aging population, increasing incidence of obesity and diabetes and the associated higher
susceptibility  to  non-healing  chronic  wounds.  Furthermore,  the  increasing  number  of  patients  requiring  advanced  treatment  represents  a  significant  cost
burden on the healthcare system. The overall cost of treating chronic wounds is rising sharply, and the current annual estimated cost in the United States
7
exceeds $28 billion .

6

Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard
of care” for treating chronic wounds such as DFUs and VLUs. If, after four weeks of standard of care therapy, the wound has not responded appropriately
or improved, clinical research has shown that advanced therapy such as a skin substitute can be beneficial as part of the patient’s treatment plan. However,
often  times  advanced  therapies  are  not  employed  due  to  current  treatment  guidelines,  product  access,  or  medical  education  around  the  clinical  and
economic benefits of advanced skin substitutes. We believe this represents a large opportunity for us to expand the market and drive initiatives resulting in
market  growth.  According  to  data  provided  by  BioMedGPS,  MIMEDX’s  EPIFIX  is  the  current  product  of  choice  for  physicians  choosing  to  use  an
amniotic skin substitute product as a barrier or cover. Our EPIFIX and EPICORD products can be stored at room temperature for up to five years compared
to certain other skin substitutes currently on the market that require cryogenic freezer storage, have limited shelf life, and may not be human-derived. In
addition,  we  market  multiple  sizes  of  EPIFIX  and  EPICORD  sheets  for  use  as  protective  barriers,  which  enables  a  healthcare  provider  to  select  an
appropriate  size  graft  based  on  the  size  of  the  wound  to  reduce  product  waste.  Our  EPICORD  and  EPICORD  Expandable  product  lines  also  offer  an
alternative treatment option to address larger, deeper wounds in a cost-effective way earlier in the treatment algorithm.

Surgical Recovery

We are expanding beyond Advanced Wound Care into areas where the use of our tissue products could help reduce complications across several surgical
specialties,  including  plastic  surgery,  general  surgery,  gynecology,  urology,  orthopedics,  spinal  surgery,  lower  extremity  repair  and  sports  medicine
procedures.  Collectively,  we  refer  to  these  areas  as  the  Surgical  Recovery  segment  of  the  market.  Certain  surgical  procedures  can  have  an  increased
likelihood of complications such as dehiscence, adhesions, and others that may affect both the recovery of the patient and the outcome of the surgery. The
rate of complications can depend on a number of factors, including the complexity of the procedure and patient specific issues, such as obesity, diabetes or
advanced age.

In  the  Surgical  Recovery  setting,  applications  of  our  products  are  used  to  augment  tissue,  serve  as  a  barrier  membrane  in  procedures  where  scar  tissue
formation may be problematic or where a second surgery may be required, or aid in incisional

6
 GlobalData: 2022 Wound Care Management- Tissue Engineered Skin Subs U.S. Updated May 2022
7
 Chronic Wounds: Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

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closure  with  the  goal  of  preventing  or  reducing  procedural  complications.  Following  a  thorough  review  of  surgical  procedures  and  potential  clinical
applications across several specialties, we have identified those areas where we believe our tissue products could be incorporated. We are targeting certain
procedures for use of our products based on unmet clinical need, potential procedural complication rate, clinical relevance, economic factors and overall
business priorities. As in Advanced Wound Care, we believe this market is expanding as a result of demographic trends, including an aging population,
increasing incidence of obesity and diabetes and the associated higher susceptibility to non-healing chronic wounds.

AXIOFILL

The  Company  launched  AXIOFILL  during  the  third  quarter  of  2022.  AXIOFILL  is  an  extracellular  matrix  derived  from  human  placental  disc,  and  is
designed to provide a cost-effective human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries. Our
AXIOFILL product has seen initial adoption by clinicians primarily focused on Surgical Recovery applications.

AMNIOEFFECT

The  Company  also  launched  AMNIOEFFECT  during  the  third  quarter  of  2022.  AMNIOEFFECT  is  a  tri-layer  placental  tissue  allograft  that  contains
amnion, intermediate layer, and chorion membranes. This product is designed to meet the needs of surgeons performing procedures where a more robust
allograft with expansive size offerings is desired.

AMNIOFIX

AMNIOFIX  is  a  semi-permeable,  protective  barrier  allograft  comprised  of  dehydrated  human  amnion/chorion  membrane  that  may  be  used  in  Surgical
Recovery applications. AMNIOFIX is available in an assortment of sheet configurations and sizes for internal use, including in the areas of lower extremity
repair, spine, orthopedic, sports medicine, gastrointestinal, urologic, and other general surgery applications.

International

The  Company  is  actively  pursuing  international  expansion,  with  an  initial  focus  on  Japan.  Estimates  for  2022  indicate  that  within  a  total  Japanese
population  of  approximately  126  million  people,  there  are  approximately  629,000  chronic  leg  ulcers,  100,000  of  which  are  potential  candidates  for  an
Advanced Wound Care product . The Japanese population has the largest proportion of people 65 or older in the world, estimated to be approximately 36.2
million (28.8%) in 2020, increasing the potential need for healthcare products and services . We believe these demographic trends, along with an increasing
incidence  of  obesity  and  diabetes  and  the  associated  higher  susceptibility  to  non-healing  chronic  wounds,  present  a  significant  unmet  patient  need  and
underpenetrated market opportunity.

8

9

MIMEDX received regulatory approval from the Japanese Ministry of Health, Labor and Welfare (“JMHLW”) in June 2021 to market EPIFIX in Japan, as
the first amniotic tissue approved for hard-to-heal chronic wounds, such as DFUs and VLUs, which do not respond to conventional therapy. We secured
reimbursement  approval  in  September  2022,  and  are  putting  in  place  the  necessary  structure,  medical  education  programs,  and  market  development
initiatives to operationalize our commercial strategy. In December 2022, we announced an exclusive distribution agreement with Gunze Medical for sales
of EPIFIX in the Japanese market. Under the terms of the agreement, Gunze Medical and its team of dedicated sales representatives will work to distribute
EPIFIX for clinicians to treat patients with hard-to-heal DFUs and VLUs across Japan. MIMEDX will be responsible for the supply of EPIFIX to Gunze
Medical,  which  will  sell  the  products  locally,  pursuant  to  the  indications  for  use  and  reimbursement  rates  secured  for  the  product.  The  parties  will
collaborate to continue physician education activities and drive further key opinion leader engagement in-country.

The Company is also evaluating opportunities for geographic expansion in the United Kingdom and certain other countries in Europe and the Middle East.
Current efforts are focused on the collection of real-world evidence to support the development of patient treatment guidelines, health economic analysis,
and product reimbursement in core markets.

Biologics License Application (BLA) Programs

In 2017, the FDA released guidance clarifying its views that certain cellular and tissue-based products, including certain products marketed by MIMEDX,
are considered drugs, devices, and/or biological products subject to Section 351 requirements under the federal Food, Drug and Cosmetic Act (the “FD&C
Act”). In order to conform to this regulatory guidance, MIMEDX is pursuing an indication under the BLA pathway, although there can be no assurance that
we will obtain a BLA and we may ultimately decide not to pursue a BLA for this product or indication.

8
 GlobalData: 2022 Wound Care Management – Tissue Engineered Skin Subs, Japan, updated May 2022; management estimates
9
 Statistics Bureau of Japan, https://www.stat.go.jp/english/data/handbook/c0117.html

12

mDHACM is our lead BLA product candidate and we are currently focused on conducting a post-Phase 2B registrational clinical trial for the KOA market,
which we initiated in February 2023. See Clinical Trials, below, for more information.

After  oral  non-habit  forming  pain  medication  fails  to  adequately  relieve  a  patient’s  joint,  ligament  or  tendon  pain,  market  available  injections  such  as
corticosteroids  and  hyaluronic  acid  are  commonly  used  treatment  options.  However,  a  number  of  patients  still  do  not  get  adequate  relief  from  these
injections, or do not want to use corticosteroids for a variety of reasons. Additionally, in light of the crisis with opioid abuse, non-surgical treatments and
alternative approaches to musculoskeletal pain management are under consideration. Patients and physicians are searching for new products that are safe
and effective for the management of chronic and degenerative musculoskeletal conditions.

11

Osteoarthritis (“OA”) is a disease characterized by progressive articular cartilage destruction, ultimately leading to disabling pain and joint dysfunction.
The  knee  is  the  most  commonly  affected  joint  and  knee  OA  represents  the  leading  cause  of  disability  in  the  adult  population.  Estimates  indicate  that
approximately 18 million people suffered from symptomatic knee osteoarthritis in 2022 , and this number is expected to increase to 19 million people by
2025 .  According  to  the  Arthritis  Foundation,  more  than  half  of  knee  osteoarthritis  sufferers  are  younger  than  65  years  old.  Current  treatment  options
include  analgesics,  non-steroidal  anti-inflammatory  drugs  (“NSAIDs”),  injectable  corticosteroids,  viscosupplements,  platelet  rich  plasma,  and  other
emerging  therapies.  Approximately  80%  of  symptomatic  knee  OA  patients  fail  conservative  therapy .  When  conservative  and  non-operative  treatment
options  fail,  patients  often  consider  surgical  intervention.  According  to  estimates  by  Global  Data’s  United  States  Knee  Reconstruction  Model,
approximately one million people required knee reconstruction surgery in 2022 with 2% needing bilateral knee replacement. Costs for knee replacement
procedures can exceed $55,000, on average. We believe there is significant unmet need for a non-surgical treatment option to reduce pain and improve
function in patients suffering from knee osteoarthritis. Current estimates of the potential addressable market for mDHACM are dependent on many factors,
including the results of our clinical trial program, recommended place in the knee osteoarthritis treatment algorithm, anticipated dosing regimen, as well as
the  potential  for  our  clinical  trials  to  demonstrate  disease  modifying  characteristics  which  could  further  amplify  the  market  opportunity.  However,
mDHACM has not yet been approved by the FDA for any such use.

10

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Marketing and Sales

Our  direct  sales  team  includes  field  sales  representatives  and  field  sales  management,  who  call  on  hospitals,  wound  care  clinics,  physician  offices,  and
federal health care facilities such as the Department of Veterans Affairs (the “VA”) and Department of Defense (“DoD”) hospitals. Our direct sales force
focuses on the Advanced Wound Care and Surgical Recovery categories through multiple sites of service. We also maintain a network of independent sales
agents that focus on Surgical Recovery applications leveraging the complementary products in their portfolios, and provide access to certain customers, as
well as sales coverage for areas where we do not have a full-time sales representative.

We also sell our products through distributors. Distributors purchase products from us at wholesale prices and resell products to providers and end users.
For example, in Japan, our distribution partner, Gunze Medical, purchases products from us and is responsible for sales to the end users for the approved
indications of use and at the prevailing reimbursement rate for the product. See Note 12, Revenue to our consolidated audited financial statements included
in Item 8 of this Annual Report.

Coverage and Reimbursement

With the exception of government accounts, most purchasers of our products include physicians, hospitals, or ambulatory surgery centers (“ASCs”) that
rely  on  reimbursement  by  third-party  payers.  Accordingly,  our  growth  substantially  depends  on  adequate  levels  of  third-party  reimbursement  for  our
products  from  these  payers.  Third-party  payers  are  sensitive  to  the  cost  of  products  and  services  and  are  increasingly  seeking  to  implement  cost
containment measures to control, restrict access to, or influence the purchase of health care products and services. In the U.S., such payers include U.S.
federal  healthcare  programs  (e.g.,  Medicare  and  Medicaid),  private  insurance  plans,  managed  care  programs,  and  workers’  compensation  plans.  Federal
healthcare  programs  have  prescribed  coverage  criteria  and  reimbursement  rates  for  medical  products,  services,  and  procedures.  Similarly,  private,  third-
party  payers  have  their  own  coverage  criteria  and  negotiate  reimbursement  amounts  for  medical  products,  services,  and  procedures  with  providers.  In
addition, in the U.S., an increasing percentage of insured individuals are receiving their medical care through managed care programs (including managed
federal healthcare programs) which monitor and may require pre-approval of the products and services that a member receives. Ultimately, however, each
third-party payer determines whether and on what conditions they will provide coverage for our products, and such decisions often include each payer’s
assessment of the science and efficacy of the applicable product.

A portion of our products is purchased by U.S. government accounts (e.g., the VA and the Public Health Service, including the Indian Health Service),
which do not depend on reimbursement from third-party payers. In order for us to be eligible to have

10

11

12

 GlobalData: 2022 Orthopedic Devices — Knee Reconstruction – US – 2015-2030
 GlobalData: 2020 Orthopedic Devices – Knee Reconstruction – US – 2015-2030
 GlobalData: 2020 Orthopedic Devices – Viscosupplementation – US – 2015-2030

13

our products purchased by such federal agencies and paid for by the Medicaid program, federal law requires us to participate in the VA Federal Supply
Schedule (“FSS”) pricing program.

Medicare Coverage

The  largest  third-party  payer  in  the  United  States  is  the  Medicare  program,  which  is  a  federally-funded  program  that  provides  healthcare  coverage  for
senior citizens and certain disabled individuals. The Medicare program is administered by the Centers for Medicare and Medicaid Services (“CMS”), an
agency  within  the  U.S.  Department  of  Health  and  Human  Services  (“HHS”).  Medicare  Administrative  Contractors  (“MACs”)  are  private  insurance
companies  that  serve  as  agents  of  CMS  in  the  administration  of  the  Medicare  program  and  are  responsible  for  making  coverage  decisions  and  paying
claims for the designated Medicare jurisdiction. There are seven Part A/B MACs in the U.S., which cover 12 unique geographical jurisdictions. Each MAC
also has its own standards and process for determining coverage and reimbursement for a procedure or product. Private payers often follow the lead of
governmental  payers  in  making  coverage  and  reimbursement  determinations.  Therefore,  achieving  favorable  Medicare  coverage  and  reimbursement  is
usually a significant gating factor for successful adoption of a new product or clinical application by private payers.

The  coverage  and  reimbursement  framework  for  products  under  Medicare  is  determined  in  accordance  with  the  Social  Security  Act  and  pursuant  to
regulations promulgated by CMS, as well as the agency’s coverage and reimbursement guidance. In some cases, CMS does not specify coverage, leaving
each  of  the  MACs  to  determine  whether  and  on  what  conditions  they  will  provide  coverage  for  the  product.  Such  decisions  are  based  on  each  MAC’s
assessments  of  the  science  and  efficacy  of  the  applicable  product.  As  noted  below  under  the  heading  “Research  and  Development,”  we  have  devoted
significant resources to clinical studies to provide data to the MACs, as well as other payers, in order to demonstrate the clinical efficacy and economic
effectiveness  of  our  tissue  technologies.  As  of  the  date  of  this  report,  both  EPIFIX  and  EPICORD  allografts  are  eligible  for  coverage  by  all  MACs.  In
January  2019,  EPIFIX  and  EPICORD  received  separate  CMS  HCPCS  Codes,  Q4186  and  Q4187,  distinguishing  each  product  in  coverage  and
reimbursement policies.

For  Medicare  reimbursement  purposes,  our  EPIFIX  and  EPICORD  allografts  are  classified  as  “skin  substitutes.”  Current  reimbursement  methodology
varies between the hospital outpatient department (“HOPD”) and ASC setting versus the physician office. Currently, within the HOPD and ASC places of
service,  skin  substitutes  are  reimbursed  under  a  “packaged”  or  “bundled”  methodology  that  provides  a  single  payment  for  both  the  application  of  the
product as well as the product itself. CMS classifies skin substitutes into low cost or high cost groups, based on a geometric mean unit cost and per day
cost. For 2022, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was $48 per square centimeter, and
the per day cost threshold was $949. For 2023, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was
$47 per square centimeter, and the per day cost threshold was $949. The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD
allograft products was $1,549 in 2019, $1,623 in 2020, $1,715 in 2021, $1,749.26 in 2022, and is $1,725 in 2023. CMS assigns lower national rates to the
ASC to reflect a less resource-intensive place of service. Revenue in the ASC setting constitutes less than 1% of the Company’s annual net sales. Medicare
payments for most items and services, including EPIFIX and EPICORD sheet products, have been subject to sequestration reductions of approximately 2%
periodically from 2013.

Currently, providers that administer EPIFIX or EPICORD allografts and other skin substitutes in the physician office setting are reimbursed based on the
size of the graft, computed on a per square centimeter basis. The payment rate is calculated using the manufacturer’s reported average sales price (“ASP”)
submitted quarterly to CMS. This payment methodology applies to physician offices, as well as places of service such as patient home, assisted living and
nursing home. The Medicare payment rates are updated quarterly based on this ASP information for many skin substitute products but not all. EPIFIX and
EPICORD are included on the Medicare national ASP Drug Pricing File. The published skin substitute Medicare payment rate established by statute is
ASP  plus  6%.  Reimbursement  for  products  not  included  on  the  Medicare  national  ASP  Drug  Pricing  File  are  at  the  discretion  of  each  MAC,  which
typically is invoice cost or wholesale acquisition cost (“WAC”) plus 6%.

Recently, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office,
and  are  under  consideration  by  the  CMS.  In  addition,  three  MACs  have  recently  published  for  public  comment  changes  to  their  Local  Coverage
Determinations (“LCDs”) that they are considering. If adopted, these proposals would significantly change Medicare policies governing the reimbursement
of skin substitute products principally when used for wound treatment in the private physician office setting. The LCDs in the proposals could adopt a new
standard  of  clinical  evidence  required  as  a  prerequisite  to  coverage.  In  addition,  the  proposals  all  require  a  confirmation  that  the  products  are  regulated
solely under Section 361 of the Public Health Service Act as a prerequisite to continued coverage. We have the required confirmation for EPIFIX, but not
currently  for  EPICORD.  The  proposed  LCDs  also  include  language  that  could  lower  the  number  of  allowed  applications  of  a  product  below  what  is
commonly used in standard practice by physicians today (supported by clinical evidence) and reflected by LCDs currently in force with the MACs. The
Company as well as stakeholders across the wound care industry do not support lowering the applications.

Private Payers

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We have devoted considerable resources to clinical trials to support coverage and reimbursement of our products. An increasing number of private payers
reimburse for EPIFIX and EPICORD in the physician office, the HOPD and the ASC settings, and we have complete national commercial coverage for the
use of EPIFIX in the treatment of DFUs. Coverage and reimbursement vary according to the patient’s health plan and related benefits. The majority of
health  plans  currently  provide  coverage  for  EPIFIX  and  EPICORD  for  the  treatment  of  DFUs,  and  many  include  treatment  of  VLUs.  MIMEDX  has
secured payer coverage for over 300 million covered lives, allowing a significant number of patients access to our products. Information contributing to the
coverage determination included a third-party technical brief (by the Agency for Healthcare Research and Quality (“AHRQ”)) that evaluated a number of
skin substitutes for treating chronic wounds, in which EPIFIX was noted to have the most Randomized Controlled Trials, a low risk of overall study bias,
and statistically significant findings.

We  have  established  and  continue  to  grow  a  reimbursement  support  group  to  educate  providers  and  patients  with  regard  to  accurate  coverage  and
reimbursement information regarding our products, and plan to continue investing in clinical data supportive of coverage for our products in additional
clinical areas of use.

Hospital Use

Products administered in the hospital inpatient setting are bundled when submitted as part of the hospital’s claim under a diagnosis-related group (“DRG”).
In these cases, we continue to educate the hospital that our products are cost-effective, and have the potential to improve patient outcomes and reduce the
length of stay. We are working to develop additional health economic data to support this effort. As noted above, the ability to sell products in a hospital is
dependent upon demonstrating to the hospital the product’s efficacy and cost effectiveness.

Seasonality

Revenues  during  our  fourth  quarter  tend  to  be  stronger  than  other  quarters  because  many  hospitals  increase  their  purchases  of  our  products  during  the
fourth quarter to coincide with the end of their budget cycles in the United States. Satisfaction of patient deductibles through the course of the year also
results in increased revenues later in the year. In general, our first quarter usually has lower revenues than the preceding fourth quarter, the second and third
quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in the year.

Customer Concentration

For the years ended December 31, 2022, 2021, and 2020, our net sales to all U.S. government accounts comprised approximately 2%, 3% and 5% of our
net sales, respectively. See discussion below in Item 1A, Risk Factors under the heading “A portion of our revenues and accounts receivable come from
government accounts.”

Competition

Due to lower barriers of entry in the Section 361 HCT/P regulated market, competition in the placenta-based and allograft tissue field is intense and subject
to  new  entrants  and  evolving  market  dynamics.  Companies  within  the  industry  compete  on  the  basis  of  price,  ease  of  handling,  logistics  and  efficacy.
Another important factor is third-party reimbursement, which is difficult to obtain as it is a time-consuming and expensive process. We believe our success
in  obtaining  third-party  reimbursement,  our  strong  position  with  group  purchasing  organizations,  capabilities  and  investments  to  apply  CGMP,  and
established clinical evidence for our products are competitive advantages.

In February 2020, the AHRQ published a technology assessment analyzing Skin Substitutes for Treating Chronic Wounds. AHRQ conducted a literature
search  yielding  164  studies  and  81  Supplemental  Evidence  and  Data  for  Systematic  Reviews  (“SEADs”)  submissions.  Only  22  randomized,  controlled
trials (“RCTs”) met the inclusion criteria to be reviewed in the AHRQ analysis, and out of the 22 RCTs MIMEDX had six RCTs included in the final brief.
Of  the  22  studies  reviewed,  only  12  were  assessed  as  low  risk  of  bias,  of  which  five  were  MIMEDX  RCTs.  This  important  government  assessment
highlights our commitment to providing unbiased level 1 clinical evidence in advanced wound treatment. This dedication to elevating the standard of care
is  further  underscored  by  the  fact  that  the  AHRQ  points  out  in  its  assessment  that  MIMEDX  was  the  only  entity  to  provide  two  studies  out  of  the  22
evaluated  that  performed  a  subgroup  analysis  of  patients  with  DFUs  that  received  adequate  debridement.  Both  studies  reported  an  increase  in  wounds
healed with adequate debridement.

Advanced Wound Care therapies employ technologies to aid in wound healing in cases where the wound is chronic and healing progress has stalled or
stopped. The primary competitive products in the skin substitutes category include, among others, placental-tissue allografts, tissue-engineered living skin
equivalents, porcine-, bovine- and fish skin-derived xenografts and collagen matrix products. Xenografts, or tissue transplants from non-human species,
serve mainly as an extracellular matrix and have to undergo aggressive processing to remove immunogenic animal products from the tissue. In addition,
challenges with xenografts include limited clinical published data, and some products may require suturing or stapling to the wound bed, making handling
more difficult. Furthermore, other skin substitutes currently on the market require cryogenic freezer storage and have limited shelf life.

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Our  main  competitors  in  the  skin  substitute  market  include  Integra  LifeSciences  Holdings  Corporation,  Organogenesis,  Inc.,  and  Smith  &  Nephew  plc,
which  sell  a  variety  of  Advanced  Wound  Care  products,  including  skin  substitutes  and  placental  tissue  allografts.  In  addition,  the  overall  market  is
competitive, with a large number of other, smaller competitors that compete regionally and nationally.

Our  Regenerative  Medicine  efforts  around  KOA  are  also  subject  to  a  wide  range  of  potential  future  competitors.  Based  on  published  information  from
across the medical device and biotherapeutics industry, there are over 70 other active R&D programs currently developing potential treatments for KOA
using a variety of different scientific approaches. The speed with which we can successfully develop our product, complete clinical trials, obtain regulatory
clearance, and begin commercialization efforts for our KOA offering will influence our ability to succeed in this market.

Government Regulation

The products manufactured and processed by the Company are derived from human tissue. As discussed below, our Section 361 HCT/Ps are tissue-based
products that are regulated solely under Section 361 and do not require pre-market clearance or approval by the FDA. Our Section 351 HCT/Ps are also
tissue products, but are regulated as biological products, and, in order to be lawfully marketed in the United States, require FDA pre-market approval.

Tissue Products

In  1997,  the  FDA  proposed  a  regulatory  framework  for  cells  and  tissues.  This  framework  was  intended  to  provide  adequate  protection  of  public  health
while enabling the development of new therapies and products with limited regulatory burden. A key innovation in the system was that covered HCT/Ps
would be regulated solely under Section 361 and would not be subject to pre-market clearance. The registration and listing rules were finalized in January
2001  in  21  CFR  Part  1271.  Additional  rules  regarding  donor  eligibility  and  good  tissue  practices  were  soon  adopted.  Together,  these  rules  form  a
comprehensive system intended to encourage significant innovation.

The FDA requires each HCT/P establishment to register and establish that its product meets the requirements to qualify for regulation solely under Section
361. To be a Section 361 HCT/P, a cellular or tissue-based product generally must meet all four of the following criteria (fully set forth in 21 CFR Part
1271):

•
•
•
•

it must be minimally manipulated;
it must be intended for homologous use;
its manufacture must not involve combination with another article, except for water, crystalloids or a sterilizing, preserving or storage agent; and
it must not have a systemic effect and must not be dependent upon the metabolic activity of living cells for its primary function.

Certain amniotic and other birth tissues are considered cellular and tissue-based articles and are therefore eligible for regulation solely as a Section 361
HCT/P depending on whether the specific product at issue and the claims made for it are consistent with the criteria set forth above. HCT/Ps that do not
meet these criteria are subject to more extensive regulation as drugs, medical devices, biological products, or combination products.

Products Regulated Solely as Section 361 HCT/Ps

The FDA has specific regulations governing HCT/Ps, including some regulations specific to Section 361 HCT/Ps, which are set forth in 21 CFR Part 1271.
All establishments that manufacture Section 361 HCT/Ps must register and list their HCT/Ps with the FDA’s Center for Biologics Evaluation and Research
within five days after commencing operations. In addition, establishments are required to update their registration annually in December or within 30 days
of certain changes and submit changes in HCT/P listing at the time of or within six months of such change.

The regulations in 21 CFR Part 1271 also require establishments to comply with donor screening, eligibility and testing requirements, and CGTP to prevent
the introduction, transmission and spread of communicable diseases. The CGTP govern, as may be applicable, the facilities, controls, and methods used in
the manufacture of all HCT/Ps, including processing, storage, recovery, labeling, packaging, and distribution of Section 361 HCT/Ps. CGTP require us,
among  other  things,  to  maintain  a  quality  program,  train  personnel,  control,  and  monitor  environmental  conditions  as  appropriate,  control  and  validate
processes, properly store, handle and test our products and raw materials, maintain our facilities and equipment, keep records and comply with standards
regarding  recovery,  pre-distribution,  distribution,  tracking  and  labeling  of  our  products,  and  complaint  handling.  21  CFR  Part  1271  also  mandates
compliance with adverse reaction and CGTP deviation reporting and labeling requirements.

The FDA conducts periodic inspections of HCT/P manufacturing facilities, and contract manufacturers’ facilities, to assess compliance with CGTP. Such
inspections  can  occur  at  any  time,  with  or  without  written  notice,  at  such  frequency  as  determined  by  the  FDA  in  its  sole  discretion.  To  determine
compliance  with  the  applicable  provisions,  the  inspection  may  include,  but  is  not  limited  to,  an  assessment  of  the  establishment’s  facilities,  equipment,
finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers and controls required to be maintained under
21 CFR Part 1271.

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If the FDA were to find serious non-compliant manufacturing or processing practices during such an inspection, it could take regulatory actions that could
adversely affect our business, results of operations, financial condition, and cash flows.

2017 FDA Guidance and Transition Policy for HCT/Ps

In  November  2017,  the  FDA  released  four  guidance  documents  that,  collectively,  the  agency  described  as  a  “comprehensive  policy  framework”  for
applying existing laws and regulations governing regenerative medicine products, including HCT/Ps. One guidance document in particular, “Regulatory
Considerations for Human Cells, Tissues, and Cellular and Tissue – Based Products: Minimal Manipulation and Homologous Use – Guidance for Industry
and Food and Drug Administration Staff,” offered important clarity.

The  guidance  documents  confirmed  that  sheet  forms  of  amniotic  membrane  generally  are  appropriately  regulated  as  solely  Section  361  HCT/Ps  when
intended for use as a barrier or covering. We continually evaluate our marketing materials for each of our products to align with FDA guidance.

Second, the guidance documents confirmed the FDA’s stance that all micronized amniotic membrane products are more than minimally manipulated, and
therefore do not qualify as Section 361 HCT/Ps. However, the guidance documents also stated that the FDA intended to exercise enforcement discretion
under limited conditions with respect to the IND application and pre-market approval requirements for certain HCT/Ps through November 2020, which was
later extended through May 2021. This period of enforcement discretion was intended to give sponsors time to evaluate their products, have a dialogue with
the agency and, if necessary, begin clinical trials and file the appropriate pre-market applications. The FDA’s approach was risk-based, and the guidance
documents clarified that high-risk products and uses could be subject to immediate enforcement action.

This  enforcement  discretion  applied  across  our  industry,  and  during  the  period,  the  Company  continued  to  market  its  products  under  this  policy  of
enforcement  discretion.  After  May  31,  2021,  the  Company  no  longer  markets  or  sells  its  products  that  were  impacted  by  enforcement  discretion  in  the
United States. We are pursuing the BLA pre-market approval process for certain uses of mDHACM. However, there is no assurance that the FDA will
grant these approvals on a timely basis, or at all, or that we will not discontinue our pursuit of a BLA for certain products or indications. See “Clinical
Trials” below for more information.

Products Regulated as Biologics – The BLA Pathway

The typical steps for obtaining FDA approval of a BLA to market a biological product in the United States include:

•
•

•

Completion of preclinical laboratory tests, animal studies and formulations studies under the FDA’s Good Laboratory Practice regulations;
Submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin and
which must include independent Institutional Review Board approval at each clinical site before the trials may be initiated;
Performance of adequate and well-controlled clinical trials in accordance with Good Clinical Practices to establish the safety and efficacy of the
product and its dosage (as applicable) for each indication;

• Development  of  purity,  potency  and  identity  tests  to  demonstrate  consistency  and  reliability  of  the  manufacturing  process  through  a  chemistry,

manufacturing and control program;
Submission to the FDA of a BLA for marketing the product that includes, among other things, reports of the outcomes and full data sets of the
clinical trials, and proposed labeling and packaging for the product;
Satisfactory review of the contents of the BLA by the FDA, including the satisfactory resolution of any questions raised during the review;
Satisfactory completion of an FDA Advisory Committee review, if applicable;
Satisfactory  completion  of  an  FDA  inspection  of  the  manufacturing  facility  or  facilities  at  which  the  product  is  produced  to  assess  compliance
with FDA’s CGMP regulations, to assure that the facilities, methods and controls are adequate to ensure the product’s identity, potency, quality and
purity; and
FDA approval of the BLA, including agreement on post-marketing commitments, if applicable.

•

•
•
•

•

Generally, clinical trials are conducted in three phases, though the phases may overlap or be combined. Phase 1 trials typically involve a small number of
healthy volunteers and are designed to provide information about the product safety and to evaluate the pattern of drug distribution and metabolism within
the  body.  Phase  2  trials  are  conducted  in  a  larger  but  limited  group  of  patients  afflicted  with  a  particular  disease  or  condition  in  order  to  determine
preliminary efficacy, dosage tolerance and optimal dosing, and to identify possible adverse effects and safety risks. Dosage studies are typically designated
as Phase 2A, and efficacy studies are designated as Phase 2B. Phase 3 clinical trials are generally large-scale, multi-center, comparative trials conducted
with patients who have a particular disease or condition in order to provide statistically valid proof of efficacy, as well as safety and potency. In some cases,
the FDA will require Phase 4, or post-marketing trials, to collect additional data after a product is on the market. All phases of clinical trials are subject to
extensive record keeping, monitoring, auditing, and reporting requirements.

The  FDA  has  broad  regulatory  compliance  and  enforcement  powers.  If  the  FDA  determines  that  the  Company  has  failed  to  comply  with  applicable
regulatory requirements, it can take a variety of compliance or enforcement actions, such as issuing an FDA Form 483 notice of inspectional observations;
sending a warning letter or untitled letter; issuing an order of retention,

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destruction, or cessation of marketing; imposing civil money penalties; suspending or delaying issuance of approvals; requiring product recalls; imposing a
total or partial shutdown of production; withdrawing approvals or clearances already granted; pursuing product seizures, consent decrees or other injunctive
relief; and criminal prosecution through the Department of Justice (“DOJ”).

Clinical Trials

Trial Overview

The Company previously completed four IND studies investigating the use of mDHACM to reduce pain and increase function in patients with KOA, as
well as plantar fasciitis and Achilles tendonitis. The Company is not currently pursuing the use of mDHACM to treat plantar fasciitis or Achilles tendonitis.
The  Company  continues  to  pursue  the  use  of  mDHACM  to  treat  KOA.  The  Company  has  instituted  several  actions  with  respect  to  its  ongoing  and
anticipated clinical trials to address the resources, capabilities, and expertise needed for an effective dialogue with the FDA regarding our BLA progress.
However, there can be no assurance that we will obtain BLA approval and we may ultimately decide not to pursue a BLA for this or for other products or
indications.

Knee Osteoarthritis Trial Overview

In March 2018, the FDA granted mDHACM the Regenerative Medicine Advanced Therapy (“RMAT”) designation for use in the treatment of osteoarthritis
of the knee. RMAT-designated products are eligible for increased and earlier interactions with the FDA, similar to those interactions available to fast-track
and breakthrough-designated therapies. In addition, these products may be eligible for rolling review and accelerated approval. The meetings with sponsors
of RMAT- designated products may include discussions of whether accelerated approval would be appropriate based on surrogate or intermediate endpoints
reasonably likely to predict long-term clinical benefit or reliance upon data obtained from a meaningful number of sites.

In  March  2018,  we  initiated  a  Phase  2B  prospective,  double-blinded  RCT  investigating  a  single  intra-articular  injection  of  40  mg  of  mDHACM  as
compared to a single injection of saline (placebo control) in the treatment of pain and functional impairment in patients with osteoarthritis of the knee. This
trial was planned to enroll 318 patients, with an interim analysis to assess adequacy of this sample size built into the statistical plan. This blinded interim
analysis  was  performed  in  July  through  August  2019  and  revealed  that  while  differences  in  the  treatment  groups  were  observed,  the  power  to  observe
statistically and clinically significant results would be enhanced by increasing the sample size to 466 patients. Amendments to the protocol to allow this
increase were subsequently approved. It should be noted that during the first half of 2020 in particular, study enrollment slowed considerably due to the
ongoing COVID-19 pandemic, although this impact did begin to resolve in the third quarter of the year. Due to actual dropout rates observed in the study
being lower than planned, in September 2020 we completed enrollment of 447 patients. We also amended the protocol to establish an open label extension
to the trial and allow patients to receive a second injection of the active treatment at six months, nine months, or 12 months subsequent to their completion
of study visits, if their pain has not resolved or responded, regardless of treatment arm. The study was still blinded to subjects, sites, and MIMEDX during
this extension. The six months blinded efficacy visits in this study were completed during the second quarter of 2021, and analyses were completed during
the third quarter of 2021. The final study visits occurred (open label extension) during the second quarter of 2022. The final endpoint of the study was at 12
months.  All  12-month  visits  have  now  been  completed,  and  data  analysis  has  been  accomplished.  MIMEDX  is  currently  evaluating  these  results  and
preparing a clinical report.

As  previously  announced,  the  trial  did  not  meet  its  primary  endpoints  at  six  months.  However,  in  a  cohort  of  190  subjects  enrolled  prior  to  a  planned
interim analysis performed for sample size correction in July through August 2019, a statistically significant and clinically meaningful difference in favor
of mDHACM in WOMAC total scores and both the pain and function subscales compared to the placebo was observed. Subjects enrolled after this interim
analysis  did  not  show  separation  of  results  from  the  mDHACM  treated  from  those  of  the  placebo  arm.  Third-party  biostatisticians  validated  the
improvement in WOMAC Pain at three and six months, respectively (p=0.032 and p=0.009), WOMAC Function (p=0.046 and p=0.009), and WOMAC
Total (p=0.038 and p=0.008) for the Pre-Interim Analysis Cohort of 190 patients. A root-cause analysis determined that the potency of the investigational
product  decreased  as  it  aged,  which  we  believe  caused  the  study  to  fail  to  meet  its  primary  endpoints.  The  Company’s  proprietary  biochemical  and
biological  tests,  along  with  the  clinical  observations,  detected  this  reduced  potency.  Based  on  the  clinically  meaningful  and  statistically  significant  data
from the Pre-Interim Analysis Cohort of 190 patients in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing
scientific mechanism of action research, the Company initiated the first of two registrational KOA trials in February 2023 and has been working closely
with the FDA in advancing this program.

There can be no assurance, however, that our anticipated time frame for the registrational KOA trials and submitting a BLA will be achieved or that we will
receive  FDA  approval  for  mDHACM  and  be  able  to  commercialize  this  product,  or  that  such  approval  will  not  be  delayed  for  a  variety  of  reasons,
including failure of the studies to achieve their endpoints; the impact of the COVID-19 pandemic or other public health emergencies on study enrollment
and FDA operations; the potential that the results of the clinical studies do not merit further investment; and the work required to achieve commercial and
manufacturing readiness.

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Prior to May 31, 2021, the date the FDA’s period of enforcement discretion ended, we also filed investigational applications for additional indications for
AMNIOFIX Injectable and EPIFIX Micronized. These two INDs were allowed to proceed for the injectable products, one in chronic wounds, another in
surgical incisions. We have not yet initiated any clinical trials related to these applications, and have no immediate plans to advance these programs.

BLA Process

If  study  results  support  potential  product  approval  and  potential  for  commercialization,  we  intend  to  file  a  BLA  as  described  above.  The  process  of
obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources, and may take years to complete, including costs
incurred on top of those fees incurred as part of conducting various clinical studies. The fee for filing a BLA and the annual user fees payable with respect
to any establishment that manufactures biologics and with respect to each approved product are substantial. While there can be no assurance that we will
ultimately  obtain  regulatory  approval  for  our  micronized  products,  we  have  already  completed  substantial  work  towards  our  BLA  program,  including
engineering our manufacturing processes to conform to CGMP requirements.

FDA Post–Market Regulation

Tissue  processors  regulated  solely  under  Section  361  are  still  required  to  register  as  a  tissue  establishment  with  the  FDA.  As  a  registered  tissue
establishment, we are required to comply with regulations regarding labeling, record keeping, donor eligibility, screening, and testing. We are also required
to process the tissue in accordance with established CGTP, as well as report any deviations from core CGTP requirements or adverse reactions caused by a
possible transmission of an infectious disease attributed to our tissue. Our facilities are also subject to periodic inspections to assess our compliance with
the regulations.

Products covered by a BLA, New Drug Application, 510(k) clearance or a pre-market approval are subject to numerous additional regulatory requirements,
which  include,  among  others,  compliance  with  CGMP  (or,  in  the  case  of  devices,  with  FDA’s  Quality  System  Regulation),  which  imposes  certain
procedural,  substantive  and  record  keeping  requirements,  and  labeling  regulations  to  ensure  the  product’s  identity,  potency,  quality,  and  purity.  These
products are also subject to the FDA’s general prohibition against promoting products for unapproved or “off-label” uses, and additional adverse reaction
reporting.

As part of our BLA development effort, we are updating our manufacturing establishments into maintaining application of CGMP for production of our
injectable and other applicable Section 351 products. The process includes development and enhancement of production processes, procedures, tests, and
assays,  and  it  requires  extensive  validation  work.  It  also  involves  the  procurement  and  installation  of  new  production  and  lab  equipment.  These  efforts
require  human  capital,  expertise,  and  resources.  We  have  made  significant  improvements  over  the  last  two  years.  We  have  engaged  industry  experts  to
assess our state of compliance and to provide guidance on the additional activities needed to maintain CGMP. Significant improvements include a newly
built, validated processing suite applying CGMP that is utilized for processing of Section 351 products.

Other Regulation Specific to Tissue Products

National Organ Transplant Act

Procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act (“NOTA”), which
prohibits the transfer of certain human organs, including skin and related tissue, for valuable consideration, but permits the reimbursement of reasonable
expenses  associated  with  the  removal,  transportation,  implantation,  processing,  preservation,  quality  control,  and  storage  of  human  tissue  and  skin.  Our
wholly-owned  subsidiary,  MiMedx  Tissue  Services,  LLC,  is  registered  with  the  FDA  as  an  establishment  that  manufactures  human  cells,  tissues,  and
cellular and tissue- based products and is involved with the recovery and storage of donated human placental tissues. We reimburse tissue banks, hospitals,
and physicians for their services associated with the recovery and storage of donated human tissue.

Tissue Bank Laws, Regulations, and Related Accreditation

As discussed above, we are required to register with the FDA as an establishment that manufactures human cells, tissues, and cellular and tissue-based
products. We are licensed, registered, or permitted as a tissue bank in California, New York, Delaware, Illinois, Oregon, and Maryland. Additionally, we
received  and  actively  maintain  AATB  accreditation.  The  AATB  has  issued  operating  standards  for  tissue  banking.  Compliance  with  these  standards  is
required  in  order  to  become  an  AATB-accredited  tissue  establishment.  AATB  standards  include  specific  requirements  for  recovery,  screening,  testing,
labeling, processing, and storing of birth tissue. We maintain compliance with AATB standards and our state licensure requirements.

To the extent we sell our products outside of the United States, we also are subject to laws and regulations of foreign countries.

Other Healthcare Laws and Compliance Requirements

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In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including CMS,
other divisions of the HHS (e.g., the Office of Inspector General), the DOJ and individual United States Attorney offices within the DOJ, and state and
local governments. These regulations include those described below.

•

•

•

The federal Anti-Kickback Statute (“AKS”), which is a criminal law that prohibits, among other things, any person from knowingly and willfully
offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in
cash or in kind, to induce or reward referrals, purchases or orders, or arranging for or recommending the purchase, order or referral of any item or
service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs. The
term “remuneration” has been broadly interpreted to include anything of value. The Patient Protection and Affordable Care Act amended the intent
requirement of the federal AKS, so that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. A
conviction for violation of the AKS results in criminal fines and requires mandatory exclusion from participation in federal health care programs.
Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices
from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully
satisfy all elements of an available exception or safe harbor.

The  federal  False  Claims  Act  (“FCA”)  imposes  significant  civil  liability  on  any  person  or  entity  that  knowingly  presents,  or  causes  to  be
presented, a claim for payment to the U.S. government, including the Medicare and Medicaid programs, that is false or fraudulent. The FCA also
allows a private individual or entity as a whistleblower to sue on behalf of the government to recover civil penalties and treble damages. FCA
liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of between
$11,181  and  $22,363  per  false  claim  or  statement  for  penalties  assessed  after  January  29,  2018,  with  respect  to  violations  occurring  after
November 2, 2015. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or
demand” for money or property presented to the U.S. government.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) fraud and abuse provisions prohibit executing a scheme to
defraud  any  healthcare  benefit  program,  willfully  obstructing  a  criminal  investigation  of  a  health  care  offense,  or  making  false  statements  or
concealing a material fact relating to payment for healthcare benefits, items or services.

• While  manufacturers  of  human  cell  and  tissue  products  regulated  solely  under  Section  361  are  not  subject  to  the  federal  Physician  Payments
Sunshine  Act  and  its  implementing  regulations  (together  with  the  Act,  the  “Sunshine Act”),  in  the  future,  if  we  expand  our  product  portfolio
beyond those regulated solely under Section 361, this law will require us (with certain exceptions) to report information to CMS related to certain
payments or other transfers of value we make to U.S.-licensed physicians and teaching hospitals, and for reports submitted on or after January 1,
2022, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives. If we receive a
BLA  approval,  the  Sunshine  Act  would  also  require  us  to  report  annually  certain  ownership  and  investment  interests  held  by  U.S.-licensed
physicians and their immediate family members. Such information will subsequently be made publicly available by CMS on the Open Payments
website. There is a risk that CMS or another government agency may take the position that our products are not human cell and tissue products
regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties
and the administrative burden of having to comply with the law.

•

•

Federal conflicts of interest laws, the Standards of Ethical Conduct for Employees of the Executive Branch, and local site policies for each federal
institution we call upon govern our interactions with federal employees at our various government accounts (e.g., DoD, VA, etc.) and impose a
number of limitations on such interactions.

There  are  state  law  equivalents  of  each  of  the  above  federal  laws,  such  as  anti-kickback  and  false  claims  laws,  which  may  apply  to  items  or
services reimbursed by any third-party payer, including commercial insurers, many of which differ from each other in significant ways and often
are not preempted by federal laws, thus complicating compliance efforts.

In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing regulations, imposes
certain  requirements  relating  to  the  privacy,  security  and  transmission  of  protected  health  information.  Among  other  things,  HITECH  made  HIPAA’s
privacy  and  security  standards  directly  applicable  to  “business  associates,”  independent  contractors  or  agents  of  covered  entities  that  receive  or  obtain
protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary
penalties,  amended  HIPAA  to  make  civil  and  criminal  penalties  directly  applicable  to  business  associates  and  possibly  other  persons  and  gave  state
attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees
and  costs  associated  with  pursuing  federal  civil  actions.  In  addition,  state  laws  govern  the  privacy  and  security  of  health  information  in  certain
circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

International Regulation (Japan)

20

MIMEDX received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (JMHLW) to market EPIFIX in Japan. Under JMHLW
guidelines, EPIFIX is classified as a Class IV Medical Device and “Specified Biological Product” and is approved for the treatment of refractory ulcers,
such  as  DFUs  and  VLUs  that  do  not  respond  to  conventional  therapy.  As  a  condition  of  the  final  approval,  MIMEDX  will  conduct  post-market
surveillance, consisting of a limited study over 75 participants. The JMHLW has the ultimate responsibility of granting final approval on all Class III and
IV  Medical  Devices  and  “Specified  Biological  Products.”  All  approved  products  in  Japan,  including  EPIFIX,  are  regulated  by  the  Pharmaceuticals  and
Medical Devices Agency (“PMDA”), which acts as the technical arm of the JMHLW. The PMDA serves in a similar function as the FDA in the United
States, and is responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices in Japan. The PMDA provides review and
approval of medical devices, QMS/GLP/GCP inspections, and collection and analysis of adverse event reports.

MIMEDX also secured reimbursement approval from JMHLW on September 1, 2022 with an awarded rate of 35,100 Yen/cm , and subsequently entered
into  an  exclusive  distribution  agreement  with  Gunze  Medical  for  sales  of  EPIFIX  in  Japan.  Insurance  coverage  for  EPIFIX  will  provide  doctors  and
patients in Japan with new treatment options and optimal wound care.

2

Research and Development

Our  research  and  development  group  has  extensive  experience  in  developing  products  for  our  target  markets,  and  works  to  design  products  that  are
intended to improve patient outcomes, simplify techniques, shorten procedures, reduce hospitalization and rehabilitation times and, as a result, reduce costs.
Our research and development group also works to establish scientific evidence in support of the use of our products. Clinical trials that demonstrate the
safety, efficacy and cost effectiveness of our products are key to obtaining broader third-party reimbursement for our products. In addition to our internal
staff, we contract with outside laboratories and physicians who aid us in our research and development process. See Part II, Item 7, below, for information
regarding expenditures for research and development in each of the last three fiscal years.

Environmental, Social & Governance Matters (“ESG”)

At MIMEDX, we are committed to improving people’s health and lives through innovation that makes healing possible. Our product offering is derived
from donated human placental and umbilical cord tissue, which are processed into products used by health professionals to treat patients suffering from
both acute and chronic hard-to-heal wounds. We are continuously looking to expand the breadth of our product offering, further leveraging birth tissue that
would otherwise become medical waste, and have a product pipeline that includes innovations for wound and surgical end markets as well as a potential
treatment  option  for  other  conditions  such  as  knee  osteoarthritis  (KOA).  Our  Core  Values  define  how  we  lead  the  field  with  rigorous  science,  help
clinicians elevate the standard of care, provide a safe and healthy environment for our employees, and work and grow as a company.

In an effort to deliver long-term value to all of our stakeholders, we incorporate environmental, social, and governance (ESG) objectives that are relevant to
our business. These ESG objectives are informed by a combination of feedback from our stakeholders as well as leading ESG frameworks, such as the
Sustainability Accounting Standards Board (SASB) Medical Equipment & Supplies standards, under the oversight of our Board of Directors.

Environmental Matters

Stewardship is a Core Value at MIMEDX. We are stewards of a precious, life-protecting and life-giving resource – human birth tissue – which currently
represent the biological source material for all of our products. Without our placental donation and recovery program, this material would most likely be
discarded as medical waste at the hospital. We do not produce a significant amount of emissions from our operations.

Environmental Management

We recently worked with a third-party to conduct an environmental, health, and safety gap assessment in order to accurately benchmark our environmental
impact. The review looked at several areas including:

• Air Pollution Control Management
Battery Handling and Disposal
•
•
Community Right-to-Know (Hazardous Material Reporting)
• Hazardous Waste Management
•
•
•
•

SARA Title III (Release Reporting)
Solid Waste Management
Spill, Prevention, Control and Countermeasure
State Pollutant Discharge Elimination System (SPDES)

21

•
Storm Water Management
• Universal Waste Management
• Waste Oil Management

We are evaluating the results of this exercise in order to consider implementation of measures in support of our Environmental Management program.

Waste Management

We work with waste removal providers to responsibly dispose of medical waste and biohazardous waste and have a program in place for the management
of all medical and biohazardous waste processed in our facilities. In addition, we follow applicable packaging requirements for regulated medical waste,
and  conduct  regular  required  training  for  all  employees  responsible  for  packaging  medical  waste  for  shipment.  Our  waste  management  initiatives  also
include  the  shredding  and  recycling  of  paper  waste  from  our  facilities,  our  transition  to  digital  systems  where  possible  to  reduce  print  waste,  and  the
distribution of electronic tablets to our sales teams to minimize printing needs, shipping costs, and printed materials.

Our facilities management team collects recyclable and reusable material when possible, including for cardboard, plastics, batteries, fluorescent lamps, and
ballasts.  We  have  significantly  reduced  the  use  of  plastic  and  aluminum  materials  with  the  installation  of  filtered  water  and  soda  machines  within  our
facilities. The packaging of our product cartons is recyclable and, since 2015, has been reduced in size by 50%.

Human Capital

As  of  December  31,  2022,  we  had  867  full  time  employees.  Generally,  we  consider  our  relationships  with  our  employees  to  be  good,  and  none  of  our
employees are covered by a collective bargaining agreement. We conduct regular surveys of employees to monitor engagement levels and act on feedback
received through this process.

Our Diversity and Inclusion

MIMEDX values the diversity of perspective, experience, and background within our Company. We have stated goals to promote diversity, inclusion, and
equal opportunity regardless of race, gender, nationality, ethnic origin, religion, age, or sexual orientation. Intimidation or harassment of any kind are not
acceptable in our workplace.

Our  business  requires  a  workforce  with  a  wide  range  backgrounds,  experiences,  skills,  and  knowledge  and  a  culture  that  blends  this  diversity  into  an
effective team. In order for our employees to do their best work, and for us to achieve our mission, everyone at MIMEDX must feel respected, valued, and
included.  Comprised  of  employees  across  the  company,  our  Inclusion  and  Diversity  Council  implements  programs  to  create  greater  visibility  to  work
environment challenges, champion diversity, and provide an intentional link for each employee to the company values and goals.

The table below provides an overview of MIMEDX’s diversity as of December 31, 2022:

Board of Directors

Employee Gender Diversity

Employee Ethnic/Racial
Diversity

Women and minorities hold one-third of the seats on our Board, including the Chair of the Board.
Women represented 57% of our workforce as of December 31, 2022.
Women represented 61% of our new hires in 2022.
Black or African American: 25%
Hispanic or Latino: 8%
Other Non-White (including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific Islander): 6%

Recruiting, Retaining, and Engaging Talent

Talent is our greatest asset and we are dependent on being able to recruit, develop, and retain talent that share our Core Values. We use tools, such as an
interview guide and a process reviewed by our Inclusion and Diversity Council, designed to prevent us from bias in our hiring decisions. We are currently
in compliance with affirmative action reporting. As part of our Affirmative Action Plan, we leverage targeted outreach in our hiring process to ensure our
postings reach underrepresented groups.

We  are  focused  on  retaining  our  talented  professionals  who  we  believe  are  key  to  the  Company’s  success.  Our  human  resource  group  continuously
monitors and benchmarks employee turnover and other trends in our industry and on a regional level to ensure MIMEDX is competitive and responsive to
changes in the broader marketplace. Combining this data with feedback from exit interviews in any instances of voluntary employee turnover, we are able
to use these actionable insights to improve

22

 
 
 
employee engagement, provide opportunities for career development, evolve our total rewards offering and evaluate implementation of additional resources
to enhance the employee experience at MIMEDX.

Training and Development

We provide financial assistance to employees earning certifications through our Tuition Reimbursement Plan. Internally, we provide personal development
and goal setting courses and counsel to help our employees understand how to grow their careers and learn new things.

Compensation and Benefits

We offer all full-time employees a comprehensive benefits package, including:

• Health coverage, including Medical, Dental, Vision insurance, a wellness incentive program and virtual and text-based healthcare
•
•
•
•
•
•

Paid Parental and Caregiver leave
Employee Assistance Program
Paid company holidays, recently adding Juneteenth
Tuition Reimbursement Program
401(k) plan, including Employer match
Employee Stock Purchase Plan

Available Information

We are required to file proxy statements, annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K with the SEC. The
SEC maintains an internet site, www.sec.gov, where these reports are available free of charge. We also make these reports available free of charge on our
website,  www.mimedx.com,  under  the  heading  “Investors–SEC  Filings.”  In  addition,  our  Audit  Committee,  Compensation  Committee,  Ethics  and
Compliance Committee, and Nominating and Corporate Governance Committee Charters as well as our Code of Business Conduct and Ethics, are on our
website  under  the  heading  “Investors–Corporate  Governance.”  The  reference  to  our  website  does  not  constitute  incorporation  by  reference  of  any
information contained on that site.

23

Item 1A. Risk Factors

An investment in our Common Stock involves a substantial risk of loss. Set forth below is a summary of the risks and uncertainties affecting our business
that  we  currently  believe  to  be  material.  We  caution  you  to  read  the  following  risk  factors,  which  have  affected,  and/or  in  the  future  could  affect,  our
business,  prospects,  operating  results,  and  financial  condition.  Additional  risks  and  uncertainties  not  currently  known  to  us  or  that  we  currently  deem
immaterial may also affect our business, prospects, operating results, and financial condition. Additional risks and uncertainties are described under other
captions in this report and should also be considered by our stockholders. If any of these risks materialize, our business, financial condition or operating
results could suffer. In this case, the trading price of our Common Stock could decline, and you may lose part or all of your investment.

Risks Related to Our Business and Industry

If we do not successfully execute our priorities, our business, operating results and financial condition could be adversely affected.

•
• We  are  in  a  highly  competitive  and  evolving  field  and  face  competition  from  well-established  tissue  processors  and  medical  device

Summary of Risk Factors

manufacturers, as well as new market entrants.
Rapid technological change could cause our products to become obsolete.

•
• Our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.
•

Public  health  emergencies,  such  as  the  COVID-19  pandemic  and  the  governmental  and  societal  responses  thereto  have  adversely  affected  our
business in the past and future outbreaks could harm our business in the future.

• We depend on our senior leadership team and may not be able to retain or replace these employees or recruit additional qualified personnel.
• A portion of our revenues and accounts receivable come from government accounts.
• Our  revenues  depend  on  adequate  reimbursement  from  public  and  private  insurers  and  health  systems  and  changes  to  the  way  in  which  our

products are reimbursed in various sites of service could adversely impact our financial results.

• Our revenue, results of operations and cash flows may suffer upon the loss of a Group Purchasing Organization or Integrated Delivery Network.
• We contract with independent sales agents and distributors.
• Disruption of our processing could adversely affect our business, financial condition and results of operations.
•

To be commercially successful, we must convince physicians, where appropriate, how and when our products are proper alternatives to existing
treatments and that our products should be used in their procedures.
If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial
condition, and results of operations could be adversely impacted.
The  formation  of  physician-owned  distributorships  could  result  in  increased  pricing  pressure  on  our  products  or  harm  our  ability  to  sell  our
products to physicians who own or are affiliated with those distributorships.

•

•

The products we manufacture and process are derived from human tissue and therefore have the potential for disease transmission.

• We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.
•
• We may implement a product recall or voluntary market withdrawal.
• A cyberattack or significant disruptions of information technology systems could adversely affect our business.
• We may expand or contract our business through acquisitions, divestitures, licenses, investments, and other commercial arrangements.
• New lines of business or new products and services may subject us to additional risks.
• Our international expansion and operations outside the U.S. expose us to risks.

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

•

•

Certain of our products no longer qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of
the Public Health Service Act, which has resulted in removal of the applicable products from the market, made the introduction of some new
tissue  products  more  expensive,  significantly  delayed  the  expansion  of  our  tissue  product  offerings  and  subjected  us  to  additional  post-market
regulatory requirements. Additional regulatory requirements may be imposed in the future.
If any of the BLAs are approved, the Company would be subject to additional regulation which will increase costs and could result in adverse
sanctions for non-compliance. Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and
time consuming and may impede our ability to fully exploit our technologies.

24

 
 
•

If any of the BLAs are approved, we would be subject to additional regulation which will increase costs and could result in adverse sanctions for
non-compliance.

• Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time consuming and may impede

our ability to fully exploit our technologies.

• Our business is subject to extensive regulation by the FDA and other authorities, which is costly.
• We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for unapproved,

or off-label, uses.

• We and our sales representatives must comply with various federal and state anti-kickback, self-referral, false claims and similar laws.
• Our results of operations may be adversely affected by current and potential future healthcare reforms.
• We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.
•

Federal and state laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect and use
that information and subject us to liability if we are unable to fully comply with such laws.

Risks Related to Our Intellectual Property

• Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate.
• We may become subject to claims of infringement of the intellectual property rights of others.
• We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed
alleged  trade  secrets,  proprietary  or  confidential  information  of  our  competitors  or  are  in  breach  of  non-competition  or  non-solicitation
agreements with our competitors.

Risks Related to our Past Audit Committee Investigation, Consolidated Financial Statements, Internal Controls and Related Matters

•

If we fail to maintain adequate internal control over financial reporting in the future, this could adversely affect our business, financial condition
and operating results.

• Negative publicity, including publicity relating to or arising from the Restatement, the Audit Committee Investigation, or related matters, has had

and could continue to have an adverse effect on our business, results of operations and financial condition.

• We are currently, in the past have been, and may in the future be, subject to substantial litigation and ongoing investigations that could cause us to

incur significant legal expenses and result in harm to our business.

Risks Related to the Securities Markets and Ownership of Our Common Stock
• Our substantial indebtedness may adversely affect our financial health.
• Our variable rate indebtedness under the Hayfin Loan Agreement subjects us to interest rate risk.
•
EW Healthcare Partners and its interests may conflict with those of our other shareholders.
• Holders of shares of our Series B Preferred Stock have rights, preferences and privileges that are not held by, and are preferential to, the rights of,

our common shareholders.

• Our Series B Preferred Stock is convertible into shares of our Common Stock, and any such conversion may dilute the value of our Common

Stock.
The price of our Common Stock has been, and will likely continue to be, volatile.
Securities analysts may elect not to report on our common stock or may issue negative reports that adversely affect the stock price.
Fluctuations in revenue or results of operations could cause additional volatility in our stock price.

•
•
•
• We do not intend to pay cash dividends on our Common Stock.
•

Certain provisions of Florida law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control.

25

 
 
 
Risks Related to Our Business and Industry

If we do not successfully execute our priorities, our business, operating results and financial condition could be adversely affected.

Our priorities in our Advanced Wound Care and Surgical Recovery Wound & Surgical business are to address large, underpenetrated market opportunities,
domestically  and  internationally,  including  by  launching  new  organic  or  inorganic  products.  We  intend  to  implement  and  maintain  rigorous  CGMP
standards throughout our entire supply chain and continue to advance the scientific body of evidence substantiating clinical efficacy, economic viability and
the underlying mechanism of action for our PURION processed placental tissue platform through additional peer-reviewed publications, rigorous scientific
research  and  clinical  studies.  We  are  also  focused  on  pursuing  FDA  approval  for  mDHACM  as  a  platform  technology  in  our  Regenerative  Medicine
segment  to  treat  musculoskeletal  degeneration  across  multiple  indications,  and  initiated  a  post-Phase  2B  registrational  KOA  program  study  in  February
2023.

We have sought and may continue to seek capital to implement our priorities. In developing our priorities, we evaluated many factors including, without
limitation, those related to developments in our industry, customer demand, competition, regulatory developments, and general economic conditions.
Actual conditions may be different from our assumptions, and we may not be able to successfully execute our priorities. If we do not successfully execute
our priorities, or if actual results vary significantly from our assumptions, our business, operating results and financial condition could be adversely
impacted.

We are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device manufacturers, as
well as new market entrants.

Our  business  is  in  a  very  competitive  and  evolving  field.  Competition  from  other  tissue  processors,  medical  device  companies,  and  biotherapeutic
companies, and from research and academic institutions, is intense, expected to increase and subject to rapid change and could be significantly affected by
new product introductions as well as changes in reimbursement that could favor certain products and competitors over others. Established competitors and
newer market entrants are investing in additional clinical research that may allow them to gain further clinician usage, adoption and payer coverage of their
products.  In  addition,  consolidation  and  cost  containment  measures  in  the  healthcare  industry  may  cause  hospitals  to  consolidate  their  purchases  with
suppliers that have a broad portfolio of products. This would continue to give rise to demands for price concessions, which could have an adverse effect on
our business, results of operations and financial condition. Further, competitors may introduce placental-based membrane products in the future at lower
prices,  adding  new  features  or  gaining  additional  reimbursement  coverage,  or  utilize  sales  and  marketing  practices  that  negatively  impact  the  industry.
Further, they may copy our products outside the United States. The presence of this competition may lead to pricing pressure, which could have an adverse
effect on our business, results of operations and financial condition.

Rapid technological change could cause our products to become obsolete and, if we do not enhance our product offerings through our research and
development efforts, we may be unable to compete effectively.

The technologies underlying our products are subject to rapid technological change. Competition intensifies as technical advances in each field are made
and become more widely known. Others may develop services, products or processes with significant advantages over the products, services and processes
that we offer or are seeking to develop. Any such occurrence could have an adverse effect on our business, results of operations and financial condition.

We  plan  to  enhance  and  broaden  our  product  offerings  as  part  of  a  strategy  that  involves  responding  to  changing  customer  demands  and  competitive
pressure and technologies, among other factors. The success of any new product offering or enhancement to an existing product will depend on numerous
factors, including our ability to:

•
•
•
•
•
•

properly identify and anticipate physician and patient needs;
acquire, through licensing, co-development or outright purchase, new technology developed outside of MIMEDX;
develop and introduce new products or product enhancements in a timely manner;
adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties;
demonstrate the safety and efficacy of new products; and
obtain the necessary regulatory clearances or approvals for new products or product enhancements.

If  we  do  not  develop  and,  when  necessary,  obtain  regulatory  clearance  or  approval  for  new  products  or  product  enhancements  in  time  to  meet  market
demand, or if there is insufficient demand for these products or enhancements, our results of operations and financial condition will suffer. Our research
and  development  efforts  may  require  a  substantial  investment  of  time  and  resources,  including  additional  capital,  before  we  are  adequately  able  to
determine  the  commercial  viability  of  a  new  product,  technology,  material  or  other  innovation.  In  addition,  even  if  we  are  able  to  successfully  develop
enhancements or new generations of our products, these enhancements or new generations of products may not produce sales in excess of the costs

26

of development, or they may never receive required regulatory approval and they may be quickly rendered obsolete by changing customer preferences or
the introduction by our competitors of products embodying new technologies or features.

Our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.

The success of our human tissue products depends upon, among other factors, the availability of tissue from human donors. Any failure to obtain tissue
from our sources will interfere with our ability to effectively meet demand for our products incorporating human tissue. The availability of donated tissue
could  also  be  adversely  impacted  by  regulatory  changes,  public  opinion  of  the  donor  process  and  our  own  reputation  in  the  industry.  We  may  not  be
successful in our ability to scale tissue recovery efforts to meet the potential future demand of our pipeline. Obtaining adequate supplies of human tissue
involves several risks, including limited control over availability (due to for example, access to hospital accounts and the number of consenting mothers),
quality, delivery schedules, and eligibility requirements. In addition, any interruption in the supply of any human tissue component could harm our ability
to manufacture our products until a new source of supply, if any, could be found. We also utilize third-party providers of placental donations on an as-
needed basis to mitigate risks but there can be no assurance that these third parties will be able to provide donated tissues at all times. We may be unable to
find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable terms, if at all, which would have an adverse effect
on our business, results of operations and financial condition.

Public health emergencies, such as the COVID-19 pandemic and the governmental and societal responses thereto have adversely affected our business,
results of operations and financial condition in the past, and future outbreaks could harm our business, results of operations, and financial condition
in the future.

The  COVID-19  pandemic  and  governmental  and  societal  responses  thereto  have  adversely  affected  our  business,  results  of  operations  and  financial
condition and future public health emergencies could have similar and wide-ranging impacts to our business. See Item 7, Management’s Discussion and
Analysis - Results of Operations. Public health emergencies such as these have the potential to adversely affect our operations and increase our costs and
expenses in numerous ways. For example:

• We source raw materials for our products from donated placentas from scheduled C-section births via a large, geographically-diverse network of
donor hospitals. We may experience shortages of donated placentas if donors or our recovery specialists are excluded from hospitals, or if other
disruptions occur. We experienced interruptions from a portion of our hospitals in certain geographic areas in the first half of 2020, in late 2021
and in early 2022. To date, we have been successful in mitigating this disruption to our supply by adding additional donor hospitals, increasing
efforts at hospitals that did not impose access limits, and using third-party providers of donated placentas (where necessary and in accordance with
MIMEDX  quality  standards).  However,  there  can  be  no  assurance  that  our  efforts  to  source  raw  materials  for  our  products  will  continue  to  be
successful, and we may experience shortages of raw materials, especially if the current pandemic, including further strains, or responses thereto
intensify.  Additionally,  we  may  experience  shortages  of  donated  placentas  if  additional  testing  protocols  are  implemented  for  donated  tissues
based on guidance issued by the AATB, the FDA, or other standards, and are screened as ineligible.

• We process donated tissue using aseptic techniques in a controlled environment. However, the manufacturing space is a confined space area in
which  an  infected  employee  may  spread  viruses  such  as  the  flu  and  COVID-19  to  other  employees  despite  the  use  of  personal  protective
equipment required for all areas at MIMEDX. To date, we have been successful in mitigating these risks through a variety of measures, however,
there  can  be  no  assurance  that  our  efforts  to  prevent  wide-scale  infections  among  our  processing  staff  will  continue  to  be  successful.  If  we
experience wide-scale infections among our production staff, we may experience a shortage of finished goods.

• Our ability to sell our products was previously hampered by the COVID-19 pandemic. In many areas of the country, our sales force was excluded
from hospitals and the offices of other health care providers for periods of time. Additionally, many patients stayed away from hospitals and other
medical facilities. This had adverse effects on our revenues for periods of time in the past. We are not able to estimate the future effect of COVID-
19 or other public health emergencies on patient behavior and, consequently, future demand or the ability of providers to pay for our products.

•

Similarly, our clinical researchers, clinical study coordinators, and their patients have experienced restrictions in their access to hospitals and
ability to access other healthcare providers, which has slowed enrollment in our clinical trials in the past. If such access were to be restricted again,
it might again impair or delay the initiation, approval and launch of future products or additional clinical trials.

27

If our leadership, employees, sales agents, suppliers, medical professionals, or users of our products are impacted by an epidemic, by illness, or through
social  distancing,  quarantine  or  other  precautionary  measures  taken  in  connection  therewith,  then  our  manufacturing  operations,  sales,  demand  for  our
products, and clinical trials may be adversely affected.

Disruptions to the health care system generally, such as if patients are unable or unwilling to visit health care providers, or if health care providers prioritize
treatment of acute or communicable illnesses over wound care, have affected and may continue to adversely affect our revenues and results of operations.

The ultimate impact of the COVID-19 pandemic remains uncertain and subject to change. We do not yet know the full extent of delays or impacts on our
business,  our  clinical  trials,  healthcare  systems  or  the  global  economy  as  a  whole,  or  how  long  such  effects  will  endure.  The  effects  of  the  COVID-19
pandemic or other public health emergencies could have an adverse impact on our business, results of operations and financial condition.

We depend on our senior leadership team and may not be able to retain or replace these employees or recruit additional qualified personnel, which
would harm our business, results of operations and financial condition.

Our  business  and  success  are  materially  dependent  on  attracting  and  retaining  members  of  our  senior  leadership  team  to  formulate  and  execute  the
Company’s business plans. Since June 2018, we have made significant changes to our senior leadership team, and hired several new senior leaders.

Leadership  changes  can  be  inherently  difficult  to  manage  and  may  cause  material  disruption  to  our  business  or  management  team.  Changes  in  senior
management  could  also  lead  to  an  environment  that  presents  additional  challenges  in  recruiting  and  retaining  employees,  which  could  have  an  adverse
effect  on  our  business,  results  of  operations  and  financial  condition.  We  experienced  difficulties  in  recruiting  due  to  legal  and  business  uncertainties
resulting from the issues that were the subject of the Audit Committee Investigation.

Our future success will also depend, in part, upon our ability to attract and retain skilled personnel, including sales, managerial and technical personnel.
There can be no assurance that we will be able to continue to find and attract additional qualified employees to support our expected growth or retain any
such personnel.

A portion of our revenues and accounts receivable come from government accounts.

Some of our revenues are derived from sales, both direct and through a distributor, to the government. Any disruption of our products on the FSS or any
change in the way the government purchases products like ours or the price it is willing to pay for our products could adversely affect our business, results
of operations and financial condition.

Our revenues depend on adequate reimbursement from public and private insurers and health systems and changes to the ways in which our products
are reimbursed in various sites of service could adversely impact our financial results.

Our success depends on the extent to which our customers receive adequate reimbursement for the costs of our products and related treatments from third-
party payers, including government healthcare programs, such as Medicare and Medicaid, as well as private insurers and health systems. Government and
other third-party payers attempt to contain healthcare costs by limiting both coverage and the level of reimbursement of medical products, particularly new
products. Therefore, significant uncertainty may exist as to the reimbursement status of new healthcare products by third-party payers. Although EPIFIX
and EPICORD have coverage with the majority of large payers, a significant number of public and private insurers currently do not cover or reimburse our
other products.

The reimbursement landscape for our products varies depending upon the site in which the products are administered. If we are not successful in obtaining
adequate coverage and reimbursement for our products from these third-party payers in one or more of the sites of service where our products are used, it
could have an adverse effect on market acceptance of our products. Inadequate reimbursement levels would likely also create downward price pressure on
our products. Even if we do succeed in obtaining widespread coverage and reimbursement rates or policies for our products, future changes in coverage or
reimbursement rates or policies could have a negative impact on our business, financial condition and results of operations.

Further, we have experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for
which we have published clinical efficacy data. Recently, several wide-ranging proposals have been published for public comment, including relating to
payment  methodology  within  the  physician  office,  and  are  under  consideration  by  the  U.S.  Centers  for  Medicare  and  Medicaid  Services  (CMS).  In
addition, three Medicare Administrative Contractors (MACs) have recently published for public comment changes to their Local Coverage Determinations
(LCDs) that they are considering. If adopted, these proposals would significantly change Medicare policies

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governing the reimbursement of skin substitute products principally when used for wound treatment in the private physician office setting. The LCDs in the
proposals could adopt a new standard of clinical evidence required as a prerequisite to coverage. In addition, the proposals all require a confirmation that
the  products  are  regulated  solely  under  Section  361  of  the  Public  Health  Service  Act  as  a  prerequisite  to  continued  coverage.  We  have  the  required
confirmation for EPIFIX, but not currently for EPICORD. The proposed LCDs also include language that could lower the number of allowed applications
of a product below what is commonly used in standard practice by physicians today (supported by clinical evidence) and reflected by LCDs currently in
force with the MACs. The Company as well as industry stakeholders across the wound care industry do not support lowering the applications.

Changes  in  the  coverage  and  reimbursement  environment  as  described  above  could  result  in  declines  in  our  revenue  that  would  adversely  affect  our
business, financial condition and results of operation.

Our revenue, results of operations and cash flows may suffer upon the loss of a Group Purchasing Organization or Integrated Delivery Network.

As  with  many  manufacturers  in  the  healthcare  space,  the  Company  contracts  with  Group  Purchasing  Organizations  (“GPOs”)  and  Integrated  Delivery
Networks (“IDNs”)  to  establish  contracted  pricing  and  terms  and  conditions  for  the  members  of  GPOs  and  IDNs.  Approximately  three-quarters  of  our
sales in the year ended December 31, 2022 came from customers that are members of our primary GPOs or IDNs.

Our agreements with GPOs and IDNs allow us to sell our products efficiently to large groups of customers. Our agreements with GPOs and IDNs typically
provide  their  members  with  favorable  ordering  terms  and  conditions  and  access  to  favorable  product  pricing.  These  customers  purchase  our  product
through  GPO  and  IDN  arrangements  in  part  because  of  the  favorable  pricing  and  terms  and  conditions.  If  our  agreement  with  any  GPO  or  IDN  is
terminated or expires without being extended, renewed or renegotiated, this could adversely affect our revenue, results of operations and cash flows.

We contract with and are dependent upon independent sales agents and distributors.

In 2022, approximately 22% of our sales were through our relationships with independent agents, and we also use a small number of distributors, primarily
outside the United States, and may use more in the future. (Sales agents act directly on behalf of MIMEDX to arrange sales, while distributors take title to
product and may set their own prices.) See Note 12, Revenue to our audited consolidated financial statements included in Item 8, Consolidated Financial
Statements and Supplementary Data.

If our relationships with our independent sales agents were terminated for any reason, it could materially and adversely affect our revenues and profits.
Because the independent agent often controls the customer relationships within its territory, there is a risk that if our relationship with the agent ends, our
relationship with the customer will be lost.

Because our agents and distributors are not employees, there is a risk we will be unable to ensure that our sales processes, compliance safeguards, and
related policies will be adhered to despite our communication and training of agents and distributors regarding these requirements. Furthermore, if we fail
to  maintain  relationships  with  our  key  independent  agents,  or  fail  to  ensure  that  our  independent  agents  adhere  to  our  sales  processes,  compliance
safeguards and related policies, there could be an adverse effect on our business, results of operations, and financial condition.

We  may  obtain  the  assistance  of  additional  distributors  and  independent  sales  representatives  to  sell  products  in  certain  sales  channels,  particularly  in
territories and fields where agents are commonly used. Our success is partially dependent upon our ability to train, retain and motivate our independent
sales  agencies,  distributors,  and  their  representatives  to  appropriately  and  compliantly  sell  our  products  in  certain  territories  or  fields.  They  may  not  be
successful in implementing our marketing plans or compliance safeguards. Some of our independent sales agencies and distributors do not sell our products
exclusively and may offer similar products from other companies. Our independent sales agencies and distributors may terminate their contracts with us,
may devote insufficient sales efforts to our products or may focus their sales efforts on other products that produce greater commissions for them, which
could have an adverse effect on our business, results of operations and financial condition. We also may not be able to find additional independent sales
agencies and distributors who will agree to appropriately and compliantly market or distribute our products on commercially reasonable terms, if at all. If
we are unable to establish new independent sales representative and distribution relationships or renew current sales agency and distribution agreements on
commercially acceptable terms, our business, financial condition, and results of operations could be materially and adversely affected.

Disruption of our processing facilities could adversely affect our business, financial condition and results of operations.

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Our business depends upon the continued operation of our processing facilities in Marietta, Georgia and Kennesaw, Georgia. Risks that could impact our
ability to use these facilities include the occurrence of natural and other disasters, the outbreak of pandemics, and the need to comply with the requirements
of directives from government agencies, including the FDA. See above, for example, “ - Public health emergencies, such as the COVID-19 pandemic and
governmental  and  societal  responses  thereto  have  adversely  affected  our  business,  results  of  operations  and  financial  condition  in  the  past,  and  future
outbreaks could harm our business, results of operations, and financial condition in the future.”

Either  of  our  two  processing  facilities  can  serve  as  a  redundant  processing  facility  for  most  of  our  Section  361  products  in  the  event  the  other  facility
experiences a disaster event. For clinical trial requirements of our Section 351 products, we have transitioned manufacturing to our Kennesaw, Georgia
facility to comply with CGMP standards, and implemented these standards for upstream and downstream supply chain activities at our Marietta, Georgia
facility. However, if our processing facilities were to become unavailable, this could have a material adverse effect on our business, financial condition and
results of operations during the period of such unavailability.

To  be  commercially  successful,  we  must  educate  physicians,  where  appropriate,  how  and  when  our  products  are  proper  alternatives  to  existing
treatments and that our products should be used in their procedures.

We  believe  physicians  will  only  use  our  products  if  they  determine,  based  on  their  independent  medical  judgment  and  experience,  clinical  data,  and
published peer reviewed journal articles, that the use of our products in a particular procedure is a favorable alternative to other treatments. Physicians may
be hesitant to change their existing medical treatment practices for the following reasons, among others:

•
•

their lack of experience with advanced therapeutics, such as our placenta-based allografts;
lack of evidence supporting additional patient benefits of advanced therapeutics, such as our placenta-based allografts, over conventional methods
in certain therapeutic applications;
perceived liability risks generally associated with the use of new products and procedures;
limited availability of reimbursement from third-party payers;

•
•
• more favorable reimbursement for other market-available products; and
•

the time that must be dedicated to physician training in the use of our products.

If  we  cannot  successfully  address  quality  issues  that  may  arise  with  our  products,  our  brand  reputation  could  suffer,  and  our  business,  financial
condition, and results of operations could be adversely impacted.

In  the  course  of  conducting  our  business,  we  must  adequately  address  quality  issues  that  may  arise  with  our  products,  as  well  as  defects  in  third-party
components included in our products, as any quality issues or defects may negatively impact physician use of our products. Although we have established
internal  procedures  to  minimize  risks  that  may  arise  from  quality  issues,  we  may  not  be  able  to  eliminate  or  mitigate  occurrences  of  these  issues  and
associated liabilities. If the quality of our products does not meet the expectations of physicians or patients, then our brand reputation could suffer and our
business could be adversely impacted. We must also ensure any promotional claims made for our products comport with government regulations.

The formation of physician-owned distributorships (“PODs”) could result in increased pricing pressure on our products or harm our ability to sell our
products to physicians who own or are affiliated with those distributorships.

PODs  are  medical  product  distributors  that  are  owned,  directly  or  indirectly,  by  physicians.  These  physicians  derive  a  proportion  of  their  revenue  from
selling or arranging for the sale of medical products for use in procedures they perform on their own patients at hospitals that agree to purchase from or
through the POD, or that otherwise furnish ordering physicians with income that is based directly or indirectly on those orders of medical products. The
Office of Inspector General (“OIG”) of the Department of Health & Human Services has issued a Special Fraud Alert on PODs, indicating that they are
inherently suspect under the federal Anti-Kickback Statute.

Our commercial strategy emphasizes selling directly to healthcare providers and, to a limited extent, through distributors. To our knowledge, we do not
directly  sell  to  or  distribute  any  of  our  products  through  PODs.  The  number  and  strength  of  PODs  in  the  industry  may  continue  to  grow  as  economic
pressures increase throughout the industry and hospitals, insurers and physicians search for ways to reduce costs, and, in the case of the physicians, identify
additional  sources  to  increase  their  incomes.  These  companies  and  the  physicians  who  own,  or  partially  own,  PODs  may  have  significant  market
knowledge,  access  to  and  influence  on  the  physicians  who  use  our  products  and  the  hospitals  that  purchase  our  products,  and  we  may  not  be  able  to
compete effectively for business from physicians who own PODs.

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We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.

Our business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing and marketing of human tissue products.
We  may  be  subject  to  such  claims  if  our  products  cause,  or  appear  to  have  caused,  an  injury.  Claims  may  be  made  by  patients,  healthcare  providers  or
others  selling  our  products.  Product  liability  claims  can  be  expensive  to  defend  (regardless  of  merit),  divert  our  management’s  attention,  result  in
substantial damage awards against us, harm our reputation, and generate adverse publicity, which could result in the withdrawal of, or reduced acceptance
of, our products in the market.

Although we have product liability insurance that we believe is adequate, this insurance is subject to deductibles and coverage limitations, and we may not
be able to maintain this insurance at an acceptable cost or on acceptable terms or be able to secure increased coverage (if needed), nor can we be sure that
existing or future claims against us will be covered by our product liability insurance. Moreover, the existing coverage of our insurance or any rights of
indemnification and contribution that we may have may not be sufficient to offset existing or future claims. If we are unable to maintain product liability
insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect ourselves against potential product liability claims or we
underestimate the amount of insurance we need, we could be exposed to significant liabilities, which may harm our business. A product liability claim or
other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our
business. Even if a claim is not successful, defending such claim would be time-consuming and expensive, may damage our reputation in the marketplace,
and would likely divert our management’s attention.

The products we process are derived from human tissue and therefore have the potential for disease transmission.

The utilization of human tissue creates the potential for transmission of communicable disease, including, without limitation, human immunodeficiency
virus,  viral  hepatitis,  syphilis  and  other  viral,  fungal  or  bacterial  pathogens.  We  are  required  to  comply  with  federal  and  state  regulations  intended  to
prevent communicable disease transmission.

We  maintain  strict  quality  controls  designed in accordance with  CGTP  to  ensure  the  safe  procurement  and  processing  of  our  tissue,  including  terminal
sterilization of our products. These controls are intended to prevent the transmission of communicable disease. However, risks exist with any human tissue
implantation. We are also implementing and maintaining CGMP systems to comply with the regulations that will apply to our Section 351 HCT/Ps, and
believe this provides an added level of quality throughout our manufacturing process. However, negative publicity concerning disease transmission from
other  companies’  improperly  processed  donated  tissue  could  have  a  negative  impact  on  the  demand  for  our  products  and  adversely  affect  our  business,
financial condition and results of operations.

We may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation, disrupt our
business and adversely affect our business, results of operations and financial condition.

The  processing  and  marketing  of  our  tissue  products  involves  an  inherent  risk  that  our  tissue  products  or  processes  may  not  meet  applicable  quality
standards  and  requirements.  In  the  event  that  one  or  more  of  our  products  experiences  a  failure  to  meet  such  standards  and  requirements,  we  may
voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority.

A recall or market withdrawal of one of our products could be costly and may divert management resources. A recall or withdrawal of one of our products,
or  a  similar  product  processed  by  another  entity,  also  could  impair  sales  of  our  products  as  a  result  of  confusion  concerning  the  scope  of  the  recall  or
withdrawal, or as a result of the damage to our reputation for quality and safety.

A cyberattack or significant disruptions of our information technology systems could adversely affect our business, results of operation and financial
condition.

A cyberattack, a disruption in availability, or the unauthorized alteration of systems or data could adversely affect our business, results of operations and
financial condition. We rely on technology for day-to-day operations as well as positioning to enhance our stance in the market. We generate intellectual
property  that  is  central  to  the  future  success  of  the  business  and  transmit  large  amounts  of  confidential  information.  Additionally,  we  collect,  store  and
transmit confidential information of customers, patients, employees and third parties. We also have outsourced significant elements of our operations to
third  parties,  including  significant  elements  of  our  information  technology  infrastructure,  and,  as  a  result,  we  are  managing  many  independent  vendor
relationships with third parties who may or could have access to our confidential information. The continually changing threat landscape of cybersecurity
today makes our systems potentially vulnerable to service interruptions

31

or  to  security  breaches  from  inadvertent  or  intentional  actions  by  our  employees,  partners,  and  vendors,  and  from  attacks  by  malicious  third  parties,
including  supply  chain  attacks  originating  at  our  third-party  partners.  Such  attacks  are  of  ever-increasing  levels  of  sophistication.  Attacks  are  made  by
individuals  or  groups  that  have  varying  levels  of  expertise,  some  of  which  are  technologically  advanced  and  well-funded  including,  without  limitation,
nation states, organized criminal groups and hacktivists organizations.

To  ensure  protection  of  our  information,  we  have  invested  in  cybersecurity  and  have  implemented  processes  and  procedural  controls  to  maintain  the
confidentiality and integrity of such information. We measure these controls and their success through a cybersecurity framework that is based on industry
standards.  While  we  have  invested  in  the  protection  of  our  data  and  technology,  there  can  be  no  guarantees  that  our  efforts  will  prevent  all  service
interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and result in the loss of
critical or sensitive confidential information or intellectual property, and could result in financial, legal and reputational harm to our business, including
legal  claims  and  proceedings,  liability  under  laws  that  protect  the  privacy  of  personal  information,  government  enforcement  actions  and  regulatory
penalties, as well as remediation costs. We also maintain cyber liability insurance. However, this insurance may not be sufficient to cover the financial,
legal or reputational losses that may result from an interruption or breach of our systems.

We  may  expand  or  contract  our  business  through  acquisitions,  divestitures,  licenses,  investments,  and  other  commercial  arrangements  with  other
companies or technologies, which may adversely affect our business, results of operations and financial condition.

We  periodically  evaluate  opportunities  to  acquire  companies  or  divest  divisions,  technologies,  products,  and  rights  through  licenses,  distribution
agreements,  investments,  and  outright  acquisitions  to  grow  our  business.  In  connection  with  one  or  more  of  those  transactions,  we  may,  subject  to  the
requirements and limitations set forth in our secured credit agreement (the “Hayfin Loan Agreement”) with Hayfin Services, LLP (“Hayfin”) an affiliate
of Hayfin Capital Management LLP:

•
•
•
•
•

•
•

issue additional equity securities that would dilute the value of equity currently held by our shareholders;
divest or license existing products or technology;
use cash that we may need in the future to operate our business;
incur debt that could have terms unfavorable to us or that we might be unable to repay;
structure the transaction in a manner that has unfavorable tax consequences, such as a stock purchase that does not permit a step-up in the tax basis
for the assets acquired;
be unable to realize the anticipated benefits, such as increased revenues, cost savings, or synergies from additional sales; and
be unable to secure the services of key employees related to the transaction(s).

Any  of  these  items  could  adversely  affect  our  revenues,  results  of  operations  and  financial  condition.  Business  acquisitions  also  involve  the  risk  of
unknown liabilities associated with the acquired business, which could be material. Incurring unknown liabilities or the failure to realize the anticipated
benefits of any transaction could adversely affect our business if we are unable to recover our initial investment. Inability to recover our investment, or any
write off of such investment, associated goodwill or assets could have an adverse effect on our business, results of operations and financial condition.

New lines of business or new products and services may subject us to additional risks.

From time to time, we may implement or may acquire new lines of business or offer new products and services within existing lines of business. There are
risks and uncertainties associated with these efforts, particularly in instances where the markets are not fully developed or are evolving. In developing and
marketing  new  lines  of  business  and  new  products  and  services,  we  may  invest  significant  time  and  resources.  External  factors,  such  as  regulatory
compliance obligations, competitive alternatives, and shifting market preferences, may also impact the successful implementation of a new line of business
or a new product or service. Failure to successfully manage these risks in the development and implementation of new lines of business or new products or
services could have an adverse effect on our business, results of operations and financial condition.

Our international expansion and operations outside the U.S. expose us to risks associated with international sales and operations.

We are pursuing further expansion outside the U.S., including in Japan. Managing a global organization is difficult, time consuming and expensive. Our
ability to conduct international operations is affected by many of the same risks we face in our U.S. operations, as well as unique costs and difficulties of
managing international operations, including the relationships and

32

operations of distributors we elect to work with in these markets. Adoption of our products in new geographic regions could take longer and cost more than
we  anticipate.  Risks  inherent  in  international  operations  also  include,  among  others,  potential  adverse  tax  consequences,  greater  difficulty  in  enforcing
intellectual  property  rights,  risks  associated  with  the  Foreign  Corrupt  Practices  Act  and  local  anti-bribery  law  compliance,  and  other  international
regulations.  These  regulations  may  limit  our  ability  to  market,  sell,  distribute  or  otherwise  transfer  our  products  to  prohibited  countries  or  persons.
International regulations may also limit what promotional claims we may make for our products.

Compliance with these regulations and laws is costly, and failure to comply with applicable legal and regulatory obligations could adversely affect us in a
variety of ways that include, without limitation, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and
penalties, denial of export privileges, seizure of shipments and restrictions on certain business activities. Also, the failure to comply with applicable legal
and regulatory obligations could result in the disruption of our distribution and sales activities.

These risks may limit or disrupt our expansion, restrict the movement of funds or result in the deprivation of contractual rights or the taking of property by
nationalization  or  expropriation  without  fair  compensation.  Operating  outside  of  the  U.S.  also  requires  significant  management  attention  and  financial
resources.

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

Certain of our products no longer qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of the
Public Health Service Act (“Section 361”), which has resulted in removal of the applicable products from the market, made the introduction of some
new  tissue  products  more  expensive,  significantly  delayed  the  expansion  of  our  tissue  product  offerings  and  subjected  us  to  additional  post-market
regulatory requirements. Additional regulatory requirements may be imposed in the future.

The  products  we  manufacture  and  process  are  derived  from  human  tissue.  Amniotic  and  other  birth  tissue  have  in  the  past  generally  been  regulated  as
HCT/P and were therefore eligible to be subject to regulation solely under Section 361 (“Section 361 HCT/P”) depending on whether the specific product
at  issue  and  the  claims  made  for  it  were  consistent  with  the  applicable  criteria.  HCT/Ps  that  do  not  meet  these  criteria  are  subject  to  more  extensive
regulation  as  drugs,  medical  devices,  biological  products,  or  combination  products.  These  HCT/Ps  must  comply  with  both  the  FDA’s  requirements  for
HCT/Ps and the requirements applicable to biologics, devices or drugs, including pre-market clearance or approval from the FDA. Obtaining FDA pre-
market clearance or approval involves significant time and investment by the Company.

In accordance with the FDA Guidance, as discussed above in “Business – Government Regulation,” after May 31, 2021, the Company no longer markets or
sells its products that were impacted by enforcement discretion in the United States, has requested the return of unused consignment inventory as of that
date, and does not intend to sell such products in the United States until the FDA grants pre-market approval. Our sales of such products for all uses was
$2.4 million, $17.6 million, and $31.8 million, respectively, in 2022, 2021, and 2020. Prior to May 31, 2021 these sales were primarily in the United States.
However, we are pursuing the BLA pre-market approval process for certain use of mDHACM, as more fully discussed above in “Business - Government
Regulation.” The loss of our ability to market and sell our micronized products has had an adverse impact on our revenues, business, financial condition
and results of operations.

Also,  the  Company  currently  markets  EPICORD  and  AMNIOCORD,  tissue  products  derived  from  the  protective  covering  and  extracellular  matrix
cushioning layers of the human umbilical cord, as providing a protective environment or as a barrier. In warning letters to several companies marketing
human umbilical cord derived products for a variety of uses, the FDA has stated that those products fail to meet one or more of the Section 361 criteria,
including  the  minimal  manipulation  criterion,  the  dependence  on  the  metabolic  activity  of  living  cells  for  their  primary  function  criterion,  and  the
homologous use criterion, as “the product is not intended to perform the same basic function or functions of umbilical cord in the recipient as in the donor,
such as serving as a conduit.” We are engaged with the FDA regarding the classification of our umbilical cord-derived products. If the FDA makes a final
determination that our umbilical cord products do not meet the requirements for regulation solely under Section 361, in order to continue to market the
products, we would be required to obtain the appropriate FDA approval or clearance. The loss of our ability to market and sell our umbilical cord derived
products  would  have  an  adverse  impact  on  our  revenues,  business,  financial  condition  and  results  of  operations.  Included  in  net  sales  were  sales  of
umbilical  cord-derived  products  totaling  $23.2  million,  $23.6  million,  and  $16.1  million,  respectively,  in  2022,  2021,  and  2020,  almost  entirely  in  the
United States.

Any  future  regulatory  changes  could  also  have  adverse  consequences  for  us  and  make  it  more  difficult  or  expensive  for  us  to  conduct  our  business  by
requiring  pre-market  clearance  or  approval  and  compliance  with  additional  post-market  regulatory  requirements  with  respect  to  those  products.  For
example, the FDA may in the future impose conditions, such as labeling restrictions, and the requirement that a product be manufactured in compliance
with CGMP. Although the Company is

33

preparing for these requirements in connection with its pursuit of a BLA for certain of its products, earlier compliance with these conditions would require
significant additional time and cost investments by the Company. Moreover, increased regulatory scrutiny within the industry in which we operate could
lead  to  increased  regulation  of  HCT/Ps,  including  Section  361  HCT/Ps,  which  could  ultimately  increase  our  costs  and  adversely  impact  our  business,
results of operations and financial condition. If the FDA approves the BLAs we seek, we will incur increased compliance costs on an ongoing basis. See “ -
If any of the BLAs are approved, the Company would be subject to additional regulation which will increase costs and could result in adverse sanctions for
non-compliance” below.

If any of the BLAs are approved, the Company would be subject to additional regulation which will increase costs and could result in adverse sanctions
for non-compliance.

Products  subject  to  the  FDA’s  BLA  requirements  must  comply  with  a  range  of  pre-  and  post-market  provisions.  Pre-market  compliance  includes  the
conduct of clinical trials in support of BLA approval, the development and submission of a BLA, and the production of product for use in the clinical trials
that meets FDA’s quality expectations. We have been making enhancements in our fixed plant as well as incurring costs and reduced product yields due to
testing against CGMP drug requirements to ensure quality, identity, purity, and potency. Post-approval requirements for BLA products include: compliance
with CGMP, which will require us to comply with promotional and labeling requirements, which limit our ability to make claims about regulated products;
submission of annual reports in appropriate circumstances; compliance with the FDA’s “Biological Product Deviation Reporting System,” when applicable;
submission of adverse events; reporting and correcting product problems within established timeframes; recalling or stopping the manufacture of a product
if a significant problem is detected; complying with the appropriate laws and regulations relevant to the biologics licensed and identifying any changes
needed to help ensure product quality. In some instances, the FDA can also require that applicants conduct post-market studies or trials of the product. This
additional compliance burden may increase costs, and failure to comply with such requirements may subject the Company to sanctions that would have an
adverse impact on our business, results of operations and financial condition.

Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time consuming and may impede our
ability to fully exploit our technologies.

The process of obtaining regulatory clearances or approvals to market a biological product or medical device from the FDA or similar regulatory authorities
outside of the U.S. may be costly and time consuming, and such clearances or approvals may not be granted on a timely basis, or at all. We are pursuing
approval of BLAs for certain of our micronized products, but have not yet submitted a BLA for review. Additionally, the FDA may take the position that
some of the other products that we currently market require a BLA as well. Some of the future products and enhancements to our current products that we
expect  to  develop  or  may  acquire  and  market  may  require  marketing  clearance  or  approval  from  the  FDA.  However,  clearance  or  approval  may  not  be
granted with respect to any of our products or enhancements and further FDA review may add delays that could adversely affect our ability to market such
products or enhancements.

The process of obtaining an approved BLA, including clinical trial development and execution as well as manufacturing processes, requires the expenditure
of  substantial  time,  effort  and  financial  resources  and  may  take  years  to  complete,  including  costs  incurred  on  top  of  those  fees  incurred  as  part  of
conducting various clinical studies. The fee for filing a BLA and program fees payable with respect to any establishment that manufactures biologics are
substantial.  Additionally,  there  are  significant  costs  associated  with  clinical  trials  that  can  be  difficult  to  accurately  estimate  until  a  BLA  is  approved.
Clinical  trials  may  not  be  successful  or  may  return  results  that  do  not  support  approval.  Moreover,  data  obtained  from  clinical  trials  are  not  always
conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on
a timely basis, or at all, or we may decide not to pursue a BLA for certain products or indications, or need to conduct additional trials for a given indication.
Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the
products. If we do receive approval, some types of changes to the approved product, such as adding new indications or doses, manufacturing changes and
additional labeling claims, are subject to further testing requirements and FDA review and approval. Our revenues will be adversely affected if we fail to
obtain  BLA  approvals  on  a  timely  basis  or  at  all,  or  if  the  FDA  limits  the  indications  for  use  or  requires  other  conditions  that  restrict  the  commercial
application of our products.

Clinical trials will be necessary to support future BLA submissions and potential product approvals by the FDA. The clinical trial process is lengthy
and  expensive  with  uncertain  outcomes,  and  often  requires  the  enrollment  of  large  numbers  of  patients,  and  suitable  patients  may  be  difficult  to
identify and recruit. Delays or failures in our clinical trials could prevent us from commercializing any modified or new products and would adversely
affect our business, operating results and prospects.

The results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable
results  in  later  clinical  trials.  Our  interpretation  of  data  and  results  from  our  clinical  trials  does  not  ensure  that  we  will  achieve  similar  results  in  future
clinical trials. In addition, clinical data are often susceptible to various

34

interpretations and analyses, and many companies that have believed their products performed satisfactorily in earlier clinical trials or retrospective studies
have nonetheless failed to replicate results in later clinical trials. Products in later stages of clinical trials may fail to show the desired safety and efficacy
despite having progressed through nonclinical studies and earlier clinical trials and retrospective studies, and such failures can occur at any stage of clinical
testing. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical
and non-clinical testing in addition to those we have planned.

The initiation and completion of a trial may be prevented, delayed, or halted for numerous reasons, including, but not limited to, the following:

•

•
•
•

•
•

regulatory  authorities  do  not  approve  a  clinical  study  protocol,  force  us  to  modify  a  previously  approved  protocol,  or  place  a  clinical  study  on
hold;
patients do not enroll in, or enroll at a lower rate than we expect or need, or do not complete a clinical study;
patients or investigators do not comply with study protocols;
the  FDA  may  require  us  to  submit  data  on  a  greater  number  of  patients  than  we  originally  anticipated  and/or  for  a  longer  follow-up  period  or
change the data collection requirements or data analysis applicable to our clinical trials;
patients do not return for post-treatment follow-up at the expected rate;
patients may experience serious or unexpected adverse side effects for a variety of reasons that may or may not be related to our product causing a
clinical trial study to be put on hold;

• we may be unable to recruit a sufficient number of clinical trial sites;
•
•

sites participating in an ongoing clinical study may withdraw, requiring us to engage new sites;
third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or act
in ways inconsistent with the investigator agreement, clinical study protocol, good clinical practices, or other regulatory requirements;
third-party entities do not perform data collection and analysis in a timely or accurate manner;

•
• we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we

•
•

may be required to submit to regulatory authorities for approval;
the cost of clinical trials may be greater than we anticipate; and
regulators or other reviewing bodies may fail to approve or subsequently find fault with our manufacturing processes or facilities, the supply of
materials  necessary  to  conduct  clinical  trials  may  be  insufficient,  inadequate  or  not  available  at  an  acceptable  cost,  or  we  may  experience
interruptions in supply.

Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a
delay in the commencement or completion of clinical trials may also ultimately lead to the denial of certification or regulatory approval of our product
candidates.

Our ability to consistently and reliably manufacture our biologic products will be key to the marketing of any future Section 351 products. Also, our
current manufacturing facilities may be inadequate to produce sufficient quantities if our planned BLA program is approved.

The  manufacture  of  biologic  products  requires  significant  expertise  and  capital  investment,  including  the  development  of  advanced  manufacturing
techniques  and  process  controls,  and  the  approval  of  BLAs  require  one  to  demonstrate  the  ability  to  manufacture  pursuant  to  specified  chemistry  and
manufacturing controls. Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up initial production as would
be the case at any new facility. These problems can include difficulties with production costs and yields, quality control (including stability of the product
candidate and quality assurance testing), shortages of qualified personnel, and compliance with strictly enforced federal, state and foreign regulations. If we
were to encounter any of these difficulties, or otherwise fail to comply with our obligations under applicable regulations, then our ability to provide product
candidates to patients in our clinical trials or commercially would be jeopardized, and any delay or interruption in the supply of product could delay the
commercial launch of the product or impair our ability to meet demand for the product.

Our products can be manufactured only in a facility that has undergone a satisfactory inspection by the FDA and other relevant regulatory authorities. We
may not be able to replace manufacturing capacity for our products quickly if we were unable to use our manufacturing facilities as a result of a fire, natural
disaster  (including  an  earthquake),  equipment  failure,  or  other  difficulty,  or  if  such  facilities  were  deemed  not  in  compliance  with  the  regulatory
requirements and such non-compliance could not be rapidly rectified. An inability or reduced capacity to manufacture our products could have a material
adverse effect on our business, financial condition, and results of operations.

Our existing manufacturing facilities have been adequate for the products we currently sell, but may become inadequate for future products if our planned
BLA for mDHACM is approved or if our sales of current and future Wound & Surgical products ramps at a rate faster than we are able to manufacture.
Therefore,  we  have  begun  planning  changes  to  our  processes  to  increase  manufacturing  capacity.  Failure  to  adequately  expand  capacity  could  delay
commercialization of our current or

35

future product candidates, depriving us of potential product revenue. Any manufacturing problem could be disruptive to our operations and result in lost
sales.

Our business is subject to extensive regulation by the FDA and other authorities, which is costly, and our failure to comply could result in negative
effects on our business, results of operations and financial condition.

As discussed above, the FDA has specific regulations governing our tissue-based products, or HCT/Ps. The FDA has broad post-market and regulatory and
enforcement powers, even for Section 361 HCT/Ps. The FDA’s regulation of HCT/Ps includes requirements for registration and listing of products, donor
screening and testing, processing and distribution, labeling, record keeping and adverse-reaction reporting, and inspection and enforcement.

HCT/Ps that are regulated as drugs, biological products or medical devices are subject to even more stringent regulation by the FDA. Even if pre-market
clearance or approval is obtained, the approval or clearance may place substantial restrictions on the indications for which the product may be marketed or
to  whom  it  may  be  marketed,  may  require  warnings  to  accompany  the  product  or  impose  additional  restrictions  on  the  sale  or  use  of  the  product.  In
addition, regulatory approval is subject to continuing compliance with regulatory standards, including the FDA’s quality system regulations.

If we fail to comply with the FDA regulations regarding our tissue products, the FDA could take enforcement action, including, without limitation, any of
the following sanctions and the manufacture of our products or processing of our tissue could be delayed or terminated:

untitled letters, warning letters, cease and desist orders, fines, injunctions, and civil penalties;
recall or seizure of our products;
operating restrictions, partial suspension or total shutdown of production;
refusing our requests for clearance or approval of new products;

•
•
•
•
• withdrawing or suspending current applications for approval or approvals already granted;
•
•

refusal to grant export approval for our products; and
criminal prosecution.

The FDA’s regulation of HCT/Ps may continue to evolve. Complying with any such new regulatory requirements may entail significant time delays and
expense, which could have an adverse effect on our business, results of operations and financial condition.

The AATB has issued operating standards for tissue banking. Compliance with these standards is a requirement in order to become an accredited tissue
bank. In addition, some states have their own tissue banking regulations.

In addition, procurement of certain human organs and tissue for transplantation is subject to the restrictions of the NOTA, which prohibits the transfer of
certain  human  organs,  including  skin  and  related  tissue  for  valuable  consideration,  but  permits  the  reasonable  payment  associated  with  the  removal,
transportation,  implantation,  processing,  preservation,  quality  control  and  storage  of  human  tissue  and  skin.  We  reimburse  tissue  banks,  hospitals  and
physicians for their services associated with the recovery and storage of donated human tissue. Although we have independent third party appraisals that
confirm the reasonableness of the service fees we pay, if we were to be found to have violated NOTA’s prohibition on the sale or transfer of human tissue
for valuable consideration, we could potentially be subject to criminal enforcement sanctions, which could adversely affect our results of operations.

Finally,  we  and  other  manufacturers  of  skin  substitutes  are  required  to  provide  average  ASP  information  to  CMS  on  a  quarterly  basis.  The  Medicare
payment rates are updated quarterly based on this ASP information. If a manufacturer is found to have made a misrepresentation in the reporting of ASP,
such  manufacturer  is  subject  to  civil  monetary  penalties  of  up  to  $10,000  for  each  misrepresentation  for  each  day  in  which  the  misrepresentation  was
applied, and potential False Claims Act liability. See “We and our sales representatives, whether employees or independent contractors, must comply with
various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause an adverse effect on our business,
results of operations and financial condition.”

We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-
label, uses.

As a general rule, FDA regulations require that the marketing of 361 HCT/Ps only be for appropriate homologous uses, and that the promotion of pre-
approved biological products or devices only be for FDA-approved indications. Generally, unless the products are approved by the FDA for alternative
uses, the FDA contends that we may not make claims about the safety or

36

effectiveness of our products, or promote them as safe or effective for uses other than those specifically approved by the FDA. Such limitations present a
risk  that  the  FDA  or  other  federal  or  state  law  enforcement  authorities  could  determine  that  the  nature  and  scope  of  our  sales,  marketing  and  support
activities, though designed to comply with all FDA requirements, constitute the promotion of our products for an unapproved use in violation of the federal
FD&C  Act.  We  also  face  the  risk  that  the  FDA  or  other  governmental  authorities  might  pursue  enforcement  based  on  past  activities  that  we  have
discontinued  or  changed,  including  sales  activities,  prior  marketing  materials,  arrangements  with  institutions  and  doctors,  educational  and  training
programs and other activities.

Investigations concerning the promotion of unapproved product uses and related issues are typically expensive, disruptive and burdensome and generate
negative  publicity.  If  our  promotional  activities  are  found  to  be  in  violation  of  the  law,  we  may  face  significant  legal  action,  fines,  penalties,  and  even
criminal liability and may be required to substantially change our sales, promotion, grant and educational activities. There is also a possibility that we could
be enjoined from selling some or all of our products for any unapproved use. In addition, as a result of an enforcement action against us or any of our
executive officers, we could be excluded from participation in government healthcare programs such as Medicare and Medicaid.

However, under the Guidance, as discussed above in “Business – Government Regulation,” after May 31, 2021, the Company no longer markets or sells its
products that were impacted by enforcement discretion in the United States, and does not intend to sell such products in the United States until the FDA
grants pre-market approval. We will ultimately only be able to market such products for indications that have been cleared or approved by the FDA.

Nevertheless,  while  we  believe  we  are  fully  in  compliance  with  the  FDA's  Guidance  on  HCT/Ps,  there  can  be  no  assurance  that  we  have  correctly
interpreted the FDA Guidance, or that we will not need to discontinue marketing a product and/or may be subject to fines, penalties, injunctions, and other
sanctions if we are deemed to be promoting the use of our products for unapproved uses. Such regulatory penalties by the FDA could adversely affect our
business and results of operations.

We  and  our  sales  representatives,  whether  employees  or  independent  contractors,  must  comply  with  various  federal  and  state  anti-kickback,  self-
referral,  false  claims  and  similar  laws,  any  breach  of  which  could  cause  an  adverse  effect  on  our  business,  results  of  operations  and  financial
condition.

Our  relationships  with  physicians,  hospitals  and  other  healthcare  providers  are  subject  to  various  federal  and  state  healthcare  fraud  and  abuse  laws.
Healthcare fraud and abuse laws are complex and, in some instances, even minor or inadvertent violations can give rise to liability. Possible sanctions for
violation of the healthcare fraud and abuse laws include, without limitation, monetary fines, civil and criminal penalties, exclusion from participating in the
federal and state healthcare programs, including, without limitation, Medicare, Medicaid, the VA health programs and TRICARE (the healthcare program
administered by or on behalf of the U.S. Department of Defense for uniformed service members, including both those in active duty and retirees, as well as
their  dependents),  and  forfeiture  of  amounts  collected  in  violation  of  such  prohibitions.  Many  states  have  similar  fraud  and  abuse  laws,  imposing
substantial penalties for violations. A finding of a violation of one or more of these laws, or even a government investigation or inquiry into the same,
would likely result in a material adverse effect on the market price of our Common Stock, as well as on our business, results of operations, and financial
condition.

The federal Anti-Kickback Statute (AKS) is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, paying,
soliciting  or  receiving  remuneration,  directly  or  indirectly,  in  cash  or  in  kind,  to  induce  or  reward  referrals,  purchases  or  orders  or  arranging  for  or
recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program,
such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The Patient Protection
and Affordable Care Act (the “PPACA”)  amended  the  federal  AKS  to  clarify  the  intent  that  is  required  to  prove  a  violation.  Under  the  federal  AKS  as
amended, a person or entity need not have actual knowledge of this statute or specific intent to violate it. The PPACA also amended the federal AKS to
provide that any claims for items or services resulting from a violation of the federal AKS are considered false or fraudulent for purposes of the federal
FCA. A conviction for violation of the AKS results in criminal fines and requires mandatory exclusion from participation in federal health care programs.
Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices from
prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all
elements  of  an  available  exception  or  safe  harbor.  We  have  entered  into  consulting  agreements,  speaker  agreements,  research  agreements  and  product
development agreements with physicians, including some who may order or recommend our products or make decisions to use them. In addition, some of
these physicians own our stock, which they purchased in arm’s-length transactions on terms identical to those offered to non-physicians, or received stock
awards  from  us  in  the  past  as  consideration  for  services  performed  by  them.  While  we  believe  these  transactions  generally  meet  the  requirements  of
applicable  laws,  including  the  federal  AKS  and  analogous  state  laws,  it  is  possible  that  our  arrangements  with  physicians  and  other  providers  may  be
questioned by regulatory or enforcement authorities under such laws, which could lead us to redesign

37

the arrangements and subject us to significant civil or criminal penalties. We have designed our policies and procedures to comply with the federal AKS,
FCA, and industry best practices. In addition, we have conducted training sessions on these principles. If, however, regulatory or enforcement authorities
were to view these arrangements as non-compliant with applicable laws, there would be risk of government investigations/inquiries or penalties. There is
also  risk  that  one  or  more  of  our  employees  or  agents  will  disregard  the  rules  we  have  established.  Because  our  strategy  relies  on  the  involvement  of
physicians who consult with us on the design of our products, perform clinical research on our behalf or educate other health care professionals about the
efficacy and uses of our products, we could be materially impacted if regulatory or enforcement agencies or courts interpret our financial relationships with
physicians who refer or order our products to be in violation of applicable laws. This could harm our reputation and the reputations of the physicians we
engage to provide services on our behalf. In addition, the cost of noncompliance with these laws could be substantial since we could be subject to monetary
fines and civil or criminal penalties, and we could also be excluded from federally-funded healthcare programs, including Medicare, Medicaid, VA and
TRICARE.

The  FCA  imposes  civil  liability  on  any  person  or  entity  that  knowingly  submits,  or  causes  the  submission  of,  a  false  or  fraudulent  claim  to  the  U.S.
government. Damages under the FCA can be significant and consist of the imposition of fines and penalties. The FCA also allows a private individual or
entity to sue on behalf of the government to recover civil penalties and treble damages as a whistleblower. FCA liability is potentially significant in the
healthcare industry because the statute provides for treble damages and mandatory penalties of between $11,181 and $22,363 per false claim or statement
for penalties assessed after January 29, 2018, with respect to violations occurring after November 2, 2015.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the
submission of false or fraudulent claims. The PPACA provides that claims tainted by a violation of the federal AKS are false for purposes of the FCA. The
DOJ on behalf of the government has previously alleged that the marketing and promotional practices of pharmaceutical and medical device manufacturers,
including the off-label promotion of products or the payment of prohibited kickbacks to doctors, violated the FCA, resulting in the submission of improper
claims  to  federal  and  state  healthcare  programs  such  as  Medicare  and  Medicaid.  In  certain  cases,  manufacturers  have  entered  into  criminal  and  civil
settlements  with  the  federal  government  under  which  they  entered  into  plea  agreements,  paid  substantial  monetary  amounts  and  entered  into  onerous
corporate integrity agreements with the government that require, among other things, substantial reporting and remedial actions, as well as oversight and
review by an outside entity, an Independent Review Organization (“IRO”), at substantial expense to the Company.

Under the HIPAA criminal federal healthcare fraud statute, it is a crime to knowingly and willfully execute, or attempt to execute, a scheme or artifice to
defraud any health care benefit program or to obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property
owned by, or under the custody or control of, any health care benefit program, in connection with the delivery of or payment for health care benefits, items
or services.

There are federal and state laws requiring detailed reporting of manufacturer interactions with and payments to healthcare providers, such as the federal
Physician  Payments  Sunshine  Act  (Sunshine  Act).  The  Sunshine  Act  requires,  among  others,  “applicable  manufacturers”  of  drugs,  devices,  biological
products, and medical supplies reimbursed under Medicare, Medicaid or the Children’s Health Insurance Program to annually report to CMS information
related  to  payments  and  other  transfers  of  value  provided  to  “covered  recipients.”  The  term  covered  recipients  includes  U.S.-licensed  physicians  and
teaching hospitals, and, for reports submitted on or after January 1, 2022, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse
anesthetists, and certified nurse-midwives. While manufacturers of human cell and tissue products regulated solely under Section 361 are not subject to the
Sunshine Act, in the future, if we receive a BLA, we will be subject to this law. There is the risk that CMS or another government agency may take the
position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the
Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.

There are state law equivalents to the AKS and FCA. There are also so-called state “all-payer” anti-kickback laws which may apply to items or services
reimbursed by any third-party payer, including commercial insurers, as well as when no insurer is involved (i.e. cash-pay patients).

The enforcement of all of these laws is uncertain and subject to rapid change. Federal or state regulatory or enforcement authorities may investigate or
challenge our current or future activities under these laws. Any investigation or challenge could have a material adverse effect on our business, financial
condition  and  results  of  operations.  Any  state  or  federal  regulatory  or  enforcement  review  of  us,  regardless  of  the  outcome,  would  be  costly  and  time
consuming. Additionally, we cannot predict the impact of any changes in these laws, whether these changes are retroactive or will have effect on a going-
forward basis only.

38

Our results of operations may be adversely affected by current and potential future healthcare reforms.

In response to perceived increases in healthcare costs in recent years, there have been and continue to be proposals by the U.S. federal government, state
governments, regulators and third-party payers to control these costs and, more generally, to reform the U.S. healthcare system. In the U.S., the PPACA
was  enacted  in  2010  with  a  goal  of  reducing  the  cost  of  healthcare  and  substantially  changing  the  way  healthcare  is  financed  by  both  government  and
private insurers.

In addition, other legislative changes have been proposed and adopted in the U.S. since the PPACA was enacted. The Budget Control Act of 2011 created
measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of
at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several
government  programs.  This  included  aggregate  reductions  of  Medicare  payments  to  providers  of  2%  per  fiscal  year,  which  went  into  effect  on  April  1,
2013. In January 2013, the American Taxpayer Relief Act was signed into law, which, among other things, further reduced Medicare payments to several
provider types, including hospitals.

In addition to the ACA, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) repealed the Sustainable Growth Rate formula used to
calculate  Medicare  payment  updates  for  physicians  providing  services  to  Medicare  beneficiaries.  In  its  place,  MACRA  introduced  the  Quality  Payment
Program  (“QPP”),  which  is  a  value-based  program  that  focuses  on  quality  and  outcomes  as  a  metric  for  physician  reimbursement.  The  Centers  for
Medicare and Medicaid Services released its final rules for the QPP in October 2016. The QPP, which impacts more than 600,000 physicians and other
practice-based clinicians, represents a fundamental change in physician reimbursement, transitioning from a system that solely rewards volume of care to
one that also rewards quality and value of care. The rule may have an impact on our revenue in the future. The program’s increased emphasis on quality
and cost of care may encourage physicians to merge practices or seek direct employment with hospitals. In addition, the ACA encourages hospitals and
physicians to work collaboratively through shared savings programs as well as other bundled payment initiatives. These shifts could lead to a consolidation
of hospital providers into larger delivery networks with increased price negotiation strength resulting in downward pressure on our selling prices. Although
we believe that we are well positioned to minimize any such impact on our business, our inability to address the consolidation trend could materially and
adversely affect our business and results of operations.

There  is  uncertainty  with  respect  to  the  impact  the  U.S.  Administration,  the  executive  order,  and  the  attempted  legislation  may  have,  if  any,  and  any
changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our products.
We believe that substantial uncertainty remains regarding the net effect of the PPACA, or its repeal and potential replacement, on our business, including
uncertainty over how benefit plans purchased on exchanges will cover our products, how the expansion or contraction of the Medicaid program will affect
access to our products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on
coverage for our product, and the effect of the general increase or decrease in federal oversight of healthcare payers. The taxes imposed and the expansion
in government’s role in the U.S. healthcare industry under the PPACA, if unchanged, may result in decreased revenues, lower reimbursements by payers for
our products and reduced medical procedure volumes, all of which could have a material adverse effect on our business, results of operations and financial
condition.

We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.

We currently market our products in a small number of foreign countries, and are actively pursuing international expansion, including in Japan. Foreign
jurisdictions  require  separate  regulatory  approvals  and  compliance  with  numerous  and  varying  regulatory  requirements.  The  approval  procedures  vary
among countries and may involve requirements for additional testing. Certain of our products require clearance or approval by the FDA. However, such
clearance or approval does not ensure approval or certification by regulatory authorities in other countries or jurisdictions, and approval or certification by
one foreign regulatory authority does not ensure approval or certification by regulatory authorities in other foreign countries or by the FDA. The foreign
regulatory approval or certification process may include all of the risks associated with obtaining FDA clearance or approval. We may not obtain foreign
regulatory  approvals  on  a  timely  basis,  if  at  all.  We  may  not  be  able  to  file  for  regulatory  approvals  or  certifications  and  may  not  receive  necessary
approvals to commercialize our products in any foreign jurisdiction. Furthermore, many foreign jurisdictions operate under socialized medical care, and
obtaining  reimbursement  for  our  products  under  that  construct  may  also  prove  difficult.  If  we  fail  to  receive  necessary  approvals,  certifications,  or
reimbursements  necessary  to  commercialize  our  products  in  foreign  jurisdictions  such  as  Japan  on  a  timely  basis,  or  at  all,  our  business,  results  of
operations and financial condition could be adversely affected. Further, governmental authorities outside the U.S. have become increasingly stringent in
their regulation of medical devices, and our products may become subject to more rigorous regulation by non-U.S. governmental authorities in the future.
U.S. or non-U.S. government regulations may be imposed in the future that may have a material adverse effect on our business and operations.

39

Federal and state laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect and use that
information and subject us to liability if we are unable to fully comply with such laws.

Numerous  federal  and  state  laws,  rules  and  regulations  govern  the  collection,  dissemination,  use,  security  and  confidentiality  of  personal  information,
including protected health information and individually identifiable health information. These laws include:

•

provisions of HIPAA that limit how covered entities and business associates may use and disclose protected health information, provide certain
rights to individuals with respect to that information and impose certain security requirements;

• HITECH, which strengthened and expanded the HIPAA Privacy Rule and Security Rules, imposed data breach notification obligations, created
new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and gave
state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce the federal HIPAA laws and
seek attorneys’ fees and costs associated with pursuing federal civil actions;
other federal and state laws restricting the use and protecting the privacy and security of personal information, including health information, many
of which are not preempted by HIPAA;
federal and state consumer protection laws; and
federal and state laws regulating the conduct of research with human subjects.

•
•

•

The California Consumer Protection Act (“CCPA”), which became effective on January 1, 2020, is a privacy law that requires certain companies doing
business in California to disclose information regarding the collection and use of a consumer’s personal data and to delete a consumer’s data upon request.
The  Act  also  permits  the  imposition  of  civil  penalties  and  expands  existing  state  security  laws  by  providing  a  private  right  of  action  for  consumers  in
certain circumstances where consumer data is subject to a breach. We are still evaluating whether and how this rule will impact our U.S. operations and/or
limit the ways in which we can provide services or use personal data collected while providing services.

As part of our business operations, including our medical record keeping, third-party billing and reimbursement and research and development activities,
we collect and maintain protected health information in paper and electronic format. Standards related to collecting and maintaining health information,
whether implemented pursuant to HIPAA, HITECH, state laws, federal or state action or otherwise, could have a significant effect on the manner in which
we handle personal information, including healthcare-related data, and communicate with payers, providers, patients, donors and others, and compliance
with  these  standards  could  impose  significant  costs  on  us  or  limit  our  ability  to  offer  services,  thereby  negatively  impacting  the  business  opportunities
available to us.

If we are alleged to have not complied with existing or new laws, rules and regulations related to personal information, we could be subject to litigation and
to sanctions that include monetary fines, civil or administrative penalties, civil damage awards or criminal penalties.

Risks Related to Our Intellectual Property

Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate, which
could have an adverse effect on our business, results of operations and financial condition.

Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products. We rely on patent protection, as
well  as  a  combination  of  copyright,  trade  secret  and  trademark  laws  and  nondisclosure,  confidentiality  and  other  contractual  restrictions  to  protect  our
proprietary technology, including our licensed technology. These legal means afford only limited protection and may not adequately protect our rights or
permit us to gain or keep any competitive advantage. In addition, our pending patent applications include claims to material aspects of our products and
procedures that are not currently protected by issued patents. The patent application process can be time consuming and expensive. Our pending patent
applications might not result in issued patents. Competitors may be able to design around our patents or develop products that provide outcomes that are
comparable or even superior to ours. Although we have taken steps to protect our intellectual property and proprietary technology, including entering into
confidentiality  agreements  and  intellectual  property  assignment  agreements  with  some  of  our  officers,  employees,  consultants  and  advisors,  such
agreements  may  not  be  enforceable  or  may  not  provide  meaningful  protection  for  our  trade  secrets  or  other  proprietary  information  in  the  event  of
unauthorized use or disclosure or other breaches of the agreements.

40

The failure to obtain and maintain patents or protect our intellectual property rights could have an adverse effect on our business, results of operations, and
financial condition. Whether a patent claim is valid is a complex matter of science, facts and law, and therefore we cannot be certain that, if challenged, our
patent claims would be upheld. If any of those patent claims are invalidated, our competitive advantage may be reduced or eliminated.

In  the  event  a  competitor  infringes  upon  our  licensed  patents,  issued  patents,  pending  patent  applications  or  other  intellectual  property  rights,  enforcing
those rights may be costly, uncertain, difficult and time consuming. Even if successful, litigation to enforce or defend our intellectual property rights could
be  expensive  and  time  consuming  and  could  divert  our  management’s  attention.  Further,  bringing  litigation  to  enforce  our  patents  subjects  us  to  the
potential for counterclaims. Other companies or entities also have commenced, and may again commence, actions seeking to establish the invalidity of our
patents  and  certain  related  claims.  In  the  event  that  any  of  our  patent  claims  are  challenged,  a  court,  the  United  States  Patent  and  Trademark  Office
(“USPTO”), or the Patent Trial and Appeal Board (“PTAB”) of the USPTO may invalidate one or more challenged patent claims or determine that the
patent is unenforceable, which could harm our competitive position. If the USPTO or the PTAB ultimately cancels or narrows the claim scope of any of our
patents  through  these  proceedings,  it  could  prevent  or  hinder  us  from  being  able  to  enforce  them  against  competitors.  Such  adverse  decisions  could
negatively impact our business, results of operations, and financial condition.

In  addition,  the  laws  of  some  foreign  countries  do  not  protect  intellectual  property  rights  to  the  same  extent  as  the  laws  of  the  United  States.  Many
companies have encountered significant problems in enforcing and defending intellectual property rights in certain foreign jurisdictions. This could make it
difficult for us to stop infringement of our foreign patents, if obtained, or the misappropriation of our other intellectual property rights. For example, some
foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, some countries limit the
enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or
no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain
outcomes.  Accordingly,  we  may  choose  not  to  seek  patent  protection  in  certain  countries,  and  we  will  not  have  the  benefit  of  patent  protection  in  such
countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business. Accordingly, our efforts to protect our intellectual property rights in some countries may be inadequate.

We may become subject to claims of infringement of the intellectual property rights of others, which could prohibit us from developing our products,
require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages.

Third parties could assert that our products infringe their patents or other intellectual property rights. Whether a product infringes a patent claim or other
intellectual property right involves a complex combination of legal and factual issues, the determination of which is often uncertain. Therefore, we cannot
be  certain  that  we  have  not  infringed  the  intellectual  property  rights  of  others.  Because  patent  applications  may  take  years  to  issue,  there  also  may  be
applications now pending of which we are unaware that may later result in issued patent claims that our products or processes infringe. There also may be
existing patents or pending patent applications of which we are unaware that our products or processes may inadvertently infringe.

Any infringement claim could cause us to incur significant costs, place significant strain on our financial resources, divert management’s attention from our
business  and  harm  our  reputation.  If  the  relevant  patent  claims  at  issue  in  such  a  dispute  were  upheld  as  valid  and  enforceable  and  we  were  found  to
infringe,  we  could  be  prohibited  from  selling  any  product  that  is  found  to  infringe  those  claims  unless  we  could  obtain  licenses  to  use  the  technology
covered by the asserted patent claims or other intellectual property, or are able to design around the patent claim or claims at issue or other intellectual
property.  We  may  be  unable  to  obtain  such  a  license  on  terms  acceptable  to  us,  if  at  all,  and  we  may  not  be  able  to  redesign  our  products  to  avoid
infringement. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the
compensatory  damages  and  award  attorney  fees.  These  damages  could  be  substantial  and  could  harm  our  reputation,  business,  financial  condition  and
operating results. A court also could enter orders that temporarily, preliminarily or permanently enjoin us and our customers from making, using, or selling
products, and could enter an order mandating that we undertake certain remedial measures. Depending on the nature of the relief ordered by the court, we
could become liable for additional damages to third parties. Further, because of the substantial amount of discovery required in connection with intellectual
property litigation, there is a risk that some of our trade secrets or other confidential information could be compromised by inadvertent or court-ordered
disclosure during this type of litigation.

We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged
trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our
competitors.

41

Some of our employees were previously employed at other medical device, pharmaceutical or tissue companies. We may also hire additional employees
who  are  currently  employed  at  other  medical  device,  pharmaceutical  or  tissue  companies,  including  our  competitors.  Additionally,  consultants  or  other
independent  agents  with  which  we  may  contract  may  be  or  have  been  in  a  contractual  arrangement  with  one  or  more  of  our  competitors.  Although  no
claims are currently pending, we may be subject to claims that we, our employees, or our independent contractors have inadvertently or otherwise used or
disclosed  trade  secrets  or  other  proprietary  information  of  these  former  employers  or  competitors.  In  addition,  we  have  been  and  may  in  the  future  be
subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary
to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to
management. If we fail to defend such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any
future litigation or the threat thereof may adversely affect our ability to hire additional direct sales representatives. A loss of key personnel or their work
product could hamper or prevent our ability to market existing or new products, which could severely harm our business, financial condition and operating
results.

Risks Related to Our Past Audit Committee Investigation, Consolidated Financial Statements, Internal Controls and Related Matters

If we fail to maintain adequate internal control over financial reporting in the future, this could adversely affect our business, financial condition and
operating results.

We have in the past reported material weaknesses in our internal control over financial reporting which we have now remediated. If additional material
weaknesses or deficiencies in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements might
contain  material  misstatements  and  we  could  be  required  to  restate  our  financial  results.  Moreover,  because  of  the  inherent  limitations  of  any  control
system, material misstatements due to error or fraud may not be prevented or detected on a timely basis, or at all. If we are unable to provide reliable and
timely financial reports in the future, our business and reputation may be further harmed. Failures in internal controls may also cause us to fail to meet
reporting obligations, negatively affect investor confidence in our management and the accuracy of our financial statements and disclosures, or result in
adverse  publicity  and  concerns  from  investors,  any  of  which  could  have  a  negative  effect  on  the  price  of  our  Common  Stock,  subject  us  to  regulatory
investigations and penalties or shareholder litigation, and adversely impact our business, results of operations and financial condition.

Negative publicity, including publicity relating to or arising from the Restatement, the Audit Committee Investigation, or related matters, has in the past
had and could continue to have an adverse effect on our business, results of operations and financial condition.

We have been and could continue to be the subject of negative publicity focusing on the Restatement, the results of the Audit Committee Investigation, and
related matters. As a result, our customers and others with whom we do business have voiced concerns regarding our accounting and control environment
and our ability to be a long-term provider to our customers. Further negative publicity could adversely affect our business, financial condition and results of
operations.

We have incurred significant legal and accounting expenditures as a result of the Restatement and have become subject to a number of additional risks and
uncertainties, including being a party to certain litigation relating to the Restatement. See Item 3, Legal Proceedings and Item 8, Financial Statements and
Supplementary Data, Note 16, Commitments and Contingencies for additional information. As a result of the Restatement, we may continue to be at risk
for further government investigations, shareholder litigation, and additional accounting and legal fees in connection therewith, as well as loss of investor
confidence in us, and a negative impact on our stock price.

We are currently, in the past have been, and in the future may be, subject to substantial litigation and ongoing investigations that could cause us to
incur significant legal expenses, divert management’s attention, and result in harm to our business.

We  are  exposed  to  potential  liabilities  and  reputational  risk  associated  with  litigation,  regulatory  proceedings  and  government  enforcement  actions.  We
were party to a securities class action lawsuit subject to appeal alleging, among other things, violations of Section 10(b) of the Securities Exchange Act of
1934. See Item 3, Legal Proceedings and Item 8, Financial Statement and Supplementary Data, Note 16, Commitments and Contingencies for information
regarding proceedings that we believe may be significant to the Company as of the date of the filing of this Annual Report. We may be subject to additional
lawsuits, including class action or securities derivative lawsuits, and further government investigations as well as incur additional legal fees and may face
negative  impacts  to  our  stock  price  and  reputation.  In  addition,  we  are  obligated  to  indemnify  and  advance  expenses  to  certain  individuals  involved  in
certain of these proceedings.

42

Any adverse judgment in or settlement of any pending or any future litigation could result in significant payments, fines and penalties that could have a
material adverse effect on our business, results of operations, financial condition and reputation. Such payments, damages or settlement costs, if any, related
to  these  matters  could  be  in  excess  of  our  insurance  coverage.  The  amount  of  time  that  is  required  to  resolve  these  lawsuits  is  unpredictable  and  any
litigation  or  claims  against  us,  even  those  without  merit,  may  cause  us  to  incur  substantial  costs,  divert  management’s  attention  from  the  day-to-day
operation of our business, and materially harm our reputation.

Risks Related to the Securities Markets and Ownership of Our Common Stock

Our substantial indebtedness may adversely affect our financial health.

As of December 31, 2022, the Company had an aggregate of $50.0 million of borrowings outstanding under the Hayfin Loan Agreement. Our substantial
outstanding  debt  may  limit  our  ability  to  borrow  additional  funds  or  may  adversely  affect  the  terms  on  which  such  additional  funds  may  be  available.
Additionally, a default under certain other indebtedness constitutes an event of default under the Hayfin Loan Agreement. Consequently, the effects of a
default  under  other  debt  may  be  amplified  by  the  lender  exercising  the  remedies  available  to  it  in  the  Hayfin  Loan  Agreement  for  events  of  default,
including  foreclosure  on  the  collateral  securing  our  obligations  and  the  declaration  that  all  amounts  outstanding  under  the  Hayfin  Loan  Agreement  are
immediately due and payable. The limitations on our ability to access additional borrowing and the potential effects of a cross-default under the Hayfin
Loan Agreement may limit our liquidity and have an adverse effect on our business, financial condition, and results of operations.

The restrictive covenants in the Hayfin Loan Agreement, and the Company’s obligation to make debt payments under the Hayfin Loan Agreement,
limit our operating and financial flexibility and may adversely affect our business, results of operations and financial condition.

The  Hayfin  Loan  Agreement,  as  amended,  imposes  operating  and  financial  restrictions  and  covenants.  For  example,  the  Hayfin  Loan  Agreement,  as
amended,  contains  (a)  covenants  that  impose  certain  reporting  and/or  performance  obligations  on  the  Company  and  its  subsidiaries,  including  (i)  a
Minimum Consolidated Total Net Sales (as defined in the Hayfin Loan Agreement) of varying amounts from now until maturity at June 30, 2025, in each
case tested quarterly; and (ii) Minimum Liquidity (as defined in the Hayfin Loan Agreement) of $20 million, an at-all-times covenant tested monthly and
(b) certain negative covenants that generally limit, subject to various exceptions, the Company and its subsidiaries from taking certain actions, including,
without  limitation,  incurring  indebtedness,  making  investments,  incurring  liens,  paying  dividends  and  engaging  in  mergers  and  consolidations,  sale  and
leaseback transactions and asset dispositions.

Our ability to comply with the financial covenants in the Hayfin Loan Agreement is in part dependent on our success in our overall strategies, including
pursuing expansion beyond Advanced Wound Care into areas of Surgical Recovery, introducing new products and seeking international growth. A breach
of a financial covenant in the Hayfin Loan Agreement could result in an event of default that would trigger the lenders’ remedies, including the right to
accelerate  the  entire  principal  balance  of  the  loan  under  the  Hayfin  Loan  Agreement.  We  currently  have  sufficient  cash  on  hand  to  repay  all  amounts
outstanding,  however,  there  can  be  no  assurances  that  we  will  be  able  to  find  alternative  financing  in  case  of  such  or  other  event  of  a  default.  Even  if
alternative  financing  were  available,  should  an  event  of  a  default  occur  under  the  Hayfin  Loan  Agreement,  it  might  be  on  unfavorable  terms,  and  the
interest rate charged on any new borrowings could be substantially higher than the interest rate under the Hayfin Loan Agreement, thus adversely affecting
our  cash  flows,  liquidity,  and  results  of  operations.  Acceleration  of  the  repayment  of  the  loan  pursuant  to  the  terms  of  the  Hayfin  Loan  Agreement,  in
combination with the Company’s current commitments and contingent liabilities, could also cast doubt on the Company’s ability to continue as a going
concern.

Our variable rate indebtedness under the Hayfin Loan Agreement subjects us to interest rate risk, which could result in higher expense in the event of
increases in interest rates and adversely affect our business, financial condition, and results of operations.

Borrowings under the Hayfin Loan Agreement, as amended, bear interest at a per annum rate equal to London Interbank Offered Rate (“LIBOR”), subject
to a “floor” of 1.5%, plus a margin of 6.75%. As a result, we are exposed to interest rate risk, which we do not hedge. If LIBOR rises, the interest rate on
outstanding borrowings under the Hayfin Loan Agreement will increase. Therefore, an increase in LIBOR will increase our interest payment obligations
under  the  Hayfin  Loan  Agreement  and  have  a  negative  effect  on  our  cash  flows  and  liquidity,  and  could  have  a  negative  effect  on  our  ability  to  make
payments due under the Hayfin Loan Agreement.

EW Healthcare Partners and its interests may conflict with those of our other shareholders.

43

As of December 31, 2022, EW Healthcare Partners and their affiliates own 90% of the outstanding shares of our Series B Preferred Stock which, upon
conversion into shares of Common Stock, would result in an ownership interest of approximately 18.3% of our Common Stock (calculated on the basis
described in Item 12, “Security Ownership Of Certain Beneficial Owners And Management” below). Also, for as long as EW Healthcare Partners and its
affiliates collectively hold at least (i) 10% of the outstanding shares of our Common Stock (calculated on an as converted basis), EW Healthcare Partners
has  the  right  to  designate  two  directors  to  our  Board  and  (ii)  5%  (but  less  than  10%)  of  the  outstanding  shares  of  our  outstanding  Common  Stock
(calculated on an as converted basis), EW Healthcare Partners has the right to designate one individual to serve on our Board. Such individuals will initially
be  preferred  directors  and  therefore  not  subject  to  election  by  the  holders  of  Common  Stock.  EW  Healthcare  Partners  designated  Martin  P.  Sutter  and
William A. Hawkins, III, who continue to serve on our board as preferred directors. The interests of EW Healthcare Partners may conflict with those of our
other shareholders, and EW Healthcare Partners may seek to influence, and may be able to influence, us through its director designation rights and its share
ownership.

Holders of shares of our Series B Preferred Stock have rights, preferences and privileges that are not held by, and are preferential to, the rights of, our
common shareholders.

Holders of shares of our Series B Preferred Stock are currently entitled to cumulative dividends at a rate of 6.0% per annum, compounding quarterly in
arrears. The dividends are payable quarterly in whole or in part, in cash. However, the Company may, at its option, elect not to pay any such dividend in
cash and instead to accrue the amount of such dividend. The payment of regular dividends in cash to the holders of Series B Preferred Stock could impact
our  liquidity  and  reduce  the  amount  of  cash  available  for  working  capital,  capital  expenditures,  growth  opportunities,  acquisitions,  and  other  general
corporate purposes. If we elect to accrue the dividends in lieu of paying them in cash, holders of Common Stock could effectively be diluted because such
accrual  of  dividends  will  increase  the  number  of  shares  of  Common  Stock  into  which  the  Series  B  Preferred  Stock  would  then  be  convertible.  Our
obligations to the holders of Series B Preferred Stock could also limit our ability to obtain additional equity or debt financing or increase our borrowing
costs, which could have an adverse effect on our financial condition.

The Series B Preferred Stock ranks senior to our Common Stock with respect to dividends and distributions on liquidation, winding-up, and dissolution.
Upon a liquidation, dissolution, or winding-up of the Company, holders of Series B Preferred Stock will be entitled to receive $1,000 per share of Series B
Preferred  Stock  (subject  to  adjustment),  plus  any  accrued  and  unpaid  dividends.  This  amount  will  be  payable  prior  to  any  distribution  of  our  available
assets to the holders of our Common Stock.

Holders  of  Series  B  Preferred  Stock  generally  are  entitled  to  vote  together  as  a  single  class  with  the  holders  of  the  shares  of  Common  Stock,  on  an  as
converted basis, on all matters submitted for a vote of holders of our Common Stock subject to certain limitations on their voting rights contained in the
related Articles of Amendment to our Restated Articles of Incorporation. Additionally, certain matters will require the approval of the holders of a majority
of the outstanding shares of Series B Preferred Stock, voting as a separate class, including the following actions:

•
•

•
•

any changes to the rights, preferences, or privileges of the Series B Preferred Stock;
amendments  or  restatements  of  any  organizational  document  of  the  Company  or  its  subsidiaries  in  a  manner  that  materially,  adversely,  and
disproportionately affects the rights, preferences, and privileges of the Series B Preferred Stock as compared to our Common Stock;
the authorization or creation of any class or series of senior or parity equity securities; and
the  declaration  of  any  dividends  or  any  other  distributions,  or  the  repurchase  or  redemption,  of  any  equity  securities  of  the  Company  ranking
junior to or on parity with the Series B Preferred Stock (subject to certain exceptions).

The interests of our holders of Series B Preferred Stock and our Common Stock may conflict in certain circumstances, and these provisions may constrain
the  Company  from  taking  certain  actions  that  may  be  in  the  best  interest  of  the  holders  of  its  Common  Stock.  Additionally,  as  long  as  EW  Healthcare
Partners  holds  at  least  10%  of  our  outstanding  Common  Stock  (calculated  on  an  as  converted  basis),  it  has  certain  preemptive  rights  to  participate  in
offerings of Common Stock to any person, subject to customary exceptions.

Furthermore,  in  the  event  that  the  Company  undergoes  a  change  of  control  (as  defined),  the  holders  of  Series  B  Preferred  Stock  will  have  certain
redemption  rights,  which,  if  exercised,  could  require  us  to  repurchase  all  of  the  outstanding  shares  of  Series  B  Preferred  Stock  for  cash  at  the  original
purchase price of Series B Preferred Stock plus all accrued and unpaid dividends thereon. Any required repurchase of the outstanding Series B Preferred
Stock could impact our liquidity and reduce

44

the amount of cash available for working capital, capital expenditures, growth opportunities, acquisitions, and other general corporate purposes.

The  preferential  rights  of  the  Series  B  Preferred  Stock  could  also  result  in  divergent  interests  between  the  holders  of  Series  B  Preferred  Stock  and  our
common shareholders.

Our Series B Preferred Stock is convertible into shares of our Common Stock, and any such conversion may dilute the value of our Common Stock.

Holders of shares of Series B Preferred Stock have the right, at their option, to convert each share of Series B Preferred Stock into shares of our Common
Stock, except that no holder may convert its shares of Series B Preferred Stock into shares of Common Stock if such conversion would result in such holder
and its affiliates holding more than 19.9% of the aggregate voting power of our Common Stock or beneficially owning in excess of 19.9% of our then-
outstanding shares of Common Stock. Additionally, each share of Series B Preferred Stock (including any accrued and unpaid dividends) will automatically
convert  into  shares  of  our  Common  Stock  at  any  time  after  July  2,  2023,  provided  that  our  Common  Stock  has  traded  at  200%  or  more  of  the  then
conversion price (i) for 20 out of 30 consecutive trading days preceding, and (ii) as of the close of trading on the date immediately prior to conversion. The
conversion of Series B Preferred Stock may significantly dilute our common shareholders and adversely affect both our net income per share of Common
Stock and the market price of our Common Stock.

The price of our Common Stock has been, and will likely continue to be, volatile.

The  market  price  of  our  Common  Stock,  like  that  of  the  securities  of  many  other  healthcare  companies  that  are  engaged  in  research,  development,  and
commercialization, has fluctuated over a wide range, and it is likely that the price of our Common Stock will fluctuate in the future. The market price of our
Common Stock could be impacted by a variety of factors, including:

Changes in government regulations or our failure to comply with any such regulations;

Fluctuations in stock market prices and trading volumes of similar companies or of the markets generally;

•
• Our ability to successfully launch, market and earn significant revenue from our products;
• Our ability to obtain additional financing to support our continuing operations;
• Disclosure of the details and results of our clinical trials and our regulatory applications and proceedings;
• Developments in and disclosure or publicity regarding existing or new litigation or contingent liabilities;
•
• Additions or departures of key personnel;
• Our investments in research and development or other corporate resources;
• Announcements of technological innovations or new commercial products by us or our competitors;
• Developments in the patents or other proprietary rights owned or licensed by us or our competitors;
•
• Actual or anticipated fluctuations in our operating results, including as a result of seasonality in our business, as well as any restatements of

The timing of new product introductions;

previously reported results;

• Our ability to effectively and consistently process or manufacture our products and avoid costs associated with the recall of defective or potentially

defective products;

• Our ability and the ability of our distribution partners to market and sell our products;
•
•

Changes in reimbursement for our products or the price for our products to our customers;
Removal of our products from the FSS, or changes in how government accounts purchase products such as ours or in the price for our products to
government accounts;

• Activities of market participants and investors, including analysts and MIMEDX shareholders;
• Material amounts of short-selling of our Common Stock; and
•

The other risks detailed in this Item 1A.

Any unanticipated shortfall in our revenue in any fiscal quarter could have an adverse effect on our results of operations in that quarter. The effect on our
net income of such a shortfall could be exacerbated by the relatively fixed nature of most of our costs, which primarily include personnel costs as well as
facilities  costs.  These  fluctuations  could  cause  the  trading  price  of  our  stock  to  be  negatively  affected.  Our  quarterly  operating  results  have  varied
substantially in the past and may vary substantially in the future, including as a result of seasonality in our business. Price volatility or a decrease in the
market  price  of  our  Common  Stock  could  have  an  adverse  effect  on  our  ability  to  raise  capital,  liquidity,  business,  financial  condition  and  results  of
operations.

Securities analysts may elect not to report on our common stock or may issue negative reports that adversely affect the stock price.

45

We have conducted extensive investor relations outreach to the investment analysts community with the goal of attracting analyst coverage. However, at
this time, only four securities analysts provide coverage on us, and we compensate one of those analyst’s firms. There can be no assurance that any other
analysts will cover our stock or, if they do, that they will continue to report on our common stock or that additional analysts will initiate reporting on our
common stock.

If we fail to attract the coverage or securities analysts, or if securities analysts discontinue covering our common stock, the lack of research coverage may
adversely  affect  the  actual  and  potential  market  price  of  our  common  stock.  The  trading  market  for  our  common  stock  may  be  affected  in  part  by  the
research and reports that industry participants, industry analysts or financial analysts publish about our business. If one or more analysts elect to cover us
and then downgrade the stock, the stock price would likely decline rapidly. If one or more of these analysts cease coverage of us, we could lose visibility in
the market, which in turn could cause our stock price to decline.

Fluctuations in revenue or results of operations could cause additional volatility in our stock price.

Any unanticipated shortfall in our revenue in any fiscal quarter could have an adverse effect on our results of operations in that quarter. The effect on our
net income of such a shortfall could be exacerbated by the relatively fixed nature of most of our costs, which primarily include personnel costs as well as
facilities  costs.  These  fluctuations  could  cause  the  trading  price  of  our  stock  to  be  negatively  affected.  Our  quarterly  operating  results  have  varied
substantially in the past and may vary substantially in the future.

We do not intend to pay cash dividends on our Common Stock.

Holders of our Series B Preferred Stock are entitled to contractually-determined dividends before holders of our Common Stock. See above “- Holders of
shares  of  Series  B  Preferred  Stock  have  rights,  preferences  and  privileges  that  are  not  held  by,  and  are  preferential  to,  the  rights  of,  our  common
shareholders.”

We have never declared or paid cash dividends on our Common Stock. We currently expect to use available funds and any future earnings to pay dividends
on the Series B Preferred Stock; in the development, operation and expansion of our business; to repay debt; and, to the extent authorized by our Board,
repurchasing  our  Common  Stock.  We  do  not  anticipate  paying  any  cash  dividends  on  our  Common  Stock  in  the  foreseeable  future.  As  a  result,  capital
appreciation, if any, of our Common Stock will be an investor’s only source of potential gain from our Common Stock for the foreseeable future.

Certain provisions of Florida law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control, even if
an  acquisition  would  be  beneficial  to  shareholders,  which  could  affect  our  share  price  adversely  and  prevent  attempts  by  shareholders  to  remove
current management.

The Florida Business Corporation Act (the “FBCA”) includes several provisions applicable to the Company that may discourage potential acquirors. Such
provisions include provisions that:

•
•

•

allow directors to take other stakeholders into account in discharging their duties;
a requirement that certain transactions with a shareholder of 10% or more ownership must be approved by the affirmative vote of two-thirds of the
other shareholders unless approved by a majority of the disinterested directors or certain fair price requirements are met; and
voting  rights  acquired  by  a  shareholder  at  ownership  levels  at  or  above  one-fifth,  one-third  and  a  majority  of  voting  power  are  denied  unless
authorized by the Board prior to such acquisition or by a majority of the other shareholders (excluding interested shares (as defined in the FBCA)).

Additionally, our organizational documents contain provisions:

•
•
•
•

authorizing the issuance of blank check preferred stock;
restricting persons who may call shareholder meetings;
permitting shareholders to remove directors only “for cause” and only by super-majority vote; and
providing the Board with the exclusive right to fill vacancies and to fix the number of directors.

These provisions of Florida law and our articles of incorporation and bylaws could negatively affect our share price, prevent attempts by shareholders to
remove  current  management,  prohibit  or  delay  mergers  or  other  takeovers  or  changes  of  control  of  the  Company  and  discourage  attempts  by  other
companies to acquire us, even if such a transaction would be beneficial to our shareholders.

46

Item 1B. Unresolved Staff Comments

There are no unresolved SEC Staff comments with respect to our SEC filings.

Item 2. Properties

Our corporate headquarters are located in Marietta, Georgia, where we lease office, laboratory, tissue processing and warehouse space. We lease a facility
in Kennesaw, Georgia, which primarily consists of laboratory, tissue processing and warehouse space, and are currently subletting additional warehouse
space in Marietta, Georgia through May 31, 2023. Our properties, excluding the sublet space, are used by our Wound & Surgical segment, which includes
the design, manufacture and marketing of products and tissue processing services primarily for the wound care, burn, Surgical Recovery, and non-operative
sports medicine sectors of healthcare, additionally, our Kennesaw facility is used for the Regenerative Medicine segment.

The Company’s properties are suitable and adequate for current business operations. We are making investments to increase our manufacturing capacity, as
well as enhancements to facilitate the processing of products required to be manufactured under CGMP.

Item 3. Legal Proceedings

The description of our securities class action and the Welker v. MiMedx, et. al. case contained in Note 16, Commitments and Contingencies to our financial
statements included in Item 8 is incorporated herein by reference.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

PART II

Market for Common Stock

Our Common Stock trades on The Nasdaq Stock Market under the trading symbol “MDXG”.

Holders

Based upon information supplied from our transfer agent, there were approximately 857 shareholders of record of our Common Stock as of February 21,
2023.

Stock Performance Graph

The following graph compares the cumulative total stockholder return on our Common Stock with the cumulative total stockholder return of the Nasdaq
Composite Index, the Nasdaq Biotechnology Index and the Russell 2000 Index, assuming an investment of $100.00 on December 31, 2017.

47

ASSUMES $100 INVESTED ON DEC. 31, 2017
ASSUMES DIVIDEND REINVESTMENT; NO DIVIDENDS ISSUED BY MIMEDX
FISCAL YEAR ENDED DEC. 31, 2022

Change in Comparison Index

During 2022, we changed our Cumulative Total Return comparison from the Nasdaq Biotechnology Index to the Russell 2000 Index. The Russell 2000
Index, which includes the Company’s common stock, is a stock index consisting of 2000 publicly-traded small-cap companies. We use the Russell 2000 for
peer benchmarking in certain compensation arrangements with certain of our employees.

We believe the Russell 2000 provides more meaningful information than the Nasdaq Biotechnology Index because the breadth of the latter index contains
significant diversity in market capitalization, stage of clinical development, total addressable markets, and other factors. The Company’s common stock is
not included on the Nasdaq Biotechnology Index.

48

 
 
Securities Authorized for Issuance Under Equity Compensation Plans

Information about securities authorized for issuance under our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this
Annual Report.

Recent Sales of Unregistered Securities

None.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

The  following  table  sets  forth  information  regarding  the  purchases  of  the  Company’s  equity  securities  made  by  or  on  behalf  of  the  Company  or  any
affiliated purchaser (as defined in Rule 10b-18 under the Exchange Act) during the three-month period ended December 31, 2022.

Period
October 1, 2022 - October 31, 2022
November 1, 2022 - November 30, 2022
December 1, 2022 - December 31, 2022

Total for the quarter

Total Number of
Shares Purchased

Average
Price Paid
 per Share

Total Number of Shares
Purchased as Part of
Publicly Announced
Plans
or Programs

Approximate Dollar Value
of Shares that May Yet Be
Purchased Under Plans or
Programs

—  $
—  $
—  $
—  $

— 
— 
— 

— 

—  $
—  $
—  $
—  $

— 
— 
— 

— 

49

 
 
 
Item 6. [Reserved]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

MIMEDX is a pioneer and leader in placental biologics focused on addressing the needs of patients with acute and chronic non-healing wounds. We are
also advancing a promising late-stage biologics pipeline targeted at decreasing pain and improving function for patients with knee osteoarthritis (“KOA”).
To accomplish these goals, we operate under two defined internal business units: Wound & Surgical and Regenerative Medicine. All of our products are
regulated by the FDA.

We have two classes of products: (1) Advanced Wound Care products, or Section 361 products, consisting of our tissue and cord sheet allograft products, as
well as certain particulate products regulated under Section 361, and (2) Section 351 products, consisting of our micronized and certain other particulate
products, which, prior to May 31, 2021, the date the FDA’s period of enforcement discretion ended (as described below), were used to treat a variety of
clinical  conditions,  including  both  advanced  wound  care  and  musculoskeletal  applications.  Our  Advanced  Wound  Care  products  include  two  product
categories: Tissue/Other and Cord products. We apply Current Good Tissue Practices (“CGTP”) and Current Good Manufacturing Practices (“CGMP”)
standards in addition to terminal sterilization to produce our allografts.

The Wound & Surgical business focuses on the Advanced Wound Care and Surgical Recovery markets through sales of our existing product portfolio (as
described in detail in the Our Products section below) and product development to serve these primary end markets. This business unit is responsible for
substantially all sales of our Advanced Wound Care products, as well as the sale of our Section 351 products internationally.

The  Regenerative  Medicine  business  focuses  on  progressing  our  placental  biologics  platform  towards  registration  as  an  FDA-approved  biological  drug.
Micronized dehydrated human amnion chorion membrane (“mDHACM”) is an injectable placental biologic product candidate in our late-stage pipeline
targeted at achieving FDA approval for an indication to help decrease pain and improve function in patients suffering from KOA. Prior to May 31, 2021,
this business unit was responsible for domestic sales of our Section 351 products. Regenerative Medicine does not currently generate revenue.

Our Products

Our primary platform technologies include tissue allografts derived from human placental membrane (EPIFIX, AMNIOFIX, and AMNIOEFFECT), tissue
allografts derived from human umbilical cord (EPICORD and AMNIOCORD), and a particulate extracellular matrix derived from human placental disc
(AXIOFILL).

EPIFIX and EPICORD products are marketed for external use, such as in Advanced Wound Care applications, while our AMNIOFIX, AMNIOEFFECT,
AXIOFILL,  and  AMNIOCORD  products  are  positioned  for  use  in  Surgical  Recovery  applications,  including  lower  extremity  repair,  plastic  surgery,
vascular surgery and multiple orthopedic repairs and reconstructions.

In November 2017, the FDA published a series of guidance documents that established an updated framework for the regulation of cellular and tissue-
based products. These guidance documents clarified the FDA’s views about the criteria that differentiate those products subject to regulation under Section
361 of the Public Health Service Act from those considered to be drugs, devices, and/or biological products subject to licensure under Section 351 of the
Public Health Service Act and related regulations. The FDA exercised enforcement discretion under limited conditions with respect to IND applications
and pre-market approval requirements for Section 351 products. The FDA’s period of enforcement discretion ended effective May 31, 2021. We are not
currently marketing our micronized and certain particulate products affected by the guidance in the United States.

This discussion, which presents our results for the fiscal years ended December 31, 2022 and 2021, should be read in conjunction with our Consolidated
Financial Statements and the accompanying notes. Also please refer to Part I, Item 1, Business, and Part I, Item 1A, Risk Factors, which include detailed
discussions of various items impacting our business, results of operations and financial condition. We intend for this discussion to provide the reader with
information that will assist in understanding our financial statements, the changes in certain key items in those financial statements from period to period
and  the  primary  factors  that  accounted  for  those  changes.  We  also  discuss  certain  performance  metrics  that  management  uses  to  assess  the  Company's
performance.

Our  Annual  Report  for  the  year  ended  December  31,  2021  includes  a  discussion  and  analysis  of  our  total  company  financial  condition  and  results  of
operations for 2021 compared to 2020 in Part II, Item 7, Management’s Discussion and Analysis of

50

Financial Condition and Results of Operations. A discussion of the results of operations and financial condition for Wound & Surgical and Regenerative
Medicine for 2021 compared to 2020 are presented herein.

Impact of COVID-19 Pandemic

The  COVID-19  pandemic  is  still  ongoing,  though  the  effects  on  our  operations,  such  as  access  restrictions  to  hospitals  and  difficulties  obtaining  donor
materials that we observed during the year ended December 31, 2020 and, to a lesser degree, during the year ended December 31, 2021, did not materially
affect our operations during the year ended December 31, 2022. We are continuously monitoring developments with respect to novel variants of the virus
and government and societal responses to mitigate the spread of COVID-19, which could impact our operations.

We continue to exercise an abundance of caution with respect to the health and well-being of our employees. Our offices are open and staffed, and we are
operating under a hybrid work model for some personnel as well as encouraging all employees to get vaccinated if they have not already done so. None of
these efforts have materially affected the Company’s operations for the year ended December 31, 2022.

Components of and Key Factors Influencing Our Results of Operations

In assessing the performance of our business, we consider a variety of performance and financial measures. We believe the items discussed below provide
insight into the factors that affect these key measures.

Net sales

Net sales is recognized based on the consideration we expect to receive from the sale at the point in time when control of the goods is transferred to the
customer,  which  generally  occurs  upon  our  delivery  to  a  third-party  carrier.  This  consists  of  the  gross  selling  price  of  the  product,  less  any  discounts,
rebates, fees paid to GPOs, and returns.

We  derive  the  majority  of  our  revenue  from  selling  our  tissue  and  cord  products  in  the  United  States.  We  are  actively  working  to  broaden  our  product
portfolio in a number of clinical applications, while also seeking regulatory approval with the appropriate regulators to expand our geographic footprint,
beginning  in  Japan.  In  early  2023,  we  announced  the  execution  of  an  exclusive  distribution  agreement  with  Gunze  Medical  Limited  to  sell  EPIFIX  in
Japan.

Cost of goods sold and gross profit

Cost  of  goods  sold  includes  product  testing  costs,  quality  assurance  costs,  personnel  costs,  manufacturing  costs,  raw  materials  and  product  costs,
depreciation  and  facility  costs  associated  with  our  manufacturing  and  warehouse  facilities.  Fluctuations  in  our  cost  of  goods  sold  correspond  with  the
fluctuations in these costs as well as sales volume.

Gross profit is calculated as net sales less cost of goods sold. Gross margin is calculated as gross profit divided by net sales. Our gross margin is affected by
product and geographic sales mix, realized pricing of our products, the efficiency of our manufacturing operations and the costs of materials used to make
our products. Regulatory actions, including with respect to reimbursement for our products, may require costly expenditures or result in pricing pressure,
and may decrease our gross profit and gross margin.

Selling, general and administrative expense

Selling, general and administrative (“SG&A”) expense includes costs to execute our sales strategy. These include personnel costs pertaining to our sales
force and sales support functions, including salaries, commissions and other incentive compensation, commissions to sales agents, customer support, travel
expenses, and bad debt expense. We expect our SG&A expense to fluctuate based on revenue fluctuations, geographic changes, and any changes to the size
of our headcount, particularly that of our sales and marketing forces. Certain of these costs scale with sales, but can fluctuate depending on sales mix. For
example, we pay sales agents a greater commission than our internal sales force, meaning that we could incur greater commission expenses if a greater
proportion of our sales are through sales agents.

SG&A expense also includes costs related to functions which support both of our business units, such as legal, finance, human resources, and other such
functions. These costs include personnel costs associated with these units, as well as insurance, and certain professional fees. These costs tend to fluctuate
based on headcount, which will vary depending on our projected business needs.

51

Research and development expense

Research and development expense relates to our investments in clinical trials to expand our product pipeline and platforms, as well as expenditures in
improvements to our manufacturing process and the enhancement of existing products. Our research and development costs also include expenses such as
salaries and benefits related to our research department, consulting costs and advisory costs, and regulatory costs.

We expense research and development costs as incurred. Fluctuations in research and development expenses can be impacted by the timing and cadence of
our clinical trials.

Investigation, restatement and related expense

Investigation, restatement and related expense primarily relates to legal fees advanced to certain former officers and directors of the Company under certain
indemnification agreements and our liability from legal proceedings taken against us which arose from the findings of the Audit Committee Investigation.
The timing and extent of these expenses depend on the stage and status of legal proceedings. Other activity includes amounts received from certain director
and officer insurance providers.

Interest expense

We incur interest expense primarily through stated interest on our outstanding term loan. The interest on our term loan is tied to the three-month London
Interbank Offered Rate (“LIBOR”), subject to a floor of 1.5%. Increases in LIBOR could cause our interest expense to increase. Other activity influencing
interest expense relates to the amortization of deferred financing costs and original issue discount associated with credit facilities outstanding.

Results of Operations for 2022 Compared to 2021

Total Company

Net sales

Cost of sales

Gross profit

Selling, general and administrative

Research and development
Investigation, restatement and related
Amortization of intangible assets
Impairment of intangible assets
Interest expense, net
Other expense, net

Income tax provision expense

Net loss

Net Sales

Year Ended December 31,
(in thousands)

2022

2021

$ Change

% Change

$

$

267,841  $
48,316 

219,525

208,789 
22,829 
12,177 
701 
— 
(5,016)
(4)

(206)
(30,197) $

258,615  $
43,283 

215,332 

198,359 

17,344 
3,791 
820 
53 
(4,980)
(23)

(247)

9,226 
5,033 

4,193 

10,430 

5,485 
8,386 

(119)
(53)
(36)

19 

41 

(10,285) $

(19,912)

3.6 %

11.6 %

1.9 %

5.3 %

31.6 %
nm

(14.5)%
(100.0)%
0.7 %

(82.6)%

(16.6)%

nm

We recorded net sales for the year ended December 31, 2022 of $267.8 million, an increase of $9.2 million or 3.6% over 2021 net sales of $258.6 million.

Our sales by product were as follows (amounts in thousands):

52

Advanced Wound Care

Tissue/Other
Cord

Total Advanced Wound Care
Section 351
Other

Total

Year Ended December 31,

2022

2021

Change

$

%

$

$

241,992  $
23,211 
265,203 
2,379 
259 
267,841  $

216,418  $
23,599 
240,017 
17,610 
988 
258,615  $

25,574 
(388)
25,186 
(15,231)
(729)
9,226 

11.8 %
(1.6)%
10.5 %
(86.5)%
(73.8)%

3.6 %

The increase in net sales reflects sales growth in our Advanced Wound Care products of $25.2 million or 10.5%, year-over-year. Our sales growth in this
area  was  a  result  of  our  focus  on  the  application  of  these  products  into  areas  of  Surgical  Recovery,  including  the  introduction  of  AMNIOEFFECT  and
AXIOFILL to the market during 2022. We saw further gains as a result of our prior initiatives to expand, realign and train our sales team.

The  increase  was  partially  offset  by  our  inability  to  sell  our  Section  351  products  in  the  United  States  as  a  result  of  the  end  of  the  FDA’s  period  of
enforcement discretion on May 31, 2021. Sales of our Section 351 products were $2.4 million for the year ended December 31, 2022 compared to $17.6
million for the year ended December 31, 2021, a decrease of $15.2 million. Sales of Section 351 products during the year ended December 31, 2022 were
derived from outside the United States.

Gross Margin and Cost of Sales

Gross  margin  in  2022  was  82.0%,  compared  to  83.3%  in  2021.  Cost  of  sales  and  gross  profit  for  2021  included  inventory  write-downs  of  $1.7  million
related to our Section 351 products, resulting from the end of enforcement discretion and products which were discontinued. There were no significant
unusual write-downs during 2022. Decreases in margins were driven by negative impacts from production variances, primarily due to lower product levels.

Cost of sales for the year ended December 31, 2022 was $48.3 million, an increase of $5.0 million, or 11.6%, compared to $43.3 million for the year ended
December 31, 2021. In addition to the factors affecting gross margin discussed above, overall increases in sales volume contributed to the increase in cost
of sales.

Selling, General and Administrative Expense

SG&A expense increased $10.4 million, or 5.3%, to $208.8 million for 2022, compared to $198.4 million for 2021. The increase in SG&A expense was
driven by:

•

•

•

•

an increase in travel expenses, reflecting the lifting of travel restrictions that were in place during the year ended December 31, 2021,

increases in sales commissions, resulting from higher sales volumes through sales agents, who carry higher commission rates than our internal
sales force.

an increase in bad debt expense resulting from the deterioration of credit for certain specific customers, and

an increase in severance costs incurred with the intention of reducing corporate costs. This effect was partially offset by a year-over-year decrease
in  share-based  compensation  expense,  primarily  driven  by  the  reversal  of  previously  recognized  share-based  compensation  expense  associated
with forfeitures of awards from the separated individuals.

These amounts were offset, primarily, by year-over-year decreases in professional service expenses.

Research and Development Expense

Our  research  and  development  expense  increased  $5.5  million,  or  31.6%,  to  $22.8  million  for  the  year  ended  December  31,  2022,  compared  to  $17.3
million for the year ended December 31, 2021. The increase reflects higher personnel costs and clinical trial-related expenses to support clinical research
efforts, primarily connected to our commercial and late-stage pipelines.

Investigation, Restatement and Related Expense

53

Investigation, restatement, and related expenses increased $8.4 million to $12.2 million for the year ended December 31, 2022, compared to $3.8 million
for  the  year  ended  December  31,  2021.  In  2021,  we  received  funds  from  insurance  providers  and  reductions  in  legal  expenses  that  were  reflected  as
reductions to expense for the year ended December 31, 2021.

We  remain  subject  to  indemnification  agreements  with  certain  former  officers  and  directors  of  the  Company  (other  than  Messrs.  Petit  and  Taylor,  our
former  Chief  Executive  Officer  and  Chief  Operating  Officer)  for  whom  legal  proceedings  are  still  ongoing,  in  particular,  our  former  Chief  Financial
Officer.

Amortization of Intangible Assets

Amortization expense related to intangible assets decreased $0.1 million from $0.8 million for the year ended December 31, 2021 to $0.7 million for the
year ended December 31, 2022. The decrease was the result of the avoidance of amortization expense from assets that had become fully-amortized during
2021.

Impairment of Intangible Assets

Impairment of intangible assets was $0.1 million for the year ended December 31, 2021, reflecting the impairment of a supplier relationship asset. There
were no impairments in 2022.

Interest Expense, Net

Interest expense was $5.0 million for each of the years ended December 31, 2022 and 2021. The rise in LIBOR rates during 2022 caused an increase in
interest expense on our outstanding term loan. In addition, we recognized interest income on our income tax receivable resulting from the Coronavirus Aid,
Relief,  and  Economic  Security  Act.  These  effects  were  offset  by  the  avoidance  of  interest  expense  associated  with  the  delayed  draw  term  loan  facility
option under the Hayfin Loan Agreement that terminated on June 30, 2021.

We expect interest expense to increase in future quarters as a result of rising interest rates.

Income Tax Provision Expense

The effective tax rate for 2022 and 2021 was (0.7)% and (2.5)%, respectively on pre-tax book losses of $30.0 million and $10.0 million, respectively. There
were  no  discrete  items  which  materially  influenced  the  effective  tax  rate  in  either  period,  and  net  operating  losses  generated  were  offset  by  a  valuation
allowance.

Segment Results

Wound & Surgical

Our Wound & Surgical business focuses on the Advanced Wound Care and Surgical Recovery markets through sales of our existing product portfolio and
product development to serve these end markets. Its platform technologies include tissue allografts derived from human placental membrane (EPIFIX®,
AMNIOFIX®,  and  AMNIOEFFECT™),  tissue  allografts  derived  from  human  umbilical  cord  (EPICORD®  and  AMNIOCORD®),  and  a  particulate
extracellular  matrix  derived  from  human  placental  disc  (AXIOFILL™).  This  segment  is  also  responsible  for  the  international  sales  of  our  Section  351
products.

Several factors affect reported net sales for our Wound & Surgical business in any period, including product, payer and geographic sales mix, operational
effectiveness,  pricing  realization,  marketing  and  promotional  efforts,  timing  of  orders  and  shipments,  regulatory  actions  including  healthcare
reimbursement scenarios, competition, and business acquisitions that involve our customers or competitors.

SG&A  expense  includes  costs  to  execute  our  sales  strategy.  These  include  personnel  costs  pertaining  to  our  sales  force  and  sales  support  functions,
including salaries, commissions and other incentive compensation, commissions to sales agents, customer support, travel expenses, and bad debt expense.

Research and development expenses for Wound & Surgical focus on the expansion of our product portfolio into similar areas of healthcare, specifically
Advanced Wound Care and Surgical Recovery.

Wound & Surgical Results of Operations 2022 Compared to 2021

54

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Segment contribution

$

$

264,906  $
44,462 
145,887 
7,836 
66,721  $

238,940  $
35,204 
123,583 
5,864 
74,289  $

25,966 
9,258 
22,304 
1,972 
(7,568)

10.9 %
26.3 %
18.0 %
33.6 %
(10.2)%

2022

2021

$ Change

% Change

Year Ended December 31,
(in thousands)

Our Wound & Surgical business recorded $264.9 million of net sales for the year ended December 31, 2022, a $26.0 million, or 10.9%, increase compared
to the $238.9 million we recorded for the year ended December 31, 2021. This increase was the result of our focus on the application of these products into
areas of Surgical Recovery, including the introduction of AMNIOEFFECT and AXIOFILL to the market during 2022. We saw further gains as a result of
our prior initiatives to expand, realign and train our sales team.

Cost of sales for the year ended December 31, 2022 was $44.5 million, a $9.3 million, or 26.3%, increase compared to the $35.2 million recognized for the
year ended December 31, 2021. Cost of sales increased due to negative impacts from production variances, primarily due to lower production levels, as
well as increases in sales volume.

SG&A expense was $145.9 million for the year ended December 31, 2022, a $22.3 million, or 18.0%, increase over the year ended December 31, 2021,
during  which  we  incurred  $123.6  million  of  expenses.  The  increase  was  driven  by  travel  expenses,  sales  commissions,  and  bad  debt  expense.  Travel
expenses increased due to the lifting of restrictions that were in place during the year ended December 31, 2021 due to the COVID-19 pandemic. Increases
in sales commissions reflected our focus on sales of products into areas of Surgical Recovery, resulting in a proportional increase in sales through sales
agents, who carry higher commission rates than our internal sales force. The increase in bad debt expense was primarily the result of the deterioration of
credit for certain specific customers.

Research and development expense was $7.8 million for the year ended December 31, 2022, compared to $5.9 million for the year ended December 31,
2021, an increase of $2.0 million, or 33.6%. The increase was primarily the result of expenses related to AMNIOEFFECT and AXIOFILL, both of which
launched during the year ended December 31, 2022.

Wound & Surgical Results of Operations 2021 Compared to 2020

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Segment contribution

$

$

238,940  $
35,204 
123,583 
5,864 
74,289  $

213,489  $
30,185 
103,039 
3,979 
76,286  $

25,451 
5,019 
20,544 
1,885 
(1,997)

11.9 %
16.6 %
19.9 %
47.4 %
(2.6)%

2021

2020

$ Change

% Change

Year Ended December 31,
(in thousands)

Our Wound & Surgical business recorded $238.9 million of net sales for the year ended December 31, 2021, a $25.5 million, or 11.9%, increase compared
to  the  $213.5  million  we  recorded  for  the  year  ended  December  31,  2020.  This  increase  was  primarily  the  result  of  an  increase  in  sales  volume  due  to
lessening  of  restrictions  implemented  at  the  onset  of  the  COVID-19  pandemic,  including  access  to  hospitals  and  travel  restrictions.  The  increase  also
reflected the initial results of our commercial focus on areas of Surgical Recovery. Finally, we saw growth in new products, such as EPICORD Expandable,
which launched in September 2020.

Cost of sales for the year ended December 31, 2021 was $35.2 million, a $5.0 million, or 16.6%, increase compared to the $30.2 million recognized for the
year ended December 31, 2020. Cost of sales increased due to year-over-year increases in sales volumes as well as the unfavorable effects of production
variances, year-over-year.

SG&A expense was $123.6 million for the year ended December 31, 2021, a $20.5 million, or 19.9%, increase over the year ended December 31, 2020,
during  which  we  incurred  $103.0  million  of  expenses.  The  increase  was  driven  by  salaries,  travel  expenses,  and  sales  commissions.  Salary  expenses
increased due to the restoration of full-salary levels, which were reduced for

55

a portion of 2020 as part of our response to the COVID-19 pandemic. Salary expenses also increased as a result of merit increases and costs associated with
expansion of our sales force. Travel expenses increased due to the lifting of restrictions that were in place during the year ended December 31, 2020 due to
the COVID-19 pandemic, as well as result of inflationary pressures experienced during the year ended December 31, 2021. Increases in sales commissions
reflected higher sales volumes.

Research and development expense was $5.9 million for the year ended December 31, 2021, compared to $4.0 million for the year ended December 31,
2020, an increase of $1.9 million, or 47.4%. The increase was driven by higher personnel costs due to headcount increases and the restoration of full salary
levels and merit increases, which were restricted for a portion of 2020.

Regenerative Medicine

Our  Regenerative  Medicine  business  focuses  solely  on  Regenerative  Medicine  technologies,  specifically  progressing  our  placental  biologics  platform
towards  registration  as  an  FDA-approved  biological  drug.  mDHACM  is  the  lead  product  candidate  in  its  late-stage  pipeline  targeted  at  achieving  FDA
approval for an indication to help decrease pain and improve function in patients suffering from KOA.

Prior to May 31, 2021, net sales for the Regenerative Medicine segment consisted of domestic sales of Section 351 products. Regenerative Medicine does
not currently generate revenue, and will only produce revenue if and after such time that the FDA approves a BLA for mDHACM. After that point in time,
we re-focused our sales and marketing efforts exclusively toward the advancement of our Wound & Surgical products in the United States. For this reason,
our Regenerative Medicine segment does not generate meaningful SG&A expense.

Research and development expenditures for Regenerative Medicine are driven by clinical trial activities, primarily those undertaken by our clinical research
organization, which we have engaged to provide full operational support related to our upcoming KOA clinical trial program.

Regenerative Medicine Results of Operations 2022 Compared to 2021

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Segment contribution

$

$

—  $
— 
— 
14,993 
(14,993) $

16,596  $
3,655 
12,910 
11,480 
(11,449) $

(16,596)
(3,655)
(12,910)
3,513 
(3,544)

(100.0)%
(100.0)%
(100.0)%
30.6 %
31.0 %

2022

2021

$ Change

% Change

Year Ended December 31,
(in thousands)

Research and development expense was $15.0 million for the year ended December 31, 2022, compared to $11.5 million for the year ended December 31,
2021, an increase of $3.5 million, or 30.6%. The increase was primarily the result of increases in headcount and the incurrence of clinical trial expenses to
support our clinical research efforts.

Regenerative Medicine Results of Operations 2021 Compared to 2020

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Segment contribution

$

$

16,596  $
3,655 
12,910 
11,480 
(11,449) $

32,362  $
5,856 
17,546 
7,736 
1,224  $

(15,766)
(2,201)
(4,636)
3,744 
(12,673)

(48.7)%
(37.6)%
(26.4)%
48.4 %
nm

2021

2020

$ Change

% Change

Year Ended December 31,
(in thousands)

Our  Regenerative  Medicine  business  recorded  $16.6  million  of  net  sales  for  the  year  ended  December  31,  2021,  a  $15.8  million,  or  48.7%,  decrease
compared  to  the  $32.4  million  we  recorded  for  the  year  ended  December  31,  2020.  Likewise,  cost  of  sales  for  the  year  ended  December  31,  2021  was
$3.7 million, a $2.2 million, or 37.6%, decrease compared to the year ended

56

December  31,  2020,  where  we  recognized  cost  of  sales  of  $5.9  million.  These  decreases  reflected  our  inability  to  sell  our  Section  351  products  in  the
United States as a result of the end of the FDA’s period of enforcement discretion on May 31, 2021.

SG&A expense for the year ended December 31, 2021 was $12.9 million, a $4.6 million, or 26.4%, decrease from the year ended December 31, 2020,
where we recognized $17.5 million. This decrease reflected the re-focusing of our sales and marketing efforts toward the advancement of our Wound &
Surgical business.

Research and development expense was $11.5 million for the year ended December 31, 2021, compared to $7.7 million for the year ended December 31,
2020, an increase of $3.7 million, or 48.4%. The increase was driven by higher personnel costs due to headcount increases to support investments in our
clinical trials and the restoration of full salary levels and merit increases, which were restricted for a portion of 2020. We also incurred higher consulting
fees in 2021, primarily to assist in the evaluation of the results of our clinical trials.

Corporate

Our  Corporate  function  represents  activities  which  support  both  of  our  business  units,  such  as  legal,  finance,  human  resources,  and  other  supporting
functions. Corporate expenses include personnel costs associated with these units, as well as insurance, and certain professional fees.

SG&A expense for the Corporate function was $62.9 million, or 23.5% of net sales, for the year ended December 31, 2022, compared to $61.9 million, or
23.9% of consolidated net sales for the year ended December 31, 2021. The increase was primarily the result of an increase in severance costs associated
with  headcount  reductions  to  lower  ongoing  costs.  This  effect  was  partially  offset  by  a  year-over-year  decrease  in  share-based  compensation  expense,
primarily driven by forfeitures of awards from the separated individuals.

SG&A  expense  for  the  Corporate  function  was  $61.9  million,  or  23.9%  of  consolidated  net  sales,  for  the  year  ended  December  31,  2021,  compared  to
$60.4 million, or 24.3% of consolidated net sales for the year ended December 31, 2020. The increase reflected greater personnel costs and professional
services fees.

Liquidity and Capital Resources

We require capital for our operating activities, including costs associated with the sale of product through direct and indirect sales channels, the conduct of
clinical  trials  and  other  research  and  development  activities,  compliance  costs,  costs  to  sell  and  market  our  products,  regulatory  fees,  and  legal  and
consulting  fees  in  connection  with  ongoing  litigation  and  other  matters.  We  generally  fund  our  operating  capital  requirements  through  our  operating
activities and cash reserves. We expect to use capital in the near and medium term to commence late-stage clinical trials for certain of our products, invest
in the international expansion of our business and the broadening of our product portfolio, and invest in certain capital projects.

As of December 31, 2022, we had $66.0 million of cash and cash equivalents.

Our net working capital at December 31, 2022 was $90.6 million, a decrease of $15.5 million from $106.2 million at December 31, 2021. Our current ratio
was 3.1 to 1 as of December 31, 2022 and 3.5 to 1 as of December 31, 2021.

The  Company  is  currently  paying  its  obligations  in  the  ordinary  course  of  business.  We  believe  that  our  anticipated  cash  from  operating  activities  and
existing cash and cash equivalents will enable us to meet our operational liquidity needs for the twelve months following the filing date of this Annual
Report.

Contractual Obligations

Contractual obligations associated with ongoing business activities are expected to result in cash payments in future periods. The table below summarizes
the amounts and estimated timing of these future cash payments as of December 31, 2022 (in thousands):

57

Contractual Obligations

Total

Less than
1 year

1-3 years

3-5 years

Thereafter

Hayfin Term Loan Principal
(1)
Hayfin Term Loan Interest
Operating lease obligations
Severance obligations to former employees
Meeting space commitments
Finance lease obligations

Total

(1) Reflects an interest rate of 11.5% through maturity.

Nordic Agreement

$

$

50,000  $
14,558 
4,216 
3,677 
1,383 
115 
73,949  $

—  $

5,836 
1,638 
2,513 
989 
55 
11,031  $

50,000  $
8,722 
2,124 
1,164 
394 
60 
62,464  $

—  $
— 
454 
— 
— 
— 
454  $

— 
— 
— 
— 
— 
— 
— 

In  June  2022,  we  entered  into  a  collaboration  agreement  (the  “Nordic  Agreement”)  with  Nordic  Bioscience  Clinical  Development  A/S  (“NBCD”)  to
provide full operational support for our upcoming KOA clinical trial program.

As  part  of  the  agreement,  NBCD  will  perform  site  selection  and  monitoring,  manage  patient  recruitment  and  enrollment,  data  management,  statistical
analysis and reporting activities for the duration of the trial. Under the terms of the Nordic Agreement, we are obligated to pay $10.2 million upon the
achievement of specified milestones over the course of the clinical trial. These amounts are not included in the table above because the timing of these
payments is inherently uncertain.

The  milestones  are  based  upon  various  factors  including,  but  not  limited  to,  site  selection  and  enrollment,  patient  enrollment,  patient  completion,  and
certain  other  activities  related  to  clinical  trial  activities.  The  milestone  payments  are  revised  semi-annually  based  on  fluctuations  in  the  consumer  price
index. We have the ability to terminate the Nordic Agreement with 30 days written notice to NBCD. At such time, we would be required to pay for services
performed through the date of termination and any non-cancelable obligations. In addition to the milestone payments, the Company will reimburse NBCD
for actual expenses incurred related to third-party vendors to be contracted and managed by NBCD.

On  January  24,  2023,  we  executed  a  change  order  to  the  Nordic  Agreement  (the  “Change Order”),  primarily  to  reflect  additional  elements  required  in
conducting  the  trial.  The  Change  Order  modified  the  scope  of  NBCD’s  responsibilities  under  the  Nordic  Agreement,  shifting  certain  activities  to  other
vendors to be administered by NBCD and certain other activities to MIMEDX. These responsibilities primarily related to areas of patient recruitment and
screening  and  statistical  analysis,  among  other  areas  of  the  trial.  Pursuant  to  the  Change  Order,  the  total  payments  owed  to  NBCD  relating  to  NBCD’s
responsibilities decreased from $13.3 million to $10.2 million. While our total obligation to NBCD has decreased pursuant to the Change Order, we expect
to pay these expenses to other vendors. We have paid $2.0 million under the Nordic Agreement as of December 31, 2022 relating to milestones which have
been achieved through that date.

Turn Agreement

As described above under Item 1. “Business-Our Product Portfolio & Pipeline”, we acquired intellectual property rights pursuant to the Turn Agreement.
We paid an up-front cash payment of $1.0 million upon the execution of the agreement, and are obligated to make additional payments upon the meeting of
regulatory and product commercial milestones, including $9.6 million if and when Turn receives 510(k) clearance from the FDA for FleX. In addition, we
are obligated to pay royalties on the sales of FleX and any products derived from PermaFusion. These amounts are not included in the table above because
the timing of these payments are inherently uncertain.

Term Loan

On June 30, 2020, we entered into a Loan Agreement with, among others, Hayfin Services, LLP, (“Hayfin”) an affiliate of Hayfin Capital Management,
LLP (the “Hayfin Loan Agreement”), under which Hayfin provided us with a senior secured term loan of $50 million (the “Term Loan”). The Term Loan
matures on June 30, 2025 (the “Maturity Date”).  On  February  28,  2022,  we  executed  an  Amendment  to  the  Hayfin  Loan  Agreement  (as  amended,  the
“Amended Hayfin Loan Agreement”).

58

No principal payments are due on the Term Loan until the Maturity Date. Interest is payable on the Term Loan for principal outstanding quarterly through
the Maturity Date. Interest on any borrowings under the Term Loan is equal to LIBOR (subject to a floor of 1.5%) plus a margin of 6.75%. If LIBOR is
unavailable, the loan will carry interest at the greatest of the Prime Rate, the Federal Funds Rate plus 0.5% per annum, and 2.5% plus the 6.75% margin.
An  additional  3.0%  margin  would  be  applied  to  the  interest  rate  upon  the  occurrence  of  an  Event  of  Default  as  defined  in  the  Amended  Hayfin  Loan
Agreement. As of December 31, 2022, the Term Loan carried an interest rate of 11.5%.

The Amended Hayfin Loan Agreement contains financial covenants requiring the Company, on a consolidated basis, to maintain the following:

• Minimum Consolidated Total Net Sales (as defined in the Amended Hayfin Loan Agreement) of varying amounts, required to be calculated on a

quarterly basis, and

• Minimum Liquidity (as defined in the Amended Hayfin Loan Agreement) of $20 million, an at-all-times financial covenant, tested monthly.

As of December 31, 2022, we are in compliance with all applicable financial covenants under the Amended Hayfin Loan Agreement.

The Amended Hayfin Loan Agreement also specifies that any prepayment of the Term Loan, voluntary or mandatory, as defined in the agreement, would
subject us to a prepayment premium applicable as of the date of the prepayment, as follows:

• On or before July 2, 2023: 2% of the principal balance repaid.

• After July 2, 2023 but on or before July 2, 2024: 1% of the principal balance repaid.

• After July 2, 2024: no premium.

The Amended Hayfin Loan Agreement also includes certain negative covenants and events of default customary for facilities of this type, and upon the
occurrence  of  such  events  of  default,  subject  to  customary  cure  rights,  all  outstanding  loans  under  the  Amended  Hayfin  Loan  Agreement  may  be
accelerated  or  the  lenders’  commitments  terminated.  Mandatory  prepayments  are  also  required  in  the  event  of  a  change  in  control,  incurring  other
indebtedness, certain proceeds from disposal of assets and insured casualty event (as defined in the Amended Hayfin Loan Agreement). Annually, we are
required to prepay the outstanding loans based on the percentage of our Excess Cash Flow (as defined in the Amended Hayfin Loan Agreement), if such is
generated. To date, we have not been required to make any prepayments under this provision.

A breach of a financial covenant in the Amended Hayfin Loan Agreement, if uncured or unable to be cured, would likely result in an event of default that
could  trigger  the  lender’s  remedies,  including  acceleration  of  the  entire  principal  balance  of  the  loan  as  well  as  any  applicable  prepayment  premiums.
Future compliance with the financial covenants, as amended, requires continuing growth in net sales consistent with the Company’s business strategy and
plans.  Our  business  is  subject  to  inherent  uncertainties  that  could  impact  the  Company’s  net  sales  growth,  including,  but  not  limited  to,  the  regulatory
pathway of our cord-derived products.

While we currently have sufficient cash to repay all such amounts in an event of default, we may require alternative financing to cover other obligations.
Even if alternative financing were available in an event of default under the Amended Hayfin Loan Agreement, it might be on unfavorable terms, and the
interest rate charged on any new borrowings may be substantially higher than the interest rate under the Amended Hayfin Loan Agreement, thus adversely
affecting our future cash flows, liquidity, and results of operations.

59

Series B Preferred Stock

We have 100,000 shares of Series B Preferred Stock outstanding as of December 31, 2022.

The Series B Preferred Stock currently accumulates dividends at a rate of 6.0% per annum. Dividends are declared at the sole discretion of our board of
directors. Dividends, if declared, are paid in cash at the end of each quarter based on dividend amounts that accumulate beginning on the last payment date
through the day prior to the end of each quarter. In lieu of paying a dividend in cash, we may elect to accrue the dividend owed to shareholders. Dividend
balances accumulate at the prevailing dividend rate for each dividend period for which they are outstanding.

Each share of Series B Preferred Stock, including any accrued and unpaid dividends, is convertible into our common stock at any time at the option of the
holder  at  a  conversion  price  of  $3.85  per  common  share,  or  259.74  common  shares  for  each  Series  B  Preferred  Share  prior  to  any  accrued  and  unpaid
dividends. The Series B Preferred Stock, including any accrued and unpaid dividends, automatically converts into common stock at any time after July 2,
2023, provided that the common stock has traded at $7.70 or higher (i) for 20 out of 30 consecutive trading days and (ii) on such date of conversion.

If we undergo a change of control, we will have the option to repurchase some or all of the then-outstanding shares of Series B Preferred Stock for cash in
an amount equal to the liquidation preference and any accumulated and unpaid dividends, subject to the rights of the holders of the Series B Preferred Stock
in connection with such change in control. If we do not exercise such repurchase right, holders of the Series B Preferred Stock will have the option to (1)
require us to repurchase any or all of our then-outstanding shares of Series B Preferred Stock for cash in an amount equal to the liquidation preference or
(2) convert the Series B Preferred Stock, including accrued and unpaid dividends into common stock and receive its pro rata consideration thereunder.

We have not declared or paid any cash dividends on our Series B Preferred Stock since their issuance. Dividends in arrears as of December 31, 2022 were
$13.8  million.  Assuming  we  do  not  declare  or  pay  a  cash  dividend,  the  holders  do  not  exercise  their  option  to  convert,  and  the  other  conversion  or
redemption features are not triggered, we would accumulate and accrue $7.0 million of dividends in 2023, $15.3 million in aggregate in 1-3 years, and
$17.2 million in aggregate in 3-5 years.

As of December 31, 2022, the Series B Preferred Stock was convertible into 29,559,946 common shares.

Refer to Item 8, Note 11, Equity, for more detailed discussion regarding the rights and preferences of our Series B Preferred Stock.

Regulatory Items

There is a possibility that the FDA may rule that our cord-derived products do not meet the requirements to be regulated solely under the authority of
Section 361 of the Public Health Service Act. In such a case, in order to continue to market the products, we would be required to obtain the appropriate
FDA clearance or approval. The loss of our ability to market and sell our umbilical cord-derived product would have an adverse effect on the Company’s
revenue, business, financial condition, and results of operations. Sales of our cord products were $23.2 million and $23.6 million in 2022 and 2021,
respectively.

Reimbursement Developments

Recently, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office,
and are under consideration by the U.S. Centers for Medicare and Medicaid Services. In addition, three Medicare Administrative Contractors have recently
published for public comment changes to their Local Coverage Determinations that they are considering. If adopted, these proposals would significantly
change  Medicare  policies  governing  the  reimbursement  of  skin  substitute  products  principally  when  used  for  wound  treatment  in  the  private  physician
office setting. Refer to Item 1A, Risk Factors — Our revenues depend on adequate reimbursement from public and private insurers and health systems and
changes to the ways in which our products are reimbursed in various sites of service could adversely impact our financial results.

Other Liquidity Considerations

Further, our liquidity will be impacted by expected and unexpected costs, investments in clinical trials to support BLAs, and contingent liabilities:

• Advancement of our clinical trials will involve substantial cost. Products subject to the FDA’s BLA requirements must comply with a range of pre-
and  post-market  provisions.  Pre-market  compliance  includes  the  conduct  of  clinical  trials  in  support  of  BLA  approval,  the  development  and
submission of a BLA, and the production of product for use in the

60

clinical  trials  that  meets  the  FDA’s  quality  expectations.  See  Item  1A  -  Risk  Factors  -  “Obtaining  and  maintaining  the  necessary  regulatory
approvals for certain of our products will be expensive and time consuming and may impede our ability to fully exploit our technologies,” and “If
any  of  the  BLAs  are  approved,  the  Company  would  be  subject  to  additional  regulation  which  will  increase  costs  and  could  result  in  adverse
sanctions for non-compliance.”

•

•

The continued expansion of our product lines and the development of new products will require continuous investment in intellectual property and
research and development.

International expansion of our business will require investment through the costs to achieve necessary regulatory approvals and reimbursement
schemes,  establishing  a  physical  presence  through  office  and  warehouse  space,  identifying  and  hiring  employees,  and  other  costs  to  establish
ongoing operations.

• We  are  exposed  to  potential  liabilities  and  reputational  risk  associated  with  litigation,  regulatory  proceedings,  and  government  enforcement
actions. The amounts, if any, for which we may be liable resulting from such proceedings are highly uncertain. See Item 3, Legal Proceedings and
Item  8,  Note  16,  Commitments  and  Contingencies  and  Item  1A,  “Risk  Factors”  -  “We  are  currently,  and  may  in  the  future  be,  subject  to
substantial litigation and ongoing investigations that could cause us to incur significant legal expenses and result in harm to our business.”

•

The  application  of  CGMP  requires  investment  in  our  manufacturing  establishments  for  production  for  our  micronized  products.  The  transition
process includes development and enhancement of production processes, procedures, test and assays, and it requires extensive validation work. It
can  also  involve  the  procurement  and  installation  of  new  production  or  lab  equipment.  These  efforts  require  human  capital,  expertise  and
resources. See Item 1A. – “Risk Factors” under the heading “Certain of our products no longer qualify for regulation as human cells, tissues and
cellular and tissue-based products solely under Section 361 of the Public Health Service Act (“Section 361”), which has resulted in removal of the
applicable products from the market, made the introduction of some new tissue products more expensive, significantly delayed the expansion of
our  tissue  product  offerings  and  subjected  us  to  additional  post-market  regulatory  requirements.  Additional  regulatory  requirements  may  be
imposed in the future.”

Discussion of Cash Flows

Operating Activities

During the year ended December 31, 2022, net cash used in operating activities increased $15.9 million to $17.9 million compared to $2.0 million for the
year ended December 31, 2021. The increase in cash used was primarily the result of increases in selling, general, and administrative expenses and research
and  development  expenses  during  the  year  ended  December  31,  2022.  In  addition,  cash  used  for  the  year  ended  December  31,  2021  was  positively
impacted by an income tax refund of $9.2 million and insurance settlements of $8.0 million.

Investing Activities

During the year ended December 31, 2022, net cash used in investing activities was $2.7 million, a decrease of $0.7 million, compared to $3.4 million for
the  year  ended  December  31,  2021.  The  primary  reason  for  the  decrease  was  a  $1.7  million  decrease  in  capital  expenditures,  year-over-year,  offset  by
$1.0 million of payments made pursuant to the Turn Agreement.

Financing Activities

During the year ended December 31, 2022, net cash used in financing activities was $0.6 million, a decrease of $2.8 million compared to cash used in
financing activities of $3.4 million for the year ended December 31, 2021. Activity in 2022 was driven by year-over-year decreases in the cash paid for
shares repurchased for tax withholding ($3.6 million), offset by decreases in proceeds from option exercises ($0.8 million).

61

Non-GAAP Financial Measures

In  addition  to  our  GAAP  results,  we  provide  the  following  Non-GAAP  measures:  Earnings  Before  Interest,  Taxes,  Depreciation  and  Amortization
(“EBITDA”) and Adjusted EBITDA. We believe that the presentation of these measures provides important supplemental information to management and
investors regarding our performance. These measurements are not, and should not be used as, a substitute for GAAP measures. Company management uses
these Non-GAAP measures as aids in monitoring our on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for
benchmarking against comparable companies.

We  provide  EBITDA  and  Adjusted  EBITDA  to  facilitate  comparisons  to  results  of  other  companies.  We  use  EBITDA  as  a  measure  of  our  operating
performance, planning, and budgeting purposes as it eliminates the effects of financing and investing activities, as well as irregular and non-cash expenses.
EBITDA is widely used by investors and analysts to measure operating performance and evaluate enterprise value.

EBITDA consists of GAAP net loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, net, (iv) loss on extinguishment of
debt, and (v) income tax provision.

Adjusted EBITDA is intended to provide an enduring, normalized view of EBITDA and our broader business operations that we expect to experience on an
ongoing basis by removing from EBITDA certain items which may be irregular, non-recurring, or non-cash items not excluded when calculating EBITDA.
This enables us to identify underlying trends in our business that could otherwise be masked by such items.

Adjusted  EBITDA  consists  of  GAAP  net  loss  excluding:  (i)  depreciation,  (ii)  amortization  of  intangibles,  (iii)  interest  expense,  net,  (iv)  loss  on
extinguishment of debt, (v) income tax provision, (vi) costs incurred in connection with Audit Committee Investigation and Restatement, (vii) share-based
compensation, and (vii) impairment of intangible assets.

A reconciliation of GAAP net loss to EBITDA and Adjusted EBITDA appears in the table below (in thousands):

Net loss

$

(30,197) $

(10,285) $

(49,284)

2022

Year Ended December 31,
2021

2020

Non-GAAP Adjustments:
Depreciation expense
Amortization of intangible assets
Interest expense, net
Loss on extinguishment of debt
Income tax provision expense (benefit)

EBITDA

Additional Non-GAAP Adjustments:

Costs incurred in connection with Audit Committee Investigation and
Restatement
Share-based compensation
Impairment of intangible assets

Adjusted EBITDA

62

3,345 
701 
5,016 
— 
206 
(20,929) $

4,363 
820 
4,980 
— 
247 
125  $

12,177 
12,666 
— 
3,914  $

3,791 
14,757 
53 
18,726  $

5,782 
1,073 
7,941 
8,201 
(12,259)
(38,546)

59,465 
15,357 
1,027 
37,303 

$

$

 
 
Critical Accounting Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses our consolidated financial statements, which have
been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of these financial
statements  requires  that  we  make  judgments  and  estimates  which  may  affect  the  reported  amounts  of  assets  and  liabilities,  the  disclosure  of  contingent
assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We derive these
judgments  and  estimates  on  historical  experience  and  other  relevant  factors  which  we  believe  to  be  reasonable.  Actual  results  may  differ  from  these
estimates.

Net Sales

Description

We record estimates for returns and allowances as a reduction to net sales based on our expectation for such returns.

Judgments and Uncertainties

We  sell  our  products  to  individual  customer  and  independent  distributors  (collectively  referred  to  as  “customers”).  Customers  obtain  and  use  products
either  through  ship  and  bill  sales  or  consignment  arrangements.  We  recognize  revenue  as  performance  obligations  are  fulfilled,  which  generally  occurs
upon the shipment of product to customers for ship and bill sales or upon implantation for consignment sales. We recognize revenue based on consideration
we expect to receive from the sale. This consists of the gross selling price of the product, less any discounts, rebates, fees paid to GPOs, and an expectation
for sales returns.

We maintain a return policy that allows our customers to return product for any reason within 30 days of sale, and to return product that is damaged or non-
conforming, ordered in error, or due to recall at any time.

We  derive  an  expectation  for  product  returns  based  on  historical  return  patterns  and  other  factors,  including  shifts  in  our  regulatory  environment  and
product recalls. Determinations involving other factors are based on our estimates for product at customer sites that are eligible for return.

Additions or reversals to our return allowance, as determined necessary, are accounted for prospectively and recorded as a decrease or increase to net sales,
respectively. Actual returns are recorded against the recorded accrual.

Sensitivity of Estimate to Change

We  have  accrued  $0.7  million  for  sales  returns  as  of  December  31,  2022.  Changes  in  return  patterns  or  unforeseen  changes  in  regulations  or  identified
product recalls could cause returns significantly in excess of this estimate.

Contingencies

Description

We record contingent liabilities related to legal and other proceedings at such point in time when loss is probable and reasonably estimable.

Judgments and Uncertainties

We evaluate the probability of loss and the range of potential losses based on salient details about a case. These evaluations consider evidence derived from
discussions with counsel and include the merits and jurisdiction of the proceeding, the nature and the number of other similar current and past proceedings,
damages  sought  by  the  counterparty,  settlement  offers  we  have  extended  to  the  counterparty  and  other  factors.  From  this  information,  we  make  a
judgmental  determination  of  whether  loss  from  a  case  is  probable  and  whether  a  reasonable  estimate  of  loss  can  be  derived.  In  situations  where  a
reasonable estimate is a range of estimates, we record the most likely amount in the range or, if no single amount is more likely than any of the others, we
record the minimum amount of the range.

63

Sensitivity of Estimate to Change

As of December 31, 2022, we have reserved $0.2 million for potential losses relating to legal proceedings discussed in Item 8, Note 16, Commitments and
Contingencies. The outcome of court judgments could lead to a change in our evaluation of probability of loss or our estimate for such loss. In addition,
court judgments may result from matters for which we had previously assessed loss as being not probable or which result in losses which materially depart
from our estimate, either favorably or unfavorably.

We believe that our estimates applied are based on reasonable assumptions, but are inherently uncertain. Actual results may differ from the assumptions
and judgments used to derive our accrual.

Income Taxes

Description

We record a valuation allowance to offset our net deferred tax asset to the extent that realization is not likely.

Judgments and Uncertainties

Deferred  income  taxes  arise  from  temporary  differences  between  the  tax  basis  of  assets  and  liabilities  and  their  reported  amounts  in  the  financial
statements. Transactions which result in lower taxable income in the future give rise to deferred tax assets.

We evaluate our ability to recover deferred tax assets based on projected future taxable income, scheduled reversals of deferred tax liabilities, tax planning
strategies,  and  our  recent  operating  results.  Judgment  is  required  to  determine  whether  the  totality  of  this  evidence  suggests  that  we  can  recover  our
deferred tax assets in the future.

Sensitivity of Estimate to Change

As  of  December  31,  2022,  we  had  $47.6  million  of  valuation  allowances  recorded,  fully  offsetting  our  net  deferred  tax  asset.  This  determination  may
change due to changes in tax law, a revision to our expectation regarding taxable income in the future, taxable income generated in a period in which we
had not previously anticipated taxable income, a change in scheduled reversals of deferred tax liabilities, and other changes.

Historically, exclusive of changes in tax law such as that enacted under the Coronavirus Aid, Relief and Economic Security Act, we have not reversed our
valuation allowance.

If  the  weight  of  available  evidence  suggests  that  some  or  all  of  this  amount  is  more  likely  than  not  to  be  realized,  we  will  derecognize  the  valuation
allowance as an income tax benefit to the extent that the underlying deferred tax asset is more likely than not to be realized.

Recently Adopted Accounting Pronouncements

See Item 8, Note 2, Significant Accounting Policies, in the Consolidated Financial Statements for recently adopted accounting pronouncements.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to risks associated with changes in interest rates that could adversely affect our results of operations and financial condition. We do not
hedge against interest rate risk.

The interest rate on our Term Loan is determined quarterly based on the 3-month U.S. dollar LIBOR rate, subject to a floor of 1.5%. As of December 31,
2022, the interest rate on our Term Loan was 11.5%. A 100 basis point change in LIBOR, to the extent that such change would not cause LIBOR to be
below the 1.5% minimum, would change interest expense by $0.5 million on an annualized basis.

During the year ended December 31, 2022, we incurred $0.4 million in incremental interest expense as a result of increases in LIBOR during the year.

64

Item 8. Financial Statements and Supplementary Data

Index to Financial Statements

Report of Deloitte & Touche LLP, Independent Registered Public Accounting Firm (PCAOB ID: 34)
Report of BDO USA, LLP, Independent Registered Public Accounting Firm (PCAOB ID: 243)
Consolidated Balance Sheets – As of December 31, 2022 and 2021
Consolidated Statements of Operations – For the years ended December 31, 2022, 2021 and 2020
Consolidated Statements of Stockholders’ (Deficit) Equity – For the years ended December 31, 2022, 2021 and 2020
Consolidated Statements of Cash Flows – For the years ended December 31, 2022, 2021 and 2020
Notes to Consolidated Financial Statements
Schedule II - Valuation and Qualifying Accounts

F- 2
F- 4
F- 5
F- 6
F- 7
F- 8
F- 9
F- 44

F- 1

 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and the Board of Directors of MiMedx Group, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of MiMedx Group, Inc. and subsidiaries (the "Company") as of December 31, 2022 and
2021, the related consolidated statements of operations, stockholders' (deficit) equity, and cash flows, for the years then ended, and the related notes and the
schedule listed in the Index at Item 8 (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the United States of America.

We  have  also  audited,  in  accordance  with  the  standards  of  the  Public  Company  Accounting  Oversight  Board  (United  States)  (PCAOB),  the  Company's
internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued
by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 28, 2023, expressed an unqualified opinion on
the Company's internal control over financial reporting.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial
statements  based  on  our  audits.  We  are  a  public  accounting  firm  registered  with  the  PCAOB  and  are  required  to  be  independent  with  respect  to  the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance  about  whether  the  financial  statements  are  free  of  material  misstatement,  whether  due  to  error  or  fraud.  Our  audits  included  performing
procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to
those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The  critical  audit  matter  communicated  below  is  a  matter  arising  from  the  current-period  audit  of  the  financial  statements  that  was  communicated  or
required  to  be  communicated  to  the  audit  committee  and  that  (1)  relates  to  accounts  or  disclosures  that  are  material  to  the  financial  statements  and  (2)
involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical
audit matter or on the accounts or disclosures to which it relates.

Net Sales - Revenue Recognition — Refer to Note 2 to the Financial Statements

Critical Audit Matter Description

The Company sells its products primarily to individual customers and independent distributors (collectively referred to as “customers”). Customers obtain
and use products either through ship and bill sales or consignment arrangements. Under ship and bill arrangements, the Company retains possession of the
product  until  the  customer  submits  an  order  and  the  product  orders  is  shipped  to  the  customer.  Under  consignment  arrangements,  the  customer  takes
possession  of  the  product,  but  the  Company  retains  title  until  the  implantation,  or  application  of  the  Company’s  product  to  the  end  user.  The  Company
recognizes revenue as performance obligations are fulfilled, which generally occurs upon the shipment of product to the customers for ship and bill orders
or upon implantation for consignment sales.

We  identified  the  timing  of  revenue  recognition  for  ship  and  bill  and  consignment  sales  at  or  near  year  end  as  a  critical  audit  matter  because  of  the
judgments involved in evaluating that the performance obligations are fulfilled. This required extensive audit effort due to the volume of transactions and a
degree of auditor judgment when performing audit procedures and evaluating the results of those procedures.

F-2

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to the timing of revenue recognition transactions included the following, among others:

• We tested the effectiveness of controls over the recognition of ship and bill and consignment sales at or near year end.

• We created data visualizations using a detail of all revenue transactions and evaluated trends in the transactional revenue data with emphasis on

activity at or near year end.

• We evaluated and tested corollary relationships between revenue and related accounts.

• We evaluated the appropriateness and consistency of the methods and assumptions utilized by management to estimate consignment revenue.

• We tested a sample of consignment revenue transactions manually accrued as of year end and evaluated whether the transactions were recorded in

the correct period.

• We  selected  a  sample  of  ship  and  bill  revenue  transactions  close  to  year  end  by  agreeing  the  amounts  recognized  to  source  documents  and

evaluating whether the transaction was recorded in the correct period.

• We tested a sample of credits issued after year end by agreeing to documents supporting the authorization for the issuance of the credit and to

evaluate if the credit was issued in the correct period.

/s/ Deloitte & Touche LLP
Atlanta, Georgia 
February 28, 2023

We have served as the Company's auditor since 2021.

F-3

 
 
Report of Independent Registered Public Accounting Firm

Shareholders and Board of Directors
MiMedx Group, Inc.
Marietta, Georgia

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated statement of stockholders’ equity (deficit), operations and cash flows for the year ended December 30,
2020 of MiMedx Group, Inc. (the “Company”) and the related notes and schedule (collectively referred to as the “consolidated financial statements”). In
our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020, and
the results of its operations and its cash flows for the year ended December 31, 2020, in conformity with accounting principles generally accepted in the
United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our  audit  included  performing  procedures  to  assess  the  risks  of  material  misstatement  of  the  consolidated  financial  statements,  whether  due  to  error  or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis
for our opinion.

/s/ BDO USA, LLP
We served as the Company's auditor from 2019 to 2020.
Atlanta, Georgia

March 8, 2021, except for the change in reportable segments discussed in Notes 2 and 13, as to which the date is February 28, 2023

F-4

 
 
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)

ASSETS

Current assets:

Cash and cash equivalents
Accounts receivable, net
Inventory
Prepaid expenses
Income tax receivable
Other current assets

Total current assets
Property and equipment, net
Right of use asset
Goodwill
Intangible assets, net
Other assets

Total assets

LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ (DEFICIT) EQUITY

Current liabilities:

Accounts payable
Accrued compensation
Accrued expenses
Other current liabilities

Total current liabilities
Long term debt, net
Other liabilities
Total liabilities
Commitments and contingencies (Note 16)
Convertible preferred stock Series B; $.001 par value; 100,000 shares authorized, issued and outstanding at
December 31, 2022 and December 31, 2021
Stockholders’ (deficit) equity:

Preferred stock Series A; $.001 par value; 5,000,000 shares authorized; 0 issued and outstanding at December
31, 2022 and 0 issued and outstanding at December 31, 2021
Common stock; $.001 par value; 187,500,000 shares authorized, 113,705,447 issued and outstanding at
December 31, 2022 and 112,703,926 issued and 111,925,216 outstanding at December 31, 2021
Additional paid-in capital
Treasury stock at cost; 0 shares at December 31, 2022 and 778,710 shares at December 31, 2021
Accumulated deficit

Total stockholders’ (deficit) equity

Total liabilities, convertible preferred stock, and stockholders’ (deficit) equity

 See notes to the consolidated financial statements.

F-5

December 31,

2022

2021

65,950  $
43,084 
13,183 
8,646 
704 
2,631 
134,198 
7,856 
3,400 
19,976 
5,852 
148 
171,430  $

8,847  $

21,852 
11,024 
1,834 
43,557 
48,594 
4,773 
96,924  $

87,083 
40,353 
11,389 
6,146 
743 
2,809 
148,523 
9,165 
4,696 
19,976 
5,383 
186 
187,929 

7,385 
23,595 
9,812 
1,565 
42,357 
48,127 
4,869 
95,353 

92,494  $

92,494 

—  $

— 

114 
173,804 
— 
(191,906)
(17,988)
171,430  $

113
165,695 
(4,017)
(161,709)
82 
187,929 

$

$

$

$

$

$

$

 
 
 
 
 
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)

2022

$

Year Ended December 31,
2021

2020

267,841  $
48,316 
219,525 

258,615  $
43,283 
215,332 

208,789 
22,829 
12,177 
701 
— 
(24,971)

(5,016)
(4)
— 
(29,991)
(206)
(30,197) $

198,359 
17,344 
3,791 
820 
53 
(5,035)

(4,980)
(23)
— 
(10,038)
(247)
(10,285) $

248,234 
39,330 
208,904 

181,022 
11,715 
59,465 
1,073 
1,027 
(45,398)

(7,941)
(3)
(8,201)
(61,543)
12,259 
(49,284)

Net sales
Cost of sales
Gross profit

Operating expenses:

Selling, general and administrative
Research and development
Investigation, restatement and related
Amortization of intangible assets
Impairment of intangible assets

Operating loss

Other expense, net

Interest expense, net
Other expense, net
Loss on extinguishment of debt
Loss before income tax provision
Income tax provision (expense) benefit

Net loss

$

$

$
$

Net loss available to common stockholders (Note 10)

Net loss per common share - basic
Net loss per common share - diluted

(36,777) $

(16,421) $

(83,328)

(0.33) $
(0.33) $

(0.15) $
(0.15) $

(0.77)
(0.77)

Weighted average common shares outstanding - basic
Weighted average common shares outstanding - diluted

112,909,266 
112,909,266 

110,353,406 
110,353,406 

108,257,112 
108,257,112 

See notes to the consolidated financial statements.

F-6

 
 
 
 
 
 
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share data)

Common Stock

Shares

Amount

Additional
Paid-in
Capital

112,703,926  $

113  $

147,231 

Treasury Stock

Amount

Accumulated
Deficit

Total

(10,806) $

(102,140) $

34,398 

Balance at December 31, 2019
Issuance of Series B Convertible
Preferred Stock
Deemed dividends
Share-based compensation expense
Exercise of stock options
Issuance of restricted stock
Restricted stock shares
canceled/forfeited
Shares repurchased for tax withholding
Net loss
Balance at December 31, 2020
Deemed dividends
Shares repurchased for tax withholding
Share-based compensation expense
Exercise of stock options
Restricted stock shares
canceled/forfeited
Issuance of restricted stock
Other
Net loss
Balance at December 31, 2021
Shares repurchased for tax withholding
Share-based compensation expense
Exercise of stock options
Issuance of restricted stock
Restricted stock shares
canceled/forfeited
Net loss

— 
— 
— 
— 
— 

— 
— 
— 

112,703,926  $

— 
— 
— 
— 

— 
— 
— 
— 

112,703,926  $

— 
— 
160,762 
840,759 

— 
— 

Balance at December 31, 2022

113,705,447  $

— 
— 
— 
— 
— 

— 
— 
— 
113  $
— 
— 
— 
— 

— 
— 
— 
— 
113  $
— 
— 
— 
1 

— 
— 
114  $

32,954 
(32,028)
15,733 
(3,180)
(5,463)

3,363 
— 
— 
158,610 
(926)
— 
14,757 
(1,199)

515 
(4,053)
(2,009)
— 
165,695 
— 
12,666 
(618)
(3,969)

30 
— 
173,804 

Shares
1,885,277  $

— 
— 
— 
(359,328)
(613,146)

425,388 
435,492 
— 

1,773,683  $

— 
469,239 
— 
(487,361)

73,056 
(810,405)
(239,502)
— 
778,710  $
249,442 
— 
(151,239)
(882,251)

— 
— 
— 
3,591 
5,463 

(3,363)
(2,334)
— 
(7,449) $
— 
(4,751)
— 
2,636 

(515)
4,053 
2,009 
— 
(4,017) $
(1,190)
— 
1,269 
3,968 

— 
— 
— 
— 
— 

— 
— 
(49,284)
(151,424) $

— 
— 
— 
— 

— 
— 
— 
(10,285)
(161,709) $

— 
— 
— 
— 

5,338 
— 
—  $

(30)
— 
—  $

— 
(30,197)
(191,906) $

32,954 
(32,028)
15,733 
411 
— 

— 
(2,334)
(49,284)
(150)
(926)
(4,751)
14,757 
1,437 

— 
— 
— 
(10,285)
82 
(1,190)
12,666 
651 
— 

— 
(30,197)
(17,988)

See notes to the consolidated financial statements.

F-7

 
 
 
 
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Cash flows from operating activities:

Net loss
Adjustments to reconcile net loss to net cash used in operating activities:

Share-based compensation
Depreciation
Bad debt expense
Non cash lease expenses
Amortization of intangible assets
Amortization of deferred financing costs and debt discount
Accretion of asset retirement obligation
(Gain) loss on fixed asset disposal
Impairment of intangible assets
Loss on extinguishment of debt
Increase (decrease) in cash resulting from changes in:

Accounts receivable
Inventory
Prepaid expenses
Other assets
Accounts payable
Accrued compensation
Accrued expenses
Income taxes
Other liabilities

Net cash flows used in operating activities
Cash flows from investing activities:

Purchases of property and equipment
Cash paid for licensing agreement
Patent application costs
Principal payments from note receivable
Proceeds from property and equipment sale

Net cash flows used in investing activities
Cash flows from financing activities:

Stock repurchased for tax withholdings on vesting of restricted stock
Proceeds from exercise of stock options
Payments under finance lease obligations
Proceeds from sale of Series B convertible preferred stock
Stock issuance costs
Proceeds from term loans
Deferred financing costs
Repayment of term loans
Prepayment premium on early repayment of term loan
Net cash flows (used in) provided by financing activities
Net change in cash
Cash and cash equivalents, beginning of year

Cash and cash equivalents, end of year

Years Ended December 31,
2021

2022

2020

$

(30,197) $

(10,285) $

(49,284)

12,666 
3,345 
2,820 
1,259 
701 
467 
92 
(17)
— 
— 

(5,550)
(1,794)
(2,500)
(333)
1,053 
(1,744)
1,762 
39 
38 
(17,893)

(1,514)
(1,000)
(170)
— 
24 
(2,660)

(1,190)
651 
(41)
— 
— 
— 
— 
— 
— 
(580)
(21,133)
87,083 
65,950  $

14,757 
4,363 
— 
989 
820 
1,055 
81 
262 
53 
— 

(4,930)
(1,028)
(542)
675 
(326)
5,128 
(21,197)
9,302 
(1,159)
(1,982)

(3,218)
— 
(252)
75 
— 
(3,395)

(4,751)
1,437 
(38)
— 
— 
— 
— 
— 
— 
(3,352)
(8,729)
95,812 
87,083  $

15,357 
5,782 
— 
983 
1,073 
2,276 
10 
1 
1,027 
8,201 

(3,096)
(1,257)
1,064 
(119)
177 
(2,459)
1,746 
(10,027)
(1,718)
(30,263)

(4,228)
— 
(327)
— 
— 
(4,555)

(2,334)
411 
—
100,000 
(7,470)
59,500 
(3,235)
(83,872)
(1,439)
61,561 
26,743 
69,069 
95,812 

$

See notes to the consolidated financial statements.

F-8

 
 
 
 
 
 
 
 
 
 
 
 
MIMEDX GROUP, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

1.

Nature of Business

MiMedx Group, Inc. (together with its subsidiaries, except where the context otherwise requires, “MIMEDX,” or the “Company”) is a is a pioneer and
leader in placental biologics focused on addressing the needs of patients with acute and chronic non-healing wounds. The Company is also advancing a
promising late-stage biologics pipeline targeted at decreasing pain and improving function for patients with knee osteoarthritis (“KOA”).  To  accomplish
these goals, the Company operates as two defined, internal business units: Wound & Surgical and Regenerative Medicine. All of our products sold in the
United States are regulated by the United States Food and Drug Administration (“FDA”).

The Wound & Surgical business focuses on the Advanced Wound Care and Surgical Recovery markets through sales of the Company’s existing product
portfolio  and  product  development  to  serve  these  end  markets.  This  business  unit  is  responsible  for  substantially  all  sales  of  the  Company’s  Advanced
Wound  Care  products,  as  well  as  the  sale  of  the  Company’s  micronized  and  certain  particulate  products  (collectively,  the  “Section  351  products”)
internationally.

The  Regenerative  Medicine  business  focuses  on  progressing  the  Company’s  placental  biologics  platform  towards  registration  as  a  FDA-approved
biological drug. Micronized dehydrated human amnion chorion membrane (“mDHACM”) is an injectable placental biologic product candidate in its late-
stage pipeline targeted at achieving FDA approval for an indication to help decrease pain and improve function in patients suffering from KOA. Prior to
May 31, 2021, this business unit was responsible for domestic sales of the Company’s Section 351 products. Regenerative Medicine does not currently
generate revenue.

Additional information regarding the principal operations and results of these business units can be found in Note 13, Segment Information.

The Company’s business is focused primarily on the United States of America but the Company is pursuing opportunities for international expansion, with
specific focus on the sale of its placental tissue products in Japan.

2.    Significant Accounting Policies

Principles of Consolidation

The  consolidated  financial  statements  include  the  accounts  of  MiMedx  Group,  Inc.  and  its  wholly-owned  subsidiaries.  All  intercompany  balances  and
transactions have been eliminated upon consolidation.

Use of Estimates

The  consolidated  financial  statements  have  been  prepared  in  accordance  with  accounting  principles  generally  accepted  in  the  United  States  of  America
(“GAAP”).  GAAP  requires  management  to  make  estimates  and  assumptions  that  affect  the  reported  amounts  of  assets  and  liabilities  and  disclosure  of
contingent  assets  and  liabilities  at  the  date  of  the  consolidated  financial  statements  and  the  reported  consolidated  statements  of  operations  during  the
reporting period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property
and  equipment,  goodwill  and  intangible  assets,  estimates  of  loss  for  contingent  liabilities,  estimate  of  allowance  for  doubtful  accounts,  management’s
assessment of the Company’s ability to continue as a going concern, estimate of fair value of share-based payments, estimates of returns and allowances,
and valuation of deferred tax assets.

Segment Reporting

The application of GAAP requires the use of the “management approach” model for segment reporting. The management approach model is based on the
way a company’s chief operating decision maker (“CODM”) organizes segments within the Company for which separate financial information is available
regarding resource allocation and assessing performance. The Company has concluded that its Chief Executive Officer (“CEO”) is its CODM. Prior to June
30, 2022, the Company assessed that it operated as one operating and reportable segment. The Company reassesses the existence of operating segments
when facts and circumstances suggest that there may have been a change in the way that the Company is managed.

On September 30, 2022, the Company reassessed its operating segments, concluding that the CODM assesses performance and allocates resources between
two,  distinct  reportable  segments:  Wound  &  Surgical  and  Regenerative  Medicine.  Information  regarding  the  principal  operations  and  results  of  these
segments can be found in Note 13, Segment Information.

F-9

Cash and Cash Equivalents

Cash and cash equivalents include cash held at various banks. The Company considers all highly-liquid investments purchased with an original maturity of
three months or less at the date of purchase and money market mutual funds to be cash equivalents.

Market Concentrations and Credit Risk

The  Company  places  its  cash  and  cash  equivalents  on  deposit  with  U.S.-based  financial  institutions.  The  U.S.  Federal  Deposit  Insurance  Corporation
(“FDIC”)  provides  insurance  coverage  for  deposits  up  to  $250,000  for  substantially  all  depository  accounts.  As  of  December  31,  2022  and  2021,  the
Company had cash and cash equivalents of approximately $65.2 million and $86.4 million, respectively, in excess of the insured amounts in four depository
institutions.

Accounts Receivable

Accounts receivable represent amounts due from customers for which revenue has been recognized. Generally, the Company does not require collateral or
any other security to support its receivables.

Bad debt expense and the allowance for doubtful accounts are based on historical trends and current expectations for credit losses. The Company’s policy
to reserve for potential bad debts is based on the aging of the individual receivables as well as customer-specific qualitative factors, such as bankruptcy
proceedings. The Company manages credit risk by routinely performing credit checks on customers prior to sales. Individual receivables are written-off
after all reasonable efforts to collect the funds have been made. Actual write-offs may differ from the amounts reserved.

Inventory

Inventory  is  valued  at  the  lower  of  cost  or  net  realizable  value.  Costs  of  inventory  sold  are  recognized  using  the  first–in,  first-out  (“FIFO”)
method. Inventory is tracked through raw material, work-in-process, and finished goods stages as the product progresses through various production steps
and stocking locations. Labor and overhead costs are absorbed through the various production processes up to when the work order closes. Historical yields
and normal capacities are utilized in the calculation of production overhead rates. Write-downs are utilized to account for slow-moving inventory as well as
inventory no longer needed due to diminished demand or regulatory action.

Property and Equipment, Net

Property  and  equipment  are  recorded  at  cost  and  depreciated  on  a  straight-line  method  over  their  estimated  useful  lives,  principally  three  to  seven
years. Leasehold improvements are depreciated on a straight-line method over the shorter of the estimated useful lives and the remaining lease term.

Asset Retirement Obligations

The Company records obligations associated with the legal requirement to retire long-lived assets at the sooner of the imposition of the legal requirement
and when an estimate for the cost of retirement can reasonably be made. The Company reviews legal obligations associated with the retirement of long-
lived assets that result from contractual obligations or the acquisition, construction, development and/or normal use of the assets. If it is determined that a
legal obligation exists, regardless of whether the obligation is conditional on a future event, the fair value of the liability for an asset retirement obligation is
recognized  in  the  period  in  which  it  is  incurred,  if  a  reasonable  estimate  of  fair  value  can  be  made.  The  fair  value  is  calculated  as  the  estimate  of  the
expected cash outflow to satisfy the legal obligation discounted to present value using the Company’s incremental borrowing rate. At such point in time, an
asset and liability are recorded for the amount of the expected liability. The asset amount is depreciated, straight-line, over the life of the underlying asset,
while the liability is accreted to the amount of the expected outflow through selling, general and administrative expense using the effective interest method.
Subsequent  revisions  to  estimates  for  future  cash  flows  related  to  the  asset  retirement  obligations  are  recorded  as  equal  increases  or  decreases  to  the
retirement asset and liability.

F-10

Impairment of Long-lived Assets

The  Company  evaluates  the  recoverability  of  its  long-lived  assets  (property,  equipment,  right  of  use,  and  intangible  assets  with  finite  lives)  whenever
adverse  events  or  changes  in  business  climate  indicate  that  the  expected  undiscounted  future  cash  flows  from  the  related  assets  may  be  less  than  their
carrying  amounts.  When  a  situation  arises  which  results  in  a  conclusion  that  it  is  more  likely  than  not  that  an  asset  is  not  recoverable,  the  Company
estimates cash flows expected to be derived from the continuing use and eventual disposition of the asset. If the sum of those cash flows, not discounted to
present value, does not exceed the net book value of the asset, the Company estimates the fair value of the asset. Impairment loss is recorded to the extent
that the net book value exceeds the fair value of the asset.

Impairment reviews are based on an estimated future cash flow approach that requires significant judgment with respect to future revenue and expense
growth rates, selection of appropriate discount rate (as applicable), asset groupings, and other assumptions and estimates. The Company uses estimates that
are consistent with its business plans and a market participant view of the assets being evaluated. Actual results may differ from these estimates.

The Company recorded impairment losses on amortizable intangible assets of $0, $0.1 million, and $1.0 million in in 2022, 2021, and 2020, respectively.
The Company recorded no impairment losses with respect to any other classes of long-lived assets in those periods.

Goodwill and Indefinite-lived Intangible Assets

The  Company  assesses  goodwill  for  impairment  at  least  annually  on  October  1  and  more  frequently  whenever  events  or  substantive  changes  in
circumstances indicate that it is more likely than not that goodwill is impaired. In performing the goodwill impairment test, the Company first assesses
qualitative factors to determine the existence of impairment. If the qualitative factors indicate that the carrying value of a reporting unit exceeds its fair
value, the Company proceeds to a quantitative test to measure the existence and amount, if any, of goodwill impairment. The Company may also choose to
bypass the qualitative assessment and proceed directly to the quantitative test.

In performing the quantitative test, impairment loss is recorded to the extent that the carrying value of the reporting unit exceeds its assessed fair value.

If the Company concludes that the way in which it is being managed has changed and results in a change to its concluded reporting units, the goodwill
assigned to the original reporting unit is allocated to the new reporting units based on the relative fair value of the new reporting units.

The Company determines the fair value of reporting units using the income and market approaches, as applicable. Under the income approach, the fair
value of a reporting unit is the present value of its future cash flows as viewed from the lens of a hypothetical market participant in an orderly transaction.
These future cash flows are derived from expectations of revenue, expenses, tax deductions and credits, working capital flows, capital expenditures, and
other projected sources and uses of cash, as applicable. Value indications are developed by discounting expected cash flows to their present value using a
discount  rate  commensurate  with  the  risks  associated  with  the  reporting  unit  subject  to  testing.  Under  the  market  approach,  the  Company  uses  market
multiples derived from various comparable companies based on measures salient to investors in those companies.

As  indicated  above,  on  September  30,  2022,  the  Company  changed  its  operating  segments,  determining  that  it  operates  as  two  reportable  segments.  In
concert with this re-evaluation, the Company concluded that it has two reporting units for goodwill impairment testing purposes. Management performed a
goodwill impairment test as of September 30, 2022 on its previous reporting unit, concluding that goodwill was not impaired as of that date. Management
subsequently allocated the goodwill assigned to its previous reporting unit to its new reporting units. Refer to Note 7, Goodwill and Intangible Assets, Net,
for information regarding the reallocation of goodwill to the reporting units.

As part of the goodwill impairment test performed on October 1, 2022, the Company performed a quantitative assessment, concluding that goodwill was
not impaired for any of its reporting units.

There were no recorded impairment losses related to goodwill in 2022, 2021, or 2020. The Company recorded no impairment losses related to any of our
other indefinite-lived intangible assets during 2022, 2021, or 2020.

Patent Costs

The Company incurs certain legal and related costs in connection with patent applications. The Company capitalizes such costs to be amortized over the
expected life of the patent to the extent that an economic benefit is anticipated from the resulting patent

F-11

or an alternative future use is available to the Company. The Company capitalized $0.2 million, $0.3 million, and $0.3 million of patent costs for the years
ended December 31, 2022, 2021, and 2020, respectively.

Leases

The Company determines if a contract is, or contains, a lease at inception. Leases provide the Company with the right to control an underlying asset for a
contractual term, subject to certain renewal and other rights, in exchange for a series of stipulated cash flows. Right of use (“ROU”) assets represent the
Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from
the lease.

Lease assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term. The
Company  calculates  the  present  value  of  lease  payments  by  discounting  the  lease  payments  using  the  Company’s  incremental  borrowing  rate  for  a
collateralized or secured borrowing over a term equivalent to that of the lease. Lease payments that vary according to an index or rate are measured using
the index or rate at lease inception. The lease term and applicable payments include options to extend or terminate the lease when it is reasonably certain
that the Company will exercise such options. Options to renew or terminate a lease are included in the lease term to the extent that such provisions are
reasonably certain to be exercised. This determination is reassessed as new information arises and is accounted for prospectively. As an accounting policy
election, the Company does not capitalize leases having initial terms of 12 months or fewer. The Company has made an accounting policy election not to
separate lease components from non-lease components in the event that the agreement contains both.

Operating lease right of use assets and the related liabilities are included in right of use asset, other current liabilities, and other liabilities, respectively, in
the consolidated balance sheets. Lease expense associated with operating leases is recognized, straight-line, over the lease term. The Company does not
recognize interest expense as part of operating lease liabilities.

Finance  lease  right  of  use  assets  and  the  related  liabilities  are  included  in  property  and  equipment,  net,  other  current  liabilities,  and  other  liabilities,
respectively, in the consolidated balance sheets. Finance lease right of use assets are amortized, straight-line, over the lease term as depreciation expense.
Interest expense is recognized using the effective interest method on finance lease liabilities as part of interest expense, net.

Treasury Stock

Shares repurchased by the Company are recorded as treasury stock at the cost to acquire such shares. Subsequent issuances of shares held in treasury are
assumed to be released on a FIFO basis.

Contingencies

The Company is or has been subject to various patent challenges, product liability claims, government investigations, former employee matters, and other
legal proceedings, see Note 16, Commitments and Contingencies. Legal fees and other expenses related to litigation are expensed as incurred and included
in selling, general and administrative expenses in the consolidated statements of operations. The Company records an accrual for resolution costs and other
contingencies in the consolidated financial statements when the Company determines that a loss is both probable and reasonably estimable. Subsequent
revisions to the Company’s accrual are made as new information emerges and are accounted for prospectively. The Company discloses all ongoing legal
matters for which a loss is reasonably possible, regardless of whether an estimate can be reasonably determined.

Due to the fact that legal proceedings and other contingencies are inherently unpredictable, the Company’s estimates of the probability and amount of any
such liabilities involve significant judgment regarding future events. The actual costs of resolving a claim may be substantially different from the amount of
reserve the Company recorded. The Company records a receivable from its insurance carriers only when the resolution of any dispute has been reached and
realization of the amounts equal to the potential claim for recovery is considered probable. Any recovery of an amount in excess of the related recorded
contingent loss will be recognized only when all contingencies relating to recovery have been resolved.

Revenue Recognition

Current Policy

The Company sells its products primarily to individual customers and independent distributors (collectively referred to as “customers”). Customers obtain
and use products either through ship and bill sales or consignment arrangements. Under ship and bill arrangements, the Company retains possession of the
product  until  the  customer  submits  an  order.  Upon  approval  of  the  sales  order,  the  Company  ships  product  to  the  customer  and  invoices  them  for  the
product sold. Under consignment

F-12

arrangements, the customer takes possession of the product, but the Company retains title until the implantation or application of the Company’s product to
the end user.

The Company recognizes revenue as performance obligations are fulfilled, which generally occurs upon the shipment of product to the customers for ship
and bill orders or upon implantation for consignment sales.

Revenue is recognized based on the consideration the Company expects to receive from the sale. This consists of the gross selling price of the product, less
any discounts, rebates or other amounts paid to customers, fees paid to Group Purchasing Organizations (“GPOs”), and returns (collectively, “deductions”
or “sales deductions”). Gross selling price is a standard set by the Company for all customers unless a contract governing the sale provides for a specified
price. Sales deductions are specified in individual contracts with customers. The Company estimates the total sales deductions which a specific customer
will achieve over the relevant term and applies the reduction to sales as they are made throughout the period.

Sales deductions owed to customers and other parties are accrued and recorded in accrued expenses on the consolidated balance sheets.

The  Company  acts  as  the  principal  in  all  of  its  customer  arrangements  and  records  revenue  on  a  gross  basis.  Shipping  is  considered  immaterial  in  the
context of the overall customer arrangement, and damages or loss of goods in transit are rare. Therefore, shipping is not deemed a separately recognized
performance  obligation  and  the  Company  has  elected  to  treat  shipping  costs  as  activities  to  fulfill  the  promise  to  transfer  the  product.  The  Company
maintains a returns policy that allows its customers to return product that is damaged or non-conforming, ordered in error, or due to a recall. The estimate
of the provision for returns is based upon historical experience with actual returns. The Company’s payment terms for customers are typically 30 to 60 days
from receipt of title of the goods.

Remaining Contracts

Prior  to  2020,  the  Company’s  control  environment  was  such  that  it  created  uncertainty  surrounding  all  of  its  customer  arrangements,  which  required
consideration  related  to  the  proper  revenue  recognition  under  the  applicable  literature.  The  control  environment  allowed  for  the  existence  of  extra-
contractual or undocumented terms or arrangement initiated by or agreed to by the company and former members of Company management at the outset of
the  transactions  (side  agreements).  Concessions  were  also  agreed  to  subsequent  to  the  initial  sale  (e.g.  sales  above  established  customer  credit  limits
extended and unusually long payment terms, return or exchange rights, and contingent payment obligations) that precluded the Company from recognizing
revenue at the time that product was shipped to a customer.

Because of the prevalence of these arrangements, the Company’s sales arrangements did not qualify as contracts under Accounting Standards Codification
(“ASC”)  Topic  606,  Revenue  from  Contracts  with  Customers,  until  consideration  was  collected  from  customers.  This  determination  precluded  the
recognition of revenue at the time of shipment. Instead, recognition of revenue was deferred until: (1) the customer returned the product prior to payment;
or (2) the Company received payment from the customer. Cost of sales associated with product shipped was deferred until collection was received.

The Company implemented changes and remediated weaknesses, which gave rise to the above conclusion beginning in mid-2018. Management concluded
that these efforts had been sufficiently implemented such that customers were aware of the Company’s sales policies and procedures and that a contract
existed  prior  to  the  transfer  of  title  or  the  implantation  of  product  for  ship-and-bill  and  consignment  sales,  respectively,  by  the  third  quarter  of  2019.
Accordingly, the Company changed its pattern of revenue recognition effective October 1, 2019 to the policy described under the section titled “Current
Policy” above.

The Company also reassessed whether the revenue recognition criteria had been met for all shipments of products where payment had not been received as
of  September  30,  2019.  While  the  measures  summarized  above  provided  significant  evidence  necessary  to  understand  the  terms  of  the  Company’s
contractual  arrangements  with  its  customers,  certain  of  these  customers  continued  to  exhibit  behaviors  that  resulted  in  extended  periods  until  cash
collection. Such delays in collection suggested that uncertainty regarding extra-contractual arrangements may continue, particularly as it relates to payment
terms. As a result, the Company concluded the following for any existing arrangements, which remained unpaid at September 30, 2019:

•

•

For customer arrangements where collection was considered probable within 90 days from the date of original shipment or implantation of the
products, the Company concluded the revenue recognition criteria were met. The revenue associated with this event was recognized prior to 2020.

For the remaining customer arrangements (the “Remaining Contracts”), the Company concluded that, due to the uncertainty that extra-contractual
arrangements may continue, the revenue recognition criteria would not be satisfied until the Company received payment from the customer. At
that point, the Company determined that an accounting

F-13

contract  would  exist  and  the  performance  obligations  for  the  Company  to  deliver  product  and  the  customer  to  pay  for  the  product  would  be
satisfied.  The  Company  continued  to  reassess  the  Remaining  Contracts  for  settlement  of  the  revenue  recognition  criteria  prior  to  payment,
concluding that the revenue recognition criteria continued to not be met due to the same circumstances described above.

The effect of the cash collections on the Remaining Contracts on net sales and cost of sales for each of the years ended December 31, 2022, 2021, and 2020
were as follows (amounts in thousands):

2022

Year Ended December 31,
2021

2020

Net sales
Cost of sales
Gross profit

$

$

259  $
— 
259  $

1,038  $
174 
864  $

7,767 
1,087 
6,680 

Group Purchasing Organization Fees

The  Company  sells  to  GPO  members  who  transact  directly  with  the  Company  at  GPO-agreed  pricing.  Group  Purchasing  Organizations  are  funded  by
administrative fees that are paid by the Company. These fees are set as a percentage of the purchase volume, which is typically 3% of sales made to the
GPO members. Fees paid to GPOs are presented as a reduction to net sales.

Cost of Sales

Cost of sales includes all costs directly related to bringing the Company’s products to their final selling destination. Amounts include direct and indirect
costs to manufacture products including raw materials, personnel costs and direct overhead expenses necessary to convert collected tissues into finished
goods,  product  testing  costs,  quality  assurance  costs,  facility  costs  associated  with  the  Company’s  manufacturing  and  warehouse  facilities,  including
depreciation, freight charges, costs to operate equipment and other shipping and handling costs for products shipped to customers.

The Company obtains raw material in the form of human placenta donations from participating mothers who give birth via scheduled Caesarean section.

Research and Development Costs

Research  and  development  costs  consist  of  direct  and  indirect  costs  associated  with  the  development  of  the  Company’s  technologies.  These  costs  are
expensed as incurred.

Advertising expense

Advertising expense consists primarily of print media promotional materials. Advertising costs are expensed as incurred. Advertising expense for the year
ended December 31, 2022, 2021, and 2020 was $0.2 million, $0.1 million, and $0.1 million respectively.

Income Taxes

Income  tax  provision  (expense)  benefit,  deferred  tax  assets  and  liabilities,  and  liabilities  for  unrecognized  tax  benefits  reflect  management’s  best
assessment of estimated current and future taxes to be paid. The Company is subject to income taxes in the United States and numerous states.

Deferred  income  taxes  arise  from  temporary  differences  between  the  tax  basis  of  assets  and  liabilities  and  their  reported  amounts  in  the  financial
statements, which will result in taxable or deductible amounts in the future. The Company recognizes deferred tax assets to the extent that it believes these
assets are more likely than not to be realized. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of
their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance.

In evaluating the Company’s ability to recover its deferred tax assets within the jurisdiction from which they arise, management considers all available
positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax-planning strategies, results of
recent operations, and changes in tax laws. In projecting future taxable income, the Company begins with historical results and incorporates assumptions
about the amount of future state and federal

F-14

pretax operating income adjusted for items that do not have tax consequences. The assumptions about future taxable income require significant judgment
and are consistent with the plans and estimates the Company uses to manage the underlying businesses. In evaluating the objective evidence that historical
results  provide,  management  considers  three  years  of  cumulative  income  (loss).  The  Company  accounts  for  income  taxes  under  the  asset  and  liability
method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement
and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in
tax rates on deferred tax assets and liabilities is recognized in the tax provision (benefit) in the period that includes the enactment date.

The calculation of income tax liabilities involves dealing with uncertainties in the application of complex tax laws and regulations both for U.S. federal
income tax purposes and across numerous state jurisdictions. ASC Topic 740, Income Taxes, states that a tax benefit from an uncertain tax position may be
recognized when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation
processes,  on  the  basis  of  the  technical  merits.  The  Company  (1)  records  unrecognized  tax  benefits  as  liabilities  in  accordance  with  ASC  Topic  740
included within other liabilities on the consolidated balance sheets, and (2) adjusts these liabilities when management’s judgment changes as a result of the
evaluation of new information not previously available. Because of the complexity of some of these uncertainties, the ultimate resolution may result in a
payment that is materially different from management’s current estimate of the unrecognized tax benefit liabilities. These differences will be reflected as
increases or decreases to the deferred tax asset or income tax expense in the period in which new information is available.

The Company records uncertain tax positions in accordance with ASC Topic 740 on the basis of a two-step process whereby (1) it determines whether it is
more likely than not that the tax positions will be sustained on the basis of the technical merits of the position, and (2) for those tax positions that meet the
more-likely-than-not recognition threshold, it recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate
settlement with the related tax authority.

The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the consolidated statements of
operations. Accrued interest and penalties, if any, are included within the related deferred tax liability line in the consolidated balance sheets and recorded
as a component of income tax expense.

Share-based Compensation

The Company grants share-based awards to employees and members of the Company’s Board of Directors (the “Board”). Awards to employees and the
Board are generally made annually. Grants are issued outside of the annual cadence for certain new hires, promotions, and other events.

The amount of expense to be recognized is determined by the fair value of the award using inputs available as of the grant date. The fair value of equity
incentive awards that are not subject to a market condition is the value of common stock on the grant date. For equity incentive awards that are subject to a
market condition, the fair value of common stock on the grant date is adjusted to reflect the value of the market condition, generally using a path-dependent
pricing model, such as a Monte Carlo simulation.

For  awards  with  service-based  vesting  conditions  only,  the  Company  recognizes  share-based  compensation  expense  on  a  straight-line  basis  through  the
vesting  date  of  the  last  tranche  of  the  award.  For  awards  with  service-  and  performance-based  vesting  conditions,  the  Company  recognizes  stock-based
compensation expense using the graded-vesting method, treating each tranche as if it were a separately-granted award and recognizing expense through the
vesting date of each individual tranche. In each scenario, the Company recognizes share-based compensation expense based upon the probability that the
award will ultimately vest. The Company recognizes the cumulative effect of changes in the probability outcomes in the period in which the changes occur.

For awards subject to a market condition, the resolution of the market condition is not subsequently considered in expense recognition. Consequently, the
Company could recognize expense for awards that do not ultimately vest.

Basic and Diluted Net Loss per Common Share

Basic net loss per common share is calculated as net loss available to common stockholders divided by weighted average common shares outstanding for
the applicable period. Net loss available to common stockholders is calculated by adjusting net loss for periodic preferred accrued or deemed dividends.
These amounts include (i) dividends accumulated on the Company’s Series B Convertible Preferred Stock (“Series B Preferred Stock”) during the period,
(ii) periodic amortization of the beneficial conversion feature, and (iii) periodic accretion of the increasing-rate dividend feature.

F-15

This amount is divided by the weighted average common shares outstanding during the period. Weighted average common shares outstanding is calculated
as shares of the Company outstanding adjusted for the portion of the period for which they are outstanding. Unvested restricted stock awards are excluded
from the calculation of weighted average common shares outstanding until they have vested.

Diluted net loss per common share adjusts basic net loss per common share for convertible securities, options, equity incentive awards, and other share-
based payment awards which have yet to vest, to the extent such adjustments reduce basic net loss per common share.

The Company uses the if-converted method to calculate the dilutive effect of the Series B Preferred Stock and other convertible securities to the extent they
are outstanding. The if-converted method assumes that convertible securities are converted at the later of the issuance date or the beginning of the period. If
the hypothetical conversion of convertible securities, and the consequential avoidance of any deemed or accumulated preferred dividends, would decrease
basic net loss per common share, these effects are incorporated in the calculation of diluted net loss per common share, adjusted for the proportion of the
period the securities were outstanding.

The  Company  uses  the  treasury  stock  method  to  calculate  the  dilutive  effect  of  outstanding  options,  restricted  stock  awards,  and  other  share-based
payments. The treasury stock method assumes that the proceeds from exercise are used to repurchase common shares at the weighted average market price
during the period, increasing the denominator for the net effect of shares issued upon exercise less hypothetical shares repurchased.

If  the  dilutive  effects  noted  above  would  cause  diluted  net  loss  per  common  share  to  exceed  basic  net  loss  per  common  share,  such  effects  are  not
incorporated into the calculation, as they are deemed antidilutive. For all periods with a net loss available to common stockholders, any adjustment for
potential common shares would be naturally anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted net
loss per common share are the same for periods with a net loss.

Fair Value of Financial Instruments and Fair Value Measurements

The respective carrying value of certain on-balance sheet financial instruments approximated their fair values due to the short-term nature and type of these
instruments.  These  financial  instruments  include  cash  and  cash  equivalents,  accounts  receivable,  notes  receivable,  and  certain  other  financial  assets  and
liabilities.

The Company measures certain non-financial assets at fair value on a non-recurring basis. These non-recurring valuations include evaluating assets such as
long-lived assets, and non-amortizing intangible assets for impairment, allocating value to assets in an acquired asset group, and accounting for business
combinations. The Company uses the fair value measurement framework to value these assets and reports these fair values in the periods in which they are
recorded or written down.

Fair value financial instruments are recorded in accordance with the fair value measurement framework. The fair value measurement framework includes a
fair  value  hierarchy  that  prioritizes  observable  and  unobservable  inputs  used  to  measure  fair  values  in  their  broad  levels.  These  levels  from  highest  to
lowest priority are as follows:

•

•

•

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities;

Level 2: Quoted prices in active markets for similar assets or liabilities or observable prices that are based on inputs not quoted on active markets,
but corroborated by market data.

Level 3: Unobservable inputs or valuation techniques that are used when little or no market data is available.

The determination of fair value and the assessment of a measurement’s placement within the hierarchy require judgment. Level 3 valuations often involve a
higher  degree  of  judgment  and  complexity.  Level  3  valuations  may  require  the  use  of  various  valuation  methodologies  which  incorporate  unobservable
inputs, management estimates, and assumptions. Management’s assumptions could vary depending on the asset or liability valued and the valuation method
used.  Such  assumptions  could  include:  estimates  of  prices,  earnings,  costs,  actions  of  market  participants,  market  factors,  or  the  weighting  of  various
valuation methods. The Company may also engage external advisors to assist it in determining fair value, as appropriate.

Although  the  Company  believes  that  the  recorded  fair  value  of  its  financial  instruments  is  appropriate,  these  fair  values  may  not  be  indicative  of  net
realizable value or reflective of future fair values.

Government Assistance

F-16

The  Company  receives  benefits  from  various  government  entities  for  various  purposes  from  time  to  time.  With  respect  to  any  benefits  that  are  not
dependent on income (which are subject to the policy described under Income Taxes, above), the Company recognizes such benefits at the point in time in
which  all  barriers  to  receive  the  assistance  have  been  overcome  in  an  amount  equal  to  the  expected  benefit.  Benefits  are  reflected  in  the  consolidated
statements of operations in the line item to which the associated benefit relates.

Recently Adopted Accounting Pronouncements

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-10, “Government Assistance
(Topic  832)”,  which  provides  disclosure  requirements  regarding  government  grants  and  contributions.  The  ASU  requires  disclosure  of  the  nature  of
transactions  and  related  accounting  policies  used  to  account  for  transactions,  the  effect,  including  amounts,  of  government  assistance  on  individual  line
items on the financial statements, and significant terms and conditions of the transactions, including commitments and contingencies. This ASU is effective
for fiscal years beginning after December 15, 2021. The Company adopted the provisions of this ASU effective January 1, 2022. There was no impact upon
adoption. Refer to Note 20, Government Assistance, for the disclosures required by this ASU.

Recently Issued Accounting Pronouncements Not Yet Adopted

In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848)”, which provides temporary, optional expedients and exceptions to
accounting guidance for certain contract modifications and hedging arrangements to ease financial reporting burdens as a result of market transitions from
the London Interbank Offered Rate (“LIBOR”) to alternative reference rates. The guidance is available for prospective application and can generally be
applied  to  contract  modifications  and  hedging  relationships  entered  into  beginning  March  12,  2020  through  December  31,  2022.  In  December  2022,
following the issuance of ASU 2022-06, “Reference Rate Reform (Topic 848) — Deferral of the Sunset Date of Topic 848”, the end date was extended to
December 31, 2024.

As of December 31, 2022, the Company has long-term debt outstanding which carries an interest rate tied to LIBOR, the agreement for which contemplates
an  interest  rate  alternative  in  the  event  that  LIBOR  is  unavailable.  The  LIBOR  tenor  which  underlies  the  Company’s  term  loan  is  expected  to  sunset
effective June 30, 2023.

The  Company  is  evaluating  the  possibility  of  adoption  and  the  related  impact  on  its  financial  statements.  If  adopted,  the  Company  does  not  expect  the
provisions of this ASU to have a material impact on its consolidated financial statements.

All other ASUs issued and not yet effective as of December 31, 2022, and through the date of this report, were assessed and determined to be either not
applicable or are expected to have minimal impact on the Company’s current or future financial position or results of operations.

3.    Accounts Receivable, Net

Accounts receivable, net, consists of the following (in thousands):

Accounts receivable, gross
Allowance for doubtful accounts

Accounts receivable, net

December 31,

2022

2021

$

$

46,867 
(3,783)
43,084 

$

$

41,540 
(1,187)
40,353 

Activity related to the Company’s allowance for doubtful accounts during the year ended December 31, 2022 was as follows (in thousands):

Balance at December 31, 2021
Bad debt expense
Write-offs

Balance at December 31, 2022

Bad debt expense and write-offs were not material for the year ended December 31, 2021.

F-17

Allowance for Doubtful
Accounts

$

$

1,187 
2,820 
(224)
3,783 

 
 
4.    Inventory

Inventory consists of the following (in thousands):

Raw materials
Work in process
Finished goods

Inventory

December 31,

2022

2021

$

$

810 
6,855 
5,518 
13,183 

$

$

364 
6,112 
4,913 
11,389 

As a result of the conclusion of the FDA’s period of enforcement discretion on May 31, 2021, the Company wrote down $1.0 million of its Section 351
product inventory and $0.7 million related to discontinued product during the year ended December 31, 2021. There were no significant, unusual write-
downs of inventory during the year ended December 31, 2022.

Consignment inventory, included as a component of finished goods in the table above, was $3.4 million and $2.6 million as of December 31, 2022 and
2021, respectively.

5.    Property and Equipment, Net

Property and equipment, net, consists of the following (in thousands):

Lab and clean room equipment
Furniture and office equipment
Leasehold improvements
Construction in progress
Asset retirement cost
Finance lease assets

Property and equipment, gross

Less: accumulated depreciation and amortization

Property and equipment, net of accumulated depreciation and amortization

December 31,

2022

2021

$

$

16,422  $
15,016 
9,190 
1,983 
983 
189 
43,783 
(35,927)

7,856  $

16,567 
14,975 
9,052 
397 
863 
189 
42,043 
(32,878)
9,165 

Depreciation expense for each of the years ended December 31, 2022, 2021, and 2020 was recorded in certain captions of the consolidated statements of
operations for those periods in the amounts shown in the table below (in thousands):

Cost of sales
Selling, general, and administrative expense
Research and development expense

Total

$

$

2022

Year Ended December 31,
2021

2020

1,816  $
1,243 
286 
3,345  $

1,787  $
2,278 
298 
4,363  $

2,022 
3,416 
344 
5,782 

F-18

 
 
 
 
6.     Leases

The Company has leases for corporate offices, manufacturing facilities, vehicles, and certain equipment. Such leases do not require any contingent rental
payments, impose any financial restrictions, or contain any residual value guarantees.

Supplemental balance sheet information related to the Company’s leases, including the financial statement caption in which the amounts are presented, is as
follows (amounts in thousands, except lease term and discount rate):

Operating Leases
December 31,

Finance Leases
December 31,

2022

2021

2022

2021

Assets

Right of use asset
Property and equipment, net

Total assets

Liabilities

Other current liabilities
Other liabilities

Total liabilities

Weighted-average remaining lease term (years)
Weighted-average discount rate

$

$

$

$

$

$

$

$

3,400
—
3,400

1,391
2,381
3,772

2.8
8.3 %

$

$

$

$

4,696
—
4,696

1,203
3,812
5,015

4.0
8.4 %

— $
98
98

$

49
57
106

$

$

2.1
8.3 %

Information related to lease costs are as follows (amounts in thousands):

Operating lease cost

Amortization of finance lease ROU assets

Interest expense on finance lease liabilities

Maturities of lease liabilities are as follows (amounts in thousands):

2022

Year Ended December 31,
2021

2020

$

1,620  $

1,327  $

47 

10 

43 

13 

Year Ending December 31,
2023
2024
2025
2026
2027
Thereafter
Total lease payments
Less: imputed interest

Lease liability

Asset Retirement Obligations

Operating Leases

Finance Leases

Total

$

$

1,638  $
1,618 
506 
419 
35 
— 
4,216 
(444)
3,772  $

55  $
55 
5 
— 
— 
— 
115 
(9)
106  $

—
145
145

45
106
151

3.1
8.3 %

1,392 

— 

— 

1,693 
1,673 
511 
419 
35 
— 
4,331 
(453)
3,878 

Certain lease agreements require the Company to return designated areas of leased space to its original condition upon termination of the lease agreement,
for  which  the  Company  records  an  asset  retirement  obligation  and  a  corresponding  capital  asset  in  an  amount  equal  to  the  estimated  fair  value  of  the
obligation. In subsequent periods, the asset retirement obligation is accreted for the change in its present value and the capitalized asset is depreciated, both
over the term of the associated lease

F-19

agreement. Asset retirement obligations of $1.2 million and $1.0 million are included in other liabilities in the consolidated balance sheets as of December
31, 2022 and 2021, respectively.

Sublease

The Company subleases one of its leased industrial warehouse spaces. The sublease income from the facility offsets the lease expense associated with the
facility. Sublease income for the facility was $0.1 million for each of the years ended December 31, 2022, 2021, and 2020, respectively, and is presented as
a reduction to selling, general, and administrative expense on the consolidated statements of operations in those periods.

7.    Goodwill and Intangible Assets, Net

Goodwill

Historically, the Company had concluded that it operated as a single operating segment and single reporting unit. For the year ended December 31, 2022, as
a  result  of  changes  in  the  management  of  the  Company’s  business,  management  concluded  that  the  Company  operates  as  three  operating  segments,
including  two  distinct  reportable  segments:  Wound  &  Surgical  and  Regenerative  Medicine.  See  Note  13,  Segment Information,  for  a  description  of  the
Company’s operating segments. Management further concluded that these two reportable segments reflected its reporting units for goodwill impairment
testing purposes.

The Company allocated $20.0 million of consolidated goodwill, which was entirely allocated to its previous reporting unit, to each of its Wound & Surgical
and Regenerative Medicine segments based on their relative fair values from a market participant standpoint. The result was $19.4 million and $0.5 million
allocated to Wound & Surgical and Regenerative Medicine, respectively. A third reporting unit associated with the Company’s third operating segment was
deemed immaterial and no goodwill was assigned to it.

The Company performed goodwill impairment tests using the Company’s single reporting unit and the new reporting units on September 30, 2022. In all
cases, the Company concluded that the estimated fair values of each reporting unit exceeded its respective carrying values. Therefore, the Company did not
record impairment for goodwill on September 30, 2022.

For the annual impairment test performed October 1, 2022, the Company performed a quantitative assessment to determine the existence of impairment.
The quantitative assessment concluded that it was more likely than not that goodwill was not impaired. No impairment was recorded for the year ended
December 31, 2022.

For the annual impairment test performed on October 1, 2021, the Company performed a qualitative assessment to determine the existence of impairment.
The qualitative assessment concluded that it was more likely than not that goodwill was not impaired. The Company did not proceed to the quantitative
assessment, and no impairment was recorded for the year ended December 31, 2021.

The following table indicates the changes in the carrying amount of goodwill for 2022 and 2021 (in thousands):

Previous Reporting
Unit

Wound & Surgical

Regenerative Medicine

Total Company

Balance as of January 1, 2021
Activity

Balance as of December 31, 2021
Reallocation

Balance as of December 31, 2022

$

$

$

19,976  $
— 
19,976  $

(19,976)

—  $

F-20

—  $
— 
—  $

19,441 
19,441  $

—  $
— 
—  $

535 
535  $

19,976 
— 
19,976 

— 
19,976 

Intangible Assets, Net

Intangible assets, net, are summarized as follows (in thousands):

Gross Carrying
Amount

December 31, 2022
Accumulated
Amortization

Net Carrying
Amount

Gross Carrying
Amount

December 31, 2021
Accumulated
Amortization

Net Carrying
Amount

Amortized intangible assets
Patents and know-how
Licenses

Total amortized intangible assets

Unamortized intangible assets
Tradenames and trademarks
Patents in process

Total intangible assets

$

$

$

$

9,923  $
1,000 
10,923  $

(7,106) $

(4)
(7,110) $

2,817  $
996 
3,813  $

9,578  $
— 
9,578  $

(6,408) $
— 
(6,408) $

1,008 
1,031 
12,962 

$

$

1,008  $
1,031 
5,852  $

1,008 
1,205 
11,791 

$

$

3,170 
— 
3,170 

1,008 
1,205 
5,383 

Amortization expense and impairment expense for the years ended December 31, 2022, 2021, and 2020, is summarized in the table below (amounts in
thousands):

Amortization of intangible assets
Impairment of intangible assets

$

701  $
— 

820  $
53 

2022

Year ended December 31,
2021

2020

1,073
1,027

Impairment  of  intangible  assets  in  2021  related  to  supplier  relationship  assets  that  were  determined  to  be  unrecoverable  due  to  attrition.  Impairment  of
intangible assets in 2020 related to customer relationship assets that were determined to be unrecoverable due to lower than expected margins.

Expected future amortization of intangible assets as of December 31, 2022, is as follows (in thousands):

Year Ending December 31,
2023
2024
2025
2026
2027
Thereafter

Total amortization expense

F-21

Estimated
Amortization
Expense

756 
756 
361 
207 
206 
1,527 
3,813 

$

$

 
 
8.    Accrued Expenses

Accrued expenses consist of the following (in thousands):

Legal costs

External commissions

Accrued rebates

Estimated returns

Accrued GPO Fees

Accrued travel

Accrued clinical trials

Other

Total

9.    Long Term Debt

Hayfin Loan Agreement

December 31,

2022

2021

$

$

4,447  $

2,941 

707 

659 

638 

566 

90 

976 
11,024  $

2,806 

2,630 

1,343 

788 

559 

385 

694 

607 
9,812 

On  June  30,  2020,  the  Company  entered  into  a  Loan  Agreement  with,  among  others,  Hayfin  Services,  LLP,  (“Hayfin”)  an  affiliate  of  Hayfin  Capital
Management LLP (the “Hayfin Loan Agreement”), which was funded on July 2, 2020 and provided the Company with a senior secured term loan in an
aggregate amount of $50.0 million (the “Term Loan”). The Term Loan matures on June 30, 2025 (the “Maturity Date”). Interest is payable quarterly on the
Term Loan for the principal balance outstanding through the Maturity Date. No principal payments are due and payable until the Maturity Date.

The Hayfin Loan Agreement also provided the Company with an option to draw on an additional delayed draw term loan (the “DD TL”, collectively with
the Term Loan, the “Credit Facilities”) in the form of a committed but undrawn $25.0 million facility until June 30, 2021. The Company did not exercise
the option.

On February 28, 2022, the Company executed an Amendment to the Hayfin Loan Agreement (as amended, the “Amended Hayfin Loan Agreement”). The
amendment was accounted for as a modification. No gain or loss was recognized nor was there a change to the carrying amount of the debt as a result of the
amendment.

Interest on any borrowings under the Amended Hayfin Loan Agreement is equal to the London Interbank Offered Rate (“LIBOR”) (subject to a floor of
1.5%) plus a margin of 6.75% per annum. If LIBOR is unavailable, the Term Loan will carry interest at the 6.75% margin plus the greatest of the Prime
Rate, the Federal Funds Rate plus 0.5% per annum, and 2.5%.

An additional 3.0% margin is applied to the interest rate in the event of default as defined by the Amended Hayfin Loan Agreement. The Term Loan carried
an interest rate of 8.3% at issuance and 11.5% as of December 31, 2022.

The Amended Hayfin Loan Agreement contains financial covenants requiring the Company, on a consolidated basis, to maintain the following:

• Minimum Consolidated Total Net Sales (as defined in the Amended Hayfin Loan Agreement) of varying amounts, required to be calculated on a

quarterly basis, and

• Minimum Liquidity (as defined in the Amended Hayfin Loan Agreement) of $20 million, an at-all-times financial covenant tested monthly.

As of December 31, 2022, the Company is in compliance with all applicable financial covenants under the Amended Hayfin Loan Agreement.

F-22

The Amended Hayfin Loan Agreement also includes certain negative covenants and events of default customary for facilities of this type, and upon the
occurrence  of  such  events  of  default,  subject  to  customary  cure  rights,  the  Term  Loan  may  be  accelerated  or  the  lenders’  commitments  terminated.
Mandatory prepayments are also required in the event of a change in control, incurring other indebtedness, certain proceeds from disposal of assets and
insured  casualty  event  (as  defined  in  the  Amended  Hayfin  Loan  Agreement).  Annually,  beginning  with  the  fiscal  year  ended  December  31,  2021,  the
Company is required to prepay the outstanding loans based on a percentage of Excess Cash Flow (as defined in the Amended Hayfin Loan Agreement), if
such is generated. No such prepayments have been required as of December 31, 2022.

The Amended Hayfin Loan Agreement, as amended, also specifies that any prepayment of the loan, voluntary or mandatory, will subject the Company to a
prepayment premium applicable as of the date of the prepayment:

• On or before July 2, 2023: 2% of the principal balance repaid.

• After July 2, 2023, but on or before July 2, 2024: 1% of the principal balance repaid.

• After July 2, 2024: no premium.

Hayfin maintains a first-priority security interest in substantially all of the Company’s assets.

A breach of a financial covenant in the Amended Hayfin Loan Agreement, if uncured or unable to be cured, would likely result in an event of default that
could  trigger  the  lender’s  remedies,  including  acceleration  of  the  entire  principal  balance  of  the  loan  as  well  as  any  applicable  prepayment  premiums.
Future compliance with the financial covenants, as amended, requires continuing growth in net sales consistent with the Company’s business strategy and
plans. The Company is subject to inherent uncertainties that could impact the Company’s net sales growth, including, but not limited to, the regulatory
pathway  of  the  Company’s  EPICORD®  and  AMNIOCORD®.  If  the  FDA  were  to  determine  that  these  products  do  not  meet  the  requirements  for
regulation  solely  under  Section  361,  the  Company  would  be  required  to  obtain  the  appropriate  FDA  clearance  or  approval  to  continue  marketing  these
products. The loss of the Company’s ability to market and sell its umbilical cord-derived products would have an adverse effect on the Company’s revenue,
business,  financial  condition,  and  results  of  operations,  including  its  ability  to  comply  with  the  financial  covenants  set  forth  pursuant  to  the  Amended
Hayfin Loan Agreement. Refer to Note 12, Revenue, for net sales derived from the Company’s cord products.

Original issue discount and deferred financing costs were allocated between the sale of the Series B Preferred Stock (which occurred simultaneously with
the funding of the Hayfin Loan Agreement, collectively the “Financing Transactions”) and the Term Loan on the basis of the relative fair values of the
transactions. The costs allocated to the Hayfin Loan Agreement were further allocated between the Term Loan and the DD TL on the basis of the maximum
potential principal outstanding between the Credit Facilities. The allocation of the deferred financing costs and original issue discount between Term Loan
and the DD TL on July 2, 2020 was as follows (amounts in thousands):

Original issue discount
Deferred financing costs

$

333  $

2,169 

167  $

1,084 

Term Loan

July 2, 2020
DD TL

Total

500 
3,253 

Deferred  financing  costs  and  original  issue  discount  allocated  to  the  Term  Loan  are  amortized  using  the  effective  interest  method  through  the  Maturity
Date.  The  amortization  of  such  amounts  is  presented  as  part  of  interest  expense,  net  on  the  consolidated  statement  of  operations  for  the  years  ended
December 31, 2022, 2021, and 2020.

Deferred financing costs and original issue discount associated with the DD TL were amortized using the straight-line method through the expiration of the
DD TL commitment term on June 30, 2021. Amortization of these amounts are presented as part of interest expense, net on the consolidated statements of
operations for the years ended December 31, 2021 and 2020.

The balances of the Term Loan as of December 31, 2022 and 2021 were as follows (amounts in thousands):

F-23

December 31,

2022

2021

Outstanding principal
Deferred financing costs
Original issue discount

Long term debt, net

$

$

50,000  $
(1,219)
(187)
48,594  $

50,000 
(1,624)
(249)
48,127 

Interest expense related to the Term Loan, included in interest expense, net in the consolidated statements of operations, was as follows (amounts in
thousands):

Stated interest
Amortization of deferred financing costs
Accretion of original issue discount

Interest expense

$

$

4,559  $
405 
62 
5,026  $

4,182  $
372 
58 
4,612  $

2022

Year Ended December 31,
2021

2020

Interest expense related to the DD TL, included in interest expense, net in the consolidated statements of operations, was as follows (amounts in
thousands):

Commitment fee
Amortization of deferred financing costs
Accretion of original issue discount

Interest expense

$

$

—  $
— 
— 
—  $

126  $
542 
83 
751  $

2022

Year Ended December 31,
2021

2020

Scheduled principal payments on the Term Loan as of December 31, 2022 are as follows:

2,085 
173 
26 
2,284 

128 
542 
83 
753 

Year ending December 31,
2023
2024
2025
2026
2027
Thereafter

Outstanding principal

$

$

Principal

— 
— 
50,000 
— 
— 
— 
50,000 

As of December 31, 2022, the fair value of the Term Loan was $46.7 million. This valuation was calculated based on a series of Level 2 and Level 3 inputs,
including a discount rate based on the credit risk spread of debt instruments of similar risk character in reference to U.S. Treasury instruments with similar
maturities,  with  an  incremental  risk  premium  for  risk  factors  specific  to  the  Company.  The  remaining  cash  flows  associated  with  the  Term  Loan  were
discounted to December 31, 2022 using this discount rate to derive the fair value.

BT Term Loan

F-24

On  June  10,  2019,  the  Company  entered  into  a  loan  agreement  (the  “BT  Loan  Agreement”)  with  Blue  Torch  Finance  LLC  (“Blue  Torch”),  as
administrative  agent  and  collateral  agent,  to  borrow  funds  with  a  face  value  of  $75.0  million  (the  “BT  Term  Loan”),  of  which  the  full  amount  was
borrowed and funded. The proceeds from the BT Term Loan were used (i) for working capital and general corporate purposes and (ii) to pay transaction
fees, costs and expenses incurred in connection with the BT Term Loan and the related transactions. The BT Term Loan would have matured on June 20,
2022 and was repayable in quarterly installments of $0.9 million, with the balance due on June 20, 2022. Blue Torch maintained a first-priority security
interest in substantially all the Company’s assets. The BT Term Loan was issued net of the original issue discount of $2.3 million. The Company incurred
$6.7 million of deferred financing costs.

On  April  22,  2020,  the  Company  amended  the  BT  Loan  Agreement  with  Blue  Torch.  The  amendment  provided  for  an  increase  in  the  maximum  Total
Leverage Ratio, which was a quarterly test, for the remainder of 2020, and also provided for a reduction in the minimum Liquidity requirement from April
2020 through November 2020. In connection with the amendment, the Company agreed to pay a one-time fee of approximately $0.7 million, added to the
principal balance, and a 1 percentage point increase in the interest rate to LIBOR plus 9%.

On July 2, 2020, a portion of the proceeds from the Financing Transactions was used to repay the outstanding balance of principal, accrued but unpaid
interest, and prepayment premium under the BT Loan Agreement. In connection with the repayment of the BT Term Loan, the Company terminated the BT
Loan Agreement. The Company has no continuing obligations related to the BT Term Loan as of December 31, 2021.

The  Company  recorded  a  loss  on  extinguishment  of  debt  of  $8.2  million  during  the  year  ended  December  31,  2020.  The  composition  of  the  loss  on
extinguishment of debt was as follows (amounts in thousands):

Unamortized deferred financing costs
Unamortized original issue discount
Unamortized amendment fee
Prepayment premium
Other fees

Loss on extinguishment of debt

$

$

July 2, 2020

4,528 
1,538 
671 
1,439 
25 
8,201 

Interest expense related to the BT Term Loan, included in interest expense, net in the consolidated statements of operations was as follows (amounts in
thousands):

Year ended December
31, 2020

Interest on principal balance
Accretion of original issue discount
Accretion of amendment fee
Amortization of deferred financing costs

Total BT Term Loan interest expense

$

$

3,773 
354 
53 
1,051 
5,231 

Paycheck Protection Program Loan

The Company applied for and, on April 24, 2020, received proceeds of $10.0 million in the form of a loan under the Paycheck Protection Program (the
“PPP Loan”). On May 11, 2020, the Company repaid the PPP Loan in full. There are no continuing obligations under the PPP Loan as of December 31,
2022.

10.    Basic and Diluted Net Loss Per Common Share

Net loss per common share is calculated using two methods: basic and diluted.

Basic Net Loss Per Common Share

F-25

The following table provides a reconciliation of net loss to net loss available to common shareholders and calculation of basic net loss per common share
for each of the years ended December 31, 2022, 2021, and 2020 (amounts in thousands, except share and per-share amounts):

Net loss
Adjustments to reconcile to net loss available to common stockholders:

Accumulated dividend on Series B Preferred Stock
Amortization of beneficial conversion feature
Accretion of increasing-rate dividend feature

Total adjustments
Net loss available to common stockholders
Weighted average common shares outstanding
Basic net loss per common share

Diluted Net Loss Per Common Share

2022

Year ended December 31,
2021

2020

(30,197) $

(10,285) $

(49,284)

6,580 
— 
— 
6,580 
(36,777) $

5,210 
— 
926 
6,136 
(16,421) $

112,909,266 

110,353,406 

(0.33) $

(0.15) $

2,016 
31,110 
918 
34,044 
(83,328)
108,257,112 
(0.77)

$

$

$

The following table sets forth the computation of diluted net loss per common share (in thousands, except share and per-share amounts):

Net loss available to common stockholders
Adjustments:

Dividends on Series B Preferred Stock
Less: antidilutive adjustments

Total adjustments
Numerator
Weighted average common shares outstanding
Adjustments:

Potential common shares
Less: antidilutive potential common shares (a)

Total adjustments
Weighted average common shares outstanding adjusted for potential common shares
Diluted net loss per common share

2022

Year ended December 31,
2021

2020

(36,777) $

(16,421) $

(83,328)

6,580 
(6,580)
— 
(36,777) $

6,136 
(6,136)
— 
(16,421) $

112,909,266 

110,353,406 

28,705,593 
(28,705,593)
— 
112,909,266 

29,801,836 
(29,801,836)
— 
110,353,406 

(0.33) $

(0.15) $

34,044 
(34,044)
— 
(83,328)
108,257,112 

15,687,044 
(15,687,044)
— 
108,257,112 
(0.77)

$

$

$

(a) Weighted average common shares outstanding for the calculation of diluted net loss per common share does not include the following adjustments

for potential common shares below because their effects were determined to be anti-dilutive for the periods presented:

Series B Preferred Stock
Restricted stock unit awards
Restricted stock awards
Outstanding stock options
Performance stock unit awards
Employee stock purchase plan

Potential common shares

2022

Year ended December 31,
2021

2020

27,850,916 
546,883 
217,971 
65,720 
5,251 
18,852 
28,705,593 

26,497,570 
1,393,910 
1,121,019 
771,409 
17,928 
— 
29,801,836 

12,987,013 
616,141 
1,299,770 
752,499 
31,621 
— 
15,687,044 

F-26

 
 
 
 
11.    Equity

Series B Convertible Preferred Stock

The Series B Preferred Stock are convertible, cumulative securities which rank senior to the Company’s Series A Junior Participating Preferred Stock and
the Company’s common stock. The Series B Preferred Stock accumulated dividends at a rate of 4.0% per annum through June 30, 2021, and 6.0% per
annum thereafter. Dividends are declared at the sole discretion of the Board. Dividends are paid at the end of each quarter based on the dividend amounts
that accumulate beginning of the last payment date through the day prior to the end of each quarter. In lieu of paying a dividend, the Company may elect to
accrue the dividend owed to the holders of the Series B Preferred Stock. Accrued dividend balances accumulate dividends at the prevailing dividend rate
for each dividend period for which they are outstanding.

Each share of Series B Preferred Stock is convertible into Company’s common stock at any time at the option of the Holder. Shares are converted based on
the  liquidation  preference  of  $1,000  per  share  (the  “Liquidation  Preference”)  plus  any  accrued  or  accumulated  dividends  through  the  date  of  the
conversion at a conversion price of $3.85 per common share. The Series B Preferred Stock, including any accumulated and unpaid dividends, automatically
converts into common stock at any time after July 2, 2023, provided that the common stock has traded at $7.70 per common share or more (i) for 20 out of
30 consecutive trading days and (ii) on such date of conversion.

The holders of the Series B Preferred Stock, voting as a class, are entitled to appoint two members to the board of directors. The holders of the Series B
Preferred Stock are entitled to vote on all matters to be voted on by the Company’s shareholders on an as-converted basis as a single class with the common
stock; provided that the votes represented by a single holder of Series B Preferred Stock cannot exceed 19.9% of the total voting stock of the Company and
no share of Series B Preferred Stock held can entitle the holder to a number of votes that exceeds the quotient of the Liquidation Preference divided by
$5.25 per share.

Holders  of  the  Series  B  Preferred  Stock  are  also  entitled  to  the  Liquidation  Preference  and  all  accumulated  and  unpaid  dividends  in  the  event  of  a
liquidation, dissolution, or winding-up of the Company.

If the Company undergoes a change of control (as defined), the Company will have the option to repurchase some or all of the then-outstanding shares of
Series B Preferred Stock for cash in an amount equal to the Liquidation Preference plus any accumulated and unpaid dividends, subject to the rights of the
holders of the Series B Preferred Stock in connection with such change in control. If the Company does not exercise such repurchase right, holders of the
Series B Preferred Stock will have the option to (1) require the Company to repurchase any or all of their then-outstanding shares of Series B Preferred
Stock for cash in an amount equal to the Liquidation Preference plus accumulated and unpaid dividends or (2) convert the Series B Preferred Stock into
common stock and receive their pro rata consideration thereunder. Since the contingent redemption of the Series B Preferred Stock by the holders in the
event of a change in control is outside the Company’s control, the Series B Preferred Stock is classified as temporary equity.

At  the  time  of  the  issuance  of  the  Series  B  Preferred  Stock,  the  Company’s  common  stock,  into  which  the  Company’s  Series  B  Preferred  Stock  is
convertible,  had  an  estimated  fair  value  exceeding  the  effective  conversion  price  of  the  Series  B  Preferred  Stock,  giving  rise  to  a  beneficial  conversion
feature in the amount of $31.1 million. This amount was immediately recognized as a deemed dividend on the commitment date since there is no stated
redemption date and the Series B Preferred Stock is immediately convertible.

The  Series  B  Preferred  Stock  instrument  contains  an  increasing-rate  cumulative  dividend  feature.  The  Company  determined  the  present  value  of  the
difference between the (1) dividends that will be payable in the period preceding commencement of the perpetual dividend and (2) the perpetual dividend
amount  for  a  corresponding  number  of  periods  in  order  to  ascribe  a  fair  value  to  this  feature.  These  amounts  were  discounted  to  present  value  using  a
market rate for dividend yield as of the date on which the Series B Preferred Stock was issued. The Company calculated the amount of the increasing-rate
dividend feature as $1.8 million. This amount was amortized as a deemed dividend to preferred shareholders using the effective interest method through
June 30, 2021. During each of the years ended December 31, 2021 and 2020, the Company recognized $0.9 million of deemed dividends related to the
amortization of the increasing-rate dividend feature.

F-27

The below table illustrates changes in the Company’s balance of the Series B Preferred Stock for the years ended December 31, 2022, 2021, and 2020 (in
thousands, except per share amounts):

Balance at December 31, 2019
Issuance of Series B Preferred Stock
Deemed dividends

Balance at December 31, 2020
Deemed dividends

Balance at December 31, 2021
Activity

Balance at December 31, 2022

Series B Preferred Stock

Shares

Amount

—  $

100,000 
— 
100,000  $

— 
100,000  $

— 
100,000  $

— 
59,540 
32,028 
91,568 

926 
92,494 

— 
92,494 

The Company has not declared or paid any dividends on the Series B Preferred Stock since issuance. Dividends in arrears as of December 31, 2022 were
$13.8 million. As this amount has not been declared, the Company has not recorded this amount on its consolidated balance sheet as of December 31, 2022.

As of December 31, 2022, based on accumulated dividends as of that date, the Series B Preferred Stock was convertible into an aggregate of 29,559,946
shares of the Company’s common stock.

Stock Incentive Plans

The Company has two share-based compensation plans which provide for the granting of equity awards, including qualified incentive and non-qualified
stock options and restricted stock awards: the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan Amended and Restated through October 2, 2020
(the “2016 Plan”), which was approved by shareholders on May 18, 2016, and the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (the “Prior
Incentive Plan”). During the years ended December 31, 2022, 2021, and 2020 the Company used only the 2016 Plan to make grants.

The  2016  Plan  permits  the  grant  of  equity  awards  to  the  Company’s  employees,  directors,  consultants  and  advisors  for  up  to  8,400,000  shares of  the
Company’s common stock plus (i) the number of shares of the Company’s common stock that remain available for issuance under the Prior Incentive Plan,
and (ii) the number of shares that are represented by outstanding awards that later become available because of the expiration or forfeiture of the award
without  the  issuance  of  the  underlying  shares.  Awards  granted  under  the  2016  Plan  are  subject  to  a  vesting  schedule  as  set  forth  in  each  individual
agreement.

Stock Options

A summary of stock option activity for the year ended December 31, 2022 is presented below:

Outstanding at January 1, 2022
Granted
Exercised
Unvested options forfeited
Vested options expired

Outstanding at December 31, 2022

Exercisable at December 31, 2022

Weighted-
Average
Exercise
Price

Weighted-
Average
Remaining
Contractual
Term
(in years)

Aggregate
Intrinsic
Value

5.18 
— 
2.09 
— 
4.02 
6.46 

6.46 

0.87

0.87 $

— 

— 

Number of
Shares
1,444,845  $

— 
(312,001)
— 
(198,950)
933,894 

933,894  $

The intrinsic values of the options exercised during the years ended December 31, 2022, 2021 and 2020 were $0.6 million, $3.3 million, and $1.9 million,
respectively. Cash received from option exercise under all share-based payment arrangements for the years ended December 31, 2022, 2021 and 2020 was
$0.7 million, $1.4 million, and $0.4 million, respectively. The actual tax

F-28

 
 
 
 
 
 
 
 
 
 
 
 
benefit  for  the  tax  deductions  from  option  exercise  of  the  share-based  payment  arrangements  totaled  $0.2  million,  $2.0  million,  and  $1.6  million,
respectively, for the years ended December 31, 2022, 2021 and 2020. The Company has a policy of using its available repurchased treasury stock to satisfy
option exercises prior to the issuance of new shares of common stock.

No options vested during the years ended December 31, 2022, 2021 and 2020. There was no unrecognized compensation expense at December 31, 2022.

During 2021 and 2020, certain stock option holders elected to return restricted shares to the Company as consideration to exercise stock options. In total,
41,810 and 148,972 shares were returned to the Company during the year ended December 31, 2021 and 2020, respectively, for an aggregate fair value of
$0.4 million and $0.9 million, respectively. There were no similar transactions for the year ended December 31, 2022.

Equity Incentive Awards

The Company has issued several classes of stock awards to employees: restricted stock (“RSAs”), restricted stock unit awards (“RSUs”), and performance
stock  unit  awards  (“PSUs”,  collectively  the  “Equity  Incentive  Awards”).  The  following  is  summary  information  for  such  awards  for  the  year  ended
December 31, 2022.

Restricted  stock  and  RSUs  generally  vest  over  a  one-  to  three-year  period  in  equal  annual  increments  and  require  the  recipient  to  provide  continuous
service  through  each  vesting  date.  PSUs  vest  based  on  the  achievement  of  specific  performance  targets  subject  to  agreements  with  employees  and  also
require the recipient to provide continuous service through a specified date or event.

As  of  December  31,  2022,  there  was  $19.8  million  of  total  unrecognized  stock-based  compensation  related  to  unvested  Equity  Incentive  Awards. That
expense is expected to be recognized over a weighted-average period of 1.72 years, which approximates the remaining vesting period of these grants. RSAs
are considered common shares issued and outstanding upon grant, while shares underlying the RSUs and PSUs are considered issued and outstanding only
upon vesting. Therefore, all RSAs noted below as unvested are considered issued and outstanding as of December 31, 2022, while unvested RSUs and
PSUs are not considered issued and outstanding as of December 31, 2022. RSAs, RSUs, and PSUs are not reflected in weighted average common shares
outstanding for purposes of calculated basic net loss per common share.

A summary of Equity Incentive Award activity, by class of award, for the year ended December 31, 2022 is presented below:

RSA

RSU

PSU

Unvested at January 1, 2022
Granted
Vested
Forfeited

Unvested at December 31, 2022

Weighted-
Average Grant
Date
 Fair Value

Number of
Shares

877,197  $

— 
(749,104)
(5,338)
122,755  $

4.26 
— 
3.95 
5.11 

6.13 

Number of
Shares
4,228,919  $
4,232,390 
(1,724,530)
(1,961,808)
4,774,971  $

Weighted-
Average Grant
Date
 Fair Value

Weighted-
Average Grant
Date
 Fair Value

Number of
Shares

8.64 
4.80 
8.33 
6.37 

6.28 

—  $

441,965 
— 
(200,893)
241,072  $

— 
4.62 
— 
4.62 

4.62 

The total fair value of equity incentive awards vested during the years ended December 31, 2022, 2021 and 2020, was $10.9 million, $20.1 million, and
$10.1 million, respectively.

F-29

 
 
 
 
 
 
For the years ended December 31, 2022, 2021, and 2020 the Company recognized share-based compensation as follows (in thousands):

Cost of sales
Selling, general and administrative expenses
Research and development expense
Total share-based compensation
Income tax benefit, before consideration of valuation allowance

Total share-based compensation, net of tax benefit

Performance Stock Units

Years Ended December 31,
2021

2020

2022

$

$

1,213  $
9,578 
1,875 
12,666 
(3,132)
9,533  $

813  $

13,108 
836 
14,757 
(3,649)
11,108  $

520 
14,549 
288 
15,357 
(3,792)
11,565 

The Company granted 441,965 PSUs to certain executive officers during the year ended December 31, 2022. These PSUs vest based on and to the extent
that stipulated cumulative net sales targets are achieved. Of the granted PSUs:

•

•

•

25% can vest based on net sales achieved for the year ended December 31, 2022,

25% can vest based on net sales achieved for the two-year period ending December 31, 2023, and

the remaining award can vest based on net sales achieved for the three-year period ending December 31, 2024.

Achievement of the performance targets allow for vesting of 50% to 150% of the PSUs granted. If performance is below 50%, the PSUs do not vest. To the
extent that the vesting percentage in a subsequent period exceeds the vesting percentage achieved in a previous period, a recipient is eligible to receive the
amount of shares from the previous period based on the vesting percentage in the subsequent period. If total shareholder return (“TSR”), as defined below,
is negative, vesting is limited to 100% of the award for all periods, regardless of actual achievement against the stipulated net sales targets.

All of the PSUs require recipients to continue employment with the Company through the vesting date, which will occur upon approval of the results with
respect to the established targets by the Compensation Committee of the Board of Directors after December 31, 2024, but no later than March 15, 2025.

The TSR is calculated as the average trading price of the Company’s common stock during the final 30 trading days of 2024, adjusted for dividends paid on
the Company’s common stock, less the average trading price during the final 30 trading days of 2021. Since TSR is based on the Company’s share price, it
represents a market condition, which is incorporated in the grant date fair value of the shares in excess of 100% vesting. These awards are not reflected in
the table above.

The fair value of these awards on the date of grant was estimated using a Monte Carlo simulation, the inputs for which were informed by a Black-Scholes
option pricing model. The assumptions used in determining the fair value of these PSUs were as follows:

Risk-free interest rate
Expected term (years)
Expected volatility (annualized)
Dividend yield
Closing stock price on grant date
Grant date fair value

$
$

Assumption

2.68 %
2.74
63.7 %
— %

4.62 
2.78 

The expected term was derived from the date of the grant through the latest date of the resolution of the market condition. The risk-free interest rate was
derived based on the U.S. Treasury Yield curve in effect at the date of grant for maturities of similar periods to the concluded term. The expected volatility
was based on the Company’s historical daily stock price movements for a term similar in length to the expected term. The dividend yield was based on the
Company’s history of dividends on its common stock.

F-30

 
 
 
Expense related to PSUs is recognized, straight-line, based on the grant date fair value of the relevant shares, over the requisite service period related to
each individual tranche, limited to the extent that the achievement of the associated performance condition associated with that tranche is probable. These
expectations are derived from the Company’s actual results, latest budget, and forecasts for net sales in the associated periods. Subsequent adjustments to
the expectation for vesting are reflected as a cumulative adjustment to expense. The fair value of the portion of the award subject to a market condition and
expense  recognized  on  such  awards  are  not  subsequently  reconsidered  based  on  the  probability  of  or  actual  achievement  of  the  market  condition.
Accordingly, the Company may recognize share-based compensation expense for awards that do not ultimately vest.

Employee Stock Purchase Plan

On June 7, 2022, the Company adopted the Employee Stock Purchase Plan of MiMedx Group, Inc. (the “ESPP”). The ESPP is intended to qualify as an
“employee stock purchase plan” under Section 423 of the Internal Revenue Code. All regular full-time employees of the Company (including officers) and
all other employees who meet the eligibility requirements of the plan may participate in the ESPP. The ESPP provides eligible employees an opportunity to
acquire the Company’s common stock on a semi-annual basis at a purchase price of 85% of the lower of the closing price per share of the Company’s
common stock on the first day and the last day of each six-month purchase period (the “Purchase Period”). The aggregate number of shares which may be
issued and sold under the ESPP is 3 million shares of common stock. The first Purchase Period under the ESPP commenced on August 1, 2022 and resulted
in a purchase of shares on January 31, 2023.

For the year ended December 31, 2022, the Company recorded $0.2 million in stock-based compensation related to the ESPP. As of December 31, 2022,
the Company had cumulative payroll deferrals under the ESPP for future share purchases of $0.6 million. This amount is included in accrued compensation
in the consolidated balance sheet. No shares have been issued under the plan to date.

Unrecognized stock compensation for the period is less than $0.1 million to be recognized over a weighted average period of 0.08 years.

2020 RSU Modification

During  the  year  ended  December  31,  2019,  the  Company  granted  a  fixed-dollar  value  RSU  award  to  the  members  of  its  Board  in  the  amount  of  $1.6
million. The RSU awards vested at the date of the 2019 Annual Meeting and were settled in common stock with the number of shares of common stock
based on the closing price of the Company’s share price on August 5, 2020, a date thirty days after the Company became current on its SEC filings. Upon
this event, these awards were modified from a fixed dollar-amount of awards to be settled in a variable number of shares to a fixed number of shares based
on the closing price of the Company’s common stock on August 5, 2020. This event constituted a modification of the awards from liability-based awards to
equity-based awards. This event did not change the total amount of expense recognized. Prior to August 5, 2020, the Company recorded $1.3 million of
expense, of which $0.9 million was recognized during the year ended December 31, 2020. The Company reclassified $1.3 million of recorded liability to
additional  paid-in  capital  to  reflect  this  modification  on  August  5,  2020.  Subsequent  to  the  modification,  $0.3  million  of  expense  was  recognized  as
additional paid-in capital during the year ended December 31, 2020.

Treasury Stock

Repurchases of shares of Common Stock in connection with the satisfaction of employee tax withholding obligations upon vesting of restricted stock and
exercise  of  stock  options  for  the  years  ended  December  31,  2022,  2021,  and  2020  were  249,442,  469,239,  and  435,492,  respectively,  for  an  aggregate
purchase price of $1.2 million, $4.8 million, and $2.3 million, respectively.

12.     Revenue

Net Sales by Product

MIMEDX has two classes of products: (1) Advanced Wound Care, or Section 361, products, consisting of its tissue and cord sheet allograft products as
well as certain particulate products regulated under Section 361, and (2) Section 351 products, consisting of the Company’s micronized and certain other
particulate products. Advanced Wound Care is further disaggregated between the Company’s Tissue/Other and Cord products.

F-31

Information regarding the business units responsible for the sale of each of these classes of product can be found in Note 13, Segment Information.

Below is a summary of net sales by each class of product (in thousands):

Advanced Wound Care

Tissue/Other
Cord

Advanced Wound Care
Section 351
(1)
Other
Total

Year Ended December 31,

2022

2021

2020

$

$

241,992  $
23,211 
265,203 
2,379 
259 

216,418  $
23,599 
240,017 
17,610 
988 

267,841  $

258,615  $

192,566 
16,073 
208,639 
31,828 
7,767 

248,234 

(1) “Other” includes the Remaining Contracts and other revenue transactions in the indicated period relating to performance obligations settled prior to October 1, 2019, the date at which the
Company  changed  its  pattern  of  revenue  recognition.  For  all  practical  purposes,  the  Company  is  not  able  to  allocate  these  revenue  transactions  to  different  product  groups.  This  revenue  is
reflected as part of the Wound & Surgical segment.

Net Sales by Site of Service

MIMEDX has three sites of service for its products (1) Hospital settings and wound care clinics, which are stable reimbursement settings in which products
are  used  for  surgical  applications,  (2)  Private  offices,  which  generally  represents  doctors  and  practitioners  with  independent  operations,  and  (3)  Other,
which includes federal facilities, international sales, and other sites of service.

Below is a summary of net sales by site of service (in thousands):

Hospital
Private Office
Other

Total

Year Ended December 31,

2022

2021

2020

$

$

163,206  $
77,158  $
27,477 
267,841  $

154,580  $
75,816  $
28,219 
258,615  $

144,285 
75,638 
28,311 
248,234 

Disaggregation of Revenue by Customer

Prior  to  May  31,  2021,  the  conclusion  of  the  FDA’s  enforcement  discretion  period,  the  Company  evaluated  its  revenue  on  the  basis  of  its  two  primary
distribution  channels:  (1)  direct  to  customers  (healthcare  professionals  and/or  facilities)  (“Direct  Customers”);  and  (2)  sales  through  distributors
(“Distributors”).

Below is a summary of net sales by each customer type (in thousands):

Year Ended December 31,

2022

2021

2020

Direct Customers
Distributors

Total

$

$

261,508  $
6,333 
267,841  $

250,009  $
8,606 
258,615  $

240,690 
7,544 
248,234 

The Company did not have significant foreign operations or a single external customer from which 10% or more of revenues were derived during the years
ended December 31, 2022, 2021, or 2020.

13.     Segment Information

F-32

The Company has two reportable segments: Wound & Surgical and Regenerative Medicine.

• Wound & Surgical  focuses  on  the  Advanced  Wound  Care  and  Surgical  Recovery  markets  through  the  sale  of  the  Company’s  existing  product
portfolio  and  product  development  to  serve  these  primary  end  markets.  Its  platform  technologies  include  tissue  allografts  derived  from  human
placental membrane (EPIFIX®, AMNIOFIX®, and AMNIOEFFECT®), tissue allografts derived from human umbilical cord (EPICORD® and
AMNIOCORD®), and a particulate extracellular matrix derived from human placental disc (AXIOFILL®™). This segment is also responsible for
the international sales of the Company’s Section 351 products.

•

The Regenerative Medicine  business  focuses  solely  on  Regenerative  Medicine  technologies,  specifically  progressing  the  Company’s  placental
biologics platform towards registration as an FDA-approved biological drug. mDHACM is the lead product candidate in its late-stage pipeline
targeted at achieving FDA approval for an indication to help decrease pain and improve function in patients suffering from KOA.

The Company’s Corporate function includes expenses incurred by executive, finance, human resource, information systems, legal, other functions which
are generally shared and whose activities are not specifically identifiable solely to either of the other segments. It also includes amortization of intangible
assets. The Company has another operating segment related to an expiring dental sales contract, reflecting all sales of the Company’s dental product. All
net sales and cost of sales presented in the Corporate & Other columns below relate to this operating segment.

Wound & Surgical net sales reflects sales of the Company’s Advanced Wound Care products (as discussed in Note 12, Revenue), except for sales of the
Company’s dental product. In addition, Wound & Surgical reflects international sales of the Company’s Section 351 products, which represent all Section
351 sales not reflected in Regenerative Medicine.

The Company evaluates the performance of its segments and allocates resources based on segment contribution, defined as net sales less (i) cost of sales,
(ii) selling, general and administrative expense, (iii) research and development expense, and (iv) amortization of intangible assets. Prior period results were
recast on the basis of new operating segments. The only components which comprise loss before income tax provision that are not included in operating
loss are interest expense, net and other expense, net.

Net sales and segment contribution for each reportable segment for the year ended December 31, 2022 were as follows (in thousands):

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Amortization of intangible assets

Segment contribution
Investigation, restatement and related expense
Operating loss
Supplemental information
Depreciation expense
Share-based compensation

Wound & Surgical

Regenerative
Medicine

Corporate & Other

Consolidated

$

$

$
$

264,906  $
44,462 
145,887 
7,836 
— 
66,721  $

—  $
— 
— 
14,993 
— 
(14,993)

1,791  $
6,513  $

165  $
1,158  $

2,935  $
3,854 
62,902 
— 
701 

$

1,389  $
4,995  $

267,841 
48,316 
208,789 
22,829 
701 

12,177 
(24,971)

3,345 
12,666 

Net sales and segment contribution for each reportable segment for the year ended December 31, 2021 were as follows (in thousands):

F-33

 
Wound & Surgical

Regenerative
Medicine

Corporate & Other

Consolidated

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Amortization of intangible assets

Segment contribution
Investigation, restatement and related expense
Impairment of intangible assets
Operating loss
Supplemental information
Depreciation expense
Share-based compensation

$

$

$
$

238,940  $
35,204 
123,583 
5,864 
— 
74,289  $

16,596  $
3,655 
12,910 
11,480 
— 
(11,449)

1,644  $
5,158  $

246  $
1,461  $

3,079  $
4,424 
61,866 
— 
820 

$

2,473  $
8,138  $

258,615 
43,283 
198,359 
17,344 
820 

3,791 
53 
(5,035)

4,363 
14,757 

Net sales and segment contribution for each reportable segment for the year ended December 31, 2020 were as follows (in thousands):

Wound & Surgical

Regenerative
Medicine

Corporate & Other

Consolidated

Net sales
Cost of sales
Selling, general and administrative expense
Research and development expense
Amortization of intangible assets

Segment contribution

Investigation, restatement and related expense
Impairment of intangibles

Operating loss
Supplemental information
Depreciation expense
Share-based compensation

$

$

$
$

213,489  $
30,185 
103,039 
3,979 
— 
76,286  $

32,362  $
5,856 
17,546 
7,736 
— 
1,224 

1,755  $
4,373  $

451  $
1,256  $

2,383  $
3,289 
60,437 
— 
1,073 

$

3,576  $
9,728  $

248,234 
39,330 
181,022 
11,715 
1,073 

59,465 
1,027 
(45,398)

5,782 
15,357 

The  Company  does  not  allocate  any  assets  to  the  reportable  segments.  No  asset  information  is  reported  or  disclosed  to  the  CODM  in  the  financial
information for each segment.

14.    Income Taxes

Deferred  income  taxes  reflect  the  net  tax  effects  of  temporary  differences  between  the  carrying  amounts  of  assets  and  liabilities  for  financial  reporting
purposes and the amounts used for income tax purposes.

Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands):

F-34

 
 
Deferred Tax Assets:

Net operating loss

Research and development and other tax credits

Interest limitation carry forward

Accrued expenses

Capitalized research and development expenditures

Share-based compensation
Allowance for doubtful accounts
Lease liabilities
Sales return and allowances
Accrued settlement costs

Other

Deferred Tax Liabilities:

Prepaid expenses
Right of use asset
Intangible assets

Property and equipment

Net Deferred Tax Assets

Less: Valuation allowance

December 31,

2022

2021

$

23,719  $

23,333 

8,384 

4,898 

3,501 

3,586 

3,145 
1,033 
962 
163 
50 

885 

(1,400)
(867)
(351)

(77)

47,631 
(47,631)

6,297 

3,970 

3,385 

— 

4,220 
601 
1,277 
195 
235 

1,115 

(1,337)
(1,197)
(263)

(705)

41,126 
(41,126)

— 

Net Deferred Tax Assets after Valuation Allowance

$

—  $

The reconciliation of the federal statutory income tax rate of 21% to the effective rate is as follows:

Federal statutory rate
Tax credits
Employee retention credit
NOL carryback rate differential
Meals and entertainment

State taxes, net of federal benefit
Uncertain tax positions
Nondeductible compensation

Deferred tax adjustments
Share-based compensation
Valuation allowance

Other

Effective tax rate

Year ended December 31,

2022

2021

2020

21.00 %
2.01 %
3.37 %
— %

(1.13)%

4.53 %
0.02 %

(13.77)%

14.63 %
23.31 %

(52.70)%

(3.73)%
(2.46)%

21.00 %
0.32 %
— %
10.99 %

(0.50)%

(0.20)%
0.24 %

(0.89)%

— %
(1.24)%

(8.14)%

(1.66)%
19.92 %

21.00 %
5.85 %
— %
— %

(0.10)%

(0.55)%
(0.58)%

(2.22)%

(2.89)%
(4.03)%

(17.59)%

0.42 %
(0.69)%

F-35

Current and deferred income tax (benefit) expense is as follows (in thousands):

Current:

Federal
State
Total current

Deferred:
Federal
State

Total deferred

Total expense (benefit)

2022

Year Ended December 31,
2021

2020

$

$

—  $
206 
206 

— 
— 
— 

91  $
156 
247 

— 
— 
— 

(12,418)
159 
(12,259)

— 
— 
— 

206  $

247  $

(12,259)

Certain items of income and expense are not reported in tax returns and financial statements in the same year. The tax effects of such temporary differences
are reported as deferred income tax assets and liabilities. The measurement of deferred tax assets is reduced, if necessary, by the amount of any tax benefit
that,  based  on  available  evidence,  is  not  expected  to  be  realized.  The  Company  establishes  a  valuation  allowance  for  deferred  tax  assets  for  which
realization is not more likely than not. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view
of the future realization of deferred tax assets.

A  valuation  allowance  of  $47.6  million  and  $41.1  million  was  recorded  against  the  deferred  tax  asset  balance  as  of  December  31,  2022  and  2021,
respectively. The Company maintains a full valuation allowance because it is not more likely than not the deferred tax assets will be utilized based on all
available positive and negative evidence. In the event that the weight of the evidence changes in the future, any reduction in the valuation allowance would
result in an income tax benefit.

At December 31, 2022 and 2021, the Company had income tax net operating loss (“NOL”) carryforwards for federal and state purposes of $84.9 million
and $109.8 million and $84.2 million and $104.2 million, respectively. A portion of the Company’s NOLs and tax credits are subject to annual limitations
due  to  ownership  change  limitations  provided  by  Internal  Revenue  Code  Section  382.  All  of  the  Company’s  federal  NOL  carryforwards  have  been
generated since 2018 and will carry forward indefinitely. The majority of the Company’s state NOL carryforwards will expire between 2027 and 2042; the
remainder of the Company’s state NOLs will carryforward indefinitely. As of December 31, 2022, the Company has recorded a deferred tax asset for both
federal and state NOL carryforwards of approximately $17.8 million and $5.9 million, respectively. As of December 31, 2021, the Company has recorded a
deferred tax asset for federal and state NOL carryforwards of $17.7 million and approximately $5.6 million, respectively.

Unrecognized Tax Benefits

The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands) included in other liabilities in the consolidated
balance sheets:

Unrecognized tax benefits - January 1
Increases - tax positions in current period
Increases - tax positions in prior period
Decreases in prior year positions

Unrecognized tax benefits - December 31

2022

2021

2020

$

$

469  $
98 
78 
— 
645  $

477  $
20 
— 
(28)
469  $

627 
— 
— 
(150)
477 

Included in the balance of unrecognized tax benefits are tax benefits of $0.6 million and $0.5 million for the years ended December 31, 2022 and 2021,
respectively, that, if recognized, would affect the effective tax rate.

F-36

The  Company  recognizes  accrued  interest  related  to  unrecognized  tax  benefits  and  penalties  as  income  tax  expense.  Related  to  the  unrecognized  tax
benefits  noted  above,  the  Company  accrued  $0.0  million  of  interest  during  the  years  ended  December  31,  2022  and  2021.  The  Company  accrued  and
recognized $0.1 million of interest during 2020.

The Company is subject to taxation in the U.S. and various state jurisdictions. As of December 31, 2022, the Company’s tax returns for 2019 through 2022
generally remain open for exam by taxing jurisdictions. Additional prior years may be open to the extent attributes are being carried forward to an open tax
year.

CARES Act

On  March  27,  2020,  the  U.S.  government  enacted  the  Coronavirus  Aid,  Relief,  and  Economic  Security  Act  (the  “CARES  Act”)  which,  among  other
changes, eliminated the taxable income limit for certain net operating losses (“NOL”), allowed businesses to carry back NOLs arising in 2018, 2019, and
2020 to the five prior years, and provided a payment delay of employer payroll taxes during 2020 after the date of enactment. These provisions allowed the
Company to carry back federal tax losses related to 2018 and 2019. The Company recorded net tax receivable totaling $11.3 million in 2020 related to these
provisions, of which $1.2 million had been collected as of December 31, 2020, and another $9.2 million was collected during the year ended December 31,
2021. The remaining $0.9 million is reflected in income tax receivable on the consolidated balance sheets as of December 31, 2022 and 2021.

The Company had a deferred payment of $2.2 million in employer taxes that was included as part of accrued compensation on the consolidated balance
sheet as of December 31, 2021. $1.1 million was paid in January 2022 and the remaining balance paid in December 2022.

15.    Supplemental Disclosure of Cash Flow and Non-Cash Investing and Financing Activities

Selected cash payments, receipts, and non-cash activities are as follows (in thousands):

Cash paid for interest
Income taxes paid
Cash paid for operating leases
Non-cash activities:

Purchases of equipment included in accounts payable
Lease right of use asset and liability
Deemed dividends of Series B Preferred Stock
Fair value of non-cash consideration received for option exercise
Note receivable for sale of property and equipment
Amendment fee on previous term loan
Deferred financing costs

16.    Commitments and Contingencies

Contractual Commitments

Years Ended December 31,
2021

2022

2020

$

4,569  $
181 
1,567 

4,327  $
169 
1,522 

417 
(37)
— 
— 
— 
— 
— 

8 
2,251 
926 
380 
75 
— 
— 

7,456 
208 
1,569 

1,062 
1,169 
32,028 
922 
— 
722 
53 

The  Company  has  commitments  for  meeting  spaces,  generally  for  hotel  and  conference  spaces  for  company  functions.  These  commitments  generally
contain renewal options.

The estimated meeting space commitments are as follows (in thousands):

Year ending December 31,
2023
2024

Total

F-37

Meeting Space
Commitments

$

$

989 
394 
1,383 

 
Separation Agreement with Timothy R. Wright

On  September  15,  2022,  the  Company  entered  into  a  Separation  Agreement  and  General  Release  with  Timothy  R.  Wright,  the  former  Chief  Executive
Officer of the Company (the “Separation Agreement”). Pursuant to the terms of the Separation Agreement and Mr. Wright’s general release of all claims
against the Company, the Company will pay Mr. Wright a total of $3.1 million in cash in a series of installments through September 2024. The terms of the
severance benefits provided in the Separation Agreement were the same as those provided for in the original employment Letter Agreement between Mr.
Wright and the Company dated April 8, 2019. The $3.1 million was recorded as part of selling, general and administrative expense on the consolidated
statement of operations for the year ended December 31, 2022.

Of the $3.1 million, $1.9 million is reflected in accrued compensation and $1.2 million is reflected in other liabilities in the consolidated balance sheet as of
December 31, 2022. No payments were required to be made to Mr. Wright under the terms of the Separation Agreement during the year ended December
31, 2022.

Nordic Agreement

In  June  2022,  the  Company  entered  into  a  collaboration  agreement  (the  “Nordic  Agreement”)  with  Nordic  Bioscience  Clinical  Development  A/S
(“NBCD”) to provide full operational support for the Company’s upcoming Knee Osteoarthritis (“KOA”) clinical trial program. As part of the agreement,
NBCD will perform site selection and monitoring, manage patient recruitment and enrollment, data management, statistical analysis and reporting activities
for the duration of the trial. Under the terms of the Nordic Agreement, as of December 31, 2022, the Company was obligated to pay $13.3 million upon the
achievement of specified milestones over the course of the clinical trial. The milestones are based upon various factors including, but not limited to, site
selection and enrollment, patient enrollment, patient completion, and certain other activities related to clinical trial operations. These milestone payments
are revised semi-annually based on fluctuations in the consumer price index. The Company has the ability to terminate the Nordic Agreement with 30 days
written  notice  to  NBCD.  At  such  time,  the  Company  would  be  required  to  pay  for  services  performed  through  the  date  of  termination  and  any  non-
cancelable obligations.

In  addition  to  the  $13.3  million,  the  Company  will  reimburse  NBCD  for  actual  expenses  incurred  related  to  third-party  vendors  to  be  contracted  and
managed by NBCD.

As  of  December  31,  2022,  the  Company  has  paid  $2.0  million  under  the  Nordic  Agreement,  relating  to  milestones  which  have  been  achieved  from
inception through that date. During the year ended December 31, 2022, the Company recognized $1.0 million of expense related to the Nordic Agreement.
This amount is included as part of research and development expense in the consolidated statement of operations. The remaining $1.0 million is reflected in
prepaid expenses on the consolidated balance sheet as of December 31, 2022.

In January 2023, the Company executed a change order to the Nordic Agreement. Refer to Note 21, Subsequent Events, for more details.

Turn Agreement

On  December  7,  2022,  the  Company  acquired  intellectual  property  rights  pursuant  to  a  Platform  Intellectual  Property  License  (the  “Turn Agreement”)
with  Global  Health  Solutions,  Inc.  (d.b.a.  Turn  Therapeutics  or  “Turn”).  The  Turn  Agreement  provided  MIMEDX  with  an  exclusive,  worldwide,  sub-
licensable license to use Turn’s proprietary antimicrobial technology platform (PermaFusion®) to develop antimicrobial line extensions and new products.
In addition, the Turn Agreement granted the Company the commercial rights to Turn’s placental collagen matrix product, FleX™ AM (“FleX”), contingent
upon Turn’s receipt of FDA 510(k) clearance and other conditions.

During the year ended December 31, 2022, the Company paid $1.0 million upon the execution of the Turn Agreement to acquire the license. This amount
was capitalized and is included as part of intangible assets, net, on the consolidated balance sheet as of December 31, 2022. The Company is obligated to
make additional payments upon the meeting of regulatory and product commercial milestones, including $9.6 million if and when Turn receives 510(k)
clearance from the FDA for FleX. This amount is not reflected in the consolidated balance sheet as of December 31, 2022.

Litigation and Regulatory Matters

In the ordinary course of business, the Company and its subsidiaries may be a party to pending and threatened legal, regulatory, and governmental actions
and  proceedings  (including  those  described  below).  In  view  of  the  inherent  difficulty  of  predicting  the  outcome  of  such  matters,  particularly  where  the
plaintiffs or claimants seek very large or indeterminate damages or where the matters present novel legal theories or involve a large number of parties, the
Company generally cannot predict what the

F-38

eventual outcome of the pending matters will be, what the timing of the ultimate resolution of these matters will be, or what the eventual recovery, loss,
fines or penalties related to each pending matter may be.

In accordance with applicable accounting guidance, the Company accrues a liability when those matters present loss contingencies that are both probable
and estimable. The Company's financial statements at December 31, 2022 reflect the Company's current best estimate of probable losses associated with
these  matters,  including  costs  to  comply  with  various  settlement  agreements,  where  applicable.  As  of  December  31,  2022,  the  Company  had  reserved
$0.2 million related to expected settlement costs related to legal matters.

The  Company  paid  $0.7  million  toward  the  resolution  of  legal  matters  involving  the  Company  during  the  year  ended  December  31,  2022.  In  addition,
insurance providers paid $0.6 million on the Company’s behalf to settle legal matters.

The Company paid $6.7 million to settle legal proceedings during 2021. In addition, $1.1 million was paid on the Company’s behalf through an insurance
provider  during  2021  relating  directly  to  settlement  matters.  In  addition,  during  2021,  the  Company  received  funds  from  certain  director  and  officer
insurance policies for previously-incurred legal expenses under the Company’s indemnification agreements. These funds were recognized as a reduction to
investigation, restatement and related expense on the consolidated statement of operations.
The Company paid $7.4 million to settle legal proceedings during 2020. In addition, $3.5 million was paid on the Company’s behalf through an insurance
provider during 2020.

The actual costs of resolving these matters may be in excess of the amounts reserved.

Securities Class Action

On January 16, 2019, the United States District Court for the Northern District of Georgia entered an order consolidating two purported securities class
actions (MacPhee v. MiMedx Group, Inc., et al. filed February 23, 2018 and Kline v. MiMedx Group, Inc., et al. filed February 26, 2018). The order also
appointed  Carpenters  Pension  Fund  of  Illinois  (“CPFI”)  as  lead  plaintiff.  On  May  1,  2019,  CPFI  filed  a  consolidated  amended  complaint,  naming  as
defendants the Company, Michael J. Senken, Parker H. “Pete” Petit, William C. Taylor, Christopher M. Cashman and Cherry Bekaert & Holland LLP. The
amended  complaint  alleged  violations  of  Section  10(b)  of  the  Securities  Exchange  Act  of  1934,  as  amended  (the  “Exchange  Act”),  Rule  10b-5
promulgated thereunder, and Section 20(a) of the Exchange Act. It asserted a class period of March 7, 2013 through June 29, 2018. Following the filing of
motions  to  dismiss  by  the  various  defendants,  CPFI  was  granted  leave  to  file  an  amended  complaint.  CPFI  filed  its  amended  complaint  against  the
Company, Michael J. Senken, Parker H. Petit, William C. Taylor, and Cherry Bekaert & Holland (Christopher Cashman was dropped as a defendant) on
March 30, 2020; defendants filed motions to dismiss on May 29, 2020. On March 25, 2021, the Court granted defendants’ respective motions to dismiss,
finding that CPFI lacked standing to bring the underlying claims and also could not establish loss causation because it sold all of its shares in MIMEDX
prior to any corrective disclosures, and dismissed the case. On April 22, 2021, CPFI filed a motion for reconsideration of the dismissal and for leave to
amend to add a new plaintiff to attempt to cure the standing and loss causation issues. The Company opposed CPFI’s motions and the hearing on the same
was held on September 24, 2021.

On  January  28,  2022,  the  Court  denied  CPFI’s  motion  to  reconsider  and  motion  to  substitute  class  representative.  On  February  25,  2022,  CPFI  filed  a
Notice of Appeal in the 11th Circuit Court of Appeals. Oral arguments were held on January 24, 2023.

Welker v. MiMedx, et. al.

On November 4, 2022, Troy Welker and Min Turner, former optionholders of the Company, brought a lawsuit in Fulton County State Court against the
Company, former directors Terry Dewberry and Charles Evans, and former officers Parker H. “Pete” Petit, William C. Taylor, and Michael Senken alleging
violations of the Georgia Racketeer Influenced and Corrupt Organizations (“RICO”) Act against all defendants and conspiracy to violate the Georgia RICO
Act and breach of fiduciary duty against the individual defendants.

The Company is defending against the allegations and removed the case to the United States District Court for the Northern District of Georgia. Plaintiffs
have filed a motion to remand back to state court, which is currently pending.

F-39

Investigations

On February 8, 2021, the Company received a subpoena issued by the Department of Defense Office of Inspector General seeking records regarding the
sales  of  the  Company’s  micronized  and  other  products  to  federal  medical  facilities  and  federal  contracting  offices,  including  those  operated  by  the
Department of Veterans Affairs or the Department of Defense. The subpoena also seeks information regarding the Company’s communications with the
FDA regarding its products. The Company understands that the Office of the United States Attorney for the Western District of Washington Civil Division
is  overseeing  the  investigation,  which  is  being  conducted  principally  by  agents  employed  by  the  Department  of  the  Army  Criminal  Investigation
Command.  The  Company  is  cooperating  with  the  government’s  investigation  and  at  this  time  the  Company  is  unable  to  predict  the  outcome  of  the
investigation, including whether the investigation will result in any action or proceeding against the Company.

Former Employee Litigation and Related Matters

On January 12, 2021, the Company filed suit in the Circuit Court of the Eleventh Judicial District in and for Miami-Dade County, Florida (MiMedx Group,
Inc.  v.  Petit,  et.  al.)  against  its  former  CEO,  Parker  H.  “Pete”  Petit,  and  its  former  COO,  William  C.  Taylor,  seeking  a  determination  of  its  rights  and
obligations under indemnification agreements with Petit and Taylor following a federal jury’s guilty verdict against Petit for securities fraud and Taylor for
conspiracy to commit securities fraud. The Company is seeking a declaratory judgment that it is not obligated to indemnify or advance expenses to Petit
and Taylor in connection with certain cases to which Petit and Taylor are parties and also seeking to recoup amounts previously paid on behalf of Petit and
Taylor in connection with such cases. On April 22, 2021, Petit and Taylor filed an answer and asserted counterclaims against the Company alleging breach
of their indemnification agreements, breach of the covenant of good faith and fair dealing with respect to their indemnification agreements, and seeking a
declaration that the Company remains obligated to indemnify and advance fees in connection with certain cases. Petit and Taylor simultaneously filed a
motion  seeking  to  compel  the  Company  to  advance  and  reinstate  its  payments  of  Petit  and  Taylor’s  legal  expenses.  The  Company  opposed  Petit  and
Taylor’s  motion  and  a  hearing  was  set  for  June  23,  2021.  At  the  joint  request  of  the  parties,  the  hearing  was  cancelled  to  allow  the  parties  to  attend  a
mediation to attempt a resolution of this matter; such mediation was held on August 11, 2021.

Following the mediation, the Company and Taylor reached an agreement to settle the matter between them. Negotiations with Petit are ongoing.

Other Matters

Under the Florida Business Corporation Act and agreements with its current and former officers and directors, the Company is obligated to indemnify its
current and former officers and directors who are made party to a proceeding, including a proceeding brought by or in the right of the corporation, with
certain exceptions, and to advance expenses to defend such matters. The Company has already borne substantial costs to satisfy these indemnification and
expense advance obligations and may continue to do so in the future.

In addition to the matters described above, the Company is a party to a variety of other legal matters that arise in the ordinary course of the Company’s
business, none of which is deemed to be individually material at this time.

Previously-Settled Matters

The  matters  discussed  below  have  been  settled  with  the  counterparty  and  their  resolution  has  been  disclosed  in  previously-issued  financial  statements.
There are no contingent or continuing obligations associated with these matters.

Shareholder Derivative Suits

On December 6, 2018, the United States District Court for the Northern District of Georgia entered an order consolidating three shareholder derivative
actions (Evans v. Petit, et al. filed September 25, 2018, Georgalas v. Petit, et al. filed September 27, 2018, and Roloson v. Petit, et al. filed October 22,
2018) that had been filed in the Northern District of Georgia. On January 22, 2019, plaintiffs filed a verified consolidated shareholder derivative complaint.
The consolidated action sets forth claims of breach of fiduciary duty, corporate waste and unjust enrichment against certain former officers, and certain
current and former directors, of the Company: Parker H. Petit, William C. Taylor, Michael J. Senken, John E. Cranston, Alexandra O. Haden, Joseph G.
Bleser,  J.  Terry  Dewberry,  Charles  R.  Evans,  Larry  W.  Papasan,  Luis  A.  Aguilar,  Bruce  L.  Hack,  Charles  E.  Koob,  Neil  S.  Yeston  and  Christopher  M.
Cashman. The allegations generally involve claims that the defendants breached their fiduciary duties by causing or allowing the Company to misrepresent
its financial statements as a result of improper revenue recognition. The Company filed a motion to stay on February 18, 2019, pending the completion of
the investigation by the Company’s Special Litigation Committee. The Special Litigation Committee completed its investigation relating to this action and
filed an executive summary of its findings with the Court on July 1, 2019. The parties (together with parties from the

F-40

Hialeah derivative lawsuit, the Nix and Demaio derivative lawsuit, and the Murphy derivative lawsuit, each described below) held a mediation on February
11, 2020. Following continued discussions, on May 1, 2020, the parties notified the Court that plaintiffs and the Company had reached an agreement in
principle to settle this consolidated derivative action, which settlement also encompasses all claims asserted in the Hialeah derivative lawsuit, the Nix and
Demaio derivative lawsuit, and the Murphy derivative lawsuit. The hearing on final approval was held on December 21, 2020 and the Court entered an
Order granting final approval of the settlement the same day.

On October 29, 2018, the City of Hialeah Employees Retirement System (“Hialeah”) filed a shareholder derivative complaint in the Circuit Court for the
Second  Judicial  Circuit  in  and  for  Leon  County,  Florida  (the  “Florida Court”).  The  complaint  alleges  claims  for  breaches  of  fiduciary  duty  and  unjust
enrichment against certain former officers, and certain current and former directors, of the Company: Parker H. Petit, William C. Taylor, Michael J. Senken,
John E. Cranston, Alexandra O. Haden, Joseph G. Bleser, J. Terry Dewberry, Charles R. Evans, Bruce L. Hack, Charles E. Koob, Larry W. Papasan, and
Neil  S.  Yeston.  The  allegations  generally  involve  claims  that  the  defendants  breached  their  fiduciary  duties  by  causing  or  allowing  the  Company  to
misrepresent its financial statements as a result of improper revenue recognition. The Company moved to stay the action on February 7, 2019, to allow the
prior-filed consolidated derivative action in the Northern District of Georgia to be resolved first and to allow the Company’s Special Litigation Committee
time  to  complete  its  investigation.  The  Company  also  filed  a  motion  to  dismiss  on  April  8,  2019.  As  discussed  above,  the  plaintiff  participated  in  the
mediation  that  took  place  in  connection  with  the  prior-filed  consolidated  derivative  action  in  the  Northern  District  of  Georgia  and  is  a  party  to  the
agreement  settling  that  consolidated  derivative  action.  In  accordance  with  the  terms  of  the  settlement,  Hialeah  filed  a  motion  for  leave  to  dismiss  its
derivative action with prejudice on January 4, 2021.

On May 15, 2019, two individuals purporting to be shareholders of the Company filed a shareholder derivative complaint in the Superior Court for Cobb
County, Georgia. (Nix and Demaio v. Evans, et al.) The complaint alleges claims for breaches of fiduciary duty, corporate waste and unjust enrichment
against  certain  current  and  former  directors  and  officers  of  the  Company:  Parker  H.  Petit,  William  C.  Taylor,  Michael  J.  Senken,  John  E.  Cranston,
Alexandra O. Haden, Chris Cashman, Lou Roselli, Mark Diaz, Charles R. Evans, Luis A. Aguilar, Joseph G. Bleser, J. Terry Dewberry, Bruce L. Hack,
Charles E. Koob, Larry W. Papasan and Neil S. Yeston. The allegations generally involved claims that the defendants breached their fiduciary duties by
causing or allowing the Company to misrepresent its financial statements as a result of improper revenue recognition. The Court ordered this matter stayed
pending the resolution of the consolidated derivative suit pending in the Northern District of Georgia. As discussed above, the plaintiffs participated in the
mediation  that  took  place  in  connection  with  the  prior-filed  consolidated  derivative  action  in  the  Northern  District  of  Georgia  and  are  a  party  to  the
agreement settling that consolidated derivative action. In accordance with the terms of the settlement, plaintiffs filed a notice of settlement and voluntary
dismissal with prejudice on January 13, 2021.

On August 12, 2019, John Murphy filed a shareholder derivative complaint in the United States District Court for the Southern District of Florida (Murphy
v. Petit, et al.). The complaint alleged claims for breaches of fiduciary duty and unjust enrichment against certain former officers, and certain current and
former directors, of the Company: Parker H. Petit, William C. Taylor, Michael J. Senken, John E. Cranston, Alexandra O. Haden, Charles R. Evans, Luis
A. Aguilar, Joseph G. Bleser, J. Terry Dewberry, Bruce L. Hack, Charles E. Koob, Larry W. Papasan and Neil S. Yeston. The allegations generally involve
claims  that  the  defendants  breached  their  fiduciary  duties  by  causing  or  allowing  the  Company  to  misrepresent  its  financial  statements  as  a  result  of
improper revenue recognition. The Company filed a motion to transfer this action to the Northern District of Georgia. Prior to resolution of that motion, the
plaintiff voluntarily dismissed this action without prejudice. As discussed above, the plaintiff participated in the mediation that took place in connection
with the prior-filed consolidated derivative action in the Northern District of Georgia and is a party to the agreement settling that consolidated derivative
action. Pursuant to the terms of the settlement, this action is deemed dismissed with prejudice.

Qui Tam Matters

On January 19, 2017, a former employee of the Company filed a qui tam False Claims Act complaint in the United States District Court for the District of
South  Carolina  (United  States  of  America,  ex  rel.  Jon  Vitale  v.  MiMedx  Group,  Inc.)  alleging  that  the  Company’s  donations  to  the  patient  assistance
program,  Patient  Access  Network  Foundation,  violated  the  Anti-Kickback  Statute  and  resulted  in  submission  of  false  claims  to  the  government.  The
government declined to intervene and the complaint was unsealed on August 10, 2018. The Company filed a motion to dismiss on October 1, 2018. The
Company’s motion to dismiss was granted in part and denied in part on May 15, 2019. The parties have reached an agreement to resolve this matter.

On January 20, 2017, two former employees of the Company, filed a qui tam False Claims Act complaint in the United States District Court for the District
of Minnesota (Kruchoski et. al. v. MiMedx Group, Inc.). An amended complaint was filed on January 27, 2017. The operative complaint alleges that the
Company  failed  to  provide  truthful,  complete  and  accurate  information  about  the  pricing  offered  to  commercial  customers  in  connection  with  the
Company’s Federal Supply Schedule contract. On May 7, 2019, the Department of Justice (“DOJ”) declined to intervene, and the case was unsealed. In
April 2020,

F-41

without admitting the allegations, the Company agreed to pay $6.5 million to the DOJ to resolve this matter. This amount was paid during the year ended
December 31, 2020.

Former Employee Matters

In December 2019, MiMedx received notice of a complaint filed in July 2018 with the Occupational Safety and Health Administration (“OSHA”) section
of  the  Department  of  Labor  (“DOL”)  by  Thomas  Tierney,  a  former  Regional  Sales  Director,  against  MiMedx  and  the  referenced  individuals,  Tierney v.
MiMedx Group, Inc., Parker Petit, William Taylor, Christopher Cashman, Thornton Kuntz, Jr. and Alexandra Haden, DOL No. 4-5070-18-243. Mr. Tierney
alleged that he was terminated from MiMedx in retaliation for reporting concerns about revenue recognition practices, compliance issues, and the corporate
culture, in violation of the anti-retaliation provisions of the Sarbanes-Oxley Act. The parties settled this matter and OSHA dismissed the complaint on May
20, 2020.

Intellectual Property Litigation

The NuTech Action

On March 2, 2015, the Company filed a patent infringement lawsuit against NuTech Medical, Inc. (“NuTech”) and DCI Donor Services, Inc. (“DCI”) in
the United States District Court for the Northern District of Alabama (MiMedx Group, Inc. v. NuTech Medical, Inc. et. al.). The Company has alleged that
NuTech  and  DCI  infringed  and  continue  to  infringe  on  the  Company’s  patents  through  the  manufacture,  use,  sale  and/or  offering  of  their  tissue  graft
product. The Company also asserted that NuTech knowingly and willfully made false and misleading representations about its products to customers and
prospective customers. The Company is seeking permanent injunctive relief and unspecified damages. The case was stayed pending the restatement of the
Company’s financial statements. Since the Company has completed its restatement, the case resumed. The parties reached a settlement in the matter and the
case was dismissed with prejudice.

The Osiris Action

On  February  20,  2019,  Osiris  Therapeutics,  Inc.  (“Osiris”)  refiled  its  trade  secret  and  breach  of  contract  action  against  the  Company  (which  had  been
dismissed in a different forum) in the United States District Court for the Northern District of Georgia (Osiris Therapeutics, Inc. v. MiMedx Group, Inc.).
The parties reached a settlement in the matter and the case was dismissed with prejudice on October 26, 2020.

17.    401(k) Plan

The Company has a 401(k) plan (the “401(k) Plan”) covering all employees who have completed one month of service. Under the 401(k) Plan, participants
could defer up to 90% of their eligible wages to a maximum of $20,500 per year (annual limit for 2022). Employees age 50 or over in 2022 could make
additional pre-tax contributions up to $6,500. In 2022 and 2021, the Company matched 50% of employee contributions up to 8% of the employee’s eligible
compensation.  In  2020,  the  Company  matched  50%  of  employee  contributions  up  to  5%  of  the  employee’s  eligible  compensation.  The  matching
contribution for the years ended December 31, 2022, 2021, and 2020 was $3.3 million, $2.7 million, and $1.5 million, respectively.

18.     Related Party Transactions

The Company has employed Thomas Koob as its Chief Scientific Officer (a non-executive officer) since 2006. Thomas Koob is the brother of a former
director, Charles Koob. Subsequent to the Company’s employment of Thomas Koob, Charles Koob was appointed as a director of the Company in March
2008. Charles Koob's term as a Director expired at the 2020 Annual Meeting held on November 20, 2020. In 2020, the Company paid Thomas Koob an
annual salary of $0.2 million and provided equity, incentive compensation and other compensation of $0.3 million.

The Company had no related party transactions for the years ended December 31, 2022 or 2021.

19.    Restructuring

2018 Restructuring

Set forth below are disclosures relating to restructuring initiatives that resulted in material cash expenditures during the year ended December 31, 2020.
Employee retention and certain other employee benefit-related costs related to the Company’s restructuring were expensed ratably over an agreed-upon
service period. One-time employee separation and related employee benefit costs were generally expensed as incurred.

F-42

In  December  2018,  the  Company  announced  a  reduction  of  the  Company’s  workforce  by  approximately  240  full-time  employees,  or  24%  of  its  total
workforce, of which approximately half were sales personnel as part of the plans to implement a broad-based organizational realignment, cost reduction
and efficiency program to better ensure the Company’s cost structure was appropriate given its revenue expectations.

The Company’s restructuring program concluded in 2020. All obligations related to the Company’s restructuring program were settled as of December 31,
2020.

Changes to this liability during the year ended December 31, 2020 was as follows (in thousands):

Liability balance as of December 31, 2019

Expenses

Cash distributions

Liability balance as of December 31, 2020

$

3,561 
— 

(3,561)

— 

2022 Reorganization

On  September  2,  2022,  the  Company  separated  from  its  Chief  Executive  Officer.  Subsequent  to  this  event,  the  Company  realigned  the  organization  to
improve profitability. As part of these efforts, the Company incurred $2.0 million of one-time employee separation costs. Of this amount, $0.6 million was
outstanding as of December 31, 2022. The remaining amount is reflected as part of accrued compensation on the consolidated balance sheet as of that date.

20.    Government Assistance

Employee Retention Credit

The CARES Act provided an employee retention credit (“ERC”), which was a refundable tax credit against certain payroll taxes. Upon determination that
the Company overcame the barriers required to receive the credit, the Company qualified and filed to claim the ERC. The Company reflected the ERC as a
reduction to the respective captions on the consolidated statements of operations associated with the employees to which the payroll tax benefit related. For
the  year  ended  December  31,  2021,  the  Company  recorded  $1.6  million  as  a  reduction  to  selling,  general  and  administrative  expense.  Of  this  amount,
$1.4 million and $1.6 million were reflected as part of other current assets in the consolidated balance sheets as December 31, 2022 and 2021, respectively.
During year ended December 31, 2022, the Company received $0.2 million relating to the ERC.

21.     Subsequent Events

Nordic Agreement Change Order

On  January  24,  2023,  the  Company  executed  a  change  order  to  the  Nordic  Agreement  (the  “Change Order”),  primarily  to  reflect  additional  elements
required in conducting the trial. The Change Order modified the scope of NBCD’s responsibilities under the Nordic Agreement, shifting certain activities to
other vendors to be administered by NBCD and certain other activities to MIMEDX. These responsibilities primarily related to areas of patient recruitment
and screening and statistical analysis, among other areas of the trial. Pursuant to the Change Order, the total payments owed to NBCD relating to NBCD’s
responsibilities decreased from $13.3 million to $10.2 million.

Hiring of Chief Executive Officer

On  January  27,  2023,  the  Board  of  Directors  appointed  Joseph  H.  Capper  to  serve  as  Chief  Executive  Officer.  The  Company  entered  into  a  Letter
Agreement with Mr. Capper that included, among other things, a grant of 3,300,000 PSUs and a grant of a non-qualified stock option (the “Option”) for
3,600,000 shares of the Company’s common stock.

The PSUs vest over a four-year performance period ending December 31, 2026 based upon the achievement of specified performance conditions, up to a
maximum of 200% of the granted PSUs, and subject to Mr. Capper’s continued employment. The Option vests over a four-year period ending January 31,
2027 contingent upon the achievement of share price performance goals and subject to Mr. Capper’s continued employment. Mr. Capper will is eligible to
vest  in  25%  of  the  Option  on  or  after  each  of  the  first  four  anniversary  dates  subsequent  to  the  date  of  grant,  provided  certain  share  price  performance
targets are achieved at any point during the four-year vesting period.

F-43

In concert with the hiring of Mr. Capper’s, K. Todd Newton stepped down and ceased to serve as Interim Chief Executive Officer. Upon Mr. Capper’s
hiring,  200,000  RSUs  granted  to  Mr.  Newton  pursuant  to  the  Interim  Executive  Employment  Agreement  between  him  and  the  Company  vested
immediately. Mr. Newton remains on the Board of Directors.

Schedule II Valuation and Qualifying Accounts

MIMEDX GROUP, INC. AND SUBSIDIARIES
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS
Years ended December 31, 2022, 2021 and 2020 (in thousands)

Balance at 
Beginning of
Year

Additions charged to
Expense or Revenue

Deductions 
and write-offs

Balance at
 End of Year

For the year ended December 31, 2022
Allowance for product returns

For the year ended December 31, 2021
Allowance for product returns

For the year ended December 31, 2020
Allowance for product returns

2,549  $

2,449  $

(2,304) $

2,694 

2,321  $

2,508  $

(2,280) $

2,549 

4,115  $

705  $

(2,499) $

2,321 

$

$

$

F-44

 
 
 
 
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. Controls and Procedures

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and the Board of Directors of MiMedx Group, Inc.

Opinion on Internal Control over Financial Reporting

We have audited the internal control over financial reporting of MiMedx Group, Inc. and subsidiaries (the “Company”) as of December 31, 2022, based on
criteria  established  in  Internal  Control  —  Integrated  Framework  (2013)  issued  by  the  Committee  of  Sponsoring  Organizations  of  the  Treadway
Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December
31, 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated
financial statements as of and for the year ended December 31, 2022, of the Company and our report dated February 28, 2023, expressed an unqualified
opinion on those financial statements.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of
internal control over financial reporting, included in the accompanying Item 9A Managements Report on Internal Control over Financial Reporting. Our
responsibility  is  to  express  an  opinion  on  the  Company’s  internal  control  over  financial  reporting  based  on  our  audit.  We  are  a  public  accounting  firm
registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance  about  whether  effective  internal  control  over  financial  reporting  was  maintained  in  all  material  respects.  Our  audit  included  obtaining  an
understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating
effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation  of  financial  statements  in  accordance  with  generally  accepted  accounting  principles,  and  that  receipts  and  expenditures  of  the  company  are
being  made  only  in  accordance  with  authorizations  of  management  and  directors  of  the  company;  and  (3)  provide  reasonable  assurance  regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial
statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness  to  future  periods  are  subject  to  the  risk  that  controls  may  become  inadequate  because  of  changes  in  conditions,  or  that  the  degree  of
compliance with the policies or procedures may deteriorate.

/s/ Deloitte & Touche LLP
Atlanta, Georgia
February 28, 2023

79

Evaluation of Disclosure Controls and Procedures

Management  maintains  a  set  of  disclosure  controls  and  procedures  (as  defined  in  Rules  13a-15(e)  and  15d-15(e)  under  the  Securities  Exchange  Act  of
1934, as amended (the “Exchange Act”), designed to ensure that information required to be disclosed by us in reports that we file or submit under the
Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms, and that such information is
accumulated and communicated to management, including our CEO and CFO, to allow for timely decisions regarding required disclosure.

An evaluation of the effectiveness of the design and operation of our disclosure controls and procedures was performed under the supervision and with the
participation of our management, including our CEO and CFO. As a result of this evaluation, our CEO and CFO concluded that our disclosure controls and
procedures were effective as of December 31, 2022.

Management's Report on Internal Control Over Financial Reporting

Management, including our CEO and CFO, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act and based upon the criteria established in Internal Control-Integrated Framework (2013) issued by
the  Committee  of  Sponsoring  Organizations  of  the  Treadway  Commission  (the  "COSO  framework").  The  Company's  internal  control  over  financial
reporting  is  a  process  designed  to  provide  reasonable  assurance  regarding  the  reliability  of  our  financial  reporting  and  the  preparation  of  our  financial
statements for external purposes in accordance with United States Generally Accepted Accounting Principles (“GAAP”).

An  effective  internal  control  system,  no  matter  how  well  designed,  has  inherent  limitations,  including  the  possibility  of  human  error  or  overriding  of
controls,  and  therefore  can  provide  only  reasonable  assurance  with  respect  to  reliable  financial  reporting.  Because  of  its  inherent  limitations,  internal
control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures
may demonstrate.

Under the supervision and with the participation of our management, including our CEO and CFO, we have conducted an evaluation of the effectiveness of
our internal control over financial reporting based on the COSO framework. Based on evaluation under these criteria, management determined that we did
maintain effective internal control over financial reporting as of December 31, 2022.

Our independent registered public accounting firm, Deloitte & Touche LLP, has audited the effectiveness of our internal control over financial reporting as
of December 31, 2022, as stated in their report which appears on page 79 of this Form 10-K.

Changes in Internal Control Over Financial Reporting

There  were  no  changes  during  the  quarter  ended  December  31,  2022  in  our  internal  control  over  financial  reporting  (as  such  term  is  defined  in  the
Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Item 9B. Other Information

None.

Item 9C. Disclosures Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

PART III

Item 10. Directors, Executive Officers and Corporate Governance

Information  required  by  this  Item  will  be  contained  in  our  definitive  proxy  statement  relating  to  our  2023  Annual  Meeting  of  Shareholders  under  the
captions “Executive Officers,” “Election of Directors” and similar captions which are incorporated herein by reference.

80

Item 11. Executive Compensation

Information  required  by  this  Item  will  be  contained  in  our  definitive  proxy  statement  relating  to  our  2023  Annual  Meeting  of  Shareholders  under  the
caption “Executive Compensation Discussion and Analysis,” “Summary Compensation Table (2022, 2021 and 2020,” “Grants of Plan Based Awards for
2022,”  “Outstanding  Equity  Awards  on  December  31,  2022,”  “2022  Options  Exercised  and  Stock  Vested  Table,”  “2022  Potential  Payments  Upon
Termination  or  Change  in  Control,”  “2022  Director  Compensation,”  “Compensation  Committee  Report”  and  “Compensation  Committee  Interlocks  and
Insider Participation” or similar captions which are incorporated herein by reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Information  required  by  this  Item  will  be  contained  in  our  definitive  proxy  statement  relating  to  our  2023  Annual  Meeting  of  Shareholders  under  the
captions “Security Ownership of Certain Beneficial Owners and Management,” and “Equity Compensation Plan Information,” or similar captions which
are incorporated herein by reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence

Information  required  by  this  Item  will  be  contained  in  our  definitive  proxy  statement  relating  to  our  2023  Annual  Meeting  of  Shareholders  under  the
captions  “Policies  and  Procedures  for  Approval  of  Related  Party  Transactions,”  “Related  Party  Transactions,”  and  "Director  Independence"  or  similar
captions which are incorporated herein by reference.

Item 14. Principal Accounting Fees and Services

Information  required  by  this  Item  will  be  contained  in  our  definitive  proxy  statement  relating  to  our  2023  Annual  Meeting  of  Shareholders  under  the
captions “Audit Matters,” or a similar caption which is incorporated herein by reference.

81

PART IV

Item 15. Exhibits, Financial Statement Schedules

(a) Documents filed as part of this report:

(i)

Financial Statements

(ii)

Financial Statement Schedule:

The following Financial Statement Schedule is filed as part of this Report:

Schedule II Valuation and Qualifying Accounts for the years ended December 31, 2022, 2021 and 2020

(iii)

Exhibits

See Item 15(b) below. Each management contract or compensation plan has been identified with an asterisk.

(b) Exhibits

Notes

*

#

##

Exhibit
Number

3.1

3.2

3.3

3.4

4.1

10.1##

10.2##

10.3

10.4

10.5

Indicates a management contract or compensatory plan or arrangement

Filed herewith

Certain exhibits and schedules have been omitted pursuant to Item 601(b)(10) of Regulation S-K, but a copy
will be furnished supplementally to the Securities and Exchange Commission upon request. 

 Description 
Restated Articles of Incorporation, adopted March 4, 2021, effective March 5, 2021 (incorporated by reference to
Exhibit 3.1 to the Registrant’s Annual Report on Form 10-K filed on March 8, 2021).
Articles of Amendment to Restated Articles of Incorporation, effective June 3, 2021 (incorporated by reference to
Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 10, 2021).
Articles of Amendment to Restated Articles of Incorporation, effective June 3, 2021 (incorporated by reference to
Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on June 10, 2021).
Amended and Restated Bylaws of MiMedx Group, Inc., as amended and restated as of February 16, 2023
(incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on February 23, 2023).
The  description  of  the  Registrant’s  Securities  Registered  Pursuant  to  Section  12  of  the  Securities  Exchange  Act  of
1934 (incorporated by reference to the Registrant’s Registration Statement on Form 8-A filed on November 2, 2020).
Loan Agreement dated as of June 30, 2020 by and among MiMedx Group, Inc., certain subsidiaries of MiMedx
Group, Inc. parties thereto, the Lenders from time to time party hereto, Hayfin Services LLP, as administrative agent
for the Lenders and as collateral agent for the Secured Parties (incorporated by reference to Exhibit 10.36 to
Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
Securities  Purchase  Agreement,  dated  as  of  June  30,  2020,  by  and  between  MiMedx  Group,  Inc.,  Falcon  Fund  2
Holding  Company,  L.P.  and  certain  other  investors  (incorporated  by  reference  to  Exhibit  10.38  to  the  Registrant’s
Annual Report on Form 10-K filed July 6, 2020).
Registration Rights Agreement dated as of July 2, 2020, by and between MiMedx Group, Inc. and Falcon Fund 2
Holding Company, L.P. (incorporated by reference to Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K
filed on July 6, 2020).
Lease effective May 1, 2013 between Hub Properties of GA, LLC and MiMedx Group, Inc. (incorporated by reference
to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on May 10, 2013).
First Amendment to Lease dated March 7, 2017 between CPVF II West Oak LLC (as successor in interest to HUB
Properties  of  GA,  LLC)  and  MiMedx  Group,  Inc.  (incorporated  by  reference  to  Exhibit  10.1  to  the  Registrant’s
Current Report on Form 8-K filed on March 13, 2017).

82

 
 
 
 
Exhibit
Number
10.6

10.7*

10.8*

10.9*

10.10*

10.11*

10.12*

10.13*

10.14*

10.15*

10.16*

10.17*

10.18*

10.19*

10.20*

10.21*

10.22*

10.23*

10.24*

10.25*

10.26*

 Description 
Third Amendment to Lease made as of November 30, 2021 for real property and improvements located at 1775 West
Oak Commons Court, Marietta, Georgia between RE Fields, LLC, successor in interest to HUB Properties GA, LLC,
and  CPVF  II  West  Oak  LLC,  and  MiMedx  Group,  Inc.,  dated  January  25,  2013,  as  amended  March  7,  2017
(incorporated  by  reference  to  Exhibit  10.6  to  the  Registrant’s  Annual  Report  on  Form  10-K  filed  on  February  28,
2022).
MiMedx  Group,  Inc.  Assumed  2006  Stock  Incentive  Plan,  as  amended  and  restated  effective  February  25,  2014
(incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on March 3, 2014).
Form  of  Incentive  Stock  Option  Agreement  under  the  MiMedx  Group,  Inc.  Assumed  2006  Stock  Incentive  Plan
(incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
Form of Nonqualified Stock Option Agreement under the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan
(incorporated by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
Form  of  Restricted  Stock  Agreement  for  Non-Employee  Directors  under  the  MiMedx  Group,  Inc.  2006  Assumed
Stock Incentive Plan (incorporated by reference to Exhibit 10.66 to the Registrant’s Quarterly Report on Form 10-Q
filed on August 8, 2013).
Form  of  Restricted  Stock  Agreement  under  the  MiMedx  Group,  Inc.  2006  Assumed  Stock  Incentive  Plan
(incorporated by reference to Exhibit 10.3 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
2016 Equity and Cash Incentive Plan, as amended and restated through October 2, 2020 (incorporated by reference to
Exhibit 4.6 to the Registrant’s Registration Statement on Form S-8 filed on December 17, 2020).
Form  of  Incentive  Stock  Option  Agreement  under  the  MiMedx  Group,  Inc.  2016  Equity  and  Cash  Incentive  Plan
(incorporated  by  reference  to  Exhibit  10.2  to  the  Registrant’s  Quarterly  Report  on  Form  10-Q  filed  on  August  2,
2016).
Form of Restricted Stock Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (for shares
not registered under the Securities Act of 1933) (incorporated by reference to Exhibit 10.9 to the Registrant’s Current
Report on Form 8-K filed on May 30, 2019).
Form  of  Restricted  Stock  Agreement  under  the  MiMedx  Group,  Inc.  2016  Equity  and  Cash  Incentive  Plan
(incorporated  by  reference  to  Exhibit  10.3  to  the  Registrant’s  Quarterly  Report  on  Form  10-Q  filed  on  August  2,
2016).
Form  of  Restricted  Stock  Agreement  for  Non-Employee  Directors  under  the  MiMedx  Group,  Inc.  2016  Equity  and
Cash Incentive Plan (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report on Form 8-K filed
on May 30, 2019).
Form of Nonqualified Stock Option Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan
(incorporated  by  reference  to  Exhibit  10.4  to  the  Registrant’s  Quarterly  Report  on  Form  10-Q  filed  on  August  2,
2016).
Form  of  Director  Restricted  Stock  Unit  Award  Agreement  (incorporated  by  reference  to  Exhibit  10.16  to  the
Registrant’s Annual Report on Form 10-K filed on March 17, 2020).
Form of Employee (Time-Vested) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.33
to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
Form  of  Employee  (Performance-Vested,  uncertain  number  of  shares)  Restricted  Stock  Unit  Award  Agreement
(incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
Form  of  Employee  (Performance-Vested,  certain  number  of  shares)  Restricted  Stock  Unit  Award  Agreement
(incorporated by reference to Exhibit 10.35 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
Form  of  Non-Employee  Restricted  Stock  Award  Agreement  (vest  into  retirement)  (incorporated  by  reference  to
Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 4, 2020).
Form of Employee (Time-Vested) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.25
to the Registrant’s Annual Report on Form 10-K filed on March 8, 2021).
Letter  Agreement  dated  April  10,  2019  between  MiMedx  Group,  Inc.  and  Timothy  R.  Wright  (incorporated  by
reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on May 9, 2019).
Employment Offer Letter between MiMedx Group, Inc. and Peter M. Carlson, as amended and restated on June 30,
2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3,
2021).
Employment  Offer  Letter  between  MiMedx  Group,  Inc.  and  William  F.  Hulse  IV  dated  November  4,  2019,
(incorporated by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).

83

 
 
 
Exhibit
Number
10.27*

10.28*

10.29*

10.30*

10.31*

10.32*

10.33*

10.34

10.35

10.36##

10.37*

10.38*

10.39*

10.40*

10.41*

10.42*

10.43*

10.44# ##

16.1

21.1#
23.1#
23.2#
24.1#
31.1#

 Description 
Employment Offer Letter between MiMedx Group, Inc. and Rohit Kashyap dated as of July 23, 2020 (incorporated by
reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on November 20, 2020).
Employment Offer Letter between MiMedx Group, Inc. and Robert B. Stein effective August 1, 2020 (incorporated by
reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on November 20, 2020).
Form of Key Employee Retention and Restrictive Covenant Agreement (incorporated by reference to Exhibit 10.1 to
the Registrant’s Current Report on Form 8-K filed on December 21, 2020).
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.65 to the Registrant’s Current Report on
Form 8-K filed on July 15, 2008).
Form  of  Director  Restricted  Stock  Unit  Award  Agreement  (Type  I  -  Initial  Grant,  Full  Amount)  (incorporated  by
reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
Form of Director Restricted Stock Unit Award Agreement (Type II - Initial Grant, Pro Rata Amount) (incorporated by
reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
Form  of  Director  Restricted  Stock  Unit  Award  Agreement  (Type  III  -  Annual  Grant)  (incorporated  by  reference  to
Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
Technology License Agreement dated January 29, 2007 between MiMedx, Inc., Shriner's Hospitals for Children and
University  of  South  Florida  Research  Foundation  (incorporated  by  reference  to  Exhibit  10.32  to  the  Registrant’s
Current Report on Form 8-K filed on February 8, 2008).
Cooperation Agreement dated as of May 29, 2019 among MiMedx Group, Inc., M. Kathleen Behrens Wilsey, K. Todd
Newton, Richard J. Barry, Prescience Partners, LP, Prescience Point Special Opportunity LP, Prescience Capital LLC,
Prescience Investment Group, LLC d/b/a Prescience Point Capital Management LLC and Eiad Asbahi (incorporated
by reference to Exhibit 10.32 to the Registrant’s Current Report on Form 8-K filed on May 30, 2019).
Amendment  No.  1  to  Loan  Agreement  dated  as  of  February  28,  2022,  which  amends  that  certain  Loan  Agreement
dated  as  of  June  30,  2020  by  and  among  MiMedx  Group,  Inc.,  certain  subsidiaries  of  MiMedx  Group,  Inc.  parties
thereto, the Lenders from time to time party hereto, Hayfin Services LLP, as administrative agent for the Lenders and
as  collateral  agent  for  the  Secured  Parties  (incorporated  by  reference  to  Exhibit  10.38  to  the  Registrant’s  Annual
Report on Form 10-K filed on February 28, 2022)
Separation Agreement and General Release between MiMedx Group, Inc. and Timothy R. Wright dated September 15,
2022 (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on September
14, 2022).
Interim Executive Employment Agreement between MiMedx Group, Inc. and K. Todd Newton dated September 14,
2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September
14, 2022).
Restricted  Stock  Unit  Agreement  between  MiMedx  Group,  Inc.  and  K.  Todd  Newton  dated  September  15,  2022
(incorporated  by  reference  to  Exhibit  10.2  to  the  Registrant’s  Current  Report  on  Form  8-K  filed  on  September  14,
2022).
Employment Offer Letter between MiMedx Group, Inc. and Ricci S. Whitlow dated December 27, 2022 (incorporated
by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 3, 2023).
Letter  Agreement  between  MiMedx  Group,  Inc.  and  Joseph  H.  Capper  dated  January  27,  2023  (incorporated  by
reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
Performance  Stock  Unit  Agreement  between  MiMedx  Group,  Inc.  and  Joseph  H.  Capper  dated  January  27,  2023
(incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
Nonqualified Stock Option Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023
(incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
Platform Intellectual Property License Agreement by and between MiMedx Group, Inc. and Global Health Solutions,
Inc. (d.b.a. Turn Therapeutics), dated as of December 7, 2022.
Letter  from  BDO  USA,  LLP  dated  March  30,  2021  (incorporated  by  reference  to  Exhibit  16.1  to  the  Registrant’s
Current Report on Form 8-K filed on March 30, 2021).
Subsidiaries of MiMedx Group, Inc.
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
Consent of BDO USA, LLP, Independent Registered Public Accounting Firm.
Power of Attorney (included on the signature page to this Report).
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

84

 
 
 
Exhibit
Number
31.2#
32.1#
32.2#
101.INS#
101.SCH#

101.CAL#
101.DEF#
101.LAB#
101.PRE#

 Description 
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document
XBRL Taxonomy Extension Label Linkbase Document
XBRL Taxonomy Extension Presentation Linkbase Document

Item 16. Form 10-K Summary

Not applicable.

85

 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.

SIGNATURES

February 28, 2023

MIMEDX GROUP, INC.

By:

/s/ Peter M. Carlson
Peter M. Carlson
Chief Financial Officer and Principal Financial Officer

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints William F. Hulse IV
and Sajid N. Ajmeri and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution and
resubstitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report for the year ended December 31, 2022, and to
file  the  same,  with  exhibits  thereto  and  other  documents  in  connection  therewith,  with  the  Securities  and  Exchange  Commission,  hereby  ratifying  and
confirming our signatures as they may be signed by our said attorney to any and all amendments to said Annual Report.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.

86

 
 
 
 
 
 
 
Signature / Name

/s/ Joseph H. Capper
Joseph H. Capper

/s/ Peter M. Carlson
Peter M. Carlson

/s/ William L. Phelan
William L. Phelan

/s/ M. Kathleen Behrens
M. Kathleen Behrens

/s/ James L. Bierman
James L. Bierman

/s/ Michael J. Giuliani
Michael J. Giuliani

/s/ William A. Hawkins III
William A. Hawkins III

/s/ Cato T. Laurencin
Cato T. Laurencin

/s/ K. Todd Newton
K. Todd Newton

/s/ Martin P. Sutter
Martin P. Sutter

/s/ Phyllis I. Gardner
Phyllis I. Gardner

Title

Chief Executive Officer and Director
(Principal Executive Officer)

Chief Financial Officer
(Principal Financial Officer)

Senior Vice President and Chief Accounting Officer
(Principal Accounting Officer)

Date

February 28, 2023

February 28, 2023

February 28, 2023

Chair of the Board (Director)

February 28, 2023

Director

Director

Director

Director

Director

Director

Director

87

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[***]  Certain  information  in  this  document  has  been  excluded  pursuant  to  Regulation  S-K,  Item  601(b)(10).  Such  excluded  information  is  not
material and is the type that the registrant treats as private or confidential.

EXHIBIT 10.4

PLATFORM INTELLECTUAL PROPERTY LICENSE AGREEMENT

THIS PLATFORM INTELLECTUAL PROPERTY LICENSE (the “Agreement”), effective as of the 30th day of November 2022 (the “Effective Date”),
is made by and between Global Health Solutions, Inc. (d.b.a. Turn Therapeutics), a Delaware corporation, with its principal offices at 250 N Westlake Blvd,
Suite 210, Westlake Village, CA 91362 (“Turn”), and MiMedx Group, Inc., a Florida corporation, with its principal offices at 1775 West Oak Commons
Court, NE, Marietta, GA 30062 (“MIMEDX”). MIMEDX  and  Turn  are  sometimes  referred  to  herein,  individually,  as  a  “Party” or, collectively, as the
“Parties.”

BACKGROUND
A.        Turn  has  developed,  licensed  or  owns  proprietary  technologies  and  biomaterials  which  may  be  used  in  wound  care,  burn  care  and  surgical  care,
including as related to or comprising the FleX Product (as defined below);

B.    The Parties entered into that certain License Agreement dated as of May 21, 2022 (“Original Effective Date”) under which Turn granted to MIMEDX
certain  exclusive  and  nonexclusive  licenses  to  certain  Turn  technology  and  intellectual  property  rights  associated  with  the  FleX  Product  (the  “FleX
License”);

C.    The Parties desire to terminate the FleX License and enter into this Agreement to grant to MIMEDX rights and licenses to Turn intellectual property,
technologies and biomaterials including as relating to the FleX Product in order to allow MIMEDX to develop and commercialize the FleX Product and
other products in the Field (as defined below), all in accordance with the terms and conditions set forth herein; and

D.    Turn desires to grant such licenses to MIMEDX, all upon terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the covenants, conditions and obligations expressed herein, the sufficiency of which is hereby acknowledged by
the Parties, and intending to be legally bound thereby, the Parties hereto agree as follows:

Capitalized terms used in this Agreement have the meaning given thereto in this Article 1 or elsewhere in this Agreement.

ARTICLE 1
DEFINITIONS

1.1    “Affiliate” means, with respect to each Party, any company or other entity which directly or indirectly controls or is controlled by
or is under common control with that Party. An entity shall be regarded as in control of another entity for purposes of this definition if it owns or controls
fifty percent (50%) or more of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation,
for the election of the corresponding managing authority).

1.2        “Calendar  Quarter”  means  the  respective  periods  of  three  (3)  consecutive  calendar  months  ending  on  March  31,  June  30,
September 30 and December 31; provided, that (a) the first Calendar Quarter of the Term shall begin on the Effective Date and end on the first to occur of
March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of the Term shall end on the last day of the Term and (b) the first
Calendar Quarter of a Royalty Term for the Product in a country shall begin on the Launch Date of the Product in such country and end on the first to occur
of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of a Royalty Term shall end on the last day of such Royalty
Term.

1.3    “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31;
provided, that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on the first December 31 thereafter and the last Calendar
Year of the Term shall end on the last day of the Term.

1.4        “Commercialization”  or  “Commercialize”  means  any  and  all  activities  directed  to  Manufacturing,  having  Manufactured,
marketing, promoting, distributing, importing, exporting, using, offering to sell and/or selling a product, including the conduct of Post-Approval Studies,
and activities directed to obtaining pricing and reimbursement approvals, as applicable.

1.5    “Commercially Reasonable Efforts” means the carrying out of obligations in good faith and in a diligent and sustained manner
using  such  effort  and  employing  such  resources  as  MIMEDX  would  and  does  employ  for  other  wholly  new  products  (not  modifications  to  existing
products, i.e., “soft launch”) it markets, distributes and sells; provided, that it is no less than what would normally be exerted or employed by a similarly
situated life sciences company with similar resources for a product of similar market or profit potential or strategic value at a similar stage of its product
life. For purposes

 
of  the  above,  all  relevant  factors  as  measured  by  the  facts  and  circumstances  at  the  time  such  efforts  are  due  shall  be  taken  into  account,  including,  as
applicable  and  without  limitation,  mechanism  of  action;  efficacy  and  safety;  product  profile;  actual  or  anticipated  Regulatory  Agency  approval  and
labeling; the nature and extent of market exclusivity (including patent coverage, proprietary position and regulatory exclusivity); costs; time required for
and likelihood of obtaining Marketing Approval; expected competitive position of the Product vis-à-vis other therapies that have been or are reasonably
expected to be developed, marketed and sold or used for the same or similar indications; the presence of third-party Patent Rights and Technology that is
reasonably expected to impact the marketability of any such products; regulatory landscape; anticipated pricing and reimbursement for the Product; and
actual or projected profitability.

1.6    “Control” means, with respect to Intellectual Property Rights, possession by the Party granting the applicable license to the other
Party as provided herein of the power and authority, whether arising by ownership, license or other authorization, to grant such license without giving rise
to (i) any payment or other consideration becoming due to a Third Party as a result of the grant or exercise of such license; or (ii) a violation of the terms of
any written agreement with any Third Party.

1.7        “Development,”  “Developing”  or  “Develop”  means  the  research  and  development  activities  related  to  the  generation,
characterization, optimization, construction, expression, use and production of a product, any other research and development activities related to the pre-
clinical testing and qualification of a product for clinical testing, and such other tests, studies and activities as may be required or recommended from time
to time by any Regulatory Agency to obtain Marketing Approval of a product.

attached hereto.

1.8        “Exclusive  Licensed  Trademark”  means  those  of  Turn’s  trademarks,  trade  names  and  logos  that  are  set  forth  on  Exhibit  B-1

or in combination with a synthetic material), for use in the wound care, burn care, and surgical care field.

1.9    “Field” means biological products, including human or animal collagen, tissue, biologic or cellular-based materials (whether alone

1.10    “FDA” means the United States Food and Drug Administration, or any successor agency thereto.

applied.

1.11        “GAAP”  means  generally  accepted  accounting  principles  in  the  United  States,  or  internationally,  as  appropriate,  consistently

1.12        “Intellectual  Property  Rights”  means  all  intellectual  property  rights  worldwide  arising  under  statutory  or  common  law  or
otherwise including all (i) Patent Rights; (ii) rights associated with works of authorship including copyrights and mask work rights; (iii) rights relating to
the protection of trade secrets and confidential information; (iv) trademarks, service marks, trade dress and trade names; and (v) any right analogous to
those set forth herein and any other proprietary rights relating to intangible property.

schematic or concept, whether patentable or not.

1.13    “Invention” means any idea, invention, formulae, discovery, design, utility model, process, method, development, improvement,

authority of MIMEDX to a Third-Party customer in any part of the Territory after Marketing Approvals in such country.

1.14    “Launch Date” means, with respect to a Product in a country, the date of the first commercial sale of the Product by or under

kind whatsoever of any governmental authority or Regulatory Agency within the applicable jurisdiction.

1.15    “Law” means, individually and collectively, any and all laws, ordinances, orders, rules, rulings, directives and regulations of any

1.16        “Licensed  Assets”  means  any  and  all  information  and  tangible  materials  comprising  proprietary  Inventions  and  Technology,
regulatory  approvals,  data  packages  and  files,  including  actual,  pending  and  draft  supplements  thereto,  supply  agreements,  clinical  and  regulatory
information,  marketing/  sales/  distribution  information,  manufacturing  rights,  and  inventory,  in  each  case  pertaining  to  FleX,  Licensed  Patents,  Turn
Inventions or any Product, and in each case that is Controlled by Turn and reasonably necessary for the Commercialization of a Product by MIMEDX in
accordance with this Agreement.

2

1.17    “Licensed Patents” means the Patent Rights listed in Exhibit A and any Patent Rights covering a Turn Invention (including all
reissues,  extensions,  substitutions,  confirmations,  re-registrations,  re-examinations,  invalidations,  supplementary  protection  certificates  and  patents  of
addition)  and  continuation  patent  applications  (including  all  provisional  applications,  requests  for  continuation,  continuations,  continuations-in-part  and
divisionals) and all PCT applications, including any corresponding national stage applications.

1.18    “Licensed Technology” means, individually and collectively, without duplication, the Licensed Patents and Licensed Assets.

1.19    “Licensed Trademarks” means the Exclusive Licensed Trademarks and the Non-Exclusive Licensed Trademarks.

1.20    “Manufacturing” or “Manufacture” means, as applicable, all activities associated with the production, manufacture, processing,
filling,  finishing,  packaging,  labeling,  shipping,  and  storage  of  a  product,  including  process  and  formulation  development,  process  validation,  stability
testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance
and quality control development, testing and release.

commence marketing and sales of the Product in such jurisdiction, including, without limitation, 510(k) clearance in the United States from the FDA.

1.21    “Marketing Approval” means, with respect to the Product in a jurisdiction, approval from the relevant Regulatory Agency to

1.22        “MIMEDX Inventions”  means  any  Invention  or  Technology,  whether  or  not  patentable,  discovered,  developed,  conceived  or
reduced  to  practice  by  MIMEDX  or  its  Affiliates  or  sublicensees  during  the  Term,  including  without  limitations,  any  improvements  of  MIMEDX
Background IP or any new Product Developed by MIMEDX hereunder.

sold to Third Parties in the Territory in a particular Calendar Quarter, less the following deductions:

1.23    “Net Sales” means the total of the gross revenue received and recognized by MIMEDX from commercial sales of the Product(s)

(i)    transport, freight and value added (or like) tax;

(ii)    regular trade and quantity and cash discounts, allowances and credits;

and billing errors;

(iii)    any credits, allowances or chargebacks given or made for rejection or returns of Product or for retroactive price reductions

(iv)    any price protections, rebates and cash discounts to place inventory in trade;

(v)    freight, postage, insurance and other transportation charges paid by MIMEDX;

(vi)    bad debt written off by MIMEDX;

(vii)    sales and commissions paid by MIMEDX to distributors or selling agents; and

MIMEDX.
All calculations shall be made in accordance with GAAP and based on or valued as based on bona fide arm’s length transactions.

(viii)        applicable  taxes  paid  by  MIMEDX  (other  than  taxes  based  on  net  income)  or  withheld  from  amounts  payable  to

2 attached hereto.

1.24    “Non-Exclusive Licensed Trademarks” means those of Turn’s trademarks, trade names and logos that are set forth on Exhibit B-

1.25    “Patent Rights” means all domestic and international patents (including all reissues, extensions, substitutions, confirmations, re-
registrations,  re-examinations,  invalidations,  supplementary  protection  certificates  and  patents  of  addition)  and  patent  applications  (including  all
provisional  applications,  requests  for  continuation,  continuations,  continuations-in-part  and  divisionals)  and  all  PCT  applications,  including  any
corresponding national stage applications.

3

Product in such country.

1.26    “Post-Approval Study” means a clinical study of the Product initiated in a country after receipt of Marketing Approval for the

1.27    “Product” means (i) Turn’s FleX  Antimicrobial Collagen Matrix product as further described on Exhibit C attached hereto (the
“FleX Product”)  or  (ii)  any  product  that  (a)  is  covered  in  whole  or  in  part  by  a  Valid  Claim  under  the  Licensed  Patents;  and/or  (b)  the  development,
manufacture, use, sale, offering for sale, or importation of which incorporates, uses, has used or is derived from, in whole or in part, the Licensed Assets.

TM

approval, sale, distribution, packaging, reimbursement, pricing or use of the Product, including the FDA.

1.28        “Regulatory  Agency”  means  any  governmental  regulatory  authority  that  regulates  the  Development,  Manufacture,  market

1.29    “Royalty Term” means, for each Product, on a country by country basis, the period beginning on the Launch Date of the Product
in such country and ending on the latest to occur of the last date on which the Product is covered by a Valid Claim within the Licensed Patents in such
country.

grants a sublicense to such Third Party of the rights granted by Turn to MIMEDX pursuant to this Agreement.

1.30    “Sublicense Agreement” means a written agreement between MIMEDX (or its Affiliate) and a Sublicensee in which MIMEDX

such Third Party will supply all of MIMEDX’s requirements for the FleX Product.

1.31    “Supply Agreement” means a supply and quality agreement to be entered into between MIMEDX and a Third Party under which

hereunder.

1.32        “Sublicensee”  means  a  Third  Party  to  whom  MIMEDX  grants  a  sublicense  under  the  rights  granted  to  MIMEDX  by  Turn

1.33        “Technology”  means  any  and  all  biological  materials  and  other  tangible  materials,  data,  information,  technology,  know-how,
processes,  techniques,  methods,  skills,  proprietary  information,  trade  secrets,  assays,  skills,  experience,  techniques  and  results  of  experimentation  and
testing, including pre-clinical and clinical test date and quality control data, patentable or otherwise.

Singapore, South Korea, Taiwan and the UAE; (ii) for all other Products, worldwide.

1.34        “Territory”  means:  (i)  for  the  FleX  Product,  United  States,  Australia,  Canada,  Japan,  Kuwait,  New  Zealand,  Saudi  Arabia,

1.35    “Third Party” means any person, corporation or other business entity, other than MIMEDX, Turn and their respective Affiliates.

1.36    “[***]” means the [***]

or sublicensees prior to or during the Term.

1.37    “Turn Inventions” means any Patent Rights, Technology or Inventions, conceived or reduced to practice by Turn or its Affiliates

1.38    “Valid Claim” means a claim (i) of any issued, unexpired patent within the Licensed Patents that has not been revoked or held
unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to
which  an  appeal  is  not  taken  within  the  time  allowed  for  appeal,  and  that  has  not  been  disclaimed  or  admitted  to  be  invalid  or  unenforceable  through
recission, disclaimer, or otherwise or (ii) of any patent application within the Licensed Patents that was filed in good faith and is being prosecuted actively
and in good faith and has not been cancelled, withdrawn, or abandoned and has not been pending for more than seven (7) years. If a claim of a patent
application ceases to be a Valid Claim under item (i) because of the passage of time and later issues as part of a patent within item (ii), then it shall again be
considered to be a Valid Claim effective as of the grant or issuance of such patent.

1.39        Interpretation.  The  captions  and  headings  in  this  Agreement  are  for  convenience  only  and  are  to  be  of  no  force  or  effect  in
construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the
particular Articles, Sections and Exhibits to this Agreement and references to this Agreement include all Exhibits hereto. Unless context otherwise clearly
requires, whenever used in this Agreement: (i) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without
limitation;” (ii) the word “day” or “year” shall mean a calendar day or year unless otherwise specified; (iii) the word “notice” shall mean notice in writing
(whether or not specifically stated) and shall include notices, consents, approvals and other written communications

4

contemplated  under  this  Agreement;  (iv)  the  words  “hereof,”  “herein,”  “hereby”  and  derivative  or  similar  words  refer  to  this  Agreement  (including  all
Exhibits); (v) provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like shall require that such agreement, consent or
approval be specific and in writing, whether by written agreement, letter; or otherwise; (vi) words of either gender include the other gender; (vii) words
using the singular or plural number also include the plural or singular number, respectively; and (viii) references to any specific Law or article, section or
other division thereof, shall be deemed to include the then current amendments thereto or any replacement thereof. For purposes of this Agreement, neither
Party shall be deemed to be acting “under authority of” the other Party.

2.1    License.

ARTICLE 2
LICENSE

2.1.a    Subject to the terms and conditions of this Agreement, Turn hereby grants to MIMEDX an exclusive, sublicensable (in
accordance  with  Section  2.2)  license  in,  to  and  under  the  Licensed  Patents  and  in,  to  and  under  the  Licensed  Assets  during  the  Term  to  Develop,
Manufacture and Commercialize Products in the Field and Territory. 

2.1.b    Subject to the terms and conditions of this Agreement (including, without limitation, Section 4.2), Turn hereby grants to
MIMEDX a license during the Term to use the Licensed Trademarks in the Territory in connection with the Commercialization of the Products pursuant to
the terms and conditions of Section 4.2.  The license granted to MIMEDX under this Section 2.1.b (i) with respect to the Exclusive Licensed Trademarks
shall be exclusive in the Field and Territory, and (ii) with respect to the Non-Exclusive Licensed Trademarks shall be non-exclusive and used solely for the
purpose of the Commercialization of the Products in the Field and Territory. 

shall be responsible for the acts and omissions of any such Affiliates as if such acts and omissions were those of MIMEDX.

2.1.c    MIMEDX shall have the right to exercise the foregoing licenses through one or more Affiliates; provided that MIMEDX

2.1.d.          Upon  MIMEDX’s  reasonable  request,  Turn  shall  provide  MIMEDX  with  a  list  of  Licensed  Patents  that  cover  the
Products  itself  in  order  for  MIMEDX  to  mark  Products  and/or  the  packaging,  and  labels  thereof  with  such  patent  information  as  required  by  Law,  and
MIMEDX shall appropriately mark the Products marketed and sold by MIMEDX with reference to the Licensed Patents.

2.2    Sublicense. MIMEDX shall have the right to grant sublicenses to all or any portion of the rights granted in Section 2.1 above to a
Sublicensee. Each sublicense granted by MIMEDX pursuant to this Section 2.2 shall be subject and subordinate to the terms of this Agreement and shall
contain  terms  consistent  with  this  Agreement,  including  but  not  limited  to  MIMEDX’s  royalty  obligations  under  Section  3.1.  Turn  will  not  assert  the
Licensed  Technology  against  any  Third  Party  that  purchases  Product  directly  or  indirectly  from  MIMEDX  (or  its  Affiliates  or  distributors)  in  full
compliance  with  the  terms  of  this  Agreement.  MIMEDX  shall  be  fully  financially  responsible  to  Turn  for  the  acts  or  omissions  of  any  Sublicensee,
including but not limited for any breach of this Agreement. For each sublicense, MIMEDX shall deliver to Turn written notice of the terms, including the
proposed sublicensee's identity, of any proposed sublicense agreement, or modification.

2.3    No Other Rights. Each Party acknowledges that the rights and licenses granted under this Article 2 and elsewhere in this Agreement
are limited to the scope expressly granted. Accordingly, except for the rights and licenses expressly granted in this Agreement, neither Party is granted any
right or license under any Patent Rights or Intellectual Property Rights of the other Party, nor shall any such right or license be implied or imputed, by
estoppel or otherwise. All rights with respect to Patent Rights or Intellectual Property Rights that are not specifically granted herein are reserved to the
owner thereof.

2.4    Right to Notice and First Refusal. During the Term, MIMEDX will be Turn’s preferred Commercialization partner in the Field, such
that Turn shall afford MIMEDX the opportunity to acquire exclusive Development, Manufacture and Commercialization rights for the FleX Product in the
Field for countries and jurisdictions outside of the Territory in accordance with this Section 2.4. Turn will promptly notify MIMEDX in writing (“Turn
Notice”) prior to entering into bona fide negotiations with a Third Party for Development, Manufacture and Commercialization rights for the FleX Product
outside the Territory (the “New Territory”). Similarly, Turn will promptly notify MIMEDX in writing (“Second Turn Notice”) prior to entering into any
bona fide term sheet with a Third Party for Development, Manufacture and

5

 
Commercialization rights for the FleX Product in a New Territory. MIMEDX shall have up to thirty (30) days after receipt of the Turn Notice to notify Turn
in writing of its interest in obtaining a royalty-bearing license to the FleX Product in the New Territory. If Turn received a bona fide proposed term sheet
from Third Party, MIMEDX shall notified Turn in writing of its interest in obtaining a royalty-bearing license to the FleX Product in the New Territory
within at least ten (10) days of the Second Turn Notice. If MIMEDX notifies Turn in writing within the shorter of such thirty (30) day or ten (10) day
period that it is interested in such New Territory, then the Parties shall promptly commence good faith negotiations for a period of up to three (3) months
after  Turn’s  receipt  of  such  notice  if  there  is  no  bona fide  term  sheet  proposed  by  a  Third  Party  in  an  effort  to  reach  a  mutually  acceptable  definitive
agreement (or amendment to this Agreement) for such New Territory (the “New Territory Negotiation Period”). If there is a bona fide term sheet proposed
by a Third Party, then the Parties shall commence or continue good faith negotiations for no more than thirty (30) days in an effort to reach a mutually
acceptable  definitive  agreement  (or  amendment  to  this  Agreement)  or  at  least  a  binding  term  sheet  to  continue  working  towards  a  mutually  acceptable
definitive  agreement  (or  amendment  to  this  Agreement).  If  (a)  MIMEDX  does  not  notify  Turn  in  writing  within  the  applicable  time  period  that  it  is
interested in the subject New Territory or (b) despite each Party’s good faith efforts, Turn and MIMEDX are not able to reach agreement on and execute a
definitive agreement within such three (3) month period, or at least a binding term sheet within such thirty (30) day period, then Turn may enter into a term
sheet  or  execute  an  agreement  with  any  Third  Party  for  Development,  Manufacture  and  Commercialization  rights  to,  or  Develop,  Manufacture  and
Commercialize on its own, the FleX Product in the Field in the New Territory provided that any such agreement with a Third Party shall not be on more
favorable terms to the Third Party that any final offer proposed by MIMEDX during the Negotiation Period (provided that MIMEDX reinstates such offer
to acquire said rights).

2.5    Assignment by Turn to a Third Party. Turn acknowledges and agrees that in the event Turn sells, conveys, assigns or otherwise
transfers the Licensed Technology, in whole or any portion thereof, to a Third Party, the Licensed Technology shall remain subject to the rights in such
Licensed Technology granted to MIMEDX hereunder and the obligations under this Agreement applicable to such sold, conveyed, assigned or transferred
Licensed Technology, including with respect to the license under such Licensed Technology granted to MIMEDX hereunder, will run with such Licensed
Technology.

2.6    Bankruptcy. The Parties acknowledge and agree that all rights and licenses granted under or pursuant to this Agreement by Turn to
MIMEDX are and shall otherwise be deemed to be, for purposes of 11 U.S.C. 365(n), license rights to “intellectual property” as defined under the U.S.
Bankruptcy  Code.  In  this  regard,  the  Licensed  Technology  shall  be  deemed  to  be  “intellectual  property”  within  the  meaning  of  11  U.S.C.  365(n).  The
Parties hereto agree that MIMEDX, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under
the  U.S.  Bankruptcy  Code  including,  without  limitation,  its  rights  pursuant  to  11  U.S.C.  365(n).  The  Parties  further  agree  that  (a)  in  the  event  of  the
commencement of bankruptcy proceedings by or against Turn under the U.S. Bankruptcy Code, MIMEDX shall be entitled to retain all of its rights under
this Agreement; provided, that MIMEDX continues to perform under the Agreement; and (b) to avoid a loss of rights under this Agreement in the event of
a bankruptcy proceedings by or against MIMEDX under the U.S. Bankruptcy Code, Turn hereby is granted and obtains a lien against the license rights to
the  “intellectual  property”  granted  by  this  Agreement  for  continued  payment  as  a  secured  creditor  under  the  U.S.  Bankruptcy  Code.  MIMEDX  will
cooperate with Turn to execute document(s) to perfect this security interest. Except as provided herein in connection with sublicensing under and subject to
this Agreement, MIMEDX may not, as part of a bankruptcy proceeding, assign or transfer any of its rights or obligations under this Agreement without the
prior  written  consent  of  Turn,  such  consent  not  to  be  unreasonably  withheld,  whether  by  operation  of  law  or  otherwise,  including  in  connection  with  a
change in control, merger, acquisition, consolidation, asset sale or other reorganization, and any attempt at such assignment or transfer will be void.

ARTICLE 3    
PAYMENTS, ROYALTIES and MILESTONES

3.1    Royalty Payments on Products.

3.1.a    Royalty Rate on Sales Amount. Subject to the terms and conditions of this Agreement, in further consideration of the
license granted by Turn to MIMEDX under this Agreement, during the Royalty Term, MIMEDX shall pay to Turn on a quarterly basis a royalty of [***] of
Net Sales.

3.1.b    Royalty Reports; Royalty Payment. Commencing in the first Calendar Quarter following the Launch Date, MIMEDX
shall  provide  to  Turn  a  written  report  within  forty-five  (45)  days  of  the  end  of  each  Calendar  Quarter  during  the  Term,  setting  forth:  (i)  the  MIMEDX
calculation  of  Net  Sales  of  each  Product  during  such  Calendar  Quarter;  and  (ii)  the  total  royalties  payable  to  Turn  hereunder.  Simultaneously  with  the
delivery of each such report, MIMEDX shall pay to Turn the total royalties due to Turn for the period of such report. If no royalties are due, MIMEDX
shall so report. In the event that MIMEDX or its Affiliates or Sublicensees make any adjustment to such deductions after the associated Net Sales

6

 
have been reported pursuant to this Section 3.1.b, the adjustments and payment of any amounts due shall be reported with the next quarterly report.

3.1.c    Records. MIMEDX shall keep, and shall require its Affiliates and Sublicensees to keep, complete and accurate records
related to Product in sufficient detail to enable the royalties payable under this Agreement to be determined. Such records shall be kept at the principal
place of business of MIMEDX for at least thirty-six (36) months following the end of the Calendar Year to which such books and records pertain.

3.1.d        Audits. Upon  Turn’s  reasonable  request,  but  not  more  frequently  than  once  in  each  Calendar  Year  during  the  Term
(except  as  required  by  law  or  regulators),  MIMEDX  shall  permit  an  independent  certified  public  accountant  selected  by  Turn,  reasonably  acceptable  to
MIMEDX  in  good  faith,  and  operating  under  a  confidentiality  agreement  acceptable  to  MIMEDX  in  its  sole  discretion,  to  have  access  during  normal
business hours to such records of MIMEDX and its Affiliates at MIMEDX’s principal place of business for the purpose of and to the extent necessary to
verify the accuracy of the reports provided by MIMEDX pursuant to Section 3.1.b. The independent public accountant shall disclose to Turn only (a) the
accuracy of Net Sales reported and the basis for royalty payments made to Turn under this Agreement and (b) the difference, if any, by which such reported
and paid amounts vary from amounts determined as a result of the audit and the details concerning such difference. Except as required by applicable law,
no other information shall be provided to Turn. No record may be audited more than once and audits may not be conducted for any calendar year ending
more than three (3) years prior to the date of such request. If such accounting firm identifies in its written report a discrepancy made during any period,
MIMEDX  shall  pay  to  Turn  any  underpayment  discovered  by  such  audit  within  thirty  (30)  days  after  the  accountant’s  report.  If  the  audit  reveals  an
overpayment by MIMEDX, then MIMEDX may take a credit for such overpayment against any future payments due to Turn. If the audit reveals either an
overpayment or accurate payments by MIMEDX, then Turn’s next opportunity to audit MIMEDX’s royalty payments shall be delayed (i.e., skip) a year. If
Turn opts not to conduct an audit during any Calendar Year, or if due to a prior audit Turn’s loses the right to conduct an audit during a Calendar Year, Turn
does not lose the right to audit any royalty payments not previously audited by Turn. The written report from any audit shall identify the royalty payments
being  audited  and  shall  be  binding  upon  the  Parties.  The  fees  charged  by  such  accounting  firm  shall  be  paid  by  Turn,  unless  the  audit  discovers  an
underpayment by MIMEDX of ten percent (10%) or more of the total amounts due hereunder in the audited period, in which case such fees shall be paid by
MIMEDX.

3.1.e    Adjustment for Third Party Royalties. If MIMEDX reasonably believes that it is necessary to obtain or maintain a license
from any Third Party under any Patent Rights in order to Manufacture or Commercialize a Product in the Field and in the Territory (each, a “Third Party
License”), then MIMEDX will have the right to credit up to fifty percent (50%) of any royalty payments actually paid by MIMEDX or its Affiliates under
such Third Party License in any Calendar Quarter against any royalty payment payable to Turn for such Product; provided that Turn’s contribution shall
never  exceed  fifty  percent  (50%)  of  the  royalties  due  and  owing  to  Turn  under  this  Agreement  for  such  Product  without  the  Third  Party  License.
Notwithstanding  the  foregoing,  all  royalties  MIMEDX  is  required  to  pay  to  a  Third  Party  in  connection  with  the  [***]  may  be  deducted  from  royalty
payments payable to Turn without regard to the limitations set forth in this Section 3.1e.

(in the aggregate by MIMEDX itself, an Affiliate or a Sublicensee) of each milestone event set forth below.

3.2    Milestone Payments. MIMEDX will pay Turn the non-refundable one-time payments set forth in the table below upon achievement

I.

Execution of the Agreement

Milestone

Payment

$[***]

7

I.

I.

I.

I.

I.

The later of Flex Product: (i) Marketing
Approval in the United States from the FDA,
(ii) MIMEDX entering into the Supply
Agreement, or (iii) Turn’s completion of the
regulatory and quality activities set forth in
Exhibit D (“Turn Activities”)

Upon Launch of each Product

First occurrence of aggregate Product(s) Net
Sales in the Territory of greater than [***]
during a Calendar Year.

First occurrence of aggregate Product(s) Net
Sales in the Territory of greater than [***]
during a Calendar Year.

First occurrence of aggregate Product(s) Net
Sales in the Territory of greater than [***]
during a Calendar Year.

         $[***]

$[***]

$[***]

$[***]

$[***]

8

I.

I.

I.

First occurrence of aggregate Product(s) Net
Sales in the Territory of greater than [***]
during a Calendar Year.

First occurrence of aggregate Product(s) Net
Sales in the Territory of greater than Two
Hundred Million Dollars ($200,000,000)
during a Calendar Year.

First Occurrence of aggregate Product(s) Net
Sales greater than [***] during a Calendar
Year for two (2) consecutive Calendar Years.

$[***]

$[***]

$[***]

MIMEDX shall notify Turn in writing within sixty (60) days after the achievement of each such milestone event set forth in this Section 3.2 and each such
notice shall be accompanied by the corresponding milestone payment set forth in this Section 3.2. Further each Milestone IV-IX shall only payable once
upon the first occurrence of such event.

ARTICLE 4    
DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT

4.1        Development  and  Commercialization  of  Products.  MIMEDX  shall  use  Commercially  Reasonable  Efforts  to  Develop  and/or
Commercialize one or more Products under this Agreement. MIMEDX shall be solely responsible for and have sole authority to conduct all Development
and Commercialization activities that are required to commercialize the Product(s) in the Field in the Territory, including (i) developing and executing a
commercial launch plan, (ii) developing a strategy for, and negotiating with applicable Regulatory Agencies regarding the price and reimbursement status
of the Product, (iii) marketing and promotion, (iv) booking sales, and distribution and performance of related services, (v) handling all aspects of order
processing, invoicing, (vi) providing customer support, and (vii) conforming its practices and procedures to applicable Law relating to the marketing and
promotion of the Product in the Field in the Territory. Without limiting Section 3.2, Turn acknowledges and agrees that MIMEDX does not guarantee that it
will  be  successful  in  any  Development  or  Commercialization  efforts  hereunder,  including,  without  limitation,  as  the  result  of  any  failure  to  obtain
Marketing Approvals with respect to a Product in particular jurisdictions. Notwithstanding the generality of the foregoing, MIMEDX will be responsible
for

9

 
complying with all applicable Laws and regulatory responsibilities, regarding its use of the Licensed Technology, Licensed Trademark, and all its activities
associated with Commercialization of the Product.

4.2    Licensed Trademarks.

4.2.a    Use of Licensed Trademarks. During the Term, and as provided for herein, MIMEDX and its Affiliates and Sublicensees
will  have  the  right  to  use  the  Licensed  Trademarks  only  in  connection  with  the  Commercialization  of  the  Products,  including  by  placing  the  Licensed
Trademarks  on  all  marketing  and  promotional  materials  and  packaging  materials  for  the  Products  (the  “Permitted  Use”).  Unless  otherwise  agreed  in
writing,  MIMEDX  and  its  Affiliates  and  Sublicensees  are  not  permitted  to  make  any  use  of  the  Licensed  Trademarks  in  connection  with  products  or
services other than the Permitted Use. For the avoidance of doubt, nothing under this Section 4.2.a shall be deemed to require MIMEDX or its Affiliates or
Sublicensees  to  mark  any  Product  with  any  Licensed  Trademark.  It  is  understood  that  the  size  and  placement  of  the  Licensed  Trademarks  may  be
subordinate to the trademarks of MIMEDX and its Affiliates. During the term of this Agreement and at all times following termination or expiration of this
Agreement, MIMEDX and its Affiliates and Sublicensees shall not use (a) any trademark or service mark which is confusingly similar to, or a colorable
imitation  of,  the  Licensed  Trademarks  or  any  part  thereof,  or  (b)  any  word,  symbol,  character,  or  set  of  words,  symbols,  or  characters,  which  in  any
language would be identified as the equivalent of the Licensed Trademarks or that are otherwise confusingly similar to, or a colorable imitation of, the
Licensed Trademarks. Neither Party shall knowingly engage in any conduct which may place the Licensed Trademarks in a negative light or context.

4.2.b    Quality Standards. All representations of Licensed Trademarks that MIMEDX intends to use shall be in the form as set
forth on Exhibits B-1 and B-2. If MIMEDX uses any of the Licensed Trademarks, MIMEDX shall cause the appropriate designation “
” or registration
symbol “®” to be placed adjacent to the Licensed Trademarks, and agrees that the nature and quality of advertising, promotional, and other uses of the
Licensed Trademarks by MIMEDX shall conform to standards set by, and be under the control of, Turn. MIMEDX acknowledges and agrees that Turn may
adopt reasonable standards and specifications for the use of the Licensed Trademarks (the “Quality Standards”) and that MIMEDX shall abide by such
Quality Standards in the use of the Licensed Trademarks, provided  that  no  such  Quality  Standard  prohibits  or  inhibits  MIMEDX’s  use  of  the  Licensed
Marks as agreed herein.  MIMEDX acknowledges and agrees that the Turn may amend the Quality Standards from time to time and that, upon written
notice  from  Turn  of  any  and  all  such  amendments,  MIMEDX,  as  soon  as  commercially  practicable  thereafter,  shall  conform  its  marketing,  promoting,
advertising, distributing, provision and selling of Product under Licensed Trademarks to such amended Quality Standards, provided that no such amended
Quality Standard prohibits or inhibits MIMEDX's use of the Licensed Marks as agreed herein.

TM

4.2.c    Rights in Licensed Trademarks. The Licensed Trademarks will remain the exclusive property of Turn, and all use of the
Licensed Trademarks and any goodwill associated therewith shall inure to the exclusive benefit of Turn. Unless otherwise agreed, Turn shall, at its sole cost
and expense, register, maintain, and enforce the Licensed Trademarks at its reasonable and sole discretion. If Turn fails to continue to register, maintain,
and enforce the Licensed Trademarks, Turn will provide MIMEDX with timely notice and will provide MIMEDX with a reasonable opportunity to assume
responsibility for the continued register, maintain, and enforce the Licensed Trademarks.

4.3    Advertising and Promotional Materials. MIMEDX will be responsible for the creation, preparation, production, reproduction and
filing with the applicable Regulatory Agencies, of relevant written sales, promotion and advertising materials relating to the Product as required by Law
(“Promotional  Materials”)  for  use  in  the  MIMEDX  Territory.  All  such  Promotional  Materials  will  be  compliant  with  all  applicable  laws,  rules  and
regulations.

4.4    Launch Date. MIMEDX will use Commercially Reasonable Efforts to have a Launch Date of the FleX Product in the United States
no later than four (4) months after the later of (i) the execution of the Supply Agreement, or (ii) the date of Marketing Approval in the United States from
the FDA for the Product. For clarity, failure of MIMEDX to use Commercially Reasonable Efforts to achieve a Launch Date for the FleX Product in the
United States as provided under this Section 4.4 shall not permit Turn to terminate the license under Licensed Technology granted to MIMEDX hereunder
with respect to its license for the FleX Product unless MIMEDX fails to launch the Product within ten (10) months after the later of (i) or (ii) above. With
the exception of delays to the Launch Date due to Turn’s failure to complete the Turn Activities or other agreed upon regulatory and quality obligations, the
Parties further agree that, if the Product is not launched within the four (4) month period, then MIMEDX shall be obligated to make monthly payment to
Turn in the amount of [***]; provided that such amounts paid to Turn by MIMEDX shall be deducted from Milestone II payment. All payments pursuant to
this Section 4.4 are non-refundable.

ARTICLE 5    
INTELLECTUAL PROPERTY RIGHTS

10

 
5.1        Inventorship. Inventorship  for  patentable  inventions  conceived  or  reduced  to  practice  during  the  course  of  the  performance  of
activities pursuant to this Agreement shall be determined in accordance with the principles that are used to determine inventorship under the patent laws of
the country where such invention is made; provided, however, that if Joint IP is invented in more than one country and one of such countries is the United
States, such inventorship shall, if permitted by the applicable local Law, be determined by United States patent laws; provided, further, however, that any
patent application filed in the United States shall comply with the United States patent laws relating to inventorship.

5.2    Ownership of Inventions.

5.2.a    Subject to the licenses granted to MIMEDX under Section 2.1, as between the Parties, all Inventions and Technology
(including  all  Intellectual  Property  Rights  therein)  Controlled  by  either  Party  prior  to  the  Effective  Date  and/or  developed,  invented  or  conceived  and
reduced to practice by such Party independently from the activities contemplated under this Agreement (collectively, “Background IP”) are and shall, as
between the Parties, remain the sole property of such Party.

5.2.b    Subject to the licenses granted to MIMEDX under Section 2.1, Turn shall own the entire right, title and interest in and to
all  Turn  Inventions  (and  Patent  Rights  claiming  patentable  inventions  therein)  first  made  or  discovered  solely  by  employees  or  consultants  of  Turn  or
acquired solely by Turn.

patentable inventions therein) first made or discovered solely by employees or consultants of MIMEDX or acquired solely by MIMEDX.

5.2.c    MIMEDX shall own the entire right, title and interest in and to all MIMEDX Inventions (and Patent Rights claiming

5.2.d    Unless otherwise agreed in a separate development or other agreement, if MIMEDX and Turn jointly develop, invent or
conceive and reduce to practice any Inventions or Technology during the Term that relate to any Product(s) (“Joint IP”), Turn agrees that it will assign to
MIMEDX all of Turn’s interest in and to such Joint IP, including all Intellectual Property Rights therein, and that such Joint IP shall be deemed MIMEDX
Inventions for the purposes of this Agreement. MIMEDX shall have exclusive rights under such Joint IP in the Field and shall grant, and hereby does grant,
Turn exclusive rights under such Joint IP for all uses outside of the Field. Neither Party shall have any obligation to pay the other Party any royalties or
other fees for exercise of its rights to the Joint IP as set forth herein.

5.3    Prosecution and Maintenance of Patent Rights.

5.3.a    Licensed Patents. During the Term of this Agreement, Turn shall make commercially reasonable efforts to prosecute to
issuance,  maintain  the  Licensed  Patents  and  perfect  the  intellectual  property  rights  licensed  to  MIMEDX  under  this  Agreement,  including  paying  all
applicable fees (including, without limitation, all taxes and maintenance fees) in its sole and reasonable discretion. If Turn fails to continue to prosecute to
issuance or maintain any Licensed Patents or Patent Rights that Cover Turn Inventions pertaining to the Product, prior to abandoning such Licensed Patents
or Patent Rights, Turn will provide MIMEDX with timely notice and will provide MIMEDX with a reasonable opportunity to assume responsibility for the
continued  prosecutions  and  maintenance  of  such  Licensed  Patents  or  Patent  Rights  the  Cover  Turn  Inventions  pertaining  to  the  Product.  If  any  of  the
applications for the Licensed Patents are abandoned, rejected or not maintained and such abandonment, rejection or non-maintenance has a material effect
on the protection offered by the Licensed Technology to MIMEDX, the Parties will negotiate in good faith a reasonable reduction of the Royalty payable to
Turn.  MIMEDX  may  designate  in  writing  any  country  or  countries  in  which  MIMEDX  desires  Turn  to  file,  prosecute  and  maintain  Patent  Rights  (in
addition to those Licensed Patents set forth on Exhibit A). If Turn agrees to file such additional Patent Rights, Turn shall be responsible for paying all
applicable  fees  and  such  additional  Patent  Rights  shall  be  deemed  Licensed  Patents  under  this  Agreement.  If  Turn  does  not  wish  to  file,  prosecute  and
maintain such additional Patent Rights in any country, Turn will assign all such Patent Rights in such country to MIMEDX and MIMEDX shall have the
sole right to prosecute and maintain such Patent Rights in MIMEDX’s name.

Rights comprising MIMEDX’s Background IP and MIMEDX Inventions.

5.3.b    MIMEDX Technology. MIMEDX has the sole right to, at its discretion and expense, to prosecute and maintain all Patent

5.3.c    Joint IP. Subject to Turn’s continuing right to the timely prior review of and comment on material documents, MIMEDX
has the initial right, at its sole discretion, to file, prosecute and maintain all Patent Rights comprising Joint IP in the name of MIMEDX. MIMEDX shall
promptly notified Turn in writing of its intention to (or not to) file, prosecute or maintain any or all such Patent Rights, or to abandon any or all such Patent
Rights. If MIMEDX opts not to file, prosecute or maintain any or all Joint IP Patent Rights, Turn shall have the right, at its sole discretion, to file, prosecute
and

11

maintain all Patent Rights comprising Joint IP. The Parties shall use Commercially Reasonable Efforts to make available to the other Party or its authorized
attorneys, agents or representatives, such of its employees, consultants and representatives as the Party filing, prosecuting or maintaining said Patent Rights
deems necessary in order to assist in obtaining or maintaining patent protection for Joint IP. Each Party shall sign, or use Commercially Reasonable Efforts
to have signed, all legal documents necessary to file and prosecute patent applications or to obtain or maintain patents in respect of such Joint IP, at its own
cost and expense.

5.3.d    Cooperation; Patent Challenges. Each Party hereby agrees: (i) to make its employees, agents and consultants reasonably
available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable such Party
to undertake patent prosecution for the Licensed Patents, Patent Rights in any Turn Inventions or any Joint IP; (ii) to provide the other Party with copies of
all material correspondence pertaining to prosecution of the Licensed Patents, Patent Rights in any Turn Inventions or any Joint IP with the patent offices in
the Territory; (iii) to cooperate, if necessary and appropriate, with the other Party in gaining patent term extensions wherever applicable to the Licensed
Patents, Patent Rights in any Turn Inventions or any Joint IP ; and (iv) to endeavor in good faith to coordinate its efforts with the other Party to minimize or
avoid interference with the prosecution and maintenance of the other Party’s patent applications. Without limiting the foregoing but excluding with respect
to  any  Patent  Rights  in  any  MIMEDX  Inventions,  the  Party  prosecuting  and  maintaining  the  Patent  Rights  shall  furnish  to  the  other  Party  copies  of
substantive documents (e.g., applications, office actions and responses) relevant to any such efforts in advance with sufficient time for such other Party to
review  and  provide  comments  on  such  documents  and  shall  in  good  faith  take  such  comments  into  account.  The  Parties  acknowledge  that  they  have  a
shared community of legal interest in the development of products that can be manufactured, used, sold and otherwise commercialized without infringing
the intellectual property rights of any third party. The Parties may exchange confidential attorney-client communications to advance certain common legal
interests in accordance with this Agreement and shall not disclose such communications to a third party, nor to employees of either party who do not have a
need to know the content of such communication.

to Patent Rights shall be borne by each Party filing, prosecuting and maintaining such Patent Rights under this Article 5.

5.3.e    Patent Expenses. The patent filing, prosecution and maintenance expenses incurred after the Effective Date with respect

5.3.f    Turn’s Rights. For clarity, Turn’s rights to any Background IP and Turn Inventions will be subject to the licenses granted
to MIMEDX under Section 2.1 above, including with for clarity the associated exclusivity obligations with respect to the Field in the Territory for the Term
of this Agreement.

maintain any Patent Rights in any MIMEDX Background IP and any MIMEDX Inventions hereunder in the name of MIMEDX.

5.3g    MIMEDX Rights. For clarity, MIMEDX will have the sole right and authority, in its sole discretion, to file, prosecute and

5.4    Third Party Infringement. Each party will promptly notify the other if it becomes aware of acts of infringement or misappropriation
of the Licensed Technology related to any Product by a Third Party which infringement bears adversely on MIMEDX’s enjoyment of the rights granted
hereunder (“Commercially Relevant Infringement”). The Parties shall provide each other with all evidence or information relating to such Commercially
Relevant Infringement which is available to it and which it is legally able to disclose. MIMEDX shall have the initial right (but not the obligation) during
the Term, at its own cost and expense, to institute and conduct legal action against third-party infringers of the Licensed Technology with respect to the
Product, with counsel determined by MIMEDX. MIMEDX shall notify Turn within thirty (30) days of receiving written notice of Commercially Relevant
Infringement as to whether it intends to commence any legal action. If no legal action is commenced within ninety (90) days of receiving written notice of
Commercially Relevant Infringement, Turn shall have the right during the Term, at its own cost and expense, to institute and conduct legal action against
third-party infringers of the Licensed Technology with respect to the Product, with counsel determined by Turn.

In connection with any action to enforce any Licensed Technology, a Party will provide reasonable cooperation to the Party instituting and conducting legal
action against third-party infringers (the “Enforcing Party”) concerning factual matters including, for example, by becoming a named party in the litigation
if reasonably required to maintain the action, answering discovery requests, and providing testimony at deposition and trial without charge to the Enforcing
Party other than recovery of statutory witness fees and its actual reasonable out-of-pocket costs incurred in connection with providing such cooperation. 
Any and all recoveries from any suit or action instituted or prosecuted based on infringement of the Licensed Technology for the Product shall first be
distributed to reimburse each Party’s reasonable out-of-pocket costs and expenses incurred in connection with the suit or action. The remaining recoveries
shall be shared ninety-ten percent (90%/10%) in favor of MIMEDX if MIMEDX is the Enforcing Party, and on a fifty-fifty percent (50%/50%) basis if
Turn is the Enforcing Party.

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5.5    Claimed Infringement. Except as provided below in Section 5.6, in the event that a Third Party at any time provides written notice
of a claim to, or brings an action, suit or proceeding against, any Party, or any of their respective Affiliates or Sublicensees, claiming infringement of such
Third Party’s Patent Rights based upon an assertion or claim arising out of the Manufacture or Commercialization of a Product in the Field (“Infringement
Claim”), such Party shall promptly notify the other Party thereof, enclosing a copy of the claim and all papers served. MIMEDX, in consultation with Turn,
shall assume primary responsibility to defend and respond to any Infringement Claims brought against either Party or its Affiliate or Sublicensees in the
Territory using legal counsel reasonably acceptable to Turn. Neither Party shall settle any Infringement Claim without the consent of the other Party, such
consent not to be unreasonably withheld or delayed. All liabilities, damages, costs and expenses arising out of such Infringement Claims shall be borne by
Turn; provided that with respect to the [***], MIMEDX shall pay for the litigation expenses and shall thereafter invoice Turn for fifty percent (50%) of
such litigation expenses as they are incurred, and subject to a right to reasonably audit and request reasonable evidence of such invoiced expenses, Turn
shall pay such invoiced amounts to MIMEDX within thirty (30) days of receipt of such invoice. MIMEDX shall keep Turn reasonably informed of the
status of such claims and any defense.

5.6    Inter Partes Review. In the event the Parties agree to file for an Inter Partes Review with respect to any Patent Rights (“IPR”),
MIMEDX, in consultation with Turn, shall assume primary responsibility to litigate the IPR using legal counsel mutually agreed upon by the parties using
reasonable efforts. MIMEDX shall pay for the litigation expenses and shall thereafter invoice Turn for fifty percent (50%) of such litigation expenses as
they are incurred, and Turn shall pay such invoiced amounts to MIMEDX within thirty (30) days of receipt of such invoice.

ARTICLE 6    
MANUFACTURING AND SUPPLY

MIMEDX with its requirements for the FleX Product.

6.1    Supply Agreement. MIMEDX agrees to negotiate in good faith the Supply Agreement pursuant to which a Third Party will supply

6.2    Exclusivity. During the Term, neither Turn nor its Affiliates will supply, or authorize a Third Party to supply, the FleX Product to
any  Third  Party  throughout  the  Territory  for  use  within  the  Field,  and  neither  Turn  nor  its  Affiliates  during  the  Term  will  use  the  FleX  Product  to
Manufacture any product for sale within the Field in the Territory.

ARTICLE 7    
REGULATORY MATTERS

7.1    U.S. Marketing Approval. Turn will (i) oversee, monitor and coordinate all regulatory actions, communications and filings with,
and  submissions  to  the  FDA  with  respect  to  initial  Marketing  Approval  for  the  FleX  Product  in  the  United  States,  (ii)  be  responsible  for  interfacing,
corresponding and meeting with each Regulatory Agency with respect to initial Marketing Approval for the FleX Product in the United States, (iii) until
assigned to MIMEDX in accordance with Section 7.2, be responsible for maintaining all regulatory filings for the FleX Product in the United States, and
(iv) apprise Turn of all material communications from Regulatory Agencies relating to the FleX Product as soon as reasonably possible but in any event
within ten (10) business days after receipt thereof

7.2    Assignment and Transfer of Regulatory Documents and Approvals. Within thirty (30) days following receipt of initial Marketing
Approval  for  the  FleX  Product  in  the  United  States,  Turn  shall  transfer  to  MIMEDX  all  of  Turn’s  right,  title  and  interest  in  and  to  all  such  Marketing
Approvals and all regulatory documents and applications submitted to Regulatory Agencies with respect to the FleX Product.

7.3    Other Regulatory Filings and Interactions. Except as set forth in Sections 7.1 and 7.2, as between the Parties, MIMEDX will own
all Marketing Approvals and any regulatory documents and applications submitted to the applicable Regulatory Agencies with respect to a Product, and
will  (i)  be  solely  responsible  to  oversee,  monitor  and  coordinate  all  regulatory  actions,  communications  and  filings  with,  and  submissions  to,  each
Regulatory  Agency,  (ii)  be  solely  responsible  for  interfacing,  corresponding  and  meeting  with  each  Regulatory  Agency,  (iii)  be  solely  responsible  for
maintaining  all  regulatory  filings,  (iv)  be  identified  as  the  marketing  authorization  holder,  and  (v)  apprise  Turn  of  all  material  communications  from
Regulatory  Agencies  relating  to  the  FLeX  Product  as  soon  as  reasonably  possible  but  in  any  event  within  ten  (10)  business  days  after  receipt  thereof.
Without limiting the terms of this Section 7.3, Turn shall use Commercially Reasonable Efforts to complete the Turn Activities as soon as practicable, and
the Parties shall use Commercially Reasonable Efforts to cooperate to complete the regulatory and quality activities set forth in Exhibit E attached hereto as
soon as practicable (the “Cooperative Activities”).

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ARTICLE 8    
ADVERSE EVENTS; RECALLS

8.1    Notice of Adverse Events. Each Party will maintain a record of any and all complaints it or its Affiliates and Sublicensees receive
with respect to FleX Product. Each Party will notify the other Party in reasonable detail of any such complaints within sufficient time to allow the other
Party  and  its  Affiliates  and  Sublicensees  (if  applicable)  to  comply  with  any  and  all  regulatory  and  other  requirements  imposed  upon  them  in  any
jurisdiction  in  which  the  FleX  Product  is  being  marketed.  MIMEDX  will  maintain  at  its  own  expense  a  common  adverse  event  database  for  the  FleX
Product, and Turn will have access to all data in such adverse event database. MIMEDX shall be responsible, at its own expense, for submitting adverse
event reports with respect to the FleX Product to the applicable Regulatory Agency. The Parties will cooperate in good faith in the exchange of safety data
and  the  collection,  investigation,  reporting,  and  exchange  of  information  concerning  any  adverse  experiences,  and  any  product  quality  and  product
complaints involving adverse experiences, related to the FleX Product, such that each Party is able to comply with its legal and regulatory obligations.

8.2    Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Agency issues or requests a recall or takes a
similar action in connection with the FleX Product, the Party notified of such recall or similar action, shall within twenty-four (24) hours advise the other
Party thereof by telephone, or by email or facsimile together with telephone confirmation. MIMEDX, in its sole discretion, shall decide whether to conduct
a recall and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when MIMEDX may act without
such advance notice but shall notify Turn as soon as possible). MIMEDX shall bear the expense of any such recall in the Field in the Territory (“Recall
Expenses”); provided, however, that Turn shall bear the expense of any such recall to the extent the recall is the result of Turn’s breach of its obligations
under this Agreement.

ARTICLE 9
PAYMENT

9.1    Payment Method. All payments due to Turn under this Agreement shall be made by bank check or wire transfer in immediately
available funds to an account designated by Turn. All payments hereunder shall be made in the legal currency of the United States of America, and all
references to “$” or “Dollars” shall refer to United States dollars (i.e., the legal currency of the United States). MIMEDX is responsible for all taxes other
than taxes imposed with respect to Turn’s income.

9.2    Currency Conversion. In the case of Net Sales made or expenses incurred by MIMEDX and its Affiliates and Sublicensees, the rate
of exchange to be used in computing the amount of currency equivalent in United States dollars due shall be made at the rate of exchange utilized by such
person in its worldwide accounting system and calculated in accordance with GAAP (or in accordance with MIMEDX’s accounting methods applied in the
Territory consistent with applicable law), prevailing on the third to the last business day of the month preceding the month in which such sales or expenses
are recorded, as the case may be.

9.3    Withholding Taxes. MIMEDX may deduct the amount of any taxes imposed on Turn that are required to be withheld or collected by
MIMEDX or its Affiliates or Sublicensees on amounts owing from hereunder to the extent MIMEDX or its Affiliates or Sublicensees pay such withholding
taxes to the appropriate governmental authority on behalf of Turn. MIMEDX will promptly deliver to Turn proof of payment of such taxes together with
copies of all communications from or with such governmental authority with respect thereto.

ARTICLE 10    
REPRESENTATIONS AND WARRANTIES AND COVENANTS

10.1    Mutual Representations and Warranties. Each Party represents and warrants to the other Party that as of the Effective Date:

and authority to enter into this Agreement, and to carry out the provisions hereof.

10.1.a    It is duly organized and validly existing under the laws of its jurisdiction of incorporation, and has full corporate power

persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action.

10.1.b    It is duly authorized to execute and deliver this Agreement, and to perform its obligations hereunder, and the person or

14

 
 
 
10.1.c    This Agreement is legally binding upon it and enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party and by which
it may be bound, or with its charter or by-laws.

granted to the other Party hereunder.

10.1.d    It has not granted, and will not grant, during the Term, any right to any Third Party that would conflict with the rights

10.1.e        Neither  Party  nor  any  of  its  Affiliates  has  been  debarred  or  is  subject  to  debarment  and  neither  Party  nor  any  of  its
Affiliates will use in any capacity, in connection with the exercise of its rights and the performance of its obligations under this Agreement, any person or
entity  that  has  been  debarred  pursuant  to  Section  306  of  the  United  States  Federal  Food,  Drug,  and  Cosmetic  Act  or  any  similar  law  in  any  foreign
jurisdiction, or that is the subject of a conviction described in such section or similar law in any foreign jurisdiction. Each Party agrees to inform the other
Party in writing immediately if it or any person or entity that is performing activities under this Agreement, is debarred or is the subject of a conviction
described  in  Section  306  or  similar  law  in  any  foreign  jurisdiction,  or  if  any  action,  suit,  claim,  investigation  or  legal  or  administrative  proceeding  is
pending or, to the best of the notifying Party’s knowledge, is threatened, relating to the debarment or conviction of the notifying Party or any person or
entity used in any capacity by such Party or any of its Affiliates in connection with the performance of its obligations under this Agreement.

10.2    Representations and Warranties of Turn. Turn makes the following representations and warranties to MIMEDX:

including as necessary to Develop, Manufacture and Commercialize the FleX Product.

10.2.a        Turn  is  the  rightful,  sole,  exclusive  and  beneficial  owner  of  the  Licensed  Technology  and  Licensed  Trademarks,

10.2.b    The Licensed Technology and Licensed Trademarks are valid and enforceable and, to the best of Turn’s knowledge, the
practice and use of the foregoing as set forth under this Agreement will not infringe or violate any Intellectual Property Rights of any third party in the
Territory.

control or making any adverse claim of ownership of the exclusively licensed Intellectual Property Rights in the Territory.

10.2.c    There are no claims pending against or, to the best of Turn’s knowledge, threatened challenging Turn’s ownership or

10.2.d        Except  for  the  [***],  Turn  has  not  received  any  written  notice  from  any  Third  Party  asserting  or  alleging  that  any
Development, Manufacture or Commercialization of a Product by Turn prior to the Effective Date infringed or misappropriate the Patent Rights or other
Intellectual Property Rights of such Third Party.

MIMEDX under this Agreement.

10.2.e        There  are  no  Third-Party  rights  that  could  interfere  with  or  materially  conflict  with  the  grant  of  rights  by  Turn  to

EXCEPT  AS  EXPRESSLY  SET  FORTH  IN  SECTION  10.2,  TURN  DISCLAIMS  ALL  REPRESENTATIONS  AND
WARRANTIES,  WHETHER  WRITTEN,  ORAL,  EXPRESS,  IMPLIED,  STATUTORY,  OR  OTHERWISE,  CONCERNING  THE  VALIDITY,
ENFORCEABILITY, AND SCOPE OF THE LICENSED TECHNOLOGY, THE ACCURACY, COMPLETENESS, SAFETY, USEFULNESS FOR ANY
PURPOSE,  OR  LIKELIHOOD  OF  SUCCESS  (COMMERCIAL,  REGULATORY  OR  OTHER)  OF  THE  PRODUCTS,  LICENSED  TECHNOLOGY,
AND  ANY  OTHER  TECHNICAL  INFORMATION,  TECHNIQUES,  MATERIALS,  METHODS,  PRODUCTS,  PROCESSES,  OR  PRACTICES  AT
ANY TIME MADE AVAILABLE BY TURN, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY, QUALITY, FITNESS FOR A
PARTICULAR  PURPOSE,  NON-INFRINGEMENT,  AND  WARRANTIES  ARISING  FROM  A  COURSE  OF  DEALING,  COURSE  OF
PERFORMANCE, USAGE, OR TRADE PRACTICE.

10.3    MIMEDX Warranties/Disclaimer. Turn acknowledges and agrees that, other than as expressly provided herein, MIMEDX does not
make any representation or warranty or guarantee as to the amount of royalties or milestone payments or fees to be made by MIMEDX or the income that
Turn will derive from this Agreement. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 10.1, MIMEDX DISCLAIMS ALL REPRESENTATIONS
AND  WARRANTIES,  WHETHER  WRITTEN,  ORAL,  EXPRESS,  IMPLIED,  STATUTORY,  OR  OTHERWISE,  INCLUDING  ALL  IMPLIED
WARRANTIES  OF  MERCHANTABILITY,  QUALITY,  FITNESS  FOR  A  PARTICULAR  PURPOSE,  NON-INFRINGEMENT,  AND  WARRANTIES
ARISING FROM A COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE, OR TRADE PRACTICE.

15

10.4    Employee Inventions. Prior to performing any activities in connection with this Agreement, the Parties shall ensure that its and its
Affiliates’ employees, agents and consultants have executed valid and binding agreements with it that assign and otherwise effectively vest in them any and
all rights that such employees, agents and/or consultants might otherwise have in any invention made by such employees, agents and/or consultants. Should
any royalties or other consideration become payable to such employees, agents and/or consultants, the respective Party shall remain solely responsible for
making such payments.

ARTICLE 11    
INDEMNIFICATION; SET-OFF

11.1        By  MIMEDX.  MIMEDX  shall  indemnify,  protect,  defend  and  hold  harmless  Turn,  Affiliates  and  their  respective  directors,
officers,  employees,  successors  and  assigns  from  and  against  any  and  all  liabilities,  damages,  harm,  loss,  costs,  penalties  and  expenses  (including
reasonable attorneys’ fees) (collectively, “Liabilities”), arising out of any claim, complaint, suit, proceeding, or cause of action brought or claimed by any
Third Party (each, a “Claim”) to the extent arising out of, relating to or resulting from (i) MIMEDX’s breach of any representation or warranty made to
Turn under this Agreement; (ii) the acts or omissions of any Sublicensee; or (iii) use by MIMEDX of the Licensed Technology or Licensed Trademarks, the
Manufacture, Commercialization or any sale of the Products by MIMEDX, but excluding any Claim arising out of a Product or Licensed Technology or
Licensed Trademarks for which Turn is liable under this Agreement or obligated to indemnify, protect, defend and hold MIMEDX harmless in accordance
with Section 11.2.

11.2        By Turn. Turn  agrees  to  indemnify,  protect,  defend  and  hold  harmless  MIMEDX,  its  Affiliates  and  their  respective  directors,
officers,  employees,  successors  and  assigns  from  and  against  any  Liabilities,  arising  out  of  any  Claim  to  the  extent  arising  out  of  or  resulting  from:
(i) Turn’s breach of any obligation under this Agreement or any representation or warranty made by Turn to MIMEDX under this Agreement; (ii) a Claim
that the FleX Product or any Licensed Technology as delivered by Turn to MIMEDX, or the Development, Manufacture or Commercialization thereof, by
MIMEDX or any of its sublicensees, distributors or customers, or the use by MIMEDX of the Licensed Trademarks (as authorized by Turn under Section
4.2) infringes upon the U.S. Intellectual Property Right of a Third Party; and (iii)  the [***].

11.3        Indemnification  Procedure.  A  Party,  its  director,  officer,  employee,  successor  or  assign  that  intends  to  claim  indemnification
(“Indemnitee”)  under  this  Article  11  shall  promptly  notify  the  indemnifying  Party  (“Indemnitor”)  in  writing  of  any  Claim  with  respect  to  which  the
Indemnitee intends to claim such indemnification, and, subject to Section 5.5, the Indemnitor shall have sole control of the defense and settlement of the
Claim; provided that the Indemnitor shall not enter into any settlement that admits the fault of Indemnitee without the prior written consent of Indemnitee,
such consent not to be unreasonably withheld. The Indemnitee shall have the right to participate, at its own expense, with counsel of its own choosing in
the defense or settlement of the Claim. The indemnification obligations under this Article 11 shall not apply to amounts paid in settlement of any Claim if
such settlement is effected without the consent of the Indemnitor. The Indemnitee and its employees, at the Indemnitor’s request and expense, shall provide
full information and reasonable assistance to Indemnitor and its legal representatives with respect to Claims.

amounts owed by Turn to MIMEDX under this Agreement or the Supply Agreement.

11.4    Set-Off. MIMEDX may set off any amounts owed to Turn hereunder, including any royalties or milestone payments, against any

ARTICLE 12    
CONFIDENTIAL INFORMATION

12.1    Definition. Each Party may from time to time disclose to the other Party Confidential Information. As used herein, “Confidential
Information” means any information and data disclosed by one Party to the other Party in connection with this Agreement, including all scientific, pre-
clinical, clinical, regulatory, manufacturing, marketing, financial, trade secret and commercial information or data, whether communicated orally or by any
other  method.  Notwithstanding  the  foregoing,  Confidential  Information  shall  not  include  any  information  to  the  extent  that  such  information,  as
demonstrated by written documentation: (i) is or becomes generally available to the public through no fault of the receiving Party; (ii) is known by the
receiving  Party,  other  than  under  an  obligation  of  confidentiality,  at  the  time  of  its  disclosure  by  the  other  Party;  (iii)  is  demonstrably  independently
developed  by  the  receiving  Party  after  the  date  of  disclosure  without  the  application  or  use  of  the  disclosing  Party’s  Confidential  Information;  or
(iv) becomes known to the receiving Party without an obligation of confidentiality from a source other than the disclosing Party without breach of this
Agreement by such Party, provided, that such source has the lawful right to disclose such Confidential Information to such Party.

its respective employees and agents shall not use or disclose to any Third Parties any

12.2    Confidentiality. Except as reasonably necessary to fulfill its obligations or exercise its rights under this Agreement, each Party and

16

 
 
Confidential Information of the other Party. Nothing contained in this Article 12 shall prevent either Party from disclosing any Confidential Information of
the  other  Party  to  the  extent  necessary  in  complying  with  applicable  Laws  or  orders;  provided  that  if  a  Party  is  required  by  Law  to  make  any  such
disclosure of the other Party’s Confidential Information, other than pursuant to a confidentiality agreement, it will, to the extent legally permissible, give
reasonable  advance  notice  to  the  other  Party  of  such  disclosure  and  will  use  its  reasonable  efforts  to  secure  confidential  treatment  of  such  Confidential
Information. Notwithstanding the foregoing: a Party may disclose the other Party’s Confidential Information to the extent required by Regulatory Agencies
in connection with Product.

12.3    Prior Agreements. This Agreement supersedes the Letter of Intent between MIMEDX and Turn dated January 21, 2022, the Letter
of Intent between MIMEDX and Turn dated February 28, 2022 (collectively, the “Prior LOIs”), the Non-Disclosure Agreement between MIMEDX and
Turn and dated August 16, 2021 (the “Prior NDA”) and the FleX License with respect to information disclosed thereunder. All  information  exchanged
between the Parties under the Prior LOIs and the Prior NDA shall be deemed to have been disclosed under this Agreement and shall be subject to the terms
of this Article 12 from and after the Effective Date.

12.4        Confidential  Terms.  Each  Party  shall  treat  the  terms  of  this  Agreement  as  the  Confidential  Information  of  the  other  Party.
Notwithstanding  anything  to  the  contrary,  however,  each  Party  may  disclose  the  terms  of  this  Agreement  (i)  to  advisors,  actual  or  potential  investors,
acquisition  partners  and  others  on  a  need-to-know  basis  under  circumstances  that  reasonably  ensure  the  confidentiality  thereof,  or  (ii)  as  required  by
securities or other applicable Laws or regulations, such as SEC regulations.

12.5    FOIA. In the event either Party receives a request under the United States Freedom of Information Act (5 U.S.C. §552) or similar
Law related to the Licensed Technology, any Marketing Approval or this Agreement, such Party shall promptly deliver a copy of such request to the other
Party. The Parties agree to work in good faith in responding to such request, including, by redacting any information not required by such Laws.

ARTICLE 13    
TERM AND TERMINATION

13.1    Term of Agreement. The initial term of this Agreement shall be effective as of the Effective Date and, unless earlier terminated
pursuant to this Article 13, shall remain in effect until the last date on which any Product is covered by a Valid Claim within the Licensed Patents (the
“Term”). Upon expiration of the Term, all licenses granted under Article 2 then in effect shall become fully paid-up, perpetual (exclusive or non-exclusive
as applicable pursuant to Article 2) licenses provided, however, that to the extent MIMEDX thereafter continues to Commercialize the FleX Product and
such Commercialization requires the use of Turn’s trade secrets to Commercialize the FleX Product after the Term, MIMEDX shall pay Turn a royalty of
[***] of Net Sales for the FleX Product made after the Term for a period expiring ten (10) years after Launch of the FleX Product.

13.2    Termination.

13.2.a    By Either Party. This Agreement may be terminated by either Party as follows:

other Party, which breach is not cured within such ninety (90) day period; or

(i)    Upon ninety (90) days prior written notice to the other Party, in the event of a material breach of this Agreement by such

(ii)    Upon prior written notice to the other Party: (i) if the other Party is declared bankrupt by a court of competent jurisdiction,
(ii)  if  a  voluntary  or  involuntary  petition  in  bankruptcy  is  filed  in  any  court  of  competent  jurisdiction  against  the  other  Party  and  such  petition  is  not
dismissed within sixty (60) days after filing, or (iii) if the other Party shall make or execute an assignment of substantially all of its assets related to this
Agreement for the benefit of creditors.

13.2.b        By MIMEDX. MIMEDX  may  terminate  this  Agreement,  or  any  license(s)  granted  herein,  in  whole  or  in  part,  for
convenience upon three (3) months’ prior written notice to Turn.   In addition, MIMEDX may terminate the license to the FleX Product and the related
FleX Product obligations in this Agreement in the event that: (i) the FleX Product does not receive Marketing Approval in the United States from the FDA
by March 31, 2023 or (ii) has not completed the Turn Activities set forth in Exhibit D by March 31, 2023.

fails to launch the FleX Product within ten (10) months after the later of (i) the execution of the

13.2.c By Turn. Turn may terminate this Agreement solely with respect to rights granted for the FleX Product if (i) MIMEDX

17

 
Supply Agreement, or (ii) the date of Marketing Approval in the United States from the FDA for the Product. If Turn terminates this license with respect to
the FleX Product under this Section 13.2, all rights to the FleX Product will revert to Turn as contemplated in Section 13.3(b) and the obligations of Turn in
Section 6.2 shall terminate.

13.3    Effect of Termination.

13.3.a    Termination Dispute. If Turn provides MIMEDX with a notice of a termination for material breach pursuant to Section
13.2a(i) and MIMEDX disputes whether it has materially breached this Agreement or whether the applicable breach has been cured, then MIMEDX may
pursue resolution of such dispute in accordance with Section 15.7. If MIMEDX provides written notice of such dispute in accordance with Section 15.7,
this  Agreement  and  licenses  herein  will  remain  in  full  force  and  effect  for  so  long  as  MIMEDX  pursues  resolution  of  such  dispute  in  accordance  with
Section 15.7  (including  the  pendency  of  any  arbitration  or  dispute  resolution  proceedings),  and  the  cure  period  will  be  tolled  during  pendency  of  the
dispute. If as a result of any dispute resolution proceeding it is determined that MIMEDX did not materially breach the Agreement, or that any material
breach was cured during the cure period), then no termination with be effective and this Agreement and the licenses herein will continue in full force and
effect.

13.3.b    Reversion of Rights. In the event that this Agreement is terminated only with respect to certain of the licenses granted
herein as permitted herein, the remaining rights and licenses shall remain in full force and effect in accordance with and subject to the terms set forth in this
Agreement. In the event that this Agreement is terminated in its entirety by Turn pursuant to Section 13.2 due to uncured material breach by MIMEDX
(and subject to Section 13.3.a) or by MIMEDX under Section 13.2(b), the licenses granted by Turn to MIMEDX under this Agreement shall terminate and
all  rights  in  the  Licensed  Technology  and  Licensed  Trademarks  shall  revert  to  Turn.  In  addition  if  this  Agreement  is  terminated  in  its  entirety  or  with
respect  to  the  FleX  Product,  MIMEDX  shall  as  promptly  as  practicable  transfer  to  Turn  or  Turn’s  designee  (A)  possession  and  ownership  of  all
governmental or regulatory correspondence, conversation logs, filings and approvals (including without limitation all Marketing Approvals and pricing and
reimbursement approvals) relating to the FleX Product and execute any and all documents and carry out any other actions as may be requested by Turn to
assist Turn with all regulatory filings with the applicable Regulatory Agencies required in connection with the termination of this Agreement to ensure that
all Marketing Approvals for the FleX Product in the MIMEDX Territory can be transferred or issued to Turn or Turn’s designee if necessary, and (B) copies
of all data, reports, records and materials in MIMEDX’s possession or Control relating to the FleX Product, including without limitation all non-clinical
and  clinical  data  relating  to  the  Product,  including  without  limitation  customer  lists  and  customer  contact  information  and  all  adverse  event  data  in
MIMEDX’s possession or Control. Upon termination of this Agreement, MIMEDX shall have the right for a period of no more than six (6) months after
the effective date of such termination to sell off any existing Products in its inventory or in the process of Manufacture, in each case as of the effective date
of such termination (the “Sell-Off Period”) and the licenses granted under Section 2.1 shall survive for such period of time for MIMEDX to exercise its
rights under this Section 13.3.b; provided that MIMEDX shall remain obligated to make payment of royalties to Turn for such Product in accordance with
Section 3.1.

time of such termination or expiration, has already accrued to the other Party.

13.3.c    Accrued Liability. Termination or expiration of this Agreement shall not relieve a Party from any liability that, at the

the Term, Sections 5.4 and 5.5 of this Agreement shall survive the expiration or termination of this Agreement for any reason.

13.3.d    Survival. The provisions of Articles 1, 8, 10, 11, 12, 13, 14 and 15 and, with respect to infringement occurring during

ARTICLE 14    
LIMITATION OF LIABILITY/ INSURANCE

14.1        Limitation  of  Liability.  EXCEPT  AS  OTHERWISE  PROVIDED  HEREIN,  IN  NO  EVENT  SHALL  EITHER  PARTY  BE
LIABLE TO THE OTHER PARTY, OR ANY THIRD PARTY, FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES
(INCLUDING DAMAGES FOR LOSS OF BUSINESS OR PROFITS) ARISING FROM ANY CLAIM RELATED TO THIS AGREEMENT OR THE
SUBJECT  MATTER  HEREOF,  WHETHER  SUCH  CLAIM  IS  BASED  ON  CONTRACT,  TORT  (INCLUDING  NEGLIGENCE  AND  STRICT
LIABILITY)  OR  OTHERWISE,  EVEN  IF  SUCH  PARTY  IS  ADVISED  OF  THE  POSSIBILITY  OR  LIKELIHOOD  OF  THE  SAME.  THE
LIMITATIONS  OF  LIABILITY  UNDER  THIS  SECTION  14.1  SHALL  NOT  APPLY  TO  ANY  CLAIMS,  DAMAGES  OR  LIABILITIES  ARISING
FROM (I) BREACH OF ARTICLE 12, (II) BREACH BY TURN OF THE EXCLUSIVITY OBLIGATIONS SET FORTH IN THIS AGREEMENT, (III)
A  PARTY’S  INDEMNIFICATION  OBLIGATIONS  UNDER  THIS  ARTICLE  11,  (IV)  WILFULL  MISCONDUCT  OR  GROSS  NEGLIGENCE  OF  A
PARTY; OR (V) WILFULL MISCONDUCT OR GROSS NEGLIGENCE OF A SUBLICENSEE OR IN THE SUBLICENSING OR MONITORING OF
A SUBLICENSEE.

18

14.2    Insurance.  During  the  Term  and  for  a  period  of  at  least  five  (5)  years  after  the  last  commercial  sale  of  the  Product  under  this
Agreement,  each  Party  shall  obtain  and/or  maintain  in  full  force  and  effect  general  commercial  liability  insurance  that  names  the  other  Party  as  an
additional insured with a reputable, solvent insurer in an amount appropriate for its business and products of the type that are the subject of this Agreement,
but in no event with coverage levels of less than $2,000,000 per occurrence and $10,000,000 in annual aggregate, and in the geographical market in which
the relevant insurable activity is being performed, and for its obligations under this Agreement. Upon request, each Party shall provide the other Party with
evidence of the existence and maintenance of such insurance coverage.

ARTICLE 15    
MISCELLANEOUS

15.1    Entire Agreement; Amendment. This Agreement, including all Exhibits hereto, sets forth the entire agreement and understanding
between the Parties and supersedes all previous agreements, promises, representations, understandings and negotiations, whether written or oral, between
the Parties, with respect to the subject matter hereof, including the Prior LOIs ,the Prior NDA and the FleX License. Upon execution of this Agreement, the
FleX License shall be automatically terminated. None of the terms of this Agreement shall be amended or modified except in writing signed by the Parties
hereto.

15.2        Assignment.  This  Agreement  shall  not  be  assignable  by  either  Party  without  the  prior  written  consent  of  the  other  Party.
Notwithstanding  the  foregoing,  either  Party  may  assign  this  Agreement  without  such  consent  to  a  successor  to  all  or  substantially  all  of  its  business  or
assets to which this Agreement relates, whether by way of merger, consolidation, sale of stock, sale of assets, operation of Law or otherwise; provided that
such assignee assumes in writing the assignor’s obligations under this Agreement and agrees to be bound by the terms and conditions hereof.

15.3    Severability. If, and solely to the extent that, any provision of this Agreement shall be invalid or unenforceable, or shall, if kept
effective in this Agreement, render this entire Agreement to be invalid or unenforceable, such offending provision shall be of no effect and shall not affect
the  validity  of  the  remainder  of  this  Agreement  or  any  of  its  provisions;  provided, however,  the  Parties  shall  use  their  respective  reasonable  efforts  to
renegotiate the unenforceable provisions to best accomplish the original intentions of the Parties with respect to such provisions.

15.4        Waivers. Any  waiver  of  the  terms  and  conditions  hereof  must  be  explicitly  in  writing.  A  waiver  by  any  Party  of  any  term  or
condition of this Agreement in any one instance shall not be deemed or construed to be a waiver of such term or condition for any similar instance in the
future or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative
and none of them shall be a limitation of any other remedy, right, undertaking, obligation or agreement.

15.5    Force Majeure. Neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this
Agreement (except for an obligation to pay) for the time and to the extent such failure or delay is directly caused by earthquake, riot, civil commotion, war,
terrorist  acts,  strike,  flood,  plague,  epidemic,  pandemic  or  governmental  acts  or  restriction,  or  other  cause  that  is  beyond  the  reasonable  control  of  the
respective Party (“Force Majeure Event”). The Party affected by such force majeure will provide the other Party with full particulars thereof as soon as it
becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities) and will use Commercially
Reasonable Efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable. If the performance of
any such obligation under this Agreement is delayed owing to such a force majeure for any continuous period of more than ninety (90) days, the Parties
will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement.

principles and excluding the 1980 U.N. Convention on Contracts for the Biosciences Sale of Goods.

15.6    Governing Law. This Agreement shall be governed by the Laws of the State of Delaware, without reference to conflict of Laws

15.7    Disputes. In the event of any dispute or claim arising out of or in connection with this Agreement, or the performance, breach or
termination  thereof,  either  Turn  or  MIMEDX  may,  by  written  notice  to  the  other  Party,  have  such  dispute  referred  to  the  Chief  Executive  Officers  (or
designee) of Turn and MIMEDX, for attempted resolution by good faith negotiations. The Parties will negotiate in good faith and reasonably for a period of
not less than ninety (90) days. If the Parties are unable to resolve such dispute within such ninety (90) day period, such dispute shall be finally settled by
binding  arbitration  by  the  American  Arbitration  Association  (the  “AAA”)  under  its  rules  of  arbitration,  by  a  single  arbitrator  selected  by  the  mutual
agreement of the Parties; provided that if the Parties are unable to agree on an arbitrator, the arbitrator shall be appointed in accordance with the AAA rules.
The decision and/or award rendered by the arbitrator shall be written, final and non-

19

 
appealable, and judgment on such decision and/or award may be entered in any court of competent jurisdiction. The arbitral proceedings and all pleadings
and evidence shall be in the English language. The place of arbitration shall be in the State of Delaware, U.S.A. The  costs  of  any  arbitration,  including
administrative fees and fees of the arbitrator(s), shall be shared equally by the Parties to the dispute, unless otherwise determined by the arbitrator(s). Each
Party  shall  bear  the  cost  of  its  own  attorneys’  and  expert  fees.  The  Parties  agree  that,  any  provision  of  applicable  Law  notwithstanding,  they  will  not
request, and the arbitrator shall have no authority to award, punitive or exemplary damages against any Party.

certified airmail (postage prepaid), overnight courier or by facsimile (receipt confirmed) and addressed as follows:

15.8    Notices. Any  notice,  consent  or  approval  permitted  or  required  under  this  Agreement  shall  be  in  writing  sent  by  registered  or

If to Turn:    
Turn Therapeutics
250 N Westlake BLVD, Suite 210
Westlake Village, CA 91362    

If to MIMEDX:

Attn: General Counsel
MiMedx Group, Inc.
1775 W Oak Commons Ct
Marietta, Georgia 30062    
Fax: (770) 590-3567

All notices shall be deemed to be effective on the business day after delivery of such notice to the overnight courier, the day such notice is
received by addressee via registered or certified mail, or the day on which such notice is sent by facsimile. In case any Party changes its address at which
notices are to be received, written notice of such change shall be given as soon as practicable to the other Party.

hereof.

15.9    Implied Obligations. This Agreement sets forth all of the rights and obligations of the Parties with respect to the subject matter

15.10        Relationship  of  the  Parties.  The  relationship  hereby  established  between  MIMEDX  and  Turn  is  solely  that  of  independent
contractors;  this  Agreement  shall  not  create  an  agency,  partnership,  joint  venture  or  employer/employee  relationship,  and  nothing  hereunder  shall  be
deemed to authorize either Party to act for, represent or bind the other except as expressly provided in this Agreement.

15.11    Third Party Beneficiaries. Except  solely  on  behalf  of  Indemnitees  with  respect  to  the  enforcement  of  Article  11  on  behalf  of
themselves, nothing herein shall be deemed to create (by implication or otherwise) any right on behalf of any Third Party to enforce any provision of this
Agreement or any other right.

which together shall constitute a single instrument.

15.12    Counterparts. This Agreement may be executed in two or more counterparts, each of which shall constitute an original, and all of

15.13    Remedies. In addition to any other relief afforded under the terms of this Agreement or by law, each Party has the right to seek
enforcement this Agreement by injunction issued against the other Party, it being understood that both damages and an injunction may be proper modes of
relief and are not to be considered as alternative remedies.

15.14 Publicity. Neither Party may issue or release any announcement, statement, press release, or other publicity or marketing materials
relating to this Agreement or, unless expressly permitted under this Agreement, otherwise use the other party's trademarks, service marks, trade names,
logos, domain names, or other indicia of source, association, or sponsorship, in each case, without the prior written consent of the other Party.

[remainder of page left blank intentionally; signature page follows]

20

    
 
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the Effective Date by their duly
authorized officers.

GLOBAL HEALTH SOLUTIONS, INC. MIMEDX GROUP, INC.

By: /s/ Bradley Burnam By: /s/ K. Todd Newton
Name: Bradley Burnam Name: K. Todd Newton
Title: CEO Title: Interim Chief Executive Officer

List of Exhibits:

Exhibit A    Licensed Patents
Exhibit B-1    Exclusive Licensed Trademarks
Exhibit B-2    Non-Exclusive Licensed Trademarks
Exhibit C    Product Description
Exhibit D    Turn Activities
Exhibit E    Cooperative Activities
Exhibit F    [***]

[***]  Certain  information  in  this  document  has  been  excluded  pursuant  to  Regulation  S-K,  Item  601(b)(10).  Such
excluded information is not material and is the type that the registrant treats as private or confidential. 

Exhibit 21.1

Company
MiMedx Tissue Services, LLC
MiMedx Processing Services, LLC
MiMedx Japan, Godo Kaisha

MiMedx Group, Inc. 

List of Subsidiaries

Jurisdiction of Organization
Georgia
Florida
Japan

 
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in Registration Statement No. 333-259103 on Form S-3 and Registration Statement
Nos. 333-251434, 333-211900, 333-199841, 333-189784, 333-183991, 333-153255 and 333-265689 on Form S-8 of our reports
dated February 28, 2023, relating to the financial statements of MiMedx Group, Inc. and subsidiaries and the effectiveness of
MiMedx Group, Inc. and subsidiaries’ internal control over financial reporting appearing in this Annual Report on Form 10-K for
the year ended December 31, 2022.

/s/ Deloitte & Touche LLP
Atlanta, Georgia
February 28, 2023

Consent of Independent Registered Public Accounting Firm

MiMedx Group, Inc.
Marietta, Georgia

We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-259103) and Form S-8
(No. 333-153255, 333-183991, 333-189784, 333-199841, 333-211900, 333-251434 and 333-265689) of MiMedx Group, Inc. of
our reports dated March 8, 2021, except with respect to our opinion on the consolidated financial statements infsofar as it relates
to  the  change  in  reportable  segments  discussed  in  Notes  2  and  13,  as  to  which  the  date  is  February  28,  2023,  relating  to  the
consolidated financial statements and schedule, which appear in this Form 10-K.

/s/ BDO USA, LLP
Atlanta, Georgia
February 28, 2023

CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO RULES 13a-14(A) AND 15d-14(A)
OF THE SECURITIES EXCHANGE ACT OF 1934

Exhibit 31.1

I, Joseph H. Capper, certify that:

1. I have reviewed this Annual Report on Form 10-K of MiMedx Group, Inc. (the “Report”); 

2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the

statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;

3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:

(a)  Designed  such  disclosure  controls  and  procedures,  or  caused  such  disclosure  controls  and  procedures  to  be  designed  under  our
supervision,  to  ensure  that  material  information  relating  to  the  registrant,  including  its  consolidated  subsidiaries,  is  made  known  to  us  by
others within those entities, particularly during the period in which this Report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision,  to  provide  reasonable  assurance  regarding  the  reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for
external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this Report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this Report based on such evaluation; and

(d) Disclosed in this Report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)  All  significant  deficiencies  and  material  weaknesses  in  the  design  or  operation  of  internal  control  over  financial  reporting  which  are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.

Date:

February 28, 2023

/s/ Joseph H. Capper
Joseph H. Capper
Chief Executive Officer

 
 
 
 
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULES 13a-14(A) AND 15d-14(A)
OF THE SECURITIES EXCHANGE ACT OF 1934

Exhibit 31.2

I, Peter M. Carlson, certify that:

1. I have reviewed this Annual Report on Form 10-K of MiMedx Group, Inc. (the “Report”);

2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the

statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;

3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Report;

4.  The  registrant’s  other  certifying  officer  and  I  are  responsible  for  establishing  and  maintaining  disclosure  controls  and  procedures  (as  defined  in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:

(a)  Designed  such  disclosure  controls  and  procedures,  or  caused  such  disclosure  controls  and  procedures  to  be  designed  under  our
supervision,  to  ensure  that  material  information  relating  to  the  registrant,  including  its  consolidated  subsidiaries,  is  made  known  to  us  by
others within those entities, particularly during the period in which this Report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision,  to  provide  reasonable  assurance  regarding  the  reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for
external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this Report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this Report based on such evaluation; and

(d) Disclosed in this Report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)  All  significant  deficiencies  and  material  weaknesses  in  the  design  or  operation  of  internal  control  over  financial  reporting  which  are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.

Date:

February 28, 2023

/s/ Peter M. Carlson
Peter M. Carlson
Chief Financial Officer

 
 
 
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32.1

    The undersigned Joseph H. Capper, the Chief Executive Officer of MiMedx Group, Inc. (the “Company”), has executed this certification in connection
with the filing with the Securities and Exchange Commission of the Company’s Annual Report on Form 10-K for the period ending December 31, 2022
(the  “Report”).  Pursuant  to  18  U.S.C.  Section  1350,  as  adopted  pursuant  to  Section  906  of  the  Sarbanes-Oxley  Act  of  2002,  the  undersigned  hereby
certifies, to his knowledge, that:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date:

February 28, 2023

/s/ Joseph H. Capper
Joseph H. Capper
Chief Executive Officer

 
 
 
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 Exhibit 32.2

    The undersigned Peter M. Carlson, the Chief Financial Officer of MiMedx Group, Inc. (the “Company”), has executed this certification in connection
with the filing with the Securities and Exchange Commission of the Company’s Annual Report on Form 10-K for the period ending December 31, 2022
(the  “Report”).  Pursuant  to  18  U.S.C.  Section  1350,  as  adopted  pursuant  to  Section  906  of  the  Sarbanes-Oxley  Act  of  2002,  the  undersigned  hereby
certifies, to his knowledge, that:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date:

February 28, 2023

/s/ Peter M. Carlson
Peter M. Carlson
Chief Financial Officer