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Item 1. Business

2025-02-26 compared with 2024-02-28 · 142 added, 176 removed, 305 unchanged (51% of the section changed)

MIMEDX is a pioneer and leader in placental biologics focused on helping humans heal by addressing unmet clinical needs.

MIMEDX is a pioneer and leader in placental biologics focused on helping humans heal.

With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare.

The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life.

With deep expertise and real-world data in the field of placental biologics, MIMEDX develops and distributes placental tissue allografts that are manufactured using patent-protected, proprietary processes for multiple sectors of healthcare.

Today, our product portfolio is made up entirely of human placental allografts, which are human tissues that are derived from one person (the donor) and used to produce products that treat multiple people (the recipients).

MIMEDX has supplied roughly three million allografts, through all shipments, filling direct orders and consignment orders, through December 31, 2023.

Our products help clinicians treat patients suffering from chronic and other hard-to-heal wounds.

With deep expertise, leading peer-reviewed data and an expansive library of additional scientific and real-world evidence in the field of placental biologics, MIMEDX develops and distributes placental tissue allografts that are manufactured using patent-protected, proprietary processes for multiple sectors of healthcare.

Additionally, we began offering animal-derived products, or xenografts, in 2024 and have plans to further expand our product offering to serve our large and growing customer base.

Today, our product offering is comprised of solutions designed to help clinicians treat patients suffering from chronic and other hard-to-heal wounds, primarily in the wound care, burn, and surgical sectors of healthcare.

These wounds can be slow to respond or unresponsive to conventional treatments and may benefit from advanced treatments, such as through the use of our products, in order to support the healing process.

The manufacturing of our product offering begins with donated birth tissue, namely the placenta, umbilical cord and placental disc, which we source through a large donor network developed over multiple years with leading hospitals and clinician groups.

Our placental allografts are human tissues that are derived from one person (the donor) and used to process products that treat multiple people (the recipients).

The manufacturing of our human derived product offering begins with donated birth tissue, namely the human placental membrane, umbilical cord and the placental disc, which we source through a large donor network developed over multiple years with leading hospitals and clinician groups.

In partnership with these facilities, we are able to obtain donated birth tissue from consenting mothers, which then are shipped to our manufacturing facilities in Marietta, Georgia, and undergo a series of testing followed by our proprietary tissue manufacturing workflow, which we refer to as the PURION® process.

MIMEDX has supplied over three million allografts, through all shipments, filling direct orders and consignment orders, through December 31, 2024.

In 2024, we obtained the exclusive rights for and launched our first xenograft product and first U.S.

Food & Drug Administration (“ FDA ”) 510(k)-cleared product, HELIOGEN™ Fibrillar Collagen Matrix, a particulate product aimed at addressing complex wounds primarily in the surgical setting.

HELIOGEN is manufactured by Regenity Biosciences, a developer and manufacturer of bioresorbable technologies.

We employ Current Good Tissue Practices (“ CGTP ”) and terminal sterilization to produce our allografts.

MIMEDX provides products primarily for use in the wound care, burn, and surgical 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.

We devote significant research and development resources and expertise to the therapeutic potential of placental tissue in an effort to grow our product offering, develop innovative products that address a wide range of chronic and acute health conditions affecting large patient populations, and generate best-in-class clinical evidence and data to support the use of our products.

All of our products sold in the United States are regulated by the FDA, and to the extent we sell our products outside the United States, by other regulatory agencies in such international markets.

We devote significant research and development resources and expertise to the therapeutic potential of human derived, animal derived and synthetic tissues in an effort to grow our product offering, develop innovative products that address a wide range of chronic and acute health conditions affecting large patient populations, and generate best-in-class clinical evidence and data to support the use of our products.

Market Overview

Domestic sales currently account for substantially all of our revenue today.

Domestic sales currently account for the vast majority of our revenue today.

In the United States, our primary areas of clinical use include applications in surgical settings as well as for the treatment of wounds and burns.

Additionally we are actively pursuing international expansion, primarily targeting Japan, as discussed below.

The unmet need for healing solutions is large and growing, with an estimated 2.1% of the total U.S.

population, or approximately 7 million people, suffering from chronic, non-healing wounds 1 .

The treatment of chronic wounds is often referred to as Advanced Wound Care (“ AWC ”).

Additionally we continue to pursue international expansion, primarily targeting Japan, as discussed below.

The unmet need for healing solutions is large and growing, with an estimated 1-2% of the population in developed countries and worldwide experiencing a chronic wound sometime in their lives 1 .

In the U.S., the most recently available data indicates that chronic wounds affect 10.5 million Medicare beneficiaries and nearly 2.5% of the total population in the U.S.

22 The treatment of chronic wounds with advanced treatments is often referred to as Advanced Wound Care (“ AWC ”).

Chronic wounds are defined and characterized as those that do not progress through the normal process of healing and remain open for an extended period of time, which, depending on the wound, can be from several weeks to a few months.

There are numerous underlying causes of these wounds, with this patient population typically sharing some combination of comorbidities, including age, obesity, smoking history, diabetes and heart and vascular diseases.

Due to the rising incidence of each of these factors, we expect the AWC market will continue to grow.

Due to the rising incidence of each of these factors, we expect the AWC market will continue to grow worldwide.

Patients present with chronic wounds in a variety of care settings and these wounds vary in severity and complexity to treat.

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Taken together, nearly 60% of the chronic wounds in the U.S.

are categorized as chronic leg ulcers (which include DFUs and VLUs), with 47% treated with Advanced Wound Care dressings such as skin substitutes 2 .

These wounds require intervention and active management by clinicians and are treated in a variety of sites-of-service, with numerous products aimed at achieving healing for the patie

1 Chronic Wounds:

Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

2 GlobalData:

2022 Wound Care Management- Tissue Engineered Skin Subs U.S.

Updated May 2022

are categorized as chronic leg ulcers (which include DFUs and VLUs), with 47% of these wounds treated with Advanced Wound Care dressings such as skin substitutes 3 .

These wounds require intervention and active management by clinicians and are treated in a variety of sites-of-service, with numerous products aimed at achieving healing for the patient.

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 large and 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 exceeds $28 billion 3 .

The overall cost of treating chronic wounds is rising sharply, and the annual estimated cost in the United States has recently been estimated to exceed $28 billion 4 .

Complications from non-healing chronic wounds can ultimately result in significant, life-altering adverse outcomes, such as limb amputation 5 .

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MIMEDX is a leader in the cellular tissue products/skin substitute segment of the AWC category and the amniotic tissue allograft sub-category.

The AWC market is comprised of many product types, such as medical devices, advanced dressings, xenografts, biological products, and Human Cells, Tissues, and Cellular and Tissue - Based Products ( “HTC/Ps” ), which are used as skin substitutes to treat severe and chronic wounds.

The AWC market is comprised of many product types, such as medical devices, advanced dressings, xenografts, synthetically derived grafts, biological products, and Human Cells, Tissues, and Cellular and Tissue - Based Products ( “HCT/Ps” ), which are used as skin substitutes to treat severe and chronic wounds.

Not included in AWC 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.

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While historically we have focused primarily on the U.S.

market, we are in the process of expanding our footprint internationally, most notably with the recent launch of our EPIFIX product in Japan.

EPIFIX is the first and currently the only amniotic tissue product approved in Japan for wound treatment across a broad range of conditions.

market, we are in the process of expanding our footprint internationally, most notably in Japan where EPIFIX is the first and currently the only amniotic tissue product approved in the country 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 Chronic Wounds Primer, https://pmc.ncbi.nlm.nih.gov/articles/PMC10352385/

2 Human Wound and Its Burden:

Updated 2022 Compendium of Estimates, https://pmc.ncbi.nlm.nih.gov/articles/PMC10615092/

3 GlobalData:

2022 Wound Care Management- Tissue Engineered Skin Subs U.S.

Updated May 2022

4 Chronic Wounds:

Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

5 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

6 Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease, https://www.ahajournals.org/doi/10.1161/ATVBAHA.120.314595

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, oftentimes advanced therapies are not employed due to current treatment guidelines, product access, or medical education around the clinical and economic benefits of AWC products, including skin substitutes.

We believe this represents a large opportunity for us to expand the market and drive initiatives resulting in market growth.

According to recent data, 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, EPICORD® and EPIEFFECT® products can be stored at room temperature for up to five years, in contrast to certain other skin substitutes currently on the market that have performance, storage or handling limitations.

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Our EPICORD, EPICORD Expandable and EPIEFFECT product lines also offer an alternative treatment option to address larger, deeper wounds in a cost-effective way at a point earlier in the treatment algorithm.

With broad payor coverage, the largest body of Level 1 clinical evidence among placental allograft products and a dedicated sales team calling on each of the major sites-of-service, we expect to continue to expand our presence in the AWC market, driving future growth of our business 6 .

3 Chronic Wounds:

Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

4 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

5 Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease, https://www.ahajournals.org/doi/10.1161/ATVBAHA.120.314595

With broad commercial payor coverage, Medicare coverage under the Local Coverage Determinations (“ LCDs ”) scheduled for implementation in April 2025, the largest body of Level 1 clinical evidence among placental allograft products and a dedicated sales team calling on each of the major sites-of-service, we expect to continue to expand our presence in the AWC market, driving future growth of our business 7 .

In addition to our presence in the AWC settings, our products are also used in a variety of surgical settings, and our strategic goals include building a body of evidence and real-world use data for our products in a wide range of procedures.

The applications in Surgical range from those involving the closure of an acute wound (which we refer to as “ Surgical Recovery ”), to those where our allografts are used inside the body to protect or reinforce tissues and/or regions of interest.

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.

In other surgical settings, the use of our products in a wide range of procedures presents a growing number of meaningful opportunities for our business.

For example, the use of our tissues in anastomotic procedures has shown a statistically significant reduction in complications arising from leaks.

In other procedures, the need to protect sensitive nerves, tissues or other areas may occur.

We are working with surgeons in a range of disciplines to build the body of clinical, scientific and health outcomes evidence to support the use of our products broadly.

We believe our product offering is ideally suited for applications in a growing number of surgical specialties that we are targeting and expect the utilization of our products to continue to grow over time in this market.

Our strategy is to continue to deliver advanced products that serve patient needs within the Advanced Wound Care and Surgical markets and increase access to our products through clinical data generation and physician education.

Our Strategic Priorities

We manage our business by focusing on the following strategic priorities, which we believe are paramount to the success of MIMEDX over the short- and long-term.

Our first priority is to innovate and diversify our product portfolio to maximize growth.

Achievement of this priority is measured by our ability to maximize our commercial opportunities in the markets we serve with existing and future products, continue to introduce new products from our organic pipeline, such as the late-2023 launch of EPIEFFECT as well as the 2024 launch of HELIOGEN and accelerate market expansion internationally with a particular focus on continuing to grow our presence in Japan.

Our second priority is to develop and deploy programs to expand our surgical footprint.

We believe our ability to further penetrate the surgical setting is significant and will be enabled by our ability to leverage our existing evidence for surgical applications, invest in additional research and data in new indications and to drive market adoption of new surgical products, like our recently launched HELIOGEN offering.

Our third priority is to enhance our customer intimacy, which is a company-wide effort intended to implement programs and introduce offerings in support of lowering customer turnover.

To that end, in March 2024 we launched MIMEDX Connect, an

7 Zelen CM, et al.

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2019;16(3):761-767

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.

In other surgical settings, the need to protect sensitive nerves, tissues or other areas may occur during the course of a procedure and presents an opportunity for the use of our products.

We believe our placental-based allografts are ideally suited for these applications in a growing number of surgical specialties that we are targeting and expect the utilization of our products to continue to grow over time in this market.

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 7 .

We expect the U.S.

wound and surgical market will grow at an annual rate of 7-10% over the next three to five years beginning in 2023 8 .

Our Strategic Priorities

We manage our business by focusing on the following strategic priorities, which we believe are paramount to the success of MIMEDX over the short- and long-term.

Our first priority is to build our leadership position in Wound & Surgical.

Achievement of this priority is measured by our ability to grow in all sites-of-service, regain share in the private office setting and expand our presence throughout the Surgical end markets.

Our second priority is to develop opportunities for MIMEDX in adjacent markets.

We believe our ability to continue to innovate and develop new products has provided us with a rich product pipeline that will result in numerous product launches in future periods.

In addition to these in-house efforts, we are actively evaluating opportunities to expand inorganically through acquisitions, licensing agreements or other arrangements that would afford us the opportunity to augment the Company’s growth profile and expand our offering in existing and new care settings.

In 2023, we made several decisions related to the Company’s strategy and also made structural changes to our organization, including disbanding our Regenerative Medicine business unit given the substantial uncertainties surrounding clinical trial costs and outcomes, as well as regulatory pathways and timing, which had the effect of improving our profitability and cash flow compared to prior periods.

Moving forward, we plan to continue to focus on enhancing efficiencies across our organization and setting expense, profitability and cash flow targets as we grow our business.

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.

online product ordering and account management portal available to our customers designed to streamline ordering, payment processing and reimbursement submissions,

We believe execution of these strategic priorities can and will differentiate the value of our portfolio, address multiple areas of significant unmet clinical need, and support our continued growth in both new and existing segments of the market.

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.

Our Product Portfolio & Pipeline

Our product offering is comprised of tissue allografts derived from human placental membrane, umbilical cord and the placental disc.

These products were developed and are manufactured using our proprietary processes.

We sell our placenta-based allograft products under our own brands.

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Our Quality Management System is focused on compliance with the American Association of Tissue Banks’ (“ AATB ”) standards, the FDA’s CGTP regulations, and applicable foreign regulations.

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

7 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021

8 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021

EPIFIX, EPICORD and EPIEFFECT products are marketed for external use, such as in Advanced Wound Care applications, while our AMNIOFIX, AMNIOCORD and AMNIOEFFECT products are positioned for use in Surgical applications, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstruction, and our AXIOFILL product is positioned for use in the replacement or supplementation of damaged or inadequate integumental tissue.

Wound Portfolio

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.

EPICORD is a dehydrated human umbilical cord allograft that may be used to provide a protective environment for the healing process.

Compared to EPIFIX, EPICORD is 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 is available as a sheet or an expandable form that can expand to twice its size.

EPIEFFECT is a lyophilized, tri-layer placental tissue allograft that contains amnion, intermediate layer, and chorion membranes.

This product was launched in October 2023 and represents the latest innovation in our product pipeline to deliver a thick, robust allograft to the market in a wide range of sizes for use as a barrier during chronic wound treatment, including deep or tunneling wound areas.

Surgical Portfolio

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.

MIMEDX also has a micronized version of this product that it no longer markets or sells in the United States.

As further discussed below under the heading “ Government Regulation and Compliance - 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 of the Public Health Service Act ( “Section 351” ).

AMNIOCORD is a dehydrated human umbilical cord allograft that may be used to provide a protective environment for the healing process.

These products are thicker than our amniotic membrane allografts and can be used in surgical settings where an allograft needs to be applied to a deeper area or needs to be sutured in place.

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.

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 most uptake by clinicians primarily focused on Surgical applications.

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

Our Wound products, such as EPIFIX are marketed for external use, such as in Advanced Wound Care applications, while products such as AMNIOEFFECT are positioned for use in Surgical applications, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstruction, and our AXIOFILL product is positioned for use in the replacement or supplementation of damaged or inadequate integumental tissue.

Our product portfolio also includes products for the burn market and others.

In 2024, we launched HELIOGEN, our first xenograft (animal-derived) and our first 510(k) cleared product in our portfolio.

HELIOGEN is an advanced bovine collagen matrix containing type I and type III collagen that is intended for the management of moderately to heavily exudating wounds and to control minor bleeding.

The product may be used for the management of exudating wounds such as pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds, such as trauma and surgical wounds, and partial-thickness burns.

We continue to research new opportunities for additional human and animal derived products in a variety of configurations and sizes, and we have additional offerings in various stages of conceptualization and development.

Placenta Donation Program

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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.

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 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.

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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 FDA initiated inspections covering our Marietta, Georgia, and Kennesaw, Georgia, processing facilities from February 22, 2023, through March 2, 2023.

The FDA most recently inspected our Marietta, Georgia, and Kennesaw, Georgia, processing facilities in 2023.

At the conclusion of the inspections, the agency confirmed that the observations made in connection with its prior inspection in 2019 had all been satisfactorily closed out and/or resolved and there were no observations relating to noncompliance with 21 CFR 1271.

During the inspections, the FDA communicated that our product, AXIOFILL, appeared to be regulated under Section 351 of the Public Health Service Act (the “ PHS Act ”).

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All observations were related to our AXIOFILL product and 21 CFR 211.

There were no observations relating to noncompliance with 21 CFR 1271.

MIMEDX engaged with the FDA regarding the inspections’ observations and the appropriate classification of AXIOFILL.

MIMEDX received a Warning Letter on December 21, 2023, relating to the inspections and classification of AXIOFILL.

MIMEDX continues to engage with the FDA on this matter, working through the process outlined by the FDA to obtain a formal determination of AXIOFILL’s classification.

In December 2019, the FDA also conducted inspections at each of our Marietta, Georgia and Kennesaw, Georgia processing facilities.

The FDA also issued a Form 483 for each facility at the conclusion of the inspection, which consisted of nine observations at our Marietta, Georgia processing facility and 14 observations at our Kennesaw, Georgia processing facility.

During the FDA’s audit of our facilities in 2023, it was confirmed that these observations were closed out and/or resolved.

Subsequent to the inspections, MIMEDX engaged with the FDA regarding the observations and the appropriate classification of AXIOFILL, including a pre-Request for Designation (“ RFD ”) and a formal RFD process, which define the regulatory identity or classification of a product as a drug, device, biological product or combination product.

While the Company was engaged with FDA through the formal RFD process regarding AXIOFILL, MIMEDX received a Warning Letter on December 21, 2023, relating to the inspections and classification of AXIOFILL.

In March 2024, the FDA issued a determination letter in connection with the RFD process for AXIOFILL, reaffirming its position that the product does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“ HCT/P ”) under Section 361 of the Public Health Service Act (“ PHSA ”).

In response to the RFD determination letter, MIMEDX subsequently filed suit in the U.S.

District Court for the Northern District of Georgia and intends to exhaust all legal options available, given the arbitrary and capricious manner in which FDA is regulating like-kind products.

These proceedings are ongoing.

Notably, while these proceedings are taking place, the Company is permitted to continue marketing AXIOFILL.

Intellectual Property

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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.

Globally, the Company has over 200 issued and pending patents, and from time to time seeks to enforce its intellectual property rights.

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 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 VA and Department of Defense (“ DoD ”) hospitals.

Our direct sales force primarily focuses on the Wound and Surgical categories through multiple sites of service.

We also maintain a network of independent sales agents that focus on Surgical 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 maintain a network of independent sales agents that focus on Surgical 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.

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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.

Third-party payers have historically been 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.

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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.

On July 1, 2023, EPIEFFECT received a CMS Code Q4278, also.

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.

For Medicare reimbursement purposes, our EPIFIX, EPICORD and EPIEFFECT 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.

For 2024, the geometric mean unit cost threshold applicable to our EPIFIX, EPICORD and EPIEFFECT allograft products is $47 per square centimeter, and the per day cost threshold was $807.

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 $1,725 in 2023.

CMS classifies skin substitutes into low cost or high cost groups.

Our EPIFIX, EPICORD and EPIEFFECT products are all reimbursed under the high cost bundle in these settings.

The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD allograft products was $1,715 in 2021, $1,749.26 in 2022, $1,725 in 2023, and $1,738 in 2024.

The national HOPD average packaged (“bundled”) rate for our EPIFIX, EPICORD and EPIEFFECT products in 2025 is $1,829.23.

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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, EPICORD or EPIEFFECT 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, EPICORD and EPIEFFECT 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%.

In 2022, CMS announced plans to potentially change the reimbursement mechanism for skin substitutes in the physician office setting but did not propose or enact any national changes to the rules for these products.

In March 2023, the Office of Inspector General published a report entitled, “Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements,” which detailed extensive problematic expenditure issues associated with the current Medicare reimbursement landscape in the private physician office setting for some skin substitute products.

In alignment with many industry stakeholders, including MIMEDX, the report recommended that all skin substitute products transition to ASP-based payments as soon as possible in an effort to substantially reduce Medicare expenditures for these products.

Over the last several quarters, there has been a notable increase in the number of skin substitute products listed on the Medicare ASP list, but non-ASP or WAC-based products still remain available in the marketplace.

In August 2023, three MACs published changes to their Local Coverage Determinations (“ LCDs ”) that were intended to go into effect on October 1, 2023, before ultimately being abandoned.

These LCDs included language that would have lowered 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.

Additionally, the LCDs outlined those skin substitute products which would explicitly be eligible for coverage and those which would not.

While these LCDs ultimately were not implemented, the MACs have indicated plans to bring forth a new proposed LCD for skin substitutes in the future, which could include elements that could be unfavorable to our business.

Medicare reimbursement in the physician office and associated care settings has been under increased scrutiny over the last couple of years and has led to changes in the manner in which products qualify for coverage and are reimbursed.

We expect additional reimbursement changes over the course of 2025 associated with skin substitutes.

Beginning in 2022, CMS announced plans to potentially change the reimbursement mechanism for skin substitutes in the physician office setting but has not proposed or enacted any national changes to the rules for these products to date.

Over the last several years, a combination of rapidly escalating prices and volumes in the industry has resulted in Medicare spending on skin substitutes to increase dramatically, with annual spending in 2020 of about $500 million to a monthly run-rate of over $1 billion per month by the end of 2024.

In response to this dramatic increase in Medicare spending, the MACs together released a proposed Local Coverage Determination (“ LCD ”) in April 2024 that was further refined and finalized in November 2024.

This policy, which is scheduled to become effective April 13, 2025 includes lists of skin substitute products which would explicitly be eligible for coverage and those which would not, based upon prospective, peer-reviewed randomized, controlled trials (“ RCTs ”).

The Company’s EPIFIX and EPICORD products are recognized in the document for having sufficient evidence for coverage, with EPIFIX listed as covered for DFUs and VLUs and EPICORD covered for DFUs.

EPIEFFECT, the Company’s other primary product for the Wound markets, will not be covered under this policy initially.

We are currently enrolling an RCT for EPIEFFECT designed to generate and publish the requisite evidence for coverage in the future.

Private Payers

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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.

Additionally, EPIEFFECT has also started to receive private reimbursement in certain regions of the U.S.

and we are focused on continuing to increase the number of covered lives eligible for this product in the future, most notably through the completion of a well designed and powered RCT that we are currently enrolling.

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.

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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.

Our newest product, EPIEFFECT, has also started to receive private reimbursement in certain regions of the U.S.

and we are focused on continuing to increase the number of covered lives eligible for this product in the future.

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.

We have established and continue to grow a reimbursement support group to provide providers and patients with 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.

Products administered in the hospital inpatient setting are bundled when submitted as part of the hospital’s claim under a diagnosis-related group (“ DRG ”).

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government accounts comprised approximately 1%, 2% and 2%, respectively, of our net sales.

Due to lower barriers to 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.

Due to lower barriers to entry in the Section 361 HCT/P regulated market, competition is intense in the skin substitute market, particularly among human derived products 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.

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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.

Only 22 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.

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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.

Our main competitors in the skin substitute market include Integra LifeSciences Holdings Corporation, Organogenesis, Inc., and Smith & Nephew plc, which sell a variety of AWC products, including skin substitutes and placental tissue allografts.

In addition, the overall market is competitive, with a large number of other, smaller and oftentimes privately-held competitors that compete regionally and nationally.

Our main publicly-traded competitors in the skin substitute market include Integra LifeSciences Holdings Corporation, Organogenesis, Inc., and Smith & Nephew plc, which sell a variety of AWC products, including skin substitutes and placental tissue allografts.

In addition, the overall market is competitive, with a large number of other, oftentimes privately-held competitors that compete regionally and nationally, primarily in the physician office and associated care settings due to the historical Medicare reimbursement and pricing dynamics that resulted in significant growth of Medicare expenditures for skin substitutes.

Government Regulation and Compliance

The products we sell are regulated by the FDA in the United States.

The products currently manufactured and processed by the Company are derived from human tissue.

The majority of the products currently manufactured and processed by the Company are derived from human tissue.

Generally, our products currently sold in the United States are regulated as Human Cells, Tissues, and Cellular and Tissue - Based Products ( “HCT/Ps” ), and are subject solely to Section 361 of the Public Health Service Act (“ Section 361 ”) and related regulations, which do not require pre-market clearance or approval by the FDA.

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Section 351 HCT/Ps are regulated as biological products, and, in order to be lawfully marketed in the United States, require FDA pre-market approval.

Beginning in 2024, we began commercializing a xenograft product, HELIOGEN, which is a 510(k) cleared product manufactured by Regenity Biosciences, a contract manufacturer.

As a result, MIMEDX assumes FDA regulatory responsibilities associated with medical device distribution including complaint handling and medical device reporting as well as certain state requirements for medical device distribution.

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.

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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.

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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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 ceased marketing or selling in the United States its products that were impacted by enforcement discretion, including its micronized dehydrated human amnion chorion membrane ( “mDHACM” ) products.

The Company is engaged with the FDA regarding the classification of AXIOFILL and certain of its other products.

If the FDA makes a final determination that these products do not meet the requirements for regulation solely under Section 361 then, in order to continue to market the products, the Company would be required to obtain the appropriate FDA clearance or approval.

The FDA has broad regulatory compliance and enforcement powers.

In March 2024, the FDA issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing.

In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements under Section 361.

In response to the RFD determination letter, the Company has filed suit in the U.S.

District Court for the Northern District of Georgia and intends to exhaust all legal options available, given the arbitrary and capricious manner in which FDA is regulating like-kind products.

Notably, while these proceedings are taking place, the Company is permitted to continue marketing AXIOFILL.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;

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• 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.

For our HELIOGEN product only, this law requires 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.

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.

There is a risk we do not report the information related to HELIOGEN accurately and that CMS or another government agency may take the position that our other 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.

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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 of over 75 participants.

As a condition of the final approval, MIMEDX is conducting post-market surveillance, consisting of a limited study of 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.

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MIMEDX also secured reimbursement approval from JMHLW in September 2022 with an awarded rate of 35,100 Yen/cm 2 , 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.

Insurance coverage for EPIFIX provides doctors and patients in Japan with new treatment options and optimal wound care.

Research and Development

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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.

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.

We focus on providing best-in-class solutions for the AWC and surgical markets.

Our leading portfolio of placental allografts and xenograft products are used by healthcare professionals to treat patients suffering from both acute and chronic, hard-to-heal wounds.

Our mission, vision, and core values guide our commitment to leading the category in research and clinical evidence, helping clinicians elevate the standard of care, and providing a safe and healthy environment for our employees.

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.

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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.

We are stewards of a precious, life-protecting and life-giving resource – human birth tissue – which currently represent the biological source material for many 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.

We have 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:

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• 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

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The packaging of our product cartons is recyclable and, since 2015, has been reduced in size by 50%.

Greenhouse Gas (GHG) Emissions

MIMEDX has established a baseline of environmental metrics for our business operations as of 2023:

• Scope 1 emissions:

1,025 MT CO 2 e

• Scope 2 emissions:

3,685 MT CO 2 e

(MT CO 2 e = metric tons of carbon dioxide equivalent)

We remain committed to monitoring these insights and minimizing our environmental impact as we continue to grow our business.

Environment, Health, and Safety (EHS)

As a healthcare company, we strive to make a positive impact on our people, our patients, our partners, and our world.

A critical part of this commitment is enhancing our EHS initiatives and establishing goals and objectives to track our progress and communicate the results.

Our Global EHS Policy can be found on our Sustainability webpage.

Human Capital

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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 reviews programs created to support best practices for our work environment challenges, champion diversity, and provide an intentional link for each employee to the company values and goals.

That’s why we remain focused on cultivating a work environment that encourages healthy growth, development, and promotion of all employees while embracing and valuing everyone’s dimensions of diversity.

The table below provides an overview of MIMEDX’s diversity as of December 31, 2024:

Board of Directors Women and minorities hold one-third of the seats on our Board, including the Chair of the Board.

Employee Gender Diversity Women represented 56% of our workforce.

Board of Directors Women and minorities hold over 40% of the seats on our Board, including the Chair of the Board.

Employee Gender Diversity Female:

Women represented 56% of our new hires in 2023.

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Other Non-White (including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific Islander):

Two or more races:

Not specified:

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 use tools, such as an interview guide, designed to prevent us from bias in our hiring decisions.

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.

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Compensation and Benefits

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

We offer all of our full-time employees a comprehensive benefits package and market competitive compensation programs, including:

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

• Life insurance options (employer paid and supplemental plans)

• Paid Parental and Caregiver leave

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• 401(k) plan, including employer match

• Employee Stock Purchase Plan opportunity.

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).

• Employee Stock Purchase Plan

Available Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business