About MiMedx Group

MiMedx Group, Inc. and its subsidiaries (MIMEDX) operate as a pioneer and leader in placental biologics, focuses on helping humans heal by addressing unmet clinical needs. 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. 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. The company’s 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. The company’s products help clinicians treat patients suffering from chronic and other hard-to-heal wounds. These wounds can be slow to respond or unresponsive to conventional treatments and may benefit from advanced treatments, such as through the use of the company’s products, in order to support the healing process. The manufacturing of the company’s product offering begins with donated birth tissue, namely the placenta, umbilical cord and placental disc, which it sources through a large donor network developed over multiple years with leading hospitals and clinician groups. In partnership with these facilities, the company is able to obtain donated birth tissue from consenting mothers, which then are shipped to its manufacturing facilities in Marietta, Georgia, and undergo a series of testing followed by its proprietary tissue manufacturing workflow, which it refers to as the PURION process. The company employs Current Good Tissue Practices (CGTP) and terminal sterilization to produce its allografts. MIMEDX provides products primarily for use in the wound care, burn, and surgical sectors of healthcare. All of the company’s products sold in the United States are regulated by the U.S. Food & Drug Administration (FDA), and to the extent it sells its products outside the United States, by other regulatory agencies in such international markets. The company devotes significant research and development resources and expertise to the therapeutic potential of placental tissue in an effort to grow its 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 its products. Market Domestic sales account for substantially all of the company’s revenue today. In the United States, the company’s primary areas of clinical use include applications in surgical settings, as well as for the treatment of wounds and burns. Additionally, the company is actively pursuing international expansion, primarily targeting Japan. The company’s products can be found in many of these sites of service, including the private physician office (e.g., podiatry clinics), wound care centers, hospital inpatient and outpatient settings, nursing homes and federal facilities, such as those operated by the Department of Veterans Affairs (VA). In addition to its presence in the AWC settings, the company’s products are also used in a variety of surgical settings, and its strategic goals include building a body of evidence and real-world use data for its products in a wide range of procedures. The company’s strategy is to continue to deliver advanced products that serve patient needs within the Advanced Wound Care and Surgical markets and increase access to its products through clinical data generation and physician education. Product Portfolio and Pipeline The company sells its placenta-based allograft products under its own brands. The company maintains strict controls on quality at each step of the manufacturing process beginning at the time of procurement. The company’s Quality Management System focuses on compliance with the American Association of Tissue Banks’ (AATB) standards, the FDA’s CGTP regulations, and applicable foreign regulations. The company’s 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). EPIFIX, EPICORD and EPIEFFECT products are marketed for external use, such as in Advanced Wound Care applications, while the company’s 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 its AXIOFILL product is positioned for use in the replacement or supplementation of damaged or inadequate integumental tissue. Wound Portfolio 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. EPICORD 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 its 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 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 the company’s 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 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. 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 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 the company’s 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 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 AXIOFILL is an extracellular matrix derived from human placental disc, and is designed to provide a human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries. The company’s AXIOFILL product has seen most uptake by clinicians primarily focused on Surgical applications. The company continues to research new opportunities for amniotic and other placental tissue, and it has additional offerings in various stages of conceptualization and development. Placenta Donation Program In order to obtain the source material for its human birth tissue-based product portfolio, the company partners with physicians and hospitals to recover donations of these materials at hospitals around the United States. Through its 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. The company operates a licensed tissue bank that is registered as a tissue establishment with the FDA, and it is an accredited member of the AATB. All donor records and test results are reviewed by the company’s Medical Director and staff prior to the release of the tissue for distribution. The company has developed a large, geographically diverse, network of hospitals across the United States that participate in its placenta donation program, and it employs a dedicated staff that work with these hospitals. The company also utilizes third-party providers of placenta donations on an as- needed basis to mitigate business risk. The company 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. 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. The company’s facilities are subject to periodic announced and unannounced inspections by regulatory authorities and may undergo compliance inspections conducted by the FDA and corresponding state and foreign agencies. The company is registered with the FDA as a tissue establishment and is subject to the FDA’s CGTP quality program regulations, state regulations, and regulations promulgated by various regulatory authorities outside the United States. Intellectual Property Patents and Patent Applications As of December 31, 2023, in addition to international patents and patent applications, the company owned 74 U.S. patents related to its amniotic tissue technology and products, and 25 additional patent applications covering aspects of this technology are pending at the United States Patent and Trademark Office. The vast majority of the company’s domestic patents covering its core amniotic tissue technology and products will not begin to expire until August 2027. Globally, the company has over 200 issued and pending patents. Marketing and Sales The company’s 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. The company’s direct sales force primarily focuses on the Wound and Surgical categories through multiple sites of service. The company also maintains a network of independent sales agents that focus on Surgical applications leveraging the complementary products in their portfolios, and provides access to certain customers, as well as sales coverage for areas where it does not have a full-time sales representative. The company also sells its products through distributors. Distributors purchase products from it at wholesale prices and resell products to providers and end users. For example, in Japan, the company’s distribution partner, Gunze Medical, purchases products from it and is responsible for sales to the end users for the approved indications of use and at the prevailing reimbursement rate for the product. Seasonality Revenues during the company’s fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of its 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, the company’s 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 (year ended December 31, 2023). Customer Concentration For the year ended December 31, 2023, the company’s top ten customers accounted for 20% of its net sales, and net sales to all the U.S. government accounts consisted of approximately 2% of its net sales. Competition The company’s 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. Research and Development The company’s research and development expenses were $12.7 million for the year ended December 31, 2023. Government Regulation The company’s 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. The company’s 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. CGTP require the company, 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 the company’s products and raw materials, maintain the company’s facilities and equipment, keep records and comply with standards regarding recovery, pre-distribution, distribution, tracking and labeling of the company’s products, and complaint handling. 21 CFR Part 1271 also mandates compliance with adverse reaction and CGTP deviation reporting and labeling requirements. The company continually evaluates its marketing materials for each of the company’s products to align with FDA guidance. The company is pursuing the BLA pre-market approval process for certain uses of mDHACM. As part of the company’s BLA development effort, the company is updating its manufacturing establishments into maintaining application of CGMP for production of its injectable and other applicable Section 351 products. The company’s 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. The company is required to register with the FDA as an establishment that manufactures human cells, tissues, and cellular and tissue-based products. The company is licensed, registered, or permitted as a tissue bank in California, New York, Delaware, Illinois, Oregon, and Maryland. Additionally, the company received and actively maintain AATB accreditation. To the extent the company sells its products outside of the United States, it is also subject to laws and regulations of foreign countries. In the United States, the company’s 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 the federal Anti-Kickback Statute; the federal False Claims Act; the federal Health Insurance Portability and Accountability Act of 1996; the federal Physician Payments Sunshine Act and its implementing regulations; federal conflicts of interest laws; and anti-kickback and false claims laws. 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. 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. History MiMedx Group, Inc. was incorporated in 2011.