EX-99.3 4 d866445dex993.htm EX-99.3 EX-99.3

Exhibit 99.3 Investor Presentation August 2024 helping humans heal.


Disclaimer & Cautionary Statements This presentation includes forward-looking statements. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Such forward-looking statements include statements regarding: • Future sales or sales growth; • Estimates of potential market size and demand for the Company’s current and future products; • Plans for expansion outside of the U.S.; • The effectiveness of amniotic tissue as a therapy for any particular indication or condition; • Expected spending on research and development and litigation; • Expectations regarding the reimbursement environment for the Company’s products; • The Company’s long-term strategy and goals for value creation, the status of its pipeline products, expectations for future products, and expectations for future growth and profitability 2


Disclaimer & Cautionary Statements Additional forward-looking statements may be identified by words such as believe, expect, may, plan, potential, will, preliminary, and similar expressions, and are based on management's current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: • Future sales are uncertain and are affected by competition, access to customers, patient access to hospitals and healthcare providers, the reimbursement environment and many other factors; • The future market for the Company’s products can depend on regulatory approval of such products, which might not occur at all or when expected, and is based in part on assumptions regarding the number of patients who elect less acute and more acute treatment than the Company’s products, market acceptance of the Company’s products, and adequate reimbursement for such therapies; • 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. is costly and time consuming, and such clearances or approvals may not be granted on a timely basis, or at all, and the ability to obtain the rights to market additional, suitable products depends on negotiations with third parties which may not be forthcoming; and • The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this presentation and the Company assumes no obligation to update any forward-looking statement. 3


A Pioneer and Leader in Healing Solutions for Wound & Surgical To be the leading global Helping Our Our provider of healing solutions Humans through relentless innovation Why Vision Heal to restore quality of life. Large, national placental New product innovations The most studied portfolio A key partner to healthcare donation network and leading to untapped of placental-based products professionals with industry opportunities for growth, with 50+ clinical & scientific proprietary tissue leading support services publications and over 300 processing. including an increasing and customer-focused footprint in the Surgical million payer covered lives. approach. market. 4


The Unmet Need for Wound Healing Solutions Is Large and Growing 1 million people suffer from chronic, non-healing wounds in the U.S. >10 • Aging population Favorable • Obesity Demographic • Smoking history• Heart & vascular disease Trends • Diabetes Chronic Wounds ~16% of the Medicare beneficiary population is impacted by Burden Medicare 1 chronic wounds—and this proportion is increasing. Beneficiaries Ineffective Wound It is estimated that up to 85% of amputations are avoidable with a Management holistic multispecialty team approach that incorporates innovative Leads to Poor 2 treatments and adherence to treatment parameters. Outcomes Advances Driving When applied following parameters for use, patients treated with EPIFIX® 2 Improved Outcomes experienced reductions in major amputations and hospital utilization. for Patients 1) Sen CK. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Adv Wound Care (New Rochelle). 2023;12(12):657-670. 5 2) Tettelbach WH, et al. Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. J Wound Care. 2022 Feb 1;31(Sup2):S10-S31.


The Patient Journey in Wound Care MIMEDX products are available in all settings …and are used on a range of chronic and other where patients receive care… hard-to-heal wounds. Private Acute Wounds Office Wound Hospital Care Clinic Inpatient Mohs surgery Burn/Trauma Hospital Home Chronic Wounds Outpatient Health Diabetic Foot Ulcer Venous Leg Ulcer Assisted Mobile Living Health Complex/ Facility Dehisced Wounds …and other Nursing care Facility settings 6 Limb Salvage Dehiscence


Significant Opportunity to Drive Further Utilization in Surgical Neuro Mohs Orthopedic Spine Colorectal Anastomoses Procedures Cranioplasty Procedures with AMNIOFIX® with AMNIOFIX Gastrointestinal 3 1 Anastomotic Leak Rate with & without AMNIOFIX Clinical Outcomes with Conventional Methods 4% OB/GYN Average Frequent Fibrosis has dissection time fibrosis increased ~30 minutes reported complications Vascular p=0.0022 2 Clinical Outcomes with AMNIOFIX 1.03% Average Minimal dural No dissection time fibrosis in 86% intraoperative Foot & Ankle < 3 minutes of patients complications Conventional Closure Procedures with AMNIOFIX 1) Lee B. MIMEDX interview with Bryan Lee, MD. October 4, 2023. Leak / N 80 / 2,000 4 / 390 2) Endicott L, Ehresman J, Tettelbach W, Forsyth A, Lee B. Dehydrated human amnion/chorion membrane (DHACM) use in emergent craniectomies shows minimal dural adhesions. J Wound 7 Care. 2023;32(10):634-640. 3) F. Raymond Ortega, MD, FACS; Dennis Choat, MD, FACS, FASCRS; Emery Minnard, MD; Jeffrey Cohen, MD. The American College of Surgeons Clinical Congress, Oct 22-26, 2017, San Diego, CA.


Our Strategic Priorities • Continue momentum with new organic products in Wound & Surgical Innovate & Diversify Build leadership position Product Portfolio to • Consider additional inorganic additions in Wound & Surgical Maximize Growth to our product offering • Drive further uptake of EPIFIX® in Japan • Increase our presence in targeted Develop & Deploy surgical settings with our portfolio Programs to Expand Footprint in Surgical• Invest in clinical data, partnering with KOLs • Execute on initiatives to increase Enhance Customer customer “stickiness” and reduce Intimacy churn helping humans heal. 8


Advanced Wound Care Market by Technology Platform Current MIMEDX Product Offering Placental-derived allografts Animal-derived xenografts Synthetically manufactured grafts Section 361 regulatory pathway; FDA 510(k) regulatory pathway; claims FDA 510(k) regulatory pathway; claims homologous use; barrier around management of wounds around management of wounds Sourced from a large, national donation Sourced from closed herds of bovine, Made using a variety of materials, including network recovering placentas from porcine and other select animals electrospun fibers, glass, etc. scheduled c-section live births MIMEDX launched first xenograft in portfolio, Antimicrobial features, potential for use as Undergoes proprietary processing to create HELIOGEN , a bovine-derived collagen day 1 products make this attractive potential a wide variety of MIMEDX products particulate in June 2024 vertical 9


Expanding Breadth of Skin Substitutes Leading Human-Derived Portfolio Emerging Xenograft Platform Best-in-Class Wound Product Portfolio Recently announced exclusive manufacturing and supply agreement with Regenity Biosciences. HELIOGEN builds on our goal to augment our growth through strategic portfolio expansion. Provides MIMEDX with a bovine-derived collagen matrix particulate product that is 510(k)-cleared and indicated for the management of exudating wounds and to control minor bleeding. Innovative Offering for Surgical Market 10


Physician Office Medicare Reimbursement Overhaul Underway 1 Increasing the number of skin substitutes on the Medicare Medicare Allowed Charges for skin substitutes have Resulting in a de-facto national 2 ASP List has proven insufficient, with a significant number exploded since 2020 coverage proposal of products priced above $500/sq.cm… $4.0B $4 6 Average Price of Skin $0 $500 $1,000 $1,500 $2,000 $2,500 Substitutes on ASP List Has Q1:22 Increased More Than Threefold 5 Since Q1:22 $3 4 3 LCDs proposed in April 2024 $2 3 Q3:24 would disallow coverage of ~180 products in the category $1.5B Price per sq. cm on ASP List 2 $1.0B $1 …and the top 5 Q coded products accounting for nearly EPIFIX and EPICORD® are 1 ¾ of the 2023 Medicare spend on skin substitutes $0.5B among the 15 covered products eligible for $0 0 Q4262 Q4236 Q4217 Q4253 Q4205 reimbursement in the proposal 2020 2021 2022 2023 $1.4B $0.5B $0.4B $0.3B $0.3B Medicare Allowed Charges Skin Substitute Volume Recent Proposed LCDs Reflect Unified National Approach to Curb Abuses in Private Office 1) The Moran Company. (2024). Volume and Total Payment by Skin Substitute Product, CY 2019-2023. 2) ASP List refers to the Medicare Part B ASP Drug Pricing Files and CMS refers to the Centers for Medicare and Medicaid Services, Data Source: ASP Pricing Files. Centers for Medicare & Medicaid Services. Accessed March 18, 2024. https://www.cms.gov/medicare/payment/all-fee-service-providers/medicare-part-b-drug-average-sales-price/asp-pricing-files 11 3) LCDs refer to “Local Coverage Determination” $ billions Volume (millions)


Diversified Business by Product & Across Multiple Sites of Service Product Type Segment Commentary Led by best-in-class placental allograft, 35% Wound EPIFIX and our newest product innovation, EPIEFFECT® 65% Continuing to see expanding use cases for Surgical allografts and xenografts in a large and growing number of surgical settings Site of Service Segment Commentary Hospital Setting Stable reimbursement settings and 13% (Inpatient & growing with expanded use of products Outpatient) & in surgical applications Wound Care Clinics Medicare reimbursement evolving, 55% 32% Private Office resulting in opportunity for EPIFIX & EPICORD Derived from other sites of service, Other including federal facilities and international 12 *Sales mix based upon trailing twelve months net sales ending June 30, 2024


Q2:24 Highlights 1 Net Income Net Sales Gross Margin Adjusted EBITDA $18MM $87MM 83% $20MM +7% year-over-year 23% of net sales Portfolio Expansion First Publication Cash Balance Free Cash Flow into Xenografts in 1 $69MM $21MM 13 1 – EBITDA, Adjusted EBITDA, related margins and Free Cash Flow are non-GAAP financial measures. See our Earnings Release for the quarter ended June 30, 2024 for a reconciliation to the nearest GAAP measure.


Management Team with Track Record of Success in MedTech Doug Rice Kim Moller Joe Capper John Harper, Ph.D. Butch Hulse Kate Surdez Matt Notarianni Ricci Whitlow Chief Financial Chief Commercial Chief Executive Chief Scientific Officer & Chief Administrative Chief Human Head of IR Chief Operating Officer Officer Officer SVP, R&D Officer & General Counsel Resource Officer Officer Prior Roles Include: 14


Conclusion Committed to Pioneer Expanding and leader presence in delivering above- in Advanced Wound & market growth Wound Care Surgical and profitability helping humans heal. 15