UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Important Cautionary Statement
This report includes forward-looking statements. Statements regarding: (i) future sales or sales growth; (ii) our 2025 and longer term financial goals and expectations for future financial results, including levels of net sales, Adjusted EBITDA, Adjusted EBITDA margin, corporate expenses and cash; (iii) our expectations regarding the placental tissue market; (iv) our expectations regarding Medicare spending and (v) continued growth in different care settings, are forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “goal,” “outlook,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations.
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: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment and many other factors; (ii) the Company may change its plans due to unforeseen circumstances; (iii) the results of scientific research are uncertain and may have little or no value; (iv) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (v) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (vi) we may alter the timing and amount of planned expenditures for research and development based on the results of clinical trials and other regulatory developments. 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 report and the Company assumes no obligation to update any forward-looking statement.
| Item 7.01 | Regulation FD |
MiMedx Group, Inc. (the “Company”) updated its investor presentation on January 14, 2025. A copy of the presentation materials is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
The information in this Current Report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description of Exhibit | |
| 99.1 |
Investor Presentation dated January 2025 | |
| 104 |
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. | |
SIGNATURES
Pursuant to the requirements of the Exchange Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIMEDX GROUP, INC. | ||||||
| January 14, 2025 | By: | /s/ Doug Rice | ||||
| Doug Rice Chief Financial Officer | ||||||
Exhibit 99.1 Investor Presentation January 2025
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, sales growth, profitability and Adjusted EBITDA margins; • 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, including to innovate and diversify our product portfolio; • Investments in data; • Expectations regarding the reimbursement environment for the Company’s products, including Medicare Spending; • Manner of local coverage determination (LCD) implementation; • Expectations regarding plans to reduce customer churn and enhancing customer relationships; • Expectations that HELIOGEN will be a meaningful contributor to our financial performance in 2025; • The stage of development of the placental-derived products market; • 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 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. Investor Presentation – January 2025 2
A Pioneer and Leader Focused on Helping Humans Heal Our vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. Over a decade of experience Leading the industry with Poised to capitalize on favorable helping clinicians manage chronic innovative products and robust market trends to drive top line and other hard-to-heal wounds supporting clinical data growth and profitability Investor Presentation – January 2025 3
The Most Comprehensive End-to-End Product Ecosystem New product innovations leading to untapped opportunities The most studied for growth, including an portfolio of placental increasing footprint in products with 50+ clinical the Surgical market. & scientific publications and over 300 million payer covered lives. Large, national A key partner to healthcare placental donation professionals with industry network and leading support services proprietary tissue and customer-focused processing. approach. Investor Presentation – January 2025 4
Commercial Scale, Leverage & Extensive Reach 3+ Over 200 direct sales Over 75 agencies Robust corporate Extensive commercial Experience selling Growing presence professionals with 200+ agents support network coverage with over 300 more than 3 million in Japan nationwide nationwide million payer lives allografts covered Investor Presentation – January 2025 5
Expansive Donor Network & IP Power Our Product Offering National Network of Birthing Center Partners Proprietary Processing Backed by Broad Portfolio of Intellectual Property Expectant Mothers Delivery of Healthy Proprietary Processing & Shelf-Stable, Packaged Product Consent for Introduced to Donation Baby via Caesarean Terminal Sterilization of Tissues Available to Ship Donation Obtained Program Section Tissues Transported Donor Tissue Donated Significant Opportunity for Robust IP Estate with 200+ Patents to MIMEDX Placental Tissues Tested & Continued Scale Prepared for Recovered Manufacturing Ample Placental Supply and Manufacturing Capabilities to Support Continued Growth and Industry Demand Investor Presentation – January 2025 6
Addressing a Large and Unmet Need for Healing Solutions Favorable Demographic Trends Increasing Clinical Evidence Expanding Potential For Products Ineffective Wound Advances Driving Emerging 10+ ~16% Management Leads to Improved Outcomes Opportunities in Poor Outcomes for Wound Patients Surgical Setting million people of Medicare beneficiaries Population suffering Population is impacted It is estimated that up When applied MIMEDX products are from chronic, non- by chronic wounds— to 85% of amputations following parameters available in all settings healing wounds in the and this proportion is are avoidable with a for use, patients where patients receive 1 1 U.S. , including diabetic increasing. holistic multispecialty treated with EPIFIX® care, increasingly used foot ulcers (DFUs), team approach that experienced in a variety of surgical venous leg ulcers incorporates reductions in major settings, representing (VLUs), pressure ulcers innovative treatments amputations and incremental market 2 and more. and adherence to hospital utilization. opportunities. 2 treatment parameters. 1) Sen CK. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Adv Wound Care (New Rochelle). 2023;12(12):657-670. 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. Investor Presentation – January 2025 7
Increasing Awareness of Massive Potential for Placental Tissue October 10, 2024 Her Face Was Unrecognizable After an Explosion. A Placenta Restored It. “Research has found placenta-derived grafts can reduce pain and inflammation, heal burns, prevent the formation of scar tissue and adhesions around surgical sites and even restore vision. They’re also gaining popularity as a treatment for the widespread issue of chronic wounds.” “…Tending to such wounds can be a matter of life and death for the millions of people with them, including 10.5 million Medicare beneficiaries as of 2022…” “…The five-year mortality rate for people with one type, a diabetic foot ulcer, is close to 30 percent. That rate rises above 50 percent for those who require amputation.” Investor Presentation – January 2025 8
Large Wound Care Business with Growing Surgical Footprint LTM Wound Performance LTM Surgical Performance* LTM Sales Mix by $250,000 $250,000 Product Type +14% $200,000 $200,000 $150,000 $150,000 34% +12% 66% $100,000 $100,000 $50,000 $50,000 $0 $0 Wound LTM @ Q3:23 LTM @ Q3:24 LTM at Q3:23 LTM @ Q3:24 Surgical Led by best-in-class placental allograft, EPIFIX, Continuing to see expanding use cases for and our newest product innovation, EPIEFFECT® allografts and xenografts in a large and *LTM Surgical growth at Q3:24 calculated excluding the impacts of AXIOFILL and Dental growing number of surgical settings Investor Presentation – January 2025 9 $000s $000s
Evolving Strategic Priorities Heading into 2025 1 2 3 Innovate & Diversify Develop & Deploy Enhance Customer Product Portfolio to Programs to Expand Intimacy Maximize Growth Surgical Footprint Maximize opportunity Leverage existing Continue to build out for EPIFIX & EPICORD evidence for surgical customer intimacy under new LCDs applications programs Invest in additional Expand utilization of Introduce new products from organic research and data MIMEDX Connect pipeline generation for surgical use Accelerate OUS Drive market adoption of market expansion, with continued growth HELIOGEN in Japan Investor Presentation – January 2025 10
Best-In-Class Human Allograft Wound Products Flagship products with multiples sizes and Lyophilized human placental allograft membrane configurations available for differing wound types Includes the amnion layer, intermediate layer, and chorion Backed by industry-leading RCT data layer Extensive commercial payor coverage RCT underway in order to obtain broad reimbursement Investor Presentation – January 2025 11
The Patient Journey in Wound Care MIMEDX products are available in all settings where patients receive care… Wound Assisted …and other Private Mobile Hospital Nursing Hospital Home Living Care care Office Health Inpatient Facility Outpatient Health Clinic Facility settings …and are used on a range of chronic and other hard-to-heal wounds. Acute Wounds Chronic Wounds Complex/Dehisced Wounds Burn/Trauma Limb Salvage Dehiscence Mohs surgery DFU VLU Investor Presentation – January 2025 12
Expanding & Innovative Offering for Surgical Market Generating Clinical Data in Numerous Surgical Disciplines Incorporating Use of MIMEDX Products HELIOGEN augments our pipeline through Solutions strategic portfolio expansion Deep/tunneling, ✓ irregular-shaped defects Soft tissue deficit First xenograft in MIMEDX portfolio ✓✓✓✓ Large area coverage ✓✓ ✓ 510(k)-cleared, bovine-derived collagen matrix Able to be sutured in ✓✓ particulate indicated for the management of place exudating wounds and to control minor bleeding Thickness-desired ✓✓✓ Fenestrated ✓ configurations available Investor Presentation – January 2025 13
Building Library of Evidence for Surgical Applications Recent Publications Showcase Breadth of Potential Use Cases for MIMEDX Products in Surgery Neuro EPIFIX® in Mohs Procedures Cranioplasty Procedures with AMNIOFIX® 1 4 Mohs Clinical Outcomes with Conventional Methods Peer-reviewed Retrospective Study 29% Orthopedic 15% Average dissection Frequent fibrosis Fibrosis has time ~30 minutes reported 10% 10% increased Plastic 8% complications 2% 2% 2 0% 0% 0% Clinical Outcomes with AMNIOFIX Transplant Surgical Revisions Infection Poor Cosmesis Experienced Reintervention Complications Gastrointestinal Autologous Flap / FTSG Group (n=143) dHACM Group (n=143) Average dissection Minimal dural fibrosis No intraoperative Urology time < 3 minutes in 86% of patients complications OB/GYN AMNIOEFFECT® in Bunion Correction Surgery Colorectal Anastomoses Procedures with AMNIOFIX 5 Case Study – SAWC Fall 2023 3 Anastomotic Leak Rate with & without AMNIOFIX Vascular The use of LHACM as a barrier membrane during Lapiplasty 3D Bunion Leak / N Correction surgery is an effective strategy to improve surgical outcomes. Procedures 1.03% 4 / 390 with AMNIOFIX p=0.0022 Conventional 4% 80 / 2,000 Closure Foot & Ankle 1) Lee B. MIMEDX interview with Bryan Lee, MD. October 4, 2023. 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 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. 4) Toman J. Facial Plast Surg Aesthet Med. 2022;24(1):48-53. Investor Presentation – January 2025 14 5) Franklin Polun, DPM, DABFAS, FACFAS FACFAS; Jake Michaelson. Symposium on Advanced Wound Care Fall, Nov 2-5, 2023, Las Vegas, NV.
Studies in Process Focused on Significant Surgical Opportunities AMNIOFIX in AMNIOFIX in AMNIOFIX in EPIFIX Mohs HECON GI Anastomosis Liver Transplant Breast Reduction Accepted for Publication Manuscript Pending RCT Enrollment Underway RCT Enrollment Underway EPIFIX used in Mohs procedures Wound breakdown rates are a associated with avoidance of Evaluating utility of placental Seeking to demonstrate common complication of large postoperative complications allografts to help reduce biliary reduction in the rate of leaks volume breast reductions and and ancillary procedures, complications, improve when using placental allografts. could benefit from utilizing compared to patients treated healing and reduce fibrosis. placental tissue. with standard of care. Generating Clinical Data in Numerous Surgical Disciplines Incorporating Use of MIMEDX Products Investor Presentation – January 2025 15
Diversified Customer Base Site of Service Segment Commentary Hospitals & Stable reimbursement settings and 55% Wound Care growing with expanded use of products Clinics in surgical applications 32% Medicare reimbursement evolving, Private Office resulting in opportunity for EPIFIX & EPICORD Derived from other sites of service, Other including federal facilities and international 13% Investor Presentation – January 2025 16
Maturing Medicare Reimbursement Underway Worsening Medicare Spending Crisis Underscores Need for Overhaul in Wound Care 1 Medicare Allowed Charges for skin substitutes have exploded since 2020 resulting in Recent Medicare abuses in private office and run rate spend of over $1 billion of spend PER MONTH on products in the category associated care settings driving reform that prioritizes data and proven efficacy of products $4.0B $4 6 New LCDs provide Medicare Trust Fund with 5 short-term solution to curb runaway spending $3 on skin substitutes 4 $2 3 MIMEDX engaged in advocacy with CMS, MACs & Congress to urge action to rein in $1.5B runaway Medicare spend 2 $1.0B $1 1 $0.5B & Eligible for reimbursement under New LCDs, which go into effect February 12, 2025 $0 0 2020 2021 2022 2023 Medicare Allowed Charges Skin Substitute Volume Investor Presentation – January 2025 17 $ billions Volume (millions)
Financial Highlights Quarterly Net Cash Balance $70MM LTM Net Sales LTM Gross Margin $343MM 83% +11% year-over-year $50MM $34MM $32MM 1 $29MM LTM Adjusted EBITDA LTM GAAP Net Income $20MM $78MM $88MM 23% of net sales Q2:23 Q3:23 Q4:23 Q1:24 Q2:24 Q3:24 Cash Balance LTM Free Cash Flow Strong & improving financial profile & balance sheet $89MM $56MM provides growth capital for the business +$20MM vs. Q2:24 1) EBITDA, Adjusted EBITDA, related margins and Free Cash Flow are non-GAAP financial measures. See our Earnings Release for the quarter ended September 30, 2024 for a reconciliation to the nearest GAAP measure. Investor Presentation – January 2025 18
Full Year 2024 and Long-Term Financial Goals* Committed to delivering sustained growth and profitability in the short- and long-term Full Year Long-Term 2024 Net Sales High single-digits Low double-digits % Growth vs. 2023 Profitability Adjusted EBITDA Margin Above 20% *As disclosed on our Third Quarter Operating & Financial Results conference call on October 30, 2024. Investor Presentation – January 2025 19
Experienced, Skillful Leadership Team Executing Strategy Management Team with Track Record of Success in MedTech Prior Roles Include: Doug Rice Joe Capper Butch Hulse Chief Financial Chief Executive Chief Administrative Officer Officer Officer & General Counsel Kim Moller John Harper, Ph.D. Ricci Whitlow Chief Commercial Chief Scientific Officer & Chief Operating Officer SVP, R&D Officer Kate Surdez Matt Notarianni Chief Human Head of IR Resource Officer Investor Presentation – January 2025 20
Conclusion 1 Large & expanding addressable markets 2 Maturing reimbursement & regulatory landscape 3 Competitive advantage with defensible IP and proprietary technology 4 Strong & improving financial profile & balance sheet 5 Experienced & skillful leadership team more than capable of executing strategy Investor Presentation – January 2025 21