Mimedx Group, Inc · NASDAQ:MDXG

Mimedx — Investor Presentation (September 2021)

21 slides from Mimedx's investor presentation, Sep 13, 2021

  1. Slide 1: Advancing Regenerative Medicine Treatment Through Placental Science

    1 ADVANCING REGENERATIVE MEDICINE TREATMENT THROUGH PLACENTAL SCIENCE Investor Presentation September 2021

  2. Slide 2: Disclaimer & Cautionary Statements

    2 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 for

  3. Slide 3: Disclaimer & Cautionary Statements

    3 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 ar

  4. Slide 4: Industry Leader in Utilizing Amniotic Tissue as a Platform for Regenerative Medicine

    4 Base Business Advanced Wound Care Promising Late-Stage Pipeline Musculoskeletal INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A PLATFORM FOR REGENERATIVE MEDICINE Distinct drivers of significant shareholder value with current and future growth potential

  5. Slide 5: Plan to Progress KOA Program to Phase 3 Confirmatory Efficacy Studies

    5 PLAN TO PROGRESS KOA PROGRAM TO PHASE 3 CONFIRMATORY EFFICACY STUDIES STATISTICAL DIFFERENCES BETWEEN PATIENTS TREATED WITH mdHACM AND WITH PLACEBO Assessment TOTAL TRIAL (446 PATIENTS) Pre-Interim Analysis (190 patients) Post-Interim Analysis (256 patients) VAS Not significant Not significant Not

  6. Slide 6: Plan to Progress KOA Program to Phase 3 Confirmatory Efficacy Studies

    6 Current IND Studies Do Not Plan to Proceed with BLA PLAN TO PROGRESS KOA PROGRAM TO PHASE 3 CONFIRMATORY EFFICACY STUDIES Knee Osteoarthritis: • Anticipate two Phase 3 KOA studies will be required to file a BLA • 6-month open-label extension and safety readout anticipated in October 2021 • Plan to

  7. Slide 7: Continued R&D Investment Focused on Advancing Understanding of mdHACM Mechanism of Action

    7 CONTINUED R&D INVESTMENT FOCUSED ON ADVANCING UNDERSTANDING OF mdHACM MECHANISM OF ACTION • mdHACM injections significantly reduced erosions and prevented lesion formation at day 21 • mdHACM rapidly sequestered in the synovial membrane following intra-articular injection and attenuates cartilage d

  8. Slide 8: The BLA Process Is Lengthy and Requires Careful Planning and Coordination with the FDA

    8 Initial IND Submissions End of Phase 2 Meeting Pre-BLA or NDA Meeting Market Application Submissions Basic Research Prototype Design or Discovery Preclinical Development Clinical Development FDA Filing / Approval & Launch PreparationPhase 1 Phase 3Phase 2 IND Review Phase and Ongoing Submissions A

  9. Slide 9: Four Key Drivers to Achieve Growth in Base Business

    9 Existing Base Business Drive disease state awareness across care continuum Publish additional data Expand into additional wound applications FOUR KEY DRIVERS TO ACHIEVE GROWTH IN BASE BUSINESS Portfolio Expansion Advance market assessments and analytics Leverage clinical and regulatory expertise I

  10. Slide 10: Targeted Investment for Geographic Expansion

    10 TARGETED INVESTMENT FOR GEOGRAPHIC EXPANSION Current primary market 1-2 year expansion 2-3 year expansion * Establishment of reimbursement pricing may take until mid-2022 to finalize, based on the JMHLW approval calendar. Source: Global Data Tissue Engineered-Skin Sub Data Model Wound Management

  11. Slide 11: Financial Strength Fortifies Sustainable and Profitable Growth

    11 FINANCIAL STRENGTH FORTIFIES SUSTAINABLE AND PROFITABLE GROWTH Adj. Free Cash Flow3 $19M (1) Trailing twelve months period ended June 30, 2021. Adjusted Net Sales and Adjusted Gross Margin are non-GAAP measurements and exclude impact of Revenue Transition amounts; Refer to slide 14 for the respec

  12. Slide 12: 2021 Objectives Support Current and Future Growth Potential

    12 2021 OBJECTIVES SUPPORT CURRENT AND FUTURE GROWTH POTENTIAL Commercial  Top-line growth >10% (excludes impact of enforcement discretion)  Sales force growth >10%  Japan approval  Pursue organic and inorganic growth opportunities Operations  CGMP compliance R&D  Interim data readouts (PF/KOA

  13. Slide 13: Appendix

    APPENDIX Cs] MIMEDX

  14. Slide 14: Industry Leader in Utilizing Amniotic Tissue as a Platform for Regenerative Medicine

    14 INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A PLATFORM FOR REGENERATIVE MEDICINE 2,000,000+ Allografts Distributed4 83.3% Gross Margin2 $261.0M TTM 6/30/21 Net Sales1 $2.1B Market Cap3 1,000+ patients studied under IND clinical programs11 (1) Net sales for the TTM ended June 30, 2021, as repo

  15. Slide 15: Base Business Has Stabilized and Is Now Positioned for Growth

    15 BASE BUSINESS HAS STABILIZED AND IS NOW POSITIONED FOR GROWTH Adjusted Net Sales1 ($M) Net Sales ($M) (1) Adjusted net sales excludes impact of Revenue Transition amounts. Adjusted net sales is a non-GAAP measurement. Refer to slides 20 and 21 for more information and reconciliation to the neares

  16. Slide 16: Summary Balance Sheets

    16 SUMMARY BALANCE SHEETS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Assets Cash and Cash Equivalents 69.1 53.5 48.2 109.6 95.8 84.7 85.0 Accounts Receivable, net 32.3 31.9 30.1 33.0 35.4 35.4 37.2 Inventory, net 9.1 9.2 10.6 11.0 10.4 11.6 10.1 Other Current Assets 12.7 21.2 18.7 17.9 19.0 18.

  17. Slide 17: Summary Income Statements

    17 SUMMARY INCOME STATEMENTS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Net Sales 76.4 61.7 53.6 64.3 68.5 60.0 68.2 Cost of Sales 12.7 10.0 8.2 10.3 10.8 9.7 12.8 Gross Profit 63.7 51.7 45.4 54.0 57.7 50.3 55.4 Research & Development 2.7 2.7 2.3 3.4 3.4 4.3 4.1 Selling, General, and Administra

  18. Slide 18: Summary Cash Flow Statements

    18 SUMMARY CASH FLOW STATEMENTS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) (1.8) Share-Based Compensation 2.9 3.3 4.4 3.7 3.9 3.2 4.1 Depreciation 1.6 1.5 1.4 1.5 1.3 1.2 1.3 Other Non-Cash Effects 1.2 1.2 1.3 9.5 1.7 1.1 0.9 Changes in Assets (14.

  19. Slide 19: Revenue Detail

    19 REVENUE DETAIL Quarter Trailing 12 Months ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q20 4Q20 1Q21 2Q21 Advanced Wound Care / Section 3611 56.2 48.5 45.8 55.1 59.3 51.5 59.3 205.6 208.7 211.7 225.2 Section 3511 12.0 8.7 6.1 8.2 8.7 8.2 8.6 35.0 31.7 31.2 33.7 Adjusted Net Sales2 68.2 57.2 5

  20. Slide 20: Non-GAAP Metrics Reconciliation

    20 NON-GAAP METRICS RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Net Sales – Reported 76.4 61.7 53.6 64.3 68.5 60.0 68.2 Less: Revenue Transition Impact1 (8.2) (4.5) (1.7) (1.0) (0.5) (0.3) (0.3) Adjusted Net Sales 68.2 57.2 51.9 63.3 68.0 59.7 67.9 Gross Profit 63.7 51.7 45.4 54.0

  21. Slide 21: Adjusted EBITDA Reconciliation

    21 ADJUSTED EBITDA RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) (1.8) Depreciation & Amortization 1.8 1.8 1.7 1.8 1.6 1.5 1.5 Interest Expense 2.4 2.4 2.6 1.5 1.5 1.5 1.4 Loss on Extinguishment of Debt 0.0 0.0 0.0 8.2 0.0 0.0 0.0 Incom

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