Mimedx Group, Inc · NASDAQ:MDXG
Mimedx — Shareholder Meeting (November 2020)
31 slides from Mimedx's shareholder meeting presentation, Nov 20, 2020
Slide 1: Welcome to 2020 Annual Shareholders Meeting
WELCOME TO 2020 ANNUAL SHAREHOLDERS MEETING NOVEMBER 20, 2020 Exhibit 99.1
Slide 2: Important Cautionary Statement
IMPORTANT CAUTIONARY STATEMENT This presentation contains forward-looking statements. Investors are cautioned against placing undue reliance on these statements. All statements relating to events or results that may occur in the future are forward-looking statements, including, without limitation, s
Slide 3: Meeting Agenda
MEETING AGENDA Introductions Annual Meeting Matters Company Highlights Commercial Research & Development Question & Answer Session 1 2 3 4 5 6
Slide 4: Annual Meeting Matters
ANNUAL MEETING MATTERS
Slide 5: Annual Meeting Agenda
ANNUAL MEETING AGENDA QUORUM DESCRIPTION OF BUSINESS ITEMS: Election of Two Class I Directors Approval of Amendment to Charter to Increase the Number of Authorized Shares of Common Stock Approval of Amendments to the Company’s 2016 Equity and Cash Incentive Plan OPENING OF POLLS FOR VOTING CLOSING O
Slide 6: Company Highlights
COMPANY HIGHLIGHTS
Slide 7: Patients are why we are here
PATIENTS ARE WHY WE ARE HERE. WE HAVE AN OPPORTUNITY AND RESPONSIBILITY TO MAKE A DIFFERENCE FOR THESE PATIENTS. AND IN DOING SO, GROW A SUCCESSFUL AND MEANINGFUL HEALTHCARE COMPANY.” “ TIMOTHY R. WRIGHT CHIEF EXECUTIVE OFFICER ALVIN PHYLLIS NICK RUTH
Slide 8: MiMedx is a pioneer in placental biologics
MIMEDX IS A PIONEER IN PLACENTAL BIOLOGICS Leading Brands in Existing Core Business Position Company to Capitalize on Late-stage Pipeline Business now positioned for sustainable & profitable growth Existing Core Business Late-Stage Pipeline Market opportunity Clinical evidence Commercialization
Slide 9: MiMedx is a pioneer in placental biologics: Market Opportunity
MIMEDX IS A PIONEER IN PLACENTAL BIOLOGICS Market Opportunity 17.5M Patients1 Clinical Evidence Target Product Profile Commercialization Strategy Existing Core Business Late-Stage Pipeline (1) Global Data Knee Reconstruction Data Model United States 2020 Business now positioned for sustainable & pro
Slide 10: Increasing optimism in knee OA opportunity
Offers non-surgical treatment option to reduce pain & improve function INCREASING OPTIMISM IN KNEE OA OPPORTUNITY (1) Knee Osteoarthritis; Global Data Knee Reconstruction Data Model United States 2020; (2) 2014 IQVIA Claims data with 2% growth rate; (3) Bannuru RR, Brodie CR, Sullivan MC, McAlindon
Slide 11: Three primary domains of value creation
THREE PRIMARY DOMAINS OF VALUE CREATION Operations Commercial R&D Core business investment drives sustainable growth and creates competitive advantage
Slide 12: Commercial
COMMERCIAL
Slide 13: Four key drivers to achieve core growth
Existing Core Business Drive disease state awareness across care continuum Publish additional data Expand into additional wound applications FOUR KEY DRIVERS TO ACHIEVE CORE GROWTH Portfolio Expansion Advance market assessments and analytics Leverage clinical and regulatory expertise Invest in prior
Slide 14: Amniotic tissue: largest & fastest growing segment of skin/dermal substitute market
6% CAGR $1B skin substitutes AMNIOTIC TISSUE: LARGEST & FASTEST GROWING SEGMENT OF SKIN/DERMAL SUBSTITUTE MARKET Amniotic Tissue Allografts Xenograft Skin Substitutes ~$233M Others +8-10% CAGR U.S. Amniotic Tissue Market Source: BioMed GPS SmartTrak; CAGR 2019-2024E Competitor A Others Competitor B
Slide 15: Maximizing opportunities in our core business
Existing Core Business MAXIMIZING OPPORTUNITIES IN OUR CORE BUSINESS 2 1 3 Increase Market Opportunity Capture Disproportionate Share Invest to Enhance Commercial Excellence Model
Slide 16: Increase market opportunity
STRATEGIES TACTICS Raise Patient Awareness Enhance Provider Engagement Leverage New Products Direct-to-patient initiatives Quality medical education for 1,500+ HCPs Leverage treatment options throughout care continuum 1 INCREASE MARKET OPPORTUNITY new!
Slide 17: Capture disproportionate share
CAPTURE DISPROPORTIONATE SHARE STRATEGIES TACTICS Communicate Product Differentiation Build Provider Confidence Build Payor Confidence Proprietary process More than 2 million allografts AHRQ data1,2 Generate health economic data Prove value to total cost of care Expand coverage to additional areas o
Slide 18: Invest to enhance commercial excellence model
3 INVEST TO ENHANCE COMMERCIAL EXCELLENCE MODEL TACTICS Identify, Target, Educate Demand Generation Fulfillment Build Analytics and Customer Segmentation Target high value customers Education programs that drive awareness & utilization Expand Sales Team by 10%+ Near-term investment in structure and
Slide 19: Research & Development
RESEARCH & DEVELOPMENT
Slide 20: Pipeline R&D strategic imperatives
Existing Core Business Pipeline R&D STRATEGIC IMPERATIVES “361” pathway “Minimally manipulated” and “Homologous Use” Current Good Tissue Practices (CGTP) Requires FDA review “351” pathway More than “minimally manipulated” and/or “non-homologous use” Current Good Manufacturing Practices (CGMP) Requir
Slide 21: Phase 2B study demonstrates significant benefit
PHASE 2B STUDY DEMONSTRATES SIGNIFICANT BENEFIT Primary Efficacy Endpoint: reduction in VAS (visual analog scale) score for pain (p<0.0001) Secondary Efficacy Endpoint: improvement in FFI-R (Foot Function Index-Revised) score (p=0.0004) At 3-month follow-up visit, average reduction VAS score for pai
Slide 22: Plantar fasciitis current status
PLANTAR FASCIITIS (PF) CURRENT STATUS Phase 2B study completed Phase 3 study enrollment completed 277 patients in September 2020 Last patient out in Q2 2021 Potential timeline* Meeting with FDA mid-2021 BLA filing 1H 2022 FDA approval and product launch 1H 2023 PF Study Informs Safety, Efficacy and
Slide 23: Results of retrospective study by Dr. Kris Alden
RESULTS OF RETROSPECTIVE STUDY BY DR. KRIS ALDEN INDICATE SIGNIFICANT BENEFIT FROM mdHACM INJECTIONS Source: Alden KJ, Harris S, Hubbs B, Kot K, Istwan NB, Mason D. Micronized Dehydrated Human Amnion Chorion Membrane Injection in the Treatment of Knee Osteoarthritis-A Large Retrospective Case Series
Slide 24: Knee osteoarthritis current status
Knee Osteoarthritis 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 2021 2022 2023 2024 2025 2026 KNEE OSTEOARTHRITIS (OA) CURRENT STATUS Phase 2B study ongoing Enrollment completed September 2020 Completed early, despite COVID-19 challenges 447 patients enrolled Drop-out rates lower than expected – 3% actual c
Slide 25: Injectable amnion-chorion pipeline timeline
2020 2021 2022 2023 2024 2025 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H INJECTABLE AMNION-CHORION Plantar Fasciitis Achilles Tendonitis Knee Osteoarthritis BLA APPROVAL REQUIRES CMC+CGMP+RCTs PHASE 3 PHASE 2 PHASE 3 LPI LPO LPI LPO 25 LPI = last patient in LPO = last patient out End of Enforcement Discret
Slide 26: MiMedx is a pioneer in placental biologics
MIMEDX IS A PIONEER IN PLACENTAL BIOLOGICS Core business investment drives sustainable growth and creates competitive advantage Existing Core Business Late-Stage Pipeline Market opportunity Clinical evidence Commercialization Business now positioned for sustainable & profitable growth
Slide 27: Question & Answer Session
QUESTION & ANSWER SESSION
Slide 28: Appendix
APPENDIX
Slide 29: Regulatory environment overview
REGULATORY ENVIRONMENT OVERVIEW 361 351 Human Tissue (i.e., placental tissue) When minimally manipulated When more than minimally manipulated Indication for use Homologous use* As indicated by clinical trial Manufacturing process cGTP cGMP FDA Oversight Regulated by the FDA for risk of disease trans
Slide 30: Phase 2B study demonstrates significant benefit: Plantar Fasciitis
PHASE 2B STUDY DEMONSTRATES SIGNIFICANT BENEFIT Plantar Fasciitis (PF) Phase 2b Study, AIPF004 147, subjects randomized, 100.68% complete enrollment Total number of sites: 14 Study closed to enrollment, 12-month efficacy endpoint completed, study closeout visits completed Final site monitoring visit
Slide 31: Injectable dHACM in the treatment of knee osteoarthritis
INJECTABLE DEHYDRATED HUMAN AMNION/CHORION MEMBRANE (dHACM) IN THE TREATMENT OF KNEE OSTEOARTHRITIS Methods Conclusions To our knowledge, these data represents the largest single-physician experience with injectable amniotic tissue in the treatment of knee OA to date. In our experience, injectable d