Mimedx Group, Inc · NASDAQ:MDXG
Mimedx — Investor Day (December 2021)
95 slides from Mimedx's investor day presentation, Dec 7, 2021
Slide 1: A Transformational Placental Biologics Company
A TRANSFORMATIONAL PLACENTAL BIOLOGICS COMPANY Investor Day December 7, 2021 1
Slide 2: Disclaimer & Cautionary Statements
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
Slide 3: Disclaimer & Cautionary Statements
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
Slide 4: Timothy R. Wright, Chief Executive Officer
TIMOTHY R. WRIGHT CHIEF EXECUTIVE OFFICER
Slide 5: Why We Are Here
TRANSFORMING THE LIVES OF PATIENTS IS WHY WE ARE HERE
Slide 6: Our Placental Biologics Have the Potential to Transform Medicine
OUR PLACENTAL BIOLOGICS HAVE THE POTENTIAL TO TRANSFORM MEDICINE 6
Slide 7: Strategy Expands Opportunity
STRATEGY EXPANDS OPPORTUNITY Participation in large and high-growth markets with significant unmet need $4B+ $2.7B Other OUS + Japan Japan $1.1B + + Surgical Recovery Surgical Recovery + + Advanced Wound Care Advanced Wound Care Advanced Wound Care Current 2022/23 2026+ BioMed GPS SmartTrak; Global
Slide 8: Strategy Expands Opportunity
STRATEGY EXPANDS OPPORTUNITY Participation in large and high-growth markets with significant unmet need Knee Osteoarthritis + $2.7B Other OUS + Japan Japan $1.1B + + Surgical Recovery Surgical Recovery + + Advanced Wound Care Advanced Wound Care Advanced Wound Care Current 2022/23 2026+ BioMed GPS S
Slide 9: Strategy Expands Opportunity
STRATEGY EXPANDS OPPORTUNITY Participation in large and high-growth markets with significant unmet need DMOAD Knee Osteoarthritis + $2.7B Other OUS + Japan Japan $1.1B + + Surgical Recovery Surgical Recovery + + Advanced Wound Care Advanced Wound Care Advanced Wound Care Current 2022/23 2026+ BioMed
Slide 10: Clear Strategy for Long-Term Value Creation
CLEAR STRATEGY FOR LONG-TERM VALUE CREATION • Accelerate KOA program R&D • Increase Product Vitality Index • Advance portfolio of scientific evidence • Implement CGMP throughout supply chain OPERATIONS • Leverage cost base • Optimize quality, processes and scale • Achieve sustainable double-digit gr
Slide 11: 2021 Investor Day Highlights
2021 INVESTOR DAY HIGHLIGHTS Musculoskeletal Pipeline Commercial KOA Program: Solid Execution: • p-values < 0.01 at 6 months • Expectations for 2021 Net Sales reflect • Root cause analysis reveals 13% to 15% growth in AWC controllable factors • Highly confident in proceeding with Phase 3 confirmator
Slide 12: Robert B. Stein M.D., Ph.D.
ROBERT B. STEIN M.D., Ph.D. EXECUTIVE VICE PRESIDENT RESEARCH & DEVELOPMENT
Slide 13: We Are Confident in the Therapeutic Potential of mdHACM
WE ARE CONFIDENT IN THE THERAPEUTIC POTENTIAL OF mdHACM mdHACM works to reduce pain and increase function in mild-to-moderate KOA We have determined why our positive results were not sustained throughout the entire Phase 2B study Potency of investigational product faded as it aged We know how to fix
Slide 14: Knee Osteoarthritis Is Triggered by Trauma and Inflammation
KNEE OSTEOARTHRITIS IS TRIGGERED BY TRAUMA AND INFLAMMATION Chondrocytes Matrix 14
Slide 15: WOMAC Is a Widely Used Measure for Osteoarthritis Severity
WOMAC IS A WIDELY USED MEASURE FOR OSTEOARTHRITIS SEVERITY Used to evaluate the condition of patients with osteoarthritis of the knee and hip • 24 questions: • 5 questions on pain • 17 questions on function • 2 questions on joint stiffness • Scoring: • 0 = no problem • 4 = extreme problems • WOMAC S
Slide 16: mdHACM = micronized dehydrated Human Amnion Chorion Membrane
mdHACM = micronized dehydrated Human Amnion Chorion Membrane • Manufactured from PURION® processed placental amnion and chorion layers • Micronized product is reconstituted with saline for injection • Flowable through 18-25 gauge needle 16
Slide 17: Strong Benefits from mdHACM in Moderate-to-Severe KOA
STRONG BENEFITS FROM mdHACM IN MODERATE-TO-SEVERE KOA KOOS Subscales (Mean % Increase) over Time 140% 120% Daily Living Pain Increase from Baseline Quality of Life 100% Sports/Recreation Symptoms 80% Overall KOOS 60% 40% 20% 0% Pre-Injection 6 Weeks 3 Months 6 Months Alden KJ, Harris S, Hubbs B, Kot
Slide 18: Phase 2B KOA Randomized Controlled Trial
PHASE 2B KOA RANDOMIZED CONTROLLED TRIAL 6 mo. blinded 6 mo. open observation observation mdHACM 40 mg i.a. 446 0 3 6 6 12 patients WOMAC with mild-to- moderate KOA Saline i.a. 6 mo. blinded 6 mo. open 1:1 Randomization observation observation • FPI August 2018 • Interim Power Analysis August 2019 o
Slide 19: WOMAC Total
WOMAC TOTAL n=190 n=256 p=0.038 p=0.008 n=446 Placebo mdHACM 19
Slide 20: WOMAC Pain
WOMAC PAIN n=190 n=256 p=0.032 p=0.009 n=446 Placebo mdHACM 20
Slide 21: WOMAC Function
WOMAC FUNCTION n=190 n=256 p=0.046 p=0.009 n=446 Placebo mdHACM 21
Slide 22: Why Do Positive Results for the 190 Differ from the 256?
WHY DO THE POSITIVE RESULTS FOR THE 190 DIFFER FROM THE NEGATIVE RESULTS FOR THE 256? INTENSIVE ANALYSIS CONDUCTED COVID-19 Pandemic Clinical Sites Use of Ultrasound Patient Demographics Age Gender KOA Severity Change in mdHACM 22
Slide 23: Potency of Investigational Product Faded
WHY DO THE POSITIVE RESULTS FOR THE 190 DIFFER FROM THE NEGATIVE RESULTS FOR THE 256? INTENSIVE ANALYSIS CONDUCTED COVID-19 Pandemic Clinical Sites Use of Ultrasound Potency of investigational Patient Demographics product faded Age as it aged Gender KOA Severity Change in mdHACM 23
Slide 24: Aging – WOMAC Total with Placebo
AGING – WOMAC TOTAL WITH PLACEBO Impact of investigational product age as percentage compared to baseline age of 100% investigational product at time of initial injection 80% 30-36 months Score as a percent of baseline 24-30 months 60% Placebo - total 18-24 months 12-18 months 40% 6-12 months 20% 0%
Slide 25: Biological Testing on Investigational Product
BIOLOGICAL TESTING ON INVESTIGATIONAL PRODUCT 25
Slide 26: What We Learned About mdHACM & KOA
WHAT WE LEARNED ABOUT mdHACM & KOA? mdHACM works to reduce pain and improve function in KOA • One injection of 40 mg produces benefits for at least 6 months • mdHACM is very safe and well-tolerated Potency faded as investigational product aged • Our proprietary biochemical and biological tests can d
Slide 27: What Else Have We Learned?
WHAT ELSE HAVE WE LEARNED? mdHACM modulates cell functions that are central to maintaining healthy cartilage: • Wnt pathway signaling • Nuclear Factor Kappa β signaling • Transforming Growth Factor β signaling mdHACM is a potential Disease Modifying Osteoarthritis Drug (DMOAD) • An agent which slows
Slide 28: What Next for mdHACM in KOA?
WHAT NEXT FOR mdHACM IN KOA? We will conduct two registrational Phase 3 trials of mdHACM in KOA • 400 – 500 patients in each study • Beginning in 2022 • BLA filing in late-2025 • WOMAC-Pain & WOMAC-Function as co- primary endpoints • DMOAD assessment as secondary endpoint The Phase 2B results and th
Slide 29: Reasons to Believe
REASONS TO BELIEVE Retrospective Evidence Positive Results from 190 Real-world Data Mechanism of Action Research 29
Slide 30: Michelle Massee
MICHELLE MASSEE ASSOCIATE VICE PRESIDENT PRODUCT DEVELOPMENT
Slide 31: mdHACM Regulates Key Pathways
mdHACM mdHACM REGULATES KEY PATHWAYS IMPLICATED IN OA DISEASE PROGRESSION 31
Slide 32: Amniotic Membranes
AMNIOTIC MEMBRANES The intrinsic properties of amniotic membranes have been utilized for wound healing since at least 19101 Placenta Barrier properties • Immunologically privileged tissue2 Biologically active tissue • Nutrient-rich tissue Availability of placental tissue • Post-partum recovery Amnio
Slide 33: PURION-Processed Amniotic Membranes
PURION-PROCESSED AMNIOTIC MEMBRANES Chorion is 4-5x thicker than amnion dHACM is an amnion and chorion bilayer 80% of growth factors derived from chorion 33
Slide 34: PURION-Processed Amniotic Membranes
PURION-PROCESSED AMNIOTIC MEMBRANES Relative amount of MMP and FIVE classes of Protease Inhibitors regulatory proteins (nmoles/mg) and enzymes MMP-1, MMP-2, MMP-3, MMP-8, MMP-9, MMP-10, MMP-13 TIMP-1 TIMP-2 Inflammatory TIMP-4 Cytokines lnflammatory Chemokines α2M Matrix Protease Metalloproteases In
Slide 35: PURION-Processed Amniotic Membranes
PURION-PROCESSED AMNIOTIC MEMBRANES Fibroblasts Endothelial Cells 1. Migration dHACM Epithelial Cells 2. Proliferation Stem Cells 3. Biosynthesis Diabetic Stem Cells dHACM is biologically active (1) Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties o
Slide 36: MIMEDX Publication Timeline
PURION-PROCESSED AMNIOTIC MEMBRANES MIMEDX PUBLICATION TIMELINE 15+ Scientific Publications 36
Slide 37: PURION-Processed Amniotic Membranes: Animal OA Study
PURION-PROCESSED AMNIOTIC MEMBRANES Medial Meniscal Transection Week 3 Images Model to Induce OA Saline Control mdHACM MMT Surgery Injection Treatments: Micronized dHACM vs. Saline Occurrence of Defects 4 - * Injection Imaging Imaging 3 - MMT 2 - 1 - 0 Saline AmnioFix Saline AmnioFix Day 0 1 3 Day 2
Slide 38: PURION-Processed Amniotic Membranes: Animal OA Study
PURION-PROCESSED AMNIOTIC MEMBRANES Medial Meniscal Transection Week 3 Images Model to Induce OA Saline Control mdHACM MMT Surgery Injection Saline Control mdHACM Treatments: Micronized dHACM vs. Saline Occurrence of Defects 4 - * Injection Imaging Imaging 3 - MMT 2 - 1 - 0 Saline AmnioFix Saline Am
Slide 39: Wnt Signaling
WNT SIGNALING Implications: • Critical pathway for maintaining tissue homeostasis in most ALL cells • Hyperactivation (ON) is associated with disease progression ranging from osteoarthritis to cancer metastasis • Small molecule Wnt inhibitor investigated for therapeutic applications: Samumed (SM0469
Slide 40: mdHACM Down-Regulates Wnt Signaling
mdHACM DOWN- REGULATES WNT SIGNALING Key Targets: • Phosphorylation of GSK3β • β-catenin translocation to the nucleus • TCF/LEF gene expression • AXIN2 gene expression Cell Reporter Line HEK293 cells modified with a luciferase reporter gene under the control of Wnt-responsive promoters (TCF/LEF) Wnt
Slide 41: Disease Modification Potential
DISEASE MODIFICATION POTENTIAL HYPERACTIVE mdHACM WNT SIGNALLING TREATMENT β-catenin nuclear localization mdHACM regulates proliferative and hypertrophic changes in the synovium and cartilage 41
Slide 42: Disease Modification Potential
DISEASE MODIFICATION POTENTIAL HYPERACTIVE mdHACM WNT SIGNALLING TREATMENT β-catenin nuclear localization mdHACM regulates proliferative and hypertrophic changes in the synovium and cartilage 42
Slide 43: NF-κβ Signaling
NF-κβ SIGNALING Implications • Critical pathway for maintaining tissue homeostasis in most ALL cells • Dysregulation is associated with disease progression ranging from osteoarthritis to COPD Liu, T., Zhang, L., Joo, D. et al. NF-κB signaling in inflammation. Sig Transduct Target Ther 2, 17023 (2017
Slide 44: NF-κβ Signaling
NF-κβ SIGNALING Key Targets: • Phosphorylation IκBα • P65 translocation to the nucleus • Inflammatory and protease gene expression mdHACM regulates NF- κβ signal transduction and downstream gene expression 44
Slide 45: Disease Modification Potential
DISEASE MODIFICATION POTENTIAL HYPERACTIVE mdHACM NF-κβ SIGNALLING TREATMENT mdHACM regulates degradative changes in the chondrocytes, in vitro 45
Slide 46: mdHACM Regulates Key Pathways
mdHACM mdHACM REGULATES KEY PATHWAYS IMPLICATED IN OA DISEASE PROGRESSION 46
Slide 47: Vibeke Strand, M.D.
VIBEKE STRAND, M.D. ADJUNCT CLINICAL PROFESSOR, DIVISION OF IMMUNOLOGY AND RHEUMATOLOGY STANFORD UNIVERSITY SCHOOL OF MEDICINE
Slide 48: Executive Summary – Knee OA
EXECUTIVE SUMMARY – KNEE OA • Last patients completed in October – data prepared for analysis • Phase 2B KOA trial top-line interim results demonstrated mixed efficacy signals between patient cohorts pre- [n=190] and post-interim analysis [n=256] • Clear evidence of a positive efficacy signal in the
Slide 49: WOMAC Pain Scores
WOMAC PAIN SCORES WOMAG Pain Score LS Mean (+ SE) mdHACM (N Placebo (N Day 0 Pre-Injection Visit 2 (1M) Visit 3 ( mal Placebo (N= 95) ] 93 WOMAC Pain Score LS Mean (+ SE) mi Visit 5 (6M) WOMAG Pain Score LS Mean (+ SE) Day 0 Pre-Injection Visit 2 (1M) mdHACM (N= 127) Placebo (N= 129) 127 128 Visit 3
Slide 50: WOMAC Physical Function Scores
WOMAC PHYSICAL FUNCTION SCORES 50
Slide 51: WOMAC Total Scores by Product Age
WOMAC TOTAL SCORES BY PRODUCT AGE > 6 - < 12 Months > 12 - < 18 Months > 18 - < 24 Months > 24 - < 30 Months > 30 - < 36 Months 51
Slide 52: Study Summary
STUDY SUMMARY • Although overall study did not demonstrate separation of mdHACM from placebo: • Efficacy signal in 190 patient Interim Analysis Cohort, consistent with previous published studies; encouraging • Learnings from research and manufacturing advancements are important • Clinical data will
Slide 53: Thomas M. Mick, M.D. and Kris J. Alden, M.D., Ph.D.
THOMAS M. KRIS J. ALDEN, MICK, M.D. M.D., Ph.D. MIMEDX MEDICAL ORTHOPAEDIC DIRECTOR SURGEON CLINICAL HIP, KNEE & DEVELOPMENT SHOULDER RECONSTRUCTION
Slide 54: Question & Answer Session
QUESTION & ANSWER SESSION 54
Slide 55: Rohit Kashyap, Ph.D. and John R. Harper, Ph.D.
ROHIT KASHYAP, Ph.D. EXECUTIVE VICE PRESIDENT CHIEF COMMERCIAL OFFICER JOHN R. HARPER, Ph.D. SENIOR VICE PRESIDENT RESEARCH & PRODUCT DEVELOPMENT CHIEF TECHNOLOGY OFFICER
Slide 56: Key Messages
KEY MESSAGES Multiple Large MIMEDX Value Executable Strategy Underpenetrated Proposition for Growth Opportunities Advanced Customer Current Commercial Wound Care Focus +7-8% Innovation & Market Surgical Clinical Development Recovery Evidence +2-3% International Scale, Reach & Growth Expansion Market
Slide 57: Key Messages
KEY MESSAGES Multiple Large Underpenetrated Opportunities Advanced Customer Current Commercial Wound Care Focus +7-8% Innovation & Market Surgical Clinical Development Recovery Evidence +2-3% International Scale, Reach & Growth Expansion Markets Relationships +2-3% 57
Slide 58: Advanced Wound Care Is an Underserved Market with Growth Potential
ADVANCED WOUND CARE IS AN UNDERSERVED MARKET WITH Total Addressable GROWTH POTENTIAL Market $1.5B Diabetic foot ulcers $1.1B Growth Drivers: Venous leg ulcers Aging population +7% Increasing diabetes Annual Pressure ulcers Increasing obesity Complex wounds 2021 2026 BioMed GPS SmartTrak; Management
Slide 59: Expansion into Surgical Recovery Market Propels Growth
EXPANSION INTO SURGICAL RECOVERY MARKET PROPELS GROWTH Total Addressable Market $1.3B Tissue augmentation Growth Drivers: $0.9B Aging population Barrier properties +10% Increasing obesity Annual Surgical closure Awareness & penetration 2021 2026 BioMed GPS SmartTrak; 3rd party proprietary assessment
Slide 60: Large Potential as First to Market in Japan with Amniotic Tissue
LARGE POTENTIAL AS FIRST TO MARKET IN JAPAN WITH AMNIOTIC TISSUE FOR WOUND TREATMENT Total Addressable Market 100,000 Addressable market $0.7B 626,000 Chronic Leg Ulcers $0.5B 126 Million Japan Population (2021) 2021 2026 Potential to expand beyond lower extremity wounds Global Data Tissue Engineere
Slide 61: Hiroto Terashi, M.D., Ph.D.
HIROTO TERASHI, M.D., Ph.D. President of the Japan Society for Surgical Wound Care Professor of the Department of Plastic Surgery, Kobe University Graduate School of Medicine Hiroto Terashi M.D., Ph.D. is Chief Professor in the Department of Plastic and Reconstructive Surgery, Kobe University, Japan
Slide 62: Key Messages
KEY MESSAGES MIMEDX Value Proposition Advanced Customer Current Commercial Wound Care Focus +7-8% Innovation & Market Surgical Clinical Development Recovery Evidence +2-3% International Scale, Reach & Growth Expansion Markets Relationships +2-3% 62
Slide 63: MIMEDX Customer-Focused Ecosystem Provides Competitive Advantage
MIMEDX CUSTOMER-FOCUSED ECOSYSTEM PROVIDES COMPETITIVE ADVANTAGE Leading Proprietary Portfolio Technology Proven Best-in-Class Outcomes Sales & Support Clinical Support Broad Access & Education and Coverage 63
Slide 64: AHRQ Publication Validated Commitment to Quality Clinical Evidence
AHRQ PUBLICATION VALIDATED COMMITMENT TO QUALITY CLINICAL EVIDENCE 5 of 12 were From a rigorous from MIMEDX evaluation of and 3 others over 240 missed their studies on endpoints 76 skin substitutes1 (1) Snyder DL, et al. Agency for Healthcare Research and Quality. https://www.cms.gov/Medicare/Covera
Slide 65: Real-World Evidence Confirms Clinical and Economic Benefits
REAL-WORLD EVIDENCE CONFIRMS CLINICAL AND ECONOMIC BENEFITS Use of EPIFIX® early in the treatment algorithm with regular application intervals results in best observed outcomes + meaningful cost savings1 Average cost/episode with EPIFIX was approximately $3,000 less versus other advanced treatments
Slide 66: Access, Relationships and Scale Support Growth Strategy
ACCESS, RELATIONSHIPS AND SCALE SUPPORT GROWTH STRATEGY Broad Provider Resources at Access Relationships Your Service1 100% 2,000+ 300+ National GPOs Hospitals Sales & Support Under Agreement 300 Million+ 1,100+ 50+ Covered Lives Wound Care Centers Agencies 1,500+ 20+ Field Reimbursement Private Off
Slide 67: Key Messages
KEY MESSAGES Executable Strategy for Growth Advanced Customer Current Commercial Wound Care Focus +7-8% Innovation & Market Surgical Clinical Development Recovery Evidence +2-3% International Scale, Reach & Growth Expansion Markets Relationships +2-3% 67
Slide 68: Wound Care Growth Driven by Expanding Access & Commercial Excellence
WOUND CARE GROWTH DRIVEN BY EXPANDING ACCESS & COMMERCIAL EXCELLENCE • Targeting Points of Leading Portfolio Aggregation • Selling Value versus Features & Benefits • Educate – Build Market Scale Across Sites of Care1 Awareness • New Products & Services In-patient 29% Private • Expand Reimbursement O
Slide 69: Surgical Recovery Growth Driven by Market Development
SURGICAL RECOVERY GROWTH DRIVEN BY MARKET DEVELOPMENT Leveraging Portfolio • Expand Reach in O.R. • Procedural Training • KOL Development by Specialty Targeting Unmet Needs • New Product Launches Tissue Handling • Clinical & Economic Evidence Antimicrobial Platform Functional Healing 69
Slide 70: Japan Commercial Strategy
JAPAN COMMERCIAL STRATEGY Dec ’21 – Mid ’22 Mid ’22 – Late ’23 2024+ Stage 1 Stage 2 Stage 3 Market Establish Achieve Development Treatment Scale $10M+ $50M+ Secure Generate local Expand reimbursement evidence reimbursement Medical education Leverage KOL / peer- Leverage local to-peer ed
Slide 71: Above-Market Growth Driven by Market Expansion and Portfolio Innovation
ABOVE-MARKET GROWTH DRIVEN BY MARKET EXPANSION AND PORTFOLIO INNOVATION 3.0% 14.0% 3.0% + 2.0% = 11.0% 8.0% + 2.0% 7.0% Existing Products New Products/ International Overall Growth Expansion Management estimates of annual revenue growth rate. 71
Slide 72: Unmet Needs Drive Opportunity for Disciplined Portfolio Expansion
UNMET NEEDS DRIVE OPPORTUNITY FOR DISCIPLINED PORTFOLIO EXPANSION Complex Patients Placental Iterations Wound Care Placental Tissue Matrix Continuum Deep & Large Surface Core Product Enablers Area Soft Tissue Defects Surgical Antimicrobial Platforms Implantable 72
Slide 73: Robust Near-Term Pipeline
ROBUST NEAR-TERM PIPELINE Care Setting Unmet Need Deeper / Larger Wounds AMNIOEFFECT™ Inpatient / Outpatient Surgical Implantable Placental Deep / Tunneling Inpatient Collagen Matrix Soft Tissue Defects Single Layer Inpatient Burns Amnion 73
Slide 74: 2022 Launches Expand Placental Portfolio
2022 LAUNCHES EXPAND PLACENTAL PORTFOLIO Placental AMNIOEFFECT™ Collagen Matrix Wide range of sizes Particulate format fulfills up to 9x20 key portfolio gap Improved handling for Retains key extracellular minimally invasive matrix components procedures Launch 1H2022 Launch 1H2022 74
Slide 75: Opportunities to Extend Leadership in Differentiated Clinical Evidence
OPPORTUNITIES TO EXTEND LEADERSHIP IN DIFFERENTIATED CLINICAL EVIDENCE AREAS OF FOCUS • Chronic wound clinical & health economic outcomes • Treating challenging surgical wounds • Complex incision management • Orthopaedic surgical recovery Mohs Defect Repair with Dehydrated Human Amnion/Chorion Membr
Slide 76: William H. Tettelbach, M.D.
WILLIAM H. TETTELBACH, M.D. MIMEDX PRINCIPAL MEDICAL OFFICER HEAD OF MEDICAL AFFAIRS B I D HA N B . CA R O L I NE JONATHAN D A S , M. D . CL A R K E, M. D . LABOVITZ, D.P.M. COLON, RECTAL PLASTIC, PODIATRIC FOOT & & GENERAL RECONSTRUCTIVE & ANKLE SURGEON SURGEON COSMETIC SURGEON
Slide 77: Question & Answer Session
QUESTION & ANSWER SESSION 77
Slide 78: Peter M. Carlson
PETER M. CARLSON EXECUTIVE VICE PRESIDENT CHIEF FINANCIAL OFFICER
Slide 79: Advanced Wound Care Growing at Double-Digits
ADVANCED WOUND CARE GROWING AT DOUBLE-DIGITS Results for the nine-months ended September 30 ($M) Advanced Wound Care (AWC)/ Net Sales Adjusted Net Sales1 Section 361 Net Sales2 +6.4% +10.3% +15.9% $191 $190 $180 $172 $173 $149 2020 2021 2020 2021 2020 2021 Updating 2021 expectations – represents 13%
Slide 80: Existing Cash Levels Are Sufficient to Support Near-Term R&D Efforts
EXISTING CASH LEVELS ARE SUFFICIENT TO SUPPORT NEAR-TERM R&D EFFORTS Free cash flow Free cash positive flow neutral Sept ‘21 Business Capital Other Dec ‘22 Business Capital Other Dec ‘23 Results Expenditures Uses Results Expenditures Uses Increase Decrease Total Cash and cash equivalents at Septembe
Slide 81: Summary
SUMMARY 1 Updated 2021 Adjusted Net Sales Range of $253 – $258 million • Includes 13% to 15% expected growth in AWC Net Sales from 2020 2 Expect business to be free cash flow neutral over next 12-15 months 3 Plan to provide further financial outlook at JPM Conference • Presentation Wednesday, Januar
Slide 82: Timothy R. Wright, Chief Executive Officer
TIMOTHY R. WRIGHT CHIEF EXECUTIVE OFFICER
Slide 83: Our Placental Biologics Have the Potential to Transform Medicine
OUR PLACENTAL BIOLOGICS HAVE THE POTENTIAL TO TRANSFORM MEDICINE 83
Slide 84: Differentiated Value Proposition Delivers Attractive Near- & Long-Term Growth
DIFFERENTIATED VALUE PROPOSITION DELIVERS ATTRACTIVE NEAR- & LONG-TERM GROWTH Sustainable above-market growth from commercial business in multiple underpenetrated markets Native & multimodal therapeutic properties of placental tissue provide unlimited range of organic product innovation KOA indicati
Slide 85: Appendix
APPENDIX 85
Slide 86: KOA Kellgren-Lawrence (KL) Grades
KOA KELLGREN-LAWRENCE (KL) GRADES 86
Slide 87: KOA Phase 2B Study Population
KOA PHASE 2B STUDY POPULATION Parameter mdHACM Placebo Total Gender – Male/Female 54%/46% 63%/37% 58%/42% Age – Mean/Median 57.9/58.5 years 58.5/60.0 years 58.2/59.0 years Age Group – 18 to 64 / 65+ 71%/29% 65%/35% 68%/32% BMI Categories: < 18.5 0% 0% 0% 18.5 to < 25.0 20% 22% 21% 25.0 to < 30.0 36%
Slide 88: KOA Phase 2B Study Visual Analog Score (VAS)
KOA PHASE 2B STUDY VISUAL ANALOG SCORE (VAS) Pre-IA Cohort (n=190) Post-IA Cohort (n=256) Total Cohort (n=446) Placebo mdHACM 88
Slide 89: Revenue Outlook Reconciliation
REVENUE OUTLOOK RECONCILIATION (in millions} 2020 2021 Estimate Advanced Wound Care / Section 3611 $208.8 $236 – $240 Section 3511 $31.7 $17 – $18 Adjusted Net Sales2 $240.5 $253 – $258 Revenue Transition amounts $7.7 $1 Net Sales $ 248.2 $254 – $259 (1) Section 361 includes Tissue + Cord sales. Sec
Slide 90: Summary Balance Sheets
SUMMARY BALANCE SHEETS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 Assets Cash and Cash Equivalents 69.1 53.5 48.2 109.6 95.8 84.7 85.0 90.6 Accounts Receivable, net 32.3 31.9 30.1 33.0 35.4 35.4 37.2 36.5 Inventory, net 9.1 9.2 10.6 11.0 10.4 11.6 10.1 11.2 Other Current Assets 12.7 21.2 1
Slide 91: Summary Income Statements
SUMMARY INCOME STATEMENTS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 Net Sales 76.4 61.7 53.6 64.3 68.6 60.0 68.2 63.1 Cost of Sales 12.7 10.0 8.2 10.3 10.8 9.7 12.8 10.1 Gross Profit 63.7 51.7 45.4 54.0 57.8 50.3 55.4 53.0 Research & Development 2.7 2.7 2.3 3.4 3.4 4.3 4.1 4.3 Selling, Ge
Slide 92: Summary Cash Flow Statements
SUMMARY CASH FLOW STATEMENTS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) (1.8) (2.3) Share-Based Compensation 2.9 3.3 4.4 3.7 3.9 3.2 4.1 3.8 Depreciation 1.6 1.5 1.4 1.5 1.3 1.2 1.3 0.9 Other Non-Cash Effects 1.2 1.2 1.3 9.5 1.7 1.1 0.9 0.6 Ch
Slide 93: Revenue Detail
REVENUE DETAIL Quarter Trailing 12 Months ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q20 1Q21 2Q21 3Q21 Advanced Wound 56.2 48.5 45.8 55.1 59.4 51.5 59.3 62.3 208.8 211.8 225.3 232.5 Care / Section 3611 Section 3511 12.0 8.7 6.1 8.2 8.7 8.2 8.6 0.5 31.7 31.2 33.7 26.0 Adjusted Net Sales2
Slide 94: Non-GAAP Metrics Reconciliation
NON-GAAP METRICS RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 Net Sales – Reported 76.4 61.7 53.6 64.3 68.6 60.0 68.2 63.1 Less: Revenue Transition (8.2) (4.5) (1.7) (1.0) (0.5) (0.3) (0.3) (0.3) Impact1 Adjusted Net Sales 68.2 57.2 51.9 63.3 68.1 59.7 67.9 62.8 Gross Profit 6
Slide 95: Adjusted EBITDA Reconciliation
ADJUSTED EBITDA RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) (1.8) (2.3) Depreciation & Amortization 1.8 1.8 1.7 1.8 1.6 1.5 1.5 1.1 Interest Expense 2.4 2.4 2.6 1.5 1.5 1.5 1.4 1.0 Loss on Extinguishment of 0.0 0.0 0.0 8.2 0.0 0.