Mimedx Group, Inc · NASDAQ:MDXG
Mimedx — Raymond James Human Health Innovation Conference 2021
25 slides from Mimedx's conference presentation, Jun 23, 2021
Slide 1: Advancing Regenerative Medicine Treatment Through Placental Science
Exhibit 99.1 ADVANCING REGENERATIVE MEDICINE TREATMENT THROUGH PLACENTAL SCIENCE Raymond James Human Health Innovation Conference June 23, 2021 1Exhibit 99.1 ADVANCING REGENERATIVE MEDICINE TREATMENT THROUGH PLACENTAL SCIENCE Raymond James Human Health Innovation Conference June 23, 2021 1
Slide 2: Disclaimer & Cautionary Statements
DISCLAIMER & CAUTIONARY STATEMENTS Important Cautionary Statement 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
Slide 3: Industry Leader in Utilizing Amniotic Tissue as a Platform for Regenerative Medicine
INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A PLATFORM FOR REGENERATIVE MEDICINE Promising Late- Base Business Stage Pipeline Advanced Wound Care Musculoskeletal Distinct drivers of significant shareholder value with current and future growth potential 3INDUSTRY LEADER IN UTILIZING AMNIOTIC TISS
Slide 4: Base Business Has Stabilized and Is Now Positioned for Growth
BASE BUSINESS HAS STABILIZED AND IS NOW POSITIONED FOR GROWTH Net Sales ($M) 2,3 Section 361 vs. Section 351 Sales Breakdown (2.9%) 2020 1Q21 $76 $69 $64 $62 $60 13% 14% $54 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 87% 86% 1 Adjusted Net Sales ($M) +4.2% Section 351 Sales Section 361 Sales $68 $68 $63 $60 $57
Slide 5: Clear Strategy for Value Creation
CLEAR STRATEGY FOR VALUE CREATION Industry leading base business with high gross margins provides foundation for long-term, stable growth, fueling late-stage pipeline • Targeting 10%+ growth in base advanced wound care business • Japan approval received June 2021, providing foundation for further in
Slide 6: The Placenta Is a Sophisticated Biological System That Supports Growth and Healing
THE PLACENTA IS A SOPHISTICATED BIOLOGICAL SYSTEM THAT SUPPORTS GROWTH AND HEALING 1 Known Properties of Amniotic Tissue 2 • Regulator of angiogenesis • Modulates inflammation • Barrier membrane • Inhibitor of fibrosis and scars 3 • Promoter of epithelialization • Non-immunogenic material Our librar
Slide 7: PURION Processed Dehydrated Human Amnion Chorion Membrane (dHACM)
® PURION PROCESSED DEHYDRATED HUMAN AMNION CHORION MEMBRANE (dHACM) The Company’s early work characterized the core properties of our technology, including the identification of regulatory proteins and basic biological functions, such as cellular proliferation, migration, and biosynthesis 1-3 Non-vi
Slide 8: Versatile Platform with Broad Potential Across Multiple Applications
VERSATILE PLATFORM WITH BROAD POTENTIAL ACROSS MULTIPLE APPLICATIONS Placental Tissue Injectable Amnion/Chorion Umbilical Cord Matrix Amnion/Chorion 1 1 2 2 Applications : Applications : Indications : Indications : • Acute & Chronic • Acute & Chronic • Soft Tissue Defects • Musculoskeletal & Wounds
Slide 9: Investing Heavily in Promising Late-Stage Pipeline with Significant Growth Opportunities
INVESTING HEAVILY IN PROMISING LATE-STAGE PIPELINE WITH SIGNIFICANT GROWTH OPPORTUNITIES MUSCULOSKELETAL/SPORTS MEDICINE 1H 2022 PHASE 3 Plantar Fasciitis (PF) Est. BLA filing PHASE 3 Achilles Tendonitis (AT) * 2H 2024 / 1H2025 PHASE 2B Knee Osteoarthritis (OA) Est. BLA filing ADVANCED WOUND CARE Ch
Slide 10: More Than 300 Regulatory Factors Are Preserved in PURION Processed dHACM
MORE THAN 300 REGULATORY FACTORS ARE 1-3 ® PRESERVED IN PURION PROCESSED dHACM (1) Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40.; (2) Koo
Slide 11: dHACM Contains a Complex Variety of Matrix Components and Regulatory Proteins
dHACM CONTAINS A COMPLEX VARIETY OF MATRIX COMPONENTS AND REGULATORY 1 PROTEINS MMP = matrix metalloproteinase TIMPs = Tissue Inhibitors of matrix metalloproteinase (1) Lei J, Priddy LB, Lim JJ, Massee M, Koob TJ. Identification of extracellular matrix components and biological factors in micronized
Slide 12: Growth Factors Contained Within dHACM Are Released Over Time
GROWTH FACTORS CONTAINED WITHIN 1 dHACM ARE RELEASED OVER TIME Method Combine Incubate Centrifuge Analyze dHACM Soluble 24 Hours growth factors Growth factors Saline bound in the matrix Solution @ 4C° Results Determined by ELISA Assay (N=5) PDGF-AA 13% 87% PDGF-BB 4% 96% bFGF 44% 56% TGF-ß1 24% 76%
Slide 13: dHACM Supports the Recruitment & Proliferation of Multiple Reparative Cell Types
dHACM SUPPORTS THE RECRUITMENT & PROLIFERATION OF MULTIPLE REPARATIVE CELL TYPES Fibroblasts Endothelial Cells Migration Epithelial Cells Proliferation dHACM HSCs Biosynthesis bmMSCs ADSCs Healthy & Diabetic Type I, II 1-8 • Signals released from dHACM create a chemotactic gradient to recruit cells
Slide 14: dHACM Demonstrated Preferential Recruitment of Stem Cells in a Mouse Parabiosis Model
dHACM EFFECTIVELY DEMONSTRATED PREFERENTIAL RECRUITMENT OF STEM CELLS 1 IN A MOUSE PARABIOSIS MODEL GFP+ cells travel through Surgically join skin so mice All cells in GFP mouse circulation to normal mouse, fluoresce green share blood circulation = exit blood and migrate “parabiosis” toward chemotac
Slide 15: dHACM Promotes Production of Hyaluronic Acid by Human Synoviocytes
dHACM PROMOTES PRODUCTION OF HYALURONIC ACID (HA) BY HUMAN SYNOVIOCYTES ACROSS 1 NORMAL, OA AND RA CELL TYPES Deficient cells respond to dHACM by stimulating production of necessary components (HA) Purion processed dHACM could be potentially effective for treatment of joint diseases due to the multi
Slide 16: mdHACM Protects Cartilage Degradation In Vivo Following Intra-Articular Injection
mdHACM PROTECTS CARTILAGE DEGRADATION IN VIVO FOLLOWING INTRA-ARTICULAR 1 INJECTION Medial Meniscal Transection Model to Induce OA mdHACM Injected into Joints with Induced OA • Confirmed OA in saline-treated joints • Histology confirmed presence of particles at day 3 and 21 • No differences in carti
Slide 17: The BLA Process Is Lengthy and Requires Careful Planning and Coordination with the FDA
THE BLA PROCESS IS LENGTHY AND REQUIRES CAREFUL PLANNING AND COORDINATION WITH THE FDA MIMEDX has assembled the right Board and Management Team with the relevant clinical, scientific and regulatory expertise required to navigate the BLA pathway Industry – FDA Interactions During Development Prototyp
Slide 18: Industry Leader in Utilizing Amniotic Tissue as a Platform for Regenerative Medicine
INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A PLATFORM FOR REGENERATIVE MEDICINE Promising Late- Base Business Stage Pipeline Advanced Wound Care Musculoskeletal Distinct drivers of significant shareholder value with current and future growth potential 18INDUSTRY LEADER IN UTILIZING AMNIOTIC TIS
Slide 19: Appendix
APPENDIX 19APPENDIX 19
Slide 20: Summary Balance Sheets
SUMMARY BALANCE SHEETS 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 ($ millions) Assets Cash and Cash Equivalents 69.1 53.5 48.2 109.6 95.8 84.7 Accounts Receivable, net 32.3 31.9 30.1 33.0 35.4 35.4 Inventory, net 9.1 9.2 10.6 11.0 10.4 11.6 Other Current Assets 12.7 21.2 18.7 17.9 19.0 18.3 Total Current Assets
Slide 21: Summary Income Statements
SUMMARY INCOME STATEMENTS 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 ($ millions) Net Sales 76.4 61.7 53.6 64.3 68.5 60.0 Cost of Sales 12.7 10.0 8.2 10.3 10.8 9.7 Gross Profit 63.7 51.7 45.4 54.0 57.7 50.3 Research & Development 2.7 2.7 2.3 3.4 3.4 4.3 Selling, General, and Administrative 45.4 46.9 37.3 48.0 48
Slide 22: Summary Cash Flow Statements
SUMMARY CASH FLOW STATEMENTS 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 ($ millions) Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) Share-Based Compensation 2.9 3.3 4.4 3.7 3.9 3.2 Depreciation 1.6 1.5 1.4 1.5 1.3 1.2 Other Non-Cash Effects 1.2 1.2 1.3 9.5 1.7 1.1 Changes in Assets (14.2) (8.2) 2.9 (1.8) (6.2) 0
Slide 23: Revenue Detail
REVENUE DETAIL QUARTER TRAILING 12 MONTHS ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 3Q20 4Q20 1Q21 Advanced Wound Care 56.2 48.5 45.8 55.1 59.3 51.5 205.6 208.7 211.7 1 /Section 361 1 Section 351 12.0 8.7 6.1 8.2 8.7 8.2 35.0 31.7 31.2 2 Adjusted Net Sales 68.2 57.2 51.9 63.3 68.0 59.7 240.6 240.4
Slide 24: Non-GAAP Metrics Reconciliation
NON-GAAP METRICS RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 Net Sales – Reported $ 76.4 $ 61.7 $ 53.6 $ 64.3 $ 68.5 $ 60.0 1 Less: Revenue Transition Impact 8.2 4.5 1.7 1.0 0.5 0.3 Adjusted Net Sales $ 68.2 $ 57.2 $ 51.9 $ 63.3 $ 68.0 $ 59.7 $ 63.7 $ 51.7 $ 45.4 $ 54.0 $ 57.7 $ 50.3 G
Slide 25: Adjusted EBITDA Reconciliation
ADJUSTED EBITDA RECONCILIATION ($ millions) 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 Net Loss (7.5) (4.8) (8.5) (19.4) (16.6) (8.4) 1.8 1.8 1.7 1.8 1.6 1.5 Depreciation & Amortization 2.4 2.4 2.6 1.5 1.5 1.5 Interest Expense Loss on Extinguishment of Debt 0.0 0.0 0.0 8.2 0.0 0.0 0.3 (11.3) 0.0 0.0 (1.0) 0.1 In
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