Mimedx Group, Inc · NASDAQ:MDXG
Mimedx — Investor Presentation (September 2020)
35 slides from Mimedx's investor presentation, Sep 21, 2020
Slide 1: Management Presentation September 21-25, 2020
MANAGEMENT PRESENTATION SEPTEMBER 21-25, 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: Advanced Wound Care and Therapeutic Biologics Company
ADVANCED WOUND CARE AND THERAPEUTIC BIOLOGICS COMPANY Pioneer with leading brands and a late-stage pipeline 40+ Scientific & clinical publications 1,900,000+ Allografts Distributed1 84% Gross Margin4 $281M Net Sales2 $711M Market Cap1 696 Employees3 Reimbursement coverage: 286M+ lives MDXG (OTC PINK
Slide 4: Advanced Wound Care Sector Is Large and Growing, With Considerable Unmet Need
ADVANCED WOUND CARE SECTOR IS LARGE AND GROWING, WITH CONSIDERABLE UNMET NEED Source: Global Data 2019 Market Size and Growth Report: United States, Wound Care Management Market 2019. BioMed GPS SmartTrak; CAGR 2019-2024E U.S. Wound Care $3B are advanced wounds $12B 4% CAGR Growth drivers: Aging pop
Slide 5: Amniotic Tissue Represents Largest & Fastest Growing Portion of Skin Substitute Market
6% CAGR $1B skin substitutes AMNIOTIC TISSUE REPRESENTS LARGEST & FASTEST GROWING PORTION 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 Com
Slide 6: Transforming the Business
TRANSFORMING THE BUSINESS 2021 + 2020 2019 New CEO New external auditor Debt financing New board members Key hires Restatement Resolution of SEC/VA cases Recapitalization Product launch Completed trial enrollment Profitable growth International expansion Pipeline maturation SUSTAIN STABILIZE GROW
Slide 7: Investment Highlights
INVESTMENT HIGHLIGHTS 1 2 3 4 5 7 6 Leader in tissue-based products for advanced wound care Strong & differentiated infrastructure to deliver growth Versatile product offerings supported by robust clinical evidence Underserved, growing market opportunity Promising pipeline targets unmet needs in lar
Slide 8: Strong and Differentiated Infrastructure to Deliver Growth
STRONG AND DIFFERENTIATED INFRASTRUCTURE TO DELIVER GROWTH 40+ clinical & scientific publications in peer-reviewed, indexed journals Best-in-class evidence recognized by AHRQ1 Robust publication strategy with accompanying medical education support Universal tissue with broad applicability Proprietar
Slide 9: The Placenta Is a Sophisticated Biological System That Supports Growth and Healing
THE PLACENTA IS A SOPHISTICATED BIOLOGICAL SYSTEM THAT SUPPORTS GROWTH AND HEALING Demonstrated Power of the Placenta EpiFix in Venous Leg Ulcer (VLU) Day 42 Day 1 Day 7 Day 35 EpiFix in Diabetic Foot Ulcer (DFU) Regulator of angiogenesis2 Modulates inflammation Barrier membrane Inhibitor of fibrosi
Slide 10: Versatile Platform with Broad Potential Across Multiple Applications
VERSATILE PLATFORM WITH BROAD POTENTIAL ACROSS MULTIPLE APPLICATIONS new! (1) 361 HCT/Ps (Human Cell Tissue/ Products) for homologous use only; HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent. As define
Slide 11: Clinical Evidence Demonstrates Differentiation & Supports Reimbursement
CLINICAL EVIDENCE DEMONSTRATES DIFFERENTIATION & SUPPORTS REIMBURSEMENT Statistically significant results* Randomized controlled trials across multiple applications Head-to-head study results demonstrate superior clinical outcomes & substantially lower cost-to-closure compared to Apligraf® Studies d
Slide 12: Donation Program Protects Quality with Integrated Supply and Delivery Network
DONATION PROGRAM PROTECTS QUALITY WITH INTEGRATED SUPPLY AND DELIVERY NETWORK 1 2 3 4 5 6 7 Expectant Mom Introduced to Donation Program Mom Consents to Donate; Completes Medical History & Risk Assessment Questionnaire Delivery of Healthy Baby via Caesarean Section Micro-biological & Viral Testing o
Slide 13: Invest Commercially to Drive Growth Advantaged by Strong Infrastructure
INVEST COMMERCIALLY TO DRIVE GROWTH ADVANTAGED BY STRONG INFRASTRUCTURE Enhance Sales Effectiveness New commercial leadership Structure, deployment and scale Value-based selling Invest in Market Development Medical education Brand & digital assets New products Highlight Differentiation from Competit
Slide 14: Targeted Investment for Geographic Expansion
TARGETED INVESTMENT FOR GEOGRAPHIC EXPANSION UK GERMANY JAPAN Total Wound Care Market ~$380M ~$740M ~$430M DFU + VLU 225K 500K 650K MiMedx Addressable Market 35K 80K 100K Regulatory Status Approved Approved Anticipated 2021 Reimbursement Status In process In process 3-6 months post-approval Current
Slide 15: 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 16: Late-Stage Pipeline Leverages Leadership in Placental Science
LATE-STAGE PIPELINE LEVERAGES LEADERSHIP IN PLACENTAL SCIENCE Potential to address unmet patient needs as a platform technology across multiple markets * Clinical study initiation will depend on FDA feedback for program PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MUSCULOSKELETAL/SPORTS MEDICINE Plantar Fas
Slide 17: Late Stage Clinical Programs Maturing
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 LATE STAGE CLINICAL PROGRAMS MATURING PHASE 3 PHASE 2 PHASE 3 LPI LPO LPI LPO LPI = last patient in LPO = last patient out End of Enforcement Discreti
Slide 18: Planned IND / IDE Filings Broaden Pipeline
PLANNED IND / IDE FILINGS BROADEN PIPELINE 2020 2021 2022 2023 1H 2H 1H 2H 1H 2H 1H 2H INJECTABLE AMNION-CHORION Chronic Wounds Surgical Incisions PLACENTAL TISSUE MATRIX Soft Tissue Defects Proof of Concept IND / IDE Filing Proof of Concept IND Enabling Studies IND Enabling Studies IND Enabling Stu
Slide 19: PF Study Informs Safety, Efficacy and Other Future Indications
PF STUDY INFORMS SAFETY, EFFICACY AND OTHER FUTURE INDICATIONS (1) Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010;39(5):227-231; (2) Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis.
Slide 20: Retrospective Study Provided Insight into Potential for Reducing Pain and Improving Function
RETROSPECTIVE STUDY PROVIDED INSIGHT INTO POTENTIAL FOR REDUCING PAIN AND IMPROVING FUNCTION Knee Osteoarthritis (KOA) (1) 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 Retrospecti
Slide 21: Gaps in Current Treatment Options Provide Opportunity to Advance Non-Surgical Treatment Algorithm
GAPS IN CURRENT TREATMENT OPTIONS PROVIDE OPPORTUNITY TO ADVANCE NON-SURGICAL TREATMENT ALGORITHM Knee Osteoarthritis (KOA) Offers non-surgical treatment option to reduce pain & improve function (1) Global Data Knee Reconstruction Data Model United States 2020 (2) 2014 IQVIA Claims data with 2% grow
Slide 22: Adjusted Net Sales Trends Reflect Stabilization Post COVID-19 Downturn
ADJUSTED NET SALES TRENDS REFLECT STABILIZATION POST COVID-19 DOWNTURN Net Sales Adjusted Net Sales1 (1) Adjusted Net Sales excludes impact of Revenue Transition amounts. See Appendix for reconciliation to Net Sales. ($ millions) $60-$63 Revenue presentation includes impact of 2019 transition in rev
Slide 23: Recent Transactions Provide Financial Flexibility
Financing transactions1 provide ability to: RECENT TRANSACTIONS PROVIDE FINANCIAL FLEXIBILITY Stabilize business Prioritize investment in growth drivers Pursue attractive growth opportunities Initial holders are affiliates of EW Healthcare Partners (90%) and Hayfin Capital Management (10%) Two board
Slide 24: 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 MATT – VLU PATIENT IVY – BURN PATIENT
Slide 25: Experienced Leadership Team Now in Place
= Joined since 2018 EXPERIENCED LEADERSHIP TEAM NOW IN PLACE ROBERT STEIN, MD, PhD EVP, Research & Development SCOTT TURNER SVP, Operations & Procurement MARK ROGERS VP, Global Quality Assurance & Regulatory PETE CARLSON Chief Financial Officer MARK GRAVES Chief Compliance Officer STAN MICEK SVP, Bu
Slide 26: Appendix
APPENDIX
Slide 27: Clinical Study Summary
CLINICAL STUDY SUMMARY (1) Zelen, C.M., Serena, T.E., Denoziere, G. and Fetterolf, D.E. (2013), A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J, 10: 502-507. doi:10.1111/iwj.12097; (2) Zelen CM, Serena TE, Sn
Slide 28: 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 29: Intellectual Property Overview
INTELLECTUAL PROPERTY OVERVIEW PATENT PORTFOLIO OVERVIEW Domestic patents issued: 91 Domestic patents pending: 40 Foreign patents issued: 97 Foreign patents pending: 54 Placental Tissue: 52 domestic 33 foreign CollaFix: 36 domestic 64 foreign HydroFix: 3 domestic ISSUED PATENTS BY TECHNOLOGY CATEGOR
Slide 30: Summary Balance Sheets
SUMMARY BALANCE SHEETS ($ millions) 1Q19 2Q19 3Q19 4Q19 Unaudited 1Q20 2Q20 Assets Cash and Cash Equivalents 28.4 96.9 94.1 69.1 53.5 48.2 Accounts Receivable, net 0.0 0.0 21.4 32.3 31.9 30.1 Inventory, net 16.4 15.0 12.0 9.1 9.2 10.6 Other Current Assets 12.4 10.6 6.5 12.7 21.2 18.7 Total Current A
Slide 31: Summary Income Statements
SUMMARY INCOME STATEMENTS ($ millions) 1Q19 2Q19 3Q19 4Q19 Unaudited 1Q20 2Q20 Net Sales 66.6 67.4 88.9 76.4 61.7 53.6 Cost of Sales 7.4 9.7 13.2 12.7 10.0 8.2 Gross Profit 59.1 57.7 75.7 63.7 51.7 45.4 Research & Development 2.9 2.8 2.7 2.7 2.7 2.3 Selling, General, and Administrative 50.9 50.6 51.
Slide 32: Summary Cash Flow Statements
SUMMARY CASH FLOW STATEMENTS ($ millions) 1Q19 2Q19 3Q19 4Q19 Unaudited 1Q20 2Q20 Net Income (Loss) (13.3) (17.2) 12.4 (7.5) (4.8) (8.5) Effect of Change in Revenue Recognition 0.0 0.0 (17.4) 0.0 0.0 0.0 Share-Based Compensation 3.0 3.5 2.7 2.9 3.3 4.4 Depreciation 1.7 1.6 1.6 1.6 1.5 1.4 Other Non-
Slide 33: Adjusted EBITDA Reconciliation
ADJUSTED EBITDA RECONCILIATION ($ millions) 3Q19 4Q19 1Q20 2Q20 Net Income (Loss) 12.4 (7.5) (4.8) (8.5) Depreciation & Amortization 1.9 1.8 1.8 1.7 Interest Expense 2.3 2.4 2.4 2.6 Income Tax (0.3) 0.2 (11.3) 0.0 EBITDA 16.2 (3.0) (12.0) (4.2) Investigation, Restatement & Other 7.2 20.1 15.6 11.4 R
Slide 34: Reconciliation of Adjusted Net Sales
RECONCILIATION OF ADJUSTED NET SALES (1) Impact of revenue transition includes the Transition Adjustment during 3Q2019 and cash collected in 4Q2019, 1Q2020 and 2Q2020 related to the remaining contracts. For a discussion of the revenue transition and the defined terms, refer to Item 8, Notes to the C
Slide 35: June 30, 2020 Balance Sheet Does Not Reflect Improved Liquidity from Transactions
JUNE 30, 2020 BALANCE SHEET DOES NOT REFLECT IMPROVED LIQUIDITY FROM TRANSACTIONS (in millions) AS REPORTED IMPACT OF TRANSACTIONS1 AS REPORTED PLUS IMPACT OF TRANSACTIONS WHEN CONVERTED2 Cash $ 48.2 $ 65.4 $ 113.6 Other 102.7 0.9 103.6 Total Assets $ 150.9 $ 66.3 $ 217.2 Long-term debt, including c
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