2012 Biomet Company Profile & Analysis: Biologics Division TABLE OF CONTENTS TABLE OF CONTENTS............................I LIST OF FIGURES..............................V LIST OF CHARTS.............................VI EXECUTIVE SUMMARY........................... 1 1.1 BIOMET OVERVIEW ........................... 1 1.2 CORPORATE REVENUE GROWTH BY BUSINESS UNIT............... 2 1.3 GLOBAL REVENUE BY REGION...................... 3 1.4 MARKET SHARE: ORTHOPEDIC BIOMATERIALS ................. 4 RESEARCH METHODOLOGY....................... 5 2.1 IDATA’S 9-STEP METHODOLOGY ..................... 5 2.1.1 Step 1: Project Initiation & Team Selection ................. 5 2.1.2 Step 2: Prepare Data Systems and Perform Secondary Research........ 8 2.1.3 Step 3: Preparation for Interviews & Questionnaire Design ......... 9 2.1.4 Step 4: Performing Primary Research.................. 10 2.1.5 Step 5: Research Analysis: Establishing Baseline Estimates .......... 12 2.1.6 Step 6: Market Forecast and Analysis .................. 13 2.1.7 Step 7: Identify Strategic Opportunities .................. 15 2.1.8 Step 8: Final Review and Market Release ............... 16 2.1.9 Step 9: Customer Feedback and Market Monitoring........... 17 BIOMET COMPANY OVERVIEW ..................... 18 3.1 INTRODUCTION ............................. 18 3.2 COMPANY PROFILE.......................... 18 3.2.1 Business Units............................ 18 3.2.1.1 Orthopedic Reconstruction....................18 3.2.1.2 Orthopedic Trauma, Spine and Biologics.............18 3.2.1.3 Sports Medicine .........................19 Table of Contents © iData Research Inc., 2011 ii 3.2.1.4 Craniomaxillofacial......................19 3.2.1.5 Dental ............................19 3.3 GLOBAL REVENUES ......................... 20 3.3.1 Global Revenues by Division .................... 20 3.3.2 Global Revenues by Geography................... 24 3.4 COMPANY HISTORY......................... 26 3.5 COMPANY INFORMATION ......................... 28 3.5.1 Size.............................. 28 3.5.2 Office and Facility Locations.................... 29 FINANCIAL METRICS.......................... 30 4.1 INCOME STATEMENT .......................... 30 4.2 BALANCE SHEET........................... 31 4.2.1 Balance Sheet.......................... 31 4.2.2 Company Debt ........................... 32 PRODUCT PIPELINE.......................... 33 5.1 ORTHOPEDIC BIOMATERIALS ...................... 33 5.1.1 U.S. FDA Investigational Device Exemption (IDE) ............ 33 5.1.1.1 Platelet Rich Plasmas for Tennis Elbow...............33 5.1.2 U.S. FDA Phase 1 Trials ....................... 33 5.1.2.1 Bone Marrow Aspirate Concentration for Critical Limb Ischemia....33 5.1.3 U.S. FDA 510(k) Submissions...................... 34 5.1.3.1 Bone Marrow Concentration System.................34 5.1.4 European CE Mark Trials ..................... 34 5.1.4.1 ChonDux Trail Suspension ....................34 5.1.4.2 Fat Concentration System...................34 SWOT ANALYSIS............................. 35 6.1 ORTHOPEDIC BIOMATERIALS SWOT ANALYSIS.............. 35 6.1.1 Strengths .............................. 35 6.1.1.1 Joint Reconstruction .....................35 6.1.1.2 History in Orthopedic Biologics..................36 6.1.1.3 Market Leader in Cell Concentration Systems ...........36 6.1.1.4 Restructured Management.....................36 Table of Contents © iData Research Inc., 2011 iii 6.1.2 Weaknesses ............................. 37 6.1.2.1 Competition from Larger Competitors ..............37 6.1.2.2 Lack of Advanced Bone Graft Substitute Product ............37 6.1.2.3 Partial Reliance on Distributors in the United States .........38 6.1.2.4 High Debt Levels .......................38 6.1.2.5 Spine and Trauma Fixation Divisions ...............38 6.1.2.6 Staff Restructuring ........................38 6.1.3 Opportunities .......................... 39 6.1.3.1 Undeveloped Asian and Emerging Markets Presence.........39 6.1.3.2 Underdeveloped Hyaluronic Acid Viscosupplementation Potential...39 6.1.3.3 Migration to Chinese Manufacturing ................39 6.1.4 Threats .............................. 40 6.1.4.1 Cost Control ........................40 6.1.4.2 Medical Conservatism .....................41 6.1.4.3 Department of Justice Sanction ...................41 6.1.4.4 European Sovereign Debt Crisis of 2010 and Onward ..........43 6.1.4.5 Potential for Acquisition.....................43 ORTHOPEDIC BIOMATERIALS MARKET SHARE.............. 45 7.1 MARKET INTRODUCTION....................... 45 7.1.1 Bone Graft Substitutes ........................ 45 7.1.1.1 Introduction .........................45 7.1.1.2 Indications ...........................46 7.1.1.3 Materials...........................46 7.1.2 Cell Concentration........................ 48 7.1.2.1 Introduction .........................48 7.1.2.2 Platelet Rich Plasma.....................49 7.1.2.3 Bone Marrow Aspirate ....................50 7.1.3 Hyaluronic Acid Viscosupplementation................ 52 7.1.3.1 Introduction .........................52 7.1.3.2 Benefits of Viscosupplementation ................53 7.1.3.3 Synovial Fluid.........................53 7.1.3.4 Three-Injection Cycle Products...................54 7.1.3.5 Five-Injection Cycle Products ..................54 Table of Contents © iData Research Inc., 2011 iv 7.1.3.6 Single-Injection Cycle Products ..................54 7.2 KEY PRODUCTS............................. 55 7.2.1 Bone Graft Substitutes ........................ 55 7.2.1.1 Allograft / DBM .........................55 7.2.1.2 Synthetic Bone Void Fillers ...................55 7.2.2 Hyaluronic Acid Viscosupplementation................ 55 7.2.3 Cell Concentration........................ 55 7.3MARKET SHARE AND REVENUE ANALYSIS................ 56 7.3.1 Bone Graft Substitutes ........................ 56 7.3.1.1 Global Market Share .......................56 7.3.1.2 United States Market Share ...................56 7.3.1.3 European Market Share......................57 7.3.1.3.1 European Market Share by Country (Germany, France, U.K., Spain, Italy, Benelux, Scandinavia, Switzerland, Austria, Portugal and Greece)...57 7.3.1.4 International Market Share ...................58 7.3.2 Cell Concentration (Platelet and Bone Marrow) ............. 60 7.3.2.1 Global ............................60 7.3.2.2 U.S. Market Share......................60 7.3.2.3 European and International Market Share..............60 7.3.3 Hyaluronic Acid Viscosupplementation................ 62 7.3.3.1 Global ............................62 7.3.3.2 U.S. Market Share......................62 7.3.3.3 European Market Share......................62 7.3.3.4 International Market Share ...................62 ABBREVIATIONS............................. 64 List of Figures © iData Research Inc., 2011 v LIST OF FIGURES EXECUTIVE SUMMARY..................... 1 RESEARCH METHODOLOGY................... 5 BIOMET COMPANY OVERVIEW ................. 18 Figure 3-1: Global Revenues by Division, Biomet, (US$M), 2010 – 2011... 20 Figure 3-2: Global Revenues Growth by Division, Biomet, 2011 ....... 21 Figure 3-3: Global Revenues by Geography, Biomet, (US$M), 2010 – 2011 .. 24 Figure 3-4: Global Revenues by Geography, Biomet, 2011.......... 25 Figure 3-5: Company Size, Biomet, 2011............... 28 Figure 3-6: Key Facilities, Biomet, 2011 ............... 29 FINANCIAL METRICS ...................... 30 Figure 4-1: Income Statement, Biomet, 2009 – 2011 (US$M)......... 30 Figure 4-2: Balance Sheet, Biomet, 2009 – 2011 (US$M)......... 31 Figure 4-3: Company Debt, Biomet, 2011 (US$M)............. 32 PRODUCT PIPELINE...................... 33 SWOT ANALYSIS ....................... 35 ORTHOPEDIC BIOMATERIALS MARKET SHARE ........... 45 Figure 7-1: Bone Graft Substitutes Market Share, Biomet, 2011 (US$M).... 56 Figure 7-2: Bone Graft Substitutes Market Share by Country, Europe, Biomet, 2011 (US$M)......................... 57 Figure 7-3: Cell Concentration Market Share, Biomet, 2011 ........ 60 Figure 7-4: Hyaluronic Acid Viscosupplementation Market Share by Country, Biomet, 2011 (US$M)..................... 62 ABBREVIATIONS ....................... 64 List of Charts © iData Research Inc., 2011 vi LIST OF CHART S EXECUTIVE SUMMARY..................... 1 Chart 1-1: Business Unit Revenue by Percentage, Biomet, 2011 ....... 1 Chart 1-2: Annual Revenue Growth by Business Unit, Biomet, 2011 ...... 2 Chart 1-3: Percentage of Global Revenues by Region, Biomet, 2011 ...... 3 Chart 1-4: Global Biomaterials Market Share, Biomet, 2011 ......... 4 RESEARCH METHODOLOGY................... 5 BIOMET COMPANY OVERVIEW ................. 18 Chart 3-1: Global Revenues by Division, Biomet, 2011............ 22 Chart 3-2: Global Revenue Growth by Division, Biomet, 2011 ....... 23 FINANCIAL METRICS ...................... 30 PRODUCT PIPELINE...................... 33 SWOT ANALYSIS ....................... 35 ORTHOPEDIC BIOMATERIALS MARKET SHARE ........... 45 Chart 7-1: Bone Graft Substitutes Market Share, Biomet, 2011 ......... 59 Chart 7-2: Cell Concentration Market Share, Biomet, 2011 ......... 61 Chart 7-3: Hyaluronic Acid Viscosupplementation Market Share by Country, Europe, Biomet, 2011 ..................... 63 ABBREVIATIONS ....................... 64