Impedimed Limited · ASX:IPD
Impedimed — Shareholder Meeting (November 2013)
17 slides from Impedimed's shareholder meeting presentation, Nov 8, 2013
Slide 1: Annual General Meeting
For personal use only Annual General Meeting ASX:IPD November 2013
Slide 2: Disclaimer
Disclaimer • This presentation has been produced by ImpediMed Limited (“ImpediMed”) only and may contain forward-looking statements that are based on management’s current expectations, beliefs and assumptions and are subject to a number of risks and For personal use only uncertainties. The forward-l
Slide 3: FY13 - Transforming the Business
FY13 - Transforming the Business For personal use only New Direction • New CEO • New executive team • New strategy New Focus Lymphoedema • Building the core lymphoedema business • Clear reimbursement plan of action • Clinical requirements and regulatory pathway • Strong financial discipline • Expand
Slide 4: Dramatically Improved our Financial Position and Invested in our Future
Dramatically Improved our Financial Position and Invested in our Future Expenses Months of Cash On Hand For personal use only $4.0 20 19 18 Instituting strong 17 financials controls $3.0 15 allowed us to: 13 1. Reduce expenses by 12 $4.7 million Months Millions $2.0 10 2. Invest in critical long- te
Slide 5: Focusing on the Lymphoedema Business Paid Off
Focusing on the Lymphoedema Business Paid Off For personal use only Total Revenue Lymphoedema Revenue Lymphoedema Mix ($) $4.0 $1.5 FY13 Global lymphoedema business grows 43% 35% in FY13: $3.0 $1.1 •US +51% •International Millions Millions $2.0 $0.8 +15% FY12 $1.0 $0.4 Changed global lymphoedema 30%
Slide 6: FY2013 Significant Investments/Accomplishments
FY2013 Significant Investments/Accomplishments For personal use only U.S. - Expanded Adoption of L-Dex • Required for CPT Category 1 Code submission “The procedure or service is performed by many physicians across the US” • Across healthcare channels • Introduced new business model Food and Drug Adm
Slide 7: L-Dex: The only FDA Cleared Technology for the Assessment of Lymphoedema
L-Dex: The only FDA Cleared Technology for the Assessment of Lymphoedema For personal use only • A hand held device designed specifically to assist in clinical assessment and monitoring of lymphoedema • Bioimpedance Spectroscopy (BIS), Class II Medical Device • FDA cleared, ARTG listed, CE marked •
Slide 8: L-Dex Provides Significant Advantages
L-Dex Provides Significant Advantages For personal use only Direct Measure Detects Sub- Volume Change Standardised Ease for Easily Regulatory Standard of Method of Extracellular Clinical Required for Detection Reproducible Clearance Patients, Non- Portable Care Fluid (Stage 0) Detection Criteria inv
Slide 9: Value Proposition
Value Proposition For personal use only Early Detection • Enables early treatment • Enhances treatment options Because... • Emerging data from the University of Pittsburg Medical Center shows a 97% reduction in lymphoedema progressing beyond stage 0 if detected early and treated effectively Which...
Slide 10: Lymphoedema Market
Lymphoedema Market For personal use only Current Clinical Practice Incidence Rates Cleared for L-Dex Readings Markets Cancer* Lymphoedema Total Number of Time and Protocol L-Dex Readings 8,245 2,720 Year 1 Base line plus 5 46,723 15,419 quarterly readings Years 2-4 582,200 192,126 Annual or quarterl
Slide 11: Significant Growth Opportunities
Significant Growth Opportunities For personal use only Lymphoedema Consumable Market $1 Phase III - Expand into High Billion Potential Geographies { } Regulatory Cleared Markets $312 Phase II - Lower Limb and Million Melanoma Cancers $104 Million } Phase I - Breast Cancer (underway) 11
Slide 12: Key Reimbursement Milestones
Key Reimbursement Milestones For personal use only CY2013 CY2014 CY2015 CY2016 CY2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 CPT 1® Preparation RUC Meeting and Results Published Fee Scheduled Published New Codes Effective Medicare Pivotal Trial Design 1st Patient Enrolled Full E
Slide 13: Clinical Trial - Principal Investigators
Clinical Trial - Principal Investigators For personal use only Sheila Ridner, PhD, FAAN • Professor with Tenure: Vanderbilt University School of Nursing • Member National Lymphoedema Network since 2001; member of its Research Committee since 2003; Research Committee Chair since 2010; member of its M
Slide 14: Current and Future Opportunities
Current and Future Opportunities For personal use only Medical Commercial Lymphoedema Dialysis Elite Athletes Obesity Geriatric Health Venous Insufficiency General Health Wound Care Nutrition Muscle Wasting Core Business (IP Protected) Presence (IP Protected) Opportunity (IP Protected) 14
Slide 15: Next Generation BIS Platform
Next Generation BIS Platform For personal use only Technology • BIS Platform - Strong IP position • Robust data integration and reporting - Treatment optimisation • Longitudinal monitoring - Integrated into the patient treatment continuum • Form Factor - Depending on application • Design for manufac
Slide 16: Key Objectives and Milestones
Key Objectives and Milestones For personal use only • Add U.S. Healthcare experienced board members • CPT Category 1 Code - January 2016 • Pivotal Clinical Trial - first enrollment 2014 • Develop new and / or expand existing strategic partnerships • Expand use of our devices for drug and / or therap
Slide 17: For personal use only
For personal use only