Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (January 2014)
27 slides from Impedimed's investor presentation, January 2014
Slide 1: Investor Presentation January 2014
For personal use only Investor Presentation (ASX:IPD) January 2014
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: Company Snapshot
Company Snapshot For personal use only Corporate Financials (at 30 Sept 2013) Australian listed company: Cash and cash equivalents: • ASX: IPD • $5.62 million ! Operations: • Brisbane (AUS) ImpediMed - three businesses • San Diego (USA) • Lymphoedema Listing date: • Body Composition • October 2007 •
Slide 4: New Executive Team
New Executive Team Proven Record of Success For personal use only Rick joined ImpediMed in July 2013 with an impressive thirty year record for building world-class organisations for global corporations in the medical technology and consumer goods industries, including a twelve year executive career
Slide 5: FY13 - Transformed the Business
FY13 - Transformed 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 6: 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 Millions Months $2.0 10 2. Invest in critical long- te
Slide 7: Focusing on the Lymphoedema Business Paid Off
Focusing on the Lymphoedema Business Paid Off For personal use only Total Revenue Lymphoedema Revenue Lymphoedema Mix ($) $4.0 $1.2 FY13 Global lymphoedema business grows 43% 35% in FY13: $3.0 $0.9 •US +51% •International Millions Millions $2.0 $0.6 +15% ! FY12 $1.0 $0.3 Changed global lymphoedema 30
Slide 8: 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 9: Lymphoedema is a Significant Unmet Medical Need
Lymphoedema is a Significant Unmet Medical Need For personal use only An estimated 3 million people develop secondary lymphoedema each year due to cancer ! One out of every three survivors of breast, pelvic (including gynaecological and prostate), or melanoma cancer will develop lymphoedema ! Curren
Slide 10: 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 marke
Slide 11: L-Dex: Key to Early Detection of Lymphoedema
L-Dex: Key to Early Detection of Lymphoedema For personal use only L-Dex technology (BIS) is a direct measure of extra cellular fluid (ECF), all other techniques used today measure volume Figures demonstrate the advantage in longitudinally monitoring extracellular fluid levels versus total limb volu
Slide 12: 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 13: 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 14: Lymphoedema Market Potential
Lymphoedema Market Potential 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 o
Slide 15: 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 (underway) $104 Million } Phase I - Breast Cancer (executing) 15
Slide 16: 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 Reimbursement Strategy RUC Meeting and Results Published Accelerated by 1 Year Fee Scheduled Published New Codes Effective Medicare Pivo
Slide 17: Pivotal Trial - Principal Investigators
Pivotal 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 Me
Slide 18: Nutrition and Body Composition ASX Announcement
For personal use only ASX: IPD 17 December 2013 ASX ANNOUNCEMENT Nutrition and Body Composition ImpediMed, Fonterra, University of Auckland and University of Queensland Working Together to Improve Nutritional Health Brisbane, Australia – ImpediMed Limited (ASX: IPD) (“the Company”) today announced t
Slide 19: 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 20: 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) 20
Slide 21: Current and Future Opportunities
Current and Future Opportunities $3.3 Billion For personal use only Dialysis Venous Insufficiency $0.4 Billion Lymphoedema Lymphoedema Clinical Sports Clinical Geriatrics Clinical Obesity 21
Slide 22: Key Objectives and Milestones
Key Objectives and Milestones For personal use only • Add U.S. Healthcare experienced board members 15 • 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 the
Slide 23: Investment Case
Investment Case For personal use only • Highly experienced executive team • Acceptance of a CPT Category 1 Code effective 1 January, 2015 • Regulatory clearances in AU, US, and EU • First mover advantage in lymphoedema market • Substantial IP portfolio • Proven technology • L-Dex is the assessment to
Slide 24: Appendix
For personal use only 24 Appendix
Slide 25: Board of Directors
Board of Directors Experienced and Influential For personal use only Cherrell Hirst, AO FTSE Cherrell Hirst is a medical doctor and was a leading practitioner in the area of breast cancer screening and diagnosis. Cherrell serves as the Chairman of the Board. Cherrell was appointed Deputy Chairman on
Slide 26: Lymphoedema
Lymphoedema For personal use only Lymphoedema is the build-up of fluid in soft body tissues when the lymph system is damaged or blocked. Lymphoedema occurs when the lymph system is damaged or blocked. Fluid builds up in soft body tissues and causes swelling. It is a common problem that may be caused
Slide 27: Stages of Lymphoedema
Stages of Lymphoedema For personal use only Stage 0 (or Ia) which refers to a latent or sub-clinical condition where swelling is not evident despite impaired lymph transport. It may exist months or years before overt oedema occurs (Stages I-III). ! Stage I represents an early accumulation of fluid r