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Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014. Disclaimer Development of Arterial Function Study.
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Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014
Disclaimer Development of Arterial Function Study Itamar Medical Ltd. (the "Company") is furnishing this presentation and any information given during this presentation, solely for the consideration of eligible investors who have the knowledge and experience in financial and business matters and the capability to conduct their own due diligence investigation in connection with the investment outlined herein. Prospective investors are urged to conduct an independent evaluation of the Company. This presentation does not constitute an offer of securities of the Company, or a solicitation to acquire or sell the Company’s securities or to participate in any investment in the Company. The statements in this presentation should not be regarded as a basis for an investment decision of any kind, or as recommendation or opinion, or a substitute for investor discretion. Statements in this presentation that are not historical facts might be considered as forward-looking statements based on current expectations of future events, in accordance with the Israeli Securities law, 5728-1968 (the “Securities Law”). These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements as a result of different factors including, but not limited to, the market demands for the Company's products; changes in general economic and business conditions; inability to maintain market acceptance of the Company's products; inability to timely develop and introduce new technologies and products; rapid changes in the market for the Company's products; loss of market share and pressure on prices resulting from competition; introduction of competing products by other companies; inability to manage growth and expansion; inability to attract and retain qualified personnel; and inability to protect the Company's proprietary technology. All forward-looking statements included in this presentation are made only as of the date of this presentation. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors. The United States and Israeli securities laws prohibit any person who has material non-public information about a company ("Inside Information"), from purchasing or selling securities of such company, or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities. Statements in this presentation and in any information given during this presentation might be considered as Inside Information, in accordance with the Securities Law. Therefore, any person aware of this presentation or of any information given during this presentation, may neither use, nor cause any third party to use, any Inside Information or any other information provided in connection with the presentation, in contravention of the Securities Law or any such rules and regulations thereunder. The Company, and its respective affiliates, employees and representatives expressly disclaim any and all liability relating to or resulting from the use of this presentation or any information given during this presentation or such other information by a prospective investor or any of its affiliates or representatives.
Mission Improving Health Through the PAT® Signal Vision Making the PAT® Signal Standard of Care
Investment Highlights Development of Arterial Function Study • Patented platform PAT® technology – Accurate assessment of multiple disease states • Non Invasive • Easy to use • More than a Decade: Pioneering of Science and Technology – • > 400 Published peer-reviewed outcome studies in multiple disease states • now ripe for commercialization • Commercialized proprietary product lines in 2 major growth markets • CE, MHLW, FDA-cleared • Sleep apnea and cardiovascular disease • Reimbursement in most major markets in the world • Growth drivers • Favorable healthcare trends and economics for both products • Newly published outcome studies • Channel development under way • Philips Japan – exclusive WatchPAT™ distribution • Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement • Experienced management team and board and a solid shareholder base
Investment Highlights Development of Arterial Function Study • Patented platform PAT® technology – Accurate assessment of multiple disease states • Non Invasive • Easy to use • More than a Decade: Pioneering the Science and Technology • > 400 Published peer-reviewed outcome studies in multiple disease states • Framingham heart study, Prevent IT Guttenberg Heart study, KORA • now ripe for commercialization • Commercialized proprietary product lines in 2 major growth markets • CE, MHLW, FDA-cleared • Sleep apnea and cardiovascular disease • Reimbursement in most major markets in the world • Growth drivers • Favorable healthcare trends and economics for both products • Newly published outcome studies • Channel development under way • Philips Japan – exclusive WatchPAT™ distribution • Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement • Experienced management team and board and a solid shareholder base
Facts and Figures Development of Arterial Function Study • Publicly traded since 2007 (TASE:ITMR) • 2 Product lines • WatchPAT™ - home diagnostic device for sleep disorders • EndoPAT™ - the only functional marker proven to predict cardiovascular risk beyond commonly used risk scores • Business indices • > 650,000 patients diagnosed • > 5,500 WatchPAT™ sold • > 1,500 EndoPAT™ sold • Financial indices • Gross profit >70% • 2013 Sales: $13.5MM • Market Cap: ~$120M • Currently ~50% sales from disposables • Broad scientific base • 370 peer-reviewed publications, 490 abstracts • Broad IP coverage • 72 patents issued, 25 pending • Reimbursement Dedicated CPT codes: • WatchPAT™ - 95800 • EndoPAT™ 0337T • Major distribution deals • Philips Japan • Medtronic US • Thorne
Facts and Figures Development of Arterial Function Study • Publicly traded since 2007 (TASE:ITMR) • 2 Product lines • WatchPAT™ - home diagnostic device for sleep disorders • EndoPAT™ - the only functional marker proven to predict cardiovascular risk beyond commonly used risk scores • Broad scientific base • 370 peer-reviewed publications, 490 abstracts • Broad IP coverage • 72 patents issued, 25 pending • Reimbursement Dedicated CPT codes: • WatchPAT™ - 95800 • EndoPAT™ 0337T • Business indices • > 650,000 patients diagnosed • > 7,000 machines sold • Financial indices • Gross profit >70% • 2013 Sales: $13.5MM • Market Cap: ~$120M • Razor-Razor blade model • Currently ~50% sales from disposables • Major Shareholder – Medtronic (22%) • Major distribution deals / Customers • Philips Japan • Medtronic US • Thorne • Kaiser Permanente • VA (Veterans Affairs)
The Scientific Foundations Development of Arterial Function Study Furchgott, Ignarro & Murad discover Nitric-Oxide’s role in CV regulation. Nobel Prize awarded in 1998 Ganz’s group assess intra-coronary endothelial function 1980 1992 2004 1986 Celermajer & Deanfield describe technique of ultrasonic assessment of Flow Mediated Dilation Lerman’s group validateEndo-PAT2000 with intra-coronary AcetylCholine
The Technology • Innovative proprietary technology: PAT® - Peripheral Arterial Tone – a unique signal • Combination of pulse pneumatic and optical sensors • Detecting changes in and responses of the sympathetic autonomic nervous system WatchPAT™ ALGORYTHMS Sleep Need to add a picture of the device in a test environment (Pts+device) – to be in same format as the watchPAT Heart EndoPAT™
IP Portfolio WatchPAT™ and EndoPAT™ are both protected by a robust IP portfolio protecting all aspects of the proprietary platform Expiration of Initial PAT patents: 2017 Expiration of major extension patents: 2022 Provisional extensions: >2030
Gilad Glick Chief Executive Officer Martin Gerstel Prof. Amir Lerman Assoc. Chair Cardiovascular Division for Academic Affairs , Mayo Clinic Shaul Sharoni Chief Financial Officer Gary Ellis SVP & CFO, Medtronic Prof. Peter Ganz Chief Division of Cardiology, UCSF, SF General Hospital Dr. Giora Yaron Prof. Mark Creager Director Vascular Center, Brigham & Women’s Hospital, Harvard Medical. Dr. Koby Sheffy SVP & Chief Technology Officer Prof. Giora Pillar Head of pediatrics Department, Carmel Hospital, and sleep laboratory at Rambam Medical Center Eldad Singer Vice President, International Sales Dr. Morry Blumenfeld Past Managing Director Efrat Litman VP, Research & Development Regina Ungar CPA Prof. Michael Shechter Director Clinical Research Unit, Heart Center, Sheba Medical Center, Tel Aviv Shlomo Ayanot VP Engineering & Operations Miri Katz Past Chairman of Israeli Securities Authority Dr. Steven Lamm, Internal Medicine; Faculty NYU School of Medicine Maya Tal Director, Global Marketing Ilan Biran Prof. Peter Collins, Chief Cardiol. Imperial College & Brompton Hospital Chris Hallett VP US Sales Experienced Leadership and Advisory Team Management Board of Directors Scientific Advisory Board Have added compugen logo
The EndoPAT® Test • The only non-invasive, FDA-cleared device assessing endothelial dysfunction– functional test of arterial health • 15 minute • Non-invasive • Office-based diagnostic test • 350,000+ tests to date • Can be performed by an AHP • Reimbursed Animation
The EndoPAT® Test • The only non-invasive, FDA-cleared device assessing endothelial dysfunction– functional test of arterial health • 15 minute • Non-invasive • Office-based diagnostic test • 350,000+ tests to date • Can be performed by an AHP • Reimbursed Animation
Adverse Cardiac Events Published Outcome Evidence PAT Score Prevalence in the US ( Million Patients) Good Bad 8% 32% Matsazawa et al 2013 528 pts 4% 15.8% Matsue et al, 2014 213 pts 28% 48% Rubinstein et al, 2010 270 pts 8.8% 28.1% Akiyama et al, 2012 320 pts
Current Environment Positions EndoPAT™ for Success Outcome studies
Adverse Cardiac Events Published Outcome Evidence EndoPAT Score Prevalence*in the US ( Million Patients) Good Bad 8% 32% Matsazawa et al 2013 528 pts Need to add duration of the Study 4% 15.8% Need to adjust format – spaces, missing “,” Matsue et al, 2014 213 pts 28% 48% Rubinstein et al, 2010 270 pts 8.8% 28.1% Need to add yesterday paper Akiyama et al, 2012 320 pts * Not mutually exclusive
Current Environment Positions EndoPAT™ for Success Affordable care act readmissions focus Outcome studies CPT code Jan 2014 Cardiac technology maturing CMS 2-midnight rule Personalized medicine
Current Environment Positions EndoPAT™ for Success Affordable care act readmissions focus Outcome studies CPT code Jan 2014 Need to add: Readmission = loss of revenues/reimbursement Cardiac technology maturing CMS 2-midnight rule Personalized medicine
The 3 Horizons for Growth Horizon 3 Cardiology Primary care Primary prevention “Blood-pressure” like test Horizon 2 Cardiology Acute care Horizon 1 Core market Growth Primary care * Readmission Mng Symptomatic & CAD patients * US patient population based on AHA statistics
Top 10 Medical Innovation for 2010 Cleveland Clinic Taking on The Underserved Cardiology Market WatchPAT™ 23
Obstructive Sleep Apnea (OSA) • 40 million Americans undiagnosed with OSA* • Costly personal health issues • Adverse OSA outcomes • High blood pressure • Vascular disease and mortality • Arrhythmias • Metabolic syndrome and diabetes • Sexual dysfunction • Cognitive impairment & accidents * Source: American Academy of Sleep Medicine Sleep Apnea causes serious illnesses directly increasing medical costs Confidential
Sleep Disorder Diagnosis The Old Polysomnography Way The New WatchPAT® Way
itamar WatchPAT: best in breed for Home Sleep Testing – easy & informative Obstructive Sleep Apnea Product Landscape Kaiser/ VA In-lab PSG tests >6 parameters Unattended PSG tests Embla, Aura-Grass, Braebon Unique: w/CloudPAT & Bracelet Clinical information 4-5 parameters Home Sleep tests Embletta, ARES, Stardust, ApneaLink+, Nox Pulse Oximetry Nonin, Masimo 1-2 parameters Simplicity Confidential
The Traditional Sleep Market – USA 2010 vs. 2016 Sleep Market Structure 2012 Need to emphasis Cardiology We see positive momentum/ movement to HST but have decided to leverage our strength and relationship in Cardiology . Going to be Premier Company in cardiology space *-Source: BCC Research; www.bccresearch.com/report/HLC081A.htmlcompany assessment, and empirical analysis based upon deployment in Israelwww.ibisworld.com/industry/sleep-disorder-clinics.html 27
Itamar’s Potential Market Beyond The Traditional Sleep Market Sleep Apnea Prevalence Device market ($ Bn) 83% 86% Check Prevalence % 49% Need to correct miss-spelling 59% Source: Epidemiological studies, Market reports
Obstructive Sleep Apnea - Common Comorbidity of AF OSA occurs when the muscles in the back of the throat fail to keep the airway open and resulting in brief and repeated breathing interruption during sleep OSA prevalence in AF patients1 OSA Prevalence in the general population2 49% 9-24% Anesthesiology Practice Guidelines state that for patients with clinical signs and symptoms suggesting the possibility of OSA, a sleep study is encouraged prior to surgery3 How are you currently managing your potential AF ablation candidates that might have OSA?
Evidence and Literature – OSA and AF Treatment of Obstructive Sleep Apnea Reduced the Risk of Atrial Fibrillation Recurrence After Catheter Ablation (Fein, Josephson et al. JACC July 2013 ) • PVI + no OSA • PVI + CPAP treated OSA • No PVI + CPAP treated OSA • PVI + untreated OSA • Subjects: Retrospective review of 426 PVI patients, of which 62 patients with OSA Method: During a follow-up period of 12 months after PVI, CPAP therapy resulted in higher AF-free survival rate (71.9% vs. 36.7%; p = 0.01) . • The authors concluded that “CPAP is an important therapy in OSA patients undergoing PVI that improves arrhythmia free survival. PVI offers limited value to OSA patients not treated with CPAP.”
The Japanese Sleep Market • Cardiologist • Sleep specialist • GP Therapy • ENTs In a market without sleep docs – Philips chose WatchPAT™ as their flagship product
The 3 Horizons for Growth Horizon 3 Beyond Cardiology Horizon 2 Cardiology Diabetes Obesity Horizon 1 Core market Growth • Philips Japan • MDT Afib US • CRT space Traditional Sleep market New studies demonstrating WP is significantly more sensitive
Strategic Focus – by Geographic Regions Ageing population Advanced medicine Endothelial function awareness The largest medical device market Ageing population Center of Excellence USA Israel Japan
Investment Highlights Development of Arterial Function Study • Patented platform PAT® technology • 2 Commercialized proprietary product lines in major growth markets • CE, MHLW, FDA-cleared • sleep apnea and cardiovascular disease • Published peer-reviewed outcome studies in multiple disease states • Reimbursement in most major markets in the world • Growth drivers • Philips Japan – exclusive WatchPAT™ distribution • Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement • Favorable healthcare trends and economics for both products • Newly published outcome studies • Experienced management team and board and a solid shareholder base
Investment Highlights Development of Arterial Function Study • Patented platform PAT® technology – Accurate assessment of multiple disease states • Non Invasive • Easy to use • More than a Decade: Pioneering the Science and Technology • > 400 Published peer-reviewed outcome studies in multiple disease states • Framingham heart study, Prevent IT Guttenberg Heart study, KORA • now ripe for commercialization • Commercialized proprietary product lines in 2 major growth markets • CE, MHLW, FDA-cleared • Sleep apnea and cardiovascular disease • Reimbursement in most major markets in the world • Growth drivers • Favorable healthcare trends and economics for both products • Newly published outcome studies • Channel development under way • Philips Japan – exclusive WatchPAT™ distribution • Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement • Experienced management team and board and a solid shareholder base
Business Model Shaul to add tonight
Incumbents are Penalized for Bypassing Specialists Nobel Biocare tried to do directly to general dentists – and never recovered Sales, $, Million Market cap : 13x Revenue Market cap : 1.3x Revenue Acquired SteriOss 41
Value-Based Payment Methods of the Federal Government - CMS As part of the health reform - Affordable Care Act Hospitals will be compared to the average so either they continue improving or they will get less funding * Source: Value based purchasing at a glance, Studer group, CMS
The Problem: cardiology-related readmissions % Medicare Patients Readmitted to Hospitalsin 2010 within 30-days Itamar’s strength • Post-stenting • Unexplained chest pain • Heart failure * Source: American Heart Association, 2010 * Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”
Itamar’s Potential Market Beyond the Traditional Sleep Market Source: ResMed investor presentation Q3 2013