Itamar Medical. November 2016
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1 Itamar Medical November 2016
2 Disclaimer 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, (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; regulatory changes; changes in medical insurance reimbursement policy; 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, regulatory changes, delay or withholding of regulatory approvals, inability to obtain or maintain medical insurance reimbursement fro Company's products, negative results of clinical trials 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. 2
3 Itamar World Leader in Sleep Apnea Management Solution to Cardiology patients 3
4 Itamar Medical Publicly traded (TASE:ITMR) since 2007 HQ, R&D and production in Israel (140 employees) Product lines WatchPAT Ambulatory sleep disorders & Total Sleep Solution EndoPAT Early detection and risk assessment of cardiovascular disease Main Markets US, Japan, China & Europe Sales 2015: $16.8M Yelin Lapidot 6.7% Phoenix 5.4% Public & Other SH 24.3% Note: The above reflect the holdings rates as of September 30, Migdal 7.9% Holdings Martin Gerstel 5.6% Itamar Medical Corporate HQ Itamar Medical HQ (Franklin, MA) Itamar Medical Japan HQ (Tokyo) Viola 25.4% Medtronic 14.4% Dr. Giora Yaron 10.4% 4
5 Latest Reported Update WatchPAT Unique HST News: - Unified (H2 14 ) WW - Age 12 17: CE clearance FDA Clearance - Central Sleep Apnea Completed clinical trial FDA submission Q2 16 Total Sleep Solution For Cardiologists News: - MDT renewed 3 rd Y - Growing Sales force - Change pricing model :CPT - Cardiology events (IDSS, HRS) Therapeutics News: - Devilbiss Dist. Rights 5 Diminished Focus on EndoPAT outside Japan and China
6 Itamar Medical s Proprietary Technology Health Being Made Simple The autonomic nervous system WatchPAT EndoPAT The arterial endothelial system 6
7 WatchPAT
8 Sleep: WatchPAT Simply Transforming Sleep Management 8
9 A Better Way to Diagnose Sleep Apnea Polysomnography (PSG) WatchPAT Spend a night in a lab Requires skilled staff Sleep in your own bed Easy self-administration 9
10 Obstructive Sleep Apnea (OSA) Major Prevalence ~25% of adult population * -70% undiagnosed* Treatment options readily available: Normal Breathing Airway is open, Air flows freely to lungs CPAP Surgery Oral Appliance Obstructive Sleep Apnea Airway collapses, Blocked air flow to lungs 10 Sleep Apnea - a significant comorbidity to most cardiac disease directly increasing medical costs ** * Source: American Academy of Sleep Medicine, Peppard, et al., American Journal of Epidemiology (2013) ** Seet & Chung, Anestsiology Clin 2010
11 The Traditional Sleep Market USA Number of Sleep Tests Performed (M)* Lab Lab Lab Home Test Home Test Obstructive Sleep Apnea is expected to grow during at one of the fastest rates among all Medical Technologies (Goldman Sachs Research) 11 *Sleep Testing Volumes and Reimbursement in the United States; Frost & Sullivan, August 13th, 2014,
12 A Paradigm Shift to Home Sleep Testing Current Disadvantages? Not with WP! 12
13 Simplicity of Pulse Oximetry, Accuracy of PSG 8+ parameters + sleep stages, + true sleep time Lab PSG Home PSG Embla, Aura-Grass, Philips Alice Pdx WatchPAT Test completion rate 98% vs 80%* Misdiagnosis 3% vs 20%** Auto-detection of Central Apnea mix*** PARAMETERS 4-5 parameters AHI, RDI, snoring, position Cardio Pulmonary Systems Embletta, ARES, Philips Stardust, Resmed Apnea link, Carefusion Nox T3, Cadwell ApneaTrak 1-2 parameters saturation motion Pulse Oximetry Nonin, Masimo 13 SIMPLICITY / COMFORT US and European Sleep Disorder Diagnostic Devices Market, Frost & Sullivan ; M9AC-54 February 2014 ** Comparison of Apnea Hypopnea Index (AHI) Using Recording Time vs. Sleep Time ; Schutte-Rodin; SLEEP Volume 37, 2014 *** FDA submission June 8 th 2016 pending FDA clearance
14 Sleep Apnea - a Significant Comorbidity to Most Cardiac Disease OSA Comorbidity US patients M Drug resistant hypertension 83% 7.2 Congestive heart failure Diabetes typ 2 Diabetes type 2 76% 72% Stroke Pacemakers Arrhythmias Coronary heart disease Atrial fibrillation Depression 63% 59% 58% 57% 49% 45% Source: Seet & Chung, Anestsiology Clin 2010
15 Providing a Solution to an Unmet Need in Cardiology Primary symptoms: snoring, fatigue Sleep apnea (OSA) Secondary impact: cardiology comorbidity Traditional sleep market Underserved cardiology market Pulmonologists Cardiologists Complex, uncomfortable sleep lab tests with long wait times MISSING: a full solution for the cardiology department 15
16 Treatment of OSA Reduces Cardiovascular Disease Readmission Non-readmission probability Cardiovascular patients with OSA: Heart failure Arrhythmias Mayocordial infarction PAP compliance: 16 Upenn Schwab,et el Journal of Clinical Sleep medicine, Oct 2014
17 Treatment of OSA Reduces AFib Recurrence Post Ablation Sleep apnea, not treated 36.7% 12 months AF success rate Atrial fibrillation patients after a catheter ablation Sleep apnea, treated No sleep apnea 71.9% 66.7% 17 Simplified results from Fein, Anter, Josephson et al. JACC July 2013 See Video of Prof. Anter:
18 Treatment of OSA Reduces AFib Recurrence Post Ablation 18 See Video of Prof. Chintz:
19 Full Solution for Cardiologists Total Sleep Solution (TSS) 19
20 TSS for AFib a Systematic Approach: a Consensus in the Making Prof. Hugh Calkins, chairman of the AFib task force by HRS/AHA/ESC Director of the Electrophysiology Laboratory and Arrhythmia Service at Johns Hopkins Hospital Prof. Babak Mokhlesi, Director of the University of Chicago's Sleep Disorder Center There is clear evidence demonstrating OSA to be a significant risk factor for AF. In addition, treatment of OSA is an important component of AF management, particularly when cardioversion or PVI is used. The strength of the evidence warrants consideration of routine clinical screening for OSA prior to use of a rhythm control strategy. Electrophysiologists are increasingly acknowledging the link between atrial fibrillation and sleep apnea. At the University of Chicago sleep physicians work with heart rhythm specialists in a new care model that could improve patient outcomes. 20
21 Leverage through Partnerships Patient Medical Record Mobilization AFib* Treatment Reimbursement Co-Marketing Sleep WatchPAT Reimbursement Total Cardiology Direct Treatment Patient Screening & Referral TSS Sleep Study Reimbursement Cardiology Sleep Distribution Study Interpretation CPAP TX for Cardio ITMR Distribution *Core sleep US is still a significant base and revenue growth source 21 WatchPAT total solution for cardiology - putting cardiac diseases to sleep
22 EndoPAT
23 Vascular Health: EndoPAT Simply Assessing Vascular Health 23
24 Traditional Risk Factors are not Effective in Predicting Heart Attacks FACT: >50% of coronary deaths* had NO previous symptoms FACT: ~50% of heart attacks were NOT high risk! EndoPAT was proven to be an independent risk factor for heart disease 24 * 64% of women who died suddenly had no symptoms! AHA 2014 Statistics
25 How Does the EndoPAT Test Work? 15 min Short test at the physician s office Operator Independent Non-invasive Measurement with fingertip sensors Easy to Use Immediate Results automatically generated Proven as Independent Risk Factor 25 The only non-invasive test FDA cleared for Endothelial Dysfunction testing
26 Early Detection of Underlying Disease Progression Primary Endothelial Dysfunction Secondary Prevention 26
27 Addressing Clinical Needs New Risk Factor A novel, independent risk factor that may be used for restratification of patients Treatment Titration Monitoring and optimization of treatment effectiveness Patient Compliance Monitoring of patients compliance to given treatment 27
28 Clinical Indications 28 Cardio Vascular Disease (CVD) EndoPAT serves as a predictor of CVD and in identifying near-future cardiac risk Diabetes - EndoPAT is the only device that can assess the micro vessel function - a key component in diabetes Women's Health - EndoPAT effectively helps identify high-risk women who present atypical symptoms and can otherwise go undiagnosed Erectile Dysfunction (ED) EndoPAT can attest that the ED is a manifestation of endothelial dysfunction Smoking Cessation - EndoPAT acts as a strong motivating tool to convince patients to stop smoking and monitor their progress Occupational Screening EndoPAT can act as a health screening tool for employers/payers
29 Sales
30 Total Sales Q4.14 to Q3.16 Q3 YoY: +26% 9 Months YoY: +7% מליוני דולרים 30 * Last 4 Quarters compared to previous 4 quarters. ** Sales In $M
31 Products Sales Breakdown (Sales In $ 000) WW WatchPAT YoY: +31% QoQ: +57% YTD: +24% EndoPAT YoY: -49% Sales Q4.15 to Q3.16 WatchPAT $14.6M (83%) EndoPAT $3.1M (17%) Product Sales Q4.14 & Q * Last 4 Quarters compared to previous 4 quarters.
32 US- Products Sales Breakdown (Sales in $ 000) US WatchPAT YoY*: +51% QoQ: +63% YTD: +41% US EndoPAT YoY*: -47% Sales Q4.15 Inc Product Sales Q4.14 to Q3.16 Q3.16 עד WatchPAT $11.2M (90%) EndoPAT $1.3M (10%) 32 * Last 4 Quarters compared to previous 4 quarters.
33 Thank You!
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