itamar medical ltd. transferring great science into patient care april 2014
TRANSCRIPT
Itamar Medical Ltd. Transferring Great Science into Patient Care
April 2014
Disclaimer Development of Arterial Function StudyItamar 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.
Making the PAT® Signal Standard of Care
Mission
Vision
Improving Health Through the PAT® Signal
Investment HighlightsDevelopment 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
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
Investment HighlightsDevelopment of Arterial Function Study
Facts and FiguresDevelopment of Arterial Function Study• Publicly traded since 2007 (TASE:ITMR)
• 2 Product lines1. WatchPAT™ - home diagnostic device
for sleep disorders 2. 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
• ReimbursementDedicated CPT codes:– WatchPAT™ - 95800– EndoPAT™ 0337T
• Major distribution deals– Philips Japan– Medtronic US– Thorne
Facts and FiguresDevelopment of Arterial Function Study• Publicly traded since 2007 (TASE:ITMR)
• 2 Product lines1. WatchPAT™ - home diagnostic device
for sleep disorders 2. 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
Ganz’s group assessintra-coronary endothelial
function
Lerman’s group validateEndo-PAT2000 with
intra-coronary AcetylCholine
Furchgott, Ignarro & Muraddiscover Nitric-Oxide’s role
in CV regulation.Nobel Prize awarded in 1998
Celermajer & Deanfielddescribe technique of ultrasonic
assessment of Flow Mediated Dilation
1980 1986 1992 2004
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
ALGO
RYTHM
S
Sleep
Heart
WatchPAT™
EndoPAT™
Need to add a picture of
the device in a test
environment (Pts+device)
– to be in same format as
the watchPAT
IP Portfolio
Expiration of Initial PAT patents: 2017Expiration of major extension patents: 2022
Provisional extensions: >2030
Product-specific
Umbrella Patents PAT®
WatchPAT™ EndoPAT™
WatchPAT™ and EndoPAT™ are both protected by a robust IP portfolio protecting all aspects of the proprietary platform
Experienced Leadership and Advisory TeamGilad GlickChief Executive Officer
Shaul SharoniChief Financial Officer
Eldad Singer Vice President, International Sales
Dr. Koby SheffySVP & Chief Technology Officer
Efrat LitmanVP, Research & Development
Shlomo AyanotVP Engineering & Operations
Martin Gerstel Prof. Amir LermanAssoc. Chair Cardiovascular Division for Academic Affairs , Mayo Clinic
Gary EllisSVP & CFO, Medtronic
Dr. Giora Yaron
Dr. Morry BlumenfeldPast Managing Director
Regina UngarCPA
Miri KatzPast Chairman of Israeli Securities Authority
Ilan Biran
Prof. Peter GanzChief Division of Cardiology, UCSF, SF General Hospital
Prof. Mark CreagerDirector Vascular Center, Brigham & Women’s Hospital, Harvard Medical.
Prof. Michael ShechterDirector Clinical Research Unit, Heart Center, Sheba Medical Center, Tel Aviv
Dr. Steven Lamm, Internal Medicine; Faculty NYU School of Medicine
Prof. Peter Collins, Chief Cardiol. Imperial College & Brompton Hospital
Prof. Giora PillarHead of pediatrics Department, Carmel Hospital, and sleep laboratory at Rambam Medical Center
Maya TalDirector, Global Marketing
Chris Hallett VP US Sales
Management Board of Directors Scientific Advisory Board
Have added compugen logo
EndoPAT®
The EndoPAT® Quiet Revolution
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
The EndoPAT® Test
Post stenting
CAD patients
Chest pain
Heart failure
7.8
16
8.9
5.1
Prevalence in the US( Million Patients)
Good Bad
8% 32%
4% 15.8%
28% 48%
8.8% 28.1%
Matsazawa et al 2013
Matsue et al, 2014
Rubinstein et al, 2010
Akiyama et al, 2012
528 pts
213 pts
270 pts
320 pts
Adverse Cardiac Events
PAT ScorePublished Outcome Evidence
Current Environment Positions EndoPAT™ for Success
Outcome studies
Post stenting
CAD patients
Chest pain
Heart failure
7.8
16
8.9
5.1
Prevalence* in the US( Million Patients)
Good Bad
8% 32%
4% 15.8%
28% 48%
8.8% 28.1%
Matsazawa et al 2013
Matsue et al, 2014
Rubinstein et al, 2010
Akiyama et al, 2012
528 pts
213 pts
270 pts
320 pts
Adverse Cardiac Events
EndoPAT Score
* Not mutually exclusive
Need to add duration of the Study
Need to adjust format – spaces, missing “,”
Need to add yeste
rday paper
Published Outcome Evidence
Current Environment Positions EndoPAT™ for Success
Outcome studies CPT code Jan 2014 Affordable care act readmissions
focus
CMS 2-midnight rule
Personalized medicine
Cardiac technology maturing
Current Environment Positions EndoPAT™ for Success
Outcome studies CPT code Jan 2014 Affordable care act readmissions
focus
CMS 2-midnight rule
Personalized medicine
Cardiac technology maturing
Need to add: Readmission = loss of revenues/reimbursement
Strategy Implementation is Underway
The 3 Horizons for Growth
Readmission MngSymptomatic & CAD
patients
Primary prevention“Blood-pressure” like test
Horizon 1Core market
GrowthPrimary care
Horizon 2CardiologyAcute care
Horizon 3CardiologyPrimary care
*
* US patient population based on AHA statistics
23
Cleveland ClinicTop 10 Medical
Innovation fo
r 2010WatchPAT™
Taking on The Underserved Cardiology Market
Obstructive Sleep Apnea (OSA)
Sleep Apnea causes serious illnesses directly increasing medical costs
Confidential
• 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 Disorder Diagnosis
The Old Polysomnography Way The New WatchPAT® Way
Obstructive Sleep Apnea Product Landscape
Confidential
In-lab PSG tests
Unattended PSG testsEmbla, Aura-Grass, Braebon
Home Sleep testsEmbletta, ARES, Stardust,
ApneaLink+, Nox
Pulse OximetryNonin, Masimo
Simplicity
Clin
ical
info
rmati
on
>6 parameters
4-5 parameters
1-2 parameters
WatchPAT: best in breed for Home Sleep Testing – easy & informative
itamar
Unique: w/CloudPAT & Bracelet
Kaiser/ VA
The Traditional Sleep Market – USA2010 vs. 2016
27
*-Source: BCC Research; www.bccresearch.com/report/HLC081A.html company assessment, and empirical analysis based upon deployment in Israel www.ibisworld.com/industry/sleep-disorder-clinics.html
ResMed40%
Philips43%
FP10%
other7%
Sleep Market Structure2012
20102013
20160
1
2
3
4
5
6
7
Home test
Home test
Home test
Lab
Lab
Lab
Number of Sleep Tests Performed in M
Need to emphasis CardiologyWe 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
Itamar’s Potential Market Beyond The Traditional Sleep Market
Source: Epidemiological studies, Market reports
Drug resistant hypertension
Congestive Heart Failure - CRT
Aririal Fibrillation
Pacemakers
0.2
2.1
2.6
3
Sleep Apnea Prevalence
83%
86%
49%
59%
Device market ($ Bn)
Check Prevalence %
Need to correct miss-spelling
OSA prevalence in AF patients1
OSA Prevalence in the general population2
49%
9-24%
How are you currently managing your potential AF ablation candidates that might have OSA?
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
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
Obstructive Sleep Apnea - Common Comorbidity of AF
Treatment of Obstructive Sleep Apnea Reduced the Risk of Atrial Fibrillation Recurrence After Catheter Ablation (Fein, Josephson et al. JACC July 2013 )
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.”
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) .
PVI + no OSAPVI + CPAP treated OSANo PVI + CPAP treated OSAPVI + untreated OSA
Evidence and Literature – OSA and AF
The Japanese Sleep Market
In a market without sleep docs – Philips chose WatchPAT™ as their flagship product
Sleep specialist
Cardiologist
GP
ENTs
GP SLEEP study THERAPY
Cardiologist SLEEP study THERAPY
ENT SLEEP study THERAPY
Therapy
Horizon 1Core market
Growth
Horizon 2Cardiology
Horizon 3Beyond
Cardiology
Traditional Sleep marketNew studies demonstrating WP is significantly more sensitive
Philips Japan MDT Afib US‒ CRT space
DiabetesObesity
The 3 Horizons for Growth
USA IsraelJapan
The largest medical device market
Ageing population
Center of
ExcellenceAgeing population
Advanced medicineEndothelial function
awareness
Strategic Focus – by Geographic Regions
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 HighlightsDevelopment of Arterial Function Study
Investment HighlightsDevelopment 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
Financials
Business Model
Shaul to add tonight
Thank you!
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1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales, $, Million
Acquired SteriOssMarket cap : 1.3x Revenue
Market cap : 13x Revenue
Nobel Biocare tried to do directly to general dentists – and never recovered
Incumbents are Penalized for Bypassing Specialists
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
• Post-stenting
• Unexplained chest pain
• Heart failure
* Source: American Heart Association, 2010
Heart failure
Heart attack
Pneumonia Circulatory system
disorders
Other
24.70%
19.90% 18.30%
10.40%
26.70%
* Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”
Itamar’s strength
% Medicare Patients Readmitted to Hospitalsin 2010 within 30-days
Source: ResMed investor presentation Q3 2013
Drug resistant hypertension
Obesity
Congestive Heart Failure
Diabetes type 2
Stroke
Pacemakers
Arrhythmias
Coronary heart disease
Atrial Fibrillation
Depression
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
83%
77%
76%
72%
63%
59%
58%
57%49%
45%
Itamar’s Potential Market Beyond the Traditional Sleep Market