value appreciation via sound asthma management• 40,000 mobile health apps generated $718 million...
TRANSCRIPT
Value Appreciation Via Sound Asthma Management
March 2012
© iSonea Ltd. 2011 Confidential & Proprietary 1
Michael J. Thomas, CEO Australian Investor Presentations F
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Disclaimer
• This presentation does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor.
• Certain statements made in this presentation are forward-looking statements. These forward looking statements are not historical facts but rather are based on iSonea’s current expectations, estimates and projections about the industry in which iSonea operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks,” "estimates,“ “guidance” and similar expressions are intended to identify forward-looking statements. and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of iSonea, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. iSonea cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of iSonea only as of the date of this presentation. The forward-looking statements made in this presentation relate only to events as of the date on which the statements are made. iSonea will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
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What Does iSonea Do?
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Acoustic Respiratory Monitoring (ARM™) Developer, manufacturer and marketer of devices, software & mobile health applications for management of chronic respiratory diseases:
• Asthma • COPD (Chronic obstructive pulmonary disease) • Sleep Disorders
• Regulatory clearance in US, EU, AU • IP strongly protected • Corporate HQ: Annapolis, MD, USA • Manufacturing: Haifa, Israel • Head Office: Melbourne, Australia
• ASX: ISN • US OTCQX: ISOAY • www.iSoneaMed.com
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• Asthma & Chronic Obstructive Pulmonary Disease (COPD) affect an estimated 300,000,000 people worldwide. Source: World Health Organization
• 25 million in US have asthma, including 10% of children –
growth to >40 million expected by 2016. Source: CDC
• The cost burden of asthma in the US alone exceeds $56
billion annually. Source: CDC
• Traditional diagnostic tests (spirometry, auscultation) are
appropriate in physician’s office and clinics, but not for remote monitoring.
• CDC National Health Interview Survey underscores a great need for routine asthma monitoring in real life settings: o 40% of patients use peak flow meter o 33% of patients use long-term control medications o 26% report emergency department visits for asthma
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Asthma: A Costly, Global Epidemic
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2001 2009
US Asthma Patients (mm)
Source: CDC, Data from National Health Interview Survey
Medical Expenses Associated with Asthma
(Direct & Indirect Costs)
~$3,300 Per Person/Year
Source: NIH, NHLBI Data 2007
+21%
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Daily Monitoring Improves Asthma Management
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• Disease management devices via traditional market channels
(Business through Physician)
• Disease management through Smartphone Apps
(Business to Consumer)
iSonea Product Family
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Traditional Medical Device Path: Physician Rx
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Physician Strategy
PUSH
Strategic Partners
• Distribution channels
• Physician access
US Clinical Studies
Pursue Coverage
Establish Data Portal
Physician Promotion
• Spirometry equivalence
• Pediatric diagnosis
• Symptom correlation
• Data to build foundation for payers
• Revenue model defined
• Dashboard to track patient data
• Integrate with EMRs e.g. Microsoft, Google, Facebook, etc.
• Target market penetration Major Steps:
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The traditional medical device path will leverage strategic partner access and evidence-based WheezeRATE™ data for creating physician demand for ARM™ devices among target segments: pediatricians, pulmonologists, and asthma/allergy specialists.
Create Medical Demand
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Milestone Value Creation – Rx Physician Push
Strategic Partners
US Clinical Studies
Pursue Payer Coverage
Physician Data Portal
Target Physician Launch
• US & global distribution channels • Established access to target physicians • Critical mass for market penetration
Milestone Value Impact
• Establish clinical equivalence to standard • Gain KOL “top/down” advocacy • Create required data for payers/reimbursement
• Obtaining coverage is complex, lengthy process • Data requirements are well-established • Opens door to physician prescribing & usage
• Real-time patient status & trending • Easy management of Asthma Action Plan • Alerts for attacks, medication changes
• Demand creation among pulms, peds, etc. • Establish wheeze monitoring in clinical practice • Ideal choice for remote patient monitoring
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iSonea ‘Business Through Physician’ Mechanism
Effortless Global Disease Management
Acoustic Respiratory Monitoring
Smart Technology
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Proprietary Sensors
IT Systems Connectivity
Clinically Developed Form Factors
Lung Sound Analysis
Proprietary algorithms
IP Coverage
iSonea can set a new gold standard for clinical assessment of symptom assessment in respiratory disease management.
Reduce Enormous Cost Burden
Address 8% Global Prevalence Rate
Meet Global Standards of Asthma Care Confidential & Proprietary
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Mobile Health 2012: 247MM Users, $1.3B Rev1
• 40,000 mobile health apps generated $718 million in revenue in 20111
• # people downloading a health app at least once this year will reach 247 million, up from 124 million in 20111
• 500M smart phones sold globally in 2011 – expected to be >1B phones annually by 2015. • 7.4B mobile subscriptions projected by 2015. • Number of health management apps for smart phones has grown >4X since 2010. • Nearly 1/3 of US adults using apps downloaded health management apps in 2011. •
2993
8924
13110
02000400060008000
100001200014000
2010 Feb 2011 July 2012 July
iPhone Health Apps
# Health Apps
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2. Source: Pew Research Center 2011
(Projected)
+338%
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Global Mobile Health Revenue Projections
• Global mHealth market revenues are projected to reach $23B by 2017. • Monitoring services for chronic diseases are expected to account for 65% or $15B. • Healthcare apps are expected to generate $2.4B in revenues by 2017.
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Source: GSMA 2012
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2017 mHealth Services Revenue US $ Billions
Monitoring
Diagnosis
Treatment
Ancillary
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Physicians Advocate Patient Use of mHealth Tools
New market research from Float Learning reveals what physicians want from mHealth platform tools: • 90% want patients to use mobile devices/apps to monitor health indicators
• 40% believe that mHealth apps can reduce patient office visits
• 56% of physicians say their own use of mHealth devices expedites health
decision-making
• 40% say use of mobile devices increases administrative efficiciency
• More than 80% of physicians now use smartphones
• Physicians are 250% more likely to own iPad than the average consumer
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Source: Float Learning 2012
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Harnessing the Mobile Trend “Tsunami”
• Shortest path to revenue • Fewer regulatory challenges • Reimbursement not needed • Greater value creation • Greater gross profit margins
OTC Development Rationale iSonea is applying its core DNA – Acoustic Respiratory Monitoring (ARM) technology, proprietary software and analytical algorithms – to the mobile health platform, developing apps and digital hardware to turn smart phones into monitoring devices.
Mobile devices provide a ubiquitous platform for innovative ARM™ technology – making asthma monitoring possible for anyone with a smartphone.
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Remote Monitoring Asthma “Security System”
• Integrating the ISN wheeze sensors with mobile apps will provide the most convenient and effortless method for frequent monitoring to improve asthma management
• Unique algorithm empowers the smartphone for GPS-linked monitoring of symptoms • Auto alerts when environmental factors, triggers & symptoms suggest asthma risk • Encourages adherence to disease management guideline monitoring best practices • Facilitates physician adjustment of individual asthma action plans
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Smartphone Asthma Apps Path: Consumer Demand
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Consumer Strategy
PULL
Develop Asthma Apps
Social Media Campaign
Intro Functional
Apps
Gen 2 Smart Phone Device
Gen3 Smart Phone Device
Major Steps:
• Launch new tracking tools
• Establish customer base
• Educate & create brand preference
• Expand technology platform
• Expand gross profit margins
• Launch smart multi function Apps
• Consumable hardwire sensors
• Launch next device with mobile health App
• Intelligent portal between patient & MD with real time feed back control
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Social media-driven awareness and disease management empower the asthma consumer as a principal driver of demand.
Create Consumer Demand
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Milestone Value Creation – OTC Consumer Pull
Develop Asthma Apps
Social Media Campaign
Lower COGS & ASP
OTC Wheeze Monitor
Launch Gen2 Device
Milestone Value Impact
• Immediate revenue from OTC App downloads • iSonea brand awareness & consumer demand • Create customer base for OTC & Gen2 devices
• Create educated, motivated asthma consumers • Cost efficient means of launching asthma apps • Brand recognition with support groups & blogs
• Increase profit margins • Improve price for OTC consumer sales • Increase installed customer base
• Quicker revenue than traditional Rx path • Widespread access via pharmacies, internet • Consumer testimonials for promotion
• Easiest system enables frequent monitoring • Automatic reporting to family & physician • Establishes ISN as leader in asthma monitoring
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iSonea ‘Business to Consumer’ Mechanism
Huge Global Market
Opportunity
Enabling Technology
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Web-Based Disease
Management
iSonea’s mobile health platform combines novel ARM™ technology with a universally available hardware platform to address a growing market need with limited cross-border restrictions.
Proprietary Sensors & Software
Fundamental IP Coverage
Innovative ARM™ Sound Analysis
Cloud-Based Data Warehouse
& Portal
Smartphone Embedded
Analysis
Real-Time Physician-Integrated
Action Plan Access $1B Global Asthma Monitoring Market Opportunity
Meet Global Standards of Asthma Care Reduce Global
Disease Cost Burden Confidential & Proprietary
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Product Development Pipeline – Q1 CY 2012
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Research Design & Implementation
Verification & Validation
Regulatory Submission Marketed
AsthmaSense App v1.1
AsthmaSense App v2.0
AsthmaSense App v2.1
Digital Peak Flow Meter
Digital Snoring Meter
AsthmaSense App v1.0
AirSonea Wheeze Monitor
Gen 2 OTC Wheeze Monitor
Asthma Home 2net Hub
OTC Wheezometer
Rx Pulmotrack
Rx WHolter
Rx Wheezometer
Rapid Daytime Test for OSA
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New Product Development Timeline
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Code Project
ISN101 AsthmaSense™ App v1.0
ISN102 AsthmaSense™ App v1.1 Service & Web
ISN103 AsthmaSense ™ App v2.0
ISN104 AsthmaSense™ App v2.1
ISN105 AirSonea™ Monitor
ISN106 OTC WheezoMeter™ (Current EU availability)
ISN107 OTC Gen2 Wheeze Monitor
ISN108 AsthmaHome™ 2net Hub™
ISN109 Digi-Peak Flow Meter
ISN110 Digi-Snoring Monitor
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 CY 2012 CY 2013
Commercial Availability Goal USA EU
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Model Generates Multiple Revenue Sources
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Asthma Consumers
Sponsorship Partners
Healthcare Providers
$ App downloads
$ Data subscription
$ App upgrades
$ Disposable Sensors
$ OTC Wheeze Monitor Devices
$ Diagnostic Monitoring Devices
$ Disposable Sensors
$ OTC Wheeze Monitor Devices
$ Data Services
$ Advertisements
Each customer segment represents multiple revenue sources for iSonea.
Recurring Revenue Streams
$ Market Research For
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Significant Progress Since Restructuring
The first half of FY 2012 was a transition period. The new CEO and management team re-assessed the commercial status of products, developed a new business plan, and raised capital to execute that plan.
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Milestones Achieved – Half Year FY 2012
New CEO – June 2011
Re-branded company - iSonea Limited
Reduced cash burn rate
Hired new management team
Raised $5.6 million in new capital
New clinical development & launch strategies
Initiated re-engineering to lower COGS
New technology patents filed & issued
Listed ADRs on U.S. OTC QX
Designed protocol for 1st U.S. pediatric wheeze correlation study
Conducted 1st U.S. asthma consumer research on asthma app usage & monitoring practices (n=369)
Announced mHealth technology development collaboration with Qualcomm Life
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Key Milestones – Balance of 2012
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Milestone Development Stage Target Date US Pediatric Wheeze Correlation Study (n=95)
• Protocol approved • Sites selected
Enroll: Q4 FY2012 End: Q1 FY2013
FDA Submission – OTC WheezoMeter™
Regulatory Review Q1 FY 2013
AsthmaSense™ v1.0 Asthma App Launch
Design & Implementation Q4 FY 2012
AsthmaSense™ v1.1 Asthma App Launch
Research Q2 FY 2013
FDA Submission – Gen 2 Wheeze Monitor
Design & Implementation Q2 FY 2013
AsthmaHome™ 2net™ Hub Design & Implementation Q2 FY 2013 SoundAsthma.com - Internet Consumer Educational & Promotional Initiatives
• Social media channels launched
• Website in development
Q3 FY 2012
Development of a fundamental data set in the US, launch of initial mHealth asthma management tools, and regulatory submission of non-Rx products will be the most significant accomplishments for the rest of 2012.
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Michael J. Thomas Chief Executive Officer
Steve Tunnell SVP of Operations
David Model SVP of Finance
Jonathan Freudman, MD Medical Director
Michael Cheney VP, Marketing
Jan P. Barker VP, Business Development
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Experienced Management Team
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• Michael J. Thomas - new CEO with successful track record and in-depth knowledge of breathing disorder technologies & markets:
• 3 VC start ups, 1 IPO (NASDAQ: PATI), 1 M&A (NYSE: GE) • ~$100MM in growth equity raised • Former CEO roles: Appian Partners; Sleep Solutions, Inc. • Former AdvaMed BOD member
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Influential & Successful Board
Ross Haghighat Executive Chairman
• 25+ years of new venture creation and venture financing • 8 start ups, 3 M&As, $1.9 B in shareholder value created • Member of 4 for-profit and 1 non-profit Board of Directors • Founder and CEO of Triton Systems – an full service business venturing company
Paul Hopper Managing Director Cappello Group
• 20+ years experience in international public companies focusing on biotechnology, nutraceuticals, and medical & healthcare services.
• Currently focused on start-up and rapid growth companies in US and Australia. • Experience in IPOs, public company mergers and extensive capital market equity raisings.
Fabio Pannuti CEO, Consegna Ltd
• 20+ years experience in international public companies in agriculture, property development, mining/oil & gas, telecommunications, and biotechnology • Formerly Chairman of Mobi Ltd – ASX telecommunications company • Managing Director and CEO of Consegna Ltd – ASX drug delivery technology company
Jerry Korten GM, Business Development GE Healthcare
• 25 Years of private and public company executive, director • CEO Versamed Inc. (acquired by GE HC) • President Vitaltrends Technology, Inc. • Director Product Development, Spacelabs Medical
David Dantzker, MD General Partner Wheatley Partners, LP
• 10+ years of medical technology portfolio management for venture capital fund and corporate board experience
• Past President of North Shore- Long Island Jewish Health System • Former Vice Chairman, Dept. of Internal Medicine, University of Texas Health Science Center • Former Director of Pulmonary & Critical Care Medicine, University of Texas • Former Chairman, American Board of Internal Medicine, Pulmonary Disease Sub-specialty
Board
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Senior Scientific Advisor: Lynn M. Taussig, MD – renowned authority on asthma • Special Advisor to the Provost for Life Sciences at University of Denver • Retired President & CEO of National Jewish Medical & Research Center • Former Chair of the Steering Committee for NIH Childhood Asthma Research & Education Network • Author of >180 scientific publications
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Why Invest Now?
The iSonea opportunity will create shareholder value appreciation over the next 12 -24 months with substantive milestone achievements and increasing US investment.
• First mover advantage – the 1st convenient, effortless asthma monitoring system
– Makes frequent asthma monitoring possible for any patient, anytime, anywhere – Better monitoring improves disease management
• Innovative & Unique ARM Technology – assets to leverage and monetize • Asthma Prevalence & Mobile Health Proliferation
– 300 million people worldwide affected by asthma & COPD – 25 million in the US have asthma – Mobile health app trends are skyrocketing – Monitoring services for chronic diseases are expected to account for $15B globally in 2017
• Low Valuation – Company has substantial value creation potential • Delivery of Milestones in 2012 – 2013 will drive significant shareholder value • New Management Team – seasoned, successful team is in place, with experience
commercializing medical devices and software • Company trades on ASX: ISN and ADRs trade on US OTCQX: ISOAY
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