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ADHERIUM LIMITED — AGM Information 2020
Jul 23, 2020
64305_rns_2020-07-23_1e0ec4b7-e6f8-46e8-a0ce-30e0f701e580.pdf
AGM Information
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Adherium Extraordinary General Meeting CEO update
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July 2020
Disclaimer and Forward Looking Statement
The following material is of a general nature and has only been prepared as a presentation aid. This presentation does NOT contain all of the information that may be required for evaluating Adherium Limited ACN 605 352 510 (Adherium or the Company), its assets, prospects or potential opportunities.
This presentation may contain budget information, forecasts and forward looking statements in respect of which there is NO guarantee of future performance and which of themselves involve significant risks (both known and unknown). Actual results and future outcomes will in all likelihood differ from those outlined herein.
Forward-looking statements are statements that are not historical facts. Words such as “expect(s)”, “feel(s)”, “believe(s)”, “will”, “may”, “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding market size, future results, regulatory approvals, production targets, sales, staffing levels etc. All of such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
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These risks and uncertainties include, but are not limited to: (i) the possible delays in and the outcome of product development, (ii) risks relating to possible partnering or other like arrangements, (iii) the potential for delays in regulatory approvals, (iv) the unknown uptake and market penetration of any potential commercial products and (vi) other risks and uncertainties related to the Company’s prospects, assets / products and business strategy. This is particularly the case with companies such as Adherium which operate in the field of developing and commercializing medical devices and related services. You are cautioned not to place undue reliance on these forwardlooking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forwardlooking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Additionally there are a number of factors, both specific to Adherium and of a general nature, which may affect the future performance of Adherium. There is no guarantee that Adherium will achieve its stated objectives/milestones, that any of its forecasts will be met or that forward looking statements will be realized.
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Adherium: Overview
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➢ A leader in digital inhaled device adherence, remote monitoring and data management solutions for asthma and COPD patients
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➢ Adherium develops, manufacturers and supplies a broad range of connected sensors for inhaled respiratory medications for patients, healthcare providers, pharmaceutical companies, and contract research organisations.
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➢ Adherium’s Hailie[®] platform is designed to help patients achieve better adherence and improve health economic outcomes for patients, physicians and payors
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➢ Hailie[®] technology effectiveness has been demonstrated :
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85 peer reviewed publications
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Over 170,000 sensors sold globally
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~13,000 patients
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30+ countries
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Patents in place; proprietary algorithms
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➢ Hailie[®] Sensor portfolio covers 80% of the US market for inhaled asthma and COPD drugs
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➢ Company currently ~ 20 FTEs based in Auckland, Melbourne, UK and North America
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➢ Company founded in 2001. Listed on ASX in 2015
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- Hailie is a registered trademark of Adherium
Hailie[®] Platform is Designed to Capture & Report Data Enabling Physicians to Improve Patient Outcomes
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Payer / Provider Online interfaces
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®
• Monitors device
activation, adherence Data
and timing management
• Physiological measures and analytics,
• in developmentReimbursement- Microsoft Azure
compliant data
• Patient Feedback via Regulatory-compliant
app as appropriate cloud infrastructure
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Patient data reporting
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Reimbursement-compliant reports
Billing support Audit trail
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Clinician
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Sensor attaches to inhaled medication device. Captures medication use and physiological measure data
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Future Data And
Freemium
Services
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Tailored Clinical Data reports Clinical Dashboard Direct-connect to cloud
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Percentage 59% 80% 61% 39% 15%
reduction vs. Missed Hospital Acute Oral Steroid Missed School
doses admissions Attacks Use Days
control group
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Vision and Strategy
Adherium Vision and Positioning
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To be the preferred respiratory inhalation monitoring system, enabling better clinical and financial outcomes for physicians, payers and patients with severe, uncontrolled asthma and COPD
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Critical success factors in place to secure business traction
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Market Environment
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High medical unmet
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Compelling economic rationale in severe asthma/COPD patients
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Economic incentives for remote monitoring
Technology market ready for extensive commercial use
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Extensive market validation across multiple customers, geographies healthcare settings
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Bluetooth[®] synchronisation with set-up and maintenance supported by customer support tools web/call centre
Meaningful customer data generation with outcome measures
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Improves patient adherence
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Supports healthcare cost savings
Digital interface “humanised” with customer interface
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Establish call centre support through partners
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securing adoption & maintenance of patient engagement
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facilitating physician interface & reimbursement processing
Business model driven by established specialist partners
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Established partners agnostic to therapeutic choices
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Recurring revenue generation potential vs. project-based activity
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Significant unmet need and healthcare burden in severe Asthma (25million, US) & COPD (24million, US)
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24% GINA Step 4-5 treatment
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Over 8m treated maintenance asthma patients in US demonstrate “uncontrolled symptoms” Approx. 50% patients fail to take dose as prescribed
17%
Difficult-to-treat asthma
- = GINA Step 4-5 treatment + poor symptom control
Proportion of asthmatics with difficult to treat and or severe asthma
US economic burden of asthma & COPD > US$100bn Approx. US$4bn estimated as preventable healthcare cost for uncontrolled patients
3.7%
Severe asthma
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= GINA Step 4-5 treatment + poor symptom control
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- good adherence and inhaler technique
Over 1.3m severe treated asthma & COPD patients in US Severe treated patient cost > US$10,000 per annum
Graphic adapted from © Global Initiative for Asthma, www.ginasthma.org
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- Hekking et al, JACI 2015
These data are from a Dutch population survey of people ≥18 years with asthma
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GINA guidelines recommend electronic adherence monitoring for difficult to treat/severe asthmatics
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GP OR SPECIALIST CARE
Investigate and manage adult and adolescent patients with difficult-to-treat asthma
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Consider referring to specialist or severe asthma clinic at any stage
Diagnosis Confirm the diagnosis Optimize Review response
“Difficult- 1 (asthma differential diagnoses) ® 3 management 4 after ~3-6 months
to-treat Look for factors contributing to symptoms,
asthma” exacerbations and poor quality of life:
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• Incorrect inhaler • Suboptimal adherence
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SPECIALIST CARE; SEVERE ASTHMA CLINIC IF AVAILABLE
Assess and treat severe asthma phenotypes
Continue to optimise management as in section 3 (including inhaler technique, adherence, comorbidities)
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Assess the severe • Ahead of biologic treatment Consider Consider add-non-
5 asthma phenotype • Assess adherence objectively, monitoring ® 6a non-biologic 6b biologic Type 2
and factors of life prescribing / dispensing records, blood prednisolone treatments targeted treatments
and exacerbations level, or electronic inhaler monitoring
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SPECIALIST AND PRIMARY CARE IN COLLABORATION
Monitor/manage severe asthma treatment
Continue to optimise management Review Continue to optimise 7 response 8 management
An opportunity for Adherium at diagnosis and at the transition to biologicals to optimise medication use, saving healthcare $$ with providers reimbursed through payment codes
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Graphic adapted from © Global Initiative for Asthma, www.ginasthma.org
Business plan generates recurring revenue
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Patient physiological data is
captured/recorded
Provider bills
CPT Code #99453/4/7
US$1,400
per patient
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Positive Covid-19:
Reimbursement Accelerated
Environment Adoption
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Over 8m treated maintenance asthma patients in US demonstrate “uncontrolled symptoms” Approx. 50% patients fail to take dose as prescribed
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Positive International Treatment Guidelines
US economic burden of asthma & COPD > US$100bn Approx. US $ 34bn estimated as preventable healthcare cost for uncontrolled patients
Over 1.3m severe treated asthma & COPD patients in US Severe patient cost > US$10,000 per annum
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Approved Products & Pipeline
Recurring Revenue
Customer Adoption Innovation partner Specialist Partners HGE Health Disease Management
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Specialist sales and distribution
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Per sensor per member per month fee
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Enhanced risk share savings over historic baseline
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Providers to access the CPT fee, with Adherium accessing fee for service
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Sell Adherium devices with a license fee per patient and data access payment
Enhanced Product & Platform Portfolio development
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Sensor development partnership programme 2020 - 2021
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CURRENT IN DEVELOPMENT
GSK Ventolin HFA Teva ProAir HFA Merck Proventil
GSK Advair HFA GSK Flovent HFA BI Respimat Spiriva BI HandiHaler Spiriva
GSK Diskus
AZ Symbicort Advair/Flovent GSK Ellipta Breo/Trelegy
RESCUE/RELIEVER
PREVENTER
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SENSOR DEVELOPMENT PIPELINE
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Adherium and Planet Innovation teams
progress portfolio development
H2 2020
First new sensors with physiological
measure launch in US to support
CPT code reimbursement
H1 2021
Completion of enhanced
sensor portfolio launches in
US across Asthma and COPD
H2 2021
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Software development partnership programme 2020 - 2021
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®
Sensor attaches to inhaled Data
medication device. Captures
management
medication use and
physiological and analytics,
measure data Microsoft Azure
Regulatory-
Patient data reporting compliant cloud
• Monitors device activation, adherence and timing infrastructure
• Physiological measures in development
• Reimbursement-compliant data
• Patient Feedback via app as appropriate
Future Data And
Freemium
Services
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Payer / Provider
Online interfaces
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Reimbursement-compliant reports
Billing support Audit trail
Clinician
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Tailored Clinical Data reports
Clinical Dashboard
Direct-connect to cloud
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SOFTWARE
DEVELOPMENT
PIPELINE
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Increase Platform
capacity and capability
H2 2020
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*Add new features to app and platform including physiological measures
Enhanced software to improve user experience and flexibility of data integration
H2 2020
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Business Road Map
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1 2 3 Q3 2020 – Q1 2021 Q2 2021 – Q4 2021 2022 Initial partner model Partner scale up in US Full expansion and platform establishment / proof of concept with revenue traction leverage in US and ex US
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➢ Testing and proving of HGE and ➢ Scale up of HGE and Trudell activity Trudell commercial operations with progressive revenue growth and Adherium sensor/software alongside introduction of first wave with limited initial sensor new sensors enabling physiological/ volumes and orders peak flow measurement
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➢ Appointment of key leadership ➢ Development completion and market roles in US and CTO in Australia launch of full range of physiologically enabled sensor and software in both COPD and Asthma
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➢ Limited highly selective non-US key account management/initial Adherium commercialisation
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➢ Accelerated US partners activity with all major new sensors on market
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➢ Potential expanded scale up in EU/ROW territories
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➢ Potential next wave device development including nebulisers/integrated sensors
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➢ Potential multi-provider data integration leverage and monetisation
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Investor opportunity for significant value re-rating with business progression
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➢ High level of investor interest in technology and digital funds
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➢ Telehealth/Remote Patient Monitoring acceleration and COVID-19 intensifying investor focus in segment
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➢ Series of successful established and start up medical device businesses adopting digital platforms with Remote Patient Monitoring reimbursement
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Medtronic
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Resmed
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Livongo/Dexcom
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Senseonics
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➢ Adherium opportunity enhanced with new reimbursement coding and de-risked following key learnings since IPO with qualified experienced management
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➢ Opportunity for organic re-rating alongside strategic M+A as seen with Resmed acquisition of Propeller Health for US$225m in 2019
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Adherium: Compelling Business & Investment Opportunity
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➢ High Unmet Medical Need and Healthcare Resource Burden in Asthma and COPD especially in more severe uncontrolled patient segments
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➢ Global Treatment Guidelines now recommend use of electronic monitoring tools in assessment of severe patient segment prior to changes in medication
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➢ Reimbursement for Remote Patient Monitoring now established in US with adoption of telehealth / remote monitoring accelerating further as a result of COVID-19
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➢ Adherium’s clinically supported technology platform with extensive inhaled device coverage
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➢ Adherium strategy, business model, portfolio and new management team in place with key learnings applied since IPO
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New Highly Qualified Management in Place
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Geoff Feakes
James Ward-Lilley Chairman
Mike Motion Chief Executive Officer
Anne Bell
Chief Financial Officer
Chief Technical Officer
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Qualified as a Chartered Accountant in 1984 with Arthur Young before joining Arthur Andersen & becoming a partner in the Business Consulting practice
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25 years of information technology governance and leadership, solution innovation and realization across Australia and Internationally including Europe, USA and Asia
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Extensive experience in operational & executive leadership roles in pharmaceutical & medical devices industry
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35 years experience in medical devices & pharmaceuticals
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15 years Baxter Healthcare in manufacturing, sales & marketing & international commercial leadership roles
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28 years in global roles at AstraZeneca , successfully leading their Respiratory & AutoImmune Global Franchise
• Joined Colonial (subsequently acquired by Commonwealth Bank of Australia) in 1996
- Executive positions in the Acute healthcare sector in Australia and 10 years with **Tunstall Healthcare** , both globally and Australasia
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Joined Biocompatible's , 2005, led commercialisation of its interventional oncology (IO) portfolio, setting up a direct US sales force & global distributor network
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Then joined Vectura PLC , the inhaled respiratory formulation and device specialists, as Chief Executive
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Global roles with AstraZeneca 2003-2008
• Extensive experience with Remote Patient and Chronic Disease management platforms and solutions, including development and market release
• CFO for Invida, which was bought by Menarini in 2011 – remained at Menarini until 2018
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Grew the IO business to ∼ US$40m; acquired by BTG , 2011 for US$283m
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During time at both AstraZeneca and at Vectura , worked closely with both Adherium & Propeller Health
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Led BTG Oncology, Digital & Vein franchises until BTG acquired by Boston Scientific 2019
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Board Member and Vice Chair of Australia’s Personal Emergency Response Services Limited (PERSL), and committee member of the Medical Technology Association of Australia (MTAA)
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Joined Adherium , November 2019: key activities to date include re-financing activity, refresh of strategy, new business model, technology development plan
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Jane Lapon Head of Pricing & Reimbursement
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25 years international experience in pricing and reimbursement in medical devices
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Held executive positions with Bristol-Myers Squibb, BTG and Boston Scientific
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Exemplary track record ensuring physicians get paid by public & private payers for company products globally
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Achievements include securing reimbursement for:
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Failing pulmonology device in Germany, reversing business trajectory
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Flagship device in France, securing ∼ €60m/year in public funding, resulting in exponential sales in a previously untapped market
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