Sphere Medical Corporate Presentation January 2015

Corporate Presentation
© Sphere Medical Holding plc
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© Sphere Medical plc
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Investment Highlights
Proxima is a CE marked, patient-attached, arterial blood gas analyser for
the critical care market
Disruptive technology represents a potential game changer
Global market potential validated by partner, Ortho Clinical Diagnostics
Strong KOL support
Sales launch of Proxima 3 in September 2014
Clear growth catalysts over next 18 months
£48 million invested to date via blue-chip and specialist investors
Commercially focused management team with relevant med tech
experience
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Unmet Need – Two KOL opinions
“… one of the things we have learnt is that the
careful control of patient physiology has a
huge potential to improve outcome”
Member of Sphere Medical Advisory Board and
Chief Investigator Proxima Method Comparison Study
Dr. Tom Clutton-Brock
Senior Lecturer and Head of the
Department of Anaesthesia and
Intensive Care,
University of Birmingham, UK
“… Proxima has the potential to bring about a
paradigm shift in the intensive and critical
care setting …”
Chairman of Sphere Medical Advisory Board
Professor Vincent is Professor of Intensive
Care at the Université Libre de Bruxelles
and the Head of the Department of
Intensive Care, Erasme University Hospital
(University of Brussels)
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Current Practice
Current clinical practice for blood gas
measurements (1)
On average blood gases are measured every 3
hours
For critically ill patients, up to 19 measurements
are made per day
Unstable patients would benefit from more
frequent measurements
Detect onset of critical conditions earlier to
prevent complications
Detect improvements earlier to wean off
ventilation
Current barriers to more frequent measurements
Increased workload for nursing staff
Rise in blood anaemia
Rise of infection risk
(1) Nursing in Critical Care 2008
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Current Players
Laboratory blood gas analysers
Large instruments sited in a central laboratory
High volume measurements with high accuracy
Key players include: Radiometer, Siemens, Instrumentation
Labs, Roche
Benchtop blood gas analysers
Smaller instruments sited ‘near patient’ in the ward
Medium volume measurements with high accuracy
Key players include: Radiometer, Siemens, Instrumentation
Labs, Roche
Point of Care analysers
Transportable or hand held device used at patient bedside
Single use cartridge with high accuracy
Key players include: Abbott POC
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Proxima – The Potential Game Changer
Disposable patient-attached
device
Closed system mounted in
arterial line
Blood returned to patient
Integrates into existing
practices and workflow
Designed to measure up to
72 hours, as frequently as
possible
Sensor panel = pH, pCO2,
pO2, Haematocrit, K+
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Proxima Benefits
Keeps nurse at the patient’s bedside
Conserves patient blood
Reduces infection risk
Easy to make more frequent measurements
Enables closer control of therapeutic response
Expected to improve patient outcome
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Attractive Market
$3.2 billion market worldwide for blood gas and
electrolyte testing in 2013(1)
Instruments, service, consumables
CAGR 3.1%
$0.9 billion Point of Care market worldwide in 2013
CAGR 4.9%
$0.3 billion Point of Care market Europe in 2013
CAGR 4.8%
(1) Blood Gas and Electrolyte Analysers, Global Industry Analysts Inc. 2012
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Market Launch
Proxima 3 launched in UK at the Association of
Anaesthetists of Great Britain and Ireland (AAGBI)
conference 17-19 September 2014
Presented Proxima 3 at the British Association of
Critical Care Nurses (BACCN) conference in early
September 2014 and received several hospital
evaluation requests
Appointed new VP Sales direct from Abbott Point of
Care to lead Proxima’s sales activities
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Target Markets
Target market segments where patient management
requires frequent measurements
Severe sepsis and septic shock
Acute respiratory distress syndrome (ARDS)
Major trauma
Neuro trauma
Target early adopters which treat patients within target
segments from 2014 onwards
83 hospitals in the UK(1)
Expand sales to Europe via own focused sales team
Germany, Benelux in H1 2015
(1) Source NHS critical care bed report 2013
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Our Global Partner OCD
Strong global presence
World leading sales and marketing capabilities
Shared vision
Estimated sales opportunity > $200 million at full market
penetration
Collaborative product enhancements based on market
feedback
Partnership structure
Development deal signed in 2013
Opportunity to negotiate a potential distribution deal H2
2015, upon completion of development milestones
Hold 13.7% of Sphere Medical’s shares
New ownership
Carlyle Group has acquired OCD from J&J (June 2014)
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Catalysts for Growth
Geographical sales expansion
Germany, Benelux H1 2015
Potentially sign worldwide distribution partnership H2 2015
Market penetration
Proxima 4 (launch expected in Europe H1 2016)
Add glucose and sodium to sensor panel
Connectivity to HIS/LIS systems
Obtain FDA approval
Future product evolution planned
Expand analytes on sensor panel
Penetrate new target market segments
Method comparison study
Birmingham H2
Proxima 3 UK launch
September
2014
Proxima 3 EUR launch
H1
Potential worldwide distribution deal
H2
2015
© Sphere Medical plc
Proxima 4 EUR launch
H1
2016
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Clear Investment Opportunity
Proxima is a CE marked, patient-attached, arterial blood gas analyser for the
critical care market
Disruptive technology represents a potential game changer
Global market potential validated by partner, Ortho Clinical Diagnostics
Strong KOL support
Sales launch of Proxima 3 in September 2014
Clear growth catalysts over next 18 months
£48 million invested to date via blue-chip and specialist investors
Commercially focused management team with relevant med tech experience
© Sphere Medical plc
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Frost and Sullivan Point-of-Care Technologies
award for Technology Innovation of the Year
“The One to Watch” investment award, March
2011, at IBIZ 2011, organised by UKTI
Appendix
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Presentation team
Dr. Wolfgang Rencken
CEO
Matthew Hall
CFO
Appointed CEO in February 2014
More than 15 years’ experience in
healthcare and medical devices industries
Joined Sphere in 2011 as CFO
the
Proven track record in developing and
commercialising medical devices and driving
significant product revenue growth
Previous roles:
CEO of MAQUET Cardiopulmonary AG, an
international medical devices group with over
1,000 employees. Over three years as CEO, he
oversaw revenue growth of over 50% and more
than doubled EBITDA
Chartered Accountant
economics
a
degree
in
Previous roles:
CFO of IS Pharma, specialist pharmaceutical
group listed on AIM, which merged with Sinclair
Pharma in May 2011
20 years corporate finance experience – held
positions at Noble Group, Close Brothers
Group, Hill Samuel Group, Merrill Lynch,
Deloitte Touche Tohmatsu
COO and a director of Definiens AG
Siemens AG over a 15 year period
© Sphere Medical plc
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Non-Executive Directors
Non-executive Chairman
Non-executive Director
Non-executive Director
Dr Anthony Martin
Stephen H. Mahle
John Gregory
Joined Sphere in 2005
Joined Sphere in December 2011
Joined Sphere in December 2011
Senior Independent Director
Current roles
Non-executive Chairman - Phico Therapeutics
Ltd
Non-executive Director- Abcam plc, Orthofix
International N.V.
Previous roles
Current roles
Previous roles
Former Executive Vice President of Medtronic
Inc. and President of Medtronic’s largest
division, Pacing and subsequently President of
Cardiac Rhythm Disease Management - retired
after 37 years
Non-executive Chairman –
Immunodiagnostics Systems Holdings plc,
NeuTec Pharma plc, Tepnel Life Sciences,
Molecular Probes Inc.
Non-executive Director
Non-executive Director
Dr David Martyr
Meinhard Schmidt
Current roles
CEO - Tecan AG
Non-Executive Director - ALDA (Analytical Life
Science Diagnostics Association), Washington
DC
Previous roles
Group President Leica Microsystems and VP
& Group Executive, Danaher Corporation
Previous roles
Non-executive Chairman – IS Pharma,
Sinclair IS Pharma
Non-executive Director - Noble Fund
Managers
CEO – Molecular Probes Inc., Invitrogen
Corporation, Celsis International
Joined Sphere in 2015
Non-executive Chairman – Foresight VCT
Joined Sphere in 2015
Current roles
Founder and Managing Partner - mt:onyx AG,
Director of Quanta Fluid Solutions Ltd,
ValuationLab AG, Promimic AB (Sweden)
Previous roles
Director of Cellnovo Ltd, CEO, SVP & Head
Business Unit Prosthetics/Digitalization Institut Straumann AG and Open Digital
Dentistry AG, SVP Head Roche Decentralized
Solutions – Roche Diagnostics
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Medical Advisory Board
Medical Advisory Board
Professor Jean-Louis Vincent
Professor of Intensive Care at the Université
Libre de Bruxelles
Head of the Department of Intensive Care,
Erasme University Hospital (University of
Brussels)
President of the World Federation of Societies
of Intensive and Critical Care Medicine
Medical Advisory Board
Medical Advisory Board
Dr Tom Clutton-Brock
Professor Michael Quintel
Senior Lecturer and Head of the Department of
Anesthesia & Intensive Care, University of
Birmingham Medical School
Director of the Department of Anaesthesiology,
Emergency and Intensive Care Medicine at the
University of Göttingen, Germany
Programme Director PGDip & MSc Physicians’
Assistant (Anaesthesia)
Member of the European Society of Intensive
Care Medicine (ESICM) group on respiratory
failure
Consultant in Anaesthesia and Critical Care,
University Hospitals NHS Foundation Trust
Associate Medical Director for Audit & Clinical
Effectiveness, University Hospitals NHS
Foundation Trust
Elected member of Council, Royal College of
Anaesthetists
Past President of the German Interdisciplinary
Society of Intensive Care Medicine (DIVI) and a
past council member of the German Society of
Anaesthesia and Intensive Care (DGAI).
Professor Quintel is also a member of the
German Sepsis Society and an Investigator in
the SepNet Sepsis Clinical Trial Network in
Germany and has participated in numerous
sepsis and critical care trials.
Member of Interventional Procedures
Committee, NICE
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Member of the Scientific Committee of
International ECMONet
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Customers
The champion for adoption in the ICU will be the
physician
Clinical effectiveness of the product
Other key influencers in the purchase will be
Critical care nurses – usability and workflow
impact
Finance/procurement – cost-benefit analysis
Laboratory Point of Care Committee –
analytical performance of the product
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Competition
Laboratory benchtop analysers
Radiometer, Siemens, Instrumentation Labs,
Roche
Near patient benchtop analysers
Radiometer, Siemens, Instrumentation Labs,
Roche
Point of Care analysers
Abbott POC
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Sales Process
Each geographical region will have dedicated sales
teams
Each sales team will consist of a commercial and a
technical team member
Every prospective customer will receive an
evaluation of the product
Training of the staff (1 week)
Continuing in use support (1 week)
Support to prepare business case for investment
proposal
Revenue models
Purchase monitor hardware and disposables
separately
Up charging model (premium on the disposables)
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Marketing Activities
Rebalance Medical Advisory Board with leading
European KOLs
Professor Jean-Louis Vincent appointed in August
2014
Gather clinical evidence
Conduct 2 clinical studies in 2014
Proxima 3 method comparison study QE
Hospital Birmingham 20-40 patients (ongoing)
Time and motion study (planned)
2015 onwards
Engage various KOLs and clinicians to
conduct case studies and publish results in
targeted market segments
Raise market awareness
2014 Attend AAGBI, BACCN, ICS trade shows in
UK
2015 Attend ISICEM, Brussels, 3 national shows
(UK, DE, NL)
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Interim Results - 6 months to June 30, 2014
Operating expenses were £3.1 million (H1 2013: £3.0 million)
Product Development and Realisation costs £1.5 million (H1
2013: £2.0)
Administrative costs £1.1 million (H1 2013: £0.8 million),
including one-off costs of change in CEO
Loss for the period £3.0 million (H1 2013: £2.9 million)
Cash and cash equivalents as at 30 June 2014 £6.3 million (30
June 2013: £2.6 million)
R&D tax credit refund of £523,000 received in July 2014
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