Uncommon Grace The Autobiography of Isaac Folorunso
Dvfa life-science-conference-proceedings-2017
1. Society of Investment Professionals in Germany
Digital Transformation in Healthcare
13 June 2017
DVFA Center, Frankfurt am Main
10th DVFA Life Science Conference
Supported by
Media Partner
Schnee Research
Plattform
Life Sciences
Networking Partner
Conference Proceedings
3. The 10th DVFA Life Science Conference focused on the challenges and opportunities of Digital Transformation in Healthcare. With
the explosive growth in health and biomedical data the digital transformation of the healthcare sector is gaining momentum.
Participants got insights in Network medicine, Telematics Infrastructure, Electronic Health Records (EHR), Medical Apps &
Cloud, EU data protection rules and discuss the future of digital medicine with industry experts.
u Topics
Digital Transformation in Healthcare: Challenges & Opportunities
The Telematics Infrastructure: The coming eHealth Revolution in Germany
Connected Diabetes Management
Increased data protection and data security requirements under the new EU Data Protection Regulation
Panel Discussion – New Business Models Digital Health
Next Generation Sequencing & Big Data
The Health Revolution – Better Outcomes with Smart Data
Panel Discussion – Digital Health: A Capital Market Perspective
Digital Health – Startup-Slam
u Speakers & Moderators
Dr. Christa Bähr, CEFA, CFA, Founder and Business Owner, CB HealthCare
Kai Brüning, CEFA, Fundsmanager, apoAsset Management GmbH
Eric Cohen, IR, Cellnovo Group
Dr. Lothar Ende, Partner, HEUKING KÜHN LÜER WOJTEK
Jason Gammack, Vice President Head of Marketing Life Sciences, QIAGEN N.V.
Dr. Lutz Martin Keppeler, Senior Associate, Certified Specialist Lawyer for Information Technology Law,
HEUKING KÜHN LÜER WOJTEK
Prof. Dr. Dr. Gerhard Lingg PhD, Chairman, imi mHealth Solutions Ltd.
Dr. med. Markus Manns, Chairman DVFA Life Science Commission, Equities Fund Manager, Union Investment
Privatfonds GmbH
Klaus May, Geschäftsführer, Genomatix
Dr. Martin Pöhlchen, Partner, Alira Health
Karlheinz Schmelig, Managing Partner, Creathor Venture
Carsten Schmitt, Investment Banking, Renell Bank
Dr. Julia Schüler, CBA, Investor Relations, SynapCon
Roman Schweiger, CFO, HUMANOO
Julian Shapley, CSO, Cellnovo Group
Dr. Clemens Suter-Crazzolara, VP Product Management, Health, SAP SE
Dr. Klaus Suwelack, New Venture Lead Germany, Johnson & Johnson Innovation/Janssen
Christian B. Teig, CFO, CompuGroup Medical
Lesli Wagstaffe, CEO, imi mHealth Solutions Ltd.
LIFE SCIENCE_
Conference 13 June 2017, 9 a.m.
4. LIFE SCIENCE
DVFA LIFE SCIENCE CONFERENCE_
08:45 a.m . u Check-in
09:00 a.m. u Welcome
Dr. Christa Bähr, CEFA, CFA, Chairwoman DVFA Life Science Commission,
CB HealthCare
09:10 a.m. u Digital Transformation in Healthcare – Challenges & Opportunities
Dr. Martin Pöhlchen, Partner, Alira Health - Presentation
09:45 a.m. u The Telematics Infrastructure: The Coming eHealth Revolution in Germany
Christian B. Teig, CFO, CompuGroup Medical - Presentation
10:20 a.m. u Connected Diabetes Management - Presentation
Julian Shapley, CSO, and Eric Cohen, IR, Cellnovo Group
10:50 a.m. u Coffee Break
11:10 a.m. u Increased Data Protection and Data Security Requirements under the
New EU Data Protection Regulation - Presentation
Dr. Lothar Ende, Partner, and Dr. Lutz Martin Keppeler, Senior Associate,
Certified Specialist Lawyer for Information Technology Law, HEUKING
KÜHN LÜER WOJTEK
11:45 a.m. u Panel I: New Business Modells Digital Health
• Dr. Lutz Martin Keppeler, Senior Associate, Certified Specialist Lawyer for
Information Technology Law, HEUKING KÜHN LÜER WOJTEK
• Dr. Martin Pöhlchen, Partner, Alira Health
• Karlheinz Schmelig, Managing Partner, Creathor Venture - Presentation
• Christian B. Teig, CFO, CompuGroup Medical
• Moderation: Dr. Klaus Suwelack, New Venture Lead Germany, Johnson &
Johnson Innovation/Janssen
12:45 p.m. u Lunch
01:30 p.m. u Next Generation Sequencing & Big Data - Presentation
Jason Gammack, Vice President Head of Marketing Life Sciences, QIAGEN N.V.
02:05 p.m. u The Health Revolution – Better Outcomes with Smart Data - Presentation
Dr. Clemens Suter-Crazzolara, VP Product Management, Health, SAP SE
02:40 p.m. u Coffee Break
03:00 p.m. u Panel II: Digital Health - A Capital Market Perspective
• Kai Brüning, CEFA, Fundsmanager, apoAsset Management GmbH
• Prof. Dr. Dr. Gerhard Lingg PhD, Chairman, imi mHealth Solutions Ltd.
• Carsten Schmitt, Investment Banking, Renell Bank
• Dr. Clemens Suter-Crazzolara, VP Product Management, Health, SAP SE
• Moderation: Dr. med. Markus Manns, Chairman DVFA Life Science
Commission, Equities Fund Manager, Union Investment Privatfonds
GmbH
04:00 p.m. u Digital Health - Startup-Slam
• Genomatix: Klaus May, Geschäftsführer - Presentation not released
• HUMANOO: Roman Schweiger, CFO - Presentation
• imi mHealth Solutions Ltd.: Lesli Wagstaffe, CEO
• SynapCon: Dr. Julia Schüler, CBA, Investor Relations - Presentation
not released
• Moderation: Karlheinz Schmelig, Managing Partner, Creathor Venture
04:45 p.m. u Get-together
Programme
13 June 2017
Clicking on the title will take
you directly to the appropriate
page.
5. June 13, 2017
Digital Transformation in Healthcare –
Challenges & Opportunities
Dr. Martin Pöhlchen
Partner, Germany
6. 2
Strictly Confidential
Strategy. Execution. Innovation.
Alira Health is an
international
advisory firm
providing integrated
strategy, execution
and innovation
services for
healthcare and life
science companies.
STRATEGY EXECUTION INNOVATION
CORPORATE STRATEGY
MARKET ACCESS
MARKET RESEARCH
COMMERCIAL DUE DILIGENCE
IP AND PRODUCT PORTFOLIO
STRATEGY
REIMBURSEMENT AND PRICING
HEALTH ECONOMICS
REGULATORY STRATEGY
LEADERSHIP EMPOWERMENT
VALUATION AND FAIRNESS OPINION
SELL AND BUY ADVISORY
STRATEGIC PARTNERSHIP
AND ALLIANCE MANAGEMENT
GROWTH CAPITAL
AND EXPANSION FINANCING
IN- AND OUT-LICENSING
SCIENTIFIC AND CLINICAL
DUE DILIGENCE
BUSINESS DEVELOPMENT
PROJECT MANAGEMENT
FOR REGULATORY SUBMISSION
PRECLINICAL AND CLINICAL TRIALS
CLINICAL COMMUNICATION AND
EDUCATION
NEW PRODUCT DEVELOPMENT
NEW IP DEVELOPMENT
CLINICAL AND SCIENTIFIC GUIDANCE
ON INNOVATION
INCUBATION OF
BREAKTHROUGH TECHNOLOGIES
7. 3
Strictly Confidential
Our Knowledge. Your Power.
Patient
» Biotech and R&D Companies
» RX Pharmaceuticals » Orphan Pharmaceuticals
» Specialty Pharmaceuticals » Primary Care Therapies
» Generics » Active Pharmaceutical Ingredients
» Contract Manufacturing Organization
» Contract Research Organization
» Over the Counter » Consumer Care
» Nutraceuticals
» Cosmetics
» Critical Care
» Wound Care
» Medical Imaging
» Infection Control
» Drug Delivery
» Fluid Management
» Cardiovascular
» Neurovascular
» Interventional Devices
» Surgical Equipment
» Orthopedics
» In Vitro Diagnostics
» Laboratory» Health Education
» Health Data Analytics
» Population Health Management
» Telehealth
» Electronic Medical Records
» Big Data
» Pharmacy Management Systems
» Revenue Cycle Management
» Precision Medicine
» Wearables
» Patient Monitoring
» Telemedicine
» Biostatistics
» Drug Adherence
» Drug & Device
Combination
Products
» Companion
Diagnostics
Payers
Healthcare
Providers
Product
& Solution
Suppliers
Our expertise
extends beyond
the walls of
convention and
throughout every
life science and
healthcare sector.
8. 4
Strictly Confidential
Source: Berger, Roland (2016). Digital health market development 2015-2020 [USD bn].
39
48
59
73
89
110
8
14
21
28
37
46
12
14
17
19
22
26
20
20
21
22
23
24
-
50
100
150
200
250
2015 2016 2017 2018 2019 2020
Wireless Health Mobile Health Telehealth EMR/HER
+23%
+41%
+15%
+4%
79
96
118
142
172
206>
+21% p.a.
The Digital Health
industry is
expected to grow
at an annual rate
>20 %.
9. 5
Strictly Confidential
Source: Berger, Roland (2016). Digital health market development 2015-2020 [USD bn].
Hypothesis: the
digital healthcare
revolution will
come from R&D.
DIGITAL VALUE POCKETS ALONG WITH THE VALUE CHAIN
Understand how digitalization will impact your market segment
R&D
MANUFACTURING/
SUPPLY CHAIN
MEDICAL/
MARKETING
SALES
Pharma
Companies
Digital
Tools
SMART DATA
INDUSTRY 4.0 DIGITAL HEALTH
MULTICHANNEL
MANAGEMENT
10. 6
Strictly Confidential
The era of the
Frank Zappa drug
development
strategy comes to
an end. However,
the non-
responder
problem persists.
11. 7
Strictly Confidential
From closed expert
systems to
informed
customers
Drug
Development
Monitoring
Prevention
Imaging
Electronic
Health Record
Proteomics
Metabolics
Genomics
Lab
Management
System
Mobile Health
Social Media
Quantified Self
Customer
12. 8
Strictly Confidential
▪ Stronger engagement of IT companies in Digital Health
▪ New business models and cooperation in Digital Health
• Cooperation with new players who directly connect R&D with payers and patients
▪ Enormous research budgets and stronger engagement of non-profit-organizations (NPOs) in
Digital Health
13. 9
Strictly Confidential
▪ Stronger engagement of IT companies in Digital Health
▪ New business models and cooperation in Digital Health
• Cooperation with new players who directly connect R&D with payers and patients
▪ Enormous research budgets and stronger engagement of non-profit-organizations (NPOs) in
Digital Health
14. 10
Strictly Confidential
Stronger engagement of IT companies in Digital Health (1)
▪ Verily: “Google of human systems biology” (March 3, 2016)
• Andy Conrad, who heads up Verily (formerly known as Google Life Sciences), is working with a
coalition of academic hospitals, physiscians, universities, and patient advocates to bring medical
information into one place.
Source: Future Genomics (March 3-4, 2016). La Jolla, US. https://www.fastcompany.com/3057455/verily-is-building-a-google-for-medical-information.
15. 11
Strictly Confidential
Stronger engagement of IT companies in Digital Health (2)
▪ Buzz: Apple plans to add 23andMe-style spit (May 8, 2015)
• Apple has designs on the DNA sequencing sector.
• The tech giant is reportedly working with research to make 23andMe-style DNA sequencing spit
kits part of ResearchKit.
• This platform turned every iPhone user into a potential study participant.
16. 12
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Stronger engagement of IT companies in Digital Health (3)
▪ IBM launches new health unit, teams up with Apple, J&J, Medtronic (April 13, 2015)
• Launch of new company in Boston with 2,000 employees
• Analysis of 700 million iPhone users
• Acquisition of Explorys and Phytel to strengthen healthcare data analytics
17. 13
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▪ Stronger engagement of IT companies in Digital Health
▪ New business models and cooperation in Digital Health
• Cooperation with new players who directly connect R&D with payers and patients
▪ Enormous research budgets and stronger engagement of non-profit-organizations (NPOs) in
Digital Health
18. 14
Strictly Confidential
Source: FierceBiotech (June 5, 2017). http://www.fiercebiotech.com/medtech/ibm-watson-novartis-join-forces-breast-cancer.
New business models and cooperation in Digital Health (1)
▪ IBM Watson, Novartis join forces on breast cancer (June 5, 2017)
• The collaboration seeks to use real-world data to better understand the expected outcomes of
various breast cancer treatments. Novartis will bring its breast cancer expertise, while IBM will
contribute its data analytics and machine learning chops.
• «As the industry shifts toward value-based care, it's critical for clinicians to understand the real-
world outcomes of therapeutics on subsets of their patients, and our goal ultimately is to put those
insights into oncologists' hands.»
19. 15
Strictly Confidential
New business models and cooperation in Digital Health (2)
▪ Merck KGaA and Peter Thiel’s Palantir join forces to speed up R&D (January 13, 2017)
• Merck and Palantir have teamed up on big data to help the pharma industry combine its
research with other bioinformatics to zero in on those cancer patients who could be helped the
most by new meds, and then use this to help store up its R&D process.
• Palantir, which also does business with GSK, said its data analytics would be used to help Merck
«better, faster develop and deliver medicines to patients, commercialize new products and improve
patient outcomes.»
20. 16
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New business models and cooperation in Digital Health (3)
▪ Teva taps IBM Watson for drug repurposing project (October 26, 2016)
• Three-year collaboration to build a systematic process for drug repurposing using IBM Watson
Health Cloud.
• The allies plan to develop technologies that combine machine-learning algorithms, real-world
data and human input to take some of the guesswork out of drug repurposing.
• IBM will apply Watson’s natural language processing capabilities to unstructured health data
trying to find correlations between molecules and diseases.
21. 17
Strictly Confidential
New business models and cooperation in Digital Health (4)
▪ FDA teams with Flatiron for real-world cancer data analytics project (May 27, 2016)
• «Demonstrate the safety and efficacy of immunotherapies and other emerging anticancer drugs.
• Flatiron, an oncology analytics shop that has received funding from Google Ventures and Roche.
• Focus on the use of immunotherapies to treat advanced non-small cell lung cancer, an indication
in which Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda are approved.»
22. 18
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New business models and cooperation in Digital Health (5)
▪ Novartis Pharmaceutical collaborates with Qualcomm in digital innovation with the Breezhaler™
inhaler device to treat COPD (January 5, 2016)
• «The collaboration further supports Novartis' focus to empower patients making it easier for them
to manage their own chronic disease by having near real time access to their own data on
inhalation use.»
23. 19
Strictly Confidential
New business models and cooperation in Digital Health (6)
▪ AbbVie partners with Google's Calico on $1.5B R&D operation focused on aging (September 3,
2014)
• AbbVie Pharmaceuticals has followed up today with a plan to partner with Google's closely
watched biotech upstart Calico on a new research operation that will cost up to $1.5B to get
started.
24. 20
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New business models and cooperation in Digital Health (7)
▪ Data-gathering implantable chips to be tested in schizophrenia trial (November 13, 2015)
• Transformation of wearables into implantables
• Pierre Fabre tests a chip in an ongoing Phase II clinical trial of a schizophrenia drug in
development.
• The Swiss Federal Institute of Technology in Lausanne (EPFL): implantable biosensor chip to track
pH, temperature, blood glucose, while keeping tabs on the concentration of any drugs
administered to the individual.
25. 21
Strictly Confidential
▪ Stronger engagement of IT companies in Digital Health
▪ New business models and cooperation in Digital Health
• Cooperation with new players who directly connect R&D with payers and patients
▪ Enormous research budgets and stronger engagement of non-profit-organizations (NPOs) in
Digital Health
26. 22
Strictly Confidential
Enormous research budgets and stronger engagement of NPOs in Digital Health (1)
▪ France plans $745M investment to build 235,000-genome-a-year sequencing operation (June 27,
2016)
• The plan is to invest approximately $745M to build a network of sequencing and analysis centers
capable of processing the equivalent of 235,000 genomes a year by 2020.
• If successful, France will make genome sequencing part of routine healthcare for people with
rare diseases and patients with metastatic, refractory cancers. The expectation is that as of 2020
France will sequence 20,000 rare disease patients and their parents.
27. 23
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Enormous research budgets and stronger engagement of NPOs in Digital Health (2)
▪ Horizon 2020: IMI2, Big Data For Better Outcomes (December 2015)
• Provide a platform and resources for defining and developing enablers of the outcomes
transparency evolution together with patients, payers, physicians, regulators, academic
researchers, healthcare decision makers, etc. key enablers:
– Definition of outcome metrics, protocols, tools to access high quality data
– Methodologies and analytics to drive improvements
– Digital and other solutions that increase patient engagement
28. 24
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Enormous research budgets and stronger engagement of NPOs in Digital Health (3)
▪ Medizininformatik (November 16, 2015, BMBF and extension June 2017)
• Improve patient care and research via innovative IT Systems
• These IT systems should enable usage of data from healthcare, biomedical and clinical research
without considering locations and academic institutions.
• 1st deadline: March 31, 2016, Consortia formed and approved August 2016
29. 25
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Enormous research budgets and stronger engagement of NPOs in Digital Health (4)
▪ Health Policy: National Rural Health Mission in India
• A pilot program for 270 million school children to start a lifetime data collection, using mobile
tablets for data entry and could storage for all health data.
• Goals: determine the need for medical support, prevent epidemics, and provide analysis
capabilities to aid in the understanding of health trends across the population.
• Current figures: > 60,000 children enrolled
Source: Collaboration between Indian Ministry for Health and SAP. http://www.forbes.com/sites/sap/2014/04/10/health-in-rural-india-will-never-be-the-same.
30. 26
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Enormous research budgets and stronger engagement of NPOs in Digital Health (5)
▪ ASCO: Health Information Technology Platform: CancerLinQ
• «Big data is about to get bigger. CancerLinQ is assembling vast amouts of usable, searchable, real-
world cancer information into a powerful database. This national initiative was inspired and
informed by the cancer experts at ASCO, so it’s not merely an exercise in IT.»
Source: ASCO & SAP (May 30, 2015) http://cancerlinq.org/.
31. 27
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Challenges (1)
Source: Harvard Medical School, Partners Healthcare.
Data analysis not
in line with lab
analysis
Current manual methods
Automated and scalable
interpretation
Classification of gene
variants takes 20
minutes to 3 hours
0
1
10
100
1000
10000
100000
1000000
Variant Gene Panel Exome Genome
Necessaryworkinghoursfor
interpretationoftests
Type of testHorizon
33. 29
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Challenges (3)
▪ Insufficient and already outdated e-Health legislation in Germany
▪ Missing Transparency Directive for health insurance data and usage for R&D similar to Clinical
Trials Directive and other EU transparency guidelines
▪ Missing international, national and even regional harmonization concerning data security and
public acceptance
▪ Convergence of legal regulations for „Medical Records“ in the areas of „e- and Mobile Health“ as
well as new regulations for data exchange regarding „Medical Records“ in hospitals, etc. (for
example for research purposes / Biotech R&D)
34. 30
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Challenges (4)
▪ Monolithic data silos and information gaps between biotech, pharma, CROs, patients and
healthcare providers and payers
▪ Rising costs of interpretation of data versus wet lab costs and missing reimbursement
▪ Missing technical standards for efficient exchange of data among different industries
▪ Reglatory issues (see FDA) in terms of data veracity and data security
▪ Technical challenges of semantic Web 3.0
35. 31
Strictly Confidential
Challenges (5)
▪ Not enough well educated data scientists and executives to manage and implement Big Data
analytics at the intersections of IT, healthcare and life science
▪ Public perception and unpredictable user behavior concerning Quantified Self Movement and
data security
▪ Industry transformation in healthcare and life science from expert systems to customer oriented
solutions
36. 32
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Referentenentwurf des Bundesministeriums des Innern
Source: Kabinettsentwurf Januar 2017 (BMI).
Entwurf eines Gesetzes zur
Anpassung des
Datenschutzrechtes an die
Verordnung (EU) 2016/679
und zur Umsetzung der
Richtlinie (EU) 2016/680
(Datenschutz-Anpassung-
und Umsetzungsgesetz EU
DSAnpUG-EU)
A. PROBLEM UND ZIEL
Am 25. Mai 2018 wird die Verordnung (EU) 2016/679 des Europäischen Parlaments und des
Rates vom 27. April 2016 zum Schutz natürlicher Personen bei der Verarbeitung
personenbezogegen Daten, zum freien Datenverkehr und zur Aufhebung der Richtlinie 95/46/EG
(Datenschutz-Grundverordnung) (ABI. L 119 vom 4.5.2016, S.1) unmittelbar geltendes Recht in
allen Mitgliedstaaten der Europäischen Union sein. Ziel der Verordnung (EU) 2016/679 ist ein
gleichwertiges Schutzniveau für die Rechte und Freiheiten von natürlichen Personen bei der
Verarbeitung von Daten in allen Mitgliedstaaten (Erwägungsgrund 10). Der Unionsgesetzgeber
hat sich für die Handlungsformen einer Verordnung entschieden, damit innerhalb der Union ein
gleichmäßiges Datenschutzniveau für natürliche Personen gewährleistet ist (Erwägungsgrund
13). Die Verordnung (EU) 2016/679 sieht eie Reihe von Öffnungsklauseln für den nationalen
Gesetzgeber vor. Zugleich enthält die Verordnung (EU) 2016/679 konkrete, an die
Mitgliedstaaten gerichtete Regelungsaufträge. Daraus ergibt sich gesetzlicher Anpassungsbedarf
im nationalen Datenschutzrecht.
37. 33
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Questions for discussion
What will be the first▪ «Uber moment» in Digital Healthcare?
Will IT companies become the most innovative pharma companies or vice versa?▪
Will IT companies become the best health care insurance companies?▪
Which new▪ “convergent” business models and cooperation between pharma, healthcare and IT
are possible, in particular in Germany and Europe?
Who pays for what and who earns the▪ money?
Where▪ is the patient?
38. 34
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Summary
▪ New business models and cooperations among different industries, payers, patients and healthy
people are mandatory for success.
▪ A balanced individual/personalized access and public anonymized access to R&D, clinical data,
health records, social media, health insurance data and open architecture is the key to success.
▪ Big returns on Digital Health investments takes more time as „big“ success is linked to
development time lines of novel products/services in Life Science and Healthcare.
▪ Convergence of data protection and data security legislation are necessary.
▪ Veracity and validity of data in Digital Health applications and outdated data silos remain a
challenge.
39. 35
Strictly Confidential
USA
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31 RUE DE MONCEAU,
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TEL +33 (0)1 44 54 96 23
FAX +33 (0)1 44 54 90 20
PARIS@ALIRAHEALTH.COM
ITALY
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CORNAGGIA 10,
20123 MILAN, ITALY
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FAX +39 (02) 94 19 50 07
MILAN@ALIRAHEALTH.COM
GERMANY
KURFÜ̈RSTENSTRAßE 22,
80801 MUNICH, GERMANY
TEL +49 (89) 416 14 22-0
FAX +49 (89) 416 14 22-99
MUNICH@ALIRAHEALTH.COM
USA
SAN FRANCISCO
101 MONTGOMERY ST,
SUITE 2300, SAN FRANCISCO,
CA, 94104 USA
TEL +1 (774) 777 5255
SANFRANCISCO@ALIRAHEALTH.COM
THANK YOU VERY MUCH
FOR YOUR ATTENTION!
Dr. Martin Pöhlchen, Partner, Germany
martin.poehlchen@alirahealth.com
40. 37
Strictly Confidential
Digital Health Trends (Panel I discussion)
▪ Hypothesis 1: The barrier between healthy beings and patients will become obsolete.
▪ Hypothesis 2: From monitoring only to diagnosis, prevention and treatment
▪ Hypothesis 3: Personalized medicine and longitudinal studies become standard.
▪ Hypothesis 4: From “wellness” tracking to medical grade devices
▪ Hypothesis 5: From “classic” wearables to ingestible, transdermal and implantable
sensors/medical devices and combinations
41. Synchronizing HealthcareBerenberg Bank & Goldman Sachs
German Corporate Conference, Munich
Christian B. Teig, CFO
24 September, 2013
10th DVFA Life Science Conference 2017
The Telematics Infrastructure
The Coming eHealth Revolution in Germany
Christian B. Teig, CFO
Frankfurt
13th June, 2017
42. The coming secure communication arena in German healthcare
Source: gematik
10th DVFA Life Science Conference 201713/06/20172
43. The Telematics Infrastructure is based on the eGK
The purpose of the German “Electronic Health Card” (eGK) is to improve
the medical care of patients
The eGK shall ensure that all healthcare providers have immediate
access to all necessary medical information to deliver high quality and
cost efficient care
10th DVFA Life Science Conference 201713/06/20173
44. Gematik GmbH is behind the eGK / TI roll-out
Facts
Founded in January 2005
Owned by the 15 top organizations of the German health system (e.g.
Bundesärztekammer, DAV - Deutscher Apothekerverband, Deutsche
Krankenhausgesellschaft, GKV-Spitzenverband, KBV - Kassenärztliche
Bundesvereinigung)
Working closely with the Federal Ministry of Health
Tasks
Defining withing technical specifications for components, services and
applications to be used in the Telematics Infrastructure
Introduction, maintenance and enhancement of
eGK
electronic prescriptions
and additional applications
10th DVFA Life Science Conference 201713/06/20174
45. Realizing the Telematics Infrastructure has been a long process
2001
2003
Lipobay
scandal
2005
Introduction of eGK
by 1.1.2006 written
into German Law
EU tender
„bIT4health“
Foundation of
Gematik GmbH
GesKVO
„Plan B“
2006
North Rhine-
Westphalia eGK
pilot region
2009 2010
Rössler at
CeBIT: eGK is coming!
2012
Telematics
Infrastructure
tender process
10th DVFA Life Science Conference 201713/06/20175
46. The largest IT project ever in German healthcare
A total of 9 EU-wide tender processes have been completed:
Online Rollout Level 1 (ORS-1): Testing of the Telematics Infrastructure in 2 test regions, each
with 500 providers (doctors, dentists and hospitals). 3 contracts awarded through EU-wide
tenders:
LOS 1: Construction and operation of decentralized components and necessary infrastructure services;
testing in Region South-East (Award: T-Systems)
LOS 2: Construction and operation of decentralized components and necessary infrastructure services;
testing in Region North-West (Award: Booz/CGM/KoCo consortium)
LOS 3: Construction and operation of the central services and infrastructure surroundings for the
Telematics Infrastructure (Award: Arvato Systems)
G2 Cards: 5 contracts for a new generation of chip cards awarded through EU-wide tenders:
LOS 1 & 2: Card Operating System (COS) for all card systems: eGK, HBA, SMC-B, gSMC-K and gSMC-KT
(Awards: Giesecke & Devrient, T-Systems)
LOS 3 & 4: Production of all relevant cards to be used in the ORS-1 test regions: eGK, HBA, SMC-B, gSMC-
K and gSMC-KT (Awards: Bundesdruckerei, T-Systems)
LOS 5: PKI infrastructure and associated services for Card Verifiable Certificates (Award: Atos)
Scientific evaluation: 1 contract awarded through EU-wide tender for scientific evaluation of
the two ORS-1 test regions (Award: Friedrich-Alexander-Universität)
10th DVFA Life Science Conference 201713/06/20176
47. Tender process for 2 pilot regions (ORS-1)
December 11
Gematik reaches a
new decision to
test the Telematics
Infrastructure
May 12
Bidder Contest
October 12
Confirmation of five
qualified vendors
for the final offering
November 12
Publication of
specifications and
request for final
offers
Tender process
10th DVFA Life Science Conference 201713/06/20177
48. Two contracts were awarded in December 2013
November 13
Deadline for final
offers
December 13
Acceptance of
tender for two
partnerships
2014/2015
Test of the
Telematics
Infrastructure and
Evaluation
2016 (est)
Start of the rollout
of the Telematics
Infrastructure
Tender process
Winners announced 3 December 2013:
Region North-West1: Booz / CGM / KoCo consortium
Region South-East2: T-Systems
1: Schleswig-Holstein, Nordrhein-Westfalen, Rheinland-Pfalz
2: Sachsen, Bayern
10th DVFA Life Science Conference 201713/06/20178
49. Project scope of ORS-1
Construction and operation of decentralized components and necessary infrastructure
services:
Phase 1: Insured Master Data Management (VSDM)
Phase 2:
Qualified Electronic Signature (QES)
Secure communication between healthcare providers (KOM-LE)
Tasks
Planning and conception
Recruit providers to participate in the pilots: Doctors (375), Dentists (125), Hospitals (5)
Build a central VPN-access service and ensure its operations
Develop, test and certify the necessary decentralized components (Konnektor (1x), Card
terminals (10x ))
Update and integrate existing doctor, dental and hospital software applications with the
Telematics Infrastructure (13x)
Rollout, service und support of the decentralized components for about 3 years
10th DVFA Life Science Conference 201713/06/20179
50. The most important parties/products
10th DVFA Life Science Conference 201713/06/201710
51. The full scale pilot in the Northwest region
was launched in December 2016.
All test installations have been
successfully connected, more than 550,000
tests of the insured master data (VSDM) have
been successfully carried out and information
on more than 125,000 electronic health cards
have been updated in real time.
As a result, CGM has exceeded the project target of half a million online card tests
more than two months before the end of the trial period.
The installations and pilot operation are running without any material problems.
Based on the successful results, gematik declared last week the Telematics
Infrastructure to begin live operation 1 July 2017
Despite many delays and revised planning scenarios, the goal is still to have the
nation-wide roll-out completed by 1 July 2018 as required by the eHealth law
Current status
11 13/06/2017 10th DVFA Life Science Conference 2017
52. Parallel to the gematik project, the German federal Ministry of Health began in
2014 the preparation of a new bill – “The eHealth Law” (Gesetzes für sichere
digitale Kommunikation und Anwendungen im Gesundheitswesen)
With clear majority, the bill was approved in the Bundestag on December 3rd
2015 and the new law became effective January 1st 2016
The eHealth law contains clear
deadlines and financial
incentives/penalties to ensure
the timely roll-out of the
Telematics Infrastructure in
healthcare all over Germany
in the 2016-2018 timeframe
The German eHealth Law
10th DVFA Life Science Conference 201713/06/201712
53. Rollout timeline in the eHealth law
1.1.2016
30.06.2016
The Law
comes into
force
1.1.2018
* If the deadline is not met, from 2017 on the expenditure in the budgets of the GKV SpiBu and the KBV must not
exceed the expenditure of 2014 minus 1% each year until the action is performed
(1% = app. 100 mio €)
All pre-conditions for
roll-out of VSDM must
be in place*
Nation-wide roll-out of the
Telematik Infrastructure has to
be completed*
1.7.2018
Doctors’ compensation will be reduced by flat
rate of 1% if they are not using VSDM.
10th DVFA Life Science Conference 201713/06/201713
54. VSDM (eligibility check and update of insurance data) is the core service of the Telematics
Infrastructure.
Emergency Data Set (blood type, chronic diseases, allergies etc.) stored on the electronic
health card. Service must be available beginning 2018. Doctors who create and maintain such
datasets on behalf of patients will be compensated (no amount given)
Medication plan (for patients with more than 3 current prescriptions). Service must be
available from October 2016 in paper form and then in the ‘medium term’ (Mittelfristig) be
available over the electronic health card.
Electronic letters (Medical reports, referrals and discharge letters between ambulatory
doctors and hospitals). Doctors get an incentive of 55 cents per medical report sent
electronically and 50 cents per discharge letter received electronically in 2016 and 2017.
Hospitals get 1 Euro per discharge letter sent electronically from 1 July 2016. From 2018, the
incentives for electronic letters will only be paid if the transmission is done over the
telematics infrastructure (no amount given).
Telemedicine. Electronically transmitted radiology reports will be compensated beginning
1 April 2017 (no amount given). The regions also has the mandate to consider additional paid
telemedicine services.
Services prescribed in the eHealth law
10th DVFA Life Science Conference 201713/06/201714
58. Data center B
13/06/2017 10th DVFA Life Science Conference 201718
The Danish Health Data Network (SDN) and VANS network
User User User User User User User User
Secured connections between secured local
networks
Datacenters owned by MedCom,
operations outsourced by EU tender
(currently Netdesign A/S)
MPLS
Internet
VPN
Fixed lines
Secure messaging (EDI) via
private VANS operators KMD or
Highjump
Data center A
KMD HighJump
59. Evolution of services in the network
19
2001
2003
The “Good EDI
letter” defined
by MedCom
2005
Sundhed.dk – the
Danish eHealth
portal
Citizens’ access to
their own
prescriptions
EDI becomes XML
‚e-journal‘ -wider
access to journal
data for citizens
2007
Telemedicine is
deployed nationwide
2009
2011 2014
Shared
Medication
Record (FMK)
New standards
HL7 - IHE
13/06/2017 10th DVFA Life Science Conference 2017
60. 13/06/2017 10th DVFA Life Science Conference 201720
Evolution of GP electronic communication
0,0
0,2
0,4
0,6
0,8
1,0
1,2
1,4
1,6
1,8
92 93 94 95 96 97 98 99 20 01 02 03 04 05 06 07 08 09 10 11 12
E-Prescriptions = 90 %
Disch Letters = 100 %
Lab reports = 100 %
Lab test Orders = 100 %
E-Referrals = 95 %
MedCom Messages / Month (in million)
+6000 doctors, pharmacies, municipalities and hospitals
65 IT vendors
6 milllion messages/month
15% growth/year
70-90% of all documents
Source: MedCom
61. 13/06/2017 10th DVFA Life Science Conference 201721
Denmark’s e-Health portal introduced in 2003
Online Electronic Health Record
from hospitals
Cross-sectorial personal electronic
medicine profile
Overview of personal medical
history since 1977 (list of contacts
with hospitals)
Overview of contact with primary
sector clinics since 2003
Online organ donor registration
’My log’ (lets the patient see which
health professionals have accessed
their personal data)
62. 13/06/2017 10th DVFA Life Science Conference 201722
FMK – Shared medication data base from 2014
63. 13/06/2017 10th DVFA Life Science Conference 201723
Norsk Helsenett (Norwegian Health Network)
Rolled out nationwide in 2006-2007 to all doctors and hospitals
Transformed to a state-owned enterprise in 2009, owned by the Ministry of health and care
services
Runs as a government monopoly with approximately 150 employees
Backbone network, operations, support and consultancy services are mostly subcontracted
through EU tenders
In addition to all healthcare providers, the network is also open to about 100 connected,
third-party service providers (hereunder CGM)
All activity is governed by the «Code of Conduct for information security in the healthcare,
care, and social services sector»
64. 13/06/2017 10th DVFA Life Science Conference 201724
Sjunet (Swedish Health Network)
Since 1998 the Sjunet
application has been
connected to virtually all
Swedish hospitals and
Primary Care Centres
Sjunet is offered by Inera AB
Inera is a common service
provider for county councils
in Sweden
3 ways to connect to Sjunet:
Dedicated fixed line from
Inera
3rd party local network
connected to Sjunet
IPSEC-encrypted VPN-
connection via Internet
65. Austria and Germany have similar eHealth strategies
25
Political discussions from 2003
ELGA GmbH
e-card
GesundheitsInformationsNetz
GINA-Box
eHealth law 2012
E-Medikation
….etc…..
13/10/2017 10th DVFA Life Science Conference 2017
Political discussions from 2001
gematik GmbH
eGK
Telematik Infrastruktur
Konnektor
eHealth law 2015
Medikationsplan mittels eGK
….etc….
66. 13/06/2017 10th DVFA Life Science Conference 201726
Where we stand
Germany is late w.r.t. eHealth
So is Austria
More pragmatic technology and security solutions have enabled the healthcare
economies in Scandinavia to become networked 10-20 years ago
However, many issues related to identification, authentication and authorization
remain unresolved in these early countries
Based on the eGK and Telematics infrastructure, Germany now has an excellent
opportunity to leapfrog to the forefront of eHealth
The next 3 years will see a late but powerful eHealth revolution in Germany
There is reason to be optimistic!
67. 10th DVFA Life Science Conference 2017
Thank you for your attention!
CompuGroup Medical SE
Investor Relations
Maria Trost 21
56070 Koblenz
www.cgm.com
Phone: +49 (0) 261 8000-6200
Email: investor@cgm.com
13/06/201727
69. Page 2
D i s c l a i m e r
This confidential document and the information contained in this document (the “Presentation”) constitutes neither an offer for sale or subscription nor a
solicitation of a purchase or subscription order for Cellnovo shares in any country. No offer of shares is made, or will be made in France, before obtaining a
visa from the Autorité des Marchés Financiers (the “AMF”) on a prospectus comprising a registration statement (document de base) and securities note
(note d’opération) that will be submitted to the AMF.
In particular, this Presentation does not constitute an offer for sale of securities or any solicitation of a purchase or subscription order for securities in the
United States or by U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act of 1933, as amended (the “Securities Act”).
Cellnovo shares may be only offered or sold in the United States pursuant to an effective registration statement under the Securities Act or under an
exemption from the registration requirement of the Securities Act. Cellnovo shares have not been and will not be registered under the Securities Act, and
Cellnovo has no intention of making any public offering of its shares in the United States.
This Presentation does not constitute a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and of the Council of
November 4, 2003, as amended, in particular by Directive 2010/73/EC of the European Parliament and of the Council of November 24, 2010 (the
“Prospectus Directive”). Its dissemination may be governed by specific regulations in certain countries. Persons in possession of this Presentation should
therefore acquaint themselves and comply with any local restrictions.
No action has been taken or will be taken for the purpose of enabling a public offering of securities requiring the publication by Cellnovo of a prospectus in
a Member State other than France. Consequently, the Cellnovo shares may not and will not be offered in any Member State other than France, except in
accordance with the exceptions set forth in Article 3.2 of the Prospectus Directive or in other cases not requiring publication by the Company of a
prospectus pursuant to Article 3.2 of the Prospectus Directive or other applicable regulations in that Member State.
Regarding the United Kingdom, this Presentation has not been approved by an authorised person in accordance with Section 21 of the Financial Services
and Markets Act 2000 and therefore it is intended to be delivered solely and for information purposes only to persons who (i) are investment professionals
within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as currently in effect, hereinafter the
“Financial Promotion Order”), (ii) are referred to at Article 49(2) (a) to (d) (“high net worth companies, unincorporated associations, etc.”) of the Financial
Promotion Order, (iii) are outside the United Kingdom, or (iv) are persons to whom an Presentation or incitement to engage in investment activities (within
the meaning of section 21 of the Financial Services and Markets Act 2000) in the context of the issuance or disposal of securities may legally be extended,
directly or indirectly (all such persons being collectively named “Authorised Persons”). This Presentation may not be used by any person who is not an
Authorised Person. By accepting this Presentation and not immediately returning it, the recipient represents and warrants that they are a person who falls
within the above description of persons entitled to receive the Presentation.
70. Page 3
A M a n a g e m e n t Te a m W i t h A S u c c e s s f u l Tr a c k R e c o r d
Dr. Sophie Baratte
CEO
l 20 years experience in Sales & Marketing functions in the medical technology sector, including Sorin Group
l Served as CEO of CIT, General Manager for the In Vitro Diagnostics branch of Johnson and Johnson in France
and senior EMEA Sales & Marketing Director for Lifecell
Engineer, PhD in biotechnology and MBA
Erwan Martin
CFO
l 20 years experience in finance and in biotechnologies
l Former CFO of Genomic Vision, co-founded Cytomics Pharmaceuticals, served as project manager at Syndex
Julian Shapley
CSO, Founder
l NASA experience
l Founder of Cellnovo since 2008
MBA at Warwick Business School
Ph.D. in micro-fluidics at Cardiff University
John Brooks
Chairman
l Serverd as CEO and Founder of Insulet
l and as CEO of Joslyn Diabetes center
l Over 30 years of experience in the medical device industry in diabetes
Javaid Masoud
CTO
l Served at Medtronic and at Sorin Group in Senior director roles, for wireless technologies, embedded firmware
development for implantable cardiac defibrillators, wireless communication protocol, embedded firmware for
implantable devices, and software for external instruments
71. Page 4
C e l l n o v o i n a N u t s h e l l
• Cellnovo develops and commercialises a disruptive Insulin Micro-pump
• A $2.5Bn market: growing and well reimbursed
Focused on Type 1 diabetes with potential for larger Type 2 market
• Addressing clear market needs
The only real time data device, for better patients outcome
• Unique Accuracy and Safety features
• A clearly defined global strategy supported by strategic partners
- Roche: contract for Blood Glucose Measurement
- Flex: manufacturing partner
- Air Liquide: major distribution partner
• Road map towards Artificial Pancreas and smartphone
• IPO on Euronext Paris on July 2015: €32.4m raised to date
• Private placement of €5.4m achieved in Q3 2016
The First Connected All-in-one Diabetes Management System
1. North America+ Main European countries, Medtronics, Investor Conference, June 2014
72. Page 5
• Informing payers of compliance to
treatment
• Lower pricing than other Wearable
pumps
C e l l n o v o , a b r e a k t h r o u g h i n I n s u l i n D e l i v e r y, f o r a l l s t a k e h o l d e r s
Driving Efficiency
and Better Outcomes
Driving Savings
• The ultimate wearable pump
• Requested by patients
• E- connected for family’s peace of
mind
• Real time information to drive
Better Patients Outcomes
• The un-equalled accuracy and safety
of drug delivery in micro-pumps
Cost Effective Patients support
• Effective patients’ communication and trouble shooting,
based on Real time back-end data
Freedom and peace of mind
The only E-connected, Accurate, Wearable insulin pump
73. Page 6
A S t r o n g U p c o m i n g N e w s F l o w
20182017
Flex industrialize
Cellnovo insulin
cartridges
Q2 Q3 Q4
Commercial
agreements
with AP Type
Zero
Diabeloop
enters CE
marking clinical
trial
New
distribution
partners
New Blue Tooth
Android System
510K
clearance
Artificial
Pancreas filling
of CE marking
First sales in
the US
CE marking of
“Smartphone”
Connection of
Blue Tooth BGM
Type Zero
studies in the US
and in EU
Artificial Pancreas
commercialization in
the EU
Cellnovo completely
outsources
manufacturing
Connection of
CGM
New food
library
✔
✔ ✔
All the fundamentals
in place Huge growth and introduction of more breakthrough technologies
Production
Product
Development
Commercialization
Artificial
Pancreas
Timeline
75. Page 8
Ty p e 1 : A l a r g e m a r k e t , w e l c o m i n g i n n o v a t i o n
T1 Patient Market* MDI Tubed Pump Micro Pump
US % Patient Use 70% 25% 5%
EU % Patient Use 85% 12% 3%
Market Size $2 B $400 M
Growth Rate <5% 40%
Market Players
Pumps are providing short and long term benefits to patients, despite low penetration
* company estimates
76. Page 9
E a s y t o A c c e s s w i t h F a v o u r a b l e R e i m b u r s e m e n t
Cellnovo micro-pump has access to public funding across many geographies
Market Durables 3 Day disposables
USA $4,500 $15
UK £2,750 £11.30
France €2,340 €16.65
Italy €4,800 €18
Germany €2,800 €12
1. Source : Company
Simple market access based on Existing codes
• Market access provided by CE marking
o Already CE marked
• Market access provided by 510K Clearance
o Expected end of 2017
• Reimbursement using traditional pumps codes
o Established codes in each countries
o Describing a durable pump and a consumable
part
• Reimbursement using CPT code 1
Tube pumps’ prices
78. Page 11
C e l l n o v o : A G a m e C h a n g e r f o r I n s u l i n P u m p Te c h n o l o g y
The perfect combination between a new generation of patch pump and a mobile handset
to allow the best accuracy and a 24/7 health remote monitoring
Intuitive operation, wireless Internet connectivity and real-time tracking
= all industry firsts
• The insulin reservoir
• Pumping mechanism
• Occlusion sensor
• High resolution, full colour touch screen
• GSM Modem
• Micro SD port
• Apps friendly
• Roche BG Meter integrated
• Bolus calculator
• Real-time data
• Automated capture of data
and transmission
• Analytics and trends
• Stakeholders access• Pump microprocessors and
memory
• Rechargeable battery
• Accelerometer
• Precision reservoir sensor
Insulin Cartridge
Mobile
Handset
Online
Wireless
DurablesDisposables
79. Page 12
C e l l n o v o B e n e f i t s c o m p a r e s p o s i t i v e l y t o t h e o t h e r m i c r o - p u m p s
for Additional
Comfort
Better Outcome
and Peace of Mind
Better COGS
and Eco-friendly Device
High Quality of
Treatment
A Key Feature for All
Intuitive Usage
E-Health in real time
Higher Accuracy of
delivery
Disposable plastics
Detachable
Enhanced Safety
Touch Screen Color
Handset
80. Page 13
C e l l n o v o , t h e d a t a s o l u t i o n f o r b e t t e r o u t c o m e
CLINIC &
CLINICIANS
PATIENTS’
FAMILIES PAYER
Reducing pressure
on National Health
Systems’ resources
Peace of Mind with no
intrusion in patients’ life
with apps and portal
access
• Informs and Guides the
patients
• Informs the family
• Generates bespoke
alarms on Family’
Smartphones
Increasing Efficiency and
Generating better
outcomes
• Prioritization of treatments
• Cost reduction
• Productivity
• Reactivity
• Cost reduction
• Care improvement
• Reduction of
complications
• m-health: modernized
healthcare system
AND PARTNERS
• Informed trouble shooting calls
• Easy logistics
81. Page 14
C e l l n o v o s y s t e m i s m o s t a c c u r a t e p a t c h p u m p i n d r u g d e l i v e r y
Not all micro-pumps are equal
Cellnovo: 2 part pumping system
-100,0%
-50,0%
0,0%
50,0%
100,0%
0 50 100 150 200
Flow rate error
Observation duration (minutes)
Omnipod
Percentage error vs. observation window (Time based).
-100,0%
-80,0%
-60,0%
-40,0%
-20,0%
0,0%
20,0%
40,0%
60,0%
80,0%
100,0%
0 50 100 150 200
Flow rate error
Observation duration (minutes)
Cellnovo
Percentage error vs. observation window (Time based).
Cardiff University, UK- Jenna L Bowen and Chris J Allender - Trumpet curves for a typical Cellnovo and OmniPod™ patch pump device showing the maximum positive and maximum negative flow rate
error (green solid lines) and the average flow rate error (red dotted line) for 2, 5, 11, 19 and 31 pulses.
o Accuracy of the Wax-powered
pumping mechanism
o Superiority of durable electronics
and Drop-by-drop alterations
control system
A difference explained by the design
Traditional patch pump: fully disposable, all in
one system
o Low cost, low
sophistication electronics
o Flat rate pumping
mechanism
82. Page 15
A c c u r a c y, t h e r e s u l t o f a u n i q u e m e c h a n i s m o f d e l i v e r y
The core technology: the paraffin wax Micro-actuator
The expansion of
heated paraffin wax
serves as mechanism
to push a piston
against a membrane,
thereby creating a
pumping mechanism
OCCLUSION
VALVE
INLET
VALVE
OUTLET
VALVE
PUMPING
CHAMBER GEARING
PISTON
DIODE WAX
Cool Wax Heated Wax
After
melting
+15%
Volumetric
Expansion
(%)
Solid phase Liquid phase
IP protected until 2035
Wax Micro Actuator
Displacement
Sensor
Micro- Valve
Cyber security
83. Page 16
S a f e t y s y s t e m s o n b o a r d
Product Time to Occlusion Alarm Missed Insulin (U)
Cellnovo 24.12 2.02
Omnipod Gen2 41.35 3.46
Medtronic 57.49 4.82
Animas Vibe 44.09 3.68
Roche Spirit Combo 28.47 2.39
Best in class in case of occlusion
Intelligent Delivery SystemDelivery Sensor
Automatic release mechanism
Temperature risk alarm
Insulin delivery alarms
72-hour Expiry alarm
Encryption
The pump’s electronics, to bring safety to a new level
85. Page 18
C o n s u m a b l e : l a r g e s c a l e p r o d u c t i o n w i t h F l e x
• High volume automation and
manufacture
• Stacked basic components,
suitable for high cavity moulding
Flextronics’ Mass productionCellnovo’s Limited production
NowUntil Q2 2017
IC capacity Per production line
Capacity pa 650,000
IC capacity 2015
Capacity pa 50,000
From Cellnovo’s R&D workshop
To flex Austria in Q2 2017
Followed by producing in a low labor cost country in Q1 2018.
Design to cost to further optimize COGS1 2 3 4
1
2
3
4
Increasing volumes of consumable parts
Reducing COGS
86. Page 19
D u r a b l e e l e m e n t s : a s i m p l e p r o d u c t i o n r o a d m a p
The mid-term manufacturing strategy favors Outsourcing
Cellnovo to remain lean with low Overheads
Relatively low production volumes are required: each patient needs 2 pumps and 1 handset
The manufacturing roadmap will aim at decreasing COGS by 2 folds by mid 2018
2018 :
Replaced by a smartphone tablet
2017-mid 2018:
Assembled by Cellnovo
Production strategy
2017:
Assembled by Cellnovo
• PCB made by Sony
The Micro-Pump
The Handset
Mid-2018:
outsourced
*
* Picture non-contractual• PCB made by Sony
88. Page 21
C e l l n o v o ’ s c o m m e r c i a l r o a d m a p
A network with direct sales forces and experienced distributors
Objective 2020 horizon: 45,000 patients
2014
System introduction through proprietary sales force
in the UK and France
2016
Expansion into other major European countries using
specialized distributors : Netherlands, Italy
2017
Expansion into Spain, Ireland, Greece, Israel, ..
2016
510k submission
2017
Launch in the US
Launch in Canada
First countries in L.A.
2017
Launch in Australia/NZ
Launch in Hong Kong
2018
Launch in India
2019/2020
Launch in China
Europe USA China/Asia
Direct Distribution (UK, France)
Air Liquide Santé network: Benelux, Italy
Expansion to new European countries
89. Page 22
C e l l n o v o U S S t r a t e g y
Targeted launch
Q4 2017 – Q2 2018
• Targeting main KOL
• Regional complementarity
• Payers complementarity
Objective: demonstrate the business case
Patients’ preference / Payers’ acceptance / E-health benefits
• Light structure to guarantee
o Leadership
o Sales
o Training
o Marketing
o H&E
US National launch
Q3 2018
• Through an established partner
Benefits
Price
Cellnovo will reinforce the distributor effort by putting in place its own organization
5 Main Cities Cellnovo Structure Pricing Strategy
2 to 3 Distributors
91. Page 24
C e l l n o v o , t h e s y s t e m o f c h o i c e f o r A r t i f i c i a l P a n c r e a s
• US Well proven program, with 215,501 hours of
clinical trial
• Data on 30 patients “80% of hours on target”
• CE marking early 2018, followed by EU launch
• “Natural” EU partner
o Commercial contract pending
• WW commercial license agreed
• Integration of the product on-going
• Clinical studies in discussion
• Best placed US partner
All projects with Dexcom G5
• French atomic center mathematicians and 12 major
teaching hospitals in France
CONTINUOUS
GLUCOSE
SENSOR
CONTROL
ALGORITHM
• Automatic adjustments of the
insulin delivery
• Based on expert Software and
Continuous Blood Glucose reading
• Un-Equaled Quality of Life
• Less Deadly Complications
The potential to be N1 Artificial Pancreas using a
Micro pump
Artificial Pancreas, the next break through in Diabetes management
Cellnovo ‘s partners Commercial strategy
92. Page 25
C o m p a r i s o n Ty p e Z e r o / M e d t r o n i c
• Founded in 2005, spin-off from UVA
• In clinical trials since 2011
• The most published Artificial Pancreas
SW
• Well financed by the NIH
• CGM: G5 Dexcom
Type Zero, a Strong partner
TypeZero
inControl
Medtronic PID-IFB
Paper
Ly, Buckingham et al
Diabetes Care, 2016
Ly, Buckingham et al
DT&T, 2016
Control
24/7 – 85 days and
nights
Overnight only – 55
nights
Average BG
Overnight
128 mg/dl 132 mg/dl
Overnight
time within
70-180 mg/dl
90.3% 79.9%
Overnight
time within
70-150 mg/dl
76% 66.4%
Overnight
time below
70 mg/dl
1.4% 5.4%
24/7 time
within 70-
180 mg/dl
78.6% n/a
24/7 time
below 70
mg/dl
1.8% n/a
94. Page 27
K e y F i n a n c i a l s o f t h e G r o u p - S a l e s
• 667 systems shipped in total since launch with 38 new systems in Q1 2017
• Production Capacity of Insulin Cartridges constrained at 50,000 per year before the transfer to Flex
• On April 2017, Flex has completed the first commercial batch of consumables for its diabetes management system.
Annual Quarterly – 3 months
2016 2015 Q1 2017 Q1 2016
Sales (in
Euros)
1,416,744 608,125 185,592 435,209
At full capacity, the Flex’s production line is able to produce 600,000 insulin cartridges per year.
• A cash position of €5,8 million at March 31, 2017
• Cellnovo is in the final stage of securing a Loan facilities with a first draw down of at least €5M.
Strong 2016 sales growth / Sales constrained in Q1 2017 by limited production capacity
95. Page 28
K e y F i n a n c i a l s o f t h e G r o u p – P & L
Simplified P&L in K€ – IFRS FY2016 FY2015
Revenues
Sales 1,419 609
Operating expenses
o/w Costs of production (6,647) (5,845)
o/w Research and Development (2,366) (3,244)
o/w Sales & Marketing (2,545 (1,557)
o/w General & Administration (4,476) (5,135)
Total Operating Expenses (16,034) (15,781)
Other operating income and expenses 2 551
Operating profit / (loss) (14,614) (14,622)
Financial result (559) (969)
Income tax 625 1,126
Net profit/(loss) (14,549) (14,464)
96. Page 29
C e l l n o v o o n t h e m a r k e t
Shareholding structure as of September 30th 2016
Financial calendar
• Market listed on Euronext (Euronext Paris)
• Share price: €5,3 (April 30th, 2017)
• Number of shares: 12,070,597 (March 31th
, 2017)
• Market Cap: €64 million (April 30th
, 2017)
Stock market information
Events Date
2016 FY sales Tuesday January 31, 2017
2016 FY results and 2017 Q1 sales Wednesday April 26, 2017
2017 H1 sales Tuesday July 25, 2017
2017 H1 results Wednesday September 27, 2017
2017 Q3 sales Tuesday October 31, 2017
Board of Directors
• John Brooks, Chairman
• Sophie Baratte, CEO
• Julie Drapier, Aliad
• Marie Landel, Independent
• Sofia Loannidou, censor, Edmond de Rothchild I.P.
• Raj Parekh, Advent Venture Partners
• Holger Reithinger, Forbion Capital Partners
• Rémi Soula, Independent
• Raphael Wisniewski, Edmond de Rothchild I.P.
Forbion
14,5%
EDRIP
14,3%
Healthcare
Ventures
9,4%
Advent
International
9,4%
NBGI
5,5%
Omnes Capital
4,1%
Air Liquide
Investissement
3,5%
Autres
39,4%
Others
98. Page 31
C e l l n o v o ’ s K e y S e l l i n g P o i n t s
Completed
since the IPO
✔
✔
✔
✔
Breakthrough technology on a high growth market
Cost advantages over current wearable pumps
Real time data for Patients and HCP benefits
US market entry by end 2017
Patients superior comfort of use
First Artificial pancreas on the market early 2018
Set for large scale commercialisation
99. Increased data protection and data security requirements
under the new EU Data Protection Regulation
13 June 2017
Dr. Lothar Ende
Dr. Lutz M. Keppeler
DVFA Life Science Conference 2017
100. • Heuking Kühn Lüer Wojtek •
Overview on data flows – simple case of a consumer device
13.06.2017 DVFA Life Science Conference 2017 2
Icon made by Freepik from www.flaticon.com
Wearables
Smartphone/App of
a user (medical
device?)
Provider of Operating
System/Smartphone
Cloud
Cloud Provider
ABC Ltd.
XYZ Inc.
Health
insurance
Hospital
101. • Heuking Kühn Lüer Wojtek •
Overview on data flows – simple case of a professional medical device
13.06.2017 DVFA Life Science Conference 2017 3
Icons made by Freepik from www.flaticon.com
Cloud Provider? Own Servers?
Health
insurance
External
Physician
Provider of Medical Device?
102. • Heuking Kühn Lüer Wojtek •
General Requirements under the GDPR
13.06.2017 DVFA Life Science Conference 2017 4
Duty to examine the lawfulness of processing of personal data according to Articles 6 and 9
GDPR (Every act of data processing must be based on a Section which allows it)
Compliance with the provisions for declarations of consent according to Articles 7 and 8
GDPR
Transparent information of customers on the data processing (with respect to customers and
employees) according to Articles 13,14 GDPR
Duty to delete data, the storage of which is no longer admissible (Art. 17 GDPR)
Duty to make data provided by customers/employees available– in a conventional format – to
the customer/employee upon request (right to data portability) according to Art. 20 GDPR
103. • Heuking Kühn Lüer Wojtek •
General Requirements under the GDPR
13.06.2017 DVFA Life Science Conference 2017 5
Compliance with the provisions on data protection by design and data protection by default
Art. 25 GDPR
Obligation regarding data protection measures according to the state of the art (Art. 32 GDPR
- “data security by design”)
Reports of data outflows after an IT security incident according to Art. 33 GDPR
Compliance with the provisions in the case of the outsourcing of a data processing to a service
provider and other processors according to Art. 28 GDPR, including the provisions on the
transmission of data outside the EU or to subsidiary/sister companies)
104. • Heuking Kühn Lüer Wojtek •
Special rules on health-related data
13.06.2017 DVFA Life Science Conference 2017 6
Special acts are applicable, particularly for health-related data:
Law on medical products (Medizinproduktegesetz – Sec. 2 para. 4)
Art. 9 paras. 1, 2 (a) GDPR (specific higher requirements for declarations of consent on
health-related data)
Special requirements on personal data of clinical studies (Sec. 40 para. (1) No. 3 c)
German Drug Law - Arzneimittelgesetz)
Special data protection requirements in the public healthcare sector (Social Code -
Sozialgesetzbuch V and X)
Wide interpretation of the term “health-related data”
Disclosure of health-related data by physician or by dentist, veterinarian, pharmacist is
considered as crime (imprisonment not exceeding one year or a fine) (Sec. 203 German
Criminal Code - Strafgesetzbuch)
105. • Heuking Kühn Lüer Wojtek •
New dimension of administrative fines
13.06.2017 DVFA Life Science Conference 2017 7
Currently only a maximum fine of EUR 300,000 can be imposed
Fines in the amount of up to EUR 10/20 million or 2/4% of the worldwide annual turnover
Adequate to threaten international IT-Corporations / Dangerous for medium size companies
Software/Medical devices are often not designed to comply with data protection requirements
106. • Heuking Kühn Lüer Wojtek •
Basic concepts of data protection law according to the GDPR
13.06.2017 DVFA Life Science Conference 2017 8
The definition of „Personal data“ is defined extremely broad
even dynamic IP-addresses must be considered as personal data
Definition of „data processing“ is extremely broad
Each controller must for each step of data processing comply with all before mentioned
requirements
Joint controllership is possible (necessity to define who fulfils which requirement)
107. • Heuking Kühn Lüer Wojtek •
Compliance Obligation
13.06.2017 DVFA Life Science Conference 2017 9
(…) the controller shall implement appropriate technical and organisational measures to
ensure and to be able to demonstrate that processing is performed in accordance with this
Regulation. Those measures shall be reviewed and updated where necessary (Art. 24 GDPR)
Each controller and, where applicable, the controller's representative, shall maintain a record
of processing activities under its responsibility (Art. 30 GDPR)
Where a type of processing (…) likely to result in a high risk (…) the controller shall, prior
to the processing, carry out an assessment of the impact of the envisaged processing
operations on the protection of personal data (Art. 35 GDPR)
= High documentation obligations and, as a result, a reversal of the burden of proof
108. • Heuking Kühn Lüer Wojtek •
IT-Security
… the controller and the processor shall implement appropriate technical and organizational
measures to ensure a level of security appropriate to the risk (Art. 32 GDPR – data
security by design)
Medical devices will have to be designed in a way that allow the processor to establish and
maintain necessary IT-security level if not – defect, product liability
What is appropriate?
(…) taking into account the state of the art, the costs of implementation and the nature,
scope, context and purposes of processing (…)
Not defined by case law
− Recommendation: Usage of recognized standards, such as ISO 2700x; BSI-
Grundschutz-Kataloge; „Standard-Datenschutz-Model („SDM“)
− Usually three steps: Risk analysis; Choice of adequate measures; Implementation
Conclusion: Be pragmatic but document and explain why
13.06.2017 DVFA Life Science Conference 2017 10
109. • Heuking Kühn Lüer Wojtek •
Obligations to notify data breach
GDRP: In the case of an IT security incident, an obligation to "promptly" notify the responsible
data protection authority (Art. 33 GDPR) and a message towards each affected data subject
(Art. 34 GDPR) is required
German IT-Security Law: Notification to the Federal Office for Information Security; only
applicable on „provider of critical infrastructure” (like cloud service provider; hospitals)
Parallel to this, ad-hoc publicity for listed companies
Consequence: definition of the reporting process,
Verification of the necessity to report
Coordination of various departments (including public relations) and various undertakings
13.06.2017 DVFA Life Science Conference 2017 11
110. • Heuking Kühn Lüer Wojtek •
Berlin
Kurfürstendamm 32
10719 Berlin/Germany
T +49 30 88 00 97-0
F +49 30 88 00 97-99
Chemnitz
Weststrasse 16
09112 Chemnitz/Germany
T +49 371 38 203-0
F +49 371 38 203-100
Düsseldorf
Georg-Glock-Straße 4
40474 Düsseldorf/Germany
T +49 211 600 55-00
F +49 211 600 55-050
Frankfurt
Goetheplatz 5-7
60313 Frankfurt a. M./Germany
T +49 69 975 61-0
F +49 69 975 61-200
Hamburg
Neuer Wall 63
20354 Hamburg/Germany
T +49 40 35 52 80-0
F +49 40 35 52 80-80
Cologne
Magnusstrasse 13
50672 Cologne/Germany
T +49 221 20 52-0
F +49 221 20 52-1
Munich
Prinzregentenstrasse 48
80538 Munich/Germany
T +49 89 540 31-0
F +49 89 540 31-540
Stuttgart
Augustenstrasse 1
70178 Stuttgart/Germany
T +49 711 22 04 579-0
F +49 711 22 04 579-44
Brussels
Rue Froissart 95
1040 Brussels/Belgium
T +32 2 646 20-00
F +32 2 646 20-40
Zurich
Bahnhofstrasse 3
8001 Zurich/Switzerland
T +41 44 200 71-00
F +41 44 200 71-01
www.heuking.de
13.06.2017 DVFA Life Science Conference 2017 12
Thank you very much for your attention!
111. 1
DIGITAL HEALTH TRENDS - WHAT ARE THE OPPORTINITIES FOR VENTURE CAPITAL
June 2017
The material set out in this draft document is confidential and may not be discussed with a third party nor passed to any third party except with the authorisation of Creathor Venture. Each person that receives a copy by acceptance
thereof represents and agrees that it will not reproduce, distribute or provide it to any other party. Creathor makes no representations or warranties with regard to the documents’ accuracy, completeness, non‐infringement or
suitability for a particular purpose.
115. 5Private and Confidential
OUR TEAM WITH PROVEN TRACK RECORD
TEAM OVERVIEW
PlatformServices
Cédric Köhler
Team Support (DE)
Angela Will-Jamin
Finance Manager
Adrian Giessler
Team Support (DE)
Ute Molders
Christian Weniger
Alex Stöckl
Daniel Karsberg
Dr. Christian Weiss
Marianne Uddman
Christian Leikert
ManagingPartners
InvestmentTeam
SupportTeam
Thomas Dreiling
PR & Com-
munications
Marketing
Swetlana Gross
Karlheinz SchmeligDr. Gert Köhler
Atanas Mukov
Kathrin Leonhard
Team Support (CH)
Business
Intelligence
Fabian Degenhardt
116. 6Private and Confidential
30+yearsventurecapitalinvesting
1984 2016
Sold to „Cheetah
Mobile“ #3 top
app publisher
after Facebook
and Google
2015
Sold NASH
program to
„Gilead
Sciences“
$1B+
valuation
$1B+
valuation
$1B+
valuation
$1B+
valuation
$1B+
valuation
$1B+
valuation
$1B+
valuation
200+ investments
20 IPOs
1/3 own investment of the managing partners in the fund
7th fund generation
117. 7Private and Confidential
INVESTMENT FOCUS
Technology
HR
Finance / Insurance
Travel
and Mobility
Property and
Real-Estate
NEXTGEN
SOFTWARE
Internet
of
Things
Sharing
Economy
Personalized
Medicine
ArtificialIntelligence
(incl. Big Data, Cloud, and
autonomus systems)
Medtech
GROWINGAREA OF TECH-
ENABLEDLIFE-SCIENCES
Tools
Diagnostics
118. 8Private and Confidential
INVEStment FOCUS
Technology
HR
Finance / Insurance
Travel
and Mobility
Property and
Real-Estate
NEXTGEN
SOFTWARE
Internet
of
Things
Sharing
Economy
Personalized
Medicine
ArtificialIntelligence
(incl. Big Data, Cloud, and
autonomus systems)
Medtech
GROWINGAREA OF TECH-
ENABLEDLIFE-SCIENCES
Tools
Diagnostics
120. 10Private and Confidential
Wearables and
biosensing
Self Tracking
Analytics and Big
data
Smart Home
Care Coordination Telemedicine
TRENDS IN Digital Health
124. 14Private and Confidential
The GERMAN Healthcare System (EUR250BN)
80.2 Million Inhabitants
(90% statutatory health
insurance, 10% private
insurance)
2.000 hospitals
200.000 practitioners
120 health insurance
companies
20.000 pharmacies
26.000 nursing homes,
residential care homes etc.
1.150 rehab centers/clinics
Administration through 200 non-interoperative IT-Systems
125. 15Private and Confidential
The GERMAN Healthcare System
80.2 Million Inhabitants
(90% statutatory health
insurance, 10% private
insurance)
2.000 hospitals
200.000 practitioners
120 health insurance
companies
20.000 pharmacies
26.000 nursing homes,
residential care homes etc.
1.150 rehab centers/clinics
126. 16Private and Confidential
Governance of the german healthcare system
Government
Gesundheitsministerium (Exekutive) Bundestag (Legislative)
delegation & decision making
Self - administration
2.000 hospitals 200.000 practitioners
120 health insurance
companies
20.000 pharmacies
26.000 nursing homes,
residential care homes etc.
1.150 rehab centers/clinics
128. 18Private and Confidential
History and future of digital health law in germany
2004: GKV-Modernisierungsgesetz
…
2015: E-Health Gesetz passed
2018: Roll-Out
1. IT – Infrastructure (gematik) finalized
2. Patient basic data management
3. Emergency Case data
4. E-Medication Plan
5. Telemedicine approaches (e-consultation, e x-ray interpretation)
6. Electronic Health record
130. 20
Hypothesis-market
pharma & medtech
health insurers, singlepayer health care systems
tech giants (Google, Apple, IBM, Amazon, etc.)
try to find innovative solutions for the needs of
131. 21
Hypothesis-needs
I. Ability to deliver more personalized patient care
II. Engage more fully with physicians and patients
III. Advanced analytics to increase pipeline and commercial value
132. 22
Hypothesis-needs
Sensors and digital services for tailored, 24/7 treatment
E.g. mobile app for
managing type 2 diabetes,
smartphonebased
electrocardiogram, etc.
I. Ability to deliver more personalized patient care
133. 23
Hypothesis-needs
Omnichannel conversations with physicians and
patients
Anytimeanywhere virtual care – portals, apps,
online patient communities
I. Ability to deliver more personalized patient care
II. Engage more fully with physicians and patients
134. 24
Hypothesis-needs
I. Ability to deliver more personalized patient care
II. Engage more fully with physicians and patients
III. Advanced analytics to increase pipeline and commercial value
135. 25
III. Advanced analytics to increase pipeline and commercial value
Hypothesis-needs
In R&D digital discovery
and testing of molecules
with advanced modeling
and simulation techniques
“in silico screening”
In clinical development
speed up recruitment (via
social networks)
Patient monitoring (Sensors
& mobile apps)
Electronic data capture &
storage
In Marketing and Sales
advanced analytics to
understand prescribing
behavior and potential
patient profiles, enabling
more precise targeting
136. 26Private and Confidential
Company Name Short Profile Creathor’s Role
Mobile testing Co‐lead
Developer of the world’s smartest connected bike system Co‐lead
Multi‐modal travel booking platform Investor
Meta‐search and booking platform for rental cars Co‐lead
Mobile job marketplace Co‐lead
Mobile corporate e‐health solution and platform Investor
Indoor navigation solution Investor
Digital insurance manager Investor
International B2B online sales and marketing tool Co‐lead
Ai‐enhanced marketplace for expert translations Co‐lead
Mobile app (brain training) Co‐lead
Market place for local crowd‐sourced service ecosystem Investor
Machine‐to‐machine communication for industrial applications Co‐lead
Mobile shopping and payment platform Lead
Mobile advertising Lead
Online referral marketing software & services Lead
Video marketing platform Lead
Web based sales support system Lead
Hotel booking solution Lead
Heyjobs
Lead investor or CO-Lead investor in majority of investments
Active Portfolio - Technology
137. 27Private and Confidential
Company Name Short Profile Creathor’s Role
Innovative drug delivery platform with a focus on controlled‐release
formulations
Lead
High throughput multiplex protein/DNA analysis for both basic and clinical
research
Co‐lead
Chemical proteomics technology that permits the analysis of small molecule
interactions within protein mixtures in a targeted and directed manner
Lead
Recombinant proteins previously out of reach & scalable viral vectors Co‐lead
The Prostatype® Test System – a new gene test for prostate cancer patients Co‐lead
Proprietary cryotherapy system for use in the treatment of coronary artery
disease that causes heart attacks
Co‐Lead
Dedicated products and services for membrane protein applications that
facilitate analysis and drug development
Lead
Secure, smart and simple healthcare communication for doctors, patients and
medical professionals
Investor
Drug discovery and development company focused on small‐molecule drug
discovery with a special emphasis on the target class of nuclear receptors
Co‐lead
CE marked lacrimal stent for the treatment of Chronic Rhinosinusitis (CRS) and
Epiphora
Investor
Viral vector technologies from gene therapy and vaccination development to
customization of cell modelling tools
Lead
Significant ownership percentage and board positions in majority of investments
Active Portfolio - Life Sciences
138. Sample to Insight
Next-generation sequencing and big data
Jason T. Gammack
Vice President; Marketing & Product Management
Head of Global Marketing & Strategic Portfolio Management
DVFA Conference, June 2017 1
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Disclaimer
2
Safe Harbor Statement: This presentation contains both historical and forward-looking statements. All statements other than statements of historical fact
are, or may be deemed to be forward looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section
21E of the U.S. Securities Exchange Act of 1934, as amended. These statements are based on current expectations of future events. If underlying
assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from our own expectations and
projections. Some of the factors that could cause actual results to differ include, but are not limited, to the following: general industry conditions and
competition; risks associated with managing growth and international operations (including the effects of currency fluctuations, regulatory processes and
dependence on logistics), variability of operating results and allocations between customer classes, and the commercial development of markets for our
products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic
partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including factors such as general
economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products;
technological advances of our competitors and related legal disputes; difficulties in successfully adapting QIAGEN's products to integrated solutions and
producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitor
products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer
to “Risk Factors” section of reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC). We undertake no
obligation, and do not intend, to update these forward-looking statements as a result of new information or future events or developments unless and to the
extent required by law.
Regulation G: QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, and other non-U.S. GAAP figures (generally
accepted accounting principles), to provide additional insight on performance. In this presentation, adjusted results include adjusted net sales, adjusted
operating expenses, adjusted EBITDA, adjusted diluted EPS and free cash flow. Adjusted results are non-GAAP financial measures QIAGEN believes
should be considered in addition to reported results prepared in accordance with GAAP, but should not be considered as a substitute. QIAGEN believes
certain items should be excluded from adjusted results when they are outside of its ongoing core operations, vary significantly from period to period, or
affect the comparability of results with its competitors and its own prior periods. Please see the Appendix provided in this presentation “Reconciliation of
Non-GAAP to GAAP Measures” for reconciliations of historical non-GAAP measures to comparable GAAP measures and the definitions of terms used in
the presentation. QIAGEN does not reconcile forward-looking non-GAAP financial measures to the corresponding GAAP measures due to the high
variability and difficulty in making accurate forecasts and projections that are impacted by future decisions and actions. Accordingly, reconciliations of
these forward-looking non-GAAP financial measures to the corresponding GAAP measures are not available without unreasonable effort. However, the
actual amounts of these excluded items will have a significant impact on QIAGEN’s GAAP results.
GeneReader NGS System: The QIAGEN GeneReader® NGS System is intended for Research Use Only. This product is not intended for the diagnosis,
prevention or treatment of a disease. QIAGEN Clinical Insight® is an evidence-based decision support software intended as an aid in the interpretation of
variants observed in genomic sequencing data. The software evaluates genomic variants in the context of published biomedical literature, professional
association guidelines, publicly available databases and annotations, drug labels and clinical-trials. Based on this evaluation, the software proposes a
classification and bibliographic references to aid in the interpretation of observed variants. The software is not intended as a primary diagnostic tool by
physicians or to be used as a substitute for professional healthcare advice. Each laboratory is responsible for ensuring compliance with applicable
international, national and local clinical laboratory regulations and other accreditation requirements.
DVFA Conference, June 2017
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DVFA Conference, June 2017
SCIENTIFIC BREAKTHROUGHS
WE ARE EXPERIENCING A NEW AGE OF
Dramatic breakthroughs in molecular biology enable big data creation
We are creating more biological data
every 6 months than in all of prior history
1) Source: Cisco Systems, GenBank and Alliance Bernstein
3
141. Sample to Insight
DVFA Conference, June 2017 4
Data phase Astronomy Twitter YouTube Genomics
Acquisition 25 zetta-bytes/year 0.5-15 billion tweets/year 500-900 million
hours/year
1 zetta-bases/year
Storage 1 EB/year 1-17 PB/year 1-2 EB/year 2-40 EB/year
Analysis In situ data reduction Topic and sentiment
mining
Limited requirements Heterogenous data and
analysis
Real-time processing Metadata analysis Variant calling, -2 trillion
central processing unit
(CPU) hours
Massive volumes All-pairs genome
alignments, - 10,000
trillion CPU hours
Distribution Dedicated lines from
antennae to server
Small units of
distribution
Major component of
modern user’s
bandwidth (10MB/s)
Many small (10 MB/s)
and fewer massive (10
TB/s) data movement
Genomics is truly a big (BIG!) data environment
The four domains of big data in 2015(1)
1) Source: Stephens ZD, Lee SY, Faghri F, Campbell RH, Zhai C, et al. (2015) Big Data: Astronomical or Genomical?
142. Sample to Insight
DVFA Conference, June 2017 5
Rapidly evolving sequencing techniques initiated a new era of genomic insights
1953 1977
Sanger develops
1st DNA sequencing
technique
1st personal
human genome
is sequenced
1st bacterium
genome is
sequenced
1995 2002
1st mammal
genome
is sequenced
2009
First NGS
tumor genome
analysis
1st Illumina
human genome
is sequenced
2008
1st 454
human genome
is sequenced
Next-generation DNA
sequencing technology
is introduced
2007
143. Sample to Insight
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The growth of DNA sequencing
1) Source: Stephens ZD, Lee SY, Faghri F, Campbell RH, Zhai C, et al. (2015), Big Data: Astronomical or Genomical?
The power of genomics is fueled by big data
144. Sample to Insight
DVFA Conference, June 2017 7
How can we extract
insights
from increasingly large
and complex data?
145. Sample to Insight
8DVFA Conference, June 2017
How can we
share data
And find new models
of collaboration?
146. Sample to Insight
9DVFA Conference, June 2017
How can we
scale
interpretation
despite skill and
time requirements?
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10DVFA Conference, June 2017
How can we use
Big Data
to make better
treatment decisions?
148. Sample to Insight
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PharmaAcademia Molecular Diagnostics
Applied
Testing
QIAGEN well-positioned across all segments of the NGS market
GeneReader NGS System
Universal NGS
Single-cell genomics
Gene expression
Targeted resequencing
Whole exome
Whole genome
Clinical research
Translational medicine
Oncology
Hereditary diseases
Infectious diseases
Interpretation
Nucleic acid
collection &
extraction
Target
enrichment
Library
preparation
Next-
generation
sequencing
Data
analysis
Universal NGS:
QIAseq portfolio
Universal NGS:
CLC / Ingenuity / QCI
GeneReader NGS System
149. Sample to Insight
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QIAGEN Bioinformatics driving innovations from R&D to the clinic
Research &
Discovery
Clinical
Development
Microbial Pro Suite
IPA
Genomics Workbench
Genomics Server
Microbial RNA-Seq
Microbial Epigenetics
ExploreRNA
HVSS
IVA
Biomedical Workbench
HVSS
HGMD
QCI-Analyze
QCI-Interpret
Knowledge base
curation
Services
Algorithm development
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Delivering faster and better insights across full range of customer needs
DVFA Conference, June 2017
Acquisition of OmicSoftEnhancing QIAGEN Bioinformatics portfolio
Leader in enterprise solutions for large-scale omics
data management
Curation, standardization and comparative analysis
of large-scale NGS and omics datasets
Adds infrastructure solutions for
Own data mining
Data sharing
Adds highly curated data set
Highly
curated
literature
Data
sharingHighly
curated
content
Own data
mining
NEW NEW
QIAGEN now covers the full range of
data interpretation and sharing needs
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14
Actionable
insights
Expertise
and service
First complete
NGS workflow
Flexibility to
fit needs
Reliable resultsEase of use
Unique automation Data interpretation
QIAcube® GeneRead QIAcube® GeneReaderTM Bioinformatics portfolio
Predictable
costs
The world’s first complete Sample to Insight NGS solution for actionable results
1 3 4 52
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Setting new standards with QIAGEN Clinical Insight in clinical decision making
QCI workflow
Full integration for fast and seamless data analysis
Easy-to-use analysis tool for clinical researchers
Efficient pre-designed data analysis optimized to panel content
Operational scale: workflow and decision-assisted automation
Aligned with regulatory and reimbursement requirements
Integration of HGMD (Human Gene Mutation Database)
Identify
variants
Analyze Review Report
QIAGEN Clinical Insight is an integral part of GeneReader NGS workflow
153. Sample to Insight
0
10
20
30
40
50
60
70
80
90
Manual QCI Interpret
Hours
DVFA Conference, June 2017 16
QIAGEN Clinical Insight: Helping to achieve faster and more accurate insights
75%
time reduction
InterpretationLiterature curation
Case study: the power of QIAGEN Bioinformatics
33% reduction in
variants of unknown
significance
0
10
20
30
40
50
60
70
80
90
Pathogenic Likely
Pathogenic
VUS Likely
Benign
Benign
Variants
With QIAGENWithout QIAGEN
Case study: Cardiology variant classification(1)Case study: QCI interpretation time benefits
(1) Data from QCI Interpret with and without QIAGEN curated primary literature.
Data is represented as the difference between variant classifications with QIAGEN content minus variant classifications without QIAGEN content.
154. Sample to Insight
Screening Diagnosis Prognosis Treatment Monitoring Surveillance
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Molecular methods support decision making along the patient journey
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QCI Interpret: Streamlining interpretation and reporting of NGS data
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QCI Interpret: Streamlining interpretation and reporting of NGS data
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Solving challenges of complex genomic data
Market leader in analysis, interpretation and content
Portfolio with strong commercial traction
20
Summary
DVFA Conference, June 2017