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Dvfa life-science-conference-proceedings-2017

The 10th DVFA Life Science Conference focused on digital transformation in healthcare. Topics included challenges and opportunities of digital transformation, connected diabetes management, increased data protection requirements, new business models in digital health, next generation sequencing, using smart data for better health outcomes, and a capital market perspective on digital health. There were presentations from industry experts and startup companies, as well as panel discussions on these topics.

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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
LIFE SCIENCE_ Disclaimer_ This brochure contains information from sources believed to be reliable but has not been verified or testified. The corporate data provided has been transmitted and converted elec- tronically. Therefore, the information cannot be guaranteed to be secure or error-free as the transmitted and converted information could be intercepted, corrupted, lost or incomplete. Thus, DVFA does not accept liability for any errors or omissions regarding the contents of this information. Financial data presented by the companies as reported by the corporates. The conference brochure is provided for information purposes and should not be construed as a solicitation or offer to buy or sell any securities or related financial instruments. Please note that the data given in this brochure may be rounded. Deviations may thus oc- cur, e.g. regarding percentage figures. The company information is provided by the respective companies. DVFA cannot assume any responsibility for the correctness and completeness of this information. Any copying, distribution or any action taken or omitted to be taken in reliance on it is pro- hibited and may be unlawful. © 2017 DVFA GmbH ALL RIGHTS RESERVED. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher and the co- pyright holder.
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.
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.
June 13, 2017 Digital Transformation in Healthcare – Challenges & Opportunities Dr. Martin Pöhlchen Partner, Germany
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
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.
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 %.
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
6 Strictly Confidential The era of the Frank Zappa drug development strategy comes to an end. However, the non- responder problem persists.
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
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
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
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.
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.
12 Strictly Confidential 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
13 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 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.»
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.»
16 Strictly Confidential 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.
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.»
18 Strictly Confidential 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.»
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.
20 Strictly Confidential 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.
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
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.
23 Strictly Confidential 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
24 Strictly Confidential 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
25 Strictly Confidential 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.
26 Strictly Confidential 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/.
27 Strictly Confidential 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
28 Strictly Confidential Challenges (2)
29 Strictly Confidential 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)
30 Strictly Confidential 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
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
32 Strictly Confidential 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.
33 Strictly Confidential 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?
34 Strictly Confidential 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.
35 Strictly Confidential USA BOSTON 1 GRANT STREET, SUITE 400 FRAMINGHAM, BOSTON, MA, 01702 USA TEL +1 (774) 777 5255 BOSTON@ALIRAHEALTH.COM SPAIN CASAFRANCA 38, 08017 BARCELONA, SPAIN TEL +34 (93) 406 71 71 BARCELONA@ALIRAHEALTH.COM FRANCE 31 RUE DE MONCEAU, 75008 PARIS, FRANCE TEL +33 (0)1 44 54 96 23 FAX +33 (0)1 44 54 90 20 PARIS@ALIRAHEALTH.COM ITALY VIA CARLO OTTAVIO CORNAGGIA 10, 20123 MILAN, ITALY TEL +39 (02) 36680198 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
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
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
The coming secure communication arena in German healthcare Source: gematik 10th DVFA Life Science Conference 201713/06/20172
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
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
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
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
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
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
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
The most important parties/products 10th DVFA Life Science Conference 201713/06/201710
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
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
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
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
Potential additional products and services Nr. Product / Service Customer / User Source 1 Elektronischer Entlassbrief Krankenhaus eHealth Law 2 Konsiliarische Befundbeurteilung Ärzte eHealth Law 3 Notfalldatensatz Zahnärzte eHealth Law 4 Arzneimitteltherapiesicherheit (AMTS) Ärzte / Apotheke eHealth Law 5 Medikationsplan Ärzte / Apotheke eHealth Law 6 Sicher Übermittlung elektronischer Briefe Ärzte / Krankenhaus eHealth Law 7 Organsspendeausweis Krankenhaus gematik 8 Elektronische Fallakte Ärzte / Krankenhaus gematik 9 Elektronisches Patientenfach Ärzte / Krankenhaus gematik 10 Elektronische Patienttenquittung Ärzte / Krankenhaus / Zahnärzte gematik 11 Fachdienst VSDM Telematik Infrastruktur gematik 12 VPN-Zugangsdienst Telematik Infrastruktur gematik 13 Patientenverfügung Ärzte / Krankenhaus CGM 14 Impfstatus und Impfplanung Ärzte CGM 15 Zahnstatus Zahnärzte CGM 16 Ernährungsplan Ärzte CGM 17 Elektronische Patientenakte Ärzte / Krankenhaus CGM 10th DVFA Life Science Conference 201713/06/201715
Potential additional products and services (2) Nr. Product / Service Customer / User Source 18 Laborbefund Ärzte / Krankenhaus CGM 19 Röntgenbefund Ärzte / Krankenhaus CGM 20 AU - Bescheinigung Ärzte CGM 21 KH Einweisung Ärzte / Krankenhaus CGM 22 Heil- und Kostenplan Zahnärzte CGM 23 .. weitere Formulare Ärzte / Krankenhaus CGM 24 One-Klick Abrechnung (der KBV) Ärzte CGM 25 Zuzahlungsinformationen Ärzte / Krankenhaus / Zahnärzte CGM 36 Teilnahme an Selektivverträgen Ärzte / Krankenhaus CGM 27 Arzneimittelkonto Ärzte / Krankenhaus CGM 28 Software Assisted Medicine - Diabetes Ärzte / Krankenhaus CGM 29 Software Assisted Medicine - Herzinsuffizienz Ärzte / Krankenhaus CGM 30 Software Assisted Medicine - Rückenschmerz Ärzte / Krankenhaus CGM 31 Software Assisted Medicine - Depression Ärzte / Krankenhaus CGM 32 Software Assisted Medicine - Rauchentwöhnung Ärzte CGM 33 Software Assisted Medicine - Gesundes Gewicht Ärzte / Krankenhaus CGM 34 Software Assisted Medicine - Blutdruckstabilisierung Ärzte / Krankenhaus CGM 10th DVFA Life Science Conference 201713/06/201716
1.346 1.497 1.517 1.531 1.540 1.577 1.582 1.605 1.614 1.674 1.684 1.695 1.752 1.768 1.781 1.806 1.844 1.848 1.851 1.876 1.916 1.972 2.010 2.071 2.087 2.121 2.133 2.158 2.167 2.490 Lithuania Latvia Slovakia Malta Poland Slovenia Cyprus Greece Luxembourg Czech Republic Hungary Romania Bulgaria Belgium Germany Turkey Portugal Hungary Ireland France Iceland Italy Sweden United Kingdom Finland Netherlands Estonia Norway Spain Denmark 13/06/2017 10th DVFA Life Science Conference 201717 The EU scorecard for Healthcare IT Source: Benchmarking Deployment of eHealth among General Practitioners (2013) – European Commission Composite index of IT adoption by country
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
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
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
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)
13/06/2017 10th DVFA Life Science Conference 201722 FMK – Shared medication data base from 2014
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»
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
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….
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!
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
May 2017│Confidential Investor Presentation
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.
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
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
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
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
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
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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)
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
Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
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
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
• 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
• 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?
• 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
• 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)
• 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)
• 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
• 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)
• 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
• 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
• 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
• 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!
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.
2Private and Confidential AGENDA Creathor Venture Profile Trends in Digital Health Areas of Interest for Venture Capital
3Private and Confidential AGENDA Creathor Venture Profile Trends in Digital Health Areas of Interest for Venture Capital
4Private and Confidential Earlystageventurecapitalfund Zurich BadHomburg Stockholm 30%LifeScience 70%Technology €220mAuM
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
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
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
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
9Private and Confidential Creathor Venture Profile Trends in Digital Health Areas of Interest for Venture Capital
10Private and Confidential Wearables and biosensing Self Tracking Analytics and Big data Smart Home Care Coordination Telemedicine TRENDS IN Digital Health
11Private and Confidential TRENDS IN Digital Health: Plunging costs of IOT Sensors
12Private and Confidential Source: https://www.genome.gov/sequencingcostsdata/ TRENDS IN Digital Health: Plunging costs OF dNA Sequencing
13Private and Confidential Source: http://www.startuphealth.com/ TRENDS IN Digital Health: VENTURE CAPITAL INVESTMENTS
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
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
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
17Private and Confidential
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
19Private and Confidential Creathor Venture Profile Trends in Digital Health Areas of Interest for Venture Capital AGENDA
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
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
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
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
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
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
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
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
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
Sample to Insight 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
Sample to Insight 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
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?
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
Sample to Insight DVFA Conference, June 2017 6 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
Sample to Insight DVFA Conference, June 2017 7 How can we extract insights from increasingly large and complex data?
Sample to Insight 8DVFA Conference, June 2017 How can we share data And find new models of collaboration?
Sample to Insight 9DVFA Conference, June 2017 How can we scale interpretation despite skill and time requirements?
Sample to Insight 10DVFA Conference, June 2017 How can we use Big Data to make better treatment decisions?
Sample to Insight DVFA Conference, June 2017 11 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
Sample to Insight 12 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 DVFA Conference, June 2017
Sample to Insight 13 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
Sample to Insight 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 DVFA Conference, June 2017
Sample to Insight DVFA Conference, June 2017 15 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
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.
Sample to Insight Screening Diagnosis Prognosis Treatment Monitoring Surveillance DVFA Conference, June 2017 17 Molecular methods support decision making along the patient journey
Sample to Insight DVFA Conference, June 2017 18 QCI Interpret: Streamlining interpretation and reporting of NGS data
Sample to Insight DVFA Conference, June 2017 19 QCI Interpret: Streamlining interpretation and reporting of NGS data
Sample to Insight Solving challenges of complex genomic data Market leader in analysis, interpretation and content Portfolio with strong commercial traction 20 Summary DVFA Conference, June 2017
Clemens Suter-Crazzolara, PhD. May 2017 The Health Revolution – Better Outcomes with Smart Data
2© 2017 SAP SE or an SAP affiliate company. All rights reserved. Legal Disclaimer The information in this document is confidential and proprietary to SAP and may not be disclosed without the permission of SAP. This document is not subject to your license agreement or any other service or subscription agreement with SAP. SAP has no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation and SAP’s strategy and possible future developments, products and or platforms directions and functionality are all subject to change and may be changed by SAP at any time for any reason without notice. The information on this document is not a commitment, promise or legal obligation to deliver any material, code or functionality. This document is provided without a warranty of any kind, either express or implied, including but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. This document is for informational purposes and may not be incorporated into a contract. SAP assumes no responsibility for errors or omissions in this document, except if such damages were caused by SAP intentionally or grossly negligent. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates, and they should not be relied upon in making purchasing decisions.
3© 2017 SAP SE or an SAP affiliate company. All rights reserved. Global Trends Impacting Patients and the Industry at Large Escalating Costs Increasing Demand ‘Sleeping Giant’: Patients as Consumers
4© 2017 SAP SE or an SAP affiliate company. All rights reserved. Value-Based Care and Patient Outcomes Response to Market Forces Drives Transformational Change Escalating Costs Increasing Demand Patients as Consumers Legislation / Payment Reform MACRA APM MIPS MACRA = Medicare Access and CHIP Reauthorization Act APM = Advanced Alternative Payment Models MIPS = Merit-based Incentive Payment System Population Health, Disease Management and Precision Medicine Patient Engagement
5© 2017 SAP SE or an SAP affiliate company. All rights reserved. The Opportunity: Combining Cross Ecosystem Data in Innovative New Ways to Reveal Breakthrough Findings Patient timeline PubMed Biomedical Article Database Clinical Trials Currently more than 30,000 recruiting on ClinicalTrials.gov Cancer Patient Records at the National Center for Tumor (NCT) Diseases in Heidelberg Clinical information management systems Often more than 50 GB Human Proteome data points (2.4 GB) per sample; 7.6 TB raw proteome data on ProteomicsDB.org Prescription Data records from 10,000 doctors and 10 million patients (100 GB) Human Genome and Biological Data from a single genome; >15 PB in databases of leading institutes Medical Imaging Data 1 second scan of a single organ Gain Longitude Views of Patient Healthcare History Gain Comprehensive Views of Cross-Population Health and Industry Insights 160M 1.5B 50GB 160K >25M 10GB 800MB 30K Diagnosis Tumor Stage Pathology Report Tissue Sample Genomic Markers Radiotherapy
6© 2017 SAP SE or an SAP affiliate company. All rights reserved. Framework for Live Business from SAP
7© 2017 SAP SE or an SAP affiliate company. All rights reserved. S4 PA S4 ERP Patient Relationship Management SAP Expertly Applies Technology within Healthcare Business Contexts to Power Innovation Research and Clinical Delivery How do I assemble and manage my care team based on the needs of my patient? How do I design and run my supply chain based on the needs of my patients? S4 ERP Ariba Fieldglass SucessFactors S4 PM SAP Health Leonardo Co-Innovation Patient Revenue Optimization • How do I maximize my revenue and collections from patient (billing) • How to acquire new patients and retain existing ones (marketing)? Research & Clinical Delivery How do I enable my clinicians to deliver evidence-based care Supply Chain/ Ops Workforce Engagement
8© 2017 SAP SE or an SAP affiliate company. All rights reserved. Specialized Hospitals Rehabilitation Community Practice Pharma Research Payer Medical Devices LabsProviders SAP Health Enables Actionable Insights by Leveraging the Healthcare Ecosystem Patient Connected Integrate evolving data sets across the healthcare continuum Real-time Provide up-to-the-moment insights for improved decision making and greater patient and population health insights Actionable Advanced analytics and queries to spot trends, run scenarios, set new standards for treatment and delivery
9© 2017 SAP SE or an SAP affiliate company. All rights reserved. SAP Health Drives Innovation as the Catalyst for Healthcare Transformation SAP Applications • Patient Engagement • Patient Management • Clinical Research • Clinical Quality . Partner Applications Facilitates Healthcare Network collaboration through integrated insights and application services that support coordinated patient-centric, health and wellness scenarios SAP Federated Data and Analytics Connecting data silos, providing real time insights, and supported by SAP HANA in- memory computing for improved decision- making, hypothesis-building and testing Accelerated Innovation with broad application portfolio, connected medical devices, automation and machine learning Integrated User Interface SAP Health Platform SAP HANA Platform
10© 2017 SAP SE or an SAP affiliate company. All rights reserved. “There’s nothing that can make a difference in the world more than improving the outcomes of health in society. And therefore, we’re totally dedicated to it.” Bill McDermott, CEO of SAP SAP Dedication to Improving Patient Outcomes
Thank you. Contact information: Clemens Suter-Crazzolara, PhD Chief Product Expert SAP Health www.twitter.com/clesucr Tel:+4916090819863
OUR GOAL IS TO HELP EVERYONE REACH THEIR PERSONAL HEALTH GOALS ANYTIME, ANYWHERE
CORPORATE HEALTH MANAGEMENT IT PAYS OFF TO HAVE HEALTHY EMPLOYEES.
ANNUAL LOSS OF PERFORMANCE MAIN CAUSE OF ABSENCES - MUSCULOSKELETAL DISORDERS AVERAGE NUMBER OF SICK DAYS PER EMPLOYEE DEMOGRAPHIC CHANGE
CORPORATE HEALTH MANAGEMENT UP TO NOW AND WITH HUMANOO UP TO NOW ● Varying performance standards ● Different reports – no possibility to summarise findings ● High costs for experts ● No possibility to compare different branches of the company ● No comprehensive management solution ● No single solution for treating physical and mental issues WITH HUMANOO ● ONE performance standard ● ONE report ● NO additional costs for a range of services ● DIRECT comparison of different branches of the company ● ONE comprehensive management solution ● ONE tool for treating physical and mental issues
THE HUMANOO BOX IMPROVE THE HEALTH OF YOUR EMPLOYEES ● Exclusive gift box to spark the interest of your employees ● Contains a fascia ball, earphones and a one-time activation code ● Facilitates the integration of HUMANOO into the company and increases the activation rate ● Employees can get started straight away after registering through the app or online ● Random assignment of boxes protects the personal data of every employee
EUROPE’S BIGGEST HEALTH DATABASE PHYSIO Physiotherapy & yoga coaching WORKOUTS Effective training sessions MENTAL TRAINING Meditations and autogenic training NUTRITION Recipes and tips CHAT Employees can speak to our experts if they have specific questions or acute issues OVER 1000 MOTIVATIONAL COACHINGS
REPORTING & DATA ANALYSIS COMPREHENSIVE COMPANY REPORT RECEIVE AGGREGATE DATA AS WELL AS PERSONALISED RECOMMENDATIONS FOR ACTION PHYSICAL HEALTH MENTAL TRAINING NUTRITION GENERAL Affected areas of the body Mental state of your workforce Eating habits of your employees General numbers and statistics Stress Motivation Sleep Concentration Number of vegetarians Number of vegans Other eating habits Percentage of activated profiles Number of chat requests
DATA PROTECTION AND DATA SECURITY HUMANOO COMPLIES TO THE STRICTEST EU DATA PROTECTION POLICIES DEVELOPED AND CONTROLLED BY THE DATA PROTECTION SUPERVISOR PWC
HUMANOO’S EXPERTS AND RESEARCH CENTRES Anna Trökes Yoga teacher and author of over 30 books Claudia Kunze Motivational trainer and coach for autogenic training in companies Stina Spiegelberg Author of many successful vegan cookbooks Doris Kastl Owner of Germany’s largest physiotherapy practice and respiratory therapy expert Maria Boettner Meditation expert, actress and CEO of the Du hast Pause meditation app Prof. Dr Ingo Fietze Director of the Interdisciplinary Sleep Disorder Centre of the Charité Berlin
HUMANOO ADVANTAGES ● Increase in performance ● Financial optimisation ● A comprehensive management solution ● Clear competitive edge ● Happy healthy employees ● Modern eHealth approach COMPANY ● Promotion of health ● Reduce doctor’s visits ● Improve quality of life ● Boost productivity ● Increase job satisfaction ● Reduce stress EMPLOYEES INSURANCE ● Digital health tool to offer private and supplemental insurances ● Access routes to reach new clients ● Analysis of public health statistics
THE TIME THAT WE TAKE IS THE TIME THAT GIVE US SOMETHING BACK. ERNST FERSTL
eTherapists GmbH Oppelnerstr. 26-27 10997 Berlin, Germany Tel: +49 (0) 30 120 88 552 Email: sales@humanoo.de www.humanoo.com
DVFA Michael Kolb Tel.: +49 (0)69 264848 130 Fax: +49 (0)69 264848 489 Mail: konferenzen@dvfa.de Content: DVFA Photos: www.shutterstock.com Subject to modifications. Copyright 2017 DVFA GmbH Members of the DVFA Life Science Commission Sascha Alilovic, MorphoSys AG, Martinsried/Planegg Dr. Christa Bähr, CEFA, CFA, Chairwoman, CB HealthCare, Berlin Dr. Viola Bronsema, BIO Deutschland e.V., Berlin Kai Brüning, apo Asset Management GmbH, Düsseldorf Ines-Regina Buth, CBA, akampion, Berlin Dr. Ralf Emmerich, European Investment Fund, Luxemburg Andreas Heinrichs, Bank Vontobel Europe AG, Köln Stefan Höfer, Deutsche Börse AG, Eschborn Dr. Kai Gregor Klinger, RHÖN-KLINIKUM AG, Bad Neustadt a.d. Saale Dr. jur. Dr. med. Adem Koyuncu, COVINGTON & BURLING LLP, Brüssel Dr. Solveigh Karola Mähler, MC SERVICES AG, Düsseldorf Dr. med. Markus Manns, Chairman, Union Investment Privatfonds GmbH, Frankfurt Dr. Markus Metzger, STADA Arzneimittel AG, Bad Vilbel Dr. Marie-Luise Roth, DIB Deutsche Industrievereinigung Biotechnologie, Frankfurt Dr. Martin Schnee, CBA, CCrA, Schnee Research, Maintal Dr. Julia Schüler, CBA, BioMedServices, Darmstadt Prof. Dr. Joerg Vienken, Nephro-Solutions AG, Hamburg DVFA – Society of Investment Professionals in Germany DVFA is the Society of Investment Professionals in Germany, founded in 1960. Currently, DVFA has more than 1,400 individual members representing over 400 investment firms, banks, asset managers, consultants and counselling businesses. DVFA assures the credibility of the professionals and the integrity of the market by offering internationally recognised qualification programmes, by providing platforms for professional financial communication, and by effective self-regulation. Via EFFAS, the umbrella organisation of European Analysts Societies, DVFA offers access to a pan-European network with more than 17,000 investment professionals in 27 nati- ons. Via ACIIA, the Association of Certified International Investment Analysts, DVFA is part of a worldwide network of more than 100,000 investment professionals.

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Dvfa life-science-conference-proceedings-2017

  • 1.
    Society of InvestmentProfessionals 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
  • 2.
    LIFE SCIENCE_ Disclaimer_ This brochurecontains information from sources believed to be reliable but has not been verified or testified. The corporate data provided has been transmitted and converted elec- tronically. Therefore, the information cannot be guaranteed to be secure or error-free as the transmitted and converted information could be intercepted, corrupted, lost or incomplete. Thus, DVFA does not accept liability for any errors or omissions regarding the contents of this information. Financial data presented by the companies as reported by the corporates. The conference brochure is provided for information purposes and should not be construed as a solicitation or offer to buy or sell any securities or related financial instruments. Please note that the data given in this brochure may be rounded. Deviations may thus oc- cur, e.g. regarding percentage figures. The company information is provided by the respective companies. DVFA cannot assume any responsibility for the correctness and completeness of this information. Any copying, distribution or any action taken or omitted to be taken in reliance on it is pro- hibited and may be unlawful. © 2017 DVFA GmbH ALL RIGHTS RESERVED. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher and the co- pyright holder.
  • 3.
    The 10th DVFALife 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 LIFESCIENCE 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 DigitalTransformation 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 eraof the Frank Zappa drug development strategy comes to an end. However, the non- responder problem persists.
  • 11.
    7 Strictly Confidential From closedexpert 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 ▪ Strongerengagement 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 ▪ Strongerengagement 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 engagementof 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 engagementof 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 Strictly Confidential Stronger engagementof 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 Strictly Confidential ▪ Strongerengagement 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 businessmodels 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 Strictly Confidential New businessmodels 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 businessmodels 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 Strictly Confidential New businessmodels 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 businessmodels 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 Strictly Confidential New businessmodels 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 ▪ Strongerengagement 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 researchbudgets 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 Strictly Confidential Enormous researchbudgets 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 Strictly Confidential Enormous researchbudgets 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 Strictly Confidential Enormous researchbudgets 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 Strictly Confidential Enormous researchbudgets 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 Strictly Confidential 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
  • 32.
  • 33.
    29 Strictly Confidential 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 Strictly Confidential 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 Strictly Confidential Referentenentwurf desBundesministeriums 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 Strictly Confidential Questions fordiscussion 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 Strictly Confidential Summary ▪ Newbusiness 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 BOSTON 1 GRANTSTREET, SUITE 400 FRAMINGHAM, BOSTON, MA, 01702 USA TEL +1 (774) 777 5255 BOSTON@ALIRAHEALTH.COM SPAIN CASAFRANCA 38, 08017 BARCELONA, SPAIN TEL +34 (93) 406 71 71 BARCELONA@ALIRAHEALTH.COM FRANCE 31 RUE DE MONCEAU, 75008 PARIS, FRANCE TEL +33 (0)1 44 54 96 23 FAX +33 (0)1 44 54 90 20 PARIS@ALIRAHEALTH.COM ITALY VIA CARLO OTTAVIO CORNAGGIA 10, 20123 MILAN, ITALY TEL +39 (02) 36680198 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 HealthTrends (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 securecommunication arena in German healthcare Source: gematik 10th DVFA Life Science Conference 201713/06/20172
  • 43.
    The Telematics Infrastructureis 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 isbehind 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 TelematicsInfrastructure 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 ITproject 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 for2 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 wereawarded 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 ofORS-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 importantparties/products 10th DVFA Life Science Conference 201713/06/201710
  • 51.
    The full scalepilot 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 thegematik 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 inthe 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 checkand 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
  • 55.
    Potential additional productsand services Nr. Product / Service Customer / User Source 1 Elektronischer Entlassbrief Krankenhaus eHealth Law 2 Konsiliarische Befundbeurteilung Ärzte eHealth Law 3 Notfalldatensatz Zahnärzte eHealth Law 4 Arzneimitteltherapiesicherheit (AMTS) Ärzte / Apotheke eHealth Law 5 Medikationsplan Ärzte / Apotheke eHealth Law 6 Sicher Übermittlung elektronischer Briefe Ärzte / Krankenhaus eHealth Law 7 Organsspendeausweis Krankenhaus gematik 8 Elektronische Fallakte Ärzte / Krankenhaus gematik 9 Elektronisches Patientenfach Ärzte / Krankenhaus gematik 10 Elektronische Patienttenquittung Ärzte / Krankenhaus / Zahnärzte gematik 11 Fachdienst VSDM Telematik Infrastruktur gematik 12 VPN-Zugangsdienst Telematik Infrastruktur gematik 13 Patientenverfügung Ärzte / Krankenhaus CGM 14 Impfstatus und Impfplanung Ärzte CGM 15 Zahnstatus Zahnärzte CGM 16 Ernährungsplan Ärzte CGM 17 Elektronische Patientenakte Ärzte / Krankenhaus CGM 10th DVFA Life Science Conference 201713/06/201715
  • 56.
    Potential additional productsand services (2) Nr. Product / Service Customer / User Source 18 Laborbefund Ärzte / Krankenhaus CGM 19 Röntgenbefund Ärzte / Krankenhaus CGM 20 AU - Bescheinigung Ärzte CGM 21 KH Einweisung Ärzte / Krankenhaus CGM 22 Heil- und Kostenplan Zahnärzte CGM 23 .. weitere Formulare Ärzte / Krankenhaus CGM 24 One-Klick Abrechnung (der KBV) Ärzte CGM 25 Zuzahlungsinformationen Ärzte / Krankenhaus / Zahnärzte CGM 36 Teilnahme an Selektivverträgen Ärzte / Krankenhaus CGM 27 Arzneimittelkonto Ärzte / Krankenhaus CGM 28 Software Assisted Medicine - Diabetes Ärzte / Krankenhaus CGM 29 Software Assisted Medicine - Herzinsuffizienz Ärzte / Krankenhaus CGM 30 Software Assisted Medicine - Rückenschmerz Ärzte / Krankenhaus CGM 31 Software Assisted Medicine - Depression Ärzte / Krankenhaus CGM 32 Software Assisted Medicine - Rauchentwöhnung Ärzte CGM 33 Software Assisted Medicine - Gesundes Gewicht Ärzte / Krankenhaus CGM 34 Software Assisted Medicine - Blutdruckstabilisierung Ärzte / Krankenhaus CGM 10th DVFA Life Science Conference 201713/06/201716
  • 57.
  • 58.
    Data center B 13/06/201710th 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 servicesin 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 DVFALife 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 DVFALife 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 DVFALife Science Conference 201722 FMK – Shared medication data base from 2014
  • 63.
    13/06/2017 10th DVFALife 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 DVFALife 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 Germanyhave 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 DVFALife 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 LifeScience 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
  • 68.
  • 69.
    Page 2 D i sc 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 an 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 ll 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 Ce 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 tr 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
  • 74.
    Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3.A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 75.
    Page 8 Ty p e1 : 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 sy 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
  • 77.
    Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3.A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 78.
    Page 11 C e ll 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 ll 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 ll 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 ll 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 cu 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 fe 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
  • 84.
    Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3.A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 85.
    Page 18 C o ns 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 ra 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
  • 87.
    Agenda 1. Positioned on a fast growing, accessible market 2. Aunique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 88.
    Page 21 C e ll 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 ll 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
  • 90.
    Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3.A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 91.
    Page 24 C e ll 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 mp 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
  • 93.
    Agenda 1. Positioned on a fast growing, accessible market 2. A unique technology 3.A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 94.
    Page 27 K e yF 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 yF 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 ll 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
  • 97.
    Agenda 1. Positioned on a fast growing, accessible market 2. Aunique technology 3. A company well placed on COGS 4. An aggressive commercial strategy 5. The next breakthrough: the Artificial Pancreas 6. Financials 7. Conclusions
  • 98.
    Page 31 C e ll 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 protectionand 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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 KühnLüer 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.
  • 112.
    2Private and Confidential AGENDA CreathorVenture Profile Trends in Digital Health Areas of Interest for Venture Capital
  • 113.
    3Private and Confidential AGENDA CreathorVenture Profile Trends in Digital Health Areas of Interest for Venture Capital
  • 114.
  • 115.
    5Private and Confidential OURTEAM 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 19842016 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 INVESTMENTFOCUS 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 INVEStmentFOCUS 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
  • 119.
    9Private and Confidential CreathorVenture Profile Trends in Digital Health Areas of Interest for Venture Capital
  • 120.
    10Private and Confidential Wearablesand biosensing Self Tracking Analytics and Big data Smart Home Care Coordination Telemedicine TRENDS IN Digital Health
  • 121.
    11Private and Confidential TRENDSIN Digital Health: Plunging costs of IOT Sensors
  • 122.
    12Private and Confidential Source:https://www.genome.gov/sequencingcostsdata/ TRENDS IN Digital Health: Plunging costs OF dNA Sequencing
  • 123.
    13Private and Confidential Source:http://www.startuphealth.com/ TRENDS IN Digital Health: VENTURE CAPITAL INVESTMENTS
  • 124.
    14Private and Confidential TheGERMAN 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 TheGERMAN 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 Governanceof 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
  • 127.
  • 128.
    18Private and Confidential Historyand 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
  • 129.
    19Private and Confidential CreathorVenture Profile Trends in Digital Health Areas of Interest for Venture Capital AGENDA
  • 130.
    20 Hypothesis-market pharma & medtech healthinsurers, 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 todeliver 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 digitalservices 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 withphysicians 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 todeliver 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 analyticsto 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 CompanyName 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 CompanyName 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-generationsequencing and big data Jason T. Gammack Vice President; Marketing & Product Management Head of Global Marketing & Strategic Portfolio Management DVFA Conference, June 2017 1
  • 139.
    Sample to Insight Disclaimer 2 SafeHarbor 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
  • 140.
    Sample to Insight DVFAConference, 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 DVFAConference, 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 DVFAConference, 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 DVFAConference, June 2017 6 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 DVFAConference, June 2017 7 How can we extract insights from increasingly large and complex data?
  • 145.
    Sample to Insight 8DVFAConference, June 2017 How can we share data And find new models of collaboration?
  • 146.
    Sample to Insight 9DVFAConference, June 2017 How can we scale interpretation despite skill and time requirements?
  • 147.
    Sample to Insight 10DVFAConference, June 2017 How can we use Big Data to make better treatment decisions?
  • 148.
    Sample to Insight DVFAConference, June 2017 11 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 12 QIAGENBioinformatics 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 DVFA Conference, June 2017
  • 150.
    Sample to Insight 13 Deliveringfaster 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
  • 151.
    Sample to Insight 14 Actionable insights Expertise andservice 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 DVFA Conference, June 2017
  • 152.
    Sample to Insight DVFAConference, June 2017 15 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 ManualQCI 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 ScreeningDiagnosis Prognosis Treatment Monitoring Surveillance DVFA Conference, June 2017 17 Molecular methods support decision making along the patient journey
  • 155.
    Sample to Insight DVFAConference, June 2017 18 QCI Interpret: Streamlining interpretation and reporting of NGS data
  • 156.
    Sample to Insight DVFAConference, June 2017 19 QCI Interpret: Streamlining interpretation and reporting of NGS data
  • 157.
    Sample to Insight Solvingchallenges of complex genomic data Market leader in analysis, interpretation and content Portfolio with strong commercial traction 20 Summary DVFA Conference, June 2017
  • 158.
    Clemens Suter-Crazzolara, PhD. May2017 The Health Revolution – Better Outcomes with Smart Data
  • 159.
    2© 2017 SAPSE or an SAP affiliate company. All rights reserved. Legal Disclaimer The information in this document is confidential and proprietary to SAP and may not be disclosed without the permission of SAP. This document is not subject to your license agreement or any other service or subscription agreement with SAP. SAP has no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation and SAP’s strategy and possible future developments, products and or platforms directions and functionality are all subject to change and may be changed by SAP at any time for any reason without notice. The information on this document is not a commitment, promise or legal obligation to deliver any material, code or functionality. This document is provided without a warranty of any kind, either express or implied, including but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. This document is for informational purposes and may not be incorporated into a contract. SAP assumes no responsibility for errors or omissions in this document, except if such damages were caused by SAP intentionally or grossly negligent. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates, and they should not be relied upon in making purchasing decisions.
  • 160.
    3© 2017 SAPSE or an SAP affiliate company. All rights reserved. Global Trends Impacting Patients and the Industry at Large Escalating Costs Increasing Demand ‘Sleeping Giant’: Patients as Consumers
  • 161.
    4© 2017 SAPSE or an SAP affiliate company. All rights reserved. Value-Based Care and Patient Outcomes Response to Market Forces Drives Transformational Change Escalating Costs Increasing Demand Patients as Consumers Legislation / Payment Reform MACRA APM MIPS MACRA = Medicare Access and CHIP Reauthorization Act APM = Advanced Alternative Payment Models MIPS = Merit-based Incentive Payment System Population Health, Disease Management and Precision Medicine Patient Engagement
  • 162.
    5© 2017 SAPSE or an SAP affiliate company. All rights reserved. The Opportunity: Combining Cross Ecosystem Data in Innovative New Ways to Reveal Breakthrough Findings Patient timeline PubMed Biomedical Article Database Clinical Trials Currently more than 30,000 recruiting on ClinicalTrials.gov Cancer Patient Records at the National Center for Tumor (NCT) Diseases in Heidelberg Clinical information management systems Often more than 50 GB Human Proteome data points (2.4 GB) per sample; 7.6 TB raw proteome data on ProteomicsDB.org Prescription Data records from 10,000 doctors and 10 million patients (100 GB) Human Genome and Biological Data from a single genome; >15 PB in databases of leading institutes Medical Imaging Data 1 second scan of a single organ Gain Longitude Views of Patient Healthcare History Gain Comprehensive Views of Cross-Population Health and Industry Insights 160M 1.5B 50GB 160K >25M 10GB 800MB 30K Diagnosis Tumor Stage Pathology Report Tissue Sample Genomic Markers Radiotherapy
  • 163.
    6© 2017 SAPSE or an SAP affiliate company. All rights reserved. Framework for Live Business from SAP
  • 164.
    7© 2017 SAPSE or an SAP affiliate company. All rights reserved. S4 PA S4 ERP Patient Relationship Management SAP Expertly Applies Technology within Healthcare Business Contexts to Power Innovation Research and Clinical Delivery How do I assemble and manage my care team based on the needs of my patient? How do I design and run my supply chain based on the needs of my patients? S4 ERP Ariba Fieldglass SucessFactors S4 PM SAP Health Leonardo Co-Innovation Patient Revenue Optimization • How do I maximize my revenue and collections from patient (billing) • How to acquire new patients and retain existing ones (marketing)? Research & Clinical Delivery How do I enable my clinicians to deliver evidence-based care Supply Chain/ Ops Workforce Engagement
  • 165.
    8© 2017 SAPSE or an SAP affiliate company. All rights reserved. Specialized Hospitals Rehabilitation Community Practice Pharma Research Payer Medical Devices LabsProviders SAP Health Enables Actionable Insights by Leveraging the Healthcare Ecosystem Patient Connected Integrate evolving data sets across the healthcare continuum Real-time Provide up-to-the-moment insights for improved decision making and greater patient and population health insights Actionable Advanced analytics and queries to spot trends, run scenarios, set new standards for treatment and delivery
  • 166.
    9© 2017 SAPSE or an SAP affiliate company. All rights reserved. SAP Health Drives Innovation as the Catalyst for Healthcare Transformation SAP Applications • Patient Engagement • Patient Management • Clinical Research • Clinical Quality . Partner Applications Facilitates Healthcare Network collaboration through integrated insights and application services that support coordinated patient-centric, health and wellness scenarios SAP Federated Data and Analytics Connecting data silos, providing real time insights, and supported by SAP HANA in- memory computing for improved decision- making, hypothesis-building and testing Accelerated Innovation with broad application portfolio, connected medical devices, automation and machine learning Integrated User Interface SAP Health Platform SAP HANA Platform
  • 167.
    10© 2017 SAPSE or an SAP affiliate company. All rights reserved. “There’s nothing that can make a difference in the world more than improving the outcomes of health in society. And therefore, we’re totally dedicated to it.” Bill McDermott, CEO of SAP SAP Dedication to Improving Patient Outcomes
  • 168.
    Thank you. Contact information: ClemensSuter-Crazzolara, PhD Chief Product Expert SAP Health www.twitter.com/clesucr Tel:+4916090819863
  • 169.
    OUR GOAL ISTO HELP EVERYONE REACH THEIR PERSONAL HEALTH GOALS ANYTIME, ANYWHERE
  • 170.
    CORPORATE HEALTH MANAGEMENT ITPAYS OFF TO HAVE HEALTHY EMPLOYEES.
  • 171.
    ANNUAL LOSS OF PERFORMANCE MAINCAUSE OF ABSENCES - MUSCULOSKELETAL DISORDERS AVERAGE NUMBER OF SICK DAYS PER EMPLOYEE DEMOGRAPHIC CHANGE
  • 172.
    CORPORATE HEALTH MANAGEMENT UPTO NOW AND WITH HUMANOO UP TO NOW ● Varying performance standards ● Different reports – no possibility to summarise findings ● High costs for experts ● No possibility to compare different branches of the company ● No comprehensive management solution ● No single solution for treating physical and mental issues WITH HUMANOO ● ONE performance standard ● ONE report ● NO additional costs for a range of services ● DIRECT comparison of different branches of the company ● ONE comprehensive management solution ● ONE tool for treating physical and mental issues
  • 173.
    THE HUMANOO BOX IMPROVETHE HEALTH OF YOUR EMPLOYEES ● Exclusive gift box to spark the interest of your employees ● Contains a fascia ball, earphones and a one-time activation code ● Facilitates the integration of HUMANOO into the company and increases the activation rate ● Employees can get started straight away after registering through the app or online ● Random assignment of boxes protects the personal data of every employee
  • 174.
    EUROPE’S BIGGEST HEALTHDATABASE PHYSIO Physiotherapy & yoga coaching WORKOUTS Effective training sessions MENTAL TRAINING Meditations and autogenic training NUTRITION Recipes and tips CHAT Employees can speak to our experts if they have specific questions or acute issues OVER 1000 MOTIVATIONAL COACHINGS
  • 175.
    REPORTING & DATAANALYSIS COMPREHENSIVE COMPANY REPORT RECEIVE AGGREGATE DATA AS WELL AS PERSONALISED RECOMMENDATIONS FOR ACTION PHYSICAL HEALTH MENTAL TRAINING NUTRITION GENERAL Affected areas of the body Mental state of your workforce Eating habits of your employees General numbers and statistics Stress Motivation Sleep Concentration Number of vegetarians Number of vegans Other eating habits Percentage of activated profiles Number of chat requests
  • 176.
    DATA PROTECTION ANDDATA SECURITY HUMANOO COMPLIES TO THE STRICTEST EU DATA PROTECTION POLICIES DEVELOPED AND CONTROLLED BY THE DATA PROTECTION SUPERVISOR PWC
  • 177.
    HUMANOO’S EXPERTS ANDRESEARCH CENTRES Anna Trökes Yoga teacher and author of over 30 books Claudia Kunze Motivational trainer and coach for autogenic training in companies Stina Spiegelberg Author of many successful vegan cookbooks Doris Kastl Owner of Germany’s largest physiotherapy practice and respiratory therapy expert Maria Boettner Meditation expert, actress and CEO of the Du hast Pause meditation app Prof. Dr Ingo Fietze Director of the Interdisciplinary Sleep Disorder Centre of the Charité Berlin
  • 178.
    HUMANOO ADVANTAGES ● Increasein performance ● Financial optimisation ● A comprehensive management solution ● Clear competitive edge ● Happy healthy employees ● Modern eHealth approach COMPANY ● Promotion of health ● Reduce doctor’s visits ● Improve quality of life ● Boost productivity ● Increase job satisfaction ● Reduce stress EMPLOYEES INSURANCE ● Digital health tool to offer private and supplemental insurances ● Access routes to reach new clients ● Analysis of public health statistics
  • 179.
    THE TIME THATWE TAKE IS THE TIME THAT GIVE US SOMETHING BACK. ERNST FERSTL
  • 180.
    eTherapists GmbH Oppelnerstr. 26-27 10997Berlin, Germany Tel: +49 (0) 30 120 88 552 Email: sales@humanoo.de www.humanoo.com
  • 181.
    DVFA Michael Kolb Tel.: +49(0)69 264848 130 Fax: +49 (0)69 264848 489 Mail: konferenzen@dvfa.de Content: DVFA Photos: www.shutterstock.com Subject to modifications. Copyright 2017 DVFA GmbH Members of the DVFA Life Science Commission Sascha Alilovic, MorphoSys AG, Martinsried/Planegg Dr. Christa Bähr, CEFA, CFA, Chairwoman, CB HealthCare, Berlin Dr. Viola Bronsema, BIO Deutschland e.V., Berlin Kai Brüning, apo Asset Management GmbH, Düsseldorf Ines-Regina Buth, CBA, akampion, Berlin Dr. Ralf Emmerich, European Investment Fund, Luxemburg Andreas Heinrichs, Bank Vontobel Europe AG, Köln Stefan Höfer, Deutsche Börse AG, Eschborn Dr. Kai Gregor Klinger, RHÖN-KLINIKUM AG, Bad Neustadt a.d. Saale Dr. jur. Dr. med. Adem Koyuncu, COVINGTON & BURLING LLP, Brüssel Dr. Solveigh Karola Mähler, MC SERVICES AG, Düsseldorf Dr. med. Markus Manns, Chairman, Union Investment Privatfonds GmbH, Frankfurt Dr. Markus Metzger, STADA Arzneimittel AG, Bad Vilbel Dr. Marie-Luise Roth, DIB Deutsche Industrievereinigung Biotechnologie, Frankfurt Dr. Martin Schnee, CBA, CCrA, Schnee Research, Maintal Dr. Julia Schüler, CBA, BioMedServices, Darmstadt Prof. Dr. Joerg Vienken, Nephro-Solutions AG, Hamburg DVFA – Society of Investment Professionals in Germany DVFA is the Society of Investment Professionals in Germany, founded in 1960. Currently, DVFA has more than 1,400 individual members representing over 400 investment firms, banks, asset managers, consultants and counselling businesses. DVFA assures the credibility of the professionals and the integrity of the market by offering internationally recognised qualification programmes, by providing platforms for professional financial communication, and by effective self-regulation. Via EFFAS, the umbrella organisation of European Analysts Societies, DVFA offers access to a pan-European network with more than 17,000 investment professionals in 27 nati- ons. Via ACIIA, the Association of Certified International Investment Analysts, DVFA is part of a worldwide network of more than 100,000 investment professionals.