Life Science Activities in the Area of Economic Policy, Innovation and Technology Peter Schintlmeister

Overview 2  Why Life Sciences?  The Life Science Sector in Austria  Action Plan Biotechnology 2013  Life Sciences Strategy 2016  Programme Life Science Austria (LISA)  Instruments for Financing: PreSeed, Seedfinancing  Business-Plan-Competition: Best of Biotech (BOB)  International Marketing of Austria as a Location for Life Sciences  Knowledge Transfer Centre Life Sciences – Translational Research  Support Programme „Rare Diseases“  Further Support Measures for Life Science in Austria

Why Life Sciences?  Working Definition of Life Sciences:  Biotechnology  Pharmaceutical Science  Medical Devices  Sector specific problems  High regulatory requirements  Working in/with patients  Animal testing  Ethical Requirements  Long time to market  e.g. for New Medical Entities (NME): 8-12 years to market entrance  High Development Costs  e.g. for New Medical Entities (NME): in average up to 1.2 bn. € up to market entrance  Sector specific market failure 3 HIGH INTENSITY IN R&D The share of R&D in the Austrian Life Sciences sector is about 14% (of turnover). The average of the industry as a whole is around 2%

The Austrian Life Science sector Turnover equals 5.8% of Austrian GDP Definition: Biotechnology, Pharmaceuticals, Innovative Medical Devices Status: bn. € Turnover Workforce 823 Enterprises

Action Plan Biotechnology 5  Strategic Action Plan of the BMWFW in 2013  specific actions in the area of Life Sciences for immediate implementation  Applied Research:  Knowledge Transfer Center Life Science / Translational Research Center  specific Call in „Research Studios Austria“ 2013 (16,8 Mio. € – 1,3 Mio. € per studio)  Development:  Relaunch of the Seedfinancing-Programme (6 Mio. € per year)  Support Programme for Rare Diseases (10 Mio. €)  Growth Phase / Market entry:  Risk Capital – Business Angel Fund, Young Entrepreneurs Fund („Gründerfonds“)  Competence Centres: COMET

Life Sciences Strategy  Strategy of the BMWFW along the whole value chain  covers all aspects of life science and health:  Basic Science  Personalized Medicine / Precision Medicine  Clinical Trials  Cooperation Science and Industry  Translational Research  Start-Ups / Foundation of enterprises  Research Infrastructure  Production and Market, Public Procurement  Communication, Science Dialogue  more than 250 stakeholders directly involved, public consultation now open!  to be presented in June 2016

Life Science Support 7 INDIRECT PROPORTIONALITY OF RISK AND FINANCIAL REQUIREMENTS The closer the proximity to the market the less the necessity for financial support by public means. Technical Risk Double Equity, Gründerfonds, BA Fund, VC Initiative Guarantees, Loans Applied Research / Development Growth / Market Basic Research R&D PoC Loans, Guarantees, Equity Grants PreSeed BOB Seed- financing Applied Research Support and Consulting via AcademiaplusBusiness Center (AplusB) Financial Requirements Various Funding Instruments Support for Basic Res. Support by the Regions Interim Management Programm (“Management auf Zeit”)

LISA - Life Science Austria 8 - BOB – Best of Biotech Business-Plan-Competition -Counselling & Due Diligence during Pre-Start-Up-Phase - Knowledge-Transfer Center Life Sciences -Strategic Analyses, Statistics, Studies FINANCEFUEL PreSeed € Seedfinancing € ADVANCE - International Marketing of Austria as a Life Science Location - Support in finding further investors - Life Science-Lectures FOSTER LISA is a comprehensive set of support measures for strengthening the Life Science sector in Austria.

LISA Seedfinancing Overview 9  LISA PreSeed – before the firm exists  highly research-intensive projects with high technological risk  max € grant per project  : 64 projects approved  Out of 49 PreSeed-projects firms already have been founded  LISA Seedfinancing – from the start-up to the growth  projects with a high technological and economical risk  max € per project  grant – repayable in case of extraordinary business success  : 75 projects approved (47,8 Mio. €) FIRMS SUPPORTES BY LISA WERE ( ) ABLE TO: - ACQUIRE MORE THAN 1,17 BN. € ADDITIONAL PRIVATE EQUITY - GENERATE REVENUES OF MORE THAN 550 MIO. €

LISA success stories 10 License and sales deals of successfully supported start-ups

Best of Biotech  International Business-Plan-Competition  Held (biennially) since 2000 (2015: 7. issue)  2 Phases:  Phase I: submission of short business ideas/concepts  Phase II: submission of elaborate business plans  Intensive coaching for participants  Evaluation by an international jury  Prizes in Cash (up to €)  Benefits for the BMWFW:  Increase in entrepreneurial potential in the life sciences  Raise in profile for Austria/CEE in its role as Life Science Business Incubator  since 2000 more than 80 companies founded! 11 PARTICIPANTS 2015 CAME FROM: Austria, Italy, Finland, India, Poland, Slovenia, Czech Republic, Hungary Denmark, Germany, USA, United Kingdom, Uganda

LISA international Marketing Health Technology Cluster ecoplus LISAvienna Cluster Life Sciences Tirol Human.technology Styria Since October 2007 LISA - Life Science Austria – represents all Austrian Life Science activities externally as a common brand. Partners are the aws (Funding Agency) as well as the regional Life Science Clusters 12

WTZ Life Sciences  Thematic Knowledge Transfer Centre Life Sciences  17 Partner in the consortium  9 Universities  6 Research Institutions  2 Technology Transfer Centres  Coordinator: Universität Wien  Funding Volume: € per year  Start: August 2014  Development of preclinical projects for new medical entities in therapeutic and diagnostic uses (biologicals as well as classic pharmaceutical compounds) 13

WTZ Life Sciences 14 Thematic Knowledge Transfer Centre Life Sciences

Rare Diseases 15  Rare diseases but many affected  EU Definition: less than 5 out of people are affected by a specific condition  but: in total ca – different conditions  thereof are ca. 80% genetic disorders  in total 6-8% of the (European) population is affected!  Examples:  Cystic Fibrosis  Epidermolysis bullosa („Butterfly Children“)  Mucopolysaccharidosis  …  Severe market failure:  Low case numbers  High technological risk  Long time (<12 years) and high costs (<1,2 bn. €) up to market entry  Low incentive for pharma industry to develop new therapies/diagnostics

Rare Diseases 16  Anchored in Action Plan Biotechnology 2013  Since 2013 own programme within FFG „ Basis Programme“  Budget: 10 Mio. € (2013 – 2016)  Higher support intensity (grant percentage up to 70%) raises incentive for R&D  Increased availability of capital for R&D  leverage within the FFG „Basis Programme“ ca. 1:1  (1 € grant is coupled with ca. 1 € of low-interest loan)  Results up to 2015  14 new applications (75% SME)  9 applications approved (sum of grants 6,43 Mio. €)  all projects contribute to new or improved therapies or diagnoses

Further support in Life Sciences 17  Österreichische Forschungsförderungsgesellschaft (FFG)  Basis Programme (278 Mio. €, variable mix of grant and loan)  Support of clinical studies for SME (Klipha)  Rare Diseases  Start-up support  Competence Headquarters  BRIDGE  COMET (Competence Centres)  Research Studios Austria  Christian Doppler Association (Cluster: Life Sciences, Medicine)  tax premium (12% of expenses in R&D)  Regional Support schemes / AplusB-Zentren

18 Further Information Federal Ministry of Science, Research and Economy Division C1/9 technical-economic Research DI Peter Schintlmeister Stubenring 1 | 1010 Wien | Austria Tel.: +43 (0)