Bedre innovasjon gjennom europeisk forskningssamarbeid våre erfaringer

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1 Bedre innovasjon gjennom europeisk forskningssamarbeid våre erfaringer Forskningsrådet / NHO / Norsk Industri / Innovasjon Norge Frokostmøte Knut T. Smerud, CEO 1

2 Agenda Innovasjon definisjon SMERUD s forretningsidè SMERUD s innovasjonsmodell Resultater Erfaringer Fast Track to Innovation 2

3 Innovasjon: definisjon Iht OECD: En innovasjon er implementeringen av et nytt eller et betydelig forbedret produkt (vare eller tjeneste), eller en prosess, en ny salg og markedsføringsmåte, eller en ny organisasjonsmetode; i forretningspraksis, arbeidsplassorganisering eller eksterne relasjoner. 3

4 Innovasjon: i praksis Merverdi skapt gjennom fornyelse og forbedringer Forutsetter kompetanse og innebærer endringer FoU som oftest integrert Innovasjonsgrad og økonomisk verdiskapning korrelert Mål: økt lønnsomhet og konkurranseevne Interne og eksterne impulser gir innovasjonsevne Utvikling og mobilisering av bedriftens egne ressurser 4

5 SMERUD s forretningsidè Bransje Kjernekompetanse Marked 5

6 Drug development Time Scale of the Research Process 6

7 Utviklingskostnader for et legemiddel Mill USD Kilde: J.A. DiMasi and H.G. Grabowski, The Cost of Biopharmaceutical R&D: Is Biotech Different?, Managerial and Decision Economics 28 (2007):

8 Competencies needed to develop a drug Regulatory Affairs Drug manufacturing Legal & IP Non-Clinical Development Project Core Team Business & Marketing Clinical development Health Economics Statistics 8

9 SMERUD s core business Fee-for service Contract Research Organisation (CRO) Managing clinical trials Local/regional specialists for regulatory affairs Clinical monitoring Data management and Statistics Medical Writing Clients mainly non-norwegian, global big pharma Outsourcing of specialised R&D personnel Consulting 9

10 Markedssituasjon ca Internasjonal finanskrise Big pharma revurderte sin posisjon og investeringsvilje i R&D, særlig i Norden Marked for kliniske utprøvninger i Norden -40% mht antall Endring i størrelse (verdi) av prosjektene; trolig % Prisfall 10

11 Norway by phase 11

12 Status praesens 2010: Samling i bånn SMERUD-gruppen 93 ansatte, 85 årsverk Norge, Sverige, Danmark. Finland, UK, Polen Ordrereserve tilsvarende 30 årsverk Høy kompetanse og erfaring Sviktende marked Sterk likviditetsreserve Strategisk ledelsesbetraktninger Nedbemanne (halvere stab, akseptere tap), eller Kjærringa mot strømmen -strategi og investere? Eureka: INNOVASJON 12

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14 Revidert strategi: SMERUD s core business Invest into internal R&D Understand international R&D grant opportunities Seek leadership roles in consortia Exploit free capacity in such R&D projects Co-finance projects with cash-strapped partner companies Offer risk-taking with companies that previously were clients Provision of competent venture capital 14

15 RESULTATER 15

16 SMERUD R&D investment ( ) Individual projects (#) 62 R&D hours (#) 92,350 Full-time equivalents (man-years) 57.7 Fraction of total hours (%) 19.8 R&D expenses (mnok) 60.0 (6.0 m ) (7.3 m ) EU funds raised* (mnok) *through 7 contracts with Eurostars, FP7, ETB, Euronanomed covering (2.8 m ) (3.4 m ) 16

17 SMERUD R&D portfolio Selected examples with public R&D co-funding Eurostars Alimenta / mucosal patch technique for diagnosing IBS AlgiPharma / oligog for the treatment of cystic fibrosis Wnt Research / Foxy-5 for metastatic cancers Lytix / diabetic foot infections EuroTransBio Aromics: Serpins in the treatment of hepc/hiv Euronanomed II NANOASIT: Novel delivery method for allergy vaccination Framework Program 7 Premacure/Shire: IGF-1 for prevention of retinopathy Athera: PC-mAB in preventing secondary CVD events 17

18 SMERUD internationalisation / revenues Stoppet l nedgang i norsk omsetning Domestic vs international as % of total revenues (year ) 18

19 Outcome Gradually becoming a drug development company Controlling larger portion of value chain Raising internal competency Enabling world-class career development for talents Turned financial losses ( ) into profit ( ) and with underlying project assets not yet activated as income However, cash is king : we still deliver CRO services as our bread & butter revenue generating business 19

20 Concluding advice to Norwegian SMEs Always consider internationalisation as key strategy EU R&D consortia excellent tools Training ground as Partner, then Driver s seat as Coordinator Start with Eurostars, advance into H2020 Be aware of and exploit national R&D support Norway UK Best in Europe support from National Contact Points Eurostars Horizon 2020, for Health and SMEs PES SkatteFUNN Best in Europe R&D tax refund 20

21 Hva med Fast Track to Innovation? Ligner på Eurostars? Større budsjett pr prosjekt EU-finansiert ikke nasjonalt; mindre søketaktikk Lengre tid til grant Kun måneder til implementering Demonstration Market-oriented R&D Max 36 måneder fra grant til markedsføring Men hva betyr market-ready results F.eks. selge produktet etter fase 2 til big pharma? 21

22 Outcome 2: Ikke-kvantifiserbar verdiskapning... Vårt eget Theatre of Dreams Champions League er Champions League! Utsikt fra SMERUD s Manchester-kontor 22

23 Thank you for your attention! Web Phone Mobile

24 Back-up slides 24

25 Internationalisation / SMERUD locations Smerud Medical Research International AS Established 1993, now 70 employees HQ in Norway, 100% owned subsidiaries in 10 countries Denmark, 1996 Sweden, 1997 Finland, 1997 Poland, 2005 United Kingdom, 2006 Austria, 2011 Germany, 2014 Russia, Hungary, (United States, 2009) 25

26 All phases Nordic area 26

27 SMERUD R&D portfolio pending still hoping Horizon 2020 Submitted September 2014 / stage 1 SMR-3056 (Norwegian biotech) SMR-3106 (Swedish academic group) SMR-3011 (Swedish biotech) Advanced to stage 2 SMR-3056 (Norwegian biotech) SMR-3106 (Swedish academic group) 27

28 SMERUD R&D portfolio with local R&D co-funding UK R&D relief for corporation tax; the SME scheme Tax relief on allowable R&D costs = 225% Employee costs Materials Payments to clinical trial volunteers Subcontracted R&D: 65% claim back Upper limit 7.5 million per project 28

29 Lessons learned Globalisation means threats and opportunities, but we have no choice there is no local environment Global players compete domestically Domestic players must adapt to international levels in terms of quality, complexity, pace, pricing Has required and rewarded Innovative thinking Agility Flexibility International hiring (and firing) Transformation to international business proactivity, competitiveness and ambitions 29

30 Lessons learned Internal change management of Operations Technology Markets Business segments Investment Increased focus on export fosters international thinking at management level Relocation Outsourcing International project partnering with clients Networking with other SMEs 30

31 Concluding advice to politicians Norway could be a leader per capita in medical biotech Good market to establish a company Very good R&D support systems for SME companies Strengthen national budget for early-phase clinical trials (up to and including phase 2) Eurostars national grants remove upper limit per project PES Support biotech clusters, and there are other areas than cancer Kidney transplantation Rheumatology Neurology Osteoporosis 31

32 Summary Internationalisation A bit for fun, but mostly a strategic approach to Foster competence building Attract global talents Build corporate culture Raise R&D grants through collaborative consortia Expose your business to investors, stakeholders, clients outside our domestic pond You ll get to know a number of airports, but it s certainly worth it 32