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Entrepreneurship in Innovation

Entrepreneurship in Innovation. November 24, 2008. THE EIT – SHAPING THE KNOWLEDGE AND INNOVATION COMMUNITIES (KICs). Alexander von Gabain. Safe Harbour Statement.

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Entrepreneurship in Innovation

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  1. Entrepreneurship in Innovation November 24, 2008 THE EIT – SHAPING THE KNOWLEDGE AND INNOVATION COMMUNITIES (KICs) Alexander von Gabain

  2. Safe Harbour Statement • These materials contain certain forward-looking statements relating to the business of Intercell AG (the “Company”), including with respect to the progress, timing and completion of the Company’s research, development and clinical trials for product candidates, the Company’s ability to manufacture, market, commercialize and achieve market acceptance for product candidates, its ability to protect its intellectual property and operate its business without infringing on the intellectual property rights of others, the Company’s estimates for future performance and its estimates regarding anticipated operating losses, future revenues, capital requirements and its needs for additional financing. In addition, even if the Company’s actual results or development are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of the Company’s results or developments in the future. In some cases, you can identify forward-looking statements by words such as “could,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” or similar words. These forward-looking statements are based largely on the Company’s current expectations as of the date of this presentation and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the Company’s expectations could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, the impact of the global credit crisis, and the Company’s ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. The Company is providing the information in these materials as of this date, and we disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ENTREPRENEURSHIP IN INNOVATION

  3. Vaccines a visionary mission for the better of our blue planet • Novel vaccines, a desperate need for customers in developed and less developed countries • The market place of a vaccine biotech player • Case study Intercell: from technologies to novel vaccines • How to combine innovation and entrepreneurship in biotech ENTREPRENEURSHIP IN INNOVATION

  4. Microbial infections – key threat of human life OVERVIEW • Terminate every 4th human life • 13 million deaths per year in developing countries • Three major killers: Malaria, AIDS and Tuberculosis • Novel emerging pathogens • Bioterrorism • Pandemic influenza Worldwideapprox. 500,000 people killed by the annual flu epidemic • Multi-drug resistant microbes Estimated 50,000,000 people killed by pandemic flu 1918 NOVEL VACCINES, A DESPERATE NEED FOR CUSTOMERS IN DEVELOPED AND…

  5. Vaccine dosesin m • Casesper 100,000 Vaccines the most successful medical intervention – a cost efficient success story • EXAMPLE: HIB MENINGITIS CASES AFTER INTRODUCTION OF THE VACCINE IN THE US NOVEL VACCINES, A DESPERATE NEED FOR CUSTOMERS IN DEVELOPED AND…

  6. The vaccine field: challenges ahead and new paradigms • FORCES AT WORK • Many existing vaccines do not protect important population cohorts (e.g. neonates and elderly), are produced by • outdated tools and have unacceptable side • effects • List of licensed vaccines against infectious diseases is short • List of microbial diseases without efficacious vaccine regimen is long "Come-back of vaccines" • Novel technologies & scientific progress in micro- and immune-biology re-opened the vaccine field: HBV, Pneumo,HIB, Rotavirus, JEV, HPV • Triangle between industry, academia and NGOs has opened an alliance to develop vaccines in parallel for the developed and less developed world: e.g. TB, Malaria, HIV,JEV,Pneumo NOVEL VACCINES, A DESPERATE NEED FOR CUSTOMERS IN DEVELOPED AND…

  7. Growing knowledge in immunology, host parasite interaction and production technology: enabling factor of novel vaccines DELIVERY SYSTEMS ANTIGEN ADJUVANT Live attenuated Killed whole cell Subunit Polysaccharides Proteins/peptides Aluminium salts LT-Patch, IC31® MF59, MPL and more T-cell immunity(e.g. Hepatitis C, Hepatitis B, Tuberculosis...) B-cell immunity(e.g. Japanese Encephalitis, Polio, TBE, Group A Streptococcus...) NOVEL VACCINES, A DESPERATE NEED FOR CUSTOMERS IN DEVELOPED AND…

  8. Industry landscape % of market share Vaccines: operating in an attractive market segment with blue chip players GLOBAL VACCINE MARKET Traditional and combinations US$ bn Novel and therapeutic vaccines 21.9 16.6 11.7 • Others** • sanofi-pasteur 8.8 6.8 • Novartis 2.0 1990 2001 2003 2005 2007 2009E • GSK Expected CAGR 2003 - 2009 • Merck & Co. * sanofi-pasteur – World Market Analysis 2007** New Players in US/EU and developing countries • Global vaccine market 16% • Novel and improved vaccines 38% • Wyeth THE MARKET PLACE OF A VACCINE BIOTECH PLAYER

  9. The innovation gap of the established pharma and vaccine industry - a fact DIFFICULT TO CLOSE WITHOUT INSOURCING Number of new FDA approved drugs • bn US$ Pharma R&D spending Source: Phar-maceutical Research and Manu-factures of America, FDA, Burill & Co. THE MARKET PLACE OF A VACCINE BIOTECH PLAYER

  10. Pharma and biotech products take time, need significant investments and are not risk free WITHOUT RISK AND INCENTIVES NO NOVEL DRUGS Clinical development Development(pre-clinical) Submissionof license Productlicensing Research Phase I1st year Phase II 1 - 2 year Phase III 3 - 4 year • Likelihood of success • (percent) • 5 • 10 • 10 - 20 • 20 - 50 • 50 - 90 • 90 - 95 • 99 • Cost • (m US$) • 10 - 250 • 20 - 225 • 20 - 200 • 50 - 175 • 100 - 125 • 10 - 15 • 5 - 10 • S 215 - 1.000 • Time(years) • 4 - 6 • 1 - 2 • 4 - 6 • 1 THE MARKET PLACE OF A VACCINE BIOTECH PLAYER

  11. Drug and vaccine development needs gigantic investments NO NEW DRUGS WITHOUT ENTREPRENEURSHIP If you think research isexpensive, try disease Mary Lasker (1901-1994) THE MARKET PLACE OF A VACCINE BIOTECH PLAYER

  12. Biotech industry provides hope: major part of product pipeline comes from smaller biotech COMPOUNDS IN DEVELOPMENT BY COMPANY SIZE Others (mainly biotech) Top 100 Pharma players 69% Number of compounds 68% 67% 31% 55% 32% 33% 45% Source: PharmaProjects, BCG THE MARKET PLACE OF A VACCINE BIOTECH PLAYER

  13. Intercell, an international biotech player, a spin off from a public/private research center of excellence History: Spin off from the Campus Vienna Biocenter, IMP and University 1999. Today 388 employees from 33 nations in Vienna, Edinburgh & Washington DC Partners: Merck (USA), Sanofi Aventis, Novartis, Wyeth, Kirin, SSI, Biological E, EC, NIH, CDC, WRAIR, AERAS foundation, Karolinska, MPI, GBF and many more academic organizations Products: Therapeutic & prophylactic vaccines and antibody treatments based on cutting edge R&D Funding: Since 2005 listed at the ATX (ICLL): Today’s Market cap: approx. $ 1.5 bn.Since 2007 profitable People: » Key Management: G. Zettlmeissl (CEO), A. v. Gabain (CSO and founder), T. Lingelbach (COO) & W. Lanthaler (CFO) » Supervisory board: M. Gréco (Chair), E.G. Afting, S. Bakali, D. Ebsworth, J. Sulat, H. Wigzell » SAB: R. Ahmed, H. Blum, S. Cohen, F.X. Heinz, S. Kaufmann, S. Normark, H. Wigzell CASE STUDY INTERCELL: FROM TECHNOLOGIES TO NOVEL VACCINES

  14. Time • Core assets • Academic excellence • Visionary technologies • 1998 - 2002 • Efficient product development • Implementation of core technologies • 2002 - 2004 • JEV clinical success (Novartis) • AIP and IC31® (Merck, Sanofi, Kirin, Wyeth) • 2004 - 2008 History and strategic development of the company • AN AUSTRIAN BIOTECH PLAYER MOVES INTO THE EUROPEAN TOP LEAGUE “Start up” "First steps" "Growth" • Stra-tegy • Transformation from academia to industry • Risk diversifi-cation • Acquisition of further technology platforms (IOMAI) CASE STUDY INTERCELL: FROM TECHNOLOGIES TO NOVEL VACCINES

  15. Combination of complementary innovative technology platforms • LEVERAGING TECHNOLOGIES • INTERCELL • ADJUVANTS • DELIVERY • ANTIGEN • Antigen Identification Program (AIP®) • Vaccine Improvement Program (VIP) • Needle Free Vaccine Patch Technology • Protective antigens for novel vaccines • S. aureus • Pseudomonas • Pneumococcus • Borrelia • and more… • B-cell and T-cell adjuvants • IC30 • IC31® • and more… • Three complementary technology platforms enable the company and its partners to deliver novel vaccines CASE STUDY INTERCELL: FROM TECHNOLOGIES TO NOVEL VACCINES

  16. Vaccine innovation – building a pipeline • INTERCELL TODAY Strong Partnerships: • Technologies • Products • AIP® • Technology generating novel vaccine and antibody products ~10 targets • New global travelers' vaccines • Japanese Encephalitis vaccine – expected market approval US/EU/AUS 2008, India 2009 • Travelers' Diarrhea vaccine patch – expected start of Phase III H1 2009 • Innovation-driven company for vaccines, antibodies and delivery technology • Hospital-acquired infections (vaccines & antibodies) • Approach for vaccines & antibodies • S. aureus vaccine – in Phase II • Pseudomonas vaccine – expected start of Phase II/III in 2008 • IC31® • New vaccine adjuvants • Products for • Therapeutic Hepatitis C vaccine – in Phase II • Patch / Pandemic Flu vaccine – in Phase I/II • IC31® / Seasonal Flu vaccine – in Phase I/II • Protein-based Pneumococcus vaccine – expected start of Phase I early 2009 • IC31® / TB vaccine – in Phase I/II • Vaccine patch • Technology for needle free vaccine delivery CASE STUDY INTERCELL: FROM TECHNOLOGIES TO NOVEL VACCINES

  17. Entrepreneurship – a forbidden city for a professor? HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  18. Academia and Commerce – how to combine them in a company Gabain & Lanthaler in EMBO reports 2003, Vol. 4, No. 7, p. 642 - 646 HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  19. Understanding – the first step towards mutual respect • DRIVING FORCE AT LEADING UNIVERSITIES AND ACADEMIC INSTITUTIONS • Best of class teachers and scientists • Education of top class students • Documented competence in science or in high tech services (e.g. academic hospitals) • High impact publications, awards, etc • Successful funding of the programs • Good performance and historical record • Respect of the international peers • Lead to basic understanding of biomedical principles that pave the way for new technologiesDriving force: "curiosityand prestige“ HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  20. Understanding – the first step towards mutual respect • DRIVING FORCE AT COMPANIES • Talented scientists with managing skills merge with business developers, financial and marketing experts • Scientific ideas with product potentials approved by respected senior scientists, but also by the need of the market • Strong IP position • Investors who want a return of their investment • Validation of the technologies/ products by established pharma players • Successful positioning of the company‘s mission, achievements and products • Lead to sustainable companies and productsDriving force: "value creation" HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  21. 1% • BioTechInnovation The competence triangle of biotech companies • GREAT TALENTS IN THREE AREAS MAKE GOOD COMPANIES • Pharma • KNOW-HOW • Strategic • FINANCING & BUSINESSDEVELOPMENT • Top • R&D HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  22. How to form an efficient team with strong individuals in the biotech triangle? • ACADEMIC RESEARCH • COMPANY R&D • Go for the best but with social intelligence • Make sure they understand the masterplan & the risk to fail • Make sure they form a strong team • Create respect for the involved competence areas • Encourage everybody to balance the strength/weakness profile of the other team members Source: Science, Vol. 308, p. 640 HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  23. Building biotech: market the company, its technology and underpinning science to investors and the public CREATE MORE VALUE THAN INVESTED CASH Cash flow Value Public listing 100 500 Corporate buyer, IPO banks 300 Mezzanine investors 50 Private equity/late stage VCs 100 Early stage VCs Businessangels Time Friends,family Publicseed Incubators Source: TVM HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  24. 12 Grant income Financing history of Intercell - Investors' trust is a building block for biotech • THE ART OF BIOTECH BUILDING * Gross proceeds in € m Grants from:WWFFFGGAWSEUNIHPATHVC investors:TVMApaxNomuraMPMNIB CapitalGLSV…… • Products • R&D 98/99“A“ 99-02 Austrian technology investors 2000“B“ 2003“C“ 2005IPO 2006SPO NovartisInvest-ment Total Companyvalue (in € bn) ~10 ~40 ~65 ~45 ~160 ~400 ~800 ~1.200 HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  25. Biotech success: create value with relatively low revenues USA VERSUS EUROPE – A LONG WAY TO GO • Market cap • Revenue • In US$ bn • 2007 • 2007 Biotech Companies USA • Amgen • Genentech • Genzyme • 49.23 • 70.42 • 20.14 • 14.77 • 11.72 • 3.81 • Total • 139.79 • 20.30 Biotech Companies Europe • Actelion • Intercell • 5.77 • 1.78 • 1.32 • 1.39 Accumulated value ofUS Biotech:$ 350 bn European Biotech:$ 30 bn • Total • 7.55 • 2.71 HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  26. Europe has strong assets to support a strong entrepreneurial-driven biotech industry HOW TO CAPITALIZE ON THE ASSETS • High level of education • Solid academic base • Top science at many historical power houses of research: EMBO, Pasteur, Karolinska, Cambridge, Oxford, Max Planck, IMP etc.. • Increasing number of Centers of Excellence • Long tradition of pharma development • Excellent clinical institutions with the potential to carry out studies • Growing interaction between the national bio-medical scenes • Scientific output in biotech is even larger than in the USA HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH

  27. Lessons to be learned for Europe IT’S NOT TOO LATE • Accept the financing tools that have built the US Biotech industry (VCs, stock markets, etc…) – there is no European way to create Biotech industry • Make our continent attractive for international VCs • Prepare incentive structures in legal and tax regulations that encourage investment and entrepreneurship • Stop the incentive structure for half professor/half entrepreneur players in protected academic shelters • Stop subsidizing biotech industries with more public money than private investment • Accept failures without moral attitude and recognize the value of company built up per se • Expand the horizon of life science students towards biotech industry

  28. Why do polar bears not hunt for birds but for seals? What bioenergetics is teaching us! FOCUS TIME, ENERGY AND INVESTMENTS ON WORTHY TARGETS

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