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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

November 24, 2008

THE EIT – SHAPING THE KNOWLEDGE AND INNOVATION COMMUNITIES (KICs)

Alexander von Gabain


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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


Vaccines a visionary mission for the better of our blue planet l.jpg
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


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Microbial infections – key threat of human life planet

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…


Vaccines the most successful medical intervention a cost efficient success story l.jpg

  • 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…


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The vaccine field: challenges ahead and new paradigms planet

  • 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…


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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…


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Industry landscape and production technology: enabling factor of novel vaccines

% 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


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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


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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


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Drug and vaccine development needs gigantic investments investments and are not risk free

NO NEW DRUGS WITHOUT ENTREPRENEURSHIP

If you think research isexpensive, try disease

Mary Lasker (1901-1994)

THE MARKET PLACE OF A VACCINE BIOTECH PLAYER


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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


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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


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  • Time a public/private research center of excellence

  • 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


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Combination of complementary innovative technology platforms a public/private research center of excellence

  • 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


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Vaccine innovation – building a pipeline a public/private research center of excellence

  • 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


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Entrepreneurship – a forbidden city for a professor? a public/private research center of excellence

HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH


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Academia and Commerce – how to combine them in a company a public/private research center of excellence

Gabain & Lanthaler in EMBO reports 2003, Vol. 4, No. 7, p. 642 - 646

HOW TO COMBINE INNOVATION AND ENTREPRENEURSHIP IN BIOTECH


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Understanding – the first step towards mutual respect a public/private research center of excellence

  • 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


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Understanding – the first step towards mutual respect a public/private research center of excellence

  • 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


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1% a public/private research center of excellence

  • 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


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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


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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


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12 underpinning science to investors and the public

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


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Biotech success: create value with relatively low revenues underpinning science to investors and the public

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


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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


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Lessons to be learned for Europe entrepreneurial-driven biotech industry

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


Why do polar bears not hunt for birds but for seals what bioenergetics is teaching us l.jpg
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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