Sample & Assay Technologies- 1 -

2. DVFA-Life Science SymposiumFrankfurt, 17. Juni 2009

Von der Molekulardiagnostik zur Personalisierten Medizin

Industrietrends und Fallstudien

Dr. Thomas SchweinsVice President Marketing & Strategy

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Agenda

QIAGEN: Facts, Business Model & Strategy

Trends Molecular Diagnostics:

Case Study: Diagnostic HPV Test

Trends Personalized Medicine

Case Study: Prognostic K-ras Test

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QIAGEN at a Glance: A Focused Market Leader

Financial overview

Sales 2008 $893 M

Gross- / EBIT margin1 72% / 29%

Organic growth 10% - 15%

Market capitalization2 $3.5 B

Presence Global

Financial overview

Sales 2008 $893 M

Gross- / EBIT margin1 72% / 29%

Organic growth 10% - 15%

Market capitalization2 $3.5 B

Presence Global

Customer, Innovation and Employees

# Customer 400,000

R&D $120 M

Patents & Licenses >2,000

Products < 3 years old 17%

Employees >3,000

Customer, Innovation and Employees

# Customer 400,000

R&D $120 M

Patents & Licenses >2,000

Products < 3 years old 17%

Employees >3,000

1 Adjusted figures exclude business integration and relocation related charges as well as amortization of acquired intangibles and equity-based compensation (SFAS 123R).

2 As of June 9, 2009

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QIAGEN With a Strong Financial Performance

(1) Analyst estimatesSource: QIAGEN

in US$M

2003 2004 2005 2006 2007 2008200

300

400

500

600

700

800

900

1,000

CAGR2003-2008 = 21%

2009E(1)

Asia

North America

50% 37%

10%

Europe

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Typical Products: Instruments = 10% of Sales

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Typical Products: Consumables = 90% of sales

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Sample and Assay Technologies

Results

Information

Virus detected

Yes

No

SamplePreparation

Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mRNA, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Salts, Polymerases,

Centrioles, Immunoglobulins, DNA,, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mRNA, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Carrier proteins

DNA

Pure Genes

DNA

ComplexBiological Sample

Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mRNA, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Salts, Polymerases, Centrioles, Immunoglobulins, DNA,, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mRNA, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Carrier proteins

SAMPLETechnologies

ASSAYTechnologies

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Disseminating Technologies Into Four Markets

Product and Technology ContinuumProduct and Technology Continuum

MolecularDiagnostics

RoutineTesting

Pharma

Research &Development

Academia

Life ScienceResearch

AppliedTesting

Routine Testing

Marketleader

Marketleader

Marketleader

Marketleader

SAMPLETechnologies

ASSAYTechnologies

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Leading Position – Multiple Growth Drivers

~$150M

Pharma

~$240M

Academia

Product and Technology ContinuumProduct and Technology Continuum

SAMPLETechnologies

ASSAYTechnologies

~$70M

AppliedTesting

~$430M

MolecularDiagnostics

48%

17%8%

27%

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The Future - Our Vision

Life sciences and molecular technologies have only just started to change the world in which we live.

Molecular information is going to be important and a mega trendWhat makes humans different? And what unique?What is the difference between healthy and sick?How can we identify viruses and bacteria?How can we stop infectious diseases?How can we develop better drugs?How can we improve the food quality?How can we identify criminals?How can we stop cancer?…

Molecular Information Expected to Fuel RevolutionMolecular Information Expected to Fuel Revolution

NIH invests 40.000.000.000 $ per annumEU invests 20.000.000.000 $ per annumPharma invests 40.000.000.000 $ per annumBiotech invests 15.000.000.000 $ per annumAsia invests 6.000.000.000 $ per annum

> Σ

120.000.000.000 $ per annum

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Fast Growing and Very Attractive Market

Molecular Diagnostics within the Health Care System With Increase ImportanceMolecular Diagnostics within the Health Care System With Increase Importance

0

10

20

30

40

50

60

70

Microbiology Immuno MDx

$5 - $10$10- $15

$10- $150

Average price per tests

High value tests increase value … … and significance in health care… …and lead to attractive industry growth

Medical Devices

Therapeutics

Other

IVD

Predisposition

Blood Screening

Virology

Microbiology

Oncology

Women's Health

0

2.000

4.000

6.000

8.000

2006 2008 2010 2012 2014

6.700

5.000

3.800

3.000

2.400

CAGR ~ 18%

Share of health care cost MDx Market Development

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Market Leadership in Molecular Diagnostics

QIAGEN’s market position

No. 1 in HPV testing

No. 1 in automated sample processing

No. 1 in manual sample preparation

No. 2 in PCR technology in MDx

No. 2 in HLA testing

No. 1 in emerging countries

Largest infectious disease assay portfolio

Technology & Infrastructure

120 Mio $ R&D budget in molecular technologies

IP estate: 2.000+ patents & licenses

Broad technology platform

450 individuals in Sales & Marketing

435

350

220

150 140

90

45

0

50

100

150

200

250

300

350

400

450

500

QIAGENRoc

he M

DxGen

probe

Abbott

Siemens

Cepheid

Hologic

(1) Excluding Viral Load and Blood banking business

Molecular Diagnostic Landscape (1) Leading Positions

~

Sales in US$ millions

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Data source: GeneTests database (2006) / www.genetests.org

New Content & Dissemination Drive Market Growth

0

500

1.000

1.500

2.000

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

CT/NG CT/NGHIV

CT/NGHIVHCV

CT/NGHIVHCV

Other ID

CT/NGHIVHCV

Other IDHPV

CT/NGHIVHCV

Other IDHPVHer-2

CT/NGHIVHCV

Other IDHPVHer-2

CF

CT/NGHIVHCV

Other IDHPVHer-2

CFMRSA

CT/NGHIVHCV

Other IDHPVHer-2

CFMRSA

CT/NG

Molecular Dx parameter and # of MDx laboratories Labs /Dx marker

No of LaboratoriesDisease marker for which tests are available

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Increasing Importance of Medical Value Expected

Increasingtesting efficiency

Improvingmedical value

Value creation

2000 2010 2020

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QIAGEN With Focus on Efficiency and Medical Value

Increasing Testing efficiency Improving Medical value

Value creation

2000 2010 2020

Integrated workflows

MRSA for HAI

Cervical Cx Screening Colon cancerstratification

Molecular Tumor Staging

HIV: Test & treat

Ultra-fast sepsis analysis

POC Antibiotics selection

Breast cancerprediction

Integrated systems

Point-of-care testing

Instrument size

Multiplexing

Menu breath

Data integration

Ease-of-use

High Resolution

SensitivityConnectivity

New-born predisposition

HPV: Test & Vaccinate

Examples

OTC TestsConsumer Tests

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From Patient Sample To Clinical Results QIAGEN Provides Advanced Sample And Assay Technologies

Sample and Assay Technologies from Sample to ResultSample and Assay Technologies from Sample to Result

Diagnostic Results

Patient sample Sample technologies Assay technologies

SampleStabilization

Storage

Sample Collection

NA PurificationManual & Autom.

LT – MT – HT Assay Technologies(PCR, QIAplex, HPV)

qPCR Pathogen Detection

Multiplex Pathogen Detection

HPV Testing

Pyro- sequencing

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Agenda

QIAGEN: Facts, Business Model & Strategy

Trends Molecular Diagnostics:

Case Study: Diagnostic HPV Test

Trends Personalized Medicine

Case Study: Prognostic K-ras Test

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. The digene HPV Test – Preventing Cervical Cancer . The digene HPV Test – Preventing Cervical Cancer

The Cervical Cancer - HPV Connection

Persistent infection with HPV is proven cause of cervical cancer

500.000 new cases every year

250.000 die of cervical cancer

Single HPV test in women age 30

and over is an excellent proxyfor persistent infections

. HPV and Cervical Cancer Prevalence

. Source: National Cancer Institute SEER data

Clinical relevance

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HPV Diagnostic - Enormous Market Potential

Europe45-50M

US50-55M

Asia/Latin America40-50M

Global pap test market

Total WW Pap: 145-160M

(1) Age-adjusted for women age over 30

HPV market potential

~$3.B Total ~100M ~$1.3B

Eligibleannual tests(1)

Potential IVD Market

($)

U.S. 35 M $525 M

Europe 35 M $455 M

Asia/Latin America 35 M $350 M

Potential Lab Market

($)

$1.700M

$1.500M

$900M

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Large Variation in Market Penetration within USA

(1) Area not proportional to market potential

Penetration in %

New York

Los Angeles

Total avail.Market

kTest p.a.

.

HPV Screening Market USA - Metropolitan Areas

0

500

1.000

1.500

2.000

2.500

0% 20% 40% 60% 80% 100%

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team

Patient makesappointment

Doctor orders HPV

Test

Physician discuss test results with patient

Lab runsHPV test

Well Established Multi-Channel Distribution

Patient reimbursed

for test

Physician visit

. QIAGEN with Pharma Business Model in Sales and Marketing. QIAGEN with Pharma Business Model in Sales and Marketing

Key Opinion Leaders

Lab Sales~40 professionalsPhysician detailing

~120 professionals

Key Opinion Leaders

DTC TV Advertising130M impressions

Reimbursement~5 professionals

Women advocacy

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TV Commercial: Jody‘s Story

Pap Did Not Find the Cervical Disease But The HPV Test Did !Pap Did Not Find the Cervical Disease But The HPV Test Did !

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Agenda

QIAGEN: Facts, Business Model & Strategy

Trends Molecular Diagnostics:

Case Study: Diagnostic HPV Test

Trends Personalized Medicine

Case Study: Prognostic K-ras Test

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Patient Stratification: A Win-Win Situation

Potential benefits for PharmaTargeted medicine = higher pricesIncreased success rates in clinical trialsIncreased complianceReduced risks for side effects

Benefits for PatientsIncreased efficacyReduced unnecessary treatmentsIncreased safety and less side effects

Benefits for Payer and ProviderIncreased in efficiencyReduction in health care costs

A

B

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Cancer related

Chronic myeloid leukemia

Gastrointestinal stromal tumor (GIST):

Breast cancer

Pharmaceutical and surgical prevention options

Monitors immune response to heart transplant

Inherited cardiac channelopathies: Prevention & drug selection

Pharmaceutical and surgical prevention options

Guides therapy selection based on resistant HIV mutations

Quantifies the the likelihood of breast cancer

Drug side effects in colon cancer treatment

Treatment dose for drugs that are metabolized by P450

Relevance of tamoxifen citrate in breast cancer therapy

Dose adjustment in acute lymphoblastic leukemia treatment

Show that their type of HIV enters CD4 cells via CCR5

Exclusion of K-Ras mutants increase efficacy

Helps assess Warfarin sensitivity

Adverse reactions in AIDS patients

Personalized Medicine Becomes Reality

Molecular Biomarker Test IndicationTherapy

BCR-ABL

c-KIT

HER-2/neu receptor

BRCA 1,2

AlloMap® gene profile

Familion® 5-gene profile

p16/CDKN2A

TruGene®-HIV 1 Genotyping Kit

Oncotype DX™ 21-gene assay

UGT1A1

Amplichip® CYP2D6/CYP2C19

Estrogen receptor

TPMT

HIV enters CD4 cells via CCR5K-

Ras (B-Raf)

CYP2C9 and VKORC1

HLA-B*5701 allele

Gleevec®

Gleevec®

Herceptin®

Breast/ ovarian cancer

Immunosuppressiva

Pharmaceutical prevention

Melanoma:Preventive treatment

Anti-retroviral drugs

Cancer treatment regimens

Camptosar®

Drugs metabolized by P450

Tamoxifen

Purinethol®

Selzentry

Vectibix, Erbitux

Warfarin

Abacavir

Source: Personalized Medicine Coalition, 2008

A

B

Sample & Assay Technologies- 26 -

How to Detect Cancer ?

Organized structure:Prostate glands (white areas)Surrounded by epithelial cells (blue)

Normal prostate tissue

Cancerous tissue completely disorganizedUncontrolled growth of malignant cells Destroys the normal glandular structure.

Prostate cancer tissue

Pathology is used to determine if a tissue has progressed to cancerPathology is used to determine if a tissue has progressed to cancer

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Molecular Diagnostics is the Future

Yesterday: Pathology Future: Molecular Diagnostics

Macroscopic observationBased on microscopeInnovative staining reagents (Immunohistochemistry/IHC)

Molecular detectionChanges in expression patternDetection of genetic and epigenetic changes

Molecular Dx Enables Better Diagnosis, Classification and TreatmentMolecular Dx Enables Better Diagnosis, Classification and Treatment

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Ras-Pathway: Molecular Mechanisms of Cell Growth

Ras–Raf–pathway

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Single-Run Identification of Oncogenic K-ras Mutants

Sequence to analyze: GGT GGC GTA GGGly12 Gly13

Gly12, Gly13

Gln61

K-ras Sequence Pyrosequencing results for different samples

WildtypeK-Ras

OncogenicMutant in 12

OncogenicMutant in 12

Mutants in 61 are sequenced in parallel in second well Mutants in 61 are sequenced in parallel in second well

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Personalized Medicine: $14 B With Targeted Therapy

5,2

3,9

2,6

0,8

2,1

Genentech Roche Novartis BMS Others

Targeted therapy - Cancer drug sales 2006

US$B

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Roche Strategy: Focus on Personalized Medicine

Acquisition of $3,4 Bio USD for $240 Mio USD sales

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Roche: Companion Dx Program for Each Project

Very few other pharma companies with Dx competenceVery few other pharma companies with Dx competence

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Novartis Launches Internal Molecular Dx Unit

In addition to developing companion diagnostics Novartis is charged with developing "standalone" diagnostics "that have no relationship with our drugs whatsoever."

In addition to developing companion diagnostics Novartis is charged with developing "standalone" diagnostics "that have no relationship with our drugs whatsoever."

Novartis has extended and expand its blood screening collaboration with Gen-Probe until 2025

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More and More Collaboration & Internal Programs Emerge

Pharma – Diagnostics Collaboration

Source: Company reports

Integrated Rx and Dx Divisions

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Strong push towards personalized medicine

Source: FDA, 2004, 2005

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Questions?