Post on 20-Jul-2020
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
Sample & Assay Technologies- 2 -
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
Sample & Assay Technologies- 9 -
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
Sample & Assay Technologies- 17 -
Agenda
QIAGEN: Facts, Business Model & Strategy
Trends Molecular Diagnostics:
Case Study: Diagnostic HPV Test
Trends Personalized Medicine
Case Study: Prognostic K-ras Test
Sample & Assay Technologies- 18 -
. 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
Sample & Assay Technologies- 22 -
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 !
Sample & Assay Technologies- 23 -
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
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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
Sample & Assay Technologies- 33 -
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?