qiagen_ivd testing market
TRANSCRIPT
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QIAGEN Sample and Assay Technologies
2007 Analyst Meeting
Peer M. Schatz
Chief Executive Officer
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Safe Harbor Statement:Certain of the statements contained in this presentation may be consideredforward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, asamended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extentthat any of the statements contained herein relating to QIAGEN's products and markets and operatingresults are forward-looking, such statements are based on current expectations that involve a numberof uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associatedwith management of growth and international operations (including the effects of currencyfluctuations), variability of operating results, the commercial development of the DNA sequencing,genomics and synthetic nucleic acid-related markets, as well as the nucleic acid-based moleculardiagnostics, applied testing markets and genetic vaccination and gene therapy markets, competition,rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products(including fluctuations for certain events including funding, budgets, and others), difficulties insuccessfully adapting QIAGENs products to integrated solutions and producing such products, theability of QIAGEN to identify and develop new products and to differentiate its products fromcompetitors, and the integration of acquisitions of technologies and businesses. For furtherinformation, refer to the discussion in reports that QIAGEN has filed with or furnished to the U.S.Securities and Exchange Commission (SEC).
Note:In the attached presentation, QIAGEN will use the term molecular diagnostics. The use of thisterm is in reference to certain countries, such as the United States, limited to products subject toregulatory framework. Current QIAGEN molecular diagnostics products are 34 EU CE IVD assays, 3EU CE IVD sample preparation products, 1 510k PAX RNA product, 9 China SFDA IVD assays and98 general purpose reagents.
Forward Looking Statements
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A Well Defined Core CompetencyLeveraged into Multiple Markets
Molecular Diagnostics Applied Testing Life Science Research- Academia- Industry
QIAGEN Sample and Assay Technologies
Common Core Addressing 3 Markets
Sample and AssayTechnologies
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Sample and Assay Technologies
DNASample Technologies
RNASample Technologies
DNAAssay Technologies
RNAAssay Technologies
RNAiAssay Technologies
ProteinAssay Technologies
RegulatedAssay Technologies
ProteinSample Technologies
RegulatedSample Technologies
SAMPLETECHNOLOGIES
ASSAYTECHNOLOGIES
Leading Integrated Complete
AutomationOf Assay Technologies
AutomationOf Sample Technologies
Sample and AssayTechnologies
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ScaleLeveraging Technologies Into Multiple Markets
Olerup SSP Kits
QIAplex Assays
artusAssays
QuantiTect Assays
RT-PCR Reagents
Taq Polymerases
PAXgene
Allprep Protein/RNA Kit
QIAquick
RNeasy
QIAamp
QIAprep
Product Example
yesnoyesHLA+HSE
yesyesyesPathogen Multiplex Detection
yesyesyesPathogen Detection
yesnonoGene Expression
Closed Platforms
yesyesyesReal-time PCR
yesyesyesEndpoint PCR
Open Platforms
Assay TechnologiesyesnoyesSample Stabilization
yesyesnoSample Preparation, Protein
yesyesyesSample Preparation, PCR
yesyesyesSample Preparation, RNA
yesyesyesSample Preparation, gDNA, viral DNA
yesnonoSample Preparation, Plasmid
Sample Technologies
Life ScienceResearch
AppliedTesting
MolecularDiagnostics
Representative but not complete list
Sample and AssayTechnologies
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Customer focused Scaleable Critical mass
One core multiple channels
Globally aligned Sales and Marketing
Diagnostic
VeterinaryForensics
Food
PharmaBiotech
Basic research
Biomed research
DiagnosticsSales
Specialists
ATSales
Developers
PharmaKAMs
Life Sciences
Sales
DiagnosticMarketing Manager
Applied TestingMarketing Manager
PharmaMarketing Manager
Life Sciences
Marketing Manager
CustomerSalesMarketing
We are
Life ScienceSales
PharmaKey Account Manager
Applied TestingSales Developer
Molecular DxSales
Channel Segmentation
Sample and AssayTechnologies
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Automation of Sample and Assay TechnologiesAll Volumes - All Markets
Molecular diagnostics
Applied testing
Low throughput applications (1-6 samples)
Highest process safety and ease of usethrough
pre-filled reagents application cards
BioRobot EZ1
For every laboratory
Low to mid throughput system for fullyautomated purification of nucleic acidsor proteins using QIAGEN spin kits.
Molecular diagnostics
Applied testing
Life Science research
Lowmid throughput (1-12 samples per run)
QIAcube
BioRobot Universal
Widest range of applications for samplepreparation and assay setup. Microtiter-format consumables.
Molecular diagnostics (e.g. PreAnalytiX)
Applied testing
Life Sciences
Medium-high throughput (up to 384 samples per run)
BioRobot MDx
Sample preparation and assay setup forMDx applications (CE-IVD compliance) inEurope as well as MDx research.
Molecular diagnostics (e.g. PreAnalytiX)
Applied testing
Life science research: clinical development
Medium-high throughput (up to 384 samples per run)
Representative but not complete list
Sample and AssayTechnologies
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QIAGEN Leading in Molecular Diagnostics
Strong In-House Capabilities - Core Competence
QIAGEN Leading in Molecular Diagnostics
Proven standard in sample and assay technologies
Unparalleled range of applications in sample technologies
Largest molecular diagnostics assay portfolio Certified applications and systems
QIAGEN portfolios in regulated markets
Sample technologies (including de novo 510k approvals)
Assay technologies artusassays
PG Biotech assays
QIAplex (Genaco) multiplex assays
QIAGEN Regulatory Group
Significantly expanded in 2004 and early 2006
Regulatory and clinical affairs in USA, Europe and China
Molecular Diagnostics
MolecularDiagnostics
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Yates RR. New intervention strategies for reducing antibiotic resistance.Chest 1999;115:24S-27S.
Piquette RK. A targeted review of vancomycin use. Can J Hosp Pharm 1991;44:83-7.
25 bn
400 bn
Diagnostics Pharmaceuticals
Approx. US$100 bn wasted due to incorrect therapy
Example: antibiotics
approx. US$25 billion market (human)
approx. 50% probably not effective wrong application Resistances approx. US$50 billion in costs approx. 20,000 casualties
Diagnostics
approx. 5% ofpharmaceutical
industry approx. 1% of
Health Care
Diagnostics Untapped PotentialMolecular
Diagnostics
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QIAGEN Regulatory Strategy
Genaco Assays: Regulatory strategy and timeline
Plan: Two assays to be submitted to FDA 2007, three in 2008
Plan: CE marks for all panels throughout 2007/2008
Milestones in Expanding MDx Leadership
MolecularDiagnostics
2007 2008
H5N1 Staphplex Resplex IUS:FDA 510K
Resplex II
Europe:CE Marking
All panels throughout 2007/2008
HAI
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From Patient Sample To Clinical ResultsQIAGEN Provides Advanced Sample And Assay Technologies
Broad Portfolio - StreamlinedBroad Portfolio - Streamlined
DiagnosticResults
Patientsample Sample technologies Assay technologies
Sample
StabilizationStorage
SampleCollection
Endpoint andReal-time PCR
reagents
Closedassays
(e.g. artus)
QIAplex(Multiplexing)
MolecularDiagnostics
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CAGR =15%+
Projected MDx Market Sector Growth Unique Subsector of Clinical Testing
Fast growing area in in-vitro diagnostics
Market 2006 2.4bn with projectedCAGR of 15%+
MDx with high value & high marginproducts (unlike traditional Dx)
Technologies are covered by extensive IP
Holds promise of pharmacogenomics
Technologies can be leveraged in
Academia, Pharma and Applied Testing New tests in oncology and other fields
yield room for further growth
In Bn US$
Molecular DiagnosticsGrowth by Segments 2004 - 2010
Source: Divers Market Research
MolecularDiagnostics
2,1
2,4
4,2
3,7
3,2
2,8
0,0
1,0
2,0
3,0
4,0
5,0
2005 2006 2007 2008 2009 2010
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QIAGEN Expanding in Applied Testing
Proven Industry Standards Fuel Molecular Testing in Applied Markets
Applied Testing
QIAGEN Expanding in Applied Testing
Long experience in complex sample processing
Proven industry standards in sample and assay technologies
Certified applications
QIAGEN portfolios
Sample technologies
Assay technologies (artusassays, PG assays)
QIAGEN Partner in Applied Testing, includes VLA (British Veterinary Laboratories Agencies)
Vetsuisse Faculty, University of Bern, Switzerland
QIAGEN Outlook
Veterinary diagnostics focus in 2007 Exciting product launches in 2007
- sample technologies incl. automated solutions- assays
AppliedTesting
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Applied TestingMarket Entry Barriers And Market Size & Growth Of Segments
(1) Evalution parameters: regulatory, competition, customer willingness to change
Speed of Adoption (1)
MarketGrowth
High Medium Low
Human ID
Vet
QC Pharma & PCP
Food Pathogen
Biosecurity
Food GMO
0%
10%
20%
30%
40%
0 1 2 3
Forensics
$1 billion
NAT AndTraditional
Market Size 2008
AppliedTesting
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QIAGEN Standard in Life Science Research
Life Science Research
QIAGEN Standards in Life Science Research
QIAGEN leads in sample and assay technologies
Creating standards early
Large component of academia is biomedical research
Pharma research and development go molecular Core to strategy in MDx and Applied Testing
QIAGEN portfolios
Sample technologies
Assay technologies: (include: RNAi, PCR, real-time PCR,closed test assays)
QIAGEN Partner of Pharma
QIAGEN products in > 100 clinical trials
Clinical research: exciting milestones and growth
QIAGEN Outlook
Academia: stable growth, regional differences
Pharma actively using new clinical development paradigms
Life Sciences
At the Forefront of Science Creating Standards Early
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Molecular Diagnostics Applied Testing Life Science Research- Academia- Industry
QIAGEN Sample and Assay Technologies
Common Core Addressing 3 Markets
A Well Defined Area of Expertise - Multiple MarketsOutlook
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0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2006 2010 2015
Applied Testing
MDx
Pharma/BiotechAcademia
Development of Customer SegmentsAs Percentage of Revenues
40%
25%
25%
10%
29%
21%
34%
16%
18%
14%
43%
25%
Molecular Diagnostics Customers Could Represent the Largest
Revenue Share in Three Years From Now
Estmated CAGRs2006-2015:
Academia 3%
Pharma/Biotech 6%Molecular Dx 20%Applied Testing 25%
Applied Testing
Molecular Diagnostics
Life Science Research
Note: this graph is for demonstration only and is projecting currently assumed market growth rates
Outlook
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Focused on Executing our Strategy
Innovation
- 67 new products launched in 2006
- 42 new products in sample technologies
- 25 new products in assay technologies
- Exciting pipeline in sample and assay technologies
Customer focus - premium partner for
- MDx
- Applied testing
- Life Sciences (pharma + academia)
Growth
- Industry-leading organic growth
- Integration of catalytic acquisitions well on track
- Further acquisitions in sample and assay technologies
- Geographical presence (Asia, India, South America,
Eastern Europe)
Well Laid-Out Mission Exciting Future
Outlook