QIAGEN Development Programs Innovation in Sample and Assay Technologies Dr. Joachim Schorr Senior Vice President Global R&D QIAGEN Analyst and Investor Day, February 14, 2008 -1- Sample & Assay Technologies Forward Looking Statements Safe Harbor Statement: Certain of the statements contained in this presentation may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products and markets and operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations), 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 molecular diagnostics, 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 in successfully adapting QIAGEN’s products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors, and the integration of acquisitions of technologies and businesses. For further information, refer to the discussion in reports that QIAGEN has filed with or furnished to the U.S. Securities and Exchange Commission (SEC). QIAGEN Analyst and Investor Day, February 14, 2008 -2- Sample & Assay Technologies Agenda Global R&D Organization R&D Project Portfolio QIAGEN Innovations Technology Roadmap: Planning the Future QIAGEN Analyst and Investor Day, February 14, 2008 -3- Sample & Assay Technologies 1 Global R&D Competence Center in USA , Europe and Asia North America Asia Assay & Systems Development Women's Health (HPV, CT,NG) Assay Development siRNA Europe Application Labs Application Development Application Development Assay Development Applied Testing Automated Systems GEX; Proteomics; Corp. R&D Systems Integration, Microfluidics 450 Scientists in Research & Development Enabling Technologies for Sample Preparation in Life Science, Applied Testing, MDx QIAGEN Analyst and Investor Day, February 14, 2008 -4- Sample & Assay Technologies R&D Competence Center Focus on Applications & Customer Segments Applications Application DNA Molecular Diagnostics Gene Function Amplification & modification Protein Customer Segments DNA Handling, Purification Genotyping, Storage, ... Diagnostic Sample Technology, Assay Technology (HC&PCR), Content Life Science Research Gene Silencing Gene Expression Pharma PCR and other Amplification Technologies Proteomics Sample and Assay Technologies Applied Testing Automated Systems Basic Research Sample and Assay Technology, automated New Technology Development Molecular Diagnostics QIAGEN Analyst and Investor Day, February 14, 2008 -5- Sample & Assay Technologies 2 Portfolio Teams Defining Product Applications within Customer Segment Customer Segments Products & Projects artus RPA (Regulated Products) B. pertussis LC PCR Kit RUO Enterovirus LC RT-PCR Kit RUO WNV LC RT-PCR Kit RUO Molecular Diagnostics QIAplex Assays Mvplex RUO ResPlex III HAI Y.chromosome MagAttract Virus+Blood IVD for EZ1 Cador BVDV PCR Screening Kit RUO BVDV PCR Subtyping Kit RUO Taylorella, Rabies PCR Kits RUO Applied Testing hc (hybrid capture) 2.0 Add-ons Women’s Health Molecular Diagnostics Next Generation Hybrid Capture Screening Assay and Platform NexGen Hybrid Capture Genotyping Assay („Probe Set“) NexGen Plus Isothermal Amplification Assays Fast HPV („dcHPV = developing countries“) Diagnostic PCR Genotyping Assays (Luminex-detection) Custom PCR Genotyping Assays for Pharma (Luminex-detection) QIAGEN Analyst and Investor Day, February 14, 2008 -6- Pharma Sample & Assay Technologies Portfolio Teams Defining Product Applications within Customer Segment Products & Projects Application DNA Customer Segments REPLI-g FFPE DNA Kit REPLI-g Fragmented DNA SBTexcellerator HLA QIAcube Applications Life Science Research Gene Silencing Genome siRNA Sets miRNA assays + reagents Gene Function Gene Expression AllPrep DNA/RNA 96 RNeasy 96 Plus QuantiTect Multiplex Virus Quantifast Fastlane 1-step qRT-PCR WTA (Whole Transcriptome Amplification) EpiTect controls Applied Testing Protein Expression constructs on Gene Globe Qxp crude lysate NTA Univ. System EasyXtal custom screens Recombinant Membrane Protein Purification QIAcube Automated Systems EZ1 CE IVD Pharma QIAsymphony QIAGEN Analyst and Investor Day, February 14, 2008 -7- Sample & Assay Technologies 3 R&D Budget Allocation Women’s Health ~30% ~15% Automated Systems ~15% RPA ~5% Gene Function ~3% Gene Expression ~3% Protein Application DNA ~3% ~2% Basic Research Reg./ IP & Other QIAGEN Analyst and Investor Day, February 14, 2008 ~20% -8- Sample & Assay Technologies Agenda Global R&D Organization R&D Project Portfolio QIAGEN Innovations Technology Roadmap: Planning the Future QIAGEN Analyst and Investor Day, February 14, 2008 -9- Sample & Assay Technologies 4 R&D Development Process: Gate review & focus PT Phase 0 PRC PRC PRC Phase 2 Phase 1 PRC/GRM PRC Phase 3 Launch Phase 4 168 Phase 0-2 Projects 58 Phase 3-5 Projects Total Innovation Index Project Portfolio 5 7,0 6,0 4 P roject A ttractiven ess In n o v a tio n G ra d e 5,0 4,0 3,0 3 2 2,0 1 1,0 0 0,0 0,0 1,0 2,0 3,0 4,0 5,0 6,0 0 7,0 1 2 3 4 5 Project Performance Market Attractivity Sample & Assay Technologies - 10 - QIAGEN Analyst and Investor Day, February 14, 2008 58 Phase 3-5 Projects Selection by Project Attractiveness & Performance Project Score Project Portfolio Project E 5 P ro je c t A ttra c tiv e n e s s 4 Project A 1 Project A 6,7 2 Project B 6,7 3 Project C 6,6 4 Project D 6,4 5 Project E 6,3 6 Project F 6,3 7 Project G 6,2 8 Project H 6,1 9 Project I 5,9 10 Project J 5,8 11 Projekt K 5,8 12 Project L 5,8 13 Project M 5,8 14 Project N 5,8 15 Project O 5,7 3 2 Project G Project M 1 0 0 1 2 3 4 5 Project Performance QIAGEN Analyst and Investor Day, February 14, 2008 - 11 - Sample & Assay Technologies 5 Agenda Global R&D Organization R&D Project Portfolio QIAGEN Innovations Technology Roadmap: Planning the Future Sample & Assay Technologies - 12 - QIAGEN Analyst and Investor Day, February 14, 2008 Define the Field of Innovation Identical Workflows In All Areas Of Life Sciences Collection Stabilization & Storage Life Science Research Disruption Enrichment Pharma Purification Amplification / Modification Applied Testing Content Detection Molecular Diagnostics QIAGEN Analyst and Investor Day, February 14, 2008 Bio-informatics - 13 - Sample & Assay Technologies 6 Portfolio Team Output: 170 New Products New Products Launched in 2005, 2006 and 2007 2005 REPLI-gKit HotStar HiFidelity ; HotStarTaq Plus REPLI-g Service CompactPrep Plasmid BIOROBOT Universal EZ1 RNA Universal Tissue ; RNA Cell Mini RNeasy Plus Mini Kit QuantiTect Primer Assay TurboCapture 8 / 96 / 384 AllPrep DNA/RNA Mini Kit QuantiTect Multiplex RT-PCR HiPerFect Transfection Reagent Qproteome div. PAXgene Blood RNA Kit CE, FDA & MDx dNTP Mix Appl. Pack QuantiTect Rev.Transcription Kit (50) FastLane Cell cDNA HP Guaranteed siRNA ; HP Flexible siRNA Design ; HP GenomeWide siRNA ; Customized siRNA Gene Sets Customized siRNA Gene Sets ; Genome Sets div. Ni-NTA Fast Start ; BioSprint 15 EasyXpress div LiquiChip Total Detection Kits div. BioSprint 15 / 96 DNA Plant 2006 2007 HotStarTaq Plus Master Mix ; QIAGEN Fast Cycling ; QIAGEN LongRange QuickLyse Miniprep ; QIAGEN PlasmidAmp MaXtract Low Density ; QIAGEN RNase Inhibitor ; IPTG ; Nuclease-Free Water EpiTect Bisulfite Kit, GelPilot EZ1 DNA Investigator Kit EZ1 Virus Mini Kit v2.0, TissueRuptor + TissueRuptor Probes RNeasy Protect Saliva ; RNeasy FFPE ; RNeasy Protect Cell Mini RNAprotect Cell Reagent, AllPrep RNA Protein Kit FlexiPlate siRNA (tube + plate) AllStars Neg. siRNA miRNeasy Mini Kit ; miRNeasy 96 Kit EasyXtal ; NeXtal, MassSpecSamplePrep artus (new kits) PAX Bone Marrow Autopure Consumables, Puregene, Autopure Instrument, Generation dNTP Set REPLI-g UltraFast ; REPLI-g Screeing ; REPLI-g Mitochondrial EZ1 DNA Investigator Card ; EZ1 VRS Card V2.0 App. Package, M48 QuantiTect Rev.Transcription Kit (200) QuantiTect Qproteome Plasma Membrane ; Qproteome Mitochondria ; Qproteome FFPE Tissue EasyXpress Insect Kit II ; EasyXpress Linear Template Kit Plus EasyXpress pIX3.0 Vector Qproteome GlycoArray Kit REPLI-g Fragmented DNA Kit QuantiTect Multiplex Virus REPLI-g (human-ID) QIAcube EZ1 CE IVD QIAsymphonie Quantifast Fastlane 1-step qRT-PCR WTA Allprotect Reagent Rat 1.0 miRNA assays + reagents Genaco MagAttract Virus+Blood IVD for EZ1 IVD SBTexcellerator HLA PAX xNA RNA Blood QIAGEN Analyst and Investor Day, February 14, 2008 Sample & Assay Technologies - 14 - QIAGEN Innovations Examples of 2007 & 2008 Product Launches Stabilization & Storage Allprotect Tissue Reagent QIAcube & QIAsymphonySP Purification Amplification / Modification Content Reverse Transcriptase HotStart . BVDV PCR Screening Kit QIAxcel Detection QIAsymphony: Integrated Platform Technology QIAGEN Analyst and Investor Day, February 14, 2008 - 15 - Sample & Assay Technologies 7 Allprotect Tissue Reagent Stabilization & Storage Features Proprietary stabilization technology Simultaneous preservation of DNA, RNA and native proteins in one tissue sample Immediate stabilization of harvested tissues Shipment / storage 1 day at 37°C up to 7days at 25°C at least 12 months at 2-8°C archiving at -20°C/-80°C Compatible with “all” QIAGEN kits for target purification Wide range of downstream assays Non-toxic QIAGEN Analyst and Investor Day, February 14, 2008 - 16 - tion a v o Inn Aw 2 ard 7 00 Sample & Assay Technologies Bovine Viral Diarrhea Virus (BVDV) Content Mucosal Disease MD BVD Virus Pest virus in cattle (also sheep and goats) Closely related to Border Disease Virus in sheep Classical Swine Fever Virus Infertility, abortion, congenital defects in calves Persistent infected (PI) calves constant source of reinfection Mucosal Disease (MD), severe deadly infection Not infectious to man BVDV costs US$20 – US$160 per year and animal US$ 97M & EU 85M cattle Eradication programs in several countries high awareness QIAGEN Analyst and Investor Day, February 14, 2008 - 17 - Sample & Assay Technologies 8 Complete Solution From Sample To Result Content Sample & Assay Technologies For BVD Testing Sample Technologies Assay Technologies Automated sample prep BioRobot Universal System cador BVDV RT-PCR Kit cador BVDV Type 1/2 RT-PCR Kit Manual sample prep QIAamp Viral RNA Mini Kit RNeasy Mini Kit Additional veterinary assays artus M. paratuberculosis LC PCR Kit artus Influenza/H5 LC RT-PCR Kit Further assays under development TissueLyser QIAGEN Analyst and Investor Day, February 14, 2008 Sample & Assay Technologies - 18 - T1 Product Launches 2008 Product ADNA Product CompactPrep mega/giga RNAi QIASymphony system EZ1 Advanced AIS QIAxcel System/cartridges FlexiPlate Gene Family updates Human WG/DG siRNA Set v 4.0 AllStars hs cell death control miScript additions New DNA transfection reagent Next generation Lipofection & Nanofection HiPerFect for miRNA Online transfection protocols QIAcube: additional protocols Gene Function TissueLyser II RPA Protein FPLC Column extension NTA, StrepTactin 5ml cartridges QIAcard FTA QIAsafe VET BVDV PCR Screening Kit VET BVDV PCR Subtyping Kit VET Taylorella PCR Kit RUO QIAamp DSP Virus Kit Modif. CD&US T1 = Term 1 (January – April) QIAGEN Analyst and Investor Day, February 14, 2008 - 19 - Sample & Assay Technologies 9 Selected Regulatory Approval Projects Europe Year Project 2008 2009 2010 2011 artus HIV RG artus HCV RG EZ1 upgrade virus Candor BVDV TM RT Kit QIAplex ResPlex II NextGen HPV Genotyping Approval/Launch Submission Running / planned project Sample & Assay Technologies - 20 - QIAGEN Analyst and Investor Day, February 14, 2008 Selected Regulatory Approval Projects USA Year Project 2008 2009 2010 2011 artus CMV LC artus EBV LC artus CMV + EBV Taqman HLA I HLA II QIAplex ResPlex II NextGen HPV Screening HPV Genotyping DML 3000 HAI Running / planned project 510K Submission QIAGEN Analyst and Investor Day, February 14, 2008 PMA Submission - 21 - Approval/Launch (typically 12 months after submission) Sample & Assay Technologies 10 Selected Regulatory Approval Projects Asia Year Project 2008 2009 2010 2011 Blood Screening Project PG Biotech HBV Kit PG Biotech HCV Kit PG Biotech HIV Kit Fast HPV Running / planned project QIAGEN Analyst and Investor Day, February 14, 2008 Approval/Launch (typically 12 months after submission) Submission - 22 - Sample & Assay Technologies Agenda Global R&D Organization R&D Project Portfolio QIAGEN Innovations Technology Roadmap: Planning the Future QIAGEN Analyst and Investor Day, February 14, 2008 - 23 - Sample & Assay Technologies 11 Technology Roadmap: Sample and Assay Technologies Structure base on identical Workflows in all segments Stabilization & Storage Life Science Research Automated Systems Disruption Purification Amplification / Modification Assay Technologies Pharma Enrichment Integrated Microsystems Sample Technologies Collection Applied Testing Molecular Diagnostics Content Detection Bio-informatics Sample & Assay Technologies - 24 - QIAGEN Analyst and Investor Day, February 14, 2008 Technology Roadmap Results From 3000 Technologies to 100 Projects 1 2 3 Technology Life Cycle Norm Strategies Technology Overview Emerging Technology Program software C++ …. Key Technology Ko nze ptio nell Technology Plan Technology Implementation Activities QIAGEN’s Relative Technology Position Year Quarter 2005 Q1 Q2 Development Growth Maturity high In ve st 72 14 strong 51 Pilot Projects “little resources” 1 ve st Alarm signal for persent Alarm signal for survival Maturity Decrease Monitoring low medium Development Growth I 14. Xxx 2008 Q4 Q1 Q2 Q3 Q4 Launch on track · Next Step: Alternative to Venus · · Big uncertainty for launch date · Next Step: Targets · Resource allocation critical! · · Estimated launch date: Q2/06 17. Xxx Millipore collaboration unclear 18. Xxx Forensic, Vet, Biodefense 19. Xxx V Technological Competitive Position Q3 ·· · · 11. Xxx 15. Xxx Disinvest Life Cycle Stage of Technology high Q2 · 9. Xxx 16. Xxx Obsolete Technologies 54 low Q1 10. Xxx 13. Xxx IV Q4 Kits on track, controls delayed 71 72 2007 Q3 · · 12. Xxx 54 Alarm signal for future Q2 · 6. Xxx 7. Xxx tenable Q1 · 3. Xxx 4. Xxx 8. Xxx Optimization “short ROI” 52 4 73 Technological Life Cycle (Technological Development Status) Q4 · 2. Xxx 5. Xxx II 21 22 D es in Invest “long ROI” III Industry average med 8 Decrease Alarm signal for waste of ressources 1 62 25 55 Opportunities for present competitive advantage Opportunities for future advantage Core Technologies 2006 Q3 1. Xxx high New Technologies (for QIAGEN) Usability HMI ….. 5 Base Technology medium Software LIMS Standards CMV XML Pacing Technology Evaluation of Relevance Consumables Process cartridges and reagents, tubes, tips …… Technology Attractiveness Network / Data Integration Sensors Standard sensors 1-D Barcode 2-D Barcode …… Liquid Handling Fluid systems Air displacement systems .... low Drive Technologies Drive control DC, step motor … T e ch n o lo g y P e r fo r m a n ce Process Technologies Magnetic bead handling …. Cont. 4 20. Xxx · · · Major decision point Delay >60 days Dela y 30-60 days On track Resources t Overview on >3000 Technologies „ Approx. 1000 Technologies analyzed Approx.200 Technologies identified as Relevant For QIAGEN Implementation and Ranking of 100 new projects - QIAGEN Analyst and Investor Day, February 14, 2008 - 25 - Sample & Assay Technologies 12 Exploring Translational Research: Roadmap to new Diagnostic Content Sample & Assay Technologies QIAGEN Analyst and Investor Day, February 14, 2008 Key Elements for new Content Discovery: Collaboration Goals Validated Samples International network will provide excess to relevant diagnostics patient samples Guarantee standardized sample management of patient samples Sample Management Integrated Data Analysis Collection Stabilization Purification & Automation Need for unique algorithm to perform integration of multiple data types QIAGEN Analyst and Investor Day, February 14, 2008 - 27 - Sample & Assay Technologies 13 Van Andel Institute Unique Institution Independent Research Institution Founded in 2000 250 Scientists & Staff Phase II 800 Scientific Advisory Board of 5 Nobel Laureates Focused on Translational Research from Bench Side to Bedside Significant Endowment International Expansion Success through Collaboration QIAGEN Analyst and Investor Day, February 14, 2008 - 28 - Sample & Assay Technologies Traditional Work Process Clinic ResearchGrants Data Data Mgt Publish Data Analysis Public Data ClinicalPatients Records Clinical Samples Diagnostics Treatments TIME Discovery Application Limited Integration –> In-Efficient Translation QIAGEN Analyst and Investor Day, February 14, 2008 - 29 - Sample & Assay Technologies 14 Integrated Approach Application Clinic Diagnostics Treatments Patients Retrospective Analysis Clinical Samples Clinical Records Public Research Data Analysis Data Molecular Data Mgt Data Prospective Application Discovery Discovery to Application Through Integration QIAGEN Analyst and Investor Day, February 14, 2008 - 30 - Sample & Assay Technologies Exploring Translational Research Key Elements in Place Through network collaborations (selection) Excess to Samples Exprimage: 20.000 FFPE Cancer Samples Van Andel Breast Cancer Study: 185 Patients full data set PROCEED: Early diagnosis of prostate cancer : 33 cancer risk related gene signatures FFPE Samples represent the vast majority of all tumor tissue samples Sample & Analytes Advantage is the fixation of morphology Challenge has been the extraction of Analytes QIAGEN Technology can extract DNA, RNA & Proteins from the same FFPE sample XenoBase BioIntegration Suite (van Andel Institute) BioInformatics Data Access & Management Visualization Tools Research & Analysis Reporting Prospective Diagnostics QIAGEN Analyst and Investor Day, February 14, 2008 - 31 - Sample & Assay Technologies 15 Questions & Answers QIAGEN Analyst and Investor Day, February 14, 2008 - 32 - Sample & Assay Technologies 16
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