Sample & Assay Technologies - Qiagen · company assumptions ... The following slides contain certain summary information about ... Fully automated sample and assay technologies. Sample

Sample & Assay Technologies- 1 -

QIAGENSample & Assay Technologies

Needham Life Sciences ConferenceNew York, June 11, 2009

Peer M. SchatzChief Executive Officer


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 geneticvaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations from 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, the management of intellectual property, and the integration of acquisitions of technologies and businesses. In addition certain statements contained in this news release are based on company assumptions, including, but not limited, to revenue allocations based on business segments. 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).

Regulation G: The following slides contain certain summary information about QIAGEN N.V.’s sales, gross profit, operating income, net income, and earnings per share over a specific period and the comparable period, which information is presented on a “non-GAAP financial measures” basis rather than in accordance with U.S. generally accepted accounting principles (GAAP). Please review QIAGEN’s press releases for information on the company’s operating income, net income, and earnings per share for these periods presented on a GAAP basis. Such GAAP-basis information will also be contained in the company’s reports on Form 20-F or Form 6-K to be filed with or furnished to the U.S. Securities and Exchange Commission.

Forward Looking Statements


Sample & Assay Technologies

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, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, DNA, 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, Salts, Polymerases, Centrioles, DNA, Immunoglobulins, Carrier proteins, 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, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, 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, Talin, ...

Complexsample

DNAPureAnalyte

InformationAssayTechnologies

Target Detected

Yes

No

SampleTechnologies

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, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, DNA, 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, Salts, Polymerases, Centrioles, DNA, Immunoglobulins, Carrier proteins, 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, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, tRNA, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, 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, Talin, ...


Revenues: 2008: $ 893 million 05–08 CAGR: 31%Net income1: 2008: $ 163 million 05–08 CAGR 33%EPS1: 2008: $ 0.80 05–08 CAGR: 20%

Product Range:>500 consumable products □ Sample technologies: to collect, separate, purify,

isolate, stabilize and store samples□ Assay technologies: to make such isolated target

information (DNA, RNA, proteins, etc.) visibleInstrumentation for above consumables

Customers (>400,000)Academic researchPharma/BiotechApplied Testing (veterinary, forensics etc.)Molecular Diagnostics

IP (03/09): >2’000 patents(750+ issued, 780+ pending, 500+ licensed)

Employees: >3‘000 employees based > 30 subsidiaries

1 excluding acquisition, integration and relocation related charges as well as amortization ofacquired IP and equity-based compensation (SFAS 123R)

QIAGEN at a Glance


Leading Position – Multiple Growth Drivers

Product and Technology Continuum

SAMPLETechnologies

ASSAYTechnologies

~27% of sales

PublicPrivate

~20% of sales

DiscoveryDevelopment

~7% of sales

VeterinaryForensicsBio defense

~46% of sales

Sample TechAssay Tech: PCR etc.OEMRegulated assays

Life ScienceResearch

PharmaceuticalIndustry

AppliedTesting

MolecularDiagnostics


QIAGEN Customer SegmentsMultiple, Independent Growth Engines

Molecular diagnostics (approx. 46% of total revenues)Solid end markets, significant growth potentialHighlights: HPV, K-ras, HIV, landmark studies in HPV testingPlatform breadth, expanding menu

Life Science Research (approx. 27% of total revenues)Improved outlook for long term fundingHighlights: StimuliStimulus package: $10.4B approved for NIH research funds

Pharma (approx. 20% of total revenues)Highlights: Pyrosequencing: K-ras, Braf , mergers in industryDevelopment strong: personalized medicineDiscovery arm still slow (~10% of revenues)

Applied testing (approx. 7% of total revenues)Market volume still very small but fast growing (+15%)Highlights: new BVDV assay, QIAsymphony InvestigatorBig synergies with MDx


Leading in Molecular Diagnostics

Sales in MDx: approx. 46% of sales#1 (excluding blood banking and viral load monitoring)

Sample technologies: proven standard

Assay technologies: unparalleled breadth (>120 assays)PCR and real-time PCR assaysMultiplexing leader: QIAplexLeading in key assay areas (HPV)Broad platform base

Regulated portfolio – global and growing5 FDA (PMA approved or 510k cleared) products38 CE-marked assays, 6 CE-marked sample preparation products9 SFDA approved assays 98 general purpose reagents


QIAGEN Platforms: Today and Tomorrow

.Full Range of Instrument Platforms: .Different Technologies - All Through-Put Ranges - From Stand Alone to Fully Integrated

Respiratory Influenza RSV MetapneumovirusAdenovirus SARSBordetellaM. pneumoniaeC. pneumoniae

HPV ScreeningGenotyping

Transplant CMV EBV HSV-1/2 VZV HHV-6

STD Panel CT Mycopl. genitTrichomonasNG HSV

OncologyK-rasB-rafEGFR

EncephalitisInfluenza CMV , EBVEnterovirusBorreliaM. pneumoniaeM. tuberculosis West Nile virus Parvo B19

BloodbourneHCVHIVHBVParvo 19

Detection

Sample Processing

QIAsymphony QIAgility EZ1 Autopure QIAcube

Example of QIAGEN’sDx content

Today andTomorrow(1)

Product Portfolio

Decapper

QIAensembleFragment analysis RT-PCR and HRM Pyrosequencing

PyroMarkQIAxcel RotorGeneQIAsymphony plus CareHPV


Multiple Detection Capabilities

Sample Preparation Assay Set Up Detection

Low ThroughputModules

Endpoint (qualitative) PCR

QIAxcel

Medium-High ThroughputModules

Multiplexing

LiquiChip

Medium ThroughputFully integrated System

Real time (quantitative) PCR

RotorGene

High resolution sequence detection and quantification

PyroMark

~400


K-ras Test Emerging Blockbuster in Companion Diagnostics

K-ras gene – key element in normal cell growth pathway:

Critical for EGFR inhibitor drugsFirst drugs for colon cancer>140 trials ongoing

K-ras gene often mutated (can lead to resistance)Lung 15% - 20%Pancreas up to 90%Colon 35% - 45%

Current market:

Colon/rectum cancer: >1 million incidences, 50% mortalitySome laboratory developed testsSome other tests in Europe using PCR

Clinical study by Uppsala University Hospital, Sweden:

QIAGEN’s PyroMark test identifiesHigh number of mutations in codons 12 and 13 (expected)High number of mutations in codon 61 (unexpected)New (!) mutation in codon 60

QIAGEN PyroMark - Best Suited for Companion Diagnostics


AIDSreal-time PCROlerup SSP ® HLA-B*5701, RUO, CE

Thrombosis, Atherosclerosisreal-time PCRartus MTHFR PCR Kit, RUO, CE

Leukemia, Crohn’s Disease

real-time PCRartus TPMT LC PCR Kit, RUO, CE

Various cancersPyrosequencingPyroMark CpG LINE-1; RUO

Various cancersPyrosequencingPyroMark CpG p16, RUO

Assay Platform Potential Applications and Research

PyroMark KRAS, RUO, CE Pyrosequencing Colon cancer

PyroMark BRAF, RUO Pyrosequencing

Colon cancerMelanoma

Ovarian cancerThyroid cancer

PyroMark CpG MLH1, RUO PyrosequencingColon cancer

(hereditary forms)

PyroMark CpG MGMT, RUO Pyrosequencing Glioblastoma

Fungi ITS2 Primers for PCR, ASR Pyrosequencing/Multiplex Antifungal treatment

MOTT 16S Primers for PCR, ASR Pyrosequencing/Multiplex Antibiotic resistance

Companion DiagnosticsSelected Diagnostic Assays

CpG = positions of methylation

MDx instrumentPyroMark Q24

Complete platform

Complete toolbox


HPV ScreeningSignificant Untapped Potential for HPV Testing

Adoption of existing guidelines

Patient, physician communications

Key focus: market penetration, conversion to Pap+HPV

Adoption into medical guidelines (>30 countries!)

Advocacy, patient, physician communications

Laboratory marketing (>20 players, QIAGEN with ~70%)

Adoption into medical guidelines

Significant cost/benefit advantages

Emerging national (primary) screening programs

Substantial Market – Diverse Marketing Profiles

U.S.Current tests: ~ 11.4MPenetration: ~ 30%

EuropeCurrent tests: ~ 2.3MPenetration: ~ 7%

Asia/Latin America:Current tests: 0.9MPenetration: ~ 3%

Asia/LatinAmerica~ $280M

U.S.~ $490M

Europe~ $350M

Total: >$1.1 billionNote: Represents market from existing Pap Smear Tests onlySource: 4/24/07 Long Range Plan


HPV ScreeningSignificant Untapped Potential for HPV Testing

U.S.

Europe

Asia/LatinAmerica

Hol

ogic

RocheAbbottGreinerGenProbeHologic......

Commercials(many)

Homebrew

QIAGEN undisputed market leader in HPV screening

Focus on market penetration: only ~30% penetrated

Superior to commercial competition: automation, validation


Only few guidelines, spotty reimbursement

QIAGEN gaining share: test performance and validation

Strong competitor companies

Complete, integrated platforms and tests available


Only few guidelines

Focus on adoption: including primary screening programs

QIAGEN solutions for developing world

Homeb

rew

Homebrew


Workflow Performance: The digene HPV Test

Semi-automated use Assay automation

Current solutions

NextGen Evolution: Next-generation HC2 (starting 2009)

Fully automated sample preparation from liquid cytology vials on QIAsymphonySP

Fully automated assay

Genotyping 16/18/45 reagents

NextGen Revolution QIAensemble (2010, 2012 in US)

Broad menu high throughput screening system

Fully automated sample and assay technologies

HPV testing on novel chemistry, leveraging HC2

Unprecedented throughput and utility


Molecular DiagnosticsScreening Solutions to Increase Safety of Blood Donations

Brazilian national PCR-based HIV/HCV blood screening program

Supply agreement with Bio-Manguinhos

QIAGEN sample technologiesQIAGEN assay technologies (HIV, HCV)InstrumentationOperational know-howTrainingRun-time: 5 years (program starts in 2010)

Current market:

Brazil: Largest country in South America5 million blood donations per year0.1% and 0.3% positive for HIV and HCV

Significant step in expansion in emerging marketsLatin and South America markets are focusUnderscores QIAGEN’s strength in blood screening

Huge Potential for Blood Screening in Emerging Markets WW


Key Investment ConsiderationsStrong Growth at Low-Risk

Strong Strategic Position

Addressing high growth marketsFocused, complete and technology-leading portfolioCritical mass, well functioning organizationInnovation success – acquisition success

Innovation is keyProven innovation leadership in industry> 80 product launches in 20085% of revenue growth from new introduced products

Strong Financial Performance 2008 Revenue growth: 37%Organic adj. growth: 13%Operating cash flow up 98% to US$168 M in 2008

Documents

Sample & Assay Technologies - Qiagen · company assumptions ... The following slides contain certain summary information about ... Fully automated sample and assay technologies. Sample