Sample & Assay Technologies - Qiagen...Sample & Assay Technologies QuantiFERON-TB: Expanding use in key target groups Latent tuberculosis (TB) A key driver of latent TB testing: Growing

Sample & Assay Technologies

Peer M. Schatz, Chief Executive OfficerJ.P. Morgan Healthcare ConferenceJanuary 7, 2013

Sample & Assay Technologies Forward looking statements

Safe Harbor Statement: Certain of the statements contained in this presentation may be considered forward-looking statementswithin the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities ExchangeAct of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategyor operating results, including without limitation its expected operating results, are forward-looking, such statements are based oncurrent expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but arenot limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations,regulatory processes and dependence on logistics), variability of operating results and allocations between business segments, thecommercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics,women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers andstrategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products(including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); ourability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutionsand producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect ourproducts from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies andbusinesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S.Securities and Exchange Commission (SEC).

Regulation G: Some of the slides in this presentation contain certain summary information about QIAGEN N.V.’s sales, gross profit,operating income, net income, and earnings per share, which information is presented on a “non-GAAP financial measures” basisrather than in accordance with U.S. generally accepted accounting principles (GAAP). Please review QIAGEN’s press releases,which can be found in the Investor Relations section of QIAGEN’s webpage under www.QIAGEN.com, for information on theCompany’s operating income, net income, and earnings per share presented on a GAAP basis. Such GAAP-basis information willalso 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 andExchange Commission.

2J.P. Morgan Healthcare Conference, January 2013

Sample & Assay Technologies World leader in Sample & Assay Technologies

� Enable access to molecular information

� Address broad range of customer needs

� Expanding global presence

� Healthy financial position

3

QIAGEN at a glance

48%

8%

20%

24%

Molecular Diagnostics

Applied Testing

2012 9M net sales: $908 million

J.P. Morgan Healthcare Conference, January 2013

Pharma

Academia

Sample & Assay Technologies Every lab process starts with a biological sample

Sample Technologies Assay TechnologiesBIOLOGICAL SAMPLE

VALUABLE MOLECULAR

INFORMATION


Automation

Molecular content

Assay reagents

Bioinformatics

Access to DNA and RNA


Instruments

Comprehensive product range to support workflows

2012 9M net sales: $908 million

5

Leading portfolio of molecular tests for use with range of instruments

Consumables

87% 13%



2012 9M sales Key customers Product highlights

~48% � Reference labs

� Hospitals

� Prevention: HPV, QuantiFERON-TB

� Profiling: Infectious diseases

� Personalized Healthcare: Companion diagnostics

� Point of Need: AmniSure, ESE

~8% � Forensic labs

� Industrial

� Governments

� Human identification

� Veterinary medicine

� Food safety

~20% � Big Pharma

� Specialty / Biotech

� CROs

� GeneGlobe: Gene and pathway analysis

� Biomarkers

~24% � Government research

� Academic labs

� Life sciences research

� Translational medicine

Supporting >500,000 customers worldwide

Applied Testing

Pharma

Academia




Sample Technologies

AssayTechnologies


Applied Testing

Pharma / Academia

World leader

Real-time PCR

■ ArtusIpsogentherascreencare

■ LDT reagents

■ cadormericoninvestigator

■ LDT reagents

■ PCR reagents

■ GeneGlobe

PCR panels ■ GeneGlobe

Non-amplified (HC2, latent disease)

■ HPV■ QuantiFERON

(TB and CMV)

Pyrosequencing■ therascreen Pyro■ LTDs

■ Pyro ■ Pyro

Next-gen sequencingClinical / Biomedical

■ NGS (2013 launch)



Next-gen sequencingWhole genome

Whole genomediagnostics

Whole genome discovery

Building selected sample-to-result leadership positions

J.P. Morgan Healthcare Conference, January 2013 7

BIOLOGICAL SAMPLE

VALUABLE MOLECULAR

INFORMATION

Sample & Assay Technologies Accelerating pace of life sciences breakthroughs


BCR-ABL role in CML patients

Gleevec®

approved

JAK2 V617Frole in cancers

>10 drugs indevelopment

1960 2000 2010199019801970 2013

~40 years

~7-8 years

PI3K role in cancers

>20 drugs indevelopment

Advantages of comprehensive portfolio covering R&D continuum


Prevention

Molecular Diagnostics portfolio with attractive potential


QuantiFERON-TB

AmniSure and ESE

therascreen companion diagnostics

Expanding infectious disease menu

Applied Testing

Pharma

Academia


Personalized Healthcare

Point of Need Profiling

Sample & Assay Technologies Driving innovation and growth in 2012

Strategy Initiatives 2012 achievements

Grow installed base� Exceeded QIAsymphony goal� NGS initiative under way� QIAensemble Decapper launch

Offer new tests across all customers classes

� Gained 2 U.S. approvalstherascreen KRASartus Influenza

� Completed 2 U.S. submissionstherascreen EGFRQuantiFERON CMV

Expand in attractive markets � Dynamic growth in top 7 EGM

Grow with best-in-class teams� Organizational and

leadership changes� Free up resources to reinvest

Drive platform success

Add content

Grow efficiently and effectively

Broaden geographicpresence



QIAsymphony: Unparalleled features driving dissemination of molecular testing

QIAsymphony: Exceeded 2012 year-end placement goal


40%

35%

7%

18%

Europe

North America

Latin America

Asia-Pacific / Japan

QIAsymphony placements (As of December 2012)


Life Sciences

~70% ~30%

Sample & Assay Technologies Many R&D milestones achieved in 2012

Key regulatory decisions Type Status

Rotor-Gene Q MDx Real-time PCR instrument 510(k)

therascreen KRAS (Erbitux) Companion diagnostic in metastatic colorectal cancer

PMA

artus Influenza Influenza test 510(k)

therascreen BRAF Biomarker test for melanoma CE IVD

careHPV Low-cost HPV test for developing countries sFDA

Key regulatory submissions Type Status

therascreen EGFR (afatinib)Companion diagnostic in non-small cell lung cancer

PMA

QuantiFERON CMVCytomegalovirus (CMV) infections in transplant patients

510(k)


NEW

NEW

NEW

NEW

Sample & Assay Technologies Developing several new molecular diagnostic assays

Selected tests in current portfolio Potential submissions

Blood Borne VirusHIV �

HBV �

HCV �

HAV �

Parvo B19 �HEV �

Personalized Healthcare

KRAS ��

EGFR ��

BRAF �

JAK2 �

BCR-ABL �

PML-RARa�

WT1 � IDH1/2 �

PI3K �

ALK �

NRAS �

JAK2 �

BCR-ABL �

T315I �

Other ��

Women’s HealthCT �

HSV 1/2 �

CT/GC ��

HPV �

M. gen ��

GBS ��

Trich ��

Hospital-Acquired Infections

MRSA ��

C. Diff ��

VanR ��

ESBL ��

TransplantationCMV ��

EBV ��

HSV 1/2 ��

VZV ��

BKV ��

CMV �

HSV 1/2 �

Other DiseasesM-TB �

SARS �

Borrelia �

WNV �

Influenza �

Enterovirus �

Malaria �

Multi Resp �


This information is intended to outline QIAGEN’s general product intentions. The development, timing and launch of any of our products aresubject to regulatory approval and remains at our discretion.

� Europe (CE-IVD)� U.S. (PMA / 510(k) submissions)� ASRs (Analyte Specific Reagents)

2125

21 additions12 additions

0 additions


Selected QIAGEN biomarkersIncreasing pathway knowledge

New biomarkers with potential as companion diagnostics


KRAS BCR-ABLEFGR JAK2BRAF IDH 1 / 2NRAS PML-RARaMGMT WT1UGTA1 NPM1ALK BAALCGIST CBFß-MYH11T315I AML1-ETORET RASROS1 FLT3DEPDC1 HSP110

NEW

Non-small celllung cancer

Colorectalcancer

NEW

Adding scientific breakthroughs to industry-leading biomarker portfolio

Sample & Assay Technologies U.S. KRAS market conversion progressing well

Oncologists demanding therascreen test� Designated teams

� Awareness campaigns

� NCCN guidelines

� Medical Advisory Board


~ 110,000

~ 75,000

~ 45,000

Expansionopportunities

End-2012QIAGEN share1

U.S. colorectal cancer patients(Eligible for KRAS testing)

Establishing therascreen brand for wave of companion diagnostics

Complementary U.S. market conversion initiatives

Labs promoting therascreen test� Drive test adoption

� Co-marketing programs

� Sales training

� Future tests on platform

CurrentKRAStesting

1 Annualized estimate


Project Partner Indication Biomarker Status

Erbitux (cetuximab)

Colorectalcancer

KRAS U.S. regulatory approval in July 2012

Vectibix(panitumumab)

Colorectalcancer

KRAS U.S. submission (PMA) in H2 2011

PF-00299804(dacomitinib)

Lung cancer(NSCLC)

KRAS In development

Iressa(gefitnib)

AstraZenecaLung cancer(NSCLC)

EGFRCE-IVD kit in Europe and other non-U.S. markets

(afatinib)Lung cancer(NSCLC)

EGFR U.S. submission (PMA) in H2 2012

Early-stage compound Blood cancer JAK2 In development

Various projects

Not disclosed Various In development

Not disclosed Confidential Non-oncology Confidential In development

Industry-leading portfolio of co-development projects

Selected co-development projects

16

Covering multiple technologies: PCR, panels and NGS options


Sample & Assay Technologies Expanding NGS from research to routine clinical use

17

AcademiaPharma

Applied Testing

Molecular DiagnosticsCus

tom

ercl

asse

s

High-throughput sequencing

Wor

kflo

w

need

s


QIAGEN aiming to drive NGS into clinical research and molecular diagnostics

Benchtop sequencing

Basic research / early studies Data validation Routine testing

Target market

Sample & Assay Technologies Preparing to launch first NGS workflows in 2013


Assay Technologies

NGS workflow

Competitive portfolio

GeneGlobecapabilities

Global leader in Sample Technologies

Automation options

Bioinformatics from QIAGEN

and SAP

Sample Technologies

Data alignment /

analysisNGS run

Library preparation

Target enrichment

DNA / RNApreprocessing

Primary sample to purified

DNA / RNA

� Sample-to-result workflows

� Flexibility and scalability

� Reliable and accurate results

� Using many proven QIAGEN technologies

� Cost competitive

Key features

QIAsymphony NGS version

QIAcube version

Sample & Assay Technologies QuantiFERON-TB: Expanding use in key target groups

Latent tuberculosis (TB)

A key driver of latent TB testing: Growing use of biological medicines


1 in 3 people worldwide…

has latent TB

And of those with latent TB…

1 in 10 develop active TB

Latent TB test target groups

Public health TB control

Employmentscreening

Medical staffFire and police

Communityliving

Correctional sitesMilitaryUniversitiesNursing homes

Immuno-suppressedpatients

TB risk detection

Clinicaltrials

Patient selection


� Single visit, results in <24 hours

� Objective, high specificity: 99.2%

� Not affected by BCG vaccine

Tuberculin Skin Test (1890s) QuantiFERON-TB Gold (2000s)

QuantiFERON-TB: Conversion to new gold standard


� 2-4 visits required

� Subjective, low specificity: 65.9%

� Not reliable for TB-vaccinated people

Latent TB testing: >$1 billion total addressable market potential


� 70 million patients, ~5 million new annually

� TNF-alphas effective in ~60-70% of patients

� Results visible after 6 months

� Patients want effective therapies

Rheumatoid arthritis: Need for a companion diagnostic

1.5 years 5 years

Developing attractive franchise of diagnostics supporting RA patients


RA: Challenging autoimmune disease

� Aim: Predict efficacy of TNF-alpha inhibitors

� Set of 5 biomarkers

� Complements QuantiFERON-TB Gold

� Latent TB testing already required

� First double-blinded clinical trial to start soon

� Earlier trial: High sensitivity, specificity

� QIAGEN investment in Drug Response Dx

pre.mark-TNF NEW


Strategy Initiatives

Accelerate organic and strategic growth

New product launchesQIAsymphony rolloutExpansion in emerging markets

Deliver efficiency and effectiveness

Maximize resource allocation

Employer of choice Best talent and top teams

Enhance customer experience

Exceed customer expectations

Perspectives on 2013


Executing on 2013 initiatives to drive growth and innovation at a faster pace

Sample & Assay Technologies Key considerations: Strong growth potential

� World leader in Sample & Assay Technologies

� Attractive and growing markets

� Accelerating pace of innovation and growth



Thank you!

Sample & Assay Technologies - Qiagen...Sample & Assay Technologies QuantiFERON-TB: Expanding use in key target groups Latent tuberculosis (TB) A key driver of latent TB testing: Growing

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