J.P. Morgan Healthcare Conference€¦ · January 2012. Sample & Assay Technologies 2. Forward...

Sample & Assay Technologies

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J.P. Morgan Healthcare ConferencePeer M. Schatz Chief Executive OfficerJanuary 2012


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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, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions 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, regulatory processes and dependence on logistics), variability of operating results and allocations between business segments, the commercial 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 and strategic 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); our ability to obtain regulatory approval of our products; 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 and protect our products from competitors' products; market acceptance of QIAGEN's

new products and the integration of acquired technologies and businesses. 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”

basis rather 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 the Company’s operating income, net income, and earnings per share 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.

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World leader in Sample & Assay Technologies

Enable access to molecular information

Biological sample to digital result

> 500 core products

Consumable kits and instruments

> 500,000 customers worldwide

Molecular Diagnostics

Applied Testing

Pharma

Academia

Innovative power

~2,500 patents

Healthy financial position

Strong cash conversion

Improving margins

2010 key figures (In $ millions)

Net sales (CER) 1,087 + 8%

Adjusted net income 222.7 +12%

Adjusted EPS

(In $ per share) 0.93

Free cash flow 171.1

Employees 3,600

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CER –

Constant exchange rates


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Broad product offering with common purpose

From biological sample to clinical result

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SAMPLE Technologies ASSAY

TechnologiesBIOLOGICAL SAMPLE

VALUABLE MOLECULAR

INFORMATION


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Pharma

Making improvements in life possible

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Molecular revolution is only just beginning

How do we secure food supplies and protect

public safety?

Applied Testing AcademiaMolecular Diagnostics

How do we fight diseases

and improve healthcare?

How do we develop

better and safer drugs?

How do we achieve

scientific breakthroughs

even faster?


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Operating in attractive markets

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Applied Testing AcademiaMolecular Diagnostics

9M 2011 sales ~46% ~7% ~21% ~26%

Long-term growth opportunities +++ +++ ++ +Key customers

Reference labs

Hospitals

Forensic labs

Industrial

Government agencies

Big Pharma

Specialty / Biotech

CROs

Government research

Academic and private labs

Highlights

Personalized Healthcare

Virology

QuantiFERON

HPV

Forensics

Vet and food safety portfolio

GeneGlobe:

Pathway analysis

Biomarkers

Trusted brand

Involvement with breakthroughs

Translational research

9M 2011 sales: $835.3 million


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Covering R&D continuum to meet customer needs

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Automation solutions

Basic research Biomarkers Translational

medicine

Clinicaltrials

Regulatory

approvals

Productcommercialization

Academia

Pharma


Applied Testing



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Well positioned in competitive landscape

Applied Sciences MDx MDx

Sample Technologies

Life Sciences - - - -

Molecular Diagnostics (MDx) -

Assay Technologies

Life Sciences -

MDx -

Automation instruments -

R&D continuum coverage - - - -

Life Sciences customers

Academia - - - -

Pharma - - - -

Applied Testing - - - -

MDx

customers

Prevention - - - -

Profiling - - - -

Personalized Healthcare - - - -

Point of Need - - - -

Geographic presence

Narrow Broad

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Academia / Pharma

/ Applied Testing


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Growth drivers in place, addressing challenges

Growth driver contributions

2011 Near-

to medium-term

Long-term

Key growth drivers

QIAsymphony

Profiling: Viral load testing

Personalized Healthcare: CDx

Applied Testing: Forensic standards

Applied Testing: Veterinary/food safety Academia/Pharma: Molecular pathways Academia/Pharma: Translational medicine MDx

Prevention: QuantiFERON

Key challenges

Lower U.S. healthcare utilization (HPV) ()U.S. HPV competition reduces growth ()Managing broad pipeline Macroeconomic factors

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Long-term positivefundamentals

Short-termtransitory

headwinds


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Preparing for a new growth phase after disruptions

2007 2009 2011 2013

Expand life sciences leadership and build up MDx Targeted acquisitions Customer relations Global expansion

Growth drivers for next wave

QIAsymphony

Expanding test menu

High-growth markets

Personalized Healthcare

Updatedgrowth plan

Recession impact

HPV uptake in U.S.

R&D funding

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Project Full Potential:

1. Accelerate sales growth

2. Reallocate resources


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Strategic initiatives to drive growth and innovation

Drive platform success

Roll out QIAsymphony

worldwide

Advance QIAensemble

strategy

Leverage leadership in Sample & Assay Technologies

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Add content

New tests across all customer classes

Broaden geographic presence

Target high-growth emerging markets

Grow efficiently and effectively

Sustained growth and improved profitability

Leverage synergies across customer classes

Best-in-class team and work environment


Applied Testing

Academia


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Delivered on 2011 goals, setting ambitions for 2012

Strategic initiatives 2011 goals 2012 goals

End-2011 target: >550 QIAsymphony

systems

Decapper

launch

Update QIAensemble

strategy

Increase QIAsymphony

base

Improve HPV test automation

Deliver QIAensemble

milestones

Selected submissions:

KRAS (Erbitux)

KRAS (Vectibix)

Influenza

careHPV

Cellestis

and Ipsogen

Complete selected submissions:

EGFR (Tomtovok)

artus

CMV

QuantiFERON

CMV… and many others

Dynamic growth in top 7 EGM

Direct entry in India / Taiwan

Target high-growth regions: Eastern Europe, Asia, Americas

Sales and earnings growth

Launch productivity initiatives

Reallocating resources

Grow at a faster pace than 2011

Drive productivity initiatives

Improve margins

Drive platform success

Add content

Grow efficiently and effectively

Broaden geographicpresence

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QIAsymphony

RGQ: New era of automation

QIAsymphony

RGQ –

Integrated workflow QIAsymphony

placements

Most versatile molecular testing system

QIAsymphony

SP

Sample input module

Automates purification

QIAsymphony

AS

Eluate

input

Automates assay setup

Sample Result

Rotor-Gene Q Detection Analysis

End 2011

target

> 550

2008

Achieved 2011 target500

1,000

Installed base

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(QIAsymphony

SP launch)

NEW

Ongoing global expansion(~50 new placements per quarter)


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QIAsymphony

RGQ: Across all customer classes

Americas~40%

Europe~30%

Asia-Pacific/Japan~30%

Asia-Pacific/

Japan~10%

Europe~55%

Americas~35%

Applied Testing

Pharma

Academia~40%


~60%

>550 QIAsymphony

placements by end 2011


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QIAsymphony

RGQ driving “lean labs”

Typical mid-sized European hospital laboratory

49 molecular tests

Annual volume: ~70,000 tests and growing

Process tests for 8 hospitals and clinics

Issues

Redundant instruments

Administrative tasks

Need for consolidation

Conducted “lean”

analysis

Minimize waste

Consolidate platforms and vendors

Outcome: 38 of 49 tests

now on QIAsymphony

RGQ

Case study: St. Elisabeth Hospital, Tilburg, The Netherlands

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Assay providers

Com

petit

ors

Com

petit

ors

Past Present

Past Present

Platform providers


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Early phase of long-term product cycle

Sales

Launch ~15 years

New system

Build installed base Expand test menu / Add new features

Maximize value / Develop new system

Typical product cycle

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QIAsymphony

RGQ

(Late 2010 launch)

QIAsymphony

SP/AS (2008-2009 launches)

Targeting sustained QIAsymphony

RGQ expansion

Today


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Adding content to automation platforms

Selected key menu submissions

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QIAsymphony(Marketed)

QIAensemble(In development)

2011submissions

Planned submissions2012

Planned submissions≥

2013

careHPV

artus Influenza

QuantiFERON

tests

therascreen KRAS (Vectibix)

therascreen KRAS (Erbitux)

QuantiFERON

CMV

artus CT/NG

artus CMV

artus HIV

artus HCV

therascreen JAK2

therascreen EGFR

therascreen KRAS (lung)

therascreen BRAF

therascreen BCR-ABL

artus CT/NG

Rotor-Gene Q(Marketed)


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Rapid growth in Personalized Healthcare

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Personalized Healthcare sales2011 estimate: ~$75 million

Co-developmentprojects(Molecular Diagnostics)

Other(Molecular Diagnostics

Clinical research in Academia / Pharma)

Commercial

biomarker assays

(Molecular

Diagnostics)

Milestone payments

Broad portfolio for solid and hematological

tumors


Biomarker analysis and validation

Automation instruments

Third-party manufacturing (OEM)

Ongoing strong double-digit sales expansion

NEW EGFR biomarker test approved in Japan

(December 2011)

NEW ALK biomarker

(January 2012)

NEW IGH1 / IGH2 biomarkers

(January 2012)

Sample & Assay Technologies Leading co-development project portfolio

Selected Personalized Healthcare co-development projects

Project Partner Indication Biomarker Status

Eribitux

(cetuximab)

Colorectal

cancer KRAS Submitted U.S.

(PMA) in H2 2011

Vectibix

(panitumumab)

Colorectal

cancer KRAS Submitted U.S.

(PMA) in H2 2011

PF-00299804

(dacomitinib)

Lung cancer

(NSCLC) KRAS In development

Iressa

(gefitnib)

Lung cancer

(NSCLC) EGFR CE-IVD kit in Europe and

other non-U.S. markets

Tomtovok

(afatinib)

Lung cancer

(NSCLC) EGFR U.S. submission planned

for 2012

Early-stage compound Blood cancer JAK2 In development

Not disclosed Confidential partners Oncology and non-oncology Various In development

Partner of choice: Industry-leading 15 projects under way

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TB remains a major health issue

QuantiFERON: New gold standard for latent TB detection

Superior to 120-year-old Tuberculin Skin Test (TST)

No impact from BCG vaccination

Only one visit

U.S:, Europe and Japan approval and reimbursement

R&D collaboration with Max Planck Institute (Berlin)

Follow-up PCR-based test

Assess risk for latent TB activation

QuantiFERON-TB Gold: New global test standard

Test group QuantiFERON-TB Gold Tuberculosis Skin Test (TST)

Specificity1 99.2% 65.9%

Sensitivity for active TB 89.0% 76.0%

Bacille

Calmette-Guerin (BCG) vaccination

Unaffected2 20% -

40% are false positive3

Non-TB mycobacterial

infections (NTM)

Mostly unaffected4 In U.S.-born, up to 50% false positive5

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1

Menzies

D, et al., 2007 2

Mori t., et al., 2004 3

Farhat

M., et al., 2006 4

Anderson P., et al., 2000 5

von Reyn

C.F., et al., 2001

Ongoing strong double-digit sales expansion

“TB is an old disease that never went away, and now it is evolving with a vengeance.”-

Zsuzsanna

JakabWHO regional director Europe (Reuters, Sept 2011)

NEW


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Expanding QuantiFERON-TB Gold target markets

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Global addressable market: > 50 million tests

ClinicalPatients with TB symptoms

Contact tracingPublic health / Hospitals

ScreeningHealthcare / Immigration

Travel / Military

ImmunosuppressionCancer / Dialysis

Rheumatology / HIV

QuantiFERON-TB Gold application areas


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Broadening TB portfolio with risk assessment test

Latent or

active

TB

Latent TB

Treatment

Monitoring

Future QuantiFERON

screening opportunity

Treatment

Isolation

Identification and treatment critical to TB disease control

Active TB Test(MDx)

Quantiferon

TB Gold

Risk test

(R&D

project)

Sample & Assay Technologies Addressing HPV market dynamics

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9M 2011

U.S. –

Solidify market leadership

Driving HPV testing conversion

~45% penetration

Guidelines favor HPV / Pap co-screening

Untapped opportunities

Working with customers

Renewing major multi-year contracts

Benefits: Gold standard and switching risks

Providing automation improvements

QIAensemble

Decapper

launched in Q4 2011

Building on HPV status

Blockbuster assay

Strong relations with many labs

Rest of world –

Convert to primary screening

Unrivaled clinical data

Regional actions

Europe: Leader

Latin America: Mexico implementation

Asia-Pacific/Japan: Opportunities

MolecularDiagnostics(non-HPV)

~26%

Pharma~21%

Academia~26%

Applied Testing~7%

$835.3 million

MolecularDiagnostics

(HPV)

U.S. ~15%

Ex-U.S. ~5%

All figures at actual exchange rates

QIAGEN sales overview

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~46%

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NEW


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Expanding geographic presence

First nine months 2011 net sales by region

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Targeting expansion in Eastern Europe and Latin America

48%

33%

17% Asia-Pacific / Japan

Europe / Middle East / Africa

Americas

Until 2004 2004 -

2007 2008 -

2010 2011 -

Future

US, Europe and Japan

Distributions in other regions

Asia-Pacific

Brazil and Mexico

Turkey

India and Taiwan

Eastern Europe

Latin America

Africa


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Net sales (In $ millions) Adjusted net income (In $ millions)

Sustained sales and earnings improvement

2005 –

2010 CAGR: 22% 2005 –

2010 CAGR: 26%

Adjusted net income excludes business integration and relocation-related charges as well as amortization of acquired intellectual

property and equity-based compensation (SFAS 123R)

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Healthy financial position

As of Sept 30, 2011

Group liquidity (In $ millions) 486

Net debt (In $ millions) -336

Shareholder equity ratio 65%

Net debt / adjusted EBITDA ratio 0.9

Healthy financial position supporting business expansion

Leverage ratio: Net debt / EBITDA

Cash flow (In $ millions) Q3 2011 9M 2011

Net operating cash flow 59 165

Purchases of property, plant and equipment -17 -56

Free cash flow 42 109

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For further information on adjustments, please refer to the reconciliation tables in QIAGEN's

Q3 2011 earnings release or appendices

0.00.2

3.3

2.2

0.4

0.1

0.9

-0.5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

2005 2006 2007 2008 2009 2010 20119M

Digene

acquisition

Cellestis

and Ipsogen

acquisitions

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Sustainable sales expansion

2012: Improving CER growth vs. 2011

2013 onwards: Return to faster growth

Margin improvement

New projects to unlock efficiency gains

End-2013 target: ≥

31% adjusted operating margin

Taxes and capital allocation

Further tax rate reductions

Capital allocation measures –

including share repurchase program –

under review

Focus on delivering shareholder returns

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1

2

3

CER –

Constant exchange rates

Focus on maximizing bottom-line growth and delivering shareholder returns

Drive adjusted EPS

growth


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Track record of growth and innovation

Robust development pipeline

Strong free cash flow

World leader in Sample & Assay Technologies

Driving the dissemination of molecular testing

Key considerations: Strong growth potential

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Attractive and growing markets

Building leadership in Molecular Diagnostics

Highly competitive offering in Academia, Pharma

and Applied Testing

Capitalizing on diverse growth opportunities

Pioneer in Personalized Healthcare

Expansion into high-growth markets


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Thank you!

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J.P. Morgan Healthcare Conference€¦ · January 2012. Sample & Assay Technologies 2. Forward...

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Transcript of J.P. Morgan Healthcare Conference€¦ · January 2012. Sample & Assay Technologies 2. Forward...