Sample & Assay Technologies - Qiagen...Sample & Assay Technologies QuantiFERON-TB: Expanding use in...
Transcript of Sample & Assay Technologies - Qiagen...Sample & Assay Technologies QuantiFERON-TB: Expanding use in...
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.
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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
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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
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Automation
Molecular content
Assay reagents
Bioinformatics
Access to DNA and RNA
Sample & Assay Technologies
Instruments
Comprehensive product range to support workflows
2012 9M net sales: $908 million
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Leading portfolio of molecular tests for use with range of instruments
Consumables
87% 13%
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Sample & Assay Technologies
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
Molecular Diagnostics
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Sample & Assay Technologies
Sample Technologies
AssayTechnologies
Molecular Diagnostics
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)
■ NGS (2013 launch)
■ NGS (2013 launch)
Next-gen sequencingWhole genome
Whole genomediagnostics
Whole genome discovery
Building selected sample-to-result leadership positions
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BIOLOGICAL SAMPLE
VALUABLE MOLECULAR
INFORMATION
Sample & Assay Technologies Accelerating pace of life sciences breakthroughs
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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
Sample & Assay Technologies
Prevention
Molecular Diagnostics portfolio with attractive potential
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QuantiFERON-TB
AmniSure and ESE
therascreen companion diagnostics
Expanding infectious disease menu
Applied Testing
Pharma
Academia
Molecular Diagnostics
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
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Sample & Assay Technologies
QIAsymphony: Unparalleled features driving dissemination of molecular testing
QIAsymphony: Exceeded 2012 year-end placement goal
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40%
35%
7%
18%
Europe
North America
Latin America
Asia-Pacific / Japan
QIAsymphony placements (As of December 2012)
Molecular Diagnostics
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)
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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 �
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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
Sample & Assay Technologies
Selected QIAGEN biomarkersIncreasing pathway knowledge
New biomarkers with potential as companion diagnostics
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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
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~ 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
Sample & Assay Technologies
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
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Covering multiple technologies: PCR, panels and NGS options
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Sample & Assay Technologies Expanding NGS from research to routine clinical use
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AcademiaPharma
Applied Testing
Molecular DiagnosticsCus
tom
ercl
asse
s
High-throughput sequencing
Wor
kflo
w
need
s
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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
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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
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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
Sample & Assay Technologies
� 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
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� 2-4 visits required
� Subjective, low specificity: 65.9%
� Not reliable for TB-vaccinated people
Latent TB testing: >$1 billion total addressable market potential
Sample & Assay Technologies
� 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
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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
Sample & Assay Technologies
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
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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
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Sample & Assay Technologies
Thank you!