Disruptive portfolio focused on high-growth, high-demand opportunities - Thierry Bernard Senior Vice President, Head of Molecular Diagnostics ...
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2019 Analyst & Investor Day
Molecular Diagnostics
Disruptive portfolio focused on high-growth, high-demand opportunities
Thierry Bernard
Senior Vice President, Head of Molecular Diagnostics Business Area
Sample to Insight
Disclaimer
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Sample to Insight
2019 Analyst & Investor Day 2
Molecular Diagnostics market maintains status as fastest growing IVD sector
Our customers Total addressable market(1) Key trends
• MDx dissemination: Acute to routine testing
Growing demands for near-patient testing for
QIAGEN market share: ~12%
acute conditions combined with routine test
consolidation (approved and LDTs)
~$8 bn • Dynamic opportunities
~+6-7% CAGR
Move to “gold standard” testing with innovation –
e.g. liquid biopsy and biomarkers
~$6 bn
• Simpler and faster automation
Demand for end-to-end solutions – not just
technologies – to process increasing volumes
Molecular Diagnostics • Reimbursement opportunities
Payor pressure to show value through outcomes,
Reference labs and deliver efficiency vs. other testing methods
Hospitals
Healthcare network labs
Pharma companies
(companion diagnostics) 2019 2023
estimate
(1) QIAGEN addressable markets excluding blood-bank testing LDTs – Laboratory developed tests
Sample to Insight
2019 Analyst & Investor Day 3
Disruptive portfolio focused on high-growth, high-demand opportunities
Molecular Diagnostics sales trends Immune Response
2019-2023 target:
~+9-10% CER CAGR
QuantiFERON technology for latent disease testing: #1
Expanding latent TB testing, Lyme disease test in development
~+5% CER CAGR
~$679 m ~$732 m
~$614 m ~$663 m
Infectious Diseases
New entrant into syndromic testing (QIAstat-Dx) and integrated Top 3
PCR testing (NeuMoDx), build on QIAsymphony RGQ success
2012 2014 2016 2018 2023
mid-term target Oncology and Precision Medicine
2018 MDx sales by region and product mix Trusted partner with >25 pharma co-development #1
partnerships, only supplier of both PCR and NGS solutions
Instruments Consumables
Asia-Pacific / Japan
~10% ~90%
~20%
Americas
LDT Workflow Solutions
EMEA
~50% Leading provider of full range of LDT assay components, Top
Top 2
~30% in particular for use on modular QIAsymphony system
Sample to Insight
2019 Analyst & Investor Day 4
Strategy: Deliver above-market growth with disruptive portfolio, agility and partnerships
Immune Response: Develop QuantiFERON (QFT) franchise and automated platforms
2023 target: >$400 million of QFT-TB sales, deliver QFT-Access and QFT-Lyme
Focus on
Infectious Diseases: Execute on launch opportunities for new automation systems
high-growth 2023 target: >$150 million of combined sales from QIAstat-Dx and NeuMoDx
opportunities
to develop
sustainable
leadership Oncology and Precision Medicine: Maximize leadership, build up new areas
2023 target: Launch at least 8 new CDx tests from portfolio of >25 pharma partnerships
positions
LDT Workflow Solutions: Addressing demands for high-quality assay components
2023 target: Place over 800 new QIAsymphony systems from 2020-2023
Sample to Insight
2019 Analyst & Investor Day 5
QIAGEN offers the most comprehensive and differentiated automation portfolio
0 Pre-molecular assays Real-time PCR technology NGS technology
Market potential >$0.2 billion
with current menu
>$1 billion >$2.7 billion >$0.3 billion >$0.8 billion
(Clinical oncology)
QuantiFERON NeuMoDx QIAsymphony GeneReader
QIAstat-Dx
QuantiFERON-TB / Access N96 / N288 SP / AS / RGQ NGS System
Applications: Various diseases Integrated testing Modular sample processing Rapid syndromic testing Oncology gene panels
(TB, CMV, Lyme, etc.) for infectious diseases for commercial test / LDTs and future applications NIPT in development
Immune
Modulation
Infectious
Diseases
Oncology
Precision
Medicine
LDT
Workflow
Solutions
Primary use Secondary use Future development
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2019 Analyst & Investor Day 6
Immune Response: Broaden QuantiFERON menu and create new tests with partners
Drive QFT-TB market conversion Launch QFT-Access in mid-2020 Expand DiaSorin menu: QFT-Lyme
>$1 billion market opportunity:
Leverage best-in-class automation
partnership to drive market conversion of
~70 million annual latent TB tests
Leverage best-in-class with automation Advance TB control in high-burden, low- Launch ultra-sensitive Lyme disease test
partners to drive market conversion of resource countries – particularly in with DiaSorin – up to 20 million tests per
~70 million annual latent TB tests per year Asia, Africa and Latin America year in U.S. and Europe
NEW NEW
Goal: Achieve >$400 million of QuantiFERON-TB sales in 2023, Goal: Launch in 2021 and enter
with portfolio addition of QuantiFERON-TB Access set to support global expansion $400-600 million market opportunity
Sample to Insight
2019 Analyst & Investor Day 7
QuantiFERON: Significant conversion potential from skin test to modern gold standard
QuantiFERON-TB sales trends LTBI market only 18% penetrated QuantiFERON: ModernLTBI test gold standard
QuantiFERON-TB Gold (4th generation)
>$400 m Market
opportunity: Can be fully automated
$223 m >70 million annual Highly specific
$143 m Only one patient visit
$70 m $102 m latent TB tests
No inter-reader variability
Electronic results
2012 2014 2016 2018 2023 goal
Quality-assured lab test(1)
2018 QuantiFERON-TB regional sales Tuberculin skin test (TST)
Manual test
Affected by BCG vaccine
Asia-Pacific/ Japan
Two patient visits required
~20%
Inter-reader variability
Americas Poor surveillance tool
EMEA
~55% Often no quality controls
~25%
LTBI – Latent TB infection BCG – Bacillus Calmette-Guerin vaccine NTM – Non-tuberculosis mycobacteria IGRA – Interferon-gamma release assay (1) Not available in all markets
Sample to Insight
2019 Analyst & Investor Day 8
QuantiFERON: Developing complementary solutions to address global LTBI test demands
QuantiFERON-TB Gold (QFT-TB Gold Plus) QuantiFERON-TB Access (QFT-Access)
NEW Planning
2023
No continuous power No calibration or for
sales goal:
supply needed maintenance needed mid-2020
>$400
CE-IVD
Option million No computer
needed launch
OR
Option
Easy Incubation DiaSorin Test
single-tube step LIAISON® XS / XL results No cold chain for
blood collection Test read-out consumables
>8,000 systems worldwide
>130 test menu
Expand modern TB testing in industrialized countries Expand modern TB testing access to new markets
and large-scale testing needs in high disease burden, low-resource countries
Sample to Insight
2019 Analyst & Investor Day 9
QuantiFERON: QFT-Lyme in development to address unmet needs
Targeting potential $400-600 million market opportunity Rising occurrence of Lyme disease
Confirmed cases Potential testing market 40.000
Planned
Europe ~35,000 per year ~12-14 million tests per year CE-IVD
launch in
U.S. ~30,000 per year ~5 million tests per year 30.000
2021
20.000
Combining synergistic QuantiFERON and DiaSorin capabilities
10.000
Lyme IgG
Increased sensitivity in
Effective treatment and
Lyme IgM acute infections drives
monitoring of infected
antibiotic therapy
patients 0
NEW Lyme QFT decision
1991 2001 2011 2017
CDC: https://www.cdc.gov/lyme/why-is-cdc-concerned-about-lyme-
disease.html
(1) https://ecdc.europa.eu/sites/portal/files/media/en/healthtopics/vectors/world-health-day-2014/Documents/factsheet-lyme-borreliosis.pdf
(2) https://www.cdc.gov/lyme/datasurveillance/index.html 3 EDMA Market Data & proprietary market intelligence 4 US healthcare insurance reimbursement data
Sample to Insight
2019 Analyst & Investor Day 10Infectious Diseases: Expand PCR test portfolio with next generation of microfluidic systems
Roll out QIAstat-Dx and NeuMoDx Develop deep test menu
Ensure flawless launch of new infectious disease testing platforms Develop a critical mass of infectious disease tests in key focus areas
Blood-borne viruses Oncology
QIAstat-Dx ~$800 million new market opportunity Women’s health Respiratory
NeuMoDx ~$2.7 billion new market opportunity Transplantation Gastrointestinal
Sexually transmitted diseases
NEW NEW
Goal: At least 8 CE-IVD and FDA panels on QIAstat-Dx
Goal: Achieve >$150 million of combined sales in 2023 (base case)
and at least 20 CE-IVD tests on NeuMoDx in 2023
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2019 Analyst & Investor Day 11Infectious Diseases: Next generation of systems addressing urgent customer needs
Core / Hospital laboratories Near-patient clinical laboratories
2019 market opportunity 2019 market opportunity
~$2.7 billion ~$800 million
~+7-9% annual CAGR Hospital and Community hospitals and ~+20-25% annual CAGR
reference lab networks reference lab “outreach” centers
Requirements: Requirements:
• Full automation • Fast turnaround time
• Fast time to result • Shorter care window
• Random access and • Acute conditions
continuous loading
• Syndromic / comprehensive tests
• Longer therapeutic window
• CLIA status (medium / waived)
• Chronic conditions
• Breadth of menu
• High volume / Low-cost
• Workflow
• Breadth of menu
• Low volume / Medium cost
• Low plex / Targeted
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2019 Analyst & Investor Day 12NeuMoDx: Simplest, fastest next generation of clinical PCR testing
Two platforms with identical consumables and technology
PCR chamber
Microplate
format
DNA / RNA capture chamber
12 sample ports
12 PCR ports
NeuMoDx 96 NeuMoDx 288
Select European test menu expansion plans
Specification NeuMoDx N288 NeuMoDx N96 TBD (6)
Sample throughput: High-throughput Mid-throughput HAI (3) HAI (3)
Trich + MG Trich + MG Trich + MG
Samples per 8-hour shift Up to 340 Up to 150 HIV HIV HIV
FluA / B-RSV FluA / B-RSV FluA / B-RSV
Maximal sample loading 288 96
HPV HPV HPV
Walk-away time (no intervention) ~7 hours ~5 hours EBV EBV EBV
GAS GAS GAS
Time to result 40 to 80 min 40 to 80 min CMV CMV CMV
Onboard assays Up to 30 assays Up to 20 assays HCV HCV HCV HCV
HBV HBV HBV HBV
Footprint 183 cm x 109 cm 136 cm x 108 cm CT/NG CT/NG CT/NG CT/NG
Onboard refrigeration necessary No No GBS GBS GBS GBS
Available 2019 2020 2023
Sample to Insight
2019 Analyst & Investor Day 13QIAstat-Dx: Next generation of syndromic testing
Breakthrough system based on microfluidic technologies
Results in All-in-one mini-lab
about one hour provides one-step process
Exclusive dry Both wet and dry
swab protocol reagents on board
Room temperature Up to 48 plex using
storage real-time PCR
QIAstat-Dx
Select menu expansion plans
Specification QIAstat-Dx Comp B TBD (2)
Blood culture Blood culture
Real-time PCR quantification No Pneumonia Pneumonia
Selected
Meningitis Meningitis Meningitis
U.S. assay Respiratory Respiratory Respiratory Respiratory
Amplification curves / Ct values No menu plans Gastro Gastro Gastro Gastro
Time to result ~1 hour ~1 hour TBD (2)
Blood culture Blood culture
Selected
Pneumonia Pneumonia
Reagent reconstitution Not required Required CE-IVD assay Oncology Oncology Oncology
menu plans Meningitis Meningitis Meningitis Meningitis
Hands-free sample preparation Required Respiratory Respiratory Respiratory Respiratory
Gastro Gastro Gastro Gastro
2019 2020 2021 2023
Sample to Insight
2019 Analyst & Investor Day 14Oncology and Precision Medicine: Extending our leadership for molecular CDx solutions
Deepen pharma partnerships Strengthen PCR / NGS offering Leverage leading bioinformatics
>25 pharma co-development master Only supplier of full molecular CDx portfolio Drive growth with leading solutions
collaboration agreements to date with QIAsymphony RGQ and GeneReader designed for routine cancer testing
NGS System
NEW NEW
Goal: Add at least 8 new Goal: Launch multiplex oncology Goal: Dynamic growth in number of patients
FDA / CE-IVD CDx tests by 2023 panels on QIAstat-Dx by 2021 analyzed with QCI solutions by 2023
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2019 Analyst & Investor Day 15Oncology and Precision Medicine: Partner of choice for molecular CDx solutions
Precision medicine molecular testing overview Selected pharma co-development CDx partners
Requirements:
• Access to PCR and NGS technologies
• Full automation
2019 market opportunity
• Throughput and
~$1.1 billion
workflow flexibility
~+15% annual CAGR
• Integrated bioinformatics Currently mostly LDTs
• Customizable menu
PCR technology NGS technology
7 FDA approvals Only supplier of both Developing
and PCR and NGS I-O panels and
5 CE-IVD CDx tests technologies multiplex gene panels
for CDx partners
for CDx partners
QIAsymphony RGQ QIAstat-Dx GeneReader NGS System
(Oncology in development)
I-O – Immuno-oncology
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2019 Analyst & Investor Day 16Oncology and Precision Medicine: GeneReader NGS System complete workflow solution
Integrating top performing chemistry with best-in-class bioinformatics analysis and interpretation
Proprietary QIAGEN chemistry 3 x 3 GB flowcells QCI-Interpret
Selected Research Use Only assay menu
GeneReader Comp. I Comp. T
NIPT
Fully integrated workflow No Partly
TMB TMB
Integrated bioinformatics No Partly Lung LB Monitoring Lung LB Monitoring
Myeloid DNA UMI Myeloid DNA UMI Myeloid DNA UMI
Scalable, flexible throughput No No
BRCA Adv UMI BRCA Adv UMI BRCA Adv UMI
Price per insight No No AIT DNA UMI AIT DNA UMI AIT DNA UMI
Custom Panel Custom Panel Custom Panel
Continuous loading No No
2018 2019 2022
TMB – Tumor mutation burden AIT – Actionable Insight Tumor panel UMI – Unique molecular identifier
Sample to Insight
2019 Analyst & Investor Day 17LDT Workflow Solutions: Addressing demands for high-quality assay components
Drive QIAsymphony placements Grow sales of LDT solutions Expand QIAsymphony portfolio
>3,300
>2,500
>1,500
2015 2019 goal 2023 goal
On track to achieve >2,500 cumulative Enhance portfolio for LDT processing in New applications and platform extensions
QIAsymphony placements by end-2019 ~$1 billion market opportunity in development – e.g. processing for higher
input volumes and increased throughput
NEW NEW
Goal: Deliver >200 new placements Goal: Deliver above-market CER growth Goal: Launch new applications and
annually from 2020-2023 from LDT solutions platform extensions by 2023
LDTs – Laboratory-developed tests
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2019 Analyst & Investor Day 18Summary
• Disruptive portfolio focused on high-growth, high-demand areas of MDx
• Expanding QuantiFERON with automation partners, new Lyme assay
• Executing on launch of differentiated platforms to capture large opportunities
• Addressing clinical lab testing needs with sample technologies and LDTs
Sample to Insight
2019 Analyst & Investor Day 19Appendix Sample to Insight
NeuMoDx: A disruptive integrated PCR testing platform in a $2.7 billion market opportunity
Competitive benchmarking
Cobas 6800
Panther Beckman Veris
NeuMoDx 288 NeuMoDx 96 Panther (+ Omni LDT Cobas 8800 Alinity M
Fusion (Discontinued)
channel)
Volume in '00,000s cm3 38 16 18 27 81 120 38 48
On-board analytes 30 20 4 32 12 12 20 20
True random access Yes Yes Only 4 assays PCR or TMA Random batch Random batch No Random batch
Random access menu breadth 30 20 4 32 3 3 No 20
Continuous loading of IVD + LDTs Yes Yes No Yes No No No No
Time to first result (minutes) 40 40 150-210 150-210 210 210 90 115
On-board sample capacity 288 96 120 120 350 350 48 150
Throughput (in 8 hours) 360 150 275 335 384 960 150 300
LDT capabilities Yes Yes No Yes Yes No No No
(PCR only)
Reagent reconstitution required No No Yes Yes No No No No
Source: QIAGEN estimates based on industry data. Benchmark based on NeuMoDx 288 system.
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2019 Analyst & Investor Day 21QIAstat-Dx: Novel syndromic testing system entering an $800 million market opportunity
Competitive benchmarking
QIAstat-Dx
Biofire FilmArray Biofire Torch ePlex Verigene
(4 scalable slots
(1 slot) (12 slots) (12 slots) (1 slot)
used for comparison)
Throughput (in 8 hours) 28 9 108 60 4
Throughput per slot (in 8 hours) 7 9 9 5 4
Sound emission < 60 dB Yes No No Yes Yes
Integrated CPU and Reader Yes No Yes Yes No
Hands-on time (in minutes)You can also read
