Committed to innovation and growth - Roche1b990e38-cacf-4ca3-a5aa-39acb70094… · Committed to...
Transcript of Committed to innovation and growth - Roche1b990e38-cacf-4ca3-a5aa-39acb70094… · Committed to...
Business model & strategy
Q3 2014 overview
Major products, launches and newsflow
Building a leading sequencing solution
Outlook
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In-Vitro Diagnostics market overview Large and growing market; Roche is market leader
3 Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy
Market share
20%
11%
10%
8% 7% 3%
40%
Roche
Abbott
Siemens
J&J Danaher Biomerieux
Others
Market size
USD 52 bn
Molecular Diagnostics
Professional Diagnostics
Tissue Diagnostics
Diabetes Monitoring
Our business model Place instruments to generate recurring revenues through reagent usage
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Closed Systems
best instrument technology broadest menu
Our strategy Differentiation through innovation in testing efficiency and medical value
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2012 2020
Medical Value
Drivers of competitive differentiation
Testing Efficiency
Business model & strategy
Q3 2014 overview
Major products, launches and newsflow
Building a leading sequencing solution
Outlook
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2014
2013
CHFm CHFm CHF CER
Diagnostics Division 7,792 7,677 1 6
Professional Diagnostics 4,397 4,251 3 8
Diabetes Care 1,721 1,781 -3 1
Molecular Diagnostics 1,165 1,164 0 5
Tissue Diagnostics 509 481 6 10
Change in %
YTD Sept 2014: Diagnostics sales Growth driven by Professional Diagnostics
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=Constant Exchange Rates
North America +6%
25% of divisional sales
Latin America +12%
7% of divisional sales
Japan +3%
4% of divisional sales EMEA1
+3%
46% of divisional sales
YTD Sept 2014: Diagnostics regional sales Growth across all geographies
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Asia Pacific +15%
18% of divisional sales
15% growth in E7 countries1
1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates
Business model & strategy
Q3 2014 overview
Major products, launches and newsflow
Building a leading sequencing solution
Outlook
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First fully-automated Anti-Müllerian hormone test for fertility
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• Expands leading immunoassay portfolio • Target market (IVF): ~ 25 mCHF ; +10% • AMH test superior to FSH, estradiol and ultrasound
measurements • Competitive advantages vs manual AMH testing:
- High sensitivity - Improved accuracy - At any day of the menstrual cycle - Short time to result
• Test is currently also in development as CDx assay
Elecsys AMH cobas e411
FSH = follicle-stimulating hormone; rFSH = recombinant follicle-stimulating hormone; IVF = in vitro fertilization; AMH = Anti-Müllerian hormone
Medium Hospitals
Large Hospitals
Reference Labs
High Throughput
Low Throughput
cobas® 6800
cobas® 4800
cobas® 8800
Molecular Diagnostics: Meet the new family – launches of cobas 6800/8800
• Advanced PCR automation • Highest throughput (3x above closest
competitor) • CE launch of blood screening and
virology assays
• Low to middle volume throughput • Broadest menu incl HPV testing
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HPV testing Approval for primary screening in US and Canada
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• HPV market ~CHF 300m (+13%)
• FDA recommends cobas HPV test as primary screening for cervical cancer and expand screening age to 25 - 29
• ATHENA study: Pap smear misses cervical disease in 1 in 7 HPV 16 positive women
• Ongoing pilot studies: Sweden, Netherlands, UK and Italy
Three results in one test • HPV genotype 16 • HPV genotype 18 • 12 high risk HPV pool
cobas HPV test (+59%) HPV primary screening
Global access program Landmark partnership in HIV with United Nations
The program
cobas AmpliPrep/cobas TaqMan HIV-1 Test
The goals
• Special access pricing partnership • 40% savings on viral load tests
• UNAIDS target by 2020: - 90% diagnosed - 90% treated - 90% virally suppressed
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Entering Molecular Point of Care Diagnostics Acquisition of Iquum and launch of cobas Liat™ analyzer Target market:
• ~CHF 350m, growing ~20%
Liat (laboratory in a tube) technology: • Fastest and easy to use with automated
process performed in a test tube • Brings laboratory PCR to the Point of Care • Offers real-time PCR in 20 min or less • CLIA waiver expected in 2015 Portfolio: • Influenza A/B and Strep A test are both CE
Marked and FDA cleared • Respiratory Syncytial Virus tests in clinical
studies • Planned expansion into MRSA and C-difficile
Liat™ Analyzer Liat™ tube
Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus 16
Diabetes Care: Personalized management New product launches in 2014
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Blood glucose monitoring
• Wireless transfer of blood glucose results • Connect: App with proven bolus advisor • Data synchronization with healthcare
professional portal via cloud
Diabetes therapy system
• Two-way bluetooth communication between pump and remote control
• Remote control with proven bolus advisor • Discrete and easy handling; intuitive display
Accu-Chek Aviva / Performa Connect Accu-Chek Insight
Business model & strategy
Q3 2014 overview
Major products, launches and newsflow
Building a leading sequencing solution
Outlook
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DNA testing market*: 10-year estimates Next-generation sequencing (NGS) will be the fastest-growing segment
DNA testing uses different technologies which are complementary in applications: • Molecular (PCR):
– virology – blood screening – Oncology – Infectious disease
• In situ hybridization (ISH) – oncology
• Sequencing: – Whole genome sequencing and
targeted sequencing – Mutation detection – Oncology – Pre-natal, newborn – Infectious disease
Roche is market leader in DNA testing Complement offering with leading sequencing solution
* Includes Lab developed tests; PCR: polymerase chain reaction; Sanger: oldest sequencing technology; ISH: in situ hybridization
Sample preparation DNA isolation
Sequencing Menu Development
Library preparation Target enrichment
P ?
Data / Result Storage
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2° and 3° Analysis Reporting
New Diagnostic Technology: Sequencing Our vision: Complete end to end solution
Menu Development:
Oncology, Genetic Testing
AvanSci: technology acquisition; Abvitro: technology acquisition; Kapa Biosystems: distribution agreement; Garvan Institute: research collaboration; Nimblegen: acquisition; Ariosa: acquisition; Genia: acquisition; Pacific Biosciences: partnership; Stratos: research collaboration; Bina: acquisition
Genia Sequencing Technology Next generation sequencing
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Target market: CHF 1.1bn (+20% pa until 2018)
Genia technology: • Single DNA molecule sequencing • Biological nanopore electrical detection • Shorter turnaround time, better sensitivity &
accuracy than existing NGS1 platforms • Opportunity to reduce sequencing costs
Genia technology
1NGS = Next Generation Sequencing
Sequencing menu: Non-invasive prenatal testing Acquisition of Ariosa
Target market • $400m sales worldwide in 2013, +32% pa
Technology • Analyzes circulating fetal DNA with microarray
technology • Highly cost effective and accurate • Screens for the risk of Down syndrome (trisomy 21),
Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13) in a pregnancy
Strategy • Expand market access through kit distribution model • Add test to Roche sequencing platform when available
HarmonyTM Prenatal Test
Digital analysis of selected regions (DANSRTM) technology results in a 10x more efficient approach
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Business model & strategy
Q3 2014 overview
Major products, launches and newsflow
Building a leading sequencing solution
Outlook
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Key launches 2014
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Area Product Market BA1
Instruments/
Devices
Labs
cobas 6800/8800 – Next generation molecular (PCR) system cobas m 511 – Fully integrated and automated hematology system cobas 6500 – Automated urinalysis work area platform Connect-V – Middleware providing connectivity to LIS2
WW* EU EU WW
RMD RPD RPD RTD
Diabetes Care
Accu-Chek Insight- Next generation insulin pump & bGm3 system Accu-Chek Connect – bG meter with connectivity to smart phones, mobile App and cloud
EU
EU
RDC
RDC
Tests /
Assays
Infectious Diseases / Blood Screening
MPX 2.0 – Next generation blood screening multiplex test MPX (HIV, HCV, HBV), HEV, DPX4, WNV5 – Full NAT blood screening menu for cobas 6800/8800 HIV, HCV, HBV – Virology tests for cobas 6800/8800 HSV- Detection of Herpes Simplex Virus on cobas 4800 Syphilis– Immunoassay for the detection of Treponema pallidum
US WW*
WW* EU EU
RMDRMD
RMD RMD RPD
Microbiology MRSA/SA – Next generation assay on cobas 4800 C-difficile – Diagnosis of infections and associated diarrhea
EU EU
RMD RMD
Women’s Health
PE Prognosis- Claim extension for short-term prediction of Preeclampsia in pregnancy AMH- Assessment of ovarion reserve for fertility
EU EU
RPD RPD
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*Excluding US; 1 Business Areas: RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics, RTD: Roche Tissue Diagnostics; 2 hospital information systems; 3 blood glucose monitoring; 4 parvovirus B19 and hepatitis A virus; 5 west nile virus
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Outlook Sustain sales growth and profitability
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Drivers
• Further expand installed base and test menu • Launch next generation platforms and drive lab efficiency • Continue to strengthen leading presence in emerging markets • Ongoing adjustments in Diabetes Care to adapt to market environment • Grow PHC* and companion diagnostics collaborations
* Personalised healthcare