Committed to innovation and growth - Roche1b990e38-cacf-4ca3-a5aa-39acb70094… · Committed to...

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Committed to innovation and growth Roland Diggelmann, COO Roche Diagnostics Bad Ragaz, 16 Jan 2015

Transcript of Committed to innovation and growth - Roche1b990e38-cacf-4ca3-a5aa-39acb70094… · Committed to...

Committed to innovation and growth Roland Diggelmann, COO Roche Diagnostics Bad Ragaz, 16 Jan 2015

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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Roche Diagnostics Test Portfolio Industry Leading Menu

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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

Invest for growth Reagent manufacturing in China

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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

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Doing now what patients need next