Committed to innovation and growth - Roche · PDF filecobas AmpliPrep/cobas TaqMan HIV-1 Test . The goals ... Roche is market leader in DNA testing Complement offering with leading

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

2

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

4

Closed Systems

best instrument technology broadest menu

Our strategy Differentiation through innovation in testing efficiency and medical value

5

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

6

7

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

8

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

9

Roche Diagnostics Test Portfolio Industry Leading Menu

10

First fully-automated Anti-Müllerian hormone test for fertility

11

• 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

12

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

13

HPV testing Approval for primary screening in US and Canada

14

• 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

15

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

17

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

18

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

20

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

21

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

22

Business model & strategy

Q3 2014 overview

Major products, launches and newsflow

Building a leading sequencing solution

Outlook

23

Key launches 2014

24

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

ü

ü ü

ü

ü

ü

ü

ü

ü

ü

*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

ü

ü

ü

Outlook Sustain sales growth and profitability

25

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

26

Doing now what patients need next