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Committed to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014

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Page 1: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Committed to innovation and growth

Roland Diggelmann,COO Roche Diagnostics

Chicago, 29 July 2014

Page 2: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014 Group results

DiagnosticsOverview & strategyHY 2014 overview Outlook

2

Page 3: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014: Highlights

3

Regulatory updates

Innovation

1 CER=Constant Exchange Rates; 2 Breakthrough Therapy Designation; 3 Lipopolysaccharide transporter; 4 Subcutaneous; 5 Platinum resistant

Growth

• EU approval: MabThera SC4

• CHMP positive opinion: Gazyvaro CLL front line, Avastin in ovarian cancer5

• Japan approval: Alectinib in lung cancer

Immunology • EU approval: Actemra SC4

• US approval: Xolair in chronic idiopathic urticaria

Oncology

• Solid sales performance driven by HER2 franchise (+20%1), Avastin (+6%1), Professional Diagnostics (+9%1)

Profit / Cash

Sales

• +7% core EPS growth1, driven largely by strong underlying business • Strong operating free cash flow (+11%1)

• Priority review for Avastin (cervical & ovarian), BTD2 in aPDL1 (bladder), fast track for LptD3 (antibiotic)

• Acquisition of Seragon, IQuum & Genia

Page 4: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014: Both Divisions growing in all regionsInternational growth increasing in Q2

4

0

2

4

6

8

10

Japan International Europe US

DiagnosticsPharma

+5%

+3%+2%

+7%

+2%

+12%

+4%

+6%

CHFbn

+5%

+3%

+6%

+5%

All growth rates at constant exchange rates (CER)

Page 5: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

5

HY 2014: Increase in core operating profit & margin

9.168.25 8.64

9.499.41

37.2% 38.1% 38.5%40.7%

41.0%

HY 2010 HY 2011 HY 2012 HY 2013 HY 2014

+7% at CER

CER=Constant Exchange Rates

CHFbn

Page 6: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

6

HY 2014: Continued increase in Core EPS

6.95 6.68 6.887.58

7.57

HY 2010 HY 2011 HY 2012 HY 2013 HY 2014

CHF

+7% at CER

CER=Constant Exchange Rates

Page 7: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

2014 Outlook

71At constant exchange rates

Group sales growth1 Low- to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

Page 8: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014 Group results

DiagnosticsOverview & strategyHY 2014 overview Outlook

8

Page 9: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

In-Vitro Diagnostics market overviewLarge and growing market; Roche is market leader

Market share Market size

9

USD 52 bn

Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy

20%

11%

10%

8%7%3%

40%

Roche

Abbott

Siemens

J&J DanaherBiomerieux

Others Molecular Diagnostics

Professional Diagnostics

Tissue Diagnostics

Diabetes Monitoring

Page 10: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Our business modelPlace instruments to generate recurring revenues through reagent usage

10

ClosedSystems

best instrument technology broadest menu

Page 11: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Our strategyDifferentiation through innovation in testing efficiency and medical value

11

2012 2020

MedicalValue

Drivers ofcompetitive differentiation

TestingEfficiency

Page 12: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014 Group results

DiagnosticsOverview & strategyHY 2014 overview Outlook

12

Page 13: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014: Diagnostics sales Growth driven by Professional Diagnostics

13

HY 2014 HY 2013 change in %CHFm CHFm CHF CER

Diagnostics Division 5,140 5,133 0 +6Professional Diagnostics 2,904 2,825 +3 +9

Diabetes Care 1,140 1,205 -5 0

Molecular Diagnostics1 762 781 -2 +4

Tissue Diagnostics 334 322 +4 +9

1Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +6% CER=Constant Exchange Rates

Page 14: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

North America+6%

25% of divisional sales

Latin America+11%

7% of divisional sales

Japan+4%

4% of divisional salesEMEA1

+2%

47% of divisional sales

HY 2014: Diagnostics regional sales Growth across all geographies

Asia Pacific+15%

17% of divisional sales

14

16% growth in E7 countries2

1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates

Page 15: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

0%

15

HY 2014: DiagnosticsGrowth driven by Professional Diagnostics

FDA approval for cobas HPV test for primary screening in cervical cancer. HPV (+59%), virology (+5%) and blood screening (+7%)

Sales driven by Accu-Chek Aviva/Performa (+2%), Accu-Chek Mobile (+22%) and Insulin Delivery Systems (+6%)

Growth driven by advanced staining portfolio (+8%) and companion diagnostics (+29%)

1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +6% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa

Sales CHFbn

CER growth

1

+9%

+4%

+9%

Continued double digit growth in immunodiagnostics (+12%) Launch of cobas 6500 fully automated urinalysis system

0 1 2 3

Tissue Dia

MolecularDia

DiabetesCare

ProfessionalDia

EMEANorth AmericaRoW

Page 16: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

HY 2014: Diagnostics DivisionProfit influenced by unfavorable base effects

16

2014 vs. 2013CHFm % sales CER growth

Sales 5,140 100.0

Royalties & other op inc 64 1.2Cost of sales -2,319 -45.0M & D -1,170 -22.8R & D -492 -9.6

G & A -235 -4.6

Core operating profit 988 19.2

HY 2014

18%

0%

6%

0%

10%

-10%

6%

18%

Excl. one-off item PSI*: +2%

Admin: +4%Excl. PSI: +3%

CER = Constant Exchange Rates (avg full year 2013) * One-off item: impacts from past service income (PSI) in 2013

-9% in CHF

Page 17: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

RPD: Growth driven by serum work area solutionsLargest footprint and broadest menu in the industry

23%Roche

Others

Leader in CHF 19bn SWA market

cobas 8100

Integrated SWA1 solution

• 41% of Diagnostics sales in SWA (+11%):– Immunodiagnostics (+12%)– Clinical chemistry (+9%)

*Source: Roche Analysis, Company reports for 2013 validated by an independent IVD consultancy; 1SWA: serum work area (immunodiagnostics & clinical chemistry)

Page 18: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

RPD: Launch of cobas 6500 for urinalysisFully automated urine testing solution

18

• Target market ~CHF 600m• Combines urine strip testing & digital

microscopy• 23 parameters measured to help

diagnose urinary tract infections, kidney diseases and diabetes

• Competitive advantages: – Fastest and most accurate instrument– Reagent free– Minimizes manual steps– Improves safety

cobas 6500

urine work area

Page 19: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

RPD: Launch of Elecsys® Syphilis TestFor infectious disease and blood screening

19STD=Sexually transmitted diseases

Elecsys Syphilis

cobas 6000

• Expands leading immunoassay portfolio• Target market (HIV, Syphilis, Herpes immunoassay):

~CHF 850m• Test can be performed across entire cobas analyzer

platform series• Competitive advantages:

• High sensitivity/specificity• Low blood sample volume• Short time to result

• Offers complete solution for STD and pre-natal infections testing

• Fulfills WHO requirements for blood safety solutions

Page 20: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Molecular Diagnostics: HPV testingApproval for primary screening in US and Canada

20

• 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

Page 21: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

RMD: cobas 8800/6800/4800Setting new standards for molecular testing

Blood Screening Virology HPV & CT/NG Microbiology Genomics & Oncology

• Multiplex HIV, HCV, HBV• West Nile Virus• B19 and HAV

• HIV• Hepatitis B, C• HSV• CMV

• Human Papillomavirus

• Chlamydia & Gonorrhea

• MTBMAI• MRSA• C. Difficile

• BRAF • K-RAS• EGFR• PIK3CA

cobas 4800 SystemRMD Platform Strategy

cobas 8800/6800 Systems

RMD Assays

21

• Advanced PCR automation• Highest throughput (3x above closest competitor)• Broadest menu

• Low to middle volume throughput• Broadest menu

Page 22: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

IQuum acquisitionEntering Point of Care in molecular diagnostics

22

Target market:• ~CHF 350m, growing ~20%

Liat (laboratory in a tube) technology:• Fast and simple with automated process

performed in a test tube• Brings laboratory PCR to the Point of Care• Short turnaround time

Portfolio:• Analyzer and Influenza A/B assay approved• Strep A and Respiratory Syncytial Virus tests

in clinical studies• Planned expansion into MRSA and C-difficile

Liat™ Analyzer

Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus

Page 23: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Genia acquisition Strengthening next generation sequencing pipeline

23

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

Page 24: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

2014 Group results

DiagnosticsOverview & strategyHY 2014 overview Outlook

24

Page 25: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

*Excluding US;1Business 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

Key launches 2014

25

Area Product Market BA1

Instruments/

Devices

Labs

cobas 6800/8800 – Next generation molecular (PCR) systemcobas m 511 – Fully integrated and automated hematology systemcobas 6500 – Automated urinalysis work area platformConnect-V – Middleware providing connectivity to LIS2

WW*EUEUWW

RMDRPDRPDRTD

Diabetes Care

Accu-Chek Insight- Next generation insulin pump & bGm3 systemAccu-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 testMPX (HIV, HCV, HBV), HEV, DPX4, WNV5 – Full NAT blood screening menu for cobas 6800/8800 HIV, HCV, HBV – Virology tests for cobas 6800/8800HSV- Detection of Herpes Simplex Virus on cobas 4800Syphilis– Immunoassay for the detection of Treponema pallidum

USWW*

WW*EUEU

RMDRMD

RMDRMDRPD

MicrobiologyMRSA/SA – Next generation assay on cobas 4800C-difficile – Diagnosis of infections and associated diarrhea

EUEU

RMDRMD

Women’s Health

PE Prognosis- Claim extension for short-term prediction of Preeclampsia in pregnancyAMH- Assessment of ovarion reserve for fertility

EUEU

RPDRPD

Page 26: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

OutlookSustain sales growth and profitability

26

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

Page 27: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

27

Doing now what patients need next

Page 28: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Roche strategy: Focused on medicallydifferentiated therapies and personalisedhealthcare

28

Generics

Differentiation

MedTech

OTCPrem

ium

for

inno

vatio

n

DiaPharma

Focus

Regulators: Optimised benefit / risk ratio

Payors: Optimised benefit / cost ratio

Page 29: Committed to innovation and growth - Roche to innovation and growth Roland Diggelmann, COO Roche Diagnostics Chicago, 29 July 2014. ... screening for cervical cancer and expand screening

Roche Diagnostics' commitment to PHC

29

Oncology

Neurosciencelampalizumabgeographic atrophy

Immunology /Ophthalmology

ocrelizumabMS

cobimetinib (MEKi)melanoma

lebrikizumabasthma

gantenerumabAlzheimer’s

1Phase 3 decision pending

Bcl-2i (GDC 0199)hem. cancers

alectinib (ALKi)NSCLC

taselisib (PI3Ki)1

solid tumours

pictilisib (PI3Ki)1

solid tumours

polatuzumab (aCD79b)1

hem. cancers

etrolizumabUC and CD

Oncology

Neuroscience

Ophthalmology

Immunology

anti-PDL1solid tumours

Majority of Roche Pipeline with a PHC approach

External PHC collaborations2 with more than 40 pharma & biotech companies