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1 Roche Diagnostics Daniel O’Day COO Roche Diagnostics Berenberg Bank Diagnostics Day, June 3 2010

100603 Roche Berenberg DOD6a28a70a-68e1-489c-be… ·  · 2016-11-29Protein synthesis and growth PP TSC 1 TSC 1 TSC 2 TSC 2 PP PI3KPI3K mTOR AKT ... • Identifies patients whose

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Roche DiagnosticsDaniel O’DayCOO Roche Diagnostics

Berenberg Bank Diagnostics Day, June 3 2010

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This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:

1 pricing and product initiatives of competitors;2 legislative and regulatory developments and economic conditions;3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products,

including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;

6 increased government pricing pressures; 7 interruptions in production 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation;10 loss of key executives or other employees; and11 adverse publicity and news coverage.

Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

For marketed products discussed in this presentation, please see full prescribing information on our website –www.roche.com

All mentioned trademarks are legally protected

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Pharmaceuticals 9.2 9.7 6 10

Diagnostics 2.4 2.5 7 9

Roche Group 11.6 12.2 6 9

CHF bnQ1’09 Q1’10 CHF local

% change in

Roche GroupHigh growth for both divisions

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Q1 ‘09 Q1 ‘10 CHF localCHF m CHF m growth growth

Diagnostics DivisionContinues to grow significantly above the IVD market

Professional Diagnostics 1,086 1,170 8% 9%

Diabetes Care 679 708 4% 6%

Molecular Diagnostics 294 294 0% 2%

Applied Science 196 226 15% 19%

Tissue Diagnostics 106 120 13% 21%

Diagnostics Division 2,361 2,518 7% 9%

IVD = in vitro diagnostics

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Roche Diagnostics strategy firmly on trackAccessing novel content is a key driver of differentiation

Expanding menu• Novel markers• Companion DxImproving

Medical Value

2000 2010 2020

IncreasingTesting Efficiency

• Automation• Workflow• IT

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Trop I, hsTrop T, IL-6, anti-CCP, PlGF/ SFlt1, tPSA, fPSA

HPV, CT/NGKRAS Mutations

HER2 SISH & Gastric, MET, EGFR17 Oncology Antibodies

Strip-free meter (Mobile) Combined pump & meter (Combo)

cobas 8000Consolidated clinical chemistry &

immunoassays

cobas 4800 Automated PCR

LightCycler 1536High throughput PCR

Influenza A/H1N1Sequencing reagents

Benchmark Ultra Automated IHC & ISH

Accu-Chek MobileIntegrated blood glucose meter

Innovative product launches - on both frontsExpand leadership, develop new markets, drive growth

Testing efficiency Medical value

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2008

Accu-Chek Aviva Nano

Accu-Chek Mobile

Accu-Chek Combo

Accu-Chek meters and pumpsContinued roll-out of innovative products driving growth

• Small, sleek design developed for young, high-frequency testers

• Successful competitor conversions

• Accu-chek Aviva Nano US launch H2

• Only “strip-free” system enabling less steps for greater ease of use

• Available in 12 countries in EU & APAC

• First interactive insulin pump in EU allowing patients to operate pump by meter

• Now launched in 16 markets

Accu-Chek Performa Nano

2009

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The unique Medingo patch-pump technologyLower hurdles for patients to switch to pump therapy

Bolus buttons

AdhesiveCannula

• Micro patch-pump: light weight, tubing-free • Competitive advantages:

– semi-disposable product solution- easy disconnect & reconnect function– direct bolus release on pump

• Significantly lower up-front costs for patient• Launch planned for 2012

Source: Boston Medical Consultants, Company Reports, Roche Analysis

• Insulin delivery market ~CHF 1.6 bn, growing at +11%

• Insulin patch pump segment estimated to grow over-proportionally

• Patients new to pumps in the U.S. increasingly favor patch-pumpsystems

• Current durable pumps hurdles:

– weight, size, infusion set

– high initial up-front costs

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Creating medical value Through new diagnostics tests…

Medical Value

• Screening• Diagnosis• Prognosis• Prediction• Monitoring

• Treatment selection• Response prediction• Treatment monitoring

Diagnostics

Companion Diagnostics

+

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Number of HPV tests in US

~1 m

~30 m

~50 m

Clinical Applications

US Market now$250 m, +20%

Pap HPV Colposcopy+ +

- 1 year

Pap/HPV

+ +

+ 1 year

3 years

Colposcopy

HPV Pap+ +

- 3 years

Colposcopy

ASCUS Triage

Adjunct screening

Primary screening

-- -

Cervical Cancer: HPV screening algorithmsGrowth and market size driven by adoption of screening

Company reports, Roche analysis

Future potential> $1 bn market

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The ATHENA Trial

~47,000 womenFollow-UpYear 1

Follow-UpYear 2

Follow-UpYear 3

2009 - 2010 2010 - 2011 2011 - 2012

Enrolment Completed

ATHENA trial demonstrates medical value of HPV testing and Genotyping in Cervical Cancer screening

• Targets ASCUS triage, adjunct screening and HPV 16/18 claims

• Study results confirm variability of cytology and support improved consistency of HPV DNA based cervical cancer screening programs

• Data support HPV 16/18 genotyping as actionable information for intervention

• FDA submission mid 2010; data to be presented at IPV, Montreal 07/2010

* Wright, TC., EUROGIN 2010

Women with colposcopy (~8,000)

2009

ASCUS/ HPV+

Pap-/ 16/18+Pap-/ HPV +Pap-/ HPV - ASCUS/ 16/18+

ASCUS/ HPV-

Deferred follow up Yearly follow up Immediate

follow up

4.5%5.7%6.1%6.5%CIN 2+ overall

15.5%15.6%15.7%13.8%HR HPV Positive

9.8%8.1%5.2%3.7%Cytology Abnormal

DCBASite

Increasing risk of CIN2+

Cytology vs. HPV Testing*

Immediate follow up for HPV 16/18

ATHENA establishes the value of genotyping in cervical cancer

screening programs2 % 10 %

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Overall survival from Prostate cancer*

70%, n=311

Normal

5’ Deletion

5’ Deletion/ 3’ Duplication

Surv

ival

from

Pro

stat

e C

ance

r %

* Oncogene (2008) 27, 253-263TMPRSS2= transmembrane protease, serine 2 (androgen responsive gene) ERG=Ets Related Gene

Rearrangement status may determine clinical outcome

• How aggressive is my cancer?

• What should the course of my primary therapy be?

• What is my risk of metastasis?

Prostate Cancer: Rearrangements between TMPRSS2 and ERG genes found in ~50% of prostate cancer patients

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Ventana BenchMark ULTRA

Assay in development for ERG gene rearrangementsIdentifying prostate cancer aggressiveness for appropriate treatment

Imaged Slide Review for Pathologist

5’ Deletion Likely Aggressive

Normal Likely Indolent

5’ Deletion and 3’ Duplication Highly Aggressive

Prostate cancer diagnosis via H&E

3’ InsertionLikely Aggressive

Ventana SYMPHONY

Oncologist Surgeon

Patient tumor needle biopsy

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Creating medical value Through Companion Diagnostics…

Medical Value

• Screening• Diagnosis• Prognosis• Prediction• Monitoring

• Treatment selection• Response prediction• Treatment monitoring

Diagnostics

Companion Diagnostics

+

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Strong pipeline of companion diagnosticsJoint Pharma and Diagnostics programs - Oncology

TheraScreen EGFR mutation testEGFRTarceva

TheraScreen KRAS mutation testKRASRG7167 MEK Inh/CIF

PIK3CA

Her1, 2, 3AREG, BTC

MDM2

p53

BRAF

Biomarker

RG7321 PI3K InhRG7422 PI3K Inh

RG1273 PertuzumabRG3502 T-DM1

RG7112 MDM2 Antagonist

RG7112 MDM2 Antagonist

RG7204 BRAF Inh/PLX4032RG7167 MEK Inh/CIF

Pipeline Drug

PCR PIK3CA mutationsFISH PIK3CA copy number assay

cobas MDM2 expression assay

cobas 4800 HER Family expression assay

AmpliChip p53 array

cobas 4800 BRAF V600E test

Pipeline Assay

List not exhaustive

Roche Pharma targeting multiple pathways

Molecular Tests for assessing presence of mutations offers opportunities to tailor treatment

PIP2PIP2

PPPP

PIP3PIP3

PPPP PP

SurvivalSurvival

RTK

PP

PP

PP

PP

RTK

FasL

FasL

ForkheadForkheadPP

AKTAKT

Cell cycle progression and

proliferation

Cell cycle progression and

proliferation

Cyclin D1Cyclin D1

p85p85p110ap110a

PP

PP

PTENPTEN

BadBad

p27

p27

PP

Bcl-2Bcl-2

mTORmTOR

Protein synthesis

and growth

Protein synthesis

and growth

PP

TSC1

TSC1

TSC2

TSC2

PP

PI3KPI3K

mTOR

AKT

RasRas

ERKERKPP

RafRafPP

MEKMEKPP

Raf

MEK

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Mutation in BRAF KinaseCo-development of test and drug in oncology

• Identifies patients whose tumor DNA carries BRAFV600E mutation

• Increases feasibility of drug clinical development and probability of success

• IVD timelines aligned with RG7204 accelerated development plan → joint launch

* BRAF gene mutations detected in ~8% of all cancers, over 50% of malignant melanomas

Single mutation in BRAF gene (BRAFV600E) causes activation in absence of normal growth factor stimulation

Sample collection &

DNA extraction

BRAFV600E

+ve?

YES

RG7204

Roche Real time PCR

cobas 4800

∼3 hrs

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AmpliChip p53 and MDM2 Antagonist Identifying patients with non-mutated tumor suppressor protein

* approx. 50% human tumors contain p53 mutants

• Blocking MDM2/ p53 binding enables p53 activity

• MDM2 antagonist (RG7112) may require wild-type p53*

Tumor growth

p53MDM2

Tumor regression

MDM2 antagonist

MDM2MDM2

p53

p53MDM2X

X

• Parallel development of AmpliChip p53 array

• Identifies patients with wild-type p53 gene

• Essential for RG7112 clinical development

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Key launches in 2010*

• GS Junior sequencing system (global)• Next-generation ultra-high density NimbleGen microarrays (global)• xCELLigence RTCA HT instrument (global)

Applied Science

• cobas 8000 e 602 & c 702 modules (EU, APAC, LATAM)• cobas 8000 c 701, c 502 and e 602 modules (US)• cobas b 123 for bloodgas & electrolytes (EU)• New immunoassays: 8 (US) 6 (EU)

Professional Diagnostics

• Benchmark GX (EU, APAC)• Molecular probes for Top2a and IGF-1R (EU)• Discovery Ultra for IHC & ISH research (US EU)

Tissue Diagnostics

• cobas TaqScreen DPX blood screening test for B19 virus & HAV (EU)• MRSA Test (US)• CAP/CTM CMV test (EU)

Molecular Diagnostics

• Accu-Chek Aviva Nano (US)• Accu-Chek Mobile (APAC)• Accu-Chek Combo (APAC)

Diabetes Care

Diagnostics Division Outlook: Sales growth significantly above the market

* Subject to appropriate regulatory approvals barring unforeseen events

Roche Investor event, AACC, July 26th