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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
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