1
2
Roche
Nine months YTD 2011 sales
Committed to innovation and profitable growth
October 13, 2011 Basel
3
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; and
11 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
4
Group Severin Schwan Chief Executive Officer
5
YTD Sept 2011: Highlights
Sales on track for full year guidance
• Group and Pharma: low-single digit sales growth 1,2 (+2% & +1%)
• Diagnostics: above market sales growth (+6%)
1 at Constant Exchange Rates, 2 excluding Tamiflu
Outlook confirmed
• Core EPS growth target „around 10%‟ 1
Currency impact
• Reported sales significantly impacted by strong Swiss franc (-13%p)
Newsflow
• US launch of Zelboraf for metastatic melanoma
• US filing of vismodegib (hedgehog inh.) for advanced and metastatic BCC
• Avastin: CHMP positive recommendation in 1L met. ovarian cancer and
mBC approval in Japan
6
Pharmaceuticals Division 28.4 24.4 -14 -1 +1
Diagnostics Division 7.7 7.1 -8 +6
Roche Group 35.3 31.5 -13 0 +2
Excluding
CHF bn 2010 2011 CHF CER Tamiflu1
change in %
YTD Sept 2011: Group sales
Supporting full-year guidance, strong currency impact
1 at Constant Exchange Rates, CER (average full year 2010)
7 1 avg December 2010 to avg YTD September 11 fx local absolute values at avg 2010 fx
+202 +625 +172 +423 -453
Pharma
Division
Diagnostics
Division
Group Tamiflu Group
incl.
Tamiflu
Fx Group
CHF
+1% +6% +2% 0% -13% -57%
1
YTD Sept 2011: Group sales
+2%2 sales growth excl. Tamiflu
-4,635 -4,807
2 CER = Constant Exchange Rates (average full year 2010)
Regional performance: Emerging markets
strongly contribute to sales growth
8
-6%
-4%
-2%
1%
13%
16%
-10% 0% 10% 20%
CEMAI
WE
Japan
US
Asia
Latin
America
2%
6%
4%
17%
15%
0% 10% 20%
EMEA
Japan
North
America
Asia-
Pacific
Latin
America
Returning to growth
Pharma: Political situation in North Africa
and price pressure in Eastern Europe
All countries in up-swing
Still affected by the earthquake
Continuing impact of 2010 austerity measures
All countries in up-swing
Pharma Diagnostics
CER growth rates, excluding Tamiflu
Portfolio outlook
An update on key compounds
2011 2016 2013 2014 2015 2012
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Potential
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Gly
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Larger
> CHF 1bn
Smaller
< CHF 1bn
Market
potential
9
Healthcare reforms and austerity measures
10
1. Policy on receivables strengthened in southern European countries; current
exposure to Greece government bond below CHF 50 m
2. US – continue to monitor the proposals on budget deficit reduction
3. Other countries – as of now, no major negative impact expected
Limited impact in 2011 expected / outlook confirmed
Roche: Supersector leader in Dow Jones
Sustainability Index – third year in a row
11
Reinforces commitment to creating long-term value
for all stakeholders
12
Reconfirming increased outlook for 2011
Continued strong business performance
Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2010: CHF 0.8 bn
Sales growth (CER) Group & Pharma (excl. Tamiflu): low single-digit
Diagnostics: significantly above market
Core EPS growth target
(CER) Around 10%
Genentech synergies 2011+ : CHF 1.0 bn*
Dividend outlook Grow in-line with Core EPS; maintain at least
last year‟s dividend in CHF
Operational Excellence
savings 2011 : CHF 1.8 bn
2012+ : CHF 2.4 bn
13
Pharmaceuticals Division Pascal Soriot COO Roche Pharmaceuticals
14
2010 2011 Excluding
CHF m CHF m CHF CER Tamiflu1
change in %
YTD Sept 2011: Pharma sales on track to meet
guidance
Pharmaceuticals Division 28,395 24,397 -14 -1 +1
United States 10,878 9,104 -16 +1 +1
Western Europe 7,295 6,210 -15 -4 -4
Japan 3,137 2,712 -14 -6 -2
International 7,085 6,371 -10 +1 +6
1 at Constant Exchange Rates, CER (average full year 2010)
Quarterly growth rates
% at CER vs. prior year, excl. Tamiflu 2010 2011
Q1 Q2 Q3 Q4 Q1 Q2 Q3
Pharmaceuticals Division +8 +3 +4 +4 +1 +1 0
Roche Pharma (excl. Chugai) +9 +3 +5 +3 +1 +1 +1
Chugai +2 +1 +2 +7 +1 -2 -5
15 15
United States
37% Pharma sales, +1%1
• Lucentis, Rituxan, Actemra
growing
• Avastin in mBC bottoming out
• Pegasys Q3 +15%
Emerging markets/
International
26% Pharma sales, +6%1
• Growth driven by Lat. America
and Asia-Pacific
Japan
11% Pharma sales, -2%1
• Disruption of sales activities in Q2/3
• Biennial price cuts effective April 2010
Western Europe
26% Pharma sales, -4%1
• Austerity measures
• Avastin in mBC bottoming out
• Actemra: continued uptake
YTD Sept 2011: Pharma sales +1%1
All growth at Constant Exchange Rates; 1 Excluding Tamiflu
Pharma in E7: continuous growth in key
emerging markets
16
0
500
1'000
1'500
2'000
2'500
3'000
YTD Sep
2007
YTD Sep
2008
YTD Sep
2009
YTD Sep
2010
YTD Sep
2011
Korea
Russia
Mexico
Turkey
India
China
Brazil
+5% +6%
+13%
+11%
CHF m
All at FY average 2010 exchange rates; growth at CER, excluding Tamiflu
17 17
YTD Sept 2011: Pharma Division growth contributors
Oncology, Lucentis and Actemra driving growth
Absolute amounts in CHF m at 2010 exchange rates
-600 -400 -200 0 200 400
Avastin
Neorecormon/Epogin
Mircera
Boniva/Bonviva
CellCept
Pegasys
Actemra/RoActemra
Lucentis
MabThera/Rituxan
Herceptin
US
Western Europe
Japan
International
+8%
+7%
+26%
+86%
-5%
-12%
-19%
-22%
-8%
Tamiflu: -453; -57%
+45%
Western Europe
Impact of 2010 special effects levelling out
18
8.8%
2.0%
-0.8%
-2.2%
-4.5% -4.4%
-3.6%
Q1 Q2 Q3 Q4
CER
, exc
l Tam
iflu
2010
2011
Quart
erl
y gro
wth
rate
s
EU austerity
measures Avastin mBC
impact
19
Solid growth of the oncology franchise
Major brands
CHF bn local growth
Improvement in quality and penetration of HER2 testing;
access initiatives in Emerging markets drive volumes
increase
Oncology Sept YTD 2011 sales: 14.233 bn
Growth in US, Emerging markets and Japan
Strong growth in US and Emerging markets
US & EU: Impact from mBC indication and austerity
measures; good growth in Emerging markets and Japan
USA: 1L maintenance in NHL included in new NCCN
guidelines; emerging markets driven by uptake in NHL
indications
0 1 2 3 4 5
Tarceva
Xeloda
Herceptin
Avastin
MabThera/
Rituxan
YTD Sept '11
-8%
+7%
+8%
+6%
+6%
20
Avastin update
1 local growth
Peak sales reconfirmed at CHF 7bn
Lung cancer
• AVAPERL: positive data in combination with pemetrexed in NSCLC
Ovarian cancer
• EU: CHMP positive opinion for 1st line ovarian cancer
• US: low likelihood of 1st line ovarian filing (update once OS data available)
Breast cancer
• mBC approval in Japan
• Pending FDA decision on mBC; US mBC patient share bottoming out
• AVEREL: in combo with Herceptin, unlikely to meet regulatory requirements
21
Lucentis
Driven by growing wet AMD market and new indication
1 CER; AMD=wet age-related macular degeneration; DME=diabetic macular edema; RVO=retinal vein occlusion
Genentech, a member of the Roche Group, retains commercial rights in the US and Novartis has exclusive commercial rights for rest of the world
CHF m
US sales
• Diabetic Macular Edema (DME):
Filed in the US in October
• Market share in RVO: 25% in Q3 vs. 24%
in Q2 „11
• HARBOR study recently unblinded,
efficacy data not supporting initiation of
further high-dose studies; 0.5 mg PRN
dosing to be discussed with FDA
0
300
600
900
1200
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
+26%1
Pegasys
Back to growth in US
22
US HCV Market trend
0
1'000
2'000
3'000
4'000
5'000
6'000
7'000
DAA
Launch
peginterferon Rx
Pegasys Rx
Pegasys
YTD Sept sales CHF 1.1 bn
• Renewed sales growth in the US in Q3
(+15%) after launch of new
direct-acting hepatitis C drugs, with
Pegasys as foundation of combination
therapies
• Positive momentum for EU expected as
well
• FDA approval of Pegasys ProClick
disposable auto injector (September) –
new dosage form to increase patient
convenience
Source: IMS NPA Weekly Rx reports
Weekly
Rx
Jan
„10
Apr
„10
Jul
„10
Oct
„10
Jan
„11
Apr
„11
Jul
„11
23
Actemra/RoActemra in Rheumatoid Arthritis
Growing in all regions
0
100
200
300
400
500
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
CHF m • 24-week ACT RAY X-ray monotherapy
data to be presented at ACR
• DMARD IR (first-line biologic) filing 2012
in US
• H2H trial vs Humira (ADACTA): readout
H1 2012
• Subcutaneous formulation: filing 2012
EU, 2013 US; Japanese study positive
• Did not meet primary end-point in
pivotal ankylosing spondylitis trial
• sJIA approved in US & EU
Actemra/RoActemra sales
+86%1
1 CER
2011: Major clinical news for late-stage NMEs
Supporting future growth
Compound Indication Study
Zelboraf (BRAFi) 1st line met melanoma BRIM3
Lucentis Diabetic macular edema RIDE RISE
Avastin Relapsed ovarian cancer OCEANS
pertuzumab + Herceptin 1st line HER2+ mBC CLEOPATRA
Herceptin Early HER2+BC sc HANNAH
vismodegib (Hedgehog i) Advanced BCC Pivotal study, ERIVANCE
T-DM1 1st line HER2+ mBC PFS data
GA101 Relapsed indolent NHL GAUSS H2H against MabThera/Rituxan
MetMAb NSCLC 2nd / 3rd line Final data
lebrikizumab Severe uncontrolled asthma MILLY MOLLY
mericitabine Hepatitis C PROPEL final data; JUMP-C
dalcetrapib CV risk reduction dal-VESSEL dal-PLAQUE
Ph
ase
II
P
ha
se
III
24
Significant news-flow in Q3 2011
25
Approvals /
Positive opinions
Filings
Data presented
• Zelboraf in US, metastatic melanoma
• Tarceva in EU, 1L EGFR mutated NSCLC
• Avastin in front-line ovarian cancer; positive CHMP opinion
• Lucentis in US (October), Diabetic Macular Edema (DME)
• Avastin in EU, recurrent ovarian cancer
• vismodegib (hedgehog inh) in US, advanced/met BCC
• T-DM1 vs. Herceptin 1st line HER2+ mBC ph II
• Zelboraf updated OS from BRIM3 and ph I
• lebrikizumab MILLY ph II proof of concept
• dalcetrapib dal-PLAQUE and dal-VESSEL ph II
Zelboraf
US approval and launch in record time
26
• Fastest development program
(<5 years from IND to FDA approval)
• Fastest initiation of a global Expanded
Access Program
• Fastest approval in Roche portfolio
(3.5 months after submission)
• Five days from approval to launch
• 5 weeks after launch: sales of CHF 11 m
+ BRIM2 results
2006 2007 2008 2009 2010 2011
BRIM3 results
Less than 5 years from IND to first launch
US launch
Phase I results
IND
T-DM1 vs. Herceptin + docetaxel in breast cancer
Potential for efficacy with lower rate of chemo-related side effects
27
Pro
port
ion p
rogre
ssio
n-f
ree
1.0
0.8
0.6
0.4
0.2
0.0
Trastuzumab
+ docetaxel (n=70)
T-DM1 (n=67)
Median
PFS, mos
Hazard
ratio
Log-rank
P value
T+D
T-DM1
9.2
14.2 0.594 0.0353
0 2 16 18 20
Number of patients at risk
T+D 70 66 63 53 43 27 12 4 2 2 0
T-DM1 67 60 51 46 42 35 22 15 6 3 0
Time (months)
4 6 8 10 12 14
Hurvitz SA, et al. Abstract 5.001. ESMO 2011
Filing of T-DM1 in 2nd line HER2+
breast cancer (EMILIA study) in 2012
PFS, 1st line HER2+ breast cancer
Phase II
EMCC/ESMO 2011
• significant improvement
in PFS
• markedly lower rate of
grade ≥3 AEs
(46.4% vs 89.4%)
28
Short-term newsflow
Pipeline progress
GA101 vs. MabThera/Rituxan in
indolent non-Hodgkin’s lymphoma
phase II GAUSS
ASH (December 10-13, San Diego)
Subcutaneous Herceptin in early HER2+ BC
pivotal phase III HANNAH
top-line data in Q4 2011
Pertuzumab in 1L HER2+ breast cancer
pivotal phase III CLEOPATRA
SABCS (December 6-10, San Antonio)
Roche Late-Stage Pipeline Update Focus on data presented at ESMO and ERS
London, November 7th, 2011
29
Diagnostics Division Daniel O’Day COO Roche Diagnostics
2010 2011 CHF CER
CHF m CHF m growth growth
Professional Diagnostics 3,602 3,430 -5% 9%
Diabetes Care 2,191 1,938 -12% 1%
Molecular Diagnostics 900 801 -11% 3%
Applied Science 646 544 -16% -2%
Tissue Diagnostics 393 382 -3% 15%
Diagnostics Division 7,732 7,095 -8% 6%
YTD Sept 2011: Diagnostics Division sales
Continued solid growth above the market
30 CER = Constant Exchange Rates (average full year 2010)
31 31
North America
25% Dia sales, +4%
• Immunoassays +17%
• Molecular diagnostics +8%
Latin America
7% Dia sales, +15%
• Growing strongly in all
Business Areas
• Professional Diagnostics +17%
Japan
5% Dia sales, +6%
• 12% growth in Professional
Diagnostics
• Molecular Diagnostics flat
Europe, Middle East, Africa
50% Dia sales, +2%
• Immunoassays and Coagulation
monitoring driving growth
• Impacted by reduced blood screening
YTD Sept 2011: Sales driven by Asia-Pacific,
EMEA and North-America
Asia Pacific
13% Dia sales, +17%
• Professional Diagnostics +21%
•Molecular Diagnostics up +16%
(primarily blood screening)
• China +25% growth
All growth in Constant Exchange Rates (average full year 2010)
32
Growth driven by Professional Diagnostics and
Tissue Diagnostics
CHF bn YTD Sept ‘11 vs. YTD Sept ‘10
CER growth
0 1 2 3 4
Tissue Dia
Applied
Science
Molecular
Dia
Diabetes
Care
Professional
Dia
EMEA
North America
RoW
+9%
+1%
+3%
-2%
+15%
Continued impact from deceased H1N1 testing;
Flat global research funding
cobas BRAF test launched US & EU; Won Swedish tender for pilot primary screening cervical cancer with HPV test
Maltose independent Accu-Chek Aviva Plus strips approved in US
Strong growth in Nth America (9%), Latin America
(17%) and Asia Pacific (21%); Driven by Immunoassays
Launched 11 new Abs incl. H. pylori, BCL-2 and MLH-1;
Completed acquisition of mtm labs (cervical cancer)
CER = Constant Exchange Rates (average full year 2010) EMEA = Europe, Middle East, Africa
YTD Sept 2011: Professional Diagnostics
Strong growth driven by immunoassays
• Solid instrument placements
• Continuous growth in Immunoassays
and Clinical Chemistry
• Continued roll-out of Vitamin D Total
test in EU and ROW
• POC Coagulation monitoring (+14%)
– proven medical value of testing
– superior product in CoaguChek
– strong growth in EMEA and Nth
America
33
CHF 3.4 bn, +9% CER growth
Immunoassays
(+13%)
Clinical
Chemistry
(+6%)
POC
products
(+7%)
other
CER = Constant Exchange Rates (average full year 2010) EMEA = Europe, Middle East, Africa
34
Roche awarded first public tender for primary
screening for cervical cancer with cobas HPV test
• Karolinska University Hospital in Sweden to screen
women for cervical cancer with cobas HPV test
• Represents first primary screening pilot program to
be implemented in Europe
• Results and publications to aid in evaluation for
country wide implementation
• First significant step towards replacing pap smear
in a stringent program
• In EU, 109 million women in target age group for
cervical cancer screening*
* Second edition of the European Guidelines for Quality Assurance of Cervical Cancer Screening, 2008
Genotypes 16/18 & 12 high-risk HPV in one test
Hi Risk
1
GT 16
2
GT 18
3
Control
4
Fully automated throughput up to 388/12hr
• Joint US launch of Zelboraf and cobas
BRAF test
• Roche Pharma sales force direct
oncologists to labs offering cobas BRAF
Personalised healthcare becoming reality
Commercialisation of cobas BRAF test in US and EU
BRAF gene mutations detected in ~8% of all cancers, over 50% of malignant melanomas
Approved in US for people with BRAF
V600E mutated metastatic melanoma
cobas BRAF test
• Only FDA approved companion
diagnostic for Zelboraf
• Good initial market uptake with key
labs
35
cobas BRAF test
• Identifies patients with BRAF V600E
mutations
• Detects patients missed by sequencing
• Provides consistent and reliable results
Key launches for 2011*
Professional Diagnostics • Vitamin D total and HE4 immunoassays (EU) • cobas 8000 modular analyzer series, cobas c 702 module (EU US ) • cobas b 123 POC system for bloodgas & electrolytes (US)
Diabetes Care
• Accu-Chek Mobile LCM (EU) • Accu-Chek Combo (US) • Accu-Chek Nano (US) • Accu-Chek Aviva Plus MI strip (US)
Molecular Diagnostics
• cobas 4800 HPV Test (US) • cobas 4800 EGFR Mutation Test (EU) • cobas 4800 KRAS Mutation Test (EU) • cobas 4800 BRAF V600 Mutation Test (EU, US)
Applied Science
• HLA genotyping on GS Junior & FLX sequencing systems (global) • GS FLX Titanum-XL system (global) • Ultra-high resolution CGH arrays (global) • LightCycler Nano for real time PCR analysis (global)
Tissue Diagnostics • ER/PR antibody for IHC (US) • HER2 dual colour ISH probe (US) • OptiView detection system (US, EU)
Diagnostics Division Outlook: sales growth significantly above the market
* Subject to appropriate regulatory approvals barring unforeseen events
36
37
Group Alan Hippe
Chief Financial Officer
Highlights
• Further balance sheet deleverage: tender offer for the March 2012 CHF
bond, P&L impact up to CHF -10 m
• Credit rating: Moody‟s upgrade of Roche from A2 to A1- stable outlook
• Carefully monitor receivables, particularly in Mediterranean countries
• On track to deliver Operational Excellence savings and profit targets
38
39
CER
sales
growth
YTD 9 2011
vs.
YTD 9 2010 CHF
sales
growth
YTD 9 2011
vs.
YTD 9 2010
Exchange rate impact on sales growth
Negative impact, in particular from USD and EUR
0.4%
-0.9%
-0.2%-0.8%
-0.9%
-1.1%
-2.9%
-6.4%
-12.8%
Local USD EUR
Oth
Europe As-Pac Lat-Am JPY Other CHF
CER = Constant Exchange Rates (average full year 2010)
1.28 1.30 1.29 1.301.25
1.21 1.181.12
1.20 1.221.22 1.22
1.24
1.401.38
J F M A M J J A S O N D
0.96 0.950.92 0.90 0.87
0.84 0.820.78
0.87 0.900.90 0.90
0.88
1.041.07
J F M A M J J A S O N D
Average YTD 2011
Currency impact on Swiss Franc results
40
Monthly average fx rate 2011
CHF/USD
CHF/EUR
average YTD 2010
-18%
-12% Average YTD 2011
FY
Sales -12
Core operating
profit -15
Core EPS -14
Assuming the 30 September 2011 exchange
rates remain stable until year-end, FY 2011
impact is expected to be (%)
average YTD 2010
Fx Rate at
30 Sep 2011
Roche with relatively strong credit rating
despite high debt level
Roche
GSK
Abbott
Bayer
Takeda
S&P rating
AAA
AA+
AA
AA-
A+
A
A-
BBB+
BBB
BBB-
BB+
2010 Leverage1 (%)
-35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35
1 Net Debt / Total Assets (%) Source: Thompson Datastream; Bloomberg (May 23; 2011); BCG analysis
41
Amgen
Gilead
Pfizer
Lilly Novartis
BD
BMS
Merck
AZ
J&J
Biogen
Sanofi
Moody’s upgrade of Roche
from A2 to A1- stable outlook
• “reflects Roche's solid
deleveraging after its
acquisition of Genentech in
March 2009”
• “benign exposure to patent
expiries”
• “relatively high visibility of
future cash flows”
42
Reconfirming increased outlook for 2011
Continued strong business performance
Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2010: CHF 0.8 bn
Sales growth (CER) Group & Pharma (excl. Tamiflu): low single-digit
Diagnostics: significantly above market
Core EPS growth target
(CER) Around 10%
Genentech synergies 2011+ : CHF 1.0 bn*
Dividend outlook Grow in-line with Core EPS; maintain at least
last year‟s dividend in CHF
Operational Excellence
savings 2011 : CHF 1.8 bn
2012+ : CHF 2.4 bn
43
44 44
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group YTD Sept 2011 results
Diagnostics
Foreign exchange rate information
Status as of September 30, 2011
phase I
(44 NMEs)
NME Additional Indication
Oncology
Inflammation/Immunology
Virology
Metabolic/Cardiovascular
CNS
Ophthalmology
Others
RG-No Roche Genentech managed
CHU Chugai managed
CIF/MEK inh solid tumors RG7167
Raf & MEK dual inh solid tumors RG7304
MDM2 ant (2) solid & hem tumors RG7112
PI3 kinase inh solid tumors RG7321
BRaf inh(2) BRAF mut. melanoma RG7256
anti-PLGF MAb solid tumors RG7334
anti-glypican-3 MAb liver cancer RG7686
tumor immunotherapy oncology RG7446
mGluR2 antag (2) depression RG1578
BACE inh Alzheimer‟s RG7129
ABCA1 inducer dyslipidemia RG7273
GABRA5 cogn. disorders RG1662
MEK inh solid tumors RG7420
PI3 K/mTOR inh solid & hem tumors RG7422
AKT inhibitor solid tumors RG7440
MEK inh solid tumors RG7421
anti-D22 ADC hem. malignancies RG7593
CRTH2 antag asthma RG7185
nucleoside pol inh HCV RG7432
anti-Her3/EGFR m. epithelial tumors RG7597
anti-angiogenic solid tumors RG7594
IAP ant (2) solid tum & lymphoma RG7459
anti-FGFR3 MAb oncology RG7444
Cat S antag CV risk in CKD RG7236
GIP/GLP-1 dual ago type 2 diabetes RG7685
PI3K inh oncology RG7604
- ADC prostate ca. RG7450
- ADC hematologic tumors RG7596
- ADC ovarian ca. RG7458
- solid tumors or NHL RG7603
anti-CD44-MAb solid tumors RG7356
ALK inhibitor NSCLC CHU
- solid tumors CHU
anti-IL-17 MAb RA RG4934
Bcl-2 inh CLL RG7601
- ADC oncology RG7599
Chk-1 inh tumors or lymphoma RG7602
Roche Development Pipeline Projects in Phase 1
Tweak MAb oncology RG7212
V1 receptor antag (2) autism RG7314
- metabolic RG7652
- ADC multiple myeloma RG7598
Phase I Projects - oncology Phase I Projects – other DTAs
WT-1 vaccine oncology CHU
Anti-IL 6 MAb RA CHU
triple reuptake inh depression RG7166
45
phase II
(19 NMEs + 7 Als)
phase III
(8 NMEs + 28 Als)
Registration
(2 NMEs + 6 Als)
NME Additional Indication
Oncology
Inflammation/Immunology
Virology
Metabolic/Cardiovascular
CNS
Ophthalmology
Others
RG-No Roche Genentech managed
CHU Chugai managed
RG105 MabThera is branded as Rituxan in US and Japan
RG1569 Actemra is branded as RoActemra in EU
vismodegib operable BCC RG3616
MetMAb mNSCLC RG3638
pertuzumab HER2+ EBC RG1273
pertuzumab HER2+ mBC 2nd line RG1273
T-DM1 HER2+ EBC RG3502
Avastin ovarian cancer 1st line RG4351
Tarceva NSCLC EGFR mut 1st line RG14153
MabThera ANCA assoc vascul RG105
Xolair chronic idiopathic urticaria RG3648
Rituxan NHL fast infusion RG105
Avastin HER2+ BC adj RG435
Avastin BC combo Herceptin 1st line RG435
Avastin NSCLC adj RG435
GRI schizophrenia negative sympt. RG1678
Avastin HER2-neg. BC adj RG435
Avastin relapsed ovarian ca RG4352
Avastin high risk carcinoid RG435
Avastin glioblastoma 1st line RG435
Avastin triple-neg. BC adj RG435
aleglitazar CV risk reduction in T2D RG1439
dalcetrapib atherosc. CV risk red. RG1658
Lucentis AMD high dose RG3645
pertuzumab HER2+ mBC 1st line RG1273
Herceptin HER2+ BC s.c. form. RG597
Herceptin HER2+ adj BC (2yrs) RG597
GA101 iNHL relapsed RG7159
Tarceva NSCLC adj RG1415
Actemra early RA RG1569
T-DM1 HER2+ mBC 1st l. RG3502
GA101 CLL RG7159
Actemra RA DMARD IR H2H RG1569
Avastin mCRC TML RG435
T-DM1 HER2+ adv. mBC RG3502
Actemra sc formulation RA RG1569
Tarceva NSCLC EGFR mut 1st line RG1415
MabThera NHL s.c. formulation RG105
ocrelizumab RMS RG1594
Avastin mBC 2nd line RG435
Activase extended time window AIS RG36264
Zelboraf papillary thyroid cancer RG7204
Zelboraf metastatic melanoma RG72045
GRI schizophrenia subopt control RG1678
GA101 DLBCL RG7159
GA101 iNHL front-line RG7159
tofogliflozin (SGLT2) type 2 diabetes CHU
EPOCH chemo induced anemia CHU
Roche Development Pipeline Projects in Ph 2, 3 and Registration
vismodegib advanced BCC RG36164
ocrelizumab PPMS RG1594
mericitabine HCV RG7128
lebrikizumab severe asthma RG3637
MetMAb mBC RG3638
MetMAb mCRC 1L RG3638 Lucentis diabetic macular edema RG36454
1 CHMP positive opinion EU 2 submitted in the EU
3 approved in the EU
4 submitted in the US 5 approved in the US
T-DM1 HER2+ mBC 3rd l. RG3502
46
anti-oxLDL MAb sec prev CV events RG7418
navitoclax (ABT-263) sol & hem tum RG7433
rontalizumab SLE RG7415
danoprevir HCV RG7227
mGluR5 antag (2) TRD RG7090
anti-LT alpha MAb RA RG7416
gantenerumab Alzheimer‘s RG1450
P selectin MAb ACS/CVD RG1512
anti-M1 prime MAb asthma RG7449
11 beta HSD inh metabolic diseases RG4929
rhu Mab Beta7 ulcerative colitis RG7413
anti-factor D Fab geographic atrophy RG7417
anti-EGFL7 MAb solid tumors RG7414
anti-Abeta MAb Alzheimer‘s RG7412
MAO-B inh AD RG1577
EGFR Mab solid tumors RG7160
Status as of September 30, 2011
Changes to the development pipeline Since H1 2011 update
New to Phase I New to Phase II New to Phase III New to Registration
New NMEs transitioned from Ph0
(5NMEs)
RG7212 Tweak MAb oncology
RG7314 V1 receptor antag (2)
autism
RG7129 BACE inh Alzheimer‟s
RG7598 oncology
RG7652 metabolic
New NMEs managed by Chugai
CHU WT-1 cancer vaccine
CHU anti-IL6 MAb in RA
New NME in Ph2 following FPI
RG7413 MAb Beta7 ulcerative colitis
New NME in Ph2 following in-
licensing from Evotec
RG1577 MAO-B inh in AD
New AI in Ph2 following FPI
RG3638 MetMAb mCRC 1L
New in Ph3 following FPI
RG1594 ocrelizumab RMS
New AI in Ph3 folllowing FPI
RG3502 T-DM1 HER2+ mBC 3rd
line
New NME Filed
RG3616 vismodegib advanced BCC
(US)
New AIs Filed
RG435 Avastin relapsed ovarian
cancer (EU)
RG3626 Activase extended time
window (US)
RG3645 Lucentis diabetic macular
edema (US)
Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration
NME from Chugai
CHU Topoisomerase inh in gastric
cancer
Discontinuation (1AI)
RG1569 Actemra ankylosing
spondylitis
Approved in EU
RG105 Actemra sJIA
47 NME = new molecular entity; AI = additional indication; FPI = first patient in
Projected NME Submissions and their
Additional Indications Projects Currently in Phase 2 and 3
Status as of September 30, 2011
Unless stated otherwise, submissions are planned to occur in US and EU.
indicates a submission which has occurred with regulatory action pending
* NDA timeline is driven by the event rate in dal-OUTCOMES; updated timeline estimate will
be provided in Q3 2012 after 2nd year event rate is known
# negative symptoms and sub-optimal control
§ Filing timelines in EU subject to discussion with EMA
CNS
Ophthalmology
NME
Oncology
Inflammation/Immunology
Virology
Metabolic/Cardiovascular
T-DM1 (RG3502)
HER 2+ advanced mBC
glycine reuptake inhib.
(RG1678) schizophrenia#
mericitabine
(RG7128) HCV
GA101 (RG7159)
CLL
dalcetrapib (RG1658) * atherosclerosis CV risk red.
MetMAb (RG3638)
mNSCLC, mBC, mCRC
navitoclax ABT-263 (RG7433) solid & hem tumors
pertuzumab (RG1273)
HER2+ EBC
vismodegib (RG3616)
operable basal cell ca
GA101 (RG7159)
NHL refractory
T-DM1 (RG3502)
HER2+ mBC 1st line
ocrelizumab (RG1594)
PPMS and RMS
mGluR5 antag (2) (RG7090)
Txt resistant depression
MAOB inh (RG1577)
Alzheimer’s disease
aleglitazar (RG1439)
CV risk reduction in T2D
P selectin huMab (RG1512)
CVD
lebrikizumab (RG3637)
asthma
rontalizumab (RG7415)
SLE
anti-M1 prime Mab
(RG7449) asthma
anti-LT alpha Mab (RG7416)
rheumatoid arthritis
danoprevir RG7227)
(HCV protease inh)
vismodegib (RG3616)
adv basal cell ca (US)§
pertuzumab (RG1273) HER2+ mBC1st line
Zelboraf (RG7204)
met. melanoma
2011 2012 2013 2014 Post 2014
Anti-oxLDL (RG7418)
prevent secondary CV
11 beta HSD (RG4929)
metabolic diseases
GA101 (RG7159)
NHL indolent frontline
GA101 (RG7159)
DLBCL
Zelboraf (RG7204)
Papillary thyroid ca
EGFR Mab (RG7160) solid tumors
anti-EGFL7 Mab (RG7414) solid tumors
anti-abeta Mab (RG7412)
Alzheimer’s disease
anti-factor D Fab (RG7417) geographic atrophy
Mab Beta7 (RG7413)
ulcerative colitis
gantenerumab (RG1450)
Alzheimer’s disease
48
Tarceva NSCLC adj (US)
Avastin + Herceptin HER2+ mBC 1st line
Avastin NSCLC adj
Tarceva (US) NSCLC EGFR mutation 1st line
2011 2012 2013 2014 Post 2014
Projected additional indications submissions of
existing products Projects currently in Phase 2 and 3
Lucentis diabetic macular edema (US)
Herceptin HER2+ BC adj 2 year
Avastin triple negative BC adj
Avastin glioblastoma 1st line
Avastin HER2+ BC adj
Avastin relapsed ovarian cancer (EU)
Herceptin sc formulation HER2+
Avastin HER2- BC adj
Actemra early RA
Status as of September 30, 2011
Xolair (US)
chronic idiopathic urticaria
Actemra RA DMARD H2H (EU)
Avastin ovarian cancer 1st line (US)
Avastin mCRC TML
Oncology
Inflammation/Immunology
Virology
Metabolic/Cardiovascular
CNS
Ophthalmology
Actemra sc formulation (EU)
Actemra sc formulation (US)
Avastin mBC 2nd line (EU)
Rituxan NHL faster infusion (US)
MabThera sc formulation (EU)
Unless stated otherwise, submissions are planned to occur in US and EU.
Activase extended time window AIS (US)
Actemra DMARD IR (US)
Lucentis AMD 0.5 mg PRN (US)
49
Avastin relapsed ovarian cancer (US)
Tarceva NSCLC adj (EU)
50 50
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group Q3 2011 sales
Diagnostics
Foreign exchange rate information
AvastinOvarian cancer clinical development programme
Patient population
Front-line metastatic ovarian cancer
Relapsed platinum-sensitive ovarian cancer
Phase/study Phase III GOG-0218
Phase III ICON7
Phase IIIOCEANS
# of patients N=1,873 N=1,528 N=484
Design • ARM A: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent placebo followed by placebo alone for up to 22 cycles (15 months)
• ARM B: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by placebo alone for up to 22 cycles (15 months)
• ARM C: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by Avastin alone for up to 22 cycles (15 months)
• ARM A: Paclitaxel and carboplatin for 6 cycles
• ARM B: Paclitaxel and carboplatin plus concurrent Avastin for 6 cycles followed by Avastin alone for up to 18 cycles (12 months)
• ARM A: Carboplatin, gemcitabine, and concurrent placebo for 6 cycles, followed by placebo alone until disease progression
• ARM B: Carboplatin, gemcitabine, and concurrent Avastin for 6 cycles, followed by Avastin alone until disease progression.
Avastin dose • 15 mg/kg q3 weeks • 7.5 mg/kg q3 weeks • 15 mg/kg q3 weeks
Primary endpoint
• Progression-free survival • Progression-free survival • Progression-free survival
Status • Study met its primary endpoint in Q1 2010• Data presented at ASCO 2010 and 2011
• Study met its primary endpoint Q3 2010
• Data presented at ESMO 2010 and ASCO 2011
• Study met its primary endpoint Q1 2011• Data presented at ASCO 2011
• EMA submission Q3 2011• FDA submission in Q1’12 (with more mature
overall survival data)
• EMA submission Q4 2010, positive CHMP opinion Q3’11• FDA submission in Q4 2011 only if clear benefit is seen on overall
survival endpoint
ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical Oncology. 51
Avastin
Breast cancer development programme
Patient
population First-line HER2-negative Second-line HER2-negative First-line HER2-positive
Phase/study Phase III
RIBBON-1
Phase III
AVADO
Phase III
RIBBON-2
Phase III
AVEREL
# of patients N=1,238 N=736 N=684 N=424
Design • ARM A: Anthracycline or
taxane plus Avastin OR
Xeloda plus Avastin
• ARM B: Anthracycline or
taxane plus placebo OR
Xeloda plus placebo
• ARM A: Placebo plus
docetaxel
• ARM B: 7.5 mg/kg dose of
Avastin plus docetaxel
• ARM C: 15 mg/kg dose of
Avastin plus docetaxel
• ARM A: Chemotherapy
(taxane, Xeloda, gemcitabine,
or vinorelbine) plus Avastin
• ARM B: Chemotherapy plus
placebo
• ARM A: Docetaxel plus
Herceptin
• ARM B: Docetaxel plus
Herceptin plus Avastin
Avastin dose • 10 mg/kg q2 weeks or 15
mg/kg q3 wks
• 15 mg/kg or 7.5 mg/kg q3
weeks
• 15 mg/kg q3 weeks • 15 mg/kg q3 weeks
Primary
endpoint
• Progression-free survival
(PFS) • Progression-free survival • Progression-free survival • Progression-free survival
Status • EU label extended to include
Xeloda (June 2)
• US: FDA - Received Complete
Response Letter Q4 2010
• EU: Docetaxel removed from
label after EC decision
• US: Received Complete
Response Letter Q4 2010
• ROW: Approved in 20+
countries incl. CH
• EU – Consider filing with
mature OS data in 2012
• FDA - Received Complete
Response Letter Q4 2010
• Study did not meet protocol
specified primary endpoint
• Improvement in PFS
(Investigator assessed) did not
reach significance
• Improvement in PFS (IRC
assessed) was statistically
significant but is unlikely to
meet regulatory approval
requirements
• No new safety signals
52
53 53
Avastin
Clinical development programmes in other tumor types
Patient
population Metastatic colorectal cancer High risk carcinoid Newly diagnosed glioblastoma
Phase/study
Phase III
ML18147
TML
Phase III
SWOG SO518
Phase III
AVAglio
# of patients N=810 N=424 N=920
Design • 1st-line treatment with
chemotherapy* plus Avastin
• Once patients progress, they are
randomised to:
• ARM A: Chemotherapy* alone
• ARM B: Chemotherapy* +
Avastin
* Physician‟s choice
• ARM A: Depot octreotide plus
interferon alpha
• ARM B: Depot octreotide plus
Avastin
• ARM A: Concurrent radiation and
temozolomide plus placebo;
followed by maintenance TMZ
plus placebo for 6 cycles; then
placebo until disease progression
• ARM B: Concurrent radiation and
TMZ plus Avastin; followed by
maintenance TMZ plus Avastin for
6 cycles; then Avastin (15mg/kg
q3 weeks) monotherapy until
disease progression
Avastin
dose
• 5 mg/kg q2 weeks or
7.5 mg/kg q3 weeks
• 15 mg/kg q3 weeks • 10 mg/kg q2 weeks or 15 mg/kg
q3 weeks
Primary
endpoint
• Overall survival • Progression-free survival • Progression-free survival
• Overall survival
Status • Enrolment completed Q2 2010
• Expect data Q1 2012
• FPI Q1 2008
• Expect data 2013
• FPI Q2 2009
• Enrolment completed Q1 2011
• Expect data 2012
Avastin
Adjuvant clinical development programme
Patient
population
Adjuvant
lung cancer
Adjuvant
breast cancer
Phase/study Phase III
ECOG 1505
Phase III
ECOG 5103
HER2-negative
Phase III
BEATRICE
Triple-negative
Phase III
BETH
HER2-positive
# of patients N=1,500 N=4,950 N=2,530 N=3,600
Design • ARM A: Cisplatin plus
vinorelbine, docetaxel,
gemcitabine or pemetrexed
• ARM B: Cisplatin plus
vinorelbine, docetaxel,
gemcitabine or pemetrexed
plus Avastin up to 12 months
• ARM A: Anthracycline plus
cyclophosphamide (AC)
followed by paclitaxel
• ARM B: AC plus Avastin
followed by paclitaxel plus
Avastin
• ARM C: AC plus Avastin
followed by paclitaxel plus
Avastin, followed by Avastin
up to 12 months
• ARM A: Anthracycline ±
taxane or taxane-based
chemo alone
• ARM B: Anthracycline ±
taxane or taxane-based
chemo plus Avastin for 1 year
• COHORT 1: Docetaxel/
carboplatin plus Herceptin ±
Avastin
• COHORT 2: Docetaxel plus
Herceptin ± Avastin, followed
by 5-Fluorouracil, Epirubicin,
Cyclophosphamide
For both cohorts, patients
receive Herceptin ± Avastin
to complete one year of
targeted therapy
Avastin dose • 15 mg/kg q3 weeks • 15 mg/kg q3 weeks
• Dosing equivalent to 5
mg/kg/w
• 15 mg/kg q3 weeks
Primary
endpoint • Overall survival • Disease-free survival • Disease-free survival • Disease-free survival
Status • FPI Q3 2007
• Recruitment ongoing
• FPI Q4 2007
• Enrolment completed Q2‟11
• Expect data 2014
• FPI Q4 2007
• Enrolment completed Q4 2009
• Expect data 2012
• FPI Q2 2008
• Enrolment completed Q4 2010
• Expect data 2013
54
55 55
Herceptin
The standard of care for HER2+ early breast cancer
Patient
population
Adjuvant HER2-positive
breast cancer
Early-stage HER2-positive
breast cancer
Phase/study Phase III
HERA
Phase III
HANNAH
# of patients N=5,102 N=595
Design • ARM A: Herceptin for 12 months
• ARM B: Herceptin for 24 months
• ARM C: Observation
• ARM A: Chemotherapy* concurrent with
Herceptin subcutaneous for every three
weeks for the first 8 cycles
• ARM B: Chemotherapy* concurrent with
Herceptin intravenous for every three
weeks for the first 8 cycles
*Chemotherapy = docetaxel then 5-FU,
epirubicin, and cyclophosphamide
Primary
endpoint
• Disease-free survival • Serum concentration
• Pathologic complete response
Status • Final 2-year versus 1-year analysis
expected in 2012; event-driven
• FPI Q4 2009
• Enrolment completed Q4 2010
• Expect data October of 2011
Subcutaneous Herceptin : applies Enhanze technology, partnered with Halozyme
56 56
MabThera/Rituxan
Development programmes
Oncology Immunology
Patient
population
Front-line follicular non-
Hodgkin’s lymphoma
Front-line diffuse large B-cell or
follicular non-Hodgkin’s
lymphoma
ANCA-associated vasculitis
Phase/study
Phase III
Subcutaneous study
Study being conducted ex-US
Phase IIIb
RATE*
Faster infusion study
Phase II/III
RAVE*
# of patients N=405 N=450 N=197
Design • ARM A: Intravenous MabThera
plus chemotherapy (CHOP or
CVP)
• ARM B: Subcutaneous MabThera
plus chemotherapy (CHOP or
CVP)
• Responders will continue on
maintenance every 8 weeks over
24 months
• Prospective, open-label, single arm
study
• Non-inferiority efficacy and safety
study of MabThera/Rituxan and
glucocorticoids versus
conventional therapy
(cyclophosphamide)
Primary
endpoint
• Pharmacokinetics, safety and
efficacy
• To determine the incidence of
Grade 3 or 4 infusion-related
toxicities resulting from faster
infusion of MabThera/Rituxan
• Induction of complete remission at
6 months, defined as a BVAS/WG
of 0 and off glucocorticoid therapy
Status • FPI Q1 2011
• Expect data 2012
• FPI Q3 2008
• Enrolment completed Q4 2010
• Expect data H2 2011
• Data presented at ACR 2009
• FDA approved use of Rituxan in
WG and MPA in Q2 2011
*In collaboration with Biogen Idec; subcutaneous MabThera: applies Enhanze technology, partnered with Halozyme
CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone; CVP = Cyclophosphamide, Vincristine and Prednisolone.
WG - Wegener's Granulomatosis, MPA - Microscopic Polyangiitis
57 57
Tarceva
New approaches to treating lung cancer
Patient
population
Adjuvant non-small
cell lung cancer
First-line metastatic
non-small cell lung cancer
EGFR mutation-positive*
Phase/study Phase III
RADIANT
Phase III
EURTAC
# of patients N=974
(2:1 randomisation) N=174
Design • Following surgical resection ± adjuvant
chemotherapy:
• ARM A: Tarceva up to 2 years
• ARM B: Placebo up to 2 years
• ARM A: Tarceva
• ARM B: Chemotherapy (platinum-based
doublet)
Primary
endpoint
• Disease-free survival
• EGFR IHC and/or FISH-positive
• Progression-free survival
Status • Enrolment completed Q3 2010
• Expect final results in 2012
• Study met its primary endpoint Q1 2011
• Data presented at ASCO 2011
• Expect FDA sNDA submission in 2012
• EU granted approval in Q3 2011
In collaboration with OSI Pharmaceuticals, now part of Astellas group;
Tarceva is a trademark of OSI Pharmaceuticals, LLC
58
Actemra/RoActemra
Interleukin 6 receptor inhibitor
• Rheumatoid arthritis programme
58
Patient
population
Early moderate-to-severe
rheumatoid arthritis
Rheumatoid arthritis
DMARD inadequate
responders
Moderate-to-severe
rheumatoid arthritis
Moderate-to-severe
rheumatoid arthritis
Phase/study Phase III
FUNCTION
Phase III
ADACTA
Head-to-head study
Phase III
SUMMACTA
Subcutaneous study
Phase III
BREVACTA
Subcutaneous study
# of patients N=1,128 N=300 N=1,200 N=600
Design • ARM A: Actemra 8 mg/kg
• ARM B: Actemra 8 mg/kg
plus MTX
• ARM C: Actemra 4 mg/kg
plus MTX
• ARM D: MTX alone
• ARM A: Actemra
• ARM B: Humira
• Add-on to DMARD therapy
• Weekly dosing
• ARM A: Subcutaneous
Actemra plus intravenous
placebo
• ARM B: Intravenous Actemra
plus subcutaneous placebo
• Add-on to DMARD therapy
• Dosing every two weeks
• ARM A: Subcutaneous
Actemra
• ARM B: Subcutaneous
placebo
Primary
endpoint
• DAS28 remission at 24 weeks,
1 year and 2 years
• DAS28 at 24 weeks • ACR 20 at week 24 • ACR 20 at week 24
Status • FPI Q4 2009
• Recruitment completed Q2
2011
• Expect data 2012
• FPI Q2 2010
• Expect data H1 2012
• FPI Q3 2010
• Recruitment completed Q3
2011
• Expect data 2012
• FPI Q1 2011
In collaboration with Chugai
MTX = Methotrexate; DMARD = Disease-Modifying Anti-Rheumatic Drugs.
Humira® (adalimumab) is a registered trademark of Abbott Laboratories.
59
Lucentis
For the treatment of age-related macular degeneration and macular edema following retinal vein occlusion
Patient
population
Neovascular (wet) age-related
macular degeneration Diabetic macular edema
Phase/study
Phase III
HARBOR
High dose study
Phase III
RIDE
Phase III
RISE
# of patients N=1,110 N=382 N=378
Design • Randomised double-masked study
comparing efficacy and safety of
intravitreal injections of 0.5 mg and
2.0 mg Lucentis administered
monthly or PRN in patients with wet
AMD
• Randomised, sham-controlled study of monthly intravitreal injections of 0.5
and 0.3 mg Lucentis for a total of 36 injections in patients with clinically
significant macular edema with center involvement secondary to diabetes
mellitus (Type I or Type II).
Primary
endpoint
• Mean change in best corrected
visual acuity (BCVA) compared to
baseline at 12 months
• Proportion of patients who gain ≥ 15 letters in BCVA score compared to
baseline after 24 monthly injections (secondary endpoints include 36 month
endpoint)
Status • FPI Q2 2009
• Enrolment completed Q3 2010
• Data to be presented at AAO
meeting October 2011
• Study met its primary endpoint Q1
2011
• Data presented at ADA 2011
• Submitted for FDA approval October
2011
• Study met its primary endpoint Q1
2011
• Data presented at ADA 2011
• Submitted for FDA approval October
2011
Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.
ADA – American Diabetes Association, AAO = American Academy of Opthalmology
60 60
Xolair
Evaluating potential in Chronic Idiopathic Urticaria, an IgE related disease
In collaboration with Novartis
*Refractory to H1 anti-histamines, H2 blockers, and/or leukotriene receptor antagonists (LTRAs) at the time of randomisation.
Patient
population
Chronic Idiopathic Urticaria
Patients who remain symptomatic
despite treatment*
Phase/study Phase III
ASTERIA I
Phase III
ASTERIA II
Phase III
GLACIAL
# of patients N=300 N=300 N=320
Design Add-on therapy to H1 anti-
histamines
24 week treatment period (q4-
week)
• ARM A: Xolair 300 mg
• ARM B: Xolair 150 mg
• ARM C: Xolair 75 mg
• ARM D: Placebo
Add-on therapy to H1 anti-
histamines
12 week treatment period (q4-
week)
•ARM A: Xolair 300 mg
•ARM B: Xolair 150 mg
•ARM C: Xolair 75 mg
•ARM D: Placebo
Add-on therapy to H1 anti-
histamines, H2 blockers, and/or
LTRA
24 week treatment period (q4-
week)
•ARM A: Xolair 300 mg
•ARM B: Placebo
Primary
endpoint
• Change from baseline in UAS7
weekly itch score at Week 12
• Change from baseline in UAS7
weekly itch score at Week 12
• Safety
Status • FPI Q1 2011 • FPI Q1 2011 • FPI Q1 2011
61 61
Zelboraf (vemurafenib, RG7204/PLX4032)
A selective novel small molecule that inhibits mutant BRAF
Zelboraf in collaboration with Plexxikon Inc., now part of Daiichi Sankyo Group
IRC = Independent Review Committee; RECIST = Response Evaluation Criteria in Solid Tumors.
Patient
population
Previously untreated
metastatic melanoma
BRAF mutation positive
Previously treated
metastatic melanoma
BRAF mutation positive
Previously treated papillary
thyroid cancer
BRAF mutation positive
Melanoma patients with
brain metastases
BRAF mutation positive
Phase/study
Phase III
BRIM3
Global study
Phase II
BRIM2
US and Australia
Phase II Phase II
# of patients N=675 N=132 N=40 N=132
Design • ARM A: Zelboraf
• ARM B: dacarbazine
• Single ARM: Zelboraf • Single ARM: Zelboraf • Single ARM: Zelboraf
Primary
endpoint
• Overall survival and progression-
free survival
• Best overall response rate
assessed by IRC using
RECIST criteria
• Best overall response rate • Overall Response Rate in the
brain
Status • Study met both co-primary
endpoints Q1 2011
• Data presented at ASCO 2011
• FDA granted approval Q3 2011
• Updated OS data presented at
ESMO 2011
• Positive data presented at
the International Melanoma
Congress 2010
• Updated data presented at
ASCO 2011
• FPI Q2 2011 • FPI Q3 2011
• Phase II/III clinical trials
62 62
Zelboraf (vemurafenib, RG7204/PLX4032)
A selective novel small molecule that inhibits mutant BRAF
Patient
population
Previously untreated
metastatic melanoma
BRAF mutation positive
Melanoma patients with brain
metastases
BRAF mutation positive
Phase/study Phase Ib Phase I
# of patients N=20 N=20
Design • Single ARM: Zelboraf plus
ipilimumab
• Single ARM: Zelboraf
Primary
endpoint
• Safety • Safety
Status • FPI Q4 2011 • FPI Q4 2010
Zelboraf in collaboration with Plexxikon Inc., now part of Daiichi Sankyo Group
Combination study with ipilimumab is in collaboration with Bristol-Myers Squibb.
• Phase I clinical trials
63 63
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group Q3 2011 sales
Diagnostics
Foreign exchange rate information
64 64
Pertuzumab (RG1273)
First in a new class of HER dimerization inhibitors
Patient
population
Adjuvant HER2+ breast
cancer
Neoadjuvant HER2-
positive breast cancer
Neoadjuvant HER2-
positive breast cancer
Second-line HER2-
positive metastatic
breast cancer
First-line HER2-
positive metastatic
breast cancer
Phase/study Phase III
APHINITY
Phase II
TRYPHAENA
Phase II
NeoSphere
Phase II
PHEREXA
Phase III
CLEOPATRA
# of patients N=3,806 N=225 N=417 N=450 N=808
Design • ARM A: Herceptin
plus chemotherapy
• ARM B: Herceptin,
chemotherapy plus
pertuzumab
• ARM A: FEC followed
by Taxane with
Herceptin and
pertuzumab (H+P
given concurrently)
• ARM B: FEC followed
by Taxane with
Herceptin +
pertuzumab (H+P
given sequentially)
• ARM C: TCH +
pertuzumab (H+P
given concurrently)
• ARM A: Herceptin
plus docetaxel
• ARM B: Herceptin,
docetaxel plus
pertuzumab
• ARM C: Herceptin
plus pertuzumab
• ARM D: Pertuzumab
plus docetaxel
• ARM A: Xeloda plus
Herceptin
• ARM B: Xeloda plus
Herceptin plus
Pertuzumab
• ARM A: Pertuzumab
plus Herceptin and
docetaxel
• ARM B: Placebo plus
Herceptin and
docetaxel
Primary endpoint • 3-year disease-free
survival
• Safety • Pathologic complete
response rate
• Progression-free
survival
• Progression-free
survival
Status • Expect FPI Q4 2011 • FPI Q4 2009
• Top-line data available
Q3 2011
• Data to be presented
at SABCS 2011
• FPI Q1 2008
• Data presented at
SABCS 2010
• Biomarker data to be
presented at SABCS
2011
• FPI Q1 2010 • Met primary endpoint
July 2011
• Data to be presented
at SABCS 2011
PET = Positron Emission Tomography; FEC = Fluorouracil, Epirubicin, and Cyclophosphamide; TCH = Docetaxel, Carboplatin, Herceptin;
SABCS = San Antonio Breast Cancer Symposium.
65
Trastuzumab emtansine (T-DM1) (RG3502)
Evaluating new treatment options in HER2+ breast cancer
65
In collaboration with ImmunoGen
ESMO = European Society for Medical Oncology. 1 Patients must have received prior treatment which included both: a taxane, alone or in combination with another agent, and trastuzumab in the adjuvant, locally
advanced, or metastatic setting.
Patient
population
Neoadjuvant/
Adjuvant
Patients who have
progressed on HER2
targeted treatment
Pretreated
HER2 pos. metastatic
breast cancer1
Previously untreated
HER2 pos. metastatic breast cancer
Phase/
study Phase II
Phase III
TH3RESA
Phase III
EMILIA
Randomised
Phase II
Phase III
MARIANNE
# of
patients N=135 N=795 N=980 N=137 N=1,092
Design • Single ARM: T-DM1
administered
immediately following
completion of
anthracycline
chemotherapy
• ARM A: T-DM1
• ARM B: physician‟s
choice
• ARM A: T-DM1
• ARM B: Xeloda plus
lapatinib
• ARM A: T-DM1
• ARM B: Herceptin
plus docetaxel
• ARM A: Herceptin
plus taxane
• ARM B: T-DM1 plus
pertuzumab
• ARM C: T-DM1 plus
placebo
Primary
endpoint
• Cardiac event rate
• Safety
ORR and Overall survival Co-primary endpoints:
• Progression-free
survival (PFS)
• Overall survival
• Progression-free
survival by investigator
• Progression-free
survival assessed by
IRF
Status • FPI Q4 2010
• Completed enrollment
Q2 2011
• Expect data Q1 2012
• FPI Q3 2011 • FPI Q1 2009
• Enrollment completed
• Expect PFS data 2012
• Expect to submit PFS
data for approval in
2012
• Enrolment completed
Q4 2009
• Preliminary data
presented at ESMO
2010
• Positive topline PFS
data April 2011
• Data presented at
ESMO 2011
• FPI Q3 2010
66 66
Vismodegib (RG3616/GDC-0449 )
A novel small molecule inhibitor of the hedgehog signaling pathway
Patient
population
Advanced basal
cell carcinoma
Operable basal
cell carcinoma
Phase/study Pivotal Phase II
ERIVANCE Phase II
# of patients N=104 N=49
Design • Single ARM: GDC-0449 • Single ARM: GDC-0449
Primary
endpoint
• Overall response rate • COHORT 1: Complete clearance
• COHORT 2: Durable complete
clearance
Status • Enrolment completed Q1 2010
• Positive pivotal phase II results
announced March 2011
• Data presented at EADO June 2011,
ECCO/ESMO Sep 2011, EADV Oct
2011
• Submitted for FDA approval Q3 2011
• FPI Q4 2010
In collaboration with Curis
67
GA101 (RG7159)
Type II, glycoengineered anti-CD20 monoclonal antibody
• Phase I/II clinical trials
67
Patient
population
Front-line or relapsed
indolent non-Hodgkin’s lymphoma
(NHL)
Relapsed
indolent non-Hodgkin’s lymphoma
Relapsed or refractory
non-Hodgkin’s lymphoma or chronic
lymphocytic leukaemia (CLL)
Phase/study Phase Ib
GAUDI
Phase I/II
GAUSS
Phase I/II
GAUGUIN
# of patients N=136 N=202 N=133
Design • Cohort A: GA101 plus fludarabine +
cyclophosphamide
• Cohort B: GA101 plus CHOP
• Cohort C: GA101 plus bendamustine
Phase I portion
(extended treatment for 2 years):
• Single agent: GA101
Phase II portion
(extended treatment for 2 years):
• ARM A: MabThera/Rituxan
• ARM B: GA101
Phase I portion:
• Single agent: GA101
Phase II portion:
• Single agent: GA101
Status • FPI Q1 2009
• Expect data end of 2011
Phase I portion:
• Initiated Q1 2008
• Data presented at ASH 2009
Phase II portion:
• FPI Q3 2009
• Enrolment completed Q3 2010
• Data to be presented at ASH 2011
• Phase I portion:
• Initiated Q3 2007
• Updated Phase I NHL and CLL data
presented at ASH 2009
• Phase II portion:
• All cohorts completed enrolment by Q4
2009
• Data presented at ICML/EHA 2011
In collaboration with Biogen Idec
CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; ASH = American Society of Hematology; EHA = European Hematology Association.
68
GA101 (RG7159)
Type II, glycoengineered anti-CD20 monoclonal antibody
• Phase III clinical trials
68
Patient
population
Front-line
chronic lymphocytic
leukaemia
Patients with
comorbidities
Indolent
non-Hodgkin’s
lymphoma
MabThera/Rituxan
refractory
Front-line indolent
non-Hodgkin’s
lymphoma
Diffuse large B-cell
lymphoma (DLBCL)
Phase/stu
dy
Phase III
CLL11
Phase III
GADOLIN
Phase III
GALLIUM
Phase III
GOYA
# of
patients N=780 N=360 N=1,400 N=1,400
Design • ARM A: GA101 plus
chlorambucil
• ARM B:
MabThera/Rituxan plus
chlorambucil
• ARM C: Chlorambucil
alone
• ARM A: GA101 plus
Bendamustine
• ARM B: Bendamustine
• ARM A: GA101 plus
chemotherapy followed
by GA101 maintenance
• ARM B:
MabThera/Rituxan plus
chemotherpy followed by
MabThera/Rituxan
maintenance
• ARM A: GA101 plus
CHOP
• ARM B:
MabThera/Rituxan plus
CHOP
Primary
endpoint
• Progression-free survival • Progression-free survival • Progression-free survival • Progression-free survival
Status • FPI Q4 2009
• Expect data 2013
• FPI Q2 2010
• Expect data 2015
• FPI Q3 2011 • FPI Q3 2011
In collaboration with Biogen Idec
CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
69
MetMAb (RG3638)
Anti-Met monovalent antibody that inhibits HGF-mediated activation
Patient
population
2nd- and 3rd-line metastatic
Met diagnostic-positive NSCLC
1st and 2nd-line
triple negative metastatic breast
cancer
1st-line metastatic colorectal cancer
Phase Phase III Phase II Phase II
# of patients TBD N=180 N=188
Design • ARM A: Tarceva plus MetMAb
• ARM B: Tarceva plus placebo
• ARM A: Avastin and paclitaxel plus
MetMAb
• ARM B: Avastin and paclitaxel plus
placebo
• ARM C: Paclitaxel plus MetMAb
• ARM A: FOLFOX plus MetMAb
• ARM B: FOLFOX plus placebo
Primary
endpoint
• Overall survival • Progression–free survival • Progression–free survival in ITT
• Progression-free survival in pre-
specified Met Dx+ patients
Status • Expect FPI Q4 2011 • FPI Q1 2011 • FPI Q3 2011
70
MetMAb (RG3638)
Anti-Met monovalent antibody that inhibits HGF-mediated activation – Completed Studies
Patient
population Solid Tumors
2nd- and 3rd-line metastatic
non-small cell lung cancer
Phase Phase I Phase II
# of patients N=43 N=137
Design • Stage 1: MetMAb monotherapy (n=21)
• Stage 2: MetMAb monotherapy (n=13)
• Stage 3: Bevacizumab plus MetMAb (n = 9)
• ARM A: Tarceva plus MetMAb (n=69)
• ARM B: Tarceva plus placebo (n=68)
Primary endpoint • Safety • Progression–free survival in ITT
• Progression-free survival in pre-specified Met Dx+
Status • One gastric cancer patient with a complete
response to MetMAb monotherapy
• Final data presented at AACR 2011
• Positive data presented at ESMO 2010
• LIP “go” decision Q3 2010
• Updated OS data presented at ASCO 2011
AACR = American Association ESMO = European Society for Medical Oncology;
LIP = Lifecycle Investment Point. ASCO = American Society of Clinical Oncology
Dalcetrapib (RG1658)
A first-in-class CETP modulator
In collaboration with Japan Tobacco
CHD = Stable coronary heart disease; PET/CT = Positron Emission Tomography/Computed Tomography; MRI = Magnetic Resonance Imaging;
dal-HEART Programme Global Research Initiative
Patient population
Patients with CHD or
CHD risk equivalents
(Safety Study)
Patients with CHD and
other CHD risk factors
(Safety Study)
Phase/study
Phase IIb
dal-VESSEL
Endothelial function study
Phase IIb
dal-PLAQUE
Imaging study
# of patients N=476 N=130
Design • In addition to standard medication
(including statins):
• 36 weeks treatment duration
• ARM A: Dalcetrapib
• ARM B: Placebo
• In addition to standard medication
(including statins):
• 24 months treatment duration
• ARM A: Dalcetrapib
• ARM B: Placebo
Primary endpoint • Change from baseline in mean blood
pressure (4 weeks)
• Change from baseline in % flow
mediated dilatation (12 weeks)
• Change from baseline of MRI plaque
size/burden (12 months)
• Change from baseline in plaque to
background (blood) ratio from an
index vessel by PET/CT (6 months)
Status • Initiated Q2 2008
• Enrolment completed Q3 2009
• Data presented at ESC 2011
• Initiated Q1 2008
• Enrolment completed Q4 2008
• Data presented at ESC 2011
• Phase II clinical trials
71
Dalcetrapib (RG1658)
A first-in-class CETP modulator (continued)
In collaboration with Japan Tobacco
*Study being conducted in collaboration with the Canadian Atherosclerosis Imaging Network and Montreal Heart Institute
CHD = Stable coronary heart disease; ACS = Acute Coronary Syndrome; CAD = Coronary artery disease; CVD = cardiovascular disease; IMT = Intima-Media Thickness; IVUS = Intravascular Ultrasound.
dal-HEART Programme Global Research Initiative
Patient
population
Stable CHD patients
with recent ACS Patients with evidence of CAD Patients with recent ACS
Patients with CHD, CHD risk
equivalents or at elevated risk
for CVD
Phase/study
Phase III
dal-OUTCOMES
Mortality and morbidity study
Phase III
dal-PLAQUE 2*
Imaging study
Phase III
dal-ACUTE
Biomarker study
Phase III
dal-OUTCOMES 2
Mortality and morbidity study
# of patients N=15,872 N=900 N=300 N=20,000
Design • In addition to standard medication
for ACS (including statins):
• Minimum of 24 months treatment
duration
• ARM A: Dalcetrapib
• ARM B: Placebo
• In addition to standard
medication (including statins):
• 24 months treatment duration
• Uses both IMT and IVUS
ultrasound imaging techniques
• ARM A: Dalcetrapib
• ARM B: Placebo
• In addition to standard
medication (including statins):
• 20 weeks treatment duration
• ARM A: Dalcetrapib
• ARM B: Placebo
• In addition to standard
medication (including statins):
• Event driven trial - 4 to 5 years
follow up
• ARM A: Dalcetrapib
• ARM B: Placebo
Primary
endpoint
• Time to first occurrence of any
component of the composite
cardiovascular event
• Assess the change from
baseline in the progression of
atherosclerosis using IMT and
IVUS in coronary and carotid
vascular beds in the same
patients
• To evaluate the effect of
dalcetrapib on HDL-C at week
4 when treatment is initiated
within 1 week of an ACS
• To evaluate the potential of
dalcetrapib to reduce
cardiovascular morbidity and
mortality
• To evaluate the long-term
safety and tolerability of
dalcetrapib
Status • Initiated Q2 2008
• Enrolment completed Q2 2010
• Interim analysis at 50% of events
occurred in July 2011; DSMB
recommended to continue study as
planned with no changes
• Initiated Q4 2009
• Recruitment completed
• Expect data end of 2013
• FPI Q1 2011
• Recruitment completed Q3
2011
• in preparation
• Phase III clinical trials
72
73 73
Aleglitazar (RG1439)
A balanced PPAR co-agonist - potential to reduce cardiovascular events in type 2 diabetes patients
Patient
population
Type 2 diabetes
Patients with moderate and mild
renal impairment
ACS patients with
Type 2 diabetes
Phase/study
Phase II
AleNEPHRO
Renal function study
Phase III
AleCARDIO
Cardiovascular outcomes study
# of patients N=300 N=6,000
Design • 52 week treatment duration:
• ARM A: Aleglitazar (150 µg)
• ARM B: Pioglitazone (45 mg)
• At least 2.5 years treatment period and until
950 events have occurred
• ARM A: Aleglitazar (150 µg) on top of SOC
• ARM B: Placebo on top of SOC
Primary
endpoint
• Relative change from baseline in glomerular
filtration rate at 60 weeks
• Reduction in cardiovascular mortality, non-
fatal myocardial infarction and stroke (MACE)
Status • FPI Q2 2010
• Enrollment completed Q2 2011
• Expect data end of 2012
• FPI Q1 2010
ACS = Acute Coronary Syndrome; SOC = standard of care.
74
Glycine reuptake inhibitor (GlyT-1, RG1678)
• Positive phase II (POC study) data presented at the American College of
Neuropsychopharmacology, December 2010
74 PANSS = Positive and Negative Syndrome Scale
Patient
population
Acute
exacerbation of
schizophrenia
Sub-optimally controlled symptoms of schizophrenia Persistent, predominant
negative symptoms of schizophrenia
Phase/study
Phase II
Proof of concept
study
Phase III
NIGHTLYTE
Phase III
MOONLYTE
Phase III
TWILYTE
Phase III
SUNLYTE
Phase III
DAYLYTE
Phase III
FLASHLYTE
# of
patients N=300 N=600 N=600 N=600 N=630 N=630 N=630
Design • 4-week
treatment period
•ARM A:
RG1678 daily
(10 mg)
•ARM B:
RG1678 daily
(30 mg)
•ARM C:
Olanzapine
•ARM D:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 daily
(10 mg)
•ARM B:
RG1678 daily
(20 mg)
•ARM C:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 daily
(10 mg)
•ARM B:
RG1678 daily
(20 mg)
•ARM C:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 daily
(5 mg)
•ARM B:
RG1678 daily
(10 mg)
•ARM C:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 (10
mg)
•ARM B:
RG1678 (20
mg)
•ARM C:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 (5 mg)
•ARM B:
RG1678 (10
mg)
•ARM C:
Placebo
• Add-on therapy
to anti-psychotics
• 52-week
treatment period
•ARM A:
RG1678 (10
mg)
•ARM B:
RG1678 (20
mg)
•ARM C:
Placebo
Primary
endpoint
• PANSS total
symptom factor
at week 4
• PANSS positive
symptom factor
at week 12
• PANSS positive
symptom factor
at week 12
• PANSS positive
symptom factor
at week 12
• PANSS negative
symptom factor
at week 24
• PANSS negative
symptom factor
at week 24
• PANSS negative
symptom factor
at week 24
Status • FPI Q1 2011 • FPI Q4 2010 • FPI Q4 2010 • FPI Q4 2010 • FPI Q4 2010 • FPI Q4 2010 • FPI Q4 2010
75
Ocrelizumab (RG1594)
2nd generation anti-CD20 monoclonal antibody
75
Patient
populatio
n
Relapsing multiple sclerosis (RMS) Primary progressive
multiple sclerosis (PPMS)
Phase/st
udy
Phase III
OPERA I
Phase III
OPERA II
Phase III
ORATORIO
# of
patients N=800 N=800 N=630
Design • 96-week treatment period:
• ARM A: Ocrelizumab 2x
300 mg IV followed by 600
mg IV every 24 weeks
• ARM B: Rebif® (interferon
-1a)
• 96-week treatment period:
• ARM A: Ocrelizumab 2x
300 mg IV followed by 600
mg IV every 24 weeks
• ARM B: Rebif® (interferon
-1a)
• 120-week treatment period:
• ARM A: Ocrelizumab 2x
300 mg IV every 24 weeks
• ARM B: Placebo
Primary
endpoint
• Annualized relapse rate at 96
weeks versus Rebif
• Annualized relapse rate at 96
weeks versus Rebif
• Sustained disability
progression versus placebo by
Expanded Disability Status
Scale (EDSS)
Status • FPI Q3 2011 • FPI Q3 2011 • FPI Q1 2011
Rebif is a registered trademarks of EMD Serono, Inc.
76 76
Lebrikizumab (RG3637) development programme
A humanized monoclonal antibody designed to bind specifically to IL-13
Severe uncontrolled adult asthma
Patient
population
Adult patients who are inadequately
controlled on inhaled
corticosteroids
Adult patients who
are not taking
inhaled corticosteroids
Phase/study
Phase II
MILLY
Proof of concept study
Phase II
MOLLY
Dose-ranging study
# of patients N=218 N=212
Design • ARM A: Lebrikizumab
• ARM B: Placebo
• ARM A: Lebrikizumab (low dose)
• ARM B: Lebrikizumab (medium dose)
• ARM C: Lebrikizumab (high dose)
• ARM D: Placebo
Status • Topline data Q3 2010
• LIP „go‟ decision Q4 2010
• Data published in NEJM Aug. 2011
• Data presented at ERS 2011
• FPI Q4 2009
• Topline data: Q1 2011
• Phase III „go‟ decision June 2011
LIP = Lifecycle Investment Point
77 77
Mericitabine (RG7128)
Nucleoside polymerase inhibitor
Patient
population
Treatment-naive and failure
chronic hepatitis C
Genotype 1 and 4
Treatment-naive and failure
chronic hepatitis C
Genotype 1 and 4
Chronic hepatitis C
Genotype 2 and 3
Phase/study Phase IIb
PROPEL
Phase IIb
JUMP-C
Longer duration study
Phase IIb
# of patients N=408 N= 168 TBD
Design • ARM A: RG7128 (500 mg BID) + Pegasys and Copegus for 12
weeks, followed by Pegasys and Copegus for 12 weeks*
• ARM B: RG7128 (1000 mg BID) + Pegasys and Copegus for 8
weeks, followed by Pegasys and Copegus for 16 weeks*
• ARM C: RG7128 (1000 mg BID) + Pegasys and Copegus for 12
weeks, followed by Pegasys and Copegus for 12 weeks*
*Patients who have not achieved rapid viral (RVR) response will
receive Pegasys and Copegus for a further 24 weeks.
• ARM D: RG7128 (1000 mg BID) + Pegasys and Copegus for 12
weeks, followed by Pegasys and Copegus for 36 weeks
• ARM E: Pegasys and Copegus for 48 weeks
• ARM F (non-responder to ARM E): RG7128 (1000 mg BID)
+ Pegasys and Copegus for 24 weeks, followed by Pegasys and
Copegus for 24 weeks
• ARM A: RG7128 (1000 mg BID) +
Pegasys and Copegus for 24 weeks*
*Patients achieving RVR at week 4,
sustained through week 22, will stop all
treatment at week 24; non-RVR patients
will continue treatment with Pegasys and
Copegus for another 24 weeks up to week
48.
• ARM B: Pegasys and Copegus for 48
weeks
• ARM C (non-responders to ARM B):
RG7128 (1000 mg BID) + Pegasys and
Copegus for 24 weeks, followed by
Pegasys and Copegus for 24 weeks
• RG7128 in combination with
Pegasys and Copegus
Primary
endpoint • Sustained virological response (SVR) • Sustained virological response (SVR)
Status • Cohort 1 - FPI Q2 2009; Cohort 2 – FPI Q4 2009
• ARM A to E enrolment completed Q1 2010
• FPI for ARM F Q3 2010
• Interim data presented at AASLD 2010
• Expect final data presentation at EASL 2012
• FPI Q1 2010
• ARM A and B enrolment completed Q2
2010
• FPI ARM C Q3 2010
• Interim data presented at EASL 2011
• Expect final data presentation at EASL
2012
• In preparation
Licensed from Pharmasset
AASLD = American Association for the Study of Liver Disease; EASL = European Association for the Study of the Liver
78 78
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group Q3 2011 sales
Diagnostics
Foreign exchange rate information
79 79 79 79
Oncology development programmes
Small Molecules
Apoptosis MAPK signaling
Molecule MDM2 antagonist
(RG7112)
BRAF inhibitor(2)
(RG7256)
MEK inhibitor
(CIF, RG7167)
Raf/MEK inhibitor
(CKI27, RG7304)
Patient
population
Advanced solid
tumors
Hematologic
neoplasms
(Leukaemia)
BRAF mutated
solid tumors Solid tumors Solid tumors
Phase Phase I Phase I Phase I Phase I Phase I
# of patients N=105 N=90 N=100 N=115 N=52
Design • Multiple ascending
dose-escalation
study
• Multiple ascending
dose-escalation
study
• Multiple ascending
dose study with
extension cohorts
• Dose-escalation,
followed by
expansion into 4
cohorts in specific
indications
• Dose-escalation to
MTD
Status
• Study completed Q2
2011
• Data available end of
2011
• Expect to initiate
Phase Ib studies in
2012
• Initiated Q2 2008
• Preliminary results
presented at ASH
2010 and 2011
• Expect to initiate
Phase Ib studies in
2012
• FPI Q3 2010 • Initiated April 2008
• Go decision Q4 2010
• Phase I study
continuing, further
80 patients being
enrolled
• Initiated October
2008
• Phase I study
stopped enrolment in
Q4 2010
Collaborator Plexxikon Chugai Chugai
Plexxikon Inc., now part of Daiichi Sankyo Group
80 80
Oncology development programmes
Monoclonal Antibodies
Angiogenic signaling
Molecule Anti-PlGF MAb
(RG7334)
Patient
population Glioblastoma multiforme Hepatocellular carcinoma (HCC)
Phase Phase Ib/II Phase Ib
# of patients N=80-100 N=60-70
Design Part 1 - Dose escalation portion
• RG7334 in combination with Avastin
Part 2
• ARM A: Avastin
• ARM B: Avastin plus RG7334
Part 1 - Dose escalation portion
• RG7334 in combination with sorafenib
Part 2
• ARM A: Sorafenib
• ARM B: Sorafenib plus RG7334
Primary endpoint • Part 1 - Establish dosing for Part 2
• Part 2 - PFS at 6 months
• Part 1 - Establish dosing for Part 2
• Part 2 - Safety, PK, PD
Status • FPI Q2 2011 • FPI Q1 2011
Collaborator ThromboGenics & BioInvent
81 81
Oncology development programmes
Monoclonal Antibodies (continued)
Targeted Therapy Immunomodulation / Tumor –
Stroma Interactions
Apoptosis Induction /
Immune modulation
Molecule Anti-glypican-3 MAb
(GC33, RG7686)
Anti-CD44 MAb
(RG7356)
Anti-TWEAK MAb
(RG7212)
Patient
population
Metastatic liver cancer
(hepatocellular carcinoma) Solid tumors Solid tumors
Phase Phase Ib Phase I Phase I
# of patients N= 40-50 N=50-70 N=100
Design • Study US Monotherapy
• Study Japan Monotherapy
• Combo with SoC dose escalation
study
• Multiple ascending dose study
with extension and imaging arm
• Multiple ascending dose study
with extension cohorts
Primary
endpoint
• Safety and tolerability • Safety (MTD), PK, PD, preliminary
activity
• Safety, PK, PD
Status • FPI Q4 2008 • FPI Q2 2011 • FPI Q3 2011
Collaborator Chugai
SoC – standard of care
82 82
GA201 (RG7160)
Glycoengineered enhanced ADCC/anti-EGFR monoclonal antibody
Patient
population
Head and neck squamous cell
carcinoma
1st-line metastatic
non-small cell lung cancer
2nd-line metastatic
colorectal cancer
Phase Phase I
Mechanism of action study Phase Ib/II Phase II
# of patients N=45 N=160 N=160
Design • ARM A: GA201
• ARM B: Cetuximab
Treated until disease progression:
Squamous
ARM A: GA201 plus cisplatin and
gemcitabine
ARM B: Cisplatin and gemcitabine
Non-Squamous
ARM A: GA201 plus cisplatin and pemetrexed
ARM B: Cisplatin and pemetrexed
Treated until disease progression:
KRAS Wild Type
ARM A: GA201 plus FOLFIRI
ARM B: Cetuximab plus FOLFIRI
KRAS Mutant
ARM A: GA201 plus FOLFIRI
ARM B: FOLFIRI alone
Primary
endpoint
• Pharmacodynamic • Part 1 – Safety
• Part 2 – PFS
• PFS
Status • FPI Q4 2009
• Recruitment ongoing
• Part 1 FPI Q4 2010
• Part 2 FPI Q2 2011
• FPI Q2 2011
83 83 83
Inflammation development programmes
Molecule CRTH2 antagonist
(RG7185)
huMAb IL-17
(RG4934)
Patient
population Asthma Psoriatic arthritis
Phase Phase I Phase I
# of patients N=80 N= 19
Design • Single and multiple doses • Multiple doses
Status • Enrolment initiated in healthy volunteers
in Q3 2010
• Top-line results available Q1 2012
• FPI Q1 2011
• Recruitment completed Q3 2011
Collaborator
84 84
Virology development programmes
Molecule Nucleoside polymerase inh (9)
(RG7432)
DAA Combo Program
(RG7320)
Patient
population Chronic hepatitis C
Treatment-naïve and Interferon Unable/Intolerant Patients
Chronic hepatitis C Genotype 1
Phase Phase I
Phase IIb
INFORM-SVR
Interferon-free combination trial
# of patients N=60 N=200
Design • Dose-escalation study • ARM A: Ritonavir (100 mg bid) plus danoprevir (100 mg bid) plus
RG7128 (1000 mg bid) with Copegus
• ARM B: Ritonavir (100 mg bid) plus danoprevir (100 mg bid) plus
RG7128 (1000 mg bid)
• If patients are virus negative at weeks 2 and 10, patients will be re-
randomized to stop therapy at week 12 or receive another 12 weeks
of treatment for a total of 24 weeks.
• ARM C: Ritonavir (100 mg bid) plus danoprevir (100 mg bid) plus
RG7128 (1000 mg bid) with Copegus
Primary endpoint • Sustained virological response 24 weeks after the end of study
treatment
Status • FPI Q4 2010 • FPI Q1 2011
Collaborator Pharmasset
85 85
Danoprevir (RG7227)
HCV protease inhibitor
*patients previously treated with Pegasys/RBV with less than a 2-log drop on treatments
Patient
population
Treatment-naïve
chronic hepatitis C patients
Treatment-experienced
chronic hepatitis C patients
Phase/study
Phase IIb
ATLAS
Danoprevir + Pegasys + Ribavirin in
Genotype 1
Phase IIb
DAUPHINE
Boosted Danoprevir + Pegasys + Ribavirin in
Genotype 1 +4
Phase IIb
Matterhorn
Boosted Danoprevir in Triple, Quad and Interferon-free
combinations
# of patients N=232 N=421 N=381
Design • ARM A: Danoprevir 300 mg q8h +
Pegasys and Copegus for 12 weeks
• ARM B: Danoprevir 600 mg q12h +
Pegasys and Copegus for 12 weeks
• ARM C: Danoprevir 900 mg q12h +
Pegasys and Copegus for 12 weeks (arm
discontinued)
• ARM D: Placebo + Pegasys and Copegus
for 48 weeks
Danoprevir boosted by low dose ritonavir
•ARM A: Ritonavir + Pegasys + Copegus +
Danoprevir 200 mg for 24 weeks
•ARM B: Ritonavir + Pegasys + Copegus +
Danoprevir 100 mg for 24 weeks
•ARM C: Ritonavir + Pegasys + Copegus +
Danoprevir 50 mg for 24 weeks
•ARM D: Ritonavir + Pegasys + Copegus +
Danoprevir 100 mg*
•ARM E: Pegasys and Copegus
*If patients are virus negative at week 2 and
10, patients will stop therapy at week 12.
Danoprevir boosted by low dose ritonavir in IFN-free, triple
and QUAD
Cohort A: partial responders:
•ARM A1: Ritonavir + RG7128 1000 mg + Copegus +
Danoprevir 100 mg for 24 weeks
•ARM A2: Ritonavir + Pegasys + Copegus + Danoprevir 100
mg for 24 weeks
•ARM A3: Ritonavir + RG7128 1000 mg + Pegasys +
Copegus + Danoprevir 100 mg for 24 weeks
Cohort B: null responders:
•ARM B1: Ritonavir + RG7128 1000 mg + Copegus +
Danoprevir 100 mg for 24 weeks
•ARM B2: Ritonavir + RG7128 1000 mg + Pegasys +
Copegus + Danoprevir 100 mg for 24 weeks
•ARM B3: Ritonavir + RG7128 1000 mg + Pegasys +
Copegus + Danoprevir 100 mg for 24 weeks followed by 24
weeks Pegasys + Copegus
Primary
endpoint
• Sustained virological response 24 weeks
after the end of study treatment
• Sustained virological response 24 weeks
after the end of study treatment
• Sustained virological response 24 weeks after the end of
study treatment
Status • FPI Q3 2009
• 900 mg cohort be discontinued in Q4 2009
• SVR results will be presented at AASLD Q4
2011
• FPI Q4 2010
• Recruitment completed Q1 2011
• FPI Q2 2011
• Recruitment completed Q3 2011
86 86
Metabolic development programmes
Molecule P-selectin huMAb
(RG1512)
11 Beta HSD inhibitor
(RG4929)
Patient
population
Prevention of saphenous vein
graft disease
Patients undergoing coronary artery
bypass graft (CABG) surgery
Acute Coronary Syndrome
(ACS)
Patients undergoing
Percutaneous Coronary
Intervention (PCI)
Metabolic diseases
Phase/study Phase II Phase II Phase II
Proof of mechanism study
# of patients N=384 N=516 N=80
Design 32-week treatment period
•ARM A: RG1512 (20 mg/kg)
•ARM B: Placebo
Single infusion
•ARM A: RG1512 (5 mg/kg)
•ARM B: RG1512 (20 mg/kg)
•ARM C: Placebo
12-week treatment
•ARM A: RG4929 (200 mg)
•ARM B: Placebo
Status • FPI Q4 2010 • FPI Q2 2011 • FPI Q1 2011
• Expect data Q2 2012
Collaborator Genmab
• Phase II studies
87 87
Metabolic development programmes
Molecule GLP-1/GIP dual agonist
(MAR701, RG7685)
ABCA1 inducer
(RG7273)
CatS antagonist
(RG7236)
Patient
population Type 2 diabetes Type 2 diabetes Dyslipidemia
Cardiovascular
Disease
Phase/study Phase I
Phase II
Proof of concept
study
Phase I Phase I
Design • Multiple
ascending dose
(MAD) study
• In preparation • Multiple
ascending dose
study
• Multiple ascending
dose study
Status • FPI Q2 2011
• Recruitment
completed Q3
2011
• Expect FPI Q4
2011
• FPI Q3 2011 • Expect FPI Q3 2012
Collaborator Marcadia Biotech, Inc. acquisition
• Phase II studies
88 88
CNS (Neuroscience) development programmes
Molecule
Gantenerumab
(Anti-Αβ, RG1450)
GABRA5 negative allosteric modulator (NAM)
(RG1662)
Patient
population
Prodromal Alzheimer’s
Disease Down Syndrome
Phase Phase II Phase I Phase I
# of patients N=360 N=90 N=32
Design 104-week subcutaneous treatment period
• ARM A: Gantenerumab (225 mg)
• ARM B: Gantenerumab (105 mg)
• ARM C: Placebo
• Single ascending dose
study/PET
• Multiple ascending
dose study
Primary endpoint • Change in Clinical Dementia Rating scale
Sum of Boxes (CDR-SOB) at 2 years
• Food effect, Brain
Receptor Occupancy,
Safety
• Safety
Status • FPI Q4 2010 • FPI Q1 2010
• Enrolment completed
• FPI Q4 2010
• Enrollment completed
Q3 2011
Collaborator MorphoSys
89 89
CNS (Neuroscience) development programmes
Molecule Triple reuptake inhibitor
(RG7166)
V1 receptor antagonist
(RG7314)
Monoamine oxidase type B
(MAO-B) inhibitor
(RG1577, EVT-302)
Patient
population Depression Autism Alzheimer’s Disease
Phase Phase I Phase I Phase I
# of patients N=76 TBD
Design • Extended MAD –BID dosing • SAD/MAD umbrella protocol
including food effect
Double-blind, placebo controlled
randomized study to assess the
efficacy of RG1577 in mild to
moderate patients with Alzheimer
disease
Primary
endpoint
• Safety • Safety, Tolerability • Efficacy
Status • FPI Q4 2009 • FPI Q3 2010 • Expect FPI in H2 2012
Collaborator Evotec
90 90
CNS (Neuroscience) development programmes
Metabotropic glutamate receptor pathway
Molecule mGluR2 antagonist
(RG1578)
mGluR5 antagonist
(RG7090)
Patient
population Depression
Treatment-resistant
depression Fragile X Syndrome
Phase/study Phase I Phase IIa Phase IIa
# of patients N=104 N=48 N=48
Design • Dose-escalation study ARM A: RG7090 daily
dosing (multiple dosing)
ARM B: Placebo daily
ARM A: RG7090 ascending
doses (Multiple dosing)
ARM B: Placebo
Primary
endpoint
• Safety and tolerability • Safety and tolerability • Safety and tolerability
Status • Study completed
• Additional Phase I studies
ongoing
• Phase IIb expected to start
Q4 2011
• Phase IIa study completed
• Phase IIb study to start Q4
2011
• Study completed
• Next study under
preparation
91
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group Q3 2011 sales
Diagnostics
Foreign exchange rate information
92
Oncology development programmes
Angiogenic signaling
Molecule Anti-angiogenic
(RG7594)
Anti-EGFL7 MAb
(RG7414)
Patient
population Advanced solid tumors Advanced solid tumors
First-line metastatic
non-small cell lung
cancer
First-line metastatic
colorectal cancer
Phase Phase Ia/Ib Phase Ib Phase II Phase II Prep
# of patients N=~54 N=72 N=100 TBD
Design • Dose escalation study
• Phase Ib portion in
combination with
Avastin
• ARM A: Anti-EGFL7
plus Avastin
• ARM B: Anti-EGFL7
plus Avastin and
paclitaxel
• RCC expansion: Anti-
EGFL7 plus Avastin
• Anti-EGFL7 plus Avastin
plus carbo/tax vs Avastin
plus carbo/tax
• TBD
Status • FPI Q2 2010 • FPI Q1 2010
• Phase II “go” decision
Q1 2011
• Data presented at ASCO
2011
• FPI Q2 2011 • Expect FPI Q4 2011
93
Oncology development programmes
Growth factor signaling Tumor Immunotherapy
Molecule Anti-FGFR3 MAb
(RG7444)
Anti-HER3 EGFR DAF
MAb
(RG7597)
NME MAb
(RG7446)
Patient
population
t(4;14)-positive multiple
myeloma
Relapsed refractory
metastatic bladder
cancer
Metastatic epithelial
tumors Solid tumors
Phase Phase I Phase I Phase I Phase I
# of patients N=25 N=38 N=66 N=91
Design • Dose escalation study • Dose escalation study • Dose escalation study • Dose escalation study
Status • FPI Q4 2010 • FPI Q3 2011 • FPI Q4 2010 • FPI Q2 2011
Collaborator
94
Oncology development programmes
Antibody drug conjugate (ADC)
Molecule Anti-CD22 ADC
(RG7593)
NME ADC
(RG7450)
NME ADC
(RG7596)
NME ADC
(RG7458 )
NME ADC
(RG7599)
NME ADC
(RG7598)
Patient
population
Hematologic
malignancies
Prostate
Cancer
Hematologic
malignancies Ovarian Cancer
NSCLC and
ovarian cancer
Multiple
Myeloma
Phase Phase I Phase I Phase I Phase I Phase I Phase I
# of patients N=76 N=49 N=99 N=57 N=70 N=30-45
Design • Dose
escalation
study
• Dose
escalation
study
• Dose
escalation
study
• Dose
escalation
study
• Dose
escalation
study
• Dose
escalation
study
Status • FPI Q4 2010 • FPI Q1 2011 • FPI Q1 2011 • FPI Q2 2011 • FPI Q2 2011 • FPI Q3 2011
Collaborator Seattle Genetics
PI3K signaling
Molecule PI3 Kinase inhibitor
(GDC-0941, RG7321)
Patient
population
Advanced Solid
Tumors
Advanced Solid
Tumors or Non-
Hodgkin’s
Lymphoma
1L HER2-negative
metastatic breast
cancer
2L HER2-positive
metastatic breast
cancer
1L and 2L
advanced non-
small cell lung
cancer
2L metastatic
non-small cell
lung cancer
2L ER+ metastatic
breast cancer
Phase
Phase Ia
Being conducted
in the US
Phase Ia
Being conducted
in the UK
Phase Ib Phase Ib Phase Ib Phase Ib Phase II Prep
# of
patients N=100 N=55 N=45 N=70 N=30 N=30 N=340
Design • Dose-escalating
study
• Dose-escalating
study
• Study includes
multiple myeloma
extension cohort
• Single ARM:
Evaluating GDC-
0941 plus
paclitaxel and
Avastin
• Patients who have
progressed on
Herceptin-based
treatment
• ARM A: GDC-
0941 plus T-DM1
• ARM B: GDC-
0941 plus
Herceptin
• ARM A: GDC-
0941 plus
carboplatin/
paclitaxel
(Avastin-ineligible
patients)
• ARM B: GDC-
0941 plus
carboplatin/
paclitaxel plus
Avastin (Avastin-
eligible patients)
• Single ARM:
Evaluating GDC-
0941 plus Tarceva
• ARM A: GDC-
0941 plus
hormonal therapy
• ARM B: GDC-
0980 plus
hormonal therapy
• ARM C:
Hormonal therapy
Status • FPI Q4 2007
• Additional data
presented at
ASCO 2010 and
ESMO 2010
• FPI Q1 2008
• Additional data
presented at
ASCO 2010,
ESMO 2010, and
ASCO 2011
• FPI Q3 2009 • FPI Q3 2009
• Data presented at
SABCS 2010
• FPI Q4 2009
• Data presented at
ASCO 2011
• FPI Q3 2009 • Expect FPI Q4
2011
95
Oncology development programmes
Small molecules
96
Oncology development programmes
Small molecules (continued)
PI3K signaling
Molecule PI3 Kinase/mTOR dual inhibitor
(GDC-0980, RG7422)
Patient
population
Refractory solid
tumors or
non-Hodgkin’s
lymphoma
Refractory solid
tumors or
non-Hodgkin’s
lymphoma
Metastatic breast
cancer Solid tumors Solid tumors Renal cell carcinoma
Phase Phase Ia Phase Ia Phase Ib Phase Ib Phase Ib Prep Phase II Prep
# of patients N=75 N=65 N=65 N=80 N=95 N=80
Design • Dose escalation study • Dose escalation study
• Dose escalation study
• ARM A: GDC-
0980 plus
paclitaxel
• ARM B: GDC-
0980 plus Avastin
and paclitaxel
• ARM C: GDC-
0980 plus
Herceptin and
paclitaxel
• Dose escalation study
• ARM A: GDC-
0980 plus
carboplatin and
paclitaxel
• ARM B: GDC-
0980 plus Avastin,
carboplatin and
paclitaxel
• ARM A: GDC-0980
+ Xeloda
• ARM B: GDC-0980
plus FOLFOX and
Avastin
• ARM A: GDC-0980
• ARM B: Everolimus
Status • FPI Q2 2009
• Data presented at
ASCO 2010, ESMO
2010, and ASCO 2011
• FPI Q2 2009
• Data presented at
ASCO 2010 and
ESMO 2010
• FPI Q4 2010 • FPI Q2 2011 • Expect FPI Q4 2011 • Expect FPI Q4 2011
ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical Oncology.
97
Oncology development programmes
Small molecules (continued)
PI3K signaling Apoptosis
Molecule PI3 Kinase inhibitor
(GDC-0032, RG7604)
NME
(GDC-0349, RG7603)
IAP Antagonist
(GDC-0917, RG7459)
Bcl-2 selective
inhibitor
(GDC-0199, RG7601)
ChK1 inhibitor
(GDC-0425, RG7602)
Patient
population Solid tumors Solid tumors or NHL
Solid tumors or
lymphoma
Relapsed or
refractory CLL and
NHL
Solid tumors or
lymphoma
Phase Phase I Phase Ia Phase I Phase I Phase I
# of patients N=45 N=72 N=65 N=36 N=75
Design • Dose escalation
study
• Dose escalation
study
• Dose escalation
study
• Single arm: GDC-
0199
• Dose escalation
study
Status • FPI Q1 2011 • FPI Q2 2011 • FPI Q4 2010 • FPI Q2 2011 • FPI Q3 2011
Collaborator Abbott and WEHI Array BioPharma
WEHI = The Walter and Eliza Hall Institute
98
Oncology development programmes
Small molecules (continued)
*Zelboraf in collaboration with Plexxikon Inc., now part of Daiichi Sankyo Group
AKT pathway MAPK signaling
Molecule AKT Inhibitor
(GDC-0068, RG7440)
MEK Inhibitor
(GDC-0623,
RG7420)
MEK Inhibitor
(GDC-0973, RG7421)
Patient
population Solid tumors Solid tumors Solid tumors Solid tumors Solid tumors
Metastatic melanoma
BRAF mutation
positive
Phase Phase Ia Phase Ib Phase I Phase I Phase Ib Phase Ib
BRIM7
# of patients N=57 N=90 N=62 N=90 N=212 N=~50
Design • Dose
escalation
study
• Dose escalation
with either
docetaxel or
fluoropyrimidine
plus oxaliplatin
• Dose
escalation
study
• Dose escalation
study
• Dose escalation
study evaluating
GDC-0973 plus
GDC-0941 (PI3
Kinase Inhibitor)
• Dose escalation study
evaluating Zelboraf*
plus GDC-0973
Status • FPI Q1 2010
• Data
presented
at ASCO
2011
• FPI Q3 2011 • FPI Q2 2010 • FPI Q2 2007
• Data presented
at AACR 2011
• Recruitment
completed Q3
2011
• FPI Q4 2009
• Preliminary data
presented at
AACR and ASCO
2011
• FPI Q1 2011
Collaborator Array BioPharma Exelixis
99
Navitoclax (RG7433) development programme
Small molecule designed to restore apoptosis by blocking the function of pro-survival Bcl-2 family proteins
• Phase I studies
In collaboration with Abbott
Patient
population Solid tumors
Relapsed or refractory
CD20+
lymphoid malignancies
Relapsed or
refractory chronic
lymphocytic leukaemia
Phase Phase I/Ib
M11-958
Phase Ib
M10-338
Phase Ib
M10-588
Phase Ib
M10-589
Phase Ib
M10-166
Phase Ib
M10-458
# of patients N=51 N=50 N=48 N=35 N=29 N=36
Design • ARM A:
Navitoclax +
Tarceva
• ARM B:
Navitoclax+Irin
otecan
• ARM C:
Navitoclax
alone
• Single ARM:
Navitoclax+
docetaxel
• Single ARM:
Navitoclax+
gemcitabine
• Single ARM:
Navitoclax +
paclitaxel
• Single ARM:
Navitoclax + Rituxan
• ARM A: Navitoclax+
fludarabine,
cyclophosphamide and
Rituxan (FCR)
• ARM B: Navitoclax +
bendamustine and
Rituxan (BR)
Status • FPI Q4 2009
• Enrollment
completed Q3
2011
• FPI Q3 2009 • FPI Q3 2009
• Enrollment
completed Q3
2011
• FPI Q3 2009 • FPI Q3 2009
• Data presented at ASH
2010
• Enrollment completed
Q4 2010
• FPI Q4 2009
• Data presented at ASH
2010
100
Navitoclax (RG7433) development programme
Small molecule designed to restore apoptosis by blocking the function of pro-survival Bcl-2 family proteins
• Phase II studies
In collaboration with Abbott
ASH = American Society of Hematology
Patient
population
Relapsed or refractory
lymphoid malignancies
Relapsed or
refractory chronic
lymphocytic leukaemia
Front-line chronic
lymphocytic leukaemia
Phase Phase I/IIa
M06-814
Phase I/IIa
M06-873
Phase II
FRANC
# of patients N=84 N=60 N=120
Design • Single ARM: Navitoclax • Single ARM: Navitoclax • ARM A: Rituxan
• ARM B: Rituxan + navitoclax
for a maximum of 12 weeks
• ARM C: Rituxan + navitoclax
until progression, relapse, or
unacceptable toxicity
Status • FPI Q4 2006
• Initiated Phase IIa cohort Q1
2010
• Updated Phase I data presented
at ASH 2009
• Enrolment completed Q4 2010
• FPI Q3 2007
• Initiated Phase IIa cohort Q3
2009
• Data presented at ASH 2010
• Enrolment completed Q3 2010
• FPI Q3 2010
101
Immunology development programmes
Molecule Anti-LT α
(RG7416)
Anti-M1 prime
(RG7449)
rhuMAb-β7
(RG7413)
Rontalizumab
(Anti-IFN α, RG7415)
Patient
population
Rheumatoid
arthritis Asthma
Ulcerative
colitis
Systemic lupus
erythematosus
Phase/stud
y
Phase IIa
ALTARA
Phase IIa
SOLARIO Phase I
Phase II
EUCALYPTUS
Phase II
ROSE
# of
patients N=200 N=28 N=48 N=120 N=238
Design
• ARM A: Anti-LT alpha
plus DMARD
(leflunomide or
methotrexate)
• ARM B: Humira® plus
DMARD (leflunomide
or methotrexate)
• ARM C: Placebo plus
DMARD (leflunomide
or methotrexate)
• ARM A: Anti-M1
prime
• ARM B: Placebo
• Dose escalation study • ARM A: RhuMAb-
β7 (100 mg) plus
immunosuppressant
• ARM B: RhuMAb-
β7 (300 mg) plus
immunosuppressant
• ARM C: Placebo
plus
immunosuppressant
• ARM A: Placebo
• Part 1 – IV
• Part 2 - Subcutaneous
• ARM B: Rontalizumab
• Part 1 – IV
• Part 2 – Subcutaneous
Primary
endpoint
• Disease Activity Score
(DAS28) at Day 85
• Late airway response
(LAR) at Day 86
• Safety and tolerability • Clinical Remission
(Mayo Clinic Score)
at Week 10
• Proportion of responders
at Week 24
Status • FPI Q4 2010 • FPI Q4 2010
• Enrollment completed
Q2 2011
• Enrolment completed
Q3 2010
• Phase II “go” decision
Q1 2011
• FPI Q3 2011 • FPI Q3 2009
• Enrolment completed Q3
2010
• Phase IIb go/no go
decision Q4 2011
DMARD = Disease-Modifying Anti-Rheumatic Drugs
Humira® (adalimumab) is a registered trademark of Abbott Laboratories.
102
Metabolism, neuroscience and ophthalmology
development programmes
Molecule
Anti-Αβ
(RG7412)
Anti-Factor D
(RG7417)
Anti-oxLDL
(RG7418, BI-204)
NME
(RG7652)
Patient
population
Alzheimer’s
Disease
Geographic Atrophy (GA)
secondary to age-related
macular degeneration
Secondary prevention of
cardiovascular events in
patients with ACS
Metabolic
diseases
Phase/study
Phase II
ABBY
Cognition study
Phase II Prep
BLAZE
Biomarker study
Phase Ib/II
MAHALO
Phase II
Proof of activity study Phase II
# of patients N=360 N=72 N=134 N=120 N=70
Design • ARM A: Anti-Abeta
subcutaneous
• ARM B: Anti-Abeta
IV
• ARM C: Placebo
• ARM A: Anti-Abeta
subcutaneous
• ARM B: Anti-Abeta
IV
• ARM C: Placebo
• Part 1: Open-label
• Multiple dosing
• Part 2: Randomised
• ARM A: Anti-Factor D
injection
• ARM B: Sham Injection
• ARM A: Anti-oxLDL (single
dose) and statin
• ARM B: Anti-oxLDL
(repeating dose) and statin
• ARM C: Placebo and statin
• Randomized,
placebo
controlled single
and multiple
dose study
Primary
endpoint
• Change in
cognition (ADAS-
cog) from baseline
to week 73
• Change in brain
amyloid load from
baseline to week 69
• Part 1: Safety
• Part 2: Growth rate of GA
lesion at month 12
• Change in TBR as measured
by FDG-PET/CT at week 12
• Safety and
tolerability
Status • FPI Q2 2011 • FPI Q3 2011 • Part 1 FPI Q4 2010
• Part 2 FPI Q2 2011
• FPI Q1 2011 • FPI Q3 2011
Collaborator AC Immune BioInvent
TBR = Target-to-background ratio; FDG = Fluoro-2-deoxy-D-glucose;
ACS – acute coronary syndrome. PET = Positron Emission Tomography; CT = CAT scan.
103 103 103
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group YTD Sept 2011 results
Diagnostics
Foreign exchange rate information
Geographical sales split by division and Group*
CHF m YTD Sept
2010
YTD Sept
2011
% change
in CER
Pharmaceuticals Division 28,395 24,397 -1
United States 10,878 9,104 +1
Western Europe 7,295 6,210 -4
Japan 3,137 2,712 -6
International 7,085 6,371 +1
Diagnostics Division 7,732 7,095 +6
United States 1,800 1,549 +4
Western Europe 3,081 2,758 +1
Japan 384 375 +6
International 2,467 2,413 +12
Group 36,127 31,492 0
United States 12,678 10,653 +2
Western Europe 10,376 8,968 -2
Japan 3,521 3,087 -4
International 9,552 8,784 +4 104 104
* Geographical sales split shown here does not represent operational organization; CER = Constant Exchange Rates (average full year 2010)
105
CER sales growth (%)
Quarterly development
2010 vs. 2009 2011 vs. 2010
Q1 Q2 Q3 Q4 Q1 Q2 Q3
Pharmaceuticals Division 10 -2 -5 -8 -2 -1 0 excl. Tamiflu 8 3 4 4 1 1 0
United States 10 -5 -1 -8 2 1 1 excl. Tamiflu 6 2 4 2 2 2 1
Western Europe 4 -2 -11 -13 -4 -4 -3 excl. Tamiflu 9 2 -1 -2 -4 -4 -4
Japan -9 -3 -22 -11 -7 -3 -7 excl. Tamiflu 2 1 2 7 1 -2 -5
International 25 4 5 -1 -3 0 5 excl. Tamiflu 16 6 12 13 6 6 6
Diagnostics Division 9 9 7 6 6 5 6
Roche Group 9 0 -3 -5 0 0 1 excl. Tamiflu 9 4 5 4 2 2 2
CER = Constant Exchange Rates (average full year 2010)
Pharma Division sales YTD Sept 2011 (vs. 2010)
Top 20 products
106
Global US W. Europe Japan International % % % % % CHF m CER CHF m CER CHF m CER CHF m CER CHF m CER
MabThera/Rituxan 4,417 7 2,024 6 1,182 6 177 0 1,034 10 Avastin 3,942 -8 1,774 -15 1,092 -10 438 9 638 9 Herceptin 3,905 8 1,056 5 1,463 3 204 2 1,182 19 Lucentis 1,128 26 1,128 26 - - - - - - Pegasys 1,051 -5 222 -11 227 -5 69 -15 533 -2 Xeloda 1,001 6 377 12 201 -2 80 -6 343 7 Tarceva 921 6 347 6 283 -3 64 6 227 20 CellCept 770 -12 158 -13 220 -29 45 13 347 0 NeoRec./Epogin 690 -22 - - 240 -28 246 -23 204 -13 Bonviva/Boniva 551 -19 246 -28 170 -14 - - 135 0 Xolair 446 10 446 10 - - - - - - Actemra/RoActemra 433 86 98 267 143 66 132 29 60 217 Valcyte/Cymevene 425 9 192 2 120 6 - - 113 28 Pulmozyme 358 9 208 12 76 4 - - 74 6 Activase/TNKase 331 15 300 16 - - - - 31 7 Tamiflu 301 -57 170 2 21 625 69 -60 41 -89 Nutropin 242 -6 235 -5 - - - - 7 -7 Mircera 237 45 - - 133 14 31 - 73 59 Madopar 222 8 - - 70 0 16 3 136 13 Neutrogin 200 -13 - - - - 200 -13 - - CER = Constant Exchange Rates (average full year 2010)
107
Q3/10 Q4/10 Q1/11 Q2/11 Q3/11
MabThera/Rituxan 6 10 7 6 7 Avastin 7 2 -6 -9 -10 Herceptin 8 5 8 12 4 Lucentis 34 20 35 29 17 Pegasys -8 9 -15 -7 6 Xeloda 16 14 7 2 10 Tarceva 9 0 8 1 10 CellCept -14 5 -14 -13 -9 NeoRecormon/Epogin -16 -18 -22 -18 -28 Bonviva/Boniva 2 -13 -15 -19 -24 Xolair 10 5 13 9 9 Actemra/RoActemra 176 158 111 90 69 Valcyte/Cymevene 11 14 8 10 8 Pulmozyme 2 -5 8 9 11 Activase/TNKase 15 -3 23 18 5 Tamiflu -90 -94 -47 -88 -51 Nutropin 19 11 8 1 -21 Mircera 37 37 30 21 82 Madopar 11 7 8 7 8 Neutrogin -23 -18 -24 -4 -11
Pharma Division CER sales growth1 in %
Global top 20 products
1 Q3-Q4/10 vs. Q3-Q4/09, Q1-Q3/11 vs. Q1-Q3/10
CER = Constant Exchange Rates (average full year 2010)
Pharma Division CER sales growth in %
Top 20 products by region
108
US Western Europe Japan International
Q41 Q11 Q21 Q31 Q41 Q11 Q21 Q31 Q41 Q11 Q21 Q31 Q41 Q11 Q21 Q31
MabThera/Rituxan 6 5 7 7 5 5 6 8 16 9 -5 -1 25 15 5 9 Avastin -10 -14 -15 -16 -3 -8 -12 -9 50 22 7 2 32 16 8 5
Herceptin 7 3 7 4 1 1 5 4 -10 -3 30 -23 13 25 23 9 Lucentis 20 35 29 17 - - - - - - - - - - - -
Pegasys 6 -28 -17 15 2 -2 -3 -10 5 -2 -12 -28 16 -16 -3 15 Xeloda 10 13 2 23 7 -4 -1 -1 33 2 -9 -9 21 10 5 6
Tarceva -6 10 1 7 -5 -2 -12 6 45 22 0 2 10 16 22 23 CellCept 40 -27 -12 2 -7 -24 -27 -35 25 16 9 15 3 -1 -5 5
NeoRecorm/Epogin - - - - -30 -30 -28 -26 -11 -15 -11 -42 -7 -17 -13 -8 Bonviva/Boniva -21 -19 -31 -36 -2 -10 -12 -21 - - - - -6 -9 2 7
Xolair 5 13 9 9 - - - - - - - - - - - - Actemra/RoActemra - * 356153 114 88 67 51 74 35 27 25 458 338 203 177
Valcyte/Cymevene 18 8 3 -4 7 1 11 8 - - - - 13 18 24 42 Pulmozyme 2 11 11 14 1 1 6 5 - - - - 22 5 3 12
Activase/TNKase -3 24 20 5 - - - - - - - - 5 13 1 7 Tamiflu -89 15 -56 - - 169 - * -89 -61 -68 -55 -99 -90 -97 -62
Nutropin 11 8 1 -21 - - - - - - - - -5 -15 -7 1 Mircera - - - - 20 11 16 15 - - - - 94 86 32 65
Madopar - - - - 4 -2 -5 6 5 10 1 -2 9 14 15 10 Neutrogin - - - - - - - - -18 -24 -4 -11 - - - -
1 Q4/10 vs. Q4/09, Q1-Q3/11 vs. Q1-Q3/10 * > 500%
CER = Constant Exchange Rates (average full year 2010)
109
Global US W. Europe Japan International % % % % % CHF m CER CHF m CER CHF m CER CHF m CER CHF m CER
Actemra/RoActemra 433 86 98 267 143 66 132 29 60 217
Mircera 237 45 - - 133 14 31 - 73 59
Zelboraf 11 - 11 - - - - - - -
Pharma Division sales YTD Sept 2011 (vs. 2010)
Recently launched products
CER = Constant Exchange Rates (average full year 2010)
2010 vs. 2009 2011 vs. 2010
Quarterly growth
rates % in LC
Q1 Q2 H1 Q3 Q4 FY Q1 Q2 H1 Q3
Pharmaceuticals Division 10 -2 4 -5 -8 -2 -2 -1 -1 0
excl. Tamiflu 8 3 6 4 4 5 1 1 1 0
excl. Healthcare Reforms 9 5 7 7 7 7 3 1 2 1
Impact of Healthcare Reforms
US healthcare reforms 0.4 1.0 0.7 0.6 0.8 0.7 0.5 -0.3 0.1 0.6
European austerity measures - 0.4 0.3 1.1 1.5 0.2 1.0 0.9 0.9 0.4
Japan pricing regulations - 0.8 0.4 1.0 1.1 0.4 0.9 0.0 0.4 0.0
Pharma Division Sales Growth Impact of healthcare reforms and austerity measures
110
111
US
• Sales driven by Rituxan, Herceptin and
Xeloda; Avastin in mBC bottoming out
Western Europe
• Continued growth of MabThera and
Herceptin, significant impact of austerity
measures
International
• Growth driven by major oncology products:
Herceptin, MabThera and Avastin
Japan
• Avastin is the major growth driver
YTD Sept 2011: Oncology franchise*
1CER; * YTD Sept 2011 sales: CHF 14.2 bn
-2%
-2%
+11%
Oncology sales
-1%
CH
F b
n
+1%1
0
3
6
9
12
15
18
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
Japan International
Western Europe US
112
MabThera/Rituxan
YTD sales of CHF 4.417 bn
• 1L maintenance in follicular NHL (Q2 „11): top 5 EU penetration rate doubled to ~ 62% from ~31% in Q4
2010. Adoption of 12-infusion maintenance schedule in top 5 EU ~50% in Q2 „11 from ~39% in Q4 „10.
We expect further growth in both measures.
• CLL: as of Q2 2011 top 5 EU 1st line CLL penetration rate 65% (vs 62% in Q4 2010; 61% in Q2 2010; 56%
in Q4 2009)
• RA: Phase IV data at upcoming ACR to demonstrate benefits of switching to MabThera/Rituxan after a single TNF inadequate response.
1 CER
Local growth Regional sales
US +6%
Japan +0%
International +10%
CH
F b
n
Global sales
Western Europe +6% 0.0
1.0
2.0
3.0
4.0
5.0
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
+7%1
113
Avastin
1 CER
Local growth Regional sales
US -15%
Japan +9%
Western Europe -10%
International +9%
- 8%1
Global sales
1st line mBC
EU: stabilizing (Q2 „11)
US: Q3 ‟11 low patient share bottoming
out
1st line mCRC
EU: stable (Q2 „11)
US: stable (Q3 „11)
Japan: high penetration
1st line mNSCLC
EU: stable (Q2 „11)
US: stable (Q3 „11)
Japan: penetration still low
Avastin New Patient Shares
Peak sales reconfirmed at CHF 7bn
CH
F b
n
0.0
1.0
2.0
3.0
4.0
5.0
6.0
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
114
Herceptin
YTD sales of CHF 3.905 bn
• US2: adjuvant use in eBC strong with high stable penetration ~95%; 1st line mBC use steady at about 85%.
• Western Europe (top 5 EU, Q2 „11): penetration in eBC stable ~85%, 1st line mBC use stable in the 70% range.
• US and WE: Stable treatment duration in eBC > 47 weeks.
• Metastatic gastric cancer: HER2 testing rate above 80% in EU and US
• Emerging markets: Expanded access lead to volume increase of +32.0% in Asia , +22.1% in CEMAI and +31.2% in LatAm.
1 CER; 2 penetration is reported as Herceptin eligible patients in the US, and as total patient share in top 5 EU
Japan +2%
Local growth Regional sales
Western Europe +3%
International +19%
US +5%
CH
F b
n
Global sales
+8%1
0.0
1.0
2.0
3.0
4.0
5.0
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
115
YTD sales of CHF 1.001 bn
• In US, increased use in adjuvant CC and monotherapy use in 1L metastatic BC
• Global sales further benefit from stomach cancer indication in China, expanded
metastatic colorectal cancer and inoperable advanced or recurrent stomach cancer in Japan.
• WE sales impacted by austerity measures.
Xeloda
1 CER
CH
F b
n
Global sales Local growth Regional sales
US +12%
Japan -6%
Western Europe -2%
International +7%
0.0
0.2
0.4
0.6
0.8
1.0
1.2
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
+6%1
116
YTD sales of CHF 921 m
• US: Q3‟11 NSCLC overall penetration remain stable
• EU: Market penetration in mNSCLC, top 5 EU (Q1 ‟11): 2nd line: ~40%; Pricing pressure and competitive challenges continue.
• International: strong growth
Tarceva
1 CER
Global sales Local growth Regional sales
Japan +6%
Western Europe -3%
CH
F b
n
+6%1
US +6%
International +20% 0.0
0.2
0.4
0.6
0.8
1.0
1.2
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
117
Inflammation/Autoimmune/Transplantation
YTD Sept 2011 IAT sales: CHF 2.1 bn
• Strong growth of Actemra and
MabThera/Rituxan compensated for the
further CellCept decline in US and WE
Actemra/RoActemra
Sales: CHF 433 m (+86%)
Further gain of patient share in all treatment
lines according to label; US biggest growth
contributor
CellCept
Sales: CHF 770m (-12%)
• Patent expiry key EU countries end 2010
• US prescription share ~14% (Q3 „11)
IAT sales
CH
F b
n
1 CER
0.0
0.5
1.0
1.5
2.0
2.5
YTD 9
'07
YTD 9
'08
YTD 9
'09
YTD 9
'10
YTD 9
'11
Japan International
Western Europe US
+9%1
+14%1
-2%1
+18%1
+8%1
45 50 36 106
304 349
727
533 422
170 91
17 19 3
45
233
-1
65
75
97
260
267 663
95
23
7 48
233
7
-6 -50
150
350
550
750
950
1'150
Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 Q2 10 Q3 10 Q4 10 Q1 11 Q2 11 Q3 11
Tamiflu quarterly sales 2008 - 2011
Retail and Governments/Corporations
CHF m
118
Retail
Governments & Corporations
119 119
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group YTD Sept 2011 results
Diagnostics
Foreign exchange rate information
6%
4%
2%
15%
17%
6%
Diagnostics
Division
North
America
EMEA*
Latin
America
Asia
Pacific
Japan
120
1'759
489
926
375
3'546
North America 25%
Latin America 7%
Asia Pacific 13%
Japan 5%
EMEA1 50%
sales growth (CER) CHF 7,095 m
YTD Sept 2011: Diagnostics sales by region
Driven by Asia-Pacific, EMEA and North America
1 Europe, Middle East and Africa CER = Constant Exchange Rates (average full year 2010)
121
Q2 10 Q3 10 Q4 10 Q1 11 Q2 11 Q3 11 CHF m % CER CHF m % CER CHF m % CER CHF m % CER CHF m% CER CHF m% CER
Professional 1,279 12 1,153 9 1,256 13 1,165 10 1,182 7 1,083 10 Diagnostics Diabetes 781 5 702 4 768 2 643 1 686 2 609 2 Care Molecular 310 4 296 7 289 1 274 3 270 2 257 3 Diagnostics Applied 223 9 197 -2 222 -7 198 -3 179 -5 167 1 Science Tissue 139 14 134 18 148 15 128 18 131 15 123 11 Diagnostics Dia Division 2,732 9 2,482 7 2,683 6 2,408 6 2,448 5 2,239 6
1 versus same period of prior year
Diagnostics Division quarterly sales and local growth1
CER = Constant Exchange Rates (average full year 2010)
122
Global North America EMEA RoW
% CER % CER % CER % CER
CHF m growth CHF m growth CHF m growth CHF m growth
Professional Dia 3,430 9 611 9 1,752 4 1,067 18
Diabetes Care 1,938 1 420 -6 1,164 2 354 12
Molecular Dia 801 3 270 8 322 -4 209 6
Applied Science 544 -2 208 2 216 -6 120 -4
Tissue Diagnostics 382 15 250 12 92 17 40 30
Division 7,095 6 1,759 4 3,546 2 1,790 14
YTD Sept 2011: Diagnostics Division local sales
By Region and Business Area (vs. 2010)
CER = Constant Exchange Rates (average full year 2010)
123
0.0
1.0
2.0
3.0
4.0
YTD 9 '09 YTD 9 '10 YTD 9 '11
Other POC products
Clinical Chemistry Immunoassay
YTD Sept 2011: Professional Diagnostics
Strong growth driven by immunoassays
CHF bn
+9%
+13%
+6%
+7%
2011 vs. 2010 CER growth
CER = Constant Exchange Rates (average full year 2010)
124
YTD Sept 2011: Diabetes Care
FDA approval of maltose-independent Aviva Plus BGM system
+2%
0.0
0.5
1.0
1.5
2.0
2.5
YTD 9 '09 YTD 9 '10 YTD 9 '11
Blood Glucose Insulin Delivery
+1%
-3%
CHF bn 2011 vs. 2010 CER growth
CER = Constant Exchange Rates (average full year 2010)
125
YTD Sept 2011: Molecular Diagnostics
HIV and HBV viral load tests drive growth
0
200
400
600
800
1'000
YTD 9 '09 YTD 9 '10 YTD 9 '11
Other Blood Screening Virology
+3%
CHF m 2011 vs. 2010 CER growth
+2%
+2%
CER = Constant Exchange Rates (average full year 2010)
126
0
150
300
450
600
750
YTD 9 '09 YTD 9 '10 YTD 9 '11
qPCR&NAP Custom Biotech (industrial)
Genomic Analysis (seq+array) Other
Applied Science
Pressure on research spending globally
-2%
CHF m 2011 vs. 2010 CER growth
-4%
+12%
-12%
CER = Constant Exchange Rates (average full year 2010)
127
0
100
200
300
400
YTD 9 '09 YTD 9 '10 YTD 9 '11
Other Primary Staining Advanced Staining
YTD Sept 2011: Tissue Diagnostics
Strong growth in all regions
+15%
+15%
+19%
CHF m 2011 vs. 2010 CER growth
CER = Constant Exchange Rates (average full year 2010)
128
2011: Key planned product launches
Professional Diagnostics
Product Description Region Time
Vitamin D total Measure vitamin D2 and D3 with greater precision EU H1
HE4 Tumor marker used in risk assessment of ovarian
cancer in patients with pelvic mass (with CA125)
EU H1
cobas c 702 module for cobas 8000 modular analyzer series
Clinical Chemistry module with throughput around 2,000 tests/hour for high-volume laboratories. Features automated reagent loading, enabling consolidation of a broader test menu.
EU
US
Q1
Q2
cobas b 123 POC system
Benchtop multi-parameter analyser for blood gas, electrolytes, CO-oximetry and metabolites. For use in critical care settings at the point of care
US H2
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors
EU = European Union; US = United States
√
√
√
√
129
2011: Key planned product launches
Diabetes Care
Product Description Region Time
Accu-Chek
Mobile LCM
Next-generation strip-free blood glucose monitoring
system with an integrated lancing device, significantly
smaller than current version and with enhanced
functionality
EU H2
Accu-Chek
Combo
Interactive insulin delivery system combining an insulin
pump (Accu-Chek Spirit Combo) and a blood glucose
meter (Accu-Chek Aviva Combo) with broad data
management capabilities; the meter also functions as a
pump remote control
US H2
Accu-Chek Nano Sleek version for high-frequency testers offering an
enhanced feature set
US H2
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors
EU = European Union; US = United States
130
2011: Key planned product launches
Molecular Diagnostics
Product Description Region Time
cobas 4800 HPV Test detects HPV 16 and HPV 18 individually and 12
other high-risk genotypes in a pooled result
(cervical cancer)
US H2
cobas 4800 EGFR
Mutation Test
for identification of mutations in the EGFR gene
(non-small cell lung cancer)
EU H2
cobas 4800 KRAS
Mutation Test
for identification of mutations in the KRAS gene
(colon cancer)
EU H2
cobas 4800 BRAF
V600 Mutation Test
for identification of the V600 mutation in the BRAF
gene (metastatic melanoma)
EU, US H2
√
√
√
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors
EU = European Union; US = United States
√
131
2011: Key planned product launches
Applied Science
Product Description Region Time
GS G Type HLA
primer Sets
For HLA genotyping on the GS Junior System of GS FLX
System
Global H1
GS FLX Titanum-
XL
New sequencing chemistry; enables extended read
lengths on the GS FLX system
Global H1
Roche
Nimblegen 4.2M
CGH and 2.1M
CGH/SNP arrays
Ultra-high resolution arrays for CGH validation and
combined CGH/SNP validation with 4.2 million and 2.1
million features for discovery of variations in gene copy
numbers and single nucleotides
Global H2
√
√
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors
EU = European Union; US = United States
132
2011: Key planned product launches
Tissue Diagnostics
Product Description Region Time
ER/PR antibody for
IHC testing
To support the diagnosis of breast cancer on
BenchMark ULTRA
US H2
HER2 Dual Colour ISH
Probe for ISH testing
To support the diagnosis of breast cancer US H1
OptiView Next-generation detection system for BenchMark
platforms; delivers greater specificity, sensitivity,
flexible detection options and improved turn-
around time
US, EU H1
√
√
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors
EU = European Union; US = United States
√
133 133
Roche Group development pipeline
Marketed products development programmes
Roche Pharma global development programmes
Roche Pharma research and early development
Genentech research and early development
Roche Group YTD Sept 2011 results
Diagnostics
Foreign exchange rate information
134
0.75
0.80
0.85
0.90
0.95
1.00
1.05
1.10
1.15
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
0.80
0.85
0.90
0.95
1.00
1.05
1.10
1.15
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Year-To-Date averages
Monthly averages
2010
2010
2011
2011
CHF / USD
-11% -16% -18%
135
0.75
0.80
0.85
0.90
0.95
1.00
1.05
1.10
1.15
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
monthly avg 2011
average full year 2010
monthly avg 2010
-18%
CHF / USD
average YTD 09 2011
average YTD 09 2010
136
1.10
1.15
1.20
1.25
1.30
1.35
1.40
1.45
1.50
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
1.20
1.25
1.30
1.35
1.40
1.45
1.50
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Year-To-Date averages
Monthly averages
2010
2010
2011
2011
CHF / EUR
-12%
-11%
-12%
137
1.10
1.15
1.20
1.25
1.30
1.35
1.40
1.45
1.50
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
monthly avg 2011
average full year 2010
monthly avg 2010
average YTD 09 2011
CHF / EUR
average YTD 09 2010
-12%
138
YTD 09 11 YTD 09 10 YTD 09 11 vs. YTD 09 10
USD 0.88 1.07
EUR 1.24 1.40
JPY 1.09 1.19
Average exchange rates
-18% -15% -12% -9% -6% -3% 0%
0.1% 0.4%
-9.2%
-12.0%-12.8%
-0.1%
Q1 HY YTD 9 FY
139
Development of
average exchange rates versus prior year period
CHF / EUR -12.1 % -11.5 % -11.8 %
CHF / USD -10.9 % -16.3 % -17.5 %
CHF / JPY -1.7 % -6.6 % -8.3 %
Difference
in CHF / CER -9.1 %pt -12.1 %pt -13.2 %pt
growth
CHF
growth
CER
growth
Sales
growth
2011
vs. 2010
Exchange rate impact on sales growth
Negative impact from all currencies, in particular from USD and EUR
CER = Constant Exchange Rates (average full year 2010)
-0.1% 0.3%1.2%
-9.2%
-14.9% -14.5%
Q1 Q2 Q3 Q4
140
Sales
growth
2011
vs. 2010
Difference
in CHF / CER -9.1 %pt -15.2 %pt -15.7 %pt
growth
Development of
average exchange rates versus prior year period
CHF / EUR -12.1 % -11.1 % -12.5 %
CHF / USD -10.9 % -21.4 % -20.2 %
CHF / JPY -1.7 % -11.4 % -11.9 %
Exchange rate impact on sales growth
Negative impact from all currencies, in particular from USD and EUR
CHF
growth
CER
growth
CER = Constant Exchange Rates (average full year 2010)
141 1 avg December 2010 to avg YTD September 11 fx local absolute values at avg 2010 fx
+172
-251 +423
Pharma
Division
Diagnostics
Division
Group Fx Group
CHF
-1% +6% 0% -13%
1
Group sales YTD September 2011
Net fx impact of CHF -4.8 bn or -13%p
-4,635 -4,807
CER = Constant Exchange Rates (average full year 2010)
142
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