Roche fy2011 9months_results

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

Ale

glita

za

r

Le

bri

kiz

um

ab

Me

tMA

b

Oc

relizu

ma

b

T-D

M1

Pe

rtu

zu

ma

b

Ze

lbo

raf

Vis

mo

de

gib

Me

ric

ita

bin

e

Potential

Launch

Year

GA

10

1

Gly

t-1

Da

lce

tra

pib

pRED

gRED

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

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


Virology


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


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


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


Virology


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)


anti-factor D Fab (RG7417) geographic atrophy

Mab Beta7 (RG7413)

ulcerative colitis

gantenerumab (RG1450)


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


Xolair (US)

chronic idiopathic urticaria

Actemra RA DMARD H2H (EU)

Avastin ovarian cancer 1st line (US)

Avastin mCRC TML

Oncology


Virology


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 Q3 2011 sales

Diagnostics


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


• ROW: Approved in 20+

countries incl. CH

• EU – Consider filing with

mature OS data in 2012

• FDA - Received Complete


• 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


Avastin

Adjuvant clinical development programme

Patient

population

Adjuvant

lung cancer

Adjuvant

breast cancer


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


• FPI Q4 2007



• FPI Q2 2008



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


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


• 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*


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



• FPI Q3 2008


• 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*


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


• 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

DMARD inadequate

responders

Moderate-to-severe


Moderate-to-severe



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


• Recruitment completed Q2

2011


• FPI Q2 2010

• Expect data H1 2012

• FPI Q3 2010


2011


• 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)



• 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*


ASTERIA I

Phase III

ASTERIA II

Phase III

GLACIAL


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


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


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


Previously treated papillary

thyroid cancer


Melanoma patients with

brain metastases


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


metastatic melanoma


Melanoma patients with brain

metastases


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







Diagnostics


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


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


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


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:


survival (PFS)

• Overall survival


survival by investigator


survival assessed by

IRF


• Completed enrollment

Q2 2011


• 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


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


Design • Single ARM: GDC-0449 • Single ARM: GDC-0449

Primary

endpoint

• Overall response rate • COHORT 1: Complete clearance

• COHORT 2: Durable complete

clearance


• 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


(NHL)

Relapsed


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


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:


Phase II portion:



• Expect data end of 2011

Phase I portion:

• Initiated Q1 2008

• Data presented at ASH 2009

Phase II portion:

• FPI Q3 2009


• Data to be presented at ASH 2011

• Phase I portion:


• 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


chemotherapy followed

by GA101 maintenance

• ARM B:


chemotherpy followed by

MabThera/Rituxan

maintenance


CHOP

• ARM B:


CHOP

Primary

endpoint

• Progression-free survival • Progression-free survival • Progression-free survival • Progression-free survival



• FPI Q2 2010


• 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


Phase Phase I Phase II


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


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 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


• Data presented at ESC 2011



• 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 B: Placebo

• In addition to standard

medication (including statins):

• 24 months treatment duration

• Uses both IMT and IVUS

ultrasound imaging techniques


• ARM B: Placebo



• 20 weeks treatment duration


• ARM B: Placebo



• Event driven trial - 4 to 5 years

follow up


• 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


• Interim analysis at 50% of events

occurred in July 2011; DSMB

recommended to continue study as

planned with no changes


• Recruitment completed


• FPI Q1 2011


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)


• Enrollment completed Q2 2011


• 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:


300 mg IV followed by 600

mg IV every 24 weeks

• ARM B: Rebif® (interferon

-1a)

• 120-week treatment period:


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)


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


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


• ARM C: RG7128 (1000 mg BID) + Pegasys and Copegus for 12


*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







Diagnostics


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


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


• 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


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


Collaborator ThromboGenics & BioInvent

81 81


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


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


2nd-line metastatic

colorectal cancer

Phase Phase I

Mechanism of action study Phase Ib/II Phase II


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


• Recruitment ongoing

• Part 1 FPI Q4 2010


• 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


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


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


Design • ARM A: Danoprevir 300 mg q8h +


• ARM B: Danoprevir 600 mg q12h +


• 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 +


•ARM C: Ritonavir + Pegasys + Copegus +


•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 +


•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 +


•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


• 900 mg cohort be discontinued in Q4 2009

• SVR results will be presented at AASLD Q4

2011

• FPI Q4 2010


• FPI Q2 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


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



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


dose study


• Recruitment

completed Q3

2011

• Expect FPI Q4

2011

• FPI Q3 2011 • Expect FPI Q3 2012

Collaborator Marcadia Biotech, Inc. acquisition


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


Design 104-week subcutaneous treatment period

• ARM A: Gantenerumab (225 mg)

• ARM B: Gantenerumab (105 mg)

• ARM C: Placebo

• Single ascending dose

study/PET


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



• FPI Q4 2010


Q3 2011

Collaborator MorphoSys

89 89


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


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


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







Diagnostics


92


Angiogenic signaling

Molecule Anti-angiogenic

(RG7594)

Anti-EGFL7 MAb

(RG7414)

Patient

population Advanced solid tumors Advanced solid tumors


non-small cell lung

cancer


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


• Phase II “go” decision

Q1 2011

• Data presented at ASCO

2011

• FPI Q2 2011 • Expect FPI Q4 2011

93


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


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


• 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


SABCS 2010

• FPI Q4 2009


ASCO 2011

• FPI Q3 2009 • Expect FPI Q4

2011

95


Small molecules

96


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


• 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



ASCO 2010, ESMO

2010, and ASCO 2011

• FPI Q2 2009


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



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


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



*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)


evaluating Zelboraf*

plus GDC-0973


• 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


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)


• 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


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


In collaboration with Abbott

ASH = American Society of Hematology

Patient

population


lymphoid malignancies

Relapsed or

refractory chronic


Front-line chronic


Phase Phase I/IIa

M06-814

Phase I/IIa

M06-873

Phase II

FRANC


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


• Initiated Phase IIa cohort Q1

2010

• Updated Phase I data presented

at ASH 2009


• FPI Q3 2007

• Initiated Phase IIa cohort Q3

2009

• Data presented at ASH 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



Q2 2011


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


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


• 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







Diagnostics


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


Western Europe 3,081 2,758 +1

Japan 384 375 +6

International 2,467 2,413 +12

Group 36,127 31,492 0


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


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


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%


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


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


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


• 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%


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


• 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







Diagnostics


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


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)


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


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


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%


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%


-4%

+12%

-12%


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%



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


Diabetes Care


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



130


Molecular Diagnostics


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

√

√

√



√

131


Applied Science


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

√

√



132


Tissue Diagnostics


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

√

√



√

133 133







Diagnostics


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


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


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


1.20

1.25

1.30

1.35

1.40

1.45

1.50


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


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


Negative impact from all currencies, in particular from USD and EUR


-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 %


Negative impact from all currencies, in particular from USD and EUR

CHF

growth

CER

growth


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


142

We Innovate Healthcare

Roche fy2011 9months_results

Business

Transcript of Roche fy2011 9months_results