This presentation contains certain forward-looking ... · 2 This presentation contains certain...

2

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

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4

Roche: Committed to innovation and profitable growth

Q1 2012 Sales April 12, 2012

5

Group Severin Schwan Chief Executive Officer

Q1 2012: Group sales

On track to meet full-year guidance

6 1 CER=Constant Exchange Rates

2012 2011 change in %

CHF m CHF m CHF CER

Pharmaceuticals Division 8,624 8,712 -1 2

Diagnostics Division 2,403 2,408 0 4

Roche Group 11,027 11,120 -1 2

7

Q1 2012: Highlights

5 positive late-stage trials and regulatory filings

• Avastin in metastatic colorectal cancer: treatment through multiple lines (TML)

• T-DM1 in HER2+ metastatic breast cancer (EMILIA)

• Herceptin subcutaneous in HER2+ breast cancer (HANNAH)-filed in EU

• Actemra in polyarticular-course juvenile idiopathic arthritis (CHERISH)

• Actemra in rheumatoid arthritis (ADACTA)

Sales

• Group and Pharma: +2%1 (+3%1 excluding Tamiflu)

• Diagnostics: +4%1

• Negative currency impact (-3%p)

1 at Constant Exchange Rates

2 Approvals of New Molecular Entities

• Erivedge in advanced basal cell carcinoma – approved in US

• Zelboraf in metastatic melanoma – approved in EU

Filings and launches in 2012

Oncology

Immunology

CardioMetabolism

T-DM1

HER2+ advanced mBC

8

Tarceva (US)

NSCLC EGFR mutation 1st line

Herceptin

sc formulation HER2+

Avastin

mCRC TML

Actemra

RA DMARD IR H2H (EU)

Actemra

sc formulation

Avastin

mBC 2nd line (EU)

MabThera

sc formulation (EU)

Lucentis

AMD 0.5 mg PRN (US)*

Erivedge (US)

adv. basal cell carcinoma

pertuzumab

HER2+ mBC 1st line

Zelboraf

met. melanoma

Activase

extend. time window AIS (US)

Avastin

relapsed ovarian cancer (EU)

Lucentis

diabetic macular edema (US)

Rituxan

NHL faster infusion (US)

Actemra

DMARD IR (US)

Launches Filed/awaiting launch Planned filings

New

Molecular

Entities

Additional

indications

Actemra

polyarticular JIA

* New dosing regimen for already approved indication

Financial terms

• $51.00 per share total consideration of $ 6.8 billion

Status update

• Tender offer extended to April 20th 2012

• Offer is highly attractive, representing full and fair value

• Illumina annual shareholder meeting on April 18th 2012. Slate of Roche

nominated, independent directors nominated for election to Illumina’s

board of directors

• Roche stands ready to engage in substantive dialogue with Illumina

9

Illumina Transaction

Financial terms / Status

Outlook for 2012 confirmed

10 Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2011: CHF 1.8 bn

Sales growth (CER) Group & Pharma: low to mid-single digit

Diagnostics: above market

Core EPS growth target

(CER) High single-digit

Dividend outlook Continue attractive dividend policy

Operational Excellence

savings 2012+ : CHF 2.4 bn*

11

Pharmaceuticals Division Pascal Soriot COO Roche Pharmaceuticals

Q1 2012: Pharma sales

US major contributor to growth

12 CER = Constant Exchange Rates

2012 2011 change in %

CHF m CHF m CHF CER

Pharmaceuticals Division 8,624 8,712 -1 2

United States 3,442 3,322 4 6

Western Europe 2,005 2,209 -9 -4

Japan 930 903 3 1

International 2,247 2,278 -1 2

Pharmaceuticals Division

Excluding Tamiflu 8,437 8,460 0 3

Q1 2012: Pharma sales drivers

Oncology and Pegasys main growth drivers

13 13 Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2011; all growth rates at CER

-150 -100 -50 0 50 100 150

NeoRecormon/Epogin

Boniva/Bonviva

Tamiflu

CellCept

Zelboraf

Xeloda

Actemra/RoActemra

Herceptin

MabThera/Rituxan

Pegasys

International

US

Japan

Western Europe

+32%

+7%

+7%

+46%

NA

-24%

-28%

-19%

+15%

-31%

Pharma quarterly growth (excluding Tamiflu)

14 Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2011; all YOY growth rates at CER

-,200

-,100

,0

,100

,200

,300

,400

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

US

International

WE

Japan

CH

F m

+1%

+1% 0%

+3% +3%

Q1 2012: US back to strong growth

Driven by Oncology and Pegasys

15 1 CHF m at average 2011 exchange rates; 2CER=Constant Exchange Rates

88

52

38

36

26

22

20

Pegasys

Rituxan

Herceptin

Xeloda

Zelboraf

Actemra

Tarceva

US growth contribution1 Growth2

+144%

+8%

+11%

+31%

NA

+87%

+18%

US: +6%2

Q1 2012: Western Europe

Significant impact of genericized products

16 1 CER=Constant Exchange Rates

2,117

2,039

-63

-77 +61

Q1 2011

Sales

Q1 2012

Sales

Bonviva

CellCept

Neorecormon

Mircera

Other tail products

Pricing pressure

MabThera

RoActemra

Herceptin

Zelboraf

Pegasys -4%1

@2011

FX @2011

FX

E7 countries: solid growth despite strong base

One-off effects in Q1 in China and Russia

17

,0,

200,000,

400,000,

600,000,

800,000,

1000,000,

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

Brazil

China

India

Turkey

Mexico

Russia

Korea

+5%1

1 CER=Constant Exchange Rates; absolute values in CHF m at average 2011 exchange rates

+15%

+19%

China: Roche outgrowing the market

18

14%

20%

24%

32%

29%*

19%

16% 16%

17%

0%

5%

10%

15%

20%

25%

30%

35%

Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12

Roche

Chinese market

Source: IMS Hospital Audits, January 2012; * Roche estimate for Q1 in-market sales in China

Q1 2012: Oncology franchise

Avastin back to growth, new products off to a good start

19

Major brands

CHF bn CER growth

CER = Constant Exchange Rates Oncology Q1 2012 sales: 5.1 bn

Growth driven mostly by US and China

Growth driven mainly by US, China and other Int’l

regions; US growth partially driven by shortage of IV 5FU

Japan: strong uptake in mBC; EU: launch in ovarian cancer

ongoing; US: stable market share in mCRC and mLC

Continued uptake in 1L maintenance in NHL; longer

treatment duration; further uptake in CLL

0.0 0.5 1.0 1.5 2.0

Erivedge

Zelboraf

Tarceva

Xeloda

Avastin

Herceptin

MabThera/

Rituxan

+7%

+7%

+1%

+10%

+15%

Expanded access in Emerging markets, increased HER2

testing and further uptake in HER2-positive gastric cancer

US: ~80% market share in BRAF V600 patients;

approved in EU Q1 2012

Launched in US Q1 2012

NA

NA

Lucentis

Increasingly competitive environment in wAMD

20 1 CER = Constant Exchange Rates; AMD = wet age-related macular degeneration; DME = diabetic macular edema

CHF m

US sales Q1 2012 sales: CHF 385 m

• AMD: Lucentis share moderately

declining after the launch of Eylea

New Patient Share (NPS): Lucentis

36%, Eylea 12%, Avastin 51%

• NPS in RVO stable: 26%

• Diabetic Macular Edema (DME) line

extension: PDUFA August 2012

• Filed sBLA in AMD 0.5 mg PRN (US)

0

100

200

300

400

Q1 08 Q1 09 Q1 10 Q1 11 Q1 12

0%1

Actemra/RoActemra

Clinical data support further growth

21

CHF m

Q1 2012 sales: CHF 184 m

• H2H vs Humira (ADACTA): trial met

primary and secondary end-points, data

submitted to EULAR, June 2012

• DMARD IR (first-line biologic) filed in US

in December 2011

• Subcutaneous formulation:

data expected 2012, filing before year end

• CHERISH trial in polyarticular JIA met

primary endpoint, filing expected in 1H

2012

Actemra/RoActemra sales


0

40

80

120

160

200

Q1 08 Q1 09 Q1 10 Q1 11 Q1 12

+46%1

Zelboraf: successful launch in US, approval in EU

22

79% 69%

8%

15%

13% 16%

1st line treatment

(n=127)

2nd line treatment

(n=65)

% o

f B

RA

F v

600 m

uta

tion-p

osi

tive

meta

static m

ela

nom

a p

atients

US market share in Q1 2012 (~80% of patients currently tested

for BRAF status)

Other

Yervoy

Zelboraf

Source: Quarterly chart audit: Charts of mM patients starting 1L or 2L therapy Q1 2012; Zelboraf market share: +/-11%

ROW

• EU approval in Feb 2012 with broad

label

• Also approved in Switzerland, Brazil,

New Zealand, Canada and Mexico

• Launched in Switzerland, Germany

and Israel

Erivedge successfully launched in the US

23

Q1 2012 US sales: CHF 5 m

• Launched Jan 30, 2012 in the US

• Initial uptake encouraging

• Excellent payer coverage, no

significant reimbursement hurdles

• Estimated number of US patients

treated since launch: >175

Segment

Metastatic

Substantial

Deformity

~0.2%

~0.3%

Inoperable ~1%

Poor surgical

candidate ~2%

Uncomplicated

lesion ~97%

aBCC

Securing growth for HER2 franchise

HannaH and EMILIA advancing the standard of care

24

Adjuvant BC Herceptin + chemo Herceptin subcutaneous + chemo (HannaH) Herceptin & pertuzumab + chemo

1st line mBC Herceptin +

chemo

T-DM1 &

pertuzumab

Herceptin & pertuzumab + chemo

(CLEOPATRA)

2nd line mBC Xeloda + lapatinib T-DM1 (EMILIA)

2010 2016 2012 2013 2014 2015 2011

Timelines refer to the expected dates of first filing

Established standard of care Potential new standard of care Future standard of care

• DAUPHINE (phII)

treatment-naive chronic HepC

Q2 2012: Clinical data to be presented at

upcoming meetings

25

EULAR

Berlin, June 6-9

ASCO

Chicago, June 1-5

EASL

Barcelona, April 18-22

danoprevir

mericitabine

• EMILIA (submitted)

pretreated HER2+ mBC

• PhII safety study in HER2+

eBC

• TML

treatment through

multiple lines in mCRC

• AURELIA

platinum resistant ovarian

cancer

• ADACTA (submitted)

Head-to-Head vs. Humira

• PROPEL, JUMP-C (phII)

treatment-naive and failure

chronic HepC G1/4

T-DM1

Avastin

Actemra

Virology Oncology Inflammation

• INFORM-SVR (phII,

interferon-free combination)

treatment-naive and

interferon intolerant chronic

HepC G1

danoprevir+mericitabine

Major clinical and regulatory news flow

26

Timeline Compound Indication Milestone

Avastin mCRC Ph III TML

2012

pertuzumab 1st line HER2+ mBC US, EU approval

Erivedge advanced BCC US approval EU approval (2012/13)

Zelboraf metastatic melanoma EU approval

Lucentis DME US approval

T-DM1 2nd line HER2+ mBC Ph III EMILIA

Herceptin subcutaneous early HER2+ BC Ph III HANNAH (data presentation)

Herceptin adjuvant HER2+ BC Ph III HERA 2 years vs. 1 year

MabThera subcutaneous front-line follicular NHL Ph III

Actemra RA DMARD IR Ph III ADACTA H2H vs. Humira

Actemra subcutaneous RA, moderate to severe Ph III SUMMACTA/BREVACTA

Avastin newly diagnosed glioblastoma Ph III AVAglio

2013

dalcetrapib Atherosclerosis CV risk red. Ph III dal-OUTCOMES final analysis;

2nd interim analysis in H1 2012

GA101 Front line CLL Ph III vs. chemotherapy

bitopertin (GlyT-1) Schizophrenia Ph III (several studies)

Oncology and CV outcome studies are event driven, timelines may change

27

Diagnostics Division Daniel O’Day COO Roche Diagnostics

Q1 2012: Diagnostics Division sales

Strong growth in Professional, Molecular and Tissue Diagnostics


12011 sales restated from Diabetes Care (full year impact CHF –23 m) to Professional Diagnostics (CHF +23 m full year impact)

2012 2011 change in %

CHF m CHF m CHF CER

Diagnostics Division 2,403 2,408 0 4

Professional Diagnostics 1 1,224 1,171 5 9

Diabetes Care 1 564 637 -11 -7

Molecular Diagnostics 285 274 4 8

Applied Science 183 198 -8 -4

Tissue Diagnostics 147 128 15 18

North America

+7%

25% of divisional sales

Latin America

+9%


Japan

+10%

6% of divisional sales EMEA1

-1%


Q1 2012: Diagnostics Division sales

Strong growth in all regions except for EMEA

1 Europe, Middle East and Africa; All growth at CER (Constant Exchange Rates)

Asia Pacific

+13%


29

30

Q1 2012: Diagnostics Division highlights

CHF bn Q1 2012 vs. Q1 2011

CER growth

0 0.5 1 1.5

Tissue Dia

Applied

Science

Molecular

Dia

Diabetes

Care

Professional

Dia

EMEA

North America

RoW

+9%

-7%

+8%

-4%

+18%

Continued global slowdown in research funding; strong sales

to industrial manufacturing customers

Strong sales in blood screening and HCV monitoring; FDA approval of cobas CT/NG test; new cervical cancer screening guidelines in US

Reimbursement changes in some EMEA countries; expected launch of Accu-Chek Nano SmartView in US and Accu-Chek Mobile in Europe in 2Q 2012

Strong market uptake of Vitamin D total; expansion of

Hepatitis menu; launch of new automation and IT systems

Strong growth ahead of market; expansion of breast cancer

diagnostics offering; new companion diagnostics partnerships

EMEA = Europe, Middle East and Africa, APAC = Asia Pacific CER = Constant Exchange Rates

Strengthening women’s health portfolio

FDA approval and launch of cobas CT/NG test

CT/NG Testing

• Chlamydia trachomatis (CT) and Neisseria

gonorrhoeae (NG) most common bacterial

sexually transmitted infections

• CT/NG screening global market ≈ $500m

cobas CT/NG test

• New NG component: excellent sensitivity1

& distinguished high specificity1

• Roche: strong presence in EMEA & Japan

1 NG Sensitivity 97-100% and Specificity > 99%. Source: US Package insert

cobas 4800 System

Fully automated PCR platform

• 376 CT/NG tests/day

• 282 HPV tests/day

• Full connectivity to Lab IT Systems

31

32

New cervical cancer screening guidelines in US

HPV co-testing and genotyping strongly recommended

1 American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology

New cervical cancer guidelines by

leading US organizations1

• HPV and cytology co-testing in women >30yrs

• HPV 16 & 18 genotyping in women pap(-) and

HPV(+) recommended

cobas HPV test

• numerous contract wins in US

ATHENA data

• primary screening filing expected in 2013

12 HR HPV pool

HPV Genotype 16

HPV Genotype 18

Three results in one test

cobas HPV Test

Strengthening our infectious diseases portfolio

Launch of new HCV tests

Screening and diagnosis

Treatment Evaluate

treatment duration

Treatment follow-up

• New oral therapies increase number of HCV patients treated

• Roche offers comprehensive menu of 11 tests for: • HCV detection

• genotyping

• viral load testing

• blood screening

33

COBAS® HCV

Qualit. v2.0 1

Elecsys®

anti-HCV II

COBAS ® HCV Quantitative Test, v2.011

1 COBAS ® AmpliPrep/COBAS® TaqMan ® HCV Quantitative & QualitativeTests, v2.0. Not available in the US

New!

New! New!

Roche Diagnostics commitment to PHC

Preferred Partner for Companion Diagnostics (CDx)

34

10 25 38

70

101

169

>200

2005 2006 2007 2008 2009 2010 2011

Internal

collaborations1

External

collaborations1

• Personalized Healthcare collaborations with more than

30 pharma and biotech companies

• Tissue Diagnostics signs 4 new partnerships

- Pfizer (Crizotinib – ALK IHC)

- Syndax (Entinostat- E-cadherin)

- Aeterna Zentaris (AEZS 108 – LHRH)

- Bayer (antibody-drug conjugate)

1 Including R&D collaborations and CDx projects

Key launches 2012

35

Area Product Market BA*

Instruments

/

Devices

Labs cobas t 611 - Coagulation analyzer

BenchMark Special Stains - Tissue stainer

VENTANA iScan HT - Digital tissue scanner

EU

WW

WW

RPD

RTD

RTD

Point of

Care cobas b 101 - Multi lipid and glucose analyzer

cobas b 123 - Blood gas analyzer

EU

US

RPD

RPD

Diabetes

Care Accu-Chek Nano SmartView -Small, no-code bGM1system

Accu-Chek Combo – Insulin pump & bG meter combined

Accu-Chek Mobile – Next generation strip free bGM system

SOLO Micropump – Insulin pump and bG meter combined

US

US

EU

EU

RDC

RDC

RDC

RDC

Tests/

Assays

Oncology HE4 - Ovarian cancer

ER – Breast cancer

CINtec p16 Histology- Cervical cancer

GS GType Sequencing Primer Sets- Leukemia

US

US

EU, US

WW

RPD

RTD

RTD

RAS

Infectious

Diseases CMV – Cytomegalovirus infections

CT/NG - Chlamydia and gonorrhoea infections

US

US

RMD

RMD

Metabolism Vitamin D total - Vitamin D2 & D3 US RPD

* Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics ; RAS: Roche Applied Science;

RTD: Roche Tissue Diagnostics; 1 blood glucose monitoring

Achieve sales growth above the market

36

Group Alan Hippe

Chief Financial Officer

Q1 2012: Highlights

37 1 CER = Constant Exchange Rates

Sales

• Group and Pharma: +2%1 (+3%1 excluding Tamiflu)

• Diagnostics: +4%1

• Negative currency impact (-3%p)

Debt repayments

• Repayment CHF 2.2bn notes at maturity

• Tender offer and cancellation of EUR 782m notes due March 2013

(partial redemption)

Debt refinancing

• CHF 1.5bn in three tranches:

• CHF 400m, 3M Libor+0.2%, maturity Sep 2013

• CHF 600m, 1% coupon, maturity Sep 2018

• CHF 500m, 1.625% maturity Sep 2022

• EUR 1.0bn 2% coupon, maturity Jun 2018

38

Debt maturity profile

Q1 2012 Evolution

Nominal values @ actual FX rates; *Original net proceeds in CHF

Of the CHF 48.2bn bonds and notes issued to finance the Genentech transaction,

cumulative 23.6bn (49%) have been repaid as of 31 Mar 2012 *

0

1

2

3

4

5

6

2012 2013 2014 2015 2016 2017 2018 2019 2021 2022 2023 2035 2039

USD EUR CHF GBP

Repayments in Q1/2012

Refinancing in Q1/2012

CHF bn

Tender of

EUR 782m

Repayment

of CHF

2.2bn at

maturity

Favorable loan conditions

Iberdrola

(A/A2)

E.ON

(A/A2)

AXA

(A+/A2)

EDP

(A-/A2)

Daimler

(A-/A3)

Tesco

(A-/A3)

Prudential

(A+/A2)

Endesa

(A-/A3)

Telefonica

(A-/Baa1)

Auchan

(A)

Schneider

(A-/A3)

EDP

(A-/A2)

E.ON

(A/A2)

Iberdrola

(A-/A3)

PMI

(A/A2)

Henkel

(A-/A3)

GDF Suez

(AA/Aa3)

Carrefour

(A-/A3)

EDF

(A+/Aa3)

RWE

(A/A2)

GDF Suez

(A/A1)

Bayer

(A-/A3) EWE

(A2)

Volkswagen

(A-/A3)

Linde

(A-/A3)

Iberdrola

(A-/A3)

AXA

(A+/A2)

Schlumberger

(A+/A1)

Fortum

(A/A2)

Lehman

Bankruptcy

Source: Citigroup

BASF

(A+/A1) Roche

(AA-/A1)

Verbund

(A/A2)

BMW

(A-/A2)

Air Liquide

(A)

OMV

(A3)

Talanx

(A-)

LVMH

(A)

Aegon

(A-/A3)

0

20

40

60

80

100

120

140

160

180

Sep-07 Dec-07 Mar-08 Jun-08 Sep-08 Dec-08 Mar-09 Jun-09 Sep-09 Dec-09 Mar-10 Jun-10 Sep-10 Dec-10 Mar-11 Jun-11 Sep-11 Dec-11 Mar-12

Ma

rgin

(b

ps)

1 Year 3 Year 5 Year

Margin development for

European corporate loans

39

0.94

0.91 0.91

0.91

0.910.91

0.920.91

0.94

0.88

0.91

0.89

J F M A M J J A S O N D

1.21 1.21 1.21 1.21

1.211.211.21 1.21

1.29

1.24

1.26

1.23

J F M A M J J A S O N D

extrapolated average YTD 2012

Q1 2012: currency impact on Swiss Franc results

40

CHF/USD

CHF/EUR

average YTD 2011

+3%

-2% extrapolated average YTD 2012

Q1 HY Sept

YTD

FY

Sales -3 -2 +1 0

Core

operating

profit

-3 0

Core EPS -4 -1

Assuming the 31 March 2012 exchange

rates remain stable until end of 2012,

2012 impact is expected to be (%p):

average YTD 2011

Monthly avg 2012

-2%

+1%

+4%

-6% -5%

-2%

Fx rate at 30 March 2012

Outlook for 2012 confirmed

41 Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2011: CHF 1.8 bn

Sales growth (CER) Group & Pharma: low to mid-single digit

Diagnostics: above market

Core EPS growth target

(CER) High single-digit

Dividend outlook Continue attractive dividend policy

Operational Excellence

savings 2012+ : CHF 2.4 bn*

42

We Innovate Healthcare

43 43

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 Q1 2012 sales

Diagnostics

Foreign exchange rate information

phase I

(41 NMEs+2 AIs)

New Molecular Entity (NME) Additional Indication (AI)

Oncology

Immunology

Virology

CardioMetabolism

Neuroscience

Ophthalmology

Others

RG-No Roche Genentech managed

CHU Chugai managed

CIF/MEK inh solid tumors RG7167

Raf & MEK dual inh solid tumors RG7304

BRAF inh (2) BRAF mut melanoma RG7256

PlGF MAb solid tumors RG7334

PD-L1 MAb solid tumors RG7446

BACE inh Alzheimer’s RG7129

GABRA5 cogn. disorders RG1662 MEK inh solid tumors RG7420

AKT inhibitor solid tumors RG7440

MEK inh solid tumors RG7421

CD22 ADC hem malignancies RG7593

CRTH2 antag asthma RG7185

anti-angiogenic solid tumors RG7594

GIP/GLP-1 dual ago type 2 diabetes RG7685

PI3K inh solid tumors RG7604

ADC prostate ca. RG7450

ADC heme tumors RG7596

ADC ovarian ca. RG7458

CD44 MAb solid tumors RG7356

ALK inhibitor NSCLC CHU

PI3K inh solid tumors CHU

Bcl-2 inh CLL and NHL RG7601

ADC oncology RG7599

ChK-1 inh solid tum & lymphoma RG7602

Roche Development Pipeline Projects in Phase 1

Tweak MAb oncology RG7212

V1 receptor antag autism RG7314

- metabolic diseases RG7652

ADC multiple myeloma RG7598

Oncology Other Disease Areas

WT-1 peptide cancer vaccine CHU

IL-6 MAb RA CHU

Status as of March 31, 2012

MDM2 ant solid & hem tumors RG7112

HER3 MAb solid tumors RG7116

CSF-1R MAb solid tumors RG7155

MDM2 ant solid & hem tumors RG7388

Zelboraf + ipilimumab met. melanoma RG7204

TSLPR MAb asthma RG7258

IL-17 MAb autoimmune diseases RG7624

TLR7 agonist HCV RG7795

- infectious diseases RG7667

ADC oncology RG7600

IL-17 MAb inflammatory diseases RG4934

Lucentis sust. deliv. AMD/RVO/DME RG3645

44

ADC metastatic melanoma RG7636

phase II

(22 NMEs + 9 Als)

phase III

(9 NMEs + 28 Als) Registration

(2 NMEs + 6 Als)

Roche Development Pipeline Projects in Phase 2, 3 and Registration

1 submitted in EU

2 approved in US, submitted in EU

3 submitted in US

4 submitted in US (April 5, 2012)

New Molecular Entity (NME) Additional Indication (AI)

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

Oncology

Immunology

Virology

CardioMetabolism

Neuroscience

Ophthalmology

Others

Rituxan NHL fast infusion RG105

Avastin relapsed ovarian cancer RG4351

pertuzumab HER2+ mBC 1st line RG1273

Herceptin HER2+ BC sc form RG597 1

Activase extended time window AIS RG36263

Erivedge advanced BCC RG36162

Lucentis diabetic macular edema RG36453

Lucentis AMD 0.5 mg PRN RG36454

Erivedge operable BCC RG3616

pertuzumab HER2+ mBC 2nd line RG1273

T-DM1 HER2+ EBC RG3502

Zelboraf papillary thyroid cancer RG7204

mericitabine HCV RG7128

onartuzumab mBC RG3638

onartuzumab mCRC 1L RG3638

oxLDL MAb sec prev CV events RG7418

rontalizumab SLE RG7415

danoprevir HCV RG7227

mGluR5 antag TRD RG7090

LT alpha MAb RA RG7416

P selectin MAb ACS/CVD RG1512

M1 prime MAb asthma RG7449

11 beta HSD inh metabolic diseases RG4929

etrolizumab (Beta7 ) ulcerative colitis RG7413

anti-factor D Fab geographic atrophy RG7417

EGFL7 MAb solid tumors RG7414

crenezumab (Abeta MAb) Alzheimer‘s RG7412

gantenerumab Alzheimer’s RG1450

MAO-B inh Azheimer’s RG1577

EGFR MAb solid tumors RG7160

mGluR2 antag depression RG1578

PI3K/mTOR inh solid & hem tumors RG7422

setrobuvir HCV RG7790

pertuzumab HER2+ gastric cancer RG1273

PI3K inh solid tumors RG7321

glypican-3 MAb liver cancer RG7686


* FPI April 2012

Actemra systemic sclerosis RG1569

HER3/EGFR m. epithelial tumors RG7597*

onartuzumab NSCLC non squamous RG3638*

onartuzumab mNSCLC RG3638

pertuzumab HER2+ EBC RG1273

Avastin ovarian cancer 1st line RG435*

Tarceva NSCLC EGFR mut 1st line RG1415*

MabThera ANCA assoc vascul RG105

Xolair chronic idiopathic urticaria RG3648

Avastin HER2+ BC adj RG435

Avastin NSCLC adj RG435

bitopertin schiz neg symptoms RG1678

Avastin HER2-neg. BC adj RG435

Avastin high risk carcinoid RG435

Avastin glioblastoma 1st line RG435

Avastin triple-neg. BC adj RG435

aleglitazar CV risk reduction in T2D RG1439

dalcetrapib CV risk red post ACS RG1658

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+ pretreated mBC RG3502

Actemra RA sc formulation RG1569

MabThera NHL sc formulation RG105

ocrelizumab RMS RG1594

Avastin mBC 2nd line RG435

bitopertin schiz subopt control RG1678

GA101 DLBCL RG7159

GA101 iNHL front-line RG7159

tofogliflozin (SGLT2) type 2 diabetes CHU

ocrelizumab PPMS RG1594

T-DM1 HER2+ mBC 3rd l RG3502

Suvenyl enthesopathy CHU

lebrikizumab severe asthma RG3637

dalcetrapib CHD/CVD risk reduction RG1658

* approved in EU

45

Changes to the development pipeline Since FY2011 results presentation on February 1, 2012

46

New to Phase I New to Phase II New to Phase III New to Registration

1 NME transitioned from Ph0

RG7636 unnamed ADC m. melanoma

2 NMEs transitioned from Ph1

RG7686 glypican-3 MAb liver ca

RG7597 HER3/EGFR m.

eptithelial tumors

2 AIs following FPI

RG1569 Actemra systemic

sclerosis

RG3638 onartuzumab NSCLC

non squamous

1 NME transitioned from Ph2

RG3637 lebrikizumab asthma

1 AI following FPI

RG1658 dalceptrapib CHD/CVD

risk reduction

2 AIs Filed

RG597 Herceptin SC form.

RG3645 Lucentis AMD 0.5mgPRN

Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration

Discontinuation (5 NMEs)

RG7236 CatS antag CV risk in CKD

RG7273 ABCA1inducer dyslipidemia

RG7444 FGFR3 Mab

RG7603 unnamed ONC

RG7459 IAP antag. ONC

1 NME following approval in EU

and US

RG7204 Zelboraf m. melanoma

1 AI removed by Chugai

CHU EPOCH chemo induced

anemia


GA101(RG7159)

NHL aggress. DLBCL

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

Neuroscience

Ophthalmology

NME

Oncology

Immunology

Virology

CardioMetabolism

T-DM1 (RG3502)

HER2+ advanced mBC

bitopertin

(RG1678) schizophrenia#

mericitabine

(RG7128) HCV

GA101 (RG7159)

CLL

dalcetrapib (RG1658)* CV risk red. post ACS

onartuzumab (MetMAb)

(RG3638) mNSCLC

T-DM1 (RG3502)

HER2+ mBC 1st line

ocrelizumab (RG1594)

PPMS and RMS

danoprevir (RG7227)

(HCV protease inh)

2012 2013 2014 2015 2016

onartuzumab (MetMAb)

mBC, mCRC

mGluR5 antag (RG7090)

Tx resistant depression

lebrikizumab (RG3637)

asthma

EGFR MAb (RG7160) solid tumors

anti-factor D Fab (RG7417) geographic atrophy

aleglitazar (RG1439)

CV risk reduction in T2D

GA101(RG7159)

NHL indolent refractory

pertuzumab (RG1273)

HER2+ EBC

47 Status as of March 31, 2012

dalcetrapib (RG1658)

CHD/CVD risk reduction

Tarceva NSCLC adj (US)

Avastin NSCLC adj

Tarceva (US) NSCLC EGFR mutation 1st line

2012 2013 2014 Post 2014

Herceptin HER2+ BC adj 2 year

Avastin triple negative BC adj

Avastin glioblastoma 1st line

Avastin HER2+ BC adj

Herceptin sc formulation HER2+

Avastin HER2- BC adj

Actemra early RA

Xolair (US)

chronic idiopathic urticaria

Actemra polyarticular JIA

Avastin ovarian cancer 1st line (US)

Avastin mCRC TML

Oncology

Immunology

Virology

CardioMetabolism

Neuroscience

Ophthalmology

Actemra sc formulation

Avastin mBC 2nd line (EU)

MabThera sc formulation (EU)

indicates submission to Health Authorities has occurred.

Unless stated otherwise, submissions are planned to occur in US and EU.

Lucentis AMD 0.5 mg PRN (US)

Avastin relapsed ovarian cancer (US)

Tarceva NSCLC adj (EU)

Additional indications for existing products

Submissions of projects currently in Phase 2 and 3

48


Actemra

systemic sclerosis

Zelboraf

papillary thyroid cancer

Erivedge

operable BCC

Actemra RA DMARD IR H2H (EU)

49


50 50







Diagnostics


MabThera/Rituxan

Development programmes

Oncology Immunology

Patient

population

Front-line follicular non-

Hodgkin’s lymphoma

Front-line diffuse large B-cell or

follicular non-Hodgkin’s

lymphoma

ANCA-associated vasculitis

Phase/study

Phase III

Subcutaneous study

Study being conducted ex-US

Phase IIIb

RATE*

Faster infusion study

Phase II/III

RAVE*

# of patients N=405 N=450 N=197

Design • ARM A: MabThera IV plus

chemotherapy (CHOP or CVP)

• ARM B: MabThera 1400mg sc

plus chemotherapy (CHOP or

CVP)

• Responders will continue on

maintenance every 8 weeks over

24 months

• Prospective, open-label, single

arm study

• Non-inferiority efficacy and safety

study of MabThera/Rituxan and

glucocorticoids versus

conventional therapy

(cyclophosphamide)

Primary

endpoint

• Pharmacokinetics, safety and

efficacy

• To determine the incidence of

Grade 3 or 4 infusion-related

toxicities resulting from faster

infusion of MabThera/Rituxan

• Induction of complete remission at

6 months, defined as a BVAS/WG

of 0 and off glucocorticoid therapy

Status • FPI Q1 2011

• Expect data 2012

• FPI Q3 2008

• Enrolment completed Q4 2010

• Data presented at ASH 2011

• Filed with the FDA in Q4 2011

• Data presented at ACR 2009

• FDA approved use of Rituxan in

WG and MPA in Q2 2011

• Expect EMA submission in 2012

*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

51

Avastin

Ovarian 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 III

OCEANS

# 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

• Results published in NEJM December 2011

• Study met its primary endpoint Q3

2010

• Data presented at ESMO 2010 and

ASCO 2011

• Results published in NEJM

December 2011

• Study met its primary endpoint Q1 2011

• Data presented at ASCO 2011

• EMA submission Q3 2011

• Re-evaluate FDA submission when final

overall survival results from all phase III

trials are available (expected 2013)

• EMA approval Q4 2011

• Re-evaluate FDA submission when final overall survival results from all

phase III trials are available (expected 2013)

ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical Oncology.

52

Avastin

Breast and colorectal cancer development programmes

Patient

population Second-line HER2-negative Metastatic colorectal cancer


RIBBON-2

Phase III

ML18147

TML

# of patients N=684 N=810

Design • ARM A: Chemotherapy (taxane, Xeloda,

gemcitabine, or vinorelbine) plus Avastin

• ARM B: Chemotherapy plus placebo

• 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

Avastin dose • 15 mg/kg q3 weeks • 5 mg/kg q2 weeks or 7.5 mg/kg q3 weeks

Primary

endpoint • Progression-free survival • Overall survival

Status • EU – Consider filing with mature OS data in

2012

• FDA - Received Complete Response Letter Q4

2010

• Primary end point met Q1 2012

• Data submitted for presentation at ASCO 2012

• Expect global filing in 2012

53

Patient

population High risk carcinoid Newly diagnosed glioblastoma


SWOG SO518

Phase III

AVAglio


Design • 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 • 15 mg/kg q3 weeks • 10 mg/kg q2 weeks or 15 mg/kg q3 weeks

Primary

endpoint

• Progression-free survival • Progression-free survival

• Overall survival



• FPI Q2 2009



Avastin

High risk carcinoid and brain c. development programmes

54

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

weekly

• 15 mg/kg q3 weeks

Primary

endpoint • Overall survival • Disease-free survival • Disease-free survival • Disease-free survival


• Recruitment ongoing

• Expect data 2017-2018

• FPI Q4 2007

• Enrolment completed Q2’11


• FPI Q4 2007



• FPI Q2 2008



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

Subcutaneous study

# 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 600mg sc q3w for the first 8

cycles

• ARM B: Chemotherapy* concurrent with

Herceptin IV 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

• Positive top-line data reported in October

2011

• Data presented at EBCC 2012

• Filed in EU Q1 2012

Subcutaneous Herceptin : applies Enhanze technology, partnered with Halozyme 56

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

Status • Enrolment completed Q3 2010

• Expect final results H1 2013

• Study met its primary endpoint Q1 2011


• EU granted approval in Q3 2011

• Expect FDA sNDA submission in 2012

Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc. 57

Zelboraf

A selective novel small molecule that inhibits mutant BRAF

In collaboration with Plexxikon, a member 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

papillary thyroid cancer


Melanoma patients

with brain metastases


Phase/study

Phase III

BRIM3

Global study

Phase II Phase II


Design • ARM A: Zelboraf 960mg bid

• ARM B: dacarbazine

• Single ARM: Zelboraf • Single ARM: Zelboraf

Primary

endpoint

• Overall survival and progression-

free survival

• Best overall response

rate

• Overall Response Rate

in the brain

Status • Study met both co-primary

endpoints Q1 2011


• FDA granted approval Q3 2011

• Updated OS data presented at

ESMO 2011

• Approved in EU Q1 2012

• FPI Q2 2011 • FPI Q3 2011

• Phase II/III clinical trials

58

Zelboraf

A selective novel small molecule that inhibits mutant BRAF

Patient

population

Metastatic melanoma


Melanoma patients with brain

metastases


Phase/study Phase Ib Phase I


Design • Single ARM: Zelboraf plus

ipilimumab

• Single ARM: Zelboraf

Primary

endpoint

• Safety • Safety

Status • FPI Q4 2011 • FPI Q4 2010

In collaboration with Plexxikon, a member of Daiichi Sankyo Group

Combination study with ipilimumab is in collaboration with Bristol-Myers Squibb.

• Phase I clinical trials

59

Erivedge (Vismodegib)

A novel small molecule inhibitor of the hedgehog signaling pathway

In collaboration with Curis

Patient

population

Advanced basal

cell carcinoma

Operable basal

cell carcinoma

Phase/study Pivotal Phase II

ERIVANCE Phase II


Design • Single ARM: 150 mg GDC-0449 orally once

daily until disease progression

• Single ARM: 150 mg GDC-0449 orally once

daily

Primary

endpoint

• Overall response rate • COHORT 1: Complete clearance (12 weeks

Erivedge)

• COHORT 2: Durable complete clearance (12

weeks Erivedge)

• COHORT 3: Complete clearance (16 weeks

Erivedge)


• Positive pivotal phase II results announced

March 2011

• Data presented at EADO June 2011,

ECCO/ESMO Sep 2011, EADV Oct 2011

• EMA submission accepted Q4 2011

• FDA granted approval Q1 2012

• FPI Q4 2010

• Cohort 1 data will be presented at Society for

Investigative Dermatology (May 2012)

60

Actemra/RoActemra

Interleukin 6 receptor inhibitor

Patient

population

Early moderate-to-severe

rheumatoid arthritis

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=326 N=1,200 N=600

Design 104 week treatment

• ARM A: Actemra IV 8 mg/kg

q4w plus pbo MTX

• ARM B: Actemra IV 8 mg/kg

q4w plus MTX

• ARM C: Actemra IV 4 mg/kg

q4w plus MTX

• ARM D: MTX alone

24 week treatment

• ARM A: Actemra IV 8mg/kg

q4w plus pbo Adalimumab

• ARM B: Adalimumab 40mg

sc q2w plus pbo Actemra

• Add-on to DMARD therapy

• Weekly dosing for 104

weeks

• ARM A: Actemra sc 162mg

weekly plus placebo IV q4w

• ARM B: Actemra IV 8mg/kg

q4w plus placebo sc weekly

• Add-on to DMARD therapy

• Dosing every two weeks for

104 weeks


q2w

• ARM B: Placebo sc q2w

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


• Filing expected 2013

• FPI Q2 2010

• Positive top-line data

reported Q1 2012

• Data submitted for

presentation at EULAR 2012

• Filing (EU) expected 2012

• Recruitment completed 2011

• Data 2012


• Recruitment completed 2011

• Data 2012


In collaboration with Chugai

MTX = Methotrexate; DMARD = Disease-Modifying Anti-Rheumatic Drugs. 61

Actemra/RoActemra

Interleukin 6 receptor inhibitor

Patient

population Systemic sclerosis

Polyarticular-course juvenile idiopathic

arthritis

Phase/study Phase II Phase III

CHERISH


Design Blinded 48-week treatment with weekly dosing:


• ARM B: Placebo sc

Open-label weekly dosing at weeks 49 to 96:

• Actemra sc 162mg

• Part I: All patients receive Actemra 8mg/kg or

10mg/kg (IV) q4w for 16 weeks

• Part II: Patients with adequate response from

Part I will be randomized to receive:

ARM A: Actemra 8mg/kg or 10mg/kg (IV)

q4w for up to 24 weeks + SOC*

ARM B: Placebo + SOC*

• Part III: All patients receive Actemra 8mg/kg

or 10mg/kg (IV) q4w for up to another 64

weeks

Primary

endpoint

• Change in modified Rodnan skin score (mRSS)

at week 24

• Safety

• Proportion of patients with a JIA ACR30 flare by

week 40 relative to week 16



• FPI Q4 2009

• Study met primary endpoint in Q1 2012

• Expect filing in 2012

In collaboration with Chugai

*Standard of care: non-steroidal anti-inflammatory drugs, corticosteroids, MTX 62

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


• LPI Q1 2012

• Data expected Q1 2013

• FPI Q1 2011

• LPI Q4 2011


• FPI Q1 2011

• LPI Q1 2012


63

Lucentis

Development programmes for wAMD and DME

Patient

population

Neovascular (wet) age-related

macular degeneration Diabetic macular edema

Phase/study

Phase III

HARBOR

High dose study

Phase III

RIDE

Phase III

RISE

# of patients N=1,110 N=382 N=378

Design • Randomised double-masked study

comparing efficacy and safety of

intravitreal injections of 0.5 mg and

2.0 mg Lucentis administered

monthly or PRN in patients with wet

AMD

• Randomised, sham-controlled study of monthly intravitreal injections of 0.5

and 0.3 mg Lucentis for a total of 36 injections in patients with clinically

significant macular edema with center involvement secondary to diabetes

mellitus (Type I or Type II).

Primary

endpoint

• Mean change in best corrected

visual acuity (BCVA) compared to

baseline at 12 months

• Proportion of patients who gain ≥ 15 letters in BCVA score compared to

baseline after 24 monthly injections (secondary endpoints include 36 month

endpoint)

Status • 12 month data was presented at

AAO meeting October 2011

• 0.5mg PRN sBLA filed with FDA in

April 2012


2011

• Data presented at ADA 2011

• Submitted for FDA approval October

2011


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 64

65 65







Diagnostics


Pertuzumab (RG1273)

First in a new class of HER dimerization inhibitors

Patient

population Adjuvant HER2+ breast cancer

First-line HER2-positive metastatic

breast cancer

Phase/

study

Phase III

APHINITY

Phase III

CLEOPATRA

# of

patients N=3,806 N=808

Design • ARM A: Pertuzumab (840mg

loading, 420 q3w) plus Herceptin for

52 weeks plus chemotherapy (6-8

cycles)

• ARM B: Placebo plus Herceptin (52

weeks) plus chemotherapy (6-8

cycles)

• ARM A: Pertuzumab (840mg

loading, 420mg q3w) plus Herceptin

and docetaxel

• ARM B: Placebo plus Herceptin and

docetaxel

Primary

endpoint

• 3-year disease-free survival • Progression-free survival

Status • FPI Q4 2011 • Met primary endpoint July 2011

• Data presented at SABCS 2011

• Submitted for FDA and EMA

approval Q4 2011

• FDA granted priority review in Q1

2012

SABCS = San Antonio Breast Cancer Symposium.

• Phase III clinical trials

66

Pertuzumab (RG1273)

First in a new class of HER dimerization inhibitors

Patient

population

Neoadjuvant HER2-positive

breast cancer

Neoadjuvant HER2-positive

breast cancer

Second-line HER2-positive

metastatic breast cancer

Advanced HER2-positive

gastric cancer

Phase/study Phase II

TRYPHAENA

Phase II

NeoSphere

Phase II

PHEREXA

Phase IIa

JOSHUA

# of patients N=225 N=417 N=450 N=30

Design • 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


Xeloda

• ARM B: Pertuzumab plus

Herceptin and Xeloda

• ARM A: Pertuzumab

(840mg loading, 420mg

q3w) plus Herceptin and

chemotherapy

• ARM B: Placebo plus

Herceptin and

chemotherapy

Primary

endpoint

• Safety • Pathologic complete

response rate

• Progression-free survival • Safety, efficacy

Status • Positive safety and efficacy

data presented at SABCS

2011

• FPI Q1 2008

• Data presented at SABCS

2010

• Biomarker data presented

at SABCS 2011

• FPI Q1 2010 • FPI Q4 2011

FEC = Fluorouracil, Epirubicin, and Cyclophosphamide; TCH = Docetaxel, Carboplatin, Herceptin;

SABCS = San Antonio Breast Cancer Symposium.

• Phase II clinical trials

67

Trastuzumab emtansine (T-DM1) (RG3502)

Evaluating new treatment options in HER2+ breast cancer

In collaboration with ImmunoGen

ESMO = European Society for Medical Oncology. 1 Patients must have received prior treatment which included both: a taxane, alone or in combination with another agent, and trastuzumab in the adjuvant, locally

advanced, or metastatic setting.

Patient

population Neoadjuvant/ Adjuvant

Patients who have

progressed on HER2

targeted treatment

Pretreated

HER2 pos. metastatic

breast cancer1

Previously untreated

HER2 pos. metastatic breast cancer

Phase/

study

Phase II

Cardiac safety study

Phase III

TH3RESA

Phase III

EMILIA Phase II

Phase III

MARIANNE

# of

patients N=135 N=795 N=991 N=137 N=1,092

Design • Single ARM: T-DM1

3.6mg/kg q3w

administered

immediately following

completion of

anthracycline

chemotherapy

• ARM A: T-DM1

3.6mg/kg q3w

• ARM B: physician’s

choice

• ARM A: T-DM1

3.6mg/kg q3w

• ARM B: Xeloda plus

lapatinib

• ARM A: T-DM1

3.6mg/kg q3w

• ARM B: Herceptin plus

docetaxel


taxane

• ARM B: T-DM1

3.6mg/kg q3w plus

pertuzumab

• ARM C: T-DM1 3.6

mg/kg q3w plus placebo

Primary

endpoint

• Cardiac event rate

• Safety

• ORR and Overall survival

Co-primary endpoints:


(PFS)

• Overall survival


by investigator


assessed by IRF


• Completed enrollment

Q2 2011

• Expect data Q2 2012

• FPI Q3 2011

• FPI Q1 2009

• Enrollment completed

• Positive top-line data

reported Q1 2012

• Submitted for

presentation at ASCO

2012

• Filing planned in 2012

• Enrolment completed Q4

2009

• Preliminary data

presented at ESMO 2010

• Positive topline PFS data

April 2011

• Data presented at ESMO

2011

• FPI Q3 2010

68

GA101 (RG7159)

Type II, glycoengineered anti-CD20 monoclonal antibody


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)


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

1000mg IV plus

chlorambucil

• ARM B:

MabThera/Rituxan plus

chlorambucil

• ARM C: Chlorambucil

alone

• ARM A: GA101 1000mg

IV plus Bendamustine

• ARM B: Bendamustine

• ARM A: GA101 1000mg

IV plus chemotherapy

followed by GA101

maintenance

• ARM B:


chemotherpy followed by

MabThera/Rituxan

maintenance

• ARM A: GA101 1000mg

IV plus 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

GA101 (RG7159)

Type II, glycoengineered anti-CD20 monoclonal antibody

• Phase I/II clinical trials

Patient

population

Front-line or relapsed

indolent non-Hodgkin’s lymphoma

(NHL)

Relapsed

indolent non-Hodgkin’s lymphoma

Relapsed or refractory

non-Hodgkin’s lymphoma or chronic

lymphocytic leukaemia (CLL)

Phase/stud

y

Phase Ib

GAUDI

Phase I/II

GAUSS

Phase I/II

GAUGUIN

# of

patients N=136 N=202 N=133

Design • Cohort A: GA101 plus fludarabine +

cyclophosphamide

• Cohort B: GA101 plus CHOP

• Cohort C: GA101 plus

bendamustine

Phase I portion

(extended treatment for 2 years):

• Single agent: GA101

Phase II portion

(extended treatment for 2 years):

• ARM A: MabThera/Rituxan

• ARM B: GA101

Phase I portion:


Phase II portion:


Primary

endpoint



Phase I portion:

• Initiated Q1 2008


Phase II portion:

• FPI Q3 2009



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. 70

Onartuzumab (MetMAb, RG3638)

Anti-Met monovalent antibody that inhibits HGF-mediated activation

Patient

population

2nd- and 3rd-line

Met-positive metastatic

NSCLC

1st and 2nd-line

triple negative metastatic

breast cancer

1st-line metastatic

colorectal cancer

Phase Phase III Phase II Phase II


Design • ARM A: Tarceva plus

onartuzumab

• ARM B: Tarceva plus

placebo

• ARM A: Avastin and

paclitaxel plus

onartuzumab

• ARM B: Avastin and

paclitaxel plus placebo

• ARM C: Paclitaxel plus

onartuzumab

• ARM A: FOLFOX plus

Avastin plus

onartuzumab

• ARM B: FOLFOX plus

Avastin plus placebo

Primary

endpoint

• Overall survival • Progression–free survival • Progression–free

survival in ITT


in pre-specified Met+

patients

Status • FPI Q1 2012 • FPI Q1 2011 • FPI Q3 2011

71

Onartuzumab (MetMAb, RG3638)

Anti-Met monovalent antibody that inhibits HGF-mediated activation

Patient

population 1st line non-squamous NSCLC 1st line squamous NSCLC

Phase Phase II Phase II


Design Cohort 1

•Arm A: Onartuzumab + Avastin + paclitaxel +

platinum-based chemo (cisplatin or carboplatin)

•Arm B: Placebo + Avastin + paclitaxel +


Cohort 2

•Arm A: Onartuzumab + pemetrexed +


Arm B: Placebo + pemetrexed + platinum-

based chemo (cisplatin or carboplatin)

• Arm A: Onartuzumab + paclitaxel +

platinum-based chemo (cisplatin or

carboplatin)

• Arm B: Placebo + paclitaxel + platinum-

based chemo (cisplatin or carboplatin)

Primary

endpoint

• Progression-Free Survival in the ITT

population

• Progression-Free Survival in Met-positive

population

• Progression-Free Survival in the ITT

population

• Progression-Free Survival in Met-positive

population

Status • FPI April 2012 • Expect FPI Q2 2012

72

Lebrikizumab (RG3637)

A humanized monoclonal antibody designed to bind specifically to IL-13

Severe uncontrolled adult asthma

Patient

population

Adult patients whose

asthma is uncontrolled with inhaled

corticosteroids and a second controller

medication

Adult patients whose

asthma is uncontrolled with inhaled

corticosteroids and a second controller

medication


LUTE

Phase III

VERSE

# of patients N=1,400 N=1,400

Design Subcutaneous Lebrikizumab q4w on top of SOC for 52

weeks followed by 52 week extension on Lebrikizumab

for a total of 104 weeks, with a 24 week safety follow-

up

• ARM A: Lebrikizumab highest dose

• ARM B: Lebrikizumab middle dose

• ARM C: Lebrikizumab lowest dose

• ARM D: Placebo

Patients will be tested for Periostin level

Subcutaneous Lebrikizumab q4w on top of SOC for 52

weeks followed by 52 week extension on Lebrikizumab

for a total of 104 weeks, with a 24 week safety follow-

up

• ARM A: Lebrikizumab highest dose

• ARM B: Lebrikizumab middle dose

• ARM C: Lebrikizumab lowest dose

• ARM D: Placebo

Patients will be tested for Periostin level

Primary

endpoint

• Rate of asthma exacerbations during the 52-week

placebo-controlled period

• Rate of asthma exacerbations during the 52-week

placebo-controlled period



73

Lebrikizumab (RG3637)

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 Dose level A

• ARM B: Lebrikizumab Dose level B

• ARM C: Lebrikizumab Dose level C

• ARM D: Placebo

Status • Data published Corren et al. 2011

NEJM (and NEJM correspondence

Dec 2011)

• Two abstracts accepted at ATS 2012;

i) PD marker data and ii) post hoc 32

week analysis of exacerbation rates

• FPI Q4 2009

• Topline data: Q1 2011

• Publication planned Q4 2012

• Phase II clinical trials

74

Dalcetrapib (RG1658)

A first-in-class CETP modulator

In collaboration with Japan Tobacco

CHD = Stable coronary heart disease; ACS = Acute Coronary Syndrome; CVD = cardiovascular disease.

dal-HEART Programme Global Research Initiative

Patient

population

Stable CHD 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-OUTCOMES 2

Mortality and morbidity study

# of patients N=15,872 N=20,000

Design • In addition to standard medication for ACS

(including statins):

• Minimum of 24 months treatment duration

• ARM A: Dalcetrapib

• ARM B: Placebo

• In addition to standard medication (including

statins):

• 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

• 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


• Next interim analysis at 70% of events H1 2012

• FPI Q1 2012

75

Dalcetrapib (RG1658)

A first-in-class CETP modulator

In collaboration with Japan Tobacco

CHD = Stable coronary heart disease; ACS = Acute Coronary Syndrome; CVD = cardiovascular disease.

dal-HEART Programme Global Research Initiative

Patient

population Patients with evidence of CAD Patients with recent ACS

Phase/study

Phase III

dal-PLAQUE 2*

Imaging study

Phase III

dal-ACUTE

Biomarker study


Design • In addition to standard medication (including

statins):

• 24 months treatment duration

• Uses both IMT and IVUS ultrasound imaging

techniques


• ARM B: Placebo

• In addition to standard medication (including

statins):

• 20 weeks treatment duration


• ARM B: Placebo

Primary

endpoint

• 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

Status • Initiated Q4 2009

• Recruitment completed

• Expect data end of 2013

• FPI Q1 2011

• Recruitment completed Q3 2011

76

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=7,000

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

• Expect data H2 2012

• FPI Q1 2010

ACS = Acute Coronary Syndrome; SOC = standard of care. 77

Bitopertin (GlyT-1, RG1678)

A small molecule first-in-class glycin reuptake inhibitor (GRI)

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

78

Ocrelizumab (RG1594)

2nd generation anti-CD20 monoclonal antibody

Patient

population Relapsing multiple sclerosis (RMS)

Primary progressive

multiple sclerosis (PPMS)

Phase/stud

y

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: Interferon -1a

• 96-week treatment period:


300 mg IV followed by 600

mg IV every 24 weeks

• ARM B: 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)


79

Mericitabine (RG7128)

Nucleoside NS5B polymerase inhibitor

Patient

population

Treatment-naive and failure

chronic hepatitis C

Genotype 1 and 4


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: Mericitabine (500 mg BID) + Pegasys and Copegus

for 12 weeks, followed by Pegasys and Copegus for 12 weeks*

• ARM B: Mericitabine (1000 mg BID) + Pegasys and Copegus


• ARM C: Mericitabine (1000 mg BID) + Pegasys and Copegus


*Patients who have not achieved rapid viral (RVR) response will

receive Pegasys and Copegus for a further 24 weeks.

• ARM D: Mericitabine (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): Mericitabine (1000 mg

BID) + Pegasys and Copegus for 24 weeks, followed by

Pegasys and Copegus for 24 weeks

• ARM A: Mericitabine (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):

Mericitabine (1000 mg BID) + Pegasys

and Copegus for 24 weeks, followed by


• In preparation

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

• Final data accepted for 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

• Final data accepted for presentation at

EASL 2012

Licensed from Pharmasset, now part of Gilead.

AASLD = American Association for the Study of Liver Disease; EASL = European Association for the Study of the Liver 80

Mericitabine (RG7128)

Nucleoside NS5B polymerase inhibitor

Patient

population


chronic hepatitis C

Genotype 1 and 4


chronic hepatitis C

Genotype 1 and 4

Phase/study Phase IIb

DYNAMO 1*

Phase IIb

DYNAMO 2

Longer duration study

# of patients N=100

N= 168

Design • ARM A: Boceprevir + Mericitabine (1000 mg BID) +


• ARM B: Boceprevir + Mericitabine (1000 mg BID) +

Pegasys and Copegus for 24 weeks followed by

boceprevir+Pegasys and Copegus for 24 weeks

• ARM C : Boceprevir+Pegasys and Copegus for 48 weeks

• ARM A: Telaprevir + Mericitabine (1000 mg BID) + Pegasys

and Copegus for 12 weeks, followed by + Mericitabine (1000

mg BID) + Pegasys and Copegus for 12 weeks

• ARM B: Telaprevir + Mericitabine (1000 mg BID) + Pegasys

and Copegus for 12 weeks, followed by + Mericitabine (1000

mg BID) + Pegasys and Copegus for 12 weeks, followed by


• ARM C : Telaprevir + Mericitabine (1000 mg BID) +

Pegasys and Copegus for 12 weeks, followed by Pegasys and

Copegus for 36 weeks

• ARM D: Telaprevir + Pegasys and Copegus for 12 weeks,

followed by Pegasys and Copegus for 36 weeks

Primary

endpoint • Sustained virological response (SVR) • Sustained virological response (SVR)


RG7128 licensed from Pharmasset, now part of Gilead

* In collaboration with Merck 81

Patient

population

Treatment-naïve

chronic hepatitis C patients

Phase

Phase IIb

ATLAS

Danoprevir + Pegasys + Ribavirin in

Genotype 1

Phase IIb

DAUPHINE

Boosted Danoprevir + Pegasys + Ribavirin in Genotype 1+4


Design • ARM A: Danoprevir 300 mg q8h + Pegasys and Copegus for

12 weeks

• ARM B: Danoprevir 600 mg bid + Pegasys and Copegus for 12

weeks

• ARM C: Danoprevir 900 mg bid + 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: Danoprevir 200 mg bid+ Ritonavir 100mg bid +

Pegasys + Copegus for 24 weeks

•ARM B: Danoprevir 100 mg bid + Ritonavir 100mg bid +


•ARM C: Danoprevir 50 mg bid + Ritonavir 100mg bid +


•ARM D: Danoprevir 100 mg* bid + Ritonavir 100mg bid +

Pegasys + Copegus

•ARM E: Pegasys and Copegus

*If patients are virus negative at week 2 and 10, patients will stop

therapy at week 12.

Primary

endpoint

• Sustained virological response 24 weeks after the end of study

treatment


treatment


• 900 mg cohort be discontinued in Q4 2009

• Results presented at AASLD 2011

• FPI Q4 2010


• Data accepted for presentation at EASL 2012

Danoprevir (RG7227)

HCV protease inhibitor

RG7128 licensed from Pharmasset, now part of Gilead 82

Patient

population

Treatment-naïve and Interferon Unable/Intolerant Patients

Chronic hepatitis C Genotype 1

Treatment-experienced

chronic hepatitis C patients*

Phase

Phase IIb

INFORM-SVR

Interferon-free combination trial

Phase IIb

Matterhorn

Boosted Danoprevir in Triple, Quad and Interferon-free combinations


Design • ARM A: naïve patients: Danoprevir 100 mg bid + Ritonavir 100

mg bid + Mericitabine 1000 mg bid + Copegus

• ARM B: naïve patients: Danoprevir 100 mg bid + Ritonavir 100

mg bid + Mericitabine 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: interferon unable/intolerant patients: Danoprevir 100

mg bid + Ritonavir 100 mg bid + Mericitabine 1000 mg bid +

Copegus

Danoprevir boosted by low dose ritonavir in IFN-free, triple and QUAD

Cohort A: partial responders:

•ARM A1: Danoprevir 100 mg bid+ Ritonavir 100mg bid+ Mericitabine

1000 mg bid + Copegus for 24 weeks

•ARM A2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ Pegasys +

Copegus for 24 weeks

•ARM A3: Danoprevir 100 mg bid + Ritonavir 100mg bid + Mericitabine

1000 mg bid + Pegasys + Copegus for 24 weeks

Cohort B: null responders:

•ARM B1: Danoprevir 100 mg bid + Ritonavir 100mg bid + Mericitabine

1000 mg bid + Copegus for 24 weeks

•ARM B2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ Mericitabine

1000 mg bid + Pegasys + Copegus for 24 weeks

•ARM B3: Danoprevir 100 mg bid+ Ritonavir 100mg bid + Mericitabine

1000 mg bid + Pegasys + Copegus for 24 weeks, followed by 24 weeks

Pegasys + Copegus

Primary

endpoint


treatment


treatment

Status • Recruitment completed for arms A and B Q4 2011

• Interim data accepted for presentation at EASL 2012

• Expect FPI for arm C H1 2012

• FPI Q2 2011


• Expect data H2 2012

Danoprevir (RG7227)

HCV protease inhibitor

RG7128 licensed from Pharmasset, now part of Gilead 83

84 84







Diagnostics


Oncology development programmes

Small Molecules

Apoptosis MAPK signaling

Molecule MDM2 antagonist

(RG7112)

MDM2 (4)

antagonist

(RG7388)

BRAF inhibitor(2)

(RG7256)

MEK inhibitor

(CIF, RG7167)

Raf/MEK inhibitor

(CKI27, RG7304)

Patient

population

Advanced solid

tumors

Hematologic

neoplasms

(Leukaemia)

Solid and

hematological

tumors

BRAF mutated

solid tumors Solid tumors Solid tumors

Phase Phase I Phase I Phase I Phase I Phase I Phase I

# of patients N=105 N=90 N=100 N=100 N=144 N=52

Design • Multiple

ascending

dose-

escalation

study

• Multiple

ascending dose-

escalation study

• Multiple

ascending dose-

escalation study

• Multiple

ascending dose

study with

extension

cohorts

• Dose-escalation,

followed by

expansion into 4

cohorts in

specific

indications

• Dose-escalation

to MTD

Status • Study

completed Q2

2011

• Expect to

initiate Phase

Ib studies in Q2

2012


• Preliminary

results presented

at ASH 2010 and

2011

• Expect to initiate

Phase Ib studies

in Q2 2012

• FPI Q4 2011 • FPI Q3 2010

• Recruitment

completed Q4

2011


• Phase I study

completed

recruitment into

expansion

cohorts end of

2011

• Initiated October

Q4 2008

• Phase I study

Stopped

enrolment in Q4

2010

Collaborator Plexxikon Chugai Chugai

Plexxikon Inc., a member of Daiichi Sankyo Group 85


Monoclonal Antibodies

Molecule Anti-PlGF MAb

(RG7334)

Anti-glypican-3 MAb

(GC33, RG7686)

Anti-CD44 MAb

(RG7356)

Patient

population Glioblastoma multiforme

Metastatic liver cancer

(hepatocellular

carcinoma)

2L metastatic liver cancer

(hepatocellular

carcinoma)

Solid tumors

Phase Phase Ib/II Phase Ib Phase II Phase I

# of patients N=80-100 N= 40-50 N=156 N=50-70

Design Part 1 - Dose escalation

portion

• RG7334 in combination

with Avastin

Part 2

• ARM A: Avastin

• ARM B: Avastin plus

RG7334

• Study US Monotherapy

• Study Japan Monotherapy

• Combo with SOC dose

escalation study

Adaptive design study

• ARM A: RG7686

• ARM B: placebo

Patients are stratified

according to the level of

GPC-3 expression in tumors

• Multiple ascending dose

study with extension and

imaging arm

Primary

endpoint

• Part 1 - Establish dosing

for Part 2

• Part 2 - PFS at 6 months

• Safety and tolerability • Progression-free survival • Safety (MTD), PK, PD,

preliminary activity


• Part I recruitment

completed

• FPI Q4 2008 • FPI Q1 2012 • FPI Q2 2011

Collaborator ThromboGenics & BioInvent Chugai

SOC – standard of care 86


Monoclonal Antibodies (continued)

Molecule Anti-TWEAK MAb

(RG7212)

GE-huMAb HER3

(RG7116)

CSF-1R huMAb

(RG7155)

Patient

population Solid tumors Solid tumors Solid Tumors

Phase Phase I Phase I Phase I

# of patients N=100 N=105 N-95

Design • Multiple ascending dose

study with extension

cohorts


study with extension

cohorts and imaging sub-

study

• Combination arms with

HER1-targeted therapies

(erlotinib, cetuximab)

• •Multiple ascending dose

study +/- paclitaxel with

extension cohorts

Primary

endpoint

• Safety, PK, PD • Safety, PK • Safety, PK, PD & clinical

activity


87

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

• Pharmacodynamics • Part 1 – Safety

• Part 2 – PFS

• PFS


• Recruitment

completed Q1 2012

• Non-Squamous Part 2 accrual complete

1Q 2012

• Squamous Part 1 ongoing

• FPI Q2 2011


88

Inflammation development programmes

Molecule CRTH2 antagonist

(RG7185)

huMAb IL-17

(RG4934)

huMAb anti-TSLPR

(RG7258)

Patient

population Asthma Asthma

Inflammatory

diseases

Uncontrolled

Asthma

Phase Phase I Phase II Phase II Phase I

# of patients N=80 N~450 TBD N=48

Design • Single and

multiple doses

• Double blind,

placebo controlled

in moderate to

severe asthmatics

inadequately

controlled on

Advair®

• Multiple dose

administration

• Single and

multiple doses

Primary

endpoint

• Safety &

Tolerability

• Safety

Status • Completed Q1

2012

• Expect FPI H2

2012

• Expect FPI 2012 • FPI Q4 2011

Advair® is a registered trademark of GlaxoSmithKline 89

Metabolic development programmes

Molecule P-selectin huMAb

(RG1512)

11 Beta HSD inhibitor

(RG4929)

GLP-1/GIP dual agonist

(MAR701, RG7685)

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 Type 2 diabetes

Phase/stu

dy Phase II Phase II

Phase II

Proof of mechanism study Phase I

# of

patients N=384 N=516 N=80 N=50

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


(MAD) study

Primary

Endpoint

•Sapheneous vein graft re-

occlusion

•Procedural damage

(troponin)

•Liver fat content (MRS) • Safety, PK


• Expect data Q2 2012

• Study completed

• Follow-up study in

preparation

Collaborat

or Genmab

Marcadia Biotech, Inc.

acquisition

90

Neuroscience development programmes

Metabotropic glutamate receptor pathway

Molecule mGluR2 antagonist

(RG1578)

mGluR5 antagonist

(RG7090)

Patient

population

Adjunctive Treatment of

Major Depressive Disorder

Adjunctive Treatment of

Major Depressive Disorder Fragile X Syndrome

Phase/study Phase II Phase II Phase II


Design • ARM A: RG1578 5 mg

• ARM B: RG1578 15 mg

• ARM C: RG1578 30 mg

• ARM D: Matching Placebo

ARM A: RG7090 0.5 mg

ARM B: RG7090 1.5 mg

ARM C: Matching Placebo

ARM A: RG7090 0.5 mg

ARM B: RG7090 1.5 mg

ARM C : Matching

Placebo

Primary

endpoint

• Efficacy - Montgomery

Asberg Depression Rating

Scale

• Efficacy - Montgomery

Asberg Depression Rating

Scale

• Efficacy, Safety and

Tolerability

Status • Recruitment ongoing

• Expected data H2 2013


• Expected data H2 2013

• Recruitment expected to

start Q2 2012

• Phase II studies

91


Molecule Gantenerumab

(Anti-Αβ, RG1450)

BACE inhibitor

(RG7129)

Monoamine oxidase type B

(MAO-B) inhibitor

(RG1577, EVT-302)

Patient

population Alzheimer’s Disease Alzheimer’s Disease Alzheimer’s Disease


SCarlet RoAD Phase I Phase II

# of patients N=360 N=36 TBD

Design 104-week subcutaneous treatment period

•ARM A: RG1450 (225 mg)

•ARM B: RG1450 (105 mg)

•ARM C: Placebo

• Single ascending dose study,

incl. food effect • In preparation

Primary

endpoint

• Change in Clinical Dementia Rating scale

Sum of Boxes (CDR-SOB) at 2 years

• Safety • Efficacy


• Ph I PET data published in Arch. Neur. Q4

2011

• FPI Q3 2011

• Enrollment completed Q1 2012 • Expect FPI in H2 2012

Collaborator Morphosys Siena Biotech Evotec

• Phase I/II studies

92


Molecule GABRA5 negative allosteric modulator (NAM)

(RG1662)

V1 receptor

antagonist

(RG7314)

Patient

population Down Syndrome Autism

Phase Phase I Phase I Phase Ib Phase I

# of patients N=90 N=32 N=23 N=45

Design • Single ascending

dose study/PET in

healthy volunteers

• Multiple ascending

dose study in healthy

volunteers

• Multi-center,

Randomized, Double-

blind, Placebo-

controlled, Multiple

Dose Study in

Individuals With

Down Syndrom

• SAD/MAD umbrella

protocol including

food effect

Primary

endpoint

• Food effect, Brain

Receptor Occupancy,

Safety

• Safety • Safety, tolerability • Safety, Tolerability



• FPI Q4 2010


Q3 2011

• FPI Q4 2011 • FPI Q3 2010

• Phase I studies

93

Virology development programme

Molecule Setrobuvir

(RG7790)

Patient

population Chronic Hepatitis C

Phase Phase II

# of patients N= 283

Design • ARM A: Setrobuvir/placebo (200 mg bid) + Pegasys + Copegus for 28-48

weeks* in naïve patients

• ARM B: Setrobuvir/placebo (200 mg bid) + Pegasys + Copegus for 48 weeks in

treatment experienced patients (paritial responders & relapsers)

• ARM C: Setrobuvir (200 mg bid) + Pegasys + Copegus for 48 weeks in

treatment experienced patients (null responders)

* Response guided treatment

Primary

endpoint

• Sustained virological response 24 weeks after the end of study treatment


Collaborator Anadys Pharmaceuticals Inc. acquisition

94

95







Diagnostics



Angiogenic signaling

Molecule Anti-angiogenic

(RG7594)

Anti-EGFL7 MAb

(RG7414)

Patient

population Advanced solid tumors Advanced solid tumors




colorectal cancer

Phase Phase Ia/Ib Phase Ib Phase II

NILE

Phase II

CONGO

# of patients N=~54 N=~64 N=100 N=120

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/Biopsy

Cohort: Anti-EGFL7 plus

Avastin

• Flat dose Cohort: Anti-

EGFL7 plus Avastin

• Anti-EGFL7 plus Avastin

plus carbo/tax vs Avastin

plus carbo/tax

• ARM A: Anti-EGFL7 plus

Avastin plus FOLFOX

• ARM B: Avastin plus

FOLFOX

Primary

endpoint

• Safety/PK • Safety/PK • PFS • PFS


• Data presented at ASCO

2011

• FPI Q2 2011 • FPI Q4 2011

96


Growth factor signaling Tumor Immunotherapy

Molecule Anti-HER3 EGFR DAF MAb

(RG7597)

Anti-PD-L1 MAb

(RG7446)

Patient

population

Metastatic epithelial

tumors

Metastatic/recurrent

SCCHN Solid tumors

Phase Phase I Phase II Phase I


Design • Dose escalation study • ARM A: RG7597

• ARM B: Cetuximab

• Dose escalation study

Primary

endpoint

• Safety/PK • PFS • Safety

Status • FPI Q4 2010 • Expect FPI Q2 2012 • FPI Q2 2011

97 SCCHN=Squamous Cell Carcinoma of the Head and Neck


Antibody drug conjugates (ADCs)

Molecule NME ADC

(RG7450)

NME ADC

(RG7458 )

Anti-CD22 ADC

(RG7593)

NME ADC

(RG7596)

Patient

population Prostate Cancer Ovarian Cancer

Hematologic

malignancies

Hematologic

malignancies

Phase Phase I Phase I Phase I Phase I


Design • Dose escalation

study

• Dose escalation

study

• Dose escalation

study

• Dose escalation

study

Primary

endpoint

• Safety • Safety/PK • Safety • Safety

Status • FPI Q1 2011 • FPI Q2 2011 • FPI Q4 2010 • FPI Q1 2011

Collaborator Seattle Genetics and

Agensys Seattle Genetics

98


Antibody drug conjugates (ADCs)

Molecule NME ADC

(RG7598)

NME ADC

(RG7599)

NME ADC

(RG7600)

NME ADC

(RG7636)

Patient

population Multiple Myeloma

NSCLC and ovarian

cancer

Pancreatic and

ovarian cancer

Metastatic or

unresectable

melanoma

Phase Phase I Phase I Phase I Phase I

# of patients N=30-45 N=70 N=66-96 N=44-64


study

• Dose escalation

study

• Dose escalation

study

• Dose escalation

study

Primary

endpoint

• Safety • Safety • Safety • Safety


Collaborator Seattle Genetics

99

PI3K signaling

Molecule PI3 Kinase inhibitor

(GDC-0941, RG7321)

Patient

population 2L ER+ metastatic breast cancer

Previously Untreated Advanced or

Recurrent NSCLC

Phase Phase II

FERGI Phase II

# of

patients N=340 N=302

Design • ARM A: GDC-0941 plus hormonal therapy

• ARM B: GDC-0980 plus hormonal therapy

• ARM C: Hormonal therapy + placebo

• ARM A: GDC-0941 + carboplatin +

paclitaxel

• ARM B: Placebo + carboplatin + paclitaxel

• ARM C: GDC-0941 + carboplatin +

paclitaxel + bevacizumab

• ARM D: GDC-0941 + carboplatin +

paclitaxel + bevacizumab

Primary

endpoint

• PFS • PFS



Small molecules


100

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

Phase

Phase Ia

Being conducted

in the US

Phase Ia

Being conducted

in the UK

Phase Ib Phase Ib Phase Ib Phase Ib

# of patients N=100 N=55 N=45 N=70 N=30 N=30

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

Primary

endpoint

• Safety • Safety • Safety • Safety • Safety • Safety


• 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

• Data presented at

SABCS 2011

• FPI Q3 2009


SABCS 2010

• FPI Q4 2009


ASCO 2011

• FPI Q3 2009


Small molecules (continued)

101

PI3K signaling

Molecule PI3 Kinase/mTOR dual inhibitor

(GDC-0980, RG7422)

Patient

population Renal cell carcinoma

2L ER+ metastatic breast

cancer

Persistent or recurrent

endometrial carcinoma

2L Castration-resistant

prostate cancer

Phase Phase II

ROVER

Phase II

FERGI Phase II Phase Ib/II


Design • ARM A: GDC-0980

• ARM B: Everolimus

• ARM A: GDC-0941 plus

hormonal therapy

• ARM B: GDC-0980 plus

hormonal therapy

• ARM C: Hormonal

therapy + placebo

• Single-arm GDC-0980 • ARM A: GDC-0068 +

abiraterone

• ARM B: GDC-0980 +

abiraterone

• ARM C: Placebo +

abiraterone

Primary

endpoint

• PFS • PFS • PFS • Safety (Ph IB)

• PFS (Ph II)



Small molecules


102



PI3K signaling

Molecule PI3 Kinase/mTOR dual inhibitor

(GDC-0980, RG7422)

Patient

population

Refractory solid tumors

or NHL

Refractory solid tumors

or NHL

Metastatic breast

cancer Solid tumors Solid tumors

Phase Phase Ia Phase Ia Phase Ib Phase Ib Phase Ib

# of patients N=75 N=65 N=65 N=80 N=95

Design • Dose escalation study • Dose escalation study

Dose escalation study

• ARM A: GDC-0980

plus paclitaxel

• ARM B: GDC-0980

plus Avastin and

paclitaxel

• ARM C: GDC-0980

plus Herceptin and

paclitaxel

Dose escalation study

• ARM A: GDC-0980

plus carboplatin and

paclitaxel

• ARM B: GDC-0980

plus Avastin,

carboplatin and

paclitaxel

• ARM A: GDC-0980 +

Xeloda

• ARM B: GDC-0980

plus FOLFOX and

Avastin

Primary

endpoint

• Safety • Safety • Safety • Safety • Safety



ASCO 2010, ESMO

2010, and ASCO 2011

• FPI Q2 2009


ASCO 2010 and ESMO

2010

• FPI Q4 2010 • FPI Q2 2011 • FPI Q3 2011

ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical Oncology.

• Phase I studies

103



MAPK signaling

Molecule MEK Inhibitor

(GDC-0623, RG7420)

MEK Inhibitor

(GDC-0973, RG7421)

Patient

population Solid tumors Solid tumors Solid tumors

Metastatic melanoma

BRAF mutation

positive

Phase Phase I Phase I Phase Ib Phase Ib

BRIM7

# of patients N=62 N=90 N=212 N=~50

Design • Dose escalation study • Dose escalation study • Dose escalation study

evaluating GDC-0973

plus GDC-0941 (PI3

Kinase Inhibitor)

• Dose escalation study

evaluating Zelboraf*

plus GDC-0973

Primary

endpoint

• Safety/PK • Safety/PK • Safety/PK • Safety/PK



AACR 2011

• Recruitment completed

Q3 2011

• FPI Q4 2009

• Preliminary data

presented at AACR

and ASCO 2011

• FPI Q1 2011

Collaborator Exelixis

104



Molecule AKT Inhibitor

(GDC-0068, RG7440)

ChK1 inhibitor

(GDC-0425,

RG7602)

Bcl-2 selective

inhibitor

(GDC-0199,

RG7601)

PI3 Kinase

inhibitor

(GDC-0032,

RG7604)

Patient

population Solid tumors Solid tumors

2L Castration-

resistant prostate

cancer

Solid tumors or

lymphoma

Relapsed or

refractory CLL and

NHL

Solid tumors

Phase Phase Ia Phase Ib Phase Ib/II Phase I Phase I Phase I

# of

patients N=57 N=90 N=262 N=75 N=36 N=45


study

• Dose escalation

with either

docetaxel or

fluoropyrimidine

plus oxaliplatin

• ARM A: GDC-

0068 +

abiraterone

• ARM B: GDC-

0980 +

abiraterone

• ARM C: Placebo

+ abiraterone

• Dose escalation

study

• Single arm: GDC-

0199 • Dose

escalation

study

Primary

endpoint

• Safety/PK • Safety • Safety (Ph IB)

• PFS (Ph II)

• Safety/PK • PFS (MRD Upside) • Safety/PK



ASCO 2011

• FPI Q3 2011 • FPI Q1 2012 • FPI Q3 2011 • FPI Q2 2011 • FPI Q1 2011

Collaborator Array BioPharma Abbott and WEHI

WEHI = The Walter and Eliza Hall Institute

105

Immunology development programmes

Molecule Anti-LT α

(RG7416)

Anti-M1 prime

(RG7449)

Etrolizumab

(rhuMAb-β7, (RG7413)

Patient

population

Rheumatoid

arthritis Asthma

Ulcerative

colitis

Phase/study Phase IIa

ALTARA

Phase IIa

SOLARIO Phase I

Phase II

EUCALYPTUS


Design • ARM A: Anti-LT alpha plus

DMARD (leflunomide or

methotrexate)

• ARM B: Adalimumab plus


methotrexate)

• ARM C: Placebo plus


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

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



Q2 2011

• Enrolment completed Q3

2010

• FPI Q3 2011

DMARD = Disease-Modifying Anti-Rheumatic Drugs 106

Immunology development programmes

Molecule Rontalizumab

(Anti-IFN α, RG7415)

anti-IL17

(RG7624)

Patient

population

Systemic lupus

erythematosus Autoimmune diseases


ROSE Phase Ib


Design • ARM A: Placebo

• Part 1 – IV

• Part 2 - Subcutaneous

• ARM B: Rontalizumab

• Part 1 – IV

• Part 2 – Subcutaneous

• Randomized, double-blind, placebo-

controlled, multiple ascending dose

escalation study

Primary

endpoint

• Proportion of responders at Week 24 • Safety and tolerability


• Data to be presented in H2 2012

• FPI Q1 2012

Collaborator

NovImmune

107

Neuroscience and ophthalmology development

programmes

Molecule

Crenezumab

(Anti-Αβ, RG7412)

Anti-Factor D

(RG7417)

Patient

population

Alzheimer’s

Disease

Geographic Atrophy (GA)

secondary to age-related macular

degeneration

Phase/study

Phase II

ABBY

Cognition study

Phase II Prep

BLAZE

Biomarker study

Phase Ib/II

MAHALO


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

Primary

endpoint

• Change in cognition

(ADAS-cog) and Clinical

Dementia Rating, Sum of

Boxes (CDR-SOB) score

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

Status • FPI Q2 2011 • FPI Q3 2011 • Part 1 FPI Q4 2010

• Part 2 FPI Q2 2011

• Enrollment completed Q4 2011

Collaborator AC Immune

108

Metabolism and virology development

programmes

Molecule Anti-oxLDL

(RG7418, BI-204)

NME

(RG7652)

NME

(RG7667)

Patient

population

Secondary prevention of

cardiovascular events in

patients with ACS

Metabolic diseases Infectious diseases


Proof of activity study Phase I Phase I


Design • 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

• RG7667

• Placebo

Primary

endpoint

• Change in TBR as measured

by FDG-PET/CT at week 12

• Safety and tolerability • Safety, PK


• Recruitment completed Q1

2012

• FPI Q3 2011 • FPI Q1 2012

Collaborator BioInvent

ACS – acute coronary syndrome; TBR = Target-to-background ratio;

FDG = Fluoro-2-deoxy-D-glucose; PET = Positron Emission Tomography; CT = CAT scan. 109

110 110 110







Diagnostics


Geographical sales split by divisions and Group*

CHF m Q1 2011 Q1 2012 % change CER

Pharmaceutical Division 8,712 8,624 +2

United States 3,322 3,442 +6

Western Europe 2,209 2,005 -4

Japan 903 930 +1

International 2,278 2,247 +2

Diagnostics Division 2,408 2,403 +4

United States 519 549 +8

Western Europe 966 896 -2

Japan 127 142 +10

International 796 816 +7

Group 11,120 11,027 +2

United States 3,841 3,991 +6

Western Europe 3,175 2,901 -3

Japan 1,030 1,072 +2

International 3,074 3,063 +4

* Geographical sales split shown here does not represent operational organization; CER = Constant Exchange Rates

111 111

112

CER sales growth (%)

Quarterly development

2011 vs. 2010 2012 vs. 2011

Q1 Q2 Q3 Q4 Q1

Pharmaceuticals Division -2 -1 0 3 2

excl. Tamiflu 1 1 0 3 3

United States 2 1 1 4 6


Western Europe -4 -4 -3 -1 -4

excl. Tamiflu -4 -4 -4 -2 -4

Japan -7 -3 -7 -5 1

excl. Tamiflu 1 -2 -5 -6 -3

International -3 0 5 10 2


Diagnostics Division 6 5 6 7 4

Roche Group 0 0 1 4 2


CER = Constant Exchange Rates

113

Q1/11 Q2/11 Q3/11 Q4/11 Q1/12

MabThera/Rituxan 7 6 7 10 7 Herceptin 8 12 4 14 7 Avastin -6 -9 -10 -2 1 Pegasys -15 -7 6 5 32 Lucentis 35 29 17 13 0 Xeloda 7 2 10 13 15 Tarceva 8 1 10 10 10 CellCept -14 -13 -9 -20 -19 Tamiflu -47 -88 -51 -19 -24 Actemra/RoActemra 111 90 69 48 46 NeoRec./Epogin -22 -18 -28 -27 -28 Xolair 13 9 9 12 12 Valcyte/Cymevene 8 10 8 2 9 Bonviva/Boniva -15 -19 -24 -30 -31 Activase/TNKase 23 18 5 15 17 Pulmozyme 8 9 11 12 1 Mircera 30 21 82 63 34 Nutropin 8 1 -21 -15 -9 Madopar 8 7 8 1 4 Rocephin -5 -19 -6 7 3

Pharma Division CER sales growth1 in %

Global top 20 products

1 Q1-Q4/11 vs. Q1-Q4/10, Q1/12 vs. Q1/11 CER = Constant Exchange Rates

Pharma Division sales Q1 2012 (vs. 2011)

Top 20 products

114

Global US W. Europe Japan International % % % % % CHF m CER CHF m CER CHF m CER CHF m CER CHF m CER

MabThera/Rituxan 1,605 7 752 8 413 6 62 8 378 5 Herceptin 1,428 7 405 11 495 2 71 10 457 10 Avastin 1,385 1 634 0 364 -2 156 8 231 4 Pegasys 444 32 155 144 82 1 18 -29 189 14 Lucentis 385 0 385 0 - - - - - - Xeloda 382 15 158 31 65 -1 27 1 132 11 Tarceva 337 10 136 18 88 -7 22 9 91 20 CellCept 220 -19 33 -38 60 -23 16 16 111 -13 Tamiflu 187 -24 74 -56 5 -36 91 85 17 -16 Actemra/RoActemra 184 46 50 87 60 41 44 8 30 91 NeoRec./Epogin 171 -28 - - 65 -20 45 -48 61 -15 Xolair 164 12 164 12 - - - - - - Valcyte/Cymevene 153 9 74 12 39 1 - - 40 12 Bonviva/Boniva 141 -31 70 -32 33 -45 - - 38 -10 Activase/TNKase 140 17 129 19 - - - - 11 2 Pulmozyme 128 1 79 8 26 1 - - 23 -16 Mircera 90 34 - - 31 -25 35 - 24 1 Nutropin 77 -9 75 -9 - - - - 2 -4 Madopar 75 4 - - 23 0 5 -16 47 9 Rocephin 73 3 0 1 16 -12 12 -8 45 14


115

Global US W. Europe Japan International % % % % % CHF m CER CHF m CER CHF m CER CHF m CER CHF m CER

Actemra/RoActemra 184 46 50 87 60 41 44 8 30 91

Mircera 90 34 - - 31 -25 35 - 24 1

Zelboraf 32 - 27 - 5 - - - 0 -

Erivedge 5 - 5 - - - - - - -

Pharma Division sales Q1 2012 (vs. 2011)

Recently launched products


US Western Europe Japan International

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1

MabThera/Rituxan 7 7 5 8 6 8 10 6 -5 -1 -3 8 5 9 25 5 Herceptin 7 4 7 11 5 4 9 2 30 -23 4 10 23 9 32 10

Avastin -15 -16 -9 0 -12 -9 -3 -2 7 2 2 8 8 5 17 4 Pegasys -17 15 47 144 -3 -10 -8 1 -12 -28 -35 -29 -3 15 -1 14

Lucentis 29 17 13 0 - - - - - - - - - - - - Xeloda 2 23 22 31 -1 -1 -8 -1 -9 -9 -9 1 5 6 24 11

Tarceva 1 7 16 18 -12 6 -9 -7 0 2 2 9 22 23 33 20 CellCept -12 2 -14 -38 -27 -35 -34 -23 9 15 7 16 -5 5 -14 -13

Tamiflu -56 - - -56 - * - -36 -68 -55 3 85 -97 -62 205 -16 Actemra/RoActemra 356 153 92 87 67 51 52 41 27 25 15 8 203 177 79 91

NeoRec./Epogin - - - - -28 -26 -23 -20 -11 -42 -42 -48 -13 -8 -7 -15 Xolair 9 9 12 12 - - - - - - - - - - - -

Valcyte/Cymevene 3 -4 0 12 11 8 6 1 - - - - 24 42 3 12 Bonviva/Boniva -31 -36 -36 -32 -12 -21 -34 -45 - - - - 2 7 -8 -10

Activase/TNKase 20 5 17 19 - - - - - - - - 1 7 -4 2 Pulmozyme 11 14 5 8 6 5 1 1 - - - - 3 12 43 -16

Mircera - - - - 16 15 2 -25 - - - - 32 65 35 1 Nutropin 1 -21 -15 -9 - - - - - - - - -7 1 -17 -4

Madopar - - - - -5 6 -4 0 1 -2 -16 -16 15 10 7 9 Rocephin -28 - - 1 -8 -16 17 -12 -12 -4 -2 -8 -25 -5 5 14

116

Pharma Division CER sales growth1 in %

Top 20 products by region

1 Q2-Q4 2011 vs. 2010, Q1 2012 vs. 2011 CER = Constant Exchange Rates * > 500%

117

US

• Sales growth driven by Rituxan, Herceptin,

Xeloda and Zelboraf;

Western Europe

• Continued growth of MabThera, Herceptin

and Zelboraf; some impact of pricing cuts on

Avastin

International

• Continued growth of all oncology products

Japan

• Growth driven by Avastin and Herceptin

Q1 2012: Oncology franchise

1CER = Constant Exchange Rates; Q1 2012 Oncology sales CHF 5.126 bn

+9%

+1%

+6%

Oncology sales

+5%

CH

F b

n

0

2

4

6

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

US Western Europe

International Japan

+5%1

118

MabThera/Rituxan

Q1 2012 sales of CHF 1.605 bn

• 1L maintenance in follicular NHL (Q4 ‘11): top 5 EU penetration rate increased to ~ 69% from ~62% in

Q2 2011. Adoption of 12-infusion maintenance schedule in top 5 EU ~60% in Q4 ‘11 from ~50% in Q2

‘11. We expect further growth in both measures

• CLL: as of Q4 2011 top 5 EU 1st line CLL penetration rate 69% (vs 65% in Q2 2011, 62% in Q4 2010)


CER growth Regional sales

US +8%

Japan +8%

International +5%

CH

F b

n

Global sales

Western Europe +6% 0

0.6

1.2

1.8

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

+7%1

119

Herceptin

Q1 2012 sales of CHF 1.428 bn

• US2: adjuvant use strong with high stable penetration ~94%; 1st line mBC use steady at about 87% (Q1’12)

• WE (top 5 EU, Q4 ‘12): penetration in eBC stable ~84%, 1st line mBC use stable in the 73% range

• US and WE: Stable treatment duration in eBC > 47 weeks (Q1 ‘12 and Q4 ‘11)

• Metastatic gastric cancer: HER2 testing rate ~95% in EU and US (Q1’12)

• Volume growth in all regions (single digit in WE and US and strong double digit in International markets)

• Expanded access in developing countries ongoing

1 CER; 2 penetration is reported as Herceptin eligible patients in the US, and as total patient share in top 5 EU

Japan +10%

Western Europe +2%

International +10%

US +11%

CH

F b

n

+7%1

CER growth Regional sales Global sales

0

0.6

1.2

1.8

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

0

0.6

1.2

1.8

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

120

Avastin

1 CER =Constant Exchange Rates

US 0%

Japan +8%

Western Europe -2%

International +4%

1st line mBC

EU: stabilized (Q4 ‘11)

US: Q1 ’12 low patient share, stable

Japan: indication approved in 2H 2011

1st line mCRC

EU: stable (Q4 ‘11)

US: stable (Q1 ‘12)

Japan: stable (Q1 ‘12)

1st line mNSCLC

EU: stable (Q4 ‘11)

US: stable (Q1 ’12)

Japan: stable (Q1 ‘12)

Avastin New Patient Shares


CH

F b

n

+1%1

121

Q1 2012 sales of CHF 382 m

• In US, increased use in adjuvant CC and monotherapy use in 1L metastatic BC,

partly due to shortage of 5FU.

• Sales growth in the International region driven by China and Latina America

• WE sales impacted by pricing pressure

Xeloda


CH

F b

n

US +31%

Japan +1%

Western Europe -1%

International +11%


0.0

0.1

0.2

0.3

0.4

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

+15%1

122

Q1 2012 sales of CHF 337 m

• US: Q1’12 NSCLC overall penetrations remain steady

• EU: Market penetration in mNSCLC, top 5 EU (Q4 ’11): 2nd line: ~40%; reimbursement in 1st line EGFRmut+ pending. Pricing pressure and competitive challenges continue.

• Japan: sales growth driven by uptake in in 2L NSCLC

Tarceva


Global sales CER growth Regional sales

Japan +9%

Western Europe -7%

CH

F b

n

US +18%

International +20%

0.0

0.1

0.1

0.2

0.2

0.3

0.3

0.4

0.4

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

+10%1

0.0

0.3

0.6

0.9

Q1 '07 Q1 '08 Q1 '09 Q1 '10 Q1 '11 Q1 '12

Japan International

Western Europe US

123

Inflammation/Autoimmune/Transplantation

Q1 2012 IAT sales: CHF 714 m

• Strong growth of Actemra and

MabThera/Rituxan compensated for the

further CellCept decline in US and WE

Actemra/RoActemra

Sales: CHF 184 m (+46%)

• Further gain of patient share in all treatment

lines according to label; US biggest growth

contributor

CellCept

Sales: CHF 220 m (-19%)

• Patent expiry key EU countries end 2010

• US prescription share ~13% (Q4 ‘11)

IAT sales

+4%1

CH

F b

n


+5%

+10%

-1%

+2%

Tamiflu quarterly sales 2008 - 2012

Retail and Governments/Corporations

CHF m

124

Retail

Governments & Corporations

,50 ,36 ,106

,304 ,349

,727

,533 ,422

,170 ,91

,17 ,19 ,3

,45 ,46 ,10

-,1

,65 ,75

,97

,260

,267 ,663

,95

,23 ,7

,48

,233

,7

-,6

,12

,177

-,50

,150

,350

,550

,750

,950

1,150

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 Q4 11 Q1 12

125 125







Diagnostics


126

Global North America EMEA RoW

% CER % CER % CER % CER

CHFm growth CHFm growth CHFm growth CHFm growth

Professional Diagnostics 1,224 9 233 11 607 5 384 15

Diabetes Care 564 -7 119 -5 334 -11 111 5

Molecular Diagnostics 285 8 100 11 112 8 73 5

Applied Science 183 -4 69 -1 66 -12 48 5

Tissue Diagnostics 147 18 94 14 36 21 17 36

Diagnostics Division 2,403 4 615 7 1,155 -1 633 11

Q1 2012: Diagnostics Division CER growth

By Region and Business Area (vs. 2011)


127

Q4 10 Q1 11 Q2 11 Q3 11 Q4 11 Q1 12

CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER

Professional 1,256 13 1,171 10 1,189 7 1,087 10 1,262 8 1,224 9 Diagnostics Diabetes 768 2 637 1 679 2 605 2 731 5 564 -7 Care Molecular 289 1 274 3 270 2 257 3 293 9 285 8 Diagnostics Applied 222 -7 198 -3 179 -5 167 1 196 -6 183 -4 Science Tissue 148 15 128 18 131 15 123 11 160 17 147 18 Diagnostics Dia Division 2,683 6 2,408 6 2,448 5 2,239 6 2,642 7 2,403 4

Diagnostics Division quarterly sales and local

growth1

1 versus same period of prior year CER = Constant Exchange Rates

2011 sales restated from Diabetes Care (full year impact CHF –23 m) to Professional Diagnostics (CHF +23 m full year impact)

CER sales growth CHF 2,403 m

Diagnostics Division sales Q1 2012

Growth driven by Professional Diagnostics, Tissue Diagnostics and Molecular Diagnostics

183

,285

147

1,224

,564

128

4%

-7%

9%

8%

-4%

18%

Diagnostics

Division

Diabetes

Care

Professional

Diagnostics

Molecular

Diagnostics

Applied

Science

Tissue

Diagnostics


Molecular Diagnostics 12%

Professional Diagnostics 51%

Tissue Diagnostics 6%

Diabetes Care 23%

Applied Science 8%

4%

7%

-1%

9%

13%

10%

Diagnostics

Division

North

America

EMEA*

Latin

America

Asia

Pacific

Japan

North America 25%

Latin America 7%

Asia Pacific 14%

CER sales growth CHF 2,403 m

Diagnostics Division sales Q1 2012

Growth driven by North America and Asia Pacific

,615

161

330

142

1,155

129

Japan 6%

EMEA1 48%

1 Europe, Middle East and Africa CER = Constant Exchange Rates

130

0.0

0.4

0.8

1.2

Q1 '10 Q1 '11 Q1 '12

Other POC products Clinical Chemistry Immunoassay

Professional Diagnostics

Continue to grow significantly above market

CHF bn

+9%

+14%

+6%

+4%

2012 vs. 2011 CER growth


131

Diabetes Care

Sales impacted by re-imbursement changes in EMEA

-9%

0.0

0.3

0.5

0.8

Q1 '10 Q1'11 Q1'12

Blood Glucose Insulin Delivery

-7%

+15%

CHF bn



132

Molecular Diagnostics

Strong performance across regions

+3%

+19%

,0

,100

,200

,300

Q1 '10 Q1'11 Q1'12

Other Blood Screening Virology

+8%

CHF m



133

0

50

100

150

200

250

Q1'10 Q1'11 Q1'12

qPCR&NAP Custom Biotech

Genomic Analysis Other

-4%

+1%

+5%

-15%

CHF m 2012 vs. 2011 CER growth

Applied Science

Impact from reduced research funding and competitive pressures


134

0

50

100

150

Q1 '10 Q1 '11 Q1 '12

Other Primary Staining Advanced Staining

Tissue Diagnostics

Growing ahead of market in all regions

+18%

+20%

+9%

CHF m



135

2012: Key planned product launches

Professional Diagnostics

Product Description Region

cobas t 611 Coagulation analyzer for mid and high-throughput

screening in labs

EU

cobas b 123 Benchtop multi-parameter blood gas analyzer for use in critical care settings at the point of care

US

cobas b 101

Multi-parameter blood lipid and glucose analyzer at the

point of care

EU

Elecsys Vitamin D

total assay

measures vitamin D2 and D3 with greater precision US

Elecsys HE4

immunoassay

detects tumor marker HE4 for risk assessment of early

ovarian cancer in patients with pelvic mass (with

biomarker CA125)

US

Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors

EU = European Union; US = United States

136


Accu-Chek Mobile Next-generation strip-free blood glucose monitoring

system with an integrated lancing device

EU

Accu-Chek Nano

SmartView

Small and sleek blood glucose monitoring meter with

enhanced functions, requiring no coding of test strips

US

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

US

SOLO Micropump Insulin micro pump and blood glucose meter that functions

as a handheld controller

EU




Diabetes Care

137


Molecular Diagnostics




cobas 4800 CT/NG

Test

Detection of chlamydia and gonorrhoea infections US

CAP/CTM CMV

Test

Detection and monitoring of cytomegalovirus infections US

138


Applied Science


GS GType TET2/CBL/KRAS & RUNX1 Primer Sets

Gene sequencing primer sets for leukemia research WW


EU = European Union; US = United States ; WW = Worldwide

139


Tissue Diagnostics


BenchMark Special

Stains

Fully automated tissue stainer WW

VENTANA iScan HT High-throughput scanner that enables digital viewing of tissue slides

WW

CINtec p16 Histology IHC (immunohistochemistry) assay for early detection of

cervical cancer

EU, US

ER test Estrogen receptor antibody (IHC) assay to support the

diagnosis of breast cancer

US


EU = European Union; US = United States; WW = Worldwide

140 140







Diagnostics


141

+264 +172

+92

-93

Pharma

Division

Diagnostics

Division

Group Fx Group

CHF

+2% +4% +2% -1%

1


Net fx impact of CHF -357 m or -3%p

+9

-357

1 avg YTD December 2011 to avg YTD March 2012 fx Absolute values at Constant Exchange Rates (CER, at avg full year 2011)

142

+230

+322 +264

+92 -58

-93

Pharma

Division

Diagnostics

Division

Group Tamiflu Group

incl.

Tamiflu

Fx Group

CHF

+3% +4% +3% +2% -1% -24%

1


+3% CER sales growth excl. Tamiflu

-357

1 avg YTD December 2011 to avg YTD March 2012 fx Absolute values at Constant Exchange Rates (CER, at avg full year 2011)

143

0.75

0.80

0.85

0.90

0.95

1.00

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

0.75

0.80

0.85

0.90

0.95

1.00


Year-To-Date averages

Monthly averages

2011

2011 2012

2012

CHF / USD

-2%

144

0.75

0.80

0.85

0.90

0.95

1.00


monthly avg 2012

average full year 2011

monthly avg 2011

-2%

CHF / USD

average Q1 2012

average Q1 2011

145

1.10

1.15

1.20

1.25

1.30

1.35


1.10

1.15

1.20

1.25

1.30

1.35


Year-To-Date averages

Monthly averages

2011

2011

2012

2012

CHF / EUR

-6%

146

1.10

1.15

1.20

1.25

1.30

1.35


monthly avg 2012

average full year 2011

monthly avg 2011

average Q1 2012

CHF / EUR

average Q1 2011

-6%

147

Q1 2012 Q1 2011 Q1 2012 vs. Q1 2011

USD 0.92 0.94

EUR 1.21 1.29

JPY 1.16 1.15

Average exchange rates

-8% -6% -4% -2% 0% 2%

-0.8%

2.5%

Q1

148

Development of

average exchange rates versus prior year period

CHF / EUR -6.1 %

CHF / USD -2.2 %

CHF / JPY +1.5 %

Difference

in CHF / CER -3.3 %p

growth

CHF

growth

CER

growth

Sales

growth

2012

vs. 2011

Exchange rate impact on sales growth

Negative impact in particular from USD and EUR


149

CER

sales

growth

Q1 2012

vs.

Q1 2011

CHF

sales

growth

Q1 2012

vs.

Q1 2011

Exchange rate impact on sales growth

Negative impact in particular from USD and EUR

-0.4%

-0.1%

2.5%

+0.1%

-1.5%

-0.8%

-0.6%

-0.8%

CER EUR USD

Oth

Europe Lat-Am Other As-Pac JPY CHF


150


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