Roche Investor Presentation - YTD September …8e2b3de9-6ed6-4c80-93e2-0a...3 This presentation...

Roche

YTD September 2013 sales

Basel, 17 October 2013

2

3

This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:1 pricing and product initiatives of competitors;2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing

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

6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation;10 loss of key executives or other employees; and11 adverse publicity and news coverage.Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

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

All mentioned trademarks are legally protected.

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GroupSeverin SchwanChief Executive Officer

YTD Sept 2013: Strong sales momentum continues

5CER=Constant Exchange Rates

2013 2012 Change in %CHFbn CHFbn CHF CER

Pharmaceuticals Division 27.2 26.2 4 7

Diagnostics Division 7.7 7.5 2 4

Roche Group 34.9 33.7 3 6

Group: Continued strong sales growth

6All values at constant exchange rates

-3% -5%

0% 0%

1%

4%2%

6%4%

6% 6%4%

8%

6%

-6%

-4%

-2%

0%

2%

4%

6%

8%

10%

Q310

Q410

Q111

Q211

Q311

Q411

Q112

Q212

Q312

Q412

Q113

Q213

Q313

Excluding340B sales

reserves release

Group growth supported by all regions

7All values at constant exchange rates

14%

9%

3%

7%4%

-20%

-15%

-10%

-5%

0%

5%

10%

15%

20%

Q310

Q410

Q111

Q211

Q311

Q411

Q112

Q212

Q312

Q412

Q113

Q213

Q313

US

InternationalJapanEurope

US excl. 340B

H2 2013 Highlights

8

• HER2 franchise: – Perjeta & Herceptin: FDA approval in neo-adjuvant setting– SC Herceptin: Approved in EU– Kadcyla: CHMP positive recommendation

• Etrolizumab: Decision to move to phase III• Lampalizumab: Encouraging phase II data presented• Professional Diagnostics: cobas 8100 launch

Q3 2013

• Actemra Subcutaneous: FDA action date (PDUFA) 21 Oct• GA101: Stage II of CLL11 at ASH; FDA action date (PDUFA) 20 Dec • Lampalizumab: Phase II biomarker data to be presented at AAO

Q4 2013 expected milestones

dual PI3 kinase/mTORsolid tumours

2013: Late-stage enabling milestones

9OncologyNeuroscience Metabolism

Ophthalmology

PI3 kinase solid tumours

anti-EGFL7solid tumours

anti-PCSK9metabolic diseases

crenezumabAlzheimer's

mGlu5treatment-resistant depression

lampalizumabgeographic atrophy


etrolizumabUC and CD

Immunology

onartuzumab (MetMAb)NSCLC

ocrelizumabMS

cobimetinib (MEKi)melanoma

obinutuzumab (GA101)CLL

Kadcyla (EU)HER2+ BC

bitopertinschizophrenia

lebrikizumabasthma

Ph III NMEs

gantenerumab1

Alzheimer’s

HCV DAAHepC

Virology

1Phase II/III label enabling

anti-PDL1solid tumours

Bcl-2i (GDC 0199)hem. cancers

Phase III decision pending

Data readout Q4 2013 / H1 2014

Partnering options

CD22/CD79b ADChem. cancers

Moved to phase III

inclacumab (P selectin)ACS/CVD

alectinib (ALKi)NSCLC

2013 Outlook

101At constant exchange rates; Excluding one-off Past Service Income impact of ~CHF 200m on core net income and excluding 340B reserve release impact of CHF 184m on sales and ~CHF 100m on core net income

Group sales growth1 In line with sales growth recorded in 2012

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

11

Pharmaceuticals DivisionDaniel O’DayCOO Roche Pharmaceuticals

YTD Sept 2013 sales

Innovation

Outlook

12

YTD Sept 2013: Pharma salesUS and Int’l as the major growth contributor

13

2013 2012 Change in % Excl. 340B

CHFm CHFm CHF CER CER

Pharmaceuticals Division 27,190 26,198 4 7 6United States 11,429 10,270 11 12 10

Europe 6,952 6,715 4 2

Japan 2,492 2,966 -16 3

International 6,317 6,247 1 5

CER=Constant Exchange Rates

YTD Sept 2013: Pharma salesOncology, Actemra and Tamiflu main growth drivers

1414

-400 -200 0 200 400 600

Pegasys

Evista

Neorecormon/Epogin

Perjeta

Tamiflu

Actemra/RoActemra

Herceptin

MabThera/Rituxan

Avastin

USEuropeJapanInternational

+13%

+6%

+6%

+33%

+81%

-19%

NM

-19%

-100%

Absolute amounts at 2012 exchange rates; growth at CER=Constant Exchange Rates

YTD Sept 2013 sales: Oncology franchise up 9%

15

CER growth

CER=Constant Exchange Rates Oncology YTD Sept 2013 sales: CHF 16.9bn

Good uptake in 1st line EGFR mut+ NSCLC

Solid demand ahead of the exclusivity loss(EU Dec 2013, US Feb 2014)

Continued uptake in ovarian cancer (EU), increased use in mCRC due to treatment through multiple lines label

Increased share & duration of treatment in DLBCL in Europe driving growth

0.0 2.0 4.0 6.0

Zelboraf

Tarceva

Xeloda

Avastin

HER2

MabThera/Rituxan

+6%

+13%

+3%

+13%

+5%

CHFbn

Herceptin volume growth driven by Asia and LatAm. Solid launch of Perjeta and Kadcyla

Fully penetrated in US, strong growth in Europe+65%

Herceptin

Perjeta

Kadcyla

Avastin: Continued uptake in ovarian cancer and treatment through multiple lines in mCRC

16

0

600

1'200

1'800

Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13

International

Japan

Europe

US

1% 5% 11% 8% 11%YoY CER growth

CHFm

Absolute amounts at 2012 exchange rates; growth at CER=Constant Exchange Rates

-6% -9% -10% -2%

13%14%

• Strong US uptake in HER2+ mBC 2line and beyond • TH3RESA: Kadcyla superior vs. Physicians choice (80% Herceptin) • Positive opinion in Europe

Q3 highlights in HER2 franchise

17

• Encouraging rollout in Europe• US approval of neo-adjuvant HER2+ BC

• Approval in Europe; launched in some major EU countries already

200

300

400

500

Q110

Q210

Q310

Q410

Q111

Q211

Q311

Q411

Q112

Q212

Q312

Q412

Q113

Q213

Q313

Lucentis: Solid growth

18AMD=wet age-related macular degeneration; RVO=retinal vein occlusion; DME=diabetic macular edema

AMD • Benefit from label change in AMD

DME and RVO• Further increase in patient share

Lucentis quarterly sales (USDm)

EyleawAMD

LucentisDME

AMDLess-frequent than

monthly dosing

Actemra/RoActemra: Solid growth in all regions

19

Quarterly sales

SC formulation FDA action date (PDUFA) 21 Oct 2013

0

50

100

150

200

250

300

Q3 12 Q4 12 Q1 13 Q2 13 Q3 13

US Europe Japan International

CHFm +33%+33%

+32%+30%+27%

Subcutaneous (SC)

Subcutaneous

IV

RA global market

~30% ~70%

Growth at CER=Constant Exchange Rates

0

200

400

600

800

1'000

1'200

Q1 Q2 Q3 Q4 Q1 Q2 Q3

E7 Pharma sales: Emerging markets remain strong


H1 12+13%

H2 12+15%

+16%

+28%

+161%

-28%

-14%

+4%

2012 2013

-3%

YoY CER growth

CHFm

+9%H1 13+11%

Brazil

China

IndiaTurkey

Mexico

RussiaKorea

YTD Sept 2013 sales

Innovation

Outlook

21

HER2+ BC: US approval of Perjeta & Herceptin in neoadjuvant setting

22

29.0%

45.8%

16.8%

24.0%

Herceptin +docetaxel

Herceptin& Perjeta

+ docetaxel

Herceptin& Perjeta

Perjeta+ docetaxel

path

olog

ical

com

plet

e re

spon

se

p = 0.0141

CTNeoBC Meta-analysis, FDA

Association of pCR with event-free survival (EFS) in HER2-positive BC Perjeta in neo-adjuvant setting (NEOSPHERE)

Etrolizumab: Decision to start phase IIIUlcerative colitis and Crohn’s disease

23

Best-in-disease in Inflammatory Bowel Disease >3000 patients program

• First subcutaneous gut-selective anti-integrin • Better safety profile with reduced risk of severe infection or

malignancy• PHC through αE expression as potential companion

diagnostics • Further details after discussions with healthcare authorities

FPI H1 2014. Expect first data 2018

Ulcerative colitis Crohn’s disease

Lampalizumab: Encouraging phase II data in Geographic Atrophy

24

Early AMD Intermediate AMDAdvanced AMD

Initially, visual acuity minimally affected; signs are anatomic (drusen and pigmentary changes) with symptoms of visual function impairment (e.g, dark adaptation, contrast sensitivity)

Geographic Atrophy

fovea-threatening

fovea-involved

non fovea-threatening

Wet AMD

High efficacy in subpopulation with exploratory biomarker

• GA progression rate decreased by 44% at 18 months

• All comers: 20.4 % reduction rate at 18 months

YTD Sept 2013 results

Innovation

Outlook

25

dual PI3 kinase/mTORsolid tumours

2013: Late-stage enabling milestones

26OncologyNeuroscience Metabolism

Ophthalmology

PI3 kinase solid tumours

anti-EGFL7solid tumours

anti-PCSK9metabolic diseases

crenezumabAlzheimer's


lampalizumabgeographic atrophy


etrolizumabUC and CD

Immunology

onartuzumab (MetMAb)NSCLC

ocrelizumabMS

cobimetinib (MEKi)melanoma

obinutuzumab (GA101)CLL

Kadcyla (EU)HER2+ BC

bitopertinschizophrenia

lebrikizumabasthma

Ph III NMEs

gantenerumab1

Alzheimer’s

HCV DAAHepC

Virology

1Phase II/III label enabling

anti-PDL1solid tumours

Bcl-2i (GDC 0199)hem. cancers

Phase III decision pending

Data readout Q4 2013 / H1 2014

Partnering options

CD22/CD79b ADChem. cancers

Moved to phase III

inclacumab (P selectin)ACS/CVD

alectinib (ALKi)NSCLC

Planned data presentations in Q4 2013

27

ASH

New Orleans, 7-10 Dec

obinutuzumab (GA101)CLL11 stage II rituximab vs. GA101

New Orleans, 16-19 Nov

lampalizumab(anti-factor D)Phase II biomarker data

2013: Major clinical and regulatory news flow

28Outcome studies are event driven, timelines may change

Compound Indication Milestone

Regulatory

Avastin mCRC (TML) US EU approval

Avastin Newly diagnosed glioblastoma EU filing

Actemra subcutaneous RA US approval

Erivedge Advanced BCC EU approval

Herceptin subcutaneous HER2-positive BC EU approval

Lucentis wAMD (HARBOR) US approval

Perjeta 1st line HER2-positive mBC EU approval

Perjeta Neoadjuvant HER2+ BC US filing US approval

Tarceva EGFR mut+ 1st line NSCLC US approval

Kadcyla 2nd line HER2-positive mBC US EU approval

obinutuzumab (GA101) Front line CLL US approval

Phase III

aleglitazar Metabolic diseases Ph III

obinutuzumab (GA101) Front line CLL Ph III

Tarceva Adjuvant NSCLC Ph III RADIANT

Xolair Chronic idiopathic urticaria Ph III US filing

Milestones previously expected later than 2013

Diagnostics DivisionRoland DiggelmannCOO Roche Diagnostics Picture

29

YTD Sept 2013: Diagnostics sales Growth driven by Professional Diagnostics

30

2013 2012 change in %CHF m CHF m CHF CER

Diagnostics Division 7,677 7,496 +2 +4Professional Diagnostics1 4,227 4,010 +5 +7

Diabetes Care 1,781 1,837 -3 -2

Molecular Diagnostics1 1,188 1,191 0 +2

Tissue Diagnostics 481 458 +5 +6

CER=Constant Exchange Rates; 12012 sales restated for Applied Science integration into Professional Diagnostics and Molecular Diagnostics

4%

0%

3%

12%

12%

1%

DiagnosticsDivision

NorthAmerica

EMEA*

LatinAmerica

AsiaPacific

Japan

North America 25%

CER sales growthCHF 7,677m

YTD Sept 2013: Diagnostics sales Growth driven by Asia Pacific and Latin America

31

1,912

576

1,267

3583,564

Japan 5%

EMEA* 46%

Asia Pacific 16%

Latin America 8%

CER=Constant Exchange Rates; * Europe, Middle East, Africa

32

YTD Sept 2013: Diagnostics highlights

CER growth

+7%

-2%

+2%

+6%

Sales growth driven by HPV (101%), oncology (46%) and qPCR for life sciences (7%)

Strong sales growth from new products and ongoing restructuring initiatives

Strong sales growth in immunoassays (13%), coagulation self monitoring (7%) and workflow automation (23%); launch of lab automation system cobas 8100

Growth driven by IHC1 tests; double digit growth in Europe and emerging markets

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

CHFbn 0 1 2 3 4 5

Tissue Dia

Molecular Dia

Diabetes Care

Professional Dia

EMEANorth AmericaRoW

Professional DiagnosticsLaunch of cobas 8100

33

Automated workflow series for labs• Integrated pre and post analytics• Connectivity and flexible workflow• High throughput and small footprint• Increasing testing efficiency

CE mark in Q3 2013

• Launched in all major EU countries, Singapore, Australia, and Canada.

Integrated cobas 8100

Professional DiagnosticsImmunoassays: Main driver of sales growth

34

Tumourmarkers

Thyroid Cardiac Other Women'shealth

Infectiousdiseases

Anemia CriticalCare

Hormones

14% 12%

22%

10%

12%

7%

YTD Sept: CHF 1.9bn immunoassay sales (+13%)

YoY CER growth

42%16%

7%

CER=Constant Exchange Rates; “Other” include mainly instruments and accessories

Sales

Molecular DiagnosticsStrong sales growth from HPV

35

Increasing share in US market

• Over 200 cobas 4800 systems placed

• YTD sales more than doubled

FDA filing for primary screening• 3 year data from ATHENA to expand label

for primary screening of cervical cancer• Received acceptance of submission

Ongoing pilot studies in Europe• Sweden, Netherlands, UK and Italy

12 high risk HPV pool

HPV Genotype 16

HPV Genotype 18

Three results in one test

cobas HPV Test

Sequencing: Partnership with Pacific Biosciences

36

• Building on single molecule real time technology

• Collaboration agreement:

– Pac Bio responsible for development and manufacturing of new sequencing systems intended for clinical use

– Roche undertakes product specifications, regulatory work and exclusive worldwide distribution in clinical diagnostics market

Key launches 2013

37

Area Product Market BA1

Instruments/

Devices

Labs cobas 8100 – Next generation modular pre-analytics EU RPD

Life Sciences

GS FLX+ long amplicons- Software for long read targeted sequencing WW RMD

Diabetes Care

Accu-Chek Insight- Next generation insulin pump & bGM2 systemAccu-Chek Active LCM- Next-generation bGM2 meter with maltose independent test strips

EU

EU

RDC

RDC

Tests/Assays

Oncology Calcitonin – Medullary thyroid cancerproGRP- Small cell lung cancerCINtec PLUS Cytology- Cervical pre-cancerER- Breast cancerEGFR- Lung cancer

EUEUEUUS US

RPDRPDRTDRTDRMD

Infectious Diseases

MPX 2.0 – Next generation blood screening multiplex test for HIV, HCV & HBVCAP/CTM HCV 2.0 – Next generation HCV viral load test

US

US

RMD

RMD

Transplant Cyclosporin, Tacrolimus – immunosuppressive drug monitoring EU RPD

Sequencing SeqCap EZ Reagent Kits - Targeted next gen. sequencing WW RMD

1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics,RTD: Roche Tissue Diagnostics; 2 blood glucose monitoring

38

FinanceAlan HippeChief Financial Officer

HRSA1 final ruling:340B rebates effective as

of 1 Oct 2013

340B reserve release: One-off effect in Q3 2013

39

1 Oct 2013

Aug2010

July2013

Reserves for 340B rebates for orphan and non-orphan indications

US healthcare reform

340B rebates for non-orphan

indications

Reserve released:Sales CHF +184m

Net income ~CHF +100m

• Rituxan ~55%• Herceptin ~20%• Avastin ~15%

1 Health Resources and Services Administration; 340B Drug Discount Program is a U.S federal government program that requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices

Investment in manufacturing networkEnsure supply and meet pipeline requirements

40

Vacaville

Penzberg

Mammaliancell cultureCHF 260m

Oceanside

Bacterialcell cultureCHF 350m

BaselAntibody-drug

conjugatesCHF 190m

Total investment: CHF 800m over next 5 yearsReactivation of Vacaville plant: write-back of ~CHF 500m one-off non-core income

5.9%

4.1%

8.1%

5.1%

2.7% 2.7%

Q1 Q2 Q3 Q4

Negative exchange rate impact on sales growth in Q3 due to JPY and USD

41

Salesgrowth2013

vs. 2012

Differencein CHF / CER -0.8 %p -1.4 %p -5.4%p

growth

Average exchange rates versus prior year periodCHF / EUR +1.6% +2.4% +2.6%CHF / USD +0.9% +0.7% -3.1%CHF / JPY -13.3% -18.2% -23.0%

CHFgrowth

CERgrowth


Currency impact on Swiss Franc results 2013Moderate currency impact expected

42

Q1 HY Sep YTD

FY

Sales -1 -1 -3 -3

Core operating profit

-1 -3

Core EPS -2 -4

Assuming the 30 Sept 2013 exchange rates remain stable until end of 2013, 2013 impact is expected to be (%p):

0.92 0.92 0.940.95 0.920.930.96 0.95 0.93 0.910.91 0.91

0.93

0.940.93

0.93

0.92

0.94

0.93

0.94

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

CHF / USD

1.23 1.23 1.23 1.22 1.24 1.23 1.24 1.23 1.23 1.231.23 1.23

1.231.23 1.23 1.23

1.20 1.211.201.21

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

CHF / EUR

Average YTD 2012

+1%+1%

-1% -1%

+2% +2% +2% +2%

Assumed average YTD 2013

Fx rate at 30 September 2013

Monthly avg fx rates 2013

2013 Outlook

431At constant exchange rates; Excluding one-off Past Service Income impact of ~CHF 200m on core net income and excluding 340B reserve release impact of CHF 184m on sales and ~CHF 100m on core net income

Group sales growth1 In line with sales growth recorded in 2012

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

44

Doing now what patients need next

4545

Roche Group development pipeline

Marketed products development programmes

Roche Pharma global development programmes

Roche Pharma research and early development

Genentech research and early development

Roche Group YTD Sept 2013 sales

Diagnostics

Foreign exchange rate information

Changes to the development pipelineQ3 2013 update

46

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

1 NMERG7863 TLR7 agonist (2) HBV1 AIRG3638 onartuzumab liver cancer

2 NMEsRG7440 ipatasertib (AKT inhibitor) solid tumorsRG7314 V1 receptor antag autism1 AIRG3616 Erivedge acutemyelogenous leukemia

2 AIs submissions in EURG435 Avastin rel. ovarian ca. Pt-resistantRG1569 Actemra early RA1 AI submission to FDARG3648 Xolair chronic idiopathicurticaria

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

3 NMEsRG7129 BACE1 inh Alzheimer’sRG7420 MEK inh solid tumorsWT-1 peptide cancer vaccine(removed by Chugai)

1 NMERG7414 parsatuzumab (EGFL7 MAb) solid tumors

1 AI following publication ofresults at ECC 2013RG3502 Kadcyla HER2+mBC 3rd line

1 AI EU approvalRG597 Herceptin HER2+ BC scformulation1 AI US approvalRG1273 Perjeta HER2+ BC neoadjuvant

Status as of September 30, 2013

Phase I (31 NMEs + 6 AIs)

MEK inh solid tumorsRG7167

Raf & MEK dual inh solid tumorsRG7304

GABRA5 NAM cognitive disordersRG1662GIP/GLP-1 dual ago type 2 diabetesRG7697

PI3K inh solid tumorsRG7604

PI3K inh solid tumorsCHU

Bcl-2 inh heme indicationsRG7601

ADC NaPi2b ADC oncologyRG7599

ChK1 inh solid tum & lymphomaRG7602

Tweak MAb oncologyRG7212

ADC ADC multiple myelomaRG7598

Oncology Other disease areas

IL-6R MAb RACHU


HER3 MAb solid tumorsRG7116CSF-1R MAb solid tumorsRG7155

MDM2 ant solid & hem tumorsRG7388

IL-17 MAb autoimmune diseases RG7624

TLR7 agonist HBVRG7795

ADC ADC oncologyRG7600

Lucentis sust. deliv. AMD/RVO/DMERG3645


47

ETBR ADC metastatic melanomaRG7636PI3k inh glioblastoma 2L RG7666ChK1 inh(2) solid tum & lymphomaRG7741

IL-31R MAb atopic dermatitis CHU

FIXa /FX FIXa /FX bispecific MAb hemophilia ACHU

New Molecular Entity (NME)Additional Indication (AI)

OncologyImmunologyInfectious DiseasesCardioMetabolismNeuroscienceOphthalmologyOthers

RG-No Roche Genentech managedCHU Chugai managed

PDE10A inh schizophrenia RG7203

Ang2-VEGF MAb oncologyRG7221

PD-L1 MAb+Zelboraf m. melanoma RG7446

- infectious diseasesRG7745

- metabolic diseases RG7410

- solid tumorsRG7842

Steap 1 ADC prostate ca.RG7450MUC16 ADC ovarian ca.RG7458

PD-L1 MAb+Avastin solid tumors RG7446PD-L1 MAb solid tumorsRG7446

TLR7 agonist (2) HBVRG7863

onartuzumab liver cancer HCC RG3638

CD44 MAb solid tumorsRG7356

Phase II (26 NMEs + 11 Als)

Phase III(6 NMEs + 20 Als)

Registration(2 NMEs + 6 Als)

1 US only: ongoing evaluation for FDA submission2 Submitted in EU3 Submitted in EU, US filing pending4 Approved in US, submitted in EU5 Submitted in US

Avastin glioblastoma 1st lineRG4353

New Molecular Entity (NME) Additional Indication (AI)

RG-No Roche Genentech managedCHU Chugai managedRG105 MabThera is branded as

Rituxan in US and JapanRG1569 Actemra is branded as

RoActemra in EU

OncologyImmunologyInfectious DiseasesCardioMetabolismNeuroscienceOphthalmology

Kadcyla HER2+ pretreat. mBCRG35024

obinutuzumab (GA101) CLLRG7159

Perjeta HER2+ early BC

Avastin HER2-neg. BC adj

Tarceva NSCLC adjKadcyla HER2+ mBC 1st line

Perjeta HER2+ gastric cancer

Avastin ovarian cancer 1st line

Avastin NSCLC adjAvastin high risk carcinoid

Avastin rel. ovarian ca. Pt-sensitive

onartuzumab NSCLC 2nd/3rd lineRG3638

RG1273

RG4351

Xolair chronic idiopathic urticariaRG36485

Avastin HER2+ BC adjRG435

RG435

bitopertin schiz neg symptomsRG1678

RG435

RG435

RG1415RG3502

ocrelizumab RMSRG1594

bitopertin schiz subopt controlRG1678

obinutuzumab (GA101) DLBCLRG7159

ocrelizumab PPMSRG1594

Suvenyl enthesopathyCHU

lebrikizumab severe asthmaRG3637

Avastin rel. ovarian ca. Pt-resistantRG4353

Kadcyla HER2+ early BCRG3502

Zelboraf m. melanoma adjRG7204cobimetinib combo Zelboraf m. melanomaRG7421

RG4351

oral octreotide acromegalyRG3806

RG1273

Actemra early RA RG15693

Actemra giant cell arteritisRG1569

MabThera NHL sc formulationRG1052

Zelboraf papillary thyroid cancerRG7204

mericitabine HCVRG7128

onartuzumab mCRC 1st lineRG3638

danoprevir HCVRG7227

mGlu5 NAM tx.resistant depressionRG7090

inclacumab ACS/CVDRG1512

quilizumab asthmaRG7449

etrolizumab ulcerative colitisRG7413

crenezumab Alzheimer’sRG7412

MAO-B inh Alzheimer’s RG1577mGlu2 NAM depressionRG1578

apitolisib (PI3K/mTOR) solid&hem tumorsRG7422

setrobuvir HCVRG7790

pictilisib pictilisib (PI3K inh) solid tumorsRG7321

Actemra systemic sclerosisRG1569

HER3/EGFR MAb m. epithelial tumorsRG7597

onartuzumab NSCLC non squamous 1st lRG3638onartuzumab NSCLC squamous 1st line RG3638onartuzumab glioblastoma 2nd line RG3638

Erivedge operable BCCRG3616

Kadcyla (T-DM1) HER2+ gastric cancerRG3502

pinatuzumab vedotin (CD22 ADC) hem tumorsRG7593polatuzumab vedotin (CD79bADC) hem tumorsRG7596

bitopertin obsessive compulsive dis.RG1678

rontalizumab systemic lupus erythemRG7415

- CMV RG7667

lampalizumab (factor D) geo. atrophyRG7417

PD-L1 MAb NSCLC 2nd/3rd lineRG7446

PCSK9 MAb metabolic diseasesRG7652

Perjeta HER2+ mBC 2nd lineRG1273

alectinib (ALK inhibitor) NSCLCRG7853

gantenerumab Alzheimer’sRG1450

onartuzumab gastric cancerRG3638

Bcl-2 inh CLL rel/refract 17pdelRG7601

obinutuzumab (GA101) iNHL relapsedRG7159obinutuzumab (GA101) iNHL front-lineRG7159

glypican-3 MAb liver cancerRG7686



V1 receptor antag autism RG7314

ipatasertib (AKT inh) solid tumorsRG7440

Erivedge AMLRG3616

Actemra RA sc formulationRG1569

NME submissions and their additional indicationsProjects currently in phase 2 and 3

49

Unless stated otherwise, submissions are planned to occur in US and EU* lead market China indicates a submission which has occurred with regulatory action pending# negative symptoms and sub-optimal control

NeuroscienceOphthalmologyNME

OncologyImmunologyInfectious DiseasesCardioMetabolism

bitopertin (RG1678)schizophrenia#

obinutuzumab (GA101)

CLL

onartuzumab (MetMAb)mNSCLC, 2nd/3rd line

ocrelizumab (RG1594)PPMS and RMS

obinutuzumab (GA101) iNHL relapsed


cobimetinib MEKi(RG7421) combo Zelboraf

met melanoma

mericitabine (RG7128)HCV

danoprevir*(RG7227) HCV

pictilisib PI3Ki(RG7321) solid tumors

mGlu5 NAM (RG7090)depression

crenezumab (RG7412)Alzheimer‘s

gantenerumab (RG1450)Alzheimer‘s

V1 receptor antag (RG7314)autism

mGlu2 NAM (RG1578)depression

apitolisib PI3K/mTORi(RG7422) solid & hem tumors

HER3/EGFR MAb (RG7597)m. epithelial tumors

glypican-3 MAb (RG7686)liver cancer

quilizumab (RG7449) asthma

lampalizumab anti-factor D(RG7417) geo atrophy

lebrikizumab (RG3637) asthma

etrolizumab (RG7413) ulcerative colitis

bitopertin (RG1678)obsessive compulsive dis.

2013 2014 2015 2016 and beyond

onartuzumab (MetMAb)gastric cancer & other AIs

(RG7667)CMV

oral octreotide (RG3806)acromegaly

pinatuzumab vedotin, RG7593 CD22 ADC heme tumors

obinutuzumab (GA101)Frontline NHL

alectinib ALKi(RG7853) NSCLC

PD-L1 MAb (RG7446) NSCLC 2nd/3rd line

obinutuzumab (GA101)DLBCL

Bcl-2 inh (RG7601)CLL and NHL

ipatasertib AKTi(RG7440) solid tumors

MAO-B inh (RG1577)Alzheimer‘s

polatuzumab vedotin, RG7596CD79b ADC heme tumors

TarcevaNSCLC adj

AvastinNSCLC adj

2013 2014 2015 2016 and beyond

*Avastin (EU)glioblastoma 1st line

Avastin HER2-pos BC adj

AvastinHER2-neg BC adj

**Avastin (US)ovarian cancer 1st line

OncologyImmunologyInfectious diseasesCardioMetabolism

NeuroscienceOphthalmology

indicates submission to Health Authorities has occurred.* US filing pending** Approved in EUUnless stated otherwise, submissions are planned to occur in US and EU.

**Avastin (US)rel. ovarian ca. Pt-sens

Submissions of additional indications for existing productsProjects currently in phase 2 and 3

50Status as of September 30, 2013

Actemra

systemic sclerosis

Zelboraf

papillary thyroid cancer

Perjeta

HER2-pos EBC

Perjeta

HER2-pos mBC 2ndline

Perjeta

HER2-pos. gastric cancer

Zelborafmet melanoma adj.

KadcylaHER2-pos mBC 1st line

KadcylaHER2-pos gastric cancer

Kadcyla (T-DM1)HER2-pos early BC

Perjeta (US)

HER2-pos BC neoadjuvantAvastin

cervical cancer

Actemra

giant cell arteritis*Actemra (EU)

early RA

Xolair (US)chronic idiopathic urticaria

*Avastin (EU)rel. ovarian ca. Pt-resist

onartuzumabNSCLC 1L EGFR mut+

Erivedge

AML

EU

US

Approved Pending approvals

Major granted and pending approvals 2013

51

HerceptinHer2-pos BC sc formulation

September 2013

LucentisAMD 0.5 mg PRN

February 2013


Actemrapolyarticular JIA

April 2013

ActemrapolyarticularJIA

May 2013

MabThera ANCA associated vasculitis

April 2013

KadcylaHER2-pos pretreated mBC

February 2013

KadcylaHER2-pos advanced mBC

Filed Aug 2012

PerjetaHER2-pos mBC 1st line

March 2013



Erivedgeadv. basal cell carcinoma

July 2013

TarcevaNSCLC EGFR mut+ 1st line

May 2013

MabTheraNHL sc formulation

Filed Dec 2012

ActemraRA sc formulation

Filed Dec 2012

ActemraRA sc formulation

Filed Dec 2012

AvastinmCRC TML

January 2013

Avastinglioblastoma 1st line

Filed Mar 2013

PerjetaHER2-pos BC neoadjuvant

September 2013

obinutuzumabCLL

Filed Apr 2013

obinutuzumabCLL

Filed Apr 2013

Xolairchronic idiopathic urticaria

Filed July 2013

Avastinrel. ovarian ca. Pt-resistFiled September 2013

Actemraearly RA

Filed June 2013

Major Chugai granted and pending approvals 2013

52

Pending approvals


TarcevaNSCLC EGFR mut 1st line

June 2013

Boniva/Bonviva iv.osteoporosis

June 2013



Avastinovarian cancer

Filed October 2012

Avastinmalignant glioma

June 2013

PerjetaHER2-pos mBC

June 2013

KadcylaHER2-pos mBC

September 2013

Actemrasc formulationMarch 2013

Approved

alectinibALK-pos rec/adv NSCLC

Filed October 2013

53


5454







Diagnostics


MabThera/RituxanOncology development programme

55

Patient population Front-line follicular non-Hodgkin’s lymphoma Previously untreated chronic lymphocytic leukemia

Phase/study

Phase IIISABRINA

Subcutaneous studyStudy being conducted ex-US

Phase IbSAWYER

Subcutaneous studyStudy being conducted ex-US

# of patients N=405 N=225

Design • ARM A: MabThera iv plus chemotherapy (CHOP or CVP)• ARM B: MabThera 1400mg SC plus chemotherapy

(CHOP or CVP)Two-stage design:

o Stage 1 (dose confirmation, N=127): PK primaryendpoint

o Stage 2 (N=280): Efficacy primary endpoint (ORR)Responders will continue on maintenance every 8 weeks

over 24 months

• Two-stage design:- Stage 1 (dose-finding, N=55)

- Stage 2 (N=170): CLL dose confirmation:• ARM A: MabThera iv plus chemotherapy

(fludarabine and cyclophosphamide)• ARM B: MabThera 1600mg sc plus chemotherapy

(fludarabine and cyclophosphamide)

Primary endpoint

• Pharmacokinetics, safety and efficacy • Part 1: PK (dose selection)• Part 2: PK of MabThera iv versus MabThera sc

(arm A vs arm B)

Status • Stage 1 primary endpoint (PK noninferiority) met• Presented at ASH 2012• Filed with EMA Q4 2012

• FPI (stage 2) Q3 2012• Stage 1 data presented at ASH 2012

Subcutaneous MabThera: applies Enhanze technology, partnered with HalozymeCHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone; CVP=Cyclophosphamide, Vincristine and PrednisoloneASH=American Society of Hematology.

AvastinOvarian cancer clinical development programme

56

Patient population

Front-line metastatic ovarian cancer

Phase/study Phase III GOG-0218

Phase III ICON7

# of patients N=1,873 N=1,528

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)

Avastin dose

• 15 mg/kg q3 weeks • 7.5 mg/kg q3 weeks

Primary endpoint

• Progression-free survival • Progression-free survival

Status • Study met its primary endpoint in Q1 2010• Data presented at ASCO 2010 and 2011• Results: NEJM 2011 Dec 29;365(26):2484-96

• Study met its primary endpoint Q3 2010• Data presented at ESMO 2010 and ASCO 2011• Results: NEJM 2011 Dec 29;365(26):2473-83• OS data presented at ECC 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; ECC=European Cancer CongressNEJM=New England Journal of Medicine

AvastinOvarian cancer clinical development programme

57

Patient population

Relapsed Platinum-sensitive ovarian cancer

Relapsed Platinum-resistantovarian cancer

Phase/study Phase IIIOCEANS

Phase IIIAURELIA


Design • ARM A: Carboplatin, gemcitabine, and concurrent placebo for 6-10 cycles, followed by placebo alone until disease progression

• ARM B: Carboplatin, gemcitabine, and concurrent Avastin for 6-10 cycles, followed by Avastin alone until disease progression.

• ARM A: Paclitaxel, topotecan or liposomal doxorubicin

• ARM B: Paclitaxel, topotecan or liposomal doxorubicin plus Avastin

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

Status • Study met its primary endpoint Q1 2011• Data presented at ASCO 2011• EMA approval received Q4 2012• Re-evaluate FDA submission when final overall

survival results from all phase III trials are available (expected 2013)

• Study met its primary endpoint Q2 2012• Data presented at ASCO 2012• Filed in EU Q3 2013• OS data presented at ECC 2013

ASCO=American Society of Clinical Oncology; ECC=European Cancer Congress

AvastinCervical cancer clinical development programme

58

Patient population Stage IVB, recurrent or persistent cervical cancer

Phase/study Phase IIIGOG-240

# of patients N=452

Design • ARM A: Paclitaxel, cisplatin• ARM B: Paclitaxel, cisplatin plus Avastin• ARM C: Paclitaxel, topotecan• ARM D: Paclitaxel, topotecan plus Avastin

Avastin dose • 15 mg/kg q3 weeks

Primary endpoint

• Progression-free survival

Status • Study met its primary endpoint Q1 2013• Data presented at ASCO 2013• To be filed globally 2014

ASCO=American Society of Clinical Oncology

Patient population High risk carcinoid Newly diagnosed glioblastoma First-line HER2-negative

metastatic breast cancer

Phase/study Phase IIISWOG SO518

Phase IIIAVAglio

Phase IIIMERiDiAN

# of patients N=424 N=920 N=480

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

• ARM A: Paclitaxel + Avastin• ARM B: Paclitaxel + Placebo

Avastin dose • 15 mg/kg q3 weeks • 10 mg/kg q2 weeks or 15 mg/kg q3 weeks • 10 mg/kg q2 weeks

Primary endpoint

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

• PFS in ITT• PFS in patients with high plasma

VEGF-A

Status • Recruitment completed• Expect data 2013/2014

• Co-primary endpoint of PFS met Q3 2012• Overall survival data presented at ASCO 2013• Filed in EU Q1 2013

• FPI Q3 2012

AvastinHigh risk carcinoid, brain and breast cancer development programmes

59TMZ=temozolomide; ASCO=American Society of Clinical Oncology

AvastinAdjuvant clinical development programme

60

Patient population

Adjuvant lung cancer

Adjuvant breast cancer

Phase/study Phase IIIECOG 1505

Phase IIIECOG 5103

HER2-negative

Phase IIIBETH

HER2-positive

# of patients N=1,500 N=4,950 N=3,600

Design • ARM A: Cisplatin plus vinorelbine, docetaxel, gemcitabine or pemetrexed

• ARM B: Cisplatin plus vinorelbine, docetaxel, gemcitabine or pemetrexedplus 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

• 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 • 15 mg/kg q3 weeks

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

Status • FPI Q3 2007• Recruitment ongoing• Expect data 2016

• Enrolment completed Q2 2011• Expect data 2014

• Enrolment completed Q4 2010• Expect data 2013

Herceptin Standard of care for HER2-positive early breast cancer

61

Patient population

Early-stage HER2-positivebreast cancer

Phase/studyPhase IIIHANNAH

Subcutaneous study

# of patients N=595

Design • 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

• Serum concentration • Pathologic complete response

Status • Data presented at EBCC 2012• Filed in EU Q1 2012• EU approval received Q3 2013

Subcutaneous Herceptin: applies Enhanze technology, partnered with HalozymeEBCC=European Breast Cancer Conference

PerjetaFirst in a new class of HER dimerization inhibitors

62

Patient population Neoadjuvant HER2-positive breast cancer Adjuvant HER2-positive breast

cancer

Phase/ study Phase IINEOSPHERE

Phase IITRYPHAENA

Phase IIIAPHINITY

# of patients N=417 N=225 N=4,800

Design • ARM A: Herceptin plus docetaxel• ARM B: Perjeta (840mg loading,

420mg q3w) plus Herceptin and docetaxel

• ARM C: Perjeta plus Herceptin• ARM D: Perjeta plus docetaxel

• 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: Perjeta (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)

Primary endpoint

• Pathologic complete response (pCR)

• Safety • Invasive disease-free survival (IDFS)

Status • Positive data presented at SABCS 2010

• Biomarker data presented SABCS 2011

• Positive safety and efficacy data presented at SABCS 2011

• Recruitment completed Q3 2013

• Filed in US Q2 2013• FDA approval granted Q3 2013• EU submission under evaluation

FEC=Fluorouracil, Epirubicin, and Cyclophosphamide; TCH=Docetaxel, Carboplatin, Herceptin; SABCS=San Antonio Breast Cancer Symposium.

PerjetaFirst in a new class of HER dimerization inhibitors

63

Patient population

Second-line HER2-positive metastatic breast cancer

Advanced HER2-positive gastric cancer

Advanced HER2-positive gastric cancer

Phase/ study Phase IIPHEREXA

Phase IIaJOSHUA

Phase IIIJACOB


Design • ARM A: Herceptin plus Xeloda

• ARM B: Perjeta plus Herceptin and Xeloda

• ARM A: Perjeta (840mg loading, 420mg q3w) plus Herceptin and chemotherapy

• ARM B: Placebo plus Herceptin and chemotherapy

• ARM A: Perjeta (840mg loading, 420mg q3w) plus Herceptin and chemotherapy

• ARM B: Placebo plus Herceptin and chemotherapy

Primary endpoint

• Progression-free survival • Safety, efficacy • Overall survival

Status • Recruitment completed Q3 2013


• PK endpoint met• Data presented at ECC 2013

• FPI Q2 2013

ECC=European Cancer Congress

Kadcyla (T-DM1)Evaluating new treatment options in HER2-positive breast cancer

64In collaboration with ImmunoGen, Inc.1 Patients must have received prior treatment which included both: a taxane, alone or in combination with another agent, and Herceptin in the adjuvant, locally advanced, or metastatic setting.ASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology; ECC=European Cancer Congress

Patient population

Patients who have progressed on HER2 targeted treatment

PretreatedHER2 pos. metastatic breast

cancer1

Previously untreatedHER2 pos. metastatic breast

cancer

Phase/study Phase IIITH3RESA

Phase IIIEMILIA

Phase IIIMARIANNE

# of patients N=600 N=991 N=1,092

Design • ARM A: Kadcyla 3.6mg/kg q3w • ARM B: physician’s choice

• ARM A: Kadcyla 3.6mg/kg q3w • ARM B: Xeloda plus lapatinib

• ARM A: Herceptin plus taxane• ARM B: Kadcyla 3.6mg/kg q3w

plus Perjeta• ARM C: Kadcyla 3.6 mg/kg q3w

plus placebo

Primary endpoint

• Progression free survival and overall survival

Co-primary endpoints:• Progression-free survival (PFS)• Overall survival

• Progression-free survival assessed by IRF

Status • PFS endpoint met Q2 2013• Data presented at ECC 2013

• PFS data presented at ASCO 2012• OS data presented at ESMO 2012• Submitted for FDA and EMA

approval Q3 2012• FDA approval granted Q1 2013• Positive CHMP opinion received Q3

2013

• Recruitment completed Q2 2012• Expect data in 2014

Kadcyla (T-DM1)Evaluating new treatment options in HER2-positive breast and gastric cancers

65In collaboration with ImmunoGen, Inc.

Patient population

HER2-positive early breast cancer high-risk patients

Previously Treated Locally Advanced Or Metastatic Her2-

Positive Gastric Cancer

Phase/study Phase IIIKATHERINE

Phase II/IIIGATSBY

# of patients N=1,484 N=412

Design • ARM A: Kadcyla 3.6mg/kg q3w • ARM B: Herceptin

• ARM A: Kadcyla 3.6mg/kg q3w • ARM B: Kadcyla 2.4mg/kg weekly • ARM C: Docetaxel or paclitaxel

Primary endpoint

• Invasive disease-free survival (IDFS) • Phase II: Dose-finding• Phase III: Overall survival

Status • FPI Q1 2013 • FPI Q3 2012

TarcevaNew approaches to treating lung cancer

66

Patient population

Adjuvant non-small cell lung cancer

Phase/study Phase IIIRADIANT

# of patients N=974 (2:1 randomisation)

Design • Following surgical resection ± adjuvant chemotherapy:• ARM A: Tarceva up to 2 years • ARM B: Placebo up to 2 years

Primary endpoint

• Disease-free survival• EGFR IHC and/or FISH-positive

Status • Enrolment completed Q3 2010• Expect final results H2 2013

Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a subsidiary of Astellas US, LLC

Zelboraf®

A selective novel small molecule that inhibits mutant BRAF

67In collaboration with Plexxikon, a member of Daiichi Sankyo GroupECC=European Cancer Congress; SMR=Society for Melanoma ResearchSee also combinations with: cobimetinib (MEK inhibitor) and anti-PDL1 (RG7446)

Patient population

Adjuvant therapy in patients with resected cutaneous BRAF mutation positive

melanoma

Previously treated papillary thyroid cancer

BRAF mutation positive

Melanoma patients with brain metastases


Phase/study Phase IIIBRIM8 Phase II Phase II


Design 52-week treatment• ARM A: Zelboraf 960mg bid• ARM B: Placebo

• Single ARM: Zelboraf • Single ARM: Zelboraf

Primary endpoint

• Disease-free survival • Best overall response rate • Overall response rate in the brain

Status • FPI Q3 2012 • Recruitment completed Q3 2013

• Data presented at ECC 2013


• To be presented at SMR 2013

Erivedge A novel small molecule inhibitor of the hedgehog signaling pathway

68In collaboration with Curis

Patient population

Operable basal cell carcinoma

Locally advanced or metastatic basal cell carcinoma

Acute myelogenous leukemia and relapsed refractory high-risk myelodysplastic syndrome

Phase/study Phase II Phase IISTEVIE Phase II

# of patients N=74 N=1,200 N=60

Design • Single ARM: 150 mg Erivedge orally once daily

• Single ARM: 150 mg Erivedge orally once daily

• ARM A: 150mg Erivedge orally once daily

• ARM B: Cytarabine

Primary endpoint

• COHORT 1: Complete clearance (12 weeks Erivedge)

• COHORT 2: Durable complete clearance (12 weeks Erivedge)

• COHORT 3: Complete clearance (16 weeks Erivedge)

• Safety: incidence of adverse events • Overall response rate

Status • Recruitment completed Q3 2013• Cohort 1 data presented at Society

for Investigative Dermatology (May 2012)

• FPI Q2 2011 • FPI Q3 2013

Actemra/RoActemraInterleukin 6 receptor inhibitor

69

Patient population

Early moderate-to-severe rheumatoid arthritis

Moderate-to-severe rheumatoid arthritis

Moderate-to-severe rheumatoid arthritis

Phase/study Phase IIIFUNCTION

Phase IIISUMMACTA

Subcutaneous study

Pivotal Phase IIIBREVACTA

Subcutaneous study

# of patients N=1,162 N=1,262 N=656

Design 104 week treatment• ARM A: Actemra IV 8 mg/kg q4w

plus placebo 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

• 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• ARM A: Actemra SC 162mg q2w• ARM B: Placebo SC q2w

Primary endpoint

• DAS28 remission at 24 weeks, 1 year and 2 years

• ACR 20 at week 24 • ACR 20 at week 24

Status • Primary endpoint met Q3 2012• Data presented at EULAR 2013• Filed in EU Q3 2013

• Primary endpoint met Q2 2012• Presented at ACR 2012• Filed in US and EU in Q4 2012

• Primary endpoint met Q3 2012• Presented at ACR 2012• Filed in US and EU in Q4 2012

In collaboration with ChugaiMTX=methotrexate; DMARD=Disease-Modifying Anti-Rheumatic DrugsEULAR=The European League Against Rheumatism, ACR=American College of Rheumatology

Actemra/RoActemraInterleukin 6 receptor inhibitor

70

Patient population Systemic sclerosis Giant Cell Arteritis

Phase/studyPhase II

faSScinateProof-of-concept study

Phase IIIGiACTA


Design Blinded 48-week treatment with weekly dosing:•ARM A: Actemra SC 162mg •ARM B: Placebo SC

Open-label weekly dosing at weeks 49 to 96:•Actemra SC 162mg

Part 1: 52-week blinded period • ARM A: Actemra SC 162mg qw + 26 weeks

prednisone taper• ARM B: Actemra SC 162mg q2w + 26 weeks

prednisone taper• ARM C: Placebo+ 26 weeks prednisone taper• ARM D: Placebo+ 52 weeks prednisone taper

Part II: • 104-weel open label extension – patients in remission

followed off of the study drug; Patients with active disease receive open label Actemra SC 162mg qw

Primary endpoint

• Change in modified Rodnan skin score (mRSS) at week 24

• Safety

• Proportion of patients in sustained remission at week 52

Status • Recruitment completed Q2 2013• Expect data H1 2014

• FPI Q3 2013

In collaboration with Chugai

XolairEvaluating potential in chronic idiopathic urticaria, an IgE related disease

71In collaboration with Novartis*Refractory to H1 anti-histamines, H2 blockers, and/or leukotriene receptor antagonists (LTRAs) at the time of randomization.AAAAI=American Academy of Allergy, Asthma and ImmunologyEAACI-WAO=European Academy of Allergy and Clinical Immunology – World Allergy OrganizationEADV=European Academy of Dermatology and Venereology

Patient population

Chronic idiopathic urticariaPatients who remain symptomatic despite treatment*

Phase/study Phase IIIASTERIA I

Phase IIIASTERIA II

Phase IIIGLACIAL


Design Add-on therapy to H1 anti-histamines24 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-histamines12 week treatment period(q4-week)•ARM A: Xolair 300 mg•ARM B: Xolair 150 mg•ARM C: Xolair 75 mg•ARM D: Placebo

Add-on therapy to H1 anti-histamines, H2 blockers, and/or LTRA24 week treatment period(q4-week)•ARM A: Xolair 300 mg•ARM B: Placebo

Primary endpoint

• Change from baseline in UAS7 weekly itch score at Week 12

• Change from baseline in UAS7 weekly itch score at Week 12

• Safety

Status • Enrolment completed Q1 2012• Presented at EADV 2013

• Enrolment completed Q4 2011• Presented at AAAAI 2013

• Enrolment completed Q1 2012• Data presented at EAACI-WAO

2013

• Filed in US Q3 2013

7272







Diagnostics


Onartuzumab (MetMAb, RG3638)Anti-Met monovalent antibody that inhibits HGF-mediated activation

73

Patient population

2nd- and 3rd-lineMet-positive metastatic NSCLC 1st line non-squamous NSCLC 1st line squamous NSCLC

Phase/study Phase IIIMetLung Phase II Phase II


Design • ARM A: Tarceva plus onartuzumab• ARM B: Tarceva plus placebo

Cohort 1•Arm A: Onartuzumab + Avastin + paclitaxel + platinum-based chemo (cisplatin or carboplatin) •Arm B: Placebo + Avastin + paclitaxel + platinum-based chemo (cisplatin or carboplatin)Cohort 2•Arm A: Onartuzumab + pemetrexed + platinum-based chemo (cisplatin or carboplatin)•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

• Overall survival • Progression-Free Survival in the ITT population

• Progression-Free Survival in Met-positive patients

• Progression-Free Survival in the ITT population

• Progression-Free Survival in Met-positive patients

Status • Recruitment completed Q3 2013 • FPI Q2 2012 • FPI Q3 2012


74

Patient population

Metastatic HER2-negative gastroesophageal cancer

Metastatic HER2-negative gastroesophageal cancer

Phase/study Phase IIIMetGastric Phase II


Design • ARM A: Onartuzumab plus mFOLFOX6

• ARM B: Placebo plus mFOLFOX6

• ARM A: Onartuzumab plus mFOLFOX• ARM B: Placebo plus mFOLFOX

Primary endpoint

• Overall survival in Met-positive patients

• Progression–free survival in ITT• Progression-free survival in pre-

specified Met-positive patients


mFOLFOX6=modified FOLFOX (Folinic acid, Fluorouracil, Oxaliplatin)


75

Patient population

1st-line metastatic colorectal cancer

Avastin-naïve recurrent glioblastoma

Hepatocellular carcinoma

Advanced NSCLC Met-positive with EGFR

activating mutation

Phase Phase II Phase II Phase I Phase III

# of patients N=188 N=120 N=54 N=300

Design • ARM A: FOLFOX plus Avastin plus onartuzumab

• ARM B: FOLFOX plus Avastin plus placebo

• Arm A: Onartuzumab + Avastin

• Arm B: Placebo + Avastin

• Arm C: Onartuzumab+Placebo (enrolment to arm C suspended)

• Single-agent onartuzumab in combination with sorafenib

• Arm A: Onartuzumab + Tarceva

• Arm B: Placebo + Tarceva

Primary endpoint

• Progression–free survival in ITT

• Progression-free survival in pre-specified Met-positive patients

• Progression-Free Survival in the ITT population

• Progression-Free Survival in Met-positive population

• Safety • Progression-Free Survival

Status • Enrolment completed Q4 2012

• Expect data 2014

• FPI Q3 2012 • FPI Q3 2013 • Expect FPI Q4 2013

FOLFOX=Folinic acid, Fluorouracil, Oxaliplatin

Cobimetinib (RG7421, GDC-0973)Selective small molecule inhibitor of mitogen-activated protein kinase kinase

76

Patient population

Previously untreated metastatic melanoma


Metastatic melanomaBRAF mutation positive Solid tumors Solid tumors

Phase/study Phase IIIcoBRIM

Phase IbBRIM7 Phase Ib Phase Ib

# of patients N=500 N=~100 N=212 N=108

Design • ARM A: Zelboraf1 plus cobimetinib

• ARM B: Zelboraf1 plus placebo

• Dose escalation study evaluating Zelboraf1plus cobimetinib

• Dose escalation study evaluating cobimetinib plus pictilisib (PI3 kinase inhibitor)

• Dose escalation study of cobimetinib in combination with ipatasertib2 (AKT inhibitor)

Primary endpoint


• Safety/PK • Safety/PK • Safety/PK

Status • FPI Q1 2013• Expect data 2014

• FPI Q1 2011• Data presented at

ESMO 2012• Updated data

presentation at EADO and ECC 2013

• FPI Q4 2009• Updated data presented

at ASCO 2012

• FPI Q2 2012

Cobimetinib in collaboration with Exelixis1Zelboraf In collaboration with Plexxikon, a member of Daiichi Sankyo Group; 2ipatasertib in collaboration with Array BioPharmaESMO=European Society for Medical Oncology; ECC=European Cancer Congress; EADO=European Association of Dermato-Oncology

Obinutuzumab (GA101, RG7159) Type II, glycoengineered anti-CD20 monoclonal antibody

77

Patient population

Front-line chronic lymphocytic leukaemia

Patients with comorbidities

Previously untreated chronic lymphocytic leukaemia (CLL)

Previously untreated or relapsed/refractory chronic

lymphocytic CLL

Phase/study Phase IIICLL11

Phase IGALTON

Phase IIIGREEN


Design • ARM A: GA101 1000mg iv plus chlorambucil• ARM B: MabThera/Rituxan plus chlorambucil• ARM C: Chlorambucil alone

• Cohort A: GA101 plus bendamustine• Cohort B: GA101 plus fludarabine

plus cyclophosphamide

• Single-arm cohort study: GA101 alone or in combination with different chemotherapy regimens (FC,Bendamustin or Clb)

Primary endpoint

• Progression-free survival • Safety • Safety in combination with different chemotherapy regimens

Status • Stage 1 analysis (ARM A/B vs. ARM C) positive

• Stage 1 analysis presented at ASCO 2013• Breakthrough status and priority review

granted by the FDA Q2 2013• Filed globally Q2 2013• Stage 2 analysis (ARM A vs. ARM B) positive • Updated Stage 1 and Stage 2 results to be

presented at ASH

• Recruitment completed• Expect data presentation late 2013

• Expect FPI Q4 2013

In collaboration with Biogen IdecASCO=American Society of Clinical Oncology, ASH=American Society of Hematology

Obinutuzumab (GA101, RG7159) Type II, glycoengineered anti-CD20 monoclonal antibody

78In collaboration with Biogen IdecCHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, Vincristine and Prednisolone

Patient population

Indolent non-Hodgkin’s lymphoma

MabThera/Rituxan refractory

Diffuse large B-cell lymphoma (DLBCL)

Front-line indolent non-Hodgkin’s lymphoma

Phase/study Phase IIIGADOLIN

Phase IIIGOYA

Phase IIIGALLIUM

# of patients N=360 N=1,400 N=1,400

Design • ARM A: GA101 1000mg iv plus bendamustine

• ARM B: bendamustine

• ARM A: GA101 1000mg iv plus CHOP

• ARM B: MabThera/Rituxan plus CHOP

• ARM A: GA101 1000mg iv plus chemotherapy followed by GA101 maintenance

• ARM B: MabThera/Rituxan plus chemotherpy followed by MabThera/Rituxan maintenance

Chemotherapy:• For follicular lymphoma: CHOP, CVP

or bendamustine• For non-follicular lymphoma:

physician’s choice

Primary endpoint

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

Status • FPI Q2 2010• Expect data 2015

• FPI Q3 2011• Expect data 2015

• FPI Q3 2011• Expect data 2017

Bcl-2 inhibitor (RG7601, GDC-0199) Novel small molecule Bcl-2 selective inhibitor

79

Patient population

Relapsed/Refractory CLL with 17p deletion Relapsed CLL and SLL Relapsed/Refractory

CLL and NHL

Relapsed/Refractory or previously

untreated CLL

Relapsed/Refractory or previously

untreated CLL

Phase/study Phase II Phase Ib Phase I Phase I Phase I

# of patients N=100 N=50 N=52 N=70 N=70

Design • Single-agent RG7601 • Dose-escalation study in combination with MabThera/Rituxan

• Dose-escalation study • RG7601 in combination with MabThera/Rituxan and bendamustine

• RG7601 in combination with obinutuzumab(GA101)

Primary endpoint

• Safety/MTD • Safety/MTD • Safety/PK/Response rate

• Safety/MTD • Safety/MTD

Status • FPI Q3 2013 • FPI Q3 2012 • FPI Q2 2011• NHL data presented at

ASH 2012• CLL and NHL data

presented at ASCO 2013

• FPI Q2 2013 • FPI Q4 2012

Joint project with AbbVie in collaboration with WEHI (The Walter and Eliza Hall Institute)CLL=Chronic Lymphocytic Leukemia; NHL=Non-Hodgkin's Lymphoma; SLL=Small Lymphocytic LymphomaASH=American Society of Hematology; ASCO=American Society of Clinical Oncology

Bcl-2 inhibitor (RG7601, GDC-0199) Novel small molecule Bcl-2 selective inhibitor

80

Patient population Relapsed/Refractory multiple myeloma Relapsed/Refractory multiple myeloma

Phase/study Phase I Phase I


Design Patients receiving Bortezomib and Dexamethasone as standard therapy:• Dose escalation cohort:

RG7601+bortezomib+dexamethasone• Safety expansion cohort:

RG7601+bortezomib+dexamethasone

• Dose escalation cohort• Safety expansion cohort

Primary endpoint

• Safety/MTD • Safety/MTD


Joint project with AbbVie in collaboration with WEHI (The Walter and Eliza Hall Institute)

Anti-PDL1 (MPDL3280A, RG7446)Novel approach in cancer immunotherapy

81

Patient population

Locally advanced or metastatic NSCLC

PD-L1 positive

Locally advanced or metastatic NSCLC

(2nd/3rd line)Solid tumors

Phase/study Phase IIFIR

Phase IIPOPLAR Phase I


Design Single arm study• 1200mg of Anti-PDL1 q3w

for maximum of 16 cycles

• ARM A: RG7446 1200mg IV q3w, up to 16 cycles

• ARM A: Docetaxel IV q3w

• Dose escalation study

Primary endpoint

• Efficacy and safety • Overall survival • Safety/PK

Status • FPI Q2 2013 • FPI Q3 2013 • FPI Q2 2011• Initial efficacy data presented

at ASCO 2013• Updated data presented at

ECC 2013

ASCO=American Society of Clinical Oncology; ECC=European Cancer Congress

Anti-PDL1 (MPDL3280A, RG7446)Novel approach in cancer immunotherapy

82

Patient population Solid tumors

Previously untreated metastatic melanoma BRAF

mutation positive



Design • ARM A: Anti-PDL1+Avastin• ARM B: Anti-PDL1+Avastin+

chemotherapy

• Three-arm study with different doses of anti-PDL1-Zelboraf combination

Primary endpoint

• Safety/PK • Safety/PK


Patient population Non-small cell lung cancer

Phase Phase I Phase II

# of patients N=90-100 N=215

Design • Dose escalation to MTD Patients with ALK mutation that failed crizotinib• Part 1: Dose escalation monotherapy• Part 2: Monotherapy, dose selected

based on the results of Part 1

Primary endpoint

• Safety and efficacy • Safety and efficacy

Status • Study in crizotinib-naïve patients in Japan completed; crizotinib-failure patients in US ongoing

• Data presented at ECC 2013• Japan study results: Lancet Oncology

2013 Jun;14(7):590-8• Filed in Japan October 2013

• FPI Q2 2013

• Breakthrough designation granted by the FDA in Q3 2013

Alectinib (ALK inhibitor, RG7853, AF802)New potent inhibitor of anaplastic lymphoma kinase

83In collaboration with ChugaiECC=European Cancer Congress

Lebrikizumab (RG3637) A humanized monoclonal antibody designed to bind specifically to IL-13

84

Severe uncontrolled adult asthma

Patient population

Adult patients whoseasthma is uncontrolled with inhaled corticosteroids and a second controller medication

Phase/study Phase IIILAVOLTA I

Phase IIILAVOLTA II


Design Subcutaneous lebrikizumab q4w on top of SOC for 52 weeks safety follow-up•ARM A: Lebrikizumab high dose•ARM B: Lebrikizumab low dose•ARM C: PlaceboPatients will be tested for periostin level

Subcutaneous lebrikizumab q4w on top of SOC for 52 weeks safety follow-up•ARM A: Lebrikizumab high dose•ARM B: Lebrikizumab low dose•ARM C: PlaceboPatients will be tested for periostin level

Primary endpoint

• Rate of asthma exacerbations during the 52-week placebo-controlled period




85

Severe uncontrolled adult asthma

Patient population

Adult patients whoseasthma is uncontrolled with inhaled corticosteroids and a second controller medication

Phase/study Phase IIbLUTE

Phase IIbVERSE


Design Subcutaneous lebrikizumab q4w on top of SOC for 28 to 52 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: PlaceboPatients will be tested for periostin level

Subcutaneous lebrikizumab q4w on top of SOC for 28 to 52 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: PlaceboPatients will be tested for periostin level

Primary endpoint



Status • Recruitment completed Q4 2012• Data publication in 2014

• Recruitment completed Q4 2012• Data publication in 2014


86

Patient population

Adolescent patients whoseasthma is uncontrolled with inhaled corticosteroids

and a second controller medicationIdiopathic pulmonary fibrosis

Phase/study Phase IIIACOUSTICS

Phase IIRIFF


Design Subcutaneous lebrikizumab q4w on top of SOC for 52 weeks with 52 week double-blind active treatment extension ARM A: Lebrikizumab high dose, week 1-104 or week 52-104•ARM B: Lebrikizumab low dose, week 1-104 or week 52-104•ARM C: Placebo, week 1-52

•ARM A: Lebrikizumab SC q4w•ARM B: Placebo

Primary endpoint



Status • FPI Q3 2013 • Expect FPI Q4 2013

Etrolizumab (RG7413) A humanized monoclonal antibody against beta 7 integrin

87

Patient population Ulcerative colitis

Phase/study Phase IIEUCALYPTUS

# of patients N=120

Design ARM A: Etrolizumab (100mg) plus immunosuppressant ARM B: Etrolizumab (300mg) plus immunosuppressant•ARM C: Placebo plus immunosuppressant

Primary endpoint

• Clinical Remission (Mayo Clinic Score) at Week 10

Status • Primary endpoint met Q4 2012• Presented at DDW 2013

DDW=Digestive Disease Week

Bitopertin (GlyT-1, RG1678)A small molecule first-in-class glycin reuptake inhibitor (GRI)

88PANSS=Positive and Negative Syndrome Scale

Patient population Sub-optimally controlled symptoms of schizophrenia

Phase/study Phase IIINIGHTLYTE

Phase IIIMOONLYTE

Phase IIITWILYTE


Design •Add-on therapy to anti-psychotics

•52-week treatment period•ARM A: bitopertin daily (10 mg)

•ARM B: bitopertin daily (20 mg)

•ARM C: Placebo

•Add-on therapy to anti-psychotics



•ARM C: Placebo




•ARM C: Placebo

Primary endpoint

•PANSS positive symptom factor at week 12



Status • FPI Q4 2010 •FPI Q4 2010 •Recruitment completed Q3 2013

Bitopertin (GlyT-1, RG1678)A small molecule first-in-class glycin reuptake inhibitor (GRI)

89PANSS=Positive and Negative Syndrome Scale

Patient population

Persistent, predominant negative symptoms of schizophrenia

Obsessive-compulsive disorder

Phase/study Phase IIISUNLYTE

Phase IIIDAYLYTE

Phase IIIFLASHLYTE

Phase IISKYLITE

# of patients N=630 N=630 N=630 N=99

Design •Add-on therapy to anti-psychotics

•52-week treatment period•ARM A: bitopertin (10 mg)

•ARM B: bitopertin (20 mg)

•ARM C: Placebo




•ARM C: Placebo




•ARM C: Placebo

•16-week treatment period

•Background therapy of selective serotonin reuptake inhibitors (SSRI)•ARM A: bitopertindaily (30 mg)•ARM B: bitopertindaily (10 mg)•ARM C: Placebo

Primary endpoint

•PANSS negative symptom factor at week 24



•Change in total score on Yale-Brown Obsessive Compulsive Scale

Status • FPI Q4 2010 •Enrolment completed Q2 2013

•Enrolment completed Q2 2013

•FPI Q4 2012

Ocrelizumab (RG1594)2nd generation anti-CD20 monoclonal antibody

90

Patient population Relapsing multiple sclerosis (RMS) Primary progressive

multiple sclerosis (PPMS)

Phase/study Phase IIIOPERA I

Phase IIIOPERA II

Phase IIIORATORIO


Design • 96-week treatment period:• ARM A: Ocrelizumab 2x 300

mg iv followed by 600 mg iv every 24 weeks

• ARM B: Interferon β-1a

• 96-week treatment period:• ARM A: Ocrelizumab 2x 300

mg iv followed by 600 mg iv every 24 weeks

• ARM B: Interferon β-1a

• 120-week treatment period:• ARM A: Ocrelizumab 2x 300

mg iv every 24 weeks • ARM B: Placebo

Primary endpoint

• Annualized relapse rate at 96 weeks versus Rebif

• Annualized relapse rate at 96 weeks versus Rebif

• Sustained disability progression versus placebo by Expanded Disability Status Scale (EDSS)

Status • Enrolment completed Q1 2013 • Enrolment completed Q1 2013 • Enrolment completed Q1 2013

Gantenerumab (RG1450)Fully human monoclonal antibody against amyloid-beta

91

Patient population Prodromal Alzheimer’s Disease

Phase/study Phase II/IIISCarlet RoAD

# of patients N=770

Design 104-week subcutaneous treatment period•ARM A: Gantenerumab (225 mg)•ARM B: Gantenerumab (105 mg)•ARM C: Placebo

Primary endpoint

• Change in CDR-SOB at 2 years• Sub-study: change in brain amyloid by PET at 2 years

Status • FPI Q4 2010• Phase I PET data: Archives of Neurology 2012 Feb;69(2):198-207

In collaboration with MorphosysCDR-SOB=Clinical Dementia Rating scale Sum of Boxes

Mericitabine (RG7128)Nucleoside NS5B polymerase inhibitor added to approved protease inhibitors in prior null responders to IFN/RBV

92

Patient population

Treatment-naive and failurechronic hepatitis CGenotype 1 and 4

Treatment-naive and failure chronic hepatitis CGenotype 1 and 4

Phase/study Phase IIbDYNAMO 1*

Phase IIbDYNAMO 2

Longer duration study

# of patients N=120 N= 120

Design • ARM A: Boceprevir + mericitabine (1000 mg BID) + Pegasys and Copegus for 24 weeks

• 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 Copegusfor 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 Pegasysand Copegus for 24 weeks

• ARM C : Telaprevir + mericitabine (1000 mg BID) + Pegasysand Copegus for 12 weeks, followed by Pegasys and Copegusfor 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)

Status • Recruitment completed Q3 2012• Data submitted to AASLD 2013

• Recruitment completed Q3 2012• Data submitted to AASLD 2013

Mericitabine (RG7128) licensed from Pharmasset, now part of Gilead* In collaboration with Merck

Mericitabine, danoprevir, setrobuvirIFN-free combination of different direct-acting antivirals in treatment naïve patients

93

Patient population Hepatitis C patientsTreatment-naïve or null-responders to interferon-based treatment

Phase/study Phase IIANNAPURNA

# of patients N=110

Design • ARM A: GT1a including setrobuvir, danoprevir, ritonavir, ribavirin and mericitabine• ARM B: GT1a including setrobuvir, danoprevir, ritonavir, ribavirin and mericitabine• ARM C: GT1a including setrobuvir, danoprevir, ritonavir and ribavirin• ARM D: GT1b including setrobuvir, danoprevir, ritonavir, ribavirin and mericitabine• ARM E: GT1b including setrobuvir, danoprevir, ritonavir and ribavirin

Primary endpoint • Sustained virological response at week 12 after the end of the study treatment

Status • FPI Q2 2012• Recruitment Part 1 completed in Q4 2012• Interim data submitted to AASLD 2013

Mericitabine (RG7128) licensed from Pharmasset, now part of Gilead; Danoprevir=RG7227; Setrobuvir=RG7790AASLD=American Association for the Study of Liver Diseases

Patient population

Treatment-experienced chronic hepatitis C patients*

PhasePhase IIb

MatterhornBoosted Danoprevir in Triple, Quad and Interferon-free combinations

# of patients N=381

Design Danoprevir boosted by low dose ritonavir in IFN-free, triple and QUADCohort 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 weeksCohort 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 • Sustained virological response 24 weeks after the end of study treatment

Status • Recruitment completed Q3 2011• Preliminary data presented at AASLD 2012• Manuscript submission late 2013

Danoprevir, mericitabineComparing IFN-free, IFN-based triple and IFN-based quad regimens in patients who failed IFN/RBV

94Mericitabine (RG7128) licensed from Pharmasset, now part of Gilead; Danoprevir=RG7227AASLD=American Association for the Study of Liver Diseases

9595







Diagnostics


Molecule MDM2 (4) antagonist(RG7388)

MEK inhibitor(CIF, RG7167)

Raf/MEK inhibitor(CKI27, RG7304)

Patient population Solid tumors Acute myeloid leukemia Solid tumors Solid tumors

Phase Phase I Phase I Phase I Phase I

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

Design • Multiple ascending dose-escalation study

• Multiple ascending dose-escalation study

• Dose-escalation, followed by expansion into 4 cohorts in specific indications

• Dose-escalation to MTD

Primary endpoint

• MTD • MTD • MTD and tumor assessment

• MTD and tumor assessment

Status • Completed Q2 2013 • FPI Q1 2013 • Recruitment into expansion cohorts completed Q4 2011

• Data presented at EORTC-NCI-AACR 2012

• Initiated Q4 2008• Enrolment stopped in Q4

2010

Collaborator Chugai

Oncology development programmesSmall molecules

96

Oncology development programmesMonoclonal antibodies

97

Molecule Anti-glypican-3 MAb(GC33, RG7686)

Anti-CD44 MAb(RG7356)

Patient population

Metastatic liver cancer(hepatocellular carcinoma)

2L metastatic liver cancer(hepatocellular carcinoma) Solid tumors Acute myelogenous

leukemia

Phase Phase Ib Phase II Phase I Phase I

# of patients N= 40-50 N=171 N=50-70 N=86

Design • Study US monotherapy• Study Japan monotherapy• Dose escalation study in

combo with SoC

Adaptive design studyDouble blind randomized 2:1 RG7686 : placebo

Patients are stratified according to the level of GPC-3 expression in tumor

• Multiple ascending dose study with extension and imaging arm

• Multiple ascending dose study +/- cytarabine

Primary endpoint

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

• Safety (MTD), PK, PD, preliminary clinical activity

Status • FPI Q4 2008• Dose escalation completed

for US and Japan monotherapy studies

• Dose escalation ongoing for Ph1b combo with SoC


• Final results expected H2 2013

• FPI Q2 2011 • FPI Q3 2012

Collaborator Chugai

SoC=standard of care

Oncology development programmesMonoclonal antibodies (continued)

98

Molecule Anti-TWEAK MAb(RG7212)

GE-huMAb HER3(RG7116)

Patient population Solid tumors Solid tumors

HER2-low and HER3-positive metastatic breast

cancer

Phase Phase I Phase I Phase I


Design • Multiple ascending dose study

• Multiple ascending dose study with extension cohorts and imaging sub-study

• Combination arms with HER1-targeted therapies (erlotinib, cetuximab)

• Multiple ascending dose of RG7116 in combination with Perjeta and paclitaxel

Primary endpoint

• Safety, PK, PD • Safety, PK • Safety, PK

Status • FPI Q3 2011 • FPI Q4 2011 • FPI Q3 2013

Oncology development programmesMonoclonal antibodies (continued)

99

Molecule CSF-1R huMAb(RG7155)

Ang2-VEGF MAb(RG7221)

Patient population Solid tumors Solid tumors

Phase Phase I Phase I

# of patients N≈95 N≈80

Design • Multiple ascending dose study +/- paclitaxel with extension cohorts

• Multiple ascending dose study with extension cohort to assess the PD effects

Primary endpoint

• Safety, PK, PD & preliminary clinical activity

• Safety

Status • FPI Q4 2011• Biomarker data presented at

AACR 2013

• FPI Q4 2012

AACR=American Association for Cancer Research

Metabolic development programmes

100

Molecule Inclacumab(P-selectin huMAb, RG1512)

Patient population

Prevention of saphenous vein graft diseasePatients undergoing coronary artery bypass graft

(CABG) surgery

Acute Coronary Syndrome (ACS) Patients undergoing Percutaneous Coronary

Intervention (PCI)

Phase/study Phase IISELECT-CABG

Phase IISELECT-ACS


Design 32-week treatment period•ARM A: Inclacumab (20 mg/kg)•ARM B: Placebo

Single infusion•ARM A: Inclacumab (5 mg/kg)•ARM B: Inclacumab (20 mg/kg)•ARM C: Placebo

Primary Endpoint

•Sapheneous vein graft re-occlusion •Procedural damage (troponin)

Status • Recruitment completed Q2 2012• Data in-house Q3 2013

• Recruitment completed• Data presented at ACC 2013

• Candidate for partnering-out

Collaborator Genmab

ACC=American College of Cardiology

Metabolic development programmes

101FSI=First Subject In

Molecule GLP-1/GIP dual agonist (MAR709, RG7697)

NME(RG7410)

Patient population Type 2 diabetes Metabolic diseases



Design • ARM A: RG7697 SC• AMR B: placebo

• RG7410 single dose• Placebo

Primary Endpoint

• Safety, PK • Safety

Status • MAD study ongoing • FSI Q3 2013

Collaborator Marcadia Biotech, Inc. acquisition

Neuroscience development programmes

102

Metabotropic glutamate receptor pathway

MoleculemGlu2 Negative Allosteric

Modulator (NAM)(RG1578)

mGlu5 Negative Allosteric Modulator (NAM)(RG7090)

Patient population

Adjunctive Treatment of Major Depressive

Disorder

Adjunctive Treatment of Major Depressive

DisorderFragile X Syndrome

Phase/study Phase IIArtDeCo

Phase IIMarigold

Phase IIFragxis

Phase IIFoXtail

# of patients N=480 N=300 N=180 N=45 Pediatric patients

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

ARM A: RG7090 Dose A ARM B: RG7090 Dose B ARM C : Matching

Placebo

Primary endpoint

• Efficacy - Montgomery Asberg Depression Rating Scale

• Efficacy - Montgomery Asberg Depression Rating Scale

• Efficacy, safety and tolerability

• Safety• Exploratory efficacy and

tolerability

Status • Recruitment ongoing• Expect data H1 2014

• Recruitment completed• Expect data H2 2013

• Recruitment ongoing• Expect data H1 2014

• Recruitment initiated• Expect data H1 2014


103

MoleculeMonoamine oxidase type B

(MAO-B) inhibitor(RG1577, EVT-302)

V1 receptor antagonist(RG7314)

PDE10A inhibitor(RG7203)

Patient population Alzheimer’s Disease Autism Schizophrenia

Phase Phase IIbMAyflOwer RoAD Phase II Phase I


Design • 52-week oral treatment• ARM A: RG1577 (dose 1)• ARM B: RG1577 (dose 2)• ARM C: placebo

• Multi-center, randomized, double-blind, placebo-controlled proof-of-concept study in individuals with Autism Spectrum Disorder (ASD)

• Double-blind, multiple-ascending dose, placebo controlled study in healthy volunteers

• Open-label single-dose PET study in HV

Primary endpoint

• Changes in ADAS-Cog at 52 weeks • Safety and efficacy • Safety, PK• Target engagement

Status • FPI Q4 2012 • FPI Q3 2013 • SAD completed• MAD FPI Q2 2013• SD PET FPI Q3 2013

Collaborator Evotec

HV=Healthy Volunteers


104

Molecule GABRA5 negative allosteric modulator (NAM)(RG1662)

Patient population Down Syndrome

Phase Phase I Phase Ib


Design • Molecular and functional imaging study in individuals with DS and HV

• Multi-center, randomized, double-blind, placebo-controlled, multiple dose study in individuals with Down Syndrome

Primary endpoint

• GABAA alpha5 receptor expression, occupancy and functional connectivity

• Safety, tolerability

Status • FPI Q3 2012 • Recruitment completed Q3 2013

DS=Down Syndrome; HV=Healthy Volunteers

Infectious diseases programmes

105

Molecule TLR7 agonist(RG7863)

Patient population Chronic hepatitis B

Phase Phase I

# of patients N=60

Design • Healthy volunteer study• ARM A: Single ascending dose of RG7863• ARM B: Placebo

Primary endpoint

• Safety

Status • FPI Q3 2013

106







Diagnostics



107

Angiogenic signaling

Molecule Parsatuzumab(Anti-EGFL7 MAb, RG7414)

Patient population

First-line metastaticnon-small cell lung cancer

First-line metastaticcolorectal cancer

Phase/study Phase IINILE

Phase IICONGO


Design • Parsatuzumab plus Avastin plus carbo/tax vs Avastin plus carbo/tax

• ARM A: Parsatuzumab plus Avastin plus FOLFOX

• ARM B: Avastin plus FOLFOX

Primary endpoint

• PFS • PFS

Status • Enrolment completed Q3 2012• Primary endpoint not met Q3 2013

• Enrolment completed Q3 2012• Interim analysis suggests primary

endpoint unlikely to be met

*SCCHN=Squamous Cell Carcinoma of the Head and Neck; AACR=American Association for Cancer ResearchFOLFOX=Folinic acid, Fluorouracil, Oxaliplatin; FOLFIRI=Folinic acid, Fluorouracil, Irinotecan


108

Growth factor signaling

Molecule Anti-HER3 EGFR DAF MAb(RG7597)

Patient population

Metastatic/recurrent SCCHN*

KRAS wild-type metastatic colorectal cancer

1L recurrent/metastatic squamous cell carcinoma

of head and neck

Phase/study Phase IIMEHGAN

Phase IIDARECK Phase Ib


Design • ARM A: RG7597• ARM B: Cetuximab

• ARM A: RG7597+FOLFIRI• ARM B:

Cetuximab+FOLFIRI

Evaluating safety/tolerability with two chemo backbones• Arm A: Cisplatin/5-FU• Arm B:

Carboplatin/Paclitaxel

Primary endpoint

• Progression-free survival • Progression-free survival • Safety, DLT, PK

Status • Recruitment completed Q2 2013

• FPI Q4 2012 • FPI Q3 2013

*SCCHN=Squamous Cell Carcinoma of the Head and Neck; AACR=American Association for Cancer ResearchFOLFOX=Folinic acid, Fluorouracil, Oxaliplatin; FOLFIRI=Folinic acid, Fluorouracil, Irinotecan

Oncology development programmesAntibody drug conjugates

109AACR=American Association for Cancer Research, ASCO=American Society of Clinical Oncology

Antibody drug conjugates (ADCs)

Molecule Anti-STEAP1 ADC(RG7450)

Anti-MUC16 ADC(RG7458)

NME ADC(RG7598)

Patient population Prostate cancer Ovarian cancer Multiple myeloma


# of patients N=49 N=57 N=30-45

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

Primary endpoint

• Safety • Safety/PK • Safety

Status • FPI Q1 2011• Data presented at ASCO 2013

• FPI Q2 2011• Safety and PK data presented at

AACR 2013

• FPI Q3 2011

Collaborator Seattle Geneticsand Agensys Seattle Genetics

Oncology development programmesAntibody drug conjugates (continued)

110


Molecule Anti-NaPi ADC ADC(RG7599)

NME ADC(RG7600)

Anti-ETBR ADC(RG7636)

Patient population NSCLC and ovarian cancer Pancreatic and ovarian cancer Metastatic or unresectable

melanoma


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

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

Primary endpoint

• Safety • Safety • Safety

Status • FPI Q2 2011• Safety and efficacy data presented

at ASCO 2013

• FPI Q4 2011 • FPI Q1 2012

CollaboratorSeattle Genetics

ASCO=American Society of Clinical Oncology

Oncology development programmesADC’s for hematological cancers

111


Molecule Pinatuzumab vedotin(Anti-CD22, RG7593)

Pinatuzumab vedotin (RG7593) vs. polatuzumab vedotin

(RG7596)

Polatuzumab vedotin(Anti-CD79b, RG7596)

Patient population

Hematologic malignancies Non-Hodgkin's Lymphoma Hematologic malignancies

Phase Phase I Phase II Phase I


Design • Dose escalation study • RG7593 plus Rituxan• RG7596 plus Rituxan


Primary endpoint

• Safety • Safety and anti-tumor activity • Safety

Status • Recruitment completed Q4 2012• Dose escalation data presented at

ASH 2012• Efficacy data presented at ICML

2013

• FPI Q3 2012 • Recruitment completed Q4 2012• Dose escalation data presented at

ASH 2012• Efficacy data presented at ICML

2013

Collaborator Seattle Genetics

ASH=American Society of Hematology; ICML=International Conference on Malignant Lymphoma

Oncology development programmesSmall molecules

112

PI3K signaling

Molecule Pictilisib(PI3 Kinase inhibitor, GDC-0941, RG7321)

Patient population 2L ER+ metastatic breast cancer Previously untreated advanced or

recurrent NSCLC

Locally recurrent or metastatic HER2-negative HR-positive

breast cancer

Phase Phase IIFERGI

Phase IIFIGARO

Phase IIPEGGY


Design • ARM A: pictilisib plus hormonal therapy

• ARM B: apitolisib plus hormonal therapy (ARM B discontinued)

• ARM C: Hormonal therapy + placebo

• ARM A: Pictilisib + carboplatin + paclitaxel

• ARM B: Placebo + carboplatin + paclitaxel

• ARM C: Pictilisib+ carboplatin + paclitaxel + bevacizumab

• ARM D: Pictilisib+ carboplatin + paclitaxel + bevacizumab

• ARM A: Pictilisib+ paclitaxel• ARM B: Placebo + paclitaxel

Primary endpoint

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


Oncology development programmesSmall molecules (continued)

113

PI3K signaling

Molecule PI3 Kinase inhibitor (GDC-0032, RG7604)

PI3 Kinase inhibitor (GDC-0084, RG7666)

Patient population

Solid tumors and HER2-negative HR-positive breast cancer

HER2-negative locally recurrent or metastatic breast cancer

Progressive or recurrent high-grade glioma

Phase Phase I/II Phase I Phase I


Design Phase I• RG7604• RG7604 plus letrozole or fulvestrant

Phase II• RG7604 plus fulvestrant

• RG7604 plus docetaxel• RG7604 plus paclitaxel


Primary endpoint

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

Status • FPI Q1 2011• Pre-clinical and clinical data

presented at AACR 2013

• FPI Q2 2013 • FPI Q2 2012

AACR=American Association for Cancer Research

PI3K signaling

Molecule Apitolisib(PI3 Kinase/mTOR dual inhibitor, GDC-0980, RG7422)

Patient population Renal cell carcinoma Persistent or recurrent

endometrial carcinoma2L Castration-resistant

prostate cancer

Phase Phase II ROVER

Phase IIMAGGIE Phase Ib/II


Design • ARM A: apitolisib• ARM B: Everolimus

• Single-arm apitolisib • ARM A: RG7440 + abiraterone

• ARM B: apitolisib + abiraterone

• ARM C: Placebo + abiraterone

Primary endpoint

• PFS • PFS • Safety (Ph Ib)• PFS (Ph II)

Status • Enrolment completed Q3 2012

• Enrolment completed Q3 2012

• FPI Q1 2012


114


115

MoleculeIpatasertib

(AKT inhibitor, GDC-0068, RG7440)

Patient population Solid tumors 2L Castration-resistant

prostate cancer Solid tumors1L metastatic gastric or

gastroesophageal junction adenocarcinoma

Phase Phase Ib Phase Ib/IIA.MARTIN Phase Ib Phase II

JAGUAR

# of patients N=90 N=262 N=62 N=120

Design Dose escalation with:•ARM A: docetaxelor •ARM B: fluoropyrimidineplus oxaliplatinor•ARM C: paclitaxel

• ARM A: ipatasertib + abiraterone

• ARM B: apitolisib + abiraterone

• ARM C: Placebo + abiraterone

• Dose escalations study of cobimetinib (MEK inhibitor)* in combination with ipatasertib

• ARM A: ipatasertib + mFOLFOX6

• ARM B: Placebo + mFOLFOX6

Primary endpoint

• Safety • Safety (Ph IB)• PFS (Ph II)

• Safety/PK

Status • FPI Q3 2011• Data presented at ASCO

and ESMO 2012

• Ph II FPI Q3 2013 • FPI Q2 2012 • FPI Q3 2013

Collaborator Array BioPharma

*Cobimetinib in collaboration with ExelixisASCO=American Society of Clinical Oncology; ESMO=European Society for Medical OncologymFOLFOX6=modified FOLFOX (Folinic acid, Fluorouracil, Oxaliplatin)

116

Molecule ChK1 inhibitor(GDC-0425, RG7602)

ChK1 inhibitor(GDC-0575, RG7741)

NME(GDC-0094, RG7842)

Patient population Solid tumors or lymphoma Solid tumors or lymphoma Solid tumors

Phase I Phase I Phase I Phase I


Design • Dose escalation study • Dose escalation study • Stage 1: dose escalation• Stage 2: cohort expansion

Primary endpoint

• Safety/PK • Safety/PK • Safety, MTD, PK


Collaborator Array BioPharma


117

Molecule Quilizumab(Anti-M1 prime, RG7449)

Lampalizumab(Anti-Factor D, RG7417)

Patient population Allergic asthma - inadequately controlled Geographic atrophy (GA) secondary to age-

related macular degeneration

Phase/study Phase IIbCOSTA

Phase Ib/IIMAHALO


Design SC administration on top of SoC•ARM A: RG7449 300mg•ARM B: RG7449 150mg•ARM C: RG7449 450mg•ARM D: Placebo

• Part 1: Open-label• Multiple dosing

• Part 2: Randomized• ARM A: Lampalizumab injection• ARM B: Sham injection

Primary endpoint

• Rate of protocol-defined exacerbations from baseline to week 36

• Part 1: Safety• Part 2: Growth rate of GA lesions at month 18

Status • Recruitment completed Q3 2013 • Primary endpoint met Q3 2013, higher efficacy in a subset of patients defined by exploratory biomarkers was also described

• Data presented at ASRS and EURETINA 2013• Additional data to be presented at AAO 2013

SoC=Standard of CareASRS=American Society of Retina Specialists; EURETINA=European Society of Retina Specialists; AAO=American Academy of Ophthalmology

Immunology and ophthalmology development programmes

Immunology and ophthalmology development programmes

118

Molecule Rontalizumab(Anti-INFalpha, RG7415)

anti-IL17(RG7624)

Patient population Systemic lupus erythematosus Autoimmune diseases

Phase/study Phase IIROSE Phase Ib


Design • ARM A: Placebo• Part 1 – iv• Part 2 - sc

• ARM B: Rontalizumab• Part 1 – iv• Part 2 – sc

• Randomized, double-blind, placebo-controlled, multiple ascending dose escalation study

Primary endpoint

• Proportion of responders at Week 24 • Safety and tolerability

Status • Enrolment completed Q3 2010• Data presented at ACR 2012• Candidate for partnering-out

• Enrolment completed Q2 2012

Collaborator NovImmune

ACR=American College of Rheumatology


119

Molecule Crenezumab(Anti-Αβ, RG7412)

Patient population Alzheimer’s Disease

Phase/studyPhase IIABBY

Cognition study

Phase IIBLAZE

Biomarker study


Design • ARM A: Crenezumab sc• ARM B: Crenezumab iv• ARM C: Placebo

• ARM A: Crenezumab sc• ARM B: Crenezumab iv• ARM C: Placebo

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

Status • Enrolment completed Q3 2012 • Enrolment completed Q3 2012

Collaborator AC Immune

Metabolism and infectious diseases development programmes

120

Molecule Anti-PCSK9(RG7652)

NME targeting CMV(RG7667)

NME(RG7745)

Patient population Metabolic diseases

Prevention of cytomegalovirus disease in

kidney transplantrecipients

Infectious diseases

Phase/study Phase IIEQUATOR Phase II Phase I


Design SC dosing every 4 weeks• Experimental: five different

doses of RG7652• Placebo

• ARM A: RG7667• ARM B: Placebo

• Single ascending dose of RG7745

• Placebo

Primary endpoint

• Absolute change from baseline in LDL-c concentration

• Safety, clinical activity • Safety, PK

Status • Phase I data presented at ESC 2013

• Phase II data readout in 2013• Candidate for partnering-out

• FPI Q4 2012 • Recruitment completed Q3 2013

121121121







Diagnostics


Geographical sales split by divisions and Group*

122

CHFm YTD Sep 2012 YTD Sep 2013 % change CER

Pharmaceuticals Division 26,198 27,190 +7

United States 10,270 11,429 +12Europe 6,715 6,952 +2Japan 2,966 2,492 +3International 6,247 6,317 +5

Diagnostics Division 7,496 7,677 +4United States 1,713 1,706 0Europe 2,919 3,004 +1Japan 434 358 +1International 2,430 2,609 +10

Group 33,694 34,867 +6United States 11,983 13,135 +10Europe 9,634 9,956 +2Japan 3,400 2,850 +3International 8,677 8,926 +7

* Geographical sales split shown here does not represent operational organization; CER=Constant Exchange Rates122

123

Pharma Division sales YTD Sep 2013 (vs. 2012)Top 20 products

CER=Constant Exchange Rates * over +500%

CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER MabThera/Rituxan 5,206 6 2,574 10 1,446 3 180 5 1,006 -1Avastin 4,710 13 1,984 6 1,436 16 519 17 771 24Herceptin 4,594 6 1,375 11 1,654 -1 212 7 1,353 8Lucentis 1,251 13 1,251 13 - - - - - -Xeloda 1,164 3 480 2 243 -2 80 5 361 8Pegasys 1,027 -19 263 -40 276 -11 40 -19 448 -5Tarceva 1,018 5 473 12 259 -6 70 4 216 3Actemra/RoActemra 763 33 233 37 265 29 140 19 125 56CellCept 681 1 158 27 179 -14 50 11 294 -1Xolair 590 12 590 12 - - - - - -Activase/TNKase 514 18 477 19 - - - - 37 5Valcyte/Cymevene 499 5 261 10 122 -10 - - 116 13Tamiflu 414 81 239 159 9 -1 87 9 79 94Pulmozyme 412 5 264 10 93 2 - 151 55 -11NeoRec./Epogin 400 -19 - - 168 -28 76 -30 156 0Mircera 307 25 - - 76 24 152 29 79 19Zelboraf 260 65 95 15 142 94 - - 23 *Madopar 235 2 - - 84 -1 14 5 137 4Nutropin 213 -7 208 -7 - - - - 5 -17Rocephin 201 5 0 -53 31 -7 32 -1 138 10

Global US Europe Japan International

US Europe Japan InternationalQ4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

MabThera/Rituxan 7 12 -1 20 8 2 3 6 5 0 6 8 4 -2 -3 3Avastin 1 3 3 10 13 15 17 17 20 18 18 15 3 26 29 19Herceptin 11 17 1 14 4 1 -2 -1 12 6 7 7 10 19 -1 8Lucentis -9 1 18 21 - - - - - - - - - - - -Xeloda 6 0 -3 8 -1 -4 -2 1 12 8 5 3 4 3 13 10Pegasys -17 -30 -40 -51 -2 -10 -8 -14 -6 -16 -18 -22 2 -4 -21 18Tarceva 5 14 18 5 -11 -12 -4 0 6 8 -2 8 -11 -12 12 13Actemra/RoActemra 58 45 33 33 35 29 31 26 -7 8 23 26 63 53 57 59CellCept 0 60 17 13 -13 -13 -18 -11 14 8 13 13 10 -4 6 -5Xolair 10 12 10 14 - - - - - - - - - - - -Activase/TNKase 17 36 3 19 - - - - - - - - 20 27 -5 -1Valcyte/Cymevene 18 4 14 10 -8 -1 -5 -22 - - - - 13 27 9 3Tamiflu - 171 -41 * - 54 -58 -76 57 6 121 -73 164 132 161 -17Pulmozyme 8 17 8 6 6 -3 4 6 - - 308 29 -5 -6 5 -25NeoRec./Epogin - - - - -23 -25 -31 -26 -46 -37 -29 -22 0 -3 2 3Mircera - - - - -57 -32 142 74 83 46 21 26 6 28 19 11Zelboraf 44 19 15 12 * * 51 36 - - - - - * * 489Madopar - - - - -5 -3 -2 2 11 8 3 5 13 17 -6 3Nutropin -5 -6 -8 -7 - - - - - - - - -17 -13 -12 -25Rocephin -15 -62 -65 13 -13 -14 5 -9 -11 -8 2 2 -1 -3 29 7

Pharma Division CER sales growth1 in %Top 20 products by region

1241 Q4 2012 vs. 2011, Q1 2013 – Q3 2013 vs. 2012 CER=Constant Exchange Rates * over +500%

125

Pharma Division sales YTD Sep 2013 (vs. 2012)Recently launched products

CER=Constant Exchange Rates * over +500%

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

Perjeta 186 * 136 431 37 * 5 - 8 -

Kadcyla 156 - 152 - 3 - - - 1 -

Erivedge 48 164 46 152 2 - - - - -

Global US Europe Japan International

126

Q3/12 Q4/12 Q1/13 Q2/13 Q3/13

MabThera/Rituxan 11 7 6 0 12Avastin 11 8 11 13 14Herceptin 14 8 11 0 7Lucentis -12 -9 1 18 21Xeloda 4 5 1 3 6Pegasys -4 -5 -15 -24 -16Tarceva -5 -3 0 9 5Actemra/RoActemra 27 30 32 33 33CellCept -11 1 4 1 -2Xolair 9 10 12 10 14Activase/TNKase 30 17 35 3 18Valcyte/Cymevene 9 9 8 8 0Tamiflu -64 449 84 44 115Pulmozyme 11 4 9 7 0NeoRec./Epogin -20 -25 -22 -20 -16Mircera -12 2 12 35 29Zelboraf 498 271 154 46 38Madopar 2 5 9 -4 3Nutropin -10 -5 -6 -8 -8Rocephin -8 -5 -6 19 4

Pharma Division CER sales growth1 in %Global top 20 products

1 Q3-Q4/12 vs. Q3-Q4/11, Q1-Q3/13 vs. Q1-Q3/12 CER=Constant Exchange Rates

CER sales growth (%)Quarterly development


2012 vs. 2011 2013 vs. 2012Q1 Q2 Q3 Q4 Q1 Q2 Q3

Pharmaceuticals Division 2 6 4 7 7 4 9

United States 6 6 5 13 13 7 16Europe -3 -1 -2 0 1 2 3Japan 1 0 1 5 2 2 4International 3 16 12 6 8 2 5

Diagnostics Division 4 6 1 4 1 4 7

Roche Group 2 6 4 6 6 4 8

CER sales growth (%)Impact of 340B sales reserves release


2012 vs. 2011 2013 vs. 2012 excl. 340BQ1 Q2 Q3 Q4 Q1 Q2 Q3 YTD Q3 YTD

Sep SepPharmaceuticals Division 2 6 4 7 7 4 9 7 6 6

MabThera/Rituxan 7 11 11 7 6 0 12 6 6 4Avastin 1 5 11 8 11 13 14 13 12 12Herceptin 7 14 14 8 11 0 7 6 4 5

United States 6 6 5 13 13 7 16 12 10 10MabThera/Rituxan 8 9 9 7 12 -1 20 10 7 6Avastin 0 -5 4 1 3 3 10 6 5 4Herceptin 11 9 12 11 17 1 14 11 4 7

Roche Group 2 6 4 6 6 4 8 6 6 5

128

YTD Sept 2013: Oncology franchise

129

US

• Sales growth driven by Rituxan, Kadcyla, Herceptin and Perjeta, partially due to 340B reserves release

Europe

• Major drivers Avastin and Zelboraf

International

• Strong growth for Avastin and Herceptin

Japan

• Growth driven largely by Avastin

1 CER=Constant Exchange Rates; Oncology sales CHF 16.9bn

+12%

+6%

+8%

Oncology sales

+9%

+9%1

0

3

6

9

12

15

18

YTD 9 11 YTD 9 12 YTD 9 13

Japan International Europe US

CHFb

n

130

MabThera/Rituxan

YTD Sept 2013 sales of CHF 5.206bn

• US/Europe: Growth driven primarily by population growth

• Developing market growth due largely to increased share and duration of treatment in DLBCL


0.0

1.0

2.0

3.0

4.0

5.0

6.0

YTD 909

YTD 910

YTD 911

YTD 912

YTD 913

CHFbnGlobal sales

+6%CER growth

US +10%

Europe +3%

Japan +5%

International -1%

Regional sales CER growth

131

Avastin



• Europe: strong growth driven by further uptake in ovarian and colorectal cancer (Treatment through multiple lines)

• US: increase in mCRC use associated with TML awareness• Japan: steady growth in CRC, BC, NSCLC

0.0

1.0

2.0

3.0

4.0

5.0

6.0

YTD 909

YTD 910

YTD 911

YTD 912

YTD 913

CHFbnGlobal sales

+13%CER growth

US +6%

Europe +16%

Japan +17%

International +24%


132

Herceptin



• Volume growth driven by International region

• Emerging markets: driven by access in public markets in key countries, patient access program in China and longer duration of use in early breast cancer

Europe -1%

Japan +7%International +8%


0.0

1.0

2.0

3.0

4.0

5.0

YTD 909

YTD 910

YTD 911

YTD 912

YTD 913

CHFbnGlobal sales

+6%CER growth

US +11%

133

Xeloda



• US: supply of IV 5FU normalised. Brand approaching end of lifecycle• Sales growth in the International region driven by China

0.0

0.2

0.4

0.6

0.8

1.0

1.2

YTD 909

YTD 910

YTD 911

YTD 912

YTD 913

CHFbnGlobal sales

+3%CER growth

US +2%

Europe -2%

Japan +5%

International +8%


134

Tarceva


YTD Sept 2013 sales of CHF 1.018bn• US: strong EGFR testing rates, 1L treatment rates for Mut+ve patients and increase in 1L

maintenance use for squamous patients • EU: stabilization ahead of further reimbursement approvals for 1LMut+ indication;

competitive challenges remain

0.0

0.2

0.4

0.6

0.8

1.0

1.2

YTD 909

YTD 910

YTD 911

YTD 912

YTD 913

CHFbnGlobal sales

+5%CER growth

US +12%

Europe -6%

Japan +4%

International +3%


135

Inflammation/Autoimmune/Transplantation

YTD Sept 2013 IAT sales: CHF 2.468bn

• Strong growth of Actemra/RoActemra and MabThera/Rituxan, CellCept stabilising

Actemra/RoActemraSales: CHF 763m (+33%)

• Growth driven by monotherapy use; US biggest growth contributor, good uptake of subcutaneous formulation in Japan

CellCeptSales: CHF 681m (+1%)• Patent expiry key EU countries end 2010

IAT sales +13%1

CHFb

n

1 CER=Constant Exchange Rates

+7%

+27%

+5%

+10%

0.0

0.5

1.0

1.5

2.0

2.5

YTD 9 11 YTD 9 12 YTD 9 13

Japan International Europe US

Tamiflu quarterly sales 2009 - 2013Retail and Governments/Corporations

136

CHFm

Retail

Governments & Corporations

304 349

727

533422

17091

17 19 3 45 4610 8 5 31 33 1 2

97

260

267 663

95

23

748

233

7

-6

12177

26 15

288 302

44 32

-50

150

350

550

750

950

1150

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 Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13

137137







Diagnostics


138CER=Constant Exchange Rates¹ Europe, Middle East and Africa

YTD Sept 2013: Diagnostics Division CER growth By Region and Business Area (vs. 2012)

Professional Diagnostics 4,227 7 851 4 1,900 3 1,476 14

Diabetes Care 1,781 -2 350 -11 1,076 1 355 -1

Molecular Diagnostics 1,188 2 421 4 462 0 305 3

Tissue Diagnostics 481 6 290 0 126 14 65 24

Diagnostics Division 7,677 4 1,912 0 3,564 3 2,201 10

RoW

CHFm growth CHFm growth

Global North America EMEA¹

CHFm growth CHFm growth% CER % CER % CER % CER

139CER=Constant Exchange Rates¹ versus same period of prior year

Diagnostics Division quarterly sales and CER growth1

Professional 1,362 8 1,357 8 1,433 7 1,337 4 1,472 8 1,418 9 Diagnostics

Diabetes 696 3 577 -12 729 -1 539 -5 666 -4 576 3 Care

Molecular 395 1 395 -2 436 2 386 -3 411 6 391 4 Diagnostics

Tissue 158 16 153 10 173 7 157 7 165 4 159 8 Diagnostics

Dia Division 2,611 6 2,482 1 2,771 4 2,419 1 2,714 4 2,544 7

Q3 13CHFm % CER CHFm % CER CHFm % CER

Q1 13 Q2 13Q2 12 Q3 12 Q4 12CHFm % CER CHFm % CER CHFm % CER


YTD Sept 2013: Diagnostics Division salesGrowth driven by Professional Diagnostics

Molecular Diagnostics 15%

Professional Diagnostics 56%

Tissue Diagnostics 6%

Diabetes Care 23%

CHF 7,677m CER sales growth

4%

-2%

7%

2%

6%

DiagnosticsDivision

DiabetesCare

ProfessionalDiagnostics

MolecularDiagnostics

TissueDiagnostics

1,188

4814,227

1,781


Professional DiagnosticsStrong growth driven by immunoassays

0.0

1.0

2.0

3.0

4.0

5.0

YTD 9 11 YTD 9 12 YTD 9 13

CHFbn

Immunoassay Clinical Chemistry POC products Other

+13%

+4%

+3%

2013 vs. 2012 CER growth

+7%

-1%


Diabetes CareAdapting to a challenging market environment

0.0

0.5

1.0

1.5

2.0

YTD 9 11 YTD 9 12 YTD 9 13

CHFbn

Blood Glucose Monitoring Insulin Delivery

-3%

+3%


-2%



Molecular DiagnosticsGrowth driven by HPV and qPCR for life sciences

0.0

0.2

0.4

0.6

0.8

1.0

1.2

YTD 9 11 YTD 9 12 YTD 9 13

CHFbn

Virology Blood ScreeningqPCR & NAP Systems HPV & MicrobiologyOther

+2%


0%

+1%

+7%


+9%

+2%

144CER=Constant Exchange Rates¹ Europe, Middle East and Africa; 2 Asia Pacific

Tissue DiagnosticsStrong growth in EMEA¹ and APAC 2

0.0

0.1

0.2

0.3

0.4

0.5

YTD 9 11 YTD 9 12 YTD 9 13

CHFbn

Advanced Staining Primary Staining Other


+6%

+3%

+15%


+91%

2013: Key planned product launchesProfessional Diagnostics

145

Product Description Region

cobas 8100 pre-analytical series

High throughput total lab automation system designed for up to 1100 samples per hour and connectivity to SWA, Coagulation, Hematology and Urinalysis

EU

Elecsys Calcitonin immunoassay

Aids in the diagnosis and monitoring of medullary thyroid cancer

EU

Elecsys proGRPimmunoassay

Aids in the diagnosis of small cell lung cancer EU

Elecsys Cyclosporin& Tacrolimusimmunoassays

Monitoring of immunosuppressive drug therapy in transplant patients

EU

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

146


Accu-Chek ActiveLCM

Next-generation blood glucose monitoring system maltose independent strips

EU

Accu-Chek Insight Next generation insulin delivery system combining an insulin pump and a blood glucose meter that functions as a pump remote control

EU

2013: Key planned product launchesDiabetes Care


147

2013: Key planned product launchesMolecular Diagnostics


cobas EGFR test Companion diagnostic to Tyrosine Kinase Inhibitors / Tarceva for the detection of EGFR mutation in non-small cell lung cancer

US

MPX 2.0 Next generation multiplex test for blood screening for HIV, HCV and HBV

US

CAP/CTM HCV 2.0 Next generation HCV viral load test US

Seq Cap EZ* Reagent sets for targeted next generation sequencing WW

GS FLX longamplicons*

Software for long-read targeted sequencing for DNA variant detection

WW


* From Sequencing Solutions Unit

148

2013: Key planned product launches Tissue Diagnostics


ER test Estrogen receptor antibody (IHC) assay to support the diagnosis of breast cancer

US

CINtec PLUS Cytology

Immunocytochemistry assay used to screen women for cervical pre-cancer

EU


149149







Diagnostics


CHF / USD

150

0.90

0.92

0.94

0.96

0.98

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

0.90

0.92

0.94

0.96

0.98


Year-To-Date averages

Monthly averages

2012

2012

2013

2013+1% +1% -1%

CHF / USD

151

0.90

0.92

0.94

0.96

0.98


avg full year 2012

monthly avg 2012

-1%avg YTD 09 2013

monthly avg 2013 avg YTD 09 2012

1.19

1.21

1.23

1.25


+2%

CHF / EUR

152

1.19

1.21

1.23

1.25


Year-To-Date averages

Monthly averages

2012

2012

2013

2013

+2% +2%

CHF / EUR

153

1.19

1.21

1.23

1.25


monthly avg 2013

avg full year 2012

monthly avg 2012

avg YTD 09 2013

+2%

avg YTD 09 2012

Average exchange rates

154

YTD Sep 13 YTD Sep 12 YTD Sep 13 vs. YTD Sep 12

USD 0.93 0.94

EUR 1.23 1.20

JPY 0.97 1.18

-20% -16% -12% -8% -4% 0% 4%

5.0%6.0%

5.1%

3.9% 3.5%

5.9%

Q1 HY YTD 9 FY

Exchange rate impact on sales growthIn YTD Sep negative impact primarily from JPY partially offset by positive impact from EUR

155

Development ofaverage exchange rates versus prior year periodCHF / EUR +1.6% +2.0% +2.2%CHF / USD +0.9% +0.8% -0.5%CHF / JPY -13.3% -15.8% -18.3%

Differencein CHF / CER -0.8%p -1.1 %p -2.5%p

growth

CHFgrowth

CERgrowth

Salesgrowth2013

vs. 2012


Exchange rate impact on sales growthNegative impact from JPY and Latin American currencies

156

CERsales

growthYTD Sep 2013

vs.YTD Sep 2012

CHFsales

growthYTD Sep 2013

vs.YTD Sep 2012

6.0% +0.1%-0.1%-0.2%

-0.7%

-1.9%

+0.5%

-0.2%

3.5%

CER JPY Lat-Am USD Other As-Pac OthEurope

EUR CHF


157


Roche Investor Presentation - YTD September …8e2b3de9-6ed6-4c80-93e2-0a...3 This presentation...

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Transcript of Roche Investor Presentation - YTD September …8e2b3de9-6ed6-4c80-93e2-0a...3 This presentation...