Presentation - Roche

Roche 

Nine months YTD 2012 sales 

October 16, 2012 

Basel 

2

This presentation contains certain forward-looking statements. These forward-looking 

statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, 

‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, 

among other things, strategy, goals, plans or intentions. Various factors may cause actual 

results to differ materially in the future from those reflected in forward-looking statements 

contained in this presentation, among others: 

1 pricing and product initiatives of competitors; 

2 legislative and regulatory developments and economic conditions; 

3 delay or inability in obtaining regulatory approvals or bringing products to market; 

4 fluctuations in currency exchange rates and general financial market conditions; 

5 uncertainties in the discovery, development or marketing of new products or new uses of existing 

products, including without limitation negative results of clinical trials or research projects, unexpected 

side-effects of pipeline or marketed products; 

6 increased government pricing pressures; 

7 interruptions in production; 

8 loss of or inability to obtain adequate protection for intellectual property rights; 

9 litigation; 

10 loss of key executives or other employees; and 

11 adverse publicity and news coverage. 

Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted 

to mean that Roche’s earnings or earnings per share for this year or any subsequent period will 

necessarily match or exceed the historical published earnings or earnings per share of Roche. 

For marketed products discussed in this presentation, please see full prescribing information on our 

website – www.roche.com 

All mentioned trademarks are legally protected 

3

Group 

Severin Schwan 

Chief Executive Officer 

4

YTD Sept 2012: Highlights 

Strong sales growth 

Sales on track for full year target 

• Pharma, Diagnostics and Group: +4% 1 

Pipeline newsflow supporting long-term growth 

• T-DM1 shows OS benefit (EMILIA); filed in US and EU 

• MEKi in combination with Zelboraf to start phIII 

• Aleglitazar clinical program to be expanded (AlePrevent and AleGlucose) 

• On track to deliver LIP targets for 2012 

Outlook confirmed 

• Low to mid single-digit sales growth 1 for Pharma and the Group, above 

market growth for Diagnostics 

• Core EPS growth target ‘high single-digit’ 1 

• Attractive dividend policy 

1 

at Constant Exchange Rates 

5

YTD Sept 2012: Group sales 

Supporting full-year target 

2012 2011 change in % 

CHF bn CHF bn CHF CER 

Pharmaceuticals Division 26.2 24.4 +7 +4 

Diagnostics Division 7.5 7.1 +6 +4 

Roche Group 33.7 31.5 +7 +4 

CER=Constant Exchange Rates 

6

Regional performance: US and Emerging 

markets strongly contribute to sales growth 

Asia 

14% 

Asia- 

Pacific 

16% 

China driving growth in both divisions 

Latin 

America 

12% 

Latin 

America 

14% 

Strong demand in major markets 

CEMAI 

12% 

Pharma: driven by Middle East and N. Africa 

US 

6% 

North 

America 

2% 

Pharma: strong growth for strategic products 

Dia: strong growth in IVD lab business 

Japan 

1% 

Japan 

7% 

Recovery after earthquake; biennial price cuts 

WE-2% 

EMEA 

-1% 

Pharma: impact of generic products 

Dia: price pressure in Diabetes Care 

Pharma 

Diagnostics 

CER (Constant Exchange Rates) growth rates 

CEMAI=Central & Eastern Europe, Central Asia, Middle East, Africa and Indian subcontinent; EMEA: Europe, Middle East and Africa. 

7

Group sales growth 1 

Improving performance 

8% 

6% 

4% 

4% 

2% 

6% 

4% 

2% 

0% 

-2% 

0% 

0% 

1% 

-4% 

-3% 

-5% 

-6% 

Q3 

'10 

Q4 

'10 

Q1 

'11 

Q2 

'11 

Q3 

'11 

Q4 

'11 

Q1 

'12 

Q2 

'12 

Q3 

'12 

1 

at CER=Constant Exchange Rates 

8

Pipeline 

71 NMEs supporting long-term growth 

Phase I 

(36 NMEs) 

MDM2 ant solid & hem tumors Bcl-2 inh 

CLL and NHL 

HER3 MAb 

solid tumors ChK1 inh solid tum & lymphoma 

CSF-1R MAb 

solid tumors PI3K inh 

solid tumors 

CIF/MEK inh 

solid tumors ADC metastatic melanoma 

Tweak MAb 

oncology PI3k inh 

glioblastoma 2L 

Raf & MEK dual inh solid tumors ChK1 inh(2) 

solid tumors 

CD44 MAb solid tumors ALK inhibitor NSCLC 

MEK inh 

solid tumors PI3K inh solid tumors 

MEK inh 

solid tumors WT-1 peptide cancer vaccine 

MDM2 ant solid & hem tumors IL-17 MAb autoimmune diseases 

AKT inhibitor 

solid tumors IL-6 MAb 

RA 

PD-L1 MAb 

solid tumors CIM331RA 

atopic dermatitis 

Steap 1ADC prostate ca. TLR7 agonist 

HBV 

ADC ovarian ca. - infectious diseases 

ADC heme tumors GIP/GLP-1 dual ago type 2 diabetes 

ADC multiple myeloma GABRA5 NAM cogn. disorders 

ADC oncology V1 receptor antag 

autism 

BACE inh 

Alzheimer’s 

ACE910 

hemophilia A 

Phase II 

(24 NMEs) 

EGFR MAb 

solid tumors 

PI3K inh 

solid tumors 

PI3K/mTOR inh solid & hem tumors 

EGFL7 MAb 

solid tumors 

CD22 ADC 

heme tumors 

CD79b ADC 

heme tumors 

HER3/EGFR m. epithelial tumors 

glypican-3 MAb 

liver cancer 

etrolizumab ulcerative colitis 

rontalizumab 

SLE 

pateclizumab (LT alpha Mab) RA 

quilizumab (M1 prime Mab) asthma 

mericitabine 

HCV 

danoprevir 

HCV 

setrobuvir 

HCV 

inclaumab (P selectin Mab) ACS/CVD 

oxLDL MAb sec prev CV events 

PCSK9 MAb metabolic diseases 

gantenerumab 

Alzheimer’s 

MAO-B inh 

Alzheimer’s 

mGluR2 antag 

depression 

mGluR5 antag 

TRD 

crenezumab 

Alzheimers 

anti-factor D Fab geograph. atrophy 

Phase III 

(8 NMEs) 

onartuzumab (MetMAb) solid tumors 

obinutuzumab (GA101) hem. tumors 

lebrikizumab 

severe asthma 

aleglitazar CV risk reduction in T2D 

tofogliflozin (SGLT2) type 2 diabetes 

ocrelizumab 

MS 

bitopertin 

schizophrenia 

arbaclofen fragile X syndrome (FXS) 

Registration 

(3 NMEs) 

Perjeta (pertuzumab)* HER2+ mBC 1L 

Erivedge* advanced BCC 

T-DM1 HER2+ mBC 

As of September 30 2012; * Approved in US, filed in EU 

Oncology 

Immunology 

Virology 

CardioMetabolism 

Neuroscience 

Ophthalmology 

Others 

9

Pipeline 

On track to deliver LIP targets for 2012 

LIP candidates 

2012 target: 3 out of 5 

October 2012 status 

rontalizumab 

MEK 0973 

Bcl-2 sel inh 

LIP 

 

 

etrolizumab 

rontalizumab 

etrolizumab 

anti-PCSK9 

Bcl-2 sel inh 

MEK 0973 

anti-PCSK9 

LIP=Lifecycle Investment Point 

Immunology 

Metabolism 

Oncology 

10

Outlook for 2012 confirmed 

Sales growth (CER) 

Operational Excellence 

savings 

Core EPS growth target 

(CER) 

Dividend outlook 

Group & Pharma: low to mid single-digit 

Diagnostics: above market 

2012+: CHF 2.4 bn* 

High single-digit 

Continue attractive dividend policy 

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

11

Pharmaceuticals Division 

Daniel O’Day 

COO Roche Pharmaceuticals 

12

Sales performance 

Clinical update 

13

YTD Sept 2012: Pharma sales 

US and International major growth contributors 

2012 2011 change in % 

CHF m CHF m CHF CER 

Pharmaceuticals Division 26,198 24,397 7 4 

United States 10,270 9,104 13 6 

Western Europe 5,954 6,210 -4 -2 

Japan 2,966 2,712 9 1 

International 7,008 6,371 10 9 


14

YTD Sept 2012: Pharma sales 

Oncology, Pegasys and Actemra main growth drivers 

Herceptin 

MabThera/Rituxan 

+12% 

+10% 

Avastin 

Pegasys 

Actemra/RoActemra 

Zelboraf 

+6% 

+18% 

+34% 

NM 

Tamiflu 

-25% 

Lucentis 

-8% 

CellCept 

NeoRecormon/Epogin 

Boniva/Bonviva 

-53% 

-14% 

-26% 

International 

US 

Japan 

Western Europe 

-400 -200 0 200 400 600 

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

15

YTD Sept 2012: US 

Continued strong performance 

US: +6% 

Pegasys 

Rituxan 

Herceptin 

TNKase/Activase 

Zelboraf 

Xeloda 

Actemra 

Tarceva 

Xolair 

Valcyte/Cymevene 

+11% 

+25% 

NM 

+18% 

+64% 

+14% 

+11% 

+17% 

+9% 

+85% 

• Pegasys, Rituxan and Herceptin main 

growth drivers 

• Pegasys high comparator base in 2H 

2011 

• Zelboraf, Erivedge and Perjeta: 

successful launches 

• Lucentis sales stabilising post DME 

launch 

• Actemra approved as 1 st line biologic 

0 50 100 150 200 

Growth contribution CHF m 


16

YTD Sept 2012: Western Europe 

Newly launched Zelboraf main growth contributor 

Zelboraf 

MabThera 

RoActemra 

Herceptin 

Avastin 

NA 

+6% 

+36% 

+3% 

+4% 

Strong Zelboraf launch; growth for 

MabThera, Herceptin and Avastin 

(launch in ovarian cancer) 

RoActemra: Increasing market share 

in monotherapy segment 

Tarceva 

Cellcept 

Xenical 

Mircera 

Bonviva 

CHF m 

-13% 

-18% 

-61% 

-59% 

-49% 

-90 -60 -30 0 30 60 90 

Off-patent products: Bonviva, 

CellCept, Xenical decline after patent 

loss 

Mircera: Supply issue resolved, 

available as of September 


17

E7 countries 

China continues to drive growth 

1000 

800 

+18% 1 

-32% 

+113% 

+14% 

+6% 

India 

Russia 

Korea 

Turkey 

600 

+8% 

Mexico 

400 

+31% 

China 

200 

-3% 

Brazil 

0 

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

1 

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

18

YTD Sept 2012: Oncology franchise 

Major brands 

CHF bn 

MabThera/ 

Rituxan 

Herceptin 

Avastin 

CER growth 

+10% 

+12% 

+6% 

Continued uptake in 1L maintenance in NHL; longer 

treatment duration; further uptake in CLL 

US, Emerging markets main growth contributor; increased 

HER2 testing and further uptake in HER2+ gastric cancer 

Japan: strong uptake in NSCLC and mBC; 

EU: launch in ovarian cancer, increased share in TNBC 

Xeloda 

Tarceva 

+10% 

+4% 

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

regions; US Supply of IV 5FU normalised 

Growth driven mostly by US, China and Japan 

Zelboraf 

Perjeta 

NM 

NA 

CHF 157 m; US: ~85% market share in BRAF V600 

patients; approved in EU Q1 2012 

CHF 26 m 

US: already 30% new patient share in 1L mBC 

Erivedge 

NA CHF 18 m: launched in US Q1 2012 

0.0 2.0 4.0 6.0 


Oncology Sept YTD 2012 sales: CHF 16.0 bn 

19

Lucentis 

Competitive pressure in wAMD 

500 

400 

300 

Lucentis quarterly sales (USD m) 

Eylea 

wAMD 

Lucentis 

DME 

Decline in wAMD partially offset 

by launch in DME 

AMD 

• Lucentis new patient share stabilising 

following launch of Eylea 

• 0.5 mg PRN dosing PDUFA date: 

February 2013 

• 2-year PRN data (HARBOR) to be 

presented at AAO 

RVO 

200 

Q1 

'10 

Q2 

'10 

Q3 

'10 

Q4 

'10 

Q1 

'11 

Q2 

'11 

Q3 

'11 

Q4 

'11 

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

Q1 

'12 

Q2 

'12 

Q3 

'12 

• Lucentis share stable 

DME 

• Approved in August 2012 (0.3 mg) 

20

Pegasys 

Growth affected by high comparison base and 

tender timing in Brazil 

US Pegasys weekly vials 

DAA launch 

Jan 10 May 10 Sep 10 Jan 11 May 11 Sep 11 Jan 12 May 12 Sep 12 

US 

• High base in 2H 2011 due to launch 

of DAAs 

• Wave of previously warehoused 

patients exit treatment 

International region 

• Timing of tender sale in Brazil 

significantly impacting growth 

Japan 

• Overall HCV market shrinking 

• Recently launched DAA not used in 

combination with Pegasys 

21

Sales performance 

Clinical update 

22

HER2 franchise 

Clinical updates reflect significant medical benefit 

Significant OS benefit (EMILIA) 

25.1 months (Cap+Lap) to 30.9 months (T-DM1) 

Filed in US and EU 

Significant OS benefit (CLEOPATRA) 

To be presented at SABCS 

Approved in US, CH; filed in EU 

1 Year treatment duration confirmed as the 

standard of care in early breast cancer 

23

Zelboraf in melanoma and beyond 

Targeting BRAF-driven cancers to suppress 

tumour formation 

BRAF-mutation positive tumors 

Metastatic melanoma 

Vemurafenib monotherapy 

• Patients with brain metastases (Ph2) 

MEK combination 

• Zelboraf + MEKi RG7421 BRIM7 (Ph1) 

• Phase 3: FPI expected Q4/2012 NEW 

Other combinations 

• Zelboraf + ipilimumab (Ph1) 

Adjuvant melanoma 


BRIM8 Phase 3 

FPI Q3/2012 

Other tumor types 


• Papillary thyroid cancer (Ph2) 

NEW 

• Zelboraf + anti PD-L1 RG7466 

Phase1: FPI Q3/2012 

NEW 

*RG7421=GDC-0973 

24

Aleglitazar program expansion 

• AleNEPHRO safety data un-gated program expansion 

(to be presented at ASN, Nov 1-4 2012) 

Patient 

population 

Type 2 diabetes (US,China) 

Stable CVD and type 2 diabetes 

or pre-diabetes 

Phase/study 

Phase II 

AleGlucose 

Glycemic control study 

Phase III 

AlePrevent 

Cardiovascular outcomes study 

# of patients N~1,400 N~19,000 

Design 

26 weeks treatment duration 

•ARM A: Aleglitazar (150 μg) 

monotherapy, add on to Metformin and 

add on to Sulfonylurea with or without 

Metformin 

•ARM B: Placebo 

At least 3 year treatment period and until 1260 

events have occurred 

•ARM A: Aleglitazar 150 μg daily on top of SOC 

•ARM B: Placebo daily on top of SOC 

Primary endpoint • Reduction from baseline in HbA1c • Reduction in cardiovascular mortality, nonfatal 

myocardial infarction and stroke (MACE) 

Status • Expect FPI Q4 2012 • Expect FPI Q4 2012 

25

Moves in late-stage pipeline 

Advanced 

Added 

Delayed 

onartuzumab (MetMAb) 

gastric cancer 

obinutuzumab (GA101) 

DLBCL 

PI3 kin inh (RG7321) 

solid tumors 

EGFR Mab (GA201, 

RG7160) solid tumors 

T-DM1 (RG3502) 

HER2-pos. mBC 1st line 

T-DM1 (RG3502) 

HER2-pos. gastric cancer 

mericitabine 

HCV 

MEKi ( RG7421)+ Zelboraf 

met melanoma 


iNHL relapsed 

danoprevir 

HCV 


mNSCLC 

aleglitazar 

CV risk reduction in T2D 

setrobuvir 

HCV 

 

T-DM1 (RG3502) 

HER2-pos. pretreated mBC 


CLL 

bitopertin 

schizophrenia# 

ocrelizumab 

PPMS and RMS 

mGluR5 (RG7090) 

depression 

lebrikizumab 

severe asthma 

2012 2013 2014 2015 2016 

Post 2016 

NME 

Additional indication 

indicates a submission which has occurred with regulatory action pending 

# negative symptoms and sub-optimal control 

Status as of September 30, 2012 

26

Data to be presented in Q4 2012 

ASN (Oct 30-Nov 4) 

aleglitazar 

• AleNEPHRO phII safety study 

ACR (Nov 9-14) 

rontalizumab 

• ROSE study in lupus, phII data 

Actemra SC 

• SUMMACTA/BREVACTA, ph III 

SABCS (Dec 4-8) 

Perjeta 

• CLEOPATRA, 1 st line mBC, OS data 

ASH (Dec 8-11) 

MabThera/Rituxan SC 

• SABRINA, front line fol. NHL, phIII 

Bcl-2 inh 

• CLL and NHL, Ph I 

Anti-CD22 ADC 

Anti-CD79b ADC 

MDM2 

• Hem. malignancies, Ph I 

Cardiometabolism 

Immunology 

Oncology 

27

Major clinical and regulatory news flow 

Timeline Compound Indication Milestone 

2012 

2013 

Avastin mCRC Ph III TML 

Perjeta 1 st line HER2+ mBC US approval EU approval 

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

Zelboraf metastatic melanoma EU approval 

Lucentis DME US approval 

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

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

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

MabThera subcutaneous front-line follicular NHL Ph III 

Actemra RA DMARD IR Ph III ADACTA H2H vs. Humira 

Actemra subcutaneous RA, moderate to severe Ph III SUMMACTA BREVACTA 

Avastin newly diagnosed glioblastoma Ph III AVAglio 

 

 

 

 

 

 

dalcetrapib Atherosclerosis CV risk red. 2 nd interim analysis in H1 2012 

GA101 Front line CLL Ph III vs. chemotherapy 

 

 

 

 

 

 

 

 

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

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

28

Diagnostics Division 

Roland Diggelmann 

COO Roche Diagnostics 

Picture 

29

YTD Sept 2012: Diagnostics Division sales 

Strong growth of IVD lab business 

2012 2011 1 change in % 

CHF m CHF m CHF CER 

Diagnostics Division 7,496 7,095 +6 +4 

Professional Diagnostics 1 3,807 3,447 +10 +9 

Diabetes Care 1 1,837 1,921 -4 -5 

Molecular Diagnostics 859 801 +7 +4 

Applied Science 535 544 -2 -5 

Tissue Diagnostics 458 382 +20 +15 


1 

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

30

YTD Sept 2012: Diagnostics Division sales 

Strong growth in emerging markets 

North America 

+2% 

26% of divisional sales 

EMEA 1 

-1% 


Japan 

+7% 


Latin America 

+14% 


Asia Pacific 

+16% 


19 % growth in E7 countries 2 

1 

Europe, Middle East and Africa; 2 India, Russia, South Korea, Turkey, Mexico, China & Brazil 

All growth at CER (Constant Exchange Rates) 

31

YTD Sept 2012: Diagnostics Division highlights 

CER growth 

+9% 

Launch of Elecsys ® Vitamin D test in the US; FDA clearance 

for Accu Chek Inform II, new generation wireless hospital 

blood glucose testing system 

-5% 

Increasing pricing pressures and re-imbursement cuts; restructuring 

in progress; 

Good market uptake of recent product launches 

+4% 

Strengthening of virology menu with US launch of CMV 1 test; 

Good US market uptake for cobas BRAF & HPV tests 

-5% 

Re-structuring near completion; Broadening of portfolio & 

customers with launch of new Sequence Capture products 

+15% 

Strong growth ahead of market in all regions; Strong uptake 

of recently launched Benchmark Special Stains platform 

CHF bn 


EMEA=Europe, Middle East and Africa, RoW=Rest of the World 

1 

Cytomegalovirus 

32

Diabetes Care: Tougher market environment 

Securing long-term profitability via restructuring 

Market environment 

• Reimbursement cuts 

• Increased price pressures 

Roche initiatives 

• Reducing costs in R&D and M&D 

– Restructure and consolidate 

R&D organisation 

– Optimise M&D investments 

• "One Global Operations" structure 

Blood Glucose 

Monitoring (bGM 1 ) 

Streamline Portfolio 

Maximise market uptake 

Insulin Delivery 

Systems 

Invest 

Insulin pumps prospectively integrating CGM 2 

1 

Blood glucose monitoring 2 

Continuous glucose monitoring 

33

Diabetes Care: Good market uptake for recently 

launched Accu-Chek next-generation products 

Accu-Chek Mobile 2.0 

Europe 

Convenient strip-free bGM 3 

system for frequent testers 

Launched in 11 countries within Europe 

from Q1'12 

• Led to >20% growth for Accu-Chek Mobile 

sales 1 in EMEA 2 

Accu-Chek Nano 

SmartView 

U.S. 

Small no-code bGM 3 system 

with improved functions 

Launched in the US in Q2'12 

• Promising initial demand for this next 

generation product, first new bGM 3 system 

launched in US in six years 

1 

YTD 2012, CER 

2 

Europe, Middle East and Africa 

3 

Blood glucose monitoring 

34

Professional Diagnostics: FDA clears ACCU- 

CHEK Inform II 

Meeting high performance standards 

in hospital bGM* 

•Next generation product that assures improved 

accuracy and patient safety 

Roche market leader in hospital bGM 

•Installed in 2,750 hospitals with117,000 

ACCU-CHEK Inform systems in use 

Real-time wireless transfer of patient data 

to hospital information systems 

Expected US launch in 4Q 12 

*blood glucose monitoring 

35

Professional Diagnostics: FDA clears Elecsys® 

Vitamin D test 

Significant Market Potential 

Bone Markers: 

-β-Crosslaps 

-Total P1NP 1 

-Osteocalcin 

-PTH 

Related Markers: 

Minerals: 

- Calcium 

- Phosphate 

Hormones: 

- Estradiol 

- Testosterone 

- DHEA-S 

- SHBG 

Attractive bone 

marker offering 

with a large 

installed base 

• 40% of US population vitamin D 

deficient or insufficient 

• Major role in bone metabolism 

disorders and other diseases. 

• Vitamin D assay: 

– Fully automated 

– Measures vitamin D2 and D3 

– High precision at the low end 

to aid in the assessment of 

severely deficient patients 

– Strong sales performance in 

EMEA 2 

1 

This product is in development and is not available for sale in the US; 2 CE Mark in April 2011 

36

Key launches 2012 

Area Product Market BA* 

Labs 

cobas t 611 - Coagulation analyzer 

BenchMark Special Stains - Tissue stainer 

VENTANA iScan HT - Digital tissue scanner 

EU 

WW 

EU, US 

 

 

RPD 

RTD 

RTD 

Instruments 

/ 

Devices 

Point of 

Care 

Diabetes 

Care 

cobas b 101 - Multi lipid and glucose analyzer 

cobas b 123 POC - Blood gas analyzer 

Accu-Chek Nano SmartView -Small, no-code bGM 1 system 

Accu-Chek Combo – Insulin pump & bG meter combined 

Accu-Chek Mobile – Next generation strip free bGM system 

SOLO Micropump – Insulin pump and bG meter combined 

EU 

US 

US 

US 

EU 

EU 

 

 

 

 

RPD 

RPD 

RDC 

RDC 

RDC 

RDC 

Tests/ 

Assays 

Oncology 

Infectious 

Diseases 

HE4 - Ovarian cancer 

ER – Breast cancer 

CINtec p16 Histology- Cervical cancer 

GS GType Sequencing Primer Sets- Leukemia 

CMV – Cytomegalovirus infections 

CT/NG - Chlamydia and gonorrhoea infections 

US 

US 

WW 

WW 

US 

US 

RPD 

RTD 

RTD 

RAS 

RMD 

RMD 

Metabolism Vitamin D - Vitamin D2 & D3 US RPD 

Achieve sales growth above the market 

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

RAS: Roche Applied Science; RTD: Roche Tissue Diagnostics; 1 blood glucose monitoring 

 

 

 

 

 

37

Group 

Alan Hippe 

Chief Financial Officer 

38

YTD Sept 2012: Group sales 

Net fx impact of CHF +967 m or +3%p 

+6% -2% +1% +9% +4% +4% +7% 

Pharma Division 

+4% 

+967 

+269 

+2,202 

+508 

-152 +588 

+22 

+1,235 

United 

States 

Western 

Europe 

Japan International Dia 

Divsion 

Group 

1 

Fx Group 

CHF 

1 

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

39

Currency impact on Swiss Franc results 2012 

Positive impact in Q3/4 

CHF / USD 

average 

YTD 2011 

0.94 

+2% 

+7% +6% 

0.91 

0.89 

0.88 

0.94 0.91 0.91 0.91 0.94 0.96 0.98 0.97 0.94 0.94 0.94 0.94 

Fx rate at 28 Sep 2012 

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

CHF / EUR 

-2% 

1.29 

-6% 

Monthly avg fx rates 2012 

1.27 

-5% 

1.24 

Assumed average 

YTD 2012 

1.23 

-3% -2% 

Assuming the 28 Sept 2012 exchange 

rates remain stable until end of 2012, 

2012 impact is expected to be (%p): 

Q1 HY Sep FY 

YTD 

Sales -3 -1 +3 +3 

Core 

operating 

-2 +2 

profit 

Core EPS -4 +1 

1.21 1.21 1.21 1.20 1.20 1.20 1.20 1.20 1.21 1.21 1.21 1.21 

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

40

Accounts receivable in Southern Europe 

Reduction of 22% vs. Dec 2011 due to Spain, Italy 

and Portugal 

CCC 

Greece 

211 

194 

Sep 2012 

Dec 2011 

BB 

Portugal 

152 

172 

BBB+ 

Italy 

704 

805 

BBB+ 

Spain 

506 

850 

Southern 

European 

Countries 

1,573 

2,021 

-22% 

Sovereign country ratings from Standard & Poor’s, as of 5 October 2012 

0 500 1'000 1'500 2'000 2'500 

EUR m 

41

Outlook for 2012 confirmed 

Sales growth (CER) 

Operational Excellence 

savings 

Core EPS growth target 

(CER) 

Dividend outlook 

Group & Pharma: low to mid single-digit 

Diagnostics: above market 

2012+: CHF 2.4 bn* 

High single-digit 

Continue attractive dividend policy 

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

42

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 2012 results 

Diagnostics 

Foreign exchange rate information 

44

Roche development pipeline 

Projects in phase 1 

RG7112 

RG7116 

RG7155 

RG7167 

RG7204 

RG7212 

RG7304 

RG7356 

RG7420 

RG7421 

RG7388 

RG7440 

RG7446 

RG7450 

RG7458 

RG7598 

RG7599 

RG7600 

RG7601 

RG7602 

RG7604 

RG7636 

RG7666 

RG7741 

CHU 

CHU 

CHU 

Oncology 

MDM2 ant solid & hem tumors 

HER3 MAb solid tumors 

CSF-1R MAb solid tumors 

CIF/MEK inh 

solid tumors 

Zelboraf + ipilimumab met. melanoma 

Tweak MAb 

oncology 

Raf & MEK dual inh solid tumors 

CD44 MAb 

solid tumors 

MEK inh 

solid tumors 

MEK inh 

solid tumors 

MDM2 ant solid & hem tumors 

AKT inhibitor 

solid tumors 

PD-L1 MAb solid tumors 

Steap 1 ADC prostate ca. 

ADC ovarian ca. 

ADC multiple myeloma 

ADC oncology 

ADC oncology 

Bcl-2 inh 

CLL and NHL 

ChK1 inh solid tum & lymphoma 

PI3K inh 

solid tumors 

ADC metastatic melanoma 

PI3k inh 

glioblastoma 2L 

ChK1 inh(2) solid tumors 

ALK inhibitor 

NSCLC 

PI3K inh solid tumors 

WT-1 peptide cancer vaccine 

Phase I 

(36 NMEs+2 AIs) 

RG7624 

CHU 

CHU 

RG7795 

RG7667 

RG7697 

RG1662 

RG7314 

RG7129 

RG3645 

CHU 

Other disease areas 

IL-17 MAb autoimmune diseases 

IL-6R MAb RA 

CIM331 atopic dermatitis 

TLR7 agonist 

HBV 

- infectious diseases 

GIP/GLP-1 dual ago type 2 diabetes 

GABRA5 NAM cogn. disorders 

V1 receptor antag 

autism 

BACE1 inh 

Alzheimer’s 

Lucentis sust. deliv. AMD/RVO/DME 

ACE910 hemophilia A 

New Molecular Entity (NME) 

Additional Indication (AI) 

Oncology 

Immunology 

Virology 


Neuroscience 

Ophthalmology 

Others 

RG-No Roche Genentech managed 

CHU Chugai managed 


45

Roche development pipeline 

Projects in phase 2, 3 and registration 

RG1273 

RG1273 

RG3502 

RG3502 

RG3616 

RG3638 

RG3638 

RG3638 

RG3638 

RG3638 

RG3638 

RG7160 

RG7204 

RG7321 

RG7422 

RG7414 

RG7593 

RG7596 

RG7597 

RG7686 

RG1569 

RG7413 

RG7415 

RG7416 

RG7449 

RG7128 

RG7227 

RG7790 

RG1512 

RG7652 

RG7418 

RG1450 

RG1577 

RG1578 

RG7090 

RG7412 

SST 

RG7417 

Phase II 

(24 NMEs + 14 Als) 

Perjeta 

HER2+ mBC 2 nd line 

Perjeta HER2+ gastric cancer 

T-DM1 HER2+ EBC 

T-DM1 gastric cancer 

Erivedge 

operable BCC 

onartuzumab triple-neg mBC, 1 st /2 nd line1L/2L 

onartuzumab 

mCRC 1 st line 1L 

onartuzumab NSCLC non squamous 1 st l 

onartuzumab NSCLC squamous 1 st line 

onartuzumab glioblastoma 

1 st /2 nd line 

onartuzumab 


EGFR MAb solid tumors 

Zelboraf 

papillary thyroid cancer 

PI3K inh 

solid tumors 

PI3K/mTOR inh solid & hem tumors 

EGFL7 MAb 

solid tumors 

CD22 ADC heme tumors 

CD79b ADC heme tumors 

HER3/EGFR m. epithelial tumors 

glypican-3 MAb liver cancer 

Actemra 

systemic sclerosis 

etrolizumab ulcerative colitis 

rontalizumab systemic lupus erythem 

pateclizumab (LT alpha MAb ) RA 

quilizumab (M1 prime MAb) asthma 

mericitabine 

HCV 

danoprevir 

HCV 

setrobuvir 

HCV 

inclacumab (P selectin MAb) ACS/CVD 

PCSK9 MAb metabolic diseases 

oxLDL MAb sec prev CV events 

gantenerumab 

Alzheimer’s 

MAO-B inh 

Alzheimer’s 

mGluR2 antag 

depression 

mGluR5 antag tx resistant depression 

crenezumab 

Alzheimers 

arbaclofen 

autism (ASD) 

anti-factor D Fab geographic atrophy 

Phase III 

(8 NMEs + 23 Als) 

Registration 

(3 NMEs + 8 Als) 

MabThera ANCA assoc vascul 

RG105 MabThera NHL sc formulation 

RG105 Rituxan 

NHL fast infusion 

RG435 Avastin 

HER2+ BC adj 

RG435 1 Avastin relapsed ovarian cancer 

RG435 Avastin 

HER2-neg. BC adj 

RG435 Avastin mCRC TML 

RG435 Avastin 

NSCLC adj 

RG597 1 Herceptin HER2+ BC sc form 

RG435 Avastin 

high risk carcinoid 

RG1273 2 Perjeta HER2+ mBC 1 s t line 

RG435 Avastin glioblastoma 1 st line 

RG3502 T-DM1 HER2+ pretreated mBC 

RG435 * Avastin ovarian cancer 1 st line 

RG3616 2 Erivedge advanced BCC 

RG435 Avastin ovarian cancer platinum resist. 

RG105 2 

RG1415 * Tarceva NSCLC EGFR mut 1 st line 

RG1569 1 Actemra RA DMARD IR H2H 

RG1273 Perjeta 

HER2+ EBC 

RG1569 Actemra 

polyarticular JIA 

RG1415 Tarceva 

NSCLC adj 

RG3645 3 Lucentis AMD 0.5 mg PRN 

RG3502 T-DM1 HER2+ mBC 3 rd line 

1 submitted in EU 

RG3502 T-DM1 HER2+ mBC 1 st line 

2 approved in US, submitted in EU 

RG3638 onartuzumab NSCLC 2 nd /3 rd line 

3 submitted in US 

RG7159 obinutuzumab 

CLL 

RG7159 obinutuzumab iNHL relapsed 

New Molecular Entity (NME) 

RG7159 obinutuzumab 

DLBCL 

Additional Indication (AI) 

RG7159 obinutuzumab iNHL front-line 

RG7204 Zelboraf 

m. melanoma adj 

Oncology 

Immunology 


RA sc formulation 

Virology 


early RA 


RG3637 lebrikizumab 

severe asthma 

Neuroscience 

RG3648 Xolair chronic idiopathic urticaria 

Ophthalmology 

CHU Suvenyl 

enthesopathy 

RG1439 aleglitazar CV risk reduction in T2D 

RG-No Roche Genentech managed 

CHU tofogliflozin (SGLT2) type 2 diabetes 

CHU Chugai managed 

RG1594 ocrelizumab 

RMS 

SST Seaside Therapeutics 

RG1594 ocrelizumab 

PPMS 

RG105 MabThera is branded as 

Rituxan in US and Japan 

RG1678 bitopertin schiz neg symptoms 

RG1569 Actemra is branded as 

RG1678 bitopertin schiz subopt control 

RoActemra in EU 

SST arbaclofen fragile X syndrome 

* approved in the EU 


46

Changes to the development pipeline 

Since HY 2012 update on July 26, 2012 

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

1 NME transitioned from Ph0 

RG7697 GIP/GLP-1 dual agonist 

type 2 diabetes 

2 NMEs added by Chugai 

CHU CIM331 atopic dermatitis 

CHU ACE910 hemophilia A 

2 NMEs transitioned from Ph1 

RG7593 CD22 ADC hem. tumors 

RG7596 CD79b ADC hem. tumors 

2 AIs following FPI 

RG3638 onartuzumab gastric 

cancer 

RG3502 T-DM1 gastric cancer 

HER2-positive 

1 AI following FPI 

RG7204 Zelboraf metastatic 

melanoma adj. 

1 NME and 1 AI following US and 

EU submissions 

RG3502 T-DM1 HER2-positive 

pretreated mBC (NME) 

RG435 Avastin mCRC TML 

1 AI following EU submission 

RG1569 Actemra RA DMARD IR 

H2H 

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

1 NME reverted to partner 

RG7256 BRAF inh (2) BRAF mut 

melanoma 

2 NMEs discontinued 

RG7594 anti-angiogenic solid 

tumors 

RG7685 GIP/GLP-1 dual agonist 

type 2 diabetes 

1 NME discontinued 

RG4929 11 beta HSD inh 

metabolic diseases 

1 AI removed following outcome 

of HERA 2years 

RG597 Herceptin Her2-positive adj. 

BC (2years) 

1 AI following FDA approval 

RG3645 Lucentis diabetic macular 

edema 

47

NME submissions and their additional 

indications 

Projects currently in phase 2 and 3 




DLBCL 

PI3 kin inh (RG7321) 

solid tumors 

EGFR MAb (RG7160,GA201) 

solid tumors 

T-DM1 (RG3502) 

HER2-pos. mBC 1st line 

T-DM1 (RG3502) 


mericitabine 

HCV 

MEK inhibitor 

( RG7421) combo Zelboraf 

met melanoma 


iNHL relapsed 

danoprevir 

HCV 


mNSCLC, 2 nd /3 rd line 

aleglitazar 

CV risk reduction in T2D 

setrobuvir 

HCV 

 

T-DM1 (RG3502) 

HER2-pos. pretreated mBC 


CLL 

bitopertin 

schizophrenia# 

ocrelizumab 

PPMS and RMS 

mGluR5 (RG7090) 

depression 

2012 2013 2014 2015 2016 

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

indicates a submission which has occurred with regulatory action pending 

# negative symptoms and sub-optimal control 


Oncology 

Immunology 

Virology 


Neuroscience 

Ophthalmology 

NME 

48

Submissions of additional indications for existing 

products 

Projects currently in phase 2 and 3 

 

Avastin 

mCRC TML 

Herceptin 

sc formulation (EU) 

Avastin 

ovarian cancer platin. resist. 

Zelboraf 

met melanoma adj. 

MabThera 

sc formulation (EU) 

Avastin 

relapsed ovarian cancer (US) 

Zelboraf 

papillary thyroid cancer 

Tarceva (US) 

NSCLC EGFR mut. 1 st line 

Avastin 

ovarian cancer 1 st line (US) 

Perjeta 

HER2-pos. EBC 

Actemra 


 

 

Actemra 

RA DMARD IR H2H (EU) 

Avastin 

HER2-pos. BC adj 

Avastin 

glioblastoma 1 st line 

Perjeta 

HER2-pos. mBC 2 nd line 

Perjeta 


Actemra 

sc formulation 

Tarceva 

NSCLC adj (EU) 

Avastin 

HER2-neg BC adj 

MabThera 

 

ANCA assoc vasculitis (EU) 

Xolair (US) 

chronic idiopathic urticaria 

Avastin 

NSCLC adj 

Lucentis 

 

AMD 0.5 mg PRN (US) 

Actemra 

early RA 

Tarceva 

NSCLC adj (US) 

Actemra 

systemic sclerosis 

2012 2013 2014 Post 2014 

indicates submission to Health Authorities has occurred. 

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

Oncology 

Immunology 

Virology 


Neuroscience 

Ophthalmology 

49 

Status as of September 30, 2012

Major granted and pending approvals 2012 

Approved 

Pending approvals 

Actemra 

DMARD IR 

Erivedge 

adv. basal cell ca 

T-DM1 (RG3502) 

HER2-pos pretreated mBC 

Filed Aug 2012 

US 

Perjeta 

HER2-pos. mBC 1 st line 

Lucentis 

diabetic macular edema 

Avastin 

mCRC TML 


Rituxan 

NHL faster infusion 

Filed Dec 2011 

Actemra 


Filed June 2012 

Lucentis 

AMD 0.5 mg PRN 

Filed Apr 2012 

EU 

Zelboraf 

met. melanoma 

Erivedge 

adv. basal cell ca 

Filed Nov 2011 

Actemra 

RA DMARD IR H2H 


Perjeta (RG1273) 


Filed Dec 2011 

Actemra 

polyarticularJIA 


T-DM1 (RG3502) 

HER2+ advanced mBC 


MabThera 

ANCA associated vasculitis 

Filed Apr 2012 

Avastin 

relapsed ovarian cancer 


Oncology 

Immunology 

Virology 



Neuroscience 

Ophthalmology 

NME 

Avastin 

mCRC TML 


Herceptin 


Filed Mar 2012 

50

Major Chugai granted and pending approvals 2012 

Approved 

Pending approvals 

Pulmozyme 

Improvement pulmonary 

function in cystic fibrosis 

Actemra 


Filed March 2012 

Avastin 

glioblastoma 

Filed September 2012 

Avastin 

ovarian cancer 

Filed October 2012 

Perjeta 


Filed May 2012 

Tarceva 

NSCLC EGFR mut 1 st line 


Boniva/Bonviva 

osteoporosis 

Filed July 2012 


Oncology 

Immunology 

Virology 


Neuroscience 

Ophthalmology 

NME 

51

We Innovate Healthcare 

52






Roche Group YTD Sept 2012 sales 

Diagnostics 


53


Development programmes 

Patient 

population 

Phase/study 

Front-line follicular non-Hodgkin’s lymphoma 

Phase III 

SABRINA 

Subcutaneous study 

Study being conducted ex-US 

Oncology 

Previously untreated chronic lymphocytic leukemia 

Phase Ib 

SAWYER 


Study 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 primary 

endpoint 

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 

Status 

• Pharmacokinetics, safety and efficacy 

• Stage 1 primary endpoint (PK noninferiority) met 

• Expect full stage 1 data presentation Q4 2012 

• Part 1: PK (dose selection) 

• Part 2: PK of MabThera IV vs. MabThera SC (Arm A vs Arm 

B) 

• FPI (stage 2) Q3 2012 

Subcutaneous MabThera : applies Enhanze technology, partnered with Halozyme 

CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone; CVP = Cyclophosphamide, Vincristine and Prednisolone. 

54


Development programmes 

Patient 

population 

Phase/study 

Oncology 

Front-line diffuse large B-cell or follicular 

non-Hodgkin’s lymphoma 

Phase IIIb 

RATE* 

Faster infusion study 

Immunology 

ANCA-associated vasculitis 

Phase II/III 

RAVE* 


Design • Prospective, open-label, single arm study • Non-inferiority efficacy and safety study of 

MabThera/Rituxan and glucocorticoids versus 

conventional therapy (cyclophosphamide) 

Primary 

endpoint 

• To determine the incidence of Grade 3 or 4 

infusion-related toxicities resulting from faster 

infusion of MabThera/Rituxan 

Status • Enrolment completed Q4 2010 

• Data presented at ASH 2011 

• Filed with the FDA in Q4 2011 

• Induction of complete remission at 6 months, 

defined as a BVAS/WG of 0 and off 

glucocorticoid therapy 

• Data presented at ACR 2009 

• FDA approved use of Rituxan in WG and MPA 

in Q2 2011 

• Submitted to EMA Q2 2012 

*In collaboration with Biogen Idec; 

WG - Wegener's Granulomatosis, MPA - Microscopic Polyangiitis 55

Avastin 

Ovarian cancer clinical development programme 

Patient 

population 

Phase/stud 

y 

Phase III 

GOG-0218 

# of 

N=1,873 

patients 

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 


• ARM C: Paclitaxel and carboplatin for 6 cycles plus 5 

cycles of concurrent Avastin followed by Avastin alone 


Avastin 

dose 

Primary 

endpoint 

• 15 mg/kg q3 weeks 

• Progression-free survival 

Status • Study met its primary endpoint in Q1 2010 

• Data presented at ASCO 2010 and 2011 

• Results published in NEJM December 2011 

Front-line metastatic 


Phase III 

ICON7 

N=1,528 

• 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) 

• 7.5 mg/kg q3 weeks 


• Study met its primary endpoint Q3 2010 

• Data presented at ESMO 2010 and ASCO 2011 

• Results published in NEJM December 2011 

• 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. 

56

Avastin 

Ovarian cancer clinical development programme 

Patient 

population 

Phase/study 

Relapsed platinum-sensitive 


Phase III 

OCEANS 

Relapsed platinum-resistant 


Phase III 

AURELIA 


Design 

• ARM A: Carboplatin, gemcitabine, and 

concurrent placebo for 6 cycles, followed by 

placebo alone until disease progression 

• ARM B: Carboplatin, gemcitabine, and 

concurrent Avastin for 6 cycles, followed by 

Avastin alone until disease progression. 

• 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 



Status • Study met its primary endpoint Q1 2011 

• Data presented at ASCO 2011 

• EMA submission Q3 2011 

• Positive CHMP opinion received Q3 2012 

• Re-evaluate FDA submission when final overall 

survival results from all phase III trials are 

available (expected 2013) 



• EMA submission expected Q1 2013 


57

Avastin 

High risk carcinoid and brain cancer development 

programmes 

Patient 

population 

Phase/study 

High risk carcinoid 

Phase III 

SWOG SO518 

Newly diagnosed glioblastoma 

Phase III 

AVAglio 


Design 

• ARM A: Depot octreotide plus interferon 

alpha 

• ARM B: Depot octreotide plus Avastin 

• ARM A: Concurrent radiation and 

temozolomide plus placebo; followed by 

maintenance TMZ plus placebo for 6 cycles; 

then placebo until disease progression 

• ARM B: Concurrent radiation and TMZ plus 

Avastin; followed by maintenance TMZ plus 

Avastin for 6 cycles; then Avastin (15mg/kg 

q3 weeks) monotherapy until disease 

progression 

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

Primary 

endpoint 

Status 


• Recruitment completed 

• Expect data 2013 


• Overall survival 

• Enrolment completed Q1 2011 

• Co-primary endpoint of PFS met Q3 2012 

58

Avastin 

Colorectal and breast cancer development programmes 

Patient 

population 

Phase/study 

Metastatic colorectal cancer 

Phase III 

ML18147 

TML 

First-line HER2-negative metastatic breast 

cancer 

Phase III 

MERiDiAN 


Design 

• 1 st -line treatment with chemotherapy* plus 

Avastin 

• Once patients progress, they are randomised 

to: 

• ARM A: Chemotherapy* alone 

• ARM B: Chemotherapy* + Avastin 

* Physician’s choice 

• ARM A: Paclitaxel + Avastin 

• ARM B: Paclitaxel + Placebo 

Avastin dose • 5 mg/kg q2 weeks or 7.5 mg/kg q3 weeks • 10 mg/kg q2 weeks 

Primary 

endpoint 


Status • Primary end point met Q1 2012 


• Filed globally Q3 2012 

• Priority review granted by the FDA October 

2012 

• PFS in ITT 

• PFS in patients with high plasma VEGF-A 

• FPI Q3 2012 

59

Avastin 

Adjuvant clinical development programme 

Patient 

population 

Adjuvant 

lung cancer 

Adjuvant 

breast cancer 

Phase/stud 

y 

Phase III 

ECOG 1505 

Phase III 

ECOG 5103 

HER2-negative 

Phase III 

BETH 

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 

pemetrexed plus Avastin up to 12 

months 

• ARM A: Anthracycline plus 

cyclophosphamide (AC) followed by 

paclitaxel 

• ARM B: AC plus Avastin followed 

by paclitaxel plus Avastin 

• ARM C: AC plus Avastin followed 

by paclitaxel plus Avastin, followed 

by Avastin up to 12 months 

• 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 

Primary 

endpoint 

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

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

Status • FPI Q3 2007 

• Recruitment ongoing 


• FPI Q4 2007 

• Enrolment completed Q2’11 


• FPI Q2 2008 



60

Herceptin 

Standard of care for HER2-positive early breast cancer 

Patient 

population 

Adjuvant HER2-positive 

breast cancer 

Early-stage HER2-positive 

breast cancer 

Phase/study 

Phase III 

HERA 

Phase III 

HANNAH 


# of patients N=5,102 N=595 

Design 

• ARM A: Herceptin for 12 months 

• ARM B: Herceptin for 24 months 

• ARM C: Observation 

• ARM A: Chemotherapy* concurrent with 

Herceptin 600mg sc q3w for the first 8 

cycles 

• ARM B: Chemotherapy* concurrent with 

Herceptin IV for the first 8 cycles 

*Chemotherapy = docetaxel then 5-FU, 

epirubicin, and cyclophosphamide 

Primary 

endpoint 

• Disease-free survival 

Status • Final analysis presented at ESMO 2012 

• No additional benefit seen in 2 year arm 

vs. 1 year 

• 1 year treatment duration confirmed as 

standard of care 

• Serum concentration 

• Pathologic complete response 

• Positive top-line data reported in October 

2011 

• Data presented at EBCC 2012 

• Filed in EU Q1 2012 

Subcutaneous Herceptin : applies Enhanze technology, partnered with Halozyme 

61

Perjeta 

First in a new class of HER dimerization inhibitors 

Patient 

population 

Adjuvant HER2-positive 

breast cancer 

First-line HER2-positive 

metastatic breast cancer 

Second-line HER2-positive 

metastatic breast cancer 

Advanced HER2-positive 


Phase/ 

study 

Phase III 

APHINITY 

Phase III 

CLEOPATRA 

Phase II 

PHEREXA 

Phase IIa 

JOSHUA 

# of patients N=3,806 N=808 N=450 N=30 

Design 

Primary 

endpoint 

• ARM A: Pertuzumab 

(840mg loading, 420 q3w) 

plus Herceptin for 52 weeks 

plus chemotherapy (6-8 

cycles) 

• ARM B: Placebo plus 

Herceptin (52 weeks) plus 

chemotherapy (6-8 cycles) 


(840mg loading, 420mg 

q3w) plus Herceptin and 

docetaxel 


Herceptin and docetaxel 

• ARM A: Herceptin plus 

Xeloda 

• ARM B: Pertuzumab plus 

Herceptin and Xeloda 


(840mg loading, 420mg 

q3w) plus Herceptin and 

chemotherapy 


Herceptin and 

chemotherapy 

• 3-year disease-free survival • Progression-free survival • Progression-free survival • Safety, efficacy 

Status • FPI Q4 2011 • Met primary endpoint July 

2011 

• Data presented at SABCS 

2011 

• Submitted for FDA and EMA 

approval Q4 2011 

• FDA granted approval Q2 

2012 

• FPI Q1 2010 • FPI Q4 2011 

SABCS = San Antonio Breast Cancer Symposium. 62

Tarceva 

New approaches to treating lung cancer 

Patient 

population 

Phase/study 

Adjuvant non-small 

cell lung cancer 

Phase III 

RADIANT 

First-line metastatic 

non-small cell lung cancer 

EGFR mutation-positive 

Phase III 

EURTAC 

# of patients 

Design 

Primary 

endpoint 

N=974 

(2:1 randomisation) 

• Following surgical resection ± adjuvant 

chemotherapy: 

• ARM A: Tarceva up to 2 years 

• ARM B: Placebo up to 2 years 

• Disease-free survival 

• EGFR IHC and/or FISH-positive 


• Expect final results H1 2013 

N=174 

• ARM A: Tarceva 

• ARM B: Chemotherapy (platinum-based 

doublet) 




• EU granted approval in Q3 2011 

• Expect FDA sNDA submission in 2012 

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

63

Zelboraf 

A selective novel small molecule that inhibits 

mutant BRAF 

Patient 

population 

Adjuvant therapy in patients 

with resected cutaneous BRAF 

mutation positive melanoma 

Previously treated papillary 

thyroid cancer 

BRAF mutation positive 

Metastatic melanoma 


Phase/study 

Phase III 

BRIM8 

Phase II 

Phase Ib 

# of patients N=725 N=50 N=20 

Design 

Primary 

endpoint 

• 52-week treatment 

• ARM A:Zelboraf 960mg bid 

• ARM B: placebo 

• Single ARM: Zelboraf 

• Disease-free survival • Best overall response rate • Safety 

• Single ARM: Zelboraf plus 

ipilimumab• 

Status • FPI Q3 2012 • FPI Q2 2011 • FPI Q4 2011 

In collaboration with Plexxikon, a member of Daiichi Sankyo Group 

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

See also combinations with: MEK inhibitor (RG7421) and anti-PD-L1 (RG7446) 

64

Zelboraf 

A selective novel small molecule that inhibits 

mutant BRAF 

Patient 

population 

Melanoma patients with brain metastases 


Phase/study Phase II Phase I 


Design • Single ARM: Zelboraf • Single ARM: Zelboraf 

Primary 

endpoint 

• Overall Response Rate in the brain 

• Safety 

Status • FPI Q3 2011 • FPI Q4 2010 


• Data presented at ESMO 2012 

In collaboration with Plexxikon, a member of Daiichi Sankyo Group 

65

Erivedge (Vismodegib) 

A novel small molecule inhibitor of the hedgehog signaling 

pathway 

Patient 

population 

Phase/study 

Advanced basal 

cell carcinoma 

Pivotal Phase II 

ERIVANCE 

Operable basal 

cell carcinoma 

Phase II 


Design 

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

until disease progression 

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

Primary 

endpoint 

• Overall response rate 

Status • Positive results announced Q1 2011 

• Data presented at EADO June 2011, ECCO/ESMO 

Sep 2011, EADV Oct 2011 

• EMA submission accepted Q4 2011 

• FDA granted approval Q1 2012 

• Data published NEJM June 2012 

• COHORT 1: Complete clearance (12 weeks Erivedge) 

• COHORT 2: Durable complete clearance (12 weeks 

Erivedge) 

• COHORT 3: Complete clearance (16 weeks Erivedge) 

• FPI Q4 2010 

• Cohort 1 data presented at Society for Investigative 

Dermatology (May 2012) 

In collaboration with Curis 

66


Interleukin 6 receptor inhibitor 

Patient 

population 

Early moderate-to-severe 

rheumatoid arthritis 

Rheumatoid arthritis 

DMARD inadequate 

responders 

Moderate-to-severe 


Moderate-to-severe 


Phase/study 

Phase III 

FUNCTION 

Phase III 

ADACTA 

Head-to-head study 

Phase III 

SUMMACTA 


Phase III 

BREVACTA 


# of patients N=1,162 N=326 N=1,200 N=600 

Design 

104 week treatment 

• ARM A: Actemra IV 8 mg/kg 

q4w plus pbo MTX 

• ARM B: Actemra IV 8 mg/kg 

q4w plus MTX 

• ARM C: Actemra IV 4 mg/kg 

q4w plus MTX 

• ARM D: MTX alone 

24 week treatment 

• ARM A: Actemra IV 8mg/kg 

q4w plus pbo Adalimumab 

• ARM B: Adalimumab 40mg 

sc q2w plus pbo Actemra 

• Add-on to DMARD therapy 

• Weekly dosing for 104 

weeks 

• ARM A: Actemra sc 162mg 

weekly plus placebo IV q4w 

• ARM B: Actemra IV 8mg/kg 

q4w plus placebo sc weekly 

• Add-on to DMARD therapy 

• Dosing every two weeks for 

104 weeks 

• ARM A: Actemra sc 162mg 

q2w 

• ARM B: Placebo sc q2w 

Primary 

endpoint 

• DAS28 remission at 24 

weeks, 1 year and 2 years 


• Primary endpoint met Q3 

2012 

• Data to be presented at ACR 

2012 

• Filing expected 2013 

• DAS28 at 24 weeks • ACR 20 at week 24 • ACR 20 at week 24 

• Trial met primary endpoint 

• Q1 2012 

• Data presented at EULAR 

2012 

• Submitted for EMA approval 

Q3 2012 

• Trial met primary endpoint 

Q2 2012 

• Filing expected in 2012 


2012 

• Primary endpoint met Q3 

2012 

• Filing expected in 2012 


2012 

In collaboration with Chugai 

67 

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


Interleukin 6 receptor inhibitor 

Patient 

population 

Phase/study 

Systemic sclerosis 

Phase II 

faSScinate 

Proof-of-concept study 

Polyarticular-course juvenile idiopathic 

arthritis 

Phase III 

CHERISH 


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 I: All patients receive Actemra 8mg/kg or 

10mg/kg (IV) q4w for 16 weeks 

• Part II: Patients with adequate response from 

Part I will be randomized to receive: 

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

q4w for up to 24 weeks + SOC* 

•ARM B: Placebo + SOC* 

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

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

Primary 

endpoint 

• Change in modified Rodnan skin score (mRSS) 

at week 24 

• Safety 



• Proportion of patients with a JIA ACR30 flare by 

week 40 relative to week 16 

• Study met primary endpoint in Q1 2012 

• Submitted to FDA and EMA Q2 2012 

In collaboration with Chugai 

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

68

Xolair 

Evaluating potential in Chronic Idiopathic 

Urticaria, an IgE related disease 

Patient 

population 

Chronic Idiopathic Urticaria 

Patients who remain symptomatic despite treatment* 

Phase/study 

Phase III 

ASTERIA I 

Phase III 

ASTERIA II 

Phase III 

GLACIAL 


Design 

Primary 

endpoint 

Add-on therapy to H1 antihistamines 

24 week treatment period (q4- 

week) 

• ARM A: Xolair 300 mg 

• ARM B: Xolair 150 mg 

• ARM C: Xolair 75 mg 

• ARM D: Placebo 

• Change from baseline in UAS7 

weekly itch score at Week 12 

Add-on therapy to H1 antihistamines 


week) 

•ARM A: Xolair 300 mg 

•ARM B: Xolair 150 mg 

•ARM C: Xolair 75 mg 

•ARM D: Placebo 

• Change from baseline in UAS7 

weekly itch score at Week 12 

Add-on therapy to H1 antihistamines, 

H2 blockers, and/or 

LTRA 


week) 

•ARM A: Xolair 300 mg 


•Safety 

Status • Enrollment completed Q1 2012 

• Data expected Q4 2012 

• Enrollment completed Q4 2011 

• Data in-house, under review 

• Expect data presentation H1 

2013 


• Data expected Q1 2013 

In collaboration with Novartis 

*Refractory to H1 anti-histamines, H2 blockers, and/or leukotriene receptor antagonists (LTRAs) at the time of randomisation. 

69

Lucentis 

Development programme for wAMD 

Patient 

population 

Phase/study 

Neovascular (wet) age-related 

macular degeneration 

Phase III 

HARBOR 

High dose study 

# of patients N=1,110 

Design 

• Randomised double-masked study comparing efficacy and safety of intravitreal injections of 

0.5 mg and 2.0 mg Lucentis administered monthly or PRN in patients with wet AMD 

Primary 

endpoint 

• Mean change in best corrected visual acuity (BCVA) compared to baseline at 12 months 

Status • 12 month data was presented at AAO meeting October 2011 

• 0.5mg PRN sBLA filed with FDA in April 2012 

• 24 months data will be presented at AAO meeting Nov. 2012 

Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. 

ADA – American Diabetes Association, AAO = American Academy of Opthalmology 

70







Diagnostics 


71

Trastuzumab emtansine (T-DM1, RG3502) 

Evaluating new treatment options in HER2-positive 

breast cancer 

Patient 

population 

Patients who have 

progressed on HER2 targeted 

treatment 

Pretreated 

HER2 pos. metastatic breast 

cancer 1 

Previously untreated 

HER2 pos. metastatic breast 

cancer 

Phase/ study 

Phase III 

TH3RESA 

Phase III 

EMILIA 

Phase III 

MARIANNE 

# of patients N=795 N=991 N=1,092 

Design 

Primary 

endpoint 

• ARM A: T-DM1 3.6mg/kg 

q3w 

• ARM B: physician’s choice 

• ORR and Overall survival 

• ARM A: T-DM1 3.6mg/kg 

q3w 

• ARM B: Xeloda plus lapatinib 

Co-primary endpoints: 


(PFS) 


Status • FPI Q3 2011 • PFS data presented at ASCO 

2012 

• OS endpoint met Q3 2012 

• Data presented at ESMO 2012 

• Submitted for FDA and EMA 

approval Q3 2012 

• ARM A: Herceptin plus 

taxane 

• ARM B: T-DM1 3.6mg/kg 

q3w plus pertuzumab 

• ARM C: T-DM1 3.6 mg/kg 

q3w plus placebo 


assessed by IRF 

• FPI Q3 2010 

• Recruitment completed Q2 

2012 

In collaboration with ImmunoGen, Inc. 

ASCO = American Society of Clinical Oncology 

1 

Patients must have received prior treatment which included both: a taxane, alone or in combination with another agent, and trastuzumab in the adjuvant, locally 

advanced, or metastatic setting. 

72

Trastuzumab emtansine (T-DM1, RG3502) 

Evaluating new treatment options in HER2+ 

breast and gastric cancers 

Patient 

population 

Neoadjuvant/ Adjuvant breast 

cancer 

HER2-positive advanced gastric 

cancer 

Phase/ study 

Phase II 

Cardiac safety study 

Phase II/III 


Design 

Primary 

endpoint 

• Single ARM: T-DM1 3.6mg/kg 

q3w administered immediately 

following completion of 

anthracycline chemotherapy 

• Cardiac event rate 

•Safety 

• ARM A: T-DM1 3.6mg/kg q3w 

• ARM B: T-DM1 2.4mg/kg q3w 

• ARM C: docetaxel or paclitaxel 

• Phase II: Dose-finding 

• Phase III: Overall survival 

Status • Completed enrollment Q2 2011 

• Interim data presented at ASCO 

2012 

• FPI Q3 2012 

In collaboration with ImmunoGen, Inc. 

ASCO = American Society of Clinical Oncology 

73

Onartuzumab (MetMAb, RG3638) 

Anti-Met monovalent antibody that inhibits 

HGF-mediated activation 

Patient 

population 

2 nd - and 3 rd -line 

Met-positive metastatic NSCLC 

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

Phase 

Phase III 

MetLung 

Phase II 

Phase II 

# of 

patients 

N=480 N=260 N=110 

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 


• Progression-Free Survival in the ITT 

population 

• Progression-Free Survival in Metpositive 

population 

• Progression-Free Survival in the ITT 

population 

• Progression-Free Survival in Metpositive 

population 


74

Onartuzumab (MetMAb, RG3638) 

Anti-Met monovalent antibody that inhibits 

HGF-mediated activation 

Patient 

population 

Metastatic HER2-negative 

Gastro esophageal Cancer 

1 st and 2 nd -line 

triple negative metastatic 

breast cancer 

1 st -line metastatic 

colorectal cancer 

Avastin-naïve recurrent 

glioblastoma 

Phase Phase II Phase II Phase II Phase II 

# of patients N=120 N=180 N=188 N=120 

Design 

• ARM A: Onartuzumab plus 

mFOLFOX 


mFOLFOX 

• ARM A: Avastin and 

paclitaxel plus 

onartuzumab 

• ARM B: Avastin and 

paclitaxel plus placebo 

• ARM C: Paclitaxel plus 

onartuzumab 

• ARM A: FOLFOX plus 

Avastin plus onartuzumab 

• ARM B: FOLFOX plus 

Avastin plus placebo 

• Arm A: Onartuzumab + 

Avastin 

• Arm B: Placebo + Avastin 

• Arm C: Onartuzumab 

+Placebo 

Primary 

endpoint 

• Progression–free survival in 

ITT 

• Progression-free survival in 

pre-specified Met-positive 

patients 

• Progression–free survival 

• 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 


• Enrollment completed July 

2012 

• Expect data H2 2013 

• FPI Q3 2011 • FPI Q3 2012 

75

MEK inhibitor (RG7421, GDC-0973) 

Selective small molecule inhibitor of mitogenactivated 

protein kinase 

Patient 

population 


metastatic 

melanoma BRAF 

mutation positive 

Metastatic 

melanoma 

BRAF mutation 

positive 

Solid tumors Solid tumors Solid tumors 

Phase 

Phase III 

Phase Ib 

BRIM7 

Phase I Phase Ib Phase Ib 

# of patients N=500 N=~50 N=90 N=212 N=108 

Design 

• ARME A: Zelboraf* 

plus RG7421 

• ARM B: Zelboraf* 

plus placebo 

• Dose escalation 

study evaluating 

Zelboraf* plus 

RG7421 


study 


study evaluating 

GDC-0973 plus GDC- 

0941 (PI3 Kinase 

Inhibitor) 


study of GDC-0973 in 

combination with 

GDC-0068 

Primary 

endpoint 

• Progression-free 

survival 

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

Status • Expect FPI Q4 2012 • FPI Q1 2011 

• Data presented at 

ESMO 2012 

• FPI Q2 2007 

• Data presented at 

AACR 2011 

•Recruitment 

completed Q3 2011 

• FPI Q4 2009 

• Updated data 

presented at AACR 

and ASCO 2012 

• FPI Q2 2012 

In collaboration with Exelixis 

*Zelboraf In collaboration with Plexxikon, a member of Daiichi Sankyo Group 

76

Obinutuzumab (GA101, RG7159) 

Type II, glycoengineered anti-CD20 monoclonal antibody 

• Phase III clinical trials 

Patient 

population 

Front-line 

chronic lymphocytic 

leukaemia 

Patients with 

comorbidities 

Indolent 

non-Hodgkin’s 

lymphoma 


refractory 

Front-line indolent 

non-Hodgkin’s 

lymphoma 

Diffuse large B-cell 

lymphoma (DLBCL) 

Phase/study 

Phase III 

CLL11 

Phase III 

GADOLIN 

Phase III 

GALLIUM 

Phase III 

GOYA 

# of patients N=780 N=360 N=1,400 N=1,400 

Design 

Primary 

endpoint 

• ARM A: GA101 1000mg 

IV plus chlorambucil 

• ARM B: 

MabThera/Rituxan plus 

chlorambucil 

• ARM C: Chlorambucil 

alone 

• ARM A: GA101 1000mg 

IV plus Bendamustine 

• ARM B: Bendamustine 

• ARM A: GA101 1000mg 

IV plus chemotherapy 

followed by GA101 

maintenance 

• ARM B: 


chemotherpy followed by 


maintenance 

• ARM A: GA101 1000mg 

IV plus CHOP 

• ARM B: 


CHOP 

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



Q2 2012 


• FPI Q2 2010 


• FPI Q3 2011 


• FPI Q3 2011 


In collaboration with Biogen Idec 

CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisone 

77

Obinutuzumab (GA101, RG7159) 

Type II, glycoengineered anti-CD20 monoclonal antibody 

• Phase I/II clinical trials 

Patient 

population 

Phase/study 

Front-line or relapsed 

indolent non-Hodgkin’s 

lymphoma (NHL) 

Phase Ib 

GAUDI 

Relapsed 

indolent non-Hodgkin’s lymphoma 

Phase I/II 

GAUSS 

Relapsed or refractory 

non-Hodgkin’s lymphoma or chronic 

lymphocytic leukaemia (CLL) 

Phase I/II 

GAUGUIN 


Design 

Primary 

endpoint 

• Cohort A: GA101 plus fludarabine 

+ cyclophosphamide 

• Cohort B: GA101 plus CHOP 

• Cohort C: GA101 plus 

bendamustine 

Phase I portion 

(extended treatment for 2 years): 

• Single agent: GA101 

Phase II portion 

(extended treatment for 2 years): 

• ARM A: MabThera/Rituxan 

• ARM B: GA101 

Phase I portion: 


Phase II portion: 


• Safety • Overall response rate • Phase I: Incidence of dose-limiting toxicity 

• Phase II: Overall best response rate 




• Initiated Q1 2008 



• FPI Q3 2009 




• Initiated Q3 2007 

• Updated Phase I NHL and CLL data 

presented at ASH 2009 


• All cohorts completed enrolment by Q4 

2009 

• Data presented at ICML/EHA 2011 

In collaboration with Biogen Idec 

CHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; 

ASH = American Society of Hematology; EHA = European Hematology Association. 

78

Lebrikizumab (RG3637) 

A humanized monoclonal antibody designed to bind 

specifically to IL-13 

• Phase III clinical trials 

Severe uncontrolled adult asthma 

Patient 

population 

Phase/stud 

y 

# of 

patients 

Adult patients whose 

asthma is uncontrolled with inhaled 

corticosteroids and a second controller 

medication 

Phase III 

LUTE * 

N=1,400 

Adult patients whose 

asthma is uncontrolled with inhaled 

corticosteroids and a second controller 

medication 

Phase III 

VERSE* 

N=1,400 

Design Subcutaneous lebrikizumab q4w on top of SOC for 52 

weeks followed by 52 week extension on lebrikizumab 

for a total of 104 weeks, with a 24 week safety followup 

•ARM A: Lebrikizumab highest dose 

•ARM B: Lebrikizumab middle dose 

•ARM C: Lebrikizumab lowest dose 


Patients will be tested for periostin level 

Subcutaneous lebrikizumab q4w on top of SOC for 52 

weeks followed by 52 week extension on lebrikizumab 

for a total of 104 weeks, with a 24 week safety followup 

•ARM A: Lebrikizumab highest dose 

•ARM B: Lebrikizumab middle dose 

•ARM C: Lebrikizumab lowest dose 


Patients will be tested for periostin level 

Primary 

endpoint 

• Rate of asthma exacerbations during the 52-week 

placebo-controlled period 

• Rate of asthma exacerbations during the 52-week 

placebo-controlled period 


*Programs currently under internal review - modifications pending 

79

Rontalizumab (RG7415) 

A humanized monoclonal antibody to 

interferon alpha 

Patient 

population 

Phase/study 

Systemic lupus erythematosus 

Phase II 

ROSE 

# of patients N=238 

Design 

• ARM A: Placebo 

• Part 1 – IV 

• Part 2 - Subcutaneous 

• ARM B: Rontalizumab 

• Part 1 – IV 

• Part 2 – Subcutaneous 

Primary 

endpoint 

• Proportion of responders at Week 24 


• Data to be presented at ACR 2012 

80

Aleglitazar (RG1439) 

A balanced PPAR co-agonist - potential to reduce 

cardiovascular events in type 2 diabetes patients 

Patient 

population 

Phase/study 

Type 2 diabetes 

Patients with moderate and mild 

renal impairment 

Phase II 

AleNEPHRO 

Renal function study 

ACS patients with 


Phase III 

AleCARDIO 


# of patients N=300 N=7,229 

Design 

Primary 

endpoint 

• 52 week treatment duration: 

• ARM A: Aleglitazar (150 μg) 

• ARM B: Pioglitazone (45 mg) 

• Relative change from baseline in glomerular 

filtration rate at 60 weeks 

• At least 2.5 years treatment period and until 

950 events have occurred 

• ARM A: Aleglitazar (150 μg) on top of SOC 

• ARM B: Placebo on top of SOC 

• Reduction in cardiovascular mortality, nonfatal 


Status • Enrollment completed Q2 2011 

• Primary endpoint met Q3 2012 

• Data to be presented at ASN 2012 

• FPI Q1 2010 


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

ASN = American Society of Nephrology 

81

Aleglitazar (RG1439) 

A balanced PPAR co-agonist - potential to reduce 

cardiovascular events in type 2 diabetes patients 

Patient 

population 

Type 2 diabetes (US,China) 

Stable CVD and type 2 diabetes or prediabetes 

Phase/study 

Phase III 

AleGlucose 

Glycemic control study 

Phase III 

AlePrevent 


# of patients N=1,400 N=19,000 

Design 

Primary 

endpoint 

26 weeks treatment duration 

•ARM A: Aleglitazar (150 μg) monotherapy, 

add on to Metformin and Add on to 

Sulfonylurea with or without Metformin 


• Reduction from baseline in HbA1c 

At least 3 year treatment period and until 1260 

events have occurred 

•ARM A: Aleglitazar 150 μg daily on top of SOC 

•ARM B: Placebo daily on top of SOC 

• Reduction in cardiovascular mortality, nonfatal 


Status • Expect FPI Q4 2012 • Expect FPI Q4 2012 

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

82

Bitopertin (GlyT-1, RG1678) 

A small molecule first-in-class glycin reuptake 

inhibitor (GRI) 

Patient 

population 

Acute 

exacerbation of 

schizophrenia 

Sub-optimally controlled symptoms of schizophrenia 

Phase/stud 

y 

Phase II 

CandleLyte 

Phase III 

NIGHTLYTE 

Phase III 

MOONLYTE 

Phase III 

TWILYTE 

# of 

patients 

N=300 N=600 N=600 N=600 

Design 

• 4-week treatment period 

•ARM A: RG1678 daily (10 

mg) 

•ARM B: RG1678 daily (30 

mg) 

•ARM C: Olanzapine 


• Add-on therapy to antipsychotics 


period 

•ARM A: RG1678 daily 

(10 mg) 

•ARM B: RG1678 daily 

(20 mg) 

•ARM C: Placebo 



period 


(10 mg) 


(20 mg) 




period 


(5 mg) 


(10 mg) 


Primary 

endpoint 

• PANSS total symptom factor 

at week 4 

• PANSS positive 

symptom factor at week 

12 



12 



12 

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

PANSS = Positive and Negative Syndrome Scale 

83

Bitopertin (GlyT-1, RG1678) 

A small molecule first-in-class glycin reuptake 

inhibitor (GRI) 

Patient 

population 

Persistent, predominant 

negative symptoms of schizophrenia 

Phase/study 

Phase III 

SUNLYTE 

Phase III 

DAYLYTE 

Phase III 

FLASHLYTE 


Design 



•ARM A: RG1678 (10 mg) 

•ARM B: RG1678 (20 mg) 




•ARM A: RG1678 (5 mg) 

•ARM B: RG1678 (10 mg) 




•ARM A: RG1678 (10 mg) 

•ARM B: RG1678 (20 mg) 


Primary 

endpoint 

• PANSS negative symptom 

factor at week 24 






PANSS = Positive and Negative Syndrome Scale 

84

Ocrelizumab (RG1594) 

2nd generation anti-CD20 monoclonal antibody 

Patient 

population 

Relapsing multiple sclerosis (RMS) 

Primary progressive 

multiple sclerosis (PPMS) 

Phase/study 

Phase III 

OPERA I 

Phase III 

OPERA II 

Phase III 

ORATORIO 


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 


• ARM A: Ocrelizumab 2x 300 

mg IV followed by 600 mg IV 

every 24 weeks 

• ARM B: Interferon β-1a 


• 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) 


85

Mericitabine (RG7128) 

Nucleoside NS5B polymerase inhibitor 

Patient 

population 

Phase/study 

# of patients 

Treatment-naive and failure 

chronic hepatitis C 

Genotype 1 and 4 

Phase IIb 

DYNAMO 1* 

N=100 

Treatment-naive and failure 

chronic hepatitis C 

Genotype 1 and 4 

Phase IIb 

DYNAMO 2 

Longer duration study 

N= 168 

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 Copegus for 48 weeks 

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

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

mg BID) + Pegasys and Copegus for 12 weeks 

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

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

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

Pegasys and Copegus for 24 weeks 

• ARM C : Telaprevir + mericitabine (1000 mg BID) + Pegasys 

and Copegus for 12 weeks, followed by Pegasys and Copegus 

for 36 weeks 

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

followed by Pegasys and Copegus for 36 weeks 

Primary 

endpoint 

• Sustained virological response (SVR) 

• Sustained virological response (SVR) 


• Recruitment completed Q3 2012 

• FPI Q4 2011 


RG7128 licensed from Pharmasset, now part of Gilead 

* In collaboration with Merck 

86

Mericitabine (RG7128) 

Nucleoside NS5B polymerase inhibitor 

Patient population 

Phase/study 

Hepatitis C patients 

Treatment-naïve or null-responders to interferon-based treatment 

Phase II 

ANNAPURNA 


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 


Recruitment expected to complete in Q4 2012 

RG7128 licensed from Pharmasset, now part of Gilead, Setrobuvir – Anadys Pharmaceuticals Inc. acquisiton 

87

Danoprevir (RG7227) 

HCV protease inhibitor 

Patient 

population 

Phase 

Treatment-experienced 

chronic hepatitis C patients* 

Phase IIb 

Matterhorn 

Boosted Danoprevir in Triple, Quad and Interferon-free combinations 


Design 

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

Cohort A: partial responders: 

•ARM A1: Danoprevir 100 mg bid+ Ritonavir 100mg bid+ mericitabine 1000 mg bid + 

Copegus for 24 weeks 

•ARM A2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ Pegasys + Copegus for 24 weeks 

•ARM A3: Danoprevir 100 mg bid + Ritonavir 100mg bid + mericitabine 1000 mg bid + 

Pegasys + Copegus for 24 weeks 

Cohort B: null responders: 

•ARM B1: Danoprevir 100 mg bid + Ritonavir 100mg bid + mericitabine 1000 mg bid + 

Copegus for 24 weeks 

•ARM B2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ mericitabine 1000 mg bid + 

Pegasys + Copegus for 24 weeks 

•ARM B3: Danoprevir 100 mg bid+ Ritonavir 100mg bid + mericitabine 1000 mg bid + 

Pegasys + Copegus for 24 weeks, followed by 24 weeks Pegasys + Copegus 

Primary 

endpoint 

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

Status • Recruitment completed Q3 2011 

• Preliminary data submitted to AASLD 2012 

RG7128 licensed from Pharmasset, now part of Gilead 88







Diagnostics 


89

Oncology development programmes 

Small molecules 

Apoptosis 

MAPK signaling 

Molecule 

MDM2 antagonist 

(RG7112) 

MDM2 (4) 

antagonist 

(RG7388) 

MEK inhibitor 

(CIF, RG7167) 

Raf/MEK inhibitor 

(CKI27, RG7304) 

Patient 

population 

Advanced solid 

tumors 

Hematologic 

neoplasms 

(Leukaemia) 

Solid and 

hematological 

tumors 

Solid tumors 

Solid tumors 

Phase Phase I Phase I Phase I Phase I Phase I 

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

Design • Multiple 

ascending doseescalation 

study 

• Multiple 


study 

• Multiple 


study 

• Dose-escalation, 

followed by 

expansion into 4 

cohorts in 

specific 

indications 

• Dose-escalation 

to MTD 

Status 

• Study completed 

Q2 2011 

• Phase Ib initiated 

Q2 2012 

• Study completed 

Q3 2012 

• Phase Ib initiated 

Q3 2012 

• FPI Q4 2011 • Initiated Q2 2008 

• Phase I study 

completed 

recruitment into 

expansion cohorts 

end of 2011 

• Initiated October 

Q4 2008 

• Phase I study 

Stopped enrolment 

in Q4 2010 

Collaborator 

Chugai 

90


Monoclonal antibodies 

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 

Primary 

endpoint 

• Study US Monotherapy 

• Study Japan Monotherapy 

• Combo with SOC dose 

escalation study 

Adaptive design study 

Double 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 

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

preliminary clinical activity 

• Multiple ascending dose 

study +/- cytarabine 

• Safety (MTD), PK, PD, 

preliminary clinical activity 


• Dose Escalation completed 

for US and Japan 

monotherapy studies. CSRs 

drafting is ongoing 

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

Collaborator 

Chugai 

SOC – standard of care 

91


Monoclonal antibodies (continued) 

Molecule 

Anti-TWEAK MAb 

(RG7212) 

GE-huMAb HER3 

(RG7116) 

CSF-1R huMAb 

(RG7155) 

Patient 

population 

Solid tumors Solid tumors Solid tumors 

Phase Phase I Phase I Phase I 

# of patients N=50 N=105 N-95 

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 

study +/- paclitaxel with 

extension cohorts 

Primary 

endpoint 

• Safety, PK, PD • Safety, PK • Safety, PK, PD & preliminary 

clinical activity 


92

GA201 (RG7160) 

Glycoengineered enhanced ADCC/anti-EGFR 

monoclonal antibody 

Patient 

population 

Phase 

# of 

patients 

Design 

Primary 

endpoint 

Head and neck squamous cell 

carcinoma 

Phase I 

Mechanism of action study 

• ARM A: GA201 

• ARM B: Cetuximab 

• Pharmacodynamics 

Status • Recruitment completed Q1 2012 


1 st -line metastatic 


Phase Ib/II 

2 nd -line metastatic 


Phase II 

N=45 N=160 N=160 

Treated until disease progression: 

Squamous 

•ARM A: GA201 plus cisplatin and 

gemcitabine 

•ARM B: Cisplatin and gemcitabine 

Non-Squamous 

•ARM A: GA201 plus cisplatin and 

pemetrexed 

•ARM B: Cisplatin and pemetrexed 

• Part 1 – Safety 

• Part 2 – PFS 

• Non-Squamous Part 2 accrual 

complete 1Q 2012. 

• Data from Part 1 Non-Sq. presented at 

ASCO 2012 

• Squamous Part 1 halted and to be 

investigated with new study 

Treated until disease progression: 

KRAS Wild Type 

•ARM A: GA201 plus FOLFIRI 

•ARM B: Cetuximab plus FOLFIRI 

KRAS Mutant 

•ARM A: GA201 plus FOLFIRI 

•ARM B: FOLFIRI alone 

• PFS 

• FPI Q2 2011 


• Design presented at ASCO 2012 

• Expect data in 2013 

93

Metabolic development programmes 

Molecule 

Inclacumab 

(P-selectin huMAb, RG1512) 

GLP-1/GIP dual agonist 

(MAR709, RG7697) 

Patient population 

Prevention of saphenous vein 

graft disease 

Patients undergoing coronary artery 

bypass graft (CABG) surgery 

Acute Coronary Syndrome 

(ACS) 

Patients undergoing Percutaneous 

Coronary Intervention (PCI) 


Phase/study Phase II Phase II Phase I 


Design 

32-week treatment period 

•ARM A: RG1512 (20 mg/kg) 


Single infusion 

•ARM A: RG1512 (5 mg/kg) 

•ARM B: RG1512 (20 mg/kg) 


• single ascending dose (SAD) 

study 

• ARM A: RG7697 sc 

• AMR B: placebo 

Primary Endpoint 

•Sapheneous vein graft reocclusion 

•Procedural damage (troponin) 

• Safety, PK 


Collaborator Genmab Marcadia Biotech, Inc. acquisition 

94

Neuroscience development programmes 

Molecule 

Patient 

population 

Phase/study 

Gantenerumab 

(Anti-Αβ, RG1450) 

Prodromal Alzheimer’s Disease 

Phase II/III 

SCarlet RoAD 

BACE1 inhibitor 

(RG7129) 

Alzheimer’s Disease 

Phase I 


Design 

104-week subcutaneous treatment period 

•ARM A: RG1450 (225 mg) 

•ARM B: RG1450 (105 mg) 


• Single ascending dose-escalation study 

• Multiple ascending dose-escalation study 

• CSF biomarker study 

Primary 

endpoint 

• Change in CDR-SOB at 2 years 

• Substudy: change in brain amyloid by PET at 2 

years 

• Safety 

• Pharmacokinetics 

• Pharmacodynamics 


• Ph I PET data published in Arch. Neur. Q4 2011 

• SAD: completed 

• MAD: FPI Q3 2012 

• CSF: FPI Q3 2012 

Collaborator Morphosys Siena Biotech 

CDR-SOB = Clinical Dementia Rating scale Sum of Boxes 

95


Molecule 

Patient 

population 

Monoamine oxidase type B (MAO-B) inhibitor 

(RG1577, EVT-302) 

Alzheimer’s Disease 

Phase 

Phase IIb 

MAyflOwer RoAD 

Phase I/II 

Phase I 


Design • 52-week oral treatment 

• ARM A: RG1577 (dose 1) 

• ARM B: RG1577 (dose 2) 

• ARM C: placebo 

• PET study in AD patients and 

healthy volunteers 

• Mass balance study 

Primary 

endpoint 

• Changes in ADAS-Cog at 52 

weeks 

• Brain enzyme occupancy 

• Metabolic profile 

• Route of elimination 

Status • Expect FPI Q4 2012 • FSI Q3 2012 • Clinical phase completed 

In collaboration with Evotec 

96


Metabotropic glutamate receptor pathway 

Molecule 

mGluR2 antagonist 

(RG1578) 

mGluR5 antagonist 

(RG7090) 

Patient 

population 

Adjunctive Treatment of Major 

Depressive Disorder 

Adjunctive Treatment of Major 

Depressive Disorder 

Fragile X Syndrome 

Phase/study Phase II Phase II Phase II 


Design 

• ARM A: RG1578 5 mg 

• ARM B: RG1578 15 mg 

• ARM C: RG1578 30 mg 

• ARM D: Matching Placebo 

• ARM A: RG7090 0.5 mg 

• ARM B: RG7090 1.5 mg 

• ARM C: Matching Placebo 

• ARM A: RG7090 0.5 mg 

• ARM B: RG7090 1.5 mg 

• ARM C : Matching Placebo 

Primary 

endpoint 

• Efficacy - Montgomery Asberg 

Depression Rating Scale 

• Efficacy - Montgomery Asberg 

Depression Rating Scale 

• Efficacy, Safety and Tolerability 

Status 







97


Molecule 

Patient 

population 

GABRA5 negative allosteric modulator (NAM) 

(RG1662) 

Down Syndrome 

Phase Phase I Phase I Phase Ib 


Design 

• 28 day multiple dose study 

in healthy volunteers 

• Molecular and functional 

imaging study in individuals 

with DS and HV 

• Multi-center, Randomized, 

Double-blind, Placebocontrolled, 

Multiple Dose 

Study in Individuals With 

Down Syndrome 

Primary 

endpoint 

• PK over 28 days, excretion 

and metabolism 

• GABAAalpha5 receptor 

expression, occupancy and 

functional connectivity 

• Safety, tolerability 


98


Molecule 

Patient 

population 

V1 receptor antagonist 

(RG7314) 

Autism 

Phase Phase I Phase I 

# of patients N=45 N=up to 24 

Design • SAD/MAD umbrella protocol 

including food effect 

• DDI study 

Primary 

endpoint 

• Safety, Tolerability 

• Safety, tolerability, PK and PD effects 

of multiple doses of RG7314 with a 

single dose of risperidone in healthy 

subjects 



• Expect FPI Q4 2012 

99

Virology development programme 

Molecule 

Patient 

population 

Phase 

Setrobuvir 

(RG7790) 

Chronic Hepatitis C 

Phase II 

# of patients N= 283 

Design 

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

naïve patients 

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

treatment experienced patients (paritial responders & relapsers) 

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

experienced patients (null responders) 

* Response guided treatment 

Primary 

endpoint 

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



Collaborator 

Anadys Pharmaceuticals Inc. acquisition 

Being investigated in Phase II in combination with Danoprevir and Mericitabine (see Mericitabine). 

100







Diagnostics 


101


Angiogenic signaling 

Molecule 

Anti-EGFL7 MAb 

(RG7414) 

Patient 

population 

Advanced solid tumors 





Phase 

Phase Ib 

Phase II 

NILE 

Phase II 

CONGO 

# of patients N=~64 N=104 N=128 

Design 

Primary 

endpoint 

• ARM A: Anti-EGFL7 plus 

Avastin 

• ARM B: Anti-EGFL7 plus 

Avastin and paclitaxel 

• RCC expansion/Biopsy 

Cohort: Anti-EGFL7 plus 

Avastin 

• Flat dose Cohort: Anti-EGFL7 

plus Avastin 

• Anti-EGFL7 plus Avastin plus 

carbo/tax vs Avastin plus 

carbo/tax 

• Safety/PK • PFS • PFS 



• FPI Q2 2011 


• ARM A: Anti-EGFL7 plus 

Avastin plus FOLFOX 

• ARM B: Avastin plus FOLFOX 

• FPI Q4 2011 


102


Growth factor signaling 

Molecule 

Anti-HER3 EGFR DAF MAb 

(RG7597) 

Patient 

population 

Metastatic epithelial 

tumors 

Metastatic/recurrent 

SCCHN 

KRAS wild-type metastatic 


Phase 

Phase I 

Phase II 

MEHGAN 

Phase II 

DARECK 


Design • Dose escalation study • ARM A: RG7597 

• ARM B: Cetuximab 

• ARM A: RG7597+FOLFIRI 

• ARM B: 

Cetuximab+FOLFIRI 

Primary 

endpoint 

• Safety/PK • Progression-free survival • Progression-free survival 

Status • FPI Q4 2010 • FPI Q3 2012 • Expect FPI Q4 2012 

SCCHN=Squamous Cell Carcinoma of the Head and Neck 

103


Tumor Immunotherapy 

Molecule 

Anti-PD-L1 MAb 

(RG7446) 

Patient 

population 

Solid tumors 

Solid tumors 


metastatic melanoma BRAF 

mutation positive 



Design • Dose escalation study • ARM A: RG7446+Avastin 

• ARM B: RG7446+Avastin+ 

chemotherapy 

• Dose escalation of RG7446- 

Zelboraf* combination 

Primary 

endpoint 

• Safety/PK • Safety/PK • Safety 

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

*Zelboraf In collaboration with Plexxikon, a member of Daiichi Sankyo Group 

104


Antibody drug conjugates (ADCs) 

Molecule 

Anti-STEAP1 ADC 

(RG7450) 

NME ADC 

(RG7458 ) 

Anti-CD22 ADC 

(RG7593) 

Anti-CD22 ADC 

(RG7593) vs. Anti- 

CD79b ADC 

(RG7596) 

Anti-CD79b 

(RG7596) 

Patient 

population 

Prostate cancer 

Ovarian cancer 

Hematologic 

malignancies 

Non-Hodgkin's 

Lymphoma 

Hematologic 

malignancies 

Phase Phase I Phase I Phase I Phase II Phase I 

# of patients N=49 N=57 N=76 N=120 N=99 

Design 


study 


study 


study 

• RG7593 plus 

rituximab 

• RG7596 plus 

rituximab 


study 

Primary 

endpoint 

• Safety • Safety/PK • Safety • Safety and antitumor 

activity 

• Safety 

Status • FPI Q1 2011 • FPI Q2 2011 • FPI Q4 2010 • FPI Q3 2012 • FPI Q1 2011 

Collaborator 

Seattle Genetics 

and Agensys 


105


Antibody drug conjugates (ADCs) 

Molecule 

NME ADC 

(RG7598) 

NME ADC 

(RG7599) 

NME ADC 

(RG7600) 

NME ADC 

(RG7636) 

Patient 

population 

Multiple myeloma 

NSCLC and ovarian 

cancer 

Pancreatic and ovarian 

cancer 

Metastatic or 

unresectable 

melanoma 

Phase Phase I Phase I Phase I Phase I 

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

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

Primary 

endpoint 

• Safety • Safety • Safety • Safety 

Status • FPI Q3 2011 • FPI Q2 2011 • FPI Q4 2011 • FPI Q1 2012 

Collaborator 


106


Small molecules 

• Phase II studies 

PI3K signaling 

Molecule 

Patient 

population 

Phase 

2L ER+ metastatic breast cancer 

Phase II 

FERGI 

PI3 Kinase inhibitor 

(GDC-0941, RG7321) 

Previously untreated advanced or recurrent 

NSCLC 

Phase II 

FIGARO 


Design 

Primary 

endpoint 

• ARM A: GDC-0941 plus hormonal therapy 

• ARM B: GDC-0980 plus hormonal therapy 

• ARM C: Hormonal therapy + placebo 

•PFS 

• ARM A: GDC-0941 + carboplatin + paclitaxel 

• ARM B: Placebo + carboplatin + paclitaxel 

• ARM C: GDC-0941 + carboplatin + paclitaxel 

+ bevacizumab 

• ARM D: GDC-0941 + carboplatin + paclitaxel 

+ bevacizumab 

•PFS 


107


Small molecules (continued) 

• Phase I studies 


Molecule 


(GDC-0941, RG7321) 

Patient 

population 

2L HER2-positive metastatic 

breast cancer 

1L and 2L advanced non-small 

cell lung cancer 

2L metastatic non-small cell 

lung cancer 

Phase Phase Ib Phase Ib Phase Ib 


Design 

Primary 

endpoint 

• Patients who have progressed 

on Herceptin-based treatment 

• ARM A: GDC-0941 plus T-DM1 

• ARM B: GDC-0941 plus 

Herceptin 

• ARM A: GDC-0941 plus 

carboplatin/ paclitaxel (Avastinineligible 

patients) 


carboplatin/ paclitaxel plus 

Avastin (Avastin-eligible 

patients) 

•Safety •Safety •Safety 


• Data presented at SABCS 2010 

• FPI Q4 2009 


• Single ARM: Evaluating GDC- 

0941 plus Tarceva 

• FPI Q3 2009 

108





Molecule 


(GDC-0941, RG7321) 

Patient 

population 

Advanced solid tumors 

Advanced solid tumors or Non- 

Hodgkin’s Lymphoma 

1L HER2-negative metastatic 

breast cancer 

Phase 

Phase Ia 

Being conducted 

in the US 

Phase Ia 

Being conducted 

in the UK 

Phase Ib 


Design • Dose-escalating study • Dose-escalating study 

• Study includes multiple myeloma 

extension cohort 

• Single ARM: Evaluating GDC- 

0941 plus paclitaxel and Avastin 

Primary 

endpoint 



• Additional data presented at 

ASCO 2010 and ESMO 2010 

• FPI Q1 2008 

• Additional data presented at 

ASCO 2010, ESMO 2010, and 

ASCO 2011 

• FPI Q3 2009 

• Data presented at SABCS 2011 

109



• Phase II studies 


Molecule 

PI3 Kinase/mTOR dual inhibitor 

(GDC-0980, RG7422) 

Patient 

population 

Renal cell carcinoma 

2L ER+ metastatic breast 

cancer 

Persistent or recurrent 

endometrial carcinoma 

2L Castration-resistant 

prostate cancer 

Phase 

Phase II 

ROVER 

Phase II 

FERGI 

Phase II 

Phase Ib/II 


Design 

Primary 

endpoint 

• ARM A: GDC-0980 

• ARM B: Everolimus 


hormonal therapy 


hormonal therapy 

• ARM C: Hormonal therapy 

+ placebo 

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

abiraterone 

• ARM B: GDC-0980 + 

abiraterone 

• ARM C: Placebo + 

abiraterone 

•PFS •PFS •PFS •Safety(PhIB) 

• PFS (Ph II) 


• Enrollment completed Q3 

2012 

• FPI Q3 2011 • FPI Q4 2011 • FPI Q1 2012 

110





Molecule 

Patient 

population 


(GDC-0980, RG7422) 

Metastatic breast cancer Solid tumors Solid tumors 

Phase Phase Ib Phase Ib Phase Ib 


Design 

Dose escalation study 


paclitaxel 


Avastin and paclitaxel 

• ARM C: GDC-0980 plus 

Herceptin and paclitaxel 

Dose escalation study 


carboplatin and paclitaxel 


Avastin, carboplatin and 

paclitaxel 

• ARM A: GDC-0980 + 

Xeloda 


FOLFOX and Avastin 

Primary 

endpoint 



111




Molecule 



(GDC-0980, RG7422) 

Patient 

population 

Refractory solid tumors or NHL Refractory solid tumors or NHL 

Phase Phase Ia Phase Ia 


Design • Dose escalation study • Dose escalation study 

Primary 

endpoint 

•Safety 

•Safety 


• Data presented at ASCO 2010, ESMO 

2010, and ASCO 2011 

• FPI Q2 2009 

• Data presented at ASCO 2010 and 

ESMO 2010 


112



Molecule 

Patient 

population 

Solid tumors 

Solid tumors 

AKT inhibitor 

(GDC-0068, RG7440) 

2L Castration-resistant 

prostate cancer 

Solid tumors 

Phase Phase Ia Phase Ib Phase Ib/II Phase I 


Design • Dose escalation study Dose escalation with: 

•ARM A: docetaxel 

or 

•ARM B: fluoropyrimidine 

plus oxaliplatin 

or 

•ARM C: paclitaxel 

Primary 

endpoint 

• ARM A: GDC-0068 + 

abiraterone 

• ARM B: GDC-0980 + 

abiraterone 

• ARM C: Placebo + 

abiraterone 

•Safety/PK • Safety • Safety (Ph IB) 

• PFS (Ph II) 


• Data presented at ASCO 

2011 


Q2 2012 

Collaborator 

• FPI Q3 2011 

• Data presented at ASCO 

and ESMO 2012 

Array BioPharma 

• Dose escalations study of 

GDC-0973* in 

combination with GDC- 

0068 

•Safety/PK 

• FPI Q1 2012 • FPI Q2 2012 

*GDC-0973 in collaboration with Exelixis 

113



Molecule 


(GDC-0032, RG7604) 


(GDC-0084, RG7666) 

MEK inhibitor 

(GDC-0623, RG7420) 

Patient 

population 

Solid tumors 

Progressive or recurrent 

high-grade glioma 

Solid tumors 



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

Primary 

endpoint 

•Safety/PK •Safety/PK •Safety/PK 


WEHI = The Walter and Eliza Hall Institute 

114



Molecule 

ChK1 inhibitor 

(GDC-0425, RG7602) 

ChK1 inhibitor 

(GDC-0575, RG7741) 

Bcl-2 selective inhibitor 

(GDC-0199, RG7601) 

Patient 

population 

Solid tumors or lymphoma 

Solid tumors or lymphoma 

Relapsed or refractory CLL 

and NHL 



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

Primary 

endpoint 

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


• Data submitted for 

presentation at ASH 2012 

Collaborator 

Array BioPharma 

Abbott and WEHI 

WEHI = The Walter and Eliza Hall Institute 

115

Immunology development programmes 

Molecule 

Pateclizumab 

(Anti-LT α, RG7416) 

Quilizumab 

(Anti-M1 prime, RG7449) 

Patient 

population 

Rheumatoid 

arthritis 

Asthma 

Allergic asthma patientsinadequately 

controlled 

Phase/study 

Phase IIa 

ALTARA 

Phase IIa 

SOLARIO 

Phase IIb 

COSTA 


Design 

• ARM A: Anti-LT alpha plus 

DMARD (leflunomide or 

methotrexate) 

• ARM B: Adalimumab plus 

DMARD (leflunomide or 

methotrexate) 

• ARM C: Placebo plus DMARD 

(leflunomide or methotrexate) 

• ARM A: Anti-M1 prime 

• ARM B: Placebo 

SC administration on top of SoC 

•ARM A: RG7449 300mg 

•ARM B: RG7449 150mg 

•ARM C: RG7449 450mg 


Primary 

endpoint 

• Disease Activity Score (DAS28) at 

Day 85 



• Late airway response (LAR) at Day 

86 

• FPI Q4 2010 


• Data presented at ATS 2012 and 

ERS 2012 

• Rate of protocol-defined 

exacerbations from baseline to 

week 36 

• FPI Q2 2012 

DMARD = Disease-Modifying Anti-Rheumatic Drugs 

116

Immunology development programmes 

Molecule 

Etrolizumab 

(rhuMAb-β7, (RG7413) 

anti-IL17 

(RG7624) 

Patient 

population 

Ulcerative 

colitis 

Autoimmune diseases 

Phase/study 

Phase I 

Phase II 

EUCALYPTUS 

Phase Ib 


Design • Dose escalation study • ARM A: RhuMAb-β7 (100 mg) 

plus immunosuppressant 

• ARM B: RhuMAb-β7 (300 mg) 

plus immunosuppressant 

• ARM C: Placebo plus 

immunosuppressant 

Primary 

endpoint 

• Safety and tolerability 

• Clinical Remission (Mayo Clinic 

Score) at Week 10 

Status • Enrolment completed Q3 2010 • FPI Q3 2011 


Collaborator 

• Randomized, double-blind, 

placebo-controlled, multiple 

ascending dose escalation study 

• Safety and tolerability 

• FPI Q1 2012 


NovImmune 

117

Neuroscience and ophthalmology development 

programmes 

Molecule 

Crenezumab 

(Anti-Αβ, RG7412) 

Anti-Factor D 

(RG7417) 

Patient 

population 

Alzheimer’s 

Disease 

Geographic atrophy (GA) secondary 

to age-related macular 

degeneration 

Phase/study 

Phase II 

ABBY 

Cognition study 

Phase II 

BLAZE 

Biomarker study 

Phase Ib/II 

MAHALO 


Design 

• ARM A: Anti-Abeta subcutaneous 

• ARM B: Anti-Abeta IV 

• ARM C: Placebo 

• ARM A: Anti-Abeta subcutaneous 

• ARM B: Anti-Abeta IV 

• ARM C: Placebo 

• Part 1: Open-label 

• Multiple dosing 

• Part 2: Randomised 

• ARM A: Anti-Factor D injection 

• ARM B: Sham Injection 

Primary 

endpoint 

• Change in cognition (ADAS-cog) and 

Clinical Dementia Rating, Sum of 

Boxes (CDR-SOB) score from 

baseline to week 73 



• Change in brain amyloid load from 

baseline to week 69 

• FPI Q3 2011 


• Part 1: Safety 

• Part 2: Growth rate of GA lesions at 

months 12 

• Part 1 FPI Q4 2012 

• Part 2 FPI Q2 2011 


Collaborator 

AC Immune 

118

Metabolism and virology development 

programmes 

Molecule 

Anti-oxLDL 

(RG7418, BI-204) 

Anti-PCSK9 

(RG7652) 

NME 

(RG7667) 

Patient 

population 

Secondary prevention of 

cardiovascular events in patients 

with ACS 

Metabolic diseases 

Infectious diseases 

Phase/study 

Phase II 

Proof of activity study 

Phase II 

EQUATOR 

Phase I 


Design 

Primary 

endpoint 

Status 

• ARM A: Anti-oxLDL (single dose) 

and statin 

• ARM B: Anti-oxLDL (repeating 

dose) and statin 

• ARM C: Placebo and statin 

• Change in TBR as measured by 

FDG-PET/CT at week 12 

• Study did not meet primary endpoint 

• Project will not proceed into 

phase IIb development 

SC dosing every 4 weeks 

• Experimental: five different doses of 

RG7652 

•Placebo 

• Absolute change from baseline in 

LDL-c concentration 

• RG7667 

• Placebo 

•Safety, PK 

• FPI Q2 2012 • FPI Q1 2012 


BioInvent 

119







Diagnostics 


120

Geographical sales split by divisions and Group* 

CHF m YTD Sept 2011 YTD Sept 2012 % change CER 

Pharmaceutical Division 24,397 26,198 +4 

United States 9,104 10,270 +6 

Western Europe 6,210 5,954 -2 

Japan 2,712 2,966 +1 

International 6,371 7,008 +9 

Diagnostics Division 7,095 7,496 +4 

United States 1,549 1,713 +3 


Japan 375 434 +7 


Group 31,492 33,694 +4 

United States 10,653 11,983 +5 


Japan 3,087 3,400 +2 


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

121

Pharma Division sales YTD Sept 2012 (vs. 2011) 

Top 20 products 

Global US WE Japan International 

CHF m % CER CHF m % CER CHF m % CER CHF m % CER CHF m % CER 

MabThera/Rituxan 4,998 10 2,348 9 1,230 6 210 10 1,210 16 

Herceptin 4,432 12 1,248 11 1,482 3 244 10 1,458 24 

Avastin 4,309 6 1,889 0 1,111 4 545 15 764 20 

Pegasys 1,277 18 438 85 233 4 60 -20 546 2 

Xeloda 1,149 10 474 18 192 -3 93 7 390 11 

Lucentis 1,113 -8 1,113 -8 - - - - - - 

Tarceva 989 4 424 14 242 -13 82 18 241 3 

CellCept 684 -14 125 -26 177 -18 55 14 327 -10 

Actemra/RoActemra 601 34 171 64 192 36 144 0 94 59 

Xolair 530 11 530 11 - - - - - - 

NeoRec./Epogin 521 -26 - - 200 -15 131 -51 190 -8 

Valcyte/Cymevene 478 9 240 17 119 0 - - 119 5 

Activase/TNKase 437 24 402 25 - - - - 35 12 

Pulmozyme 396 7 240 8 74 -2 - - 82 11 

Mircera 273 12 - - 54 -59 144 334 75 2 

Bonviva/Boniva 258 -53 61 -77 84 -49 - - 113 -15 

Tamiflu 241 -25 93 -49 9 -58 98 31 41 -5 

Madopar 235 6 - - 67 -3 16 -9 152 12 

Nutropin 231 -10 225 -10 - - - - 6 -14 

Rocephin 198 -2 1 -25 32 -19 39 -12 126 9 

122 

CER=Constant Exchange Rates

Pharma Division sales YTD Sept 2012 (vs. 2011) 

Recently launched products 

Global US WE Japan International 

CHF m % CER CHF m % CER CHF m % CER CHF m % CER CHF m % CER 

Zelboraf 157 * 83 * 72 - - - 2 - 

Perjeta 26 - 26 - - - - - - - 

Erivedge 18 - 18 - - - - - - - 

CER=Constant Exchange Rates * over +500% 

123

Pharma Division CER sales growth 1 in % 

Global top 20 products 

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

MabThera/Rituxan 7 10 7 11 11 

Herceptin 4 14 7 14 14 

Avastin -10 -2 1 5 11 

Pegasys 6 5 32 29 -4 

Xeloda 10 13 15 13 4 

Lucentis 17 13 0 -11 -12 

Tarceva 10 10 10 7 -5 

CellCept -9 -20 -19 -11 -11 

Actemra/RoActemra 69 48 46 32 27 

Xolair 9 12 12 12 9 

NeoRec./Epogin -28 -27 -28 -28 -20 

Valcyte/Cymevene 8 2 9 10 9 

Activase/TNKase 5 15 17 25 30 

Pulmozyme 11 12 1 8 11 

Mircera 82 63 34 25 -12 

Bonviva/Boniva -24 -30 -31 -64 -70 

Tamiflu -51 -19 -24 63 -64 

Madopar 8 1 4 11 2 

Nutropin -21 -15 -9 -12 -10 

Rocephin -6 7 3 0 -8 

124 

1 

Q3-Q4/11 vs. Q3-Q4/10, Q1-Q3/12 vs. Q1-Q3/11 CER = Constant Exchange Rates

Pharma Division CER sales growth 1 in % 

Top 20 products by region 

US Western Europe Japan International 

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

MabThera/Rituxan 5 8 9 9 10 6 6 4 -3 8 16 5 25 5 21 25 

Herceptin 7 11 9 12 9 2 4 2 4 10 -12 48 32 10 36 26 

Avastin -9 0 -5 4 -3 -2 6 8 2 8 16 19 17 4 26 31 

Pegasys 47 144 104 31 -8 1 8 5 -35 -29 -20 -10 -1 14 16 -22 

Xeloda 22 31 24 2 -8 -1 -4 -5 -9 1 10 9 24 11 13 10 

Lucentis 13 0 -11 -12 - - - - - - - - - - - - 

Tarceva 16 18 21 6 -9 -7 -8 -22 2 9 28 17 33 20 -1 -8 

CellCept -14 -38 -19 -22 -34 -23 -17 -12 7 16 16 11 -14 -13 -7 -8 

Actemra/RoActemra 92 87 61 50 52 41 35 34 15 8 1 -7 79 91 49 47 

Xolair 12 12 12 9 - - - - - - - - - - - - 

NeoRec./Epogin - - - - -23 -20 -10 -15 -42 -48 -58 -43 -7 -15 -5 -4 

Valcyte/Cymevene 0 12 26 14 6 1 -1 0 - - - - 3 12 -4 8 

Activase/TNKase 17 19 24 33 - - - - - - - - -4 2 30 3 

Pulmozyme 5 8 11 6 1 1 -2 -5 - - - - 43 -16 10 45 

Mircera - - - - 2 -25 -79 -71 - - - 65 35 1 6 -1 

Bonviva/Boniva -36 -32 - - -34 -45 -46 -59 - - - - -8 -10 -11 -24 

Tamiflu - -56 51 - - -36 44 -85 3 85 -14 -94 205 -16 193 -32 

Madopar - - - - -4 0 0 -9 -16 -16 -7 -5 7 9 20 9 

Nutropin -15 -9 -12 -10 - - - - - - - - -17 -4 -24 -13 

Rocephin - 1 2 -74 17 -12 -17 -35 -2 -8 -12 -14 5 14 12 2 

1 

Q4 2011 vs. 2010, Q1-Q3 2012 vs. 2011 CER=Constant Exchange Rates 

125

CER sales growth (%) 

Quarterly development 

2011 vs. 2010 2012 vs. 2011 

Q1 Q2 Q3 Q4 Q1 Q2 Q3 

Pharmaceuticals Division -2 -1 0 3 2 6 4 

United States 2 1 1 4 6 6 5 

Western Europe -4 -4 -3 -1 -4 -1 -2 

Japan -7 -3 -7 -5 1 0 1 

International -3 0 5 10 2 14 11 

Diagnostics Division 6 5 6 7 4 6 1 

Roche Group 0 0 1 4 2 6 4 


126

YTD Sept 2012: Oncology franchise 

CHF bn 

Oncology sales 

18 

15 

12 

9 

6 

3 

0 

YTD 9 

'08 

YTD 9 

'09 

Japan 


YTD 9 

'10 

YTD 9 

'11 

International 

US 

+9% 1 

YTD 9 

'12 

+7% 

+17% 

+3% 

+9% 

US 

• Sales growth driven by Rituxan, Herceptin, 

Zelboraf and Xeloda 


• Major drivers Zelboraf, MabThera, and 

Herceptin; Avastin growth driven by OC uptake 

International 

• Double-digit growth for major oncology 

products 

Japan 

• Growth driven by Avastin, Herceptin and 

MabThera 

1 

CER=Constant Exchange Rates; YTD Sept 2012 Oncology sales CHF 16 bn 

127


6.0 

Global sales 

+10% 1 

Regional sales 

CER growth 

US +9% 

5.0 

CHF bn 

4.0 

3.0 

2.0 

1.0 

International +16% 

Japan +10% 

Western Europe +6% 

0.0 

YTD 9 

'08 

YTD 9 

'09 

YTD 9 

'10 

YTD 9 

'11 

YTD 9 

'12 

YTD Sept 2012 sales of CHF 4.998 bn 

• 1L FL maintenance indication remains the major 2012 growth driver for MabThera in WE and US 

• Growth in emerging markets driven by uptake in NHL indications; China continued patient share growth 

and longer treatment duration in DLBCL 

1 


128

Herceptin 

CHF bn 

5.0 

4.0 

3.0 

2.0 

1.0 

Global sales 

Regional sales CER growth 

+12% 1 


US +11% 

Japan +10% 


0.0 

YTD 9 

'08 

YTD 9 

'09 

YTD 9 

'10 

YTD 9 

'11 

YTD 9' 

12 


• US: Demand growth driven by mGC uptake, increased BC testing quality 

• China: mainly driven by increase in new patients through continued PAP activities driving 

access and HER2 testing initiatives (penetration, quality) 

• Expanded access in international markets ongoing 

1 


129

Avastin 

6.0 

Global sales 

+6% 1 


CER growth 

US 0% 

CHF bn 

5.0 

4.0 

3.0 

2.0 

Japan +15% 


1.0 


0.0 

YTD 9 

'08 

YTD 9 

'09 

YTD 9 

'10 

YTD 9 

'11 

YTD 9 

'12 


• WE: successful launch in Ovarian cancer; CHMP positive opinion in recurrent, platinumsensitive 

OC. 

• US: significant increase in 2L mCRC use associated with TML awareness. 

• Japan: driven by further uptake in NSCLC and mBC 

1 


130

Xeloda 

1.4 

Global sales 

+10% 1 


CER growth 


1.2 

CHF bn 

1.0 

0.8 

0.6 

Western Europe -3% 

Japan +7% 

0.4 

0.2 

US +18% 

0.0 

YTD 9 

'08 

YTD 9 

'09 

YTD 9 

'10 

YTD 9 

'11 

YTD 9 

'12 

YTD Sept 2012 sales of CHF 1.149bn 

• US: increased demand partly due to shortage of IV 5FU, normalized as of Q3 2012. 

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

• WE sales impacted by pricing pressure 

1 


131

Tarceva 

1.2 

1.0 

Global sales 

+4% 1 


CER growth 

Western Europe -13% 

Japan +18% 

CHF bn 

0.8 

0.6 


0.4 

0.2 

US +14% 

0.0 

YTD 9 

'08 

YTD 9 

'09 

YTD 9 

'10 

YTD 9 

'11 

YTD 9 

'12 

YTD Sept 2012 sales of CHF 989 m 

• US: driven by increased EGFR testing rates, 1L treatment rates for Mut+ve patients and 

increase in 1L maintenance use for squamous patients 

• EU: Pricing pressure and competitive challenges 

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

1 


132

Inflammation/Autoimmune/Transplantation 

IAT sales 

2.5 

2.0 

+4% 1 

-3% 

YTD Sept 2012 IAT sales: CHF 2.249 bn 

• Strong growth of Actemra and 

MabThera/Rituxan compensated for the 

further CellCept decline in US and WE 

1.5 

+4% 


Sales: CHF 601 m (+34%) 

CHF bn 

1.0 

0.5 

0.0 

YTD 9 

'08 

Japan 

YTD 9 

'09 


YTD 9 

'10 

YTD 9 

'11 

International 

US 

YTD 9 

'12 

1% 

+11% 

• Further gain of patient share in all treatment 

lines according to label; US biggest growth 

contributor 

CellCept 

Sales: CHF 684 m (-14%) 

• Patent expiry key EU countries end 2010 

1 


133

Tamiflu quarterly sales 2009 - 2012 

Retail and Governments/Corporations 

CHF m 

1150 

950 

750 

267 663 

Retail 

Governments & Corporations 

550 

260 

95 

350 

150 

-50 

97 

727 

533 

422 

304 

349 

23 

233 

177 

170 7 

12 

91 48 

7 

26 15 

17 19 3 

45 46 

10 8 

-6 

5 

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 

134







Diagnostics 


135

YTD Sept 2012: Diagnostics Division CER growth 

By Region and Business Area (vs. 2011) 

Global North America EMEA RoW 

% CER % CER % CER % CER 

CHFm growth CHFm growth CHFm growth CHFm growth 

Professional Diagnostics 3,807 9 721 8 1,770 3 1,316 18 

Diabetes Care 1,837 -5 399 -7 1,053 -8 385 7 

Molecular Diagnostics 859 4 304 6 321 2 234 6 

Applied Science 535 -5 205 -8 198 -6 132 3 

Tissue Diagnostics 458 15 291 9 110 22 57 31 

Diagnostics Division 7,496 4 1,920 2 3,452 -1 2,124 14 

CER = Constant Exchange Rates 

136

Diagnostics Division quarterly sales and local 

growth 1 

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

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

Professional 1,189 7 1,087 10 1,262 8 1,224 9 1,291 8 1,292 9 

Diagnostics 

Diabetes 679 2 605 2 731 5 564 -7 696 3 577 -12 

Care 

Molecular 270 2 257 3 293 9 285 8 286 4 288 1 

Diagnostics 

Applied 179 -5 167 1 196 -6 183 -4 180 -2 172 -8 

Science 

Tissue 131 15 123 11 160 17 147 18 158 16 153 10 

Diagnostics 

Dia Division 2,448 5 2,239 6 2,642 7 2,403 4 2,611 6 2,482 1 

1 

versus same period of prior year CER = Constant Exchange Rates 

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

137

Diagnostics Division sales YTD September 2012 

Growth driven by Professional Diagnostics 

CHF 7,496 m 

CER sales growth 

1,837 

Diabetes Care 25% 

Diagnostics 

Division 

4% 

535 

Applied Science 7% 

Diabetes 

Care 

Professional 

Diagnostics 

-5% 

9% 

3,807 

859 

458 

Molecular Diagnostics 11% 

Tissue Diagnostics 6% 

Professional Diagnostics 51% 

Molecular 

Diagnostics 

Applied 

Science 

Tissue 

Diagnostics 

-5% 

4% 

15% 


138

Diagnostics Division sales YTD September 2012 

Growth driven by Asia Pacific and Latin America 

CHF 7,496 m 

CER sales growth 

1,920 

North America 26% 

Diagnostics 

Division 

4% 

550 

Latin America 7% 

North 

America 

2% 

EMEA* 

-1% 

3,452 

434 

1,140 

Asia Pacific 15% 

Japan 6% 

Latin 

America 

Asia 

Pacific 

14% 

16% 

EMEA 1 46% 

Japan 

7% 

1 

Europe, Middle East and Africa CER=Constant Exchange Rates 

139

Professional Diagnostics 

Strong growth continued 

CHF bn 

4.0 

2012 vs. 2011 

CER growth 

+9% 

3.0 

+3% 

2.0 

+6% 

1.0 

+15% 

0.0 

YTD 9 '10 YTD 9 '11 YTD 9 '12 

Other POC products Clinical Chemistry Immunoassay 


140

Diabetes Care 

Reimbursement cuts and pricing pressures 

CHF bn 2012 vs. 2011 

CER growth 

,2.5 

-5% 

,2.0 

,1.5 

+8% 

,1.0 

-6% 

,0.5 

,0.0 

YTD 9 '10 YTD 9 '11 YTD 9' 12 

Blood Glucose 

Insulin Delivery 


141

Molecular Diagnostics 

Strong performance in blood screening 

CHF m 2012 vs. 2011 

CER growth 

1,000 

+4% 

,750 

,500 

+8% 

,250 

+3% 

,0 

YTD 9 '10 YTD 9 '11 YTD 9 '12 

Other Blood Screening Virology 


142

Applied Science 

Increasing competition in sequencing 

CHF m 2012 vs. 2011 

CER growth 

600 

-5% 

400 

-21% 

200 

+5% 

+2% 

0 

YTD 9 '10 YTD 9 '11 YTD 9'12 

qPCR&NAP 

Custom Biotech 

Genomic Analysis Other 


Genomic Analysis: Sequencing and Microarrays 

143

Tissue Diagnostics 

Growing ahead of market in all regions 

CHF m 2012 vs. 2011 

CER growth 

500 

+15% 

400 

+9% 

300 

200 

+15% 

100 

0 

YTD 9 '10 YTD 9 '11 YTD 9 '12 

Other Primary Staining Advanced Staining 


144

2012: Key planned product launches 

Professional Diagnostics 

Product Description Region 

cobas t 611 

Coagulation analyser for mid and high-throughput 

screening in labs 

EU 

cobas b 123 POC 

Benchtop multi-parameter blood gas analyzer for use in 

critical care settings at the point of care 

US 

 

cobas b 101 

Multi-parameter blood lipid and glucose analyser at the 

point of care 

EU 

Elecsys Vitamin D 

assay 

Measures vitamin D2 and D3 with greater precision 

US 

 

Elecsys HE4 

immunoassay 

Detects tumour marker HE4 for risk assessment of early 

ovarian cancer in patients with pelvic mass (with 

biomarker CA125) 

US 

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

EU = European Union; US = United States 

145


Diabetes Care 


Accu-Chek Mobile 

Next-generation strip-free blood glucose monitoring 

system with an integrated lancing device 

EU 

 

Accu-Chek Nano 

SmartView 

Small and sleek blood glucose monitoring meter with 

enhanced functions, requiring no coding of test strips 

US 

 

Accu-Chek Combo 

Interactive insulin delivery system combining an insulin 

pump (Accu-Chek Spirit Combo) and a blood glucose 

meter (Accu-Chek Aviva Combo) with broad data 

management capabilities 

US 

 

SOLO Micropump 

Insulin micro pump and blood glucose meter that functions 

as a handheld controller 

EU 


EU=European Union; US=United States 

146


Molecular Diagnostics 


cobas 4800 CT/NG 

Test 

Detection of chlamydia and gonorrhoea infections 

US 

 

CAP/CTM CMV 

Test 

Detection and monitoring of cytomegalovirus infections 

US 

 


EU=European Union; US=United States 

147


Applied Science 


GS GType 

TET2/CBL/KRAS & 

RUNX1 Primer Sets 

Gene sequencing primer sets for leukemia research 

WW 

 


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

148


Tissue Diagnostics 


BenchMark Special 

Stains 

VENTANA iScan HT 

CINtec p16 Histology 

ER test 

Fully automated tissue stainer 

High-throughput scanner that enables digital viewing of 

tissue slides 

IHC (immunohistochemistry) assay for early detection of 

cervical cancer 

Estrogen receptor antibody (IHC) assay to support the 

diagnosis of breast cancer 

WW 

WW 

EU, US 

US 

 

 

 


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

149







Diagnostics 


150

CHF / USD 

1.00 

Monthly averages 

0.95 

0.90 

2012 

0.85 

0.80 

2011 

0.75 

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

1.00 

0.95 

0.90 

0.85 

0.80 

0.75 

Year-To-Date averages 

2012 

-2% +2% +7% 

2011 


151

CHF / USD 

1.00 

monthly avg 2012 

0.95 

average YTD 09 2012 

0.90 

0.85 

average full year 2011 


+7% 

0.80 


0.75 


152

CHF / EUR 

1.35 

1.30 

1.25 

1.20 

1.15 

1.10 

Monthly averages 

2012 

2011 


1.35 

1.30 

1.25 

1.20 

1.15 

1.10 

Year-To-Date averages 

2011 

-6% -5% 

-3% 

2012 


153

CHF / EUR 

1.35 

1.30 

1.25 

1.20 

1.15 

average full year 2011 


-3% 




1.10 


154

Average exchange rates 

YTD 09 12 YTD 09 11 YTD 09 12 vs. YTD 09 11 

USD 0.94 0.88 

EUR 1.20 1.24 

JPY 1.18 1.09 

-4% -2% 0% 2% 4% 6% 8% 10% 

155

Exchange rate impact on sales growth 

For YTD Sept, negative impact from EUR more 

than offset by positive impact from USD and JPY 

Development of 

average exchange rates versus prior year period 

CHF / EUR -6.1 % -5.2 % -2.6 % 

CHF / USD -2.2 % +2.5 % +6.9 % 

CHF / JPY +1.5 % +5.3 % +8.5 % 

Difference 

in CHF / CER -3.3 %p -0.6 %p +3.1 %p 

growth 

7.0% 

Sales 

growth 

2012 

vs. 2011 

2.5% 

CER 

growth 

CHF 

growth 

-0.8% 

CER = Constant Exchange Rates (avg full year 2011) 

4.1% 

3.5% 3.9% 

Q1 HY YTD 9 FY 

156


Averages Q3 for USD, JPY and EUR higher than 

in 2011 

Development of 

average exchange rates versus prior year period 

CHF / EUR -6.1 % -4.2 % +3.3 % 

CHF / USD -2.2 % +7.4 % +16.7 % 

CHF / JPY +1.5 % +9.5 % +15.4 % 

Difference 

in CHF / CER -3.3 %p +2.3 %p +11.2 %p 

growth 

14.8% 

Sales 

growth 

2012 

vs. 2011 

2.5% 

CER 

growth 

CHF 

growth 


5.7% 

8.0% 

3.6% 

-0.8% 

Q1 Q2 Q3 Q4 

157


Negative impact from EUR more than offset by 

positive impact mainly from USD and JPY 

+2.5% 

CER sales 

growth 

YTD Sept 2012 

vs. 

YTD Sep 2011 

3.9% 

-0.6% 

-0.2% 

-0.1% 

+0.1% 

+0.6% 

+0.8% 

7.0% 

CHF sales 

growth 

YTD Sept 2012 

vs. 

YTD Sep 2011 

CER EUR Lat-Am Oth 

Europe 


Other AS-Pac JPY USD CHF 

158

We Innovate Healthcare 

159

Presentation - Roche

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