· 3 This presentation contains certain forwar d-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates

1

2

Roche

2012 results

January 30, 2013

3

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

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

6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation;10 loss of key executives or other employees; and11 adverse publicity and news coverage.

Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

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

All mentioned trademarks are legally protected

4

GroupSeverin SchwanChief Executive Officer

5

Solid results 2012

Outlook

2012: Financial targets fully achieved

6

Targets for 2012 FY 2012

Pharma Low to mid single-digit1 +5%

Diagnostics Above market1 +4%

Group Low to mid single-digit1 +4%

Core EPS High single-digit1 +10%

Dividend Continue attractive dividend policy

CHF 7.35 +8%

1At CER=Constant Exchange Rates 2012 dividend as proposed by the Board of Directors

2012 Highlights

7

Efficiency• Implementation of annual savings from Operational Excellence (2.4 bn CHF) • Refocus of pRED following closure of Nutley site (Group R&D stable)• Adjustment of cost structure of Applied Science and Diabetes Care

Innovation • 11 out of 14 trials successful • HER2 franchise strengthened through Perjeta and T-DM1• Emerging pipeline to secure MabThera/Rituxan franchise• US launch of next-generation Accu-Chek portfolio

2012: Sales growth above market

8CER=Constant Exchange Rates

2012 2011 change in %CHF bn CHF bn CHF CER

Pharmaceuticals Division 35.2 32.8 +7 +5

Diagnostics Division 10.3 9.7 +5 +4

Roche Group 45.5 42.5 +7 +4

2012: +4%

2012: Sales growth accelerating1

9At CER=Constant Exchange Rates

-3%-5%

0% 0%

1%

4%2%

6%

4%6%

-6%

-4%

-2%

0%

2%

4%

6%

8%

Q3'10

Q4'10

Q1'11

Q2'11

Q3'11

Q4'11

Q1'12

Q2'12

Q3'12

Q4'12

2012: US and Emerging markets driving growth

10

-2%

2%

7%

8%

11%

15%

WE

Japan

US

CEMAI

LatinAmerica

Asia

-1%

7%

3%

15%

15%

EMEA

Japan

NorthAmerica

LatinAmerica

Asia-Pacific

Pharma DiagnosticsGrowth vs. market Growth vs. market

All growth rates at CER=Constant Exchange Rates; CEMAI=Central and Eastern Europe, Middle East, Africa, Central Asia, Indian Subcontinent; EMEA=Europe, Middle East and Africa. Source: IMS, company and independent estimates

Group core operating profit and margin

15.0716.27 16.59

15.15

17.16

33.0% 33.2%34.9% 35.6%

37.7%

2008 2009 2010 2011 2012

+11%1

1 At CER=Constant Exchange Rates

2012: Operating profit and marginfurther increased

11

CHF bn

% of sales

2012: Cash flow and margin further increased

12

12.4

15.714.1 13.7

15.4

27.1%

32.1%29.8%

32.3%33.8%

2008 2009 2010 2011 2012

Group operating free cash flow and margin

+10%1

CHF bn

% of sales


2012: Dividend further increased

13

2.002.50

3.40

4.605.00

6.006.60 6.80

7.35

2004 2005 2006 2007 2008 2009 2010 2011 2012

CHF

1 compound annual growth rate

2012payout ratio

of 54%

Pay-out ratio calculated as dividend per share divided by core earnings per share (diluted); 2012 as proposed by the Board of Directors

Average yearly dividend growth (2004-2012): 18%

14

Solid results 2012

Outlook

2012: Strong progression of pipeline11 successful late-stage clinical trials

15Positive trials

2012

ActemraADACTAActemraADACTA

AvastinTML

AvastinTML

ActemraCHERISHActemraCHERISH

dalcetrapibdal-OUTCOMES

dalcetrapibdal-OUTCOMES

AvastinAURELIAAvastin

AURELIA

MabThera SCSABRINA

MabThera SCSABRINA

AvastinBEATRICE

AvastinBEATRICE

ActemraSUMMACTA

ActemraSUMMACTA

AvastinAVAGLIOAvastin

AVAGLIOT-DM1EMILIAT-DM1EMILIA

aleglitazarAleNEPHROaleglitazar

AleNEPHRO

ActemraBREVACTA

ActemraBREVACTA

ActemraFUNCTIONActemra

FUNCTION

HerceptinHERA 2 yrsHerceptinHERA 2 yrs

dual PI3 kinase/mTORsolid tumours

2013: A rich year for late-stage enabling studiesMajor up-coming decision points

16

EGFR ADCC MAb (GA201)solid tumours

OncologyNeuroscience

MetabolismOphthalmology

PI3 kinase solid tumours

Anti-EGFL7solid tumours

Anti-PCSK9metabolic diseases

crenezumabAlzheimer's

mGluR5 antagonisttreatment-resistant depression

Anti-factor Dgeographic atrophy

mGluR2 antagonisttreatment-resistant depression

Anti-PD-L1solid tumours

etrolizumabulcerative colitis

Immunology

inclacumab (P selectin MAb)ACS/CVD

onartuzumab (MetMAb)NSCLC

ocrelizumabMS

MEKimelanoma

obinutuzumab (GA101)CLL

T-DM1HER2+ BC

bitopertinschizophrenia

aleglitazarmetabolic diseases

lebrikizumabasthma

Ph III NMEs Late stage enabling data expected in 2013

gantenerumab*Alzheimer’s

HCV comboHepC

Virology

*Phase II/III label enabling

2013 R&D to remain stable

2013 Outlook

171At constant exchange rates

Group sales growth1 In line with sales growth recorded in 2012

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

18

Pharmaceuticals DivisionDaniel O’DayCOO Roche Pharmaceuticals

2012 results

Growth drivers

Outlook

2012: Pharma salesUS and International major growth contributors

20

2012 2011 change in %CHF m CHF m CHF CER

Pharmaceuticals Division 35,232 32,794 7 5United States 13,856 12,223 13 7

Western Europe 7,926 8,221 -4 -2

Japan 4,108 3,817 8 2

International 9,342 8,533 9 9

CER=Constant Exchange Rates

2012: Pharma Division Profit margin improvement driven by higher sales

21

Sales 35,232 100.0

Royalties & other op inc 1,794 5.1Cost of sales -7,097 -20.1M & D -5,851 -16.6R & D -7,529 -21.4G & A -1,061 -3.0

Core operating profit 15,488 44.0

2012 vs. 2011CER growth

2012CHF m % sales

13%

-3%

2%

2%

-3%

18%

5%

+16% in CHF


Major clinical and regulatory news flow

22

Timeline Compound Indication Milestone

Avastin mCRC Ph III TML

2012

Perjeta 1st 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 2nd line HER2+ mBC Ph III EMILIA

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

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

MabThera subcutaneous front-line follicular NHL Ph III

Actemra RA DMARD IR Ph III ADACTA H2H vs. Humira

Actemra subcutaneous RA, moderate to severe Ph III SUMMACTA BREVACTA

Avastin newly diagnosed glioblastoma Ph III AVAglio

2013

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

GA101 Front line CLL Ph III vs. chemotherapy

bitopertin (GlyT-1) Schizophrenia Ph III

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

Data expected in 2014

2012 results

Growth drivers

Outlook

2012: Pharma salesOncology, Actemra and Pegasys main growth drivers

2424Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2011; all growth rates at CER

-600 -400 -200 0 200 400 600 800

Boniva/Bonviva

NeoRecormon/Epogin

Lucentis

CellCept

Pegasys

Zelboraf

Actemra/RoActemra

Avastin

MabThera/Rituxan

Herceptin

InternationalUSJapanWestern Europe

+11%

+9%

+6%

+33%

NM

-11%

-26%

+12%

-8%

-54%

2012: Oncology franchise Strong growth of established products

25

CER growth

CER=Constant Exchange Rates Oncology 2012 sales: CHF 21.3 bn

WE: Uptake in 1st L mut+ segment not yet compensating for pressure in 2nd L wt. US: 1st L mut+ filed end 2012.Growth driven mostly by US, China and Japan

Growth driven mainly by US, China and other Int’l regions; US supply of IV 5FU normalised

EU: Launch in ovarian cancer, increased share in LC and BCJapan: strong uptake in CRC, NSCLC and mBC

EU, US: Continued uptake in 1st L maintenance in FL Emerging markets: increased share and treatment duration in DLBCL

0.0 2.0 4.0 6.0 8.0

Tarceva

Xeloda

Avastin

Herceptin

MabThera/Rituxan +9%

+11%

+9%

+6%

+2%

CHF bn

US, Emerging markets main growth contributor; Increased HER2 testing and further uptake in HER2+ gastric cancer;SC Herceptin approval delayed at least one quarter, CHMPopinion now expected in Q2 2013

AvastinTurnaround driven by ovarian and colorectal cancer

26

ColorectalTML launch underway, offsetting competitive pressure Market share gains in EU and Japan

LungAvastin remains the standard of careMarket share gains in Japan

OvarianBest ever Avastin launch in EU. ~35% EU4 NPS in front line

BrainAVAglio met PFS co-primary endpoint. EU filing Q1 ‘13Current US glioblastoma sales ~USD 170 m

BreastFurther adoption in triple-negative segment in EU

NPS=New Patient Share

2012: Oncology franchiseNew products

27

• Good launch in US• Positive CHMP opinion in Dec ’12

• US: Market fully penetrated at ~85% 1st line NPS • WE: More than half of global sales, main growth region in 2013• Ph III in combination with MEKi started

• US: Broad prescriber base, need for education on disease definition and eligibility

• EU: Approval expected in 2013

• US PDUFA 26 February 2013, EU H2 2013• MARIANNE study data expected H1 2014

(based on current event rate)

NPS=New Patient Share

Perjeta: Encouraging launch in the US

28

Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13

US Perjeta weekly volume

• Q4 in-market demand grew by 53% over Q3

• ~75% physicians prescribing the drug

• Further increasing patient share

200

300

400

500

Q1'10

Q2'10

Q3'10

Q4'10

Q1'11

Q2'11

Q3'11

Q4'11

Q1'12

Q2'12

Q3'12

Q4'12

LucentisCompetitive pressure in wAMD

29AMD=wet age-related macular degeneration; RVO=retinal vein occlusion; DME=diabetic macular edema; NPS=New Patient Share

AMD • 0.5 mg PRN dosing approval expected

February 2013• Further pressure on AMD sales

expected in 2013, partially offset by DME

RVO• Lucentis share stable

DME• Approved in August 2012 (0.3 mg)• Strong increase in patient share

Lucentis quarterly sales (USD m)

EyleawAMD

LucentisDME

PegasysGrowth contribution to shift from US to Emerging markets

30

US• High base-line in H2 2011 • Patient warehousing ahead of

all-oral therapyWestern Europe• Slower adoption of new

combination therapies• Early warehousing observedJapan• Overall HCV market shrinkingInternational region• Main growth driver in 2013,

including HBV

US Pegasys weekly volume

DAA launch

Jan-10 Jul-10 Jan-11 Jul-11 Jan-12 Jul-12 Jan-13

Actemra: Superiority in monotherapy (ADACTA) drives market share growth

31

25%

0%

10%

20%

30%

Q1'09

Q3'09

Q1'10

Q3'10

Q1'11

Q3'11

Q1'12

Q3'12

Actemra market sharein monotherapy segment2

30%

70%

Biologic monotherapyBiologic combination

Biologic therapy today(patient shares)1

• 1st line biologic use approved in US October 2012• Subcutaneous formulation filed in US and EU December 2012

1Data from biologics registries and US claims database; 2Market share for DE, FR, IT, ESP, UK, predefined target groups

2012: Emerging markets remain strong growth driver

32

Brazil+11%

China+27%

Russia+14%

2012 International region: +9%Tailor-made access programs to continue supporting growth

All growth at CER=Constant Exchange Rates

2012 results

Growth drivers

Outlook

2013: Major clinical and regulatory news flow

34Outcome studies are event driven, timelines may change

Compound Indication Milestone

Regulatory

Avastin mCRC (TML) US EU approval

Avastin Newly diagnosed glioblastoma EU filing

Erivedge Advanced BCC EU approval

Herceptin subcutaneous HER2-positive BC EU approval

Lucentis AMD PRN US approval

Perjeta 1st line HER2-positive mBC EU approval

Tarceva EGFR mut+ 1st line NSCLC US approval

T-DM1 2nd line HER2-positive mBC US, EU approval

Phase III

obinutuzumab (GA101) Front line CLL Ph III

Tarceva Adjuvant NSCLC Ph III RADIANT

Xolair Chronic idiopathic urticaria Ph III

2013: Major late-stage enabling studies

35

Compound Indication

Phase II

crenezumab Alzheimer’s disease

Anti-EGFL7 Solid tumours

EGFR ADCC (GA201) Solid tumours

etrolizumab Ulcerative colitis

Anti-factor D Geographic atrophy

HCV combo Hepatitis C

inclacumab (P selectin Mab) ACS/CVD

mGluR2 antagonist Treatment-resistant depression

mGluR5 antagonist Treatment-resistant depression

Anti-PCSK9 Metabolic diseases

Anti-PD-L1 Solid tumours

PI3 kinase Solid tumours

Dual PI3 kinase/mTOR Solid tumours

Outcome studies are event driven, timelines may change

OutlookSustained sales growth with significant newsflow

36

Sales drivers• Avastin growth driven by Emerging markets and Europe (OC, TML)• Herceptin, MabThera/Rituxan continuing growth• Newly launched products (Perjeta, Zelboraf, Erivedge, T-DM1)• Actemra further increasing market share in monotherapy• Emerging markets

Newsflow• GA101 vs. MabThera/Rituxan in CLL, Ph III• T-DM1 approval in US and EU• Perjeta launch in EU• Significant number of late-stage enabling Ph II studies

Diagnostics DivisionRoland DiggelmannCOO Roche Diagnostics Picture

37

38

2012: Professional Diagnostics main growth driver

Refining Diabetes Care and Applied Science

Companion Diagnostics

2011 2012 CHF in %CHF m CHF m growth CER

2012: Diagnostics Division sales Sustained growth above the market*

39

Diagnostics Division 9,737 10,267 5% 4%

Professional Diagnostics 4,709 5,165 10% 8%Diabetes Care 2,652 2,566 -3% -4%Molecular Diagnostics 1,094 1,168 7% 4%Applied Science 740 737 0% -3%Tissue Diagnostics 542 631 16% 12%

*IVD market growth estimated at 3% as of end Oct 2012 by independent IVD consultancy; CER=Constant Exchange Rates

2012: Profitability impact from pricing pressures in Diabetes Care

40


2012 CHF m % sales

Sales 10,267 100.0

Royalties & other op income 151 1.4Cost of sales (CoS) -4,347 -42.3M & D -2,541 -24.7R & D -946 -9.2G & A -397 -3.9

Core operating profit 2,187 21.3 -2%

21%

4%

4%

6%

14%

4%


0% in CHF

Key launches 2012

41

Area Product Market BA1

Instruments/

Devices

Labs cobas t 611 - Coagulation analyzer BenchMark Special Stains - Tissue stainerVENTANA iScan HT - Digital tissue scanner

EUWWEU, US

RPDRTDRTD

Point of Care

cobas b 101 - HbA1c and lipid monitoring systemcobas b 123 POC - Blood gas analyzer

EUUS

RPDRPD

Diabetes Care

Accu-Chek Nano SmartView -Small, no-code bGM2systemAccu-Chek Combo – Insulin pump & bG meter combinedAccu-Chek Mobile – Next generation strip free bGM systemSOLO Micropump – Insulin pump and bG meter combined

USUSEUEU

RDCRDCRDCRDC

Tests /Assays

Oncology HE4 - Ovarian cancerER – Breast cancerCINtec p16 Histology- Cervical cancerGS GType Sequencing Primer Sets- Leukemia

USUSWWWW

RPDRTDRTDRAS

Infectious Diseases

CMV – Cytomegalovirus infectionsCT/NG - Chlamydia and gonorrhoea infections

USUS

RMDRMD

Metabolism Vitamin D - Vitamin D2 & D3 US RPD

Achieve sales growth above the market

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

North America+3%

26% of divisional sales

Latin America+15%


Japan+7%

6% of divisional salesEMEA1

-1%


2012: Diagnostics Division sales Market leader in all regions

42

Asia Pacific+15%


1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth at CER=Constant Exchange Rates)

17 % growth in E7 countries2

2012: Growth driven by Professional Diagnostics

43

CHF bn 2012 vs. 2011CER growth

+8%

-4%

+4%

-3%

+12%

Launch of LightCycler 96 qPCR system; Partnership with PSS for automation of sequencing workflow

Cobas HPV Test: Registration of primary screening indication in CE Mark; Gaining traction in US market

US launch of Accu-Chek Combo system, an insulin pump & bG meter combination

FDA approval for HE4 test for ovarian cancer diagnosis; Launch of cobas b 101 HbA1c and lipid monitoring system

Companion Diagnostics (CDx): Launch of ALK test in EMEA as CDx with crizotinib in non-small cell lung cancer

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

Q4 Highlights

0 1 2 3 4 5

Tissue Dia

AppliedScience

MolecularDia

DiabetesCare

ProfessionalDia

EMEANorth AmericaRoW

Professional Diagnostics: Industry leader growing twice as fast as the market

44

Reagent pull-through model

2012• Instrument placements in SWA1:+13%• Expanded immunoassay menu with >100 tests

1Serum Work Area: Immunoassays and Clinical Chemistry;2RPD=Roche Professional Diagnostics; Market estimates from independent IVD consultancy, Q4 2012 forward estimate;

RPD2 sales vs. market growth (%)

20122011

FY 2012: 8%

0

2

4

6

8

10

12

MarketRPD

Q3Q2Q1Q4Q3Q2Q1 Q4

Professional Diagnostics: ImmunoassaysInvesting in high growth areas

45

0.0

0.5

1.0

1.5

2.0

2.5

2000 2012

+15%

New production facility in Penzberg• Invest over CHF 240 m • Capacity expansion of

immunoassay production facilities

Over a decade of consecutive double-digit growth

CHF bn

Roche and Hitachi -35 years of partnership• Securing increasing supply

of cobas instruments

Expanding capacity

All growth at CER=Constant Exchange Rates

RPD: Strengthening presence in Point of CareStrong business with new launches in 2012

46

Operating room

Hospital wards

Hos

pita

l

Home

Accu-Chek Inform II system

cobas b 123 POC system

• Next generation wireless hospital blood glucosemonitoring system

• Blood gas testing (lung function, kidney or metabolism disorders)

New PoC product launchesPoC testing site

Market-leading PoC product line

• Coagulation monitoring – continuing strong business with sales growth +8% (CER)

CoaguChek systems

RPD=Roche Professional Diagnostics

Physician office

• Targeting diabetes and dyslipidemia(metabolic syndrome)

cobas b 101 system

47




Diabetes CareStrong presence with a comprehensive portfolio

48

Next-generation Accu-Chek Mobile

Next-generation Accu-Chek Active

Integrated systems

Prem

ium

Single strip

bGM products with selected examples

Bas

e

• Strip-free and built in lancing device

• Best fit for frequent testers

No existing market segment

• Ease of use• Maltose

independent strips

• Precise insulin dosing with bolus advisor

• Built-in software for diabetes management solutions

Accu-ChekAviva Expert

Applied Science: Focus and invest in selectareas with high growth potential

49

qPCRLaunch of LightCycler 96 System • Completes Roche’s real time PCR portfolio• Innovative features combined with ease of use• Very successful market launch

Sequencing solutions• Software upgrade for GS FLX+ platform • Partnership with PSS for improvement of

sequencing workflow• Launch of Sequence Capture Neurology and

Oncology panels

LightCycler 96

GS FLX+ platform

50




Tissue Diagnostics: SPHERE Project in ChinaCDx collaboration for HER 2 testing & Herceptin

51

PATHWAY (4B5) IHC

INFORM Dual ISH

BenchMark automatedslide staining platform CER growth

20122011

849

2385

1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

Instrument placements and sales growthfor all advanced tissue staining tests

Integrated HER 2 testingexpands patient access to Herceptin

Patients starting therapy

32

58

103123

240%

158%

101%

2009 2010 2011 2012AS placements AS assays sales

Key launches 2013

52

Area Product Market BA1

Instruments/

Devices

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

Life Sciences

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

Diabetes Care

Accu-Chek Insight- Next generation insulin pump & bGm2

systemAccu-Chek Active LCM- Next-generation bGm2 meter with maltose independent test strips

EU

EU

RDC

RDC

Tests/Assays

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

EUEUEUUS US

RPDRPDRTDRTDRMD

Infectious Diseases

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

USUS

RMDRMD

Transplant Cyclosporin, Tacrolimus – immunosuppressive drug monitoring EU RPD

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

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

OutlookSustained sales growth driven by leading IVD business

53

Drivers

• Further growth of installed base • Expansion of test menu• Emerging markets• Stabilise Diabetes Care• Increasing CDx collaborations

54

GroupAlan HippeChief Financial Officer

55

2012: Continued strong profit growth

Deleveraging

Focus on cash

Outlook

2012: Highlights

56

Core EPS +10%1

• Sales translating into profit

Productivity improvements on track

Cash flow and Balance sheet• Net debt / Total assets: 16%• Operating FCF: 10% CER growth (+12% in CHF)• FCF: +15% CER growth (+19% in CHF)

1 CER = Constant Exchange Rates

Dividend• Increased for the 26th consecutive year: from CHF 6.80 to CHF 7.35 (+8%)

Sales 42,531 45,499 +7 +4Core operating profit 15,149 17,160 +13 +11

as % of sales 35.6 37.7Core net income 10,685 11,878 +11 +10

as % of sales 25.1 26.1Attributable to Roche shareholders 10,470 11,643 +11 +10

Core EPS (CHF) 12.30 13.62 +11 +10

Operating free cash flow 13,733 15,389 +12 +10% of sales 32.3 33.8 +1.5 p

Free cash flow 3,904 4,630 +19 +15% of sales 9.2 10.2 +1.0 p

2012: Group performance Core EPS growth +10%1

57

CHF m % Change2011 2012 CHF CER


15,149

16,809

-763

+1,704Productivity

improvements1

Sales growthCore

OperatingProfit2012

@ FY11Fx rates

CoreOperating

Profit2011

@ FY11Fx rates

Pricing pressure• Diabetes Care• Japan price cuts• EU austerity

+11%

+719

2012: Sales growth as main operating profit contributor

58

CHF m

1 Includes CHF ~170 m higher royalty, out-licensing income & other (net)

11%

6%

2%

3%

0%

17%

4%

2012: Group operating performance Sales main profit growth driver

59

+13% in CHF

Higher royalty and product disposal income

Lower manufacturing costs

Better utilisation of existing infrastructure

Stable R&D

IT systems

Major driversSales

Royalties & other op. inc

Cost of salesM & D

R & D

G & A

Core operating profit


Driven by growth in Oncology and IVD businessStrong US and Emerging markets


Admin:+2%

16,59114,776

2,202

15,14913,406

2,178

17,16015,488

2,187

Roche Group Pharma Division Diagnostics Division

34.9% 35.6% 37.7% 39.9% 40.9% 44.0%

21.1% 22.4% 21.3%

2012: Core operating profit and marginStrong margin increase led by Pharma

60

CHF m % of sales

+2.2 %p1

(+2.1 %p)

-1.4 %p1

(-1.1 %p)

+3.4 %p1

(+3.1 %p)

-2 %1

(0 %)

+13 %1

(+16 %)

+11 %1

(+13 %)

2011 20122010

1 At CER=Constant Exchange Rates CER

Restructuring in 2012

61

Reinvestments and P&L impact

Net SavingsRestructuring costs

885 920

510

49110

110

396410

190

~1,440

~810

Thereof cash out

Net Savings

FY 2012 FY 2012+One-time costs

CHF m

240

190

DiagnosticsPharma IT

R&D & Diagnostics

reinvestment

P&Lsavings

~430

~150370

20190

~580*

1,330

Offsetting price pressures in RDC and investment in RAS

Reinvestment in pipeline

* 2013 CHF 500 m, 2014+ CHF +80 m

2012: Core net financial resultLower interest expenses, higher losses from fx & bond redemptions

62

-1,581 -1,581 -1,690 -1,777 -1,816 -1,797 -1,797 -1,802

-109-87

-39 -26 +45 -5

-2'000-1'800-1'600-1'400-1'200-1'000

-800-600-400-200

0

CHF m

Net interest & debtsecurityincome

Bondredemption2011 2012

Interestexpense

Fx result,net


All other,net

Equitygains

Increase of 14% in CHF / 9% at CER

21.3 ,21.3,22.7 22.7

+1.5 -0.1

in %

Other2011 2012Higher core profit contribution

from US

2012: Group Core Tax Rate Higher core profit contribution from the US

63

Implications of IAS 19 Employee Benefit accounting change - effective 2013

64

Balance sheet

Net financial income

2012 2013

Actuarialgains/losses

P&L return on plan assets

Booked against equity alreadyNo impact on P&L or balance sheet

Expected return on plan assets

Net financing chargeDiscount rate applied to

net funding position

Impact

No impact

Impact on Core EPS expected to be <1%

CHF161m additional expense

pre-tax (2012)

Restated figures for 2012 will be provided ahead of HY 2013 results

65


Deleveraging

Focus on cash

Outlook

31 December 2012: Balance sheetEquity ratio up due to strong net income

66

33.3 33.4

16.9 17.4

11.3 14.0

14.5 16.7

30.9 27.9

16.2 20.2

Non-currentassets

Assets Equity & liabilities

Non-currentliabilities

Equity(Net assets)

Other currentassets

Cash andmarketablesecurities

Currentliabilities

CHF bn

64.8 64.861.6

24% 26%

54%

28%

18%

51%

27%

22%

50% 43%

26% 31%

61.6

31/12/11 31/12/12 31/12/11 31/12/12

+28 %

+6 %

+3 %

+27 %

-7 %

+19 %

+8 % +8 %

% change in CER vs 31/12/11

% change in CER vs 31/12/11


Total equity increasing since Genentech transaction

67

53.8

9.4 11.714.5 16.7

2008 2009 2010 2011 2012

Genentechtransaction

71%

13%19%

24%26%

Total equity(CHF bn)

Equity ratio

Aiming for net debt leverage of 0-15%Still highly leveraged

68

32.5

23.9 27.519.2 18.0 15.6 17.3

10.6

76.6 74.6

61.0 61.055.3

61.6 59.664.8

HY 2009 2009 HY 2010 2010 HY 2011 2011 HY 2012 2012

Net debtCHF bn

Total assetsCHF bn

Net debt /Total assets

42%

32%

45%

31%

32%

25%

29%

16%

0

1

2

3

4

5

6

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

USD EUR CHF GBP

FY 2012: Debt maturity profile52% of Genentech related debt repaid

69Nominal values @ actual FX rates; *Original net proceeds in CHF

Of the CHF 48.2bn bonds and notes issued to finance the Genentech transaction, cumulative 24.8bn have been repaid as of December 31, 2012 *

CHF bn

Tender ofEUR 782m

Early repayment in 2013Repayments in 2012

Tender ofEUR 193m

Tender ofEUR 650m

Refinancing in Q1/2012

Call ofUSD 1.75bn

70


Deleveraging

Focus on cash

Outlook

Strong Operating Free Cash Flow & Free Cash Flow

71

14.1 13.715.4

4.7 3.9 4.6

29.8%

32.3%33.8%

2010 2011 2012

+10%1

CHF bn

OFCF margin(% of sales)

1 CER=Constant Exchange Rates

OperatingFCF

FCF

+15%1

14,14912,933

1,634

13,733 12,914

1,259

15,38914,052

1,826

Roche Group Pharma Division Diagnostics Division

29.8%32.3%

33.8% 34.9%

39.4% 39.9%

15.7%12.9%

17.8%

Operating Free Cash FlowStrong cash generation in both divisions

72

% of sales

+4.9 %p1

(+4.9 %p)

+43 %1

(+45 %)

+7 %1

(+9 %)

+10 %1

(+12 %)

2011 20122010

1 At CER=Constant Exchange Rates CER

CHF m

+1.7 %p1

(+1.5 %p)

+0.8 %p1

(+0.5 %p)

Accounts receivable in Southern EuropeSignificantly reduced

73

B-BB

BBB+

BBB-

EUR m

Sovereign country ratings from Standard & Poor’s, as of 11January 2013

2'021

850

805

172

194

1'521

500

678

135

208

0 200 400 600 800 1'000 1'200 1'400 1'600 1'800 2'000 2'200

Southern EuropeanCountries

Spain

Italy

Portugal

GreeceDec 2012Dec 2011

-25%

74


Deleveraging

Focus on cash

Outlook

Moderate currency impact in 2013 expected

75

Q1 HY Sep YTD

FY

Sales -2 -2 -3 -2

Core operating profit

-2 -3

Core EPS -3 -4

Assuming the 31 Dec 2012 exchange rates remain stable until end of 2013, 2013 impact is expected to be (%p):

0.94 0.91 0.91 0.91 0.970.980.94 0.96 0.94 0.920.930.94

0.890.91 0.88

0.94

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

CHF / USD

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

1.27

1.231.24

1.29

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

CHF / EUR

averageYTD 2011

-2%+2% +7% +6%

-6%-5%

-3% -2%

averageYTD 2012

Monthly avg fx rates 2012

2013 Outlook

761At constant exchange rates

Group sales growth1 In line with sales growth recorded in 2012

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

77

7878

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 2012 results

Diagnostics

Foreign exchange rate information

Phase I (36 NMEs+2 AIs)

CIF/MEK inh solid tumorsRG7167

Raf & MEK dual inh solid tumorsRG7304

PD-L1 MAb solid tumorsRG7446

BACE1 inh Alzheimer’s RG7129

GABRA5 NAM cogn. disordersRG1662

MEK inh solid tumorsRG7420AKT inhibitor solid tumorsRG7440

GIP/GLP-1 dual ago type 2 diabetesRG7697

PI3K inh solid tumorsRG7604

Steap 1 ADC prostate ca.RG7450ADC ovarian ca.RG7458

CD44 MAb solid tumorsRG7356

ALK inhibitor NSCLCRG7853PI3K inh solid tumorsCHU

Bcl-2 inh CLL and NHLRG7601

ADC ADC oncologyRG7599

ChK1 inh solid tum & lymphomaRG7602

Tweak MAb oncologyRG7212V1 receptor antag autism RG7314

ADC ADC multiple myelomaRG7598

Oncology Other disease areas

WT-1 peptide cancer vaccineCHU

IL-6 MAb RACHU

Status as of December 31, 2012

MDM2 ant solid & hem tumorsRG7112HER3 MAb solid tumorsRG7116CSF-1R MAb solid tumorsRG7155

MDM2 ant solid & hem tumorsRG7388

Zelboraf + ipilimumab met. melanomaRG7204

IL-17 MAb autoimmune diseases RG7624

TLR7 agonist HBVRG7795

ADC ADC oncologyRG7600

Lucentis sust. deliv. AMD/RVO/DMERG3645


79

ADC metastatic melanomaRG7636PI3k inh glioblastoma 2L RG7666ChK1 inh(2) solid tumorsRG7741

CIM331 atopic dermatitis CHU

ACE910 hemophilia ACHU

New Molecular Entity (NME)Additional Indication (AI)

OncologyImmunologyVirologyCardioMetabolismNeuroscienceOphthalmologyOthers

RG-No Roche Genentech managedCHU Chugai managed

PDE10A inh schizophrenia RG7203

Ang2-VEGF MAb oncologyRG7221

Phase II (23 NMEs + 14 Als)

Phase III(9 NMEs + 23 Als)

Registration(3 NMEs + 7 Als)

1 US only: ongoing evaluation for FDA submission 2 Submitted in EU3 Approved in US, submitted in EU4 Approved in EU, submitted in US5 Submitted in US* Opt-in opportunity from SeaSide Therapeutics

New Molecular Entity (NME) Additional Indication (AI)

RG-No Roche Genentech managedCHU Chugai managedSST Seaside Therapeutics (opt-in) RG105 MabThera is branded as

Rituxan in US and JapanRG1569 Actemra is branded as

RoActemra in EU

onartuzumab NSCLC 2nd/3rd lineRG3638

Perjeta HER2+ early BC RG1273

Avastin ovarian cancer 1st lineRG4351

Xolair chronic idiopathic urticariaRG3648

Avastin HER2+ BC adjRG435

Avastin NSCLC adjRG435

bitopertin schiz neg symptomsRG1678

Avastin HER2-neg. BC adjRG435

Avastin high risk carcinoidRG435Avastin glioblastoma 1st lineRG435

aleglitazar CV risk red post ACS in T2D RG1439

obinutuzumab iNHL relapsedRG7159

Tarceva NSCLC adjRG1415

Actemra early RA RG1569

T-DM1 HER2+ mBC 1st lineRG3502

obinutuzumab CLLRG7159

ocrelizumab RMSRG1594

bitopertin schiz subopt controlRG1678

obinutuzumab DLBCLRG7159obinutuzumab iNHL front-lineRG7159

tofogliflozin (SGLT2) type 2 diabetesCHU

ocrelizumab PPMSRG1594

T-DM1 HER2+ mBC 3rd lineRG3502

Suvenyl enthesopathyCHU

lebrikizumab severe asthmaRG3637

Avastin ovarian cancer platinum resist.RG4351

arbaclofen fragile X syndrome SST*

Perjeta HER2+ mBC 1st lineRG12733

Herceptin HER2+ BC sc formRG5972

Erivedge advanced BCCRG36163

Lucentis AMD 0.5 mg PRN RG36455

Tarceva NSCLC EGFR mut 1st lineRG14154

MabThera ANCA assoc vasculRG1053

MabThera NHL sc formulationRG1052

Actemra polyarticular JIA RG1569

T-DM1 HER2+ pretreated mBCRG3502

Perjeta HER2+ mBC 2nd lineRG1273

Zelboraf papillary thyroid cancerRG7204

mericitabine HCVRG7128

onartuzumab triple-neg mBC, 1st/2nd lineRG3638onartuzumab mCRC 1st lineRG3638

danoprevir HCVRG7227

mGluR5 antag tx resistant depressionRG7090

inclacumab (P selectin MAb) ACS/CVDRG1512

quilizumab (M1 prime MAb) asthmaRG7449

etrolizumab ulcerative colitisRG7413

anti-factor D Fab geographic atrophyRG7417

EGFL7 MAb solid tumorsRG7414

crenezumab Alzheimer‘sRG7412

MAO-B inh Alzheimer’s RG1577

EGFR MAb solid tumorsRG7160

mGluR2 antag depressionRG1578

PI3K/mTOR inh solid & hem tumorsRG7422

setrobuvir HCVRG7790

Perjeta HER2+ gastric cancerRG1273

PI3K inh solid tumorsRG7321

glypican-3 MAb liver cancerRG7686Actemra systemic sclerosisRG1569

HER3/EGFR m. epithelial tumorsRG7597

onartuzumab NSCLC non squamous 1st lRG3638

PCSK9 MAb metabolic diseasesRG7652

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

Erivedge operable BCCRG3616

onartuzumab gastric cancerRG3638

T-DM1 HER2+ early BCRG3502T-DM1 HER2+ gastric cancerRG3502

CD22 ADC hem tumorsRG7593CD79b ADC hem tumorsRG7596

Zelboraf m. melanoma adjRG7204


80

gantenerumab Alzheimer’sRG1450

aleglitazar CV risk red CVD in T2D/ pre-T2DRG1439


bitopertin obsessive compulsive disorderRG1678

rontalizumab systemic lupus erythemRG7415

arbaclofen autism (ASD)SST*

- CMV RG7667

MEK inh combo Zelboraf m. melanomaRG7421

Actemra RA sc formulationRG1569

aleglitazar type 2 diabetesRG1439

OncologyImmunologyVirologyCardioMetabolismNeuroscienceOphthalmology

Changes to the development pipelineQ4 2012 update

81

New to Phase I New to Phase II New to Phase III New to Registration2 NMEs transitioned from Ph0RG7221 ANG2-VEGF huMAboncologyRG7203 PDE10A inh schizophrenia1 NME changed from Chugaimanaged to Roche managedRG7853 ALK inhibitor NSCLC

1 NME transitioned from Ph1RG7667 in cytomegalovirusinfection (CMV)New AIRG1678 bitopertin obsessive compulsive disorder

1 NME transitioned from Ph1 RG7421 MEK inhibitor in combination with Zelboraf solid tumors 1 AI transitioned from Ph2RG3638 onartuzumab gastric cancer2 new AIsRG1439 aleglitazar type 2 diabetesRG1439 aleglitazar CV risk red CVD patients with type 2 diabetes/pre-type 2 diabetes

1AI following US submissionRG1415 Tarceva NSCLC EGFR mutation-positive 1st line1AI following EU submissionRG105 MabThera NHL sc formulation1AI following NDA submissionsin EU and US RG1569 Actemra RA sc formulation

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

2 NMEs discontinuedRG7418 oxLDL MAb metabolic diseases RG7416 pateclizumab (LT alpha MAb) RA

1 AI following US approvalRG105 Rituxan NHL fast infusion2 AIs following EU approvalRG1569 Actemra RA DMARD IR H2HRG435 Avastin relapsed ovariancancer1 AI following EU and US approvalRG435 Avastin mCRC TML

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

82

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

NeuroscienceOphthalmologyNME

OncologyImmunologyVirologyCardioMetabolism

bitopertinschizophrenia#

obinutuzumab (GA101)CLL

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

T-DM1 (RG3502)HER2-pos. mBC 1st line

ocrelizumabPPMS and RMS

2016 and beyondaleglitazarCV risk red post ACS in T2D

obinutuzumab (GA101) iNHL relapsed


T-DM1 (RG3502)HER2-pos. pretreated mBC

MEK inhibitor(RG7421) combo Zelboraf

met melanoma

T-DM1 (RG3502)HER2-pos. gastric cancer

aleglitazartype-2 diabetes (US/China)

obinutuzumab (RG7159)DLBCL and Frontline NHL

mericitabine (RG7128)HCV

danoprevir (RG7227) HCV

EGFR MAb (RG7160,GA201)solid tumors

PI3 kin inh (RG7321)solid tumors

setrobuvir (RG7790 )HCV

mGluR5 (RG7090)depression

inclacumab (RG1512)ACS/CVD

PCSK9 MAb (RG7652)metabolic diseases

crenezumab (RG7412)Alzheimer‘s

gantenerumab (RG1450)Alzheimer‘s

MAO-B inh (RG1577)Alzheimer‘s

mGluR2 antag (RG1578)depression

PI3K/mTOR inh (RG7422)solid & hem tumors

EGFL7 MAb (RG7414)solid tumors

CD22 ADC (RG7593)CD79b ADC (RG7596)

heme tumors

HER3/EGFR (RG7597)m. epithelial tumors

glypican-3 MAb (RG7686)liver cancer

quilizumab (RG7449) asthma

anti-factor D Fab (RG7417)geographic atrophy

lebrikizumab (RG3637) asthma

etrolizumab (RG7413) ulcerative colitis

bitopertin (RG1678)obsessive compulsive dis.

aleglitazarCV risk red CVD in T2D/pre-T2D

2012 2013 2014 2015 2016 and beyond

onartuzumab (MetMAb)gastric cancer & other AIs

RG7667CMV

T-DM1 (RG3502)HER2-pos. early BC

TarcevaNSCLC adj (US)

AvastinNSCLC adj

Tarceva (US)NSCLC EGFR mut. 1st line

2012 2013 2014 2015 and beyond

Avastinglioblastoma 1st line

AvastinHER2-pos. BC adj

AvastinHER2-neg BC adj

Actemraearly RA

Xolair (US)chronic idiopathic urticaria

ActemraRA DMARD IR H2H (EU)

Avastinovarian cancer 1st line (US)


NeuroscienceOphthalmology

Actemrasc formulation

MabTheraNHL sc formulation (EU)

indicates submission to Health Authorities has occurred.

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

Avastinrelapsed ovarian cancer (US)

TarcevaNSCLC adj (EU)

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

83Status as of December 31, 2012

Actemra

systemic sclerosis

Zelboraf

papillary thyroid cancer

Herceptinsc formulation (EU)

LucentisAMD 0.5 mg PRN (US)

Perjeta

HER2-pos. EBC

Perjeta

HER2-pos. mBC 2ndline

Perjeta

HER2-pos. gastric cancer

Avastinovarian cancer platin. resist.

Avastin

mCRC TML

Actemrapolyarticular JIA

MabThera ANCA assoc vasculitis (EU)

Zelborafmet melanoma adj.

EU

US

Approved Pending approvals

Major granted and pending approvals 2012

84

ActemraRA DMARD IR

RituxanNHL faster infusion

Avastinrelapsed ovarian cancer

Lucentisdiabetic macular edema

HerceptinHer2+ BC sc formulation

Filed Mar 2012

LucentisAMD 0.5 mg PRN

Filed Apr 2012


Actemrapolyarticular JIAFiled June 2012

ActemrapolyarticularJIAFiled June 2012

MabThera ANCA associated vasculitis

Filed Apr 2012

T-DM1 (RG3502)HER2-pos pretreated mBC

Filed Aug 2012

T-DM1 (RG3502)HER2+ advanced mBC

Filed Aug 2012

AvastinmCRC TML

PerjetaHER2-pos. mBC 1st line

Erivedgeadv. basal cell carcinoma

2Perjeta (RG1273)HER2-pos. mBC 1st line

Filed Dec 2011

Zelborafmet. melanoma



Erivedgeadv. basal cell ca

Filed Nov 2011

TarcevaNSCLC EGFR mut. 1st line

Filed Nov 2012

MabTheraNHL sc formulation

Filed Dec 2012

Actemrasc formulation Filed Dec 2012

ActemraRA DMARD IR H2H

1AvastinmCRC TML

2Positive CHMP opinion Dec 2012

1FDA approval Jan 2013

Major Chugai granted and pending approvals 2012

85

Pending approvals

Actemrasc formulation

Filed March 2012

PulmozymeImprovement pulmonaryfunction in cystic fibrosis


TarcevaNSCLC EGFR mut 1st line

Filed June 2012

Boniva/Bonvivaosteoporosis

Filed July 2012



Avastinovarian cancer

Filed October 2012

Avastinrecurrent glioblastomaFiled September 2012

Approved

PerjetaHER2-pos. mBCFiled May 2012

BactraminTreatment and prevention

of Pneumocystis pneumonia

86

We Innovate Healthcare

8787







Diagnostics


MabThera/RituxanDevelopment programmes

88

Oncology

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

Phase/study

Phase IIISABRINA

Subcutaneous studyStudy being conducted ex-US

Phase IbSAWYER

Subcutaneous studyStudy being conducted ex-US

# of patients N=405 N=225

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

or CVP)Two-stage design:

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

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

over 24 months

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

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

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

(fludarabine and cyclophosphamide)

Primary endpoint

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

(arm A vs arm B)

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

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

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

MabThera/RituxanDevelopment programmes

89

Oncology Immunology

Patient population

Front-line diffuse large B-cell or follicular non-Hodgkin’s lymphoma ANCA-associated vasculitis

Phase/studyPhase IIIb

RATE*Faster infusion study

Phase II/IIIRAVE*


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

• Induction of complete remission at 6 months, defined as a BVAS/WG of 0 and off glucocorticoid therapy

Status • Data presented at ASH 2011• FDA approval granted Q4 2012

• 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 IdecWG - Wegener's Granulomatosis, MPA - Microscopic PolyangiitisASH=American Society of Hematology

AvastinOvarian cancer clinical development programme

90

Patient population

Front-line metastatic ovarian cancer

Phase/study Phase III GOG-0218

Phase III ICON7

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

Design • ARM A: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent placebo followed by placebo alone for up to 22 cycles (15 months)

• ARM B: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by placebo alone for up to 22 cycles (15 months)

• ARM C: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by Avastin alone for up to 22 cycles (15 months)

• ARM A: Paclitaxel and carboplatin for 6 cycles• ARM B: Paclitaxel and carboplatin plus concurrent

Avastin for 6 cycles followed by Avastin alone for up to 18 cycles (12 months)

Avastin dose

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

Primary endpoint

• Progression-free survival • Progression-free survival

Status • Study met its primary endpoint in Q1 2010• Data presented at ASCO 2010 and 2011• Results published in NEJM December 2011

• Study met its primary endpoint Q3 2010• Data presented at ESMO 2010 and ASCO 2011• Results published in NEJM December 2011

• 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.

AvastinOvarian cancer clinical development programme

91

Patient population

Relapsed platinum-sensitive ovarian cancer

Relapsed platinum-resistantovarian cancer

Phase/study Phase IIIOCEANS

Phase IIIAURELIA


Design • ARM A: Carboplatin, gemcitabine, and concurrent placebo for 6 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

• Progression-free survival • Progression-free survival

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

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

• Study met its primary endpoint Q2 2012• Data presented at ASCO 2012• EMA submission expected Q1 2013

ASCO=American Society of Clinical Oncology.

Patient population High risk carcinoid Newly diagnosed glioblastoma

Phase/study Phase IIISWOG SO518

Phase IIIAVAglio


Design • ARM A: Depot octreotide plus interferon alpha

• ARM B: Depot octreotide plus Avastin

• ARM A: Concurrent radiation and temozolomide plus placebo; followed by maintenance TMZ plus placebo for 6 cycles; then placebo until disease progression

• ARM B: Concurrent radiation and TMZ plus Avastin; followed by maintenance TMZ plus Avastin for 6 cycles; then Avastin (15mg/kg q3 weeks) monotherapy until disease progression

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

Primary endpoint

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

Status • Recruitment completed• Expect data 2013

• Enrolment completed Q1 2011• Co-primary endpoint of PFS met Q3 2012• PFS data presented at SNO 2012• Expect OS data in 2013

AvastinHigh risk carcinoid and brain cancer development programmes

92SNO=Society for Neuro-Oncology.

Patient population Metastatic colorectal cancer First-line HER2-negative metastatic breast

cancer

Phase/studyPhase IIIML18147

TML

Phase IIIMERiDiAN


Design • 1st-line treatment with chemotherapy* plus Avastin

• Once patients progress, they are randomisedto:• 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 • Overall survival • PFS in ITT

• PFS in patients with high plasma VEGF-A

Status • Primary end point met Q1 2012• Data presented at ASCO 2012• Filed globally Q3 2012• EMA approval received Q4 2012• FDA approval received January 2013

• FPI Q3 2012

AvastinColorectal and breast cancer development programmes

93

AvastinAdjuvant clinical development programme

94

Patient population

Adjuvant lung cancer

Adjuvant breast cancer

Phase/study Phase IIIECOG 1505

Phase IIIECOG 5103

HER2-negative

Phase IIIBETH

HER2-positive

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

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

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

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

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

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

• FPI Q4 2007• Enrolment completed Q2 2011• Expect data 2014

• FPI Q2 2008• Enrolment completed Q4 2010• Expect data 2013

Herceptin Standard of care for HER2-positive early breast cancer

95

Patient population

Early-stage HER2-positivebreast cancer

Phase/studyPhase IIIHANNAH

Subcutaneous study

# of patients N=595

Design • ARM A: Chemotherapy* concurrent with Herceptin 600mg sc q3w for the first 8 cycles

• ARM B: Chemotherapy* concurrent with Herceptin iv for the first 8 cycles*Chemotherapy = docetaxel then 5-FU, epirubicin, and cyclophosphamide

Primary endpoint

• Serum concentration • Pathologic complete response

Status • 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.EBCC=European Breast Cancer Conference.

PerjetaFirst in a new class of HER dimerization inhibitors

96

Patient population

First-line HER2-positive metastatic breast cancer

Adjuvant HER2-positive breast cancer

Second-line HER2-positive metastatic breast

cancer

Advanced HER2-positive gastric cancer

Phase/ study Phase IIICLEOPATRA

Phase IIIAPHINITY

Phase IIPHEREXA

Phase IIaJOSHUA

# of patients N=808 N=4,800 N=450 N=30

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

• ARM B: Placebo plus Herceptin and docetaxel

• ARM A: Perjeta (840mg loading, 420 q3w) plus Herceptin for 52 weeks plus chemotherapy (6-8 cycles)

• ARM B: Placebo plus Herceptin (52 weeks) plus chemotherapy (6-8 cycles)

• ARM A: Herceptin plus Xeloda

• ARM B: Perjeta plus Herceptin and Xeloda

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

• ARM B: Placebo plus Herceptin and chemotherapy

Primary endpoint

• Progression-free survival • Invasive disease-free survival (IDFS)

• Progression-free survival • Safety, efficacy

Status • Primary endpoint met Q3 2011• Updated OS data presented

SABCS 2012• Submitted for FDA and EMA

approval Q4 2011• FDA granted approval Q2 2012• Positive CHMP opinion received

Q4 2012

• FPI Q4 2011 • FPI Q1 2010 • FPI Q4 2011• Enrolment completed Q4

2012

SABCS=San Antonio Breast Cancer Symposium.

TarcevaNew approaches to treating lung cancer

97

Patient population

Adjuvant non-small cell lung cancer

First-line metastatic non-small cell lung cancer

EGFR mutation-positive

Phase/study Phase IIIRADIANT

Phase IIIEURTAC

# of patients N=974 (2:1 randomisation) N=174

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

• ARM A: Tarceva• ARM B: Chemotherapy (platinum-based

doublet)

Primary endpoint

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

• Progression-free survival

Status • Enrolment completed Q3 2010• Expect final results H1 2013

• Study met its primary endpoint Q1 2011• Data presented at ASCO 2011• EU granted approval in Q3 2011• FDA sNDA submitted Q4 2012• FDA granted Priority Review January 2013

Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.ASCO=American Society of Clinical Oncology.

ZelborafA selective novel small molecule that inhibits mutant BRAF

98In 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)

Patient population

Adjuvant therapy in patients with resected

cutaneous BRAF mutation positive

melanoma

Previously treated papillary thyroid cancerBRAF mutation positive

Metastatic melanomaBRAF mutation positive

Melanoma patients with brain metastases

BRAF mutation positive

Phase/study Phase IIIBRIM8 Phase II Phase Ib Phase II

# of patients N=725 N=50 N=20 N=132

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

bid• ARM B: Placebo

• Single ARM: Zelboraf • Single ARM: Zelborafplus ipilimumab•

• Single ARM: Zelboraf

Primary endpoint

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

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

Q4 2012

• FPI Q3 2011

Erivedge (Vismodegib)A novel small molecule inhibitor of the hedgehog signaling pathway

99In collaboration with CurisEADO=European Association of Dermato-Oncology; ECCO/ESMO=European Cancer Organisation/European Society for Medical Oncology;EADV=European Academy of Dermatology and Venereology

Patient population

Advanced basal cell carcinoma

Operable basal cell carcinoma

Phase/study Pivotal Phase IIERIVANCE BCC Phase II


Design • Single ARM: 150 mg Erivedge orally once daily until disease progression

• Single ARM: 150 mg Erivedge orally once daily

Primary endpoint

• Overall response rate • COHORT 1: Complete clearance (12 weeks Erivedge)• COHORT 2: Durable complete clearance (12 weeks

Erivedge)• COHORT 3: Complete clearance (16 weeks Erivedge)

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

• FPI Q4 2010• Cohort 1 data presented at Society for Investigative

Dermatology (May 2012)

Actemra/RoActemra Interleukin 6 receptor inhibitor

100

Patient population

Early moderate-to-severe rheumatoid arthritis

Rheumatoid arthritisDMARD inadequate

responders

Moderate-to-severe rheumatoid arthritis

Moderate-to-severe rheumatoid arthritis

Phase/study Phase IIIFUNCTION

Phase IIIADACTA

Head-to-head study

Phase IIISUMMACTA

Subcutaneous study

Pivotal Phase IIIBREVACTA

Subcutaneous study

# of patients N=1,162 N=326 N=1,262 N=656

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

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

Status • Primary endpoint met Q3 2012

• Filing expected 2013

• Primary endpoint met Q1 2012

• Data presented at EULAR 2012

• Filed in EU Q3 2012• EMA approval received Q4

2012


• Presented at ACR 2012• Filed in US and EU in Q4

2012


• Presented at ACR 2012• Filed in US and EU in Q4

2012

In collaboration with ChugaiMTX=Methotrexate; DMARD=Disease-Modifying Anti-Rheumatic Drugs.

Actemra/RoActemra Interleukin 6 receptor inhibitor

101

Patient population Systemic sclerosis Polyarticular-course juvenile idiopathic

arthritis

Phase/studyPhase II

faSScinateProof-of-concept study

Phase IIICHERISH


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

Status • FPI Q1 2012• Expect data 2013

• 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

XolairEvaluating potential in chronic idiopathic urticaria, an IgE related disease

102In collaboration with Novartis*Refractory to H1 anti-histamines, H2 blockers, and/or leukotriene receptor antagonists (LTRAs) at the time of randomisation.AAAAI=American Academy of Allergy, Asthma and Immunology

Patient population

Chronic idiopathic urticariaPatients who remain symptomatic despite treatment*

Phase/study Phase IIIASTERIA I

Phase IIIASTERIA II

Phase IIIGLACIAL

# of patients N=300 N=300 N=320

Design Add-on therapy to H1 anti-histamines24 week treatment period(q4-week)

• ARM A: Xolair 300 mg• ARM B: Xolair 150 mg• ARM C: Xolair 75 mg• ARM D: Placebo

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

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

Primary endpoint

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

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

• Safety

Status • Enrolment completed Q1 2012• Expect data presentation in

2013

• Enrolment completed Q4 2011• Accepted for presentation at

AAAAI 2013

• Enrolment completed Q1 2012• Expect data presentation in

2013

LucentisDevelopment programme for wAMD

103

Patient population

Neovascular (wet) age-related macular degeneration

Phase/studyPhase IIIHARBOR

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 presented at AAO 2012

Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.AAO=American Academy of Ophthalmology

104104







Diagnostics


Trastuzumab emtansine (T-DM1, RG3502)Evaluating new treatment options in HER2-positive breast cancer

105

In collaboration with ImmunoGen, Inc.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.ASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology

Patient population

Patients who have progressed on HER2 targeted treatment

PretreatedHER2 pos. metastatic breast

cancer1

Previously untreatedHER2 pos. metastatic breast

cancer

Phase/study Phase IIITH3RESA

Phase IIIEMILIA

Phase IIIMARIANNE

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

Design • ARM A: T-DM1 3.6mg/kg q3w • ARM B: physician’s choice

• ARM A: T-DM1 3.6mg/kg q3w • ARM B: Xeloda plus lapatinib

• ARM A: Herceptin plus taxane• ARM B: T-DM1 3.6mg/kg q3w

plus Perjeta• ARM C: T-DM1 3.6 mg/kg q3w

plus placebo

Primary endpoint

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

• Progression-free survival assessed by IRF

Status • FPI Q3 2011• Recruitment completed Q4 2012

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

approval Q3 2012• FDA granted Priority Review Q4

2012

• FPI Q3 2010• Recruitment completed Q2 2012

Trastuzumab emtansine (T-DM1, RG3502)Evaluating new treatment options in HER2-positive breast and gastric cancers

106In collaboration with ImmunoGen, Inc.ASCO=American Society of Clinical Oncology

Patient population

Neoadjuvant/ Adjuvant breast cancer

HER2-positive advanced gastric cancer

Phase/study Phase IICardiac safety study Phase II/III


Design • Single ARM: T-DM1 3.6mg/kg q3w administered immediately following completion of anthracycline chemotherapy

• ARM A: T-DM1 3.6mg/kg q3w • ARM B: T-DM1 2.4mg/kg q3w • ARM C: docetaxel or paclitaxel

Primary endpoint

• Cardiac event rate• Safety

• Phase II: Dose-finding• Phase III: Overall survival

Status • Completed enrolment Q2 2011• Interim data presented at ASCO

2012

• FPI Q3 2012

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

107

Patient population

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

Phase/study Phase IIIMetLung Phase II Phase II


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

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

• Arm A: Onartuzumab + paclitaxel + platinum-based chemo (cisplatin or carboplatin)

• Arm B: Placebo + paclitaxel + platinum-based chemo (cisplatin or carboplatin)

Primary endpoint

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

• Progression-Free Survival in Met-positive patients

• Progression-Free Survival in the ITT population

• Progression-Free Survival in Met-positive patients

Status • FPI Q1 2012 • FPI Q2 2012 • FPI Q3 2012


108

Patient population

Metastatic HER2-negative gastroesophageal cancer

Metastatic HER2-negative gastroesophageal cancer

Phase/study Phase IIIMetGastric Phase II


Design • ARM A: Onartuzumab plus mFOLFOX6

• ARM B: Placebo plus mFOLFOX6

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

Primary endpoint

• Overall survival in Met-positive patients

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

specified Met-positive patients

Status • FPI Q4 2012 • FPI Q3 2012


109

Patient population

1st and 2nd-line triple negative metastatic

breast cancer

1st-line metastatic colorectal cancer

Avastin-naïve recurrent glioblastoma

Phase Phase II Phase II Phase II


Design • 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 (enrolment to arm C suspended)

Primary endpoint

• 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

Status • FPI Q1 2011• Enrolment completed Q3

2012• Expect data H2 2013

• FPI Q3 2011• Enrolment completed Q4

2012• Expect data 2014

• FPI Q3 2012

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

110

Patient population

Previously untreated metastatic

melanoma BRAF mutation positive

Metastatic melanoma

BRAF mutation positive

Solid tumors Solid tumors Solid tumors

Phase/study Phase III Phase IbBRIM7 Phase I Phase Ib Phase Ib

# of patients N=500 N=~100 N=110 N=212 N=108

Design • ARM A: Zelboraf1plus RG7421

• ARM B: Zelboraf1plus placebo

• Dose escalation study evaluating Zelboraf* plus RG7421

• Dose escalation study

• Dose escalation study evaluating RG7421 plus RG7321 (PI3 Kinase inhibitor)

• Dose escalation study of RG7421 in combination with RG74402 (AKT inhibitor)

Primary endpoint


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

Status • FPI Jan 2013• Expect data 2014

• FPI Q1 2011• Data presented at

ESMO 2012

• FPI Q2 2007• Data presented at

AACR 2011• Recruitment

completed Q4 2012

• FPI Q4 2009• Updated data

presented at ASCO 2012

• FPI Q2 2012

RG 7421 in collaboration with Exelixis1Zelboraf In collaboration with Plexxikon, a member of Daiichi Sankyo Group; 2RG7440 in collaboration with Array BioPharmaESMO=European Society for Medical Oncology; ASCO = American Society of Clinical Oncology; AACR=American Association for Cancer Research

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

111

Patient population

Front-line chronic lymphocytic

leukaemiaPatients with comorbidities

Indolent non-Hodgkin’s

lymphomaMabThera/Rituxan

refractory

Front-line indolent non-Hodgkin’s

lymphoma

Diffuse large B-cell lymphoma (DLBCL)

Phase/study Phase IIICLL11

Phase IIIGADOLIN

Phase IIIGALLIUM

Phase IIIGOYA

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

Design • ARM A: GA101 1000mg iv plus chlorambucil

• ARM B: MabThera/Rituxan plus chlorambucil

• ARM C: Chlorambucilalone

• ARM A: GA101 1000mg iv plus bendamustine

• ARM B: bendamustine

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

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

• ARM A: GA101 1000mg iv plus CHOP

• ARM B: MabThera/Rituxan plus CHOP

Primary endpoint

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

Status • FPI Q4 2009• Recruitment completed

Q2 2012• Expect data 2013

• FPI Q2 2010• Expect data 2015



In collaboration with Biogen IdecCHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

• Phase III clinical trials


112

• Phase I/II clinical trials

Patient population

Relapsed indolent non-Hodgkin’s lymphoma

Relapsed or refractory non-Hodgkin’s lymphoma or chronic lymphocytic

leukaemia (CLL)

Phase/study Phase I/IIGAUSS

Phase I/IIGAUGUIN


Design Phase I portion(extended treatment for 2 years):

• Single agent: GA101

Phase II portion(extended treatment for 2 years):

• ARM A: MabThera/Rituxan • ARM B: GA101

Phase I portion:• Single agent: GA101

Phase II portion:• Single agent: GA101

Primary endpoint

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

Status Phase I portion:• Initiated Q1 2008• Data presented at ASH 2009Phase II portion:• FPI Q3 2009• Enrolment completed Q3 2010• Data presented at ASH 2011

Phase I portion:• Initiated Q3 2007• Updated Phase I NHL and CLL data presented at

ASH 2009Phase II portion:

• All cohorts completed enrolment by Q4 2009• Data presented at ICML/EHA 2011

In collaboration with Biogen IdecASH=American Society of Hematology; EHA=European Hematology Association.


113

Patient population

Front-line or relapsed indolent non-Hodgkin’s

lymphoma (NHL)

Previously untreated chronic lymphocytic leukaemia (CLL)

Phase/study Phase IbGAUDI

Phase IGALTON


Design • Cohort A: GA101 plus fludarabine + cyclophosphamide

• Cohort B: GA101 plus CHOP• Cohort C: GA101 plus

bendamustine

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

cyclophosphamide

Primary endpoint

• Safety • Safety

Status • FPI Q1 2009• Data presented at ASH 2011

• FPI Q2 2011 • Recruitment completed• Expect data presentation late 2013

In collaboration with Biogen IdecASH=American Society of Hematology.

• Phase I/II clinical trials

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

114

Patient population Relapsed or refractory CLL and NHL

Phase/study Phase I

# of patients N=52

Design • Dose-escalation study

Primary endpoint

• Safety/PK/Response rate

Status • FPI Q2 2011• NHL data presented at ASH 2012

In collaboration with AbbVie and WEHI (The Walter and Eliza Hall Institute)ASH=American Society of Hematology.

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

115

Severe uncontrolled adult asthma

Patient population

Adult patients whoseasthma is uncontrolled with

inhaled corticosteroids and a second controller medication





Phase/study Phase IIbLUTE

Phase IIbVERSE Phase III

# of patients N=225 N=225 TBD

Design Subcutaneous lebrikizumab q4w on top of SOC for 28 to 52 weeks with a 24 week safety follow-up•ARM A: Lebrikizumab highest dose•ARM B: Lebrikizumab middle dose•ARM C: Lebrikizumab lowest dose•ARM D: PlaceboPatients will be tested for periostinlevel

Subcutaneous lebrikizumab q4w on top of SOC for 28 to 52 weeks with a 24 week safety follow-up•ARM A: Lebrikizumab highest dose•ARM B: Lebrikizumab middle dose•ARM C: Lebrikizumab lowest dose•ARM D: PlaceboPatients will be tested for periostinlevel

•Study design in preparation

Primary endpoint

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

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

Status • FPI Q1 2012• Recruitment completed Q4 2012

• FPI Q1 2012• Recruitment completed Q4 2012

• Expect FPI in 2013

Aleglitazar (RG1439)A balanced PPAR co-agonist - potential to reduce cardiovascular events in type 2 diabetes patients

116

Patient population

Type 2 diabetesPatients with moderate and mild

renal impairment

Post-ACS patients withType 2 diabetes

Phase/studyPhase II

AleNEPHRORenal function study

Phase IIIAleCARDIO

Cardiovascular outcomes study

# of patients N=302 N=7,228

Design • 52 week treatment duration:• ARM A: Aleglitazar (150 μg)• ARM B: Pioglitazone (45 mg)

• At least 2.5 years treatment period and until 950 events have occurred• ARM A: Aleglitazar (150 μg) on top of SOC• ARM B: Placebo on top of SOC

Primary endpoint

• Relative change from baseline in glomerular filtration rate at 60 weeks

• Reduction in cardiovascular mortality, non-fatal myocardial infarction and stroke (MACE)

Status • Enrolment completed Q2 2011• Primary endpoint met Q3 2012• Data presented at ASN 2012

• Enrolment completed Q2 2012• Expect data 2015

ACS=Acute Coronary Syndrome; SOC=standard of care.ASN=American Society of Nephrology

Aleglitazar (RG1439)A balanced PPAR co-agonist - potential to reduce cardiovascular events in type 2 diabetes patients

117

Patient population Type 2 diabetes (US,China) Stable CVD and type 2 diabetes or pre-

diabetes

Phase/studyPhase III

AleGlucose programGlycemic control studies

Phase IIIAlePrevent

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, non-fatal myocardial infarction and stroke (MACE)

Status • FPI Q4 2012 • FPI Q4 2012

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

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

118PANSS=Positive and Negative Syndrome Scale

Patient population Sub-optimally controlled symptoms of schizophrenia

Phase/study Phase IIINIGHTLYTE

Phase IIIMOONLYTE

Phase IIITWILYTE


Design •Add-on therapy to anti-psychotics

•52-week treatment period•ARM A: RG1678 daily (10 mg)

•ARM B: RG1678 daily (20 mg)

•ARM C: Placebo

•Add-on therapy to anti-psychotics



•ARM C: Placebo




•ARM C: Placebo

Primary endpoint

•PANSS positive symptom factor at week 12



Status • FPI Q4 2010 •FPI Q4 2010 •FPI Q4 2010



Patient population

Persistent, predominant negative symptoms of schizophrenia

Phase/study Phase IIISUNLYTE

Phase IIIDAYLYTE

Phase IIIFLASHLYTE


Design •Add-on therapy to anti-psychotics

•52-week treatment period•ARM A: RG1678 (10 mg)

•ARM B: RG1678 (20 mg)

•ARM C: Placebo


•52-week treatment period•ARM A: RG1678 (5 mg)•ARM B: RG1678 (10 mg)

•ARM C: Placebo


•52-week treatment period•ARM A: RG1678 (10 mg)

•ARM B: RG1678 (20 mg)

•ARM C: Placebo

Primary endpoint

•PANSS negative symptom factor at week 24



Status • FPI Q4 2010 •FPI Q4 2010 •FPI Q4 2010



Patient population

Acute exacerbation ofschizophrenia

Obsessive-compulsive disorder

Phase/study Phase IICandleLyte Phase II


Design • 4-week treatment period•ARM A: RG1678 daily (10 mg)•ARM B: RG1678 daily (30 mg)•ARM C: Olanzapine•ARM D: Placebo

•16-week treatment period•Background therapy of selective serotonin reuptake inhibitors (SSRI)•ARM A: RG1678 daily (30 mg)•ARM B: RG1678 daily (10 mg)•ARM C: Placebo

Primary endpoint

•PANSS total symptom factor at week 4 •Change in total score on Yale-Brown Obsessive Compulsive Scale

Status • FPI Q1 2011•Results of preliminary analysis inconclusive due to olanzapine arm not statistically separating from placebo

•Data presentation in 2013

•FPI Q4 2012

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

121

Patient population Relapsing multiple sclerosis (RMS) Primary progressive

multiple sclerosis (PPMS)

Phase/study Phase IIIOPERA I

Phase IIIOPERA II

Phase IIIORATORIO


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

300 mg iv followed by 600 mg iv every 24 weeks

• ARM B: Interferon β-1a

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

mg iv followed by 600 mg iv every 24 weeks

• ARM B: Interferon β-1a

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

mg iv every 24 weeks • ARM B: Placebo

Primary endpoint

• Annualized relapse rate at 96 weeks versus Rebif

• Annualized relapse rate at 96 weeks versus Rebif

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


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

122

Patient population Prodromal Alzheimer’s Disease

Phase/study Phase II/IIISCarlet RoAD

# of patients N=770

Design 104-week subcutaneous treatment period•ARM A: RG1450 (225 mg)•ARM B: RG1450 (105 mg)•ARM C: Placebo

Primary endpoint

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

Status • FPI Q4 2010• Phase I PET data published in Arch. Neur. Q4 2011

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

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

123

Patient population

Treatment-naive and failurechronic hepatitis CGenotype 1 and 4

Treatment-naive and failure chronic hepatitis CGenotype 1 and 4

Phase/study Phase IIbDYNAMO 1*

Phase IIbDYNAMO 2

Longer duration study

# of patients N=60 N= 120

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

• ARM B: Boceprevir + mericitabine (1000 mg BID) + Pegasys and Copegus for 24 weeks followed by boceprevir+Pegasys and Copegus for 24 weeks

• ARM C : Boceprevir+Pegasys and Copegusfor 48 weeks

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

• ARM B: Telaprevir + mericitabine (1000 mg BID) + Pegasys and Copegus for 12 weeks, followed by + mericitabine (1000 mg BID) + Pegasys and Copegus for 12 weeks, followed by Pegasysand Copegus for 24 weeks

• ARM C : Telaprevir + mericitabine (1000 mg BID) + Pegasysand Copegus for 12 weeks, followed by Pegasys and Copegusfor 36 weeks

• ARM D: Telaprevir + Pegasys and Copegus for 12 weeks, followed by Pegasys and Copegus for 36 weeks

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

Status • FPI Q4 2011• Recruitment completed Q3 2012• Publication target AASLD 2013

• FPI Q4 2011• Recruitment completed Q3 2012• Publication target AASLD 2013

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

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

124

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

Phase/study Phase IIANNAPURNA

# of patients N=180

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

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

Status • FPI Q2 2012• Recruitment Part 1 completed in Q4 2012• Interim data publication target AASLD 2013

Mericitabine (RG7128) licensed from Pharmasset, now part of Gilead.Danoprevir=RG7227, Setrobuvir=RG7790

Patient population

Treatment-experienced chronic hepatitis C patients*

PhasePhase IIb

MatterhornBoosted Danoprevir in Triple, Quad and Interferon-free combinations

# of patients N=381

Design Danoprevir boosted by low dose ritonavir in IFN-free, triple and QUADCohort A: partial responders:•ARM A1: Danoprevir 100 mg bid+ Ritonavir 100mg bid+ mericitabine 1000 mg bid + Copegus for 24 weeks•ARM A2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ Pegasys + Copegus for 24 weeks•ARM A3: Danoprevir 100 mg bid + Ritonavir 100mg bid + mericitabine 1000 mg bid + Pegasys + Copegus for 24 weeksCohort B: null responders:•ARM B1: Danoprevir 100 mg bid + Ritonavir 100mg bid + mericitabine 1000 mg bid + Copegus for 24 weeks•ARM B2: Danoprevir 100 mg bid + Ritonavir 100mg bid+ mericitabine 1000 mg bid + Pegasys + Copegus for 24 weeks•ARM B3: Danoprevir 100 mg bid+ Ritonavir 100mg bid + mericitabine 1000 mg bid + Pegasys + Copegus for 24 weeks, followed by 24 weeks Pegasys + Copegus

Primary endpoint

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

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

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

125Mericitabine (RG7128) licensed from Pharmasset, now part of Gilead.Danoprevir=RG7227

126126







Diagnostics


Molecule MDM2 antagonist(RG7112)

MDM2 (4) antagonist(RG7388)

MEK inhibitor(CIF, RG7167)

Raf/MEK inhibitor(CKI27, RG7304)

ALK inhibitor(RG7853)

Patient population

Advanced solid tumors

Hematologic neoplasms

(Leukaemia)Solid tumors Solid tumors Solid tumors Non-small cell

lung cancer

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

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

Design • Multiple ascending dose-escalation study

• Multiple ascending dose-escalation study


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

• Dose-escalation to MTD

• 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• Recruitment into

expansion cohorts completed Q4 2011

• Data presented at EORTC-NCI-AACR 2012

• Initiated Q4 2008• Enrolment

stopped in Q4 2010

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

Collaborator Chugai

Oncology development programmesSmall molecules

127EORTC=European Organisation for Research and Treatment of Cancer; AACR=American Association for Cancer Research

Oncology development programmesMonoclonal antibodies

128

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

Anti-CD44 MAb(RG7356)

Patient population

Metastatic liver cancer(hepatocellular carcinoma)

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

leukemia

Phase Phase Ib Phase II Phase I Phase I

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

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

combo with SOC

Adaptive design studyDouble blind randomized 2:1 RG7686 : placebo

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

• Multiple ascending dose study with extension and imaging arm

• Multiple ascending dose study +/- cytarabine

Primary endpoint

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

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

Status • FPI Q4 2008• Dose escalation completed

for US and Japan monotherapy studies.

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

Collaborator Chugai

SOC=standard of care

Oncology development programmesMonoclonal antibodies (continued)

129

Molecule Anti-TWEAK MAb(RG7212)

GE-huMAb HER3(RG7116)

CSF-1R huMAb(RG7155)

Ang2-VEGF MAb(RG7221)

Patient population Solid tumors Solid tumors Solid tumors Solid tumors

Phase Phase I Phase I Phase I Phase I

# of patients N=50 N=105 N≈95 N≈80

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

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

Primary endpoint

• Safety, PK, PD • Safety, PK • Safety, PK, PD & preliminary clinical activity

• Safety

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

GA201 (RG7160)Glycoengineered enhanced ADCC/anti-EGFR monoclonal antibody

130

Patient population

Head and neck squamous cell carcinoma

1st-line metastaticnon-small cell lung cancer

2nd-line metastaticcolorectal cancer

Phase Phase I Mechanism of action study Phase Ib/II Phase II


Design • ARM A: GA201• ARM B: Cetuximab

Treated until disease progression:SquamousARM A: GA201 plus cisplatin and gemcitabineARM B: Cisplatin and gemcitabine

Non-SquamousARM A: GA201 plus cisplatin and pemetrexedARM B: Cisplatin and pemetrexed

Treated until disease progression:KRAS Wild TypeARM A: GA201 plus FOLFIRIARM B: Cetuximab plus FOLFIRI

KRAS MutantARM A: GA201 plus FOLFIRIARM B: FOLFIRI alone

Primary endpoint

• Pharmacodynamics • Part 1 – Safety• Part 2 – PFS

• PFS

Status • Recruitment completed Q1 2012• Data presented at ASCO 2012

• Non Squamous - Initial data analyses (Q4 2012) showed no improvement in PFS with GA201 in addition to standard chemotherapy

• Squamous Phase Ib halted.

• FPI Q2 2011• Recruitment completed Q3 2012• Design presented at ASCO 2012• Expect data in 2013

ASCO=American Society of Clinical Oncology.

Metabolic development programmes

131

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)

Type 2 diabetes

Phase/study Phase II Phase II Phase I


Design 32-week treatment period•ARM A: RG1512 (20 mg/kg)•ARM B: Placebo

Single infusion•ARM A: RG1512 (5 mg/kg)•ARM B: RG1512 (20 mg/kg)•ARM C: Placebo

• single ascending dose (SAD) study

• ARM A: RG7697 sc• AMR B: placebo

Primary Endpoint •Sapheneous vein graft re-occlusion

•Procedural damage (troponin) • Safety, PK

Status • FPI Q4 2010• Recruitment completed Q2 2012• Data expected in 2013

• FPI Q2 2011• Data accepted for presentation at

ACC 2013

• FPI Q3 2012

Collaborator Genmab Marcadia Biotech, Inc. acquisition

ACC=American College of Cardiology

Neuroscience development programmes

132

Molecule Monoamine oxidase type B (MAO-B) inhibitor(RG1577, EVT-302)

BACE1 inhibitor(RG7129)

Patient population Alzheimer’s Disease Alzheimer’s Disease

Phase Phase IIbMAyflOwer RoAD Phase I/II Phase I Phase I Phase I

# of patients N=420 N=24 N=6 N=34 N=175

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 • Drug-drug interaction (DDI) with Ketoconazole in healthy volunteers

• Single ascending dose-escalation study


• CSF biomarker study

Primary endpoint

• Changes in ADAS-Cog at 52 weeks

• Brain enzyme occupancy

• Metabolic profile• Route of elimination

• Effect of multiple doses of ketoconazole on RG1577 AUC concentration-time curve (AUC)

• Safety• Pharmacokinetics• Pharmacodynamics

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

• Clinical phase completed

• SAD: completed• MAD: FPI Q2 2012• CSF: FPI Q2 2012

Collaborator Evotec Siena Biotech


133

Metabotropic glutamate receptor pathway

Molecule mGluR2 antagonist(RG1578)

mGluR5 antagonist(RG7090)

Patient population

Adjunctive Treatment of Major Depressive

Disorder

Adjunctive Treatment of Major Depressive

DisorderFragile X Syndrome

Phase/study Phase II Phase IIMarigold

Phase IIfragxis

Phase IIfoxtail

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

Design • ARM A: RG1578 5 mg• ARM B: RG1578 15 mg• ARM C: RG1578 30 mg• ARM D: Matching Placebo

ARM A: RG7090 0.5 mg ARM B: RG7090 1.5 mg ARM C: Matching

Placebo

ARM A: RG7090 0.5 mg ARM B: RG7090 1.5 mg ARM C : Matching

Placebo

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

Placebo

Primary endpoint

• Efficacy - Montgomery Asberg Depression Rating Scale

• Efficacy - Montgomery Asberg Depression Rating Scale

• Efficacy, safety and tolerability

• Safety• Exploratory efficacy and

tolerability

Status • Recruitment ongoing• Expect data H2 2013

• Recruitment ongoing• Expect data H2 2013

• Recruitment ongoing• Expect data H2 2013

• Recruitment initiated• Expect data H2 2013


134

Molecule GABRA5 negative allosteric modulator (NAM)(RG1662)

V1 receptor antagonist(RG7314)

Phosphodiesterase 10A (PDE10A) inhibitor

(RG7203)

Patient population Down Syndrome Autism Schizophrenia

Phase Phase I Phase Ib Phase I Phase I

# of patients N=17 N=33 N=up to 24 N=92

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

• Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Individuals With Down Syndrome

• DDI study • Double-blind, single-ascending dose, placebo controlled study

• ARM A: RG7203 single ascending dose

• ARM B: RG7203 single dose in fed and fasted state

• AMR C: Placebo

Primary endpoint

• GABAA alpha5 receptor expression, occupancy and functional connectivity

• Safety, tolerability • Safety, tolerability, PK and PD effects of multiple doses of RG7314 with a single dose of risperidone in healthy subjects

• Safety, PK


135







Diagnostics


Oncology development programmes

136

Angiogenic signaling Growth factor signaling

Molecule Anti-EGFL7 MAb(RG7414)

Anti-HER3 EGFR DAF MAb(RG7597)

Patient population

First-line metastaticnon-small cell lung

cancer

First-line metastaticcolorectal cancer

Metastatic epithelial tumors

Metastatic/recurrent SCCHN*

KRAS wild-type metastatic

colorectal cancer

Phase/study Phase IINILE

Phase IICONGO Phase I Phase II

MEHGANPhase IIDARECK


Design • Anti-EGFL7 plus Avastin plus carbo/tax vs Avastinplus carbo/tax

• ARM A: Anti-EGFL7 plus Avastinplus FOLFOX

• ARM B: Avastinplus FOLFOX


• ARM A: RG7597• ARM B: Cetuximab

• ARM A: RG7597+FOLFIRI

• ARM B: Cetuximab+FOLFIRI

Primary endpoint

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


Status • Enrolment completed Q3 2012

• Enrolment completed Q3 2012

• FPI Q4 2010 • FPI Q3 2012 • FPI Q4 2012

*SCCHN=Squamous Cell Carcinoma of the Head and Neck


137

Tumor Immunotherapy

Molecule Anti-PD-L1 MAb(RG7446)

Patient population Solid tumors Solid tumors

Previously untreated metastatic melanoma BRAF

mutation positive

Phase Phase I Phase I Phase I


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

chemotherapy

• Dose escalation of RG7446-Zelboraf1 combination

Primary endpoint

• Safety/PK • Safety/PK • Safety

Status • FPI Q2 2011• Data accepted for presentation

at AACR 2013

• FPI Q2 2012 • FPI Q3 2012

1Zelboraf In collaboration with Plexxikon, a member of Daiichi Sankyo GroupAACR=American Association for Cancer Research


138

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

malignanciesNon-Hodgkin's

Lymphoma Hematologic malignancies

Phase Phase I Phase I Phase I Phase II Phase I


Design • Dose escalation study



• RG7593 plus rituximab

• RG7596 plus rituximab


Primary endpoint

• Safety • Safety/PK • Safety • Safety and anti-tumor activity

• Safety

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

Collaborator Seattle Geneticsand Agensys Seattle Genetics


139

Antibody drug conjugates (ADCs)

Molecule NME ADC(RG7598)

NME ADC(RG7599)

NME ADC(RG7600)

NME ADC(RG7636)

Patient population Multiple myeloma NSCLC and ovarian

cancerPancreatic 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


Collaborator Seattle Genetics

PI3K signaling

Molecule PI3 Kinase inhibitor (GDC-0941, RG7321)

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

recurrent NSCLC

Locally recurrent or metastatic HER2-negative HR-positive breast

cancer

Phase Phase IIFERGI

Phase IIFIGARO

Phase IIPEGGY


Design • ARM A: RG7321 plus hormonal therapy

• ARM B: RG7422 plus hormonal therapy

• ARM C: Hormonal therapy + placebo

• ARM A: RG7321 + carboplatin + paclitaxel

• ARM B: Placebo + carboplatin + paclitaxel

• ARM C: RG7321+ carboplatin + paclitaxel + bevacizumab

• ARM D: RG7321+ carboplatin + paclitaxel + bevacizumab

• ARM A: RG7321+ paclitaxel• ARM B: Placebo + paclitaxel

Primary endpoint

• PFS • PFS • PFS


Oncology development programmesSmall molecules

140

• Phase II studies

PI3K signaling

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

Patient population Renal cell carcinoma 2L ER+ metastatic breast

cancerPersistent or recurrent endometrial carcinoma

2L Castration-resistant prostate cancer

Phase Phase II ROVER

Phase IIFERGI

Phase IIMAGGIE Phase Ib/II


Design • ARM A: RG7422• ARM B: Everolimus

• ARM A: RG7321 plus hormonal therapy

• ARM B: RG7422 plus hormonal therapy

• ARM C: Hormonal therapy + placebo

• Single-arm RG7422 • ARM A: RG7440 + abiraterone

• ARM B: RG7422 + abiraterone

• ARM C: Placebo + abiraterone

Primary endpoint

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

Status • FPI Q4 2011• Enrolment completed Q3

2012

• FPI Q3 2011 • FPI Q4 2011• Enrolment completed Q3

2012

• FPI Q1 2012

Oncology development programmesSmall molecules (continued)

141

• Phase II studies


142

Molecule AKT inhibitor(GDC-0068, RG7440)

Patient population Solid tumors Solid tumors 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 oxaliplatinor•ARM C: paclitaxel

• ARM A: RG7440 + abiraterone

• ARM B: RG7422 + abiraterone

• ARM C: Placebo + abiraterone

• Dose escalations study of GDC-0973* in combination with RG7440

Primary endpoint

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

• Safety/PK

Status • FPI Q1 2010• Data presented at ASCO

2011• Recruitment completed

Q2 2012

• FPI Q3 2011• Data presented at ASCO

and ESMO 2012

• FPI Q1 2012 • FPI Q2 2012

Collaborator Array BioPharma

*GDC-0973 in collaboration with ExelixisASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology.


143

MoleculePI3 Kinase

inhibitor (GDC-0032, RG7604)

PI3 Kinase inhibitor

(GDC-0084, RG7666)

MEK inhibitor(GDC-0623, RG7420)

ChK1 inhibitor(GDC-0425, RG7602)

ChK1 inhibitor(GDC-0575, RG7741)

Patient population Solid tumors

Progressive or recurrent high-grade glioma

Solid tumors Solid tumors or lymphoma

Solid tumors or lymphoma

Phase Phase I Phase I Phase I Phase I Phase I

# of patients N=45 N=68 N≈60 N=75 N=45

Design • Dose escalation study





Primary endpoint

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

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

Collaborator Array BioPharma

Immunology development programmes

144

Molecule Quilizumab(Anti-M1 prime, RG7449)

Patient population Asthma Allergic asthma - inadequately

controlled

Phase/study Phase IIaSOLARIO

Phase IIbCOSTA


Design • 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•ARM D: Placebo

Primary endpoint

• Late airway response (LAR) at Day 86

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

Status • FPI Q4 2010• Enrolment completed Q2 2011• Data presented at ATS 2012 and

ERS 2012

• FPI Q2 2012

ATS=American Thoracic Society; ERS=European Respiratory Society.

Immunology development programmes

145

Molecule Rontalizumab(Anti-INFalpha, RG7415)

Etrolizumab(rhuMAb-β7, (RG7413)

anti-IL17(RG7624)

Patient population

Systemic lupus erythematosus

Ulcerative colitis Autoimmune diseases

Phase/study Phase IIROSE Phase I Phase II

EUCALYPTUS Phase Ib


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

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

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

• ARM B: RhuMAb-β7 (300 mg) plus immunosuppressant

• ARM C: Placebo plus immunosuppressant

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

Primary endpoint

• Proportion of responders at Week 24

• Safety and tolerability • Clinical Remission (Mayo Clinic Score) at Week 10

• Safety and tolerability

Status • Enrolment completed Q3 2010

• Data presented at ACR 2012




• Submitted for presentation at DDW 2013

• FPI Q1 2012• Enrolment completed Q2

2012

Collaborator NovImmune

DDW=Digestive Disease Week

Neuroscience and ophthalmology development programmes

146

Molecule Crenezumab(Anti-Αβ, RG7412)

Anti-Factor D(RG7417)

Patient population

Alzheimer’sDisease

Geographic atrophy (GA) secondary to age-related macular

degeneration

Phase/studyPhase IIABBY

Cognition study

Phase IIBLAZE

Biomarker study

Phase Ib/IIMAHALO


Design • ARM A: Anti-Abeta sc• ARM B: Anti-Abeta iv• ARM C: Placebo

• ARM A: Anti-Abeta sc• ARM B: Anti-Abeta iv• ARM C: Placebo

• Part 1: Open-label• Multiple dosing

• Part 2: Randomised• ARM A: Anti-Factor D injection• ARM B: Sham injection

Primary endpoint

• Change in cognition (ADAS-cog) and Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score from baseline to week 73

• Change in brain amyloid load from baseline to week 69

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

month 18

Status • FPI Q2 2011• Enrolment completed Q3 2012

• FPI Q3 2011• Enrolment completed Q3 2012

• Part 1 FPI Q4 2012• Part 2 FPI Q2 2011• Enrolment completed Q4 2011

Collaborator AC Immune

Metabolism and virology development programmes

147

Molecule Anti-PCSK9(RG7652)

NME against CMV(RG7667)

Patient population Metabolic diseases Infectious diseases

Prevention cytomegalovirus disease in kidney transplant

recipients

Phase/study Phase IIEQUATOR Phase I Phase II


Design Sc dosing every 4 weeks• Experimental: five different

doses of RG7652• Placebo

• RG7667• Placebo

• RG7667• Placebo

Primary endpoint

• Absolute change from baseline in LDL-c concentration

• Safety, PK • Safety, clinical activity

Status • FPI Q2 2012• Enrolment completed Q4 2012• Expect Phase I data

presentation in 2013• Phase II data readout in 2013

• FPI Q1 2012• Recruitment completed Q3

2012

• FPI Q4 2012

148148148







Diagnostics


Geographical sales split by divisions and Group*

149

CHF m 2011 2012 % change CER

Pharmaceutical Division 32,794 35,232 +5

United States 12,223 13,856 +7Western Europe 8,221 7,926 -2Japan 3,817 4,108 +2International 8,533 9,342 +9

Diagnostics Division 9,737 10,267 +4

United States 2,138 2,346 +4Western Europe 3,705 3,573 -2Japan 525 593 +7International 3,369 3,755 +10

Group 42,531 45,499 +4

United States 14,361 16,202 +7Western Europe 11,926 11,499 -2Japan 4,342 4,701 +3International 11,902 13,097 +9

* Geographical sales split shown here does not represent operational organization; CER=Constant Exchange Rates149

Pharma Division sales 2012 (vs. 2011)Top 20 products

150CER=Constant Exchange Rates

CHF m % CER CHF m % CER CHF m % CER CHF m % CER CHF m % CER MabThera/Rituxan 6,707 9 3,112 8 1,643 6 291 8 1,661 13Herceptin 5,889 11 1,663 11 1,970 3 337 11 1,919 20Avastin 5,764 6 2,475 0 1,510 6 769 16 1,010 16Pegasys 1,649 12 541 49 301 3 81 -17 726 2Xeloda 1,523 9 627 15 253 -3 128 8 515 9Lucentis 1,481 -8 1,481 -8 - - - - - -Tarceva 1,314 2 571 12 317 -13 112 15 314 0CellCept 909 -11 171 -20 230 -18 77 14 431 -5Actemra/RoActemra 842 33 241 62 265 36 201 -2 135 59Xolair 705 11 705 11 - - - - - -NeoRec./Epogin 674 -26 - - 253 -17 171 -50 250 -7Valcyte/Cymevene 638 9 323 17 154 -3 - - 161 8Activase/TNKase 584 22 535 23 - - - - 49 14Tamiflu 560 48 349 106 8 -85 141 38 62 18Pulmozyme 537 6 321 8 99 -1 - - 117 7Mircera 384 8 - - 72 -59 209 203 103 0Bonviva/Boniva 323 -54 75 -77 102 -51 - - 146 -14Madopar 310 6 - - 91 -3 22 -4 197 12Nutropin 304 -9 297 -9 - - - - 7 -15Rocephin 266 -2 1 -23 44 -18 54 -11 167 6

Global US WE Japan International

Pharma Division sales 2012 (vs. 2011)Recently launched products

151CER=Constant Exchange Rates * over +500%

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

Zelboraf 234 * 112 252 115 * - - 7 -

Perjeta 56 - 54 - 2 - - - - -

Erivedge 29 - 29 - - - - - - -

Global US WE Japan International

Pharma Division CER sales growth1 in %Global top 20 products

152

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

MabThera/Rituxan 10 7 11 11 7Herceptin 14 7 14 14 8Avastin -2 1 5 11 8Pegasys 5 32 29 -4 -5Xeloda 13 15 13 4 5Lucentis 13 0 -11 -12 -9Tarceva 10 10 7 -5 -3CellCept -20 -19 -11 -11 1Actemra/RoActemra 48 46 32 27 30Xolair 12 12 12 9 10NeoRec./Epogin -27 -28 -28 -20 -25Valcyte/Cymevene 2 9 10 9 9Activase/TNKase 15 17 25 30 17Tamiflu -19 -24 63 -64 449Pulmozyme 12 1 8 11 4Mircera 63 34 25 -12 2Bonviva/Boniva -30 -31 -64 -70 -55Madopar 1 4 11 2 5Nutropin -15 -9 -12 -10 -5Rocephin 7 3 0 -8 -5

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

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

1531 Q1-Q4 2012 vs. 2011 CER=Constant Exchange Rates

CER sales growth (%)Quarterly development

154

2011 vs. 2010 2012 vs. 2011Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Pharmaceuticals Division -2 -1 0 3 2 6 4 7

United States 2 1 1 4 6 6 5 13Western Europe -4 -4 -3 -1 -4 -1 -2 -1Japan -7 -3 -7 -5 1 0 1 5International -3 0 5 10 2 14 11 7

Diagnostics Division 6 5 6 7 4 6 1 4

Roche Group 0 0 1 4 2 6 4 6


2012: Oncology franchise

155

US

• Sales growth driven by Rituxan, Herceptin, Zelboraf and Xeloda

Western Europe

• Major drivers Zelboraf, Avastin (driven by OC uptake), MabThera and Herceptin

International

• Double-digit growth for major oncology products

Japan

• Growth driven largely by Avastin

1 CER=Constant Exchange Rates; Oncology sales CHF 21.3 bn

+9%

+4%

+14%

Oncology sales

+8%

CHF

bn

+9%1

0

4

8

12

16

20

24

2008 2009 2010 2011 2012

US Western EuropeInternational Japan

MabThera/Rituxan

156

2012 sales of CHF 6.707 bn

• 1L FL maintenance indication as 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


CER growthRegional sales

US +8%

Japan +8%

International +13%

CHF

bn

Global sales

Western Europe +6%

+9%1

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

2008 2009 2010 2011 2012

157

Herceptin


• 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

CHF

bn

+11%1

CER growthRegional salesGlobal sales


0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

2008 2009 2010 2011 2012

Japan +11%

Western Europe +3%

International +20%

US +11%

158

Avastin

US 0%

Japan +16%

Western Europe +6%

International +16%

CER growthRegional salesGlobal sales

CHF

bn

+6%1


• WE: successful launch in Ovarian cancer; CHMP positive opinion in recurrent, platinum-sensitive OC.

• US: ssignificant increase in 2L mCRC use associated with TML awareness.• Japan: driven by further uptake in mNSCLC and mCRC


0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

2008 2009 2010 2011 2012

159


• 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

XelodaCH

F bn

CER growthRegional salesGlobal sales+9%1


0.0

0.4

0.8

1.2

1.6

2008 2009 2010 2011 2012

US +15%

Japan +8%

Western Europe -3%

International +9%

160

2012 sales of CHF 1.314 bn• 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

Tarceva

Global sales CER growthRegional sales

CHF

bn

+2%1


0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

2006 2007 2008 2009 2010 2011 2012

Japan +15%Western Europe -13%

US +12%

International 0%

161

Inflammation/Autoimmune/Transplantation

2012 IAT sales: CHF 3.043 bn• Strong growth of Actemra and

MabThera/Rituxan compensated for the further CellCept decline in US and WE

Actemra/RoActemraSales: CHF 842 m (+33%)

• Further gain of patient share in all treatment lines according to label; US biggest growth contributor

CellCeptSales: CHF 909 m (-11%)• Patent expiry key EU countries end 2010

IAT sales

+5%1

CHF

bn


+6%

+13%

+1%

-4%

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

2008 2009 2010 2011 2012

US Western EuropeInternational Japan

Tamiflu quarterly sales 2009 - 2012Retail and Governments/Corporations

162

CHF m

Retail

Governments & Corporations

304 349

727

533422

17091

17 19 3 45 4610 8 5 31

97

260

267 663

95

23

748

233

7

-6

12177

26 15

288

-50

150

350

550

750

950

1150

Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 Q2 10 Q3 10 Q4 10 Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12

163163







Diagnostics


164

Global North America EMEA RoW% CER % CER % CER % CER

CHFm growth CHFm growth CHFm growth CHFm growth

Professional Diagnostics 5,165 8 962 6 2,386 2 1,817 18

Diabetes Care 2,566 -4 579 -4 1,468 -6 519 4

Molecular Diagnostics 1,168 4 418 8 425 -1 325 8

Applied Science 737 -3 273 -5 280 -5 184 3

Tissue Diagnostics 631 12 402 7 151 18 78 29

Diagnostics Division 10,267 4 2,634 3 4,710 -1 2,923 13

Diagnostics Division CER growthBy Region and Business Area (vs. 2011)


165

Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER

Professional 1,087 10 1,262 8 1,224 9 1,291 8 1,292 9 1,358 7Diagnostics

Diabetes 605 2 731 5 564 -7 696 3 577 -12 729 -1Care

Molecular 257 3 293 9 285 8 286 4 288 1 309 4Diagnostics

Applied 167 1 196 -6 183 -4 180 -2 172 -8 202 2Science

Tissue 123 11 160 17 147 18 158 16 153 10 173 7Diagnostics

Dia Division 2,239 6 2,642 7 2,403 4 2,611 6 2,482 1 2,771 4

Diagnostics Division quarterly sales and CER growth1

1 versus same period of prior year CER=Constant Exchange Rates2011 sales restated from Diabetes Care (full year impact CHF –23 m) to Professional Diagnostics (CHF +23 m full year impact)

CER sales growthCHF 10,267 m

2012: Diagnostics Division salesGrowth driven by Professional Diagnostics

737

1,168

631

5,165

2,566

166

4%

-4%

8%

4%

-3%

12%

DiagnosticsDivision

DiabetesCare

ProfessionalDiagnostics

MolecularDiagnostics

AppliedScience

TissueDiagnostics


Molecular Diagnostics 11%

Professional Diagnostics 51%

Tissue Diagnostics 6%

Diabetes Care 25%

Applied Science 7%

4%

3%

-1%

15%

15%

7%

DiagnosticsDivision

NorthAmerica

EMEA

LatinAmerica

AsiaPacific

Japan

North America 26%

CER sales growthCHF 10,267 m

Diagnostics Division sales 2012 Growth driven by Asia Pacific and Latin America

2,634

774

1,556

5934,710

167

Japan 6%

EMEA1 46%

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

Asia Pacific 14%

Latin America 8%

1

168

Professional DiagnosticsContinued strong growth well above the market

CHF bn

+8%

+15%

+5%



+4%

0.0

2.0

4.0

6.0

2010 2011 2012

Immunoassay Clinical Chemistry POC products Other

0.0

1.0

2.0

3.0

2010 2011 2012Blood Glucose Insulin Delivery

169

Diabetes Care Challenging market environment for bGM*

-5%

-4%

+8%

CHF bn 2012 vs. 2011CER growth

CER=Constant Exchange Rates; * blood glucose monitoring

170

Molecular Diagnostics Strong growth in Hep C viral load testing

+2%

+5%

0

400

800

1200

2010 2011 2012

Virology Blood Screening Other

+4%CHF m



171

-3%

+5%

+8%

-19%

CHF m 2012 vs. 2011CER growth

Applied ScienceFocus on fewer growth businesses after restructuring

CER=Constant Exchange Rates Genomic Analysis: Sequencing and Microarrays

0

300

600

900

2010 2011 2012qPCR&NAP Custom BiotechGenomic Analysis Other

172

0

100

200

300

400

500

600

700

2010 2011 2012

Advanced Staining Primary Staining Other

Tissue DiagnosticsContinued growth ahead of market

+12%

+13%

+13%

CHF m 2012 vs. 2011CER growth


173

2013: Key planned product launchesProfessional Diagnostics

Product Description Region

cobas 8100 pre-analytical series

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

EU

Elecsys Calcitonin immunoassay

Aids in the diagnosis and monitoring of medullary thyroid cancer

EU

Elecsys proGRPimmunoassay

Aids in the diagnosis of small cell lung cancer EU

Elecsys Cyclosporin& Tacrolimusimmunoassays

Monitoring of immunosuppressive drug therapy in transplant patients

EU

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

174


Accu-Chek Active Next-generation blood glucose monitoring system maltose independent strips

EU

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

EU

2013: Key planned product launchesDiabetes Care


175

2013: Key planned product launchesMolecular Diagnostics


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

US

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

US

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


176

2013: Key planned product launches Applied Science


Seq Cap EZ Reagent sets for targeted next generation sequencing WW

GS FLX longamplicons

Software for long-read targeted sequencing for DNA variant detection

WW


177

2013: Key planned product launches Tissue Diagnostics


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

US

CINtec p16 Cytology Immunocytochemistry assay for diagnosis of cervical pre-cancer

EU


178178







Diagnostics


CHF / USD

179

0.75

0.80

0.85

0.90

0.95

1.00

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

0.75

0.80

0.85

0.90

0.95

1.00


Year-To-Date averages

Monthly averages

2011

2011

2012

2012

-2% +2% +7% +6%

CHF / USD

180

0.75

0.80

0.85

0.90

0.95

1.00


monthly avg 2012

average full year 2011

monthly avg 2011

+6%


CHF / EUR

181

1.10

1.15

1.20

1.25

1.30

1.35


1.10

1.15

1.20

1.25

1.30

1.35


Year-To-Date averages

Monthly averages

2011

2011

2012

2012-5%-6% -3% -2%

CHF / EUR

182

1.10

1.15

1.20

1.25

1.30

1.35


monthly avg 2012


monthly avg 2011

average full year 2012 -2%

Average exchange rates

183

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

USD 0.94 0.89

EUR 1.21 1.23

JPY 1.17 1.11

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

4.1% 3.9% 4.5%

-0.8%

3.5%

7.0% 7.0%

2.5%

Q1 HY YTD 9 FY

Exchange rate impact on sales growthSince H1, negative impact from EUR more than offset by positive impact from USD and JPY

184

Development ofaverage exchange rates versus prior year periodCHF / EUR -6.1 % -5.2 % -2.6 % -2.4 %CHF / USD -2.2 % +2.5 % +6.9 % +5.6 %CHF / JPY +1.5 % +5.3 % +8.5 % +5.6 %

Differencein CHF / CER -3.3 %p -0.6 %p +3.1 %p +2.5 %p

growth

CHFgrowth

CERgrowth

Salesgrowth2012

vs. 2011


2.5%

5.7%3.6%

6.1%

-0.8%

8.0%

14.8%

6.9%

Q1 Q2 Q3 Q4

Exchange rate impact on sales growthSignificant in Q3, negligible in Q4

185

Salesgrowth2012

vs. 2011

Differencein CHF / CER -3.3 %p +2.3 %p +11.2 %p +0.8 %p

growth

Development ofaverage exchange rates versus prior year periodCHF / EUR -6.1 % -4.2 % +3.3 % -1.8 %CHF / USD -2.2 % +7.4 % +16.7 % +2.0 %CHF / JPY +1.5 % +9.5 % +15.4 % -2.7 %

CHFgrowth

CERgrowth


Exchange rate impact on sales growthNegative impact in particular from EUR more than offset by positive impact mainly from USD

186

CERsales

growth2012

vs.2011

CHFsales

growth2012

vs.20114.5%

+0.6%

+0.6%0.0%-0.2%

-0.6%

+2.1%

0.0%7.0%

CER EUR Lat-Am OthEurope

Other AS-Pac JPY USD CHF


187

We Innovate Healthcare

Documents

· 3 This presentation contains certain forwar d-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates