Roche Translating excellence in science into customer benefit249e4cde-cb09-4d49... · Roche...

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Roche Translating excellence in science into customer benefit Cheuvreux Pan Europe Forum, London May 16, 2011 Dr. Stefan Frings, Global Head Medical Affairs Oncology Dr. Karl Mahler, Head of Investor Relations

Transcript of Roche Translating excellence in science into customer benefit249e4cde-cb09-4d49... · Roche...

RocheTranslating excellence in science into customer benefit

Cheuvreux Pan Europe Forum, LondonMay 16, 2011

Dr. Stefan Frings, Global Head Medical Affairs OncologyDr. Karl Mahler, Head of Investor Relations

2

This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:

1 pricing and product initiatives of competitors;2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products,

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

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

3

Performance update and strategy

Update on oncology portfolio

Summary and short term news flow

4

Pharmaceuticals Division 9,727 8,712 -10 -2 +1

Diagnostics Division 2,518 2,408 -4 +6 +6

Roche Group 12,245 11,120 -9 0 +2

2010 2011 ExcludingCHF m CHF m CHF local Tamiflu1

change in %

Q1 2011: Group sales Supporting full-year guidance, strong currency impact

1 local currency

5

Roche: Focused on medically differentiated therapies

Generics

Differentiation

Focus

MedTech

OTC

Prem

ium

for

inno

vatio

n

DiaPharma

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Key Pharmaceuticals & Diagnostics productsA risk-diversified portfolio of drugs and BUs

Sale

s (C

HF

bn)

* 2010 sales

0

5

10

15

20

25

30

35

'03 '04 '05 '06 '07 '08 '09 '10

2 with > than CHF 6 bn

1 with > than CHF 5 bn

11 with > than CHF 1 bn

MabThera/Rituxan

Xeloda

NeoRecormonCellCept

Herceptin

Avastin

Pegasys

Clinical Chemistry

Immunochemistry

Tarceva

Lucentis

>C

HF

6bn*

>C

HF

1bn*

>C

HF

5bn*

Diabetes Care

Molecular DxBoniva

7% Sales Lost calculated by subtracting given year sales (‘10, ’11, ‘12, ‘13) from full year sales from year prior to LOE.Data excludes sales lost impact of products with LOE prior to 2010.Source: Evaluate Pharma

Roche: Limited exposure to patent expiries in the short and medium term

40%

35%

30%

25%

0%

20%

10%

15%

5%

2010 2011 2012 2013

Business impact from biosimilars 2014/15 and beyond?

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Long patent protection Biosimilars facing high hurdles

Long primary patent protection of our key biologics

Patents US EUROW/EM

Avastin 2019 similar

Lucentis 2019 marketed by Novartis

Rituxan/ MabThera 2018 earlier

Herceptin 2019 earlier

Pegasys 2018 similar

Biosimilars outlook

US: recent healthcare legislation opens pathway for biosimilars

FDA in the process of developing guidelines

Data exclusivity for biologics 12 years

ROW/EM: investment in countries with strong IP regulations (China)

Brand awareness important

EU: legal and regulatory hurdles likely to remain high for biosimilars

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A leading pipeline12 NMEs in late-stage development

2007 2008 2009 2010

Number of NMEs

2

4

10Metabolic

Oncology

Inflammation

ocrelizumab

dalcetrapib

pertuzumab

taspoglutide

Actemra

CNS

ocrelizumab

12Virology

1 LIP decision made, phase III start pending

dalcetrapib

aleglitazar

Glycine reuptake inh

ocrelizumab MS

lebrikizumab1

HCV pol inh1

pertuzumab

BRAF inhibitor

T-DM1

Hedgehog inh

GA101(CLL, NHL)

MetMAb1

dalcetrapib

aleglitazar

Glycine reuptake inh

ocrelizumab

pertuzumab

BRAF inhibitor

T-DM1

Hedgehog inh

GA101 (CLL)

taspoglutide

1010

Creating medical value and improving patient care Six NMEs in late-stage development have PHC approach

NMEs = new molecular entities PHC = Personalised HealthcareNot all products available in all countries; some products in development

Periostin(lebrikizumab)

BRAF V600(BRAF inh)

HER2(T-DM1)

HCV load, genotype(HCV pol inh)

Met(MetMAb)

HER2/3(Pertuzumab)

Diagnostics

Companion Diagnostics

We need to stay above industry success rates

11

Success (+) Failure (-)

2008 2009 2010 2011 (Jan-Mar)

(+) (-) (+) (-) (+) (-) (+) (-)

Phase II 6 6 7 1

Phase III 21 2 20 1 10 6 4 0

Total 27 2 26 1 17 6 5 0

Ph III success rate 91% 95% 62% 100%

Based on IR up-dates

Industry ph III success rate 63%1 64%2

Roche

KMR Group, 1)= 2006-2008, 2)= 2007- 2009,

Key clinical trials since October 2010 18 positive studies in 6 months

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Compound Indication StudyMetMAb 2nd/3rd line NSCLC Randomised Phase II, ESMO 2010

Avastin front line Ovarian Cancer ICON7 Phase III, ESMO 2010

Ocrelizumab RR Multiple Sclerosis Randomised Phase II, ECTRIMS 2010

Mericitabine (RG7128) Hepatitis C PROPEL randomised Phase IIb, interim data AASLD 2010

Vemurafenib (BRAF inh) Metastatic Melanoma BRIM2 Phase II, Melanoma Research Congress 2010

GA101 Non-Hodgkin's Lymphoma Randomised Phase II, ASH 2010

Glycine Reuptake inh. (GlyT-1) Schizophrenia Randomised Phase II, ACNP 2010

Pertuzumab Neoadjuvant HER2+ Breast Cancer NEOSPHERE randomised Phase II, SABCS 2010

Lebrikizumab Asthma Randomised Phase II, data in house

Dalcetrapib CV risk reduction Dal-VESSEL, Dal-PLAQUE safety data in house

T-DM1 1st line HER2-positive breast cancer Randomised Phase II, Apr 2011

Vemurafenib (BRAF inh) Metastatic Melanoma BRIM3 Phase III interim analysis, Jan 2011

Tarceva Advanced NSCLC EURTAC Phase III interim analysis, Jan 2011

Avastin Relapsed Ovarian Cancer OCEANS Phase III, Feb 2011

Lucentis Diabetic macular edema (DME) RISE and RIDE, 2 Phase III studies, Feb-Mar 2011

Vismodegib (Hedgehog inh) Basal Cell Carcinoma (mBCC) Pivotal Phase II, Mar 2011

Pivotal studies in Q1 2011

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Performance update and strategy

Update on oncology portfolio

Summary and short term news flow

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Managing franchisesAdding benefits to key medicines; developing better ones

GA101MabThera/Rituxan MabT/Rituxan s.c.Anti-CD20oncology

T-DM1pertuzumabHerceptin Herceptin s.c.Anti-HER2

Avastin anti-PIGF anti-EGFL7Anti-angiogenesis

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Roche Group Pipeline today

Status as of March 31, 2011

phase I (36 NMEs)

phase II (18 NMEs + 8 Als)

phase III(8 NMEs + 27 Als)

Registration(6 Als)

NMEAdditional Indication

OncologyInflammation/ImmunologyVirologyMetabolic/CardiovascularCNSOphthalmologyOthers

RG-No Roche Genentech managedCHU Chugai managedEVO Evotec

RG105 MabThera is branded as Rituxan in US and Japan

RG1569 Actemra is branded as RoActemra in EU

* submitted in the EU** submitted in the US

anti-glypican Mab liver cancerRG7686

Mab Beta7 ulcerative colitisRG7413

anti-factor D Mab geographic atrophyRG7417

mGluR2 antag (2) depressionRG1578

anti-Abeta Mab Alzheimer‘sRG7412triple reuptake inh depressionRG7166

ABCA1 inducer dyslipidemiaRG7273

anti-oxLDL Mab sec prev CV eventsRG7418

GABA-A a5 inv ago cogn. disordersRG1662

anti-IL-17 Mab RARG4934

EGFR Mab solid tumorsRG7160CIF/MEK inh solid tumorsRG7167Raf & MEK dual inh solid tumorsRG7304

anti-PLGF Mab solid tumorsRG7334

MDM2 ant (2) solid & hem tumorsRG7112

MEK inh solid tumorsRG7420

PI3 K/mTOR inh solid & hem tumorsRG7422

PI3 kinase inh solid tumorsRG7321

anti-EGFL7 Mab solid tumorsRG7414

dulanermin cancerRG3639

AKT inhibitor solid tumorsRG7440

MEK inh solid tumorsRG7421

CD22 Mab ADC hem. malignanciesRG7593

CRTH2 antag asthmaRG7185

BRaf inh(2) BRAF mut. melanoma RG7256

nucleoside pol inh (9) HCVRG7432

anti-Her3 Mab m. epithelial tumorsRG7597

antiangiogenic solid tumorsRG7594

IAP ant (2) solid tum & lymphomaRG7459

FGFR3 Mab multiple myelomaRG7444

Cat S antag CV risk in CKD RG7236

GIP/GLP-1 dual ago type 2 diabetesRG7685

ALK inhibitor NSCLCCHU- solid tumorsCHU

vismodegib operable BCCRG3616MetMab mNSCLCRG3638

pertuzumab HER2+ EBC RG1273

vismodegib advanced BBCRG3616

topoisomerase I inh gastric cancerCHUnavitoclax (ABT-263) sol & hem tumRG7433

oxelumab (OX40L Mab) asthmaRG4930lebrikizumab (anti-IL13) asthmaRG3637

rontalizumab (IFN alpha Mab) SLERG7415

mericitabine (polymerase inh) HCVRG7128 danoprevir (protease inh) HCVRG7227

mGluR5 antag (2) TRDRG7090NMDA receptor antag TRDEVO

ocrelizumab RMSRG1594

anti-LT alpha Mab RARG7416

gantenerumab (A-beta) Alzheimer‘sRG1450

P selectin Mab ACS/CVDRG1512

anti-M1 prime Mab asthmaRG7449

pertuzumab HER2+ mBC 2nd lineRG1273

GA101 NHL & CLLRG7159

T-DM1 HER2+ EBCRG3502

Avastin ovarian cancer 1st lineRG435*Avastin BC combo Xeloda 1st lineRG435*

EPOCH chemo induced anemiaCHU

Tarceva NSCLC EGFR mut 1st lineRG1415*

Actemra sJIARG1569Rituxan ANCA assoc vasculRG105**

11 beta HSD inh metabolic diseasesRG4929

- solid tumorsRG7604

- prostate cancerRG7450

- hematological malignanciesRG7596

Xolair chronic idiopathic urticariaRG3648

Rituxan NHL fast infusionRG105

Avastin HER2+ BC adjRG435Avastin BC combo Herceptin 1st lineRG435Avastin NSCLC adjRG435

GRI schizophrenia negative sympt. RG1678

Avastin HER2-neg. BC adj RG435

Avastin relapsed ovarian caRG435Avastin high risk carcinoidRG435Avastin glioblastoma 1st lineRG435

Avastin triple-neg. BC adjRG435

aleglitazar CV risk reduction in T2DRG1439dalcetrapib atherosc. CV risk red.RG1658

Lucentis diabetic macular edemaRG3645Lucentis AMD high doseRG3645

pertuzumab HER2+ mBC 1st lineRG1273

Herceptin HER2+ BC subcut.RG597Herceptin HER2+ adj BC (2yrs)RG597

GA101 iNHLRG7159vemurafenib met. melanomaRG7204

Tarceva NSCLC adj RG1415

Actemra early RARG1569

T-DM1 HER2+ mBC 1st l.RG3502

GA101 CLLRG7159

Actemra RA DMARD IR H2HRG1569

Avastin mCRC TML RG435

T-DM1 HER2+ adv. mBCRG3502

Actemra sc formulation RARG1569

Tarceva NSCLC EGFR mut 1st lineRG1415

Actemra ankylosing spondylitisRG1569

MabThera NHL sc formulationRG105

ocrelizumab PPMSRG1594

GRI schizophrenia subopt. controlRG1678

Avastin mBC 2nd lineRG435

Activase extended time window AISRG3626

MetMab mBCRG3638

SGLT2 inh type 2 diabetesRG72011

1 Ph3 in Japan

vemurafenib met. melanoma 2nd/3rd l.RG7204

Major themes of our oncology franchise

• Managing existing franchises and expanding to new areas

• Subcutaneous delivery of monoclonal antibodies– Herceptin s.c., MabThera s.c.

• Antibody drug conjugates (‘armed antibodies’)– T-DM1, many more to come

• Personalized health care/targeted agents– Vemurafenib, vismodegib, MetMab, PI3k, etc

• Glyco-engineered antibodies– GA101 (anti-CD20), GA201 (anti-EGFR)

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Mutated BRAF: an important therapeutic target

1. Garnett MJ, et al. Cancer Cell 2004;6:313–319; 2. Davies H, et al. Nature 2002;417:949-54 3. Libra M, et al. Cell Cycle 2005;4:1382-4. 4. Wan PTC, et al. Cell 2004;116:855–867

5. McCubrey JA, et al. Biochim Biophys Acta 2007;1773:1263–1284.

020406080

100

Onc

ogen

icBR

AF(%

)

• Oncogenic BRAF is frequently identified in cancer1-3

• Highest incidence of BRAF mutations is in melanoma1-3

• 90% of BRAF mutations in cancer result in substitution at position V6001

– All mutations tested result in constitutive activation of BRAF kinase4

• 90% of BRAF mutations at V600 in melanoma result in substitution V600E5

0

10

20

30

40

50

60

Freq

uenc

y of

m

utat

ion

G46

3E

G46

3V

G46

5A

G46

5E

G46

5T

G46

8A

G46

8E

E58

5K

G59

6R

F594

L

V600

EV

599D

G59

6V

0

10

20

30

40

50

60

Freq

uenc

y of

m

utat

ion

G46

3E

G46

3V

G46

5A

G46

5E

G46

5T

G46

8A

G46

8E

E58

5K

G59

6R

F594

L

V600

EV

599D

G59

6V

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Vemurafenib (BRAF inhibitor)Targeting an important mediator of cellular proliferation

CellularProliferation

RTK

Raf

RG7204ATP

ATP

ERK

MEK

BRAFV600E

RAS • Oncogenic mutation of BRAF~8% of all solid tumors~50% of malignant melanomas

• shRNA knock down experiments support its role in neoplastic behavior

• BRAF mutation knock-in mice develop melanoma-like malignancies

• RG7204 arrests abnormal cell growth in melanoma models

Sosman et al, Int. Melanoma Congress 2010

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BRIM2Tumor regression occurred in majority of patients

*** 7 patients had 100% tumor shrinkage, 3 of which had confirmed CR; 1 patient had unconfirmed CR and 3 patients had non-target lesions present • 122 patients had baseline and ≥ 1post-baseline scan with measurable disease

RECIST 30% Decrease

***

Sosman et al, Int. Melanoma Congress 2010

2020

Vemurafenib meets overall survival endpointin Phase III

Patient PopulationSecond- and Third line Malignant Melanoma

BRAF mutation positive

First-line Malignant MelanomaBRAF mutation positive

Phase/Study Phase II BRIM2 Phase III BRIM3

# of Patients N=132 N=675

Design • Single ARM: RG7204 • ARM A: RG7204• ARM B: dacarbazine

Primary Endpoint • Best overall response rate assessed by IRC using RECIST criteria • Overall survival

Status• Presented at Int. Melanoma Congress 2010 • FPI Q1 2010; fully recruited in Dec 2010

• Met OS and PFS endpoints in Jan 2011

Filing dossier submitted in US and EU

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MetMAb: a new compound that inhibits HGF-mediated activation

MetMAb• Monovalent format designed to prevent HGF-mediated

stimulation of pathway • Preclinical activity across multiple tumor models

HGF=Hepatocyte Growth Factor

MetMAb

Met

α α

HGF HGF

Met

No ActivityCell growth, migration, survival

IndicationNon-small cell lung carcinoma (NSCLC)

Triple negative metastatic breast cancer

Renal cell carcinoma (RCC) Gastric cancer

Colorectal cancer (CRC) Met Autocrine tumors

Glioblastoma multiforme (brain cancer)

Head and neck squamous cell cancer

Hepatocellular carcinoma (HCC)

Ovarian cancer

Rationale for targeting Met• Met is amplified, mutated, overexpressed or uniquely

activated in various cancers• Met overexpression associated with worse prognosis

in many cancers

Cancers in which Met potentially plays role

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MetMAb + Tarceva in lung cancerEfficacy analysis in overall population

23 patients from the erlotinib+placebo arm crossed over to MetMAb.

PFS HR=1.09 OS HR=1.09

Median PFS and OS are consistent with previously reported findings in similar disease setting.

Early analysis of all patients2nd/3rd line mNSCLC

Spigel et al, ESMO 2010

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Diagnostic companion testUnderstanding the biology of Met signalling

NSCLC: Intensity of Met staining on tumor cells scored on 0–3 scale1+ 2+ 3+

Spigel et al, ESMO 2010

• Phase III in NSCLC with prospective testing of Met receptor over-expression

• Estimated that about one-half of NSCLC patients have Met high tumours

• Met IHC assay will be a companion test for the approval for MetMAb in NSCLC

‘Met high’ definition: ≥50% tumor cells with a staining intensity of 2+ or 3+

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MetMAb + Tarceva in lung cancerNew example of Personalised Healthcare approach

PFS HR=0.56 OS HR=0.55

• 54% patients had ‘Met High’ NSCLC• 12/23 patients from the Tarceva+placebo arm who crossed over to MetMAb were Met High.• Updated analysis to be presented at ASCO

Early analysis of Met High Patients 2nd/3rd line mNSCLC

Spigel et al, ESMO 2010

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MetMAb development planNSCLC and triple-negative mBC

Patient Population 2nd and 3rd line Metastatic Non-small Cell Lung Cancer

1st and 2nd line Triple Negative Metastatic

Breast Cancer

Phase Phase III Phase II

Patients Over-expressing Met Receptor N=180

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

Prospective Met status testing.

• ARM A: Avastin and paclitaxel plus MetMAb

• ARM B: Avastin and paclitaxel plus placebo

• ARM C: paclitaxel plus MetMAb

Primary end-point • Overall survival • Progression-free survival

Status • Expect FPI in 2011 • Expect FPI Q1 2011

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HER2-positive breast cancerImproving the standard of care

2010 2016

Early (adjuvant) BC

Herceptin + chemotherapy

Herceptin Subcutaneous+ chemotherapy

Herceptin & pertuzumab + chemotherapy

2012 2013 2014 20152011

1st linemBC

Herceptin + chemotherapy

T-DM1& pertuzumab(MARIANNE)

Herceptin & pertuzumab + chemotherapy(CLEOPATRA)

2nd linemBC

Xeloda + lapatinib

T-DM1 (EMILIA)

Timelines refer to the expected dates of first filing

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HER2 franchiseBuilding on the strength of Herceptin

T-DM1

• Retains Herceptin’s biologic activity

• Targeted intracellular delivery of a potent cell-killing agent, DM1

• No need for conventional chemotherapy

Pertuzumab

• Disrupts HER2:HER3 receptor dimers and downstream signaling

• In combination with Herceptin: potential to create new standard of care for women with HER2-positive metastatic BC

2828

16.8%

24.0%

45.8%

29.0%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Herceptin +

docetaxel

Herceptin &

pertuzumab +

docetaxel

Herceptin &

pertuzumab

pertuzumab +

docetaxel

path

olog

ical

com

plet

e re

spon

se

ITT population summary

p = 0.0141

p = 0.0198

p = 0.003

Herceptin & pertuzumab in neoadjuvant HER2+ BCAn encouraging result from NEOSPHERE trial

SABCS 2010

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First line HER2-positive metastatic BCHerceptin and pertuzumab: CLEOPATRA trial

Primary endpoint:

• Progression-free survival

Herceptin + docetaxel

Herceptin & pertuzumab+ docetaxel

HER2-positive mBC(N=808)

• Enrolment completed Q2 2010• Expect PFS data 2011• Filing in 2011

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Herceptin & pertuzumab in adjuvant settingPotentially increasing the cure rate

Herceptin & pertuzumab+ chemotherapy

Herceptin+ chemotherapy

HER2-positive early breast cancer

N=~4000

Primary end-point: • 3 year Disease Free Survival

Chemotherapy: FEC x 3 →TH x 3 or AC x 4 → TH x 4 or TCH x 6; Total duration of Herceptin treatment=1 yearFEC = 5-fluorouracil, Epirubicin, Cyclophosphamide; TH=Taxotere, Herceptin; AC=cyclophosphamide, doxorubicin; TCH=Taxotere, Carboplatin, Herceptin

• FPI: H2 2011• Follow-up: 3 years (median)• Expect data 2016

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Second line HER2-positive metastatic breast cancerT-DM1 to demonstrate benefit over standard of care

Second-line1

HER2-positive Metastatic Breast Cancer

Phase IIIEMILIA

N=980

• ARM A: T-DM1• ARM B: Xeloda plus lapatinib

Co-primary endpoints: • Progression-free survival• Overall survival

• FPI Q1 2009• Expect PFS data 2012

• Trial recruiting well.• Filing for accelerated approval expected in 2012, with mature PFS data.• OS data to be provided within 1.5 years thereafter.

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

Patient Population

Second-line1

HER2-positive Metastatic Breast Cancer

Phase/StudyPhase IIIEMILIA

# of Patients N=580

Design • ARM A: T-DM1• ARM B: Xeloda plus lapatinib

Primary Endpoint

• Progression-free survival

Status • FPI Q1 2009• Expect data early 2012

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Redefining HER2 blockade: pertuzumab and T-DM1 Increasing the efficacy and tolerability in first line

Herceptin+ chemotherapy

Efficacy

Tole

rabi

lity

T-DM1

Herceptin& pertuzumab

+ chemotherapy

T-DM1& pertuzumab

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Armed antibodiesTrastuzumab-DM1 (T-DM1)

Average number DM1 molecules/ monoclonal antibody = 3.5

“armed” Herceptin for HER2+ BC

DM1 = microtubule targeting agent

0

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doseM

ean

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olum

e (m

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Control: Vehicle

Antibody-A with toxin

Lymphoma Prostate

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Breast

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Control: Vehicle

Antibody-D with toxin

63% CR

Armed antibodies are effective against diverse solid and liquid

tumors (Xenografts)

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TargetScreen Pre-Early Early Stage

ResearchLate StageResearch Early Dev Phase I Phase II/III

ARCNew ADC Linker/drugNew TAP screenNew VAP ScreenRNAi Conjugate

Antibody drug conjugate portfolio

As of March 3, 2010

T-DM1

NME-8

NME-7

NME-14

NME-11

NME-15

NME-16

LSR

LSR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

ESR

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early

Pre-Early Pre-Early

Pre-EarlyPre-Early

Pre-Early

Ovarian

Melanoma

NHL

Kidney

Lung

Pancreatic

Multiple Myeloma

Prostate

Colon

Breast

LSR Go Ed Go IND Submission

ASCO 2011: Key submissionsPersonalised Healthcare becoming reality

Vemurafenib (BRAF inh.)BRIM 3; 1st line met. melanoma

Tarceva EURTAC; EGFR-mutated 1st line NSCLC

MetMAb2nd/3rd line NSCLC; final PFS and OS data

AvastinOCEANS; relapsed ovarian cancer

35

Patient selection crucial for the

success of the trials

36

Performance update and strategy

Update on oncology portfolio

Summary and short term news flow

2011: Major clinical news for late-stage NMEs 7 Phase III and 10 Phase II studies

Compound Indication Study

BRAF inh 1st line met melanoma BRIM3

Lucentis Diabetic macular edema RIDE RISE

Avastin Relapsed ovarian cancer OCEANS

Pertuzumab + Herceptin 1st line HER2+ mBC CLEOPATRA

Herceptin Early HER2+BC sc HANNAH

Actemra Early RA Head-to-Head against Humira1

Hedgehog Pathway Inh. Advanced BCC Pivotal study

T-DM1 1st line HER2+ mBC PFS data

GA101 Relapsed indolent NHL Head-to-Head against MabThera/Rituxan

MetMab NSCLC 2nd / 3rd line Final data

Lebrikizumab Asthma MILLY; MOLLY

Mericitabine Hepatitis C PROPEL final data; JUMP-C

Dalcetrapib Atheroclerosis CV risk red. dal-VESSEL; dal-PLAQUE

1 Read-out likely early 2012

Phas

e II

Phas

e III

37

3838

Outlook for 2011

Barring unforeseen events; LC=Local Currency; * vs. 2010: CHF 0.8 bn

Sales growth (in LC) Group & Pharma (excl. Tamiflu): low single-digitDiagnostics: significantly above market

Core EPS growth target (in LC)

High single-digit

Genentech synergies 2011+ : CHF 1.0 bn*

Debt Aim to return to net cash position by 2015

Dividend outlook Grow dividend in-line with Core EPS growth

Operational Excellencesavings

2011 : CHF 1.8 bn2012+ : CHF 2.4 bn

39

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