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Innovation and growth Bill Anderson Head of Global Product Strategy and Chief Marketing Officer J.P. Morgan European Healthcare Conference June 2014

Innovation and growth - Roche

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Page 1: Innovation and growth - Roche

Innovation and growth

Bill Anderson Head of Global Product Strategy and Chief Marketing Officer J.P. Morgan European Healthcare Conference June 2014

Page 2: Innovation and growth - Roche

2

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

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

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

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

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

contained in this presentation, among others:

1 pricing and product initiatives of competitors;

2 legislative and regulatory developments and economic conditions;

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

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

5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;

6 increased government pricing pressures;

7 interruptions in production;

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

9 litigation;

10 loss of key executives or other employees; and

11 adverse publicity and news coverage.

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

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

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

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

website – www.roche.com

All mentioned trademarks are legally protected

Page 3: Innovation and growth - Roche

Performance update

Great science and differentiated drugs

Summary

3

Page 4: Innovation and growth - Roche

Q1 2014: Strong sales growth

4 CER=Constant Exchange Rates

2014 2013 Change in %

CHFbn CHFbn CHF CER

Pharmaceuticals Division 9.0 9.2 -1 4

Diagnostics Division 2.5 2.4 2 7

Roche Group 11.5 11.6 -1 5

Page 5: Innovation and growth - Roche

Q1 2014: Both Divisions growing in all regions

5

0

1

2

3

4

5

Japan International Europe US

Diagnostics

Pharma+3%

+5%

+1%

+19%

+3%

+11%

+7%

+10%

CHFbn

+4%

+5%

+17%

+3%

All growth rates at constant exchange rates

Page 6: Innovation and growth - Roche

16.3 16.6 15.1

17.2 17.9

33.2% 34.9% 35.6%

37.7% 38.3%

2009 2010 2011 2012 2013

+8%1

1 At constant exchange rates

Group operating profit and margin

6

CHFbn

% of sales

Page 7: Innovation and growth - Roche

2014 Outlook

7 1At constant exchange rates

Group sales growth1 Low- to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

Page 8: Innovation and growth - Roche

Performance update

Great science and differentiated drugs

Summary

8

Page 9: Innovation and growth - Roche

Best science: Roche, a leading portfolio

9

MabThera

Xeloda

Herceptin

Perjeta

anti-PDL1

Beta s. PI3K2

Kadcyla

Oncology

Avastin

BCL2i

8 phase II

Gazyva

Mabthera RA

Actemra

Lucentis

Immunology/

Inflammation

1 phase II

lebrikizumab

Neuroscience

ocrelizumab

Strong and growing Strongly emerging Earlier stage

lampalizumab2

10 drugs launched

6 Phase III 4 drugs launched

4 Phase III

4 phase II

Xolair

etrolizumab1

gantenerumab

2 Phase III

Tarceva

Zelboraf

Erivedge

1 FPI expected 1H 2014; 2 Phase III decision pending

Launched

Phase III

Phase II

cobimetinib (MEKi)

Oral octreotide MetMab (onartuzumab)

Pictilisib2

Page 10: Innovation and growth - Roche

Best science: Integrated biomarker expertise

Generics

Differentiation

MedTech

OTC

Pre

miu

m f

or

inn

ova

tio

n

Dia Pharma

Focus

Personalized Healthcare at Roche

• Supports development of medically

differentiated therapies

• PHC strategy applied to vast majority of

pipeline molecules

• Leverage fully integrated biomarker and

diagnostic expertise

10

Page 11: Innovation and growth - Roche

Best Science: Tremendous # of possible combos

Key to have strong foundation in science to focus

11

ALK

Bcl-2

BCR

BRAF

CD20

CD22

CD79b

CD40

EGFR

HER2

Hormone

HP

IDO

IGFR1

Immuno

JAK

MAPK

MDM2

MEK

OX40

NaPi2b

PARP

PI3K

VEGF

ALK

Bcl-

2

BC

R

BR

AF

CD

20

CD

22

CD

79b

CD

40

EG

FR

HER

2

Horm

on

e

HP

IDO

IGFR

1

Imm

un

o

JAK

MA

PK

MD

M2

MEK

OX

40

NaP

i2b

PA

RP

PI3

K

VEG

F

Strategy 1: Try everything

• High cost approach

Strategy 2: Focus on the most

promising combinations

• Requires scientific expertise and

smart development

Hypothetical Example MoAs

Page 12: Innovation and growth - Roche

Best science: Cancer immunotherapy at Roche

Pipeline overview

12

Anti-PDL1 trials

Start planned for 2014

Stimulator

Inhibitor

Phase I

Anti-PDL1

Solid tumors

Anti-PDL1+Avastin

Solid tumors

Anti-PDL1+cobimetinib

Solid tumors

Anti-PDL1+Zelboraf

Met. Melanoma

Anti-PDL1+Tarceva

NSCLC

Anti-PDL1 + immune m.

Solid tumors

Anti-PDL1 + Gazyva

Heme tumors

CSF1R huMAb

CEA IL-2v

Phase II

Anti-PDL1

NSCLC (Dx+)

Anti-PDL1

NSCLC

Anti-PDL1+Avastin

Renal

Anti-PDL1

Bladder

Anti-PDL1

NSCLC 2/3 L

Phase III

Anti-PDL1

Bladder

Pre-clinical

ImmTAC

Neg. Regulator NME 1

Anti-cytokine NME 2

T-cell bispecific

IMA 942

Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov

Anti-OX40

Anti-CD40

INO-5150

Page 13: Innovation and growth - Roche

Urothelial bladder carcinoma (UBC)

High unmet need for patients with advanced disease

13

• US: 74, 690 new cases diagnosed p.a.1

• Metastatic UBC prognosis:

– 5-year OS ~17%

– 1L median OS: 9.3 months2

– 2L median OS: 6.9 months3

• US: no therapies approved for patients

who relapse on Pt-based chemo

Sources: 1 Siegel R, CA Cancer J Clin 2014; 64:9-29 2De Santis et al, JCO, 2012, Vol. 30, No.2, p.191-199, 3 Bellmunt J et al, JCO , 2009, Vol. 27, No 27, p.4454-4461

Galsky et. al. 2013

New therapies in RCC,

prostate and bladder cancer

UBC

RCC

Prostate cancer

No

. o

f d

rug

s a

pp

rove

d b

y F

DA

Year

Page 14: Innovation and growth - Roche

MPDL3280A (anti-PDL1) in metastatic UBC

Response by PD-L1 IHC status

• 2 complete responses in the IHC 2 / 3 cohort

• 16 of 17 responding patients had ongoing responses at the time of data cut-off

14 * Patients with complete responses. Patients with a CR had 100% reduction of the target lesions due to lymph node target lesions. All lymph nodes returned to

normal size as per RECIST v1.1.IC; tumor-infiltrating immune cells.Best response is not known for 7 patients.

IHC 0 < 1% of ICs PD-L1-positive; IHC 1 ≥ 1% but < 5%; IHC 2 ≥ 5% but < 10%; IHC 3 ≥ 10%.

Patients dosed by Nov 20, 2013 with a baseline tumor assessment. Clinical data cut-off was Jan 1, 2014.

PD-L1 IHC (n)

ORR (95% CI)

Dx+ vs Dx- ORR

(95% CI)

IHC 3 (n=10) 50% (22-78) 43% (26-63)

IHC 2 (n=20) 40% (22-64)

IHC 1 (n=23) 13% (4-32) 11% (4-26)

IHC 0 (n=12) 8% (0.4-35)

Page 15: Innovation and growth - Roche

Anti-PDL1 in metastatic non-small cell lung

cancer (mNSCLC)

15

Primary end-point: ORR

FPI Q2 2013

Data expected end ‘14

Primary end-point: OS

FPI Q3 2013

Enrollment complete

15

All comers 2,3L NSCLC

n = 850

Docetaxel

75 mg/m2 IV Q3 wk

Anti-PDL1

1200 mg IV Q3 wk

OAK: Phase III 2/3L mNSCLC

Primary end-point: OS

FPI Q1 2014

FIR: Phase II Dx-positive advanced mNSCLC

PDL1-positive

NSCLC n = 130

Anti-PDL1 1200 mg IV

Q3 weeks

All comers 2,3L NSCLC

n = 287

Docetaxel

75 mg/m2 IV Q3 wk

Anti-PDL1

1200 mg IV Q3 wk

POPLAR: Phase II 2/3L mNSCLC

BIRCH: Phase II Dx-positive advanced mNSCLC

PDL1-positive

NSCLC

n = 300

Anti-PDL1 1200 mg IV

Q3 weeks

Primary end-point: ORR

FPI Q1 2014

Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov

Phase III trials in first line NSCLC in preparation

Page 16: Innovation and growth - Roche

MPDL3280A (anti-PDL1) development

Readouts over the next 12 months

16 Outcome studies are event driven, timelines may change

Study Indication Readout

Anti-PDL1 as single agent

Phase I New tumor type First readout

Lung Follow-up data

Renal Follow-up data

Bladder Follow-up data

Melanoma Follow-up data

Phase II (FIR) NSCLC (PD-L1+) First readout

Phase II (POPLAR) 2/3L NSCLC First readout

Anti-PDL1 in combination

Phase Ib Multiple tumor types First readout

Page 17: Innovation and growth - Roche

Strategies beyond great medicines

Hematology

17

MabThera

BCL-2i

ADCs

ADC 79b

ADC 22

Replace

Extend

Replace and extend

CLL11

GOYA

GALLIUM

GADOLIN

Murano (CLL)

Romulus (NHL)

Chemo

MabThera

BCL-2i

ADCs

ADC 79b

ADC 22

Phase Ib CLL(G+Bcl-2)

Gazyva Gazyva

Me

dic

al valu

e

Bcl-2 i. in collaboration with AbbVie (ABT 199)

Page 18: Innovation and growth - Roche

Bcl-2 inhibitor (GDC-0199)+R in R/R CLL

Efficacy in combining with an anti-CD 20 antibody

18 In collaboration with AbbVie (ABT 199). Shuo Ma, ASCO 2014, abstract #7013, R: rituximab. MRD: minimal residual disease (PB or BM)

Best % change from baseline in Lymphocyte Count

* Evaluable pts have reached the month 7 bone marrow

assessment, discontinued, or progressed on therapy

Response Evaluable*

n=25

Response rate 21 (84%)

Complete response 9 (36%)

Partial response 12 (48%)

Stable disease 1 (4%)

Disease progression 1 (4%)

Discontinued prior to

assessment 2 (8%)

• High level of complete response and MRD (6/8 CR, 75%)

• Results supported move into phase III (MURANO) study in R/R CLL

Page 19: Innovation and growth - Roche

Bcl-2 inhibitor (GDC-0199) +R in R/R CLL

Encouraging duration of response

19 In collaboration with AbbVie (ABT-199). Shuo Ma ASCO 2014, abstract # 7013

R/R CLL: relapsed/refractory chronic lymphocytic leukemia. SE: safety expansion

Months on Study

AB

T-1

99 C

oh

ort

Do

se

0 5 10 15 20 25

200 mg

300 mg

400 mg

500 mg

600 mg

400 mg SE

Most patients are still progression-free, even those on lower doses

Months on study

AB

T-1

99

co

ho

rt d

ose

Page 20: Innovation and growth - Roche

Bcl-2 inhibitor (GDC-0199)

Safety update

20

• No further clinical TLS1 cases since program restart (120 new patients

treated)

• New revised monitoring agreed with FDA:

– No hospitalization for low/ medium risk patients

– Hospitalization for high risk patients2: at treatment initiation and

first escalation one week later

In collaboration with AbbVie (ABT-199). 1TLS: Tumor lysis syndrome. 2High risk is currently defined at those patients who have large tumors (10+ cm) and those patients who have

tumors 5-10 cm and high circulating lymphocyte counts

Page 21: Innovation and growth - Roche

Pre-clinical Phase I Phase II Phase III

Polatuzumab vedotin

anti-CD79b-ADC

Gazyva

ADC (RG7598)

MabThera/Rituxan

GDC-0199*

BCL-2 inhibitor

MDM2 antagonist

Anti-PDL1

ADC=Antibody-Drug Conjugate; AML=Acute Myeloid Leukemia; CLL=Chronic Lymphocytic Leukemia; NHL=Non-Hodgkin’s Lymphoma;

*Co-development molecule with AbbVie

Approved

RG7845

T-Cell Dependent Bi-

specific (TDB) AB, PIM,

CD44, Others

Erivedge

NHL

MM

NHL, CLL, MM, AML

NHL, CLL approved

CLL approved in US; ongoing in NHL

AML and solid tumors

Heme Malignancies & solid tumors

Heme malignancies

Heme malignancies

AML, solid tumors

21

Roche hematology: Entering new treatment

areas and extending benefit in existing ones

Page 22: Innovation and growth - Roche

Immunology and Ophthalmology

New late-stage compounds in a well-established franchise

22

1,191 1,037 874 790 572 1,689

MabThera/

Rituxan RA

Actemra/

RoActemra RA

CellCept Transplant

Xolair Asthma

Pulmozyme Cystic fibrosis

Lucentis Macular

degeneration

Others

Growing existing franchise (CHF 6.3bn) Developing pipeline

CHFm

lampalizumab

geographic atrophy

etrolizumab

ulcerative colitis and

Crohn’s disease

lebrikizumab

asthma

quilizumab (M1 prime)

asthma

2012

2013

Phase III Phase II

+12%

oral octreotide

acromegaly

Page 23: Innovation and growth - Roche

Entering new Therapeutic Areas

Lampalizumab in Geographic Atrophy (GA)

23

AMD

(Drusen)

Extrafoveal GA Advanced GA

Page 24: Innovation and growth - Roche

Lampalizumab: Anti-factor D

24

High efficacy in subpopulation with exploratory biomarker

• GA progression rate decreased by 44% at 18 months.

• In the subset of patients with better vision (20/50 to 20/100),

progression was reduced by 54%

• All comers: 20.4 % reduction rate at 18 months

Safety

• No unexpected or unmanageable SAEs

• Intraocular inflammation AE rates and intraocular pressure elevation

AE rates were consistent with Lucentis rates in wAMD

MAHALO study, presented at ASRS 2013, SAE= Serious Adverse Events

Page 25: Innovation and growth - Roche

Innovative business models: Tailored access

Developed Markets - access through innovative pricing

Pack based pricing Value based pricing

Need for data from healthcare systems

Undifferentiated

$$ by vial

Today Future

Combinations

Indication based

+

Episode-of-care

based

Personalized

Reimbursement

Models

25

Page 26: Innovation and growth - Roche

Note: Incremental patients treated are current estimates based upon available new patient starts data through YE 2013

Differential Pricing

>1,900 more patients treated

since 2013

Access to the public

reimbursement

+

Patient Assistance

Programs

>24,000 more patients treated

since 2011

Partnership with Cancer

Foundation, Ministry of

Health

+

17

Innovative business models: Tailored Access

Developing Markets – multiple approaches

Examples of Approaches

• Multiple approaches to

ensure access to

medicines in emerging

markets

• No ‘one-size fits all’

solution – depends on

market characteristics

and segments

Page 27: Innovation and growth - Roche

Performance update

Great science and differentiated drugs

Summary

27

Page 28: Innovation and growth - Roche

2H 2014: Upcoming clinical newsflow

ESMO

Madrid

Sep 26 - Sep 30

ENDO

Chicago

June 21-24

AAIC

Copenhagen

July 12-17

Oral octreotide

Ph III, Acromegaly

Crenezumab

Ph II, Alzheimer’s

Disease

Multiple oncology

assets

Neuroscience Oncology Immunology

Page 29: Innovation and growth - Roche

Focus on innovation and growth

1

2 Strong growth facilitated by tailored access models

3 Leading product pipeline providing value for the future

Strategic focus on innovation

29

Page 30: Innovation and growth - Roche

Doing now what patients need next