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Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer London, September 2015

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Page 1: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer

London, September 2015

Page 2: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

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 2

Page 3: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Performance update

Improving the standard of care

Outlook

3

Page 4: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Q2 2015: Sales growth for fifth consecutive year

4 All growth rates at Constant Exchange Rates (CER)

0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

7%

0%

2%

4%

6%

8%

10%

Q111

Q211

Q311

Q411

Q112

Q212

Q312

Q412

Q113

Q213

Q313

Q413

Q114

Q214

Q314

Q414

Q115

Q215

Page 5: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

HY 2015: Strong underlying Group core operating profit & margin

5

% of sales

CHFbn

CER=Constant Exchange Rates * Excluding sale of filgrastim rights in 2014 at CER

8.3 8.6 9.5 9.4 9.2

38.1% 38.5%

40.7% 41.0%

39.2%

HY 2011 HY 2012 HY 2013 HY 2014 HY 2015

+2% at CER (+7%*)

(+0.4%p excl. filgrastim*)

Page 6: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

2014: Dividend and payout ratio further increased

6 1 compound annual growth rate

8.00

31.9 34.5

38.8

44.8 48.6

51.6

55.3

54.5

54.7 56.0

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00

10.00

1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014

Dividend payout ratio (%) CHF

2014 payout ratio: 56.0%

Payout ratio calculated as dividend per share divided by core earnings per share (diluted); Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996

Page 7: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Performance update

Improving the standard of care

Outlook

7

Page 8: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Roche strategy: Focused on medically differentiated therapies

8

Generics

Differentiation

MedTech

OTC Prem

ium

for

inno

vatio

n

Dia Pharma

Focus

Regulators: Optimised benefit / risk ratio

Payors: Optimised benefit / cost ratio

Page 9: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Roche’s approach in specialty care: First and best in class necessary for success

Market share*

Years post launch

Undifferentiated products Modest differentiation Medical breakthroughs

Data source: Evaluate Pharma, Decision Resources, Roche/Genentech PMR launch trackers

Note: *Market shares represent either % sales of target product relative to sales competing products in similar indications or patient shares from Roche PMR trackers; sales data are actuals (≤ 2013) + consensus broker forecasts (2013-2020) where applicable 9

Page 10: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Roche: Making progress in advancing patient care Recognising innovation 2013-15

10

Rank Company #

1 Roche 9

2 GSK 5

2 Novartis 5

3 Merck 4

3 JNJ 4

3 BMS 4

9 Breakthrough Therapy Designations

YTD 2015

Actemra (Systemic sclerosis) Venetoclax (R/R CLL 17p) Atezolizumab (NSCLC) ACE 910 (Hemophilia)

2014 Esbriet (IPF)

Lucentis (DR) Atezolizumab (bladder)

2013 Alectinib (2L ALK+ NSCLC)

Gazyva (1L CLL)

Source: http://www.focr.org/breakthrough-therapies; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy

Page 11: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component

11

Marketed Phase 2 Phase 3/Registration

FIXa/FX bispecific MAb

SERD

CSF-1R MAb

Ang2-VEGF MAb

ipatasertib

polatuzumab vedotin

lifastuzumab vedotin

glypican-3 MAb

MAO-B inh

GABRA5 NAM

bitopertin

basimglurant

V1 receptor antag

crenezumab

olesoxime

danoprevir

Flu A MAb

LptD antibiotic

PD-L1 MAb

venetoclax (Bcl-2 inh)

alectinib (ALK inh)

taselisib

cobimetinib

lebrikizumab

etrolizumab

gantenerumab

ocrelizumab

lampalizumab

Tarceva®

Zelboraf®

Erivedge®

Rituxan®

Gazyva®

Herceptin®

Perjeta®

Kadcyla®

Avastin®

Xeloda®

Esbriet®

Pulmozyme®

Xolair®

Actemra®

Lucentis®

Oncology Immunology Infectious Diseases Neuroscience Ophthalmology

Molecular Diagnostics

Tissue Diagnostics

Professional Diagnostics

Page 12: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component

12

Marketed Phase 2 Phase 3/Registration

FIXa/FX bispecific MAb

SERD

CSF-1R MAb

Ang2-VEGF MAb

ipatasertib

polatuzumab vedotin

lifastuzumab vedotin

glypican-3 MAb

MAO-B inh

GABRA5 NAM

bitopertin

basimglurant

V1 receptor antag

crenezumab

olesoxime

danoprevir

Flu A MAb

LptD antibiotic

PD-L1 MAb

venetoclax (Bcl-2 inh)

alectinib (ALK inh)

taselisib

cobimetinib

lebrikizumab

etrolizumab

gantenerumab

ocrelizumab

lampalizumab

Tarceva®

Zelboraf®

Erivedge®

Rituxan®

Gazyva®

Herceptin®

Perjeta®

Kadcyla®

Avastin®

Xeloda®

Esbriet®

Pulmozyme®

Xolair®

Actemra®

Lucentis®

Oncology Immunology Infectious Diseases Neuroscience Ophthalmology

Molecular Diagnostics

Tissue Diagnostics

Professional Diagnostics

Page 13: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

POPLAR: Atezolizumab increased OS by 7.7 mo in IC2/3 or TC2/3 subgroup

13 aUnstratified HR. Data cut-off May 8, 2015.

TC3 or IC3 (n = 47) HRa = 0.49 (0.22, 1.07)

P value = 0.068

TC2/3 or IC2/3 (n = 105) HRa = 0.54 (0.33, 0.89)

P value = 0.014

TC1/2/3 or IC3 (n = 195) HRa = 0.59 (0.40, 0.85)

P value = 0.005 HRa = 1.04 (0.62, 1.75)

P value = 0.871

TC0 and IC0 (n = 92)

Median 15.5 mo (9.8, NE)

Median 11.1 mo (6.7, 14.4)

Median 7.4 mo (6.0, 12.5)

Median 9.7 mo (6.7, 12.0)

Median 9.7 mo (8.6, 12.0)

Median 15.5 mo (11.0, NE)

Median 9.2 mo (7.3, 12.8)

Atezolizumab Docetaxel Censored +

Median 15.1 mo (8.4, NE)

Page 14: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Atezolizumab and chemo-combos Deep and ongoing effects

14 Includes all patients dosed by 10 Nov 2014; data cut-off: 10 Feb 2015; SLD, sum of longest diameters; *PD for reasons other than new lesions

Arm C – cb/pac (n=8) Arm D – cb/pem (n=17) Arm E – cb/nab (n=16)

Max

imum

SLD

redu

ctio

n fr

om

base

line

(%)

100

50

0

–50

–100

–16 –22 –23 –25

–43 –45

–64

–84

Complete response Partial response Progressive disease Stable disease

0 42 84 126 168

Time on study (days)

210 252 294 336 378 420 450

–100

–80

–60

–40

–20

0

20

40

60

80

100 PD (n=2) PR/CR (n=9) SD (n=4) Progression* Discontinued New lesion

Chan

ge in

SLD

from

bas

elin

e (%

)

Max

imum

SLD

redu

ctio

n fr

om

base

line

(%)

100

50

0

–50

–100

9 –7 –12

–31 –31 –38 –41 –42 –47 –50 –53 –57 –57 –57 –58 –69

Max

imum

SLD

redu

ctio

n fr

om

base

line

(%)

100

50

0

–50

–100

11 9 –17

–21 –21 –22 –43

–67 –72 –72 –76

–86 –87 –100 –100

0 42 84 126 168

Time on study (days)

210 252 294 336 378 420 450

–100

–80

–60

–40

–20

0

20

40

60

80

100

Chan

ge in

SLD

from

bas

elin

e (%

)

PD (n=2) PR/CR (n=13) SD (n=1) Progression* Discontinued New lesion

Chan

ge in

SLD

from

bas

elin

e (%

)

0 42 84 126 168

Time on study (days)

210 252 294 336 378 420 450

–100

–80

–60

–40

–20

0

20

40

60

80

100 PR/CR (n=4) SD (n=4) Progression* Discontinued New lesion

Complete response Partial response Progressive disease Stable disease

Complete response Partial response Progressive disease Stable disease

Page 15: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

The 7 steps of the Cancer-Immunity Cycle guide our prioritization framework for Atezolizumab

Step 1: Release of Cancer Cell antigens: - ex: Atezo + chemo, Gazyva, aCD40

Step 2 & 3: Cancer antigen presentation & priming and activation - ex: Atezo + interferon, OX40

Steps 4 & 5: Trafficking & inflitration of T cells to tumours - ex: Atezo + Avastin, aCSF1R,

Steps 6 & 7: Recognition of cancer cells by T cells & killing of cancer cells - ex: Atezo + Meki, IDOi, aOX40

Chen and Mellman. Immunity 2013 15

Page 16: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component

16

Marketed Phase 2 Phase 3/Registration

FIXa/FX bispecific MAb

SERD

CSF-1R MAb

Ang2-VEGF MAb

ipatasertib

polatuzumab vedotin

lifastuzumab vedotin

glypican-3 MAb

MAO-B inh

GABRA5 NAM

bitopertin

basimglurant

V1 receptor antag

crenezumab

olesoxime

danoprevir

Flu A MAb

LptD antibiotic

PD-L1 MAb

venetoclax (Bcl-2 inh)

alectinib (ALK inh)

taselisib

cobimetinib

lebrikizumab

etrolizumab

gantenerumab

ocrelizumab

lampalizumab

Tarceva®

Zelboraf®

Erivedge®

Rituxan®

Gazyva®

Herceptin®

Perjeta®

Kadcyla®

Avastin®

Xeloda®

Esbriet®

Pulmozyme®

Xolair®

Actemra®

Lucentis®

Oncology Immunology Infectious Diseases Neuroscience Ophthalmology

Molecular Diagnostics

Tissue Diagnostics

Professional Diagnostics

Page 17: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

17

Secondary Progressive (SPMS) (20-25%) Initial RRMS followed by disability accumulation. Still experience relapses which eventually stop

Primary Progressive (PPMS) (10-15%) Slow but nearly continuous worsening of disease from outset (no relapses)

Relapse-Remitting (RRMS) (60-65%) Clearly defined relapses (attacks) with remissions initially returning to baseline but gradually result in sustained disability

Three major types of Multiple Sclerosis

Dis

abili

ty

Time

Relapse No Relapse

Mainly degenerative

Mainly inflammatory

Adapted from Lublin 1996, Arnold 2004

Inflammatory / Degenerative

• High unmet need: • high efficacy therapies have major

safety issues • diagnosis and classification is

difficult, often retrospective and can take 2-5 years

• Treatment decisions concentrated mainly in MS centers/hospitals

• Advocacy groups powerful in access

Page 18: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Ocrelizumab: Positive phase 3 results confirm central role of B cells in MS

18

Study Endpoint Reduction versus Rebif®

Primary Annualized Relapse Rate

Secondary

Confirmed Disability Progression

MRI endpoints

ü ü ü

Phase 3 OPERA I/II results in RMS • Superiority vs. Rebif® on primary and

major secondary endpoints achieved • Adverse events (including serious

infections) similar to Rebif®

Targeted product profile • Humanized antibody targeting CD20+ B cells • Selective depletion of a subset of B cells leaving

the ability to generate new B cells intact • Administered by IV twice yearly

SOC=standard of care; MS=multiple sclerosis; RMS=relapsing forms of MS; PPMS= primary progressive MS; Rebif® (Interferon beta-1a)

Antibody-dependent cellular cytotoxicity (ADCC)

Complement dependent cytotoxicity

(CDC)

Apoptosis

Antibody-dependent cellular phagocytosis (ADCP)

OCRELIZUMAB

Phase 3 ORATORIO in PPMS • First investigational medicines to show

efficary in PPMS

Page 19: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Multiple major pivotal trials reading out near term Significant filing and launch activities ahead

19

Year Molecule Market opportunity

Incremental infrastructure

Market characteristics

2015

Alectinib Medium Low Speciality

Cotellic/ Braf Small Low Speciality

Venetoclax Potentially large Low Speciality

Ocrelizumab Large Medium- high Speciality

Atezolizumab Large Medium Speciality

2016

Lebrikizumab Large Medium-high Specialty

APHINITY Large Low Specialty

GOYA Large Low Specialty

2017

ACE 910 Large Medium Speciality

Lampalizumab Large Medium Speciality

GALLIUM Large Low Specialty

2018

Taselisib (PI3Ki) Large Low Speciality

Idasanutlin (MDM2) Medium Low Speciality

Oncology Neuroscience Ophthalmology Immunology

Small: up to CHF 0.5 bn; medium= CHF 0.5 to CHF 1bn; large > CHF1bn

Page 20: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Performance update

Improving the standard of care

Outlook

20

Page 21: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Planned key data presentations in H2 2015

21

Vienna, 25-29 Sep

Atezolizumab • UBC: IMvigor 210 Ph II1

• NSCLC: POPLAR Ph II1,2

• NSCLC: BIRCH Ph II1 • NSCLC: Chemo combos

update2

Alectinib • ALK+NSCLC: Ph II update2

San Antonio, 8-12 Dec

Atezolizumab • TNBC: Combo with

abraxane Ph Ib (abstracts submitted)

San Francisco, 18-21 Nov

Atezolizumab • Melanoma: Combo with

Zelboraf Ph Ib (abstracts submitted)

Cobimetinib + Zelboraf • BRAF+Melanoma:

coBRIM efficacy update (abstracts submitted)

Barcelona, 7-10 Oct

Ocrelizumab • RMS: OPERA I / II Ph III • PPMS: ORATORIO Ph III

1 “Data not yet in-house; planned to be submitted to an up-coming congress”; 2 Potentially at World Conference on Lung Cancer (WCLC) 2015 UBC=Urinary Bladder Cancer; NSCLC=Non-Small Cell Lung Cancer; RMS=Relapsing forms of Multiple Sclerosis; TNBC=Triple Negative Breast Cancer

Page 22: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

2015 outlook

Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth2

Dividend outlook Further increase dividend in Swiss francs

1 At constant exchange rates 2 Excluding sale of filgrastim rights in 2014

22

Page 23: Improving the standard of care - roche.com · Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer . London, September 2015

Doing now what patients need next