Turning innovation into patient benefit

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Transcript of Turning innovation into patient benefit

Page 1: Turning innovation into patient benefit
Page 2: Turning innovation into patient benefit

Turning innovation into patient benefit

Severin Schwan, CEO Roche Group London, September 2016

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

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

‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy,

goals, plans or intentions. Various factors may cause actual results to differ materially in the future

from those reflected in forward-looking statements contained in this presentation, among others:

1 pricing and product initiatives of competitors;

2 legislative and regulatory developments and economic conditions;

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

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

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

products;

6 increased government pricing pressures;

7 interruptions in production;

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

9 litigation;

10 loss of key executives or other employees; and

11 adverse publicity and news coverage.

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

Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the

historical published earnings or earnings per share of Roche.

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

www.roche.com

All mentioned trademarks are legally protected 3

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Performance update

Innovation and differentiation

Improving the standard of care

Outlook

4

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Q2 2016: Sales growth for fifth consecutive year

5

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5% 6%

5%

7%

6%

4% 4%

6%

0%

2%

4%

6%

8%

10%

Q1

12

Q2

12

Q3

12

Q4

12

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Q2

15

Q3

15

Q4

15

Q1

16

Q2

16

All growth rates at Constant Exchange Rates (CER)

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38.5%

40.7% 41.0%39.2% 39.4%

8.69.5 9.4 9.2

9.9

HY 2012 HY 2013 HY 2014 HY 2015 HY 2016

+5% at CER

HY 2016: Strong core operating profit & margin

6

% of sales

CHFbn

CER=Constant Exchange Rates

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Continued leadership in innovation

Launches at historical high

2011 2012 2013 2014 2015 2016

OCREVUS

5 NME launches in a year

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Performance update

Innovation and differentiation

Improving the standard of care

Outlook

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Roche strategy: Focused on medically

differentiated therapies

9

Generics

Differentiation

MedTech

OTC

Pre

miu

m f

or

inn

ova

tio

n

Dia Pharma

Focus

Regulators: Optimised benefit / risk ratio

Payors: Optimised benefit / cost ratio

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Approach towards innovation

Rigorous prioritisation…

We select at late stage entry…

Clinical differentiation

Threshold

high low

low

high

Me

dic

al n

ee

d

Illustrative

…to increase sales potential

10

Greater

differentiation Sa

les

Time

Continued Disqualified

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Approach towards innovation

… and exploring broad

We invest more early stage… …to increase options to choose from

46% 40%

54% 60% R & Early D

Roche

Late D

Industry avg

11

18 19

2014 2012 2013

# of NMEs entering Pre-clinical

Industry

avg.

% of budget

External sources: Investment split based on the CMR Pharmaceutical R&D Factbook (data from 10 companies, 2014);

Number of entries into Pre-clinical for Industry based on data from KMR, data for 2011-2013. 11

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Cancer immunotherapy - Pillars of early R&D

Preserving cultures – increasing collaboration

12

aOX40

aTIGIT

aCD20/CD3 TCB 1

IDOi

aCD40

emactuzumab

aCEA/CD3 TCB

vanucizumab

aCEA-IL2v FP

aFAP-IL2v FP

aCD20/CD3 TCB 2

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Performance update

Innovation and differentiation

Improving the standard of care

Outlook

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Cotellic + Zelboraf

BRAFmut melanoma

Venclexta

R/R CLL with 17p del

OCREVUS

RMS/ PPMS

Emicizumab (ACE910)

Hemophilia A

Tecentriq

2L+ bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY)

Tecentriq+Avastin+chemo

1L NSCLC

Gazyva

R/R iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Tecentriq + Avastin

1L RCC

NM

Es

line

ext

ensi

ons

2016 2017 2018

Actemra

Giant cell arteritis (GiACTA)

Alecensa

1L ALK+ NSCLC

Tecentriq

2/3L lung cancer

Gazyva

1L iNHL (GALLIUM)

2016 onwards: Significant launch activities

Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.

FDA Breakthrough

Therapy Designation

Oncology/

hematology Neuroscience Ophthalmology Immunology

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Cotellic + Zelboraf

BRAFmut melanoma

Venclexta

R/R CLL with 17p del

OCREVUS

RMS/ PPMS

Emicizumab (ACE910)

Hemophilia A

Tecentriq

2L+ bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY)

Tecentriq+Avastin+chemo

1L NSCLC

Gazyva

R/R iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Tecentriq + Avastin

1L RCC

2016 2017 2018

Actemra

Giant cell arteritis (GiACTA)

Alecensa

1L ALK+ NSCLC

Tecentriq

2/3L lung cancer

Gazyva

1L iNHL (GALLIUM)

2016 onwards: Significant launch activities

Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 15

FDA Breakthrough

Therapy Designation

Oncology/

hematology Neuroscience Ophthalmology Immunology

NM

Es

line

ext

ensi

ons

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Tecentriq clinical program in 2/3L NSCLC

Breakthrough designation in PD-L1+ patients

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Response Rates

All comers 2/3L mNSCLC n=1100

PD-L1 stratified

Tecentriq 1200 mg IV Q3

weeks

Docetaxel 75 mg/m2 IV Q3

weeks

OAK Phase III

Overall Survival

PD-L1-selected

mNSCLC n=138

Tecentriq

1200 mg IV Q3 weeks

POPLAR Phase II

Overall Survival All comers

2/3L mNSCLC n=287

PD-L1 stratified

atezolizumab

1200 mg IV Q3 weeks

Docetaxel 75 mg/m2 IV Q3

weeks

BIRCH Phase II PD-L1-selected

mNSCLC n=667 Tecentriq

1200 mg IV Q3 weeks Response Rates

Note: Atezolizumab (Anti-PD-L1) is listed as MPDL3280A in clinicaltrials.gov

mNSCLC = metastatic Non Small-Cell Lung Cancer

Primary end-point:

FIR Phase II

Tecentriq 1200 mg IV Q3

weeks

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Significant variability in response to cancer

immunotherapy treatment

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MONOTHERAPY

DURABLE RESPONSES (PR/CR)

STABLE DISEASE (SD)

PROGRESSIVE DISEASE (PD)

* Urinary Bladder Cancer Phase 1, PR= partial responses, CR= Complete Responses

Tecentriq UBC: IC2/3

0 4 6 8 10 14 18 16 12 2

100

0

-100

Change in S

LD

Fro

m B

ase

line, %

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The seven steps of the Cancer-Immunity Cycle

guide our prioritisation framework for Tecentriq

Chen and Mellman. Immunity 2013 18

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Different tumours show different immune

phenotypes and will need different solutions

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CD8+ T cells absent

from tumour and periphery

CD8+ T cells accumulated but not

efficiently infiltrated

CD8+ T cells infiltrated,

but non-functional

Increase number of

antigen-specific T-cells or increase

antigen presentation

Bring T-cells in contact

with cancer cells

Accelerate or remove brakes on

T-cell response

Inflamed Immune Desert Immune Excluded

Lung Bladder TNBC Colorectal Gastric Ovarian Melanoma

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A rich pipeline: We are investigating into multifold

approaches across tumour phenotypes

* Dual roles in T eff activation and T reg inhibition suggest OX40 activity in both desert and inflamed phenotypes;

IND=new investigational drug application; TBA=to be announced

MEKi (e.g., Cotellic)

Chemo

Targeted (e.g., Tarceva, Herceptin)

aVEGF (Avastin)

aPDL1 (Tecentriq)

IDOi

aCSF1R

aTIGIT

Ph1b

Marketed

Marketed Ph2

Ph1b

Ph1b

Marketed

Marketed

Marketed

aOX40*

aCEA-IL2v FP

aCEA/CD3 TCB

Ph1b

Ph1b

aCD20/CD3 TCB 1

aCD20/CD3 TCB 2

TBA IND (2017)

TBA IND (2017)

TBA

TBA

Ph1b aCD40

Ph1b aFAP-IL2v FP

IND (2017)

IND (2017)

Ph1b

aAng2/VEGF Ph2

Ph1b

aOX40* Ph1b

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DESERT

Activate

EXCLUDED

Recruit / Infiltrate

INFLAMED

Kill Cancer Cells

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Cancer immunotherapy: In the near future,

nine NMEs will be reading out*

NME=new molecular entity; *Timing based LPI or estimates from FPI and are subject to change; “data” indicates full data availability (vs interim readout)

NME / Combo

vanucizumab

aCEA/CD3 TCB

aCSF1R + Tecentriq

aCD40 + Tecentriq

aOX40

aFAP-IL2 FP

aCEA/CD3 TCB

aOX40 + Tecentriq

vanucizumab + Tecentriq

aCEA-IL2v FP + Tecentriq

aCEA/CD3 TCB + Tecentriq

IDOi + Tecentriq

aTIGIT + Tecentriq

aCD40 + aCSF1R

aCD20/CD3 TCB 1

aCD40 + vanucizumab

2016 2017

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Combinations: Roche with broadest portfolio of

targeted and CIT agents

ALK

Akt

Bcl-2

BCR-ABLi

BET

BRAF

CD20

CD79b

Chk1

EGFR 1 1

ERK

HER2

LSD1

MDM2

MEK

PI3K

SERD

SLAMF7

VEGF

VEGF/Ang2

Launched In development (Ph 1-3)

Ta

rge

ted

Ag

en

ts

aCD40

aCEA-CD3

aCD20-CD3

aCEA-IL2v FP

aFAP-IL2v FP

aIL-8

aIL-10

aCTLA-4

aOX40

aCD137

aGITR

aCD73

aCEACAM1

aCXCR4

aPD-1

aPD-L1

CSF-1R

IDOi/TDOi

aTIGIT

aLAG-3

aKIR

CIT

Mo

lec

ule

s

NN NN NN NN

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emactuzumab

cergutuzumab

amunaleukin

aOX40

aCD40

IDOi

aCEA/CD3 TCB

aFAP-IL2v FP

Immunotherapy portfolio

vanucizumab

aCD20/CD3 TCB

aTIGIT

chemo chemo

taselisib

SERD

ipatasertib

chemo

Launched portfolio

azacitidine

polatuzumab

vediotin daratumumab

lenalidomide

idasanutlin

emactuzumab (aCSF-1R); cergutuzumab amunaleukin (aCEA-IL2v FP); vanucizumab (aAng2/VEGF); polatuzumab vediotin (aCD79b ADC); taselisib (PI3Ki); ipatasertib (AKTi); SERD (selective estrogen receptor degrader); idasanutlin (MDM2

antagonist); Venclexta in collaboration with AbbVie; Gazyva in collaboration with Biogen; Alecensa in collaboration with Chugai; Cotellic in collaboration with Exelixis; Zelboraf in collaboration with Plexxikon; polatuzumab in collaboration with Seattle

Genetics; ipatasertib in collaboration with Array Biopharma; IDOi in collaboration with NewLink; daratumumab in collaboration with Janssen (J&J)

Status: June 2016

Maximising value: Novel assets and combinations

Combination in development

Combination approved

Roche NME late stage

Roche NME early stage

Non-Roche apporved drugs

Chemo combination approved

Chemo combination in development

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Cotellic + Zelboraf

BRAFmut melanoma

Venclexta

R/R CLL with 17p del

OCREVUS

RMS/ PPMS

Emicizumab (ACE910)

Hemophilia A

Tecentriq

2L+ bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY)

Tecentriq+Avastin+chemo

1L NSCLC

Gazyva

R/R iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Tecentriq + Avastin

1L RCC

2016 2017 2018

Actemra

Giant cell arteritis (GiACTA)

Alecensa

1L ALK+ NSCLC

Tecentriq

2/3L lung cancer

Gazyva

1L iNHL (GALLIUM)

2016 onwards: Significant launch activities

Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 24

FDA Breakthrough

Therapy Designation

Oncology/

hematology Neuroscience Ophthalmology Immunology

NM

Es

line

ext

ensi

ons

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Ocrelizumab: Active in both RMS & PPMS

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RMS=relapsing forms of multiple sclerosis (MS) which includes patients with RRMS and SPMS with superimposed relapses; RRMS=relapsing-remitting MS; SPMS=secondary progressive MS; PPMS=primary progressive MS;

RM

S

PP

MS

• Selective depletion of a B cell subset leaving

the ability to generate new B cells intact

• Administered IV twice yearly

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Performance update

Innovation and differentiation

Improving the standard of care

Outlook

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Positive outlook

Strong pipeline enabling continuous growth

2014 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E 2023E

Marketed

products

Sales

Pipeline

Biosimilars

MabThera, Herceptin, Avastin

NME launches

Tecentriq, Venetoclax, Alectinib, Cotellic, Ocrelizumab,

ACE910, Lampalizumab

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2016 outlook

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Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend in Swiss francs

1 At Constant Exchange Rates (CER)

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Doing now what patients need next

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Appendix

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Biomarker analysis of Tecentriq yielding insights

about phenotypes and combination framework…

31 Modified from Hegde PS et al. (2016) Clin Canc Res

Inflamed Non-Inflamed

Convert to inflamed phenotype with combinations Respond favorably to

checkpoint inhibition

Mutational Load

TILs

CD8 T cells/IFNg

PD-L1 & checkpoints

Angiogenesis Reactive stroma

MDSCs

Proliferating Tumors / Low Class I

IMMUNE DESERT

CD8+ T cells

are absent

from tumor and

its periphery

IMMUNE EXCLUDED

CD8+ T cells

accumulated but

have not efficiently

infiltrated

INFLAMED

CD8+ T cells

infiltrated,

but non-

functional

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A rich pipeline: Program by tumor type

As of July 21, 2016

= approved; *External collaborations; Other CIT NMEs besides Tecentriq 32

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Breakthrough designation impacting cycle times

Shortest interval duration of all FDA designations

1.0

1.0

0.9

1.1

2.3

1.9

1.7

1.5

3.3

2.3

0.7

0.5

0.7

0.5

0.6

1.0

Accelerated review

Fast track

No designation 7.5

Breakthrough therapy 3.6

5.8

3.8

Source: Thomson Reuters Cortellis Competitive Intelligence for all a FDA approvals where milestone information is available 2012-2015.

Phase 3 cycle time is defined from phase 3 FPI to submission; which may for the two latter designations happen before phase 3 finishes.

Phase 2 Phase 1 Phase 3 Filing

Phase duration (years)

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