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Innovation and value creation Karl Mahler, Head of Investor Relations UBS Global Healthcare Conference New York, May 2016

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Page 1: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Innovation and value creation

Karl Mahler, Head of Investor Relations UBS Global Healthcare Conference

New York, May 2016

Page 2: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

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: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Performance update

Innovation and efficiency

Improving the standard of care

Outlook

3

Page 4: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Q1 2016: Sales growth for fifth consecutive year

4

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

7%

6%

4%

4%

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

All growth rates at Constant Exchange Rates (CER)

Page 5: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Q1 2016: Solid sales growth in all regions

5

0

1

2

3

4

5

6

Japan International Europe US

Diagnostics

Pharma

CHFbn

+3%

+5% +4%

+4%

-1%

+16%

-3%

0%

+3%

+3%

+3%

+7%

All growth rates at Constant Exchange Rates (CER)

Page 6: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Roche significantly advancing patient care

Recognition for innovation 2013-present

6

Rank Company #

1 Roche 12

2 BMS 8

3 Novartis 7

3 Merck 6

3 Pfizer 6

4 GSK 5

12 Breakthrough Therapy Designations

Year Molecule

2016

Ocrelizumab (PPMS)

Venclexta (AML)

Venclexta + Rituxan (R/R CLL)

2015

Actemra (Systemic sclerosis)

Atezolizumab (NSCLC)

Venclexta (R/R CLL 17p del)

Emicizumab/ACE 910 (Hemophilia A)

2014

Esbriet (IPF)

Lucentis (DR)

Atezolizumab (Bladder)

2013 Alectinib (2L ALK+ NSCLC)

Gazyva (1L CLL)

Source: http://www.focr.org/breakthrough-therapies as at 22 March 2016; PPMS=Primary Progressive Multiple Sclerosis; CLL=Chronic

Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy

Page 7: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

2015: Strong underlying Group Core operating

profit & margin

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

35.6%

37.7% 38.3%37.2%

36.4%

15.1

17.217.9 17.6

17.5

2011 2012 2013 2014 2015

+5% at CER (+7%*)

% of sales

CHFbn

(+0.7%*)

Page 8: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

2015: Dividend and payout ratio further

increased

8 1 compound annual growth rate

8.10

31.9 34.5

38.8

44.8

48.6

51.6

55.3

54.5 54.7

56.0

60.0

0

1

2

3

4

5

6

7

8

9

10

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

Dividend payout ratio (%) CHF

2015 payout ratio: 60.0%

Payout ratio calculated as dividend per share divided by Core earnings per share (diluted); 2015 dividend as proposed by the Board of Directors;

Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996

Page 9: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Performance update

Innovation and efficiency

Improving the standard of care

Outlook

9

Page 10: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Roche strategy: Focused on medically

differentiated therapies

10

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

Page 11: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Roche’s strategy remains unchanged

Success hinges on excellence in innovation & execution

• Focus investment on differentiated molecules

• Continuously improve processes

11

Page 12: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Roche/Genentech: Sustained record of cutting

edge scientific discoveries

12 (* through Oct. 2015)

0

5

10

15

20

25

4 3 4

9

4

9

4

8 10

16

12 14

9

20

Research publications in Cell, Science, or Nature

10*

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Page 13: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Approach towards innovation

Exploring broad …

13

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

46% 40%

54% 60%R & Early D

Roche

Late D

Industry avg

18

11

19

2014 2012 2013

# of NME’s 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.

Page 14: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Approach towards innovation

…but prioritizing rigorously

14

We select at late stage entry

Clinical differentiation

Threshold

high low

low

high

Greater

differentiation

Sa

les

Time

Me

dic

al

ne

ed

Continued

Disqualified

Illustrative

…to increase sales potential

Page 15: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

0

2

4

6

8

10

12

2010-14 2009-13 2008-12 2007-11 2006-10

Roche

Industry

Likelihood of launch from phase 0

Achievements: Innovation

Above-average R&D success rate

Note: Success rates calculated at the project/indication level for overlapping 5-year periods based on KMR data (13 peers and Roche) 15

5%

8%

Page 16: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Real World Data

Strengthening Pharma through collaborations

Data analysis driving innovation and efficiencies

16

Access meaningful data Create insights Create insights Realise value

Advanced analytics

of integrated data

Diagnostic Data

Clinical Trial Data

Smarter, more efficient

R&D

Improved access &

personalised patient care

Page 17: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Roche’s strategy remains unchanged

Success hinges on excellence in innovation & execution

• Focus investment on differentiated molecules

• Continuously improve processes

17

Page 18: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Driving operational efficiencies

Select examples R&D

Lean Protocol Design Sourcing Strategy Partnerships

Rethinking protocol design

to reduce complexity

Outsourcing transactional

clinical operations roles

Industry consortium

(20 companies) to drive

trial efficiency

Savings of ~100m CHF per year

18

Page 19: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Driving operational efficiencies

Optimization production capacities

19

2014 2015 2016 2017 2018 2019 2020 2021

Ca

pa

cit

y U

nit

s

2013 2014 2015 2016 2017 2018 2019 2020

Large molecules Small molecules

highly potent small molecules with lower

capacity requirements

pipeline of large molecules and entry

into new high volume segments

Savings of ~100m CHF per year

Page 20: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Performance update

Innovation and efficiency

Improving the standard of care

Outlook

20

Page 21: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

taselisib

21

NM

Es

line

ext

ensi

ons

2015 2016 2017

venetoclax

alectinib

Cotellic

lebrikizumab

atezolizumab

ocrelizumab

lampalizumab

ACE910

Post 2017

etrolizumab

crenezumab

gantenerumab

olesoxime

Herceptin + Perjeta

Gazyva

atezolizumab + chemo

Gazyva

New growth opportunities

Oncology/hematology

Neuroscience

Ophthalmology

Immunology

Page 22: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

taselisib

22

NM

Es

line

ext

ensi

ons

2015 2016 2017

venetoclax

alectinib

Cotellic

lebrikizumab

atezolizumab

ocrelizumab

lampalizumab

ACE910

Post 2017

etrolizumab

crenezumab

gantenerumab

olesoxime

Herceptin + Perjeta

Gazyva

atezolizumab + chemo

Gazyva

New growth opportunities

Oncology/hematology

Neuroscience

Ophthalmology

Immunology

Page 23: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

10 novel own CIT assets in clinical development

Targeting cancer through different mechanisms

T cell trafficking

Cancer T cell recognition

• anti-CEA/CD3 TCB

• anti-CD20/CD3 TCB

T cell infiltration

• anti-Ang2/VEGF

(vanucizumab)

T cell killing

• anti-PDL1 (atezolizumab)

• anti-CSF-1R (emactuzumab)

• IDOi (NewLink)

Antigen presentation

• anti-CD40

Antigen release

Priming & activation

• anti-CEA-IL2v FP (cergutuzumab)

• anti-FAP-IL2v FP

• anti-OX40

Chen and Mellman. Immunity 2013 NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific

23

Page 24: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

aCSF-1R

aCEA-IL2v FP

aOX40

aCD40

IDO

aCEA/CD3 TCB

24

Combination trials as of beginning 2015…

Launched/ late-stage portfolio

Immunotherapy portfolio

atezolizumab

polatuzumab

Targeted combinations approved Chemotherapy combinations approved

Roche combinations in trials

Chemotherapy combinations in trials

NMEs late stage

NMEs early stage

venetoclax

chemo

cobimetinib

alectinib

Page 25: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Combination therapies now

Maximising our unique oncology portfolio

25

Page 26: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

taselisib

26

NM

Es

line

ext

ensi

ons

2015 2016 2017

venetoclax

alectinib

Cotellic

lebrikizumab

atezolizumab

ocrelizumab

lampalizumab

ACE910

Post 2017

etrolizumab

crenezumab

gantenerumab

olesoxime

Herceptin + Perjeta

Gazyva

atezolizumab + chemo

Gazyva

New growth opportunities outside oncology

Oncology/hematology

Neuroscience

Ophthalmology

Immunology

Page 27: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Ocrelizumab: Active in both RRMS & PPMS

27

• Selective depletion of a B cell subset

leaving the ability to generate new B cells

intact

• Administered IV twice yearly

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;

: R

RM

S

Risk reduction: 40%

HR (95% CI): 0.60 (0.45, 0.81);

p=0.0006

Risk reduction: 40%

HR (95% CI): 0.60 (0.43, 0.84);

p=0.0025

Time to 12-week CDP Time to 24-week CDP

15.2

9.8

12.0

7.6

Page 28: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Secondary Endpoints: Significant reduction in

number of T1 Gd+ lesions compared with IFN β-1a

OPERA I

0.286

0.016

0.0

0.1

0.2

0.3

0.4

0.5

IFN β-1a 44 μg

(n=411)

Ocrelizumab 600 mg (n=410)

Me

an

Nu

mb

er

of T1

Gd

-

en

ha

nc

ing

Le

sio

ns

pe

r M

RI Sc

an

*

94% Reduction

vs IFN β-1a p<0.0001

ITT

*Adjusted by means calculated by negative binomial regression and adjusted for baseline T1 Gd lesion (present or not), baseline EDSS (<4.0 vs ≥4.0) and geographical region (US vs ROW).

EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhancing; IFN, interferon; MRI, magnetic resonance imaging; ROW, rest of the world.

0.416

0.021

0.0

0.1

0.2

0.3

0.4

0.5

IFN β-1a 44 μg

(n=418)

Ocrelizumab 600 mg

(n=417)

Me

an

Nu

mb

er

of T1

Gd

-

en

ha

nc

ing

Le

sio

ns

pe

r M

RI Sc

an

*

95% Reduction

vs IFN β-1a p<0.0001

OPERA II

Safety summary Overall, in OPERA I and OPERA II, ocrelizumab had a similar safety profile compared with IFN β -1a over 96 weeks

28

Page 29: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Multiple Sclerosis: Improvements over SoC

driving market growth

29

,0

5,000

10,000

15,000

20,000

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Q2

2015

19,420 18,999

15,855

13,955

12,323

11,053

10,084

8,930

6,932

5,803 5,036

4,406

Global sales

(lc) USDm

Source: Evaluate Pharma Multiple Sclerosis report, October 2015; * Includes Imusera sales; SoC=standard of care

Betaseron

Rebif

Avonex

Copaxone

Lemtrada

Tysabri

Tecfidera

Aubagio

Gilenya*

ABCRs

Orals

New

biologics

Page 30: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

taselisib

30

NM

Es

line

ext

ensi

ons

2015 2016 2017

venetoclax

alectinib

Cotellic

lebrikizumab

atezolizumab

ocrelizumab

lampalizumab

ACE910

Post 2017

etrolizumab

crenezumab

gantenerumab

olesoxime

Herceptin + Perjeta

Gazyva

atezolizumab + chemo

Gazyva

New growth opportunities outside oncology

Oncology/hematology

Neuroscience

Ophthalmology

Immunology

Page 31: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Hemophilia A: Current treatment strategies

31

Episodic (on demand) treatment

• Patients treated only when they bleed

• Can be up to 30-60 times per year

Prophylaxis

• Goal is to prevent bleeds

• IV infusion 2-3 times per week

• Can reduce bleed rate to 0-2 per year

for non-inhibitor patients

• Should be the standard, but is still not

used in ~35% of patients (treatment

burden, adherence, IV access issues)

Page 32: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

ACE910 can address the major medical needs for

both inhibitor and non-inhibitor patients

32

Potentially more

effective prophylaxis

No potential to

induce FVIII inhibitor

ACE 910

Prophylaxis treatment

3 times/week, IV

On-demand treatment

1-3 times/bleeding event, IV

Inhibiting Factor VIII antibodies in 20-30% of the patients

NO

N-I

NH

IBIT

OR

Prophylaxis with by-passing

agents

Every other day, IV

On-demand treatment with

by-passing agents

2-3h intervals, IV

INH

IBIT

OR

Immune Tolerance Induction 70-80 % success rate

limitation due to very high cost and heavy burden for patients

Less frequent & SC

injection

Page 33: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Performance update

Innovation and efficiency

Improving the standard of care

Outlook

33

Page 34: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Significant launch activities ahead

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

Oncology/

hematology Neuroscience Ophthalmology Immunology

FDA Breakthrough

Therapy Designation

Cotellic + Zelboraf

BRAFmut melanoma

Venclexta

R/R CLL with 17p del

Ocrelizumab

RMS/ PPMS

Lebrikizumab

Severe Asthma

Emicizumab (ACE910)

Hemophilia A

Atezolizumab

2L+ lung and bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY)

Atezolizumab+Avastin+chemo

1L NSCLC

Gazyva

1L aNHL (GOYA)

Gazyva

1L iNHL (GALLIUM)

Gazyva

Refractory iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Atezolizumab + Avastin

1L RCC

2016 2017 2018

Actemra

Giant cell arteritis

Alecensa

1L ALK+ NSCLC

Pharma

Diagnostics cobas e 801 launch in

immunodiagnostics

cobas t 511

cobas t 711 cobas 6000 (new)

Page 35: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Positive outlook

Strong pipeline mitigates biosimilar impact

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

Marketed

products

Sales

Pipeline

Biosimilars

MabThera, Herceptin, Avastin

NME launches

Venetoclax, Alectinib, Cotellic, Ocrelizumab, Atezolizumab,

Lebrikizumab, ACE910, Lampalizumab

35

Page 36: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

2016 outlook

36

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)

Page 37: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Appendix

37

Page 38: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Multiple major pivotal trials reading out near term

Significant filing and launch activities ahead

38

Year Molecule Indication Market

opportunity

Incremental

infrastructure

2015

Alectinib ALK+ NSCLC Low to medium

Cotellic/Zelboraf Melanoma Low

Venetoclax Hematology (CLL 17p del)* Low

2016

Ocrelizumab Multiple Scelerosis Medium

Atezolizumab NSCLC, bladder (2/3L) Medium

Lebrikizumab Asthma, AD, IPF, COPD Large

APHINITY Adj HER2+ breast cancer Low

GOYA NHL (aggressive) Low

2017

ACE 910 Hemophilia A Low to medium

Lampalizumab Geographic atrophy Low to medium

GALLIUM NHL (indolent) Low

Atezolizumab+chemo NSCLC (1L) Low

2018 Taselisib (PI3Ki) HER2-/HR+ breast cancer Low to medium

Idasanutlin (MDM2) Acute myeloid leukemia Low to medium

Oncology Neuroscience Ophthalmology Immunology

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

NSCLC=non-small cell lung cancer; CLL=chronic lymphocytic leukemia; AD=atopic dermatitis; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructive pulmonary disease; NHL=non-hodgkin’s lymphoma; * first indication

Page 39: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

39

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

ab

ilit

y

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 40: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Doing now what patients need next

Page 41: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Hemophilia A: There are significant limitations of

current treatment options

1.7 1.9

2.1 2.1

2.6

2009 2010 2011 2012 2018

FEIBA VH

NovoSeven

3%

5.3 5.5 6.0 6.1

8.4

2009 2010 2011 2012 2018

Others RecombinateHemofil M HelixateReFacto AF/Xyntha Humate P

6%

*Company reported sales; 1EvaluatePharma consensus analyst estimates

1

FVIII market (USD 6.1bn in 2012)*

By-passing agent market (USD 2.1bn)*

• Current FVIII treatments

− Limited half-life of only 8-12 hrs

− Frequent IV injections

− Induce neutralizing antibodies, which

inhibit their function

• Current bypassing treatments

− Much shorter half-life of ~4-6 hrs

− Multiple frequent IV infusions

− Long infusion times (30+mins) for FEIBA

− Unstable efficacy compared to FVIII

41

1

US

Sb

n

US

Sb

n

Page 42: Innovation and value creation - Roche · Innovation and value creation ... Head of Investor Relations ... Investment split based on the CMR Pharmaceutical R&D Factbook (data from

Ocrelizumab: Active in both RRMS & PPMS

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;

:

Primary endpoint Key secondary

PP

MS

Analysis based on ITT population; p-value based on log-rank test stratified by geographic region and age.

Patients with initial disability progression who discontinued treatment early with no confirmatory EDSS assessment were

considered as having confirmed disability progression. CDP, confirmed disability progression; EDSS, Expanded Disability

Status Scale; HR, hazard ratio; ITT, intent to treat.

Safety summary Overall, in ORATORIO ocrelizumab had a favorable safety profile

42