Roche · match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation,

Roche

2015 results

London, 28 January 2016

3

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.

4

Group Severin Schwan Chief Executive Officer

2015 performance

Outlook

5

2015: Targets fully achieved

6

Targets for 2015 FY 2015

Group sales growth1 Mid-single digit +5%

Core EPS growth1 Ahead of sales growth2 +7%

Dividend outlook Further increase dividend in Swiss francs3

(Payout ratio increased to 60% from 56%) CHF 8.10

1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014; 3 2015 dividend as proposed by the Board of Directors

7

• Cancer immunotherapy: Phase II lung (POPLAR, BIRCH), rolling filing initiated;

Phase II bladder (IMvigor 210), filed in US; 9 NMEs in clinical development

• Alecensa (alectinib): Approved in US, filed in EU

• Cotellic (cobimetinib): Approved in US and EU

• Venetoclax: Filing acceptance in R/R CLL including 17p del in US

• Gazyva: Phase III (GADOLIN) in R/R iNHL, filed in US and EU

• Emicizumab (ACE 910): Updated phase Ib, start of Phase III in inhibitors

• Ocrelizumab: Phase III in RMS (OPERA I/II) and PPMS (ORATORIO)

Growth

• Group sales +5%1 driven by HER2 franchise (+19%), Avastin (+9%),

Esbriet (n.m.), Actemra (+23%) and Professional Diagnostics (+8%)

Profit

Sales

• +7% Core EPS growth1,2 driven by strong underlying business

Innovation

Neuroscience

Oncology

Hematology

1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014

2015: Highlights

2015: Strong sales growth in both divisions

8 CER=Constant Exchange Rates

2015 2014

CHFbn CHFbn CHF CER

Pharmaceuticals Division 37.3 36.7 2 5

Diagnostics Division 10.8 10.8 0 6

Roche Group 48.1 47.5 1 5

Change in %

2015: Sales growth for fifth consecutive year

9

0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

7%

6%

4%

0%

2%

4%

6%

8%

10%

Q1

11

Q2

11

Q3

11

Q4

11

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

All growth rates at Constant Exchange Rates (CER)

2015: Strong sales growth in all regions

10

0

3

6

9

12

15

18

21

Japan International Europe US

Diagnostics

Pharma

CHFbn

+6%

+4% +5%

+6%

+2% +13%

0%

+1%

+5%

+3%

+5%

+7%

All growth rates are YoY at Constant Exchange Rates (CER)

Roche: Significantly advancing patient care

Recognition for innovation 2013-present

11

Rank Company #

1 Roche 11

2 BMS 8

3 Novartis 6

3 Merck 6

3 Pfizer 6

4 GSK 5

11 Breakthrough Therapy Designations

Year Molecule

2016 Venetoclax (AML)

Venetoclax + Rituxan (R/R CLL)

2015

Actemra (Systemic sclerosis)

Atezolizumab (NSCLC)

Venetoclax (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 21 January 2016; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-

Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy

http://www.focr.org/breakthrough-therapies




2015: Strong underlying Group Core operating

profit & margin

12 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%*)

2015: Strong underlying Core EPS growth

13

12.30

13.49 14.27 14.29

13.49

2011 2012 2013 2014 2015

+4% at CER (+7%*)

All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014

CHF

2015: Dividend and payout ratio further increased

14 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

2015: Core EPS growth bridge

15

one-time

filgrastim*

+3.7%

+2.9% +6.6%

Full Year 2015

figures as reported

Sales

+5.3%

Core EPS Core EPS

Full Year 2015

excl. filgrastim*

All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014

2015 performance

Outlook

16

2016 onwards: Significant launch activities

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

FDA Breakthrough

Therapy Designation

Oncology/

hematology Neuroscience Ophthalmology Immunology

Cotellic + Zelboraf

BRAFmut melanoma

Venetoclax

R/R CLL including 17p del

Ocrelizumab

RMS/ PPMS

Lebrikizumab

Severe Asthma

Emicizumab (ACE910)

Hemophilia A

Atezolizumab

2L+ lung and bladder cancer

Alecensa

2L ALK+ lung cancer

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 + abraxane

TNBC

Atezolizumab + Avastin

1L RCC

NM

Es

lin

e

exte

nsio

ns

2016 2017 2018

Actemra

Giant cell arteritis

Alecensa

1L ALK+ NSCLC

2016 outlook

18

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)

19

Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals

2015 results

Innovation

Outlook

20

2015: Pharma sales

Strong growth driven by all regions

21

2015 2014

CHFm CHFm CHF CER

Pharmaceuticals Division 37,331 36,696 2 5

United States 17,616 15,822 11 6

Europe 8,734 9,422 -7 4

Japan 3,224 3,301 -2 6

International 7,757 8,151 -5 5

Change in %

CER=Constant Exchange Rates

2015: Pharma Division

Core operating profit growth +8%*

22

CHFm % sales

Sales 37,331 100.0

Royalties & other op. inc. 2,119 5.7

Cost of sales -7,900 -21.2

M & D -6,066 -16.2

R & D -8,134 -21.8

G & A -1,295 -3.5

Core operating profit 16,055 43.0

2015 vs. 2014

CER growth

0% in CHF

2015

5%

-11%

7%

4%

4%

-17%

5%

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

Excl. filgrastim*

+8%

Capacity increase in

manufacturing

Excl. filgrastim*

+10%

-600 -400 -200 0 200 400 600

Pegasys

Valcyte/Cymevene

Tamiflu

Lucentis

Xeloda

Xolair

Kadcyla

Actemra/RoActemra

MabThera/Rituxan

Esbriet

Perjeta

Avastin

Herceptin

US

Europe

Japan

International

2015: Strong performance from oncology and

immunology franchises

23

+10%

+9%

+61%

n.m.

+5%

+51%

+23%

-44%

-45%

+25%

CHFm

Absolute amounts and growth rates at Constant Exchange Rates (CER)

-28%

-15%

-31%

0 2 4 6 8 10

Zelboraf

Xeloda

Tarceva

MabThera/

Rituxan

(Oncology)

Avastin

HER2

Kadcyla

Perjeta

Herceptin +19%

+9%

-7%

-31%

-21%

+4%

2015: Oncology with +8% growth

24

YoY CER growth

CHFbn

CER=Constant Exchange Rates; 2015 Oncology sales: CHF 23.7bn; CER growth +8%

• In-class competition

• EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC

• Loss of exclusivity

• Growth driven mainly by cervical and ovarian

• International: Strong growth in all regions

• Strong uptake of Perjeta and Kadcyla

• Growth of Herceptin due to longer treatment

• Competitive pressure in US and EU

• Cotellic + Zelboraf approved in Q4

• US: Growth in iNHL maintenance

HER2 franchise: Continued strong growth

25

0

500

1,000

1,500

2,000

2,500

Q4 12 Q4 13 Q4 14 Q4 15

Herceptin Perjeta Kadcyla

+10%

YoY CER growth

+19%

+20%


CHFm

+18%

HER2 franchise Q4 2015

• Herceptin (+10%): Longer treatment

duration in combo with Perjeta

• Perjeta (+50%): Strong demand in 1L mBC

• Kadcyla (+36%): Growth driven by EU

Outlook 2016

• Perjeta: Further increasing penetration and

neoadjuvant uptake

• Kadcyla: Increasing penetration and new

countries

• Ph III APHINITY data (adj. HER2+) expected

Strong subcutaneous conversion rates for

Herceptin and MabThera

26 SC=subcutaneous; * Herceptin SC has been launched in 48 countries; MabThera SC has been launched in 12 countries

SC share of MabThera NHL

sales in launched countries*

0%

5%

10%

15%

20%

25%

30%

35%

Q2

14

Q3

14

Q4

14

Q1

15

Q2

15

Q3

15

Q4

15

Sa

les m

ark

et

sh

are

(%

)

SC share of Herceptin sales in

launched countries*

0%

10%

20%

30%

40%

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Q2

15

Q3

15

Q4

15

Sa

les m

ark

et

sh

are

(%

)

Check

NHL

sales

Avastin: Growth in various indications and across

all regions

27

0

400

800

1,200

1,600

2,000

Q4 12 Q4 13 Q4 14 Q4 15

CHFm

US Europe International Japan

YoY CER growth

+8%+12%

+9%+8%


Avastin Q4 2015

• US (+11%) & EU (+5%): Growth in

ovarian and cervical cancer

• International (+7%): Driven by Asia,

mainly China (lung cancer launch)

Outlook 2016

• Continued uptake in ovarian and cervical

• EU: Avastin + Tarceva approval in EGFR+

NSCLC expected in H2

+8%

Immunology: Continued strong performance

28

0

300

600

900

1,200

1,500

1,800

Q4

12

Q4

13

Q4

14

Q4

15MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other

CHFm

CER=Constant Exchange Rates; MTX=methotrexate; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis

YoY CER growth

+8% +12%

+16%

+26%

Immunology Q4 2015

Xolair (+22%)

• Growth driven by allergic asthma and

chronic idiopathic urticaria

Actemra (+25%)

• SC formulation driving growth

• Increasing 1L monotherapy leadership

focusing on MTX intolerant patients

MabThera/Rituxan (+14%)

• Continues to grow in rheumatoid

arthritis and vasculitis (GPA and MPA)

200

300

400

500

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

Lucentis: Ongoing competitive pressure

29

Lucentis sales (USDm) Lucentis Q4 2015

• Competitive pressure in wAMD and DME

• Launch in DR ongoing after first-in-class

FDA approval in Q1 2015

• Protocol S results provide evidence of safe

alternative to laser therapy against

proliferative DR

Outlook 2016

• Moderate decline expected

wAMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy (in patients with DME)

27 32

36 44

88

141

157

177

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15

Esbriet: Market leadership in IPF established

30

US

• Strong underlying growth

• Around 100,000 IPF patients in the

US with high unmet need

EU

• Increasing differentiation due to

strengthened label including the

pooled 1 Yr mortality data

Outlook 2016

• Continued growth due to increased

penetration and longer treatment

Esbriet sales (CHFm)

2015 results

Innovation

Outlook

31

2015: Key late-stage news flow

32

Compound Indication Milestone

Regulatory

Avastin Cervical cancer EU approval

Lucentis Diabetic retinopathy US approval

Alecensa 2L ALK+ NSCLC US/EU approval/filing

Cotellic + Zelboraf 1L Melanoma US/EU approval

Phase III readouts*

Gazyva MabThera/Rituxan-refractory iNHL Ph III GADOLIN

Gazyva Front-line aNHL Ph III GOYA (interim)

ocrelizumab Relapsing forms of MS (RMS) Ph III OPERA I/II

ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO

Perjeta 2L HER2+ mBC Ph III PHEREXA

Kadcyla 2L HER2+ gastric cancer Ph II/III GATSBY

Phase III starts

atezolizumab** 2/3L Bladder cancer Ph III

atezolizumab** 1L TNBC Ph III

atezolizumab** 1L RCC Ph III

atezolizumab** Adjuvant bladder Ph III

etrolizumab Crohn`s disease Ph III

emicizumab (ACE910) Hemophilia A (inhibitors) Ph III

taselisib (PI3K inhib) HR+/PI3Kmut BC Ph III SANDPIPER

Phase II readouts*

atezolizumab 2/3L NSCLC Ph II FIR, POPLAR, BIRCH

atezolizumab Bladder cancer Ph II

ipatasertib (AKT inhib) Gastric/prostate cancers Ph II MARTIN, JAGUAR

* Outcome studies are event driven, timelines may change; ** For atezolizumab (aPDL1) only P3 trials in new indications are listed (1L and sdjuvant NSCLC starts not shown)

2016

Data in-house

Data in-house

Unlocking the full value of cancer immunotherapy

Nine in-house immunotherapy NMEs in the clinic

33

Clinical development Preclinical development

* Partnered or external

Established therapies

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

T cell Trafficking

Cancer T cell recognition anti-CEA/CD3 TCB

anti-CD20/CD3 TCB

anti-HER2/CD3 TCB

ImmTAC* (Immunocore)

T cell infiltration

anti-VEGF (Avastin)

anti-Ang2/VEGF (vanucizumab)

T cell killing anti-PDL1 (atezolizumab)

anti-CSF-1R (emactuzumab)

IDOi (NewLink)

IDOi* (Incyte)

CPI-444* (Corvus)

anti-TIGIT

IDO1/TDOi* (Curadev)

Antigen presentation T-Vec oncolytic virus* (Amgen)

INFa

anti-CD40

CMB305 vaccine* (Immune Design)

Priming & activation anti-CEA-IL2v FP

anti-FAP-IL2v FP

anti-OX40

anti-CD27* (Celldex)

entinostat* (Syndax)

EGFRi (Tarceva)

ALKi (Alectinib)

BRAFi (Zelboraf)

MEKi (Cotellic)

anti-CD20 (Gazyva)

anti-HER2 (Herceptin;

Kadcyla; Perjeta)

various chemotherapies

lenalidomide*

rociletinib* (Clovis)

Antigen release

In-house immunotherapy NMEs

aCSF-1R

aCEA-IL2v FP

aOX40

aCD40

IDO

aCEA/CD3 TCB

34

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

aCSF-1R

aCEA-IL2v FP

aOX40

aCD40

IDO

aCEA/CD3 TCB

aFAP-IL2v FP

aCD20/CD3 TCB

35

…and combination trials as of today

Immunotherapy

portfolio

lenalidomide

azacitidine

polatuzumab

venetoclax

chemo

Targeted combinations approved Chemotherapy combinations approved

Roche combinations in trials

Chemotherapy combinations in trials

Roche NMEs approval expected in 2016

Roche NMEs early stage

Approved non-Roche drugs

Launched/ late-stage portfolio

atezolizumab

Cancer immunotherapy read-outs in 2016

36

Phase III Phase I atezo

2/3L NSCLC

atezo

2/3L Bladder

atezo+Avastin+chemo

1L non sq NSCLC

atezo+chemo

1L non sq NSCLC

atezo+chemo

1L sq NSCLC

atezo

1L non sq NSCLC (Dx+)

atezo

1L sq NSCLC (Dx+)

atezo+chemo

1L TNBC

atezo

Adjuvant MIBC (Dx+)

atezo

Adjuvant NSCLC (Dx+)

atezo+Avastin

1L Renal

atezolizumab trials

NME monotherapy

Immune doublets

Results in 2016

atezo

NSCLC (Dx+)

atezo

2/3L NSCLC

atezo+Avastin

1L Renal

atezo

1/2L Bladder

Phase II

IDO

Solid tumors

atezo+ipilimumab

Solid tumors

atezo+aCD40

Solid tumors

atezo+IFN-alfa

Solid tumors

atezo+aCSF-1R

Solid tumors

atezo+aCEA-IL2v FP

Solid tumors

atezo+aOX40

Solid tumors

atezo+IDO

Solid tumors

atezo+Zelboraf

Melanoma

atezo+Tarceva

NSCLC

atezo+Avastin+/-chemo

Solid tumors

atezo+Gazyva

R/R FL / aNHL

aCD20/CD3 TCB

heme tumors

atezo+Cotellic

Solid tumors

atezo+Zelboraf+Cotellic

Melanoma

atezo+lenalidomide

MM

atezo+chemo

Solid tumors

atezo

Solid tumors

aCSF-1R

Solid tumors

aOX40

Solid tumors

aCEA/CD3 TCB

Solid tumors

aCEA-IL2v FP

Solid tumors

atezo+Alecensa

ALK+ NSCLC

atezo+/-azacitidine

MDS

atezo+Gazyva+chemo

R/R FL/aNHL

atezo+Kadcyla/Herceptin+Perjeta

HER2+ eBC/mBC

atezo+Gazyva+lenalidomide

R/R FL/aNHL

Additional 2016 results (according

to Eka`s publication list):

• Ph1: Atezo+Avastin+FOLFOX in

1L CRC

• Ph3 interim: Atezo+abraxane in

TNBC

• Ph1: aCD20/CD3 TCB

• Ph1: Atezo+lena SAFETY

• Ph1: Atezo+azacitidine SAFETY

atezo+Gazyva+polatuzumab

R/R FL/aNHL

Should we

indicate

what could

be at

ASCO?

aFAP-IL2v FP

Solid tumors

Status as of Jan 28, 2016; Outcome studies are event-driven: timelines may change.

atezo+aCEA/CD3 TCB

Solid tumors

37

Alecensa in 2L ALK+ lung cancer

First ALK inhibitor with proven activity in the brain

Phase II US and Global Studies

0

10

20

30

40

50

60

70

80

All (n=67) Measurable

CNS disease

(n=16)

All (n=122) Measurable

CNS disease

(n=34)

ORR

CR

US Study Global Study

52%

75%

51%

59%

25% 21%

All

(n=69)

Ove

rall a

nd C

NS R

esp

onse

Rate

s

• Accelerated approval in US; Filed in

the EU in Q3

• High systemic and CNS disease

control in crizotinib-failed lung cancer

• Phase III results (ALEX) in 1L ALK+

NSCLC expected in 2017

Alecensa (alectinib); ORR=overall response rate; CR=complete responses; CNS=central nervous system; PFS=progression free survival;

DOR=duration of response; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015

Mention

sales in

Japan ?

• Median PFS: 8.1m (US) , 8.9m (global)

• Median DOR: 13.5m (US),14.1m (global)

38

Cotellic + Zelboraf in 1L BRAFmut melanoma

Triple combination with atezolizumab started

Cotellic (cobimetinib); OS=overall survival; PFS=progression free survival; ORR=overall response rate; CR=complete responses;

Atkinson V. et al, SMR 2015; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015

Phase III coBRIM Study

• Approved in the US/EU

• Ph I data (at SMR) show that atezolizumab

can be combined with Zelboraf

• Ph I triplet combination of atezolizumab +

Zelboraf + Cotellic on-going

Zelboraf +

Cotellic

(n = 247)

Zelboraf +

Placebo

(n = 248)

Median OS 22.3 17.4

Median PFS 12.3 7.2

% ORR 69.6 50.0

% CR 15.8 10.5

Ocrelizumab in multiple sclerosis

First drug active in both RMS and PPMS

39 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

Phase III OPERA I/II Studies (RMS) Phase III ORATORIO Study (PPMS)

• First and only investigational medicine to suppress disease progression in both RMS and PPMS

• Results confirm B cells play a central role in MS

• US/EU filing for RMS and PPMS on track for H1 2016

Emicizumab (ACE910) in hemophilia A

First-patient-in achieved in inhibitor study

40 QW=weekly dosing; Q2W= dosing every 2 weeks; Q4W=monthly dosing; PK=pharmacokinetic study; OLE=open label extension

• First-patient-in in the inhibitor phase III study achieved

• Inhibitor non-interventional study has recruited >90 patients and will be expanded to non-inhibitors

• Non-inhibitor and pediatrics studies expected to start in 2016

• New data at ASH 2015: Patient underwent surgery without need for any Factor VIII replacement therapy

2015 2016 2017 2018

Pediatrics Inhibitor

Inhibitor Non-interventional

Inhibitor (≥12 yrs)

Weight based QW dosing

(Q4W dosing study planned)

Non-inhibitor (≥12 yrs)

QW and Q2W dosing

Japanese studies

Chugai OLE

Phase II Phase III Phase I Patient transfer

Real World Data

Strengthening Pharma through collaborations

Data analysis driving innovation and efficiencies

41

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

2015 results

Innovation

Outlook

42

2016 onwards: Significant launch activities

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

FDA Breakthrough

Therapy Designation

Oncology/

hematology Neuroscience Ophthalmology Immunology

Cotellic + Zelboraf

BRAFmut melanoma

Venetoclax

R/R CLL including 17p del

Ocrelizumab

RMS/ PPMS

Lebrikizumab

Severe Asthma

Emicizumab (ACE910)

Hemophilia A

Atezolizumab

2L+ lung and bladder cancer

Alecensa

2L ALK+ lung cancer

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 + abraxane

TNBC

Atezolizumab + Avastin

1L RCC

NM

Es

lin

e

exte

nsio

ns

2016 2017 2018

Actemra

Giant cell arteritis

Alecensa

1L ALK+ NSCLC

2016: Key late-stage news flow

44


Regulatory

Gazyva MabThera/Rituxan-refractory iNHL US/EU approval

venetoclax R/R CLL US approval

ocrelizumab RMS/PPMS US/EU filing

atezolizumab Bladder cancer US approval

atezolizumab 2/3L NSCLC US approval

Alecensa 2L ALK+ NSCLC EU approval

Phase III readouts*

lebrikizumab Severe asthma Ph III LAVOLTA I/II

atezolizumab 2/3L NSCLC Ph III OAK

Gazyva Front-line aNHL Ph III GOYA

Perjeta + Herceptin Adjuvant HER2+ BC Ph III APHINITY

Actemra Giant cell arthritis Ph III GiACTA

Alecensa 1L ALK+ NSCLC Ph III ALEX

Phase II readouts*

lebrikizumab Atopic dermatitis Ph II TREBLE, ARBAN

atezolizumab Bladder cancer Ph II IMvigor 210 (1L cohort)

atezolizumab + Avastin 1L Renal cancer Ph II IMmotion 150

venetoclax R/R FL (iNHL) Ph II CAVALLI

venetoclax 1L aNHL Ph II CONTRALTO

* Outcome studies are event driven, timelines may change


Regulatory

Gazyva MabThera/Rituxan-refractory iNHL US/EU approval US 28 Feb; EU

May

venetoclax R/R CLL US approval March

ocrelizumab RMS/PPMS US/EU filing Q2

atezolizumab Bladder US approval Sep launch

atezolizumab 2/3L NSCLC US approval Oct launch

Alecensa 2L ALK+ NSCLC EU approval Q4

Avastin Relapsed Platinum-sensitive OC US/EU filing

Phase III

readouts*

lebrikizumab Moderate to severe asthma Ph III LAVOLTA I/II Feb ATS

atezolizumab 2/3L NSCLC Ph III OAK Q3 WCLC

Gazyva Front-line aNHL Ph III GOYA (interim) Mid July ASH

Perjeta Adjuvant HER2+ BC Ph III APHINITY Q1 17 SABCS

Perjeta 2L HER2+ mBC Ph III PHEREXA ASCO

Kadcyla Neoadjuvant HER2+ BC Ph III KRISTINE (5% sucess) Feb ASCO

Gazyva Front-line iNHL Ph III GALLIUM (interim) Late May ASH

Perjeta 1L mGC Ph III JACOB (interim OS) June/July

Actemra Giant cell arthritis Ph III GIACTA Q3 ACR

Alecensa 1L ALK+ NSCLC Ph III ALEX (PFS) Sep

venetoclax R/R CLL Ph III MURANO Q4

Zelboraf Adjuvant melanoma Ph III BRIM8 Q4

Phase II

readouts*

atezolizumab + Avastin 1L RCC Ph II IMmotion ASCO

lebrikizumab Atopic dermatitis Ph II

venetoclax R/R FL (iNHL) Ph I/II CAVALLI ASCO

ipatasertib Gastric/prostate cancers Ph II MARTIN, JAGUAR ESMO?/ASCO

polatuzumab + R/G-CHP 1L aNHL Ph I/II (Ph2 expansion?) ASCO/ASH

polatuzumab + R/G-CHP NHL Ph II ROMULUS ASCO/ASH

vanucizumab CRC Ph II McCAVE

taselisib Neoadjuvant (1L) TNBC Ph II LORELEI SABCS

atezolizumab Bladder Ph II Imvigor 210 (1L cohort) ASCO

SERD ER+/HER2- mBC Ph II SABCS

lifastuzumab vediotin Platinum-sensitive OC Ph II

venetoclax 1L aNHL Ph II CONTRALTO ASH

45

Diagnostics Division Roland Diggelmann COO Roche Diagnostics

2015: Diagnostics sales

Strong sales performance

46

2015 2014

CHFm CHFm CHF CER

Diagnostics Division 10,814 10,766 0 6

Professional Diagnostics 6,175 6,045 2 8

Diabetes Care 2,128 2,392 -11 -3

Molecular Diagnostics 1,719 1,613 7 10

Tissue Diagnostics 792 716 11 12

Change in %

CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +7%

0%

1%

2%

3%

4%

5%

6%

7%

8%

Market

Roche

Roche outgrowing the market in a challenging

environment

47 Sources: 3rd party IVD consultancy, Analyst reports, Roche Analysis; *Q4 2015 market growth is an estimate

Quarterly growth (%)

2015 2014

FY 2015: 6%

Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4

• Worldwide IVD market leader

• Strong commercial presence

• Broadest test menu

*

North America

+3%

26% of divisional sales

Latin America

+11%


Japan

0%

4% of divisional sales EMEA1

+4%


2015: Diagnostics regional sales

Growth driven by APAC and EMEA

Asia Pacific

+15%


48

14% growth in E7 countries2

1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at Constant Exchange Rates

2015: Diagnostics highlights

Growth driven by Professional Diagnostics

+12%

-3%

+8%

+10%

CHFbn

1

1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7%

CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa

• Virology (+14%) incl. HPV (+27%)

• Decline in blood glucose monitoring (-4%), insulin delivering systems (+8%)

• Advanced staining portfolio (+11%)

• Growth driven by immunodiagnostics (+13%)

YoY CER growth

49

0 2 4 6 8

Tissue

Dia

Molecular

Dia

Diabetes

Care

Professional

Dia

EMEA

North America

RoW

2015: Diagnostics Division

Profitability impacted by investments in sequencing*

50

CHFm % sales

Sales 10,814 100.0

Royalties & other op. inc. 139 1.3


M & D -2,544 -23.5

R & D -1,198 -11.1

G & A -458 -4.2


2015 2015 vs. 2014

CER growth

-7% in CHF

6%

5%

7%

9%

18%

-9%

-2%

CER=Constant Exchange Rates; * Sequencing investments refer to the acquisitions of Genia, Ariosa, Bina and Signature Diagnostics

Immunodiagnostics: 15 years of consecutive

double digit growth

51

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

2000 2015

+13%

CHFbn

All growth at CER=Constant Exchange Rates

Continuous extension

• 100+ assays

• Largest installed instrument base

• Mfc capacity expansion in 2015

Outlook

• Launch of cobas e801 instrument: Double throughput with same footprint

• New reagent plant in China

Elecsys Troponin T high sensitive (TnT-hs)

Safe and effective AMI* rule-in and rule-out in 1 hour**

Rule-in

Rule-out

Observation

Conventional assays

High sensitive assays

TnT-hs One-hour algorithm

3 hours

1 hour

Enables faster treatment decisions and reduced ER waiting times

?

Reduces diagnosis time to 1h in 76-78% of acute chest pain patients

TRAPID

-AMI

* AMI: acute myocardial infarction; ** 1 hour refers to time for analysis between two samples

References: 1. Mueller, C. et al (2015) : Ann Emerg Med. 10.1016/j.annemergmed.2015.11.013

http://www.annemergmed.com/article/S0196-0644(15)01501-2/fulltext.. 2.Reichlin et al (2012). Arch Intern Med 172:1211-1218.

52

6 hours

cobas 6800 cobas 8800

Molecular Diagnostics: cobas 6800/8800

US launch of instruments and viral load tests*

53

• Fully automated PCR systems

• Highest throughput

(3x above closest competitor)

• Highest walk-away time to

increase lab efficiency

Blood Screening Virology Menu Expansion

• MPX (HIV, HCV, HBV)

• West Nile Virus • DPX (B19 & HAV)

• Hepatitis E

• HIV-1

• Hepatitis B • Hepatitis C

• CMV

• HPV

• CT/NG • HIV 1/2 Qualitative

• MTB/MAI & RIF/INH

* US approved tests for cobas 6800/8800: HBV, HCV and HIV-1

Tissue Diagnostics: Launch of VENTANA HE 600

Potential to change standard of care in H&E* staining

54

• Latest platform with individual slide staining

technology, avoids sample cross contamination

• Platform features:

– Highest result quality and reproducibility

– Highest test capacity and most efficient

workflow

– Easy and safe to operate

* hematoxylin and eosin tissue staining

Accu-Chek Insight CGM

Diabetes Care: Challenging US market

Launch of innovative products in 2016

Challenges in 2015:

• US: Spillover effect of Medicare prices to private sector

55

Opportunities in 2016:

• Product launches

– Accu-Chek Guide: New blood glucose monitoring

device with universal test strip for improved accuracy

– Accu-Chek Insight CGM*: New sensor technology

• Growth prospect

– Insulin Delivery Systems: Sustaining current growth

momentum

Accu-Chek Guide

* CGM: Continuous glucose monitoring

1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics;

RTD: Roche Tissue Diagnostics; * Submitted to FDA

Key launches 2015

56

Area Product Market BA1

Instruments /

Devices

Laboratory

cobas c 513 – dedicated HbA1C analyzer

cobas t 411– core lab coagulation analyzer

cobas 8100 V2 – Integrated pre- and post-analytical solution

cobas 6800/8800 – Medium to High volume automated real-time PCR

VENTANA HE 600 – automated H&E staining platform

EU

EU

WW

US

WW

RPD

RPD

RPD

RMD

RTD

Diabetes

Care

Accu-Chek Active no-code– next-gen. bG meter, no coding of test strips

Accu-Chek Connect – bG meter with connectivity to smartphones, mobile

applications and cloud

WW

US

RDC

RDC

Point of Care CoaguChek Pro II - professional system for PT and aPTT testing EU RPD

Tests /

Assays

Blood

Screening cobas 6800/8800 MPX – Multiplex Bloodscreening test US RMD

Infectious

Diseases

cobas Liat Influenza A/B + RSV – POC detection

HTLV– human T-lymphotropic virus diagnostics test

US

EU

RMD

RPD

Virology

cobas 6800/8800 HBV – Quantitative HBV viral load test

cobas 4800 HIV-1 - Quantitative HIV viral load test

cobas 4800 HCV – Quantitative HCV viral load test

cobas 4800 HBV – Quantitative HBV viral load test

EU

EU

EU

EU

RMD

RMD

RMD

RMD

Genomics &

Oncology cobas EGFR Test v2 - detection of EGFR in plasma EU RMD

Cardiac cobas h 232 Troponin T – Point of Care test version of Elecsys cTNT-hs EU RPD

*

*

Key launches 2016

57

Area Product Market

Instruments /

Devices

Central

Laboratory

cobas 8000 <e 801> – high throughput immunochemistry analyzer

cobas c 513 – high throughput dedicated HbA1c analyzer

EU

US

Point of Care CoaguChek INRange (Zenith) – modified analyzer for intuitive self testing with full blue

tooth connectivity EU

Sequencing Roche SMRT Sequencer – single molecule sequencer for clinical research (in collaboration

with Pacific Biosciences) WW

Diabetes

Care

Accu-Chek Guide – next-generation blood glucose monitoring system

Accu-Chek Insight CGM – new high-performance continuous glucose monitoring system

EU

EU

Tests /

Assays

Virology cobas 6800/8800 HIV Qual – early Infant Diagnosis and Confirmatory HIV Test EU

HPV /

Microbiology cobas 6800/8800 CT/NG – fully automated solution for screening and diagnosis of Chlamydia

trachomatis and Neisseria gonorrhoeae in symptomatic & asymptomatic patients EU

Point of Care cobas Liat Influenza A/B plus RSV (CLIA) – automated multiplex real time RT-PCR

assay for qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV)

US

Sequencing ctDNA oncology panels – liquid biopsy for circulating tumor DNA for cancer therapy

selection US

Companion

Diagnostics

PD-L1 (SP142) for Bladder Cancer* – companion diagnostic for atezolizumab PD-L1 (SP142) for NSCLC* – companion diagnostic for atezolizumab

US

US

* achieve commercial readiness, dependent on Pharma label and approval

58

Finance Alan Hippe Chief Financial Officer

2015: Highlights

59

Business

• Strong sales growth of +5%1 and Core EPS growth +7%1 excluding filgrastim2

• Core operating profit up +5%1, excluding filgrastim2 +7%1

• Dividend in Swiss franc and payout ratio further increased

Debt restructuring

• Attractive financing conditions in capital markets used for major debt restructuring

– Total major restructuring of USD 0.9bn and EUR 0.4bn in 2015

• Lower interest expenses of CHF 61m despite average gross debt of CHF 24bn in 2015 vs.

CHF 21bn in 2014

1 At Constant Exchange Rates (CER); 2 Excluding sale of filgrastim rights in 2014

Cash flow

• Cash generation remains strong (Op. FCF of CHF 14.9bn) despite expanding manufacturing

network and investments in intangible assets

• Accounts receivable in Southern Europe further decreased

2015 2014 Excl.

CHFm CHFm CHF CER filgrastim*

Sales 48,145 47,462 1 5

Core operating profit 17,542 17,636 -1 5 7

as % of sales 36.4 37.2

Core net income 11,837 12,533 -6 1 4

as % of sales 24.6 26.4

Core EPS (CHF) 13.49 14.29 -6 4 7

IFRS net income 9,056 9,535 -5 4

Operating free cash flow 14,872 15,778 -6 -7

as % of sales 30.9 33.2

Free cash flow 3,352 5,322 -37 -41

as % of sales 7.0 11.2

Change in %

2015: Group performance

Core EPS growth +4%, +7% excluding filgrastim*

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

2015: Group operating performance

Core OP growth +5%, +7% excluding filgrastim

61

CHFm % sales

Sales 48,145 100.0

Royalties & other op. inc. 2,258 4.7


M & D -8,610 -17.9

R & D -9,332 -19.4

G & A -2,213 -4.6


2015 2015 vs. 2014

CER growth

-1% in CHF

5%

-10%

7%

5%

5%

-12%

5%

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

Excl. filgrastim*

+7%

17,904

16,108

2,177

17,63616,001

2,096

17,54216,055

1,947

Roche Group Pharma Division Diagnostics Division

2013 2014 2015

38.3% 37.2% 36.4%

44.4% 43.6% 43.0%

20.8% 19.5%18.0%

2015: Strong Core operating profit and margin

62

CHFm

% of sales

-0.2%p1

(-0.8%p)

-1.4%p1

(-1.5%p)

+0.2%p1

(-0.6%p)

-2%1

(-7%)

+5%1

(0%)

+5%1

(-1%)

1 At CER=Constant Exchange Rates; 2 Excluding sale of filgrastim rights in 2014

+0.7 %p2 +1.4 %p2

-1,116

-1,416

+136 -281

-212

+61

-4

Interest expense

2014 2015 Net losses on debt

redemption

All other, net

Net income from equity securities

2015 with 27% CHF / 26% CER

higher net financial expense

2015: Core net financial result

Net financial expense up vs. prior year due to higher FX losses and lower income from equities


CHFm

FX G/L

24.1 26.6

+2.5

2014 Profit mix and other 2015

2015: Group Core tax rate

Relative higher Core profits in US

64

Figures in %

Relative higher

Core profits in

US and other

19%

Net debt/

total assets:

Assets Equity & liabilities

44.4 47.6

21.6 23.3

19.419.0

30.8 28.7

11.7 9.2

23.1 23.8

31/12/14 31/12/15 31/12/14 31/12/15

75.8 75.8+4%

-15%

+4%

+10%

Current

liabilities

Non-current

liabilities

Equity

(Net assets)

15% 12%

26%

59%

25%

29% 31%

75.5 75.5

% change in CER

vs 31/12/14

Current

liabilities

Non-current

liabilities

Equity

(Net assets)

63%

30%

41%

31%

38%

+6%

% change in CER

vs 31/12/14

+4%

-4%

+14%

Cash and

marketable

securities

Other

current

assets

Non-current

assets

CHFbn

Balance sheet 31 December 2015


16,38114,976

1,962

15,77814,821

1,417

14,872 14,482

963

Roche Group Pharma Division Diagnostics Division

2013 2014 2015

35.0% 33.2%30.9%

41.3% 40.4% 38.8%

18.7%13.2%

8.9%

2015: Operating free cash flow and margin

66

CHFm

-3.8%p1 (-2.3%p)

-7%1

(-6%)

1 At CER=Constant Exchange Rates

• Capex driven by expanding

manufacturing network

• Investments in intangible assets

CCC-

BB

BBB-

BBB

CHFm

2,462

1,036

980

209

236

1,836

604

819

163

251

1,645

613

733

114

185

1,171

480

433

97

161

991

322

390

103

176

0 500 1,000 1,500 2,000 2,500

Southern

European

Countries

Spain

Italy

Portugal

Greece

Dec 2015

Dec 2014

Dec 2013

Dec 2012

Dec 2011

-60%

2015: Accounts receivable in Southern Europe

further decreased

67 Sovereign country ratings from Standard & Poor’s, as of 6 Jan 2016

-14.0 +14.9 -14.1

-11.5

-3.5 Dividends -7.0

Taxes -3.7

Treasury -0.8

2015: Group net debt development

Net debt stable vs. 2014

68

0

Net debt

31 Dec 2014

Operating Free

Cash Flow

Business combinations, Currency translation

& other

Net debt

31 Dec 2015

Non-op. FCF

Free Cash Flow CHF 3.4bn

vs. 5.3bn in 2014

CHFbn

Business combinations -2.1

Currency translation, other -1.4

CER

sales

growth

2015

vs.

2014

Exchange rate impact on sales growth

Negative impact from EUR, LATAM and Europe more than offsetting positive impact of USD

CER = Constant Exchange Rates (avg full year 2014)

+5.3%

+1.4%

+2.3p -0.1p -0.3p -0.7p

-1.0p

-1.4p

-2.7p

CER USD As-Pac Other JPY Other

Europe

LATAM EUR CHF

CHF

sales

growth

2015

vs.

2014

69

Currency impact in 2015/2016

Q1 HY Sep

YTD

FY

Sales -2 -3 -4 -4

Core

operating

profit

-4 -6

Core EPS -7 -10

In 2015 impact1 is (%p): CHF / USD

CHF / EUR

+1%

+1%

+2% +2%

0.95 0.93 0.96 0.970.950.93 0.93 1.01 0.990.970.970.98

0.950.95

0.95

0.96

0.91

0.890.900.89

J F M A M J J A S O N D

1.10 1.06 1.06 1.04 1.04 1.05 1.05 1.08 1.09 1.09 1.08 1.08

1.22 1.22 1.211.22

1.071.06

1.08 1.06

J F M A M J J A S O N D

Average

YTD

2014

7% 6%

6% 5%

-12% -13% -13% -12%

Average

YTD 2015

Monthly avg fx rates 2015 Fx rates at 31 Dec 2015

70

In 2016 currency impact1 expected is

(based on 31 Dec 2015 FX rates):

• No FX impact on sales

• -2%p on Core OP and up to -5%p on

Core EPS

1 On Group growth rates

2016 outlook

71

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)

Changes to the development pipeline

Q4 2015 update

73

New to Phase I New to Phase II New to Phase III New to Registration 7 NMEs transitioned from Ph0

RG4929 NME – glaucoma

RG7834 NME – HBV

RG7461 FAP IL2v FP – solid tumors

RG7916 SMN2 (2) splicer – SMA

RG7845 BTK ihn - autoimmune diseases

RG7861 NME – infectious diseases

RG7992 NME – metabolic diseases

1 NME following Adheron acquisition

RG6125 Cadherin-11 MAb - RA

4 AIs

RG7159 obinutuzumab – hypersensitized

renal transplant

RG7159 Gazyva multiple combos - heme

indications

RG3616 Erivedge + Esbriet – IPF

RG7446 atezolizumab combo Kadcyla/

Herceptin+Perjeta – HER2+ breast cancer

1 AI

RG7159 obinutuzumab – lupus

nephritis

1 opt-in deal signed

PRO VAP-1 inh – inflammatory

diseases

1 NME transitioned from Ph1

RG7388 idasanutlin – AML

1 NME transitioned from Ph2

RG6013 emicizumab (FIXa/FX

bispecific MAb) – hemophilia A

1 AI transitioned from Ph2

RG1569 Actemra – systemic

sclerosis

2 NMEs transitioned from Ph2

RG7446 atezolizumab – bladder

cancer 2L

RG7601 venetoclax – CLL rel/ref

Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration

2 NMEs

RG7450 anti-Steap 1 ADC – prostate ca.

RG7689 NME – infectious diseases

1 NME

RG7599 lifastuzumab vedotin – Pt-

resistant ovarian cancer

1 AI

RG3502 Kadcyla – HER2+

gastric cancer 2L

1 NME following approval in

EU/US

RG7421 Cotellic+Zelboraf –

metastatic melanoma

Status as of January 28, 2016

Roche Group development pipeline

74

Phase I (40 NMEs + 17 AIs)

Raf & MEK dual inh solid tumors

ChK1 inh solid tum & lymphoma

lumretuzumab mBC

atezo+Zelboraf+/-Cotellic melanoma

atezo+Avastin+chemo solid tumors

atezo+Tarceva /Alecensa NSCLC

atezolizumab+Cotellic solid tumors

venetoclax+Gazyva CLL

atezolizumab solid tumors

ERK inh + Cotellic solid tumors

LSD1 inh AML

anti-Ly6E ADC solid tumors

MDM2 (4) IV prodrug AML

ADC ovarian ca

atezolizumab+ipi/IFN solid tumors

OX40 MAb solid tumors

ranibizumab PDS wAMD

Nav1.7 inh pain

VEGF-ANG2 biMAb wAMD

a-synuclein MAb Parkinson's Disease

SMN2 splicer spinal muscular atrophy

RG3645

RG7893

RG7716

RG7935

RG7800

HIF1 alpha LNA solid tumors

RG7304

RG7741

RG7116

RG7446

RG7446

RG7446

RG7446

RG7601

RG7446

RG7842

RG6016

RG7841

RG7775

RG7882

RG7446

RG7888

RG6061

CEA CD3 TCB+atezolizumab s. tumors RG7802

CD40 MAb+atezolizumab solid tumors RG7876

atezolizumab+Gazyva lymphoma RG7446

IL-22Fc inflammatory diseases RG7880

Cat-S antag autoimmune diseases RG7625

DBO β-lactamase inh bact. infections RG6080

emactuzumab + atezolizumab s. tumors RG7155

SERD (2) ER+(HER2-neg) mBC RG6047

IDO inh solid tumors RG6078

duligotuzumab + Cotellic solid tumors RG7597

venetoclax heme indications RG7601

therapeutic vaccine HBV RG7944

CEA IL2v FP+atezolizumab solid tumors RG7813

OX40 MAb + atezolizumab solid tumors CLL RG7888

- fibrosis RG6069

atezo+lenalidomide multiple myeloma RG7446

IDO inh + atezolizumab solid tumors RG6078

PTH1 recep. ago hypoparathyroidism CHU

crenezumab Alzheimer’s RG7412

basimglurant TRD

polatuzumab vedotin heme tumors RG7596

V1 receptor antag autism RG7314

ipatasertib solid tumors RG7440

Flu A MAb influenza A RG7745

nemolizumab (IL-31R) atopic dermatitis CHU

atezolizumab NSCLC 2/3L RG7446

basmisanil Down syndrome RG1662

emactuzumab PVNS/solid tumors RG7155

vanucizumab mCRC RG7221

Cotellic+paclitaxel TNBC RG7421

SERD ER+(HER2-neg) mBC RG6046

URAT1 inh gout CHU

Kadcyla HER2+ NSCLC RG3502

lebrikizumab +/- Esbriet IPF RG3637

olesoxime spinal muscular atrophy RG6083

TLR7 agonist HBV RG7795

lebrikizumab atopic dermatitis RG3637

Phase II (18 NMEs + 13 Als)

CD20/CD3 biMAb heme tumors RG7828

ASO Huntington’s Disease IONIS

Flu B MAb influenza B RG6024

FAP-DR5 biMAb solid tumors RG7386

lebrikizumab COPD RG3637

- glaucoma

nemolizumab (IL-31R) pruritus dialysis pts CHU

danoprevir HCV RG7227

obinutuzumab renal transplant RG7159

Cadherin-11 MAb RA RG6125

RG4929

- HBV

FAP IL2v FP solid tumors

SMN2 splicer(2) spinal muscular atrophy

BTK inh autoimmune diseases

- infectious diseases

RG7834

RG7461

RG7916

RG7845

RG7861

- metabolic diseases RG7992

RG7861

PT - hyperphosphatemia CHU

RG-No Roche/Genentech managed

CHU Chugai managed

IONIS IONIS managed

PRO Proximagen managed

codrituzumab liver cancer RG7686

taselisib ER+(HER2-neg) BC neoadj RG7604

taselisib NSCLC sq 2L RG7604

venetoclax DLBCL RG7601

venetoclax+Rituxan FL rel/ref RG7601

obinutuzumab lupus nephritis RG7159

RG7090

VAP-1 inh inflammatory diseases PRO

Gazyva multiple combos heme indications RG7159

atezolizumab + K/HP HER2+ BC RG7446

RG7986

Nav1.7 inh (2) pain RG6029

Erivedge+Esbriet IPF RG3616*

ADC r/r NHL RG7986

Immunology

New Molecular Entity (NME)

Oncology

Other

Ophthalmology Neuroscience

Infectious Diseases

CardioMetabolism

Additional Indication (AI)


Roche Group development pipeline

75

Phase III

(9 NMEs + 30 Als)

1 Global filing

2 EU only

3 Phase 3 ongoing

4 Approved in the US and Japan

lampalizumab geographic atrophy RG7417

Avastin glioblastoma 1L RG435

ocrelizumab RMS RG1594

Gazyva DLBCL1L RG7159

ocrelizumab PPMS RG1594

Actemra large-vessel vasculitis CHU

lebrikizumab severe asthma RG3637

Zelboraf melanoma adj RG7204

Perjeta+Herceptin HER2+gastric ca 1L RG1273

Actemra giant cell arteritis RG1569

etrolizumab ulcerative colitis RG7413

Perjeta+Herceptin HER2+ mBC 2L RG1273

Alecensa (alectinib) ALK+ NSCLC 1L RG7853

Gazyva iNHL rituximab-refractory RG7159

Gazyva follicular lymphoma 1L RG7159

venetoclax+Rituxan CLL rel/ref RG7601

gantenerumab Alzheimer’s RG1450

atezolizumab NSCLC 2L RG7446

Kadcyla + Perjeta HER2+ BC adj RG3502

Kadcyla + Perjeta HER2+ BC neoadj RG3502 IL-6R MAb neuromyelitis optica CHU

Perjeta+Herceptin HER2+ BC adj RG1273

Kadcyla HER2+ BC adj RG3502

venetoclax+Gazyva CLL 1L RG7601

Avastin rel. ovarian ca. Pt-sensitive RG4351

atezolizumab bladder cancer 2L RG74463

atezolizumab+Avastin RCC RG7446

MabThera SC CLL RG105

Avastin+Tarceva EGFR mut+ NSCLC RG4352

atezolizumab+chemo NSCLC non-sq. 1L 1L RG7446

NSC atezo+chemo+Avastin NSCLC non-sq. 1L RG7446

atezolizumab+chemo NSCLC sq. 1L RG7446

atezolizumab Dx+ NSCLC sq. 1L RG7446

atezolizumab Dx+ NSCLC non-sq. 1L RG7446

taselisib ER+(HER2-neg) mBC RG7604

etrolizumab Crohn’s disease RG7413

MabThera pemphigus vulgaris RG105

atezolizumab+abraxane TNBC RG7446

atezolizumab Dx+ NSCLC adj RG7446

atezolizumab muscle inv. bladder ca adj RG7446

Registration

(3 NMEs + 3 Als)

Alecensa (alectinib) ALK+ NSCLC 2L RG78534

idasanutlin AML RG7388

emicizumab (FIXa/FX biMAb)hemophilia A RG6013

venetoclax CLL rel/ref RG7601

Actemra systemic sclerosis RG1569

Immunology

New Molecular Entity (NME)

RG-No Roche/Genentech managed

CHU Chugai managed

ISIS ISIS managed

PRO Proxymagen managed

RG105 MabThera is branded as Rituxan in US and Japan

RG1569 Actemra is branded as RoActemra in EU

RG7159 Gazyva is branded as Gazyvaro in EU

Oncology

Other

Ophthalmology

Neuroscience

Infectious Diseases

CardioMetabolism

Additional Indication (AI)

Immunology


NME submissions and their additional

indications

Projects currently in phase II and III

76 Unless stated otherwise, submissions are planned to occur in US and EU

✓Indicates a submission which has occurred with regulatory action pending * EU submission pending

ocrelizumab (RG1594) RMS

danoprevir (RG7227) HCV

crenezumab (RG7412) Alzheimer‘s

gantenerumab (RG1450) Alzheimer‘s

V1 receptor antag (RG7314) autism

codrituzumab MAb (RG7686) liver cancer

lampalizumab (RG7417) geographic atrophy

lebrikizumab (RG3637) severe asthma

etrolizumab (RG7413) ulcerative colitis

2015 2018 and beyond

atezolizumab(RG7446) NSCLC 2/3L

ipatasertib (RG7440) solid tumors

polatuzumab vedotin (RG7596)

heme tumors

lebrikizumab+/-Esbriet (RG3637) IPF

2016

atezolizumab(RG7446) combo Avastin RCC

Flu A MAb (RG7745) influenza

taselisib (RG7604) HER2 neg ER+ mBC

basmisanil GABRA5 NAM

Down syndrome

atezolizumab US* ✓

bladder cancer 2L

emactuzumab (RG7155)

PVNS and solid tumors

venetoclax (RG7601)

DLBCL

vanucizumab (RG7221)

colorectal cancer

ocrelizumab (RG1594) PPMS

emicizumab FIXa /FX biMAb (RG6013) hemophilia A

Cotellic+paclitaxel TNBC

venetoclax (RG7601) + Gazyva CLL 1L

venetoclax (RG7601) + Rituxan FL rel/ref CLL

venetoclax (RG7601) ✓ CLL rel/ref

SERD (RG6046) ER+(HER2-neg) mBC

2017

Alecensa (alectinib) ✓ Alk+ NSCLC 2L

olesoxime (RG6083) SMA

atezolizumab(RG7446)+ chemo NSCLC non-sq 1L

etrolizumab (RG7413) Crohn’s disease

atezolizumab(RG7446) NSCLC sq 1L (Dx+)

atezolizumab(RG7446) NSCLC non-sq 1L (Dx+)

atezolizumab(RG7446)+ chemo NSCLC sq 1L

atezolizumab(RG7446)+chemo + Avastin NSCLC non-sq 1L

taselisib ( RG7604) ER+(HER2-neg) BC neoadj

New Molecular Entity Oncology

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Other

venetoclax+Rituxan (RG7601) CLL rel/refractory


lebrikizumab (RG3637) atopic dermatitis

TLR7 ago (RG7795) HBV

atezolizumab (RG7446) NSCLC adj (Dx+)

atezolizumab (RG7446) + abraxane TNBC

atezolizumab (RG7446) MIBC adj

lebrikizumab (RG3637) COPD

VEGF/ANG2 biMAb(RG7716) wAMD

ipatasertib (RG7440) solid tumors

polatuzumab vedotin (RG7596)

heme tumors

emactuzumab (RG7155)

PVNS and solid tumors

vanucizumab (RG7221)

colorectal cancer

SERD (RG6046) ER+(HER2-neg) mBC

taselisib ( RG7604) NSCLC sq 2L

taselisib ( RG7604) ER+(HER2-neg) BC neoadj

idasanutlin

AML

2015 2018 and beyond

✓ Indicates submission to health authorities has occurred

* Approved in EU

Unless stated otherwise, submissions are planned to occur in US and EU.

Submissions of additional indications for

existing products

Projects currently in phase II and III

77

Actemra systemic sclerosis

Perjeta + Heceptin HER2-pos. BC adj.

Perjeta+Herceptin

HER2-pos. gastric cancer 1L

Kadcyla

HER2-pos. BC adj.

Actemra giant cell arteritis

2016

Avastin (US)

GBM

Gazyva DLBCL 1L

Gazyva

iNHL rituximab-ref. ✓

Gazyva follicular lymphoma 1L

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Perjeta + Herceptin

HER2-pos. mBC 2L

Avastin +Tarceva (EU) ✓

EGFR mut+ NSCLC

Avastin rel. ovarian ca. Pt-sens.*

Kadcyla+Perjeta

HER2-pos. BC adj.

Kadcyla+Perjeta

HER2-pos. BC neoadj.

Kadcyla

HER2-pos. NSCLC

2017

Zelboraf

melanoma adj.

MabThera pemphigus vulgaris

ranibizumab PDS (US) wAMD

Alecensa (alectinib)1L Alk+ NSCLC

obinutuzumab

lupus nephritis


Major granted and pending approvals 2015

78

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

EU

US

Approved Pending approvals

Avastin cervical cancer

April 2015

Perjeta HER2+ BC neoadj.

July 2015

Cotellic + Zelboraf

m. melanoma

November 2015

MabThera SC CLL

Filed November 2014

Cotellic + Zelboraf

m. melanoma

November 2015

Lucentis diabetic retinopathy

February 2015


Japan-Chugai Xeloda gastric cancer adj.

November 2015

Bonviva osteoporosis (oral)

January 2016

Avastin + Tarceva EGFR mut+ NSCLC

Filed July 2015

Alecensa (alectinib)

ALK+ NSCLC 2L

Filed September 2015

Alecensa (alectinib)

ALK+ NSCLC 2L

December 2015

Gazyva iNHL rituximab-ref. Filed August 2015

Gazyva iNHL rituximab-ref.


Avastin

cervical cancer


atezolizumab

bladder cancer 2L

Filed January 2016

venetoclax

CLL rel/ref

Filed October 2015

venetoclax + Rituxan FL rel/ref TNBC

Roche Group Development pipeline

Combinations

79

Phase III

(12 AIs)

atezo+Zelboraf+/-Cotellic melanoma


atezo+Tarceva/ Alecensa NSCLC

atezolizumab +Cotellic solid tumors

atezolizumab +ipi/IFN solid tumors

RG7446

RG7446

RG7446

RG7446

RG7446

CD40 MAb+atezolizumab s. tumors RG7876


emactuzumab + atezolizumab s.tumors RG7155


atezo+chemo NSCLC non-sq. 1L RG7446



New Molecular Entity (NME) Additional Indication (AI)

Oncology

Immunology

RG-No Roche Genentech managed

OX40 MAb + atezolizumab s. tumors RG7888



CEA IL2v FP+atezolizumab s. tumors RG7813


venetoclax+Gazyva CLL

ERK inh + Cotellic solid tumors

RG7601

RG7842

duligotuzumab+Cotellic solid tumors RG7597

Cotellic+paclitaxel TNBC RG7421

lebrikizumab +/- Esbriet IPF

RG7601

RG3637

Perjeta+Herceptin HER2+gastric ca 1L RG1273

Perjeta+Herceptin HER2+ mBC 2L RG1273

venetoclax+Rituxan CLL rel/ref RG7601

Kadcyla + Perjeta HER2+ BC adj RG3502

Kadcyla + Perjeta HER2+ BC neoadj RG3502

Perjeta+Herceptin HER2+ BC adj RG1273

venetoclax+Gazyva CLL 1L RG7601

Avastin+Tarceva EGFR mut+ NSCLC RG4351

1 EU only

Phase I

(5 NMEs + 14 AIs)

Phase II

(3 Als)

Registration

(1 AI)

atezolizumab + K/ H+P HER2+BC RG7446

CEA CD3 TCB+atezolizumab s. tumors RG7802


Erivedge+Esbriet IPF RG3616*

Gazyva multiple combos heme indications RG7159

Cancer immunotherapy pipeline overview

80

Phase I

(7 NMEs+16 AIs)

Phase II

(1 NME + 1 Al)

Phase III

(10 AIs)


atezo+Tarceva NSCLC EGFR+

atezolizumab +Cotellic solid tumors

atezolizumab solid tumors

atezolizumab +ipi/IFN solid tumors

OX40 MAb solid tumors

RG7446

RG7446

RG7446

RG7446

RG7446

RG7888

CEA CD3 TCB + atezolizumab s. tumors RG7802

CD40 MAb+atezolizumab solid tumors RG7876


emactuzumab + atezolizumab s.tumors RG7155

IDO inh solid tumors RG6078


atezolizumab NSCLC 2/3L RG7446

emactuzumab PVNS/solid tumors RG7155 atezolizumab bladder cancer 2L RG7446

atezolizumab NSCLC 2L RG7446

atezo+chemo NSCLC non-sq. 1L RG7446



atezolizumab Dx+ NSCLC sq. 1L RG7446

atezolizumab Dx+ NSCLC non-sq. 1L RG7446

atezolizumab + IDO inh solid tumors *INCB

atezolizumab +varlilumab solid tumors *CDX

New Molecular Entity (NME) Additional Indication (AI)

Oncology

RG-No Roche Genentech managed

OX40 MAb + atezolizumab solid tumors RG7888



atezolizumab Dx+ NSCLC adj RG7446

atezolizumab muscle inv. bladder ca adj RG7446

CEA IL2v FP+atezolizumab solid tumors RG7813


CD20/CD3 biMAb hem tumors RG7828

Registration

(1 NME)

FAP IL2v FP solid tumors RG7461


atezo+Zelboraf+/-Cotellic m. melanoma RG7446

atezolizumab + K/HP HER2+ BC RG7446

* External collaborations: INCB- Incyte INCB024360,

CDX-1127- Celldex CD27 MAb; CO – Clovis CO-1686

CPI – Corvus CPI-444

atezo+rociletinib EGFRmut+ NSCLC *CO

atezo+A2Ai solid tumors *CPI

Doing now what patients need next

Documents

Roche · match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation,