roche marketed products discussed in this presentation, please see full prescribing information on...

Roche

Q1 2015 sales

Basel, 22 April 2015

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

Q1 2015: Highlights

5

Innovation

• Second Breakthrough Therapy Designation for anti-PDL1

• Phase 3 starts: Seven in immuno-oncology, etrolizumab in Crohn’s disease and taselisib in HR+

breast cancer

Growth

• Group sales +5%1 driven by HER2 franchise (+23%1), Avastin (+6%1), Actemra (+27%1) and

Professional Diagnostics (+6%1)

• Esbriet: Off to a strong start

M&A

• Foundation Medicine: Transaction closed

1 CER=Constant Exchange Rates

Q1 2015: Strong sales growth


2015 2014

CHFbn CHFbn CHF CER

Pharmaceuticals Division 9.3 9.0 3 4

Diagnostics Division 2.5 2.5 2 6

Roche Group 11.8 11.5 3 5

Change in %

Q1 2015: Continued strong growth in all regions

7

0

1

2

3

4

5

6

Japan International Europe US

Diagnostics

Pharma

CHFbn

+6%

+1% +9%

-2%

+3% +14%

-10%

+3%

+6%

+1%

-3%

+10%

*

* Japanese sales impacted by consumption tax base effect

CER=Constant Exchange Rates

Q1 2015: Sales growth for 5th consecutive year

8 All growth rates at Constant Exchange Rates (CER)

0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

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

Progressing in Personalised Healthcare

60% of phase 2 & 3 products have PHC component

9

Marketed Phase 2 Phase 3/Registration

FIXa/FX bispecific MAb

SERD

CSF-1R MAb

Ang2-VEGF MAb

ipatasertib

polatuzumab vedotin

lifastuzumab vedotin

glypican-3 MAb

MAO-B inh

GABRA5 NAM

bitopertin

basimglurant

V1 receptor antag

crenezumab

olesoxime

danoprevir

Flu A MAb

LptD antibiotic

PD-L1 MAb

venetoclax (Bcl-2 inh)

alectinib (ALK inh)

taselisib

cobimetinib

lebrikizumab

etrolizumab

gantenerumab

ocrelizumab

lampalizumab

Tarceva®

Zelboraf®

Erivedge®

Rituxan®

Gazyva®

Herceptin®

Perjeta®

Kadcyla®

Avastin®

Xeloda®

Esbriet®

Pulmozyme®

Xolair®

Actemra®

Lucentis®

Oncology

Immunology

Infectious Diseases

Neuroscience

Ophthalmology

Molecular Diagnostics

Tissue Diagnostics

Professional Diagnostics

Roche: Making progress in advancing patient care

Recognising innovation 2012-15

10

Rank Company #

1 Roche 6

1 GSK 6

3 Novartis 5

4 Merck 4

5 JNJ 4

6 Breakthrough Therapy Designations

Source: FDA

Q1 2015 Anti-PDL1 (NSCLC)

2014

Esbriet

Lucentis Diabetic Retinopathy

Anti-PDL1 (bladder)

2013 Alectinib

Gazyva

2015 outlook

11

Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth2

Dividend outlook Further increase dividend in Swiss francs

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

12

Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals

Q1 2015 sales

Innovation

Outlook

13

Q1 2015: Strong sales growth driven by US and

International

14

2015 2014

CHFm CHFm CHF CER

Pharmaceuticals Division 9,322 9,040 3 4

United States 4,392 3,873 13 6

Europe 2,178 2,425 -10 1

Japan 763 845 -10 -2

International 1,989 1,897 5 9

Change in %


Q1 2015: Strong performance from oncology and

immunology franchises; Esbriet off to a good start

15 15 Absolute amounts and growth rates at Constant Exchange Rates (CER)

-200 -150 -100 -50 0 50 100 150 200

Xeloda

Pegasys

Valcyte/Cymevene

Lucentis

Xolair

Actemra/RoActemra

Kadcyla

Avastin

MabThera/Rituxan

Esbriet

Perjeta

Herceptin

US

Europe

Japan

International

+12%

+82%

n.a.

+5%

+6%

+27%

+80%

-53%

-39%

+28%

CHFm

-41%

-9%

Q1 2015: Oncology products with +6% growth

16

0 1 2

Zelboraf

Xeloda

Tarceva

MabThera/

Rituxan

Avastin

HER2

Kadcyla

Perjeta

Herceptin +23%

+6%

+4%

-3%

-53%

-25%

CER=Constant Exchange Rates; Q1 2015 Oncology sales: CHF 5.8bn

• In-class competition

• Loss of exclusivity

• US: Continued uptake in ovarian, cervical and lung

• EU: Growth in ovarian and breast

• Strong uptake of Perjeta & Kadcyla

• Accelerated growth of Herceptin

• Competitive pressure in US & EU

• Approval of coBRIM expected in 2015

• Increased usage across a variety of indications

CHFbn

YoY CER growth

+23%

+6%

+4%

-3%

-53%

-25%

HER2 franchise: Growth of Perjeta also driving

Herceptin sales

17

0

600

1'200

1'800

2'400

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Kadcyla Perjeta Herceptin

15%

YoY CER growth CHFm

15% 20% 17%

23%

7%

23% 19% 23%


Herceptin SC launched in 44 countries

Conversion rate already exceeds 30%

18

SC share of Herceptin sales in

launched countries

0%

5%

10%

15%

20%

25%

30%

35%

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Sale

s m

ark

et

share

(%

)

Number of countries where

Herceptin SC has been launched

0

10

20

30

40

50

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Tota

l num

ber

of

countr

ies

Avastin: Strong growth across various indications

and in all regions


Avastin Q1 2015

• Main growth drivers are ovarian

(US; EU), lung (US) and cervical

cancer (US)

• EU: Positive momentum in breast

cancer due to IMELDA

• International (+11%) in all regions

Outlook

• EU launch in cervical cancer 0

300

600

900

1'200

1'500

1'800

Q1 12 Q1 13 Q1 14 Q1 15

CHFm

US Europe International Japan

YoY CER growth

+1%

+11% +6% +9%

0

500

1'000

1'500

Q1 12 Q1 13 Q1 14 Q1 15

Other (incl Esbriet) PulmozymeCellCept XolairActemra SC Actemra IVMabThera/Rituxan

Immunology franchise remains driven by Actemra,

Xolair and MabThera/Rituxan

20

• Actemra (+27%): SC launch and

1L monotherapy setting

• Xolair (+28%): Allergic asthma

and strong growth in Chronic

Idiopathic Urticaria (CIU) post

FDA approval in Q1 ‘14

• MabThera/Rituxan (+11%):

Continues to grow in rheumatoid

arthritis and vasculitis (GPA and

MPA)

CHFm YoY CER growth

+5% +11%

+11%

+20%

GPA=Granulomatosis with polyangiitis; MPA=Microscopic polyangiitis


200

300

400

500

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

Ophthalmology franchise: Competitive pressure

on Lucentis; Fast Track status for lampalizumab

21

Lucentis sales

Lucentis

DME

AMD

Less-frequent than

monthly dosing

wAMD=wet age-related macular degeneration; DME=diabetic macular edema

Lucentis Q1 2015

• Continued competitive pressure in

wAMD

• First-in-class FDA approval to treat

diabetic retinopathy (DR) in patients

with DME

Lucentis outlook

• Ongoing competition in AMD & DME

• First sales in DR

Lampalizumab update

• FDA granted Fast Track status for

geographic atrophy (GA)

• Ph3 global enrollment well on track

USDm

Esbriet: Off to a strong start

22

US launch off to strong start

• Patients still in transition to full

reimbursement post approval

• Establishing market leadership in IPF

European sales with continued

growth

• Label was strengthened by including

ASCEND and pooled 1Y mortality data

Esbriet sales (CHFm)

27 32

36

44

88

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

Q1 2015 sales

Innovation

Outlook

23

Gazyva: First positive readout in iNHL

24

GADOLIN: Ph III MabThera/Rituxan refractory indolent non-Hodgkin`s lymphoma (iNHL)

MabThera x 8 cycles + CHOP x

6 or 8

Gazyva x 8 cycles +

CHOP x 6 or 8 Front-line DLBCL

(aggressive NHL)

n=1,418

Primary end-point: PFS

Trial to continue until 2016

MabThera

q2mo x 2 years

Gazyva

q2mo x 2 years

MabThera x 8 cycles + CHOP x 6 or MabThera x 8

cycles + CVP x 8 or MabThera x 6 cycles + benda. x 6

CR, PR

Gazyva x 8 cycles + CHOP x 6 or

Gazyva x 8 cycles + CVP x 8 or

Gazyva x 6 cycles + benda. x 6 Front-line iNHL

n=1,401

Induction Maintenance


Enrolment complete Q1 2014

Data expected 2017

Gazyva

q2mo x 2 years

CR, PR,

SD

bendamustine

x 6 cycles

Gazyva

+ bendamustine

x 6 cycles MabThera-refractory iNHL

n=411

Induction Maintenance


Data at ASCO 2015

GOYA: Ph III diffuse large B-cell lymphoma (DLBCL)

GALLIUM: Ph III front-line indolent non-Hodgkin`s lymphoma (iNHL)

In collaboration with Biogen Idec

CHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, Vincristine and Prednisolone

CLL11: Ph III front-line chronic lymphocytic leukemia (CLL)

chlorambucil

MabThera/Rituxan +

chlorambucil

Gazyva 1000mg IV +

chlorambucil

Front-line CLL

n=781


Approved in Q4 2013

Roche cancer immunotherapy

Extensive phase III program to start in 2015

25

Phase II Phase III

PDL1

NSCLC (Dx+)

PDL1

2/3L NSCLC

PDL1+Avastin

1L Renal

PDL1

1/2L Bladder

Phase I

OX40

Solid tumors

CEA CD3

Solid tumors

IDO

Solid tumors

CSF-1R

Solid tumors

PDL1

Solid tumors

PDL1+Zelboraf

Melanoma

PDL1+Tarceva

NSCLC

PDL1+Avastin+FOLFOX

CRC

PDL1 + Gazyva

Blood cancer

CEA IL2v

Solid tumors

PDL1

TNBC

PDL1+Avastin

Solid tumors

PDL1+cobimetinib

Solid tumors

PDL1+ipilimumab

Solid tumors

PDL1+CD40

Solid tumors

PDL1+IFN-alfa

Solid tumors

PDL1+CSF-1R**

Solid tumors

PDL1+CEA IL2v**

Solid tumors

PDL1+OX40**

Solid tumors

PDL1+Zelboraf+cobi**

Solid tumors

PDL1

2/3L NSCLC

PDL1**

2/3L Bladder

PDL1+Avastin+chemo**

1L non sq NSCLC

PDL1+chemo**

1L non sq NSCLC

PDL1+chemo**

1L sq NSCLC

PDL1**

1L non sq NSCLC (Dx+)

PDL1**

1L sq NSCLC (Dx+)

PDL1+chemo**

1L TNBC

PDL1**

tba

PDL1**

tba

PDL1+Avastin**

1L RCC

Anti-PDL1 trials

NMEs monotherapy

2015 readout expected

Study start in 2015

Immune doublets

**

Status as at April 22, 2015

PDL1**

tba

PDL1**

tba

PDL1**

tba

Breakthrough Therapy Designation granted for

anti-PDL1 in 2/3L NSCLC in Q1

26

Primary end-point: ORR

Data at ASCO

All comers 2/3L NSCLC

(stratified by PDL1

expression)

n = 1100

docetaxel

75 mg/m2 IV Q3 wk

anti-PDL1

1200 mg IV Q3 wk

OAK: Ph III 2/3L mNSCLC

Primary end-point: OS

FPI Q1 2014

Data expected 2016

FIR: Ph II Dx-selected advanced metastatic Non-Small Cell Lung Cancer (mNSCLC)

PDL1-selected NSCLC

n = 138

anti-PDL1 1200 mg IV

Q3 weeks

POPLAR: Ph II 2/3L mNSCLC

Primary end-point: OS

Interim data at ASCO

Final data in H2 2015

All comers 2/3L NSCLC

(stratified by PDL1

expression)

n = 287

docetaxel

75 mg/m2 IV Q3 wk

anti-PDL1

1200 mg IV Q3 wk

BIRCH: Ph II Dx-positive advanced mNSCLC

PDL1-selected NSCLC

n = 667

anti-PDL1 1200 mg IV

Q3 weeks Primary end-point: ORR

Data in Q3 2015

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

Five anti-PDL1 phase III studies started addressing

the entire 1L metastatic lung cancer market

27

Study Indication Patient population Treatment arms n Primary

completion*

Combination studies

GO29436 1L Non-squamous

NSCLC

All comers

(PD-L1 subgroup

analysis)

carbo/pac/anti-PDL1

carbo/pac/Avastin/anti-PDL1

carbo/pac/Avastin

1,200 2017 (PFS)


NSCLC

All comers

(PD-L1 subgroup

analyis)

carbo/nab-p/anti-PDL1

carbo/nab-p 550 2017 (PFS)

GO29437 1L Squamous

NSCLC

All comers

(PD-L1 subgroup

analysis)

carbo/pac/anti-PDL1

carbo/nab-p/anti-PDL1

carbo/nab-p

1,200 2017 (PFS)

Monotherapy studies


NSCLC PD-L1 selected

anti-PDL1

cis or carbo/pem 400 2017 (PFS)

GO29432 1L Squamous

NSCLC PD-L1 selected

anti-PDL1

cis or carbo/gem 400 2018 (PFS)

Carbo = Carboplatin; Pac = Paclitaxel; Nab-p = Nab-paclitaxel; Cis = Cisplatin; Pem = Pemetrexed; Gem = Gemcitabine

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

* Outcome studies are event driven, timelines may change, OS endpoint included for all studies

Anti-PDL1 phase III study announced in TNBC

Updated phase I data presented at AACR

28

PD-L1

IHC (IC)

TNBC a

n

ORR,

Best

Respons

e, b %

(95% CI)

PD-L1+

vs PD-

L1- ORR, b %

(95% CI)

IHC 3 6 17%

(1,60) 33%

(10,70) IHC 2 3

67%

(14,98)

IHC 1 - - -

IHC 0 - - -

IC2/3 patientsa, nb ORR

(95% CI)

24-Week PFS

(95% CI)

21 19%

(5-42)

27%

(7-47)

• Anti-PDL1 was generally well tolerated

(n=54)

• Responses included

– 2 CRs (1 IC3 and 1 IC2) and 2 PRs (IC2)

– 3 of 4 responses ongoing

• In addition, three patients recorded as PD

appeared to experience

pseudoprogression, with durable

shrinkage of target and new lesions

• Phase III study to start in H2 2015

a PD-L1 expression was centrally evaluated on tumor-infiltrating immune cells (ICs) based on an immunohistochemistry (IHC) assay; b IC0/1 patients not yet evaluable for efficacy Emens LA, et al. AACR 2015

Foundation Medicine (FMI)

Molecular Information supporting drug development

29

Transaction closed in April 2015

Roche/FMI R&D Collaboration

DNA & RNA

sequencing

1. Comprehensive tumor analysis in

Roche` Clinical Trials

2. We will innovate together

Blood based

continuous monitoring

Immunotherapy

Panel

• Our phase III anti-PDL1 program is a

primary focus of the collaboration

• We will use FMI's FoundationOne next

generation DNA sequencing to look

at a spectrum of DNA mutations

• We will also be working with

Foundation Medicine to develop RNA

signatures that may be predictive of

patient benefit

Amyloid pathway and targets

Alzheimer’s disease: Renewed confidence in Aß

hypothesis

Cell membrane

• Aducanumab (BIIB): Similar to

gantenerumab by measure of

target engagement

• Gantenerumab and

crenezumab: Assessment on-

going to inform next steps

Aß mAb's

Amyloid

Precursor

Protein (APP) oligomeric Aβ

soluble Aβ

fibrillar Aβ

solanezumab crenezumab

bapineuzumab

gantenerumab

aducanumab

BAN2401

30

Q1 2015 sales

Innovation

Outlook

31

ASCO 2015: Highlights in various cancer types

32

Skin

• cobimetinib + Zelboraf: Ph III (coBRIM) in 1L BRAF+ mM; PFS & biomarker update

• cobimetinib + Zelboraf: Ph Ib (BRIM7) in BRAF+ mM; OS update

Lung

• alectinib: Two Ph II in 2L ALK+ NSCLC

• anti-PDL1: Ph II interim (POPLAR) in 2/3L NSCLC

• anti-PDL1: Ph II (FIR) in PDL1-selected advanced NSCLC

• anti-PDL1: Ph I update in NSCLC

• anti-PDL1: Ph I data from chemo combinations in NSCLC

• anti-PDL1: Biomarker analysis in NSCLC

Bladder • anti-PDL1: Ph I update in bladder

Breast • Kadcyla + Perjeta: Ph III (MARIANNE) in 1L

HER2+ mBC; primary data • Avastin + Letrozole: Ph III (CALGB40503) in 1L

HR+ mBC • Herceptin + Perjeta: Ph II (NEOPSPHERE) in

neoadjuvant HER2+ BC

Hematology • Gazyva: Ph III (GADOLIN) in R/R iNHL • Polatuzumab vedotin: Ph II (ROMULUS)

interim data in R/R iNHL

Zelboraf in collaboration with Plexxikon; Cobimetinib in collaboration with Exelixis; Alectinib in collaboration with Chugai, Gazyva in

collaboration with Biogen Idec; Kadcyla in collaboration with ImmunoGen

2015: Key late-stage news flow

33

Compound Indication Milestone

Regulatory

Avastin Cervical cancer EU approval

Lucentis Diabetic retinopathy US approval

alectinib 2L ALK+ NSCLC US filing

cobimetinib + 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 MS (RMS) Ph III OPERA I/II

ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO

Perjeta 2L HER2+ mBC Ph III PHEREXA

Kadcyla HER2+ gastric cancer Ph II/III GATSBY

Phase III starts

anti-PDL1 ** 2/3L Bladder Ph III

anti-PDL1 ** 1L TNBC Ph III

anti-PDL1 ** 1L RCC Ph III

anti-PDL1 ** Tumor type 1 Ph III

etrolizumab Crohn`s disease Ph III

ACE910 Hemophilia A Ph III

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

Phase II readouts*

anti-PDL1 2/3L NSCLC Ph II FIR, POPLAR, BIRCH

anti-PDL1 Bladder Ph II

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

* Outcome studies are event driven, timelines may change; ** For anti-PDL1 only P3 trials in new indications are listed (1L NSCLC starts not shown)

Compound H1/H2

Regulatory

Avastin Positive opinion Feb 27

Lucentis Approved Feb 9

alectinib Q3

Cobimetinib +

Zelboraf PDUFA date: August 11, 2015

Phase III

readouts*

Gazyva

Gazyva to be communicated in H1

ocrelizumab Q2

ocrelizumab Q3

Perjeta 2H at SABCS 2015 (planed)

Kadcyla 2H

Phase III

starts

Anti-PDL1 1H

Anti-PDL1 1H (RCC)

Anti-PDL1 1H (TNBC)

Anti-PDL1 2H (MIBC)

Etrolizumab 1H

ACE910 2H

taselisib (PI3K

inhib) 1H

Phase II

readouts*

Anti-PDL1 1H (ASCO: FIR/POPLAR); 2H BIRCH

Anti-PDL1 2H ESMO

ipatasertib

(AKT inhib) ?

2016

Picture

34

Diagnostics Division Roland Diggelmann COO Roche Diagnostics

Q1 2015: Diagnostics Division sales

Good growth in all units

35

2015 2014

CHFm CHFm CHF CER

Diagnostics Division 2,511 2,456 2 6

Professional Diagnostics 1,425 1,392 2 6

Diabetes Care 507 538 -6 1

Molecular Diagnostics 401 370 8 10

Tissue Diagnostics 178 156 14 14

Change in %

Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%


North America

+5%

27% of divisional sales

Latin America

+11%


Japan

-10%

4% of divisional sales EMEA1

+4%


Q1 2015: Diagnostics regional sales

Strong performance in APAC

Asia Pacific

+16%


36

16% growth in E7 countries2

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

Q1 2015: Diagnostics

Growth driven by Professional Diagnostics

• Virology (+10%) incl. HPV (+39%)

• Ariosa: Entry into NIPT

• Accu-Chek Aviva/Performa (+2%) and insulin delivering systems (+10%)

• Advanced staining portfolio (+13%)

1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8%

CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa; NIPT=Non-invasive prenatal testing

YoY CER growth

+6% • Growth driven by immunodiagnostics (+11%) and

coagulation self testing (+14%)

0 0.5 1 1.5

Tissue Dia

Molecular

Dia

Diabetes

Care

Professional

Dia

EMEA

North America

RoW

Sales

CHFbn

37

1 +10%

+1%

+14%

Professional Diagnostics: Global launch of cobas

8100 version 2

Integrated cobas 8100 lab solutions Elecsys assay menu

Integrated Pre-analytics

Post-analytics

Modular analyzers

• Bidirectional sample flow between pre-analytical, analytical and post-analytical steps

optimizes laboratory workflow

• Automated sample check reduces work load and enhances patient safety

38

Cardiac Thyroid Tumormarker

Women'sHealth

InfectiousDiseases

Other Critical Care Anemia Hormones

Immunoassays: 26% of Diagnostic sales growing

double digit (+11%)

39

12%

6%

14%

23%

10%

30%

YoY CER growth

4%

9%

7%

CER=Constant Exchange Rates; “Other” include Needed Common Products, Allergy, Rheumatoid Arthritis, Immunosuppressants

Sales

Molecular Diagnostics: Launch of HBV Test for

cobas® 6800/8800 systems

40

Complements the viral load monitoring portfolio of cobas 6800/8800

• Lower sample requirement, higher sensitivity and faster test results across all genotypes

• Strengthens market lead in viral load testing and helps optimize therapy for patients

cobas® 8800

Modular analyzers

Pre-analytics

Integrated cobas® 8800

Roche sequencing: Delivering on acquisitions

NEXT* study results demonstrate superiority of Harmony test vs conventional testing

41

Study results

• Significant superiority of the HarmonyTM Prenatal Test over first trimester combined

screening for assessing risk of Trisomy 21

• Lowers number of false positives which may reduce the need for invasive testing

• Single largest trial > than 18,500 pregnant women

• Supports the use of NIPT as a first line screening option

* NEXT: Non-invasive examination of trisomy; NIPT=Non-invasive prenatal testing

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

RTD: Roche Tissue Diagnostics;

Key launches 2015

42

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

43

Finance Alan Hippe Chief Financial Officer

Q1 2015: Highlights

44

Currency impact

• EUR and JPY currencies major negative contributors

• Negative 2%p impact on Q1 2015 sales growth

Q1 debt refinancing and major cash outflows

• Two bond redemptions

– USD: 0.6 bn maturity in 2019 - coupon 6.00% s.a.

– GBP: 0.5 bn maturity in 2015 - coupon 5.50%

• Two bond issuances

– USD: 0.6 bn maturity in 2020 - coupon 2.00%

– EUR: 1.0 bn maturity in 2025 - coupon 0.875%

s.a. = Semi-annual coupon

FMI transaction

• Tender offer completed

• Roche owns ~57% of the outstanding shares of FMI’s common stock on a fully diluted basis

Q1 2015: Strong sales across the board

45 Absolute values in CHFm at CER = Constant Exchange Rates (avg full year 2014)

1 avg December 2014 to avg March 2015 fx * Japanese sales impacted by consumption tax base effect

+558

+246

-221

+337

+18

-17+140

+165

+6

United

States

Europe Intl. Chugai

(Japan)

Dia Diabetes

Care

Group Fx Group

CHF

Pharma Division

Dia Division

+6%

+6% +1% +9% -2% +7% +1% +5% +3%

+4%

1

*

CER

sales

growth

Q1 2015

vs.

Q1 2014

Exchange rate impact on sales growth

USD and EUR impacts balance out

46

+4.8%

+2.9%

+2.8%p +0.2%p -0.1%p -0.6%p

-0.6%p

-0.9%p

-2.7%p

CER USD Asia-

Pac

Other Lat-Am JPY Other

Europe

EUR CHF

CHF

sales

growth

Q1 2015

vs.

Q1 2014


Negative currency impact in 2015 expected

47

Q1 HY Sep

YTD

FY

Sales -2 -2 -3 -3

Core

operating

profit

-3 -4

Core EPS -7 -8

Assuming the 31 Mar 2015 exchange

rates remain stable until end of 2015,

2015 impact is expected to be (%p):

CHF / USD

CHF / EUR

+1%

+1%

+2% +2%

0.95 0.93 0.97 0.970.98 0.97 0.970.97 0.970.97 0.97 0.97

0.960.95

0.96 0.96

0.91

0.890.90

0.89

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

1.10 1.06 1.06 1.05 1.05 1.05 1.051.05 1.051.05 1.05 1.05

1.22 1.211.221.22

1.061.08

1.06 1.05

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

Average

YTD

2014

7% 8% 7%

5%

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

Assumed average YTD 2015

Monthly avg fx rates 2015 Fx rates at 31 March 2015

Roche: Net trade working capital

Continuous improvements over the years

Group NTWC / sales

48

31.6% 31.1%

29.7%

Dec-2012 Dec-2013 Dec-2014

Accounts payable

• Renegotiated existing supply payment terms

• Simplified downstream processes

• Established standard payment terms

Accounts receivable

• Southern Europe: Reduced accounts receivables

• Eastern Europe: Adopted EU payment terms

• Pro-active collection strategy

Note: NTWC calculated as Q4 average for all years; NTWC 2014 excl. Esbriet inventory step-up

2015 outlook

49

Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth2

Dividend outlook Further increase dividend in Swiss francs

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

Changes to the development pipeline

Q1 2015 update

51

New to Phase I New to Phase II New to Phase III New to Registration

1AI

RG7813 CEA IL2v + PD-L1MAb - solid

tumors

1 NME (Trophos acquisition)

RG6083 olesoxime - SMA

1 NME (shown to reflect upcoming

submission)

RG7853 alectinib - ALK-mut. pos.

NSCLC 2L

1 AI (previous P2 in solid tumors

split out)

RG7604 taselisib - NSCLC sq. 2L

1 NME

RG7604 taselisib - ER+/HER2-

neg mBC

7 AIs

RG7413 etrolizumab - Crohn’s

disease

RG7446 PD-L1 MAb Dx-pos.

patients - NSCLC sq. 1L

RG7446 PD-L1 MAb Dx-pos.

patients - NSCLC non-sq. 1L

RG7446 PD-L1 MAb + chemo -

NSCLC sq. 1L

RG7446 PD-L1 MAb + chemo -

NSCLC non sq. 1L

RG7446 PD-L1 MAb + chemo

+/- Avastin - NSCLC non sq. 1L

RG7853 alectinib Alk-mut.pos. -

NSCLC 1L

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

Registration

2 NMEs

RG7410 TAAR1 ago - schizophrenia

RG7342 mGlu5 PAM - schizophrenia

2 NMEs

RG7790 setrobuvir – HCV

RG7321 pictilisib – solid tumors

1 AI

RG435 Avastin - NSCLC adj.

1 AI following US approval

RG3645 Lucentis - diabetic

retinopathy

1 AI following EU approval

RG435 Avastin – cervical cancer

Status as of April 22, 2015

Roche Group development pipeline

52

Phase I

(31 NMEs + 12 AIs)

Raf & MEK dual inh solid tumors

ChK1 inh solid tum & lymphoma

Oncology Other disease areas


lumretuzumab (HER3 MAb) solid tumors

idasanutlin (MDM2 ant) s. & hem tumors

New Molecular Entity (NME) Additional Indication (AI)

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Other

RG-No Roche Genentech managed

CHU Chugai managed

PD-L1+Zelboraf+/-cobimetinib melanoma

Steap 1 ADC prostate ca.

PD-L1+Avastin+chemo solid tumors

PD-L1 MAb+Tarceva NSCLC EGFR+

PD-L1 MAb+cobimetinib solid tumors

venetoclax+Gazyva CLL CLL

PD-L1 MAb solid tumors

ERK inh solid tumors

CEA IL2v solid tumors

LSD1 inh AML

ADC solid tumors

MDM2 (4) IV prodrug AML

ADC ovarian ca

PD-L1 MAb+ipi/IFN solid tumors

OX40 MAb solid tumors

Lucentis sust. deliv. AMD/RVO/DME

PDE10A inh schizophrenia

Nav1.7 inh pain

VEGF-ANG2 MAb wAMD

a-synuclein MAb Parkinson's Disease

SMN2 splicer spinal muscular atrophy

TLR7 agonist HBV RG7795

RG3645

RG7203

RG7893

aldosterone synth inh met. diseases RG7641

RG7716

RG7935

RG7800

HIF1 alpha LNA solid tumors

RG7304

RG7741

RG7116

RG7388

RG7446

RG7450

RG7446

RG7446

RG7446

RG7601

RG7446

RG7842

RG7813

RG6016

RG7841

RG7775

RG7882

RG7446

RG7888

RG6061

CEA CD3 TCB solid tumors RG7802

CD40 iMAb+PD-L1 MAb solid tumors RG7876

MSLN PE cFP solid tumors RG7787

PD-L1 MAb+Gazyva lymphoma RG7446

- inflammatory diseases RG7880

- autoimmune diseases RG7625

- infectious diseases RG7689

DBO β-lactamase inh bact. infections RG6080

TAU MAb Alzheimer’s RG7345

emactuzumab (CSF-1R) + PDL1 s.tumors RG7155

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

IDO inh solid tumors RG6078

duligotuzumab (HER3/EGFR)+ cobi s. tum. RG7597

CEA IL2v + PD-L1 MAb solid tumors RG7813

venetoclax heme indications RG7601

New Molecular Entity (NME)

Additional Indication (AI)

RG-No Roche Genentech managed

CHU Chugai 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

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Other

Roche Group development pipeline

53

Phase II (22 NMEs + 14 Als) Phase III (9 NMEs + 27 Als) Registration (1 NME + 2 Als)

1 US only : FDA submission decision pending

2 Approved in US, submitted in EU

* FPI imminent

crenezumab Alzheimer’s RG7412 lampalizumab geographic atrophy RG7417

Perjeta HER2+ BC neoadj RG12732

cobimetinib + Zelboraf m. melanoma RG7421

MabThera SC CLL RG105 Avastin glioblastoma 1L RG435

Kadcyla +/- Perjeta HER2+ mBC 1L RG3502

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

alectinib ALK+ NSCLC 1L RG7853

Gazyva iNHL rituximab-ref RG7159

Gazyva follicular lymphoma 1L RG7159

venetoclax+Rituxan CLL rel/ref RG7601

Kadcyla HER2+ gastric cancer 2L RG3502

gantenerumab Alzheimer’s RG1450

PD-L1 MAb 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 ovarian cancer 1L RG4351

Avastin rel. ovarian ca. Pt-sensitive RG4351

PD-L1 MAb bladder cancer 2L RG7446

bitopertin obsessive compulsive dis. RG1678

danoprevir HCV RG7227

basimglurant TRD RG7090

sembragiline (MAO-B inh) Alzheimer’s RG1577

Actemra systemic sclerosis RG1569

polatuzumab vedotin hem tumors RG7596

V1 receptor antag autism RG7314

ipatasertib solid tumors RG7440

lebrikizumab idiopathic pulmonary fibrosis RG3637

LptD antibiotic antibacterial

venetoclax 17p del CLL rel/ref RG7601

PD-L1 MAb +Avastin RCC RG7446

Flu A MAb influenza RG7745

IL-31R MAb atopic dermatitis CHU

FIXa/FX bispecific MAb hemophilia A RG6013

PD-L1 MAb NSCLC 2/3L RG7446

GABRA5 NAM Down Syndrome RG1662

ADC lifastuzumab vedotin Pt-resist. OC RG7599

PD-L1 MAb bladder cancer 1/2L RCC RG7446

emactuzumab (CSF-1R) PVNS/s. tumors RG7155

taselisib NSCLC sq 2L RG7604

venetoclax DLBCL RG7601

vanucizumab (Ang2-VEGF MAb) mCRC RG7221

glypican-3 MAb liver cancer RG7686

GIP/GLP-1 dual ago type 2 diabetes RG7697

Esbriet SSc–interstitial lung disease RG6062

cobimetinib+paclitaxel TNBC RG7421

Avastin+Tarceva EGFR mut+ NSCLC RG435

venetoclax+Rituxan FL rel/ref RG7601

SERD ER+(HER2-neg) mBC RG6046

URAT 1 inh gout CHU

RG7929

Kadcyla HER2+ NSCLC RG3502

lebrikizumab IPF RG3637

alectinib ALK+ NSCLC 2L RG7853

RG7929 olesoxime spinal muscular atrophy RG6083

PD-L1+chemo NSCLC non-sq 1L RG7446

NSC PD-L1+chemo+Avastin NSCLC non-sq 1L RG7446

PD-L1+chemo NSCLC sq 1L RG7446*

PD-L1 MAb Dx+ NSCLC sq 1L RG7446*

PD-L1 MAb Dx+ NSCLC non-sq 1L RG7446*

taselisib ER+(HER2-neg) mBC RG7604

etrolizumab Crohn’s disease RG7413


taselisib ER+(HER2-neg) BC neoadj RG7604

NME submissions and their additional indications

Projects currently in phase 2 and 3

54 * lead market China

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

lebrikizumab (RG3637) severe asthma

PD-L1 MAb (RG7446) NSCLC 2/3L

2016

PDL-1 MAb (RG7446) bladder cancer

ocrelizumab (RG1594) PPMS

venetoclax (RG7601) CLL rel/ref

glypican-3 MAb (RG7686) liver cancer

lampalizumab (RG7417)

geographic atrophy

ipatasertib (RG7440) solid tumors

polatuzumab vedotin (RG7596)

heme tumors

taselisib (RG7604) HER2 neg ER+ mBC

lifastuzumab (RG7599)

Pt resistant OC

emactuzumab (RG7155)

PVNS and solid tumors

vanucizumab (RG7221)

colorectal cancer

FIXa/FX bispecific MAb (RG6013) hemophilia A

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

ocrelizumab (RG1594) RMS

2015

alectinib (RG7853) Alk+ NSCLC 2L

alectinib (RG7853) Alk+ NSCLC 1L

PDL-1 MAb (RG7446) combo Avastin RCC

2017

olesoxime (RG6083) SMA

bitopertin (RG1678)

obsessive compulsive dis.

danoprevir* (RG7227) HCV

basimglurant (RG7090) depression

crenezumab (RG7412) Alzheimer‘s

gantenerumab (RG1450) Alzheimer‘s

V1 receptor antag (RG7314) autism

etrolizumab (RG7413) ulcerative colitis

sembragiline (RG1577) Alzheimer‘s

LptD antibiotic (RG7929) antibacterial

lebrikizumab (RG3637) idiopathic pulmonary fibrosis

Flu A MAb (RG7745) influenza

GABRA5 NAM (RG1662) Down syndrome

etrolizumab (RG7413) Crohn’s disease

2018 and beyond

venetoclax (RG7601)

DLBCL

cobimetinib+paclitaxel TNBC

venetoclax (RG7601) + Gazyva CLL 1L

venetoclax (RG7601) + Rituxan FL rel/ref

taselisib ( RG7604) NSCLC sq 2L

PDL1 MAb (RG7446)+ chemo NSCLC non-sq 1L

PDL1 MAb (RG7446) NSCLC sq 1L (Dx+)

PDL1 MAb (RG7446) NSCLC non-sq 1L (Dx+)

PDL1 MAb (RG7446)+ chemo NSCLC sq 1L

PDL1 MAb (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


* 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 2 and 3

55

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

2015

Kadcyla +/- Perjeta

HER2+ mBC 1L

Kadcyla

HER2+ gastric cancer 2L

Avastin (US)

GBM

Gazyva iNHL rituximab refractory

Avastin +Tarceva(EU)

EGFR mut+ NSCLC

*Avastin (US) ovarian cancer 1st L

*Avastin (US) rel. ovarian ca. Pt-sens

2018 and beyond

Actemra systemic sclerosis

Kadcyla

HER2+ BC adj

Kadcyla+Perjeta

HER2+ BC adj

Kadcyla+Perjeta

HER2+ BC neoadj

Kadcyla

HER2+ NSCLC

Perjeta+Herceptin

HER2+ gastric cancer 1L

Gazyva follicular lymphoma 1L

2017


Perjeta + Heceptin HER2+ BC adj

Actemra giant cell arteritis

2016

Gazyva DLBCL 1L

Perjeta + Herceptin

HER2+ mBC 2L

Zelboraf

melanoma adj.

Major granted and pending approvals 2015

56

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

EU

US

Approved Pending approvals

Avastin cervical cancer

April 2015

Perjeta HER2+ BC neoadj

Filed September 2014

cobimetinib + Zelboraf

m. melanoma

Filed September 2014

MabThera SC CLL

Filed November 2014

cobimetinib + Zelboraf

m. melanoma

Filed December 2014

Lucentis diabetic retinopathy

February 2015


Japan-Chugai

Xeloda gastric cancer adj

Filed December 2014

Bonviva osteoporosis (oral) Filed February 2015

Cancer immunotherapy pipeline overview

57 Status as of April 22, 2015

Phase II

(1NME + 3 Als)

PD-L1 MAb +Avastin RCC RG7446

PD-L1 MAb NSCLC 2/3L RG7446

PD-L1 MAb bladder cancer 1/2L RCC RG7446

emactuzumab (CSF-1R) PVNS/s. tumors RG7155

Phase III

(1NME + 6AIs)

PD-L1 MAb NSCLC 2L RG7446

PD-L1 MAb bladder cancer 2L RG7446

PD-L1+chemo NSCLC non-sq 1L RG7446

NSC PD-L1+chemo+Avastin NSCLC non-sq 1L RG7446

PD-L1+chemo NSCLC sq 1L RG7446

PD-L1 MAb Dx+ NSCLC sq 1L RG7446

PD-L1 MAb Dx+ NSCLC non-sq 1L RG7446

*external collaborations: INCB- Incyte INCB024360; CDX-1127- Celldex CD27 MAb

Phase I

(7 NMEs + 9 AIs)

PD-L1+Zelboraf+/-cobimetinib melanoma

PD-L1+Avastin+chemo solid tumors

PD-L1 MAb+Tarceva NSCLC EGFR+

PD-L1 MAb+cobimetinib solid tumors

PD-L1 MAb solid tumors

CEA IL2v solid tumors

PD-L1 MAb+ipi/IFN solid tumors

OX40 MAb solid tumors

RG7446

RG7446

RG7446

RG7446

RG7446

RG7813

RG7446

RG7888

CEA CD3 TCB solid tumors RG7802

CD40 iMAb+PD-L1 MAb solid tumors RG7876

PD-L1 MAb+Gazyva lymphoma RG7446

emactuzumab (CSF-1R) + PDL1 s.tumors RG7155

IDO inh solid tumors RG6078

CEA IL2v + PD-L1 MAb solid tumors RG7813

PD-L1 MAb + IDO inh solid tumors *INCB

PD-L1 MAb + varlilumab solid tumors *CDX

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