Roche Investor Presentation - 1st quarter sales 2014bcb5cc58-9503-4dc5-96d0-826685d1596c/... · Q1...

47
1

Transcript of Roche Investor Presentation - 1st quarter sales 2014bcb5cc58-9503-4dc5-96d0-826685d1596c/... · Q1...

1

Roche

Q1 2014 sales

Basel, 15 April 2014

2

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.

Group Severin Schwan Chief Executive Officer

4

Q1 2014: Highlights

5

Growth

• Strong growth in Pharma and Diagnostics

• HER2 franchise with recently launched Perjeta and Kadcyla continues good

growth (+17%)

• Immunology and ophthalmology showing solid growth

Innovation

• EU: Subcutaneous formulation of MabThera approved

• US: Xolair approved in chronic idiopathic urticaria

• HPV test recommended for primary cervical cancer screening in US

Acquisition of IQuum

• Strengthen leading Molecular Diagnostics offering

• Rapid and simple testing at Point of Care, closer to patients

Q1 2014: Strong sales growth

6 CER=Constant Exchange Rates

2014 2013 Change in %

CHFbn CHFbn CHF CER

Pharmaceuticals Division 9.0 9.2 -1 4

Diagnostics Division 2.5 2.4 2 7

Roche Group 11.5 11.6 -1 5

Q1 2014: Both Divisions growing in all regions

7

0

1

2

3

4

5

Japan International Europe US

Diagnostics

Pharma+3%

+5%

+1%

+19%

+3%

+11%

+7%

+10%

CHFbn

+4%

+5%

+17%

+3%

All growth rates at constant exchange rates

2014: 14 new compounds in late stage

development

8

Oncology

Neuroscience

lampalizumab

geographic atrophy

Immunology /

Ophthalmology

onartuzumab (MetMAb)

Gastric cance

ocrelizumab

MS

cobimetinib (MEKi)

melanoma

lebrikizumab

asthma

gantenerumab

Alzheimer’s

1 Phase III decision pending

Bcl-2i (GDC 0199)

hem. cancers

alectinib (ALKi)1

NSCLC

beta-sparing PI3K1

(mutant selective)

pictilisib (PI3K)1

anti-CD79b ADC1

etrolizumab

UC and CD

Oncology

Neuroscience

Ophthalmology

Immunology

oral octreotide

acromegaly

anti-PDL1

solid tumours

9

Pipeline: Intense Phase III activity in 2014

Compound Indication

Kadcyla/Perjeta 1L met. HER2+ BC

(MARIANNE)

cobimetinib BRAF+ mM (co-BRIM)

oral octreotide acromegaly

Compound Indication

Kadcyla adjuvant BC (KAITLIN)

Kadcyla neo-adjuvant (KRISTINE)

Bcl-2 inh Rel/Ref CLL (MURANO)

anti-PDL1 2/3L NSCLC (OAK)

alectinib ALK+ NSCLC

etrolizumab inflammatory bowel disease

gantenerumab mild AD (Marguerite RoAD)

lampalizumab geographic atrophy

Phase III readouts Key phase III starts

2014 Outlook

10 1At constant exchange rates

Group sales growth1 Low- to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

11

Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals

Q1 2014: Pharma sales

Strong growth in Japan, US and Europe

12

2014 2013 Change in %

CHFm CHFm CHF CER

Pharmaceuticals Division 9,040 9,170 -1 +4

United States 3,873 3,912 -1 +3

Europe 2,425 2,314 +5 +5

Japan 845 826 +2 +19

International 1,897 2,118 -10 +1

CER=Constant Exchange Rates

-100 -50 0 50 100 150

Xeloda

Pegasys

Herceptin

Actemra

MabThera/Rituxan

Kadcyla

Avastin

Perjeta

US

Europe

Japan

International

Q1 2014: Pharma growth contributors

Oncology and Actemra as main growth drivers

13 13

+274%

+9%

+3%

+474%

-19%

+23%

-19%

+3%

Absolute amounts and growth rates at constant exchange rates (2013)

CHFm

Q1 2014 sales: Oncology

HER2 franchise and Avastin major growth contributors

14

CER growth

CER=Constant Exchange Rates Oncology Q1 2014 sales: CHF 5.6bn

Competitive environment

Loss of exclusivity in EU (Dec 2013) and US (Mar 2014)

Growth driven by ovarian and colorectal cancer

MabThera SC approved by EMA, launch expected

throughout 2014

CHFbn

Franchise growth driven by recently launched Perjeta

and Kadcyla

Competitive environment in US, stable demand in Europe

Herceptin

Perjeta

0.0 0.5 1.0 1.5 2.0

Zelboraf

Xeloda

Tarceva

Avastin

MabThera/

Rituxan

HER2 +17%

+3%

Kadcyla

+9%

-5%

-19%

-2%

HER2 franchise: Innovative therapies define

new standard of care

15

17%

20%

15%

7% 15%

YoY CER growth Kadcyla

• US: Increasing use in labeled indications

• EU: Successful ongoing launch

• Japan: Launch expected Q2 ‘14

• MARIANNE results expected H2 ‘14

Perjeta

• US: Strong adoption in neo-adjuvant

setting; continued growth in 1L mBC

• Final CLEOPATRA OS data planned to be

presented at ESMO (Sept ‘14)

Herceptin

• Herceptin SC launched in 18 countries

Absolute amounts and growth rates at constant exchange rates (2013)

1

1.25

1.5

1.75

2

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

CHFbn

Immunology: Growing franchise with potential

new entrants

16

1.0

1.1 1.2

Q1

2012

Q1

2013

Q1

2014

CHFbn

+11%1

Immunology franchise sales Lebrikizumab in severe asthma

1 CER=Constant Exchange Rates; *Pooled across different doses

• Phase II: ~60% reduction in exacerbation

rates*

• Benefit in periostin high patients

• Phase III ongoing: filing 2016

• 2 doses tested in phase III

309

416 418 422

456

Q1

10

Q1

11

Q1

12

Q1

13

Q1

14

Lucentis: Continuing strong growth

17 AMD=wet age-related macular degeneration; RVO=retinal vein occlusion; DME=diabetic macular edema

AMD and RVO

• Stable use; increasing market

DME

• Increasing patient share

• Potential competition later in 2014

2014 outlook

• Benefit from the overall market

growth in all indications

Lucentis quarterly sales (USDm)

+8%

1H 2014: Upcoming clinical newsflow

18

ASCO

Chicago

May 30-June 3

ENDO

Chicago

June 21-24

AAIC

Copenhagen

July 12-17

Oral octreotide

Ph III, Acromegaly

Crenezumab

Ph II, Alzheimer’s

Disease

Multiple oncology

assets

Neuroscience Oncology Immunology

ASCO 2014: Highlights

19

• Anti-PDL1 data in new tumour type

• Immuno-oncology program update

• H2H Avastin vs. cetuximab in mCRC

(CALGB 80405 study)

Immuno-oncology

Avastin

• Bcl2 inh*, Ph I in CLL (combo w/

Rituxan) and DLBCL

• Anti-79b ADC, PhII ROMULUS

Hematology

• PhIb BRIM7 data

Zelboraf+cobimetinib (MEK inh)

* In collaboration with AbbVie

Analyst meeting: Sunday, June 1 2014

2014: Key late stage news flow - I

20 Outcome studies are event driven, timelines may change

Compound Indication Milestone

bitopertin Schizophrenia Ph III

cobimetinib (MEKi) Met. melanoma Ph III (combo w Zelboraf)

Kadcyla & Perjeta HER2+ mBC (1 Line) Ph III MARIANNE

onartuzumab (MetMAb) Lung cancer (2/3L) Ph III (combo w Tarceva)

oral octreotide Acromegaly Ph III

alectinib (ALKi) NSCLC Ph II

anti-HER3 EGFR DAF Head and neck, colorectal cancer Ph II (MEHGAN, DARECK)

anti-PDL1 Solid tumours Ph I/II

crenezumab Alzheimer’s Ph II

mGlu2/5 Neuroscience Ph II

quilizumab (M1 prime) Asthma Ph II (COSTA)

Major readouts

Data available

Data available

Data available

2014: Key late stage news flow - II

21 Outcome studies are event driven, timelines may change

Compound Indication Milestone

Actemra subcutaneous Rheumatoid arthritis EU approval

Avastin Glioblastoma EU approval

Avastin Cervical cancer US, EU filing

Avastin Pt-resistant ovarian cancer EU approval

MabThera subcutaneous NHL EU approval

obinutuzumab (GA101) Front line CLL EU approval

Xolair Chronic idiopathic urticaria US approval

Regulatory milestones

Diagnostics Division Roland Diggelmann COO Roche Diagnostics

Picture

22

Q1 2014: Diagnostics sales

Growth driven by Professional Diagnostics

23

2014 2013 change in %

CHFm CHFm CHF CER

Diagnostics Division 2,456 2,419 +2 +7

Professional Diagnostics 1,392 1,345 +3 +9

Diabetes Care 538 539 0 +5

Molecular Diagnostics1 370 378 -2 +4

Tissue Diagnostics 156 157 -1 +4

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

North America

+9%

25% of divisional sales

Latin America

+13%

6% of divisional sales

Japan

+7%

5% of divisional sales EMEA1

+4%

48% of divisional sales

Q1 2014: Diagnostics regional sales

Growth across all geographies

Asia Pacific

+13%

16% of divisional sales

24

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

+5%

25

Q1 2014: Diagnostics

HPV sales +56%; FDA advisory panel recommendation for cobas HPV test for primary screening in cervical cancer

US: Positive impact from change in wholesale inventories EU: Launch of Accu-Chek Insight pump

Growth driven by ex-US and advanced staining

US impacted by further reimbursement changes

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

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

CHFbn 0 0.5 1 1.5

Tissue Dia

Molecular

Dia

Diabetes

Care

Professional

Dia

EMEA

North America

RoW

Q1 highlights 2014 vs. 2013

CER growth

1

+9%

+4%

+4%

Continued double digit sales growth in immunoassays (12%)

Menu expansion by launch of Syphilis test

RPD: Launch of Elecsys® Syphilis Test

For infectious disease and blood screening

26 STD=Sexually transmitted diseases

Elecsys Syphilis

cobas 6000

• Expands leading immunoassay portfolio

• Target market (HIV, Syphilis, Herpes immunoassay):

~CHF 850m

• Test can be performed across entire cobas Elecsys

platform series

• Competitive advantages:

• High sensitivity/specificity

• Low blood sample volume

• Short time to result

• Offers complete solution for STD and pre-natal

infections testing

• Fulfills WHO requirements for blood safety solutions

Molecular Diagnostics: HPV testing

Positive recommendation on primary screening

27

FDA advisory panel 12 March 2014

• HPV test recommended as primary

screening for cervical cancer

• ATHENA study results: Pap smear missed

cervical disease in 1 in 7 HPV genotype 16

positive women

Ongoing pilot studies in Europe

• Sweden, Netherlands, UK and Italy

Three results in one test

• HPV Genotype 16

• HPV Genotype 18

• 12 high risk HPV pool

cobas® HPV system

cobas 4800 Fully automated PCR platform

HPV primary screening

Comprehensive cervical cancer portfolio

28 CINtec Plus is approved as CE-IVD in Europe. CINtec Histology is approved as CE-IVD in Europe and Class 1 in US.

detects p16 protein expression

in cervical biopsies

detects p16 & Ki-67 protein

expression in cytology

preparations

detects all HPV DNA plus genotypes

16 & 18 in cytology preparations

Screen Manage Diagnose

IQuum acquisition

Entering Point of Care in molecular diagnostics

29

Target market:

• ~CHF 350m, growing ~20%

Liat (laboratory in a tube) technology:

• Fast and simple with automated process performed in a test tube

• Brings laboratory PCR to the Point of Care

• Short turnaround time

Portfolio:

• Analyzer and Influenza A/B assay approved

• Strep A and Respiratory Syncytial Virus tests in clinical studies

• Planned expansion into MRSA and C-difficile

Liat™ Analyzer

Point of Care: e.g. physician’s office, emergency rooms, ambulance, pharmacies; MRSA: methicillin resistant Staphilococcus aureus

*Excluding US; 1Business Areas: RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics,

RTD: Roche Tissue Diagnostics; 2 hospital information systems; 3 blood glucose monitoring; 4 parvovirus B19 and hepatitis A virus; 5 west nile virus

Key launches 2014

30

Area Product Market BA1

Instruments

/

Devices

Labs

cobas 6800/8800 – Next generation molecular (PCR) system

cobas m 511 – Fully integrated and automated hematology system

cobas 6500 – automated urinalysis work area platform

Connect-V – Middleware providing connectivity to LIS2

WW*

EU

EU

WW

RMD

RPD

RPD

RTD

Diabetes

Care

Accu-Chek Insight- Next generation insulin pump & bGm3 system

Accu-Chek Connect – bG meter with connectivity to smart phones,

mobile app and cloud

EU

EU

RDC

RDC

Tests/

Assays

Infectious

Diseases /

Blood

Screening

MPX 2.0 – Next generation blood screening multiplex test

MPX (HIV, HCV, HBV), HEV, DPX4, WNV5 – Full NAT blood

screening menu for cobas 6800/8800

HIV, HCV, HBV – Virology tests for cobas 6800/8800

HSV- Detection of Herpes Simplex Virus on cobas 4800

Syphilis– Immunoassay for the detection of Treponema pallidum

US

WW*

WW*

EU

EU

RMD

RMD

RMD

RMD

RPD

Microbiology MRSA/SA – Next generation assay on cobas 4800

C-difficile – Diagnosis of infections and associated diarrhea

EU

EU

RMD

RMD

Women’s

Health

PE Prognosis- Claim extension for short-term prediction of

Preeclampsia in pregnancy

AMH- Assessment of ovarion reserve for fertility

EU

EU

RPD

RPD

31

Finance Alan Hippe

Chief Financial Officer

Q1 2014: Finance highlights

32

Major Q1 cash outflows

• Dividend (CHF 6.7bn)

• Debt repayment (CHF 1.6bn)

Major currency impact

• USD, JPY and Latin American currencies major negative contributors

• Negative 6%p impact on Q1 2014 sales growth

IQuum: Strengthen molecular diagnostics

• USD 275m upfront

• Up to USD 175m in contingent product related milestones

• The transaction is subject to customary closing conditions

Q1 2014: Group sales

6%p exchange rates impact

33

+574

+124

+121

+146

+10 +173

-667

-93

United

States

Europe Japan International Diagnostics

Division

Group Fx Group

CHF

+4%

+3% +5% +19% +7% +5% -1%

Pharma Division

+1%

Absolute values in CHFm at CER=Constant Exchange Rates (2013)

Exchange rate impact on sales growth

Negative impact from USD, JPY and LatAm currencies

34

CER sales

growth

Q1 14

vs.

Q1 13

CER=Constant Exchange Rates

+5.0% -1.7%

-1.3%

-1.3%

-0.7%

-0.4% -0.8% -0.3% -0.1%

CER USD JPY Lat-Am As-Pac Other

Europe

Other EUR CHF

CHF sales

growth

Q1 14

vs.

Q1 13

Negative currency impact in 2014 expected

35

Q1 HY Sep

YTD

FY

Sales -6 -6 -6 -5

Core

operating

profit

-8 -6

Core EPS -7 -6

Assuming the 31 Mar 2014 exchange

rates remain stable until end of 2014,

2014 impact is expected to be (%p):

CHF / USD

CHF / EUR

+1%

+1%

+2% +2%

0.90 0.89 0.89 0.890.88 0.89 0.890.89 0.890.89 0.89 0.89

0.890.89 0.89 0.89

0.930.94 0.93

0.93

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

1.23 1.22 1.22 1.22 1.22 1.22 1.221.22 1.221.22 1.22 1.22

1.23 1.231.231.23

1.22

1.22

1.221.22

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

Average YTD

2013

-4% -5%

-5% -4%

0% -1% -1% -1%

Assumed average YTD 2014

Monthly avg fx rates 2014 Fx rates at 31 March 2014

0

1

2

3

4

2014 2015 2016 2017 2018 2019 2021 2022 2023 2035 2039

USD EUR CHF GBP

Q1 2014: Debt maturity profile

71% of Genentech related debt repaid

Nominal values @ actual FX rates; *Original net proceeds in CHF

Of the CHF 48 bn bonds and notes issued to finance the Genentech

transaction, cumulative CHF 34 bn have been repaid as of March 31, 2014*

CHFbn

USD 1.0 bn repaid Q1/2014

GBP 0.45 bn repaid Q1/2014

36

2014 Outlook

37 1At constant exchange rates

Group sales growth1 Low- to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend

38

Doing now what patients need next

39 39

Roche Group development pipeline

Marketed products development programmes

Roche Pharma global development programmes

Roche Pharma research and early development

Genentech research and early development

Roche Group Q1 2014 sales

Diagnostics

Foreign exchange rate information

Changes to the development pipeline

Q1 2014 update

40 Status as of March 31, 2014

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

1 NME added by gRED

RG7841 ADC - solid tumors

1 NME in-licensed from Oryzon

RG6016 LSD1 inhibitor - AML

1 NME added by Chugai

URAT1 inhibitor - gout

1 AI

RG7746 PD-L1 MAb combination

with Tarceva – NSCLC EGFR mut-

positive

1NME (transition from phase 1)

RG7599 NaPi2b - Pt-resistant

ovarian cancer

1 AI

RG7746 PD-L1 MAb - bladder

cancer

1 NME

RG7746 PD-L1 MAb – metastatic

NSCLC 2nd line

1 AI

RG1273 Perjeta - Her2-positive

mBC 2nd line (reclassification of

Ph2 Pherexa study)

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

3 AIs

RG3616 Erivedge - operable BCC

RG3638 onartuzumab - NSCLC

squamous 1st line

RG3638 onartuzumab - NSCLC non

squamous 1st line

2 NMEs

RG1678 bitopertin - schizophrenia

neg symptoms

RG3638 onartuzumab – Met-

positive mNSCLC 2nd /3rd line

2 AIs

RG1678 bitopertin - schizophrenia

suboptimal control

RG3638 onartuzumab – adv. Met-

positive NSCLC EGFR mut-positive

1 AI EU approval

RG105 MabThera - NHL

subcutaneous formulation

1AI US approval

RG3648 Xolair – chronic idiopathic

urticaria

Phase I

(32 NMEs + 9 AIs)

MEK inh solid tumors RG7167

Raf & MEK dual inh solid tumors RG7304

PI3K inh beta sparing solid tumors RG7604

Bcl-2 inh heme indications RG7601

ChK1 inh solid tum & lymphoma RG7741

ADC ADC multiple myeloma RG7598

Oncology Other disease areas

Status as of March 31, 2014

HER3 MAb solid tumors RG7116

CSF-1R MAb solid tumors RG7155

MDM2 ant AML RG7388

ADC ADC oncology RG7600

Roche Group development pipeline

ETBR ADC metastatic melanoma RG7636

PI3k inh glioblastoma 2L RG7666

New Molecular Entity (NME) Additional Indication (AI)

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Other

RG-No Roche Genentech managed

CHU Chugai managed

ANG2-VEGF MAb oncology RG7221

PD-L1 MAb+Zelboraf m. melanoma RG7446

Steap 1 ADC prostate ca. RG7450

MUC16 ADC ovarian & pancreatic ca. RG7458

PD-L1 MAb+Avastin+chemo solid tumors RG7446

PD-L1 MAb solid tumors RG7446

onartuzumab liver cancer HCC RG3638

PD-L1 MAb+cobimetinib solid tumors RG7446

Bcl-2 inh + Gazyva CLL RG7601

PD-L1 MAb+Tarceva NSCLC EGFR+ RG7446

PI3K inh solid tumors CHU

ERK inh solid tumors RG7842

CEA IL2v IC solid tumors RG7813

- heme tumors RG7845

ADC solid tumors RG7841*

*FPI in April

GABRA5 NAM cognitive disorders RG1662

GIP/GLP-1 dual ago type 2 diabetes RG7697

IL-6R MAb RA CHU

IL-17 MAb autoimmune diseases RG7624

TLR7 agonist HBV RG7795

Lucentis sust. deliv. AMD/RVO/DME RG3645

PDE10A inh schizophrenia RG7203

TLR7 agonist (2) HBV RG7863

SMN2 splicer spinal muscular atrophy RG7800

aldosterone synth inh kidney disease RG7641

ANG2-VEGF MAb wAMD RG7716

TAAR1 ago schizophrenia RG7410

URAT1 inhibitor gout CHU

LSD1 inh AML RG6016

41

Phase II

(28 NMEs + 9 Als)

Phase III

(8 NMEs + 19 Als)

Registration

(1 NME + 4 Als)

1 US only: FDA submission pending

2 Submitted in EU, US filing pending

3 Approved in US, submitted in EU

4 Submitted in EU

Avastin glioblastoma 1st line RG4352

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

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Gazyva (obinutuzumab) CLL RG71593

onartuzumab gastric cancer RG3638

Perjeta HER2+ early BC RG1273

Avastin ovarian cancer 1st line RG4351

Avastin NSCLC adj RG435

Avastin high risk carcinoid RG435

Kadcyla +/- Perjeta HER2+ mBC 1st l RG3502

ocrelizumab RMS RG1594

Gazyva (obinutuzumab) DLBCL RG7159

ocrelizumab PPMS RG1594

Suvenyl enthesopathy CHU

lebrikizumab severe asthma RG3637

Avastin rel. ovarian ca. Pt-resistant RG4352

Kadcyla HER2+ early BC RG3502

Zelboraf melanoma adj RG7204

cobimetinib + Zelboraf m. melanoma RG7421

Avastin rel. ovarian ca. Pt-sensitive RG4351

oral octreotide acromegaly RG3806

Perjeta HER2+ gastric cancer RG1273

Actemra early RA RG15694

Actemra giant cell arteritis RG1569

onartuzumab mCRC 1st line RG3638

etrolizumab ulcerative colitis RG7413

pictilisib pictilisib (PI3K inh) solid tumors RG7321

Actemra systemic sclerosis RG1569

HER3/EGFR MAb m. epithelial tumors RG7597

pinatuzumab vedotin (CD22 ADC) hem tumors RG7593

polatuzumab vedotin (CD79bADC) hem tumors RG7596

Perjeta HER2+ mBC 2nd line RG1273

alectinib (ALK inhibitor) NSCLC RG7853

Gazyva (obinutuzumab) iNHL relapsed RG7159

Gazyva (obinutuzumab) iNHL front-line RG7159

glypican-3 MAb liver cancer RG7686

Roche Group development pipeline

Status as of March 31, 2014

ipatasertib (AKT inh) solid tumors RG7440

Erivedge AML RG3616

Actemra RA sc formulation RG15693

Avastin cervical cancer recurrent RG435

lebrikizumab idiopathic pulmonary fibrosis RG3637

Bcl-2 inh CLL rel/refract RG7601

Kadcyla HER2+ gastric cancer RG3502

Bcl-2 inh CLL rel/refract 17pdel RG7601

PD-L1 MAb + Avastin RCC 1st line RG7446

gantenerumab Alzheimer’s RG1450

PD-L1 MAb NSCLC 2nd line RG7446

PD-L1 MAb NSCLC 2nd/3rd line RG7446

mericitabine HCV RG7128

danoprevir HCV RG7227

basimglurant (mGlu5 NAM ) TRD RG7090

inclacumab ACS/CVD RG1512

quilizumab asthma RG7449

crenezumab Alzheimer’s RG7412

MAO-B inh Alzheimer’s RG1577

decoglurant (mGlu2 NAM ) depression RG1578

setrobuvir HCV RG7790

bitopertin obsessive compulsive dis. RG1678

rontalizumab systemic lupus erythem RG7415

CMV MAb CMV RG7667

lampalizumab (factor D) geo. atrophy RG7417

PCSK9 MAb metabolic diseases RG7652

V1 receptor antag autism RG7314

LptD antibiotic antibacterial RG7929

Flu A MAb influenza RG7745

IL-31R MAb atopic dermatitis CHU

FIXa /FX FIXa /FX bispecific MAb hemophilia A CHU

ADC NaPi2b ADC Pt-resist. ovarian cancer RG7599

Avastin HER2-neg. BC adj RG435

PD-L1 MAb bladder cancer RG7446*

*FPI in April 42

NME submissions and their additional

indications

Projects currently in phase 2 and 3

43

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

Indicates submission to health authorities has occurred

* lead market China

Neuroscience

Ophthalmology

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

bitopertin (RG1678) obsessive compulsive disorder

ocrelizumab (RG1594) PPMS and RMS

cobimetinib (MEK inh) combo Zelboraf

met melanoma

mericitabine (RG7128) HCV

danoprevir* (RG7227) HCV

basimglurant mGlu5 NAM (RG7090)

depression

crenezumab (RG7412) Alzheimer‘s

gantenerumab (RG1450) Alzheimer‘s

V1 receptor antag (RG7314) autism

decoglurant mGlu2 NAM (RG1578)

depression

HER3/EGFR MAb (RG7597) m. epithelial tumors

glypican-3 MAb (RG7686) liver cancer

quilizumab (RG7449) asthma

lampalizumab anti-factor D (RG7417) geo atrophy

lebrikizumab (RG3637) severe asthma

etrolizumab (RG7413) ulcerative colitis

2014 2015 2017 and beyond

(RG7667) CMV

oral octreotide (RG3806) acromegaly

pinatuzumab vedotin, RG7593

CD22 ADC heme tumors

alectinib ALK inh (RG7853) NSCLC

PD-L1 MAb (RG7446) NSCLC 2nd/3rd line

Bcl-2 inh (RG7601) CLL

MAO-B inh (RG1577) Alzheimer‘s

polatuzumab vedotin, RG7596

CD79b ADC heme tumors LptD antibiotic (RG7929)

antibacterial

lebrikizumab (RG3637) idiopathic pulmonary fibrosis

2016

Flu A MAb (RG7745) influenza

Status as of March 31, 2014

pictilisib PI3K inh (RG7321) solid tumors

ipatasertib AKT inh (RG7440) solid tumors

PDL-1 MAb (RG7446) combo Avastin RCC 1st line

PI3K inh beta sparing (RG7604) solid tumors

Bcl-2 inh (RG7601) NHL

NaPi2b ADC (RG7599) ovarian cancer

onartuzumab (MetMAb) gastric cancer

Avastin NSCLC adj

2014 2015 2017 and beyond

*Avastin (US) ovarian cancer 1st line

Oncology

Immunology

Infectious diseases

CardioMetabolism

Neuroscience

Ophthalmology

Indicates submission to health authorities has occurred.

* Approved in the EU

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

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

Submissions of additional indications for

existing products

Projects currently in phase 2 and 3

44

Status as of March 31, 2014

Actemra

systemic sclerosis

Perjeta

HER2-pos EBC

Perjeta

HER2-pos mBC 2nd line

Perjeta

HER2-pos. gastric cancer

Zelboraf met melanoma adj.

Kadcyla +/- Perjeta

HER2-pos mBC 1st line

Kadcyla

HER2-pos gastric cancer

Kadcyla

HER2-pos early BC

Avastin

cervical cancer recurrent

Actemra

giant cell arteritis

Erivedge

AML

2016

Avastin (US) rel. ovarian ca. Pt-resist

Avastin (US)

glioblastoma 1st line

Gazyva (GA101) DLBCL

Gazyva (GA101) iNHL relapsed

Gazyva (GA101) frontline NHL

Avastin HER2-neg BC adj

EU

US

Approved Pending approvals

Major granted and pending approvals 2014

45

Neuroscience

Ophthalmology

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

MabThera NHL sc formulation

Mar 2014

Actemra

RA sc formulation

Filed Dec 2012

Avastin

glioblastoma 1st line

Filed Mar 2013

Xolair

chronic idiopathic urticaria

Mar 2014

Avastin

rel. ovarian ca. Pt-resist

Filed Sep 2013

Actemra

early RA

Filed Jun 2013

obinutuzumab (GA101)

CLL

Filed Apr 2013

Status as of March 31, 2014

Major Chugai granted and pending approvals

2014

46

Neuroscience

Ophthalmology

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

alectinib ALK-pos rec/adv NSCLC

Filed October 2013

Status as of March 31, 2014

Zelboraf

m. melanoma Filed April 2014

Pending approvals

47

Doing now what patients need next