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Page 1: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer
Page 2: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Roche

Q1 2016 sales

Basel, 19 April 2016

Page 3: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

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.

Page 4: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

4

Group Severin Schwan Chief Executive Officer

Page 5: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Good start to the year

5

Growth

Sales

Innovation

Diagnostics

Oncology

Neuroscience

1 At constant exchange rates (CER); NEDA=no evidence of disease activity; MRI=magnetic resonance imaging;

IND: Investigational New Drug Application

• Group sales +4%1 driven by HER2 franchise (+9%), Immunology franchise

(+16%), Avastin (+4%), and Professional Diagnostics (+7%)

• Good growth1 in all regions: US (+3%), Europe (+3%), Japan (+3%) and

International (+7%)

• Atezolizumab: Acceptance of filing for advanced bladder and lung cancer in

the US

• Successful US launches of Alecensa and Cotellic

• US approval of Gazyva in R/R NHL (GADOLIN)

• US approval of Venclexta (venetoclax) in R/R CLL 17p deletion

• Ocrevus (ocrelizumab):

– Updated NEDA and MRI data at AAN (April, 15th – 21st)

• IND approval to initiate Zika blood screening

Page 6: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Solid sales growth continues

6 CER=Constant Exchange Rates

2016 2015

CHFbn CHFbn CHF CER

Pharmaceuticals Division 9.8 9.3 5 4

Diagnostics Division 2.6 2.5 4 5

Roche Group 12.4 11.8 5 4

Change in %

Page 7: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Sales growth for fifth consecutive year

7

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

5%

7%

6%

4%

4%

0%

2%

4%

6%

8%

10%

Q1

12

Q2

12

Q3

12

Q4

12

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Q2

15

Q3

15

Q4

15

Q1

16

All growth rates at Constant Exchange Rates (CER)

Page 8: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Solid sales growth in all regions

8

0

1

2

3

4

5

6

Japan International Europe US

Diagnostics

Pharma

CHFbn

+3%

+5% +4%

+4%

-1%

+16%

-3%

0%

+3%

+3%

+3%

+7%

All growth rates at Constant Exchange Rates (CER)

Page 9: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Roche significantly advancing patient care

Recognition for innovation 2013-present

9

Rank Company #

1 Roche 12

2 BMS 8

3 Novartis 7

3 Merck 6

3 Pfizer 6

4 GSK 5

12 Breakthrough Therapy Designations

Year Molecule

2016

Ocrelizumab (PPMS)

Venclexta (AML)

Venclexta + Rituxan (R/R CLL)

2015

Actemra (Systemic sclerosis)

Atezolizumab (NSCLC)

Venclexta (R/R CLL 17p del)

Emicizumab/ACE 910 (Hemophilia A)

2014

Esbriet (IPF)

Lucentis (DR)

Atezolizumab (Bladder)

2013 Alectinib (2L ALK+ NSCLC)

Gazyva (1L CLL)

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

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

Page 10: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Significant launch activities ahead

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

Oncology/

hematology Neuroscience Ophthalmology Immunology

FDA Breakthrough

Therapy Designation

Cotellic + Zelboraf

BRAFmut melanoma

Venclexta

R/R CLL with 17p del

Ocrelizumab

RMS/ PPMS

Lebrikizumab

Severe Asthma

Emicizumab (ACE910)

Hemophilia A

Atezolizumab

2L+ lung and bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY)

Atezolizumab+Avastin+chemo

1L NSCLC

Gazyva

1L aNHL (GOYA)

Gazyva

1L iNHL (GALLIUM)

Gazyva

Refractory iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Atezolizumab + Avastin

1L RCC

2016 2017 2018

Actemra

Giant cell arteritis

Alecensa

1L ALK+ NSCLC

Pharma

Diagnostics cobas e 801 launch in

immunodiagnostics

cobas t 511

cobas t 711 cobas 6000 (new)

Page 11: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

2016 outlook

11

Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend in Swiss francs

1 At Constant Exchange Rates (CER)

Page 12: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

12

Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals

Page 13: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016 sales

Innovation

Outlook

13

Page 14: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Pharma sales

Good growth driven by all regions

14 CER=Constant Exchange Rates

2016 2015

CHFm CHFm CHF CER

Pharmaceuticals Division 9,800 9,322 5 4

United States 4,716 4,392 7 3

Europe 2,319 2,178 6 5

Japan 853 763 12 4

International 1,912 1,989 -4 4

Change in %

Page 15: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Oncology and immunology driving

growth

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

-120 -60 0 60 120

Pegasys

Lucentis

Tarceva

Tamiflu

Activase/TNKase

Actemra/RoActemra

MabThera/Rituxan

Xolair

Avastin

Herceptin

Esbriet

Perjeta

US

Europe

Japan

International

+33%

+96%

+4%

+4%

+22%

+14%

+3%

-50%

-13%

+21%

CHFm

-14%

-6%

Page 16: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

0 1 2 3

Alecensa

Zelboraf +

Cotellic

Xeloda

Tarceva

CD20

Avastin

HER2

Kadcyla

Perjeta

Herceptin +9%

+4%

-14%

-17%

+18%

MabThera/Rituxan

(Oncology)

Gazyva/Gazyvaro

+3%

Cotellic

+161%

Q1 2016: Oncology launches off to a good start

16

CHFbn

CER=Constant Exchange Rates

Q1 2016 Oncology sales: CHF 6.1bn; CER growth +4%

YoY CER growth

• Increased competition

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

• Loss of exclusivity

• Growth driven mainly by cervical and ovarian

• Strong uptake of Perjeta and Kadcyla

• Growth of Herceptin due to longer treatment

• Back to growth post launch of Cotellic

• Gazyva approved in R/R iNHL (GADOLIN)

• US: launch off to a strong start

• Japan: Continued strong growth (J-ALEX study)

Page 17: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

HER2 franchise: Growth mainly driven by Perjeta

17

0

500

1,000

1,500

2,000

2,500

Q1 13 Q1 14 Q1 15 Q1 16

Herceptin Perjeta Kadcyla

+15%

YoY CER growth

+23%

+17%

CER=Constant Exchange Rates

CHFm

+9%

HER2 franchise Q1 2016

• Herceptin (+4%): Longer treatment duration

in combo with Perjeta

• Perjeta (+33%): Strong demand in 1L mBC

and neoadjuvant in the US and EU

• Kadcyla (+11%): Growth driven by EU,

International and Japan

Outlook 2016

• Herceptin: Further SC conversion

• Perjeta: Further increasing penetration

• Kadcyla: New launch countries

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

Page 18: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Avastin: Strong underlying growth

18 CER=Constant Exchange Rates

0

400

800

1,200

1,600

2,000

Q1 13 Q1 14 Q1 15 Q1 16

CHFm

US Europe International Japan

YoY CER growth

+11% +9%

+4% +6%

Avastin Q1 2016

• Growth impacted by Health Insurance

Plan impact in Japan

• International (+27%): 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

Page 19: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Immunology: Continued strong growth, now

>CHF 7bn on an annualised basis

19

0

300

600

900

1,200

1,500

1,800

Q1

13

Q1

14

Q1

15

Q1

16MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other

CHFm

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

YoY CER growth

+11% +11%

+20%

+16%

Immunology Q1 2016

Xolair (+22%)

• Continued strong uptake in allergic

asthma, chronic idiopathic urticaria

Actemra (+14%)

• SC formulation driving growth

• Increasing 1L monotherapy leadership

focusing on MTX intolerant patients

MabThera/Rituxan (+11%)

• Continues to grow in rheumatoid

arthritis and vasculitis (GPA and MPA)

Page 20: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Esbriet: Expanding beyond severe patients

20

CHFm

10

27

88

178

0

50

100

150

200

Q1

13

Q1

14

Q1

15

Q1

16

US Europe International

US (+145%)

• Strong underlying growth with patient

starts and treatment rate on track

• Around 100,000 IPF patients in the US

with high unmet need

EU (+36%)

• Increasing differentiation due to

strengthened label including the pooled

1 Yr mortality data

Outlook 2016

• Increasing patient pool and new launch

countries

YoY CER growth

+96%

Page 21: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016 sales

Innovation

Outlook

21

Page 22: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Venclexta* in R/R CLL with 17p deletion

First Bcl-2 inhibitor with significant upside potential

22

• Accelerated approval in the US following breakthrough therapy designation in R/R CLL 17p del

• Additional breakthrough therapy designations: Venclexta+Rituxan in R/R CLL and Venclexta in AML

• Several read-outs at ASCO in NHL, CLL, MM and AML

NHL=non-hodgkin`s lymphoma; CLL=chronic lymphoid leukemia; MM=multiple myeloma; AML=acute myeloid leukemia;

* Venclexta (venetoclax) in collaboration with AbbVie

Phase II (M13-982)

Response, n (%)

Venclexta

(n = 106)

ORR 85 (80.2)

CR/CRi 8 (7.5)

Median DOR not reached

Page 23: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Ocrelizumab: Additional efficacy data at AAN

Breakthrough therapy designation in PPMS

23

• NEDA, disability progression and MRI data to be presented at AAN (April, 15th – 21st)

• Breakthrough therapy designation granted in PPMS

• US/EU filings in RMS/PPMS on track for H1 2016

NEDA=no evidence of disease activity; MRI=magnetic resonance imaging

Page 24: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Emicizumab (ACE 910) development plan

Non-interventional study expanded to all patients

24 QW=weekly dosing; Q2W=dosing every 2 weeks; Q4W=dosing every 4 weeks; OLE=open label extension

• Inhibitor study: Enrollment progressing well

• Inhibitor non-interventional study fully recruited (>90 patients) and expanded to non-inhibitors

• Non-inhibitor, pediatric and Q4W dosing studies expected to start in 2016

2015 2016 2017 2018

Pediatrics Inhibitor

Non-interventional

Inhibitor (≥12 yrs)

Weight based QW dosing

Q4W dosing study

Non-inhibitor (≥12 yrs)

QW and Q2W dosing

Japanese studies

Chugai OLE

Phase II Phase III Phase I Patient transfer

Page 25: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Unlocking the full value of cancer immunotherapy

New deals signed in Q1

25 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

KTE-C19* (Kite Pharma)

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)

EGFRi (Tarceva)

ALKi (Alecensa)

BRAFi (Zelboraf)

MEKi (Cotellic)

anti-CD20 (Gazyva)

anti-HER2 (Herceptin;

Kadcyla; Perjeta)

various chemotherapies

lenalidomide* (Celgene)

rociletinib* (Clovis)

daratumumab* (Janssen)

Antigen release

Priming & activation anti-CEA-IL2v FP (cergutuzumab amunaleukin)

anti-FAP-IL2v FP

anti-OX40

anti-CD27* (Celldex)

entinostat* (Syndax)

Clinical development Preclinical development

* Partnered or external

Established therapies

In-house CIT NMEs in the clinic

Page 26: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Cancer immunotherapy read-outs in 2016

Priority review granted for bladder and lung cancer

26 Status as of April 19, 2016; Outcome studies are event-driven: timelines may change.

Phase III Phase I

= Read-outs expected in 2016

atezo

NSCLC (Dx+) (BIRCH)

atezo

2/3L NSCLC (POPLAR)

atezo+Avastin

1L Renal (IMmotion 150)

atezo

1/2L Bladder (IMvigor 210)

Phase II

atezo+lenalidomide

MM

atezo+daratumumab+len

R/R MM

atezo+ipilimumab

Solid tumors

atezo+aCD40

Solid tumors

atezo+IFN-alfa

Solid tumors

atezo+aOX40

Solid tumors

atezo+IDO

Solid tumors

atezo+Avastin+/-chemo

Solid tumors

atezo+Cotellic

Solid tumors

atezo+chemo

Solid tumors

atezo

Solid tumors

aOX40

Solid tumors

aCEA/CD3 TCB

Solid tumors

aCEA-IL2v FP

Solid tumors

aCD20/CD3 TCB

heme tumors

atezo+/-azacitidine

MDS

atezo+Gazyva+chemo

R/R FL/aNHL

atezo+Gazyva+polatuzumab

R/R FL/aNHL

aFAP-IL2v FP

Solid tumors

IDO

Solid tumors

atezo+aCEA/CD3 TCB

Solid tumors

atezo+aCSF-1R

Solid tumors

atezo+aCEA-IL2v FP

Solid tumors

atezo+Zelboraf

Melanoma

atezo+Tarceva

NSCLC

atezo+Gazyva

R/R FL / aNHL

atezo+Zelboraf+Cotellic

Melanoma

aCSF-1R

Solid tumors

atezo+Alecensa

ALK+ NSCLC

atezo+Kadcyla/Herceptin+Perjeta

HER2+ eBC/mBC

atezo+Gazyva+lenalidomide

R/R FL/aNHL

aCD40+vanucizumab

R/R FL/aNHL

atezo

2/3L NSCLC (OAK)

atezo

2/3L Bladder (IMvigor 211)

atezo+Avastin+chemo

1L nsq NSCLC (IMpower 150)

atezo+chemo

1L nsq NSCLC (IMpower 130)

atezo+chemo

1L sq NSCLC (IMpower 131)

atezo

1L nsq NSCLC (Dx+) (IMpower 110)

atezo

1L sq NSCLC (Dx+) (IMpower 111)

atezo+chemo

1L TNBC (IMpassion 130)

atezo

Adj MIBC (Dx+) (IMvigor 010)

atezo

Adj NSCLC (Dx+) (IMpower 010)

atezo+Avastin

1L Renal (IMmotion 151)

atezo+chemo

1L nsq NSCLC (IMpower 132)

For Background:

New Ph3 in 3L CRC for

Tecentriq+Cotellic, FPI in

May’16, data in ‘18 (OS),

approval in Q1’19

Page 27: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016 sales

Innovation

Outlook

27

Page 28: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

2016: Focus on ongoing and upcoming launches

28

Approvals &

launch

preparation

Maximise

recent

launches

• Ocrevus (ocrelizumab) in MS

• Atezolizumab in bladder and lung cancer

• Gazyva (GOYA) and Perjeta (APHINITY)

• Venclexta (venetoclax) in R/R CLL with 17p deletion

• Cotellic + Zelboraf in 1L BRAF positive metastatic melanoma

• Gazyva in Rituxan-refractory iNHL (GADOLIN)

• Alecensa in ALK positive NSCLC

* Outcome studies are event driven, timelines may change

Page 29: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

2016 onwards: Significant launch activities

29 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

Venclexta

R/R CLL with 17p del

Ocrelizumab

RMS/ PPMS

Lebrikizumab

Severe Asthma

Emicizumab (ACE910)

Hemophilia A

Atezolizumab

2L+ lung and bladder cancer

Alecensa

2L ALK+ NSCLC

Perjeta + Herceptin

eBC HER2+ (APHINITY) Atezolizumab+Avastin+chemo

1L NSCLC

Gazyva

1L aNHL (GOYA)

Gazyva

1L iNHL (GALLIUM)

Gazyva

Refractory iNHL (GADOLIN)

Lampalizumab

Geographic atrophy

Atezolizumab + Avastin

1L RCC

NM

Es

lin

e

exte

nsio

ns

2016 2017 2018

Actemra

Giant cell arteritis

Alecensa

1L ALK+ NSCLC

Page 30: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

ASCO 2016: Highlights in various cancer types

30

Solid tumors

• atezolizumab + aOX40: Ph I

• atezolizumab + Cotellic: Ph I in CRC

Lung

• Alecensa: Ph III (J-ALEX) in 1L ALK+ NSCLC

• atezolizumab: Ph II OS update (POPLAR) in

2/3L NSCLC

Bladder

• atezolizumab: Ph II (IMvigor210) 1L cohort and

2L cohort update in bladder

Breast

• Herceptin + Perjeta: Ph III (PHEREXA) in 2L HER2+ mBC

• atezolizumab + abraxane: Ph I update in TNBC

Hematology

• Venclexta: Ph II (CAVALLI) in 1L aNHL

• Venclexta: Ph I in R/R CLL and R/R NHL

• Venclexta +/- chemo: Ph I in R/R MM

• Venclexta + chemo: Ph I in AML

Cotellic in collaboration with Exelixis; Alecensa in collaboration with Chugai; Gazyva in collaboration with Biogen Idec

Page 31: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Additional key oncology presentations in 2016*

31 * Planned submissions (to be confirmed); Outcome studies are event driven, timelines may change

• atezolizumab + abraxane: Ph I in TNBC

• atezolizumab + IDOi: Ph I

• atezolizumab + Zelboraf + Cotellic: Ph1 in 1L BRAF+ mM

• atezolizumab: Ph II (IMvigor 210) in bladder

• atezolizumab: Ph I in SCLC

• atezolizumab: Ph III (OAK) in 2L NSCLC [or IASLC Vienna]

Copenhagen, 7-11 Oct San Diego, 3-6 Dec

• atezolizumab + lenalidomide: Ph I in MM (safety)

• atezoliztumab + azacytidine: Ph I in MDS (safety)

• aCD20/CD3 TCB: Ph I dose escalation in solid tumors

• Gazyva: Ph III (GOYA) in front-line aNHL

• polatuzumab + Gazyva/Rituxan: Ph II (ROMULUS) in R/R FL / aNHL

• polatuzumab + Gazyva/Rituxan + CHP: Ph I/II in 1L aNHL

• polatuzumab + Gazyva: Ph I/II in 1L aNHL and R/R FL

• Venclexta + Rituxan +/- bedamustin: Ph II (CONTRALTO) in R/R FL

• Venclexta + Gazyva or +Rituxan +/- benda: Ph I in R/R CLL

• Venclexta: Ph II in ibrutinib/idelalisib ref R/R CLL

Vienna, 4-7 Dec San Antonio, 6-10 Dec

• atezolizumab: Ph III (OAK) in 2L NSCLC

• atezoliztumab + Tarceva: Ph I in NSCLC

• atezolizumab + abraxane: Ph I update in TNBC

• taselisib: Ph II (LORELEI) in neoadjuvant HER2-/ER+ BC

• SERD: Ph II

New Orleans, 16-20 Apr Copenhagen, 9-12 Jun

• aOX40: Ph I dose escalation in solid tumors

• atezoliztumab + Avastin + FOLFOX: Ph I in CRC

• atezolizumab + Gazyva: Ph I in R/R aNHL/iNHL

• idasanutlin + AraC: Ph I in R/R AML

EHA We are hoping to show

MM and MDS data at

ASH but we cannot

confirm until later this

year.

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2016: Key late-stage news flow

32

Compound Indication Milestone

Regulatory

Gazyva Rituxan-refractory iNHL US/EU approval

Venclexta R/R CLL with 17p deletion US approval

ocrelizumab RMS/PPMS US/EU filing

atezolizumab Bladder cancer US approval

atezolizumab 2/3L NSCLC US approval

Alecensa 2L ALK+ NSCLC EU CHMP opinion

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

Venclexta + Rituxan R/R FL (iNHL) Ph II CONTRALTO

Venclexta + Rituxan/Gazyva 1L aNHL Ph II CAVALLI

* Outcome studies are event driven, timelines may change

mixed

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33

Diagnostics Division Roland Diggelmann COO Roche Diagnostics

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Q1 2016: Diagnostics Division sales

Strong sales growth in laboratory businesses

34 CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +4%

2016 2015

CHFm CHFm CHF CER

Diagnostics Division 2,614 2,511 4 5

Professional Diagnostics 1,519 1,425 7 7

Molecular Diagnostics 446 401 11 11

Diabetes Care 443 507 -13 -11

Tissue Diagnostics 206 178 16 13

Change in %

Page 35: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

North America

0%

27% of divisional sales

Latin America

+21%

6% of divisional sales

Japan

-3%

4% of divisional sales EMEA1

+1%

43% of divisional sales

Q1 2016: Diagnostics regional sales

Growth driven by Asia Pacific and Latin America

Asia Pacific

+16%

20% of divisional sales

35

23% growth in E7 countries2

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

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Q1 2016: Diagnostics highlights

Growth driven by Professional Diagnostics

36

• Driven by immunodiagnostics (+12%)

• Virology (+16%) incl. HPV (+16%)

• Advanced staining portfolio (+10%); primary

staining (+24%)

0.0 0.5 1.0 1.5 2.0

Tissue

Dia

Diabetes

Care

Molecular

Dia

Professional

Dia

EMEA

North America

RoW

+13%

-11%

+7%

+11%

CHFbn

1

1 Underlying growth of Molecular Diagnostics excluding sequencing business: +4%

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

YoY CER growth

• Spillover of US reimbursement cuts to private

sector

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Providing the full solution in hepatitis testing

Comprehensive menu in serology & molecular

37 1 Q1 2016 growth; *NAT: nucleic acid amplification technology

Complete platform and test portfolio

• Hepatitis contributes ~60% of Roche’s

Infectious Disease/Virology portfolio

• Serology hepatitis: (+5%1)

• Molecular/NAT* hepatitis: (+11%1)

Roche

25%

Others

75%

Leader in a CHF 4.3bn market

• 5yr CAGR: ~6% projected

• Strong growth potential in serology

Page 38: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

FDA approves IND for cobas Zika assay

Screening initiated at Puerto Rico blood centres

38 * IND: Investigational New Drug Application

• Currently testing in Puerto Rico, expect to

expand into southern US centres

• Operating under an IND* cost-recovery

model, no commercial sales

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Key launches 2016

39

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

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40

Finance Alan Hippe Chief Financial Officer

Page 41: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Q1 2016: Highlights

41

Sales

• Good sales growth in all regions and both divisions

Capital markets update

• Bond maturity

– EUR: 2.1bn maturity on 4 March 2016 - coupon 5.625%

• Bond tender

– USD: 0.6bn (0.86bn outstanding, maturity in 2019) – coupon 6.0% s.a.

• Bond issuance

– EUR: 0.65bn maturity in 2023 - coupon 0.5%

– USD: 1.0bn maturity in 2026 - coupon 2.625% s.a.

Currency impact

• Positive impact from USD, JPY and EUR currencies partly offset by Latin America

s.a.=semi-annual coupon

Guidance for FY 2016

• 2015 core EPS base for CER calculation: CHF 13.85

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+457

+133

+124

+581+107

+72+30

+115

United States Europe Intl. Japan Diagnostics

Division

Group Fx Group

CHF

Pharma Division

+4%

+3% +5% +4% +4% +5% +4% +5%

1

Q1 2016: Group sales

Increase driven by US & EU Pharma and Diagnostics

42 Absolute values and growth rates at Constant Exchange Rates (CER) 1 average Full Year 2015 to average Q1 2016 Fx

Page 43: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

CER

sales

growth

Q1 2016

vs.

Q1 2015

Exchange rate impact on sales growth

Positive impact from USD, JPY and EUR

CER=Constant Exchange Rates

+3.9%

+4.9%

+1.9p

+0.6p +0.4p -0.2p -0.2p

-0.2p -1.3p

CER USD JPY EUR Other

Europe

As-Pac Other Lat-Am CHF

CHF

sales

growth

Q1 2016

vs.

Q1 2015

43

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Currency impact on Swiss Franc results 2016

Low currency impact expected

Q1 HY Sep

YTD

FY

Sales 1 1 1 0

Core

operating

profit

0 -1

Core EPS -1 0

Assuming the 31 Mar 2016 exchange

rates remain stable until end of 2016,

2016 impact is expected to be (%p):

CHF / USD

CHF / EUR

+1%

+1%

+2% +2%

1.01 0.99 0.97 0.970.98 0.970.970.97 0.970.97 0.970.97

0.970.98

0.99

0.97

0.95 0.950.95

0.96

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

1.09 1.10 1.09 1.09 1.09 1.09 1.091.09 1.091.09 1.09 1.09

1.091.10 1.10 1.09

1.06 1.071.061.08

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

Average

YTD

2015

4% 3% 2% 1%

2% 3% 3% 2%

Assumed average YTD 2016

Monthly avg fx rates 2016 Fx rates at 31 March 2016

44

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2015: Core EPS base for FY 2016 guidance

45

excl. Venezuela &

Argentina FX losses 13.49

+0.36 13.85

Full Year 2015

as reported

Core EPS Core EPS

Full Year 2015

@ CER

Page 46: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

2016 outlook

46

Group sales growth1 Low to mid-single digit

Core EPS growth1 Ahead of sales growth

Dividend outlook Further increase dividend in Swiss francs

1 At Constant Exchange Rates (CER)

Page 47: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

2016: Upcoming IR events

Further details available online: http://www.roche.com/investors/agenda.htm

5 June

21 July

2 August

20 October

Analyst Event at ASCO

Half Year Results

Analyst Event on Diagnostics Division at AACC

Third Quarter Results

47

Page 48: Roche2a156912-eff5-4257... · side-effects of pipeline or marketed products; ... Refractory iNHL (GADOLIN) ... Priority review granted for bladder and lung cancer

Pipeline summary

Marketed products additional indications

Global Development late-stage trials

pRED (Roche Pharma Research & Early Development)

gRED (Genentech Research & Early Development)

Roche Group Q1 2016 sales

Diagnostics

Foreign exchange rate information 48

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Changes to the development pipeline

Q1 2016 update

49

New to Phase I New to Phase II New to Phase III New to Registration 1 NME transitioned from Ph0

RG7906 – psychiatric disorders

1 NME re-opened in Ph1

RG7203 PDE10A inh – schizophrenia

1 NME in-licensed from Amgen

RG6149 ST2 MAb - asthma

1 NME acquired from Tensha

RG6146 BET inh – oncology (CIT)

3 new AIs

RG7876 CD40+vanucizumab solid tumors

RG7601 Venclexta+Cotellic/idasanutlin –

AML

RG3616 Erivedge+ruxolitinib –

myelofibrosis

1 NME in-licensed from

Shionogi

RG6152 CAP endonuclease inh -

influenza

1 NME transitioned from Ph2

RG7412 crenezumab –

Alzheimer’s

1 AI

RG7446 atezolizumab +

chemotherapy + pemetrexed –

NSCLC non-sq. 1L

1 AI transitioned from Ph2

RG7446 atezolizumab – NSCLC 2L+

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

2 NMEs

RG7116 lumretuzumab – mBC

RG7597 duligotuzumab – solid tumors

1 NME

RG7090 basimglurant TRD

(out-licensing activities ongoing)

1 NME (status assigned to Ph1)

RG7155 emactuzumab PVNS

tumors

1NME following FDA approval

RG7601 Venclexta (venetoclax)

17pdel CLL rel/ref

Status as of April 19, 2016

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Roche Group development pipeline

50

Phase I

(43 NMEs+19 AIs)

Raf & MEK dual inh solid tumors

ChK1 inh solid tum & lymphoma

atezo+Zelboraf+/-Cotellic melanoma

atezo+Avastin+chemo solid tumors

atezo+Tarceva /Alecensa NSCLC

atezolizumab+Cotellic solid tumors

Venclexta (venetoclax)+Gazyva CLL

atezolizumab solid tumors

ERK inh + Cotellic solid tumors

LSD1 inh AML

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

RG3645

RG7893

RG7716

RG7935

HIF1 alpha LNA solid tumors

RG7304

RG7741

RG7446

RG7446

RG7446

RG7446

RG7601

RG7446

RG7842

RG6016

RG7841

RG7775

RG7882

RG7446

RG7888

RG6061

CEACD3 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

Venclexta (venetoclax) heme indications RG7601

therapeutic vaccine HBV RG7944

*CEA IL2v FP+atezolizumab s. tumors RG7813

OX40 MAb + atezolizumab solid tumors CLL RG7888

- fibrosis RG6069

atezo+lenalidomide/daratumumab MM RG7446

IDO inh + atezolizumab solid tumors RG6078

PTH1 recep. ago hypoparathyroidism CHU

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

basmisanil Down’s syndrome RG1662

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

(16 NMEs+12 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

StaphA vcRifalog TAC infect. diseases

RG7834

RG7461

RG7916

RG7845

RG7861

FGFR1/KLB MAb metabolic diseases RG7992

RG7861

PT - hyperphosphatemia CHU

codrituzumab hepatocell. carcinoma RG7686

taselisib ER+(HER2-neg) BC neoadj RG7604

taselisib NSCLC sq 2L RG7604

Venclexta (venetoclax) DLBCL RG7601

Venclexta (venetoclax)+Rituxan FLrel/ref RG7601

obinutuzumab lupus nephritis RG7159

VAP-1 inh inflammatory diseases PRO

Gazyva multiple combos heme indications RG7159

atezolizumab + K/HP HER2+ BC RG7446

RG7888

Nav1.7 inh (2) pain RG6029

Erivedge+Esbriet IPF RG3616

ADC r/r NHL RG7986

RG-No Roche/Genentech managed

CHU Chugai managed

IONIS IONIS managed

PRO Proximagen managed

Immunology

New Molecular Entity (NME)

Oncology

Other

Ophthalmology

Neuroscience

Infectious Diseases

CardioMetabolism

Additional Indication (AI)

BET inh oncology RG6146

Erivedge+ruxolitinib myelofibrosis RG3616

PDE10A inh schizophrenia RG7203

- psychiatric disorders RG7906

Venclexta+Cotellic/idasanutlin AML CL RG7601

CAP endonuclease inh influenza RG6152

* INN: cergutuzumab amunaleukin

ST2 MAb asthma RG6149

SMN2 splicer spinal muscular atrophy RG7800

CD40 MAb+vanucizumab solid tumors RG7876

Status as of April 19, 2016

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Roche Group development pipeline

51

Phase III

(10 NMEs + 30 Als)

1 Global filing

2 CHMP positive opinion Q1’16

3 EU only

4 Approved in the US

5 Phase 3 ongoing

6 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 RG71594

Gazyva follicular lymphoma 1L RG7159

Venclexta (venetoclax)+RituxanCLL rel/ref RG7601

gantenerumab Alzheimer’s RG1450

atezolizumab NSCLC 2L+

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

Venclexta (venetoclax)+Gazyva CLL 1L RG7601

Avastin rel. ovarian ca. Pt-sensitive RG4351

atezolizumab bladder cancer 2L RG74465

atezolizumab+Avastin RCC RG7446

MabThera SC CLL RG1052

Avastin+Tarceva EGFR mut+ NSCLC RG4353

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

NSC atezo+chemo+Avastin NSCLC non-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

(2 NMEs + 4 Als)

Alecensa (alectinib) ALK+ NSCLC 2L RG78536

idasanutllin AML RG7388

emicizumab hemophilia A RG6013

Actemra systemic sclerosis RG1569

New Molecular Entity (NME)

RG-No Roche/Genentech managed

CHU Chugai managed

IONIS IONIS Managed

PRO Proximagen 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

Neuroscience

Infectious Diseases

CardioMetabolism

Additional Indication (AI)

Immunology

Other

crenezumab Alzheimer’s

Ophthalmology

RG7412

RG74465

atezo+chemo+pemetrexed NSCLC non-sq. 1L RG7446

atezolizumab+chemo NSCLC sq. 1L RG7446

Status as of April 19, 2016

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NME submissions and their additional indications

Projects currently in phase 2 and 3

52 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 (RG7686) liver cancer

lampalizumab (RG7417) geographic atrophy

lebrikizumab (RG3637) severe asthma

etrolizumab (RG7413) ulcerative colitis

2016 2019 and beyond

atezolizumab (RG7446) US*

NSCLC 2L+ ✓

ipatasertib (RG7440) solid tumors

vanucizumab (RG7221)

colorectal cancer

lebrikizumab+/-Esbriet (RG3637) IPF

2017

atezolizumab(RG7446) combo Avastin RCC

Flu A MAb (RG7745) influenza

taselisib (RG7604) HER2 neg ER+ mBC

basmisanil (RG1662)

Down syndrome

atezolizumab (RG7446) US*

bladder cancer 2L ✓

Venclexta (venetoclax)

DLBCL

ocrelizumab (RG1594) PPMS

emicizumab (RG6013) hemophilia A

Venclexta (venetoclax) + Gazyva CLL 1L

Venclexta (venetoclax) + Rituxan FL rel/ref

taselisib ( RG7604) NSCLC sq 2L

2018

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

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

New Molecular Entity Oncology

Immunology

Infectious Diseases

CardioMetabolism

Neuroscience

Ophthalmology

Other

Venclexta (venetoclax) + Rituxan 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

polatuzumab vedotin (RG7596)

heme tumors

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

idasanutlin (RG7388)

AML

CAP endonuclease inh (RG6152) influenza

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

atezolizumab(RG7446)+chemo

+pemetrexed NSCLC non-sq 1L

Status as of April 19, 2016

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2016 2019 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 2 and 3

53

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

2017

Avastin (US)

GBM

Gazyva DLBCL 1L

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Perjeta + Herceptin HER2-pos. mBC 2L

*Avastin rel. ovarian ca. Pt-sens.

Kadcyla+Perjeta

HER2-pos. BC adj.

Kadcyla+Perjeta

HER2-pos. BC neoadj

Kadcyla

HER2-pos. NSCLC

2018

Zelboraf

melanoma adj.

MabThera pemphigus vulgaris

ranibizumab PDS (US) wAMD

Alecensa (alectinib) Alk+ NSCLC 1L

obinutuzumab

lupus nephritis

Cotellic+paclitaxel TNBC

Gazyva follicular lymphoma 1L

Status as of April 19, 2016

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Major granted and pending approvals 2016

54

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

EU

US

Approved Pending approval

Status as of April 19, 2016

Japan-Chugai Bonviva

osteoporosis (oral) January 2016

Alecensa (alectinib)

ALK+ NSCLC 2L

Filed September 2015

Gazyva iNHL rituximab-ref.

February 2016

Avastin

cervical cancer

Filed September 2015

atezolizumab

bladder cancer 2L

Filed January 2016

Venclexta (venetoclax)

17pdel CLL rel/ref

April 2016

atezolizumab

NSCLC 2L+

Filed February 2016

MabThera SC* CLL

Filed November 2014

Avastin + Tarceva EGFR mut+ NSCLC

Filed July 2015

Gazyva iNHL rituximab-ref.

Filed September 2015

*CHMP pos. opinion

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Venclexta (venetoclax) +Rituxan FL rel/ref TNBC

Roche Group Development pipeline

Combinations

55

Phase III

(13 AIs)

atezo+Zelboraf+/-Cotellic melanoma

atezo+Avastin+chemo solid tumors

atezo+Tarceva/ Alecensa NSCLC

atezolizumab +Cotellic solid tumors

atezolizumab +ipi/IFN solid tumors

RG7446

RG7446

RG7446

RG7446

RG7446

CD40 MAb+atezolizumab solid tumors RG7876

atezolizumab+Gazyva lymphoma RG7446

emactuzumab + atezolizumab s.tumors RG7155

atezolizumab+Avastin RCC RG7446

atezo+chemo NSCLC non-sq. 1L RG7446

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

atezolizumab+chemo NSCLC sq. 1L RG7446

New Molecular Entity (NME) Additional Indication (AI)

Oncology

Immunology

RG-No Roche Genentech managed

OX40 MAb + atezolizumab s. tumors RG7888

atezo+lenalidomide multiple myeloma RG7446

atezolizumab+abraxane TNBC RG7446

CEA IL2v FP+atezolizumab s. tumors RG7813

IDO inh + atezolizumab solid tumors RG6078

Venclexta+Gazyva CLL

ERK inh + Cotellic solid tumors

RG7601

RG7842

Cotellic+paclitaxel TNBC RG7421

lebrikizumab +/- Esbriet IPF

RG7601

RG3637

Perjeta+Herceptin HER2+gastric ca 1L RG1273

Perjeta+Herceptin HER2+ mBC 2L RG1273

Venclexta(venetoclax)+RituxanCLL rel/ref RG7601

Kadcyla + Perjeta HER2+ BC adj RG3502

Kadcyla + Perjeta HER2+ BC neoadj RG3502

Perjeta+Herceptin HER2+ BC adj RG1273

Venclexta (venetoclax)+Gazyva CLL 1L RG7601

Avastin+Tarceva EGFR mut+ NSCLC RG4351

1 EU only

Phase I

(5 NMEs + 16 AIs)

Phase II

(3 Als)

Registration

(1 AI)

atezolizumab + K/ H+P HER2+BC RG7446

CEA CD3 TCB+atezolizumab s. tumors RG7802

Status as of April 19, 2016

Erivedge+Esbriet IPF RG3616

Gazyva multiple combos heme indications RG7159

Erivedge+ruxolitinib myelofibrosis RG3616

Venclexta+Cotellic/idasanutlin AML CLL RG7601

CD40 MAb+vanucizumab solid tumors RG7876

atezo+chemo+pemetrexed NSCLC non-sq. 1L RG7446

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Cancer immunotherapy pipeline overview

56

Phase I

(8 NMEs + 19 AIs)

atezo+Avastin+chemo solid tumors

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

atezolizumab+Gazyva lymphoma RG7446

emactuzumab + atezolizumab s.tumors RG7155

IDO inh solid tumors RG6078 atezolizumab bladder cancer 2L RG7446 1

atezolizumab + IDO inh solid tumors *INCY

atezolizumab+varlilumab solid tumors *CLDX

New Molecular Entity (NME) Additional Indication (AI)

Oncology

RG-No Roche Genentech managed

OX40 MAb + atezolizumab solid tumors RG7888

atezo+lenalidomide/daratumumab MM RG7446

Phase II

(2 AIs)

atezo+NY-ESO-1 soft tissue sarcoma IMDZ

NSC atezo+entinostat TNBC SNDX

CEA IL2v FP+atezolizumab solid tumors RG7813

IDO inh + atezolizumab solid tumors RG6078

CD20/CD3 biMAb hem tumors RG7828

Registration

(1 NME + 1 AI)

FAP IL2v FP solid tumors RG7461

Status as of April 19, 2016

atezo+Zelboraf+/-Cotellic m. melanoma RG7446

atezolizumab + K/HP HER2+ BC RG7446

*external collaborations: INCY- Incyte INCB024360, CLDX - Celldex CD27 MAb; CLVS – Clovis EGFRi, CRVS – Corvus CPI-444, KITE – Kite KTE-C19, AMGN – Amgen oncolytic virus, JNJ – Janssen CD38 MAb., IMDZ – Immune Design CMB305, SNDX – Syndax HDACi

atezo+rociletinib EGFRmut+ NSCLC *CLVS

atezolizumab NSCLC 2L RG74461

1 Phase 3 ongoing

atezo+A2Ai solid tumors *CRVS

atezo+CD19 CAR-T NHL *KITE

atezo+talimogene laherp. TNBC, CRC *AMGN

atezo+daratumumab solid tumor *JNJ

Phase III

(10 AIs)

atezolizumab+Avastin RCC RG7446

atezo+chemo NSCLC non-sq. 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

atezolizumab+abraxane TNBC RG7446

atezolizumab Dx+ NSCLC adj RG7446

atezolizumab muscle inv. bladder ca adj RG7446

CD40 MAb+vanucizumab solid tumors RG7876

atezo+chemo+pemetrexed NSCLC non-sq. 1L RG7446

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Doing now what patients need next