roche note: for 1995, a special dividend was paid out to mark f. hoffmann-la roche’s 100th...

Roche

2014 results

London, 28 January 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

2014 performance

Outlook

5

2014: Targets achieved

6

Targets for 2014 FY 2014

Group sales Low to mid-single digit growth1 +5%

Core EPS Ahead of sales growth1

+5%

+7% excl. one-time

US Pharma fee2

Dividend Further increase dividend3 CHF 8.00

+3%

1 At constant exchange rates 2 One-time double charge of CHF 202m for the US Branded Prescription Drug fee in 2014, following final regulations issued by the US

Internal Revenue Service which advanced the timing of recording the liability 3 2014 dividend as proposed by the Board of Directors

2014: Highlights

7

Innovation

• Three Breakthrough Therapy Designations: Anti-PDL1, Esbriet and Lucentis

• Three Fast Track Designations: Lampalizumab, cobimetinib and LptD (antibiotic)

• Cancer immunotherapy: New PD-L1 data in bladder, TNBC, renal. Six new agents entered clinic

• Phase 3 starts: Lampalizumab, etrolizumab, alectinib, venetoclax and Kadcyla adjuvant

• Launched next generation molecular diagnostics platform (cobas 6800/8800)

Growth

• Group sales +5%1 driven by HER2 franchise (+20%1), Avastin (+6%1), Actemra (+23%1) and

Professional Diagnostics (+8%1)

• Outperformance in all major regions: +6%1 in US, Japan & International; +3%1 in Europe

M&A

• InterMune: Acquisition completed

• Foundation Medicine: Collaboration announced

1 CER=Constant Exchange Rates

First take on Swiss National Bank`s decision

8

On January 15, the Swiss National Bank (SNB) announced its decision to unpeg

the Swiss franc from the Euro

Natural hedge of the underlying business:

• 18% of operating costs in Switzerland

• US, Europe, Japan and China with complete value chain

• Interest expenses predominantly paid in USD

• 2015 dividend payout for March converted prior to SNB decision

2014: Solid sales growth

9

2014 2013

CHFbn CHFbn CHF CER

Pharmaceuticals Division 36.7 36.3 1 4

Diagnostics Division 10.8 10.5 3 6

Roche Group 47.5 46.8 1 5

Change in %

CER=Constant Exchange Rates

2014: Continued sales growth for 4 years

10

0% 0% 1%

4%

2%

6%

4%

6% 6%

4%

8%

7%

5%

4%

5%

6%

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

All growth rates at Constant Exchange Rates (CER)

2014: Both Divisions with sales growth in all

regions

11

0

2

4

6

8

10

12

14

16

18

20

Japan International Europe US

Diagnostics

Pharma

CHFbn

+6%

+3% +2%

+7%

+2%

+13%

0%

+4%

+6%

+3%

+6%

+6%

All growth rates at Constant Exchange Rates (CER)

2014: Group core operating profit & margin

remains at high levels

12

16.6

15.1

17.2 17.9 17.6

34.9% 35.6% 37.7% 38.3%

37.2%

2010 2011 2012 2013 2014

+3% at CER (+5%*) % of sales

CHFbn

(37.6%*)


* Excluding one-time double charge for the US Branded Prescription Drug fee in 2014

2014: Core EPS growth bridge

13

one-time

US Pharma fee* +5.2%

+1.7% +6.9%

Sales

+4.9%

Core EPS Core EPS

Full Year 2014 excl. one-time US Pharma fee*

Full Year 2014

figures as reported



2014: Dividend and payout ratio further increased

14 1 compound annual growth rate

8.00

31.9 34.5

38.8

44.8

48.6

51.6

55.3

54.5

54.7 56.0

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00

10.00

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

Dividend payout ratio (%) CHF

2014 payout ratio: 56.0%

Payout ratio calculated as dividend per share divided by core earnings per share (diluted); 2014 dividend as proposed by the Board of

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

Rituxan/MabThera RA

Neuroscience

6 NMEs

ocrelizumab

gantenerumab

Roche: A pipeline of differentiated products

Launched

Phase III

Phase II 10 NMEs + 9 AIs

Rituxan/MabThera

Xeloda

Herceptin

Perjeta

Kadcyla

Avastin

Gazyva/Gazyvaro

Tarceva

Zelboraf

Erivedge

Immunology/

Ophthalmology

Actemra/RoActemra

Lucentis

Xolair

Esbriet

Pulmozyme

lebrikizumab

lampalizumab3

etrolizumab2

anti-PDL1

taselisib1

venetoclax (Bcl2i)

cobimetinib4

pictilisib1

alectinib

15

Oncology

Neuroscience

Ophthalmology

Immunology

Oncology

3 AIs

1 Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma

AI = Additional Indication; NME = New Molecular Entity

2014 performance

Outlook

16

Launch new products Esbriet: US and EU

Cobimetinib + Zelboraf: US and EU

2015 milestones

17

Renew CD20 franchise Gazyva (aggressive NHL)*

Entry into Multiple Sclerosis Ocrelizumab: Phase 3 readout

Expand cancer

immunotherapy

PD-L1: Bladder, Lung, Renal, Triple Negative BC

NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3

Entry into Hemophilia ACE910: Start of pivotal trials

Diagnostics Rollout of key platforms (cobas 6800 / 8800)

* Event-driven (interim analysis)

2015 outlook

18

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

19

Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals

2014 results

Innovation

Outlook

20

2014: Pharma sales

All regions with positive growth

21

2014 2013

CHFm CHFm CHF CER

Pharmaceuticals Division 36,696 36,304 1 4

United States 15,822 15,097 5 6

Europe 9,422 9,254 2 3

Japan 3,301 3,405 -3 7

International 8,151 8,548 -5 2

Change in %


CHFm % sales

Sales 36,696 100.0

Royalties & other op. inc. 2,273 6.2

Cost of sales -7,551 -20.5

M & D -5,974 -16.3

R & D -7,876 -21.5

G & A -1,567 -4.3

Core operating profit 16,001 43.6

2014 vs. 2013

CER growth

-1% in CHF

2014

4%

4%

6%

4%

4%

50%

35%

Excl. PSI & US

Pharma fee*:+14%

Excl. filgrastim

deal: +10%

Excl. 340B: +5%

Esbriet launch

2014: Pharma Division

Investment in Esbriet launch

22

PSI &

US Pharma fee*


* Refers to 2013 past service income of CHF 131m and one-time double charge for the US Branded Prescription Drug fee in 2014

2014: Pharma sales

HER2, Avastin and Tamiflu main growth drivers

23

-800 -400 0 400 800

Xeloda

Pegasys

MabThera/Rituxan

Xolair

Actemra/RoActemra

Kadcyla

Tamiflu

Avastin

Herceptin

Perjeta

US

Europe

Japan

International

+189%

+7%

+6%

+54%

+135%

+25%

+23%

-46%

-20%

+2%

CHFm

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

0 3 6 9

Zelboraf

Xeloda

Tarceva

Avastin

MabThera/

Rituxan

HER2

Kadcyla

Perjeta

Herceptin +20%

+2%

+6%

-1%

-46%

-12%

2014: Oncology sales up +5%

24

CER growth

CHFbn

• In-class competition

• Loss of exclusivity

• Continued uptake in ovarian & cervical (US)

• Treatment through multiple lines in CRC

• Strong uptake of Perjeta & Kadcyla

• Competitive pressure in US & EU

• Potential approval of coBRIM in 2015

• Increased usage across a variety of indications

• Growth despite 340B baseline effect and Russia

+20%

+2%

+6%

-1%

-46%

-12%

CER=Constant Exchange Rates 2014 Oncology sales: CHF 22.8bn

Avastin: Growth supported by recent launches

25

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

2011 2012 2013 2014

CHFm

US Europe International Japan

YoY CER growth

-7%

+6%

+6%+13% Platinum-resistant ovarian cancer

• Launched in US and EU

Cervical cancer

• Launched in US and filed in EU

HER2 negative breast cancer

• Positive phase 3 data in treatment

through multiple lines (TML) and 1L

Colorectal cancer

• CALGB H2H data support standard of

care in 1L


HER2 franchise: Strong growth driven by Perjeta

and Kadcyla

26

0

500

1,000

1,500

2,000

2,500

Q3

12

Q4

12

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Kadcyla

Perjeta

Herceptin

16% 10%

15%

CHFm

15% 20% 17%

23%

7%

23% 19%

YoY CER growth


Immunology products: Accelerated growth

Driven by Actemra SC and Xolair

27

0

200

400

600

800

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Actemra SC

Actemra IV

Xolair

Pulmozyme

19%

YoY CER growth

CHFm

18% 20% 15%

18%

18%

26% 19%


200

300

400

500

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

Lucentis: Flattening in a competitive environment

Breakthrough designation in Diabetic Retinopathy

28

2014

• Growth driven by DME and continued

market expansion

Outlook

• Increased competition in AMD and

DME

• Breakthrough Status and Priority

Review for treatment of DR

(PDUFA date Feb 6)

Lucentis sales (USDm)

Eylea

wAMD

Lucentis

DME

AMD

Less-frequent than

monthly dosing

AMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy

Esbriet strong launch

29

US launch off to strong start

• FDA approval on 15 October 2014,

patients still in transition to full

reimbursement

• > 1,300 patients in clinical trials

European sales with strong growth

• EU label strengthened to include the

ASCEND and pooled one year

mortality data on October 23, 2014 0

10

20

30

40

50

Q113

Q213

Q313

Q413

Q114

Q214

Q314

Q414

Europe Canada US

CHFm

13

18

45

24

10

33

28

37

Q1

13

Q3

13

Q2

13

Q3

14

Q4

14

Q2

14

Q3

13

Q1

14

Q4

13

Europe Canada US

50

40

30

20

10

0

Esbriet sales

Sales based on average 2013 exchange rate

2014 results

Innovation

Outlook

30

2014: Major clinical and regulatory news flow

31

Compound Indication Milestone

Regulatory

Actemra SC Rheumatoid arthritis EU approval

Avastin Glioblastoma EU approval

Avastin Cervical cancer US, EU filing

Avastin Pt-resistant ovarian cancer US, EU approval

MabThera SC NHL EU approval

Gazyvaro Front line CLL EU approval

Xolair Chronic idiopathic urticaria US approval

Esbriet Idiopathic pulmonary fibrosis US approval

Phase III

oral octreotide Acromegaly Ph III

cobimetinib BRAF+ met. melanoma Ph III (co-BRIM)

gantenerumab Prodromal Alzheimer`s disease Ph III (SCarlet RoAD)

Kadcyla/Perjeta 1L met. HER2+ breast cancer Ph III (MARIANNE)

Esbriet Idiopathic pulmonary fibrosis Ph III (ASCEND)

Phase III starts

Kadcyla Adjuvant HER2+ breast cancer Ph III (KAITLIN)

Kadcyla Neo-adjuvant HER2+ breast cancer Ph III (KRISTINE)

venetoclax (Bcl2 inh.) Relapsed/refractory CLL Ph III (MURANO)

Anti-PDL1 2/3L NSCLC Ph III (OAK)

alectinib ALK+ NSCLC Ph III (ALEX)

etrolizumab Ulcerative colitis Ph III (HIBISCUSI/II, GARDENIA,

LAUREL, HICKORY, COTTONWOOD)

gantenerumab Mild Alzheimer`s disease Ph III (Marguerite RoAD)

lampalizumab Geographic atrophy Ph III (CHROMA, SPECTRI)

Rituxan/MabThera RA

Neuroscience

6 NMEs

ocrelizumab

gantenerumab

Roche: A pipeline of differentiated products

Launched

Phase III

Phase II 10 NMEs + 9 AIs

Rituxan/MabThera

Xeloda

Herceptin

Perjeta

Kadcyla

Avastin

Gazyva/Gazyvaro

Tarceva

Zelboraf

Erivedge

Immunology/

Ophthalmology

Actemra/RoActemra

Lucentis

Xolair

Esbriet

Pulmozyme

lebrikizumab

lampalizumab3

etrolizumab2

anti-PDL1

taselisib1

venetoclax (Bcl2i)

cobimetinib4

pictilisib1

alectinib

32

Oncology

Neuroscience

Ophthalmology

Immunology

Oncology

3 AIs

1 Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma

AI = Additional Indication; NME = New Molecular Entity

2017

HER2 franchise expected to grow further

Biosimilars delayed to 2017

33

Established standard of care New standard of care Potential new standard of care

Adjuvant

BC

Herceptin +

chemo

Herceptin sc + chemo

(HannaH)

Herceptin & Perjeta + chemo (APHINITY)

1st line

mBC Herceptin

+ chemo Herceptin & Perjeta + chemo (CLEOPATRA)

2nd line

mBC Xeloda + lapatinib Kadcyla (EMILIA)

2016 2012 2013 2014 2015 2011 2019 2018 2020

Kadcyla (KATHERINE) Kadcyla & Perjeta (KAITLIN)

Est. Biosimilars

launch (EU)

Neoadjuvant

BC Herceptin + chemo

(NOAH)1 Herceptin & Perjeta + chemo

(Neosphere, Tryphaena)2

Kadcyla & Perjeta + chemo (KRISTINE)

Key priorities in 2015

• Strengthen PERJETA as standard of care in 1L mBC & neoadjuvant, Kadcyla in 2L

• Secure durable conversion from Herceptin IV to SC

Clinical data in 2015

• PERJETA 2L PHEREXA final PFS & interim OS data expected Q3 15

• Release of the NEOSPHERE final PFS/DFS data at ASCO

Hematology franchise

Extensive late stage clinical trial program

34

Compound Combination Indication P 1 P 2 P 3

Gazyva Mono GREEN R/R CLL

Gazyva Mono GOYA aNHL

Gazyva Mono GADOLIN iNHL

Gazyva Mono GALLIUM 1L FL

Gazyva +PDL1 R/R FL

Gazyva +PDL1 aNHL

venetoclax* +Rituxan MURANO R/R CLL

venetoclax +Gazyva CLL14 CLL

venetoclax Mono R/R CLL 17p

venetoclax +Rituxan R/R FL

venetoclax Mono 1L aNHL

venetoclax Mono R/R NHL

venetoclax Mono R/R MM

venetoclax Mono AML

polatuzumab +Rituxan/Gazyva NHL

polatuzumab +Gazyva R/R FL

polatuzumab +Gazyva aNHL

* Partnered with AbbVie

venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC)

Biosimilars delayed to 2017

Anti-PDL1 in triple negative breast cancer

Encouraging early data

35

PD-L1

IHC (IC)

TNBC a

n

ORR, Best

Response, 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 - - -

• Encouraging efficacy in monotherapy

• Well tolerated

• Update at a medical conference in 2015

Emens LA, et al. SABCS, 2014

2014 Roche cancer immunotherapy:

Six NMEs moved into the clinic

36

Priming & activation

Anti-CEA-IL2v

Anti-OX40

NME (Anti-ctyokine)

Anti-CD27*

Antigen presentation

Anti-CD40

IMA942 vaccine* (Immatics)

Antigen release

T cell infiltration

T cell Trafficking

Cancer T cell recognition

Anti-CEA-CD3

Anti-HER2-TDB

Antigen/T cell bispecific Mabs

ImmTAC* (Immunocore)

Anti VEGF: Avastin

Targeted therapies:

Tarceva, cobimetinib,

Zelboraf, Gazyva

Clinical development Preclinical development

* Partnered projects (external)

Established therapies

New in 2014

T cell killing

Anti-PD-L1

Anti-CSF-1R

Anti-CEA-IL2v

Anti-OX40

IDO inhibitor (NewLink Genetics)

NME (undisclosed)

IDO inhibitor* (Incyte)

Chen and Mellman. Immunity 2013

Cancer immunotherapy program growing strongly

37

Compound Combination Indication Ph 1 Ph 2 Ph 3

PDL1 Mono

+Tarceva Lung

PDL1 Mono Bladder

PDL1 Mono

+Avastin Renal

PDL1 +Zelboraf

+Zelboraf+cobimetinib Melanoma

PDL1

Mono

+Avastin

+cobimetinib

+ipilimumab

+IFN alfa-2b

+CD40

+OX40

+CSF-R1

+CEA IL2v

Solid tumors

PDL1 +Avastin+FOLFOX Colorectal

PDL1 Mono

+Gazyva Hematology

PDL1 Mono Triple negative breast cancer

CSF-1R Mono

+CD40 Solid tumors

CEA IL-2v Mono Solid tumors

OX40 Mono Solid tumors

CEA CD3 Mono Solid tumors

IDO Mono Solid tumors

Study ongoing Study imminent Additions since Q3

Status as at January 2015

Roche cancer immunotherapy

Pipeline as of 2014 year end…

38

Phase II Phase III

Anti-PDL1

NSCLC (Dx+)

Anti-PDL1

NSCLC 2/3L

Anti-PDL1+Avastin

Renal 1L

Anti-PDL1

Bladder 1/2L

Phase I

Anti-OX40

Solid tumors

CEA CD3

Solid tumors

IDO

Solid tumors

Anti-CSF1R

Solid tumors

Anti-PDL1

Solid tumors

Anti-PDL1+Zelboraf

Melanoma

Anti-PDL1+Tarceva

NSCLC

PDL1+Avastin+FOLFOX

CRC

Anti-PDL1 + Gazyva

Blood cancer

Anti-CEA IL-2v

Solid tumors

Anti-PDL1

TNBC

Anti-PDL1+Avastin

Solid tumors

Anti-PDL1+cobimetinib

Solid tumors

Anti-PDL1+ipilimumab

Solid tumors

Anti-PDL1+ CD40

Solid tumors

Anti-PDL1+IFN-alfa

Solid tumors

Anti-PDL1

NSCLC 2/3 L

Status as at December 2014

Anti-PDL1 trials

NMEs monotherapy

Immune doublets

Roche cancer immunotherapy

…and additional trials already decided upon

39

Phase II Phase III

Anti-PDL1

NSCLC (Dx+)

Anti-PDL1

NSCLC 2/3L

Anti-PDL1+Avastin

Renal 1L

Anti-PDL1

Bladder 1/2L

Phase I

Anti-OX40

Solid tumors

CEA CD3

Solid tumors

IDO

Solid tumors

Anti-CSF1R

Solid tumors

Anti-PDL1

Solid tumors

Anti-PDL1+Zelboraf

Melanoma

Anti-PDL1+Tarceva

NSCLC

PDL1+Avastin+FOLFOX

CRC

Anti-PDL1 + Gazyva

Blood cancer

Anti-CEA IL-2v

Solid tumors

Anti-PDL1

TNBC

Anti-PDL1+Avastin

Solid tumors

Anti-PDL1+cobimetinib

Solid tumors

Anti-PDL1+ipilimumab

Solid tumors

Anti-PDL1+ CD40

Solid tumors

Anti-PDL1+IFN-alfa

Solid tumors

Anti-PDL1 + CSF1R**

Solid tumors

Anti-PDL1 + CEA-IL2v**

Solid tumors

Anti-PDL1 + OX40**

Solid tumors

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1

NSCLC 2/3 L

Anti-PDL1**

Bladder 2L

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1**

tba

Anti-PDL1 trials

NMEs monotherapy

2015 readout expected

Study start in 2015

Immune doublets

**

Status as at January 28, 2015

Oncology – Molecular Information

How we will collaborate with Foundation Medicine

40

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

What we aim to achieve together

Key initial areas for collaboration

• Roche a leader in PHC/companion

diagnostics across modalities

• FMI a leader in comprehensive genomic

profile development and molecular

information

Brings together expertise needed to

innovate for patients

• Cancer Immunotherapy test

• Continuous monitoring test

ACE 910 in Hemophilia A

A novel FVIIIa mimetic bispecific antibody

41

Mode of action

Novel approach promoting FX activation

and acceleration of coagulation

Kitazawa, Shima, Yoshioka, Hattori . Nature Medicine 2012;18(10):1570,

Sampei, et al. PLoS One 2013;8(2):e57479, Muto, Shima, Hattori . J Thromb

Haemost 2014;12:206

Targeted product profile

• Less frequent dosing

• Subcutaneous

• Avoid induction of inhibiting antibodies

Prophylaxis

3 times/week, IV

On-demand treatment

1-3 times/bleeding event, IV

Inhibiting Factor VIII antibodies in 20-33% of the patients NO

N-I

NH

IBIT

OR

Prophylaxis with bypassing

agents

Every other day, IV

On-demand treatment with

bypassing agents

2-3h intervals, IV

IN

HIB

ITO

R

Immune Tolerance Induction

70-80 % success rate

limitation due to very high cost and heavy burden for

patients

ACE 910

FVIIIa

In collaboration with Chugai

2014 results

Innovation

Outlook

42

2015: Key late-stage news flow

43

Compound Indication Milestone

Regulatory

Avastin Cervical cancer EU approval

Lucentis Diabetic retinopathy US approval

alectinib ALK+ NSCLC US filing

Cobimetinib + Zelboraf 1L Melanoma US, EU approval

Phase III readouts*

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 Bladder 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

Picture

44

Diagnostics Division Roland Diggelmann COO Roche Diagnostics

2014: Diagnostics Division sales

Growth driven by Professional Diagnostics

45

2014 2013

CHFm CHFm CHF CER

Diagnostics Division 10,766 10,476 3 6

Professional Diagnostics 6,045 5,772 5 8

Diabetes Care 2,392 2,459 -3 1

Molecular Diagnostics 1,613 1,580 2 6

Tissue Diagnostics 716 665 8 10

Change in %

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


North America

+4%

25% of divisional sales

Latin America

+13%


Japan

0%

4% of divisional sales EMEA1

+4%


2014: Diagnostics regional sales

Growth driven by APAC and EMEA

Asia Pacific

+15%


46

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

2014: Diagnostics Division

Profit growth in line with sales excl. PSI*


* PSI: 2013 past service income of CHF 67m; VAT: 2013 one-time VAT refund of CHF 45m

CHFm % sales

Sales 10,766 100.0

Royalties & other op. inc. 131 1.2


M & D -2,462 -22.9

R & D -1,037 -9.6

G & A -512 -4.8


2014 2014 vs. 2013

CER growth

-4% in CHF

6%

2%

9%

4%

3%

21%

2%

Admin: +6%

Excl. PSI*: +5%

Excl. PSI*: +5%

and VAT*: +8%

Excl. VAT*: +8%Excl. VAT*: +8%

2014: Diagnostics

Growth driven by Professional Diagnostics

+1%

• Virology (+7%) incl. HPV (+48%) • Launch of cobas 6800/8800 systems with assays for blood

screening and virology

• Accu-Chek Aviva/Performa (+7%) and Mobile (+19%)

• Advanced staining portfolio (+9%) and companion

diagnostics (+27%)

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

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

CER growth

1

+8%

+6%

+10%

• Continued double digit growth in immunodiagnostics (+13%)

• Further expansion of leading menu

0 1 2 3 4 5 6

Tissue Dia

Molecular

Dia

Diabetes

Care

Professional

Dia

EMEA

North America

RoW

Sales

CHFbn

48

Serum work area (42% of sales)*

Growing strongly in all regions

49

+5%

+8%

+15%

+19%

+8%

+10%

EMEA

Asia-Pacific

North America

Japan

Latin America

*SWA: serum work area: clinical chemistry and immunodiagnostics

2013 2014

Integrated SWA* solution

– Immunodiagnostics (+13%)

– Clinical chemistry (+7%)

Invest for growth

New reagent manufacturing in China

• Reliable local supply and right

sizing of cost base

• Reagent formulation, filling and

packaging

– Packaging to begin in 2016

– Fully operational in 2018

2012 2022E 2017E

Other

Asia

RPD reagent volume

x2

50 RPD = Roche Professional Diagnostics

Extend leading menu in women’s health

High prognostic value of preeclampsia blood test

51

Assay and claim extension

• Extends the applicability of the assay

from 3-5% of pregnancies to 20%

• Fully automated

• Test performed across entire cobas

analyzer platform series

* Hund, M., et al. (2014) BMC Pregnancy and Childbirth 14, 324;

Zeisler, H.,. et al. (2014) XX COGI World Congress 2014

*Preeclampsia can be ruled-out for 1 week after testing

Medium Hospitals

Large Hospitals

Reference Labs

High Throughput

Low Throughput

cobas® 6800

cobas® 4800

cobas® 8800

Molecular Diagnostics

Launch and implementation of cobas 6800/8800

• Advanced PCR automation

• Highest throughput (3x above closest

competitor)

• CE launch of blood screening and

virology assays

• Low to middle volume throughput

• Broadest menu incl HPV testing

52

Entering Molecular Point of Care Diagnostics

Acquisition of IQuum, launch of cobas Liat™ analyzer

53

Target market:

• ~CHF 350m, growing ~20% p.a.

Laboratory in a tube technology:

• Fast and easy to use

• CLIA waiver expected in 2015

Portfolio:

• Influenza A/B and Strep A test, CE marked and FDA cleared

• Plans to extend menu in:

– Respiratory Syncytial Virus tests

– MRSA and C-difficile

Liat™ Analyzer Liat™ tube

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

Sequencing strategy

Building a leading sequencing solution

54

Grow through

disruptive

innovation

Sample

preparation

Testing

platform

Menu of

assays

Data

analysis Reporting

Developing complete sequencing solutions

Abvitro: Technology acquisition; Ariosa: Acquisition; Genia: Acquisition; Pacific Biosciences: Partnership; Bina: Acquisition; Foundation Medicine: Partnership

Sequencing menu: Non-invasive prenatal testing

Acquisition of Ariosa

55

Target market

• USD 400m sales worldwide in 2013, +30% pa

Technology

• Analyses fetal DNA with microarray technology

• Highly cost effective and accurate

• Screens for the risk of Down, Edwards and Patau

syndrome

Strategy

• Expand market access through kit distribution model

• Add test to Roche sequencing platform when available

HarmonyTM Prenatal Test

Digital analysis of selected

regions (DANSRTM) technology

Key launches 2014

56

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

*Excluding US; 1 Business 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

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

RTD: Roche Tissue Diagnostics;

Key launches 2015

57

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

Outlook

Investing into future growth

• Continued strong growth in serum work area

• Focus on implementation of next generation platforms, e.g. cobas 6800/8800

• Continued investment into development of future sequencing solution

• Ongoing structural adjustments in Diabetes Care to adapt to continuing

challenging market environment

• Strengthen leading presence in emerging markets

58

59

Finance Alan Hippe Chief Financial Officer

2014: Highlights

60

Business

• Solid sales and Core EPS growth: +5%1; Core EPS +7%1 excluding US Pharma fee*

• Core operating profit up +3%1 or +5%1 excluding US Pharma fee*

• Cash generation remains strong with operating FCF of CHF 15.8bn, a decrease of -2%1

due to higher capital investments

• Accounts receivable in Southern Europe further decreased

Improved financial result and major currency impact

• Positive development of Core Net Financial result: +32%1 due to sale of equities and

lower interest expenses

• Increased net debt due to acquisitions

• Group currency exposure – solid natural hedge, 82% of cost base outside Switzerland



2014: Group currency exposure

Overall solid natural hedge

2%

41%

21%

8%

28%

18%

38%

17%

6%

21%

0%

10%

20%

30%

40%

50%

CHF USD EUR JPY Others

Sales

Operating costs

61

Currency

exposure

FY 2014 currency structures; operating costs include all items between the sales and the operating profit lines

2014 performance

Focus on cash

62

2014: Group performance

Core EPS growth +5%1 or +7%1 excl. US Pharma fee*

63

2014 2013 Excl. US

CHFm CHFm CHF CER Pharma fee*

Sales 47,462 46,780 1 5

Core operating profit 17,636 17,904 -1 3 5

as % of sales 37.2 38.3

Core net income 12,533 12,526 0 6 7

as % of sales 26.4 26.8

Attributable to Roche shareholders 12,329 12,316 0 6 7

Core EPS (CHF) 14.29 14.27 0 5 7

Operating free cash flow 15,778 16,381 -4 -2

as % of sales 33.2 35.0

Free cash flow 5,322 5,403 -1 1

as % of sales 11.2 11.5

Change in %



2014: Group operating performance

Core OP growth +3%1 or +5%1 excl. US Pharma fee*

64

CHFm % sales

Sales 47,462 100.0

Royalties & other op. inc. 2,404 5.1


M & D -8,436 -17.8

R & D -8,913 -18.8

G & A -2,540 -5.4


2014 2014 vs. 2013

CER growth

-1% in CHF

5%

6%

6%

4%

3%

33%

38%

Excl. filgrastim

deal: +10%

Excl. US Pharma

fee*: +5%

Excl. PSI and US

Pharma fee*:+8%


* US Pharma fee: one-time double charge for the US Branded Prescription Drug fee in 2014; PSI: 2013 past service income of CHF 302m

17,16015,488

2,187

17,904

16,108

2,177

17,63616,001

2,096

Roche Group Pharma Division Diagnostics Division

2012 2013 2014

37.7% 38.3% 37.2%

44.0% 44.4% 43.6%

21.3% 20.8% 19.5%

2014: Core operating profit and margin

Margin at high levels

65

CHFm

-0.5 %p1

(-1.1 %p)

-0.9 %p1

(-1.3 %p)

-0.2 %p1

(-0.8 %p)

+2 %1

(-4 %)

+4 %1

(-1 %)

+3 %1

(-1 %)

(-0.1%p2)

(+0.3%p2)

% of sales

1 CER=Constant Exchange Rates 2 At CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014

-1,699

-1,116

+288

+136 +69 +90

-2,000

-1,500

-1,000

-500

0

2014: Core net financial result

Higher income from equities and lower interest expenses

66

FX gains/losses

2013 2014 All other, net Interest expense

Net income from equity securities

Improvement of 34% in CHF / 32% at CER

CHFm


19%

Net debt/

total assets:

Assets Equity & liabilities

33.0 44.5

21.2 21.6

17.3

19.4

25.2 30.9

11.9

11.7

15.8

23.1

31/12/13 31/12/14 31/12/13 31/12/14

75.6 75.6

Current

liabilities

Non-current

liabilities

Equity

(Net assets)

19%

15%

28%

53%

26%

34% 29%

62.2 62.2Current

liabilities

Non-current

liabilities

Equity

(Net assets)

59%

25%

41%

31%

40%

Cash and

marketable

securities

Other

current

assets

Non-current

assets

CHFbn

Balance sheet 31 December 2014

Equity ratio at 29% due to acquisitions

67

CHFbn


22.7 24.1

+0.4

+1.0

2013 Profit mix US 2014

2014: Group core tax rate

Double R&D tax credits in 2013

68

Relative higher

core profits in US

US R&D tax credits

for 2012 and 2013,

included in 2013

while only one year

credits in 2014

Figures in %

2014 performance

Focus on cash

69

16,13514,710

1,890

16,38114,976

1,962

15,77814,821

1,417

Roche Group Pharma Division Diagnostics Division

2012 2013 2014

35.5% 35.0%33.2%

41.8% 41.3% 40.4%

18.4% 18.7%

13.2%

2014: Operating free cash flow remains at high

levels

70

CHFm

% of sales

-2.4 %p1 (-1.8 %p)

-5.3 %p1 (-5.5 %p)

-1.7 %p1 (-0.9 %p)

-24 %1 (-28 %)

0 %1

(-1 %)

-2 %1

(-4 %)


B

BB

BBB-

BBB

CHFm

2,462

1,036

980

209

236

1,836

604

819

163

251

1,645

613

733

114

185

1,171

480

433

97

161

0 400 800 1,200 1,600 2,000 2,400 2,800

Southern

European

Countries

Spain

Italy

Portugal

GreeceDec 2014

Dec 2013

Dec 2012

Dec 2011

-52%1

2014: Accounts receivable in Southern Europe

further decreased

71 1 CER=Constant Exchange Rates

Note: Sovereign country ratings from Standard & Poor’s, as of 7 January 2015

-6.7

+15.8

-14.0

-10.5

-12.6

Dividends -6.7

Taxes -3.0

Treasury -0.8

2014: Group net debt development

Higher net debt due to InterMune acquisition

Net debt

31 Dec 2013

Operating Free

Cash Flow

Business combinations, Currency translation

& other

Net debt

31 Dec 2014

Non-op. FCF

Free Cash Flow CHF 5.3bn

1% (CER) higher than 2013

Business comb. -9.6

Own equities -0.8

Other -2.2

CHFbn


Balance sheet: Net debt to total assets

Ratio higher than 2013 due to InterMune acquisition

73

16%

11%

19%

14.0

75.6

31 Dec 2012 31 Dec 2013 31 Dec 2014

Net debt

(CHFbn)

Total assets

(CHFbn)

Net debt /

total assets

0

1

2

3

4

5

2015 2016 2017 2018 2019 2021 2022 2023 2024 2035 2039 2044

GBP CHF EUR USD

December 2014: Debt maturity profile

Balanced maturity profile

74

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

cumulative CHF 36 bn have been repaid as of December 31, 2014*

CHFbn

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

Currency impact on Swiss franc results 2014

Negative currency impact

Q1 HY Sep

YTD

FY

Sales -6 -6 -5 -4

Core

operating

profit

-8 -4

Core EPS -8 -5

In 2014 impact is (%p):

CHF / USD

CHF / EUR

+1%

+1%

+2% +2%

0.90 0.89 0.880.88 0.94 0.95 0.980.960.900.89 0.90 0.91

0.910.890.890.90

0.930.930.94

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 1.22 1.21 1.21 1.21 1.20 1.20

1.231.23 1.231.23

1.21

1.22

1.221.22

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

Average YTD

2013

-4% -5% -4% -1%

0% -1%

-1% -1%

Assumed average YTD 2014

Monthly avg fx rates 2014 Fx rates at 31 Dec 2014

75

Currency sensitivities for 2014

76

Figures in CHFm Sales Core OP

US dollar 190 76

Euro 98 48

Japanese yen 37 20

All other currencies 131 70

Impact of 1% change in average exchange rate vs. the Swiss franc

2015 outlook

77

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 FY 2014 update

79

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

11 NMEs

RG6047 SERD (2) – ER-pos (HER2-

neg) mBC

RG6078 IDO inh - solid tumors

RG7802 CEA CD3 TCB - solid tumors

RG7876 CD40 iMAb+PD-L1 MAb -

solid tumors

RG7787 MSLN-PE cFP – solid tumors

RG7689 NME – infectious diseases

RG7880 NME - autoimmune diseases

RG7625 NME - autoimmune diseases

RG6080 DBO β-lactamase inh -

bacterial infections

RG7345 TAU pS422 MAb – AD

RG7597 HER3/EGFR DAF+cobimetinib

– KRAS mutation-pos tumors

2AIs

RG7155 CSF-1R+PD-L1 MAb - solid

tumorssolid tumors

RG7446 PD-L1 MAb + Gazyva –

lymphoma

2NMEs transitioned from Ph1

RG6046 SERD ER-pos (HER2-neg) mBC

CHU: URAT 1 inh - gout

5 AIs

RG3502 Kadcyla – HER2-pos advanced

NSCLC

RG435 Avastin + Tarceva - EGFR mut-

pos. NSCLC

RG6062 Esbriet – ILD, systemic sclerosis

related

RG7421 cobimetinib – triple negative

breast cancer

RG7601 venetoclax (Bcl-2-inh)+

Rituxan - rel/ref follicular lymphoma

3 AIs

RG7601 venetoclax (Bcl-2

inh)+ Gazyva - CLL 1st line

RG7446 PD-L1 bladder cancer

2nd line

CHU Actemra – large-vessel

vasculitis (added by Chugai)

1 AI following EU submission

RG105 MabThera – CLL

subcutaneous formulation

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

3 NMEs

RG7666 PI3K inh - glioblastoma 2L

RG7624 IL-17 MAb - autoimmune

diseases

RG7458 MUC16 ADC - ovarian and

pancreatic cancer

6 NMEs

RG7593 pinatuzumab vedotin (CD22

ADC) - heme tumors

RG7449 quilizumab - asthma

RG7128 mericitabine - HCV

RG1512 inclacumab - ACS/CVD

RG1578 decoglurant (mGluR2 NAM) -

depression

RG7597 HER3/EGFR DAF m. epithelial

tumors

1 AI removed by Chugai

Suvenyl - enthesopathy

1 AI following US approval

RG435 Avastin - rel. ovarian ca. Pt-

resistant

Status as of January 28, 2015

Roche Group development pipeline

80

Phase I

(33 NMEs + 11 AIs)

Raf & MEK dual inh solid tumors

venetoclax (Bcl-2) heme indications

ChK1 inh solid tum & lymphoma

Oncology Other disease areas


HER3 MAb solid tumors

MDM2 ant solid & 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 MAb+Zelboraf+/-cobimetinib m. melanoma

Steap 1 ADC prostate ca.

PD-L1 MAb+Avastin+chemo solid tumors

PD-L1 MAb solid tumors

PD-L1 MAb+cobimetinib solid tumors

venetoclax (Bcl-2)+ Gazyva CLL CLL

PD-L1 MAb+Tarceva NSCLC EGFR+

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

TAAR1 ago schizophrenia

a-synuclein MAb Parkinson's Disease

mGlu5 PAM schizophrenia

SMN2 splicer spinal muscular atrophy

TLR7 agonist HBV RG7795

RG3645

RG7203

RG7893

aldosterone synth inh met. diseases RG7641

RG7716

RG7410

RG7935

RG7342

RG7800

HIF1 alpha LNA solid tumors

RG7304

RG7601

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

- autoimmune diseases RG7880

autoimmune diseases RG7625

- infectious diseases RG7689

DBO β-lactamase inh bact. infections RG6080

TAUpS422 MAb Alzheimer’s RG7345

CSF-1R + PDL-1 MAb solid tumors RG7155

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

IDO inh solid tumors RG6078

HER3/EGFR DAF+ cobi KRAS+ s. tumors RG7597

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

81

Phase II

(23 NMEs + 12 Als)

Phase III

(9 NMEs + 21 Als)

Registration

(1 NME + 4 Als)

1 US only : FDA submission decision pending

2 Approved in US, submitted in EU

3 Submitted in US

crenezumab Alzheimer’s RG7412

lampalizumab (factor D) geo. atrophy RG7417

Lucentis diabetic retinopathy RG36453

Avastin recurrent cervical cancer RG4352

Perjeta HER2+ BC neoadj RG12732

cobimetinib + Zelboraf m. melanoma RG7421

MabThera SC CLL RG105


Avastin glioblastoma 1st line RG4351

Avastin NSCLC adj RG435

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

ocrelizumab RMS RG1594

Gazyva DLBCL 1st line RG7159

ocrelizumab PPMS RG1594

Actemra large-vessel vasculitis CHU

lebrikizumab severe asthma RG3637

Zelboraf melanoma adj RG7204

Perjeta HER2+ gastric cancer 1st line RG1273

Actemra giant cell arteritis RG1569

etrolizumab ulcerative colitis RG7413

Perjeta HER2+ mBC 2nd line RG1273

alectinib (ALK inhibitor) NSCLC RG7853

Gazyva iNHL rituximab refractory RG7159

Gazyva follicular lymphoma 1st line RG7159

venetoclax (Bcl-2) + Rit. CLL rel/ref RG7601

Kadcyla HER2+ gastric cancer 2nd line RG3502

gantenerumab Alzheimer’s RG1450

PD-L1 MAb NSCLC 2nd line RG7446

Kadcyla + Perjeta HER2+ BC adj RG3502

Kadcyla + Perjeta HER2+ BC neoadj RG3502

IL-6R MAb neuromyelitis optica CHU

Perjeta HER2+ BC adj RG1273

Kadcyla HER2+ BC adj RG3502

venetoclax+Gazyva (Bcl-2) CLL 1st line RG7601

Avastin ovarian cancer 1st line RG4351

Avastin rel. ovarian ca. Pt-sensitive RG4351

PD-L1 MAb bladder cancer 2nd line RG7446

bitopertin obsessive compulsive dis. RG1678

danoprevir HCV RG7227

basimglurant (mGlu5 NAM) TRD RG7090

MAO-B inh Alzheimer’s RG1577

Actemra systemic sclerosis RG1569

polatuzumab vedotin (CD79bADC) hem tumors RG7596

V1 receptor antag autism RG7314

ipatasertib (AKT inh) solid tumors RG7440

lebrikizumab idiopathic pulmonary fibrosis RG3637

LptD antibiotic antibacterial

RG7929

venetoclax (Bcl-2) C LL rel/refract 17pdel RG7601

PD-L1 MAb bladder cancer 1/2l RG7446

Flu A MAb influenza RG7745

IL-31R MAb atopic dermatitis CHU

FIXa /FX bispecific MAb hemophilia A RG6013

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

GABRA5 NAM Down Syndrome RG1662

ADC lifastuzumab vedotin (NaPi2bADC)Pt-resist. OC RG7599

PD-L1 MAb + Avastin RCC RG7446

CSF-1R MAb PVNS/solid tumors RG7155

taselisib (mutant-selective) solid tumors RG7604

venetoclax (Bcl-2) DLBCL RG7601

Ang2-VEGF MAb colorectal cancer RG7221

setrobuvir HCV RG7790

glypican-3 MAb liver cancer RG7686

GIP/GLP-1 dual ago type 2 diabetes RG7697

Esbriet SSc – interstitial lung disease RG6062

cobimetinib TNBC RG7421

Avastin+Tarceva EGFR mut+ NSCLC RG435

venetoclax (Bcl-2)+ Rituxan rel/ref FL RG7601

pictilisib pictilisib solid tumors RG7321

SERD ER+(HER2-neg) mBC RG6046

URAT 1 inh gout CHU

RG7929

Kadcyla HER2+ NSCLC RG3502

lebrikizumab IPF RG3637

NME submissions and their additional indications

Projects currently in phase 2 and 3

82

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

* lead market China

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

bitopertin (RG1678)

obsessive compulsive dis.

ocrelizumab (RG1594) RMS

cobimetinib (MEK inh) combo Zelboraf

met melanoma

danoprevir* (RG7227) HCV

basimglurant (RG7090) depression

crenezumab (RG7412) Alzheimer‘s

gantenerumab (RG1450) Alzheimer‘s

V1 receptor antag (RG7314) autism

glypican-3 Mab (RG7686) liver cancer

lampalizumab anti-factor D (RG7417) geo atrophy

lebrikizumab (RG3637) severe asthma

etrolizumab (RG7413) ulcerative colitis

2014 2015 2017 and beyond

alectinib (RG7853) ALK-pos. NSCLC

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

ipatasertib AKT inh (RG7440) solid tumors

MAO-B inh (RG1577) Alzheimer‘s

polatuzumab vedotin (RG7596)

CD79b ADC heme tumors

LptD antibiotic (RG7929) antibacterial

lebrikizumab (RG3637) idiopathic pulmonary fibrosis

2016

PDL-1 MAb (RG7446) combo Avastin RCC

Flu A MAb (RG7745) influenza

taselisib (PI3Ki, RG7604) (mutant-selective) solid tumors

GABRA5 NAM (RG1662) Down syndrome

lifastuzumab (RG7599)

NaPi2b ADC Pt resistant OC

PDL-1 MAb (RG7446) bladder cancer

CSF-1R MAb (RG7155)

PVNS and solid tumors

venetoclax (Bcl-2i, RG7601) + Gazyva DLBCL

Ang2-VEGF MAb (RG7221)

colorectal cancer


ocrelizumab (RG1594) PPMS

FIXa /FX bispecific MAb (RG6013) hemophilia A

cobimetinib TNBC

venetoclax (Bcl-2i, RG7601) + Gazyva CLL 1st line

venetoclax (Bcl-2i, RG7601) + Rituxan rel/ref FL

venetoclax (Bcl-2i, RG7601) CLL rel/ref

pictilisib PI3K inh (RG7321) solid tumors

SERD (RG6046)

ER+(HER2-neg) mBC

Avastin NSCLC adj

2014 2015 2017 and beyond

Indicates submission to health authorities has occurred.

* approved in EU; ** approved in US

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

83

Actemra systemic sclerosis

Perjeta HER2-pos. BC adj

Perjeta

HER2-pos. gastric cancer 1L

Zelboraf

melanoma adj.

Kadcyla +/- Perjeta

HER2-pos mBC 1st line

Kadcyla

HER2-pos gastric cancer 2L

Kadcyla

HER2-pos. BC adj

**Avastin (EU)

cervical cancer recurrent

Actemra giant cell arteritis

2016

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

Avastin (US)

GBM

Gazyva DLBCL 1st line

Gazyva iNHL rituximab refractory

Gazyva follicular lymphoma 1st line

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

Perjeta

HER2-pos. mBC 2ndline

Lucentis (US) diabetic retinopathy

**Perjeta (EU) HER2-pos. BC neoadj

MabThera SC (EU) CLL


Avastin +Tarceva(EU)

EGFR mut+ NSCLC

*Avastin (US) ovarian cancer 1st line

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

Kadcyla+Perjeta

HER2-pos. BC adj

Kadcyla+Perjeta

HER2-pos. BC neoadj

Kadcyla

HER2-pos. NSCLC

Major granted and pending approvals 2014

84

Neuroscience

Ophthalmology

Other

NME

Oncology

Immunology

Infectious Diseases

CardioMetabolism

EU

US

Approved Pending approvals

MabThera NHL sc formulation

March 2014

RoActemra

RA sc formulation April 2014

Xolair

chronic idiopathic urticaria

March 2014

Avastin

rel. ovarian ca. Pt-resist

August 2014

RoActemra

early RA

September 2014

Gazyvaro

CLL

July 2014

Avastin cervical cancer

Filed April 2014

Avastin cervical cancer

August 2014

alectinib ALECENSA ALK-pos rec/adv NSCLC

July 2014

Zelboraf

m. melanoma December 2014

Japan-Chugai

Perjeta BC neoadjuvant

Filed September 2014

cobimetinib + Zelboraf

m. melanoma

Filed September 2014

Lucentis diabetic retinopathy

Filed August 2014

Esbriet*

idiopathic pulmonary fibrosis

October 2014

Esbriet*

idiopathic pulmonary fibrosis

March 2011

* Newly acquired asset (Intermune) Status as of January 28, 2015

Avastin

rel. ovarian ca. Pt-resist

November 2014

MabThera SC CLL

Filed November 2014

cobimetinib + Zelboraf

m. melanoma

Filed December 2014

Doing now what patients need next

roche note: for 1995, a special dividend was paid out to mark f. hoffmann-la roche’s 100th...

Documents