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(1)
(2)

Roche

2014 results

(3)

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

(4)

4

Group

Severin Schwan

(5)

2014 performance

Outlook

(6)

2014: Targets achieved

6

Targets for 2014

FY 2014

Group sales

Low to mid-single digit growth

1

+5%

Core EPS

Ahead of sales growth

1

+5%

+7%

excl. one-time

US Pharma fee

2

Dividend

Further increase dividend

3

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

(7)

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

(8)

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

(9)

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 %

(10)

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

(11)

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%

(12)

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%*)

CER=Constant Exchange Rates

(13)

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

CER=Constant Exchange Rates

(14)

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

(15)

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

taselisib

1

venetoclax (Bcl2i)

cobimetinib

4

pictilisib

1

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

(16)

2014 performance

Outlook

(17)

Launch new products

Cobimetinib + Zelboraf: US and EU

Esbriet: 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)

(18)

2015 outlook

18

Group sales growth

1

Low to mid-single digit

Core EPS growth

1

Ahead of sales growth

2

Dividend outlook

Further increase dividend in Swiss francs

1 At constant exchange rates

(19)

19

Pharmaceuticals Division

Daniel O’Day

(20)

2014 results

Innovation

Outlook

(21)

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 %

(22)

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*

CER=Constant Exchange Rates

(23)

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

(24)

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%

(25)

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

(26)

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

(27)

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%

(28)

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

(29)

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

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

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

(30)

2014 results

Innovation

Outlook

(31)

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)

(32)

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

taselisib

1

venetoclax (Bcl2i)

cobimetinib

4

pictilisib

1

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

(33)

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 2018 2019 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

(34)

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)

(35)

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

(36)

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)

(37)

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

(38)

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

(39)

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

(40)

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

(41)

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

NON -IN HI B ITO R

Prophylaxis with bypassing agents

Every other day, IV On-demand treatment with

bypassing agents 2-3h intervals, IV IN HI B ITO R

Immune Tolerance Induction 70-80 % success rate

limitation due to very high cost and heavy burden for patients

ACE 910

FVIIIa

(42)

2014 results

Innovation

Outlook

(43)

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

Anti-PDL1 Tumor type 2 Ph III

Anti-PDL1 Tumor type 3 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

(44)

Picture

44

Diagnostics Division

Roland Diggelmann

(45)

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% CER=Constant Exchange Rates

(46)

North America

+4%

25% of divisional sales

Latin America

+13%

7% of divisional sales

Japan

0%

4% of divisional sales

EMEA

1

+4%

45% of divisional sales

2014: Diagnostics regional sales

Growth driven by APAC and EMEA

Asia Pacific

+15%

19% of divisional sales

46

16% growth in E7 countries

2

1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey

(47)

2014: Diagnostics Division

Profit growth in line with sales excl. PSI*

47

CER=Constant Exchange Rates

* 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

Cost of sales

-4,790

-44.4

M & D

-2,462

-22.9

R & D

-1,037

-9.6

G & A

-512

-4.8

Core operating profit

2,096

19.5

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%

(48)

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

(49)

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%)

(50)

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

2017E

2022E

Other

Asia

RPD reagent volume

x2

50

(51)

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

(52)

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

(53)

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

(54)

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

(55)

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

Harmony

TM

Prenatal Test

Digital analysis of selected

regions (DANSR

TM

) technology

(56)

Key launches 2014

56

Area

Product

Market

BA

1

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 LIS

2

WW*

EU

EU

WW

RMD

RPD

RPD

RTD

Diabetes

Care

Accu-Chek Insight-

Next generation insulin pump & bGm

3

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, DPX

4

, WNV

5

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

(57)

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

BA

1

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

(58)

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

(59)

59

Finance

Alan Hippe

(60)

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

1 CER=Constant Exchange Rates

(61)

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

(62)

2014 performance

Focus on cash

(63)

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 %

1 CER=Constant Exchange Rates

(64)

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

Cost of sales

-12,341

-25.9

M & D

-8,436

-17.8

R & D

-8,913

-18.8

G & A

-2,540

-5.4

Core operating profit

17,636

37.2

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%

1 CER=Constant Exchange Rates

(65)

17,160

15,488

2,187

17,904

16,108

2,177

17,636

16,001

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 %p

1

(-1.1 %p)

-0.9 %p

1

(-1.3 %p)

-0.2 %p

1

(-0.8 %p)

+2 %

1

(-4 %)

+4 %

1

(-1 %)

+3 %

1

(-1 %)

(-0.1%p

2

)

(+0.3%p

2

)

% of sales

1 CER=Constant Exchange Rates

(66)

-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

Interest

All other, net

2014

expense

Net income

from equity

securities

Improvement of 34% in CHF / 32% at CER

CHFm

(67)

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

Current

62.2

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

(68)

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

(69)

2014 performance

Focus on cash

(70)

16,135

14,710

1,890

16,381

14,976

1,962

15,778

14,821

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 %p

1

(-1.8 %p)

-5.3 %p

1

(-5.5 %p)

-1.7 %p

1

(-0.9 %p)

-24 %

1

(-28 %)

0 %

1

(-1 %)

-2 %

1

(-4 %)

(71)

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

Greece

Dec 2014

Dec 2013

Dec 2012

Dec 2011

-52%

1

2014: Accounts receivable in Southern Europe

further decreased

71

1 CER=Constant Exchange Rates

(72)

-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

72

(73)

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

(74)

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

(75)

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 0.88 0.88 0.89 0.90 0.90 0.91 0.94 0.95 0.96 0.98 0.91 0.89 0.89 0.90 0.93 0.94 0.93 0.93 J F M A M J J A S O N D 1.23 1.22 1.22 1.22 1.22 1.22 1.22 1.21 1.21 1.21 1.20 1.20 1.23 1.23 1.23 1.23 1.21 1.22 1.22 1.22 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

(76)

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

(77)

2015 outlook

77

Group sales growth

1

Low to mid-single digit

Core EPS growth

1

Ahead of sales growth

2

Dividend outlook

Further increase dividend in Swiss francs

1 At constant exchange rates

(78)
(79)

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+PDL1 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 SERDER-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

References

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