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Page 1: Kepler Seminar, Zurich March 24, 2011 - Roche
Page 2: Kepler Seminar, Zurich March 24, 2011 - Roche

Kepler Seminar, Zurich March 24, 2011

Roche Karl Mahler, Head of Investor Relations Nina Mojas, IR officer

Translating excellence in science into

customer benefit

Page 3: Kepler Seminar, Zurich March 24, 2011 - Roche

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: Kepler Seminar, Zurich March 24, 2011 - Roche

4

Solid fundamentals

Challenges to address

Building the future

Page 5: Kepler Seminar, Zurich March 24, 2011 - Roche

5

2010: Summary

Financial guidance fully met

Operational Excellence on track

• Most of the concerned employees individually notified

• R&D prioritised

• Divestitures of factories initiated

Pipeline is gaining strength

• 12 New Molecular Entities (NMEs) in late stage

Personalised Healthcare is becoming reality

• 6 late stage assets tailored to specific patient groups

Page 6: Kepler Seminar, Zurich March 24, 2011 - Roche

6

Pharmaceuticals Division 38,996 37,058 -5 -2 +5

Diagnostics Division 10,055 10,415 +4 +8 +8

Roche Group 49,051 47,473 -3 0 +5

2009 2010 Excluding

CHF m CHF m CHF local Tamiflu*

change in %

2010: Group sales

Solid underlying growth in line with guidance

* local currency

Page 7: Kepler Seminar, Zurich March 24, 2011 - Roche

7

2009 vs. 2008 2010 vs. 2009

Growth rates maintained despite healthcare

reforms and austerity measures

Q1 Q2 Q3 Q4 FY Q1 Q2 Q3 Q4 FY

Pharmaceuticals Division 8 14 15 8 11 10 -2 -5 -8 -2

excl. Tamiflu 7 7 5 -3 4 8 3 4 4 5

Diagnostics Division 8 7 10 10 9 9 9 7 6 8

Roche Group 8 12 14 8 10 9 0 -3 -5 0

excl. Tamiflu 7 7 6 0 5 9 4 5 4 5

Page 8: Kepler Seminar, Zurich March 24, 2011 - Roche

8

Key Pharmaceuticals & Diagnostics products

A risk-diversified portfolio of drugs and BUs

Sa

les (

CH

F b

n)

* 2010 sales

0

5

10

15

20

25

30

35

'03 '04 '05 '06 '07 '08 '09 '10

2 with > than CHF 6 bn

1 with > than CHF 5 bn

11 with > than CHF 1 bn

MabThera/Rituxan

Xeloda

NeoRecormon CellCept

Herceptin

Avastin

Pegasys

Clinical Chemistry

Immunochemistry

Tarceva

Lucentis

>C

HF 6

bn

* >

CH

F 1

bn

* >

CH

F 5

bn

*

Diabetes Care

Molecular Dx Boniva

Page 9: Kepler Seminar, Zurich March 24, 2011 - Roche

9

Pharma sales in International / emerging markets

0

1

2

3

4

5

6

7

8

9

10

2006 2007 2008 2009 2010

Tarceva

Xeloda

CellCept

Pegasys

Avastin

MabThera / Rituxan

Herceptin

Rest excl. Tamiflu

All figures at 2010 exchange rates

CHF bn

Page 10: Kepler Seminar, Zurich March 24, 2011 - Roche

10

Opportunities in emerging markets

Large untapped potential for our innovative products

Opportunities in emerging markets

• strong and long-standing presence

• providing access is key: disease

awareness, local clinical trials and

training for healthcare professionals

Current

penetration

(%) Herceptin

MabThera

oncology

China ~5% 12%

Russia 25% 26%

Emerging markets: by 2012 ~ 80% of US market value,

more than Western Europe (IMS)

Page 11: Kepler Seminar, Zurich March 24, 2011 - Roche

11

Continuous profit growth and margin improvement

16.6

16.3

33.2%

34.9%

2009 2010

Group Core operating profit and margin

+7%1

(+2%)

+2.1%p1

(+1.7%p)

CH

F b

n

% of sales

1 at constant exchange rates

Page 12: Kepler Seminar, Zurich March 24, 2011 - Roche

12

2.50

3.40

4.60

6.00

6.60

5.00

2.00

55.0%

51.6%

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

2004 2005 2006 2007 2008 2009 2010

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

55%

2010: Continuous increase of pay-out ratio over

three years1

CHF Average yearly dividend growth

(2004-2010): 22%

1 compound annual growth rate

Payout ratio

1 As announced in relation to the financial results for 2007 Pay-out ratio calculated as dividend per share divided 2010 Dividend: Proposed by the Board of Directors by core earnings per share (diluted) Pay-out ratio calculated as dividend per share divided by earnings (before exceptional items) per share (diluted)

Page 13: Kepler Seminar, Zurich March 24, 2011 - Roche

13

Solid fundamentals

Challenges to address

Building the future

Page 14: Kepler Seminar, Zurich March 24, 2011 - Roche

We need to justify the value of our products

more than ever

German Benefit Prognosis (2011) UK Value Based Pricing (2014)

Page 15: Kepler Seminar, Zurich March 24, 2011 - Roche

Narrowing labels indicate initially smaller

market opportunities

• 1980-1990: Pivotal studies considered

reasonably generalizable

• Nowadays:

– More narrow label to start with than

in the past

– Insurance companies moving towards

limiting re-imbursement in this

context

Drug X is indicated in

Metastatic Breast Cancer (MBC)

Drug X + Y is indicated

In MBC

X + Y on schedule

A indicated in MBC

X + Y on sched.

A in ‘substantive

studies’ only

1980s 1990s 2000s 2010

Page 16: Kepler Seminar, Zurich March 24, 2011 - Roche

Higher costs even when products are on the market 46% of NMEs were approved with a REMS

Level 1 Med Guide Level 2 Comm Plan Level 3 ETASU

NME

(BLAs) 11 Extavia

Cimzia, Dysport,

Simponi, Stelara,

Kalbitor, Actemra, Xiafelx,

Krystexxa

Nplate, Lumizyme

NMEs

(small molecules) 18

Vimpat, Nucynta, Savella, Banzel,

Votrient, Pradaxa

Effient, Vibativ,

Xenazine, Multaq, Samsca,

Victoza, Zortress, Prolia,

Gilenya

Promacta,

Sabril,

Entereg

Indication Change /

Label Updates 28

Treximet, Aplenzin, Trilipix,

Zolpimist, Edluar, Creon, Actoplus

MET XR, Cambia, Zipsor, Zenpep,

Colcrys, Lyrica Solution, Tyzeka

Solution, Pennsaid, Oleptro,

Silenor, Pancreaze, Suprep, H.P.

Acthar Gel, Axiron

Embeda, Ampyra, Dulera

Onsolis,

Zyprexa Relprevv, Exalgo,

Oxycontin, Suboxone

Page 17: Kepler Seminar, Zurich March 24, 2011 - Roche

Typical Promotions Less Effective Launch Trajectory

0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8 9 10 11 12

2004 2005 2006

2007 2008 2009

Months Since Launch

Ave

rag

e S

ale

s U

S$

M

Source: IMS

Page 18: Kepler Seminar, Zurich March 24, 2011 - Roche

18

Solid fundamentals

Challenges to address

Building the future

Page 19: Kepler Seminar, Zurich March 24, 2011 - Roche

19

A leading pipeline

12 NMEs in late-stage development

2007 2008 2009 2010

Number of NMEs

2

4

10 Metabolic

Oncology

Inflammation

ocrelizumab

dalcetrapib

pertuzumab

taspoglutide

Actemra

CNS

ocrelizumab

12

Virology

1 LIP decision made, phase III start pending

dalcetrapib

aleglitazar

Glycine

reuptake inh

ocrelizumab MS

lebrikizumab1

HCV pol inh1

pertuzumab

BRAF inhibitor

T-DM1

Hedgehog inh

GA101 (CLL, NHL)

MetMAb1

dalcetrapib

aleglitazar

Glycine

reuptake inh

ocrelizumab

pertuzumab

BRAF inhibitor

T-DM1

Hedgehog inh

GA101 (CLL)

taspoglutide

Page 20: Kepler Seminar, Zurich March 24, 2011 - Roche

20

HER2-positive breast cancer

Improving the standard of care

2010 2016

Early

(adjuvant) BC

Herceptin

+ chemotherapy

Herceptin Subcutaneous

+ chemotherapy

Herceptin &

pertuzumab +

chemotherapy

2012 2013 2014 2015 2011

1st line

mBC

Herceptin

+ chemotherapy

T-DM1& pertuzumab

(MARIANNE)

Herceptin & pertuzumab + chemotherapy

(CLEOPATRA)

2nd line

mBC

Xeloda

+ lapatinib

T-DM1

(EMILIA)

Timelines refer to the expected dates of first filing

Page 21: Kepler Seminar, Zurich March 24, 2011 - Roche

21

16.8%

24.0%

45.8%

29.0%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Herceptin +

docetaxel

Herceptin &

pertuzumab +

docetaxel

Herceptin &

pertuzumab

pertuzumab +

docetaxel

path

olo

gic

al com

ple

te r

esp

on

se

ITT population summary

p = 0.0141

p = 0.0198

p = 0.003

Herceptin & pertuzumab in neoadjuvant HER2+ BC

An encouraging result from NEOSPHERE trial

SABCS 2010

Phase III (CLEOPATRA) data in 1st line patients and filing in 2011

Page 22: Kepler Seminar, Zurich March 24, 2011 - Roche

22

Growth despite biosimilars

HER2 market example

Value decline

EU and RoW

Herceptin value assumption post

biosimilars launch based on the

German EPO market experience

New HER2

targeted products 3

2 Increased penetration

in International

markets

1 Pertuzumab

T-DM1

Herceptin

sub cut.

Page 23: Kepler Seminar, Zurich March 24, 2011 - Roche

23

RG7204 for metastatic melanoma meets

overall survival endpoint in Phase III

Patient Population

Second- and Third line

Malignant Melanoma

BRAF mutation positive

First-line Malignant Melanoma

BRAF mutation positive

Phase/Study Phase II BRIM2 Phase III BRIM3

# of Patients N=132 N=675

Design • Single ARM: RG7204 • ARM A: RG7204

• ARM B: dacarbazine

Primary Endpoint • Best overall response rate assessed by IRC

using RECIST criteria • Overall survival

Status • Presented at Int. Melanoma Congress 2010 • FPI Q1 2010; fully recruited in Dec 2010

• Met OS and PFS endpoints in Jan 2011

Expect filing in 2011 in US and EU

Page 24: Kepler Seminar, Zurich March 24, 2011 - Roche

24

Hedgehog pathway inhibitor in basal cell carcinoma

Positive pivotal phase II reported

• RG3616 is efficacious in treating advanced basal

cell carcinoma

– 33 BCC patients treated in Phase I*

– >50% had a response (IRF assessed)

• 2 (6.1%) complete response

• 16 (48.5%) partial response

– Median duration of response >8.8 months

– Well-tolerated with reversible, mild adverse

events

* Von Hoff, et al., New England Journal of Medicine, September 2009 In collaboration with Curis

Positive pivotal phase II data – US filing in 2011

Phase I efficacy data

Page 25: Kepler Seminar, Zurich March 24, 2011 - Roche

25

Impact on product pipeline

Progressing Personalized Healthcare

T-DM1

Metastatic breast cancer (HER-2 expression level)

Pertuzumab

Metastatic breast cancer (HER-2/3 expression level)

RG 7128

Hepatitis C (HCV viral load, genotype)

1 LIP and phase III decision pending

MetMAb

Non-small cell lung cancer (MET status)

Lebrikizumab1

Asthma (periostin level)

RG7204

Metastatic melanoma (BRAF V600E mutation)

Page 26: Kepler Seminar, Zurich March 24, 2011 - Roche

Key clinical trials since October 2010 15 of 15 in 5 months

Breast Cancer: T-DM1 in 1st line

HER2-positive breast cancer

randomised Phase II data – ESMO

(October 8–12, Milano)

Non-Small Cell Lung Cancer:

MetMAb in 2nd/3rd line NSCLC

randomised Phase II – ESMO

(October 8–12, Milano)

Ovarian Cancer: Avastin

in front line ovarian cancer

ICON7 Phase III pivotal trial – ESMO

(October 8–12, Milano)

Multiple Sclerosis:

Ocrelizumab in RRMS

randomised Phase II – ECTRIMS

(October 15, Gothenburg)

Hepatitis C: Nucleoside

Polymerase inh (RG7128)

randomised Phase IIb PROPEL interim data –

AASLD (October 28–Nov 2, Boston)

Metastatic Melanoma:

BRAF inhibitor vemurafenib

Phase II Melanoma Research Congress

(November 4–9, Sydney)

Non-Hodgkin's Lymphoma:

GA101 in aNHL

randomised Phase II data – ASH

(December 4–7, Orlando)

Schizophrenia: GlyT-1 inh

randomised Phase II – ACNP

(December 5–9, Miami)

Breast Cancer: Pertuzumab

randomised Phase II NEOSPHERE – SABCS

(December 8–12, San Antonio)

Asthma: Lebrikizumab

randomised Phase II – data in house

Metastatic Melanoma:

BRAF inhibitor vemurafenib

Phase III interim analysis results

(January 18, 2011)

Advanced Non-Small Cell

Lung Cancer (NSCLC): Tarceva

Phase III EURTAC study interim analysis

results (January 27, 2011)

Ovarian Cancer: Avastin in 2nd line

platinum sensitive ovarian cancer

OCEANS Phase III (February 8, 2011)

Diabetic macular edema (DME):

Lucentis RISE phase III

(February 14, 2011)

Basal Cell Carcinoma (mBCC)

Hedgehog inhibitor vismodegib

Pivotal Phase II

(March 21, 2011)

Page 27: Kepler Seminar, Zurich March 24, 2011 - Roche

27 27

2011: Major clinical news for late-stage NMEs 7 Phase III and 9 Phase II studies

Compound Indication Study

BRAF inh 1st line met melanoma Ph III BRIM3

Lucentis diabetic macular edema Ph III RISE Ph III RIDE

Avastin relapsed ovarian cancer Ph III OCEANS

Pertuzumab + Herceptin 1st line HER2+ mBC Ph III CLEOPATRA

Herceptin adj HER2+BC sc Ph III HANNAH

Actemra Early RA Ph III Head-to-head against Humira

Hedgehog Pathway Inh advanced BCC Ph II pivotal study

T-DM1 1st line HER2+ mBC Ph II PFS data

GA101 Relapsed indolent NHL Ph II Head-to-Head against

MabThera/Rituxan

MetMab NSCLC 2nd / 3rd line Ph II final data

Lebrikizumab asthma Ph II MILLY

Nucleoside Pol Inh Hepatitis C Ph IIb PROPEL final data; JUMP-C

Dalcetrapib Atheroclerosis CV risk red. Ph IIb dal-VESSEL; dal-PLAQUE

Page 28: Kepler Seminar, Zurich March 24, 2011 - Roche

28

Conclusions

Roche well positioned for the future

• Unchanged innovation-driven strategy

• Optimized operational setup driving current business and increasing

profitability

• Continued significant investments in industry-leading product pipeline

• Personalized Healthcare (PHC) becoming a reality

Page 29: Kepler Seminar, Zurich March 24, 2011 - Roche

29

We Innovate Healthcare

Page 30: Kepler Seminar, Zurich March 24, 2011 - Roche

30

Outlook for 2011

Barring unforeseen events; LC=Local Currency; * vs. 2010: CHF 0.8 bn

Sales growth (in LC) Group & Pharma (excl. Tamiflu): low single-digit

Diagnostics: significantly above market

Core EPS growth target

(in LC) High single-digit

Genentech synergies 2011+ : CHF 1.0 bn*

Debt Aim to return to net cash position by 2015

Dividend outlook Grow dividend in-line with Core EPS growth

Operational Excellence

savings 2011 : CHF 1.8 bn

2012+ : CHF 2.4 bn

Page 31: Kepler Seminar, Zurich March 24, 2011 - Roche

31

Long patent protection

Biosimilars facing high hurdles

Long primary patent protection

of our key biologics

Patents US EU

ROW/EM

Avastin 2019 similar

Lucentis 2019 marketed by

Novartis

Rituxan/

MabThera 2018 earlier

Herceptin 2019 earlier

Pegasys 2018 similar

Biosimilars outlook

US: FDA in the process of

developing guidelines

Long data exclusivity for biologics:

proposed 12 years

ROW/EM: investment in countries

with strong IP regulations (China)

Brand awareness important

EU: legal and regulatory hurdles

likely to remain high for biosimilars

Page 32: Kepler Seminar, Zurich March 24, 2011 - Roche

32

Priorities 2011

Improve Efficiency

• Implement ‘Operational Excellence’ as

announced

• Capture remaining synergies from

Genentech integration

Drive Innovation and Growth

• Progress late-stage pipeline

• Prepare launches for potentially three

NMEs (BRAF inhibitor, pertuzumab,

hedgehog inhibitor)

• Launch key diagnostic tests (HPV,

BRAF, KRAS, EGFR)

• Invest in emerging markets

2011: Bring personalised healthcare to patients

Page 33: Kepler Seminar, Zurich March 24, 2011 - Roche

33

Change CHF m 2009 2010 CHF m % loc %

2010: Group performance

+10% Core EPS growth1 as guided

Sales 49,051 47,473 -1,578 -3 0

Core operating profit 16,272 16,591 +319 +2 +7

as % of sales 33.2 34.9

Core net income 11,317 11,181 -136 -1

as % of sales 23.1 23.6

Attributable to Roche shareholders 10,636 10,955 +319 +3

Core EPS (CHF) 12.34 12.78 +0.44 +4 +10

1 at constant exchange rates