Roche: Defining priorities for a high tech healthcare …0a26558a-8898-4e08-8cad-4b0a4f2d1c… ·...

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1 1 Roche: Defining priorities for a high tech healthcare company Erich Hunziker, Deputy Head of the Corporate Executive Committee and CFO October 2007 2 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

Transcript of Roche: Defining priorities for a high tech healthcare …0a26558a-8898-4e08-8cad-4b0a4f2d1c… ·...

Page 1: Roche: Defining priorities for a high tech healthcare …0a26558a-8898-4e08-8cad-4b0a4f2d1c… · Roche: Defining priorities for a high tech healthcare company ... Growth objectives

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1

Roche: Defining priorities for a high tech healthcare company

Erich Hunziker, Deputy Head of the Corporate Executive Committee and CFO

October 2007

2

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; and11 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

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Performance up-date

Our priorities

4

Pharmaceuticals 23.9 27.1 13 14 17

Diagnostics 6.4 6.8 6 5 10

Roche Group 30.3 33.9 12 12 16

CHF bn 2006 2007 USDYTD Sept YTD Sept CHF local growth

% change in

Continuing excellent growthOver CHF 3.5 billion organic sales added

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55

Strong rise in Group sales and Core EPS

0

5

10

15

20

25

30

H1 2003 H1 2004 H1 2005 H1 2006 H1 2007

0

1

2

3

4

5

6

7

Sal

es (

CH

F bi

llion

s)C

ore EPS

(CH

F)

Core EPS

Sales+19 %

+15 %

+21 %

+29 %

Historical Core EPS data 2003 to 2004 restated

+14 %

+24 %

+13 %

+38 %

6

Strategic acquisitions and portfolio enhancementsCommitted to technology leadership

Driving personalisedhealthcare

Leader inPharma

Leader in Diagnostics

Earlydetection Diagnosis

Patientstratifi-cation

Treatment Monitoring

• THP (therapeutic antibody technology)

• Alnylam (RNA interference technology)

• Transgene (therapeutic HPV vaccine)

• BioVeris (electrochemiluminescencetechnology)

• 454 Life Sciences (ultra fast gene sequencing)

• NimbleGen (high-density DNA microarrays)1

• Ventana (tissue-based diagnostics)1

• Tanox (acquired by Genentech)

1 Tender offer pending 2 Acquisition not yet closed/ pending regulatory approval

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7Roche Diagnostics technology capabilities

Ventana Acquisition – Complementary TechnologiesComplete tissue-based diagnostics capabilities for customers

Testing on Tissue

IHC protein markers

FISH/CISH/SISH NA markers

Protein expressionvia IC system

ElecsysAmpliChip

DNA mutation RNAexpression

via microarray

LC480

RNA expression viamultiple RT-PCR ormutation detection

TaqMan

RNA expression viamultiple RT-PCR ormutation detection

Testing after Protein / Nucleic acid Extraction

Pathologist

Ventana technology capabilities

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Ventana Acquisition – Company OverviewChanging the practice of medicine in tissue-based cancer diagnosis

• Company facts – Founded 1985, based in Tucson, Arizona – 952 employees (year end 2006)

• 2006 Financials– Revenue `06: $ US 238 m– Rev. CAGR ’04-’06: ~20 %– Operating Margin: ~19 %

• Leader in tissue-based diagnostics– Leadership in advanced staining segment– Large installed base in pathology labs– Strong U.S. presence

Source: Ventana Investor Presentation

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• High need for test automation and standardisation

• Increasing incidence of cancer

• Targeted cancer drugs requiring companion diagnostics

CAGRm USD

Market size and growth Key growth drivers

Ventana Acquisition – New Market PotentialHistopathology; ~1 bn market, growing 10 % p.a.*

CAGR

11 %

11 %

3 %

10 %

2005 A 2006* E2011*

830960

1,600

Tissue Prep

Primary/Special Stains

Advanced / ISH/IHC Stains

Source: Analyst reports, Roche Analysis * Analysis of the histopathology market based on Analyst forecasts

10

Growth objectives for 2007Reconfirming improved outlook of Q1

Sales

• Double-digit sales growth1 for Roche Group and Pharmaceuticals Division

• Above-market sales growth in both divisions

Core EPS target

• Core earnings per share growth above sales growth

1 in local currencies barring unforeseen events

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Performance up-date

Our priorities

122006 2011 2016

1

Roche Challenge # 1Achieve above peer level sales growth for both divisions

Can we constantly

gain market share

in both divisions ?

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YTD Sept ‘07: Sales growth two to three times the market Growing share of key growth drivers

Local sales growth

4%

12%

6%

7%

6%

7%

14%

16%

12%

14%

Japan

LatinAmerica

NorthAmerica

Europe

Division

IMS YTD July '07Roche

15.5% 15.4% 14.7% 15.1%

6.5% 7.4% 11.8% 13.2%2.8%5.6%

8.9%11.0%

9.6%8.5%

6.8%5.8%

6.5%6.4%

5.7%5.4%

5.5%5.3%

4.5%4.4%

2.4%2.9%

3.0%3.1%

1.3%2.4%

2.9%2.2%

1.3%0.2%

0%

10%

20%

30%

40%

50%

60%

70%

2004 2005 2006 2007

Key products as % of pharma sales

MabThera/Rituxan

Pegasys

Avastin

Herceptin

Xeloda

Tarceva

NeoRecormon/Epogin/Mircera

Cellcept

Bonviva/Boniva

14

Key products on growth pathNew indications provide fresh growth opportunities

0

1

2

3

4

Q1-05 Q3-05 Q1-06 Q3-06 Q1-07 Q3-07

HerceptinAvastin

MabTheraTarceva

0

1

2

3

4

5

Q1-02 Q3-02 Q1-03 Q3-03 Q1-04 Q3-04 Q1-05 Q3-05 Q1-06 Q3-06 Q1-07 Q3-07

50%29%

MA

T sa

les

(CH

F bn

)

0

2

4

6

Q1-02 Q3-02 Q1-03 Q3-03 Q1-04 Q3-04 Q1-05 Q3-05 Q1-06 Q3-06 Q1-07 Q3-07

0

0.5

1

1.5

Q1-05 Q3-05 Q1-06 Q3-06 Q1-07 Q3-07

Roche Pharma salesPharma Division sales

MA

T sa

les

(CH

F bn

)

MAT = Rolling 4 quarter sales at avg. YTD Sept. '07 exchange rates

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Focus on differentiated medicines pays offA young and growing portfolio

Rocephin

RoAccutane

CellCept

MabTheraMabThera

Diabetes Care

Centralized Diagnostics

NeoRecormon/ Epogin

CellCept

Avastin

Pegasys

Diabetes Care

Centralized Diagnostics

Molecular Dx

106Value drivers

2710Sales (CHF bn)

20062001

CHF 1 billion or more

CHF 2 billion or more

CHF 3 billion or more

CHF 4 billion or more

Herceptin

Tamiflu

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Our oncology strategy: Setting new standards of care New tumor types, new combinations, new lines of intervention

In preparation

GIST

3rd

line

2nd line

1st line

Adjuvant

BC

3rd

line

2nd line

1st line

Adjuvant

NSCLC

3rd

line

2nd line

1st line

Adjuvant

CRC

Completed

Ongoing

RCCProstate

OvarianPancreatic

target all tumor types

Clinically differentiated product

Superior outcome for patients

Example Avastin

target all possible combinations

target earlier (adjuvant) intervention

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Oncology: Many market opportunities on the horizon and addressed

XelodaHerceptin

XelodaTarceva

Avastin (US)+ filed (EU)Approval

Trials P3 AvastinP3 Tarceva+Avastin

Filed Avastin (EU)P3 Avastin

line ext.

P3 Herceptin+Avastin;

Herceptin+pertuzumab

P3 Avastin+Tarceva, Tarceva

maint.

Filed Avastin (EU), Xeloda (EU,US)

line ext with oxaliplatin

Trials

Roferon AAvastin (EU),

XelodaHerceptin, Avastin

(EU)Avastin

Avastin, Xeloda (mono)

Approval

P3 Avastin; Xeloda

P3 Herceptin+Avastin

(in planning)

P3 Avastin; Tarceva

P3 Avastin, Xeloda

(combo)Trials

HerceptinXeloda (mono)Approval

RCCBC HER2-BC HER2+NSCLCCRC

Met

asta

tic1s

t lin

eM

etas

tatic

2nd

line

Adj

uvan

t

New market opportunities addressedFiledApproved

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Avastin: Building standard of care, defending leadershipEffectively maximizing a key asset

* Formerly called AVAIL

To initiate H2’07BEATRICE

mBC

To initiate H2’07E5103

Initiated Q4’05,H2 2007 completion target

RIBBON-1

Pilot study, initiated Q2’06BRIDGE

NSCLCInitiated Q4’05ATLAS

BETH

E2104

RIBBON-2

AVEREL(Herceptin+/-Avastin)

AVADO

ECOG 1505

BETA Lung

AVASQ

AVAiL

Initiated Q1’06 2nd line

Completed enrolment Q4’06HER2-negative

In preparationHER2-positive

To start soonSquamous and non-squamous

Adjuvant NSCLC

Recruitment completed Q2’071st line HER2-negative

Adjuvant BC

Initiated Q3‘061st line HER2-positive

terminated1st line squamous

Initiated Q2’052nd line

Data presented at ASCO 20071st line non-squamous

StatusMain Indication

Initiated Q2‘05CALGB 90401Hormone refractory

Prostate Cancer

To start in Q3‘07R_CHOP+/-Avastin

NHL aggr.

met primary endpoint, filedNO169661st linemCRCRecruitment completed Q2 2007AVANTAdjuvant

CC Recruitment completed Q4 2006NSABP C-08

Initiated Q1’06E5204Adjuvant rectal Ca

Initiated Q4‘06ICON7

Data availableCALGB 90206

GOG 213

GOG 218

AVITA

AVOREN

Initiated Q3‘051st lineOvarian Cancer

In preparation2nd line

Positive results Q4’06, Filing 20071st lineRCC

Recruitment completed1st linePancreatic Cancer

StatusMain Indication

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Xeloda/ Tarceva/ MabThera/ Herceptin: Maximizing across the portfolio

Final analysis 2008/2009, event drivenHERA1yr vs. 2yrs treatmentAdjuvant BC

Herceptin

MabThera

Tarceva

Xeloda

Recr. completed, Final analysis end ’07/early ’08NO16968Combo with oxaliplatin

Recruitment to complete end ‘07REACHCLL relapsed

Initiated Q4’05, Recruitment to complete end ‘07ATLASCombo with Avastin

Initiated Q2’05BETA LungCombo with AvastinNSCLC 2nd line

Recr. completedML17102CLL 1st line

Initiated Q3’05, final analysis in 2009ToGAGastric Ca

Initiated Q3‘06RADIANTAdjuvant NSCLC

Recruitment completed Q1 2007PRIMAAfter MabThera inductionNHL maintenance 1st line

Initiated Q4’05, Recruitment to complete ’07SATURNCombo with chemotherapyNSCLC 1st line maintenance

Recr. completedNO 17629Adjuvant BC

Recruitment completed Q2 2007AVANTCombo with AvastinAdjuvant CC

StatusMain Indications

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HerceptinmBC combo

hormonal

Ong

oing

AvastinmBC

AvastinNSCLC

Sta

rtin

g so

on

Xelodaadjuvant BC

The key goal of all our efforts in oncology: Moving from extending life to potentially saving life

Xelodagastric Ca

AvastinmBC 2nd line

Adjuvant Maintenance 1st Line 2nd Line

File

d

Xelodaadjuvant CC

combo

Avastinadjuvantrectal Ca

Tarceva & Avastin

NSCLC maintenance

Avastinadjuvant CC

AvastinadjuvantNSCLC

Avastinadjuvant BC

Herceptingastric Ca

AvastinmBC 1st line ext.

AvastinmCRC

1st line ext.

Avastinpancreatic Ca

Avastinovarian Ca

MabThera1st line CLL

Xeloda mCRC 1st line

combo

TarcevaNSCLC maintenance

MabTherarelapsed CLL

Avastinprostate Ca

Tarceva & Avastin

NSCLC 2nd line

XelodamCRC 2nd line

combo

AvastinNSCLC

1st line ext.

MabTheraiNHL maintenance

Avastin &Herceptin

mBC 1st line ext.

Tarcevaadjuvant NSCLC

AvastinRCC

Herceptin & Pertuzumab

HER2+ mBC

MabThera & Avastinaggr. NHL

Avastin &Herceptin

adj. BC, HER2+

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Funding: Roche oncology products are cost-effective

MabThera1st LineFollicular

NHL StageIII/IV

MabTheraAggressive

NHL

Herceptinearly BC

Tarceva 2ndline NSCLC

Statins highrisk

HerceptinmBC

Glivec CML StatinsElderly low

risk

GBP in (000)

8 2-18 5-23

29-3822-28

36-38

59-111

8 - 11

Cost per QALY for selected drugs (UK data – NICE/SMC)

We aim to expand use of our products to earlier-stage cancers, providing full benefit to patients

22

Oncology is still dramatically under funded Compared to other disease areas

Source: A pan-European comparison regarding patient access to cancer drugs, Karolinska Institute DALY: Disability-Adjusted Life Years, figures from 2002/3; Commonly used measure of the burden of disease

17.1%

16.7%

8.7%

5.9%

26.3%

Mental disease25.3%

Cardiovascular

Cancer

Injuries

Resp.

Other

6.4%Cancer

Total disease burden in DALYs

Total healthcare costs

Drugs

8%

Ambulatory16%

Other

9%

Inpatienthospital care

67%

Cost breakdown in oncology

(example: Germany)

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Roche has a low exposure to genericsLong-term sustainable business

0%

20%

40%

60%

80%

100%

2004 2006 2008 2010 2012 2014

Sales erosion due to generisation (% of 2004 sales)

Roche

Average European peers

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CellCeptPegasys

NeoRecormonHerceptin Xeloda

MabThera

Avastinin CRC

FUTURE PILLARS

ActemraBoniva

MabThera in RA Diabetes Care

Molecular Diagnostics

Immuno-Diagnostics

Mircera

USA (Greater)Europe Japan Asia China Latin

America

Tarceva

Roche: Unique geographic risk diversification

Tamiflu

Avastin in NSCLC

Avastin in BC

JTT- 705 (R1658)

GLP-1 R 1583

Roche: Unique “pillars of value” risk diversification

Roche has a unique „investment case“

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Conclusion # 1:

Roche wants to maximize assets on hands –

and to translate value opportunities into reality

Challenge # 1:

Achieve above industry-standard sales growth

The short/medium term sales perspective

26

2

Can we achieve an

attractive top-line and

still deliver strong

EPS growth?

Challenge # 2Turn attractive top line into attractive bottom line

2006 2011 2016

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• People are key!

Activate potential and constantly educate: to learn faster than

our competitors is the only sustainable factor of success!

• The right “quantum” size for Roche ?

Fixed cost versus variable cost

• Operational productivity

Doing the right things rightThree focus areas

28

Number of employees

Readiness for changelow high

Our leadership and communications efforts have to concentrate here

To achieve our ambitions we have to activate the potential of our 72,000 employees!

Activate our employees’ potentialConstant education to overcome fear of change

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The highest profitability is achieved at the top of a quantum step

Organizations do not grow linearlyFixed cost base grows in quantum steps

30

Even if costs grow considerably slower than sales”, there is risk that we build up too much infrastructure / fixed costs!

Sales

What is the right quantum size for a “sustainable”Roche?

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We must become better and cheaper in whatever we do!

Operational productivity is an important key enabler for the Roche Group

Constantly improving operational productivity

32

27.9%

25.9%

22.9%21.3%

20.2%

16.3%

Focus on differentiated products paying off Sales doubling, operating profits tripling

0

2

4

6

8

10

12

14

2001 2002 2003 2004 2005 2006

Group operating profit2 (CHF bn)

0

510

15

2025

30

3540

45

2001 2002 2003 2004 2005 2006

Group sales1 (CHF bn)

1 Pharmaceuticals and Diagnostics 2 before exceptional items

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Core EPS rising steadily

7.84

5.874.714.34

9.86

0.0

2.0

4.0

6.0

8.0

10.0

12.0

2002 2003 2004 2005 2006

Core EPS CAGR1 ('02 – '06): 23 %

CHF

1 Compound Annual Growth Rate

34

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06

Economic success translated into shareholder returnsAgain a substantial increase in 2006

CHF

Dividend CAGR1 (’91-’06): 18 %

1 compound annual growth rate1 Compound Annual Growth Rate 1995 including centenary bonus 2006 Dividend: Proposed by the Board of Directors

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Conclusion # 2:

Roche has many programs running to ensure above

industry standard EPS-growth

Challenge # 2:

Achieve above industry-standard value creation

Short/medium term bottom-line perspective

36

1

2

3

Can we produce enough

internal and external

innovation to maintain

the Roche Group’s

Leadership position?

Challenge # 3Filling the “strategic gap”

2006 2011 2016

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Which degree of innovation (= medical differentiation) is necessary to jump regulatory and reimbursement hurdles?

Research DevelopmentMarketing &DistributionProduction

CustomerbenefitInnovation

Sustainable leadershipHow can we constantly provide benefit to customers?

38

The Roche “hub & spoke”-model: Roche controls the global value chain, but is open for Research partnerships

“Roche core”

Research DevelopmentMarketing +Distribution

ProductionInnovation

partners

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Why do we network in the Research field?

DiscoveryResearch

Develop-ment

Manu-facturing

MarketingSelling

Intellectintensive

Capital intensive

Size does not increase productivity beyond a certain critical level!

Size is critical to optimize investment, speed and coverage!

Economies of scope Economies of scale: Size matters

• More trials• More patients• Investigator networks• In-licensing power

• More launches• Larger products• Market entry speed• Sales force flexibility

40

Access to Innovation is key - competition growingCosts of third party innovation is raising steeply!

0

100

200

300

400

500

2000 2001 2002 2003 2004 2005

Early-stageLate-stage

• Average cost of in-licensing deals rose 40% (CAGR) since 2000

• By 2010, 40% of Pharma peers’revenues expected to come from external sources of innovation

Average cost of in-licensing (Rx), $m

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The potential is there: unmet medical needs in many age-related diseases

Met

med

ical

nee

dsU

nmet

med

ical

nee

ds

CNS Cardio-vascular

Inflammation/ Bone

Respiratory Urology

AGE-RELATED DISEASES

Endocrine Tumors Accidents/Injuries

Alzheimer’sDementia

Parkinson’s

Depression

Hypertension

COPD

Incontinence

Diabetes T2

CancerStroke

Roche focus area

CHD / Dyslipidemia

RA / MS

Osteoporosis

42

Current and future key sources of growth

2006 2011 2016

Avastin(Metastatic use)

Herceptin MabThera(Oncology )

Mircera(Renal & oncology)

Illustrative

Autoimmune portfolio

Avastin(Adjuvant use)

Diabetes portfolio

CETP inhibitor

(Dyslipidemia)

The coming 3 to 4 years will be

decisive on how ‘well’ we can fill

the value propositions for

beyond 2015

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All

Aut

oim

mun

e

YTD Sep 2007: Autoimmune portfolioOcrelizumab additionally developed for MS and lupus

Phase I Phase II Phase III

RA

R7277 (RA)Toyama

R1295 (MS)

R3477 (MS)Actelion

MabThera(RA TNF IR)

R3421 (AI)Biocryst

MabThera(RRMS)

GNE

Approved

R7277 (RA)Toyama

R1503 (RA)p38 inhib.

MabTheraANCA aVasc.

GNE

MabThera(SLE)

GNE

MabThera(PPMS)

GNE

MabThera(LN)GNE

Ocrelizumab(RA)

Actemra(RA)

Actemra(sJIA)

MabThera (RA)

DMARD IR

CellCept(LN)

CellCept(PV)

Ocrelizumab(RA)

Actemra(RA)

MabThera (RA)

DMARD IR

IFN-alpha Ab(SLE)

GNE

MabThera(RA TNF IR)

Ocrelizumab(RRMS)

Ocrelizumab(LN) moving to ph. 3

Ocrelizumab(SLE) moving to ph. 3moving to ph. 3

44

YTD Sep 2007 Metabolism/Diabetes pipeline making good progress- major new area for Roche emerging

CETP Inhibitor

• Phase IIb data available internally: very encouraging

• Torcetrapib side effects (elevated blood pressure) appear compound-specific

GLP-1 phase II data available soon

• First phase II data (sustained release formulation) before year end

• Decision for phase III to be taken in early 2008

DDP-IV (3) moves into phase II

• Good safety profile

• Potential for weight reduction?

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Roche 2015 This program provides strategic direction and aligns our priorities to fill ‘sustainable long-term growth’ gap

Roche: Innovation

Is OurCore

Innovation Investment

Choices around how muchresources to allocate and deploy

Innovation Capabilities

Choices around how we will run our Innovation Model

Scope of Innovation

Choices around where we should focus to ensure advantaged

participation

46

Roche internal R&D5 Disease Biology Leadership Teams responsible for the start of the value chain

Site Management Committees

R&D Committee

LCC

BDC

PPG

Reg.Ph 3Ph 2Ph 1Ph 0LOLITANMP

Today’s model

Drug Safety Committee

Non-Clinical Drug Safety Committee

Disease Biology Leadership Teams (DBLT) (x5)

New model

Decision Making Committees

Decision Making Committees & Peer Reviews

Reg.Ph 3Ph 2Ph 1Ph 0LOLITANMP

Drug Safety Committee

Non-Clinical Drug Safety Committee

Strategic PortfolioCommittee

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Conclusion 3:

With Roche 2015 we have the right platform in place

to identify the right priorities

Challenge # 3:

Filling the value gap

Long-term perspective Roche 2015 is a crucial platform

We Innovate Healthcare