090601 - Corporate Presentation

7/28/2019 090601 - Corporate Presentation

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Raffaele,living with epilepsy

June 2009

Delivering to becomethe next generation biopharma leader

UCB

Corporate Presentation


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Disclaimer and safe harbour

Forward-looking statements:This presentation includes forward-looking statements relating to UCB and Schwarz Pharma that are subjectto known and unknown risks and uncertainties, many of which are outside of UCB s and Schwarz Pharma scontrol and are difficult to predict, that may cause actual results to differ materially from any future resultsexpressed or implied from the forward-looking statements. In this presentation, the words anticipates, believes, estimates, seeks, expects, plans, intends and similar expressions, as they relate to UCB orSchwarz Pharma, are intended to identify forward-looking statements. Important factors that could causeactual results to differ materially from such expectations include, without limitation: the inability to obtain

necessary regulatory approvals or to obtain them on acceptable terms; the inability to integrate successfullySchwarz Pharma within UCB or to realize synergies from such integration following the acquisition; costsrelated to the acquisition of Schwarz Pharma; the economic environment of the industries in which UCB andSchwarz Pharma operate; costs associated with research and development; changes in the prospects forproducts in the pipeline or under development by UCB or Schwarz Pharma; dependence on the existingmanagement of UCB and Schwarz Pharma; changes or uncertainties in Belgian or German tax laws or theadministration of such laws; changes or uncertainties in the laws or regulations applicable to the markets inwhich UCB and Schwarz Pharma operate. All written and oral forward-looking statements attributable to UCBor Schwarz Pharma or persons acting on either of their behalf are expressly qualified in their entirety by thecautionary statements above. Neither UCB nor Schwarz Pharma intend, or undertake any obligation, toupdate these forward-looking statements.


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UCB

Vision

To become the next generation biopharmaceutical leader

To provide breakthrough innovation for patients sufferingfrom severe diseases

Therapeutic focus

Central nervous system (CNS)

Immunology

Foundation

UCB = UCB Pharma + Celltech (2004) + Schwarz Pharma (2006)

UCB = unique combination of large, antibody-based molecules andsmall, chemically-derived molecules


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UCBOur road map

2007 ... and beyond

Realise the commercialpotential of new products

Launch a newgeneration of therapiesoffering breakthroughinnovation to patients

with severe disease

Intense growth

Breakthrough

Launch new products Invest in R&D SHAPE the organisation for the

future Prioritise products and markets Improve competitiveness and

profitability

Execution

2010


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2008UCB continues on track

SHAPE: major steps taken to accelerate the transformation of theorganisation and to increase focus on UCB core disease areas,

products and geographies

2008: three new molecular entities (NMEs) approved in the U.S.

2008/2009: major product launches - Vimpat , Neupro ,

Cimzia - ongoing and in preparation

In-line with financial guidance


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2008Financial highlights

Revenue of 3 601 million in line with previous year

Recurring EBITDA of 733 million (-1%)

Net profit 42 million (-74%) impacted by:

Significant restructuring expenses and fixed asset impairment charges

related to the SHAPE programme Financial expenses related to purchase of minority Schwarz Pharma

shares

Adjusted 1 net profit 270 million (-7%)

1 Adjusted for after-tax impact of one-off items, contribution fromdiscontinued operations and inventory step-up


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Seven regulatory approvals Cimzia Crohn's disease (U.S.) - launched Keppra XR Adjunctive therapy in epilepsy (U.S.) - launched Neupro Restless legs syndrome (EU) launch expected H1 2009 Toviaz Overactive bladder (U.S.) licensed to Pfizer Vimpat Adjunctive therapy in epilepsy (EU) - launched Vimpat Adjunctive therapy in epilepsy (U.S.) - launch expected Q2 2009 Xyzal Antihistamine oral solution (U.S.) - launched

Six filings Cimzia Rheumatoid arthritis (EU) Cimzia Rheumatoid arthritis (U.S.) Keppra Adjunctive therapy in epilepsy (infants and children 1 U.S.) Keppra Adjunctive therapy in epilepsy (infants and children 1 EU) Keppra Adjunctive therapy in epilepsy (Japan) Keppra XR Adjunctive therapy in epilepsy (U.S.)

1 For children aged from one month to under four years

20087 regulatory approvals and 6 filings


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2008Most NME approvals in the U.S.

Three out of 24 NME 1 approvals in 2008 for UCB

and one out of four Biologics License Applications (BLA) approved

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1

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A D O L O R

A M G E N

A S T E L L A S

B A Y E R

H L T H C A R E

B I O V A I L

A M E R I C A S

C E P H A L O N

E I S A I

E P I X

P H A R

M A

F E R R I N G

G E H E A L T H C A R E

G E N Z Y M E

G L A X O S M I T H K L I N E

M E D S C O

O R T H O M C N E I L J A N S S E N

P R O G E N I C S

R E G E N E R O N P H A R M

.

S I R I O N T H E R A P

T I B O T E C

U C B 3

W A T S O N L A

B S

W Y E T H P H A R M S I N C

1 New Molecular Entity - Source: FDA website2 Adolor and GlaxoSmithKline collaborated on Entereg3 Progenics and Wyeth collaborated on Relistor4 Toviaz (Pfizer), Vimpat (Schwarz Pharma) and Cimzia are all

grouped under UCB - Toviaz

is officially listed on FDA site asPfizer. NDA filed by Schwarz Pharma and while approvable, wastransferred to Pfizer

UCB 4


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20084 + 1 new product launches

Crohn's diseaseLaunched in the U.S.

Adjunctive therapy in epilepsy

Launched in Germany and U.K.


Launched in the U.S.

Oral antihistamine solution


Overactive bladder

Launched in the EU, by PfizerToviaz


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Solid CNS & immunology pipelineKey projects

Phase I Phase II Phase III Filed Approved

CDP7851bone loss disorders

CDP323multiple sclerosis

Vimpat epilepsymonotherapy - U.S.

Neupro adv. Parkinson'sdisease - U.S 1

Neupro restless legssyndrome EU2

CDP6038autoimmunediseases

epratuzumabsystemic lupuserythematosus

Vimpat diabetic neuropathicpain - EU + U.S.

Neupro restless legssyndrome - U.S. 1

brivaracetamepilepsy

Cimzia rheumatoid arthritis- EU

Keppra XR epilepsymonotherapy - U.S.

Cimzia Crohn's disease -EU

CNS Immunology

1 Neupro

Complete Response Letter (December 2008)2 CHMP recommends lifting of treatment restrictions for Neupro inEurope (May 2009)


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CNSExpansion in our core area

Epilepsy Vimpat brivaracetam

Parkinson's disease (PD) Neupro

Restless legs syndrome (RLS) Neupro

Diabetic neuropathic pain (DNP) Vimpat

Multiple sclerosis (MS) CDP323


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Epilepsy Major unmet medical need

High unmet medical need in ~1/3 of treated epilepsy patients

Patients with only one seizure/month report significant impact on theirsocial life, ability to work and standard of living

No new AEDs 1 approved in over 5 years (U.S.)

Few future treatments expected, particularly with a novel mode of action

There is a strong need for a new treatment option

Controlled on 1st monotherapy

Uncontrolled despite 2-3 AEDs

"Controlled" on more than 1 AED20-25%

50% 25-30%

1 Antiepileptic drug


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Vimpat in epilepsy a new treatment optionMonotherapy Phase III programme ongoing

Novel dual mode of action

Easy to use

No clinically significant drug-drug interactions

Multiple formulations: tablets, syrup, IV

Monotherapy Phase III trial in the U.S. ongoing

U.S. market = 70% of monotherapy market

Phase I Phase II Phase III Filed Approved Launched

Vimpat (lacosamide) Epilepsy Adjunctive therapy (EU) August2007September

2008September

2008

Vimpat (lacosamide) Epilepsy Adjunctive therapy (U.S.) November2007October

2008May

2009

Vimpat (lacosamide) Epilepsy Monotherapy (U.S.)Results

expectedQ2 2011

Lakeisha,living with epilepsy

Vimpat has been designated as a Schedule V controlledsubstance by U.S. regulators.


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Brivaracetam in epilepsy Phase III programme ongoing

Broader mechanism of action than Keppra

Population includes patients not controlled with Keppra

Phase III top line results (April 2009):

Study N01253 met its primary efficacy endpoint

Study N01252 did not meet its primary efficacy endpoint

Study N01254 confirmed brivaracetam was well tolerated

Further analysis will be conducted

Regulatory authorities will be consulted to determine next steps

Path forward update expected by year end


Brivaracetam Epilepsy adjunctive therapy April2009


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Neupro in Parkinson's diseaseGetting closer to make it available for new patients in Europe

Deviation from product approved specification

Restriction on promotion (June 2008)

To manage potential shortages: existing patients only

Full cold storage and distribution chain implemented(September 2008)

CHMP 1 positive opinion (May 2009) recommending:

Lifting of treatment restrictions for Neupro in Europe

Allowing Neupro to be available to all patients with Parkinsonsdisease


Neupro (rotigotine) Early stage Parkinson's disease (EU) February2006March2006

Neupro (rotigotine) Advanced Parkinson's disease (EU) January2007January

2007

Terry,living with Parkinsons disease

1 CHMP: EMEA's Committee for Medicinal Products for Human Use


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Neupro in Parkinson's disease Working to make it available for new patients in the U.S.

Deviation from product approved specification

Product recall (March 2008)

Out-of-stock situation

FDA Complete Response Letter (December 2008)

Substantial evidence of effectiveness in advanced Parkinsonsdisease and restless legs syndrome (RLS)

Dialogue ongoing with the FDA to bring Neupro back to U.S.patients


Neupro (rotigotine) Early stage Parkinson's disease (U.S.) May2007July2007

Neupro (rotigotine) Advanced Parkinson's disease (U.S.) December2007

Wolfgang,living with Parkinsons disease


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Neupro in restless legs syndromeIncreased awareness of an unrecognised disease

Demonstrated efficacy and well tolerated

Consistent results within comprehensive clinical program

Improved sleep and reduced daytime tiredness

Potential first line treatment EU approval (September 2008)

FDA Complete Response Letter (December 2008)

Substantial evidence of effectiveness in advanced Parkinsonsdisease and restless legs syndrome (RLS)

CHMP positive opinion (May 2009)

Recommends allowing Neupro to be launched for the treatmentof moderate to severe RLS


Neupro (rotigotine) Restless legs syndrome (EU) September2008

Neupro (rotigotine) Restless legs syndrome (U.S.) December2007

Sten,living with restless legs syndrome


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Vimpat in diabetic neuropathic painPath forward to be elaborated

Promising drug for a large unmet medical need

Demonstrated sustained efficacy and good tolerability

No drug-drug / food interactions, no weight gain

New mode of action

FDA Not Approvable Letter (July 2008)

Withdrawal of MAA1

in EU (September 2008)Optimise design of future studies to meet conservativestatistical requirements and then discuss with authorities

UCB decision expected H2 2009


Vimpat (lacosamide) Diabetic neuropathic pain (EU)

Vimpat (lacosamide) Diabetic neuropathic pain (U.S.)

1 Marketing Authorisation Application

Frieda,living with diabetic neuropathic pain


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CDP323 in multiple sclerosisOral administration

Potent and orally active small molecule antagonist of alpha 4-integrin

Successful collaboration with Biogen IDEC

Phase II programme ongoing


CDP323 Multiple sclerosisResults

expected2010


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Immunology

Crohn's disease (CD) Cimzia

Rheumatoid arthritis (RA) Cimzia

Bone loss disorders CDP7851

Systemic lupus erythematosus (SLE) epratuzumab


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Cimzia in rheumatoid arthritisOnly PEGylated Fc-free anti-TNF

Approved and launched in the U.S.

Filed with European authorities (July 2008)

Review pending


Cimzia (certolizumab pegol) Rheumatoid arthritis (U.S.) February2008May

2009May

2009

Cimzia (certolizumab pegol) Rheumatoid arthritis (EU) July2008

Alison,living with rheumatoid arthritis


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CDP7851 in bone loss disordersNovel therapy with strong potential

Development of novel anabolic therapy

Antibody to sclerostin potentially treating bone lossdisorders, incl. osteoporosis

Collaborative project with Amgen

Phase I: first positive results

UCB and Amgen are encouraged by the first-in-human data and are currently planning the futuredevelopment program Normal Sclerosteosis

Study of naturally occurring humandisorder leads to a potential newdrug therapy


CDP7851 ( anti-sclerostin ) Bone loss disordersResults

expected H22009


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Epratuzumab in systemic lupus erythematosus (SLE)Phase IIb study ongoing

Analyses of recently closed clinical trials suggest a favourable efficacyand tolerability profile

Phase IIb dose ranging study ongoing

Number of randomized patients: 210

Arms/doses: 6 arms dose range (from 150 3 600 mg/cycle)

Duration: 3 months treatment phase Primary endpoint: reduction disease activity

Population: patients with moderate/severe activity


Epratuzumab Systemic lupus erythematosusResults

expectedQ3 2009


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Solid CNS & immunology pipelineKey projects

Phase I Phase II Phase III Filed Approved

CDP7851bone loss disorders

CDP323multiple sclerosis

Vimpat epilepsymonotherapy - U.S.

Neupro adv. Parkinson'sdisease - U.S 1

Neupro restless legssyndrome EU2

CDP6038autoimmunediseases

epratuzumabsystemic lupuserythematosus

Vimpat diabetic neuropathicpain - EU + U.S.

Neupro restless legssyndrome - U.S. 1

brivaracetamepilepsy

Cimzia rheumatoid arthritis- EU

Keppra XR epilepsymonotherapy - U.S.

Cimzia Crohn's disease -EU

CNS Immunology

1 Neupro Complete Response Letter (December 2008)2 CHMP recommends lifting of treatment restrictions for Neupro in

Europe (May 2009)


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SHAPETransformation and focus

Focus on CNS and immunology

Focus on core products and geographies

Drive for breakthrough innovation for patients withsevere disease

Simplify the organisationImprove competitiveness and profitability


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SHAPE Achievements so far

Organisation simplified and focused Workforce already reduced by 15%

Resources reallocated to core assets

Pre-clinical oncology portfolio incubated with Wilex (January 2009) UCB retains buy-back options

Non-strategic emerging markets divested to GSK (January 2009)

Equasym IR/XL and Somatostatine- UCB divested (February 2009)

UCB NewMedicines Drug discovery to proof-of-concept organisation

New external focus reinforced through new partnerships with academiccollaborations

CDP6038 (IL-6) for auto-immune diseases entered Phase I (December 2008)


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UCB priorities for 2009

Successfully launch Vimpat , Neupro , Cimzia

Continue delivery of late stage pipeline

SHAPE:

Maximise core assets, optimise non-core assets

Fully implement new organisational and geographical footprintPrepare for Breakthrough Phase by building pipeline andstrengthening new biopharma capabilities

Foster patient centricity as a key driver of performance


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2009 financial outlook

Revenue expected to reach between 3.1 - 3.3 billion

Full generic competition to Keppra in the U.S for the whole year

Partially compensated by newly launched products

Recurring EBITDA target increased to greater than 680 million

Swift implementation of the SHAPE programme

Net Profit expected to exceed 130 million

Excluding expected capital gains resulting from already announced

divestments


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2009Major milestones

Brivaracetam in epilepsy Phase III top line results

Cimzia in rheumatoid arthritis U.S. approval & launch

Vimpat in epilepsy 1 Launch in the U.S.

Epratuzumab in SLE First Phase IIb results Q3 2009

CDP7851 in bone loss disorders Phase I to complete H2 2009

Vimpat has been designated as a Schedule V controlledsubstance by U.S. regulators.

1 Adjunctive therapy in epilepsy


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20092 + 1 product launches so far

Rheumatoid arthritis




Overactive bladder

Launched in the U.S., by PfizerToviaz


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UCBOur road map

2007 ... and beyond

Realise the commercialpotential of new products

Launch a newgeneration of therapiesoffering breakthroughinnovation to patients

with severe disease

Intense growth

Breakthrough

Launch new products Invest in R&D SHAPE the organisation for the

future Prioritise products and markets Improve competitiveness and

profitability

Execution

2010


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Appendix


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Epilepsy

The most common serious neurological disorder

Excessive electrical activity in part or all of the brain resulting inrecurrent seizures

In most cases, there is no known cause for epilepsy

Can affect anyone regardless of age, gender or ethnicity

There is no known cure at this time but treatments are available toreduce the frequency and severity of seizures

Prevalence: 6 million patients in 7 major markets 1

Market size: 3.2 billion in 7 major markets 2 (2007)

1 PatientBase, Decision Resources - 20082 IMS, 2008 - Sales in epilepsy only. Japan not included. U.S. =

Retail + Non-Fed hospitals


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Parkinsons disease (PD)

CNS disorder, which is the result of the loss of dopamine-producingbrain cells

Primary symptoms are tremor and trembling; stiffness of the limbs andtrunk; slowness of movement and impaired balance and coordination

No cure but a variety of medications provide relief from the symptoms


Market size: 790 million in 7 major markets 2 (2007)

1 PatientBase, Decision Resources - 20082 Sales in PD only - EU 5 only. Source: IMS, 2008


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Restless legs syndrome (RLS)

Neurological condition that is characterised by the irresistible urge tomove the legs

The cause is unknown in most patients, but is suspected to be relatedto lack of dopamine in the brain

It is a lifelong condition for which there is no cure

Few treatments available to treat moderate to severe RLS



1 PatientBase, Decision Resources - 20082 Sales in RLS only. Source: IMS, EU5, Mat 11/08


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Diabetic neuropathic pain (DNP)

Pain associated with a functional abnormality of the nervous system

Several sub-types of neuropathic pain exist

Symptoms depend on the type of nerves affected and are oftenassociated with damage to the motor nerve such as muscle weakness,cramps, and spasms

Very difficult to treat with only some 40-60% of patients achieving

partial relief



1 PatientBase, Decision Resources - 20082 Decision Resources Neuropathic Pain April 2007


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Multiple sclerosis (MS)

Chronic, inflammatory, demyelinating disease that affects the centralnervous system (CNS)

Affects the ability of nerve cells in the brain and spinal cord tocommunicate with each other

Cause not known and affects women more than men

No cure but medicines to slow it down, help control symptoms, preventnew attacks, and prevent disability are available

Prevalence: 536 000 patients in 7 major markets 1


1 PatientBase, Decision Resources 20082 Decision Resources Pharmacor: Multiple Sclerosis June 2008


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Crohns disease (CD)

Autoimmune disease that causes chronic inflammation of the GI tract

Also referred to as Inflammatory Bowel Disease (IBD)

The cause is not known

Chronic condition, which means you have for life

The disease tends to fluctuate between periods of remission and relapse

There is no known cure for CD but treatments can help reducesymptoms

Prevalence: 0.9 million patients in 7 major markets 1

Market size: 0.9 billion in 7 major markets 2

1 PatientBase, Decision Resources 20082 Datamonitor - Autoimmune Overview Forecast: Crohns Disease -

December 2007


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Rheumatoid arthritis (RA)

Autoimmune disease that causes chronic and progressive inflammation

of the jointsDebilitating systemic condition

The cause of rheumatoid arthritis is not known

Symptoms come and go, depending on the degree of tissueinflammation

There is no known cure for RA but treatments can reduce jointinflammation and pain, maximize joint function, and prevent jointdestruction and deformity



1 PatientBase, Decision Resources 20082 Decision Resources Pharmacor: Rheumatoid Arthritis June

2008


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Bone loss disorders

Reduction of bone mass (density) or presence of a fragility fracture

High associated morbidity and loss of daily independence caused bydisease

Treatments available for osteoporosis but significant need to improvethe quality of bone restored



1 PatientBase, Decision Resources - 2008 Osteoporosis2 Datamonitor Commercial Insight :Osteoporosis June 2007


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Systemic Lupus Erythematosus (SLE)

Autoimmune disease that causes inflammation and damage to various

body tissues

The word "systemic" means the disease can affect many parts of the body

The cause is not known (usually first affects people between the ages of 15 and 45 years)

The symptoms may be mild or serious, most common ones includeextreme fatigue, painful or swollen joints (arthritis), unexplained feverand skin rashes

There is no known cure for SLE but it can be effectively treated withdrugs, and most people with the disease can lead active, healthy lives

Prevalence: 0.6 million patients in 7 major markets 1


1 PatientBase, Decision Resources - 2008

2 Datamonitor, IMS data taking into account off-label sales: bothminimum and maximum sales - Mar08


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Leading products compensate for Zyrtec decline

million 2008 YTD Change

Actual 1 CER 2 Leading products Keppra 1 266 23% 30%

Zyrtec (incl. D/Cirrus ) 249 -49% -50%

Xyzal 3 173 3% 4%

Tussionex 147 29% 38%Nootropil 93 -8% -7%

New products Neupro 58 12% 16%

Cimzia 10 - -

Vimpat 2 - -

Total net sales 3 027 -5% -2%

1 Actual: change from previous year unadjusted for foreign currency impact2 CER: change from previous year adjusted for constant exchange rates3 Excluding Xyzal U.S. revenue to UCB of 39 million from profit-sharing with

sanofi-aventis

2008 net sales


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2008 net salesGeography

Europe42%

Rest of World

12%

NorthAmerica

46%

Europe47%

Rest of World

13%

NorthAmerica

40%

2007 net sales 3 188 million


*

2008 net sales


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2008 net salesTherapy area

CNS37%

Other 42%

Immun-ologyand

allergy21%

CNS47%

Other 39%

Immun-ology &allergy

14%



*

Employees


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EmployeesGeography - 2008

*

21%

13%

9%

21%

20%

16%

Belgium Germany

U.K. U.S.

Rest of EU Emerging Markets

Total number of employees

11 292

2009


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2009Corporate financial calendar

2009 half-year results 31 July

Interim update (nine months report) 22 October


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Your Investor Relations team

Antje Witte, Vice President Corporate Communications & Investor Relations

Phone +32 2 559 9414

E-mail: [email protected]

Richard Simpson, Senior Director Investor Relations

Phone: +32 2 559 9494


Michael Tuck-Sherman, Investor Relations Manager

Phone: +32 2 559 9712


Isabelle Ghellynck, Investor Relations Project Manager

Phone: +32 2 559 9588

mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

090601 - Corporate Presentation

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