progressing to become - ucb · this presentation includes “forward-looking statements” relating...

Lakeisha, living with epilepsy

Progressing to becomea patient-centric global biopharmaleader

2009 Financial ResultsLondon, March 2, 2010

2 March

2010

22

Disclaimer and safe harbour

Forward-looking statements:

This presentation includes “forward-looking statements” relating to UCB group of companies (“UCB”) that are subject to known and unknown risks and uncertainties, many of which are outside of UCB’s control and are difficult to predict, that may cause actual results to differ materially from any future results expressed 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, are intended to identify forward-looking statements. Important factors that could cause actual 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 economic environment of the industries in which UCB operates; costs associated with research and development; changes in the prospects for products in the pipeline or under development by UCB; dependence on the existing management of UCB; changes or uncertainties in tax laws or the administration of such laws; changes or uncertainties in the laws or regulations applicable to the markets in which UCB operates. All written and oral forward-looking statements attributable to UCB or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements above. UCB does not intend, or undertake any obligation, to update these forward-looking statements.

2 March

2010

3

UCB vision

2 March

2010

4

Agenda

Solid foundation for sustainable growth

• Roch Doliveux, CEO

Core products performance

• Mark McDade, COO

Financial performance

• Detlef Thielgen, CFO

Development

• Iris Loew-Friedrich, CMO

Conclusion

• Roch Doliveux, CEO

2 March

2010

555

2009 – a turning pointDelivery and execution

UCB is strengthening its position as a Patient-Centric global biopharmaceutical leader

• Major regulatory milestones achieved

• 3+1 product launches

• Organisation transformed through SHAPE initiative

• Debt re-financed

• UCB enters growth phase

2 March

2010

66

Ismail KolaExecutive VP, UCB. President UCB NewMedicines™

Highly accomplished scientist

• Track record of success in academia and the biopharma field

• Former CSO of Schering Plough Corporation

• Strong research and development background

• Led groups that brought drugs successfully to the market

• Solid track record in overseeing partnerships and financial transactions

• Authored 159 Scientific Publications in Scientific and Medical Journals of the Highest Calibre

• Named inventor on 12 patents and under his leadership 5 drugs have come to the market

Committed to lead UCB NewMedicines™ into a leading edge discovery and POC engine

Will move this organisation beyond its current achievements to deliver UCB’s breakthrough phase

2 March

2010

7

Cimzia®, Vimpat®, Neupro®

performance

Mark McDade,

Chief Operating Officer

2 March

2010

8

2009 – a turning pointDelivering 4 new medicines for patients with severe diseases

Rheumatoid arthritis

Launched in the U.S. (May 2009)Launched in Europe (October 2009)

Epilepsy adjunctive therapy

Launched in the U.S. (June 2009)

Restless legs syndrome

Launched in Europe (June 2009)

Overactive bladder

Launched in the U.S. (April 2009) –licensed to Pfizer

Toviaz®

2 March

2010

9

Epilepsy—a major CNS disease

2007 2017

USEUJapan

Prevalence (2008) ≈ 6.1 million patients in 7 major markets1

Market size (2007) ≈ $ 3.8 billion in 7 major markets2

Source: 1Decision Resource & 2Datamonitor, Commercial insight3Compound Annual Growth Rate

CAGR3 ≈

3.9%

2 March

2010

10

Keppra® franchiseExtending market leadership in Europe

Keppra® loss of exclusivity in the U.S. November 2008

Sustained growth outside the U.S., generated by use in monotherapy

Keppra® filed for adjunctive therapy in epilepsy in Japan end of 2008

• Older generation AEDs lead the market in Japan

• Only three new generation AEDs approved starting in 2006

• Industry average approval time in Japan is at least 20 months

€ million FY 2009 net sales

Actual CER

North America 320 -58% -60%

Europe 545 25% 28%

Rest of World 48 -21% -17%

Total 913 -28% -28%

AED: anti-epileptic drug

2 March

2010

11

Vimpat® in epilepsy An important new treatment option in refractory epilepsy

A new treatment option in add-on for Partial Onset Seizures (POS)

Efficacy when added to a broad range of 1st and 2nd generation AEDs

No drug-drug interactions; multiple formulations

More than 46 000 patients on Vimpat® worldwide (December 2009)

U.S. launched in June 2009

Europe first launch in September 2008

• Launched in four major European countries: France, Germany, Spain, U.K.

• Also available in 10 EU mid-markets1

1. Austria, Denmark, Greece, Ireland, Finland, Netherlands, Norway, Slovak Republic, Sweden, Switzerland


FY 2008 net sales

U.S. 30 0

Europe 16 2

Total 46 2

2 March

2010

12

Vimpat® in epilepsy Successful launch in the AED market in the U.S.

0

5,000

10,000

15,000

20,000

Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09

# o

f T

Rx

an

d N

Rx

NRx TRx

Source: IMS National Prescription Audit (NPA)

2 March

2010

13

Vimpat® in epilepsy Growing rapidly in Europe

0,0%

0,2%

0,4%

0,6%

0,8%

1,0%

1,2%

1,4%

1,6%

1,8%

2,0%

2,2%

2,4%

M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16

Germany (M1=Sept 08)UK (M1=Sept 08)France (M1= Oct 09)Spain (M1 = Oct 09)

Vimpat® Treatment Days Shares among New AED*,Monthly evolution since Vimpat launch, up to Dec 09

Source: IMS retail Dec 09, UCB calculationsTDX factorized to reflect prescription usage and average daily dose in Epilepsy

*New AEDs:Levetiracetam, Topiramate, Lamotrigine, Zonisamide, Rufinamide, Pregabalin, Oxcarbazepine, Gabapentin, Lacosamide, Eslicarbazepine

2 March

2010

14

UCB in epilepsy Trusted leadership aided by new launches

When asked which company has best reputation in epilepsy/seizuredisorders (unaided) - All Neurologists (U.S.)

9%

18%

28%

36%

39%

19%

10%

19%

11%

18%

6%4%

16%

10% 9%

4%

8%9%

7%

12.40%

6% 6%7%

3%1%

12%10%

7%9%

5%5% 5%6%

3%4%

2%0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Wave 2 of Previous ATU(n=106)

Wave 3 of Previous ATU(n=100)

August 2008 (n=150) June 2009 (n=151) January 2010 (n=201)

UCB GlaxoSmithKlineAbbott LaboratoriesPfizerOrtho McNeilNovartisDon't knowNone

(49%, 33%)

Indicates significant difference from previous wave at 90% interval. Compares only Champions of both waves. (%) indicates current wave’s Champion results.

(%,%) indicates statistical difference between Champions and Non-Champions; %’s are listed as (Champions, Non-Champions).

Please note sample differences between waves: W1: target list with Champions / Non-Champions undefined; W2: Champions only; W3: both Champions and Non-Champions.

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2010

15

Parkinson’s disease (PD)

2008 2018

USEUJapan



Source: 1Decision Resource & 2Datamonitor, Commercial insight3Compound Annual Growth Rate

CAGR3 ≈

2.6%

2 March

2010

16

Restless legs syndrome (RLS)

Prevalence (2008) ≈ 54 million patients in 7 major markets1

Market size (2007) ≈ $ 588 million in 7 major markets2

2007 2017

USEU

Source: 1Decision Resource & 2Datamonitor3Compound Annual Growth Rate

CAGR

3 ≈ 7%

2 March

2010

17

Neupro®

Rotigotine transdermal patch

Neupro®, the Parkinson's patch - 24h continuous delivery

• Continuous delivery to provide stable drug levels

• Improving daily functioning, sleep and early morning functions

Neupro®, the new treatment option for RLS

• Short- and long-term efficacy

• Improvement and sustained relief

2 March

2010

18

Neupro® - rotigotine transdermal patchContinued launch roll-out in Europe

Neupro® “New Patient” launch in Europe (June 2009)

• Newly-launched for PD in Germany, Italy, Spain, U.K. and 15 other markets1

• Launched for RLS in U.K., Germany, Austria and Ireland

• More than 53 000 Parkinson patients being treated with Neupro® in Europe at the

end of 2009

Working to make it available for patients in the U.S.

• Subject to FDA approval of the cold-chain storage and distribution system, our aim

is to make Neupro® available to U.S patients during 2010

1. Austria, Czech Republic, Denmark, Finland, Greece, Ireland, Netherlands, Norway, Poland, Slovak Republic,

Sweden, Switzerland, Iceland, Australia, Hong-Kong


FY 2008 net sales

U.S. 0 5

Europe 61 53

Total 61 58

2 March

2010

19

Neupro® - EU4 (excluding France)Monthly launch curves by country

Neupro® Treatment Days Shares among Dopamine Agonists*,Monthly evolution since Neupro launch, up to Dec 09

Source: IMS retail, UCB calculations*Market Def. Dopamine Agonists = ropinirole (Requip IR, IR, Generics), cabergoline (Cabaser & Generics), pramipexole , rotigotine + Bromocriptine, Lisuride, Pergolide, Piribedil

TDX factorized to reflect prescription usage and average daily dose in Parkinson Disease

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

M1 M4 M7 M10 M13 M16 M19 M22 M25 M28 M31 M34 M37 M40 M43 M46

Germany (M1=Mar-06) Italy (M1=Jul-09) Spain (M1=Jan-07) UK (M1=Apr-06)

Italy:

Best launch

2 March

2010

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Crohn’s disease (CD)

2007 2017

USEUJapan



Source: 1Decision Resource Pharmacor, Crohn’s Disease, Dec 20092Compound Annual Growth Rate

CAGR3 ≈

3.5%

2 March

2010

21

Rheumatoid arthritis (RA) – Anti-TNF market

2008 2018

USEUJapan

Prevalence (2008) ≈ 5 million patients in 7 major markets1

Market size (2008) ≈ $ 6.6 billion in 7 major markets

Source: 1Decision Resource2Compound Annual Growth Rate

CAGR3 ≈ 1.6%

2 March

2010Fusion Protein

(Human recombinantreceptor/Fc)

FcIgG1

Receptor

Constant 2

Constant 3

Etanercept

Chimericmonoclonal

antibody

Human monoclonal

antibody

Infliximab Adalimumab

FcIgG1

HumanisedFab′ fragmentw/o Fc region

Certolizumab pegol

Adapted with permission from Hanauer SB. Rev Gastroenterol Disord. 2004;4(suppl 3):S18-S24.

Murine component

Human component

Cimzia® – the only PEGylated anti-TNF Unique structure, unique product benefits

Unlike the other anti-TNF treatments, Cimzia® is a pegylated FAB with no FC region

2 March

2010

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Cimzia®

Unique syringe designed with RA patients for RA patients

Easy to grip wide flare

Easy to removeneedle cover

Easy to push syringe plunger

Easy to grip elleptical barrel – easy to read syringe barrel

2 March

2010

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Cimzia® roll-out in U.S.Steady build of a chronic therapy

More than 9 200 patients on Cimzia® at end of December 2009

Crohn’s disease in the U.S.

• Unique long term remission data1 with no dose escalation is key driver

Rheumatoid arthritis in the U.S.

• High ‘reach and frequency’ with high prescribing rheumatologists

• Fast and lasting improvements in all patient reported outcomes

• 2 product formulations offering physicians and patients a choice

1 Sandborn et al. Am J Gastroenterology 2008; 103 (Suppl 1): S429


FY 2008 net sales

U.S. 70 8

Europe 5 2

Total 75 10

2 March

2010

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Source: IMS National Prescription Audit (NPA) Dec 09

Cimzia® for Crohn's diseaseU.S. growth demonstrates arrival of important new option

Monthly prescriptions

IMS changed their projection methodology

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09

# o

f TR

x a

nd

NR

x

TRx NRx

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2010

262626

Cimzia® in rheumatoid arthritis Roll-out in U.S.: gaining use even in an entrenched marketplace

Source: IMS National Prescription Audit (NPA) Dec 09

0

500

1,000

1,500

2,000

2,500

May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09

# o

f T

Rx

an

d N

Rx

TRx NRx

Monthly prescriptions

2 March

2010

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Cimzia®, Vimpat® and Neupro®

Highly innovative drivers of growth

The only PEGylated anti-TNF

Efficacy when added to a broad range of AEDs

24h continuous delivery by transdermal patch

2 March

2010

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2009 financial performance

Detlef Thielgen, CFO

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2010

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FY 2009 Financial highlights

Revenue of € 3.1 billion (-13%)

• Impact of generic competition to Keppra® in the U.S. and divestitures

• Good performance of the new core products and of Keppra® in EU

Total operating expenses decreased by 15%

Recurring EBITDA of € 698 million (-5%)

Net profit1 increased to € 513 million (vs € 42 million in 2008)

Adjusted2 net profit € 226 million (-16%)

1 After minority interest 2 Adjusted for after-tax impact of non-recurring items, contribution from discontinued operations

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2010

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Recurring EBITDA

€ million

Actual Variance

FY 2009 FY 2008 Actual CER

Revenue 3 116 3 601 -13% -14%

Net sales 2 683 3 027 -11% -12%

Royalty income & fees 227 396 -43% -39%

Other revenue 206 178 15% 13%

Gross profit 2 091 2 455 -15% -16%

Marketing & selling expenses - 781 - 928 -16% -18%

R&D expenses - 674 - 767 -12% -11%

G&A expenses - 189 - 227 -17% -15%

Other operating income 6 - 1

Total operating expenses - 1 638 - 1 924 -15% -15%

Recurring EBIT 453 531 -15% -17%

Amortisation of intangible assets 142 105

Depreciation charges 102 97

Recurring EBITDA 698 733 -5% -6%

2 March

2010

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FY 2009Net sales of core and major other products

€ million FY 2009net sales

Change

Actual CER

Core productsCimzia® 75

Vimpat® 46

Neupro® 61 5% 7%

Other productsKeppra® (incl. Keppra®XR) 913 -28% -28%

Zyrtec® (incl. D/Cirrus®) 268 8% 1%

Tussionex™ 147 0% -5%

Xyzal® 1 132 -23% -22%

venlafaxine XR 109 - -

Metadate™ CD / Equasym™ XL 2 72 -6% -10%

Total net sales 2 683 -11% -12%

1 Excluding Xyzal® U.S. revenue to UCB of € 47 million from profit-sharing with sanofi-aventis2 € 3 million sales from Equasym™ XL in Europe and Rest of World before closing of the sale to

Shire early 2009

2 March

2010

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Royalty income & fees and Other revenue

€ million

Actual Variance


Biotechnology IP 116 318 -63% -60%

Toviaz® 41 5

Zyrtec® U.S. 23 30 -22% -26%

Other 48 43 9% 4%

Royalty income & fees 227 396 -43% -39%

Contract manufacturing sales 94 42 125% 119%

Xyzal® U.S. profit sharing 47 39 19% 13%

Provas™ profit sharing 26 23 11% 11%

Otsuka 26 20 29% 36%

Fesoterodine milestones 0 24

Other 14 30 -40% -40%

Other revenue 206 178 15% 13%

2 March

2010

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Gross profit

€ million

Actual Variance


Cost of sales - 1 025 - 1 146 -11% -11%

Cost of sales products & services - 769 - 847 -9% -9%

Royalty expenses - 128 - 205 -37% -37%

Amortisation of intangible assets linked to sales

- 128 - 95 35% 36%

Gross profit 2 091 2 455 -15% -16%

of which

Products & services 2 119 2 358 -10% -11%

Net royalty income 100 191 -48% -42%

Amortisation of intangible assets linked to sales

- 128 - 95 35% 36%

2 March

2010

34

FY 2009 REBITDA development

€ million

733698

Gross Profit Mix

FX

Keppra® U.S.

Re

curr

ing

EB

ITD

A 2

00

8 r

ep

ort

ed

Re

curr

ing

EB

ITD

A 2

00

9 r

ep

ort

ed

CVNadditional

investments

Shape and other expenses reduction

2 March

2010

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Net profit

1 After minority interest 2 Adjusted for after-tax impact of one-time and non-recurring items

€ millionActual Variance


Recurring EBIT 453 531 -15% -17%

Impairment charges - 126 - 160 n.s. n.s.

Restructuring expenses - 73 - 272 n.s. n.s.

Gain on disposals 594 0 n.s. n.s.

Other non recurring income/expenses (-) - 11 14 n.s. n.s.

Total non recurring income /expenses (-) 384 - 418 n.s. n.s.

EBIT 837 113 639% 614%

Net financial expenses - 162 - 156 4% 4%

Income tax (expense)/credit - 168 30 n.s. n.s.

Profit from continuing operations 507 - 12 n.s. n.s.

Net profit1 513 42 n.s. n.s.

Adjusted net profit2 226 270 -16% -18%

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2010

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Core EPS

€ millionActual

FY 2009 FY 2008

Net Profit 513 42

+ after-tax non-recurring items & financial one-offs

-298 339

- profit from discontinued operation -7 -55

+ Tax one-offs 17 -56

Adusted net profit1 226 270

+ Amortisation of intangibles 127 94

- Taxes on amortization of intangibles -39 -29

Core net profit 314 335

Weighted average number of shares (basic) 180 180

Core EPS (€) 1.74 1.86

1 Adjusted for after-tax impact of one-time and non-recurring items

2 March

2010

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Summary financials

Cash Flow Summary

Balance Sheet Summary

€ million FY 2009 FY 2008

Net profit (after minority interest) 513 42

Cash flow from operating activities 295 366

Cash flow from investing activities 473 - 673

Cash flow from financing activities - 736 278

Change in cash and cash equivalents 32 - 10

€ million Dec 2009 Dec 2008

Non current assets 7 326 7 687

Current assets 1 794 1 837

Total assets 9 120 9 524

Shareholders’ equity 4 417 4 017

Non current liabilities 2 641 2 953

Current liabilities 2 062 2 554

Total liabilities and shareholder's equity 9 120 9 524

2 March

2010

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Debt re-financing completedDiversified lender base and improved maturity profile

New debt profile

• € 750 million 5.75% Belgian retail bonds, due November 2014

• € 500 million 4.5% convertible bonds, due October 2015

• € 500 million 5.75% institutional bonds, due December 2016

• € 1.5 billion revolving credit facility (3 years + 1 year renewal option)

Old € 3.3 billion credit facility closed and debt paid down

Debt maturity profile aligned to expected cash flow generation

€ million 31 Dec 2009 31 Dec 2008

Net debt - 1 752 - 2 443

Liquid assets 491 470

Financial debt - 2 243 - 2 913

2 March

2010

39

Maturity Profile after Refinancing

0

500

1000

1500

2000

2500

2009 2010 2011 2012 2013 2014 2015 2016

EUR

Gro

ss D

ebt *

mio

New capital structure and debt maturity

New Facility

Retail Bond

EUR Bond

ConvertOld

Debt

Refinancing

Maturity Profile before Refinancing

0

500

1000

1500

2000

2500

2009 2010 2011 2012 2013 2014 2015 2016

EUR

Gro

ss D

ebt *

mio

2 March

2010

40

2010 financial outlook

Revenue expected to reach approximately € 3.0 billion

Recurring EBITDA is expected to end the year around € 700 million

Core EPS1 expected to reach approximately € 1.76 versus € 1.74 in 2009

1 based on 180 million non-diluted number of shares

2 March

2010

41

Development

Iris Loew-Friedrich,

Chief Medical Officer

Executive Vice-President

Global Projects & Development

2 March

2010

42

2009 – a turning pointRegulatory and development delivery

Cimzia® in rheumatoid arthritis U.S. approval & launch

Cimzia® in rheumatoid arthritis EU approval & launch

Brivaracetam in epilepsy Phase III top line results

CDP323 in multiple sclerosis No go decision

Keppra® in epilepsy1 EU: CHMP positive opinion

Neupro® in Parkinson’s disease Lift of restrictions - back to all

patients in Europe

Neupro® in restless legs syndrome Launch in Europe

Vimpat® in epilepsy2 U.S. launch

Epratuzumab in lupus (SLE) Phase IIb top-line results

Xyrem® in fibromyalgia3 Second Phase III top-line

results

Vimpat® has been designated as a Schedule V controlled substance by U.S. regulators. 1 Adjunctive therapy in epilepsy for children aged from one month to under four years

2 Adjunctive therapy in epilepsy3 license rights to Xyrem exclude US

2 March

2010

43

Update on clinical development

Brivaracetam in epilepsy: further Phase III study

Epratuzumab in SLE: Phase III study to start in 2010

CDP7851 in bone loss disorders: Phase II studies ongoing

• Post-menopausal osteoporosis (PMO)

• Fracture healing

Keppra® XR monotherapy: positive Phase III trial results

• Confidence strengthened in withdrawal to monotherapy design also used for

Vimpat® monotherapy trial

Xyrem® fibromyalgia: strong Phase III data

• No prescription medicines approved yet for fibromyalgia in Europe

• Update on next steps once our discussions with EMA are finalised

2 March

2010

44

The early pipeline starts to strengthenThree exciting compounds moved into Phase I

CDP6038 (Anti-IL 6) – Autoimmune diseases

• Phase I ongoing

• Potential for immunology indications including rheumatoid arthritis

MEK inhibitor (WX544) – Oncology

• The first of our oncology molecules being developed by Wilex as part of

strategic alliance with UCB

• WX544 moved into Phase I in November 2009

UCB2892 (H3 antagonist) - CNS

• Moved into Phase I

• Potential for cognitive disorder indications

2 March

2010

45

Neupro®

Working to make it available for patients in the U.S.

Deviation from approved product specification

Product recall (March 2008) - Out-of-stock situation

FDA Complete Response Letter (December 2008)

• “Substantial evidence of effectiveness in advanced Parkinson’s disease and restless legs syndrome (RLS)”

Extensive update on Neupro® and cold chain data submitted to the FDA in June 2009

Dialogue with the FDA continues

Subject to FDA approval of the cold-chain storage and distribution system, our aim is to make Neupro®

available to U.S patients during 2010

Phase I Phase II Phase III Filed Approved Launched

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

March 2005

May 2007

July2007

Neupro® (rotigotine) Advanced Parkinson's disease (U.S.) December 2007

Neupro® (rotigotine) Restless legs syndrome (U.S.) December 2007

Terry, living with Parkinson’s disease

2 March

2010

46

Brivaracetam in epilepsyPhase III programme to continue

High unmet medical need

Committed to bring brivaracetam to patients

Phase III: One study met its primary efficacy endpoint

Further Phase III trial to start H2 2010

• Adjunctive therapy in partial onset seizures

• Higher dosing ranges

• Improved selection incl. regions and sites

• Refractory patients


Brivaracetam Epilepsy - adjunctive therapy

Raffaele, living with epilepsy

2 March

2010

47

Vimpat® in epilepsyIncreasing patient access

Monotherapy in the treatment of partial-onset seizures (POS)

• Phase III trial in the U.S. ongoing• Headline results expected Q2 2013

Paediatric (2-17 yr) development in partial-onset seizures

• Phase II in the U.S. started

Epilepsy adjunctive therapy for primary generalised tonic-clonic seizures (PGTC)

• Phase II to be initiated in Q2 2010


Vimpat® (lacosamide) Epilepsy – monotherapy (U.S.) ResultsQ2 2013

Vimpat® (lacosamide) Epilepsy – adjunctive therapy1 Results Q4 2010

Vimpat® (lacosamide) Epilepsy – adjunctive therapy PGTC

1 Paediatric (2-17 years)

Lakeisha, living with epilepsy

2 March

2010

48

Cimzia® in further arthritis indicationsIncreasing patient access

Psoriatic arthritis (PsA)

• Phase III trials ongoing

• 2 active arms: monthly (400 mg) and every two week (200 mg) dosing

• Time-frame: 24 + 48 weeks

• First key results expected Q4 2011

Ankylosing spondylitis (AS)

• Phase III trials ongoing

• 2 active arms: monthly (400 mg) and every two week (200 mg) dosing

• Time-frame: 24 weeks

• Key results expected Q4 2011


Cimzia® (certolizumab pegol) Ankylosing spondylitis (AS) ResultsQ4 2011

Cimzia® (certolizumab pegol) Psoriatic arthritis (PsA) ResultsQ4 2011

Amye, living with rheumatoid arthritis

2 March

2010

49

Juvenile rheumatoid arthritis (RA)

• Clinical study start scheduled H2 2010

• Phase III study in children

Rheumatoid arthritis (Japan)

• 2 Phase III studies ongoing:

• Monotherapy and combination with MTX

• Three active arms (100, 200, 400mg), every two week dosing

• Time frame: 24 weeks

• Results expected Q3 2011

Alison, living with rheumatoid arthritis


Cimzia (certolizumab pegol) Juvenile rheumatoid arthritis Phase III start H2 2010

Cimzia (certolizumab pegol) Rheumatoid arthritis (Japan) ResultsQ3 2011

Cimzia® in further arthritis indicationsIncreasing patient access

2 March

2010

50

Epratuzumab in SLE: positive Phase IIb resultsClinically meaningful treatment effect

"EMBLEM"

• Phase IIb 12-week dose and regime-ranging study

• 227 patients with moderately (30%) and severely (70%) active disease in multiple organ systems in 6 arms, total dose range from 200 – 3 600 mg/cycle

• Primary efficacy variable: Combined Index Response rate at week 12: treatment advantage over placebo reached 24.9%

• Including BILAG: British Isles Lupus Assessment Group, a comprehensive scoring system for assessing both current SLE disease activity and changes in that activity since patient was last seen

• E-mab was well tolerated with an incidence of serious adverse events and infusion reactions similar to placebo

Phase IIb data abstracts accepted for World Lupus Congress (24-27 June 2010), Phase IIb data presentation expected at other upcoming rheumatology meetings

2 March

2010

51

Epratuzumab in systemic lupus erythematosus (SLE)Phase III to start

Phase III program to start in H2 2010

• Subject to confirmation by ongoing discussions with regulatory authorities

• Two confirmatory efficacy randomized placebo-controlled studies

• Embody 1

• Embody 2


epratuzumab Systemic lupus erythematosus (SLE) To start H2 2010

Bernadette, living with lupus

2 March

2010

52

CDP7851 in bone loss disorders Novel therapy with strong potential

Development of novel anabolic therapy

• Antibody to sclerostin potentially treating bone loss disorders, incl. osteoporosis

Collaborative project with Amgen

Phase II ongoing

• Phase II study in post-menopausal osteoporosis (PMO)

• Estimated enrolment: 400 post-menopausal women with low bone mineral density, time-frame:12 months

• Phase II study in fracture healing

• Estimated enrolment: 400 patients, time-frame: 52 weeks

• Key results expected in 2012

Normal Sclerosteosis

Study of naturally occurring human disorder leads to a potential new drug therapy


CDP7851 (anti-sclerostin) Fracture healing Results 2012

CDP7851 (anti-sclerostin) Post-menopausal osteoporosis Results 2012

2 March

2010

53

Development pipelineMajor projects

1 Complete Response Letter2 Paediatric (2-17 years)

CNS Phase I Phase II Phase III Regulatory status

Keppra® (levetiracetam) Epilepsy – adjunctive therapy (Japan) FiledNovember 2008

Neupro® (rotigotine) Advanced Parkinson's disease (U.S.) CRL1

December 2008

Neupro® (rotigotine) Restless legs syndrome (U.S.) CRL1

December 2008

Xyrem (sodium oxybate) Fibromyalgia

brivaracetam Epilepsy - adjunctive therapy New Phase III trial to start 2010

Vimpat® (lacosamide) Epilepsy – monotherapy (U.S.) Results expected Q2 2013

Vimpat® (lacosamide) Epilepsy – adjunctive therapy2 Results expectedQ4 2010

Vimpat® (lacosamide) Epilepsy – adjunctive therapy PGTC

UCB2892 H3 antagonist CNS

Immunology

Cimzia® (certolizumab pegol) Rheumatoid arthritis (Japan) Results expected Q3 2011

Cimzia® (certolizumab pegol) Ankylosing spondylitis Results expected Q4 2011

Cimzia® (certolizumab pegol) Psoriatic arthritis Results expected Q4 2011

Cimzia® (certolizumab pegol) Juvenile rheumatoid arthritis Phase III trial to start H2 2010

epratuzumab Systemic lupus erythematosus (SLE) Phase III trial to start in H2 2010

CDP7851 (anti-sclerostin) Fracture healing Results expected 2012

CDP7851 (anti-sclerostin) Post-menopausal osteoporosis Results expected 2012

CDP6038 (anti-IL 6) Autoimmune disease

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2010

54

UCB's Sustainable Growth

Roch Doliveux, CEO

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2010

55

UCB - delivering through innovation

Vision

• To become the Patient-Centric global biopharmaceutical leader

• To provide breakthrough innovation for patients suffering from severe diseases

Turning point achieved

• Approvals and other regulatory and development milestones

• Launches of our three core products

• Adaptation of the organization and financing of the company

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2010

56

UCB's Sustainable GrowthCimzia®, Vimpat® and Neupro® trigger company growth

... and beyond

Realise the full commercial potential of Cimzia®, Vimpat®, Neupro®

Launch a new generation of therapies offering

breakthrough innovation to patients with severe disease

Company growth

Breakthrough

•Optimise mature base business

•Manage remaining loss of exclusivity


2010

lifecycle management first Breakthroughs

Intense growth

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2010

57

UCB to deliver growthCimzia®, Vimpat® and Neupro® trigger company growth

Expected peak sales at least € 1.5 billion

• To be reached in the second half of this decade

• Including new indications and markets currently under development:

• Psoriatic arthritis (PsA)

• Ankylosing spondylitis (AS)

• Juvenile rheumatoid arthritis (RA)

• Rheumatoid arthritis (Japan)

• Ulcerative colitis (UC)

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2010

58


Expected peak sales at least € 1.2 billion• To be reached in the second half of this decade

• Including new indications currently under development:

• Monotherapy in the treatment of partial-onset seizures (POS)

• Paediatric (2-17 yr) development in partial-onset seizures

• Epilepsy adjunctive therapy for primary generalised tonic-clonic seizures (PGTC)

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2010

59


Expected peak sales at least € 400m • To be reached in the second half of this decade

• Parkinson's disease • Europe, U.S. and other markets

• Restless legs syndrome• Europe, U.S. and other markets

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2010

6060

UCB - sustaining growth through innovation

New therapeutic options for patients in clinical development

• Brivaracetam – Epilepsy – adjunctive therapy

• Epratuzumab - Systematic lupus erythematosus

• CDP7851 - Post-menopausal osteoporosis

• CDP7851 - fracture healing

Preparing further sustainable growth beyond

• CDP6038 (anti-IL 6) – Autoimmune disease and UCB2892 H3 antagonist - CNS

• To research, develop and launch new generation of therapies offering breakthrough

innovation and patient solutions to people living with severe diseases

Strengthening the pipeline

• Strong commitment to best in class R&D innovation, talents and processes

• Internal and external sourcing

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2010

61

UCB's Sustainable GrowthCimzia®, Vimpat® and Neupro® trigger company growth

... and beyond

Realise the full commercial potential of Cimzia®, Vimpat®, Neupro®

Launch a new generation of therapies offering

breakthrough innovation to patients with severe disease

Company growth

Breakthrough

•Optimise mature base business

•Manage remaining loss of exclusivity


2010

lifecycle management first Breakthroughs

Intense growth

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2010

62

Appendix

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2010

63

Major milestones expected in 2010

epratuzumab in SLE

• Presentation of Phase IIb data at the World Lupus Congress June 2009

• Start of the Phase III trial programme 2010

brivaracetam in epilepsy

• Start of one additional Phase III trial H2 2010

Xyrem® for fibromyalgia

• Filling to the European authorities 2010

Vimpat® in epilepsy

• Start of Phase II trial in primary generalised tonic-clonic Q2 2010

Cimzia® in juvenile rheumatoid arthritis

• Start of Phase III trial H2 2010

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2010

64

Corporate financial calendar2010

2009 annual report (online) by 31 March 2010

AGM + Interim update (three month report) 29 April 2010

2010 half-year financial results 2 August 2010

Interim update (nine month report) 21 October 2010

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2010

65

FY 2009Net sales by geography

Europe47%

Rest of World13%

North America

40%

North America

35%

Europe 51%

Rest of World 14%

FY 2008 net sales

€ 3 027 million

FY 2009 net sales

€ 2 683 million

*

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2010

66

FY 2009 Net sales by therapy area

FY 2008 net sales

€ 3 027 million

FY 2009 net sales

€ 2 683 million

*

CNS41%

Other41%

Immunology and allergy

18%

CNS47%

Other39%

Immunology and allergy

14%

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2010

67

Shareholder structureStrong and stable shareholder base

UCB controlling and important shareholders as of 1 September 2009

Capital € 550 095 156

Shares 183 365 052

1 Financière de Tubize S.A. (Tubize) 36.20%

2 UCB Fipar S.A. 1.73%

3 UCB SCA 0.01%

4 Schwarz Vermögensverwaltung GmbH 5.39%

5 KBC Bank N.V. 1.25%

6 Banque Degroof S.A. 0.36%

7 Levimmo S.A. 0.67%

8 Compar Finance S.A.Compar Finance S.A. holds additionally 165 830 UCB shares outside the concert

1.04%

9 Pharmahold S.A.Pharmahold S.A. holds additionally 1 100 000 UCB shares outside the concert

1.04%

10 Cosylva S.A.Cosylva S.A. holds additionally 1 100 000 UCB shares outside the concert

1.04%

Tubize + linked companies + concert 4-10 on the total of shares held in concert

48.73%

11 Capital Research and Management Company

11.84%

______________________________Tubize has declared acting in concert separately with each of the

shareholders 4,5,6,7,8,9,10 for the number of shares as indicated.

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2010

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Your UCB Investor Relations Team

Antje Witte, Vice President 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


progressing to become - ucb · this presentation includes “forward-looking statements” relating...

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