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Raffaele, living with epilepsy June 2009 Delivering to become the next generation biopharma leader UCB Corporate Presentation.

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Presentation on theme: "Raffaele, living with epilepsy June 2009 Delivering to become the next generation biopharma leader UCB Corporate Presentation."— Presentation transcript:

1 Raffaele, living with epilepsy June 2009 Delivering to become the next generation biopharma leader UCB Corporate Presentation

2 the next generation biopharma leader June Disclaimer and safe harbour Forward-looking statements: This presentation includes “ forward-looking statements ” relating to UCB and Schwarz Pharma that are subject to known and unknown risks and uncertainties, many of which are outside of UCB ’ s and Schwarz Pharma ’ 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 or Schwarz Pharma, 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 inability to integrate successfully Schwarz Pharma within UCB or to realize synergies from such integration following the acquisition; costs related to the acquisition of Schwarz Pharma; the economic environment of the industries in which UCB and Schwarz Pharma operate; costs associated with research and development; changes in the prospects for products in the pipeline or under development by UCB or Schwarz Pharma; dependence on the existing management of UCB and Schwarz Pharma; changes or uncertainties in Belgian or German tax laws or the administration of such laws; changes or uncertainties in the laws or regulations applicable to the markets in which UCB and Schwarz Pharma operate. All written and oral forward-looking statements attributable to UCB or Schwarz Pharma or persons acting on either of their behalf are expressly qualified in their entirety by the cautionary statements above. Neither UCB nor Schwarz Pharma intend, or undertake any obligation, to update these forward-looking statements.

3 the next generation biopharma leader June UCB Vision To become the next generation biopharmaceutical leader To provide breakthrough innovation for patients suffering from 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 and small, chemically-derived molecules

4 the next generation biopharma leader June UCB Our “road map” and beyond Realise the commercial potential of new products Launch a new generation of therapies offering breakthrough innovation 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

5 the next generation biopharma leader June UCB continues on track SHAPE: major steps taken to accelerate the transformation of the organisation and to increase focus on UCB core disease areas, products and geographies 2008: three new molecular entities (NME’s) approved in the U.S. 2008/2009: major product launches - Vimpat ®, Neupro ®, Cimzia ® - ongoing and in preparation In-line with financial guidance

6 the next generation biopharma leader June Financial highlights Revenue of € 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 from discontinued operations and inventory step-up

7 the next generation biopharma leader June 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 H Toviaz ® Overactive bladder (U.S.) – licensed to Pfizer Vimpat ® Adjunctive therapy in epilepsy (EU) - launched Vimpat ® Adjunctive therapy in epilepsy (U.S.) - launch expected Q 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.) 1For children aged from one month to under four years regulatory approvals and 6 filings

8 the next generation biopharma leader June Most 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 1New Molecular Entity - Source: FDA website 2Adolor and GlaxoSmithKline collaborated on Entereg 3Progenics and Wyeth collaborated on Relistor 4Toviaz ® (Pfizer), Vimpat ® (Schwarz Pharma) and Cimzia ® are all grouped under UCB - Toviaz ® is officially listed on FDA site as Pfizer. NDA filed by Schwarz Pharma and while approvable, was transferred to Pfizer UCB 4 2

9 the next generation biopharma leader June new product launches Crohn's disease Launched in the U.S. Adjunctive therapy in epilepsy Launched in Germany and U.K. Adjunctive therapy in epilepsy Launched in the U.S. Oral antihistamine solution Launched in the U.S. Overactive bladder Launched in the EU, by Pfizer Toviaz ®

10 the next generation biopharma leader June Solid CNS & immunology pipeline Key projects Phase IPhase IIPhase IIIFiledApproved CDP7851 bone loss disorders CDP323 multiple sclerosis Vimpat ® epilepsy monotherapy - U.S. Neupro ® adv. Parkinson's disease - U.S 1 Neupro ® restless legs syndrome – EU 2 CDP6038 autoimmune diseases epratuzumab systemic lupus erythematosus Vimpat ® diabetic neuropathic pain - EU + U.S. Neupro ® restless legs syndrome - U.S. 1 brivaracetam epilepsy Cimzia ® rheumatoid arthritis - EU Keppra ® XR epilepsy monotherapy - U.S. Cimzia ® Crohn's disease - EU CNSImmunology 1Neupro ® Complete Response Letter (December 2008) 2CHMP recommends lifting of treatment restrictions for Neupro ® in Europe (May 2009)

11 the next generation biopharma leader June CNS Expansion 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

12 the next generation biopharma leader June 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 their social life, ability to work and standard of living No new AED’s 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 20-25% 50% 25-30% 1 Antiepileptic drug

13 the next generation biopharma leader June Vimpat ® in epilepsy – a new treatment option Monotherapy 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 IPhase IIPhase IIIFiledApprovedLaunched Vimpat ® (lacosamide) Epilepsy – Adjunctive therapy (EU) August 2007 September 2008 Vimpat ® (lacosamide) Epilepsy – Adjunctive therapy (U.S.) November 2007 October 2008 May 2009 Vimpat ® (lacosamide) Epilepsy – Monotherapy (U.S.) Results expected Q Lakeisha, living with epilepsy Vimpat ® has been designated as a Schedule V controlled substance by U.S. regulators.

14 the next generation biopharma leader June 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 Phase IPhase IIPhase IIIFiledApprovedLaunched Brivaracetam Epilepsy adjunctive therapy April 2009

15 the next generation biopharma leader June Neupro ® in Parkinson's disease G etting 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 Parkinson’s disease Phase IPhase IIPhase IIIFiledApprovedLaunched Neupro ® (rotigotine) Early stage Parkinson's disease (EU) February 2006 March 2006 Neupro ® (rotigotine) Advanced Parkinson's disease (EU) January 2007 January 2007 Add New patient from AR Terry, living with Parkinson’s disease 1CHMP: EMEA's Committee for Medicinal Products for Human Use

16 the next generation biopharma leader June 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 Parkinson’s disease and restless legs syndrome (RLS)” Dialogue ongoing with the FDA to bring Neupro ® back to U.S. patients Phase IPhase IIPhase IIIFiledApprovedLaunched Neupro ® (rotigotine) Early stage Parkinson's disease (U.S.) May 2007 July 2007 Neupro ® (rotigotine) Advanced Parkinson's disease (U.S.) December 2007 Add New patient from AR Wolfgang, living with Parkinson’s disease

17 the next generation biopharma leader June Neupro ® in restless legs syndrome Increased 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 Parkinson’s disease and restless legs syndrome (RLS)” CHMP positive opinion (May 2009) Recommends allowing Neupro ® to be launched for the treatment of moderate to severe RLS Phase IPhase IIPhase IIIFiledApprovedLaunched Neupro ® (rotigotine) Restless legs syndrome (EU) September 2008 Neupro ® (rotigotine) Restless legs syndrome (U.S.) December 2007 Sten, living with restless legs syndrome

18 the next generation biopharma leader June Vimpat ® in diabetic neuropathic pain Path 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 MAA 1 in EU (September 2008) Optimise design of future studies to meet conservative statistical requirements and then discuss with authorities UCB decision expected H Phase IPhase IIPhase IIIFiledApprovedLaunched Vimpat ® (lacosamide) Diabetic neuropathic pain (EU) Vimpat ® (lacosamide) Diabetic neuropathic pain (U.S.) 1Marketing Authorisation Application Frieda, living with diabetic neuropathic pain

19 the next generation biopharma leader June CDP323 in multiple sclerosis Oral administration Potent and orally active small molecule antagonist of alpha 4-integrin Successful collaboration with Biogen IDEC Phase II programme ongoing Phase IPhase IIPhase IIIFiledApprovedLaunched CDP323 Multiple sclerosis Results expected 2010

20 the next generation biopharma leader June Immunology Crohn's disease (CD) Cimzia ® Rheumatoid arthritis (RA)Cimzia ® Bone loss disorders CDP7851 Systemic lupus erythematosus (SLE) epratuzumab

21 the next generation biopharma leader June Cimzia ® in rheumatoid arthritis Only PEGylated Fc-free anti-TNF Approved and launched in the U.S. Filed with European authorities (July 2008) Review pending Phase IPhase IIPhase IIIFiledApprovedLaunched Cimzia ® (certolizumab pegol) Rheumatoid arthritis (U.S.) February 2008 May 2009 May 2009 Cimzia ® (certolizumab pegol) Rheumatoid arthritis (EU) July 2008 Alison, living with rheumatoid arthritis

22 the next generation biopharma leader June 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 I: first positive results UCB and Amgen are encouraged by the first-in- human data and are currently planning the future development program NormalSclerosteosis Study of naturally occurring human disorder leads to a potential new drug therapy Phase IPhase IIPhase IIIFiledApprovedLaunched CDP7851 (anti-sclerostin) Bone loss disorders Results expected H2 2009

23 the next generation biopharma leader June Epratuzumab in systemic lupus erythematosus (SLE) Phase IIb study ongoing Analyses of recently closed clinical trials suggest a favourable efficacy and tolerability profile Phase IIb dose ranging study ongoing Number of randomized patients: 210 Arms/doses: 6 arms dose range (from 150 – mg/cycle) Duration: 3 months treatment phase Primary endpoint: reduction disease activity Population: patients with moderate/severe activity Phase IPhase IIPhase IIIFiledApprovedLaunched Epratuzumab Systemic lupus erythematosus Results expected Q3 2009

24 the next generation biopharma leader June Solid CNS & immunology pipeline Key projects Phase IPhase IIPhase IIIFiledApproved CDP7851 bone loss disorders CDP323 multiple sclerosis Vimpat ® epilepsy monotherapy - U.S. Neupro ® adv. Parkinson's disease - U.S 1 Neupro ® restless legs syndrome – EU 2 CDP6038 autoimmune diseases epratuzumab systemic lupus erythematosus Vimpat ® diabetic neuropathic pain - EU + U.S. Neupro ® restless legs syndrome - U.S. 1 brivaracetam epilepsy Cimzia ® rheumatoid arthritis - EU Keppra ® XR epilepsy monotherapy - U.S. Cimzia ® Crohn's disease - EU CNSImmunology 1Neupro ® Complete Response Letter (December 2008) 2CHMP recommends lifting of treatment restrictions for Neupro ® in Europe (May 2009)

25 the next generation biopharma leader June SHAPE Transformation and focus Focus on CNS and immunology Focus on core products and geographies Drive for breakthrough innovation for patients with severe disease Simplify the organisation Improve competitiveness and profitability

26 the next generation biopharma leader June 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 academic collaborations CDP6038 (IL-6) for auto-immune diseases entered Phase I (December 2008)

27 the next generation biopharma leader June 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 footprint Prepare for ‘Breakthrough Phase’ by building pipeline and strengthening new biopharma capabilities Foster patient centricity as a key driver of performance

28 the next generation biopharma leader June financial outlook Revenue expected to reach between € 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

29 the next generation biopharma leader June Major milestones Brivaracetam in epilepsy Phase III top line results Cimzia ® in rheumatoid arthritisU.S. approval & launch Vimpat ® in epilepsy 1 Launch in the U.S. Epratuzumab in SLEFirst Phase IIb resultsQ CDP7851 in bone loss disorders Phase I to complete H Vimpat ® has been designated as a Schedule V controlled substance by U.S. regulators. 1Adjunctive therapy in epilepsy

30 the next generation biopharma leader June product launches so far Rheumatoid arthritis Launched in the U.S. Adjunctive therapy in epilepsy Launched in the U.S. Overactive bladder Launched in the U.S., by Pfizer Toviaz ®

31 the next generation biopharma leader June UCB Our “road map” and beyond Realise the commercial potential of new products Launch a new generation of therapies offering breakthrough innovation 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

32 the next generation biopharma leader June Appendix

33 the next generation biopharma leader June Epilepsy The most common serious neurological disorder Excessive electrical activity in part or all of the brain resulting in recurrent 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 to reduce 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 IMS, Sales in epilepsy only. Japan not included. U.S. = Retail + Non-Fed hospitals

34 the next generation biopharma leader June Parkinson’s disease (PD) CNS disorder, which is the result of the loss of dopamine-producing brain cells Primary symptoms are tremor and trembling; stiffness of the limbs and trunk; slowness of movement and impaired balance and coordination No cure but a variety of medications provide relief from the symptoms Prevalence:≈ 3 million patients in 7 major markets 1 Market size:≈ € 790 million in 7 major markets 2 (2007) 1 PatientBase, Decision Resources Sales in PD only - EU 5 only. Source: IMS, 2008

35 the next generation biopharma leader June Restless legs syndrome (RLS) Neurological condition that is characterised by the irresistible urge to move the legs The cause is unknown in most patients, but is suspected to be related to 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 Prevalence:≈ 54 million patients in 7 major markets 1 Market size: ≈ € 100 million in 7 major markets 2 (2007) 1PatientBase, Decision Resources Sales in RLS only. Source: IMS, EU5, Mat 11/08

36 the next generation biopharma leader June 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 often associated 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 Prevalence:≈ 10 million patients in 7 major markets 1 Market size:≈ € 390 million in 7 major markets 2 (2007) 1PatientBase, Decision Resources Decision Resources – Neuropathic Pain – April 2007

37 the next generation biopharma leader June Multiple sclerosis (MS) Chronic, inflammatory, demyelinating disease that affects the central nervous system (CNS) Affects the ability of nerve cells in the brain and spinal cord to communicate with each other Cause not known and affects women more than men No cure but medicines to slow it down, help control symptoms, prevent new attacks, and prevent disability are available Prevalence:≈ patients in 7 major markets 1 Market size:≈ € 4.3 billion in 7 major markets 2 (2007) 1 PatientBase, Decision Resources – Decision Resources – Pharmacor: Multiple Sclerosis – June 2008

38 the next generation biopharma leader June Crohn’s 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 reduce symptoms Prevalence:≈ 0.9 million patients in 7 major markets 1 Market size:≈ € 0.9 billion in 7 major markets 2 1PatientBase, Decision Resources – Datamonitor - Autoimmune Overview Forecast: Crohn’s Disease - December 2007

39 the next generation biopharma leader June Rheumatoid arthritis (RA) Autoimmune disease that causes chronic and progressive inflammation of the joints Debilitating systemic condition The cause of rheumatoid arthritis is not known Symptoms come and go, depending on the degree of tissue inflammation There is no known cure for RA but treatments can reduce joint inflammation and pain, maximize joint function, and prevent joint destruction and deformity Prevalence:≈ 5 million patients in 7 major markets 1 Market size:≈ € 5.8 billion in 7 major markets 2 (2007) 1PatientBase, Decision Resources – Decision Resources – Pharmacor: Rheumatoid Arthritis– June 2008

40 the next generation biopharma leader June Bone loss disorders Reduction of bone mass (density) or presence of a fragility fracture High associated morbidity and loss of daily independence caused by disease Treatments available for osteoporosis but significant need to improve the quality of bone restored Prevalence:≈ 64 million patients in 7 major markets 1 Market size:≈ € 5.7 billion in 7 major markets 2 (2007) 1 PatientBase, Decision Resources – Osteoporosis 2 Datamonitor – Commercial Insight :Osteoporosis – June 2007

41 the next generation biopharma leader June 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 include extreme fatigue, painful or swollen joints (arthritis), unexplained fever and skin rashes There is no known cure for SLE but it can be effectively treated with drugs, and most people with the disease can lead active, healthy lives Prevalence:≈ 0.6 million patients in 7 major markets 1 Market size:≈ € 670 million in 7 major markets 2 (2007) 1PatientBase, Decision Resources Datamonitor, IMS data taking into account off-label sales: both minimum and maximum sales - Mar08

42 the next generation biopharma leader June Leading products compensate for Zyrtec ® decline € million2008YTD Change Actual 1 CER 2 Leading products Keppra ® %30% Zyrtec ® (incl. D/Cirrus ® )249-49%-50% Xyzal ® %4% Tussionex™14729%38% Nootropil ® 93-8%-7% New products Neupro ® 5812%16% Cimzia ® 10-- Vimpat ® 2-- Total net sales %-2% 1Actual: change from previous year unadjusted for foreign currency impact 2 CER: change from previous year adjusted for constant exchange rates 3Excluding Xyzal ® U.S. revenue to UCB of € 39 million from profit-sharing with sanofi-aventis

43 the next generation biopharma leader June net sales Geography 2007 net sales € million 2008 net sales € million *

44 the next generation biopharma leader June net sales T herapy area 2007 net sales € million 2008 net sales € million *

45 the next generation biopharma leader June Employees Geography * Total number of employees

46 the next generation biopharma leader June Corporate financial calendar 2009 half-year results31 July Interim update (nine months report)22 October

47 the next generation biopharma leader June Your Investor Relations team Antje Witte, Vice President Corporate Communications & Investor Relations Phone Richard Simpson, Senior Director Investor Relations Phone: Michael Tuck-Sherman, Investor Relations Manager Phone: Isabelle Ghellynck, Investor Relations Project Manager Phone:


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