470 likes | 627 Views
Delivering to become the next generation biopharma leader. UCB Corporate Presentation. Disclaimer and safe harbour. Forward-looking statements:
E N D
Delivering to becomethe next generation biopharma leader UCB Corporate Presentation
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.
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
UCB Our “road map” Breakthrough Launch a new generation of therapies offering breakthrough innovation to patients with severe disease Intense growth • Realise the commercial potential of new products Execution • Launch new products • Invest in R&D • SHAPE the organisation for the future • Prioritise products and markets • Improve competitiveness and profitability ... and beyond 2010 2007
2008UCB 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
2008 Financial 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 • Adjusted1 net profit € 270 million (-7%) 1 Adjusted for after-tax impact of one-off items, contribution from discontinued operations and inventory step-up
2008 7 regulatory approvalsand 6 filings • 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 children1 – U.S.) • Keppra® Adjunctive therapy in epilepsy (infants and children1 – 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
2008Most NME approvals in the U.S. • Three out of 24 NME1 approvals in 2008 for UCB and one out of four Biologics License Applications (BLA) approved 2 3 UCB4 1 New Molecular Entity - Source: FDA website 2 Adolor and GlaxoSmithKline collaborated on Entereg 3 Progenics and Wyeth collaborated on Relistor 4 Toviaz® (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
20084 + 1 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®
Solid CNS & immunology pipelineKey projects 1 Neupro® Complete Response Letter (December 2008) 2 CHMP recommends lifting of treatment restrictions for Neupro® in Europe (May 2009)
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
EpilepsyMajor 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’s1 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 25-30% 50% 20-25% 1 Antiepileptic drug
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 Lakeisha, living with epilepsy Vimpat® has been designated as a Schedule V controlled substance by U.S. regulators.
Brivaracetam in epilepsyPhase 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
Terry, living with Parkinson’s disease Neupro® in Parkinson's disease Getting 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) • CHMP1 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 Add New patient from AR 1 CHMP: EMEA's Committee for Medicinal Products for Human Use
Neupro® in Parkinson's diseaseWorking 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 Add New patient from AR Wolfgang, living with Parkinson’s disease
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 Sten, living with restless legs syndrome
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 conservative statistical requirements and then discuss with authorities • UCB decision expected H2 2009 Frieda, living with diabetic neuropathic pain 1 Marketing Authorisation Application
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
Immunology • Crohn's disease (CD) Cimzia® • Rheumatoid arthritis (RA) Cimzia® • Bone loss disorders CDP7851 • Systemic lupus erythematosus (SLE) epratuzumab
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 Alison, living with rheumatoid arthritis
Study of naturally occurring human disorder leads to a potential new drug therapy Normal Sclerosteosis 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
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 – 3 600 mg/cycle) • Duration: 3 months treatment phase • Primary endpoint: reduction disease activity • Population: patients with moderate/severe activity
Solid CNS & immunology pipelineKey projects 1 Neupro® Complete Response Letter (December 2008) 2 CHMP recommends lifting of treatment restrictions for Neupro® in Europe (May 2009)
SHAPE Transformation and focus • Focus on CNS and immunology • Focus on core products and geographies • Drive for breakthroughinnovation for patients with severe disease • Simplify the organisation • Improve competitiveness and profitability
SHAPEAchievements 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)
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
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
2009Major milestones • Brivaracetam in epilepsy Phase III top line results • Cimzia® in rheumatoid arthritis U.S. approval & launch • Vimpat® in epilepsy1 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 controlled substance by U.S. regulators. 1 Adjunctive therapy in epilepsy
20092 + 1 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®
UCB Our “road map” Breakthrough Launch a new generation of therapies offering breakthrough innovation to patients with severe disease Intense growth • Realise the commercial potential of new products Execution • Launch new products • Invest in R&D • SHAPE the organisation for the future • Prioritise products and markets • Improve competitiveness and profitability ... and beyond 2010 2007
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 markets1 • Market size: ≈ € 3.2 billion in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 2 IMS, 2008 - Sales in epilepsy only. Japan not included. U.S. = Retail + Non-Fed hospitals
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 markets1 • Market size: ≈ € 790 million in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 2 Sales in PD only - EU 5 only. Source: IMS, 2008
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 markets1 • Market size: ≈ € 100 million in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 2 Sales in RLS only. Source: IMS, EU5, Mat 11/08
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 markets1 • Market size: ≈ € 390 million in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 2 Decision Resources – Neuropathic Pain – April 2007
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: ≈ 536 000 patients in 7 major markets1 • Market size: ≈ € 4.3 billion in 7 major markets2 (2007) 1 PatientBase, Decision Resources – 2008 2 Decision Resources – Pharmacor: Multiple Sclerosis – June 2008
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 markets1 • Market size: ≈ € 0.9 billion in 7 major markets2 1 PatientBase, Decision Resources – 2008 2 Datamonitor - Autoimmune Overview Forecast: Crohn’s Disease - December 2007
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 markets1 • Market size: ≈ € 5.8 billion in 7 major markets2(2007) 1 PatientBase, Decision Resources – 2008 2 Decision Resources – Pharmacor: Rheumatoid Arthritis– June 2008
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 markets1 • Market size: ≈ € 5.7 billion in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 – Osteoporosis 2 Datamonitor – Commercial Insight :Osteoporosis – June 2007
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 markets1 • Market size: ≈ € 670 million in 7 major markets2(2007) 1 PatientBase, Decision Resources - 2008 2 Datamonitor, IMS data taking into account off-label sales: both minimum and maximum sales - Mar08
Leading products compensate for Zyrtec® decline 1 Actual: change from previous year unadjusted for foreign currency impact 2 CER: change from previous year adjusted for constant exchange rates 3 Excluding Xyzal® U.S. revenue to UCB of € 39 million from profit-sharing with sanofi-aventis
2008 net salesGeography 2008 net sales € 3 027 million 2007 net sales € 3 188 million *
2008 net salesTherapy area 2008 net sales € 3 027 million 2007 net sales € 3 188 million *
Employees Geography - 2008 Total number of employees 11 292 *
2009 Corporate financial calendar • 2009 half-year results 31 July • Interim update (nine months report) 22 October
Antje Witte, Vice President Corporate Communications & Investor Relations Phone +32 2 559 9414 E-mail: antje.witte@ucb.com Richard Simpson, Senior Director Investor Relations Phone: +32 2 559 9494 E-mail: richard.simpson@ucb.com Michael Tuck-Sherman, Investor Relations Manager Phone: +32 2 559 9712 E-mail: michael.tuck-sherman@ucb.com Isabelle Ghellynck, Investor Relations Project Manager Phone: +32 2 559 9588 E-mail: isabelle.ghellynck@ucb.com Your Investor Relations team