Ucb S.a. · EURONEXT:UCB
Ucb — Investor Presentation (June 2009)
47 slides from Ucb's investor presentation, June 2009
Slide 1: Delivering to become the next generation biopharma leader
Raffaele, living with epilepsy Delivering to become the next generation biopharma leader UCB Corporate Presentation June 2009
Slide 2: Disclaimer and safe harbour
Disclaimer and safe harbour 2 the next generation biopharma leader June 2009 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 Sc
Slide 3: UCB
UCB 3 the next generation biopharma leader June 2009 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
Slide 4: Our road map
UCB Our “road map” 4 the next generation biopharma leader June 2009 Breakthrough Launch a new generation of therapies Intense growth offering breakthrough innovation to patients Realise the commercial with severe disease Execution potential of new products • Launch new products • Invest in R&D • SHA
Slide 5: 2008: UCB continues on track
2008 UCB continues on track 5 the next generation biopharma leader June 2009 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. 2008/20
Slide 6: 2008 Financial highlights
2008 Financial highlights 6 the next generation biopharma leader June 2009 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
Slide 7: 2008 regulatory approvals and filings
2008 7 regulatory approvals and 6 filings 7 the next generation biopharma leader June 2009 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® Ov
Slide 8: 2008 Most NME approvals in the U.S.
2008 Most NME approvals in the U.S. 8 the next generation biopharma leader June 2009 Three out of 24 NME1 approvals in 2008 for UCB and one out of four Biologics License Applications (BLA) approved 3 2 1 0 UCB4 2 ICAS 3 A NE L ABS NC AR E LLAS E SEN I O EN R M. OR TEC P E G ON 3 ICS EISA RM ZYM CAR
Slide 9: 2008 new product launches
2008 4 + 1 new product launches 9 the next generation biopharma leader June 2009 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 To
Slide 10: Solid CNS & immunology pipeline
Solid CNS & immunology pipeline Key projects 10 the next generation biopharma leader June 2009 Phase I Phase II Phase III Filed Approved CDP7851 CDP323 Vimpat® Neupro® Neupro® bone loss disorders multiple sclerosis epilepsy adv. Parkinson's restless legs monotherapy - U.S. disease - U.S1 syndrome –
Slide 11: CNS: Expansion in our core area
CNS Expansion in our core area 11 the next generation biopharma leader June 2009 Epilepsy Vimpat® brivaracetam Parkinson's disease (PD) Neupro® Restless legs syndrome (RLS) Neupro® Diabetic neuropathic pain (DNP) Vimpat® Multiple sclerosis (MS) CDP323
Slide 12: Epilepsy: Major unmet medical need
Epilepsy Major unmet medical need 12 the next generation biopharma leader June 2009 High unmet medical need in ~1/3 of treated epilepsy patients 25-30% Controlled on 1st monotherapy 50% Uncontrolled despite 2-3 AEDs 20-25% "Controlled" on more than 1 AED Patients with only one seizure/month report s
Slide 13: Vimpat in epilepsy – a new treatment option
Vimpat® in epilepsy – a new treatment option Monotherapy Phase III programme ongoing 13 the next generation biopharma leader June 2009 Novel dual mode of action Easy to use • No clinically significant drug-drug interactions • Multiple formulations: tablets, syrup, IV Monotherapy Phase III trial in t
Slide 14: Brivaracetam in epilepsy
Brivaracetam in epilepsy Phase III programme ongoing 14 the next generation biopharma leader June 2009 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
Slide 15: Neupro in Parkinson's disease (Europe)
Neupro® in Parkinson's disease Getting closer to make it available for new patients in Europe 15 the next generation biopharma leader June 2009 Deviation from product approved specification Restriction on promotion (June 2008) AR om • To manage potential shortages: existing patients only en w fr ti
Slide 16: Neupro in Parkinson's disease (U.S.)
Neupro® in Parkinson's disease Working to make it available for new patients in the U.S. 16 the next generation biopharma leader June 2009 Deviation from product approved specification Product recall (March 2008) AR om • Out-of-stock situation en w fr ti Ne FDA Complete Response Letter (December 200
Slide 17: Neupro in restless legs syndrome
Neupro® in restless legs syndrome Increased awareness of an unrecognised disease 17 the next generation biopharma leader June 2009 Demonstrated efficacy and well tolerated Consistent results within comprehensive clinical program • Improved sleep and reduced daytime tiredness • Potential first line t
Slide 18: Vimpat in diabetic neuropathic pain
Vimpat® in diabetic neuropathic pain Path forward to be elaborated 18 the next generation biopharma leader June 2009 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 A
Slide 19: CDP323 in multiple sclerosis
CDP323 in multiple sclerosis Oral administration 19 the next generation biopharma leader June 2009 Potent and orally active small molecule antagonist of alpha 4-integrin Successful collaboration with Biogen IDEC Phase II programme ongoing Phase I Phase II Phase III Filed Approved Launched Results CD
Slide 20: Immunology
Immunology 20 the next generation biopharma leader June 2009 Crohn's disease (CD) Cimzia® Rheumatoid arthritis (RA) Cimzia® Bone loss disorders CDP7851 Systemic lupus erythematosus (SLE) epratuzumab
Slide 21: Cimzia in rheumatoid arthritis
Cimzia® in rheumatoid arthritis Only PEGylated Fc-free anti-TNF 21 the next generation biopharma leader June 2009 Approved and launched in the U.S. Filed with European authorities (July 2008) • Review pending Alison, living with rheumatoid arthritis Phase I Phase II Phase III Filed Approved Launched
Slide 22: CDP7851 in bone loss disorders
CDP7851 in bone loss disorders Novel therapy with strong potential 22 the next generation biopharma leader June 2009 Development of novel anabolic therapy Study of naturally occurring human disorder leads to a potential new drug therapy • Antibody to sclerostin potentially treating bone loss disorde
Slide 23: Epratuzumab in systemic lupus erythematosus (SLE)
Epratuzumab in systemic lupus erythematosus (SLE) Phase IIb study ongoing 23 the next generation biopharma leader June 2009 Analyses of recently closed clinical trials suggest a favourable efficacy and tolerability profile Phase IIb dose ranging study ongoing • Number of randomized patients: 210 • A
Slide 24: Solid CNS & immunology pipeline
Solid CNS & immunology pipeline Key projects 24 the next generation biopharma leader June 2009 Phase I Phase II Phase III Filed Approved CDP7851 CDP323 Vimpat® Neupro® Neupro® bone loss disorders multiple sclerosis epilepsy adv. Parkinson's restless legs monotherapy - U.S. disease - U.S1 syndrome –
Slide 25: SHAPE: Transformation and focus
SHAPE Transformation and focus 25 the next generation biopharma leader June 2009 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
Slide 26: SHAPE: Achievements so far
SHAPE Achievements so far 26 the next generation biopharma leader June 2009 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 eme
Slide 27: UCB priorities for 2009
UCB priorities for 2009 27 the next generation biopharma leader June 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 ‘Breakt
Slide 28: 2009 financial outlook
2009 financial outlook 28 the next generation biopharma leader June 2009 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 € 6
Slide 29: 2009 Major milestones
2009 Major milestones 29 the next generation biopharma leader June 2009 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 dis
Slide 30: 2009 product launches so far
2009 2 + 1 product launches so far 30 the next generation biopharma leader June 2009 Rheumatoid arthritis Launched in the U.S. Adjunctive therapy in epilepsy Launched in the U.S. Overactive bladder Toviaz ® Launched in the U.S., by Pfizer
Slide 31: Our road map
UCB Our “road map” 31 the next generation biopharma leader June 2009 Breakthrough Launch a new generation of therapies Intense growth offering breakthrough innovation to patients Realise the commercial with severe disease Execution potential of new products • Launch new products • Invest in R&D • SH
Slide 32: Appendix
32 the next generation biopharma leader June 2009 Appendix
Slide 33: Epilepsy
Epilepsy 33 the next generation biopharma leader June 2009 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 ethnic
Slide 34: Parkinson's disease (PD)
Parkinson’s disease (PD) 34 the next generation biopharma leader June 2009 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 b
Slide 35: Restless legs syndrome (RLS)
Restless legs syndrome (RLS) 35 the next generation biopharma leader June 2009 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
Slide 36: Diabetic neuropathic pain (DNP)
Diabetic neuropathic pain (DNP) 36 the next generation biopharma leader June 2009 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 suc
Slide 37: Multiple sclerosis (MS)
Multiple sclerosis (MS) 37 the next generation biopharma leader June 2009 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 t
Slide 38: Crohn's disease (CD)
Crohn’s disease (CD) 38 the next generation biopharma leader June 2009 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 betwe
Slide 39: Rheumatoid arthritis (RA)
Rheumatoid arthritis (RA) 39 the next generation biopharma leader June 2009 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 inflamm
Slide 40: Bone loss disorders
Bone loss disorders 40 the next generation biopharma leader June 2009 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 b
Slide 41: Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) 41 the next generation biopharma leader June 2009 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
Slide 42: Leading products compensate for Zyrtec decline
Leading products compensate for Zyrtec® decline 42 the next generation biopharma leader June 2009 € million 2008 YTD Change Actual1 CER2 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®
Slide 43: 2008 net sales by geography
2008 net sales Geography 43 the next generation biopharma leader June 2009 2008 net sales 2007 net sales € 3 027 million € 3 188 million *
Slide 44: 2008 net sales by therapy area
2008 net sales Therapy area 44 the next generation biopharma leader June 2009 2008 net sales 2007 net sales € 3 027 million € 3 188 million *
Slide 45: Employees by geography - 2008
Employees Geography - 2008 45 the next generation biopharma leader June 2009 Total number of employees 11 292 16% 21% 20% 13% 9% 21% Belgium Germany U.K. U.S. Rest of EU Emerging Markets *
Slide 46: 2009 Corporate financial calendar
2009 Corporate financial calendar 46 the next generation biopharma leader June 2009 2009 half-year results 31 July Interim update (nine months report) 22 October
Slide 47: Your Investor Relations team
Your Investor Relations team 47 the next generation biopharma leader June 2009 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 • E-mail: richard.