Escolar Documentos
Profissional Documentos
Cultura Documentos
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 UCBs and Schwarz Pharmas 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
3
the next generation biopharma leader June 2009
Vision
To become the next generation biopharmaceutical leader
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
UCB
Our road map
4
the next generation biopharma leader June 2009
Breakthrough
Launch a new generation of therapies offering breakthrough innovation to patients with severe disease
Intense growth
Execution
Launch
new products Invest in R&D SHAPE the organisation for the future Prioritise products and markets Improve competitiveness and profitability
2007
2010
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 (NMEs) approved in the U.S. 2008/2009: major product launches - Vimpat, Neupro, Cimzia - ongoing and in preparation In-line with financial guidance
Revenue of 3 601 million in line with previous year Recurring EBITDA of 733 million (-1%) Net profit 42 million (-74%) impacted by:
Significant restructuring expenses and fixed asset impairment charges related to the SHAPE programme Financial expenses related to purchase of minority Schwarz Pharma
shares
Adjusted for after-tax impact of one-off items, contribution from discontinued operations and inventory step-up
Neupro
Toviaz Vimpat Vimpat Xyzal
Six filings
Cimzia Cimzia Keppra
Rheumatoid arthritis (EU) Rheumatoid arthritis (U.S.) Adjunctive therapy in epilepsy (infants and children1 U.S.)
Keppra
Keppra Keppra XR
Three out of 24 NME1 approvals in 2008 for UCB and one out of four Biologics License Applications (BLA) approved
3
AS
RMA
0
ARE LLAS AD O LOR AMG EN ER H LT HC ASTE
NE
BS WYE T
GEN ZYM E
TI BO TEC
CEP HALO N
HAR M
AIL A MER IC
PRO GEN IC
ERA
UCB
WAT SON LA
FER R
PHA
MED
JANS
O MC NEIL
ORT H
1 2 3 4
New Molecular Entity - Source: FDA website Adolor and GlaxoSmithKline collaborated on Entereg Progenics and Wyeth collaborated on Relistor 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
REG ENE
BIO V
BAY
SIRIO
H PH ARM
EPIX
RO N P
N TH
S I NC
EISA I
S CO
SEN
UCB4
3
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.
Toviaz
Phase I
CDP7851 bone loss disorders CDP6038 autoimmune diseases
Phase II
CDP323 multiple sclerosis epratuzumab systemic lupus erythematosus
Phase III
Vimpat epilepsy monotherapy - U.S. Vimpat diabetic neuropathic pain - EU + U.S. brivaracetam epilepsy Keppra XR epilepsy monotherapy - U.S.
Filed
Neupro adv. Parkinson's disease - U.S1 Neupro restless legs syndrome - U.S.1 Cimzia rheumatoid arthritis - EU
Approved
Neupro restless legs syndrome EU2
CNS
Immunology
1 2
Neupro Complete Response Letter (December 2008) CHMP recommends lifting of treatment restrictions for Neupro in Europe (May 2009)
Epilepsy
Vimpat brivaracetam
Neupro
Neupro Vimpat CDP323
50%
25-30%
20-25%
Controlled on 1st monotherapy Uncontrolled despite 2-3 AEDs "Controlled" on more than 1 AED
Patients with only one seizure/month report significant impact on their social life, ability to work and standard of living
No new AEDs1 approved in over 5 years (U.S.) Few future treatments expected, particularly with a novel mode of action
Antiepileptic drug
Vimpat in epilepsy a new treatment option Monotherapy Phase III programme ongoing
13
the next generation biopharma leader June 2009
Phase I
Phase II
Phase III
Epilepsy Adjunctive therapy (EU) Epilepsy Adjunctive therapy (U.S.) Epilepsy Monotherapy (U.S.)
Results expected Q2 2011
Broader mechanism of action than Keppra Population includes patients not controlled with Keppra
Brivaracetam
Neupro in Parkinson's disease Getting closer to make it available for new patients in Europe
15
the next generation biopharma leader June 2009
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 Parkinsons disease
Terry, living with Parkinsons disease
Phase I
Phase II
Phase III
Filed
Out-of-stock situation
Substantial evidence of effectiveness in advanced Parkinsons disease and restless legs syndrome (RLS) Dialogue ongoing with the FDA to bring Neupro back to U.S. patients
Wolfgang, living with Parkinsons disease
Phase I
Phase II
Phase III
Filed
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)
Substantial evidence of effectiveness in advanced Parkinsons disease and restless legs syndrome (RLS)
Sten, living with restless legs syndrome
Recommends allowing Neupro to be launched for the treatment of moderate to severe RLS
Phase I
Phase II
Phase III
Filed
Launched
Neupro (rotigotine)
Neupro (rotigotine)
Demonstrated sustained efficacy and good tolerability No drug-drug / food interactions, no weight gain
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
Phase I
Phase II
Phase III
Filed
Approved
Launched
Potent and orally active small molecule antagonist of alpha 4-integrin Successful collaboration with Biogen IDEC Phase II programme ongoing
Phase I
Phase III
Filed
Approved
Launched
CDP323
Multiple sclerosis
Immunology
20
the next generation biopharma leader June 2009
Cimzia Cimzia
CDP7851
epratuzumab
Approved and launched in the U.S. Filed with European authorities (July 2008)
Review pending
Phase I
Phase II
Phase III
Study of naturally occurring human disorder leads to a potential new drug therapy
human data and are currently planning the future development program
Normal Sclerosteosis
Phase I
Phase II
Phase III
Filed
Approved
Launched
CDP7851 (anti-sclerostin)
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
Phase I
Phase III
Filed
Approved
Launched
Epratuzumab
Phase I
CDP7851 bone loss disorders CDP6038 autoimmune diseases
Phase II
CDP323 multiple sclerosis epratuzumab systemic lupus erythematosus
Phase III
Vimpat epilepsy monotherapy - U.S. Vimpat diabetic neuropathic pain - EU + U.S. brivaracetam epilepsy Keppra XR epilepsy monotherapy - U.S.
Filed
Neupro adv. Parkinson's disease - U.S1 Neupro restless legs syndrome - U.S.1 Cimzia rheumatoid arthritis - EU
Approved
Neupro restless legs syndrome EU2
CNS
Immunology
1 2
Neupro Complete Response Letter (December 2008) CHMP recommends lifting of treatment restrictions for Neupro in Europe (May 2009)
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)
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
divestments
Vimpat
in epilepsy1
Q3 2009 H2 2009
Vimpat has been designated as a Schedule V controlled substance by U.S. regulators. Adjunctive therapy in epilepsy
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
31
the next generation biopharma leader June 2009
Breakthrough
Launch a new generation of therapies offering breakthrough innovation to patients with severe disease
Intense growth
Execution
Launch
new products Invest in R&D SHAPE the organisation for the future Prioritise products and markets Improve competitiveness and profitability
2007
2010
32
Appendix
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 ethnicity There is no known cure at this time but treatments are available to reduce the frequency and severity of seizures Prevalence: Market size: 6 million patients in 7 major markets1 3.2 billion in 7 major markets2 (2007)
1 2
PatientBase, Decision Resources - 2008 IMS, 2008 - Sales in epilepsy only. Japan not included. U.S. = Retail + Non-Fed hospitals
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:
1 2
PatientBase, Decision Resources - 2008 Sales in PD only - EU 5 only. Source: IMS, 2008
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:
Market size:
1 2
PatientBase, Decision Resources - 2008 Sales in RLS only. Source: IMS, EU5, Mat 11/08
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: Market size: 10 million patients in 7 major markets1 390 million in 7 major markets2 (2007)
1 2
PatientBase, Decision Resources - 2008 Decision Resources Neuropathic Pain April 2007
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: Market size: 536 000 patients in 7 major markets1 4.3 billion in 7 major markets2 (2007)
1 2
PatientBase, Decision Resources 2008 Decision Resources Pharmacor: Multiple Sclerosis June 2008
Autoimmune disease that causes chronic inflammation of the GI tract Also referred to as Inflammatory Bowel Disease (IBD)
1 2
PatientBase, Decision Resources 2008 Datamonitor - Autoimmune Overview Forecast: Crohns Disease December 2007
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: Market size: 5 million patients in 7 major markets1 5.8 billion in 7 major markets2 (2007)
1 2
PatientBase, Decision Resources 2008 Decision Resources Pharmacor: Rheumatoid Arthritis June 2008
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: Market size: 64 million patients in 7 major markets1 5.7 billion in 7 major markets2 (2007)
1 2
PatientBase, Decision Resources - 2008 Osteoporosis Datamonitor Commercial Insight :Osteoporosis June 2007
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:
Market size:
1 2
PatientBase, Decision Resources - 2008 Datamonitor, IMS data taking into account off-label sales: both minimum and maximum sales - Mar08
million Leading products Keppra Zyrtec (incl. D/Cirrus) Xyzal 3 Tussionex Nootropil New products Neupro Cimzia Vimpat Total net sales
2008
YTD Change Actual1 CER2 23% -49% 3% 29% -8% 30% -50% 4% 38% -7%
58 10 2 3 027
12% -5%
16% -2%
1 2 3
Actual: change from previous year unadjusted for foreign currency impact CER: change from previous year adjusted for constant exchange rates Excluding Xyzal U.S. revenue to UCB of 39 million from profit-sharing with sanofi-aventis
3 188 million
Europe 47%
North America 46%
Europe 42%
Other 39%
CNS 47%
Immunology & allergy 14%
Other 42%
CNS 37%
16%
21%
20%
13% 9% 21%
31 July 22 October
E-mail: antje.witte@ucb.com