the next generation biopharma leader · 2016-01-20 · the next generation biopharma leader may...

Raffaele, living with epilepsy

May 2009

Delivering to becomethe next generation biopharma leader

UCB

Corporate Presentation

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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.

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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

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UCB Our “road map”

2007 ... 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

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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

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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

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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

2008 7 regulatory approvals and 6 filings

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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

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1 New Molecular Entity - Source: FDA website2 Adolor and GlaxoSmithKline collaborated on Entereg3 Progenics and Wyeth collaborated on Relistor4 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

UCB42

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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


Oral antihistamine solution


Overactive bladder

Launched in the EU, by PfizerToviaz®

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Solid CNS & immunology pipelineKey projects

Neupro®

restless legs syndrome – EU

Neupro®

restless legs syndrome - U.S.1

Vimpat®

diabetic neuropathic pain - EU + U.S.

epratuzumabsystemic lupus erythematosus

CDP6038autoimmune diseases

Immunology

Cimzia®

rheumatoid arthritis - EU + U.S.2

Neupro®

adv. Parkinson's disease - U.S1

Filed

CNS

Cimzia®

Crohn's disease -EU

Keppra® XRepilepsy monotherapy - U.S.

brivaracetamepilepsy

Vimpat®

epilepsy adjunctive therapy – U.S.

Vimpat®

epilepsy monotherapy - U.S.

CDP323multiple sclerosis

CDP7851bone loss disorders

Approved Phase IIIPhase IIPhase I

1 Neupro® Complete Response Letter (December 2008)2 Cimzia® Complete Response Letter (January 2009)

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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

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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 five years (U.S.)

Few future treatments expected, particularly with a novel mode of action

There is a strong need for a new treatment option

Controlled on 1st Monotherapy

Uncontrolled despite 2-3 AEDs

"Controlled" on more than 1 AED20-25%

50% 25-30%

1 Antiepileptic drug

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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

LaunchedApprovedFiledPhase IIIPhase IIPhase I

April 2009Epilepsy adjunctive therapyBrivaracetam

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Neupro® in Parkinson's diseaseWorking to make it available for new patients

Full cold storage and distribution chain

implemented in Europe (September 2008)

• Target: to make Neupro® available again to all patients

(including new patients) in Europe during H1 2009

To resolve U.S. 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

January2007Advanced Parkinson's disease (EU)Neupro® (rotigotine)

July2007Early stage Parkinson's disease (U.S.)Neupro® (rotigotine)


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

March 2006Early stage Parkinson's disease (EU)Neupro® (rotigotine)

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Terry, living with Parkinson’s disease

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Neupro® in restless legs syndrome Increased awareness of an unrecognised disease

Demonstrated efficacy

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)”


December2007Restless legs syndrome (U.S.)Neupro® (rotigotine)

September 2008Restless legs syndrome (EU)Neupro® (rotigotine)

Sten, living with restless legs syndrome

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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


Diabetic neuropathic pain (U.S.)Vimpat® (lacosamide)

Vimpat® (lacosamide) Diabetic neuropathic pain (EU)

1 Marketing Authorisation Application

Frieda, living with diabetic neuropathic pain

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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

Results expected

2010Multiple sclerosisCDP323


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Immunology

Crohn's disease (CD) Cimzia®

Rheumatoid arthritis (RA) Cimzia®

Bone loss disorders CDP7851

Systemic lupus erythematosus (SLE) epratuzumab

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Cimzia® in rheumatoid arthritis Only PEGylated Fc-free anti-TNF

FDA Complete Response Letter (January 2009)

Meeting with FDA defined path forward (February 2009)

• No new studies required (clinical or non-clinical)

• Further analysis of existing data and a new safety update

UCB response now submitted

February 2008Rheumatoid arthritis (U.S.)Cimzia® (certolizumab pegol)July 2008Rheumatoid arthritis (EU)Cimzia® (certolizumab pegol)


Alison, living with rheumatoid arthritis

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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 Normal Sclerosteosis

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

Results expected H2

2009Bone loss disordersCDP7851 (anti-sclerostin)


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Epratuzumab in systemic lupus erythematosus (SLE)Phase IIb study has started

Analyses of recently closed clinical trials suggest a favorable efficacy

and tolerability profile

A Phase IIb dose ranging study has started

• Number of randomized patients: 210

• Arms/doses: 6 arms dose range (from 150–3600 mg/cycle)

• Duration: 3 months treatment phase

• Primary endpoint: reduction disease activity

• Population: patients with moderate/severe activity

Results expected Q3 2009

Systemic lupus erythematosusEpratuzumab


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Solid CNS & immunology pipelineKey projects

Neupro®

restless legs syndrome – EU

Neupro®

restless legs syndrome - U.S.1

Vimpat®

diabetic neuropathic pain -EU + U.S.

epratuzumabsystemic lupus erythematosus

CDP6038autoimmune diseases

Immunology

Cimzia®

rheumatoid arthritis - EU + U.S.2

Neupro®

adv. Parkinson's disease - U.S1

Filed

CNS

Cimzia®

Crohn's disease -EU

Keppra® XRepilepsy monotherapy - U.S.

brivaracetamepilepsy

Vimpat®

epilepsy adjunctive therapy – U.S.

Vimpat®

epilepsy monotherapy - U.S.

CDP323multiple sclerosis

CDP7851bone loss disorders

Approved Phase IIIPhase IIPhase I

1 Neupro® Complete Response Letter (December 2008)2 Cimzia® Complete Response Letter (January 2009)

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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

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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)

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Major development milestones in 2009

Epratuzumab in SLE First Phase IIb results Q3 2009

Brivaracetam in epilepsy Phase III top line results

CDP7851 in bone loss disorders Phase I to complete H2 2009

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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

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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

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UCB Our “road map”

2007 ... 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

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Appendix

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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 - 20082 IMS, 2008 - Sales in epilepsy only. Japan not included. U.S. =

Retail + Non-Fed hospitals

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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


Market size: ≈ € 790 million in 7 major markets2 (2007)

1 PatientBase, Decision Resources - 20082 Sales in PD only - EU 5 only. Source: IMS, 2008

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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 relatedto 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



1 PatientBase, Decision Resources - 20082 Sales in RLS only. Source: IMS, EU5, Mat 11/08

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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



1 PatientBase, Decision Resources - 20082 Decision Resources – Neuropathic Pain – April 2007

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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


1 PatientBase, Decision Resources – 20082 Decision Resources – Pharmacor: Multiple Sclerosis – June 2008

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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 – 20082 Datamonitor - Autoimmune Overview Forecast: Crohn’s Disease -

December 2007

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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



1 PatientBase, Decision Resources – 20082 Decision Resources – Pharmacor: Rheumatoid Arthritis– June

2008

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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



1 PatientBase, Decision Resources - 2008 – Osteoporosis2 Datamonitor – Commercial Insight :Osteoporosis – June 2007

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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


1 PatientBase, Decision Resources - 20082 Datamonitor, IMS data taking into account off-label sales: both

minimum and maximum sales - Mar08

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Leading products compensate for Zyrtec® decline

YTD Change2008€ million

--2Vimpat®

16%12%58Neupro®

38%29%147Tussionex™

-5%

-

-8%

3%

-49%

23%

Actual1

-7%93Nootropil®

-2%3 027Total net sales

-10Cimzia®

New products

4%173Xyzal® 3

-50%249Zyrtec® (incl. D/Cirrus®)

30%1 266Keppra®

Leading products

CER2

1 Actual: change from previous year unadjusted for foreign currency impact2 CER: change from previous year adjusted for constant exchange rates3 Excluding Xyzal® U.S. revenue to UCB of € 39 million from profit-sharing with

sanofi-aventis

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2008 net salesGeography

Europe42%

Rest of World12%

North America

46%

Europe47%

Rest of World13%

North America

40%

2007 net sales

€ 3 188 million

2008 net sales

€ 3 027 million

*

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2008 net salesTherapy area

CNS37%

Other42%

Immun-ology and

allergy21%

CNS47%

Other39%

Immun- ology & allergy14%

2007 net sales

€ 3 188 million

2008 net sales

€ 3 027 million

*

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Employees Geography - 2008

*

21%

13%

9%21%

20%

16%

Belgium GermanyU.K. U.S.Rest of EU Emerging Markets

Total number of employees

11 292

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Corporate financial calendar

2009 half-year results 31 July

Interim update (nine months report) 22 October

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Your Investor Relations team

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


Michael Tuck-Sherman, Investor Relations Manager

• Phone: +32 2 559 9712


Isabelle Ghellynck, Investor Relations Project Manager

• Phone: +32 2 559 9588


the next generation biopharma leader · 2016-01-20 · the next generation biopharma leader may...

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