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Building the next generation biopharma
Roch Doliveux CEO
May 29, 2007
Agenda
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The next generation biopharma leader May 29, 2007
UCB today Acquisition of Schwarz Pharma
Research & Development
Outlook 2007
World biopharma market: € 482 billion (+7%)
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The next generation biopharma leader May 29, 2007
Pharmaceuticals (2006) Top 10 products global sales range Pharmaceutical Market Biologicals (2006) Top 10 products global sales range Biologicals Market
€ 2.7 – 10.3 billion Annual growth 4.6%
€ 1.6 – 3.3 billion Annual growth 17.8%
Source: Evaluate – March 20, 2007 and IMS Health Global Pharmaceutical Report 06
Amongst original brands specialist driven market is main source of growth Primary care zero growth in Europe
Original brands
North America
100 25
100
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The next generation biopharma leader May 29, 2007
Europe
50
80
SHARE OF SALES (LCD)
20
SHARE OF SALES (LCD)
80
40
30
GROWTH
20 40 10 20
40
10
20
5
0
0 2002 2003 2004 2005 2006
0
0 2002 2003 2004 2005 2006
-10
Primary care Primary care growth
Specialist driven care Specialist driven care growth
Source: IMS Health MIDAS MAT December 2006 – Ethical Non Generic Market Only
GROWTH
60
15
60
Primary care growth decline has affected major players UCB suffering in Primary care: excellent in Specialist driven
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The next generation biopharma leader May 29, 2007
Primary Driven Care
European Rank S-A GSK Pfizer Novartis AZ Market Share % 8 7 7 Growth % Share of Portfolio % 60 78 68 European Rank
Specialist Driven Care
Market Share % 9 8 6 5 5 4 3 3 3 3 49 Growth % Share of Portfolio %
-3 0 -7
Roche S-A Novartis J&J Pfizer Lilly AZ N-N GSK Abbott
26 7 11 3 10 3 11 10 0 13 10
80 40 37 67 32 79 30 92 22 66 46
7
5 4 4 3 2 2
2
3 6 2 7 7 -12
63
69 75 70 92 60 60
MSD
BSP Servier M&S Wyeth Top 10 corps UCB (33)
48
0.5
-1
-3.1
68
58
Top 10 corps
UCB (31)
0.6
25.6
42
Source: IMS Health: MIDAS MAT Dec 2006
Biopharmaceutical leaders
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The next generation biopharma leader May 29, 2007
Amgen Genentech Novo Nordisk Merck + Serono* UCB + Schwarz Genzyme UCB
23%
23% 16% 22% 25% 20% 28% 40% 21% 25%
10.4 5.7 5.2 4.0 3.2 2.4 2.2 1.3 1.2 1.1 % Investment in R&D Net Sales 2006 (€ billion)
Biogen IDEC
Lundbeck Shire
* Merck Ethicals only (excludes Generics, CHC and Chemicals)
Vision - since 2004
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The next generation biopharma leader May 29, 2007
To build a global biopharmaceutical leader,
based on unique blending of innovation, entrepreneurship and proven experience,
bringing to specialists first, new medicines to
treat patients suffering from severe diseases.
2006 Solid revenue and profit growth
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The next generation biopharma leader May 29, 2007
2006 Revenue up 11%*
3000
(8% as reported)
2 523 2 341
+36%
2400
Keppra® Xyzal® Zyrtec® Royalties Other products
Keppra®
€ million 1800
Xyzal® Zyrtec®
+13% +0%
1200
Royalties
600
+12% -9%
Other products
0
2005
2006 (36% as reported)
... double digit profit growth, up 13%*
* on a like for like basis, excluding contribution of divested businesses/products and one-off items
Net sales Therapeutic areas
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The next generation biopharma leader May 29, 2007
2005
Allergy** 34% 37% CNS* Allergy** 32%
2006
CNS* 45%
29% Others Others
23%
€ 2.0 billion
* CNS: Keppra®, Nootropil®, Metadate™ CD, Atarax® ** Allergy: Zyrtec D®, Zyrtec®, Xyzal®
€ 2.2 billion
UCB + Schwarz Pharma: strengthens and diversifies specialty portfolio
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The next generation biopharma leader May 29, 2007
UCB 2006 Net Sales
(€2.2 billion)
Pro Forma 2006 Net Sales
(€3.2 billion)
Neurology
Neurology 45%
33% 11%
Gastro Intestinal
32% 23% Allergy Other
Allergy
22% 13% 21% Other Cardio Vascular
Net sales Geography
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The next generation biopharma leader May 29, 2007
2005
Europe 38% 44% North America Europe 38%
2006
North America
46%
7% Emerging Markets
11% Japan
7% Emerging Markets
9% Japan
€ 2.0 billion
€ 2.2 billion
Leader in epilepsy and allergy
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The next generation biopharma leader May 29, 2007
# 1 in Epilepsy
(U.S.A. and E.U.)*
# 1 in Allergy
(Worldwide)
* Source: IMS (Value, US / EU5, MAT Q4/06) Epilepsy only
Keppra® Sustained high double-digit growth
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The next generation biopharma leader May 29, 2007
Net sales € 761 million in 2006
800 700 600 500
+36%
+35%
€ million
400
300 200 100 0
+34%
+67% U.S.A. Europe Emerging markets Total
2005
2006
Keppra® New indications and formulation in epilepsy
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The next generation biopharma leader May 29, 2007
Europe (EMEA) Add –on therapy • Partial on-set seizures • Adult • Pediatric • Generalised seizures • Juvenile Myoclonic • Primary Tonic Clonic Monotherapy Intravenous administration Geographic expansion Approved Approved Approved Approved
May 2006 Jan 2007
U.S.A. (FDA)
Approved Approved
Sep 2000 Sep 2005
Approved Approved
Nov 1999 Jun 2005
Approved Approved Approved
Aug 2006 Mar 2007
Aug 2006 Apr 2006
Aug 2006
South Korea China
Jan 2007 Mar 2007
Keppra® U.S.A.: Market leader
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The next generation biopharma leader May 29, 2007
35
29.1%
30
Market share in value - epilepsy
25
20
15
10
5
0
02/02
GABAPENTIN OXCARBAZEPINE
02/03
02/04
02/05
KEPPRA® TOPIRAMATE
02/06
02/07
LAMOTRIGINE ZONISAMIDE
Source: IMS (Epilepsy market share in value, US, MAT, Feb. 2007)
Keppra® Europe: Market leader
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The next generation biopharma leader May 29, 2007
35 30
Market share in value - epilepsy
25 20 15 10 5 0
25.8%
02/02
GABAPENTIN OXCARBAZEPINE
02/03
02/04
02/05
KEPPRA® TOPIRAMATE
02/06
02/07
LAMOTRIGINE ZONISAMIDE
Source: IMS (Epilepsy market share in value, Europe, MAT, Feb. 2007)
Allergy franchise Continuing solid performance
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The next generation biopharma leader May 29, 2007
Net sales € 704 million in 2006
800
+2%
600 € million
400
+12%
200
0% -17% +26%
0
U.S.A.
Europe 2005
Japan 2006
Emerging markets
Total
Allergy franchise includes Zyrtec®, Zyrtec D®, Cirrus®, Xyzal®
Zyrtec® U.S.A.: Market leader
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The next generation biopharma leader May 29, 2007
60.0%
49.2%
50.0%
Market share in value
40.0%
30.0%
20.0%
10.0%
0.0% Mar 2005
Jun 2005
Sep 2005
Dec 2005
Mar 2006
Jun 2006
Sep 2006
Dec 2006
Clarinex Allegra
Claritine Zyrtec®
Fexofenadine generics Loratadine generics
Source: IMS (Antihistamine group of products , Value, US, Feb. 07)
Xyzal® U.S. transition in allergy
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The next generation biopharma leader May 29, 2007
Significant branded prescription market Xyzal® superiority demonstrated versus competition* Potentially only promoted oral premium prescription anti-histamine Positioned for leadership Co-promotion with sanofi-aventis
U.S. launch expected during Fall 2007
* Day JH et al. Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of seasonal allergic rhinitis in subjects evaluated in the environmental exposure unit (EEU). Int J Clin Pract 2004; 58: 109-18
Agenda
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The next generation biopharma leader May 29, 2007
UCB today Acquisition of Schwarz Pharma
Research & Development
Outlook 2007
UCB + Schwarz Pharma Leaping forward
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The next generation biopharma leader May 29, 2007
Leaps forward into the next generation biopharma company Strengthens leadership position in one of our strong franchises
Broadens late stage pipeline to accelerate sustainable topline growth into the next decade
Commercial organisation increased power in U.S.A. and E.U. Additional earnings growth to fund R&D investments Significant anticipated synergies: € 300m p.a. within 3 years Builds on complementary culture of both organisations and UCB's successful transaction integration track record
Improved long term earnings prospects and cash-flow profile
UCB + Schwarz Pharma Status of acquisition process
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The next generation biopharma leader May 29, 2007
Tender offer completed on 28 December 2006 UCB owns today 87.6% of Schwarz Pharma’s outstanding shares Domination & profit and loss transfer agreement (DA) process ongoing
• Cash compensation of € 104.60 per Schwarz Pharma
share or guaranteed dividend of € 3.43 per share
• Schwarz Pharma’s General Shareholders' Meeting
(>94%) accepted all resolutions (>98%), including DA (May 8, 2007)
UCB + Schwarz Pharma Integration update
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The next generation biopharma leader May 29, 2007
Both companies being restructured to address inefficiencies and new specialist driven business model Arm’s length agreements to benefit Schwarz’s and UCB’s shareholders:
• Co-promotion of Neupro® and Keppra® • Co-promotion of Primary Care products
• Advisory services
• Purchasing
New organization planning from “Day One” post domination agreement Synergies on track
Agenda
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The next generation biopharma leader May 29, 2007
UCB today Acquisition of Schwarz Pharma
Research & Development
Outlook 2007
Rich and productive R&D pipeline
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The next generation biopharma leader May 29, 2007
Phase I
Phase II
Phase III
Filed / Launched
sclerostin
Osteoporosis
Cimzia™
Psoriasis
Cimzia™
Rheumatoid arthritis
Cimzia™
Crohn's disease
CDP323 UCB
Multiple sclerosis
brivaracetam
Epilepsy
Keppra® XR
Epilepsy in U.S.A.
Keppra®
PGTC
CMC544
Non-Hodgkin's lymphoma
seletracetam
Epilepsy
Xyrem®
Fibromyalgia
Xyzal®
Allergy in U.S.A.
CDP791
Non-small-cell lung cancer
epratuzumab
Lupus
lacosamide Schwarz Pharma
• Epilepsy monotherapy • Migraine prophylaxis • Fibromyalgia • Osteoarthritis
lacosamide
• Diabetic neuropathic pain • Epilepsy
Neupro® Patch
• Early Parkinson’s • Advanced Parkinson’s
rotigotine Nasal Spray
Restless legs syndrome
rotigotine Patch
Restless legs syndrome
fesoterodine
Overactive bladder
rotigotine Patch
Fibromyalgia
Inflammation
CNS
Other
Oncology
Epilepsy
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The next generation biopharma leader May 29, 2007
Most common serious neurological disorder
• Recurrent seizures resulting from excessive electrical
activity in the brain
Prevalence: 50 million people worldwide
• 2.2 million in Europe • 1.6 million in U.S.A.
25 - 35% of patients are inadequately controlled
Source: IMS – MAT 06 total AED market
Keppra® XR Solid succession plan in epilepsy
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The next generation biopharma leader May 29, 2007
Potentially valuable new alternative Expected improved efficacy and tolerability ratio Add-on therapy for adult patients with refractory epilepsy suffering from partial onset seizures
Potential for monotherapy indication
Potential for once daily convenience and compliance
Phase III results expected in Q4 2007
Potentially 3 years of market exclusivity in the U.S.A.
Brivaracetam Solid succession plan in epilepsy
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The next generation biopharma leader May 29, 2007
Different pharmacology than Keppra®
• 10 times more potent
• More efficacious
Broader mechanism of action Very strong efficacy in phase IIb evaluation Robust efficacy and good tolerability Population includes patients not controlled with Keppra®
Phase III trials expected to start in Q2 2007 Orphan drug program in Unverricht Lundborg Disease ongoing
Lacosamide Solid succession plan in epilepsy
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The next generation biopharma leader May 29, 2007
Different mode of action than Keppra® and brivaracetam Convenient adjunctive therapy due to no drug-drug or food interaction Easy twice daily dosing, good safety and tolerability Oral dosing and IV formulation available Expected to become a strong and convenient AED that is simple to use with multiple formulations and good tolerability Positive phase III results in adjunctive therapy Adjunctive therapy E.U. filed in May 2007 U.S. filing expected in Q4 2007
Monotherapy
Phase IIb expected to start in H2 2007
Crohn’s disease
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The next generation biopharma leader May 29, 2007
Gastro-duodenal and other <1%
Chronic inflammatory disease of the entire gastrointestinal tract Associated with episodes of relapse and remission
Isolated colon 27%
Isolated small-intestine 29%
Prevalence:
• Approximately 1 million people
worldwide
• Over 500,000 patients in Europe
Isolated anorectal 3% Ileo-cecal 41%
• Over 545,000 patients in the U.S.A.
• Over 19,000 patients in Japan
Market size: US$ 0.7 billion
Adapted from: Truelove, Gut 1976; 17(3): 192–201
Source: Decision Resources Reports: Crohn’s Disease January 2007
Cimzia™ Crohn’s disease
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The next generation biopharma leader May 29, 2007
Demonstrated efficacy with a stable once monthly dosing proven in extensive phase III programme
Filed in the U.S.A. (February 2006) and E.U. (April 2006)
Full response to Complete Review Letter Additional short-term clinical study
• Provide additional clinical efficacy to confirm the
induction of clinical response
Additional phase III study results expected in H2 2008
Rheumatoid arthritis
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The next generation biopharma leader May 29, 2007
Chronic inflammatory disease characterised by progressive joint destruction
• Debilitating systemic condition
Prevalence:
• Approximately 1% of the population
• Over 2.2 million in Europe
• Over 2.1 million patients in U.S.A. • Over 0.6 million patients in Japan
Market size: US$ 4.6 billion
Source: Decision Resources Reports: RA May 2006
Cimzia™ Rheumatoid arthritis
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The next generation biopharma leader May 29, 2007
Two positive large-scale phase III studies
• RAPID 1 (027) and RAPID 2 (050)
Primary and co-primary endpoints met with statistical significance
• Significant improvement in signs and symptoms • Significant reduction in joint damage after 1 year
(050/x-ray data) Results to be presented at key congresses
• EULAR (June 2007) and ACR (November 2007)
Regulatory submission expected by end 2007
Psoriasis
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The next generation biopharma leader May 29, 2007
Chronic dermatological inflammatory disease
• High morbidity
Prevalence:
• Estimated 2% of population • Over 4.5 million in Europe 4.1 million in the U.S.A.
Market size: US$ 0.6 billion
Source: Decision Resources Reports: Psoriasis September 2006
Cimzia™ Psoriasis
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The next generation biopharma leader May 29, 2007
Demonstrated efficacy in moderate to severe chronic plaque psoriasis in phase II study (040) Retreatment study (044) ongoing Preparation for next steps ongoing
Additional phase II results expected in Q3 2007
Parkinson’s disease
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The next generation biopharma leader May 29, 2007
Progressive neurological disease
• Characterized by loss of dopamine containing cells
• Leading to impaired movement control
Prevalence: 4 million patients world-wide Market size: US$ 2.9 billion
Neupro® Parkinson's disease
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The next generation biopharma leader May 29, 2007
First once a day non-ergolinic dopamine agonist
First transdermal patch for treatment of Parkinson’s disease
24-hour coverage for signs and symptoms of Parkinson’s disease
A new Parkinson's therapy is taking shape
Early stage Parkinson Advanced Parkinson
Launched in Europe Approved in U.S.A. Approved in Europe Planned sNDA filing 2H2007
Restless legs syndrome
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The next generation biopharma leader May 29, 2007
Neurological disorder
• Characterized by deficiency in the dopaminergic system
• Resulting in motor restlessness, poor quality of sleep,
excessive daytime sleepiness, traffic safety issues Prevalence: 10% of population Market size: US$ 350 million
Rotigotine Restless legs syndrome
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The next generation biopharma leader May 29, 2007
Transdermal system Outstanding efficacy in Restless Legs Syndrome, well tolerated and safe confirmed in two phase III trials Evidence of improved sleep and reduced daytime tiredness Excellent chance to become first line treatment for this large unmet medical need Potential to become first-line therapy
Restless Legs Syndrome (RLS): increased awareness of the unrecognized disease
Expected U.S. & E.U. regulatory filing by end 2007
Diabetic neuropathic pain
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The next generation biopharma leader May 29, 2007
Permanent damage of nerves caused by metabolic disorder
• Chronic pain, sensations of burning, electricity, extreme
cold, numbness and tingling Prevalence: 11 million patients worldwide Market size: US$ 3.5 billion
Lacosamide Diabetic neuropathic pain
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The next generation biopharma leader May 29, 2007
Promising drug for a growing market with large unmet medical need Strong and sustained efficacy in reducing diabetic neuropathy Good tolerability and safety profile No drug-drug or food interactions or weight gain Different mode of action
E.U. filing expected in Q3 2007
U.S. filing expected in Q4 2007
Agenda
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The next generation biopharma leader May 29, 2007
UCB today Acquisition of Schwarz Pharma
Research & Development
Outlook 2007
Focus for 2007
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The next generation biopharma leader May 29, 2007
Maximize Keppra® and prepare for expansion of epilepsy franchise Launch Cimzia™ in Crohn’s, Neupro® in Parkinson’s and Xyzal® in U.S.A. Realise synergies Reach major Research, Development and Regulatory milestones
• Cimzia™ • Xyzal® • Keppra® XR • brivaracetam • Neupro® • lacosamide
CD approval, Rheumatoid Arthritis filing Allergy, Approval in U.S.A. Epilepsy, complete phase III trials Epilepsy, start phase III trials Advanced Parkinson approval in U.S.A. Restless Legs Syndrome filing Filings in U.S.A. and Europe for Epilepsy and Diabetic Neuropathic Pain
UCB Next generation biopharma leader
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The next generation biopharma leader May 29, 2007
Significant long-term growth
Breakthrough
Unique science for unique medicines to meet unmet medical needs
Intense growth
Rich pipeline bears fruits
Execution
New product launches R&D investments Continuous cost improvement Change in product portfolio
2007-2009
2010
... and beyond
UCB Next generation biopharma leader
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The next generation biopharma leader May 29, 2007
Rich pipeline especially in neurology and inflammation World-leading R&D capability with unique science
Global commercial scale with a broader range of specialist products
Leading neurology company Leverages UCB’s proven sales and marketing network Complementary entrepreneurial talent base Significant synergy generation
Superior long term revenue and earnings growth
The next generation biopharma leader May 29, 2007
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