UCB presentation
Disclaimer and safe harbor
Forward-looking statements:
This presentation contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this presentation. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product
candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this presentation and expressly disclaims any duty to update any information contained in this presentation, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
Focus:
Central Nervous System & Immunology
R&D expenses 2013:
25% of € 3.4 billion revenue
Over 584 000 patients treated with UCB’s
core medicines, “CVN”
Operations in more than 40 countries
Approximately 8 700 employees globally
Inspired by
patients.
UCB’s growth prospects confirmed
Mature product portfolio
Emerging markets
Cimzia®, Vimpat®, Neupro®
S
u
p
e
ri
o
r
a
n
d
s
u
s
ta
in
a
b
le
v
a
lu
e
Schematic picture9 months key financial highlights
FY 2014 financial outlook confirmed
€ million 9M 2014 9M 2013 Actual Constant
Revenue
2 647
2 499
6% 8%Net sales CVN
1 044
847
23% 26%Cimzia
®561
423
32% 36%Vimpat
®335
294
14% 17%Neupro
®148
130
15% 15%Keppra
®504
532
-5% -3%FY 2014 outlook confirmed
Revenue
~
€ 3.5 – 3.6 billion
REBITDA
~
€ 740 - 770 million
Core EPS
€ 1.90 -2.05
UCB’s five strategic growth priorities (9M 2014)
Continuing our growth path
1 Constant exchange rate
2 Brazil, Russia, India, China, Mexico and Turkey 3 Partial-onset seizures
ן
1. Grow Cimzia
®, Vimpat
®and Neupro
®• “CVN” combined sales: € 1 044 million (+23%; +26% CER1)
• Vimpat® monotherapy approval in the U.S.
ן
2.Build emerging markets and Japan
• Emerging markets2 -3% (+5% CER); Japan -6% (+1% CER)
ן
3.Advance UCB’s rich late-stage pipeline
• Positive topline Phase 3 results for brivaracetam in epilepsy POS3 patients
ן
4.Deliver breakthrough medicines to the clinic
• Two molecules moving to Phase 2; one molecule entered Phase 1
ן
5.Reach competitive profitability
• Rheumatoid arthritis (RA)
• Psoriatic arthritis (PsA)
• Ankylosing spondylitis (AS)
• Crohn’s disease (CD)
• Rheumatoid arthritis (RA)
• Psoriatic arthritis (PsA)
• Axial spondyloarthritis (incl. AS)
• Rheumatoid arthritis (RA)
1 Brazil, Russia, India, China, Mexico and Turkey
Cimzia® available to patients in 54 countries, including Brazil, Russia, Mexico & Turkey
Numbers may not add due to rounding
€ million 9M 2014 9M 2013 Actual CER
North America
345
271
27% 31%Europe
168
120
40% 40%Japan
24
14
76% 94%Emerging markets
14
4
-9% -1%Rest of the World
19
14
32% 37%Total Cimzia
®561
423
32% 36%Cimzia
®
performance
Reaching more patients
3.0% 3.2% 3.4% 3.6% 3.8% 4.0%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
Cimzia
®
in-market performance (August 2014)
3.4% 5.3% 11.9% 0% 2% 4% 6% 8% 10% 12% 14%
Anti-TNF All Biologics Cimzia
U.S. - Cimzia® rheumatology growth
6.0% 7.0% 8.0% 9.0% 10.0% 11.0%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
EU - Cimzia® RA – R3M Patient Share
8.1% 15.6% 38.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Anti-TNF All Biologics Cimzia
EU - Cimzia® RA growth
• In-Market growth and share based on TRx
• Shares calculated based on Anti-TNF market
• In-market growth is calculated for MAT Aug ’14 vs. MAT Aug ’13 • Market share is calculated for R3M
Aug ’14
• In-Market growth and share based on Exit Patients • Shares calculated based on RA
Anti-TNF market
• In-market growth is calculated for Aug ’14 vs. Aug ’13 • Market share is calculated for
R3M Aug ’14
U.S.
EU
Rheumatology includes: Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSA), Axial Spondyloarthritis (AxSpA), and Ankylosing Spondylitis (AS) Source EU - IMS MIDAS + local UK HMSL data
Source US - US IMS NPA data
U.S. - Cimzia® Rheumatology – R3M TRx Share
Patient market share
9.9%
TRx market share 3.8%
€ million 9M 2014 9M 2013 Actual CER
North America
243
224
9% 12%Europe
81
64
27% 27%Emerging markets
14
2
68% 80%Rest of the World
7
4
59% 67%Total Vimpat
®335
294
14% 17%Vimpat
®
performance
Monotherapy in the U.S. launched in September
1 Brazil, Russia, India, China, Mexico and Turkey 2 Partial-onset seizures
3 Primary general tonic clonic seizures
Vimpat® available to patients in 43 countries, including Russia, India & Mexico
Epilepsy POS2
Epilepsy PGTCS3
Ped. adj. therapy 2017
Monotherapy (U.S.) Oct. 2013
Phase 2 Phase 3 Filing
Monotherapy (EU) Q4 2014 Adj. therapy (Asia)
H1 2015
Adj. therapy Start early 2015
Vimpat
®
in-market performance (August 2014)
• In-Market growth and share based on TRx
• In-market growth is calculated for MAT Aug ’14 vs. MAT Aug ’13 • Market share is calculated for
R3M Aug ’14
• In-Market growth and share based on TDx
• In-market growth is calculated for MAT Aug ’14 vs. MAT Aug ’13 • Market share is calculated for
R3M Aug ’14
U.S.
EU
Source EU - IMS MIDAS Source US - US IMS NPA data
4.4% 19.6% 0% 5% 10% 15% 20% 25% Market Vimpat
U.S. - Vimpat® growth
TRx market share 3.1% 2.6% 2.7% 2.8% 2.9% 3.0% 3.1% 3.2%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
U.S. - Vimpat® - R3M TRx Share
-1.3% 23.8% -5% 0% 5% 10% 15% 20% 25% 30% Market Vimpat EU - Vimpat® growth TDx market share 2.1% 1.5% 1.6% 1.7% 1.8% 1.9% 2.0% 2.1%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
Neupro
®
performance
€ million 9M 2014 9M 2013 Actual CER
North America
30
28
9% 12%Europe
102
94
8% 8%Japan
12
5
>100% >100%Emerging markets
11
1
8% 16%Rest of the World
3
2
87% 91%Total Neupro
®148
130
15% 15%On-going performance
1 Brazil, Russia, India, China, Mexico and Turkey
Neupro® available in 46 countries, including Russia & Mexico
Numbers may not add due to rounding
• Parkinson’s disease (PD)
Neupro
®
in-market performance (August 2014)
• In-market growth and share based on TRx
• Shares calculated based on PD Key Competitors markets • In-market growth is calculated for
Current R6M vs. Previous R6M • In-market share is calculated for
R3M Aug ’14
• In-market growth and share based on TDx
• Shares calculated based on PD Key Competitors markets • In-market growth is calculated for
MAT Aug ’14 vs. MAT Aug ’13 • Market share is calculated for
R3M Aug ’14
U.S.
EU
Parkinson’s Disease (PD) Source EU - IMS MIDAS Source US - US IMS NPA data
1.5% 1.5% 3.5% 0% 5% 10% 15% 20%
Market Competitors Neupro
U.S. - Neupro® PD growth
TRx market share 6.5% 2.6% 1.6% 12.2% 0% 5% 10% 15% 20%
Market Competitors Neupro
EU - Neupro® PD growth TDx market share 15.1% 5.0% 5.5% 6.0% 6.5% 7.0%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
U.S. - Neupro® PD – R3M TRx Share
13.0% 14.0% 15.0% 16.0%
Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14
UCB delivers growth
Core medicines tracking well towards peak sales targets
Expected peak sales at least € 1.5 billion
1Inflammatory arthritis indications and Crohn’s disease ■ Total net sales of € 561 million (+32%)
Expected peak sales at least € 1.2 billion
1Epilepsy partial onset seizures
■ Total net sales of € 335 million (+14%)
■ Monotherapy approved & launched in the U.S.
Expected peak sales at least € 400 million
1Parkinson’s disease and restless legs syndrome ■ Total net sales of € 148 million (+15%)
Combined expected CVN peak sales at least € 3.1 billion
1Keppra
®
performances
Status of exclusivity:
• Japan - exclusivity until 2018
• U.S. - expired November 2008 (Keppra® XR - September 2011) • Europe - expired September 2010
€ million 9M 2014 9M 2013 Actual CER
North America
151
165
-8% -5%Europe
204
237
-14% -14%Japan
53
42
25% 38%Emerging markets
168
57
20% 29%Rest of the World
28
31
-9% -8%Total Keppra
®504
532
-5% -3%Sizeable franchise
Sizeable franchise going forward!
1 Brazil, Russia, India, China, Mexico and TurkeyUCB: Building emerging markets and Japan
FX headwind and a specialty focus
*Brazil, Russia, India, China, Mexico, Turkey
Emerging markets*
• Net sales 9M 2014: -3% (+5% CER)
• Keppra®: € 68 million (+20%; +29% CER)
• Agreement with Biogen Idec to develop and commercialize multiple sclerosis and hemophilia therapies in Asia
UCB Japan
• Net sales 9M2014: -6 % (+1% CER)
• E Keppra®: € 53 million (+25 %; +38% CER)
brivaracetam
epilepsy POS1 / adj. therapy
epratuzumab
systemic lupus erythematosus
romosozumab
osteoporosis in postmenopausal women
romosozumab
osteoporosis in men UCB4940 (IL17)
psoriatic arthritis Phase 2 results: H2 2015
UCB5857 (PI3K Delta inhibitor)
immunological diseases Phase 2 start: early 2015 CDP7657 (CD40L antibody)
systemic lupus erythematosus
Phase 1 results: H2 2014
(Partner: Biogen Idec) UCB7665
immunological diseases
UCB's development pipeline
Phase 3 results: H1 2015 (Partner: Immunomedics)
Phase 3 results: H1 2016 (Partner: Amgen)
Phase 1 Phase 2 Phase 3 Filing
Pipeline filled with new molecular entities
1 Partial onset seizures
Submission: early 2015
Phase 3 results: H2 2016 (Partner: Amgen)
UCB’s promising early pipeline
Early pipeline holds breakthrough potential
Discovery:
•
Breakthrough innovation collaboration with Sanofi
• Discovery and development of innovative anti-inflammatory small molecules • Selected biologic agents to be replaced with small molecules
• Potentially treating a wide range of immune-mediated diseases
Two Phase 1 compounds (NBEs) with significant differentiation potential:
• CDP7657 (anti-CD40L) in systemic lupus erythematosus first results in H2 2014 • UCB7665, immunological diseasesUCB5857 (PI3K
Δ) successfully passed a Phase 1 study
• Phase 2 to start early 2015UCB4940 (IL17) for psoriatic arthritis moved into Phase 2
• First results in H2 2015NBE: new biological entity NCE: new chemical entity
2014 financial outlook confirmed
Full year 2014 expected dynamics
Financial outlook 2014*
Revenue
~
€ 3.5 - 3.6 billion
• Cimzia®, Vimpat®, Neupro® growthRecurring
EBITDA
~
€ 740 - 770 million
• Strong early and late-stage pipeline • Continued cost efficiencies
Core EPS
~
€ 1.90 - € 2.05
• ~192 million shares*considers application of IFRS10
EBITDA: Earning before interests, taxes, depreciation and amortization charges EPS: Earnings per share
UCB: reinventing itself, leveraging a solid heritage
to deliver sustainable and superior value for patients
1928 1980s 1990s 2004 2006 2008-2012 Today
Chemical Group Primary Care Pharma Specialty Bio-Pharma
Focus: CNS + immunology 1936 1928: Emmanuel Janssen establishes UCB in Brussels 1990s: approval of Keppra®, a novel anti-epileptic 2006: UCB acquires German pharma company Schwarz Pharma Launch of new medicines 2004: UCB acquires British biotech company Celltech 1980s: UCB registers
its novel antihistamine Zyrtec®
1936: UCB enters the United States
2005
2005: UCB divests non-pharma business
UCB HY 2014 financial highlights
EBITDA: Earning before interests, taxes, depreciation and amortization charges CER: Constant Exchange Rate
CER +10% -4% +40% +29% Actual
Good top-line performance driving growth
Revenue
• Continued sales growth of core medicines
• Adverse exchange rate impacts
€ 1 757 million
Total operating expenses
• Continuous improvement and constantly striving for improved resource allocation
• 9% lower marketing & selling expenses
• Stable research & development expenses
€ 920 million
Recurring EBITDA
€ 391 million
Net profit
• 30% tax rate
€ 113 million
Core earnings per share
(Based on 191 million weighted average shares outstanding)
€ 1.22
+6%
+66% +100% -2%
0 100 200 300 400 Cimzia® Vimpat® Neupro® Keppra® Zyrtec® Metadate™ CD Xyzal® Nootropil® omeprazole Other € million
HY 2014 net sales
€ 1 562 million (+7%; +11% CER)
Cor e m e d ici n e s M a tur e pr oduc tsHY 2013 net sales HY 2014 net sales
Total core products sales € 672 million (+25%; +29% CER)
Total mature products sales € 890 million (-4%; 0% CER)
Keppra® net sales include Keppra® XR and AG net sales
Zyrtec® net sales include Zyrtec-D® and Cirrus® net sales
Recurring EBITDA
Growth despite FX headwinds
€ million HY 2014 HY 2013 Variance
Actual (restated)1 Actual CER
Revenue 1 757 1 657 6% 10%
Net sales 1 562 1 466 7% 11%
Royalty income and fees 81 85 -5% -6%
Other revenue 114 106 8% 9%
Gross profit 1 195 1 139 5% 10%
Marketing and selling expenses -375 -413 9% 5%
R&D expenses -446 -444 0% -2%
G&A expenses -102 -107 5% 3%
Other operating income 2 3 -7% -8%
Total operating expenses -920 -961 4% 2%
Recurring EBIT 274 178 54% 74%
Amortization of intangible assets 84 94 -11% -11%
Depreciation charges 33 31 4% 5%
Recurring EBITDA 391 303 29% 40%
1 Restatement related to IFRS 10 EBIT: Earnings before interest and taxes
Net profit
€ million HY 2014 HY 2013 Variance
Actual (restated)1 Actual CER
Recurring EBIT 274 178 54% 74%
Impairment charges -26 -8 >-100% >-100%
Restructuring expenses -14 -11 -28% -30%
Gain on disposals 11 8 19% 14%
Other non-recurring income -18 -8 >-100% >-100%
Total non-recurring income / expenses (-) -47 -19 >-100% >-100%
EBIT 227 159 43% 64%
Net financial expenses -67 -72 7% 6%
Income tax expenses (-) / credit -48 -22 >-100% >-100%
Profit from continuing operations 112 65 71% >-100%
Net profit 113 68 66% 100%
Attributable to UCB shareholders 137 59 >100% >100% Attributable to non-controlling interests -24 9 >-100% >-100%
1 Restatement related to IFRS 10 EBIT: Earnings before interest and taxes
Core earnings per share
€ million HY 2014 HY 2013 Variance
Actual (restated)1 Actual CER Net profit attributable to UCB
shareholders 137 59 >100% >100%
+ After-tax non-recurring items and
financial one-offs 46 14 >100% >100%
- Profit / loss (-) from discontinued
operations -1 -3 58% 58%
+ After-tax amortization of intangibles 51 57 -11% -10%
Core net profit 233 127 84% >100%
Weighted average number of shares (mn) 191 182 5% N/A
Core EPS € 1.22 € 0.70 75% 92%
640 84 40 574 250 176 500 75 350 3001 150 100 Liquid assets 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 beyond
Belgian Commercial Paper Belgian retail bond Institutional eurobond Perpetual bond EIB loan
Debt maturity schedule
(@ 30 June 2014)
Convertible bond early redeemed in March
1 Perpetual bond with first call date in March 2016, recognized as equity on UCB’s balance sheet 658
800
225
350
HY 2014 net debt walk
-2,000 -1,729 281 (107) (91) (175) (24) 387 Net debt @ 01.01.2014 CF from OperationsTaxes paid Capex Dividends & Treasury share
issuance
Net interest FX, Convertible bond, and other
Net debt @ 30.06.2014 € million
Change in net debt: + 271 m
1 Includes: foreign exchange fluctuations, cash from discontinued operations, change in bank overdraft, available for sale debt security, non-cash portion of borrowings, and net proceeds / (loss from disposals)
North America 43% France 5% Germany 7% Italy 5% Spain 4% U.K. & Ireland 4% Europe others 11% Japan 7% Emerging markets 10% RoW + unallocated 4%
Europe
36%
HY 2014 net sales : € 1 562 million
Geographic and therapeutic breakdown
Cimzia® 353 23% Immunology -Allergy 141 9% Other 333 21% CNS - other 77 5% Keppra® 339 22% Neupro® 102 6% Vimpat® 217 14%
G&A 9% Marketing & Sales 52% R&D 13% Manufacturing 26%
Workforce distribution
Total headcount @ 30 June 2014: 8 851 employees
Employees by region Employees by function Belgium 22% France 1% Germany 8% Italy 1% UK & Ireland 8% Spain 1% Europe -Others 7% North America 20% Emerging market 26% Japan 4% Rest of the World 2%
Upcoming expected R&D milestones
2014
2017
epratuzumab SLE Phase 3 results Cimzia® Juvenile IA Phase 3 results romosozumab osteoporosis in post-menopausal women Phase 3 results Cimzia® C-Early™ results Cimzia® Exxelerate™ results Vimpat® epilepsy POS - adj. ther. (Asia) -Phase 3 results Vimpat® epilepsy
POS - mono – Phase 3 results
CNS Immunology
axSpA / AS: axial spondyloarthritis / ankylosing spondylitis IA: Idiopathic arthritis POS: Partial onset seizures SLE: Systemic lupus erythematosus PMO: Post-menopausal osteoporosis
Vimpat®
epilepsy POS - ped. adj. ther. - Phase 3 results Vimpat® PGTCS - adj. therapy - Phase 3 start CDP7657 SLE Phase 1 results UCB5857 immunology Phase 2 start brivaracetam epilepsy POS - adj. therapy submission romosozumab osteoporosis in men Phase 3 results UCB4940 psoriatic arthritis Phase 2 results
2016
2015
Vimpat® epilepsy POS - mono Cimzia® psoriasis Phase 3 startUCB's development pipeline
Life cycle management
Phase 2 Phase 3 Filing
AxSpA3 (U.S.) Feb. 2013 Juvenile IA H1 2016 Eloctate™ Multiple sclerosis daclizumab Hemophilia A Hemophilia B Alprolix™ Tecfidera® Tysabri® Plegridy™
For development in PR China
(In-licensed from Biogen Idec)
1 Partial onset seizures
2 Primary generalized tonic-clonic seizures 3 Axial Spondyloarthritis Exxelerate™ H2 2016 C-Early™ H1 2016 Epilepsy POS1 Epilepsy PGTCS2
Ped. adj. therapy 2017
Monotherapy (U.S.) Oct. 2013
Monotherapy (EU)
Q4 2014 Adj. therapy (Asia)
H1 2015
Adj. therapy Start early 2015
Psoriasis H1 2015
Lyophilized formulation accounts for approx.
20% of U.S. Cimzia® sales measured in IMS
dollarized sales
Cimzia
®
offers 2 unique solutions for the U.S. market
Consistent and continued growth of prefilled
syringe as measured in IMS dollarized sales
Lyophilized formulation and prefilled syringe
$35 $38 $47 $55 $70 H1 2012 H2 2012 H1 2013 H2 2013 H1 2014 Rapid acceleration over the last 6
months +10% +23% +17% +27% $163 $188 $206 $226 $283 H1 2012 H2 2012 H1 2013 H2 2013 H1 2014 +15% +10% +10% +25%
29 32 37 38
114 118
122 125
Jan-12 Jan-13 Jan-14 Jul-14
Access to Cimzia
®
in the U.S.
Lives in preferred or co-preferred position
C o v er ed liv e s in m illio n s
Total lives with Cimzia® (certolizumab pegol) in preferred or co-preferred position in the U.S.
Source: Preferred lives from UCB Internal Contracts Database, co-preferred from UCB internal analysis.
159 163
150 143
Phase 3 Filing Launch
Japan U.S.
Crohn’s disease (CD)
Ankylosing spondylitis (AS)
EU
Cimzia
®
path to at least € 1.5 billion peak sales
Juvenile IA (JIA)
Exxelerate™ H2 2016
C-Early™ H1 2016 Rheumatoid arthritis (RA)
Psoriatic arthritis (PsA)
Axial spondyloarthritis (AxSpA)
May 2009 Oct 2009 Mar 2013
Oct 2013 Apr 2008 Sep 2013 Nov 2013 Results H1 2016 Oct 2013 Oct 2013 Psoriasis (Ps) U.S. Feb 2013 Start H1 2015
Monotherapy
Adjunctive therapy
EU Japan
U.S.
Vimpat
®
path to at least € 1.2 billion peak sales
Asia
H1 2015
Phase 3 Filing Launch
May 2009 Sep 2008 EU Q4 2014 Pediatric 2017 Adjunctive therapy Epilepsy PGTCS² Epilepsy POS1
1 Partial onset seizures
2 Primary generalized tonic-clonic seizures
Phase 3
Start early 2015
Early stage
EU Japan
U.S.
Neupro
®
path to at least € 400 million peak sales
Phase 3 Filing Launch
May 2009 Feb 2006
Advanced stage
Parkinson’s disease (PD)
1 Partial onset seizures
2 Primary generalized tonic-clonic seizures
Restless legs syndrome (RLS) Jan 2007 Jun 2009 Jul 2012 Jul 2012 Feb 2013 Feb 2013 Feb 2013
Brivaracetam clinical development path
A potential new option for people living with epilepsy
Phase 1
30 studies
completed
Phase 2 & 3
7 studies
ongoing
10 studies
completed
(adults and children with focal and generalized epilepsy)
4 studies
completed in
other
indications
Exposure
•
> 3 000 people exposed
in completed Phase 2 / 3 studies
•
~ 6 000 patient years
of exposure
• Some patients for
> 8 years
Brivaracetam Phase 3 development program
New treatment option for patients with uncontrolled seizures
* Statistically significant
1 274 patients
(aged 16-70) Efficacy + safety 12 weeks N01252 N01253 Tolerability + safety 16 weeks N01254768 patients
(aged 16-80) Efficacy + safety 12 weeks N01358*
*
*
placebo, 20, 50, 100 mg/day Europe + India placebo, 5, 20, 50 mg/dayNorth / South America + Australia
flexible placebo, 100, 200 mg/day
(fixed dose, no titration)
U.S. + Europe + RoW (27 countries) Dosing Duration Primary endpoints Region
Positive Topline Results: Submission early 2015
Seizure reduction in treatment resistant patients
High unmet medical need in ~1/3 of treated epilepsy patients
• One of the largest Phase 3 programs seen in epilepsy
• 50% of particiants were resistant to 5+ AEDs
• Statistically significant and clinically relevant top-line results
• Seizure freedom observed
• Safety in line with previous studies*
• Presentation at upcoming epilepsy congresses
• Submissionto U.S. and EU authorities planned for early 2015
Key characteristics and headline results
AED: Anti-epileptic Drug
*The most commonly reported adverse events were somnolence, dizziness, fatigue and headache. Source: UCB data on file
25-30% 50% 20-25% Controlled on 1st monotherapy Uncontrolled despite 2-3 AEDs Controlled on more than 1 AED
Shareholder structure
(September 2014)
“Free float” investors by region
Stable shareholder base with free-float of 64%
Total number of shares: 194.5 millionWeighted average shares outstanding: 192 million
ן
Antje Witte, Vice President Investor Relations
• Phone: +32 2 559 9414 • E-mail: [email protected]
ן
Alexandra Deschner, Investor Relations Director
• Phone: +32 2 559 9683
• E-mail: [email protected]
ן
Isabelle Ghellynck, Investor Relations Manager
• Phone: +32 2 559 9588
• E-mail: [email protected]
ן
Nathalie Deldime, Investor Relations Events Manager
• Phone: +32 2 559 9291
• E-mail: [email protected]