UCB presentation

UCB presentation
Investor Relations
April 24, 2014
2
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 press release. 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. 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.
3
Inspired by patients.
Driven by science.
Focus: Central Nervous System &
Immunology
R&D expenses 2013: 25% of revenue
Over 584 000 patients treated with UCB’s
core medicines, “CVN”
Operations in more than 40 countries
Approximately 8 700 employees globally
4
Cimzia®, Vimpat®, Neupro®
Emerging markets
Mature product portfolio
Schematic picture
Superior and sustainable value
UCB’s growth prospects confirmed
5
UCB’s five strategic growth priorities
Status: first 3 months 2014
‫ ן‬1. Grow Cimzia , Vimpat
®
®
and Neupro®
• “CVN” combined sales: € 318 million (+29%, +33% at constant rates)
‫ ן‬2. Build emerging markets and Japan
• BRICMT1 -1% (+11% at constant rates); Japan -9% (+75% excl. allergy and currency effects)
• Agreement with Biogen Idec for multiple sclerosis and hemophilia therapies in Asia
‫ ן‬3. Advance UCB’s rich late-stage pipeline
• Top 2 in late-stage pipeline productivity²
• Returned global rights of tozadenant to Biotie
‫ ן‬4. Deliver breakthrough medicines to the clinic
• Breakthrough innovation collaboration with Sanofi to replace selected biologic agents with small
molecules to potentially treat a wide range of immune-mediated diseases
• Growing “super-network” fostering borderless innovation
‫ ן‬5. Reach competitive profitability
• Financial targets 2014 confirmed, on track for long-term targets
1 Brazil, Russia, India, China, Mexico and Turkey
2 Phase 3 NME/R&D expenses, U.S. and EU biopharma companies
3 Partial-onset seizures
6
Cimzia ® performance
Reaching more patients
€ million
Actual
Constant
3M 2014
3M 2013
102
76
33%
39%
Europe
49
36
36%
37%
Japan
3
4
-19%
-7%
Emerging markets1
1
1
24%
35%
Rest of the World
5
5
8%
17%
160
122
31%
36%
North America
Total Cimzia®
U.S.
EU
•
Crohn’s disease (CD)
•
Rheumatoid arthritis (RA)
•
Rheumatoid arthritis (RA)
•
Axial spondyloarthritis (incl. AS) - Oct. 2013
•
Psoriatic arthritis (PsA) - Sep. 2013
•
Psoriatic arthritis (PsA) - Nov. 2013
•
Ankylosing spondylitis (AS) - Oct. 2013
Japan launched March 2013 (partner: Astellas)
1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey
Cimzia® available to patients in 47 countries, including Japan, Brazil, Russia, Mexico & Turkey
Numbers may not add due to rounding
7
Cimzia® RA in-market performance (Feb. 2014)
U.S. - Cimzia® RA – R3M TRx Share
U.S. - Cimzia® RA growth
3.6%
8%
7%
3.5%
6%
market share
3.5%
5%
U.S.
4%
3%
1%
•
In-market growth is calculated
for MAT Feb’14 vs. MAT Feb’13
•
Market share is calculated for
R3M Feb’14
•
In-Market growth and share
based on Exit Patients
•
Shares calculated based on RA
Anti-TNF market
•
In-market growth is calculated
for Feb’14 vs. Feb’13
•
Market share is calculated for
R3M Feb’14
3.4%
All Biologics
Cimzia
3.3%
Feb'13
Apr'13
Jun'13
Aug'13
Oct'13
Dec'13
Feb'14
EU - Cimzia® RA – R3M Patient Share
EU - Cimzia® RA growth
9.0%
35%
30%
8.5%
market share
8.8%
25%
20%
8.0%
35.1%
15%
10%
5%
Shares calculated based on RA
Anti-TNF market
3.4%
3.1%
Anti-TNF
EU
•
1.3%
0%
40%
In-Market growth and share
based on TRx
3.5%
7.3%
2%
•
7.5%
14.8%
11.2%
7.0%
0%
Anti-TNF
All Biologics
RA: Rheumatoid arthritis
Source EU - IMS MIDAS + local UK HMSL data
Source US - US IMS NPA data
Cimzia
Feb'13
Apr'13
Jun'13
Aug'13
Oct'13
Dec'13 Feb'14
8
Vimpat® performance
New indication to come
€ million
Constant
3M 2013
North America
78
66
17%
22%
Europe
25
20
22%
22%
Emerging markets1
1
1
49%
64%
Rest of the World
1
1
65%
84%
105
88
19%
23%
Total Vimpat®
Epilepsy POS²
•
Actual
3M 2014
Adjunctive therapy: When monotherapy is no longer enough
Monotherapy: under review by U.S. FDA (filed Oct. 2013)
1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey
2 Partial onset seizures
Vimpat® available to patients in 38 countries, including Russia, India & Mexico
9
Vimpat® in-market performance (Feb. 2014)
U.S. - Vimpat® growth
25%
2.9%
20%
U.S.
U.S. - Vimpat® - R3M TRx Share
3.0%
market share
2.9%
15%
In-Market growth and share
based on TRx
•
In-market growth is calculated for
MAT Feb’14 vs. MAT Feb’13
•
Market share is calculated for
R3M Feb’14
2.8%
23.5%
10%
•
2.7%
2.6%
5%
3.8%
2.5%
0%
Market
Feb'13
Vimpat
Jun'13
Aug'13
Oct'13
Dec'13
Feb'14
EU – Vimpat® - R3M TDx Share
EU - Vimpat® growth
30%
Apr'13
2.0%
25%
20%
EU
1.8%
market share
1.8%
15%
26.6%
1.6%
10%
5%
0.8%
1.4%
0%
Market
Source EU - IMS MIDAS
Source US - US IMS NPA data
Vimpat
Feb'13
Apr'13
Jun'13
Aug'13
Oct'13
Dec'13
Feb'14
•
In-Market growth and share
based on TDx
•
In-market growth is calculated
for MAT Feb’14 vs. MAT Feb’13
•
Market share is calculated for
R3M Feb’14
10
Neupro® performance
Strong, on-going performance
€ million
Actual
Constant
6
> 100%
> 100%
32
29
11%
11%
Japan
5
1
> 100%
> 100%
Emerging markets1
0
0
-2%
9%
Rest of the World
1
0
49%
64%
52
36
43%
45%
3M 2014
3M 2013
North America
14
Europe
Total Neupro®
Parkinson’s disease (PD)
•
Impact across the motor and underlying symptoms of Parkinson’s disease
Restless legs syndrome (RLS)
•
Powerful and lasting symptom relief for restless legs syndrome
Latest launches:
•
U.S. (July 2012); Japan (February 2013 by Otsuka)
1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey
Neupro® available in 41 countries, including Japan, Russia & Mexico
Numbers may not add due to rounding
11
Neupro® in-market performance (Feb. 2014)
8%
U.S. - Neupro® PD growth
7%
6.2%
6%
6.0%
market share
6.2%
5%
U.S.
U.S. - Neupro® PD – R3M TRx Share
6.4%
7.0%
0.7%
0.7%
Market
Competitors
Neupro
20%
Feb'13
Apr'13
Jun'13
Aug'13
Oct'13
Dec'13
In-market growth is calculated for
Current R6M vs. Previous R6M
•
In-market share is calculated for
R3M Feb’14
Feb'14
EU5 – Neupro® PD- R3M TDx Share
15.0%
18%
16%
14.5%
14%
market share
14.6%
12%
10%
14.0%
•
In-market growth and share
based on TDx
•
Shares calculated based on PD
Key Competitors markets
•
In-market growth is calculated
for MAT Feb’14 vs. MAT Feb’13
•
Market share is calculated for
R3M Feb’14
17.2%
8%
6%
2%
•
5.0%
EU - Neupro® PD growth
4%
Shares calculated based on PD
Key Competitors markets
5.2%
1%
EU
•
5.6%
5.4%
2%
0%
In-market growth and share
based on TRx
5.8%
4%
3%
•
13.5%
4.1%
3.5%
Market
Competitors
13.0%
0%
Source EU - IMS MIDAS
Source US - US IMS NPA data
Neupro
Feb'13
Apr'13
Jun'13
Aug'13
Oct'13
Dec'13
Feb'14
12
UCB's development pipeline
Life cycle management
Phase 2
Phase 3
Epilepsy POS1
Filing
Monotherapy (EU)
Monotherapy (U.S.)
Q4 2014
Oct. 2013
Adj. therapy (Asia)
Ped. adj. Therapy
H1 2015
2017
Epilepsy PGTCS2
Adj. Therapy
AxSpA (U.S.)
Juvenile RA
H1 2016
Exxelerate
H1 2016
C-early
H2 2016
Plegridy™
Tysabri®
Multiple sclerosis
Tecfidera®
For development in PR China
daclizumab
(In-licensed from Biogen Idec)
Hemophilia A
Eloctate™
Hemophilia B
Alprolix™
1
2
Partial onset seizures
Primary generalized tonic-clonic seizures
Feb. 2013
13
UCB delivers growth
Status: first 3 months 2014
Expected peak sales at least € 1.5 billion1
Inflammatory arthritis indications and Crohn’s disease
■
Total net sales of € 160 million (+31%)
Expected peak sales at least € 1.2 billion1
Epilepsy partial onset seizures (adjunctive therapy)
■
Total net sales of € 105 million (+19%)
Expected peak sales at least € 400 million1
Parkinson’s disease and restless legs syndrome
■
Total net sales of € 52 million (+43%)
Combined expected CVN peak sales at least € 3.1 billion1
1 Second half of the decade
14
Keppra® performances
On-going erosion in Europe
€ million
Actual
Constant
3M 2014
3M 2013
North America
46
47
-2%
2%
Europe
72
82
-12%
-12%
Japan
21
14
53%
77%
Emerging markets1
19
18
2%
12%
9
11
-10%
-2%
167
171
-2%
2%
Rest of the World
Total Keppra®
Loss of exclusivity
•
U.S. - November 2008 (Keppra® XR - September 2011)
•
Europe - September 2010
Japan: market exclusivity until 2018
Sizeable franchise going forward!
1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey
Numbers may not add due to rounding
15
UCB: Building emerging markets and Japan
Emerging markets
•
Agreement with Biogen Idec to commercialize multiple sclerosis and hemophilia therapies in Asia
•
Emerging markets* net sales: € 68 million (-1%)
•
+11% at constant rates
UCB Japan
•
Net sales of € 59 million (-9%; +2% at constant rates)
•
+75% at constant rates (excl. allergy)
•
E Keppra® net sales: € 21 million (+53%)
•
Neupro® net sales: € 5 million (vs. € 1 million in Q1 2013)
*Brazil, Russia, India, China, Mexico, Turkey
1 Excludes allergy and FX effects
16
UCB's development pipeline
New molecular entities
Phase 1
brivaracetam
epilepsy POS1 / adj. therapy
epratuzumab
systemic lupus erythematosus
romosozumab (sclerostin antibody)
Phase 2
Phase 3 results H2 2014
Phase 3 results Q1 2015
(Partner: Immunomedics)
Phase 3 results H1 2016
osteoporosis in postmenopausal women
CDP7657 (CD40L antibody)
systemic lupus erythematosus
UCB5857
immunological diseases
UCB4940
immunological diseases
1 Partial onset seizures
Phase 3
(Partner: Amgen)
Results H2 2014
(Partner: Biogen Idec)
Results Q2 2014
Filing
17
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
• to replace selected biologic agents with small molecules
• to potentially treat a wide range of immune-mediated diseases
Three Phase 1 compounds with significant differentiation potential:
•
2 NBEs:
• CDP7657 (anti-CD40L) in systemic lupus erythematosus
first results in H2 2014
• UCB4940, immunological diseases
•
1 NCE:
• UCB5857, immunological diseases
NBE: new biological entity
NCE: new chemical entity
first results in Q2 2014
18
3 months key financial highlights
On track to deliver FY 2014 guidance
€ million
Actual
Constant
3M 2014
3M 2013
Revenue
840
799
5%
9%
Net sales CVN
318
247
29%
33%
Cimzia®
160
122
31%
36%
Vimpat®
105
88
19%
23%
Neupro®
52
36
43%
45%
167
171
-2%
2%
Keppra®
FY 2014 outlook confirmed
Revenue
~ € 3.5 – 3.6 billion
REBITDA
~ € 740 - 770 million
Core EPS
~ € 1.90 – € 2.05
based on ~ 192 million shares
Appendix
20
UCB FY 2013 financial highlights
Growth of core medicines – a strong foundation
actual
rates
Revenue
€ 3.4 billion
•
Continued sales growth of the core medicines: Cimzia®, Vimpat® and Neupro®
•
Keppra® generic erosion in Europe
•
Adverse exchange rate impacts
Total operating expenses
•
Lower marketing & selling expenses
•
Stable R&D expenses
constant
rates
€ 1 856 million
-1%
+2%
-4%
-1%
Recurring EBITDA
€ 689 million
+1%
+9%
Net profit
€ 200 million
-18%
-3%
Recommended gross dividend
€ 1.04 per share
+2%
Core earnings per share (EPS)
€ 1.93 *
•
29% tax rate
EBITDA: Earning before interests, taxes, depreciation and amortization charges
* Based on 182 million weighted average shares outstanding
21
Cimzia ® performance 2013
Reaching more patients
€ million
Actual
Constant
FY 2013
FY 2012
North America
379
321
18%
22%
Europe
168
133
26%
28%
Japan
20
-
>100%
>100%
6
1
>100%
>100%
22
12
83%
92%
594
467
27%
32%
Emerging markets1
Rest of the World
Total Cimzia®
U.S.
EU
•
Crohn’s disease (CD)
•
Rheumatoid arthritis (RA)
•
Rheumatoid arthritis (RA)
•
Axial spondyloarthritis (incl. AS) - Oct. 2013
•
Psoriatic arthritis (PsA) - Sep. 2013
•
Psoriatic arthritis (PsA) - Nov. 2013
•
Ankylosing spondylitis (AS) - Oct. 2013
1 Brazil, Russia, India, China, Mexico and Turkey
Cimzia® available to patients in 47 countries, including Japan, Brazil, Russia, Mexico & Turkey
Numbers may not add due to rounding
22
Vimpat® performance 2013
New indication to come
€ million
Constant
FY 2012
314
251
25%
29%
87
76
15%
16%
Emerging markets1
4
2
55%
58%
Rest of the World
6
5
25%
33%
411
334
23%
27%
North America
Europe
Total Vimpat®
Epilepsy POS²
•
Actual
FY 2013
Adjunctive therapy: When monotherapy is no longer enough
Monotherapy: Filing in the U.S. (Oct. 2013)
1 Brazil, Russia, India, China, Mexico and Turkey
2 Partial onset seizures
Vimpat® available to patients in 38 countries, including Russia, India & Mexico
23
Neupro® performance 2013
Strong, on-going performance
€ million
Actual
Constant
15
>100%
>100%
129
114
13%
14%
Japan
9
1
>100%
>100%
Emerging markets1
2
1
64%
66%
Rest of the World
3
2
50%
53%
182
133
37%
39%
FY 2013
FY 2012
40
North America
Europe
Total Neupro®
Parkinson’s disease (PD)
•
Impact across the motor and underlying symptoms of Parkinson’s disease
Restless legs syndrome (RLS)
•
Powerful and lasting symptom relief for restless legs syndrome
Latest launches:
•
U.S. (July 2012); Japan (February 2013 by Otsuka)
1 Brazil, Russia, India, China, Mexico and Turkey
Neupro® available in 41 countries, including Japan, Russia & Mexico
Numbers may not add due to rounding
24
Keppra® performances 2013
Net sales -15%
€ million
Actual
Constant
FY 2013
FY 2012
North America
223
236
-5%
-2%
Europe
315
451
-30%
-30%
Japan
62
47
32%
67%
Emerging markets1
71
64
12%
16%
Rest of the World
40
41
-2%
2%
712
838
-15%
-12%
Total Keppra®
Loss of exclusivity
•
U.S. - November 2008 (Keppra® XR - September 2011)
•
Europe - September 2010
Japan: launch of E Keppra® pediatric + dry syrup
Sizeable franchise going forward!
1 Brazil, Russia, India, China, Mexico and Turkey
Numbers may not add due to rounding
25
Recurring EBITDA 2013
Lower marketing and selling, stable R&D expenses
€ million
Revenue
Actual
2013
Variance FX
2012*
Actual
Constant
3 411
3 462
-1%
2%
3 049
3 070
-1%
3%
Royalty income and fees
172
168
2%
5%
Other revenue
190
224
-15%
-12%
2 297
2 378
-3%
2%
Marketing and selling expenses
-802
-875
8%
4%
R&D expenses
-856
-861
1%
-2%
G&A expenses
-205
-198
-3%
-5%
7
0
n.m.
n.m.
-1 856
-1 962
4%
1%
441
444
-1%
12%
184
176
4%
6%
64
64
0%
1%
689
684
1%
9%
Net sales
Gross profit
Other operating income
Total operating expenses
Recurring EBIT
Amortization of intangible assets
Depreciation charges
Recurring EBITDA
* Restated
EBIT: Earnings before interest and taxes
EBITDA: Earning before interests, taxes, depreciation and amortization charges
26
Net profit 2013
€ million
Actual
2013
Variance FX
2012*
Actual
Constant
441
444
-1%
12%
Impairment charges
-29
-10
>-100%
>-100%
Restructuring expenses
-32
-40
18%
17%
23
31
-28%
-28%
0
-7
n.m.
n.m.
Total non-recurring income / expenses (-)
-38
-26
-50%
-53%
EBIT
403
418
-3%
9%
-121
-155
22%
22%
-87
-35
>-100%
>-100%
Profit from continuing operations
195
228
-14%
2%
Net profit (including non-controlling
interests)
200
245
-18%
-3%
Recurring EBIT
Gain on disposals
Other non-recurring income
Net financial expenses
Income tax expenses (-) / credit
* Restated
EBIT: Earnings before interest and taxes
27
Core earnings per share (EPS) 2013
€ million
Actual
2013
Variance FX
2012*
Actual
Constant
207
2491
-17%
-4%
+ After-tax non-recurring items and
financial one-offs
37
33
9%
17%
- Profit / loss (-) from discontinued
operations
-5
-17
74%
74%
112
112
0%
1%
351
377
-7%
3%
Weighted average number of shares (basic)
182.2
179.3
2%
n.m.
Core EPS
€ 1.93
2.10
-8%
1%
Net profit attributable to UCB
shareholders
+ After-tax amortization of intangibles
Core net profit
* Restated
1 Adjusted for the Meizler business combination
28
IFRS 10 impact on 2013
IFRS 10 – effective 1 January 2014
•
Concept of control whether an entity should be included within consolidated financial statements
•
UCB will consolidate two additional entities which manage clinical trials
Expected impact (un-audited)
•
Higher R&D expenses
•
Lower net profit for the Group; higher net profit allocation to non-controlling interests
€ million
Revenue
2013
2013
(as reported)
(pro-forma, un-audited)
3 411
3 411
25%
26%
Recurring EBITDA
689
653
Net Profit
200
143
207
160
-7
-17
Weighted number of shares outstanding
182
182
Core EPS
1.93
1.67
R&D expenses as % of revenue
Net Profit to equity holders of UCB S.A.
Net Profit to non-controlling interest
EBITDA: Earning before interests, taxes, depreciation and amortization charges
EPS: Earnings per share
29
Geographic and therapeutic breakdown
2013 net sales: € 3 049 million
Europe
36%
30
Cimzia® in RA
To provide information for evidence-based
decisions in bio/DMARD naive patients
EXXELERATE™
 H2H: relative efficacy of certolizumab
pegol and adalimumab
 12 weeks & 104 weeks
 Approx. 900 adult patients
 First results H1 2016
C-EARLY™
 To achieve remission or low disease
activity as soon as possible and
optimize CZP treatment in early RA
remitters
 52 weeks & 104 weeks
 Approx. 800 adult patients with early
stage of the disease
(<1 year)
 First results H2 2016
31
Cimzia® in Psoriatic Arthritis (PsA)
Approved and launched in 2013
*statistical significant
Q2W
Q4W
Cimzia® in patients with adult onset active PsA demonstrated a clinically relevant and statistically
significant improvement at week 12 in the signs and symptoms of PsA.
32
Epilepsy – most common serious neurological disorder
Strong need for new treatment options
High unmet medical need in ~1/3 of treated
epilepsy patients
Epilepsy types and treatment algorithm
Monotherapy
25-30%
50%
Partial
Onset
Seizures
(POS)
29%
Add-on therapy
27%
20-25%
Controlled on 1st monotherapy
Uncontrolled despite 2-3 AEDs
Controlled on more than 1 AED
Primary
Generalised
Seizures
(PGTCS)
25%
19%
33
Romosozumab in bone loss disorders
Potential for a change of treatment paradigms
Collaborative project with Amgen
•
Phase 3 program in osteoporosis in postmenopausal
women initiated
•
First results expected first half 2016
Study of naturally occurring human
disorder leads to a potential new drug
therapy
Strong phase 2 results in osteoporosis in
postmenopausal women
•
Positive treatment effect observed, statistically significant
•
Favorable comparison with active comparators,
teriparatide and alendronate
Normal
Sclerosteosis
34
Epratuzumab in SLE – EMBODY™
Phase 3 program – First results Q1 2015
Placebo
Emab 600 mg weekly
EMBODY 1™
Emab 1200 mg every other week
Placebo
EMBODY 2™
Emab 600 mg weekly
Emab 1200 mg every other week
Emab IV dosing
Week
0
12
24
36
48
35
Epratuzumab
Maintained improvements in disease activity for 2+ years
and corticosteroid dose reductions shown*
Combined Treatment Response
10
57.2%
56.5%
Median CS dose mg/day
(prednisone equivalent)
10
7.5
60.3%
7.5
7.5
6.7
48.1%
5
40.7%
32.5%
SL0008
Screening
(N=203)
Week 24
(N=177)
Week 48
(N=154)
Week 72
(N=138)
Week 96
(N=124)
Week 108
(N=116)
Combined Treatment Response indicates patients
sustained improvements across all body systems that
had moderate or severe disease activity at baseline of
the previous study
Week 24
(N=177)
Week 48
(N=157)
Week 72
(N=138)
Week 96
(N=125)
Week 116
(N=112)
•
Median corticosteroid dose showed general
decrease over time from 10 mg/day at baseline of
EMBLEM™ study, to 5 mg/day at Week 116
•
Number of subjects with no corticosteroid use and
in lowest corticosteroid dose category (>0 to 7.5
mg/day) exceeded 50% from Week 24
•
No new safety signals were identified
36
Epratuzumab: humanized monoclonal antibody
(Human IgG1) against CD22
IgM
IgM
IgG
IgD
Memory B
pro-B
pre-B
immature B
mature B
B Blast
GC B cell
Plasma cell
CD22 Expression
Fab
(CD22 Binding)
epratuzumab:
Modulator of B-cell function
37
Epratuzumab in SLE
Phase 2b results – presented at World Lupus
Congress & ACR 2011
SL0007: Primary Efficacy Variable: Combined Index Response Rate
at Week 12, ITT Population
P=0.0239
50
P=0.0265
45,9
43,2
40,5
Percent responders
40
30,8
30
26,3
23,7
21,1
20
10
0
Placebo,
N=38
Emab 200 mg
Emab 800 mg Emab 2400 mg Emab 2400 mg
(100 mg EOW), (400 mg EOW), (600 QW), N=37 (1200 EOW),
N=39
N=38
N=37
Emab 2400 mg
Combined,
N=74
Emab 3600 mg
(1800 EOW),
N=38
37
38
More growth to come from new indications
First
results
this year
Phase 1
Phase 2
Phase 3
UCB4940
NBE, immuno
Vimpat®
epilepsy PGTCS
romosozumab
CDP7657
NBE, Lupus
tozadenant
PD
Filing
Vimpat®
Epilepsy mono
U.S.
FDA
Osteoporosis in
postmenopausal women
decision
expected
H2 2014
Cimzia®
Juvenile RA
(returned rights Mar ‘14)
Cimzia®
AxSpa in U.S.
epratuzumab
SLE
UCB5857
NCE, immuno
Vimpat®
epilepsy ped.
Vimpat®
epilepsy (Asia)
Vimpat®
Epilepsy mono EU
brivaracetam
Adj. epilepsy POS
NBE: new biological entity
NCE: new chemical entity
PGTCS: primary generalized tonic-clonic seizures
SLE: systemic lupus erythematosus
POS: partial onset seizures
AxSpA: axial spondyloarthritis
Phase 3 results
expected in H2 2014
AS: ankylosing spondylitis
PD: Parkinson’s disease
39
UCB: reinventing itself, leveraging a solid heritage
to deliver sustainable and superior value for patients
Today
1928:
Emmanuel Janssen
establishes UCB
in Brussels
1936:
UCB enters the
United States
1928
1936
Chemical Group
1990s: approval of
Keppra®,
a novel antiepileptic
2004:
UCB acquires
British biotech
Celltech
1980s:
UCB registers its
novel antihistamine
Zyrtec®
1980s
1990s
Primary Care Pharma
2006:
UCB acquires
German pharma
Schwarz Pharma
2005: UCB divests
non-pharma
business
2004
2005
Launch of new
medicines
2006
2008-2012
Specialty Bio-Pharma
Focus: CNS + immunology
Today
40
Shareholder structure (March 2014)
Stable shareholder base, free float of 63%
“Free float” investors by region
Source: Shareholder identification analysis (November 2011), 2012 and 2013 notifications and UCB underlying ownership analysis
41
Your UCB Investor Relations team
‫ן‬
‫ן‬
‫ן‬
‫ן‬
Antje Witte, Vice President Investor Relations
• Phone: +32 2 559 9414
• E-mail: [email protected]
Alexandra Deschner, Investor Relations Director
• Phone: +32 2 559 9683
• E-mail: [email protected]
Isabelle Ghellynck, Investor Relations Project Manager
• Phone: +32 2 559 9588
• E-mail: [email protected]
Nathalie Deldime, Investor Relations Events Manager
• Phone: +32 2 559 9291
• E-mail: [email protected]

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