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3 month 2016 interim update
Brussels, 25 April 2016
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Disclaimer and safe harbor 2
Forward-looking statements This presentation contains forward-looking statements, including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, and “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this presentation.
Important factors that could result in such differences include but are not limited to: 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. 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.
Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this presentation. UCB expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect any change in its expectations with regard thereto or any change in events, conditions, for circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
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Strengthening UCB's Patient Value Strategy
Shareholder value
• Patient Value Strategy – Shift from volume to patient value creation • Innovation Strategy – Differentiation • Networked Strategy – Competitive strengths + external connections • Growth Strategy – Top and bottom line growth delivering value
3
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UCB's Strategic Growth Path 4
True differentiation drives leadership and sustainability
2015
Strong Growth Cimzia®, Vimpat®, Neupro® + Keppra®
Growth expansion by Briviact® + romosozumab
Breakthrough phase - Growth expansion by next wave products
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UCB is progressing on its growth path 5
Achievements 2016 - March 2016
* New Molecular Entity
Patient value
Grow Cimzia®, Vimpat® and Neupro® Combined net sales: € 544 million; +26%
Advance and prepare launch of next wave Briviact® (brivaracetam) approved in EU and U.S. Romosozumab FRAME + BRIDGE: positive results
Deliver breakthrough solutions 9 NMEs* in Phase 2 and 1
Mid-term target: Competitive 30% rEBITDA margin in 2018
2016 financial outlook confirmed
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3 months key financial highlights 6
On track to deliver FY 2016 guidance
€ million 3M 2016 3M 2015 Variance
Actual Actual CER
Revenue 991 895 11% 9%
Immunology/Cimzia® 283 227 25% 24%
Neurology* 434 396 9% 9%
Vimpat® 188 146 29% 28%
Keppra® 170 190 -11% -10%
Neupro® 73 60 22% 22%
Numbers may not add due to rounding CER: constant exchange rate * include Briviact and multiple sclerosis therapies in Asia (partner: Biogen)
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Cimzia® performance 7
Continuously broadening patient access
Numbers may not add due to rounding 2 nr axSpA: non-radiographic axial spondyloarthritis 1 CER: constant exchange rates 3 idiopathic arthritis
• Crohn’s disease • rheumatoid arthritis • psoriatic arthritis • axial spondyloarthritis /
ankylosing spondylitis
1 083 million 2015 net sales
• Astellas (Japan - 2012) • Dermira (psoriasis - 2014)
Phase 3 • juvenile idiopathic arthritis • psoriasis • nr axial spondyloarthritis
(U.S.)
1.5 billion expected peak sales
Cimzia® € million 3M 2016 3M 2015 Actual CER1
U.S. 175 146 20% 18% Europe 81 66 21% 23% Japan 10 0 > 100% > 100% International markets 17 14 21% 33% Total Cimzia® 283 227 25% 24%
Net sales
R&D milestones
Cimzia® juvenile IA³
Phase 3 results
Cimzia® C-EARLY™ (104 weeks)
results
2018 2016 > 2017 >
Cimzia® psoriasis
Phase 3 results
Cimzia® EXXELERATE™ Phase 4 results
Cimzia® nr axSpA² (U.S.) Phase 3 results
Cimzia® women in child
bearing age Phase 4 results
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Vimpat® performance 8
Continued strong growth in all markets
Numbers may not add due to rounding 1 Partial-onset seizures CER: constant exchange rate 2 Primary Generalized Tonic-Clonic Seizures
Epilepsy POS1
679 million 2015 net sales
Daiichi Sankyo (Japan - 2014)
Phase 3 • Epilepsy POS1 – mono (EU) • Epilepsy POS1 pediatric • Epilepsy PGTCS²
1.2 billion expected peak sales
Vimpat® € million 3M 2016 3M 2015 Actual CER
U.S. 145 109 33% 31% Europe 35 31 16% 16% International markets 8 7 22% 33% Total Vimpat® 188 146 29% 28%
Net sales
R&D milestones
2016
Vimpat® epilepsy POS1 – ped. adj. therapy Phase 3 results
> 2017
Vimpat® epilepsy POS1 -
monotherapy filing EU
2018 >
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Keppra® performance 9
Continued growth & benefited in the U.S. from short supply in the market
Numbers may not add due to rounding 1 Partial-onset seizures CER: constant exchange rate 2 Primary Generalized Tonic-Clonic Seizures 3 Keppra® XR expired in Sep. 2011
737 million 2015 net sales
1.2 billion peak sales (2008)
Keppra® Net sales
R&D milestones
E Keppra® epilepsy PGTCS2
adj. therapy - approval (Japan)
• epilepsy POS1 • epilepsy PGTCS² • epilepsy myoclonic
seizures
Otsuka (Japan - 2008)
Status of exclusivity: • Japan - until 2018 • U.S.³ - Nov. 2008 • Europe - Sep. 2010
€ million 3M 2016 3M 2015 Actual CER
U.S. 51 63 -18% -20% Europe 60 64 -7% -6% Japan 25 25 0% -6% International markets 33 38 -13% -6% Total Keppra® 170 190 -11% -10%
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Numbers may not add due to rounding CER: constant exchange rate
Neupro® performance 10
Reaching more and more patients
• Parkinson’s disease • restless legs syndrome
258 million 2015 net sales
Otsuka (Japan - 2002)
400 million expected peak sales
Neupro® € million 3M 2016 3M 2015 Actual CER
U.S. 20 16 23% 20% Europe 38 36 7% 7% Japan 12 6 > 100% > 100% International markets 3 2 46% 60% Total Neupro® 73 60 22% 22%
Net sales
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FRAME co-primary endpoints: reducing the incidence of new vertebral fractures through 12 and 24 months BRIDGE primary endpoint: increasing bone mineral density (BMD) at the lumbar spine at 12 months
Romosozumab in bone loss disorders
11
Potential important treatment option for osteoporosis
Manorama, living with osteoporosis
BRIDGE: Phase 3 placebo-controlled study in men with osteoporosis (March 2016)
FRAME: Phase 3 placebo-controlled study in postmenopausal women with osteoporosis (Feb. 2016)
Overall balanced safety profile
ARCH: Phase 3 active-controlled study in ostmenopausal women with osteoporosis (expected H1 2017)
STRUCTURE: Phase 3 active-controlled study in postmenopausal women with osteoporosis (Sept. 2015)
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Osteoporosis: a silent disease 12
Globally, osteoporosis causes ~8.9m fractures per year1
1. International Osteoporosis Foundation. Osteoporosis Facts and Statistics. 2. National Osteoporosis Foundation. The Man’s Guide to Osteoporosis. 2011. 3. American Academy of Orthopaedic Surgeons. Position Statement: Osteoporosis/Bone Health in Adults as a National Public Health Priority. 4. International Osteoporosis Foundation. What Is Osteoporosis? 2015. 5. Vertebral Fracture Initiative - Overview of osteoporosis: Epidemiology and clinical management
a fracture every 3 seconds1
vertebral fracture is the most common osteoporotic fracture5
Postmenopausal osteoporosis (PMO) is the most common form of the disease.3
Men are most likely to break bones from osteoporosis later in life, making it more difficult to recover.2
PMO is a silent disease that cannot be seen or felt, and often goes undetected until a fracture occurs.4
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bimekizumab / UCB4940 (IL17AF) various indications Phase 2b start: H2 2016
bimekizumab add-on to Cimzia® rheumatoid arthritis Phase 2a results: H1 2017
dapirolizumab pegol (CD40L antibody) systemic lupus erythematosus
Phase 2b start: Q3 2016 (Partner: Biogen)
UCB0942 (PPSI) highly drug resistant epilepsy Phase 2a results: Q1 2017
seletalisib (PI3K Delta inhibitor) Sjögren’s syndrome Phase 2a results: H1 2017
UCB7665 immune thrombocytopenia (ITP) Phase 2a results: H2 2017
UCB1332 / NPT200-11 Parkinson’s disease (Partner: Neuropore)
UCB4144 / VR942 asthma (Partner: Vectura)
UCB6673 immunological diseases (Partner: King’s College London)
UCB3491 epilepsy
Early pipeline - Deliver breakthrough solutions 13
9 NMEs* in early clinical development
* New Molecular Entity
neurology
immunology
Filing Confirm phase
Phase 3 Learn phase – POC1
Phase 1 Phase 2
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Cimzia® C-Early™
results 104 weeks
romosozumab osteoporosis in
post-menopausal women (FRAME) Phase 3 results
UCB7665 ITP6
Phase 2a start
dapirolizumab pegol SLE²
Phase 2 start
2016 2017 2018 > >
Upcoming R&D milestones
1 IA: Idiopathic Arthritis 4 nr axSpA: non-radiographic axial spondyloarthritis 2 SLE: Systemic Lupus Erythematosus 5 PGTCS: Primary Generalized Tonic-Clonic Seizures 3 POS: Partial-Onset Seizures 6 idiopathic thrombocytopenia
14
Cimzia® psoriasis
Phase 3 results
romosozumab osteoporosis in men
(BRIDGE) Phase 3 results
Cimzia® EXXELERATE™ Phase 4 results
neurology
immunology
bone
UCB0942 highly drug resistant
epilepsy Phase 2 results
romosozumab osteoporosis in post-menopausal women
(ARCH) Phase 3 results
Vimpat® epilepsy POS³ – ped. adj. therapy Phase 3
results
bimekizumab various indications
Phase 2b start
seletalisib (UCB5857)
immunotherapy Phase 2 start
Cimzia® nr axSpA4 (U.S.) Phase 3 results
UCB7665 ITP6
Phase 2a results
bimekizumab add on to Cimzia® rheumatoid arthritis Phase 2a results
2019
Vimpat® epilepsy PGTCS5 – adjunctive therapy
Phase 3 results
Vimpat® epilepsy POS³ –
monotherapy (EU) - filing
Cimzia® women in child
bearing age Phase 4 results
UCB3491 epilepsy
Phase 1 start
Cimzia® juvenile IA1
Phase 3 results
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2016 and mid-term financial outlook 15
Continued, sustainable growth
* By the end of this decade
2016 guidance Revenue rEBITDA Core EPS
~ € 4.0 – 4.1 billion
~ € 970 – 1 010 million ~ € 2.90 - 3.20
Continued growth: Cimzia®, Vimpat®, Neupro®
• Expected R&D expense ratio of ~28% (+/-1%point)
• Expected underlying tax ratio in the "high twenties"
~188 million shares
Mid-term guidance
• Recurring EBITDA of 30% in 2018 • Net debt / rEBITDA ratio of 1:1 by 2018 • Cimzia®, Vimpat®, Neupro® combined peak sales of at least € 3.1 billion*
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UCB's Strategic Growth Path 16
True differentiation drives leadership and sustainability
2015
Strong Growth Cimzia®, Vimpat®, Neupro® + Keppra®
Growth expansion by Briviact® + romosozumab
Breakthrough phase - Growth expansion by next wave products
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Patient value
UCB’s value proposition: The patient preferred biopharma 17
Ready to take advantage of a changing environment
Shareholder value
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Appendix
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Growth drivers Core medicines tracking well towards peak sales target of € 3.1 billion*
19
* By the end of this decade
EXPECTED AT LEAST
Inflammatory arthritis indications and Crohn’s disease
€ 1.5 billion peak sales
Psoriasis: strategic collaboration with
Dermira
EXPECTED AT LEAST
Epilepsy partial-onset seizures
€ 1.2 billion peak sales
Monotherapy in the U.S.
Partner in Japan: Daiichi Sankyo
EXPECTED AT LEAST
Parkinson’s disease and Restless Legs
Syndrome
€ 400 million peak sales
Partner in Japan: Otsuka
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29 32 37 38 49 49 52
114 118 122 125
125 127 124
Jan 2012 Jan 2013 Jan 2014 Jul 2014 Jan 2015 Jul 2015 Jan 2016
Cov
ered
Liv
es in
Mill
ions
preferred co-preferred
Patient access to Cimzia® in the U.S. 20
Stable Live Coverage
Total lives with Cimzia® (certolizumab pegol) in preferred or co-preferred position in the U.S.
159 163 150
143
174 176 176
Source: Preferred lives from UCB Internal Contracts Database, Co-preferred from UCB internal analysis
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$35 $40 $53 $53
$81 $96
$112 $129
H1 2012 H2 2012 H1 2013 H2 2013 H1 2014 H2 2014 H1 2015 H2 2015
+12%
+33% +1%
+51%
+19%
+17%
+15%
$166 $193 $210
$247
$313 $350
$376 $395
H1 2012 H2 2012 H1 2013 H2 2013 H1 2014 H2 2014 H1 2015 H2 2015
+16% +9%
+17%
+27%
+12%
+7% +5%
Lyophilized formulation accounts for approx. 25% of U.S. Cimzia® sales measured
in IMS dollarized sales
Cimzia® offers two unique solutions for the U.S. market
Consistent and continued growth of prefilled syringe as measured
in IMS dollarized sales
IMS data is NSP
21
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Cimzia® differentiation: Exxelerate
Consistent with the ACR/EULAR recommendations for the reporting of RA disease activity in clinical studies.
Exxelerate is:
• The 1st head-to-head superiority study within the anti-TNF class in RA
• The 1st study to investigate the efficacy and safety of an ‘immediate switch’ from one TNF to the next i.e. without wash-out period
• A study providing clinical evidence for the treat-to-target principle: adjust treatment if there is no improvement after 3 months
• > 900 patients randomized
22
Study Design Highlights
Objective – Assess the short- and long-term efficacy of CZP compared with ADA in subjects who have moderate to severe RA and who are not responding adequately to MTX
Primary endpoints • Wk 12: Superiority of CZP vs ADA in ACR20 • Wk 104: Superiority of CZPvs ADA in Low Disease Activity
ADA – adalimumab, CZP – certolizumab pegol, MTX – methotrexate, H2H – head-to-head study
Study description
% with ACR20 response at Week 12
Primary Endpoints
NCT01500278
% LDA with DAS28(ESR) ≤ 3.2 at Week 104
0 12 24 102 104
Week 12 responders CZP + MTX
Week 12 non- responders ADA + MTX
ADA + MTX
Week 12 responders ADA + MTX
Week 12 non-responders CZP + MTX
CZP + MTX CZP to CZP
CZP to ADA
ADA to ADA
ADA to CZP
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4.4%
3.5%
4.0%
4.5%
5.0%
5.5%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Cimzia® Rheumatology1 R3M TRx Share
8.4% 10.7%
26.2%
0%
5%
10%
15%
20%
25%
30%
Anti TNF Biologics Cimzia®
Cimzia® vs. RA Market Growth
13.3% 13.7%
25.5%
0%
5%
10%
15%
20%
25%
30%
Anti TNF Biologics Cimzia®
Cimzia® vs. Rheumatology1 Market Growth
3.8% 4.8%
14.8%
0%
5%
10%
15%
20%
25%
30%
Anti TNF Biologics Cimzia
Cimzia® vs. Rheumatology1 Market Growth
Cimzia® in-market performance (February 2016) 23
Strong growth in rheumatology indications
1 Rheumatology includes RA, AS/AxSPA and PSA indications Shares calculated based on Anti-TNF market . In-market growth is calculated for MAT Feb’16 vs. MAT Feb’15 Market share is calculated for Feb’16 and market share growth is shown against R3M Feb’15
U.S.
+10.9%
+0.2%
Europe Japan
Source: U.S. IMS NPA In-Market KPI’s are based on TRx
+12.1%
7.9%
6.5%
7.0%
7.5%
8.0%
8.5%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Cimzia® Rheumatology 1 R3M Patient Share
+1.0%
Source: IMS MIDAS In-Market KPI’s are based on Exit Patients
+17.8%
3.6%
2.5%
3.0%
3.5%
4.0%
4.5%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Cimzia® RA R3M Patient Share
+0.6%
Source: IMS MIDAS; Cimzia® patients are considered 100% in RA In-Market KPI’s are based on Exit Patients
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3.7%
3.0%
3.2%
3.4%
3.6%
3.8%
4.0%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Vimpat® – R3M TRx Share
2.6%
2.0%
2.2%
2.4%
2.6%
2.8%
3.0%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Vimpat® – R3M TDx Share
4.0%
18.1%
0%
5%
10%
15%
20%
25%
AED Market Vimpat®
Vimpat® vs. AED Market Growth (TRx)
-0.7%
20.3%
-5%
0%
5%
10%
15%
20%
25%
AED Market Vimpat®
Vimpat® vs. AED Market Growth (TDx)
Vimpat® in-market performance (February 2016) 24
A leading therapeutic option in the AED market
AED = anti epileptic drug - AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In EU and Japan, the TDx of all these molecules are factored for epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage. AED Market and Vimpat® growth are calculated for MAT Feb'16 vs. MAT Feb'15. Vimpat® market share is calculated for R3M Feb'16 and market share growth is shown against R3M Feb'15
U.S.
+14.2%
+0.4%
Europe Japan
Source data U.S.: U.S. IMS NPA In-Market KPIs are based on TRx
+21.0%
+0.4%
Source data EU: IMS MIDAS In-Market KPI’s are based on TDx
Vimpat® filed with the Japanese authorities
(June 2015)
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-0.7%
2.5%
-10.0%
-8.0%
-6.0%
-4.0%
-2.0%
0.0%
2.0%
4.0%
6.0%
AED Market Keppra®
Keppra® vs. AED Market Growth (TDx)
4.0%
-9.2% -10.0%
-8.0%
-6.0%
-4.0%
-2.0%
0.0%
2.0%
4.0%
6.0%
AED Market Keppra®
Keppra® vs. AED Market Growth (TRx)
1.0%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Keppra® – R3M TRx Share 10.3%
7.5%
8.0%
8.5%
9.0%
9.5%
10.0%
10.5%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Keppra® – R3M TDx Share
12.1%
10.0%
10.5%
11.0%
11.5%
12.0%
12.5%
13.0%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Keppra® – R3M TDx Share
-2.3%
34.3%
-5%
0%
5%
10%
15%
20%
25%
30%
35%
40%
AED Market Keppra®
Keppra® vs. AED Market Growth (TDx)
Keppra® in-market performance (February 2016) 25
Growth in a genericized market
AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In EU and Japan, the TDx of all these molecules are factored for epilepsy usage. In the US, the TRx of 26 of these molecules are factored for epilepsy usage. For US, Keppra includes Keppra XR. For EU, Keppra does not include UCB Levetiracetam. AED Market and Keppra TRx growth are calculated for MAT Feb'16 vs. MAT Feb'15. Keppra TRx market share is calculated for R3M Feb'16 and market share growth is shown against R3M Feb'15
U.S.
-13.1%
-0.1%
Europe Japan
Source data U.S.: U.S. IMS NPA In-market KPI’s are based on TRx
+3.3%
+0.8%
Source data EU, JP: IMS MIDAS In-market KPI’s are based on TDx
+36.6%
Source data EU, JP: IMS MIDAS In-market KPI’s are based on TDx
+2.9%
-
23.5%
16%
18%
20%
22%
24%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Neupro® PD – R3M TDx Share
0.7% 0.9%
9.9%
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
PD Market PD KeyCompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TDx)
17.2%
15.0%
15.5%
16.0%
16.5%
17.0%
17.5%
18.0%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Neupro® PD – R3M TDx Share
6.9%
6.0%
6.5%
7.0%
7.5%
8.0%
8.5%
Feb-15 May-15 Aug-15 Nov-15 Feb-16
Neupro® PD – R3M TRx Share
0.4% 1.5%
38.8%
0%5%
10%15%20%25%30%35%40%45%50%
PD Market PD KeyCompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TDx)
-1.8% -1.8%
5.2%
-2.0%
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
PD Market PD KeyCompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TRx)
Neupro® in-market performance (February 2016) 26
Growth in a genericized market
PD market: All molecules in ATC3= N4A. In the EU and Japan, the TDx of all these molecules are factored for PD usage. In the US, only the TRx of Rotigotine, Pramipexole and Ropinirole are factored for PD usage. PD Key Competitors (KC) market: The 8 DA’s (Dopamine Antagonists): Bromocriptine, Cabergoline, Lisuride, Pergolide, Rotigotine, Pramipexole, Piribedil, Ropinirole. In the US, only Rotigotine, Pramipexole and Ropinirole are factored for PD usage, hence the PD market and PD KC market are the same.
U.S.
+7.1%
+0.3%
Europe Japan
Source data U.S.: U.S. IMS NPA In-market KPI’s are based on TRx
+9.0%
+1.3%
Source data EU, JP: IMS MIDAS In-market KPI’s are based on TDx
+37.4%
+5.4%
Source data EU, JP: IMS MIDAS In-market KPI’s are based on TDx
-
Numbers may not add due to rounding 1 CER: constant exchange rate
Strong Neurology Portfolio Performance 27
The right product for the right patient
€ million FY 2015 FY 2014 Actual CER
Vimpat® 679 471 44% 26% Neupro® 258 200 29% 22% Keppra® 737 665 11% 2% Total Neurology 1 675 1 337 25% 13%
Net sales
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Establishing a new foundational therapy for focal epilepsies with an ideal profile
Meeting the need for immediate control and clarity of response
Heritage to accelerate the value shift from old to new
Expanding our portfolio, creating sustainable patient value 28
Helping individuals live at their ideal is the core of our strategy
1 – “Hope” and “Trust” UCB Sponsored ethnographic research, among the largest and most robust ever conducted in epilepsy
-
Introducing BRIVIACT® in epilepsy POS1 29
New epilepsy treatment for patients experiencing uncontrolled partial-onset seizures
1 POS: partial-onset seizures 2 The most commonly reported adverse events were somnolence, dizziness, fatigue and headache. Source: UCB data on file 3 American Epilepsy Society 4 The Drug Enforcement Administration is anticipated to classify BRIVIACT® according to its drug schedule within the next 90 days, at which time BRIVIACT® will become commercially available in the U.S.
One of the largest Phase 3 programs in epilepsy involving over 1 550 patients
Statistically significant AND clinically relevant top-line results²
Now approved in EU (Jan 2016) and U.S. (Feb 2016)4
Guoqiong, living with epilepsy
Guided by patient insights: “Life in Between” – Patients spend their life waiting for:
Seizure Control The need to know
Our newest solution…
BRIVIACT® Meeting the need for
immediate control and clarity of response
-
Registrational studies in osteoporosis
• 7 180 patients (post-menopausal women)
• 12 months romosozumab followed by denosumab
• Placebo
• Incidence of new vertebral fracture
• 436 patients (post-menopausal women)
• 12 months romosozumab
• Teriparatide
• BMD DXA % change at the hip
STRUCTURE (NCT01796301)
September 2015
Romosozumab development Phase 3 program in bone loss disorders
30
Duration
Comparator
Primary Endpoint
Topline results
FRAME (NCT01575834)
• 4 094 patients (post-menopausal women)
• 12 months romosozumab followed by alendronate
• Alendronate
• Incidence of clinical fracture + incidence of new vertebral fractures at month 24
ARCH (NCT01631214)
• 245 patients (men)
• 12 months romosozumab
• Placebo
• BMD DXA % change at the lumbar spine
BRIDGE (NCT02186171)
2017 March2016 February 2016
-
UCB FY 2015 financial highlights 31
Strong net sales growth – under-proportional growth of operating expenses
EBITDA: Earning before interests, taxes, depreciation and amortization charges CER: constant exchange rate
CER
+9%
+12%
+18% +35%
Actual
Revenue • Strong net sales growth of 20% (+12% CER) • Tailwind from currency exchange rates
€ 3 876 million
Total operating expenses • Operating expense ratio improved
€ 2 142 million
Recurring EBITDA
€ 821 million
Profit of the Group • Divestiture of Kremers Urban • € 623 million attributable to UCB shareholders
€ 674 million
Core earnings per share (in 2015 based on 192 million weighted average shares outstanding; 2014: 191m)
€ 2.17
+16%
>100%
+5%
+28% +9%
>100%
-
Top and bottom line growth – improved ratios* 32
* versus revenue
2013 2014 2015 2018e
30%
21%
18%
17% 57.2%
55.3%
2014 2015
Total operating expense ratio
68.5%
70.1% Gross margin
rEBITDA ratio – accelerating towards
mid-term target
-
Topline and bottom line growth
33
Strong growth, higher gross margin, under-proportional growth of operating expenses - supported by tailwind from FX
€ million FY 2015 FY 2014 Variance
Actual Actual CER
Revenue 3 876 3 344 16% 9%
Net sales 3 512 2 938 20% 12% Royalty income and fees 176 163 9% 0% Other revenue 188 243 -23% -27%
Gross profit 2 719 2 291 19% 9%
Marketing and selling expenses -904 -779 16% 9% R&D expenses -1 037 -928 12% 6% G&A expenses -192 -201 -4% -8% Other operating expense / income -9 -4 > 100% 29%
Total operating expenses -2 142 -1 911 12% 5%
Recurring EBIT 577 379 52% 28%
Amortization of intangible assets 170 168 1% -5% Depreciation charges 74 62 22% 14%
Recurring EBITDA 821 609 35% 18%
CER: constant exchange rate EBIT: Earnings before interest and taxes EBITDA: Earning before interests, taxes, depreciation and amortization charges
-
Profit of the Group 34
KU divestiture enhances financial and strategic flexibility € million
FY 2015 FY 2014 Variance
Actual Actual CER
Recurring EBIT 577 379 52% 28% Impairment charges -88 -30 > 100% > 100% Restructuring expenses -27 -63 -57% -58% Gain on disposals 139 20 > 100% > 100% Other non-recurring income / expenses (-) -79 -34 > 100% > 100%
Total non-recurring income / expenses (-) -55 -107 -49% -40% EBIT 522 273 92% 55%
Net financial expenses -96 -162 -41% -43% Income tax expenses -111 -6 > 100% > 100%
Profit from continuing operations 315 105 > 100% > 100%
Profit from discontinued operations 359 94 > 100% > 100%
Profit of the Group 674 199 > 100% > 100%
Attributable to UCB shareholders 623 209 > 100% > 100%
Attributable to non-controlling interests 51 -10 n.s. n.s.
EBIT: Earnings before interest and taxes
-
1 287
104 250
176
500
75
350 350
300
168
118
933
18 18
243 368 368 350
176
Liquidassets
2016 2017 2018 2019 2020 2021 2022 2023 beyond
Belgian Commercial Paper Belgian retail bond Institutional eurobond
Perpetual bond Other loans EIB loan
Debt maturity schedule (@ 31 December 2015)
Perpetual bond with first call date in March 2016, recognized as equity on UCB’s balance sheet
35
(€ million)
KU divestiture enhances financial and strategic flexibility
-
Core earnings per share plus 28% (+9%) 36
€ million FY 2015 FY 2014 Variance
Actual CER
Profit attributable to UCB shareholders 623 209 > 100% > 100%
+ After-tax non-recurring items and financial one-offs
53 109 -48% -57%
- Profit (-) / loss from discontinued operations
-359 -94 > 100%
> 100%
+ After tax amortization of intangibles 100 99 1% -6% Core Profit to UCB shareholders 417 322 29% 10% Weighted average number of shares (mn) 192 191 1% n.s. Core EPS 2.17 1.69 28% 9%
1 Restated for Kremers Urban divestiture decision CER: constant exchange rate
-
Improved product mix in 2015 37
Cimzia®, Vimpat®, Neupro® + Keppra® = 77% of net sales
CER = constant currency exchange rates * After hedging
Cimzia® +36% (+21% CER) • Continuously broadening patient access
Vimpat® +44% (+26% CER) • Monotherapy available in the U.S.
(Sep 2014)
Neupro® +29% (+22% CER) • Reaching more and more patients
Keppra® +11% (+2% CER) • Post-exclusivity erosion in Europe -
strong growth in other markets
FY 2015 net sales* € 3 512 million (+20%; CER: +12%)
-
1 694 million 47 of net sales 1 179 employees
U.S.
€ %
1 203 million 34 of net sales 4 244 employees
Europe
€ %
207 million 6 of net sales 326 employees
Japan
€ %
490 million 14 of net sales 2 039 employees
Int’l markets
€ %
UCB global footprint 38
Situation @ 31 December 2015
Belgium: 1 866 employees
-
Workforce distribution 39
Total headcount @ 31 December 2015: 7 788 employees
-
Shareholder structure 40
“Free float” investors by region
Stable shareholder base with free-float of 61% Total number of shares: 194.5 million Weighted average shares outstanding in 2015: 192 million; 2016e: 188 million
Source: Notifications and UCB underlying ownership analysis
-
ן Antje Witte, Vice President Investor Relations • Phone: +32 2 559 9414 • E-mail: [email protected]
ן Isabelle Ghellynck, Director Investor Relations • 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]
Your UCB Investor Relations team 41
mailto:[email protected]:[email protected]:[email protected]
3 month 2016 �interim updateDisclaimer and safe harborStrengthening UCB's Patient Value Strategy�UCB's Strategic Growth PathUCB is progressing on its growth path3 months key financial highlightsCimzia® performanceVimpat® performanceKeppra® performanceNeupro® performanceRomosozumab in bone loss disorders �Osteoporosis: a silent diseaseEarly pipeline - Deliver breakthrough solutionsUpcoming R&D milestones2016 and mid-term financial outlookUCB's Strategic Growth PathUCB’s value proposition: The patient preferred biopharmaAppendix�Growth driversPatient access to Cimzia® in the U.S.Cimzia® offers two unique solutions for the U.S. marketCimzia® differentiation: Exxelerate�Cimzia® in-market performance (February 2016)Vimpat® in-market performance (February 2016)Keppra® in-market performance (February 2016)Neupro® in-market performance (February 2016)Strong Neurology Portfolio PerformanceExpanding our portfolio, creating sustainable patient valueIntroducing BRIVIACT® in epilepsy POS1Romosozumab developmentUCB FY 2015 financial highlightsTop and bottom line growth – improved ratios*Topline and bottom line growth�Profit of the GroupDebt maturity schedule (@ 31 December 2015)Core earnings per share plus 28% (+9%)Improved product mix in 2015UCB global footprintWorkforce distributionShareholder structureYour UCB Investor Relations team