41
3 month 2016 interim update Brussels, 25 April 2016

3 month 2016 interim update - UCB...11 . Potential important treatment option for osteoporosis . Manorama, living with osteoporosis. BRIDGE: Phase 3 placebo-controlled study in men

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

  • 3 month 2016 interim update

    Brussels, 25 April 2016

  • 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.

  • 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

  • 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

  • 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

  • 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)

  • 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

  • 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 >

  • 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%

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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*

  • 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

  • Patient value

    UCB’s value proposition: The patient preferred biopharma 17

    Ready to take advantage of a changing environment

    Shareholder value

  • Appendix

  • 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

  • 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

  • $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

  • 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

  • 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

  • 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)

  • -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

  • 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