Ucb S.a. · EURONEXT:UCB
Ucb — FY2009 Earnings Presentation
68 slides from Ucb's earnings presentation, Mar 2, 2010
Slide 1: Progressing to become a patient-centric global biopharma leader
Progressing to become a patient-centric global biopharma leader 2009 Financial Results London, March 2, 2010 Lakeisha, living with epilepsy
Slide 2: Disclaimer and safe harbour
Disclaimer and safe harbour 2 2 March 2010 Forward-looking statements: This presentation includes “forward-looking statements” relating to UCB group of companies (“UCB”) that are subject to known and unknown risks and uncertainties, many of which are outside of UCB’s control and are difficult to pre
Slide 3: UCB vision
UCB vision fw OL0Z are Z We aspire to be the Patient-Centric global biophar- maceutical leader transforming the lives of people with severe c S|
Slide 4: Agenda
Agenda 4 Solid foundation for sustainable growth 2 March 2010 • Roch Doliveux, CEO Core products performance • Mark McDade, COO Financial performance • Detlef Thielgen, CFO Development • Iris Loew-Friedrich, CMO Conclusion • Roch Doliveux, CEO
Slide 5: 2009 – a turning point
2009 – a turning point Delivery and execution 5 2 March 2010 UCB is strengthening its position as a Patient-Centric global biopharmaceutical leader • Major regulatory milestones achieved • 3+1 product launches • Organisation transformed through SHAPE initiative • Debt re-financed • UCB enters growth
Slide 6: Ismail Kola
Ismail Kola Executive VP, UCB. President UCB NewMedicines™ 6 Highly accomplished scientist 2 March 2010 • Track record of success in academia and the biopharma field • Former CSO of Schering Plough Corporation • Strong research and development background • Led groups that brought drugs successfully
Slide 7: Cimzia, Vimpat, Neupro performance
7 2 March 2010 Cimzia®, Vimpat®, Neupro® performance Mark McDade, Chief Operating Officer
Slide 8: 2009 – a turning point: Delivering new medicines
2009 – a turning point Delivering 4 new medicines for patients with severe diseases 8 Rheumatoid arthritis 2 March 2010 Launched in the U.S. (May 2009) Launched in Europe (October 2009) Epilepsy adjunctive therapy Launched in the U.S. (June 2009) Restless legs syndrome Launched in Europe (June 2009)
Slide 9: Epilepsy—a major CNS disease
Epilepsy—a major CNS disease 9 Prevalence (2008) ≈ 6.1 million patients in 7 major markets1 2 March 2010 Market size (2007) ≈ $ 3.8 billion in 7 major markets2 3 ≈3 .9% GR CA US EU Japan 2007 2017 Source: 1Decision Resource & 2Datamonitor, Commercial insight 3Compound Annual Growth Rate
Slide 10: Keppra franchise
Keppra® franchise Extending market leadership in Europe 10 € million FY 2009 Actual CER 2 March 2010 net sales North America 320 -58% -60% Europe 545 25% 28% Rest of World 48 -21% -17% Total 913 -28% -28% Keppra® loss of exclusivity in the U.S. November 2008 Sustained growth outside the U.S., genera
Slide 11: Vimpat in epilepsy
Vimpat® in epilepsy An important new treatment option in refractory epilepsy 11 € million FY 2009 FY 2008 2 March 2010 net sales net sales U.S. 30 0 Europe 16 2 Total 46 2 A new treatment option in add-on for Partial Onset Seizures (POS) Efficacy when added to a broad range of 1st and 2nd generation
Slide 12: Vimpat in epilepsy: U.S. launch
Vimpat® in epilepsy Successful launch in the AED market in the U.S. 12 2 March 2010 20,000 15,000 # of TRx and NRx 10,000 5,000 0 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 NRx TRx Source: IMS National Prescription Audit (NPA)
Slide 13: Vimpat in epilepsy: growing rapidly in Europe
Vimpat® in epilepsy Growing rapidly in Europe 13 Vimpat® Treatment Days Shares among New AED*, 2 March 2010 Monthly evolution since Vimpat launch, up to Dec 09 2,4% 2,2% 2,0% 1,8% 1,6% 1,4% Germany (M1=Sept 08) 1,2% UK (M1=Sept 08) France (M1= Oct 09) 1,0% Spain (M1 = Oct 09) 0,8% 0,6% 0,4% 0,2% 0,0
Slide 14: UCB in epilepsy
UCB in epilepsy Trusted leadership aided by new launches 14 When asked which company has best reputation in epilepsy/seizure disorders (unaided) - All Neurologists (U.S.) 2 March 2010 50% UCB 45% GlaxoSmithKline Abbott Laboratories 40% Pfizer 39% Ortho McNeil 36% (49%, 33%) 35% Novartis Don't know 3
Slide 15: Parkinson’s disease (PD)
Parkinson’s disease (PD) 15 Prevalence (2008) ≈ 3.1 million patients in 7 major markets1 2 March 2010 Market size (2008) ≈ $ 2.1 billion in 7 major markets2 3 ≈2 .6% GR CA US EU Japan 2008 2018 Source: 1Decision Resource & 2Datamonitor, Commercial insight 3Compound Annual Growth Rate
Slide 16: Restless legs syndrome (RLS)
Restless legs syndrome (RLS) 16 Prevalence (2008) ≈ 54 million patients in 7 major markets1 2 March 2010 Market size (2007) ≈ $ 588 million in 7 major markets2 3 ≈ 7% GR CA US EU 2007 2017 Source: 1Decision Resource & 2Datamonitor 3Compound Annual Growth Rate
Slide 17: Neupro
Neupro® Rotigotine transdermal patch 17 2 March 2010 Neupro®, the Parkinson's patch - 24h continuous delivery • Continuous delivery to provide stable drug levels • Improving daily functioning, sleep and early morning functions Neupro®, the new treatment option for RLS • Short- and long-term efficacy
Slide 18: Neupro - rotigotine transdermal patch
Neupro® - rotigotine transdermal patch Continued launch roll-out in Europe 18 € million FY 2009 FY 2008 2 March 2010 net sales net sales U.S. 0 5 Europe 61 53 Total 61 58 Neupro® “New Patient” launch in Europe (June 2009) • Newly-launched for PD in Germany, Italy, Spain, U.K. and 15 other markets1 •
Slide 19: Neupro - EU4 monthly launch curves by country
Neupro® - EU4 (excluding France) Monthly launch curves by country 19 2 March 2010 Neupro® Treatment Days Shares among Dopamine Agonists*, Monthly evolution since Neupro launch, up to Dec 09 18% 16% 14% Italy: 12% Best launch 10% 8% 6% 4% 2% 0% M1 M4 M7 M10 M13 M16 M19 M22 M25 M28 M31 M34 M37 M40 M43
Slide 20: Crohn’s disease (CD)
Crohn’s disease (CD) 20 Prevalence (2008) ≈ 1.0 million patients in 7 major markets1 2 March 2010 Market size (2007) ≈ $ 1.5 billion in 7 major markets1 3 ≈3 .5% GR CA US EU Japan 2007 2017 Source: 1Decision Resource Pharmacor, Crohn’s Disease, Dec 2009 2Compound Annual Growth Rate
Slide 21: Rheumatoid arthritis (RA) – Anti-TNF market
Rheumatoid arthritis (RA) – Anti-TNF market 21 Prevalence (2008) ≈ 5 million patients in 7 major markets1 2 March 2010 Market size (2008) ≈ $ 6.6 billion in 7 major markets 3 ≈ 1.6 % R CAG US EU Japan 2008 2018 Source: 1Decision Resource 2Compound Annual Growth Rate
Slide 22: Cimzia – the only PEGylated anti-TNF
Cimzia® – the only PEGylated anti-TNF Unique structure, unique product benefits Unlike the other anti-TNF treatments, Cimzia® is a pegylated FAB with no FC region 2 March 2010 Fusion Protein Chimeric Human Humanised (Human recombinant monoclonal monoclonal Fab′ fragment receptor/Fc) antibody antibod
Slide 23: Cimzia: unique syringe
Cimzia® Unique syringe designed with RA patients for RA patients 23 2 March 2010 Easy to grip elleptical barrel – easy to read syringe barrel Easy to push Easy to grip Easy to remove syringe plunger wide flare needle cover
Slide 24: Cimzia roll-out in U.S.
Cimzia® roll-out in U.S. Steady build of a chronic therapy 24 € million FY 2009 FY 2008 2 March 2010 net sales net sales U.S. 70 8 Europe 5 2 Total 75 10 More than 9 200 patients on Cimzia® at end of December 2009 Crohn’s disease in the U.S. • Unique long term remission data1 with no dose escalation
Slide 25: Cimzia for Crohn's disease
Cimzia® for Crohn's disease U.S. growth demonstrates arrival of important new option 25 2 March 2010 IMS changed their projection methodology 4,500 4,000 3,500 # of TRx and NRx 3,000 2,500 2,000 1,500 1,000 500 0 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec
Slide 26: Cimzia in rheumatoid arthritis
Cimzia® in rheumatoid arthritis Roll-out in U.S.: gaining use even in an entrenched marketplace 26 2 March 2010 2,500 2,000 # of TRx and NRx 1,500 1,000 500 0 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 TRx NRx Monthly prescriptions Source: IMS National Prescription Audit (NPA) Dec 09
Slide 27: Cimzia, Vimpat and Neupro: highly innovative drivers of growth
Cimzia®, Vimpat® and Neupro® Highly innovative drivers of growth 27 2 March 2010 The only PEGylated anti-TNF Efficacy when added to a broad range of AEDs 24h continuous delivery by transdermal patch
Slide 28: 2009 financial performance
28 2 March 2010 2009 financial performance Detlef Thielgen, CFO
Slide 29: FY 2009 Financial highlights
FY 2009 Financial highlights 29 Revenue of € 3.1 billion (-13%) 2 March 2010 • Impact of generic competition to Keppra® in the U.S. and divestitures • Good performance of the new core products and of Keppra® in EU Total operating expenses decreased by 15% Recurring EBITDA of € 698 million (-5%) Net
Slide 30: Recurring EBITDA
Recurring EBITDA 30 Actual Variance 2 March 2010 € million FY 2009 FY 2008 Actual CER Revenue 3 116 3 601 -13% -14% Net sales 2 683 3 027 -11% -12% Royalty income & fees 227 396 -43% -39% Other revenue 206 178 15% 13% Gross profit 2 091 2 455 -15% -16% Marketing & selling expenses - 781 - 928 -16% -
Slide 31: Net sales of core and major other products
FY 2009 Net sales of core and major other products 31 € million FY 2009 Change 2 March 2010 net sales Actual CER Core products Cimzia® 75 Vimpat® 46 Neupro® 61 5% 7% Other products Keppra® (incl. Keppra®XR) 913 -28% -28% Zyrtec® (incl. D/Cirrus®) 268 8% 1% Tussionex™ 147 0% -5% Xyzal® 1 132 -23% -22
Slide 32: Royalty income & fees and Other revenue
Royalty income & fees and Other revenue 32 Actual Variance 2 March 2010 € million FY 2009 FY 2008 Actual CER Biotechnology IP 116 318 -63% -60% Toviaz® 41 5 Zyrtec® U.S. 23 30 -22% -26% Other 48 43 9% 4% Royalty income & fees 227 396 -43% -39% Contract manufacturing sales 94 42 125% 119% Xyzal® U.S.
Slide 33: Gross profit
Gross profit 33 Actual Variance 2 March 2010 € million FY 2009 FY 2008 Actual CER Cost of sales - 1 025 - 1 146 -11% -11% Cost of sales products & services - 769 - 847 -9% -9% Royalty expenses - 128 - 205 -37% -37% Amortisation of intangible assets - 128 - 95 35% 36% linked to sales Gross profit 2 0
Slide 34: REBITDA development
FY 2009 REBITDA development 34 € million 2 March 2010 733 CVN FX 698 additional Recurring EBITDA 2008 reported investments Recurring EBITDA 2009 reported Shape and other expenses reduction Keppra® Gross U.S. Profit Mix
Slide 35: Net profit
Net profit 35 Actual Variance 2 March 2010 € million FY 2009 FY 2008 Actual CER Recurring EBIT 453 531 -15% -17% Impairment charges - 126 - 160 n.s. n.s. Restructuring expenses - 73 - 272 n.s. n.s. Gain on disposals 594 0 n.s. n.s. Other non recurring - 11 14 n.s. n.s. income/expenses (-) Total non
Slide 36: Core EPS
Core EPS 36 Actual 2 March 2010 € million FY 2009 FY 2008 Net Profit 513 42 + after-tax non-recurring items & -298 339 financial one-offs - profit from discontinued operation -7 -55 + Tax one-offs 17 -56 Adusted net profit1 226 270 + Amortisation of intangibles 127 94 - Taxes on amortization of inta
Slide 37: Summary financials
Summary financials 37 Cash Flow Summary 2 March 2010 € million FY 2009 FY 2008 Net profit (after minority interest) 513 42 Cash flow from operating activities 295 366 Cash flow from investing activities 473 - 673 Cash flow from financing activities - 736 278 Change in cash and cash equivalents 32 -
Slide 38: Debt re-financing completed
Debt re-financing completed Diversified lender base and improved maturity profile 38 € million 31 Dec 2009 31 Dec 2008 2 March 2010 Net debt - 1 752 - 2 443 Liquid assets 491 470 Financial debt - 2 243 - 2 913 New debt profile • € 750 million 5.75% Belgian retail bonds, due November 2014 • € 500 mil
Slide 39: New capital structure and debt maturity
New capital structure and debt maturity 39 Maturity Profile before Refinancing 2 March 2010 2500 2000 EUR Gross Debt * mio 1500 1000 500 0 2009 2010 2011 2012 2013 2014 2015 2016 Maturity Profile after Refinancing 2500 2000 EUR Gross Debt * mio 1500 Refinancing 1000 500 0 2009 2010 2011 2012 2013 20
Slide 40: 2010 financial outlook
2010 financial outlook 40 Revenue expected to reach approximately 2 March 2010 € 3.0 billion Recurring EBITDA is expected to end the year around € 700 million Core EPS1 expected to reach approximately € 1.76 versus € 1.74 in 2009 1 based on 180 million non-diluted number of shares
Slide 41: Development
41 2 March 2010 Development Iris Loew-Friedrich, Chief Medical Officer Executive Vice-President Global Projects & Development
Slide 42: 2009 – a turning point: Regulatory and development delivery
2009 – a turning point Regulatory and development delivery 42 Cimzia® in rheumatoid arthritis U.S. approval & launch 9 2 March 2010 Cimzia® in rheumatoid arthritis EU approval & launch 9 Brivaracetam in epilepsy Phase III top line results 9 CDP323 in multiple sclerosis No go decision 9 Keppra® in ep
Slide 43: Update on clinical development
Update on clinical development 43 Brivaracetam in epilepsy: further Phase III study 2 March 2010 Epratuzumab in SLE: Phase III study to start in 2010 CDP7851 in bone loss disorders: Phase II studies ongoing • Post-menopausal osteoporosis (PMO) • Fracture healing Keppra® XR monotherapy: positive Phas
Slide 44: The early pipeline starts to strengthen
The early pipeline starts to strengthen Three exciting compounds moved into Phase I 44 CDP6038 (Anti-IL 6) – Autoimmune diseases 2 March 2010 • Phase I ongoing • Potential for immunology indications including rheumatoid arthritis MEK inhibitor (WX544) – Oncology • The first of our oncology molecules
Slide 45: Neupro: Working to make it available in the U.S.
Neupro® Working to make it available for patients in the U.S. 45 Deviation from approved product specification 2 March 2010 Product recall (March 2008) - Out-of-stock situation FDA Complete Response Letter (December 2008) • “Substantial evidence of effectiveness in advanced Parkinson’s disease and r
Slide 46: Brivaracetam in epilepsy
Brivaracetam in epilepsy Phase III programme to continue 46 High unmet medical need 2 March 2010 Committed to bring brivaracetam to patients Phase III: One study met its primary efficacy endpoint Further Phase III trial to start H2 2010 Raffaele, • Adjunctive therapy in partial onset seizures living
Slide 47: Vimpat in epilepsy: Increasing patient access
Vimpat® in epilepsy Increasing patient access 47 Monotherapy in the treatment of partial-onset seizures (POS) 2 March 2010 • Phase III trial in the U.S. ongoing • Headline results expected Q2 2013 Paediatric (2-17 yr) development in partial-onset seizures • Phase II in the U.S. started Lakeisha, Epi
Slide 48: Cimzia in further arthritis indications
Cimzia® in further arthritis indications Increasing patient access 48 Psoriatic arthritis (PsA) 2 March 2010 • Phase III trials ongoing • 2 active arms: monthly (400 mg) and every two week (200 mg) dosing • Time-frame: 24 + 48 weeks • First key results expected Q4 2011 Ankylosing spondylitis (AS) Am
Slide 49: Cimzia in further arthritis indications
Cimzia® in further arthritis indications Increasing patient access 49 Juvenile rheumatoid arthritis (RA) 2 March 2010 • Clinical study start scheduled H2 2010 • Phase III study in children Rheumatoid arthritis (Japan) • 2 Phase III studies ongoing: • Monotherapy and combination with MTX Alison, livi
Slide 50: Epratuzumab in SLE: positive Phase IIb results
Epratuzumab in SLE: positive Phase IIb results Clinically meaningful treatment effect 50 "EMBLEM" 2 March 2010 • Phase IIb 12-week dose and regime-ranging study • 227 patients with moderately (30%) and severely (70%) active disease in multiple organ systems in 6 arms, total dose range from 200 – 3 6
Slide 51: Epratuzumab in systemic lupus erythematosus (SLE)
Epratuzumab in systemic lupus erythematosus (SLE) Phase III to start 51 Phase III program to start in H2 2010 2 March 2010 • Subject to confirmation by ongoing discussions with regulatory authorities • Two confirmatory efficacy randomized placebo- controlled studies • Embody 1 Bernadette, living wit
Slide 52: CDP7851 in bone loss disorders
CDP7851 in bone loss disorders Novel therapy with strong potential 52 Development of novel anabolic therapy Study of naturally occurring 2 March 2010 human disorder leads to a • Antibody to sclerostin potentially treating bone loss potential new drug therapy disorders, incl. osteoporosis Collaborati
Slide 53: Development pipeline
Development pipeline Major projects 53 Regulatory CNS Phase I Phase II Phase III status 2 March 2010 Keppra® (levetiracetam) Epilepsy – adjunctive therapy (Japan) Filed November 2008 CRL1 Neupro® (rotigotine) Advanced Parkinson's disease (U.S.) December 2008 CRL1 Neupro® (rotigotine) Restless legs s
Slide 54: UCB's Sustainable Growth
54 2 March 2010 UCB's Sustainable Growth Roch Doliveux, CEO
Slide 55: UCB - delivering through innovation
UCB - delivering through innovation 55 Vision 2 March 2010 • To become the Patient-Centric global biopharmaceutical leader • To provide breakthrough innovation for patients suffering from severe diseases Turning point achieved • Approvals and other regulatory and development milestones • Launches of
Slide 56: UCB's Sustainable Growth
UCB's Sustainable Growth Cimzia®, Vimpat® and Neupro® trigger company growth 56 2 March 2010 Intense growth Breakthrough Company Launch a new generation of therapies offering growth breakthrough innovation to Cimzia®, Vimpat®, patients with severe disease Neupro® Realise the full commercial • Optimi
Slide 57: UCB to deliver growth: Cimzia peak sales
UCB to deliver growth Cimzia®, Vimpat® and Neupro® trigger company growth 57 2 March 2010 Expected peak sales at least € 1.5 billion • To be reached in the second half of this decade • Including new indications and markets currently under development: • Psoriatic arthritis (PsA) • Ankylosing spondyl
Slide 58: UCB to deliver growth: Vimpat peak sales
UCB to deliver growth Cimzia®, Vimpat® and Neupro® trigger company growth 58 2 March 2010 Expected peak sales at least € 1.2 billion • To be reached in the second half of this decade • Including new indications currently under development: • Monotherapy in the treatment of partial-onset seizures (PO
Slide 59: UCB to deliver growth: Neupro peak sales
UCB to deliver growth Cimzia®, Vimpat® and Neupro® trigger company growth 59 2 March 2010 Expected peak sales at least € 400m • To be reached in the second half of this decade • Parkinson's disease • Europe, U.S. and other markets • Restless legs syndrome • Europe, U.S. and other markets
Slide 60: UCB - sustaining growth through innovation
UCB - sustaining growth through innovation 60 New therapeutic options for patients in clinical development 2 March 2010 • Brivaracetam – Epilepsy – adjunctive therapy • Epratuzumab - Systematic lupus erythematosus • CDP7851 - Post-menopausal osteoporosis • CDP7851 - fracture healing Preparing furthe
Slide 61: UCB's Sustainable Growth
UCB's Sustainable Growth Cimzia®, Vimpat® and Neupro® trigger company growth 61 2 March 2010 Intense growth Breakthrough Company Launch a new generation of therapies offering growth breakthrough innovation to Cimzia®, Vimpat®, patients with severe disease Neupro® Realise the full commercial • Optimi
Slide 62: Appendix
2 March 2010 62 Appendix
Slide 63: Major milestones expected in 2010
Major milestones expected in 2010 63 2 March 2010 epratuzumab in SLE • Presentation of Phase IIb data at the World Lupus Congress June 2009 • Start of the Phase III trial programme 2010 brivaracetam in epilepsy • Start of one additional Phase III trial H2 2010 Xyrem® for fibromyalgia • Filling to th
Slide 64: Corporate financial calendar
Corporate financial calendar 2010 64 2009 annual report (online) by 31 March 2010 2 March 2010 AGM + Interim update (three month report) 29 April 2010 2010 half-year financial results 2 August 2010 Interim update (nine month report) 21 October 2010
Slide 65: Net sales by geography
FY 2009 Net sales by geography 65 FY 2009 net sales FY 2008 net sales 2 March 2010 € 2 683 million € 3 027 million Rest of Rest of World World 14% 13% Europe 51% Europe North North 47% America America 35% 40% *
Slide 66: Net sales by therapy area
FY 2009 Net sales by therapy area 66 FY 2009 net sales FY 2008 net sales 2 March 2010 € 2 683 million € 3 027 million Other CNS Other 41% 41% 39% CNS 47% Immunology Immunology and allergy and allergy 18% 14% *
Slide 67: Shareholder structure
Shareholder structure Strong and stable shareholder base 67 UCB controlling and important shareholders as of 1 September 2009 2 March 2010 Capital € 550 095 156 Shares 183 365 052 1 Financière de Tubize S.A. (Tubize) 36.20% 2 UCB Fipar S.A. 1.73% 3 UCB SCA 0.01% 4 Schwarz Vermögensverwaltung GmbH 5.
Slide 68: Your UCB Investor Relations Team
Your UCB Investor Relations Team 68 Antje Witte, Vice President Investor Relations 2 March 2010 • Phone: +32 2 559 9414 • E-mail: [email protected] Richard Simpson, Senior Director Investor Relations • Phone: +32 2 559 9494 • E-mail: [email protected] Michael Tuck-Sherman, Investor Relations