Ucb S.a. · EURONEXT:UCB
Ucb — H1 2010 Earnings Presentation
60 slides from Ucb's earnings presentation, Aug 2, 2010
Slide 1: Progressing to become the patient-centric global biopharma leader
Progressing to become the patient-centric global biopharma leader Lakeisha, living with epilepsy
Slide 2: Disclaimer and safe harbour
Disclaimer and safe harbour 2 2 August 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 pr
Slide 3: UCB vision
UCB vision fw otoz jsniny z We aspire to be the Patient-Centric global biophar- maceutical leader ’ transforming the lives of people @ with severe "i diseases c S|
Slide 4: UCB is becoming the Patient-Centric global biopharmaceutical leader
146 000 patients benefited: + 40 000 in H1 (+~40%) 4 UCB is becoming the 2 August 2010 Patient-Centric global biopharmaceutical leader Fast response for predictable outcomes when monotherapy is no longer enough 24h continuous delivery by transdermal patch
Slide 5: H1 highlights
H1 highlights 5 Total revenue increased to € 1.6 billion 2 August 2010 • Cimzia®, Vimpat® and Neupro® 3% • UCB's established product portfolio Consistent solid underlying profitability (recurring EBITDA) of € 398 million 10% • In line with company guidance for the full year • Reflecting the successf
Slide 6: Net sales of major and new products
H1 2010 Net sales of major and new products 6 € million H1 2010 H1 2009 Variance net sales net sales Actual CER1 2 August 2010 Core products 177 74 138% 136% Cimzia® 83 24 240% 238% Vimpat® 55 23 135% 134% Neupro® 39 27 45% 44% Mature products 1 254 1 305 - 4% - 6% Keppra® (incl. Keppra®XR) 460 465
Slide 7: Keppra franchise
Keppra® franchise approved and coming soon to patients in Japan 7 H1 2010 H1 2009 € million Actual CER 2 August 2010 net sales net sales North America 146 184 - 21% - 21% Europe 287 255 12% 11% Rest of World 28 27 4% - 9% Total Keppra® 460 465 -1% - 3% Loss of exclusivity in the U.S. (November 2008)
Slide 8: Delivering new medicines for people living with severe diseases
Delivering new medicines for people living with severe diseases 8 2 August 2010 Fast response for predictable outcomes • Rheumatoid arthritis • Crohn's disease When monotherapy is no longer enough • Epilepsy adjunctive therapy 24h continuous delivery • Parkinson's disease • Restless legs syndrome
Slide 9: Cimzia roll-out
Cimzia® roll-out Steady build of a chronic therapy 9 H1 2010 H1 2009 € million Actual CER 2 August 2010 net sales net sales North America 72 23 219% 217% Europe 11 2 524% 518% Total Cimzia® 83 25 240% 238% More than 15 000 patients on Cimzia® - now available in 15 markets1 Crohn’s disease2 - For naï
Slide 10: Cimzia provides a fast response for results that last
Cimzia® provides a fast response for results that last1 10 Available data suggest that a clinical response is usually achieved 2 August 2010 within the first 12 weeks of CIMZIA® treatment2 * Not all patients may have responded at each time point. RAPID 1 was a 52-week, multicenter, randomized, doubl
Slide 11: Degree and speed of response with Cimzia predictive of outcomes
The degree and speed of response with Cimzia® was highly predictive of outcomes at 52 weeks3 11 Predicting response at week 12 can improve therapeutic benefit by 2 August 2010 making an early treatment decision possible and avoiding unnecessary costs and safety exposure4 * Not all patients may have
Slide 12: Cimzia in rheumatoid arthritis (NRx)
Cimzia® in rheumatoid arthritis Roll-out in U.S.: gaining use even in an entrenched marketplace 12 Cimzia® RA indexed vs Total Market (NRx)1 2 August 2010 Rolling 4 weekly cycle2 170 Indexed rolling avg 4 weekly NRx 160 150 140 130 120 110 100 90 1 0 10 10 10 -1 0 r -1 0 r -1 0 r -1 0 y- 10 y- 10 n-
Slide 13: Cimzia in rheumatoid arthritis (TRx)
Cimzia® in rheumatoid arthritis Roll-out in U.S.: gaining use even in an entrenched marketplace 13 Cimzia® RA indexed vs Total Market (TRx)1 2 August 2010 Rolling 4 weekly cycle2 180 Indexed rolling avg 4 weekly TRx 170 160 150 140 130 120 110 100 90 1 0 10 10 10 -1 0 r -1 0 r -1 0 r -1 0 y- 10 y- 1
Slide 14: Cimzia for Crohn's disease (NRx)
Cimzia® for Crohn's disease An important new option for U.S. patients 14 Cimzia® CD indexed vs Total Market (NRx) 2 August 2010 Rolling 4 weekly cycle1 115 Indexed rolling avg 4 weekly NRx 110 105 100 95 90 0 10 10 0 0 0 0 0 0 0 0 0 n- 1 b- b- a r -1 a r -1 p r -1 p r -1 r -1 ay -1 ay -1 un -1 un -1
Slide 15: Cimzia for Crohn's disease (TRx)
Cimzia® for Crohn's disease An important new option for U.S. patients 15 Cimzia® CD indexed vs Total Market (TRx) 2 August 2010 Rolling 4 weekly cycle1 130 Indexed rolling avg 4 weekly TRx 125 120 115 110 105 100 95 90 0 10 10 0 0 0 0 0 0 0 0 0 n- 1 b- b- a r -1 a r -1 p r -1 p r -1 r -1 ay -1 ay -1
Slide 16: Vimpat in epilepsy
Vimpat® in epilepsy When monotherapy is no longer enough 16 H1 2010 H1 2009 2 August 2010 € million Actual CER net sales net sales North America 40 18 121% 120% Europe 15 5 181% 179% Total Vimpat® 55 23 135% 134% More than 67 500 patients on Vimpat® - now available in 19 markets1 When monotherapy is
Slide 17: Vimpat – Improved seizure control
Vimpat® – Improved seizure control Regardless of patient’s concomitant therapy 17 2 August 2010
Slide 18: Vimpat US launch (NRx)
Vimpat® in epilepsy Successful launch in the AED market in the U.S. 18 2 August 2010 140 135 Indexed rolling avg 4 weekly NRx 130 125 120 115 110 105 100 95 90 0 10 10 0 0 0 0 0 10 10 10 10 n- 1 b- b- a r-1 a r -1 pr -1 pr -1 pr -1 a y- a y- n- n- -Ja 5- F e -F e 5- M -M 2- A -A -A -M -M -J u -J u 2
Slide 19: Vimpat US launch (TRx)
Vimpat® in epilepsy Successful launch in the AED market in the U.S. 19 2 August 2010 150 Indexed rolling avg 4 weekly TRx 140 130 120 110 100 90 0 10 10 0 0 0 0 0 10 10 10 10 n- 1 b- b- a r-1 a r -1 pr -1 pr -1 pr -1 a y- a y- n- n- -Ja 5- F e -F e 5- M -M 2- A -A -A -M -M -J u -J u 22 19 19 16 30 1
Slide 20: Vimpat growing rapidly in Europe
Vimpat® in epilepsy Growing rapidly in Europe 20 Vimpat® treatment days shares among all AED, 2 August 2010 Monthly evolution since Vimpat® launch, up to May 20101 1.4% 1.2% 1.0% 0.8% 0.6% 0.4% 0.2% 0.0% M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 Germany (M1=Sept 08)
Slide 21: Neupro - continued launch roll-out
Neupro® - rotigotine transdermal patch Continued launch roll-out 21 H1 2010 H1 2009 Actual CER € million 2 August 2010 net sales net sales North America 0 0 Europe 38 26 45% 44% Total Neupro® 38 26 45% 44% More than 63 500 patients on Neupro® - now available in 20 markets1 Neupro® 24h continuous del
Slide 22: Significantly improved non motor symptoms, for better days and nights
Significantly improved non motor symptoms, for better days and nights 22 Placebo (n=101) Neupro® (n=204) August 2010 CLEOPATRA-PD · Poewe W et al., Lancet Neurol 2007; 6:513-520
Slide 23: Neupro - EU
Neupro® - EU Monthly evolution since Neupro new patients launch 23 Treatment days market share evolution by major country 2 August 2010 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% M1 M2 M3 M4 M5 M6 M7 M8 M9 M1 0 M1 1 Germany Italy Spain UK M1 = New Patients Launch in July-09 in Spain, UK and Germany, Launch
Slide 24: UCB to deliver growth
UCB to deliver growth Cimzia®, Vimpat® and Neupro® trigger company growth 24 Fast response for predictable outcomes 2 August 2010 • Expected peak sales at least € 1.5 billion1 • Psoriatic arthritis (PsA), ankylosing spondylitis (AS), juvenile rheumatoid arthritis (RA) • RA in Japan When monotherapy
Slide 25: H1 2010 financial highlights
H1 2010 Financial highlights 25 Revenue of € 1 644 million 2 August 2010 3% • Generic competition to mature products compensated by Cimzia®, Vimpat® and Neupro® Total operating expenses € 830 million 1% • Cost savings from U.S. primary care sector exit • Increased expenses for Cimzia®, Vimpat® and N
Slide 26: Net sales H1 2010
Net sales H1 2010 € 1 431 million 26 Focused 2 August 2010 From primary care to specialist physicians Central Nervous System (CNS) and immunology Core markets: U.S., EU, Japan, selected emerging markets Specialist physicians contacted by small and efficient sales forces France 6% Germany 13% North O
Slide 27: Recurring EBITDA
Recurring EBITDA Consistent solid underlying profitability 27 Actual Variance € million H1 2010 H1 2009 Actual CER 2 August 2010 Revenue 1 644 1 596 3% 1% Net sales 1 431 1 379 4% 2% Royalty income & fees 107 114 - 6% - 7% Other revenue 106 103 2% 1% Gross profit 1 098 1 087 1% - 1% Marketing & sell
Slide 28: H1 2010 net sales
H1 2010 net sales Solid growth from core products 28 Core 2 August 2010 Mature products products € 51 m € 103 m Cimzia® Vimpat® Neupro® H1 2009 H1 2010 net sales net2010 sales Net Sales € 1 379 € 1 431 million 2009 million Net 1 431 Sales 4% 1 379
Slide 29: Recurring EBITDA
Recurring EBITDA June 2009 reported 363 H1 2010 REBITDA Mature products Cimzia® Neupro® Vimpat® Other Recurring EBITDA 398 June 2010 reported 29 2 August 2010
Slide 30: Net profit
Net profit 30 Actual Variance 2 August 2010 € million H1 2010 H1 2009 Actual CER Recurring EBIT 268 246 9% 5% Impairment charges -5 - 95 - 95% - 95% Restructuring expenses - 19 -5 278% 266% Other non recurring income 28 561 - 95% - 95% Total non recurring 4 461 - 99% - 99% income/(expenses) EBIT 272
Slide 31: Core EPS
Core EPS 31 Actual Variance € million 2 August 2010 H1 2010 H1 2009 Actual CER Net profit 148 516 - 71% - 73% + After-tax non-recurring 4 -380 n.s. n.s. items & financial one-offs - Profit from discontinued -1 -1 - 7% - 7% operation + Tax one-offs 0 0 n.s. n.s. Adusted net profit1 151 135 12% 7% + A
Slide 32: H1 2010 cash flows
H1 2010 cash flows 32 2 August 2010 Investing Financing1 activities activities € -17 m € 282 m Operating H1 2010 activities cash € 139 m € 870 million FY 2009 87% cash 87% € 466 million 1 Includes effect of exchange rate fluctuations
Slide 33: H1 2010 balance sheet
H1 2010 balance sheet 33 € million 2 August 2010 Cash and Cash Equivalents 891 1 520 Other Current Liabilities Other Current Assets 1 283 1 040 Current Debt Other Non- Current Assets 871 Other Non- 982 Current Liabilities Intangible Assets 1 975 1 724 Non-Current Debt Shareholder’s Goodwill 4 491 Eq
Slide 34: 2010 financial outlook confirmed
2010 financial outlook confirmed 34 Revenue expected to reach approximately 2 August 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 35: Update on clinical development
Update on clinical development 35 2 August 2010 • Line extension studies in psoriatic arthritis and ankylosing spondylitis ongoing • Phase III in juvenile rheumatoid arthritis under discussion • Phase II in primary generalised tonic-clonic seizures (PGTCS) started • Paediatric (Phase II) and U.S.-mo
Slide 36: Update on clinical development
Update on clinical development 36 E Keppra® in Japan 2 August 2010 • Approval to launch in epilepsy adjunctive therapy (July 2010) • UCB and Otsuka to co-promote Xyrem® in fibromyalgia • Filed with European Medicines Agency (EMA) • Feedback expected H1 2011 Brivaracetam in epilepsy • Further Phase I
Slide 37: Cimzia in further arthritis indications
Cimzia® in further arthritis indications Increasing patient access 37 Psoriatic arthritis (PsA) - Phase III trials ongoing 2 August 2010 • Two active arms: monthly (400 mg) and two week (200 mg) dosing • Time-frame: 24 + 48 weeks Phase 1 Phase 2 Phase 3 Cimzia® Results Psoriatic arthritis Q4 2011 St
Slide 38: Cimzia in further arthritis indications
Cimzia® in further arthritis indications Increasing patient access 38 Juvenile rheumatoid arthritis (RA) 2 August 2010 • Discussion ongoing with EU and U.S. regulators to finalise the study Phase III design Phase 1 Phase 2 Phase 3 Cimzia® Juvenile RA Alison, living with rheumatoid arthritis Rheumato
Slide 39: Epratuzumab in SLE
Epratuzumab in SLE Phase III to start 39 Phase III trials to start in H2 2010 2 August 2010 • Subject to confirmation from regulatory authorities after ongoing discussions • Two confirmatory randomised placebo-controlled efficacy studies (Embody 1 & 2) • Study design expected to be in line with Phas
Slide 40: Epratuzumab in SLE: positive Phase IIb results
Epratuzumab in SLE: positive Phase IIb results Clinically meaningful treatment effect 40 "EMBLEM" 2 August 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
Slide 41: CDP7851 in bone loss disorders
CDP7851 in bone loss disorders Novel therapy with strong potential 41 Development of novel anabolic therapy Study of naturally occurring 2 August 2010 human disorder leads to a potential new drug therapy • Antibody to sclerostin potentially treating bone loss disorders, incl. osteoporosis Collaborat
Slide 42: Vimpat in epilepsy
Vimpat® in epilepsy Increasing patient access 42 Monotherapy in the treatment of partial-onset seizures 2 August 2010 • Phase III trial in EU planned to start by the end of 2010 Phase 1 Phase 2 Phase 3 Vimpat® Results Monotherapy (U.S.) Q2 2013 Vimpat® Start H2 2010 Monotherapy (EU) Veronica, living
Slide 43: Brivaracetam in epilepsy
Brivaracetam in epilepsy Phase III programme to continue 43 Adjunctive therapy in partial onset seizures 2 August 2010 Further Phase III trial to start H2 2010 • Inclusion of higher doses • Improved selection incl. regions and sites • Well defined patient population Raffaele, living with epilepsy Ph
Slide 44: Neupro in the U.S.
Neupro® in the U.S. Parkinson’s disease & restless legs syndrome 44 FDA Complete Response Letter (December 2008) 2 August 2010 • “Substantial evidence of effectiveness in advanced Parkinson’s disease and restless legs syndrome” Development of room temperature-stable patch formulation on track Ursula
Slide 45: Xyrem filed in fibromyalgia
Xyrem® filed in fibromyalgia Working to make it available for patients in the EU 45 Xyrem® (sodium oxybate) in fibromyalgia filed with the European 2 August 2010 Medicines Agency (EMA) No prescription medicines approved yet for fibromyalgia in Europe Strong Phase III data Feedback from EMA expected
Slide 46: The early pipeline starts to strengthen
The early pipeline starts to strengthen 3+1 exciting compounds in Phase I 46 2 August 2010 CDP6038 CDP7657 UCB2892 MEK inhibitor (anti-IL 6) (anti-CD40L) (H3 antagonist) (WX554) Therapeutic Immunology Immunology CNS Oncology area Stage of Phase I on track Phase I ongoing Phase I ongoing Successful d
Slide 47: Development pipeline: Immunology
Development pipeline Major projects: Immunology 47 Phase 1 Phase 2 Phase 3 Cimzia® (certoluzimab pegol) Results 2 August 2010 Rheumatoid arthritis (Japan) Q3 2011 Cimzia® (certoluzimab pegol) Results Ankylosing spondylitis Q4 2011 Cimzia® (certoluzimab pegol) Results Psoriatic arthritis Q4 2011 Cimz
Slide 48: Development pipeline: Central Nervous System
Development pipeline Major projects: Central Nervous System (CNS) 48 Phase 1 Phase 2 Phase 3 Regulatory status Keppra® (levetiracetam) Approved 2 August 2010 Filed Epilepsy – adj. therapy (Japan) July 2010 November 2008 Neupro® (rotigotine) CRL* CRL1 Adv. Parkinson's disease (U.S.) Dec2010 April 200
Slide 49: UCB is delivering on…
UCB is delivering on… 49 2 August 2010 transformation organisational focus product launches increased patient reach stronger pipeline … to achieve sustainable company growth
Slide 50: UCB's Sustainable Future Growth
UCB's Sustainable Future Growth Cimzia®, Vimpat® and Neupro® trigger company growth 50 2 August 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
Slide 51: Appendix
2 August 2010 51 Appendix
Slide 52: Net sales by geography
Net sales by geography 52 H1 2010 net sales H1 2009 net sales 2 August 2010 € 1 431 million € 1 379 million France France 6% 7% Germany Germany 13% 10% North North America Italy America Italy 35% 6% 37% 5% U.K+ Ireland U.K.+ Ireland 5% 5% Spain 5% Spain 5% Other Europe Other Europe Asia Japan 16% Ot
Slide 53: Net sales by therapy area
Net sales by therapy area 53 H1 2010 net sales H1 2009 net sales 2 August 2010 € 1 431 million € 1 379 million Other Other CNS CNS 38% 39% 41% 41% Immunology Immunology Immunology & allergy Immunology & allergy & allergy 21% & allergy20% 18% 14% *
Slide 54: Summary financials
Summary financials 54 Cash flow summary 2 August 2010 € million H1 2010 H1 2009 Net profit (after non-controlling interests) 148 516 Cash flow from operating activities 139 - 45 Cash flow from investing activities - 17 477 Cash flow from financing activities 275 - 356 Change in cash and cash equival
Slide 55: Royalty income and Other revenue
Royalty income and Other revenue 55 Actual Variance € million 2 August 2010 H1 2010 H1 2009 Actual CER Biotechnology IP 50 61 - 17% - 20% Zyrtec® U.S. 9 14 - 36% - 37% Toviaz® 22 14 58% 58% Other 26 25 2% 2% Royalty income & fees 107 114 - 6% - 7% Contract manufacturing sales 48 44 9% 9% Xyzal® U.S.
Slide 56: Gross profit
Gross profit 56 Actual Variance 2 August 2010 € million H1 2010 H1 2009 Actual CER Cost of sales - 546 - 509 7% 7% Cost of sales products & - 375 - 390 - 4% - 4% services Royalty expenses - 85 - 62 39% 37% Amortisation of intangible - 86 - 58 48% 47% assets linked to sales Gross profit 1 098 1 087 1
Slide 57: Epilepsy: Strong need for new treatment options
Epilepsy Strong need for new treatment options 57 High unmet medical need in Epilepsy types and treatments 2 August 2010 ~1/3 of treated epilepsy patients algorithm Monotherapy Add-on therapy 25-30% Partial Onset Seizures 29% 27% 50% 20-25% Primary Generalised 19% Seizures 25% Controlled on 1st mono
Slide 58: Major milestones expected in 2010/2011
Major milestones expected in 2010/2011 58 2 August 2010 Epratuzumab in SLE • Start of the Phase III trial programme H2 2010 Brivaracetam in epilepsy • Start of one additional Phase III trial H2 2010 Vimpat® in epilepsy • Start of Phase III trial in monotherapy (EU) H2 2010 • Headline results paediat
Slide 59: Shareholder structure
Shareholder structure1 Strong and stable shareholder base 59 2 August 2010 Tubize 36% Concert 14% Capital Other institutional investors by region Other Research investors 12% UK & 15% Other North Ireland institutional America 17% investors 35% 23% Belgium 17% Cont. Europe 30% ROW 0.3% 1. Source: Glo
Slide 60: Your UCB Investor Relations Team
Your UCB Investor Relations Team 60 Antje Witte, Vice President Investor Relations 2 August 2010 • Phone: +32 2 559 9414 • E-mail: antje.witte@ucb.com Richard Simpson, Senior Director Investor Relations • Phone: +32 2 559 9494 • E-mail: richard.simpson@ucb.com Michael Tuck-Sherman, Investor Relation