UCB presentation. Investor Relations April 24, 2014

Transcription

1 UCB presentation Investor Relations April 24, 2014

2 Disclaimer and safe harbor 2 Forward-looking statements: This presentation contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this presentation and expressly disclaims any duty to update any information contained in this presentation, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

3 Inspired by patients. Driven by science. 3 Focus: Central Nervous System & Immunology R&D expenses 2013: 25% of revenue Over patients treated with UCB s core medicines, CVN Operations in more than 40 countries Approximately employees globally

4 UCB s growth prospects confirmed 4 Cimzia, Vimpat, Neupro Emerging markets Superior and sustainable value Mature product portfolio Schematic picture

5 UCB s five strategic growth priorities 5 Status: first 3 months 2014 ן 1. Grow Cimzia, Vimpat and Neupro CVN combined sales: 318 million (+29%, +33% at constant rates) ן 2. Build emerging markets and Japan BRICMT 1-1% (+11% at constant rates); Japan -9% (+75% excl. allergy and currency effects) Agreement with Biogen Idec for multiple sclerosis and hemophilia therapies in Asia ן 3. Advance UCB s rich late-stage pipeline Top 2 in late-stage pipeline productivity² Returned global rights of tozadenant to Biotie ן 4. Deliver breakthrough medicines to the clinic Breakthrough innovation collaboration with Sanofi to replace selected biologic agents with small molecules to potentially treat a wide range of immune-mediated diseases Growing super-network fostering borderless innovation ן 5. Reach competitive profitability Financial targets 2014 confirmed, on track for long-term targets 1 Brazil, Russia, India, China, Mexico and Turkey 2 Phase 3 NME/R&D expenses, U.S. and EU biopharma companies 3 Partial-onset seizures

6 Cimzia performance 6 Reaching more patients million 3M M 2013 Actual Constant North America % 39% Europe % 37% Japan % -7% Emerging markets % 35% Rest of the World 5 5 8% 17% Total Cimzia % 36% U.S. Crohn s disease (CD) Rheumatoid arthritis (RA) Psoriatic arthritis (PsA) - Sep Ankylosing spondylitis (AS) - Oct EU Rheumatoid arthritis (RA) Axial spondyloarthritis (incl. AS) - Oct Psoriatic arthritis (PsA) - Nov Japan launched March 2013 (partner: Astellas) 1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey Cimzia available to patients in 47 countries, including Japan, Brazil, Russia, Mexico & Turkey Numbers may not add due to rounding

7 Cimzia RA in-market performance (Feb. 2014) 7 8% U.S. - Cimzia RA growth 3.6% U.S. - Cimzia RA R3M TRx Share U.S. 7% 6% 5% 4% 3% 2% 1% 1.3% market share 3.5% 3.1% 7.3% 3.5% 3.5% 3.4% 3.4% In-Market growth and share based on TRx Shares calculated based on RA Anti-TNF market In-market growth is calculated for MAT Feb 14 vs. MAT Feb 13 Market share is calculated for R3M Feb 14 0% Anti-TNF All Biologics Cimzia 3.3% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 40% EU - Cimzia RA growth 9.0% EU - Cimzia RA R3M Patient Share EU 35% 30% 25% 20% 15% 10% 5% 11.2% market share 8.8% 14.8% 35.1% 8.5% 8.0% 7.5% In-Market growth and share based on Exit Patients Shares calculated based on RA Anti-TNF market In-market growth is calculated for Feb 14 vs. Feb 13 Market share is calculated for R3M Feb 14 0% Anti-TNF All Biologics Cimzia 7.0% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 RA: Rheumatoid arthritis Source EU - IMS MIDAS + local UK HMSL data Source US - US IMS NPA data

8 Vimpat performance 8 New indication to come million 3M M 2013 Actual Constant North America % 22% Europe % 22% Emerging markets % 64% Rest of the World % 84% Total Vimpat % 23% Epilepsy POS² Adjunctive therapy: When monotherapy is no longer enough Monotherapy: under review by U.S. FDA (filed Oct. 2013) 1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey 2 Partial onset seizures Vimpat available to patients in 38 countries, including Russia, India & Mexico

9 Vimpat in-market performance (Feb. 2014) 9 25% U.S. - Vimpat growth 3.0% U.S. - Vimpat - R3M TRx Share 20% 2.9% In-Market growth and share based on TRx U.S. 15% 10% market share 2.9% 23.5% 2.8% 2.7% In-market growth is calculated for MAT Feb 14 vs. MAT Feb 13 Market share is calculated for R3M Feb 14 5% 2.6% 0% 3.8% Market Vimpat 2.5% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 30% EU - Vimpat growth 2.0% EU Vimpat - R3M TDx Share 25% In-Market growth and share based on TDx EU 20% 15% 10% market share 1.8% 26.6% 1.8% 1.6% In-market growth is calculated for MAT Feb 14 vs. MAT Feb 13 Market share is calculated for R3M Feb 14 5% 0% 0.8% Market Vimpat 1.4% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 Source EU - IMS MIDAS Source US - US IMS NPA data

10 Neupro performance 10 million 3M M 2013 Actual Constant North America 14 6 > 100% > 100% Europe % 11% Japan 5 1 > 100% > 100% Emerging markets % 9% Rest of the World % 64% Total Neupro % 45% Parkinson s disease (PD) Impact across the motor and underlying symptoms of Parkinson s disease Restless legs syndrome (RLS) Powerful and lasting symptom relief for restless legs syndrome Latest launches: Strong, on-going performance U.S. (July 2012); Japan (February 2013 by Otsuka) 1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey Neupro available in 41 countries, including Japan, Russia & Mexico Numbers may not add due to rounding

11 Neupro in-market performance (Feb. 2014) 11 8% U.S. - Neupro PD growth 6.4% U.S. - Neupro PD R3M TRx Share U.S. 7% 6% 5% 4% 3% 2% market share 6.2% 7.0% 6.2% 6.0% 5.8% 5.6% 5.4% In-market growth and share based on TRx Shares calculated based on PD Key Competitors markets In-market growth is calculated for Current R6M vs. Previous R6M In-market share is calculated for R3M Feb 14 1% 5.2% 0% 0.7% 0.7% Market Competitors Neupro 5.0% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 EU - Neupro PD growth EU5 Neupro PD- R3M TDx Share 20% 15.0% EU 18% 16% 14% 12% 10% 8% 6% 4% 2% market share 14.6% 4.1% 3.5% 17.2% 14.5% 14.0% 13.5% In-market growth and share based on TDx Shares calculated based on PD Key Competitors markets In-market growth is calculated for MAT Feb 14 vs. MAT Feb 13 Market share is calculated for R3M Feb 14 0% Market Competitors Neupro 13.0% Feb'13 Apr'13 Jun'13 Aug'13 Oct'13 Dec'13 Feb'14 Source EU - IMS MIDAS Source US - US IMS NPA data

12 UCB's development pipeline 12 Life cycle management Phase 2 Phase 3 Filing Epilepsy POS 1 Ped. adj. Therapy 2017 Monotherapy (EU) Q Adj. therapy (Asia) H Monotherapy (U.S.) Oct Epilepsy PGTCS 2 Plegridy Adj. Therapy Juvenile RA H Exxelerate H C-early H AxSpA (U.S.) Feb Multiple sclerosis Hemophilia A Hemophilia B Tysabri Tecfidera daclizumab Eloctate Alprolix For development in PR China (In-licensed from Biogen Idec) 1 Partial onset seizures 2 Primary generalized tonic-clonic seizures

13 UCB delivers growth 13 Status: first 3 months 2014 Expected peak sales at least 1.5 billion 1 Inflammatory arthritis indications and Crohn s disease Total net sales of 160 million (+31%) Expected peak sales at least 1.2 billion 1 Epilepsy partial onset seizures (adjunctive therapy) Total net sales of 105 million (+19%) Expected peak sales at least 400 million 1 Parkinson s disease and restless legs syndrome Total net sales of 52 million (+43%) Combined expected CVN peak sales at least 3.1 billion 1 1 Second half of the decade

14 Keppra performances 14 On-going erosion in Europe million 3M M 2013 Actual Constant North America % 2% Europe % -12% Japan % 77% Emerging markets % 12% Rest of the World % -2% Total Keppra % 2% Loss of exclusivity U.S. - November 2008 (Keppra XR - September 2011) Europe - September 2010 Japan: market exclusivity until 2018 Sizeable franchise going forward! 1 Emerging markets: Brazil, Russia, India, China, Mexico and Turkey Numbers may not add due to rounding

15 UCB: Building emerging markets and Japan 15 Emerging markets Agreement with Biogen Idec to commercialize multiple sclerosis and hemophilia therapies in Asia Emerging markets* net sales: 68 million (-1%) +11% at constant rates UCB Japan Net sales of 59 million (-9%; +2% at constant rates) +75% at constant rates (excl. allergy) E Keppra net sales: 21 million (+53%) Neupro net sales: 5 million (vs. 1 million in Q1 2013) *Brazil, Russia, India, China, Mexico, Turkey 1 Excludes allergy and FX effects

16 UCB's development pipeline 16 New molecular entities Phase 1 Phase 2 Phase 3 Filing brivaracetam epilepsy POS 1 / adj. therapy epratuzumab systemic lupus erythematosus romosozumab (sclerostin antibody) osteoporosis in postmenopausal women CDP7657 (CD40L antibody) systemic lupus erythematosus UCB5857 immunological diseases UCB4940 immunological diseases Phase 3 results H Phase 3 results Q (Partner: Immunomedics) Phase 3 results H (Partner: Amgen) Results H (Partner: Biogen Idec) Results Q Partial onset seizures

17 UCB s promising early pipeline 17 Early pipeline holds breakthrough potential Discovery: Breakthrough innovation collaboration with Sanofi discovery and development of innovative anti-inflammatory small molecules to replace selected biologic agents with small molecules to potentially treat a wide range of immune-mediated diseases Three Phase 1 compounds with significant differentiation potential: 2 NBEs: CDP7657 (anti-cd40l) in systemic lupus erythematosus first results in H UCB4940, immunological diseases 1 NCE: UCB5857, immunological diseases first results in Q NBE: new biological entity NCE: new chemical entity

18 3 months key financial highlights 18 On track to deliver FY 2014 guidance million 3M M 2013 Actual Constant Revenue % 9% Net sales CVN % 33% Cimzia % 36% Vimpat % 23% Neupro % 45% Keppra % 2% FY 2014 outlook confirmed Revenue ~ billion REBITDA ~ million Core EPS ~ based on ~ 192 million shares

19 Appendix

20 UCB FY 2013 financial highlights 20 Growth of core medicines a strong foundation Revenue 3.4 billion Continued sales growth of the core medicines: Cimzia, Vimpat and Neupro Keppra generic erosion in Europe Adverse exchange rate impacts actual rates -1% constant rates +2% Total operating expenses Lower marketing & selling expenses million -4% -1% Stable R&D expenses Recurring EBITDA 689 million +1% +9% Net profit 200 million -18% -3% 29% tax rate Recommended gross dividend 1.04 per share +2% Core earnings per share (EPS) 1.93 * EBITDA: Earning before interests, taxes, depreciation and amortization charges * Based on 182 million weighted average shares outstanding

21 Cimzia performance Reaching more patients million FY 2013 FY 2012 Actual Constant North America % 22% Europe % 28% Japan 20 - >100% >100% Emerging markets >100% >100% Rest of the World % 92% Total Cimzia % 32% U.S. Crohn s disease (CD) Rheumatoid arthritis (RA) Psoriatic arthritis (PsA) - Sep Ankylosing spondylitis (AS) - Oct EU Rheumatoid arthritis (RA) Axial spondyloarthritis (incl. AS) - Oct Psoriatic arthritis (PsA) - Nov Brazil, Russia, India, China, Mexico and Turkey Cimzia available to patients in 47 countries, including Japan, Brazil, Russia, Mexico & Turkey Numbers may not add due to rounding

22 Vimpat performance New indication to come million FY 2013 FY 2012 Actual Constant North America % 29% Europe % 16% Emerging markets % 58% Rest of the World % 33% Total Vimpat % 27% Epilepsy POS² Adjunctive therapy: When monotherapy is no longer enough Monotherapy: Filing in the U.S. (Oct. 2013) 1 Brazil, Russia, India, China, Mexico and Turkey 2 Partial onset seizures Vimpat available to patients in 38 countries, including Russia, India & Mexico

23 Neupro performance million FY 2013 FY 2012 Actual Constant North America >100% >100% Europe % 14% Japan 9 1 >100% >100% Emerging markets % 66% Rest of the World % 53% Total Neupro % 39% Parkinson s disease (PD) Impact across the motor and underlying symptoms of Parkinson s disease Restless legs syndrome (RLS) Powerful and lasting symptom relief for restless legs syndrome Latest launches: Strong, on-going performance U.S. (July 2012); Japan (February 2013 by Otsuka) 1 Brazil, Russia, India, China, Mexico and Turkey Neupro available in 41 countries, including Japan, Russia & Mexico Numbers may not add due to rounding

24 Keppra performances Net sales -15% million FY 2013 FY 2012 Actual Constant North America % -2% Europe % -30% Japan % 67% Emerging markets % 16% Rest of the World % 2% Total Keppra % -12% Loss of exclusivity U.S. - November 2008 (Keppra XR - September 2011) Europe - September 2010 Japan: launch of E Keppra pediatric + dry syrup Sizeable franchise going forward! 1 Brazil, Russia, India, China, Mexico and Turkey Numbers may not add due to rounding

25 Recurring EBITDA Lower marketing and selling, stable R&D expenses million Actual Variance FX * Actual Constant Revenue % 2% Net sales % 3% Royalty income and fees % 5% Other revenue % -12% Gross profit % 2% Marketing and selling expenses % 4% R&D expenses % -2% G&A expenses % -5% Other operating income 7 0 n.m. n.m. Total operating expenses % 1% Recurring EBIT % 12% Amortization of intangible assets % 6% Depreciation charges % 1% Recurring EBITDA % 9% * Restated EBIT: Earnings before interest and taxes EBITDA: Earning before interests, taxes, depreciation and amortization charges

26 Net profit million Actual Variance FX * Actual Constant Recurring EBIT % 12% Impairment charges >-100% >-100% Restructuring expenses % 17% Gain on disposals % -28% Other non-recurring income 0-7 n.m. n.m. Total non-recurring income / expenses (-) % -53% EBIT % 9% Net financial expenses % 22% Income tax expenses (-) / credit >-100% >-100% Profit from continuing operations % 2% Net profit (including non-controlling interests) % -3% * Restated EBIT: Earnings before interest and taxes

27 Core earnings per share (EPS) million Actual Variance FX * Actual Constant Net profit attributable to UCB shareholders % -4% + After-tax non-recurring items and % 17% financial one-offs - Profit / loss (-) from discontinued % 74% operations + After-tax amortization of intangibles % 1% Core net profit % 3% Weighted average number of shares (basic) % n.m. Core EPS % 1% * Restated 1 Adjusted for the Meizler business combination

28 IFRS 10 impact on IFRS 10 effective 1 January 2014 Concept of control whether an entity should be included within consolidated financial statements UCB will consolidate two additional entities which manage clinical trials Expected impact (un-audited) Higher R&D expenses Lower net profit for the Group; higher net profit allocation to non-controlling interests million 2013 (as reported) 2013 (pro-forma, un-audited) Revenue R&D expenses as % of revenue 25% 26% Recurring EBITDA Net Profit Net Profit to equity holders of UCB S.A Net Profit to non-controlling interest Weighted number of shares outstanding Core EPS EBITDA: Earning before interests, taxes, depreciation and amortization charges EPS: Earnings per share

29 Geographic and therapeutic breakdown net sales: million Europe 36%

30 Cimzia in RA To provide information for evidence-based decisions in bio/dmard naive patients 30 EXXELERATE C-EARLY H2H: relative efficacy of certolizumab pegol and adalimumab 12 weeks & 104 weeks Approx. 900 adult patients First results H To achieve remission or low disease activity as soon as possible and optimize CZP treatment in early RA remitters 52 weeks & 104 weeks Approx. 800 adult patients with early stage of the disease (<1 year) First results H2 2016

31 Cimzia in Psoriatic Arthritis (PsA) 31 Approved and launched in 2013 *statistical significant Q2W Q4W Cimzia in patients with adult onset active PsA demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of PsA.

32 Epilepsy most common serious neurological disorder 32 Strong need for new treatment options High unmet medical need in ~1/3 of treated epilepsy patients Epilepsy types and treatment algorithm Monotherapy Add-on therapy 50% 25-30% Partial Onset Seizures (POS) 29% 27% 20-25% Controlled on 1st monotherapy Primary Generalised Seizures (PGTCS) 25% 19% Uncontrolled despite 2-3 AEDs Controlled on more than 1 AED

33 Romosozumab in bone loss disorders 33 Potential for a change of treatment paradigms Collaborative project with Amgen Phase 3 program in osteoporosis in postmenopausal women initiated First results expected first half 2016 Study of naturally occurring human disorder leads to a potential new drug therapy Strong phase 2 results in osteoporosis in postmenopausal women Positive treatment effect observed, statistically significant Favorable comparison with active comparators, teriparatide and alendronate Normal Sclerosteosis

34 Epratuzumab in SLE EMBODY 34 Phase 3 program First results Q Placebo EMBODY 1 Emab 600 mg weekly Emab 1200 mg every other week Placebo EMBODY 2 Emab 600 mg weekly Emab 1200 mg every other week Emab IV dosing Week

35 Epratuzumab Maintained improvements in disease activity for 2+ years and corticosteroid dose reductions shown* 35 Combined Treatment Response Median CS dose mg/day (prednisone equivalent) 32.5% 40.7% 48.1% 57.2% 56.5% 60.3% SL0008 Screening (N=203) Week 24 (N=177) Week 48 (N=154) Week 72 (N=138) Week 96 (N=124) Week 108 (N=116) Week 24 (N=177) Week 48 (N=157) Week 72 (N=138) Week 96 (N=125) Week 116 (N=112) Combined Treatment Response indicates patients sustained improvements across all body systems that had moderate or severe disease activity at baseline of the previous study Median corticosteroid dose showed general decrease over time from 10 mg/day at baseline of EMBLEM study, to 5 mg/day at Week 116 Number of subjects with no corticosteroid use and in lowest corticosteroid dose category (>0 to 7.5 mg/day) exceeded 50% from Week 24 No new safety signals were identified

36 Epratuzumab: humanized monoclonal antibody (Human IgG1) against CD22 36 IgM IgM IgD IgG Memory B pro-b pre-b immature B mature B B Blast GC B cell Plasma cell CD22 Expression Fab (CD22 Binding) epratuzumab: Modulator of B-cell function

37 Epratuzumab in SLE Phase 2b results presented at World Lupus Congress & ACR SL0007: Primary Efficacy Variable: Combined Index Response Rate at Week 12, ITT Population 50 P= P= ,9 43, ,5 Percent responders ,1 30,8 26,3 23, Placebo, N=38 Emab 200 mg (100 mg EOW), N=39 Emab 800 mg (400 mg EOW), N=38 Emab 2400 mg (600 QW), N=37 Emab 2400 mg (1200 EOW), N=37 Emab 2400 mg Combined, N=74 Emab 3600 mg (1800 EOW), N=38 37

38 More growth to come from new indications 38 Phase 1 Phase 2 Phase 3 Filing First results this year UCB4940 NBE, immuno CDP7657 NBE, Lupus UCB5857 NCE, immuno Vimpat epilepsy PGTCS tozadenant PD (returned rights Mar 14) romosozumab Osteoporosis in postmenopausal women Cimzia Juvenile RA epratuzumab SLE Vimpat Epilepsy mono U.S. Cimzia AxSpa in U.S. FDA decision expected H Vimpat epilepsy ped. Vimpat epilepsy (Asia) Vimpat Epilepsy mono EU brivaracetam Adj. epilepsy POS Phase 3 results expected in H NBE: new biological entity SLE: systemic lupus erythematosus AS: ankylosing spondylitis NCE: new chemical entity POS: partial onset seizures PD: Parkinson s disease PGTCS: primary generalized tonic-clonic seizures AxSpA: axial spondyloarthritis

39 UCB: reinventing itself, leveraging a solid heritage to deliver sustainable and superior value for patients 39 Today 1928: Emmanuel Janssen establishes UCB in Brussels 1990s: approval of Keppra, a novel antiepileptic 2004: UCB acquires British biotech Celltech 2006: UCB acquires German pharma Schwarz Pharma 1936: UCB enters the United States 1980s: UCB registers its novel antihistamine Zyrtec 2005: UCB divests non-pharma business Launch of new medicines s 1990s Today Chemical Group Primary Care Pharma Specialty Bio-Pharma Focus: CNS + immunology

40 Shareholder structure (March 2014) 40 Stable shareholder base, free float of 63% Free float investors by region Source: Shareholder identification analysis (November 2011), 2012 and 2013 notifications and UCB underlying ownership analysis

41 Your UCB Investor Relations team 41 ן Antje Witte, Vice President Investor Relations Phone: antje.witte@ucb.com ן Alexandra Deschner, Investor Relations Director Phone: alexandra.deschner@ucb.com ן Isabelle Ghellynck, Investor Relations Project Manager Phone: isabelle.ghellynck@ucb.com ן Nathalie Deldime, Investor Relations Events Manager Phone: nathalie.deldime@ucb.com