UCB presentation. October 2014

Transcription

1 UCB presentation October 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 presentation. 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. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 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 3.4 billion 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 9 months key financial highlights 5 FY 2014 financial outlook confirmed million 9M M 2013 Actual Constant Revenue % 8% Net sales CVN % 26% Cimzia % 36% Vimpat % 17% Neupro % 15% Keppra % -3% FY 2014 outlook confirmed Revenue ~ billion REBITDA ~ million Core EPS based on ~192 million shares

6 UCB s five strategic growth priorities (9M 2014) 6 Continuing our growth path ן 1. Grow Cimzia, Vimpat and Neupro CVN combined sales: million (+23%; +26% CER 1 ) Vimpat monotherapy approval in the U.S. ן 2. Build emerging markets and Japan Emerging markets 2-3% (+5% CER); Japan -6% (+1% CER) ן 3. Advance UCB s rich late-stage pipeline Positive topline Phase 3 results for brivaracetam in epilepsy POS 3 patients ן 4. Deliver breakthrough medicines to the clinic Two molecules moving to Phase 2; one molecule entered Phase 1 ן 5. Reach competitive profitability Financial targets 2014 confirmed 1 Constant exchange rate 2 Brazil, Russia, India, China, Mexico and Turkey 3 Partial-onset seizures

7 Cimzia performance 7 Reaching more patients million 9M M 2013 Actual CER North America % 31% Europe % 40% Japan % 94% Emerging markets % -1% Rest of the World % 37% Total Cimzia % 36% Psoriasis: strategic collaboration with Dermira in dermatology Rheumatoid arthritis (RA) Psoriatic arthritis (PsA) Ankylosing spondylitis (AS) Crohn s disease (CD) Rheumatoid arthritis (RA) Psoriatic arthritis (PsA) Axial spondyloarthritis (incl. AS) Rheumatoid arthritis (RA) 1 Brazil, Russia, India, China, Mexico and Turkey Cimzia available to patients in 54 countries, including Brazil, Russia, Mexico & Turkey Numbers may not add due to rounding

8 Cimzia in-market performance (August 2014) 8 14% U.S. - Cimzia rheumatology growth 4.0% U.S. - Cimzia Rheumatology R3M TRx Share U.S. 12% 10% 8% 6% TRx market share 3.8% 11.9% 3.8% 3.6% 3.4% In-Market growth and share based on TRx Shares calculated based on Anti- TNF market In-market growth is calculated for MAT Aug 14 vs. MAT Aug 13 4% 2% 3.4% 5.3% 3.2% Market share is calculated for R3M Aug 14 0% Anti-TNF All Biologics Cimzia 3.0% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 45% EU - Cimzia RA growth 11.0% EU - Cimzia RA R3M Patient Share 40% EU 35% 30% 25% 20% 15% 10% 5% 0% 8.1% Patient market share 9.9% 15.6% 38.5% Anti-TNF All Biologics Cimzia 10.0% 9.0% 8.0% 7.0% 6.0% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 In-Market growth and share based on Exit Patients Shares calculated based on RA Anti-TNF market In-market growth is calculated for Aug 14 vs. Aug 13 Market share is calculated for R3M Aug 14 Rheumatology includes: Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSA), Axial Spondyloarthritis (AxSpA), and Ankylosing Spondylitis (AS) Source EU - IMS MIDAS + local UK HMSL data Source US - US IMS NPA data

9 Vimpat performance 9 Monotherapy in the U.S. launched in September million 9M M 2013 Actual CER North America % 12% Europe % 27% Emerging markets % 80% Rest of the World % 67% Total Vimpat % 17% Phase 2 Phase 3 Filing Monotherapy (EU) Q Monotherapy (U.S.) Oct Epilepsy POS 2 Adj. therapy (Asia) H Ped. adj. therapy 2017 Epilepsy PGTCS 3 Adj. therapy Start early Brazil, Russia, India, China, Mexico and Turkey 2 Partial-onset seizures 3 Primary general tonic clonic seizures Vimpat available to patients in 43 countries, including Russia, India & Mexico

10 Vimpat in-market performance (August 2014) 10 25% U.S. - Vimpat growth 3.2% U.S. - Vimpat - R3M TRx Share U.S. 20% 15% 10% TRx market share 3.1% 19.6% 3.1% 3.0% 2.9% 2.8% In-Market growth and share based on TRx In-market growth is calculated for MAT Aug 14 vs. MAT Aug 13 Market share is calculated for R3M Aug 14 5% 4.4% 2.7% 0% Market Vimpat 2.6% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 30% EU - Vimpat growth 2.1% EU Vimpat - R3M TDx Share EU 25% 20% 15% 10% 5% 0% -5% TDx market share 2.1% -1.3% Market 23.8% Vimpat 2.0% 1.9% 1.8% 1.7% 1.6% 1.5% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 In-Market growth and share based on TDx In-market growth is calculated for MAT Aug 14 vs. MAT Aug 13 Market share is calculated for R3M Aug 14 Source EU - IMS MIDAS Source US - US IMS NPA data

11 Neupro performance 11 On-going performance million 9M M 2013 Actual CER North America % 12% Europe % 8% Japan 12 5 >100% >100% Emerging markets % 16% Rest of the World % 91% Total Neupro % 15% Parkinson s disease (PD) Restless leg s syndrome (RLS) 1 Brazil, Russia, India, China, Mexico and Turkey Neupro available in 46 countries, including Russia & Mexico Numbers may not add due to rounding

12 Neupro in-market performance (August 2014) 12 20% U.S. - Neupro PD growth 7.0% U.S. - Neupro PD R3M TRx Share U.S. 15% 10% TRx market share 6.5% 6.5% 6.0% 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 5% 3.5% 5.5% In-market share is calculated for R3M Aug % 1.5% 0% Market Competitors Neupro 5.0% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 EU - Neupro PD growth EU5 Neupro PD- R3M TDx Share 20% 16.0% In-market growth and share based on TDx EU 15% 10% TDx market share 15.1% 15.0% Shares calculated based on PD Key Competitors markets In-market growth is calculated for MAT Aug 14 vs. MAT Aug 13 5% 12.2% 14.0% Market share is calculated for R3M Aug 14 0% 2.6% 1.6% Market Competitors Neupro 13.0% Aug'13 Oct'13 Dec'13 Feb'14 Apr'14 Jun'14 Aug'14 Parkinson s Disease (PD) Source EU - IMS MIDAS Source US - US IMS NPA data

13 UCB delivers growth 13 Core medicines tracking well towards peak sales targets Expected peak sales at least 1.5 billion 1 Inflammatory arthritis indications and Crohn s disease Total net sales of 561 million (+32%) Expected peak sales at least 1.2 billion 1 Epilepsy partial onset seizures Total net sales of 335 million (+14%) Monotherapy approved & launched in the U.S. Expected peak sales at least 400 million 1 Parkinson s disease and restless legs syndrome Total net sales of 148 million (+15%) Combined expected CVN peak sales at least 3.1 billion 1 1 Second half of the decade

14 Keppra performances 14 Sizeable franchise million 9M M 2013 Actual CER North America % -5% Europe % -14% Japan % 38% Emerging markets % 29% Rest of the World % -8% Total Keppra % -3% Status of exclusivity: Japan - exclusivity until 2018 U.S. - expired November 2008 (Keppra XR - September 2011) Europe - expired September 2010 Sizeable franchise going forward! 1 Brazil, Russia, India, China, Mexico and Turkey Numbers may not add due to rounding

15 UCB: Building emerging markets and Japan 15 Emerging markets* FX headwind and a specialty focus Net sales 9M 2014: -3% (+5% CER) Keppra : 68 million (+20%; +29% CER) Agreement with Biogen Idec to develop and commercialize multiple sclerosis and hemophilia therapies in Asia UCB Japan Net sales 9M2014: -6 % (+1% CER) E Keppra : 53 million (+25 %; +38% CER) Vimpat Phase 3 on-going, results expected H *Brazil, Russia, India, China, Mexico, Turkey

16 UCB's development pipeline 16 Pipeline filled with new molecular entities Phase 1 Phase 2 Phase 3 Filing brivaracetam epilepsy POS 1 / adj. therapy epratuzumab systemic lupus erythematosus romosozumab osteoporosis in postmenopausal women romosozumab osteoporosis in men UCB4940 (IL17) psoriatic arthritis UCB5857 (PI3K Delta inhibitor) immunological diseases CDP7657 (CD40L antibody) systemic lupus erythematosus UCB7665 immunological diseases Phase 3 results: H (Partner: Immunomedics) Phase 3 results: H (Partner: Amgen) Phase 2 start: early 2015 Phase 1 results: H (Partner: Biogen Idec) Submission: early 2015 Phase 3 results: H (Partner: Amgen) Phase 2 results: H 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 Selected biologic agents to be replaced with small molecules Potentially treating a wide range of immune-mediated diseases Two Phase 1 compounds (NBEs) with significant differentiation potential: CDP7657 (anti-cd40l) in systemic lupus erythematosus first results in H UCB7665, immunological diseases UCB5857 (PI3K Δ) successfully passed a Phase 1 study Phase 2 to start early 2015 UCB4940 (IL17) for psoriatic arthritis moved into Phase 2 First results in H NBE: new biological entity NCE: new chemical entity

18 2014 financial outlook confirmed 18 Full year 2014 expected dynamics Financial outlook 2014* Revenue ~ billion Cimzia, Vimpat, Neupro growth Recurring EBITDA ~ million Strong early and late-stage pipeline Continued cost efficiencies Core EPS ~ ~192 million shares *considers application of IFRS10 EBITDA: Earning before interests, taxes, depreciation and amortization charges EPS: Earnings per share

19 Appendix

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

21 UCB HY 2014 financial highlights 21 Good top-line performance driving growth Actual CER Revenue Continued sales growth of core medicines Adverse exchange rate impacts million +6% +10% Total operating expenses Continuous improvement and constantly striving for improved resource allocation 9% lower marketing & selling expenses Stable research & development expenses 920 million -4% -2% Recurring EBITDA 391 million +29% +40% Net profit 30% tax rate Core earnings per share (Based on 191 million weighted average shares outstanding) 113 million % +100% EBITDA: Earning before interests, taxes, depreciation and amortization charges CER: Constant Exchange Rate

22 HY 2014 net sales million (+7%; +11% CER) million Core medicines Cimzia Vimpat Neupro Total core products sales 672 million (+25%; +29% CER) Mature products Keppra Zyrtec Metadate CD Xyzal Nootropil omeprazole Other Total mature products sales 890 million (-4%; 0% CER) HY 2013 net sales HY 2014 net sales Keppra net sales include Keppra XR and AG net sales Zyrtec net sales include Zyrtec-D and Cirrus net sales Metadate TM CD net sales include methylphenidate XR net sales

23 Recurring EBITDA 23 million Growth despite FX headwinds HY 2014 HY 2013 Variance Actual (restated) 1 Actual CER Revenue % 10% Net sales % 11% Royalty income and fees % -6% Other revenue % 9% Gross profit % 10% Marketing and selling expenses % 5% R&D expenses % -2% G&A expenses % 3% Other operating income 2 3-7% -8% Total operating expenses % 2% Recurring EBIT % 74% Amortization of intangible assets % -11% Depreciation charges % 5% Recurring EBITDA % 40% 1 Restatement related to IFRS 10 EBIT: Earnings before interest and taxes EBITDA: Earning before interests, taxes, depreciation and amortization charges

24 Net profit 24 HY 2014 HY 2013 Variance million Actual (restated) 1 Actual CER Recurring EBIT % 74% Impairment charges >-100% >-100% Restructuring expenses % -30% Gain on disposals % 14% Other non-recurring income >-100% >-100% Total non-recurring income / expenses (-) >-100% >-100% EBIT % 64% Net financial expenses % 6% Income tax expenses (-) / credit >-100% >-100% Profit from continuing operations % >-100% Net profit % 100% Attributable to UCB shareholders >100% >100% Attributable to non-controlling interests >-100% >-100% 1 Restatement related to IFRS 10 EBIT: Earnings before interest and taxes

25 Core earnings per share 25 million Net profit attributable to UCB shareholders + After-tax non-recurring items and financial one-offs - Profit / loss (-) from discontinued operations HY 2014 HY 2013 Variance Actual (restated) 1 Actual CER >100% >100% >100% >100% % 58% + After-tax amortization of intangibles % -10% Core net profit % >100% Weighted average number of shares (mn) % N/A Core EPS % 92% 1 Restatement related to IFRS 10

26 Debt maturity schedule 30 June 2014) 26 Convertible bond early redeemed in March ( million) Liquid assets beyond Belgian Commercial Paper Belgian retail bond Institutional eurobond Perpetual bond EIB loan 1 Perpetual bond with first call date in March 2016, recognized as equity on UCB s balance sheet

27 HY 2014 net debt walk 27 million Change in net debt: m ,729-2,000 (107) (91) (175) (24) Net CF from Operations Taxes paid Capex Dividends & Treasury share issuance Net interest FX, Convertible bond, and other1 Net Includes: foreign exchange fluctuations, cash from discontinued operations, change in bank overdraft, available for sale debt security, non-cash portion of borrowings, and net proceeds / (loss from disposals)

28 Geographic and therapeutic breakdown 28 HY 2014 net sales : million North America 43% RoW + unallocated 4% France 5% Germany 7% Italy 5% Emerging markets 10% Japan 7% Spain 4% U.K. & Ireland 4% Europe others 11% Europe 36% Vimpat % Neupro 102 6% Keppra % CNS - other 77 5% Cimzia % Other % Immunology - Allergy 141 9%

29 Workforce distribution 29 Total 30 June 2014: employees Employees by function Employees by region Japan 4% Rest of the World 2% R&D 13% Belgium 22% Marketing & Sales 52% Manufacturing 26% Emerging market 26% Germany 8% France 1% G&A 9% North America 20% Europe - Others 7% UK & Ireland 8% Spain 1% Italy 1%

30 Upcoming expected R&D milestones CDP7657 SLE Phase 1 results UCB4940 psoriatic arthritis Phase 2 results brivaracetam epilepsy POS - adj. therapy submission romosozumab osteoporosis in postmenopausal women Phase 3 results Vimpat epilepsy POS - ped. adj. ther. - Phase 3 results Vimpat epilepsy POS - mono Phase 3 results epratuzumab SLE Phase 3 results Vimpat epilepsy POS - adj. ther. (Asia) - Phase 3 results romosozumab osteoporosis in men Phase 3 results Vimpat epilepsy POS - mono UCB5857 immunology Phase 2 start Vimpat PGTCS - adj. therapy - Phase 3 start Cimzia C-Early results Cimzia psoriasis Phase 3 start Cimzia Exxelerate results CNS Immunology Cimzia Juvenile IA Phase 3 results axspa / AS: axial spondyloarthritis / ankylosing spondylitis IA: Idiopathic arthritis POS: Partial onset seizures SLE: Systemic lupus erythematosus PMO: Post-menopausal osteoporosis

31 UCB's development pipeline 31 Life cycle management Phase 2 Phase 3 Filing Epilepsy POS 1 Monotherapy (EU) Q Adj. therapy (Asia) H Ped. adj. therapy 2017 Monotherapy (U.S.) Oct Epilepsy PGTCS 2 Adj. therapy Start early 2015 Psoriasis H Juvenile IA H Exxelerate H C-Early H AxSpA 3 (U.S.) Feb Plegridy 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 3 Axial Spondyloarthritis

32 Cimzia offers 2 unique solutions for the U.S. market 32 Lyophilized formulation and prefilled syringe Lyophilized formulation accounts for approx. 20% of U.S. Cimzia sales measured in IMS dollarized sales Consistent and continued growth of prefilled syringe as measured in IMS dollarized sales Rapid acceleration over the last 6 months +27% +10% +25% $35 +10% $38 +23% $47 +17% $55 $70 $ % $ % $206 $226 $283 H H H H H H H H H H IMS data is NSP ending rolling 6 month, ending May 2014

33 Access to Cimzia in the U.S. 33 Lives in preferred or co-preferred position Covered lives in millions Jan-12 Jan-13 Jan-14 Jul-14 Total lives with Cimzia (certolizumab pegol) in preferred or co-preferred position in the U.S. Source: Preferred lives from UCB Internal Contracts Database, co-preferred from UCB internal analysis.

34 Cimzia path to at least 1.5 billion peak sales 34 Phase 3 Filing Launch U.S. EU Japan Crohn s disease (CD) Apr 2008 Rheumatoid arthritis (RA) C-Early H Exxelerate H May 2009 Oct 2009 Mar 2013 Psoriatic arthritis (PsA) Sep 2013 Nov 2013 Ankylosing spondylitis (AS) Oct 2013 Oct 2013 Axial spondyloarthritis (AxSpA) U.S. Feb 2013 Oct 2013 Juvenile IA (JIA) Results H Psoriasis (Ps) Start H1 2015

35 Vimpat path to at least 1.2 billion peak sales 35 Phase 3 Filing Launch U.S. EU Japan Epilepsy POS 1 Adjunctive therapy Asia H Pediatric 2017 May 2009 Sep 2008 Monotherapy EU Q Sep 2014 Epilepsy PGTCS² Adjunctive therapy Phase 3 Start early Partial onset seizures 2 Primary generalized tonic-clonic seizures

36 Neupro path to at least 400 million peak sales 36 Phase 3 Filing Launch U.S. EU Japan Parkinson s disease (PD) Early stage May 2009 Feb 2006 Feb 2013 Advanced stage Jul 2012 Jan 2007 Feb 2013 Restless legs syndrome (RLS) Jul 2012 Jun 2009 Feb Partial onset seizures 2 Primary generalized tonic-clonic seizures

37 Brivaracetam clinical development path 37 A potential new option for people living with epilepsy Phase 1 Phase 2 & 3 30 studies completed 7 studies ongoing 10 studies completed (adults and children with focal and generalized epilepsy) 4 studies completed in other indications Exposure > people exposed in completed Phase 2 / 3 studies ~ patient years of exposure Some patients for > 8 years

38 Brivaracetam Phase 3 development program 38 New treatment option for patients with uncontrolled seizures patients (aged 16-70) 768 patients (aged 16-80) Efficacy + safety Tolerability + safety Efficacy + safety Duration 12 weeks 16 weeks 12 weeks N01252 N01253 N01254 N01358 Dosing placebo, 20, 50, 100 mg/day placebo, 5, 20, 50 mg/day flexible placebo, 100, 200 mg/day (fixed dose, no titration) Region Europe + India North / South America + Australia U.S. + Europe + RoW (27 countries) Primary endpoints median % reduction (U.S.) + responder rate (EU) * * * * Statistically significant

39 Positive Topline Results: Submission early Seizure reduction in treatment resistant patients Key characteristics and headline results One of the largest Phase 3 programs seen in epilepsy High unmet medical need in ~1/3 of treated epilepsy patients 50% of particiants were resistant to 5+ AEDs Statistically significant and clinically relevant topline results Seizure freedom observed Safety in line with previous studies* Presentation at upcoming epilepsy congresses Submission to U.S. and EU authorities planned for early 2015 Controlled on 1 st monotherapy 50% Uncontrolled despite 2-3 AEDs 25-30% 20-25% Controlled on more than 1 AED AED: Anti-epileptic Drug *The most commonly reported adverse events were somnolence, dizziness, fatigue and headache. Source: UCB data on file

40 Shareholder structure (September 2014) Stable shareholder base with free-float of 64% Total number of shares: million Weighted average shares outstanding: 192 million 40 Free float investors by region Source: Shareholder identification analysis (November 2013), 2013 and 2014 notifications and UCB underlying ownership analysis

41 Your UCB Investor Relations team 41 ן Antje Witte, Vice President Investor Relations Phone: [email protected] ן Alexandra Deschner, Investor Relations Director Phone: [email protected] ן Isabelle Ghellynck, Investor Relations Manager Phone: [email protected] ן Nathalie Deldime, Investor Relations Events Manager Phone: [email protected]