2013 half-year results. 31 July 2013

Transcription

1 2013 half-year results 31 July 2013

2 Disclaimer and safe harbour 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 2013 onwards UCB s five strategic growth priorities 3 1. Grow Cimzia, Vimpat and Neupro CVN + 30% to 537 million 2. Build emerging markets and Japan BRICMT 1 +35%; Japan -30% (+42% excl. allergy and currency effects) 3. Advance UCB s rich late-stage pipeline Top 2 in late-stage pipeline productivity² 4. Deliver breakthrough medicines to the clinic Growing super-network fostering borderless innovation 5. Reach competitive profitability Financial targets 2013 confirmed, on track for long-term targets 1 BRICMT: Brazil, Russia, India, China, Mexico and Turkey 2 Phase 3 NME/R&D expenses, U.S. and EU biopharma companies

4 Continued strong growth of UCB core medicines 4 Confirming 2013 FY financial guidance FY 2013 guidance Revenue million Approx. 3.4 billion Strong growth (+30%) of Cimzia, Vimpat and Neupro Strong growth in emerging markets (+35%) Keppra generic erosion in Europe million Recurring EBITDA 319 million Higher R&D expenses reflecting late-stage pipeline Core earnings per share (EPS) 0.90 Based on million weighted average shares outstanding EBITDA: Earning before interests, taxes, depreciation and amortization charges

5 Today s HY 2013 information flow 5 Welcome and introduction Roch Doliveux, CEO In-market performance: Cimzia, Vimpat, Neupro & Keppra Jean-Christophe Tellier, Executive VP, Biopharma Brands and Solutions Financial performance Detlef Thielgen, CFO Development update Iris Loew-Friedrich, CMO Conclusion Roch Doliveux, CEO

6 In-market performance: Cimzia, Vimpat, Neupro & Keppra Jean-Christophe Tellier, Executive VP, Biopharma Brands and Solutions

7 Cimzia performances 7 HY 2013 net sales +30% million HY 2013 HY 2012 Actual Constant North America % 22% Europe % 33% Japan 8 - BRICMT 3 1 > 100% > 100% Rest of the World 9 5 > 100% > 100% Total Cimzia % 33% Crohn s disease* Effective Clinical Response and Remission Rheumatoid arthritis Rapid Response Rapid Decision * Approved in U.S., Brazil, Russia, Mexico and 5 other countries

8 Cimzia quarterly net sales 8 Continued growth momentum Launch in CD Launch in RA Launch in RA Launch in RA

9 Cimzia offers 2 unique solutions for the U.S. market 9 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 +23% +15% +10% +15% +10% $47 +20% $188 $206 $27 +12% $30 $35 $38 $ % $135 $163 H H H H H H H H H H IMS data is NSP ending rolling 3 month, ending May 2013

10 Cimzia RA in-market performance (May 2013) 10 U.S. - Cimzia RA growth U.S. - Cimzia RA - TRx Share 30% 6.0% 25% 5.0% In-Market growth and share based on TRx U.S. 20% 15% 10% market share 4.8% 28.3% 4.0% 3.0% 2.0% Shares calculated based on RA Anti-TNF market In-market growth is calculated for MAT May 13 vs. MAT May 12 5% 0% 6.3% 10.5% Anti-TNF All Biologics Cimzia 1.0% 0.0% Q Q Q Q Q Q Q % EU - Cimzia RA growth 7.0% EU4 - Cimzia RA - Patient Share 35% 30% 6.5% In-Market growth and share based on Exit Patients EU 25% 20% 15% 10% 5% market share 7.4% 11.9% 12.2% 35.3% 6.0% 5.5% 5.0% 4.5% Shares calculated based on RA Anti-TNF market In-market growth is calculated for May 13 vs. May 12 Market share is calculated for May 13 0% Anti-TNF All Biologics Cimzia 4.0% May'12 Jul'12 Sep'12 Nov'12 Jan'13 Mar'13 May'13 RA: Rheumatoid arthritis Source EU - IMS MIDAS + local UK HMSL data Source US - US IMS NPA data

11 Vimpat performances 11 HY 2013 net sales +23% million HY 2013 HY 2012 Actual Constant North America % 28% Europe % 15% BRICMT % 46% Rest of the World % 16% Total Vimpat % 25% Epilepsy POS* Adjunctive therapy: When monotherapy is no longer enough Monotherapy (U.S.): submission H * POS: Partial onset seizures

12 Vimpat quarterly net sales Successful, strong performance in the AED* market Successful, strong performance in the AED* market 12 * AED: Anti-epileptic drug

13 Vimpat in-market performance (May 2013) 13 U.S. - Vimpat growth U.S. - Vimpat TRx Share 35% 3.0% U.S. 30% 25% 20% 15% 10% market share 2.8% 29.2% 2.5% 2.0% 1.5% 1.0% In-Market growth and share based on TRx In-market growth is calculated for MAT Apr 13 vs. MAT Apr 12 Market share is calculated for Apr 13 5% 0% 3.5% Market Vimpat 0.5% 0.0% May'12 Jul'12 Sep'12 Nov'12 Jan'13 Mar'13 May'13 35% EU - Vimpat growth 2.0% EU5 Vimpat - Treatment Days Share EU 30% 25% 20% 15% 10% market share 1.6% 29.3% 1.6% 1.2% 0.8% In-Market growth and share based on TDx In-market growth is calculated for MAT May 13 vs. MAT May 12 Market share is calculated for May 13 5% 0% 1.6% Market Vimpat 0.4% 0.0% May'12 Jul'12 Sep'12 Nov'12 Jan'13 Mar'13 May'13 Source EU - IMS MIDAS Source US - US IMS NPA data

14 Neupro performances 14 Latest launches: HY 2013 net sales +48% million HY 2013 HY 2012 Actual Constant North America 16 - Europe % 14% Japan 2 - BRICMT % 53% Rest of the World % 26% Total Neupro % 48% U.S. (July 2012); Japan (February 2013 by Otsuka) Impact across the motor and underlying symptoms of Parkinson s disease (PD) Powerful and lasting symptom relief for restless legs syndrome (RLS)

15 Neupro quarterly net sales 15 Launch: U.S. (2012) + Japan (2013) Launch Launch

16 Neupro in-market performance (May 2013) 16 25% U.S. - Neupro PD growth 10.0% U.S. - Neupro PD - TRx Share U.S. 20% 15% 10% 5% market share 9.0% 21.9% 9.0% 8.0% 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% In-market growth and share based on TRx Shares calculated based on PD Key Competitors markets In-market growth is calculated for Current R3M vs. Previous R3M In-market share is calculated for May 13 0% 2.3% 2.3% Market Competitors Neupro 1.0% 0.0% May'12 Jul'12 Sep'12 Nov'12 Jan'13 Mar'13 May'13 EU - Neupro PD growth EU5 Neupro PD- Treatment Days Share 25% 17.0% EU 20% 15% 10% market share 13.1% 19.8% 16.5% 16.0% 15.5% 15.0% In-market growth and share based on TDx Shares calculated based on PD Key Competitors markets In-market growth is calculated for MAT May 13 vs. MAT May 12 5% 0% 3.3% 3.1% Market Competitors Neupro 14.5% 14.0% 13.5% May'12 Jul'12 Sep'12 Nov'12 Jan'13 Mar'13 May'13 Market share is calculated for May 13 Source EU - IMS MIDAS Source US - US IMS NPA data

17 Keppra performances 17 HY 2013 net sales -19% million HY 2013 HY 2012 Actual Constant North America % -2% Europe % -35% Japan % 5% BRICMT % 39% Rest of the World % 6% Total Keppra % -17% Loss of exclusivity U.S. - November 2008 (Keppra XR - September 2011); Europe - September 2010 Japan: approval of E Keppra pediatric (May 2013) + dry syrup (June 2013) Sizeable franchise going forward!

18 UCB to deliver growth 18 Cimzia, Vimpat and Neupro driving company growth Expected peak sales at least 1.5 billion * 2 indications on the market: RA & CD Japan launched (March 2013) 2 indications filed: axspa & PsA (February 2013) Expected peak sales at least 1.2 billion* 1 indication on the market 3 indications in development Expected peak sales at least 400 million* 2 indications on the market: PD & RLS Launch: U.S. (July 2012) + Japan (February 2013) Combined expected CVN peak sales at least 3.1 bn * * Target:

19 HY 2013 Financial Performance Detlef Thielgen, Chief Financial Officer

20 HY 2013 financial highlights financial targets confirmed Revenue million Continued sales growth of the core medicines: Cimzia, Vimpat and Neupro Keppra generic erosion in Europe Total operating expenses 941 million Higher R&D expenses reflecting late-stage pipeline Higher G&A expenses due to expansion in emerging markets and IT Recurring EBITDA 319 million Higher R&D and generic erosion -3% 0% -12% Net profit 1 20% tax rate 87 million -36% Core earnings per share (EPS) 0.90* EBITDA: Earning before interests, taxes, depreciation and amortization charges * Based on million weighted average shares outstanding

21 Mature products Core medicines HY 2013 net sales million (-4%*) Total core products sales 537 million (+30%) Total mature products sales 929 million (-17%)** HY 2012 net sales HY 2013 net sales * Adjusted for product divestitures: -2%; ** -14% Keppra net sales include Keppra XR and AG net sales Zyrtec net sales include Zyrtec-D and Cirrus net sales

22 Recurring EBITDA 22 million Generic erosion and higher R&D expenses Actual Variance FX HY 2013 HY 2012 Actual Constant Revenue % -1% Net sales % -2% Royalty income and fees % 4% Other revenue % 15% Gross profit % -1% Marketing and selling expenses % -3% R&D expenses % 7% G&A expenses % 14% Other operating income 3-3 n.a. n.a. Total operating expenses % 2% Recurring EBIT % -15% Amortization of intangible assets % 8% Depreciation charges % 0% Recurring EBITDA % -8% EBIT: Earnings before interest and taxes EBITDA: Earning before interests, taxes, depreciation and amortization charges

23 Net profit 23 Actual Variance FX million HY 2013 HY 2012 Actual Constant Recurring EBIT % -15% Impairment charges -8-1 > 100% > 100% Restructuring expenses % -4% Gain on disposals 8 0 > -100% > -100% Other non-recurring income -8-1 > 100% > 100% Total non-recurring income / expenses (-) % 30% EBIT % -18% Net financial expenses % -8% Income tax expenses (-) / credit % 52% Profit from continuing operations % -31% Net profit attributable to UCB shareholders % -30% EBIT: Earnings before interest and taxes

24 Core earnings per share (EPS) 24 million Actual Variance FX HY 2013 HY 2012 Actual Constant Net profit % -30% + After-tax non-recurring items and financial one-offs - Profit / loss (-) from discontinued operation 16 4 >100% >100% % 69% Adjusted net profit * % -22% + After-tax amortization of intangibles % 6% Core net profit % -13% Weighted average number of shares (basic) % n.a. Core EPS % -15% * Adjusted for after-tax impact of one-time and non-recurring items

25 HY 2013 net debt walk 25 million Change in net debt Net 01 Jan 2013 Cash flow from operations Taxes paid Capex Dividends Net interest FX and other* Net 30 June 2013 * 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)

26 2013 financial outlook 26 Full year 2013 financial guidance confirmed Guidance 2013 Revenue approx. 3.4 billion Strong growth: Cimzia, Vimpat, Neupro Keppra continued generic erosion Recurring EBITDA million Continued 'investments' in Cimzia, Vimpat, Neupro Continued 'investments' in pipeline Core EPS ~179 million shares EBITDA: Earning before interests, taxes, depreciation and amortization charges EPS: Earnings per share

27 Development update Iris Loew-Friedrich, Chief Medical Officer

28 UCB's development pipeline 28 Immunology Phase 1 Phase 2 Phase 3 Filing Cimzia (certolizumab pegol) axspa 1 / ankylosing spondylitis Cimzia (certolizumab pegol) psoriatic arthritis Filed (Feb 2013) Filed (Feb 2013) epratuzumab SLE² Cimzia (certolizumab pegol) juvenile idiopathic arthritis romosozumab (sclerostin antibody) post-menopausal osteoporosis CDP7657 (anti-cd40l) SLE² Phase 3 results Q Phase 3 results H Phase 3 results end 2015 Results H UCB4940 immunological diseases 1 AxSpa: axial spondyloarthritis 2 SLE: Systemic lupus erythematosus

29 UCB's development pipeline 29 Central Nervous System (CNS) Phase 1 Phase 2 Phase 3 Filing Vimpat (lacosamide) epilepsy POS 1 / monotherapy (U.S.) Vimpat (lacosamide) epilepsy POS 1 / monotherapy (EU) brivaracetam epilepsy POS 1 / adj. therapy Vimpat (lacosamide) epilepsy POS 1 / adj. therapy (Asia) Phase 3 results (March 2013) Phase 3 results Q Phase 3 results H Phase 3 results H Submission H Vimpat (lacosamide) epilepsy POS 1 / ped. adj. therapy Vimpat (lacosamide) epilepsy PGTCS² / adj. therapy tozadenant (SYN115) Parkinson s disease First phase 2 results Phase 2 results Phase 2 results Phase 3 to start H Phase 3 to start H POS: Partial onset seizures 2 PGTCS: Primary generalized tonic-clonic seizures

30 Spectrum of axial spondyloarthritis (axspa) 30 Current concept Axial Spondyloarthritis Non-radiographic axspa Ankylosing spondylitis (AS) Prevalence axspa: ~1% 1 AS: ~ 0.5%² RA: ~1% PsA: ~ 0.3% 1 (0.9% to 1.4%); source: Reveille JD, et al. Arthr Care Res. 2012;64(6): (0.03% to 0.9%); source: Helmick, CG et al. Arthritis Rheum. 2008;58(1):15-25

31 Axial spondyloarthritis (axspa) 31 Development of the disease Early Late / Established

32 Axial spondyloarthritis disease spectrum 32 Axial Spondyloarthritis (axspa) Non-Radiographic (nr-axspa) mny Ankylosing Spondylitis (AS) mny+ Inflammatory back pain Additional SpA ffeatures: (eg, uveitis, psoriasis, IBD, CRP) Sacroiliitis in MRI Definitive sacroiliitis on x-ray Variable rate of progression Braun J. Clin Exp Rheumatol. 2012;30(4suppl 73):S132-S135 Rudwaleit M, et al. Arthritis Rheum. 2009;60(3): Rudwaleit M, et al. Ann Rheum Dis. 2009;68:

33 Patients, % (95% CI) Primary endpoint (AS001) Statistically significant, clinically meaningful improvement in ASAS20, Wk 12 (overall axspa Population) p < p = % 38.3% Week % Placebo (N = 107) CZP Q2W (N = 111) CZP Q4W (N = 107) CI = confidence interval Randomized Set [NRI]

34 Patients Comparable ASAS20 and ASAS40 response (AS001) 34 AS and nr-axspa subpopulations ASAS20 100% 90% 80% 70% ASAS40 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% AS - Placebo (n = 57) Week nr-axspa - Placebo (n = 50) 60% 50% 40% 30% 20% 10% 0 AS - CZP combined (n = 121) Week nr-axspa - CZP combined (n = 97) * Nominal p 0.05 CZP combined arms vs placebo for both subpopulations Randomized Set [NRI]

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) EMBLEM (N=203) EMBLEM OLE (N=203) 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 * Open-label extension data presented at EULAR, June 2013

36 Competitive late-stage pipeline 36 Transformational potential Phase 1 Phase 2 Phase 3 Filing CDP7657 SLE Vimpat epilepsy POS / ped. adj. th. romosozumab post-menopausal osteoporosis Vimpat epilepsy POS / mono U.S. Cimzia psoriatic arthritis UCB4940 immunology Vimpat epilepsy PGTCS / adj. th. Cimzia juvenile IA epratuzumab systemic lupus erythematosus Cimzia axspa / AS tozadenant Parkinson s disease Vimpat epilepsy POS / adj. th. (Asia) brivaracetam Epilepsy POS / adj. th. Vimpat epilepsy POS / mono EU CNS Immunology POS: Partial onset seizures PGTCS: Primary generalized tonic clonic seizures axspa: axial spondyloarthritis

37 Roch Doliveux Conclusion

38 Late stage pipeline productivity 38 UCB leads the way on late stage pipeline productivity Number of New Molecular Entities (NMEs) per $bn #1 UCB #3 #4 #5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15 1 Phase 3 NMEs / 2013 R&D Source: UCB company information

39 Superior and sustainable value Growth prospects confirmed with five main drivers 39 Cimzia, Vimpat, Neupro Emerging markets Mature product portfolio

40 Appendix

41 UCB: reinventing itself, leveraging a solid heritage to deliver sustainable and superior value for patients : Emmanuel Janssen establishes UCB in Brussels 1972: A new stateof-the-art R&D center in Brainel Alleud, Belgium 1990s: approval of Keppra, a novel anti-epileptic 2006: UCB acquires German pharma company Schwarz Pharma Today Combine leadership in antibody research & chemistry expertise to better treat severe diseases 1936: UCB enters the United States 1952: UCB discovers Atarax U.S. license awarded to Pfizer 1980s: UCB registers its novel antihistamine Zyrtec 2004: UCB acquires British biotech company Celltech Launch of Cimzia, Vimpat & Neupro s 1990s Today Chemical Group Primary Care Pharma Specialty Bio-Pharma

42 Geographic and therapeutic breakdown 42 Net sales HY 2013: million Europe 39% Immunology & Allergy 24%

43 Shareholder structure 43 Stable shareholder base, free float of 62% Free float investors by region Source: Shareholder identification analysis (November 2011), 2012 and 2013 notifications and UCB S.A. underlying ownership analysis

44 Spectrum of Axial Spondyloarthritis (axspa) 44 Current Concept* Axial spondyloarthritis Peripheral spondyloarthritis PsA AS ReA Non-radiographic axspa A of IBD *The sizes of the circles do not represent comparative prevalence

45 Cimzia in active axspa: AS001 study design 45 Wk 0 Wk 12 Wk 16 Wk 24 N = 325 Screening N = 107 N = 111 Stratification by Site LD LD N = 107 LD a mny status LD 400 mg Wk 0, 2, 4 Prior anti-tnf use Double-Blind Double-Dummy CZP 200 mg Q2W sc (CZP Q2W) CZP 400 mg Q4W sc (CZP Q4W) Placebo Escape b N = 27 LD 400 mg Wk 16, 18, 20 LD CZP Q2W Dose- regimen blind follow-up to Week 48 and open-label follow-up to Week dose regimens with the same cumulative monthly dose N = 29 LD CZP Q4W CZP = Cimzia ; LD = loading dose; mny = modified New York; Q2W = 200 mg every 2 weeks; Q4W = 400 mg every 4 weeks; sc = subcutaneous. a Loading dose of placebo; b Escape = patients who did not achieve ASAS20 at both Weeks 14 and 16.

46 HY 2013 major milestones 46 Q Q Cimzia psoriatic arthritis - filing Vimpat epilepsy POS mono - phase 3 results Cimzia axspa - filing romosozumab fracture healing - no phase 3 decision Neupro PD & RLS - launch tozadenant PD - in-licensing Cimzia rheumatoid arthritis - launch CNS Immunology axspa: axial spondyloarthirtis PD: Parkinson s disease RLS: Restless legs syndrome

47 Upcoming expected R&D milestones Vimpat epilepsy POS - ped. adj. therapy - phase 3 start Cimzia Juvenile IA phase 3 results epratuzumab SLE - phase 3 results Cimzia C-Early results Vimpat epilepsy POS - mono - submission brivaracetam epilepsy POS - adj. therapy - phase 3 results romosozumab PMO phase 3 results Cimzia Exxelerate results Vimpat epilepsy POS - mono phase 3 results Vimpat epilepsy POS - adj. th. (Asia) - phase 3 results CNS Immunology POS: Partial onset seizures PGTCS: Primary generalized tonic clonic seizures SLE: Systemic lupus erythematosus IA: Idiopathic arthritis PMO: Post-menopausal osteoporosis

48 Your UCB Investor Relations team 48 Antje Witte, Vice President Investor Relations Phone: antje.witte@ucb.com Alexandra Deschner, Investor Relations Director Phone: alexandra.deschner@ucb.com Isabelle Ghellynck, Investor Relations Project Manager Phone: isabelle.ghellynck@ucb.com Nathalie Deldime, Investor Relations Events Specialist Phone: nathalie.deldime@ucb.com