2010 full-year results 2 March 2011

Transcription

1 2010 full-year results 2 March 2011 Progressing to become the patient-centric global biopharma leader Alison, living with rheumatoid arthritis

2 Disclaimer and safe harbour 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 predict, that may cause actual results to differ materially from any future results expressed or implied from the forward-looking statements. In this presentation, the words anticipates, believes, estimates, seeks, expects, plans, intends and similar expressions, as they relate to UCB, are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from such expectations include, without limitation: the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms; the economic environment of the industries in which UCB operates; costs associated with research and development; changes in the prospects for products in the pipeline or under development by UCB; dependence on the existing management of UCB; changes or uncertainties in tax laws or the administration of such laws; changes or uncertainties in the laws or regulations applicable to the markets in which UCB operates. All written and oral forward-looking statements attributable to UCB or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements above. UCB does not intend, or undertake any obligation, to update these forward-looking statements. 2

3 2010 information flow Welcome and introduction Roch Doliveux, CEO Major products performance Roch Doliveux, CEO Financial performance Detlef Thielgen, CFO R&D update: advancing the pipeline Ismail Kola, CSO Conclusion Roch Doliveux, CEO 3

4 Welcome and introduction Roch Doliveux, CEO DeOnna, living with rheumatoid arthritis

5 UCB: to be patient-centric global biopharma leader 5 Focus: Immunology and Central Nervous System R&D Spend: 22% of Revenue About patients treated with UCB s new core products Operations in more than 40 countries About employees globally Stephanie, living with rheumatoid arthritis 5

6 2010 financial highlights Revenue of million Strong Cimzia, Vimpat and Neupro 3% Strong Keppra sales in EU and venlafaxine XR in U.S. Underlying profitability (Recurring EBITDA) of 731 million 5% Core EPS of , above guidance 15% 1. based on 180 million shares outstanding 6

7 patients have now been treated An increase of 88% versus December 2009 UCB is becoming the Patient-Centric global biopharmaceutical leader Fast response for predictable outcomes patients prescribed Expected peak sales of at least 1.5 billion 1 when monotherapy is no longer enough patients prescribed Expected peak sales of at least 1.2 billion 1 24h continuous delivery by transdermal patch patients prescribed Expected peak sales of at least 400 million 1 1 to be reached in the second half of the decade 7

8 Major products performance Roch Doliveux, CEO Brett, living with crohn s disease

9 Cimzia Fast response for predictable outcomes Net sales increased by 163% million North America Europe ROW TOTAL 2010 net sales net sales Rheumatoid arthritis - Fast response for predictable outcomes Fast response with Cimzia means: The opportunity to make an informed treatment decision within 12 weeks Improved long-term outcomes Crohn s disease (U.S. + Switzerland) - For naïve or bio-experienced patients Fast Results after just 1 dose Stable & Sustainable Long-term remission with no dose escalation Stable 1 predictable subcutaneous Q4-week dose ~ patients on Cimzia 9

10 Cimzia provides a fast response for results that last 1 The degree and speed of response with Cimzia was highly predictive of outcomes at 52 weeks 3 Available data suggest that a clinical response is usually achieved within the first 12 weeks of CIMZIA treatment 2 Predicting response at week 12 can improve therapeutic benefit by making an early treatment decision possible and avoiding unnecessary costs and safety exposure 4 RAPID 1 was a 52-week, multicenter, randomized, double-blind, placebo-controlled study in 982 patients with active RA receiving CIMZIA 200 mg (n=393), CIMZIA 400 mg (n=390), or placebo (n=199) every 2 weeks + weekly methotrexate (MTX) after an initial starting dose of CIMZIA 400 mg at weeks 0, 2, and 4. The co-primary end points were ACR20 score at week 24 and change in mtss at week Similar results were seen in RAPID 2. The best-fit curve above represents the probability of LDA at week 52 in patients who do not achieve a DAS28 response 1.2 at the given time point. RAPID 1 was a 52-week, multicenter, randomized, double-blind, placebo-controlled study in 982 patients with active RA receiving CIMZIA 200 mg (n=393), CIMZIA 400 mg (n=390), or placebo (n=199) every 2 weeks + weekly methotrexate (MTX) after an initial starting dose of CIMZIA 400 mg at weeks 0, 2, and 4. The co-primary end points were ACR20 score at week 24 and change in mtss at week Similar results were seen in RAPID 2. * Not all patients may have responded at each time point. 1. Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis. Arthritis Rheum. 2008;58: CIMZIA [summary of product characteristics]. Bruxelles, Belgium: UCB Pharma, S.A.; Data on file. UCB, Inc; Smyrna, GA. 4. Aletaha D, Funovits J, Keystone EC, Smolen JS. Disease activity early in the course of treatment predicts response to therapy after one year in rheumatoid arthritis patients. Arthritis Rheum. 2007:56:

11 Cimzia in rheumatoid arthritis U.S. Gaining use even in an entrenched marketplace Cimzia RA indexed vs Total Market: 240 RA Indexed Monthly Rx Jan 10 Feb 10 Mar 10 Apr 10 May 10 Jun 10 Jul 10 Aug 10 Sep 10 Oct 10 Nov 10 Dec 10 Cimzia Nrx Cimzia Trx Total Market Nrx Total Market Trx NRx = New prescriptions / TRx = Total prescriptions 1. IMS National Prescription Audit (NPA) 11

12 Cimzia for Crohn's disease - U.S. An important new option for U.S. patients Cimzia CD indexed vs Total Market: 160 CD Indexed Monthly Rx Jan 10 Feb 10 Mar 10 Apr 10 Cimzia Nrx Cimzia Trx May 10 Jun 10 Jul 10 Aug 10 Sep 10 Oct 10 Nov 10 Total Market Nrx Total Market Trx Dec 10 NRx = New prescriptions / TRx = Total prescriptions 1. IMS National Prescription Audit (NPA) 12

13 Cimzia roll-out Launched in 20 countries + further launches planned for Launches 2009 Launches Launch Countries Ireland Italy Sw itzerland France Greece Australia Slovakia Spain Austria Belgium Hungary Finland Ne therlands Sw eden Norw ay UK Denm ark Germ any Canada U.S. Q Q Q Q Q Q Q

14 Vimpat in epilepsy When monotherapy is no longer enough Net sales increased by 190% million North America Europe ROW TOTAL 2010 net sales net sales ~ patients on Vimpat A new treatment option in add-on for POS 1 Efficacy when added to broad range of 1st and 2 nd generation AEDs 2 No drug-drug interactions; multiple formulations 1 Partial onset seizures 2 Anti-epileptic drug 14

15 Vimpat Improved seizure control Regardless of patient s concomitant therapy 15

16 Vimpat -U.S. Successful launch in the AED market 200 Indexed Monthly Rx Jan 10 Feb 10 Mar 10 Vimpat Trx Apr 10 May 10 Jun 10 Jul 10 Aug 10 Sep 10 Oct 10 Total Market Trx Nov 10 Dec 10 Vimpat Nrx Total Market Nrx * Total Market: Carbamazepine, Gabapentin, Lacosamide, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenytoin, Pregabaline, Rufinamide, Tiagabine, Topiramate, Valproic Acid, Vigabatrin, Zonisamide AED = Anti-Epileptic Drug Source: IMS National Prescription Audit (NPA) 16

17 Vimpat roll-out Launched in 22 countries + further launches planned for Launches 2009 Launches 2008 Launches Launch Countries Mexico Canada Italy Russia Australia Czech Belgium Finland Sw itzerland France Spain Norw ay U.S. Netherlands Slovakia Sweden Denmark Ireland Greece Austria UK Germ any Q Q Q Q Q Q Q Q Q Q

18 Neupro roll-out in Europe and Rest of the World 24h continuous delivery by transdermal patch Net sales increased by 37% million Europe ROW TOTAL 2010 net sales net sales ~ patients on Neupro Parkinson s disease and Restless 24h continuous delivery by transdermal patch Continuous delivery to provide stable drug levels Improving daily functioning, sleep and early morning functions 18

19 Neupro - rotigotine transdermal patch Continued launch roll-out Launch Countries Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Launches 2009 Launches 2008 Launches 2007 Launches 2006 Launches Mexico Poland Romania Czech Republic Ne therlands Australia Hong-Kong Finland Italy Slovakia Sweden Norw ay De nmark Austria Spain Sw itzerland Greece Ireland U.K. Germany 19

20 Keppra franchise Market leadership in Europe and Rest of the World million Europe 2010 net sales net sales 545 Actual 11% CER 10% North America % -18% Rest of World % 6% Total % 0% Loss of exclusivity in the U.S. (November 2008) Loss of exclusivity in the E.U. (September 2010) Sustained growth outside the U.S., generated by use in monotherapy E Keppra - most successful antiepileptic launch in Japan Sizeable franchise going forward! 20

21 2010 Financial Performance Detlef Thielgen, CFO Christer, living with Parkinson s disease

22 2010 Financial highlights Revenue of million Generic competition to mature products compensated by Cimzia, Vimpat and Neupro ; strong Keppra sales in EU and venlafaxine XR in U.S. Total operating expenses million Increased launch expenses for Cimzia, Vimpat and Neupro 3% 4% Pipeline progress trigger new clinical development programmes Recurring EBITDA of 731 million Net profit 1 of 103 million Adjusted net profit of 239 (+6%) Core EPS of Gross dividend of 0.98 per share 5% 80% 15% 6% 2% 1 After non-controlling interests 2. based on 180 million shares outstanding, see appendix for Core EPS calculation details 22

23 Net sales of major and new products Net sales 2010: million In million Core products Cimzia Vim pat Neupro +163% +190% +34% Core products combined sales of 413 million up by 127% in the first full year of sales on track to meet peak sales guidance Keppra 1 +3% 942 Zyrtec -15% 229 Mature products venlafaxine XR Xyzal 2 Tussionex Nootropil omeprazole +49% % % 80-5% +1% Total mature products sales reached million down by 5% following further generic competition Metadate -26% 54 Other products -9% 660 Note: % constant exchange rates 1 Including 83 million of Keppra XR in the U.S Excluding Xyzal U.S. revenue to UCB of 28 million from profit-sharing with sanofi-aventis

24 2010 net sales Solid growth from core products million Mature products -128 Core products net sales million 2009 Net Sales Cimzia Vimpat Neupro 2010 net 2010 sales Net Sales million % 24

25 Recurring EBITDA Consistent solid underlying profitability million Revenue Net sales Royalty income & fees Other revenue Gross profit Marketing & selling expenses R&D expenses G&A expenses Other operating income Total operating expenses Actual Variance Actual CER 3% 0% 4% 0% -3% -7% 3% 0% 4% -1% 2% -3% 5% 2% 3% 1% n.s. n.s. 4% 0% Recurring EBIT % -7% Amortisation of intangible assets % 30% Depreciation charges % -31% Recurring EBITDA % -3% 25

26 Net profit Strong REBIT impacted by non-cash, one-time charges million Recurring EBIT Impairment charges Restructuring expenses Gain on disposals Other non recurring expenses Total non recurring income/(expenses) EBIT Net financial expenses Income tax (expense)/credit Profit from continuing operations Net profit 1 Adjusted net profit 2 Actual Variance Actual CER 3% -7% 78% 73% -46% -48% n.s. n.s. n.s. n.s. n.s. n.s. -76% -80% 14% 13% n.s. n.s. -79% -85% -80% -85% 6% -8% 1 After non-controlling interest 2 Adjusted for after-tax impact of one-time and non-recurring items 26

27 2010 cash flows Operating activities 506 m Investing activities -63 m Financing 1 activities -440 m FY 2009 cash 466 million FY 2010 cash 87% 477 million 1 1 Includes effect of exchange rate fluctuations 27

28 Net debt evolution Strong free cash flow reduces net debt by 15% million 31 Dec Dec 2009 Net debt Liquid assets Financial debt Net Debt ( million) Net Debt/REBITDA 2,500 2, x 2,000 1,500 1,915 1,752 1, x 2.5x 2.1x 1, A 2008A 2009A 2010 A A 2008A 2009A 2010 A 28

29 2011 financial outlook Revenue is expected between 3.0 and 3.1 billion Recurring EBITDA expected to be in the range between 650 and 680 million Core EPS expected to reach approximately 1.60 to based on 180 million shares outstanding, see appendix for Core EPS calculation methodology 29

30 UCB's Sustainable Future Growth Cimzia, Vimpat and Neupro trigger company growth Intense growth Breakthrough Cimzia, Vimpat, Neupro Optimise mature base business Manage remaining loss of exclusivity Company growth Realise the full commercial potential of Cimzia, Vimpat, Neupro Launch a new generation of therapies offering breakthrough innovation to patients with severe disease 2010 lifecycle management first Breakthroughs... and beyond 30

31 R&D update: advancing the pipeline Ismail Kola Executive VP, UCB. President UCB NewMedicines Esperanza, living with RLS

32 Development pipeline with significant progress Central Nervous System (CNS) Neupro (rotigotine) Adv. Parkinson's disease (U.S.) Neupro (rotigotine) Restless legs syndrome (U.S.) Xyrem (sodium oxybate) Fibromyalgia (EU) Phase I Phase II Phase III Regulatory status Filed CRL* November Dec CRL* Dec 2008 CRL1 April Filed 2010 Vimpat (lacosamide) Epilepsy monotherapy (U.S.) Results Q Vimpat (lacosamide) Epilepsy monotherapy (EU) brivaracetam Epilepsy adj. therapy Vimpat (lacosamide) Epilepsy Paediatric adj. therapy first results Results Q Results H Vimpat (lacosamide) Epilepsy adj. therapy PGTCS Results H UCB0942 (PPSI) Epilepsy * Complete Response Letter 32

33 Development pipeline with significant progress Immunology Cimzia (certolizumab pegol) Rheumatoid arthritis (Japan) Cimzia (certolizumab pegol) Ankylosing spondylitis Cimzia (certolizumab pegol) Psoriatic arthritis epratuzumab SLE Phase I Phase II Phase III positive results Results Q Results Q Results H Regulatory status Cimzia (certolizumab pegol) Juvenile rheumatoid arthritis CDP7851 (anti-sclerostin) Post-menopausal osteoporosis CDP7851 (anti-sclerostin) Fracture healing olokizumab (anti-il 6) Rheumatoid arthritis Results Q Results 2012 Results Q CDP7657 (anti CD40L) SLE 33

34 Additional external pipeline options Therapeutic area / Indication Stage of development Development path + Partner SYN-115 (A2a) CNS Parkinson s disease Phase II trial ongoing; Phase IIb to start in Q Synosia/Biotie to complete Phase II; UCB to take over SYN-118 (HPPD) CNS Parkinson s disease Phase II trial ongoing Phase III development and commercialisation MEK inhibitor (WX554) Oncology Successful completion of Phase I dose escalation study Wilex to do further Phase I development 34

35 UCB NewMedicines strategy and business model A new R&D paradigm to deliver differentiated drugs Partnering and virtualisation to complement internal capabilities Deliver differentiated molecules Increase success rates Enhance scientific excellence Increase efficiency Innovative targets (Academic/biotech) SEGMENTED Wholly owned assets PORTFOLIO Implement extreme networking and open innovation Shared risk Outlicensing UCB incubators 35

36 Our model addresses the industry s low R&D developmental and commercial success rates 89% of molecules in development fail** 42% of Phase III trials fail* 70% launched products fail to recoup initial investment Pre-clinical Clinical (all phases) Commercial 2/1000 Reasons for attrition 1/10 3/10 **Ismail Kola & John Landis (2004). Nature Reviews: Drug Discovery 3 : * Source: Why drugs fall short in late stage trials, McKinsey Quarterly, Pharmaprojects, Evaluate 36

37 Attrition rates of failed Phase III candidates reveals POC Paradigm benefits OBJECTIVITY AND AND ROBUSTNESS OF REGISTERABLE OF BIOMARKER ENDPOINT H L 42% of Phase III trials fail* High Biomarker DESIRED QUADRANT FOR MOST Low POC OF PORTFOLIO Attrition rate 63% Attrition rate 25% LEAST DESIRABLE QUADRANT High POC FOR PORTFOLIO IN LATE STAGE DEVELOPMENT Low Biomarker Attrition rate 70% Attrition rate 37% H P.O.C IN MAN Source: Evaluate; Pharmaprojects; Factiva; literature search; McKinsey analysis; I. Kola Note: Includes aggregate attrition rates for following TAs: CNS, Endocrine, CV, ID, Oncology, and Respiratory. All figures are rounded 37

38 Paradigm to pick winners and kill early TEST THE THEORY - LEARN CONFIRM THE THEORY CANDIDATE APPROVAL FIH including target engagement biomarker POC-light IN MAN endpoints for internal decision making POC at Ph IIB robust register-able endpoint APPROVAL AND LAUNCH 38

39 UCB2892 (H3 antagonist) January 2011: Robust data-driven decision making Termination of Phase I program for UCB2892, an H3 antagonist with potential for cognitive disorders Results demonstrated uncompetitive clinical profile UCB s new paradigm for robust decision-making: demonstrable speed and cost efficiency in development path Comparison versus conventional approach* Timeline to defined endpoint Costs 37% % *Conventional approach = Alzheimer s trial 39

40 olokizumab (CDP6038) A highly potent anti-il6 inhibitor with a novel mechanism of action First in a new class of anti-il-6 inhibitors that selectively blocks the final assembly step of the IL-6 signaling complex Phase Ib: Study in RA patients completed in Q Potently induced and sustained CRP suppression Well tolerated at all doses Half-life of 31 days and absolute bioavailability of 75% (SC) Low incidence of immunogenicity Phase IIb: SC Dose ranging study initiated ahead of plan in Q >200 patients with active RA who have failed TNF blocker therapy Active comparator Actemra IV Headline results Q expected 40

41 Pipeline Significant January Q2 pipeline growth in 2010 through novel molecules Pipeline December 2010 CNS Phase I Phase II Phase III Filed UCB2892 (H3 antagonist) Cognitive disorders UCB0942 Epilepsy X Vimpat Paediatric programme Vimpat Adj. therapy PGTCS Vimpat Monotherapy U.S. Vimpat Monotherapy EU Xyrem Fibromyalgia FIM achieved Q4 Assets acquired Q2 SYN115 1 Parkinson s disease brivaracetam Adj. therapy SYN118 1 Parkinson s disease Immunology CDP7657 (anti-cd40l) SLE CDP7851 (anti-sclerostin) Fracture healing Cimzia Ankylosing spondylitis FIM achieved Q2 CDP7851 (anti-sclerostin) PMO Cimzia Psoriatic arthritis CDP6038 (anti-il6l) Autoimmune diseases CDP6038 (anti-il6l) Autoimmune diseases Cimzia RA / Japan POC light completed Phase IIb study started Q4 epratuzumab SLE epratuzumab SLE Oncology incubation MEK inhibitor 2 New entrant/phase transition Novel molecule Moving into phase 1 Developed by Synosia in partnership with UCB 2 Developed by Wilex in partnership with UCB 41

42 UCB NewMedicines implementing a new R&D paradigm Deliver differentiated molecules Increase success rates Enhance scientific excellence Increase efficiency Implement extreme networking and open innovation 42

43 UCB's Sustainable Growth Roch Doliveux, CEO Stephanie, living with rheumatoid arthrits

44 UCB is delivering on Financial targets Core product launches Cimzia, Vimpat, Neupro Increased patient reach Strong pipeline to achieve sustainable company growth 44

45 UCB's Sustainable Future Growth Cimzia, Vimpat and Neupro trigger company growth Intense growth Breakthrough Cimzia, Vimpat, Neupro Optimise mature base business Manage remaining loss of exclusivity Company growth Realise the full commercial potential of Cimzia, Vimpat, Neupro Launch a new generation of therapies offering breakthrough innovation to patients with severe disease 2010 lifecycle management first Breakthroughs... and beyond 45

46 Questions? 46

47 Appendix 47 47

48 Major milestones expected in 2011 Xyrem for fibromyalgia Feedback from the European authorities H CDP7851 (anti-sclerostin) in Post-menoposal osteoporosis Phase II headline results H Vimpat in epilepsy adj. therapy PGTC Phase II headline results H Cimzia in Ankylosing spondilytis Phase III headline results Q Cimzia in Psoriatic arthritis Phase III headline results Q

49 Core EPS million 2010 Net profit % After-tax non-recurring items & financial one-offs Profit from discontinued operation Tax one-offs Adusted net profit % + Amortisation of intangibles - Taxes on amortisation of intangibles Core net profit % Weighted average number of shares (basic) 180 Core EPS ( ) % +1 Actual Actual Variance n.s. n.s. n.s. 36% 32% 0% 1 Adjusted for after-tax impact of one-time and non-recurring items 49

50 Geographic and Therapeutic breakdown Net sales 2010: million Focused From primary care to specialist physicians 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 America 37% Other Int'l markets 1% Asia 5% Japan 6% Other Europe 17% Italy 5% U.K & Ireland 5% Spain 5% Europe 51% Other 37% Immuno Immunology & & allergy 18% 19% CNS 44% 50

51 2010 balance sheet million Cash and Cash Equivalents Other Current Assets Other Non- Current Assets Other Current Liabilities Current Debt Other Non- Current Liabilities Intangible Assets Non-Current Debt Goodwill Shareholder s Equity: 47% Total assets: million Total liabilities: million 51

52 Shareholder structure 1 Strong and stable shareholder base Tubize 36% Free float investors by region Concert 14% Other investors, 15% Other institutional Cont.Europe, investors 14% 20% Capital Research 12% Unidentified, 15% North America, 40% UK & Ireland, 8% Wellington 3% Belgium, 23% 1. Source: Global shareholder intelligence report, January 2010 Tubize has declared acting in concert separately with each of the shareholders 4,5,6,7,8,9,10 for the number of shares as indicated. 52