month interim update

Transcription

1 month interim update Brussels, 25 October 2016 Mariana, living with epilepsy

2 Disclaimer and safe harbor Forward-looking statements M interim update - 2 This presentation contains forward-looking statements, including, without limitation, statements containing the words believes, anticipates, expects, intends, plans, seeks, estimates, may, will, and continue and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this presentation. Important factors that could result in such differences include but are not limited to: 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. 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. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this presentation. UCB expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect any change in its expectations with regard thereto or any change in events, conditions, for circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

3 2016 9M interim update - UCB is progressing on its strategic growth path in Patient Value Strategy delivers shareholder value Strong growth Growth expansion Breakthrough phase Grow Cimzia, Vimpat and Neupro Combined net sales: billion (+18%) Advance and prepare growth expansion Briviact (brivaracetam) launched Romosozumab: filed in the U.S. Deliver breakthrough solutions Strong early pipeline with 10 NMEs 1 Continued focus Nitrates divested 2016 financial outlook confirmed Mid-term target: Competitive 30% rebitda margin in NME: New Molecular Entity

4 9 months key product performance On track to deliver FY 2016 guidance M interim update - 4 9M M 2015 Variance million Actual Actual CER Revenue % 7% Immunology / Cimzia % 21% Neurology* % 9% Vimpat % 19% Keppra % -3% Briviact 11 Neupro % 11% Numbers may not add due to rounding CER: constant exchange rate * include multiple sclerosis therapies in Asia (partner: Biogen)

5 Romosozumab in bone loss disorders M interim update - 5 Potential important treatment option for osteoporosis STRUCTURE: Phase 3 active-controlled study in postmenopausal women with osteoporosis (Sep 2015) FRAME: Phase 3 placebo-controlled study in postmenopausal women with osteoporosis (Feb 2016) BRIDGE: Phase 3 placebo-controlled study in men with osteoporosis (Mar 2016) Manorama, living with osteoporosis Biologic License Application (BLA) filed with U.S. FDA* (Sep 2016) ARCH: Phase 3 active-controlled study in postmenopausal women with osteoporosis (expected H1 2017) FRAME co-primary endpoints: reducing the incidence of new vertebral fractures through 12 and 24 months BRIDGE primary endpoint: increasing bone mineral density (BMD) at the lumbar spine at 12 months FDA: Food and Drug Administration

6 2016 9M interim update - Early pipeline to deliver breakthrough solutions 6 10 NMEs* in early clinical development dapirolizumab pegol (CD40L antibody) systemic lupus erythematosus bimekizumab (IL17A/F) various indications Learn phase POC 1 Phase 1 Phase 2 Confirm phase Phase 3 Phase 2b results H (Partner: Biogen) Phase 2b start: Sept Filing bimekizumab add-on to Cimzia rheumatoid arthritis UCB0942 (PPSI) highly drug resistant epilepsy seletalisib (PI3K δ inhibitor) Sjögren s syndrome + APDS (Phase 1b) UCB7665 immune thrombocytopenia UCB Parkinson s disease UCB4144 / VR942 - asthma UCB immunological diseases (Partner: Neuropore) Phase 2a results: H Phase 2a results: Q Phase 2a results: 2017 Phase 2a results: Q Phase 2a start: 2017 (Partner: Vectura) (Partner: King s College London) UCB epilepsy UCB auto-inflammatory diseases neurology immunology New Molecular Entity 1 Proof of concept

7 2016 financial outlook confirmed Trending towards the upper end of the ranges M interim update guidance Revenue rebitda Core EPS ~ billion ~ million ~ Continued growth: Cimzia, Vimpat, Neupro Expected R&D expense ratio of ~28% (+/-1% point) Expected underlying tax ratio in the "high twenties" ~188 million shares weighted average outstanding Mid-term guidance Recurring EBITDA of 30% in 2018 Net debt / rebitda ratio of 1:1 by 2018 Cimzia, Vimpat, Neupro combined peak sales of at least 3.1 billion by 2020

8 UCB's strategic growth path M interim update - 8 True differentiation drives leadership and sustainability Strong growth Cimzia, Vimpat, Neupro + Keppra Growth expansion by Briviact + romosozumab Breakthrough phase - Growth expansion by next wave products

9 Strong Cimzia performance across all regions M interim update - 9 Cimzia Net sales million 9M M 2015 Actual CER 1 Crohn s disease rheumatoid arthritis psoriatic arthritis axial spondyloarthritis / ankylosing spondylitis million 2015 net sales 1.5 billion expected peak sales by patent expiry (U.S. & EU) Astellas (Japan ) Dermira (psoriasis ) Phase 3 Psoriasis nr axial spondyloarthritis² (U.S.) Filed juvenile idiopathic arthritis (U.S.) U.S % 15% Europe % 24% Japan 25 5 > 100% > 100% International markets % 42% Total Cimzia % 21% C-EARLY Phase 4 results EXXELERATE Phase 4 results juvenile IA³ Phase 3 results R&D milestones 2016 > 2017 juvenile IA³ filing (U.S.) RA - Phase 3 results (China) Auto-injector CHMP positive opinion (EU) psoriasis Phase 3 results (first data) women in child bearing age Phase 4 results psoriasis Phase 3 results (3 studies) Numbers may not add due to rounding 3 IA: idiopathic arthritis 1 CER: constant exchange rates 4 RA: rheumatoid arthritis 2 nr axspa: non-radiographic axial spondyloarthritis

10 Strong neurology portfolio performance Leading epilepsy company: The right product for the right patient at the right time M interim update - 10 Net sales million 9M M 2015 Actual CER Briviact 11 Vimpat % 19% Keppra % -3% Total epilepsy % 8% Neupro % 11% Neurology other 6 2 > 100% > 100% Total Neurology % 9% Numbers may not add due to rounding 1 CER: constant exchange rates

11 Vimpat performance M interim update - 11 Robust growth in all markets, launch in Japan Vimpat Epilepsy POS million 2015 net sales 1.2 billion expected peak sales by patent expiry (U.S. & EU) Daiichi Sankyo (Japan ) Phase 3 Epilepsy POS 1 pediatric Epilepsy PGTCS² Filed Epilepsy POS 1 mono (EU) Net sales million 9M M 2015 Actual CER 1 U.S % 18% Europe % 16% Japan 3 International markets % 19% Total Vimpat % 19% epilepsy POS 1 - monotherapy filing (EU) epilepsy POS 1 adj. therapy approval (Japan) 2016 R&D milestones epilepsy POS 1 ped. - adj. therapy filing (EU) U.S. District Court confirms validity of patent epilepsy POS 1 - monotherapy filing (Japan) > 2017 epilepsy POS 1 ped. adj. therapy Phase 3 results Numbers may not add due to rounding CER: constant exchange rate 1 Partial-onset seizures 2 Primary Generalized Tonic-Clonic Seizures

12 Keppra performance M interim update - 12 Continued in-market demand Keppra epilepsy POS 1 epilepsy PGTCS² epilepsy myoclonic seizures 737 million 2015 net sales 1.2 billion peak sales (2008) Status of exclusivity: Japan - until 2018 U.S.³ - Nov Europe - Sep Net sales million 9M M 2015 Actual CER U.S % -20% Europe % 1% Japan % 2% International markets % 13% Total Keppra % -3% R&D milestones Otsuka (Japan ) epilepsy PGTCS 2 adj. therapy - approval (Japan) Numbers may not add due to rounding CER: constant exchange rate 1 Partial-onset seizures 2 Primary Generalized Tonic-Clonic Seizures 3 Keppra XR expired in Sep. 2011

13 Briviact launch M interim update - 13 New treatment option for patients living with epilepsy Briviact Epilepsy POS 1 add on therapy Available to patients in: Canada Denmark Germany Netherlands Norway U.K. U.S patent expiry (U.S. & EU) Net sales million 9M M 2015 Actual CER U.S. 5 Europe 6 International markets 0 Total Briviact 11 R&D milestones epilepsy POS 1 adj. therapy approval (EU) epilepsy POS 1 adj. therapy approval (U.S.) epilepsy POS 1 adj. therapy launch (U.S.) epilepsy POS 1 adj. therapy launch (EU) epilepsy POS 1 adj. th. approval (Canada) Numbers may not add due to rounding CER: constant exchange rate 1 Partial-onset seizures

14 Neupro performance M interim update - 14 Growing in all geographies Neupro Net sales million 9M M 2015 Actual CER Parkinson s disease restless legs syndrome 258 million 2015 net sales 400 million expected peak sales by patent expiry (U.S. & EU) U.S % 3% Europe % 12% Japan % 17% International markets % 34% Total Neupro % 11% Otsuka (Japan ) Numbers may not add due to rounding CER: constant exchange rate

15 Osteoporosis: a silent disease M interim update - 15 Globally, osteoporosis causes ~8.9m fractures per year 1 Men are most likely to break bones from osteoporosis later in life, making it more difficult to recover. 2 Postmenopausal osteoporosis (PMO) is the most common form of the disease. 3 PMO is a silent disease that cannot be seen or felt, and often goes undetected until a fracture occurs. 4 a fracture every 3 seconds 1 vertebral fracture is the most common osteoporotic fracture 5 1. International Osteoporosis Foundation. Osteoporosis Facts and Statistics. 2. National Osteoporosis Foundation. The Man s Guide to Osteoporosis American Academy of Orthopaedic Surgeons. Position Statement: Osteoporosis/Bone Health in Adults as a National Public Health Priority. 4. International Osteoporosis Foundation. What Is Osteoporosis? Vertebral Fracture Initiative - Overview of osteoporosis: Epidemiology and clinical management

16 Romosozumab development M interim update - 16 Phase 3 program in bone loss disorders Registrational studies in osteoporosis STRUCTURE FRAME BRIDGE ARCH (NCT ) (NCT ) (NCT ) (NCT ) 436 patients (postmenopausal women) patients (postmenopausal women) 245 patients (men) patients (postmenopausal women) Duration 12 months romosozumab 12 months romosozumab + 12 months denosumab 12 months romosozumab 12 months romosozumab + 12 months alendronate omparator teriparatide 12 months placebo + 12 months denosumab 12 months placebo 24 months alendronate Endpoint BMD DXA % change at the hip Incidence of new vertebral fracture BMD DXA % change at the lumbar spine Incidence of clinical fracture + incidence of new vertebral fractures at month 24 "Results" ENDO 2016 ASBMR 2016 ACR 2016 H osteoporosis in postmenopausal women filing (U.S.)

17 Romosozumab development M interim update - 17 FRAME Phase 3 results patients Average BMD T-score : -2.5 (hip) / -2.7 (lumbar) romosozumab 12 months placebo 12 months denosumab 12 months denosumab 12 months Co-Primary endpoints: incidence of new vertebral fractures 12 months 12 months months months Secondary endpoint: incidence of clinical 12months 12 months months months

18 Bimekizumab/UCB4940 (anti-il-17a and anti-il-17f) M interim update - 18 What is Bimekizumab? Structure Target IL-17F IL-17F homodimer IL-17A IL-17A homodimer IL-17A IL-17F heterodimer Bimekizumab is an immunoglobulin G1-κ humanised monoclonal antibody Bimekizumab is a dual IL-17A and IL- 17F inhibitor Bimekizumab Drug Profile: Accessed 30/11/2015.

19 Further facts and figures

20 Strengthening UCB's Patient Value Strategy M interim update - 20 Patient Value Strategy Shift from volume to patient value creation Innovation Strategy Differentiation Networked Strategy Competitive strengths + external connections Growth Strategy Top and bottom line growth delivering value Shareholder value

21 Growth drivers Core medicines tracking well towards peak sales target of 3.1 billion by M interim update - 21 EXPECTED AT LEAST 1.5 billion peak sales EXPECTED AT LEAST 1.2 billion peak sales EXPECTED AT LEAST 400 million peak sales Inflammatory arthritis indications and Crohn s disease Epilepsy partial-onset seizures Parkinson s disease and Restless Legs Syndrome Psoriasis: strategic collaboration with Dermira Monotherapy in the U.S. Partner in Japan: Daiichi Sankyo Partner in Japan: Otsuka

22 Cimzia in-market performance (Aug 2016) M interim update - 22 Strong growth in rheumatology indications U.S. Europe Japan 10% 8% 6% 4% 2% Cimzia vs. Rheumatology 1 Market Growth 2.1% 3.4% 6.9% +4.7% 30% 25% 20% 15% 10% 5% Cimzia vs. Rheumatology 1 Market Growth 22.6% 22.7% 24.8% +2.2% 30% 25% 20% 15% 10% 5% Cimzia vs. RA Market Growth 10.1% 13.5% 21.1% +11.0% 0% Anti TNF Biologics Cimzia 0% Anti TNF Biologics Cimzia 0% Anti TNF Biologics Cimzia 6.0% 5.5% 5.0% 4.5% Cimzia Rheumatology 1 R3M Patient Share +0.1% 4.5% 8.5% 8.0% 7.5% 7.0% Cimzia Rheumatology 1 R3M Patient Share 8.1% +0.8% 4.5% 4.0% 3.5% 3.0% Cimzia RA R3M Patient Share 3.8% +0.4% 4.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source: U.S. IMS Source of Business Report 6.5% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source: IMS MIDAS In-Market KPI s are based on Exit Patients 2.5% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source: IMS MIDAS; Cimzia patients are considered 100% in RA In-Market KPI s are based on Exit Patients 1 Rheumatology includes RA, AS/AxSPA and PSA indications Shares calculated based on Anti-TNF market. In-market growth is calculated for MAT Aug'15 vs. Aug'16 Market share is calculated for Aug 16 and market share growth is shown against R3M Aug 15

23 Vimpat in-market performance (Aug 2016) M interim update - 23 A leading therapeutic option in the AED market U.S. Europe Japan 20% 15% Vimpat vs. AED Market Growth (TRx) 16.0% 20% 15% Vimpat vs. AED Market Growth (TDx) 18.3% 10% 5% 0% 4.7% AED Market Vimpat +11.3% 10% 5% 0% -5% -0.3% AED Market Vimpat +18.6% Vimpat approved (July 2016) and launched (Aug 2016) 4.0% 3.8% Vimpat R3M TRx Share 3.8% 3.0% 2.8% Vimpat R3M TDx Share 2.9% 3.6% 2.6% +0.4% 3.4% 3.2% +0.3% 2.4% 2.2% 3.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data U.S.: U.S. IMS NPA In-Market KPIs are based on TRx 2.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data EU: IMS MIDAS In-Market KPI s are based on TDx AED = anti epileptic drug - AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In EU and Japan, the TDx of all these molecules are factored for epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage. AED Market and Vimpat growth are calculated for MAT Aug'16 vs. MAT Aug'15. Vimpat market share is calculated for R3M Aug'16 and market share growth is shown against R3M Aug'15

24 Keppra in-market performance (Aug 2016) M interim update - 24 U.S. Europe Japan 6.0% 4.0% 2.0% 0.0% -2.0% -4.0% -6.0% -8.0% -10.0% 4.0% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% Keppra vs. AED Market Growth (TRx) 4.7% AED Market Keppra R3M TRx Share -9.0% 0.9% 0.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data U.S.: U.S. IMS NPA In-market KPI s are based on TRx Keppra -13.6% -0.2% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% -2.0% -4.0% 14.0% 13.5% 13.0% 12.5% 12.0% 11.5% 11.0% 10.5% Keppra vs. AED Market Growth (TDx) -0.3% AED Market Keppra R3M TDx Share 6.9% Keppra 12.4% 10.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data EU, JP: IMS MIDAS In-market KPI s are based on TDx +7.2% +0.9% 50% 40% 30% 20% 10% 0% 12.5% 12.0% 11.5% 11.0% 10.5% 10.0% 9.5% 9.0% Keppra vs. AED Market Growth (TDx) 2.1% AED Market Keppra R3M TDx Share 40.0% Keppra +37.9% 12.5% +3.5% 8.5% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data EU, JP: IMS MIDAS In-market KPI s are based on TDx AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In EU and Japan, the TDx of all these molecules are factored for epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage. For U.S, Keppra includes Keppra XR. For EU, Keppra does not include UCB Levetiracetam. AED Market and Keppra TRx growth are calculated for MAT Aug'16 vs. MAT Aug'15. Keppra TRx market share is calculated for R3M Aug'16 and market share growth is shown against R3M Aug'15

25 2016 9M interim update - 25 Expanding our portfolio, creating sustainable patient value Helping individuals live at their ideal is the core of our strategy Meeting the need for immediate control and clarity of response Establishing a new foundational therapy for focal epilepsies with an ideal profile Heritage to accelerate the value shift from old to new 1 Hope and Trust UCB Sponsored ethnographic research, among the largest and most robust ever conducted in epilepsy

26 Introducing Briviact in epilepsy POS 1 New epilepsy treatment for patients experiencing uncontrolled partial-onset seizures M interim update - 26 Our newest solution Now approved in EU (Jan 2016) and U.S. (Feb 2016) 2 One of the largest Phase 3 programs in epilepsy involving over patients Guoqiong, living with epilepsy Statistically significant AND clinically relevant results³ BRIVIACT Meeting the need for immediate control and clarity of response Guided by patient insights: Life in Between Patients spend their life waiting for: Seizure control The need to know 1 POS: partial-onset seizures 2 Briviact received Drug Enforcement Administration (DEA) scheduling in May The most commonly reported adverse events were somnolence, dizziness, fatigue and headache. Source: UCB data on file

27 Neupro in-market performance (Aug 2016) M interim update - 27 Growth in a genericized market U.S. Europe Japan 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% -2.0% 8.5% 8.0% 7.5% 7.0% 6.5% Neupro PD vs. PD (KC) Market Growth (TRx) 0.1% 0.1% PD Market PD Key Neupro Competitors Neupro PD R3M TRx Share 6.7% 6.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data U.S.: U.S. IMS NPA In-market KPI s are based on TRx 2.1% +2.1% -0.3% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% 18.5% 18.0% 17.5% 17.0% 16.5% Neupro PD vs. PD (KC) Market Growth (TDx) 2.6% 2.4% PD Market PD Key Competitors Neupro PD R3M TDx Share 10.1% Neupro 17.8% 16.0% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data EU, JP: IMS MIDAS In-market KPI s are based on TDx +7.8% +1.3% 35% 30% 25% 20% 15% 10% 5% 0% 28% 26% 24% 22% Neupro PD vs. PD (KC) Market Growth (TDx) 0.5% PD Market 1.9% PD Key Competitors Neupro PD R3M TDx Share 30.1% Neupro +28.2% 25.8% +4.9% 20% Aug-15 Nov-15 Feb-16 May-16 Aug-16 Source data EU, JP: IMS MIDAS In-market KPI s are based on TDx PD market: All molecules in ATC3= N4A. In the EU and Japan, the TDx of all these molecules are factored for PD usage. In the US, only the TRx of Rotigotine, Pramipexole and Ropinirole are factored for PD usage. PD Key Competitors (KC) market: The 8 DA s (Dopamine Antagonists): Bromocriptine, Cabergoline, Lisuride, Pergolide, Rotigotine, Pramipexole, Piribedil, Ropinirole. In the US, only Rotigotine, Pramipexole and Ropinirole are factored for PD usage, hence the PD market and PD KC market are the same.

28 UCB HY 2016 financial highlights M interim update - 28 Continued delivery on growth strategy top and bottom line Revenue Net sales up by 10% (9% CER) to million Continued net sales growth of core products Total operating expenses Overall operating expense ratio improved partly due to R&D expense phasing Recurring EBITDA Higher gross profit and decrease of operating expenses Net profit of the Group 300 million attributable to UCB shareholders (+12%) Core earnings per share Based on 188 million weighted average shares outstanding (2015: 192 million) million million 549 million 316 million 1.72 Actual +5% -2% CER +5% 0% +18% +11% +9% 0% +46% +34%

29 Top and bottom line growth improved ratios* M interim update - 29 Sustainable growth and margin improvement Gross margin ratio 69% 70% 72% 30% ~24% FY 2014 FY 2015 HY 2016 Total operating expense ratio 57% 55% 50% FY 2014 FY 2015 HY % 18% 17% FY 2013 FY 2014 FY2015 FY2016e 2018e rebitda ratio tracking towards mid-term target * versus revenue

30 Debt maturity schedule 30 June 2016) KU divestiture enhances financial and strategic flexibility Perpetual bond called in March M interim update - 30 ( million) Liquid assets beyond Belgian Commercial Paper Belgian retail bond Institutional eurobond Other loans EIB loan

31 One UCB today: A Global Player Presence in 38 countries completed by a robust network of partners M interim update employees globally 2 RESEARCH CENTERS Braine-l Alleud (Belgium) Slough (U.K.) 3 DEVELOPMENT HUBS Monheim (Germany) RTP North Carolina (U.S.) Tokyo (Japan) 4 MANUFACTURING FACILITIES Braine-l Alleud (Belgium) Zuhai (China) Saitama (Japan) Bulle (Switzerland) June 2016

32 Shareholder structure M interim update - 32 Stable shareholder base with free-float of 61% Total number of shares: million Weighted average shares outstanding in 2016: 188 million Free float investors by region Source: Notifications and UCB underlying ownership analysis

33 Your UCB Investor Relations team M interim update - 33 ן Antje Witte, Vice President Investor Relations Phone: antje.witte@ucb.com ן Isabelle Ghellynck, Director Investor Relations Phone: isabelle.ghellynck@ucb.com ן Nathalie Deldime, Investor Relations Manager Phone: nathalie.deldime@ucb.com ן Check out our new IR App stay tuned wherever you go