2011 full year results - UCB...Atsumi, living with epilepsy 2011 full year results London, 2 March...

Atsumi, living with epilepsy

2011 full year resultsLondon, 2 March 2012

Roch Doliveux, CEO

Thomas, living with epilepsytalking to Joe and Chris (UCB)

Disclaimer and safe harbour

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.

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Atsumi, living with epilepsy

Focus: Central Nervous System and Immunology

R&D spend 2011:24% of €3.2 bn revenue

Over 304 000 patientstreated with UCB’s core medicines

Operations in more than40 countries

About 8 500 employeesglobally

UCB: patient-centric global biopharma leader

2011 financial highlights

Revenue of € 3246 million• Strong Cimzia®, Vimpat® and Neupro®: € 625m (+51%)• Strong Keppra®: € 966m (+3%)

Underlying profitability Recurring EBITDA of € 683 million

• Accelerated investment into our future: "C V N" and R&D

Net Profit of € 235 million• After € 103 million in 2010

Core EPS of € 1.89*

• Accelerated R&D expenses

Recommended gross dividend of € 1.00 per share

4* based on 178.5 million weighted average number of shares outstanding

1%

2%

7%

5%

126%

304 000 patients have now been treated (+50%) Peak sales expectations confirmed

Fast response for predictable outcomes33 000 patients prescribedExpected peak sales of at least € 1.5 billion*

When monotherapy is no longer enough171 000 patients prescribedExpected peak sales of at least € 1.2 billion*

Impact across the many dimensions of PD100 000 patients prescribedExpected peak sales of at least € 400 million*

5* to be reached in the second half of the decade

FY 2011 Analysts’ meeting in London Information flow

Welcome and introduction• Roch Doliveux, CEO

In-market performance: Cimzia®, Vimpat®, Neupro® and Keppra®

• Greg Duncan, President North America Operations• Khoso Baluch, Sr. VP Global Marketing & Access

Financial performance • Detlef Thielgen, CFO

Advancing the pipeline• Iris Loew-Friedrich, CMO

Conclusion• Roch Doliveux, CEO

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Cimzia® Vimpat®

Neupro® Keppra®

in-market performance

Broadening patient access

Greg DuncanPresident North America Operations

Khoso BaluchSr. VP Global Marketing & Access

DeOnna, living with rheumatoid arthritis

More than 33 000 patients on Cimzia®

Now available in 26 countries

8CD indication available in Switzerland and in the U.S.

Launched in 2011

Launched prior 2011

Cimzia® performances 2011

€ million 2011 net sales

2010 net sales Actual Constant

North America 226 166 36% 43%

Europe 81 31 >100% >100%

Rest of the World 5 1 >100% >100%

Total Cimzia® 312 198 58% 63%

9

Crohn’s disease*

Sustained long-term effectiveness at stable dose

Rheumatoid arthritis

Rapid Response – Rapid Decision

* Approved in U.S. and Switzerland, Russia

Cimzia® - North AmericaGaining momentum – 12 weeks message received

10

Launch in CD

Launch in RA

Access over time: Lives in preferred or co-preferred position

11Source: Preferred lives from UCB Internal Contracts Database, Co-preferred from UCB internal analysis.

Total lives with CIMZIA® (certolizumab pegol) in preferred or co-preferred position

*

Covered Lives

JanuaryDecemberDecember

Preferred lives show an estimated growth at a rate 50% faster than the business as a whole

Cimzia®

Strong roll-out in Europe and Rest of the World

12

EU4 market share evolution by anti-TNF product (%)

More than 171 000 patients on Vimpat®

Now available in 25 countries

13

Launched in 2011

Launched prior 2011

Vimpat® performances 2011

Adjunctive therapy in Epilepsy• When monotherapy is no longer enough

14

€ million 2011 net sales

2010 net sales Actual Constant

North America 158 96 66% 74%

Europe 57 36 57% 57%

Rest of the World 3 1 >100% >100%

Total Vimpat® 218 133 65% 70%

Vimpat® - North AmericaSuccessful, strong performance in the AED* market

15* AED – anti-epileptic drug

Vimpat® in the U.S.The highest grossing branded AED launched in the last 10 years

16

Sources: IMS, Vector One National (VONA)

Notes: IMS VONA retail dollars converted to real dollars using inflation adjustment indices (base year = 2000), Dec 2011 CPI Adjusted

0

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Vimpat®

Keppra®

lamotrigine

US Dollars

Vimpat® - EuropeStrong performances – net sales

17

Source: IMS, UCB calculations

Vimpat® - Europe EU4Out-performance

18

• Data source: IMS• EU data refers to France, Germany, Italy and Spain; UK not included due to non-availability of comparator data• Difference in EU countries launch months indexed at M1; Topiramate historical data availability only from M4• Value figures auto corrected in IMS data for any fluctuations in exchange rate• Comparator sales data factored for in-indication usage only: Adjunctive therapy in the treatment of partial seizures in

adults with epilepsy

More than 100 000 patients on Neupro®

Now available in 28 countries

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RLS indication in 8 countries: Austria, Germany, Ireland, Switzerland, U.K. (launched prior 2011)Greece , Spain, South Korea (launched in 2011)

Launched in 2011

Launched prior 2011

Neupro® performances 2011

Working to make it available for patients in the U.S.: UCB aims to bringing Neupro® to U.S. patients during 2012 subject to FDA approval

Impact across the many dimensions of Parkinson’s disease (PD) and restless-legs-syndrome (RLS)

20

€ million 2011 net sales

2010 net sales Actual Constant

Europe 94 81 16% 15%

Rest of the World 2 1 >100% >100%

Total Neupro® 95 82 16% 16%

Neupro® - rotigotine transdermal patchContinued growth in a competitive market

21

Keppra® - strong and sustainableMarket leadership around the world

Loss of exclusivity in the U.S. (Nov. 2008 + Sept. 2011/XR) and in Europe (Sept. 2010)

E Keppra® - most successful anti-epileptic launch in Japan (Sept. 2010)

Sizeable franchise going forward!

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€ million 2011 net sales

2010 net sales Actual Constant

North America 228 278 -18% -14%

Europe 630 583 8% 8%

Rest of the World 108 82 33% 34%

Total Keppra® 966 942 3% 4%

Keppra® net sales per regionLife of a 'blockbuster'

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Global net sales

Europe

North America

Rest of World

Loss of exclusivity

Keppra®

XR loss of exclusivity

Loss of exclusivity

E-Keppra®

launch

Adriana, living with rheumatoid arthritis

2011 Financial Performance

Detlef Thielgen, CFO

Financials 2011 vs. guidance and 2010

25* based on 180 million and ** based on 178.5 million weighted average number of shares

Actual2011

Guidance@March 2011

Actual2010

Revenue € 3.2 billion

€ 3.0-3.1 billion € 3.2 billion

Recurring EBITDA

€ 683 million

€ 650-680 million

€ 731 million

Core EPS € 1.89** € 1.60-1.70* € 1.99*

2011A vs2010A

1%

7%

5%

2011 net sales: € 2 876 million

26

Cor

e m

edic

ines

Mat

ure

prod

ucts

Keppra® net sales include Keppra® XR and AG net salesZyrtec® net sales include Zyrtec-D® and Cirrus® net sales

2010 net sales 2011 net sales

Total core products sales€ 625 million (+51% )

Total mature products sales€ 2 251 million (-5% )

Recurring EBITDA Strong M&S and accelerated R&D expenses

27

€ millionActual Variance

2011 2010 Actual CER

Revenue 3 246 3 218 1% 2%

Net sales 2 876 2 786 3% 5%

Royalty income & fees 187 220 -15% -15%

Other revenue 183 212 -14% -13%

Gross profit 2 233 2 165 3% 5%

Marketing & selling expenses -837 -797 5% 6%

R&D expenses -780 -705 11% 12%

G&A expenses -193 -194 -1% 0%

Other operating income/expenses 12 -2 n.a. n.a.

Total operating expenses -1 798 -1 698 6% 7%

Recurring EBIT 435 467 -7% -5%

Amortisation of intangible assets 180 190 -5% -4%Depreciation charges 68 73 -7% -9%

Recurring EBITDA 683 731 -7% -5%

Net profit more than doubled

281 After non-controlling interest

€ millionActual Variance

2011 2010 Actual CER

Recurring EBIT 435 467 -7% -5%Impairment charges -39 -223 -82% -82%Restructuring expenses -27 -40 -32% -32%Gain on disposals 0 49 n.a. n.a.Other non recurring expenses -24 -49 n.a. n.a.

Total non recurring income/ expenses (-)

-91 -263 -65% -65%

EBIT 344 204 68% 72%Net financial expenses -115 -185 -38% -37%Income tax expense(-)/credit -8 86 n.a. n.a.

Net profit1 235 103 >100% >100%

Core Earnings Per Share

29

€ millionActual Variance

2011 2010 actual

Net profit 235 103 >100%

+ After-tax non-recurring items and financial one-offs

70 216 -65%

- Profit / loss (-) from discontinued operation

-14 1 n.a.

+ Tax one-offs -66 -81 -18%

Adjusted net profit 225 239 -6%

+ Amortisation of intangibles assets linked to sales

155 173 -10%

- Tax on amortisation of intangible assets

43 53 -18%

Core net profit 337 359 -6%

weighted average number of shares (m) 178.5 180.1 -1%

Core EPS (€) 1.89 1.99 -5%

2011 Cash FlowsInventory building and restructuring of debt

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*

*incl. € 2 million cash from discontinuedoperations

Net debt evolutionLess financial debt – less liquid assets

31

€ million 31 Dec 2011 31 Dec 2010

Net debt -1 548 -1 525Liquid assets 269 498Financial debt -1 817 -2 023

2012 financial outlookFull year 2012 dynamics

32* based on 178.5 million weighted average number of shares

Guidance2012

Revenue approx. € 3.1 billion

• Strong growth:Cimzia®, Vimpat®, Neupro®

• Keppra® generic erosion in EU

Recurring EBITDA

€ 630 - € 660 million

• Continued investments in Cimzia®, Vimpat®, Neupro®

• Continued investments in pipeline

Core EPS € 1.60 - € 1.70• Underlying tax ratio ~ 30%• 177.3 million shares

Atsumi, living with epilepsy

Advancing the pipeline –Delivery to patients

Iris Löw-Friedrich, CMO

Nele, living with lupus

Development pipelineCentral Nervous System (CNS)

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Neupro® (rotigotine)Parkinson's disease (U.S.)

Neupro® (rotigotine)Restless legs syndrome (U.S.)

BrivaracetamEpilepsy – adj. therapy

Vimpat® (lacosamide)Epilepsy – monotherapy (U.S.)

Vimpat® (lacosamide)Epilepsy – monotherapy (EU)

Vimpat® (lacosamide) Epilepsy – Paediatricadj. therapy

Phase 3 to startH1 2013

Vimpat® (lacosamide) Epilepsy – adj. therapy PGTCS

Phase 3 to startQ1 2013

UCB0942 (PPSI)Epilepsy

Phase 1 Phase 2 Phase 3 Filing

Complete Response LetterApril 2010

Complete Response LetterApril 2010

Phase 3 results H1 2013

Phase 3 results Q2 2013

Phase 3 results Q4 2014

First phase 2 results

Phase 2 results

Vimpat® for PGTCS* to move into phase 3- phase 2 summary -

Phase 2, multicenter, open-label pilot study

To assess the safety of adjunctive lacosamide (400mg/day) for uncontrolled PGTC seizures in adults

Primary objective: Safety in a new epilepsy population (PGTCS)

Results:• Safety profile comparable to POS** population• Reductions in PGTCS

Next milestone: Start of phase 3 in Q1 2013

35

* Primary Generalized Tonic Clonic Seizures** Partial Onset Seizures

EpilepsyStrong need for new treatment options

36

Controlled on 1st monotherapyUncontrolled despite 2-3 AEDsControlled on more than 1 AED

High unmet medical need in ~1/3 of treated epilepsy patients

Epilepsy types and treatment algorithm

PartialOnset

Seizures(POS)

PrimaryGeneralised

Seizures(PGTCS)

Monotherapy Add-on therapy

29% 27%

25%19%

25-30%

50%

20-25%

Development pipelineImmunology

37

Cimzia® (certolizumab pegol)Rheumatoid arthritis (Japan)

Cimzia® (certolizumab pegol)Ankylosing spondylitis

Cimzia® (certolizumab pegol)Psoriatic arthritis Submission

by end 2012

epratuzuambSLE*

Cimzia® (certolizumab pegol)Juvenile rheumatoid arthritis

Phase 3 to startQ1 2012

CDP7851 (sclerostin-AB)Post-menopausal osteoporosis Phase 3 to start 2012

CDP7851 (sclerostin-AB)Fracture healing

olokizumab (anti-IL 6) Rheumatoid arthritis

CDP7657 (anti-CD40L)SLE*

Filed (Jan. 2012)

Phase 3 results next weeks

Phase 3 results H1 2014

Phase 2 results

Phase 2 results 2012

Phase 3 results

Phase 2 results

Phase 2 results Q3 2012

Phase 1 Phase 2 Phase 3 Filing

*SLE: systemic lupus erythematosus

Cimzia® in RA – to provide information for evidence-based decisions in bio/DMARD naive patients

38

EXXELERATE™

H2H: relative efficacy of certolizumab pegol and adalimumab

12 weeks & 104 weeks Approx. 900 adult patients

First results 2016

C-EARLY™

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 2016

Cimzia® in Psoriatic Arthritis (PsA) Submission by end of 2012

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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.

*statistical significant

Q2W Q4W

Epratuzumab in systemic lupus erythematosus (SLE) Phase 3 programme on-going – first results H1 2014

UCB holds world-wide rights for auto-immune indications

Phase 3 programme currently recruiting• Primary endpoint

To confirm the clinical efficacy of epratuzumab by the % of subjects meeting treatment response criteria at Week 48 according to a combined response index build primarily around BILAG

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Renee, living with lupus

In licensed from Immunomedics, Inc., May 2006

Phase 1 Phase 2Phase 3

Results H1 2014epratuzumab

SLE

Epratuzumab - Humanized monoclonal antibody (Human IgG1) against CD22

41

Fab (CD22 Binding)

pro-B pre-B immature B mature B B Blast GC B cell Plasma cell

CD22 Expression

IgM IgM IgDIgG

Memory B

epratuzumab:

Modulator of B-cell function

42

Epratuzumab in SLE Phase 2b results – presented at World Lupus Congress & ACR

SL0007: Primary Efficacy Variable: Combined Index Response Rateat Week 12, ITT Population

P=0.0265

P=0.0239

21,1

30,8

26,3

45,9

40,5

43,2

23,7

0

10

20

30

40

50

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 mgCombined,

N=74

Emab 3600 mg(1800 EOW),

N=38

Perc

ent

resp

onde

rs

EMBODY 1™

EMBODY 2™

Emab 1200 mg every other week

Placebo

Emab 600 mg weekly

Placebo

Emab 600 mg weekly

Emab IV dosing

Emab 1200 mg every other week

Week 2412 36 480

Epratuzumab in SLE – EMBODY™ programmePhase 3

43

Bone forming agent CDP7851 in bone loss disorders Potential for a change of treatment paradigms

Antibody to sclerostin potentially treating bone loss disorders

• Collaborative project with Amgen

Post-menopausal osteoporosis (PMO)• Positive Phase 2 top-line results (April 2011)• Positive treatment effect observed, statistically significant • Favorable comparison with active comparators,

teriparatide and alendronate

44

Paulette, living with osteoporosis

Fracture healing• Two Phase 2 studies are ongoing in tibia fracture and in hip fracture healing• First headline results for both studies expected in 2012

CDP7851 (sclerostin-AB)Post-menopausal osteoporosis Phase 3 to start H1 2012

CDP7851 (sclerostin-AB)Fracture healing

Phase 2 results

Phase 2 results 2012

Competitive late-stage pipelinetransformational potential

45

OlokizumabRA

Phase 2

Phase 3

Filing

CDP7851Fracture healing

CDP7851PMO

Cimzia®

Juvenile RA

Cimzia®

AS

Vimpat®

PGTCS

Vimpat®

paediatric

Vimpat®

Monoth. US

Cimzia®

PsA

epratuzumabSLE

Cimzia®

RA/Japan

brivaracetamadj. epilepsy

Neupro®

PD/US

Neupro®

RLS/US

Vimpat®

Monoth. EU

Neupro®

PD/Japan*

* By our CNS partner in Japan, Otsuka

Neupro®

RLS/Japan*

Cross-over in 2012C V N deliver UCB growth – pipeline comes on top

46

Cimzia®

Vimpat ®

Neupro ®

Keppra®

Zyrtec® /Xyzal®

Mature product portfolio

2012

UCB's sustainable future growthCimzia®, Vimpat® and Neupro® trigger company growth

47

Realise the full commercial potential of Cimzia®, Vimpat®, Neupro®

Launch a new generation of therapies offering

breakthrough innovation to patients with severe disease

Company growth

Breakthrough

•Optimise mature base business

•Manage remaining loss of exclusivity

Cimzia®, Vimpat®, Neupro®

lifecycle management first breakthroughs

AppendixSten, living with restless legs syndrome

Geographic and therapeutic breakdownNet sales 2011: € 2 876 million

Europe49%

49

Immunology & Allergy24%

Additional external pipeline options

50

Therapeutic area / Indication

Stage of development Development path & partner

SYN-115 (A2a)

CNS –Parkinson’s disease

• Phase 2b started (April 2011)

• Results expected H1 2013

• Biotie to complete Phase 2

• UCB responsible for any Phase 3 development and commercialisation

MEK inhibitor(WX554)

Oncology Successful completion of Phase 1 dose escalation study (IV delivery)

further Phase 1 development ongoing

Shareholder structureStable shareholder base

51Source: Shareholder Identification Analysis and UCB S.A. underlying ownership analysis (November 2011; notification February 2012)

“Free float” investors by region

Your UCB Investor Relations team

Antje Witte, Vice President Investor Relations• Phone: +32 2 559 9414• E-mail: antje.witte@ucb.com

Isabelle Ghellynck, Investor Relations Project Manager• Phone: +32 2 559 9588• E-mail: isabelle.ghellynck@ucb.com

Nathalie Deldime, Investor Relations Events Specialist• Phone: +32 2 559 9291• E-mail: nathalie.deldime@ucb.com

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