2012 half-year results - ucb hy a… · 2012 half-year results 1 august 2012 sally and nikolas,...

Bernadette, living with lupus

2012 half-year results

1 August 2012

Sally and Nikolas, living with Rheumatoid Arthritis

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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HY 2012 financial highlights On track to deliver updated FY 2012 guidance

Revenue € 1 706 million

• Solid growth (+45%) of Cimzia®,

Vimpat® and Neupro®

• Strong performance of E Keppra® in Japan

Recurring EBITDA € 347 million

Core EPS: € 1.09a

3 a. based on 179.1 million weighted average shares outstanding

FY 2012 guidance

To exceed € 3.2 bn

€ 630-660 million

approx. € 1.70a

354 000 patients have been treated (+50 000 vs Dec 2011) Peak sales expectations confirmed

Fast response for predictable outcomes

37 000 patients prescribed

Expected peak sales of at least € 1.5 billion*

When monotherapy is no longer enough

195 000 patients prescribed

Expected peak sales of at least € 1.2 billion*

Impact across the many dimensions of PD

122 000 patients prescribed

Expected peak sales of at least € 400 million*

* target: 2015-2020 4

5

HY 2012 information flow

Welcome and introduction

• Roch Doliveux, CEO

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

• Greg Duncan, President North American Operations

Financial performance

• Detlef Thielgen, CFO

Development update

• Iris Loew-Friedrich, CMO

Conclusion

• Roch Doliveux, CEO

Alun, living with Parkinson’s Disease

Greg Duncan, President North American Operations

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

Cimzia® performances H1 2012

Crohn’s disease*

Sustained long-term effectiveness at stable dose

Rheumatoid arthritis

Rapid Response – Rapid Decision

* Approved in U.S. and Switzerland, Russia

€ million H1 2012 net sales

H1 2011 net sales

Actual Constant

North America 145 107 36% 25%

Europe 58 34 70% 68%

Rest of the World 6 2 219% 200%

Total Cimzia® 209 143 46% 38%

7

Cimzia® Continued growth momentum

Launch in CD

Launch in RA

Launch in RA

8

Cimzia® U.S. in-market performance RA quarterly share

9

Source: IMS NPA, IMS Pharmetrics for Indication split. Market includes Cimzia, Simponi, Enbrel and Humira

2.0%

2.4% 2.5%

3.1%

3.5%

3.3% 3.4%

3.8% 4.0%

4.0%

4.3%

4.6%

Q3 2009 Q4 2009 Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012

RA

Market

Sh

are

4 8 29 34

139 127

143 150

0

20

40

60

80

100

120

140

160

180

200

co-preferred

preferred

Dec 2010 Dec 2011 Jan 2012 Jun 2012

Covere

d liv

es in m

illions

Total lives with Cimzia® (certolizumab pegol) in preferred or co-preferred position in the U.S.

Access over time in the U.S. Lives in preferred or co-preferred position

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

143 135

172 184

10

Vimpat® performances H1 2012

Adjunctive therapy in Epilepsy

• When monotherapy is no longer enough

11

€ million H1 2012 net sales

H1 2011 net sales

Actual Constant

North America 110 69 59% 48%

Europe 37 27 36% 35%

Rest of the World 3 1 178% 171%

Total Vimpat® 150 97 54% 46%

Vimpat® Successful, strong performance in the AED* market

12 * AED – anti-epileptic drug

Vimpat® U.S. in-market performance

13

0.18%

2.79%

2.51%

2.06%

0.58%

1.01%

1.55%

0

10 000

20 000

30 000

40 000

50 000

60 000

70 000

Mo

nth

1

Mo

nth

3

Mo

nth

5

Mo

nth

7

Mo

nth

9

Mo

nth

11

Mo

nth

13

Mo

nth

15

Mo

nth

17

Mo

nth

19

Mo

nth

21

Mo

nth

23

Mo

nth

25

Mo

nth

27

Mo

nth

29

Mo

nth

31

Mo

nth

33

Mo

nth

35

Mo

nth

37

TR

x

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

AE

D E

pile

psy M

ark

et T

Rx

Sh

are

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

14

Sources: IMS, Vector One National (VONA) Dec 2011 CPI Adjusted

Notes: IMS VONA retail dollars converted to real dollars using inflation adjustment indices (base year = 2000)

Vimpat®

Keppra®

Lamotrigine

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Sale

s (

th

ou

san

ds U

S$

)

Vimpat® - Europe EU4 Out-performance

15

• 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

Vimpat®

Keppra®

Topiramate

-

500

1 000

1 500

2 000

2 500

3 000

3 500

M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 M25

Sale

s (

tho

usan

ds €

)

More than 122 000 patients on Neupro® Now available in 34 countries – including the U.S.

16

Launched in 2012

Launched prior 2012

RLS indication in 9 countries Austria, Germany, Greece , Ireland, Spain, South Korea, Switzerland, U.K. (launched prior 2012)

U.S. (launched in 2012)

Neupro® performances H1 2012

U.S.: available to patients since 16 July 2012

Impact across the motor and underlying symptoms of Parkinson’s disease (PD)

Powerful and lasting symptom relief for restless legs syndrome (RLS)

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€ million H1 2012 net sales

H1 2011 net sales

Actual Constant

North America - -

Europe 53 45 19% 18%

Rest of the World 1 1 113% 112%

Total Neupro® 54 45 20% 19%

Neupro® Continued growth in a competitive market

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Keppra® - strong and sustainable Market leadership around the world

Loss of exclusivity

• U.S. - Nov. 2008 (Keppra® XR - Sept. 2011)

• Europe - Sept. 2010

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

Sizeable franchise going forward!

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€ million H1 2012 net sales

H1 2011 net sales

Actual Constant

North America 115 127 -10% -16%

Europe 250 333 -25% -25%

Rest of the World 80 47 70% 61%

Total Keppra® 445 507 -12% -15%

UCB to deliver growth

Cimzia®, Vimpat® and Neupro® driving company growth

Expected peak sales at least € 1.5 billion1

• 2 indications on the market: RA & CD

• Japan filed (January 2011)

• 2 indications to be submitted end 2012: AxSpA & PsA

Expected peak sales at least € 1.2 billion1

• 1 indication on the market

• 3 indications in development

Expected peak sales at least € 400 million1

• 2 indications on the market: PD & RLS

• U.S. launch (July 2012)

1 Target: 2015-2020

Combined expected CVN peak sales at least € 3.1 bn1

Sizeable franchise going forward

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Bernadette, living with lupus

Detlef Thielgen,

Chief Financial Officer

HY 2012 Financial Performance

HY 2012 Financial highlights

Revenue € 1 706 million

• Continued sales growth of the core medicines CVN

• Strong performance of E Keppra® in Japan

Total operating expenses € 956 million

• Higher M&S expenses due to launch activities

• Higher R&D expenses reflecting late-stage pipeline

Recurring EBITDA € 347 million

• Increase in revenue contrasted by higher operating expenses

Net profit1 € 137 million

• Higher net financial expenses

• Lower income tax expenses

Core EPS € 1.092

1 After non-controlling interests

2. based on 179.1 million weighted average shares outstanding, see slide "Core EPS" for calculation details 22

2%

14%

-22%

-31%

-25%

HY 2012 net sales € 1 527 million (+2%)

23

Co

re

me

dic

ine

s

Ma

ture

pro

du

cts

Keppra® net sales include Keppra® XR and AG net sales

Zyrtec® net sales include Zyrtec-D® and Cirrus® net sales

2011 net sales 2012 net sales

Total core products sales € 413 million (+45%)

Total mature products sales € 1 114 million (-8%)

Recurring EBITDA Strong and solid financials – in-line with guidance

€ million Actual Variance

H1 2012 H1 2011 Actual CER

Revenue 1 706 1 679 2% -2%

Net sales 1 527 1501 2% -2%

Royalty income and fees 83 96 -13% -17%

Other revenue 95 82 16% 12%

Gross profit 1 183 1 158 2% -3%

Marketing and selling expenses -440 -405 9% 3%

R&D expenses -419 -337 24% 20%

G&A expenses -94 -91 3% 1%

Other operating income -3 -6 -52% -64%

Total operating expenses -956 -839 14% 9%

Recurring EBIT 227 319 -29% -35%

Amortisation of intangible assets 88 91 -3% -6%

Depreciation charges 32 33 -5% -8%

Recurring EBITDA 347 443 -22% -27%

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Net profit

1 After non-controlling interest

€ million Actual Variance

H1 2012 H1 2011 Actual CER

Recurring EBIT 227 319 -29% -35%

Impairment charges -1 -6 -78% -79%

Restructuring expenses -12 -3 343% 342%

Other non recurring income -1 -5 -75% -76%

Total non recurring income / expenses (-) -14 -14 5% 3%

EBIT 213 305 -30% -37%

Net financial expenses -76 -63 20% 20%

Income tax expenses -2 -44 -96% -96%

Profit from continuing operations 135 198 -31% -41%

Net profit1 137 199 -31% -41%

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26

Core EPS

€ million Actual Variance

H1 2012 H1 2011 Actual CER

Net profit 137 199 -31% -41%

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

10 5 88%

- Profit from discontinued operation -2 -1 21%

Tax and financials one-offs -5 0 n.s.

Adusted net profit1 140 203 -31% -41%

+ After-tax amortization of intangibles 55 55

Core net profit 195 259

weighted average number of shares (basic)

179.1 179.5

Core EPS (€) 1.09 1.44 -25%

1 Adjusted for after-tax impact of one-time and non-recurring items

after tax effects of • non-recurring items, • financial one-offs and • amortisation of intangibles

H1 2012 cash flows

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Net debt evolution Higher net debt – lower REBITDA

28

€ million 30 June 2012 31 Dec 2011

Net debt -1 756 -1 548

Liquid assets 315 269

Financial debt -2 071 -1 817

2012 financial outlook updated Full year 2012 expected dynamics

Guidance 2012

Revenue To exceed

€ 3.2 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 approx. € 1.70 • ~179 million shares

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Mercedes, mother of son with epilepsy, chatting with Michael and Monica, living with epilepsy

Iris Loew-Friedrich,

Chief Medical Officer

Development update

Competitive late-stage pipeline transformational potential

Olokizumab RA

Phase 2

Phase 3

Filing

CDP7851 Fracture healing

CDP7851 PMO

Cimzia®

Juvenile RA

Cimzia®

AxSpA / AS

Vimpat® PGTCS

Vimpat®

paediatric

Vimpat®

Monoth. U.S.

Cimzia®

PsA

epratuzumab SLE

Cimzia®

RA/Japan

brivaracetam

adj. epilepsy

Neupro®

PD / U.S.

Neupro®

RLS / U.S.

Vimpat®

Monoth. EU

Neupro®

PD / Japan*

* By our CNS partner in Japan, Otsuka

Neupro®

RLS / Japan*

Approval

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2012 major milestones so far

Jan Feb March April May June July

Neupro® PD & RLS approval

Cimzia®

AxSpA – Phase 3 results

Cimzia® PsA - Phase 3

results

CDP7851 PMO - Phase 3

start

Cimzia® C-EARLY

start

Cimzia®

RA - Filing

Neupro® PD & RLS

launch

32

Upcoming, expected milestones

H2 2012

2013 2014 2015 2016

brivaracetam

Epilepsy POS adj. therapy

Vimpat®

Epilepsy POS monotherapy

Vimpat®

Epilepsy POS monotherapy

Vimpat®

Epilepsy POS paed. adj. th.

Vimpat®

Epilepsy PGTCS adj. th.

Cimzia®

AxSpA - submission

Cimzia®

PsA - submission

epratuzumab Systemic lupus erythematosus

Cimzia®

Juvenile idiopathic arthritis

CDP7851 Post-

menopausal osteoporosis

olokizumab rheumatoid

arthritis

CDP7851 Fracture healing

Cimzia® C-EARLY

Cimzia® EXXELERATE

33

• Psoriatic arthritis • prevalence 0.3%

Inflammation visible on X-ray? • Yes => R AxSpa = ankylosing spondylitis

• prevalence +/- 0.2% • No => NR AxSpa

• prevalence 0.2-0.5%

Spondyloarthritis

Spondylo-arthritis (SpA)

Axial SpA

SpA + skin

34

SpA family AS = the greatest unmet clinical need

35

Cimzia® Axial SpA Phase 3 study

40

325 patients with AxSpA

certolizumab pegol

placebo

n=178 (55%)

n=147 (45%)

Patients with

radiographically

evident AS

Patients with non-

radiographic axial SpA

ASAS20 primary endpoint achieved

improved the signs and symptoms of

AS and non-radiographic AxSpA

Full scientific presentation planned for upcoming scientific meeting/congress

Cimzia® RAPID-PsA™ Phase 3 study

41

409 patients with PsA

certolizumab pegol

placebo

ACR20

primary endpoint achieved

Full scientific presentation planned for upcoming scientific meeting/congress

Competitive late-stage pipeline transformational potential

Olokizumab RA

Phase 2

Phase 3

Filing

CDP7851 Fracture healing

CDP7851 PMO

Cimzia®

Juvenile RA

Cimzia®

AxSpA / AS

Vimpat® PGTCS

Vimpat®

paediatric

Vimpat®

Monoth. U.S.

Cimzia®

PsA

epratuzumab SLE

Cimzia®

RA/Japan

brivaracetam

adj. epilepsy

Neupro®

PD / U.S.

Neupro®

RLS / U.S.

Vimpat®

Monoth. EU

Neupro®

PD / Japan*

* By our CNS partner in Japan, Otsuka

Neupro®

RLS / Japan*

Approval

42

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

43

Cimzia® Vimpat® Neupro®

Keppra® Zyrtec® / Xyzal®

Mature product portfolio

2012

2012 – 'The Cross-over Year' Getting closer to the inflexion point

44

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

45

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

Sten, living with restless legs syndrome

Appendix

Geographic and therapeutic breakdown Net sales H1 2012: € 1 527 million

Europe 44%

47

Immunology & Allergy 24%

Shareholder structure Stable shareholder base, free float of 59%

48

Source: Shareholder Identification Analysis (November 2011),

Notifications 2012 and UCB S.A. underlying ownership analysis

“Free float” investors by region

Development pipeline Central Nervous System (CNS)

49

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

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

Brivaracetam Epilepsy – adj. therapy

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

Vimpat® (lacosamide) Epilepsy – monotherapy (EU)

Vimpat® (lacosamide) Epilepsy – Paediatric adj. therapy

Phase 3 to start H1 2013

Vimpat® (lacosamide) Epilepsy – adj. therapy PGTCS

Phase 3 to start Q1 2013

UCB0942 (PPSI) Epilepsy

Phase 1 Phase 2 Phase 3 Filing

Phase 3 results H1 2013

Phase 3 results Q2 2013

Phase 3 results Q4 2014

First phase 2 results

Phase 2 results

Approved!

Development pipeline Immunology

50

Cimzia® (certolizumab pegol) Rheumatoid arthritis (Japan)

Cimzia® (certolizumab pegol) AxSpA/Ankylosing spondylitis

Submission by end 2012

Cimzia® (certolizumab pegol) Psoriatic arthritis

Submission by end 2012

epratuzumab SLE*

Cimzia® (certolizumab pegol) Juvenile idiopathic arthritis

CDP7851 (sclerostin antibody) Post-menopausal osteoporosis

CDP7851 (sclerostin antibody) Fracture healing

olokizumab (anti-IL 6) Rheumatoid arthritis

CDP7657 (anti-CD40L) SLE*

January 2011

Phase 3 results

Phase 3 results H1 2014

Phase 3 results end 2015

Phase 2 results H2

2012

Phase 3 results

Phase 3 results H2 2014

Phase 2 results Q3

2012

Phase 1 Phase 2 Phase 3 Filing

*SLE: systemic lupus erythematosus

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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