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.
2
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
6
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
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000M
onth
1M
onth
2M
onth
3M
onth
4M
onth
5M
onth
6M
onth
7M
onth
8M
onth
9M
onth
10
Mon
th 1
1M
onth
12
Mon
th 1
3M
onth
14
Mon
th 1
5M
onth
16
Mon
th 1
7M
onth
18
Mon
th 1
9M
onth
20
Mon
th 2
1M
onth
22
Mon
th 2
3M
onth
24
Mon
th 2
5M
onth
26
Mon
th 2
7M
onth
28
Mon
th 2
9M
onth
30
Mon
th 3
1
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
19
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!
22
€ 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'
23
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
30
*
*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)
34
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
39
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
40
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: [email protected]
Isabelle Ghellynck, Investor Relations Project Manager• Phone: +32 2 559 9588• E-mail: [email protected]
Nathalie Deldime, Investor Relations Events Specialist• Phone: +32 2 559 9291• E-mail: [email protected]
52