2012 half-year results - ucb hy a… · 2012 half-year results 1 august 2012 sally and nikolas,...
TRANSCRIPT
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Bernadette, living with lupus
2012 half-year results
1 August 2012
Sally and Nikolas, living with Rheumatoid Arthritis
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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
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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
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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
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Alun, living with Parkinson’s Disease
Greg Duncan, President North American Operations
In-market performance: Cimzia®, Vimpat®, Neupro® + Keppra®
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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%
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Cimzia® Continued growth momentum
Launch in CD
Launch in RA
Launch in RA
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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
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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
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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%
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Vimpat® Successful, strong performance in the AED* market
12 * AED – anti-epileptic drug
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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
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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$
)
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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 €
)
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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)
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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)
17
€ 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%
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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!
19
€ 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%
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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
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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%
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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%)
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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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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
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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
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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
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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
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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
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• 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
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SpA family AS = the greatest unmet clinical need
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Cimzia® Axial SpA Phase 3 study
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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
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Cimzia® RAPID-PsA™ Phase 3 study
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409 patients with PsA
certolizumab pegol
placebo
ACR20
primary endpoint achieved
Full scientific presentation planned for upcoming scientific meeting/congress
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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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Cross-over in 2012 C V N deliver UCB growth – pipeline comes on top
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Cimzia® Vimpat® Neupro®
Keppra® Zyrtec® / Xyzal®
Mature product portfolio
2012
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2012 – 'The Cross-over Year' Getting closer to the inflexion point
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UCB's sustainable future growth Cimzia®, Vimpat® and Neupro® trigger company growth
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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
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Sten, living with restless legs syndrome
Appendix
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Geographic and therapeutic breakdown Net sales H1 2012: € 1 527 million
Europe 44%
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Immunology & Allergy 24%
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Shareholder structure Stable shareholder base, free float of 59%
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Source: Shareholder Identification Analysis (November 2011),
Notifications 2012 and UCB S.A. underlying ownership analysis
“Free float” investors by region
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Development pipeline Central Nervous System (CNS)
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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!
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Development pipeline Immunology
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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
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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]
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