2010 full-year results 3 March 2011 - UCB
2010 full-year results 3 March 2011 - UCB
2010 full-year results 3 March 2011 - UCB
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<strong>2010</strong> <strong>full</strong>-<strong>year</strong> <strong>results</strong><br />
3 <strong>March</strong> <strong>2011</strong><br />
Progressing to<br />
become<br />
the patient-centric<br />
global biopharma leader<br />
Alison, living with rheumatoid arthritis
Disclaimer and safe harbour<br />
Forward-looking statements:<br />
This presentation includes “forward-looking statements” relating to <strong>UCB</strong> group of companies (“<strong>UCB</strong>”) that are subject to<br />
known and unknown risks and uncertainties, many of which are outside of <strong>UCB</strong>’s control and are difficult to predict, that<br />
may cause actual <strong>results</strong> to differ materially from any future <strong>results</strong> expressed or implied from the forward-looking<br />
statements.<br />
In this presentation, the words “anticipates,” “believes,” “estimates,” “seeks,” “expects,” “plans,” “intends” and similar<br />
expressions, as they relate to <strong>UCB</strong>, are intended to identify forward-looking statements.<br />
Important factors that could cause actual <strong>results</strong> to differ materially from such expectations include, without limitation:<br />
the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms; the economic environment<br />
of the industries in which <strong>UCB</strong> operates; costs associated with research and development; changes in the prospects for<br />
products in the pipeline or under development by <strong>UCB</strong>; dependence on the existing management of <strong>UCB</strong>; changes or<br />
uncertainties in tax laws or the administration of such laws; changes or uncertainties in the laws or regulations applicable<br />
to the markets in which <strong>UCB</strong> operates.<br />
All written and oral forward-looking statements attributable to <strong>UCB</strong> or persons acting on its behalf are expressly qualified<br />
in their entirety by the cautionary statements above.<br />
<strong>UCB</strong> does not intend, or undertake any obligation, to update these forward-looking statements.<br />
2
<strong>UCB</strong>: to be patient-centric global biopharma leader<br />
Focus: Immunology and<br />
Central Nervous System<br />
R&D spend:<br />
22% of revenue<br />
About 203 000 patients<br />
treated with <strong>UCB</strong>’s new<br />
core products<br />
Operations in more than<br />
40 countries<br />
About 8 500 employees<br />
globally<br />
Stephanie, living with<br />
rheumatoid arthritis<br />
3<br />
3
<strong>2010</strong> financial highlights<br />
Revenue of € 3 218 million<br />
• Strong Cimzia ® , Vimpat ® and Neupro ®<br />
• Strong Keppra ® sales in EU and venlafaxine XR in U.S.<br />
Underlying profitability (Recurring EBITDA)<br />
of € 731 million<br />
Core EPS of € 1.99 1 , above guidance<br />
3%<br />
5%<br />
15%<br />
1. based on 180 million shares outstanding<br />
4
203 000 patients have now been treated<br />
An increase of 88% versus December 2009<br />
<strong>UCB</strong> is becoming the<br />
Patient-Centric global biopharmaceutical leader<br />
Fast response for predictable outcomes<br />
22 000 patients prescribed<br />
Expected peak sales of at least € 1.5 billion 1<br />
When monotherapy is no longer enough<br />
108 000 patients prescribed<br />
Expected peak sales of at least € 1.2 billion 1<br />
24h continuous delivery by transdermal patch<br />
73 000 patients prescribed<br />
Expected peak sales of at least € 400 million 1<br />
1 to be reached in the second half of the decade<br />
5
<strong>2010</strong> information flow<br />
Welcome and introduction<br />
• Roch Doliveux, CEO<br />
Major products performance in U.S. and Europe / Rest of the World<br />
• Greg Duncan, President North America Operations<br />
• Khoso Baluch, Sr. VP Global Marketing & Access<br />
Financial performance<br />
• Detlef Thielgen, CFO<br />
Advancing the pipeline<br />
• Iris Loew-Friedrich, CMO<br />
<strong>UCB</strong> NewMedicines<br />
• Ismail Kola, CSO<br />
Conclusion<br />
• Roch Doliveux, CEO<br />
6
U.S. Business<br />
Greg Duncan,<br />
President North America<br />
Operations<br />
Brett, living with crohn’s disease
Cimzia ® -U.S.<br />
Fast response for predictable outcomes<br />
Crohn’s disease - For naïve or bio-experienced patients<br />
• Fast – Results after just 1 dose<br />
• Stable & Sustainable – Long-term remission with no dose escalation<br />
• Over 4 000 prescribers – approximately 50% of target<br />
Rheumatoid arthritis - Fast response for predictable outcomes<br />
• Fast response with Cimzia ® means<br />
• The opportunity to make an informed treatment decision within 12 weeks<br />
• Over 2 200 prescribers – approximately 50% of target<br />
Net sales increased by 137%<br />
€ million<br />
North<br />
America<br />
<strong>2010</strong><br />
net sales<br />
166<br />
2009<br />
net sales<br />
70<br />
~ 18 000 patients on Cimzia ®<br />
8
Cimzia ® provides a fast response for <strong>results</strong> that last 1<br />
The degree and speed of response with Cimzia ® was highly predictive of<br />
outcomes at 52 weeks 3<br />
Available data suggest that a clinical response<br />
is usually achieved within the first 12 weeks of<br />
CIMZIA ® treatment 2<br />
RAPID 1 was a 52-week, multicenter, randomized, double-blind, placebo-controlled study in 982<br />
patients with active RA receiving CIMZIA 200 mg (n=393), CIMZIA 400 mg (n=390), or placebo (n=199)<br />
every 2 weeks + weekly methotrexate (MTX) after an initial starting dose of CIMZIA 400 mg at weeks 0,<br />
2, and 4. The co-primary end points were ACR20 score at week 24 and change in mTSS at week 52. 1<br />
Similar <strong>results</strong> were seen in RAPID 2.<br />
* Not all patients may have responded at each time point.<br />
Predicting response at week 12 can improve<br />
therapeutic benefit by making an early treatment<br />
decision possible and avoiding unnecessary costs<br />
and safety exposure 4<br />
The best-fit curve above represents the probability of LDA at week 52 in patients who do not achieve a<br />
DAS28 response ≥1.2 at the given time point.<br />
RAPID 1 was a 52-week, multicenter, randomized, double-blind, placebo-controlled study in 982 patients<br />
with active RA receiving CIMZIA 200 mg (n=393), CIMZIA 400 mg (n=390), or placebo (n=199) every 2<br />
weeks + weekly methotrexate (MTX) after an initial starting dose of CIMZIA 400 mg at weeks 0, 2, and 4.<br />
The co-primary end points were ACR20 score at week 24 and change in mTSS at week 52. 1 Similar<br />
<strong>results</strong> were seen in RAPID 2.<br />
1. Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis. Arthritis Rheum. 2008;58:3319-3329.<br />
2. CIMZIA [summary of product characteristics]. Bruxelles, Belgium: <strong>UCB</strong> Pharma, S.A.; 2009.<br />
3. Data on file. <strong>UCB</strong>, Inc; Smyrna, GA.<br />
4. Aletaha D, Funovits J, Keystone EC, Smolen JS. Disease activity early in the course of treatment predicts response to therapy after one <strong>year</strong> in rheumatoid arthritis patients. Arthritis Rheum. 2007:56:3226-3235.<br />
9
Cimzia ® main message is unique and motivating<br />
Rheums who recall the 12 week message (unaided) rate the CIMZIA ® message significantly higher on unique and<br />
different and highest on motivation to prescribe<br />
Cimzia ® : Onset of<br />
Action** within 12 weeks<br />
(sub-subnet)<br />
Humira<br />
Actemra<br />
Simponi<br />
Cimzia ®<br />
(other messages)<br />
Enbrel<br />
Remicade<br />
Orencia<br />
Motivation to Prescribe Product<br />
(n=47)<br />
(n=49)<br />
(n=50)<br />
(n=50)<br />
(n=111)<br />
(n=50)<br />
(n=50)<br />
(n=49)<br />
4.58<br />
4.56<br />
4.54<br />
4.42<br />
4.41<br />
4.88<br />
4.86<br />
Cimzia ® : Onset of Action**<br />
within 12 weeks (sub-subnet)<br />
Actemra<br />
Simponi<br />
Cimzia ® :<br />
(Other messages)<br />
Humira<br />
Orencia<br />
Enbrel<br />
Remicade<br />
**Onset of Action is made up of codes: three month/twelve week free trial, ability to make an informed treatment decision in 12<br />
weeks and rapid onset of action within 12 weeks.<br />
5.32<br />
1.0 2.0 3.0 4.0 5.0 6.0 7.0<br />
Mean Rating<br />
Uniqueness and Difference of Product<br />
(n=47)<br />
(n=50)<br />
(n=50)<br />
(n=111)<br />
(n=49)<br />
(n=49)<br />
(n=50)<br />
(n=50)<br />
3.94<br />
4.70<br />
4.68<br />
4.55<br />
4.39<br />
4.38<br />
5.22<br />
5.51<br />
1.0 2.0 3.0 4.0 5.0 6.0 7.0<br />
Mean Rating<br />
10
Cimzia ® in rheumatoid arthritis – U.S.<br />
Gaining use even in an entrenched marketplace<br />
RA Indexed Monthly Rx<br />
240<br />
220<br />
200<br />
180<br />
160<br />
140<br />
120<br />
100<br />
80<br />
Jan‐10<br />
Feb‐10<br />
Cimzia ® RA indexed vs Total Market:<br />
Mar‐10<br />
Apr‐10<br />
May‐10<br />
Jun‐10<br />
Jul‐10<br />
Aug‐10<br />
Sep‐10<br />
Oct‐10<br />
Nov‐10<br />
Cimzia® Nrx Total Market Nrx<br />
Cimzia® Trx Total Market Trx<br />
Dec‐10<br />
NRx = New prescriptions / TRx = Total prescriptions<br />
Source: IMS National Prescription Audit (NPA)<br />
11
Cimzia ® for Crohn's disease - U.S.<br />
An important new option for U.S. patients<br />
CD Indexed Monthly Rx<br />
160<br />
150<br />
140<br />
130<br />
120<br />
110<br />
100<br />
90<br />
80<br />
Jan‐10<br />
Feb‐10<br />
Cimzia ® CD indexed vs Total Market:<br />
Mar‐10<br />
Apr‐10<br />
May‐10<br />
Jun‐10<br />
Jul‐10<br />
Aug‐10<br />
Sep‐10<br />
Oct‐10<br />
Nov‐10<br />
Cimzia® Nrx Total Market Nrx<br />
Cimzia® Trx Total Market Trx<br />
Dec‐10<br />
NRx = New prescriptions / TRx = Total prescriptions<br />
Source: IMS National Prescription Audit (NPA)<br />
12
Vimpat ® U.S. When monotherapy is no longer enough…<br />
A new treatment option in add-on for POS<br />
Efficacy when added to broad range of 1st and 2nd generation AEDs<br />
No drug-drug interactions; multiple formulations<br />
Net sales increased by 220%<br />
€ million<br />
North<br />
America<br />
Already 11 000 prescribers – approximately 85% of target<br />
<strong>2010</strong><br />
net sales<br />
96<br />
2009<br />
net sales<br />
30<br />
~ 58 000 patients on Vimpat ®<br />
13
Vimpat ® – Improved seizure control<br />
Regardless of patient’s concomitant therapy<br />
14
<strong>UCB</strong>’s status as the company with the best reputation<br />
amongst neurologists continues to grow<br />
50%<br />
45%<br />
40%<br />
35%<br />
30%<br />
25%<br />
20%<br />
15%<br />
10%<br />
5%<br />
0%<br />
July 2006,<br />
Previous ATU<br />
(n=101)<br />
<strong>UCB</strong><br />
GlaxoSmithKline<br />
Abbott Laboratories<br />
Pfizer<br />
Ortho McNeil<br />
Novartis<br />
Don't know<br />
None<br />
Q58a. When thinking of pharmaceutical companies that manufacture anti-epileptic<br />
products, which one company would you say has the best reputation in<br />
epilepsy/seizure disorder category? (open-end)<br />
Company with Best Reputation (Unaided)<br />
All Neurologists<br />
Feb 2007,<br />
Previous ATU<br />
(n=106)<br />
Nov 2007,<br />
Previous ATU<br />
(n=100)<br />
August 2008<br />
(n=150)<br />
June 2009<br />
(n=151)<br />
January <strong>2010</strong><br />
(n=201)<br />
June <strong>2010</strong><br />
(n=178)<br />
Source: ATU July <strong>2010</strong><br />
15
Vimpat ® -U.S.<br />
Successful launch in the AED market<br />
Indexed Monthly Rx<br />
200<br />
180<br />
160<br />
140<br />
120<br />
100<br />
80<br />
Jan‐10<br />
Feb‐10<br />
Mar‐10<br />
Apr‐10<br />
May‐10<br />
Jun‐10<br />
Jul‐10<br />
Aug‐10<br />
Sep‐10<br />
Oct‐10<br />
Nov‐10<br />
Dec‐10<br />
Vimpat® Trx Total Market Trx<br />
Vimpat® Nrx Total Market Nrx<br />
* Total Market: Carbamazepine, Gabapentin, Lacosamide, Lamotrigine, Levetiracetam,<br />
Oxcarbazepine, Phenytoin, Pregabaline, Rufinamide, Tiagabine, Topiramate,<br />
Valproic Acid, Vigabatrin, Zonisamide<br />
AED = Anti-Epileptic Drug Source: IMS National Prescription Audit (NPA)<br />
16
Physicians report Vimpat ® is the add-on of choice for epilepsy<br />
patients and is being used earlier in the treatment algorithm<br />
Share of NWRx<br />
30%<br />
25%<br />
20%<br />
15%<br />
10%<br />
5%<br />
0%<br />
Physicians report: Vimpat ® Physicians report: Vimpat is the<br />
agent of choice when selecting an<br />
add-on therapy for epilepsy<br />
® is the<br />
agent of choice when selecting an<br />
add-on therapy for epilepsy<br />
12/09<br />
n=403<br />
1/10<br />
405<br />
2/10<br />
388<br />
3/10<br />
407<br />
Source: Impact Rx and Dec <strong>2010</strong> ATU<br />
4/10<br />
374<br />
5/10<br />
389<br />
6/10<br />
403<br />
7/10<br />
419<br />
8/10<br />
408<br />
9/10<br />
374<br />
10/10<br />
359<br />
11/10<br />
330<br />
12/10<br />
318<br />
Vimpat<br />
Keppra<br />
Lamictal<br />
Keppra XR<br />
Lamictal XR<br />
17
Europe &<br />
Rest of the World<br />
Khoso Baluch,<br />
Sr. VP Global Marketing<br />
& Access<br />
DeOnna, living with rheumatoid arthritis
Cimzia ®<br />
Fast response for predictable outcomes<br />
Rheumatoid arthritis - Fast response for predictable outcomes<br />
• Fast response with Cimzia ® means<br />
• Improved long-term outcomes<br />
• The opportunity to make an informed treatment decision within 12 weeks<br />
Crohn’s disease (approved in Switzerland)<br />
For naïve or bio-experienced patients<br />
• Fast – Results after just 1 dose<br />
• Sustainable – Long-term remission with no dose escalation<br />
• Stable – 1 predictable subcutaneous Q4-week dose<br />
Net sales increased by 528%<br />
€ million<br />
Europe<br />
ROW<br />
<strong>2010</strong><br />
net sales<br />
31<br />
1<br />
2009<br />
net sales<br />
5<br />
0<br />
~ 4 000 patients on Cimzia ®<br />
19
Cimzia ®<br />
Roll-out in Europe and Rest of the World<br />
15<br />
12<br />
9<br />
6<br />
3<br />
0<br />
Quarterly sales evolution since launch<br />
€ million<br />
1 st launch in RA<br />
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4<br />
2008 2009 <strong>2010</strong><br />
20
Cimzia ® roll-out in Europe and Rest of the World<br />
Launched in 18 countries, continued launch roll-out<br />
<strong>2010</strong><br />
Launches<br />
2009<br />
Launches<br />
Launch<br />
Countries<br />
Ireland<br />
Italy<br />
Sw itzerland<br />
France<br />
Greece<br />
Australia<br />
Slovakia<br />
Spain<br />
Austria<br />
Belgium<br />
Hungary<br />
Finland<br />
Netherlands<br />
Sw eden<br />
Norw ay<br />
UK<br />
Denmark<br />
Germany<br />
2009 <strong>2010</strong><br />
Q2 2009 Q3 2009 Q4 2009 Q1 <strong>2010</strong> Q2 <strong>2010</strong> Q3 <strong>2010</strong> Q4 <strong>2010</strong><br />
21
Vimpat ® in epilepsy<br />
When monotherapy is no longer enough…<br />
Epilepsy adjunctive therapy<br />
When monotherapy is no longer enough…<br />
• A new treatment option in add-on for POS 1<br />
• Efficacy when added to broad range of 1 st and 2 nd generation AEDs 2<br />
• Additional efficacy with manageable side effects<br />
• Sustainable – high long-term retention rate demonstrated by Vimpat ® open label<br />
extension trial<br />
• No drug-drug interactions; multiple formulations<br />
Net sales increased by 133 %<br />
€ million<br />
Europe<br />
ROW<br />
<strong>2010</strong><br />
net sales<br />
36<br />
1<br />
2009<br />
net sales<br />
16<br />
~ 49 000 patients on Vimpat ®<br />
0<br />
1 Partial onset seizures<br />
2 Anti-epileptic drug<br />
22
Vimpat ® in epilepsy<br />
Roll-out in Europe and Rest of World<br />
12<br />
9<br />
6<br />
3<br />
0<br />
Quarterly sales evolution since launch<br />
€ million<br />
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4<br />
2008 2009 <strong>2010</strong><br />
23
Vimpat ® roll-out in Europe and Rest of the World<br />
Launched in 20 countries, continued launch roll-out<br />
<strong>2010</strong><br />
Launches<br />
2009<br />
Launches<br />
2008<br />
Launches<br />
Launch<br />
Countries<br />
Mexico<br />
Italy<br />
Russia<br />
Australia<br />
Czech<br />
Belgium<br />
Finland<br />
Switzerland<br />
France<br />
Spain<br />
Norway<br />
Netherlands<br />
Slovakia<br />
Sweden<br />
Denmark<br />
Ireland<br />
Greece<br />
Austria<br />
UK<br />
Germany<br />
2008<br />
2009<br />
Q3 2008 Q4 2008 Q1 2009 Q2 2009 Q3 2009 Q4 2009 Q1 <strong>2010</strong> Q2 <strong>2010</strong> Q3 <strong>2010</strong> Q4 <strong>2010</strong><br />
<strong>2010</strong><br />
24
Neupro ® roll-out in Europe and Rest of the World<br />
24h continuous delivery by transdermal patch<br />
Parkinson’s disease and restless legs syndrome<br />
24h continuous delivery by transdermal patch<br />
• Continuous delivery to provide stable drug levels<br />
Net sales increased by 34%<br />
€ million<br />
Europe<br />
ROW<br />
<strong>2010</strong><br />
net sales<br />
• Improving daily functioning, sleep and early morning functions<br />
81<br />
1<br />
2009<br />
net sales<br />
60<br />
~ 73 000 patients on Neupro ®<br />
0<br />
25
Neupro ® - rotigotine transdermal patch<br />
Continued launch roll-out<br />
25<br />
20<br />
15<br />
10<br />
5<br />
0<br />
Quarterly sales evolution<br />
€ million<br />
New patient launch<br />
PD & RLS<br />
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4<br />
2008 2009 <strong>2010</strong><br />
26
Neupro ® - rotigotine transdermal patch<br />
Continued launch roll-out<br />
<strong>2010</strong><br />
Launches<br />
2009<br />
Launches<br />
2008<br />
Launches<br />
2007<br />
Launches<br />
2006<br />
Launches<br />
Launch Countries Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4<br />
Mexico<br />
Poland<br />
Romania<br />
Czech Republic<br />
Netherlands<br />
Australia<br />
Hong-Kong<br />
Finland<br />
Italy<br />
Slovakia<br />
Sweden<br />
Norway<br />
Denmark<br />
Austria<br />
Spain<br />
Switzerland<br />
Greece<br />
Ireland<br />
U.K.<br />
Germany<br />
2006 2007<br />
2008<br />
2009<br />
<strong>2010</strong><br />
27
Keppra ® franchise<br />
Market leadership in Europe and Rest of the World<br />
€ million<br />
Europe<br />
North America<br />
Rest of World<br />
Total<br />
<strong>2010</strong><br />
net sales<br />
606<br />
278<br />
Loss of exclusivity in the U.S. (November 2008)<br />
Loss of exclusivity in the E.U. (September <strong>2010</strong>)<br />
21%<br />
Sustained growth outside the U.S., generated by use in monotherapy<br />
E Keppra ® - most successful antiepileptic launch in Japan<br />
58<br />
942<br />
2009<br />
net sales<br />
Sizeable franchise going forward!<br />
545<br />
320<br />
48<br />
913<br />
Actual CER<br />
11%<br />
-13%<br />
3%<br />
10%<br />
-18%<br />
6%<br />
0%<br />
28
<strong>2010</strong> Financial<br />
Performance<br />
Detlef Thielgen, CFO<br />
Christer, living with Parkinson’s disease
<strong>2010</strong> Financial highlights<br />
Revenue of € 3 218 million<br />
• Generic competition to mature products compensated by Cimzia ® , Vimpat ® and<br />
Neupro ® ; strong Keppra ® sales in EU and venlafaxine XR in U.S.<br />
Total operating expenses € 1 698 million<br />
• Increased launch expenses for Cimzia ® , Vimpat ® and Neupro ®<br />
• Pipeline progress trigger new clinical development programmes<br />
Recurring EBITDA of € 731 million<br />
Net profit 1 of € 103 million<br />
• Adjusted net profit of € 239 (+6%)<br />
Core EPS of € 1.99 2<br />
Gross dividend of € 0.98 per share<br />
3%<br />
4%<br />
5%<br />
80%<br />
15%<br />
2%<br />
1 After non-controlling interests<br />
2. based on 180 million shares outstanding, see appendix for Core EPS calculation details<br />
6%<br />
30
Net sales of major and new products<br />
Net sales <strong>2010</strong>: € 2 786 million<br />
Core products<br />
Mature products<br />
In € million<br />
Cimzia®<br />
Vim pat®<br />
Neupro®<br />
Keppra® 1<br />
Zyrtec®<br />
venlafaxine XR<br />
Xyzal® 2<br />
Tussionex<br />
Nootropil®<br />
omeprazole<br />
Metadate<br />
Other products<br />
+163%<br />
+190%<br />
+34% 82<br />
+3%<br />
-15%<br />
+49%<br />
-13%<br />
-46%<br />
-5%<br />
+1%<br />
66<br />
65<br />
-26% 54<br />
-9%<br />
80<br />
133<br />
115<br />
162<br />
198<br />
229<br />
Core products combined sales of € 413 million<br />
up by 127% in the first <strong>full</strong> <strong>year</strong> of sales – on<br />
track to meet peak sales guidance<br />
660<br />
942<br />
Total mature products sales reached € 2 373 million<br />
down by 5% following further generic competition<br />
Note: % constant exchange rates<br />
1 Including € 83 million of Keppra ® XR in the U.S.<br />
31<br />
2 Excluding Xyzal ® U.S. revenue to <strong>UCB</strong> of € 28 million from profit-sharing with sanofi-aventis
<strong>2010</strong> net sales<br />
Solid growth from core products<br />
€ million<br />
2009<br />
net sales<br />
€ 2 683<br />
million 2009<br />
Net<br />
Sales<br />
1 379<br />
Mature<br />
products<br />
-128<br />
Core<br />
products<br />
+ 231<br />
Cimzia ®<br />
Vimpat ®<br />
Neupro ®<br />
<strong>2010</strong><br />
net <strong>2010</strong> sales<br />
Net<br />
Sales<br />
€ 2 786<br />
million<br />
1 431<br />
4%<br />
32
Recurring EBITDA<br />
Consistent solid underlying profitability<br />
€ million<br />
Revenue<br />
Net sales<br />
Royalty income & fees<br />
Other revenue<br />
Gross profit<br />
Marketing & selling expenses<br />
R&D expenses<br />
G&A expenses<br />
Other operating income<br />
Total operating expenses<br />
Recurring EBIT<br />
Amortisation of intangible assets<br />
Depreciation charges<br />
Recurring EBITDA<br />
<strong>2010</strong><br />
3 218<br />
2 786<br />
220<br />
212<br />
2 165<br />
-797<br />
-705<br />
-194<br />
-2<br />
-1 698<br />
467<br />
190<br />
73<br />
731<br />
Actual<br />
2009<br />
3 116<br />
2 683<br />
227<br />
206<br />
2 091<br />
-781<br />
-674<br />
-189<br />
6<br />
-1 638<br />
453<br />
142<br />
102<br />
698<br />
Actual<br />
-3%<br />
3%<br />
4%<br />
2%<br />
5%<br />
3%<br />
n.s.<br />
4%<br />
3%<br />
33%<br />
-28%<br />
Variance<br />
3%<br />
4%<br />
5%<br />
CER<br />
0%<br />
0%<br />
-7%<br />
0%<br />
-1%<br />
-3%<br />
2%<br />
1%<br />
n.s.<br />
0%<br />
-7%<br />
30%<br />
-31%<br />
-3%<br />
33
Net profit<br />
Strong REBIT impacted by non-cash, one-time charges<br />
€ million<br />
Recurring EBIT<br />
Impairment charges<br />
Restructuring expenses<br />
Gain on disposals<br />
Other non recurring expenses<br />
Total non recurring<br />
income/(expenses)<br />
EBIT<br />
Net financial expenses<br />
Income tax (expense)/credit<br />
Profit from continuing<br />
operations<br />
Net profit 1<br />
Adjusted net profit 2<br />
<strong>2010</strong><br />
467<br />
-223<br />
-40<br />
49<br />
-49<br />
-263<br />
204<br />
-185<br />
86<br />
105<br />
103<br />
239<br />
Actual<br />
2009<br />
453<br />
-126<br />
-73<br />
594<br />
-11<br />
384<br />
837<br />
-162<br />
-168<br />
507<br />
513<br />
226<br />
Actual<br />
78%<br />
-46%<br />
n.s.<br />
n.s.<br />
n.s.<br />
-76%<br />
14%<br />
n.s.<br />
-79%<br />
-80%<br />
Variance<br />
3%<br />
6%<br />
CER<br />
-7%<br />
73%<br />
-48%<br />
n.s.<br />
n.s.<br />
n.s.<br />
-80%<br />
13%<br />
n.s.<br />
-85%<br />
-85%<br />
-8%<br />
1 After non-controlling interest<br />
2 Adjusted for after-tax impact of one-time and non-recurring items<br />
34
<strong>2010</strong> cash flows<br />
FY 2009<br />
cash<br />
€ 466<br />
million<br />
Operating<br />
activities<br />
€506 m<br />
Investing<br />
activities<br />
€-63 m<br />
Financing 1<br />
activities<br />
€ -440 m<br />
FY <strong>2010</strong><br />
cash 87%<br />
€ 477<br />
million<br />
1 1 Includes effect of exchange rate fluctuations<br />
35
Net debt evolution<br />
Strong free cash flow reduces net debt by 15%<br />
€ million 31 Dec <strong>2010</strong> 31 Dec 2009<br />
Net debt -1 525 -1 752<br />
Liquid assets 498 491<br />
Financial debt<br />
2 500<br />
2 000<br />
1 500<br />
1 000<br />
500<br />
0<br />
1 915<br />
Net Debt (€ million)<br />
2 443<br />
1 752<br />
1 525<br />
2007A 2008A 2009A <strong>2010</strong> A<br />
-2 023<br />
3.5<br />
3.0<br />
2.5<br />
2.0<br />
1.5<br />
1.0<br />
0.5<br />
0.0<br />
2.6x<br />
-2 243<br />
Net Debt/REBITDA<br />
3.3x<br />
2.5x<br />
2.1x<br />
2007A 2008A 2009A <strong>2010</strong> A<br />
36
<strong>2011</strong> financial outlook<br />
Revenue is expected between €3.0 and<br />
€ 3.1 billion<br />
Recurring EBITDA expected to be in the<br />
range between € 650 and 680 million<br />
Core EPS expected to reach<br />
approximately € 1.60 to 1.70 1<br />
1. based on 180 million shares outstanding, see appendix for Core EPS calculation methodology<br />
37
<strong>UCB</strong>'s Sustainable Future Growth<br />
Cimzia ® , Vimpat ® and Neupro ® trigger company growth<br />
Cimzia ® , Vimpat ® ,<br />
Neupro ®<br />
• Optimise mature base<br />
business<br />
• Manage remaining loss<br />
of exclusivity<br />
<strong>2010</strong><br />
Intense growth<br />
Company<br />
growth<br />
Realise the <strong>full</strong> commercial<br />
potential of Cimzia ® ,<br />
Vimpat ® , Neupro ®<br />
Breakthrough<br />
Launch a new generation of<br />
therapies offering<br />
breakthrough innovation to<br />
patients with severe disease<br />
lifecycle management first Breakthroughs<br />
... and beyond<br />
38
Advancing<br />
the pipeline<br />
Iris Loew-Friedrich<br />
Chief Medical Officer<br />
Esperanza, living with RLS
Development pipeline with significant progress<br />
Central Nervous System (CNS)<br />
Neupro ® (rotigotine)<br />
Adv. Parkinson's disease (U.S.)<br />
Neupro ® (rotigotine)<br />
Restless legs syndrome (U.S.)<br />
Xyrem ® (sodium oxybate)<br />
Fibromyalgia (EU)<br />
Vimpat ® (lacosamide)<br />
Epilepsy – monotherapy (U.S.)<br />
Vimpat ® (lacosamide)<br />
Epilepsy – monotherapy (EU)<br />
brivaracetam<br />
Epilepsy – adj. therapy<br />
Vimpat ® (lacosamide)<br />
Epilepsy – Paediatric adj. therapy<br />
Vimpat ® (lacosamide)<br />
Epilepsy – adj. therapy PGTCS<br />
<strong>UCB</strong>0942 (PPSI)<br />
Epilepsy<br />
Phase 1 Phase 2 Phase 3 Regulatory status<br />
first <strong>results</strong><br />
Results<br />
H2 <strong>2011</strong><br />
Results<br />
Q2 2013<br />
Results<br />
Q4 2014<br />
Results<br />
H1 2013<br />
Filed CRL*<br />
November Dec 2008 2008<br />
CRL*<br />
Dec 2008<br />
CRL1<br />
April Filed <strong>2010</strong><br />
�<br />
�<br />
�<br />
* Complete Response Letter<br />
40
Development pipeline with significant progress<br />
Immunology<br />
Cimzia ® (certolizumab pegol)<br />
Rheumatoid arthritis (Japan)<br />
Cimzia ® (certolizumab pegol)<br />
Ankylosing spondylitis<br />
Cimzia ® (certolizumab pegol)<br />
Psoriatic arthritis<br />
epratuzumab<br />
SLE<br />
Cimzia ® (certolizumab pegol)<br />
Juvenile rheumatoid arthritis<br />
CDP7851 (anti-sclerostin)<br />
Post-menopausal osteoporosis<br />
CDP7851 (anti-sclerostin)<br />
Fracture healing<br />
olokizumab (anti-IL 6)<br />
Rheumatoid arthritis<br />
CDP7657 (anti CD40L)<br />
SLE<br />
Phase 1 Phase 2 Phase 3<br />
Results<br />
Q2 <strong>2011</strong><br />
Results<br />
2012<br />
Results<br />
Q3 2012<br />
Positive<br />
<strong>results</strong><br />
Results<br />
Q4 <strong>2011</strong><br />
Results<br />
Q4 <strong>2011</strong><br />
Results<br />
H1 2014<br />
Regulatory status<br />
�<br />
�<br />
41
Vimpat ® in epilepsy – monotherapy (EU)<br />
Phase 3 programme started – <strong>results</strong> Q4 2014<br />
Phase 3 trial initiated<br />
• adults ≥16 <strong>year</strong>s experiencing POS or PGTCS<br />
• ~1000 subjects across 120 sites in EU, Canada, Australia,<br />
and other regions<br />
• multicenter, double-blind, double-dummy, randomized,<br />
positive-controlled study comparing the efficacy and safety<br />
of LCM (200 to 600mg/day) to CBZ-CR (400 to<br />
1200mg/day) used as monotherapy<br />
• non-inferiority design to show at least a similar benefit-risk<br />
balance for LCM compared with CBZ-CR<br />
Primary endpoint<br />
Vimpat ®<br />
Monotherapy (EU)<br />
Results<br />
Q4 2014<br />
Atsumi, living with epilepsy<br />
Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive<br />
weeks) of treatment following stabilization at the last evaluated dose for each subject<br />
42
Brivaracetam in epilepsy<br />
New Phase 3 trial started – first <strong>results</strong> H1 2013<br />
Phase 3 trial currently recruiting<br />
• Refractory patient population (≥16 to 80 <strong>year</strong>s ) with partial<br />
onset seizures (POS)<br />
• 720 patients across 120 sites worldwide<br />
• Multicenter, placebo-controlled, randomized efficacy trial<br />
Placebo, brivaracetam 100mg/day, brivaracetam 200mg/day<br />
• 6 month trial (of which 12 weeks treatment period)<br />
Primary endpoint<br />
brivaracetam<br />
Adjunctive therapy<br />
Phase 1 Phase 2 Phase 3<br />
Results<br />
H1 2013<br />
Thomas, living with epilepsy<br />
• U.S.: % reduction in POS frequency per 28 days during the 12 week treatment period over placebo<br />
• Europe: 50% responder rate based on a % reduction in POS frequency from baseline to the 12<br />
week treatment period<br />
43
Epratuzumab in SLE<br />
Phase 3 programme started – <strong>results</strong> H1 2014<br />
Phase 3 trials currently recruiting<br />
• Two confirmatory Phase 3 studies (Embody 1 & Embody 2)<br />
• Moderate to severe patient population<br />
• 780 patients/trial across 130 sites worldwide<br />
• Multicenter, placebo-controlled, randomized efficacy studies<br />
� Placebo<br />
� Epratuzumab 600mg infusions delivered once a week<br />
� Epratuzumab 1200mg infusions delivered every other week<br />
• 12 month trials<br />
Primary endpoint<br />
Bernadette, living with lupus<br />
To confirm the clinical efficacy of epratuzumab by the % of subjects meeting treatment response<br />
criteria at Week 48 according to a combined response index build primarily around BILAG<br />
epratuzumab<br />
SLE<br />
Phase 1 Phase 2 Phase 3<br />
Results<br />
H1 2014<br />
SLE: systemic lupus erythematosus<br />
44
Additional external pipeline options<br />
SYN115<br />
(A2a)<br />
SYN118<br />
(HPPD)<br />
MEK inhibitor<br />
(WX554)<br />
Therapeutic area /<br />
Indication<br />
CNS –<br />
Parkinson’s<br />
disease<br />
CNS –<br />
Parkinson’s<br />
disease<br />
Oncology<br />
Stage of development<br />
Phase 2 trial ongoing;<br />
Phase 2b to start in<br />
Q1 <strong>2011</strong><br />
Phase 2 trial ongoing<br />
Successful completion of<br />
Phase 1 dose escalation<br />
study<br />
Development path<br />
+ Partner<br />
Synosia/Biotie to<br />
complete Phase 2;<br />
<strong>UCB</strong> to take over<br />
Phase 3 development<br />
and commercialisation<br />
WILEX to do further<br />
Phase 1 development<br />
45
<strong>UCB</strong> NewMedicines<br />
Ismail Kola<br />
Executive VP, <strong>UCB</strong>.<br />
President <strong>UCB</strong> NewMedicines<br />
Juan, living with restless legs syndrome<br />
46<br />
46
<strong>UCB</strong> NewMedicines strategy and business model<br />
A new R&D paradigm to deliver<br />
differentiated drugs<br />
Deliver differentiated molecules<br />
Increase success rates<br />
Enhance scientific excellence<br />
Increase efficiency<br />
Implement extreme networking<br />
and open innovation<br />
Partnering and virtualisation to<br />
complement internal capabilities<br />
Innovative targets<br />
(Academic/biotech)<br />
SEGMENTED<br />
Wholly owned assets<br />
PORTFOLIO<br />
Shared risk<br />
Outlicensing<br />
<strong>UCB</strong><br />
incubators<br />
47
Our model addresses the industry’s low R&D<br />
developmental and commercial success rates<br />
89% of molecules in development fail**<br />
42% of Phase 3 trials fail*<br />
70% launched products fail to recoup initial investment<br />
Pre-clinical Clinical (all phases) Commercial<br />
2/1000<br />
Reasons for attrition<br />
1/10<br />
**Ismail Kola & John Landis (2004). Nature Reviews: Drug Discovery 3 : 711 - 715<br />
* Source: “Why drugs fall short in late stage trials”, McKinsey Quarterly, Pharmaprojects, Evaluate<br />
3/10<br />
48
Attrition rates of failed Phase 3 candidates<br />
reveals POC Paradigm benefits<br />
OBJECTIVITY AND AND ROBUSTNESS OF<br />
REGISTERABLE OF BIOMARKER ENDPOINT<br />
H<br />
Source: Evaluate; Pharmaprojects; Factiva;<br />
literature search; McKinsey analysis; I. Kola<br />
High Biomarker<br />
Low POC<br />
Attrition rate 63%<br />
LEAST DESIRABLE QUADRANT<br />
FOR PORTFOLIO IN LATE STAGE<br />
DEVELOPMENT<br />
42% of Phase 3 trials fail*<br />
DESIRED QUADRANT FOR MOST<br />
OF PORTFOLIO<br />
Attrition rate 25%<br />
High POC<br />
Low Biomarker<br />
Attrition rate 70% Attrition rate 37%<br />
L<br />
P.O.C IN MAN<br />
H<br />
Note: Includes aggregate attrition rates for following TAs: CNS, Endocrine, CV, ID, Oncology, and<br />
Respiratory. All figures are rounded<br />
49
Paradigm to pick winners and kill early<br />
CANDIDATE<br />
APPROVAL<br />
TEST THE THEORY - LEARN<br />
FIH –<br />
including target<br />
engagement<br />
biomarker<br />
POC-light IN MAN<br />
– endpoints<br />
for internal<br />
decision making<br />
CONFIRM THE THEORY<br />
POC at Ph 2B –<br />
robust<br />
register-able<br />
endpoint<br />
APPROVAL<br />
AND<br />
LAUNCH<br />
50
<strong>UCB</strong>2892 (H3 antagonist)<br />
January <strong>2011</strong>: Robust data-driven decision making<br />
Termination of Phase 1 programme for <strong>UCB</strong>2892, an H3 antagonist with<br />
potential for cognitive disorders<br />
• Results demonstrated uncompetitive clinical profile<br />
<strong>UCB</strong>’s new paradigm for robust decision-making: demonstrable speed and<br />
cost efficiency in development path<br />
Comparison versus conventional approach*<br />
37%<br />
Timeline to defined endpoint Costs<br />
<strong>2010</strong> <strong>2011</strong> 2012<br />
*Conventional approach = Alzheimer’s trial<br />
36%<br />
51
olokizumab (CDP6038)<br />
A highly potent anti-IL6 inhibitor with a novel mechanism of action<br />
First in a new class of anti-IL-6 inhibitors that selectively blocks<br />
the final assembly step of the IL-6 signaling complex<br />
Phase 1b: Study in RA patients completed in Q4 <strong>2010</strong><br />
• Potently induced and sustained CRP suppression<br />
• Well tolerated at all doses<br />
• Half-life of 31 days and absolute bioavailability of 75% (SC)<br />
• Low incidence of immunogenicity<br />
Phase 2b: SC Dose ranging study initiated ahead of plan in Q4 <strong>2010</strong><br />
• >200 patients with active RA who have failed TNF blocker therapy<br />
• Active comparator Actemra ® IV<br />
• Headline <strong>results</strong> Q3 2012 expected<br />
52
Significant Pipeline Q2 January pipeline <strong>2010</strong> <strong>2010</strong> growth in <strong>2010</strong> through novel molecules<br />
Pipeline December <strong>2010</strong><br />
CNS<br />
FIM achieved Q4<br />
Immunology<br />
FIM achieved Q2<br />
Oncology incubation<br />
Phase 1 Phase 2 Phase 3 Filed<br />
<strong>UCB</strong>2892<br />
(H3 antagonist)<br />
Cognitive disorders<br />
<strong>UCB</strong>0942<br />
Epilepsy<br />
Assets acquired Q2<br />
CDP7657<br />
(anti-CD40L)<br />
SLE<br />
CDP6038<br />
(anti-IL6L)<br />
Autoimmune diseases<br />
MEK inhibitor 2<br />
X<br />
POC light completed<br />
Phase IIb study started Q4<br />
Vimpat ®<br />
Paediatric programme<br />
Vimpat ®<br />
Adj. therapy PGTCS<br />
SYN115 1<br />
Parkinson’s disease<br />
SYN118 1<br />
Parkinson’s disease<br />
CDP7851<br />
(anti-sclerostin)<br />
Fracture healing<br />
CDP7851<br />
(anti-sclerostin)<br />
PMO<br />
CDP6038<br />
(anti-IL6L)<br />
Autoimmune diseases<br />
epratuzumab<br />
SLE<br />
Vimpat ®<br />
Monotherapy U.S.<br />
Vimpat ®<br />
Monotherapy EU<br />
brivaracetam<br />
Adj. therapy<br />
Cimzia ®<br />
Ankylosing spondylitis<br />
Cimzia ®<br />
Psoriatic arthritis<br />
Cimzia ®<br />
RA / Japan<br />
epratuzumab<br />
SLE<br />
Novel molecule<br />
Moving into phase<br />
Xyrem ®<br />
Fibromyalgia<br />
New entrant/phase transition<br />
1 Developed by Synosia in partnership with <strong>UCB</strong><br />
2 Developed by Wilex in partnership with <strong>UCB</strong><br />
53
<strong>UCB</strong> NewMedicines<br />
implementing a new R&D paradigm<br />
Deliver differentiated molecules<br />
Increase success rates<br />
Enhance scientific excellence<br />
Increase efficiency<br />
Implement extreme networking and<br />
open innovation<br />
54
<strong>UCB</strong>'s<br />
Sustainable Growth<br />
Roch Doliveux, CEO<br />
Stephanie, living with rheumatoid arthrits
<strong>UCB</strong> is delivering on…<br />
Financial targets<br />
Core product launches – Cimzia ® , Vimpat ® , Neupro ®<br />
Increased patient reach<br />
Strong pipeline<br />
… to achieve sustainable company growth<br />
56
<strong>UCB</strong>'s sustainable future growth<br />
Cimzia ® , Vimpat ® and Neupro ® trigger company growth<br />
Cimzia ® , Vimpat ® ,<br />
Neupro ®<br />
• Optimise mature base<br />
business<br />
• Manage remaining loss<br />
of exclusivity<br />
<strong>2010</strong><br />
Intense growth<br />
Company<br />
growth<br />
Realise the <strong>full</strong> commercial<br />
potential of Cimzia ® ,<br />
Vimpat ® , Neupro ®<br />
Breakthrough<br />
Launch a new generation of<br />
therapies offering<br />
breakthrough innovation to<br />
patients with severe disease<br />
lifecycle management first Breakthroughs<br />
... and beyond<br />
57
Questions?<br />
58
Appendix<br />
59<br />
59
Major milestones expected in <strong>2011</strong><br />
Xyrem ® for fibromyalgia<br />
• Feedback from the European authorities H1 <strong>2011</strong><br />
CDP7851 (anti-sclerostin) in post-menopausal osteoporosis<br />
• Phase 2 headline <strong>results</strong> H2 <strong>2011</strong><br />
Vimpat ® in epilepsy – adj. therapy PGTCS<br />
• Phase 2 headline <strong>results</strong> H2 <strong>2011</strong><br />
Cimzia ® in ankylosing spondylitis<br />
• Phase 3 headline <strong>results</strong> Q4 <strong>2011</strong><br />
Cimzia ® in psoriatic arthritis<br />
• Phase 3 headline <strong>results</strong> Q4 <strong>2011</strong><br />
60
Geographic and therapeutic breakdown<br />
Net sales <strong>2010</strong>: € 2 786 million<br />
Focused<br />
From primary care to specialist physicians<br />
CNS and immunology<br />
Core markets: U.S., EU, Japan, selected emerging markets<br />
Specialist physicians contacted by small and efficient sales forces<br />
North<br />
America<br />
37%<br />
Other<br />
Int'l<br />
markets<br />
1%<br />
Asia<br />
5%<br />
Japan<br />
6%<br />
France<br />
6%<br />
Other<br />
Europe<br />
17%<br />
Germany<br />
13%<br />
Italy<br />
5%<br />
U.K &<br />
Ireland<br />
5%<br />
Spain<br />
5%<br />
Europe<br />
51%<br />
Other<br />
37%<br />
Immunology &<br />
allergy<br />
19%<br />
18%<br />
CNS<br />
44%<br />
61
Core EPS<br />
€ million Variance<br />
<strong>2010</strong> 2009<br />
Actual<br />
Net profit 103 513 -80%<br />
After-tax non-recurring items &<br />
financial one-offs<br />
216<br />
Profit from discontinued operation +1 -7 n.s.<br />
Tax one-offs -81 +17 n.s.<br />
Adusted net profit 239 226<br />
1 6%<br />
+ Amortisation of intangibles +173 +128 36%<br />
- Taxes on amortisation of intangibles -53 -40 32%<br />
Core net profit 359 314 14%<br />
Weighted average number of shares<br />
(basic)<br />
180<br />
Actual<br />
-297<br />
180<br />
Core EPS (€) 1.99 1.74 15%<br />
n.s.<br />
0%<br />
1 Adjusted for after-tax impact of one-time and non-recurring items<br />
62
<strong>2010</strong> balance sheet<br />
€ million<br />
Cash and Cash<br />
Equivalents<br />
Other Current<br />
Assets<br />
Other Non-<br />
Current Assets<br />
Intangible Assets<br />
Goodwill<br />
494<br />
1 237<br />
879<br />
1 641<br />
4 718<br />
Total assets:<br />
€ 8 969 million<br />
1 545<br />
308<br />
809<br />
1 715<br />
4 695<br />
4 592<br />
Total liabilities:<br />
€ 8 969 million<br />
Other Current<br />
Liabilities<br />
Current Debt<br />
Other Non-<br />
Current Liabilities<br />
Non-Current Debt<br />
Shareholder’s<br />
Equity: 47%<br />
63
Debt maturity profile<br />
Better aligned to expected CF generation<br />
1 000<br />
500<br />
0<br />
€ million<br />
<strong>2011</strong> 2012 2013 2014 2015 2016<br />
Revolving Credit Facility Belgian retail bond Convertible Institutional eurobond<br />
€ 750 million 5.75% Belgian retail bonds due November 2014<br />
€ 1 000 million Revolving credit facility due 2015<br />
€ 500 million 4.50% Convertible bonds due October 2015 (notional amount)<br />
€ 500 million 5.75% Institutional bonds due December 2016<br />
750<br />
500<br />
299<br />
500<br />
64
Shareholder structure 1<br />
Strong and stable shareholder base<br />
Other investors,<br />
15%<br />
Tubize<br />
36%<br />
Capital<br />
Research<br />
12%<br />
Concert<br />
14%<br />
Other institutional<br />
investors<br />
20%<br />
Wellington<br />
3%<br />
“Free float” investors by region<br />
Unidentified<br />
15%<br />
North America<br />
40%<br />
Belgium<br />
23%<br />
Cont.Europe<br />
14%<br />
UK &<br />
Ireland<br />
8%<br />
1. Source: Global shareholder intelligence report, January <strong>2010</strong><br />
Tubize has declared acting in concert separately with each of the shareholders<br />
4,5,6,7,8,9,10 for the number of shares as indicated.<br />
65
Update on clinical development<br />
• Phase 3 in psoriatic arthritis ongoing<br />
• Phase 3 in ankylosing spondylitis ongoing<br />
• Phase 3 design in juvenile rheumatoid arthritis under discussion<br />
• Phase 3 in rheumatoid arthritis in Japan completed positively<br />
• Phase 3 in monotherapy (U.S.) ongoing<br />
• Phase 3 in monotherapy (EU) started<br />
• Phase 2 in PGTCS 1 ongoing<br />
• Phase 2 in paediatric ongoing<br />
• On track with room temperature-stable patch formulation<br />
• <strong>UCB</strong> aims to make Neupro ® available again in the U.S. in 2012<br />
– subject to regulatory approval<br />
1 primary generalised tonic-clonic seizures<br />
66
Cimzia ® in further arthritis indications<br />
Increasing patient access<br />
Psoriatic arthritis (PsA) - Phase 3 trials ongoing<br />
• Two active arms: monthly (400 mg) and<br />
• Time-frame: 24 + 48 weeks<br />
Cimzia ®<br />
Psoriatic arthritis<br />
two week (200 mg) dosing<br />
Ankylosing spondylitis (AS) - Phase 3 trials ongoing<br />
• Two active arms: monthly (400 mg) and<br />
every two week (200 mg) dosing<br />
• Time-frame: 24 weeks<br />
Cimzia ®<br />
Ankylosing spondylitis<br />
Phase 1 Phase 2 Phase 3<br />
Results<br />
Q4 <strong>2011</strong><br />
Results<br />
Q4 <strong>2011</strong><br />
Deonna, living with<br />
rheumatoid arthritis<br />
67
Cimzia ® in further arthritis indications<br />
Increasing patient access<br />
Juvenile rheumatoid arthritis (JRA)<br />
• Discussion ongoing with EU and U.S. regulators to finalise the study<br />
Phase 3 design<br />
Cimzia ®<br />
Juvenile RA<br />
Rheumatoid arthritis (Japan) - two Phase 3 studies<br />
completed<br />
• Monotherapy and combination with MTX<br />
• Three active arms (100 mg , 200 mg, 400 mg), every two week dosing<br />
• Time frame: 24 weeks<br />
Cimzia ®<br />
RA Japan<br />
Phase 1 Phase 2 Phase 3<br />
Results<br />
Q3 <strong>2011</strong><br />
Alison, living with<br />
rheumatoid arthritis<br />
68
CDP7851 in bone loss disorders<br />
Novel therapy with strong potential<br />
Development of novel anabolic therapy<br />
• Antibody to sclerostin potentially treating bone loss disorders, incl.<br />
osteoporosis<br />
Collaborative project with Amgen<br />
Phase 2 trials ongoing<br />
• Phase 2 study in post-menopausal osteoporosis<br />
• Estimated enrolment: 400 post-menopausal women with<br />
low bone mineral density, time-frame:52 weeks<br />
CDP7851<br />
Post-menopausal<br />
•<br />
osteoporosis<br />
• Phase II study in fracture healing<br />
Results<br />
Q2 <strong>2011</strong><br />
• Estimated enrolment: 400 patients, time-frame: 52 weeks<br />
CDP7851<br />
Fracture healing<br />
Phase 1 Phase 2<br />
Results<br />
2012<br />
Paulette, living with osteoporosis<br />
69
Olokizumab (CDP6038, anti-IL-6) in rheumatoid arthritis<br />
Phase 2b programme started – <strong>results</strong> Q3 2012<br />
Phase 2b trial currently recruiting<br />
• Active RA having previously failed TNF blocker therapy<br />
• 220 patients across approximately 100 sites in U.S. and<br />
Europe<br />
• Randomised, double-blind placebo-controlled, doseranging<br />
study with an active comparator (Actemra ® iv) to<br />
evaluate efficacy and safety of olokizumab<br />
• 3 dose levels of OZK administered sc, every 2 or 4 weeks<br />
• 12 weeks treatment duration plus open-label extension<br />
Primary endpoint<br />
Olokizumab<br />
Rheumatoid arthritis<br />
Phase 1 Phase 2<br />
Results<br />
Q3 2012<br />
Stephanie, living with<br />
rheumatoid arthritis<br />
To evaluate the clinical efficacy by the change from baseline in the Disease Activity<br />
Score for olokizumab and placebo at week 12<br />
70
Vimpat ® in epilepsy<br />
Increasing patient access<br />
Monotherapy in the treatment of partial-onset seizures<br />
• Phase 3 trial in EU initiated<br />
Vimpat ®<br />
Monotherapy (U.S.)<br />
Vimpat ®<br />
Monotherapy (EU)<br />
Paediatric 1 development in partial-onset seizures<br />
Vimpat ®<br />
Paediatric adj. therapy<br />
Results<br />
Q4 2014<br />
Veronica, living with epilepsy<br />
Adjunctive therapy for primary generalised tonic-clonic seizures (PGTCS)<br />
Vimpat ®<br />
Adj. therapy PGTCS<br />
Phase 1 Phase 2 Phase 3<br />
First<br />
Results<br />
Results<br />
H2 <strong>2011</strong><br />
Results<br />
Q2 2013<br />
1 From 2 to 17 <strong>year</strong>s<br />
71
Neupro ® in the U.S.<br />
Parkinson’s disease & restless legs syndrome<br />
FDA Complete Response Letter (December 2008)<br />
• “Substantial evidence of effectiveness in advanced Parkinson’s disease and<br />
restless legs syndrome”<br />
Development of room temperature-stable patch<br />
formulation on track<br />
Complete Response Letter recommending reformulation<br />
(April <strong>2010</strong>)<br />
• <strong>UCB</strong> aims to bring Neupro ® to U.S. patients during 2012<br />
Neupro ®<br />
Parkinson’s disease<br />
Neupro ®<br />
Restless legs syndrome<br />
Christer, living with<br />
Parkinson’s disease<br />
Approved Launched<br />
Phase 1 Phase 2 Phase 3 Filed<br />
Filed<br />
CRL*<br />
Dec. 2008<br />
CRL*<br />
Dec. 2008<br />
* Complete Response Letter<br />
72
Your <strong>UCB</strong> Investor Relations team<br />
Antje Witte, Vice President Investor Relations<br />
• Phone: +32 2 559 9414<br />
• E-mail: antje.witte@ucb.com<br />
Michael Tuck-Sherman, Investor Relations Manager<br />
• Phone: +32 2 559 9712<br />
• E-mail: michael.tuck-sherman@ucb.com<br />
Isabelle Ghellynck, Investor Relations Project Manager<br />
• Phone: +32 2 559 9588<br />
• E-mail: isabelle.ghellynck@ucb.com<br />
73