. Stable total revenue of € 2.5bn; ‘CVN’ combined net sales of € 847 million; +27%
. Continued growth in emerging markets1 and Japan
. New approved indications for Cimzia®
. Vimpat® monotherapy indication (partial onset seizures) filed in the U.S.
. Financial outlook confirmed

Brussels, Belgium – 25 October 2013 - 7:00am – regulated information: UCB today announced its interim report for the first nine months of 2013.

"The first nine months of 2013 confirm the solid growth trends of our core medicines, Cimzia®, Vimpat® and Neupro® as well as in emerging markets, while we continue to absorb the remaining post exclusivity impacts on Keppra®," said Roch Doliveux, CEO of UCB. "At the same time we are pleased with the regulatory approvals for Cimzia® for new indications, further broadening patient access in the U.S. and the EU. Additionally, as planned, we have recently filed Vimpat® for monotherapy in the U.S.”

Total revenue in the first nine months of 2013 reached € 2 499 million (-3%; +1% at constant exchange rates) driven by the double digit growth of Cimzia®, Vimpat® and Neupro® reaching combined net sales of € 847 million, (+27%; +31% at constant exchange rates), which offset the Keppra® decline of 18% to € 532 million, and due to the continuous decline of the mature products as well as exchange rate effects.


Revenue 2 499 2 565 -3% 1%
Net sales CVN 847 665 27% 31%
Cimzia® 423 334 27% 31%
Vimpat® 294 237 24% 27%
Neupro® 130 93 40% 41%
Keppra® 532 652 -18% -16%

UCB confirms its financial outlook 2013, with total revenue 2013 anticipated at approximately € 3.4 billion. Recurring EBITDA is expected at approximately €680-710 million. Core earnings per share of € 1.90-2.05 are expected based on 179.3 million weighted average shares outstanding.

Cimzia® (certolizumab pegol) for Crohn’s disease (CD) and rheumatoid arthritis (RA), continued its growth trend in the U.S. and Europe with a strong launch in Japan. Patient access has also been broadened to U.S. adult patients suffering from active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) and adult patients in the EU with severe active axial spondyloarthritis (axSpA).


€ million 9m 2013 9m 2012 Actual Constant
North America 271 231 17% 21%
Europe 120 95 27% 28%
Japan 14 - >100% >100%
BRICMT1 4 1 >100% >100%
Rest of the World 14 8 86% 95%
Total Cimzia® 423 334 27% 31%
Vimpat® (lacosamide) for adjunctive therapy for epilepsy, showed consistent double digit growth in all regions where the medicine is available. UCB has filed Vimpat® in the U.S. as monotherapy treatment in adult epilepsy patients with partial-onset seizures.


€ million 9m 2013 9m 2012 Actual Constant
North America 224 177 27% 30%
Europe 64 56 14% 14%
BRICMT1 2 1 70% 70%
Rest of the World 4 3 20% 26%
Total Vimpat® 294 237 24% 27%
Neupro® (rotigotine), the patch for Parkinson’s disease (PD) and restless legs syndrome (RLS), grew by a strong 40% driven by the successful launch in the U.S. and supported by the launch in Japan.

€ million 9m 2013 9m 2012 Actual Constant
North America 28 6 >100% >100%
Europe 94 84 12% 12%
Japan 5 - >100% >100%
BRICMT1 1 1 78% 76%
Rest of the World 2 1 27% 29%
Total Neupro® 130 93 40% 41%
Net sales of the anti-epileptic drug Keppra® (levetiracetam) decreased as expected. The post exclusivity erosion continues in both affected regions, with the U.S. declining at single-digit rates and the EU at double-digit rates. In the emerging markets and Japan (at constant exchange rates), Keppra® is growing at double-digit growth rates.


€ million 9m 2013 9m 2012 Actual Constant
North America 165 176 -6% -4%
Europe 237 356 -33% -33%
Japan 42 41 4% 30%
BRICMT1 57 46 23% 25%
Rest of the World 31 33 -6% -4%
Total Keppra® 532 652 -18% -16%
Clinical pipeline update: central nervous system (CNS)
In February, Neupro® (rotigotine) was launched in Japan by Otsuka Pharmaceutical for early and advanced Parkinson’s disease (PD) as well as restless legs syndrome (RLS).

In March, Vimpat® (lacosamide) generated positive results in the Phase 3 U.S. monotherapy study in patients with partial onset seizures. The data have been submitted to the U.S. Food & Drug Administration (FDA) as part of its supplemental New Drug Application (sNDA) and were accepted for filing early October. Vimpat® for adjunctive epilepsy in children has started the phase 3 in September 2013, first results are expected in 2017.

In May, UCB and Otsuka Pharmaceutical, received regulatory approval in Japan for E Keppra® (levetiracetam) as adjunctive therapy in the treatment of partial-onset seizures in pediatric patients with epilepsy, aged four years and older.

Clinical pipeline update: immunology
In February, UCB filed with FDA and with the European Medicines Agency (EMA) applications to extend the marketing authorization for Cimzia® (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA). In March, UCB and Astellas, its immunology partner in Japan, launched Cimzia® in the treatment of rheumatoid arthritis (RA).

In September, the European CHMP adopted a positive opinion for Cimzia® in adult patients with severe active axial spondyloarthritis (axSpA) comprising ankylosing spondylitis (AS) and axSpA without radiographic evidence of AS (nr-axSpA). In October, the European Commission granted the amended marketing authorization.

In September and October respectively, the FDA approved Cimzia® for the treatment of adult patients with psoriatic arthritis (PsA) and for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter for the supplemental Biologics License Application of Cimzia® for the treatment of adults with active axial spondyloarthritis (axSpA).

In July, UCB entered into a world-wide exclusive license grant to R-Pharm, a privately owned pharmaceutical company based in Moscow, Russia, to develop and commercialize olokizumab in all indications, including rheumatoid arthritis.

For CDP7657, a CD40 ligand antibody under development in partnership with Biogen Idec, UCB started a phase 1b study in SLE. First results are expected in H2 2014.

A new compound entered the clinical development pipeline in phase 1: UCB5857, a selective and potent small molecule for the potential treatment of multiple immunological indications. First results are expected in Q2 2014.