UCB confirms positive outlook for 2005
Brussels, December 12, 2005 - UCB confirms its previous guidance that net income after tax for the year to December 31, 2005 will be at least €260 million (not including the capital gain of €470 million on the sale of the Surface Specialties activities and the operating profit of €9 million those activities earned in early 2005). The better than expected sales performance in 2005 and the higher than expected synergies enabled higher Research & Development (R&D) investment and ongoing restructuring charges beyond the previously announced €20 million.
This performance reflects the successful transformation of UCB into a pure biopharmaceutical company following the acquisition and integration of Celltech, and divestment of non core activities.
Keppra®, whose sales increase will exceed 30%, is the principal driver of UCB's 2005 sales growth. The allergy franchise continues to grow, driven by Zyrtec® in the U.S.A.([1]) and Japan([2]) and by Xyzal® in Europe, while our mature products are continuing to perform well.
The excellent phase III clinical results of Cimzia (TM) for the treatment of Crohn's disease encouraged UCB to accelerate R&D and launch-preparation investment in this product, contributing to total R&D spend increasing to 25% of net 2005 group sales. All other major R&D programs (except CDP 484 as announced early in the year) have progressed according to plan.
R&D Update
Keppra® is confirming its position as the new standard in epilepsy treatment.
Intravenous formulation
Regulatory filings are under review by both EMEA and FDA. The first launch in the first quarter of 2006 is being prepared.
Primary generalised myoclonic seizures
Regulatory filings are under review by both EMEA and FDA. The first launch by mid 2006 is being prepared.
Primary generalised tonic-clonic seizures
The submission of the regulatory file is expected by mid 2006.
The submission of the European regulatory file is expected during the first quarter of 2006.
The enrollment of the second pivotal phase III study for Keppra in the treatment of epilepsy has started in Japan.
Brivaracetam and Seletracetam
The phase II clinical studies are evolving according to plan and results are expected in the second half of 2006.
Cimzia (TM)
The preparation of the regulatory files is on track and expected to be submitted during the first quarter of 2006.
The two phase III profiling studies are evolving according to plan and first results are expected by the end of 2006.
A phase III clinical study for the treatment of psoriasis has been initiated and recruitment is ongoing.
Early Prevention of Asthma in Atopic Children (EPAAC (TM))
The EPAAC (TM) study was designed to explore the efficacy of Xyzal® beyond its already well established indications. This innovative study examined the effectiveness of levocetirizine (Xyzal®) in the prevention of asthma in a subpopulation of very young children with specific family history([3]). The primary endpoint of the study was not met. The preliminary safety analysis confirmed Xyzal®'s good safety profile in very young children.
CDP 791([4]), an anti-VEGF receptor-2 monoclonal antibody, is currently in phase II clinical evaluation for the treatment of non small cell lung cancer with results expected by the end of 2006.
Initial Trends for 2006
2006 is expected to be another year of dynamic sales growth, mainly driven by Keppra®. Royalty income, as expected, will be impacted by the expiry of the Boss technology patent.
UCB will significantly increase its investment in Cimzia (TM), which is on track for regulatory filing and is being prepared for launch during the first half of 2007. Other selling, general and administrative expenses will be tightly managed.
We expect R&D investment to increase and be around 25% of sales in 2006, principally driven by:
New and expanded clinical programs for Cimzia (TM)
Intensified development activity largely on successors to Keppra® and on CDP 791(4)
A number of new research programs expected to enter clinical evaluation.
Final results for 2005 will be announced on March 14th 2006 at which time UCB will also update the market on R&D progress and on the financial outlook for 2006.
Roch Doliveux, CEO of UCB, said, "With the successful integration of Celltech and the tremendous achievements of my UCB colleagues, our first full year of operations as a biopharmaceutical company has been very encouraging, delivering rapid growth and giving us a solid base for 2006 and beyond. 2006 will be a year of continued growth in sales as well as significant investments for the future, including the preparation for the Cimzia (TM) launch and further R&D progress."
UCB (www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, inflammatory diseases, and oncology. UCB key products are Keppra® (antiepileptic), Xyzal® and Zyrtec® (antiallergics), Nootropil® (cerebral function regulator), Tussionex® (antitussive) and Metadate(TM) / Equasym XL(TM) (attention deficit/hyperactivity disorder). UCB employs over 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels (UCB / UCBBt.BR / UCB BB).
Vice President Corporate Communication & Investor Relations
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([1]) UCB co-promotes Zyrtec in the USA with Pfizer.
([2]) Daiichi-Sankyo and GSK Japan are co-distributing Zyrtec in Japan.
([3]) EPAAC (TM) study results: Preventive effect of levocetirizine on the onset of asthma in children aged 1 to 2 a family history of atopy suffering from atopic dermatitis and sensitized to house dust mite and/or grass pollen has not been confirmed.
([4]) UCB and Imclone Systems entered in August 2005 into a development and commercialization partnership for CDP791.
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