Interim Report: UCB off to a good start in 2008

Brussels/Belgium, May 15, 2008 at 7:00 am CET - UCB announced today that the financial performance of the UCB Group in the first three months of 2008 was in-line with expectations.

 

"In the first three months of 2008, UCB made significant progress and achieved important milestones executing our strategy. In April, we launched Cimzia® in the United States for the treatment of Crohn's disease, less than 48 hours following the FDA's approval," comments Roch Doliveux, CEO of UCB. "On the other hand, in March we had to announce a recall of Neupro® and an out-of-stock situation in the United States. This issue had only limited impact to the financial performance of the UCB Group in the first three months of 2008. Overall, in the first quarter, we achieved a financial performance well in line with our stated expectations."

 

Consistent with the company's expectations, in the period from January to March 2008, UCB's revenue and net sales decreased by only a single digit percentage rate to a lower level than the prior year. Excluding the impact of currency fluctuations, the decrease was only marginal compared to the first quarter of 2007. Key products contributing to the growth in the quarter were Keppra® (levetiracetam), which continued to show double digit percentages in net sales growth as did Xyzal® (levocetirizine) revenues as well as Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex). In line with expectations, net sales and royalty income of Zyrtec® (cetirizine) in the US market decreased significantly due to the patent expiration in December 2007 while net sales of omeprazole were negatively affected by further generic competition.

 

This development is also reflected in the performance of UCB in the US market where positive sales contribution from Keppra® and Tussionex® was counter balanced by the patent expiration of Zyrtec®, generic omeprazole and the declining US-Dollar. In 2007, the US market represented 46% of UCB's total net sales. Europe, which in 2007 represented 42% of total net sales, grew year-over-year thanks to Keppra®, Xyzal® and Neupro® (rotigotine transdermal system),  despite a competitive environment. In other regions sales were more or less stable despite a competitive environment and adverse currency fluctuations.

UCB continued its integration of Schwarz Pharma and achieved further progress on the synergy achievements. The company reached a satisfying level of earnings, namely recurring EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) and net profit.

 

At the end of March, UCB announced the recall of its anti-Parkinson's drug Neupro® from the US market and of certain batches in Europe which led to an out-of stock situation in the US. Considering the resolution timeline and risk mitigation of this issue is still undetermined, the full effect on UCB's business is not yet known. Therefore, UCB's 2008 financial outlook is under review. UCB expects an update on this situation at the time of its half year reporting on August 1, 2008.

 

Cimzia® (certolizumab pegol) was approved in the US for treatment of Crohn's disease on April 22, 2008. The regulatory application of Cimzia® in rheumatoid arthritis in the US has been accepted for filing and review by the US authorities in January 2008. In Canada, the dossier of Cimzia® for the treatment of rheumatoid arthritis was accepted for review at the end of April, filing in Europe for rheumatoid arthritis is on track as planned for mid 2008.

 

End of March 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has affirmed a negative opinion on the market authorisation application for Cimzia® for the treatment of patients with Crohn's disease.

 

In 2007, UCB completed a Phase II re-treatment study for Cimzia® in psoriasis with positive results. UCB is finalising further development plans for Cimzia® in psoriasis with an update expected at the time of its half year reporting on August 1, 2008.

 

UCB successfully reached other important milestones since the beginning of 2008, such as filing of Keppra®XR (levetiracetam) in the adjunctive treatment of partial onset seizures in adults with epilepsy with the US Food and Drug Administration (FDA), approval of Xyzal® oral solution in the US and encouraging clinical Phase II trial results of the anti-cancer drug CDP791 for which UCB is looking for a partner. At the end of April, the CHMP of EMEA has adopted a positive opinion on the market authorisation application for Neupro® for the symptomatic treatment of moderate-to-severe idiopathic restless legs syndrome (RLS). UCB is hopeful that the European Commission will act favourably on the marketing authorization for restless legs syndrome. UCB will be filing a restless legs syndrome manufacturing variation with the EMEA.

Rikelta(TM) (brivaracetam)'s second Phase III study in Unverricht Lundborg Disease (ULD) has been completed. Like the first trial, the second trial did not meet the primary endpoint of symptom relief of action myoclonus, but has shown beneficial effects in a subset of patients for which additional analyses are ongoing. UCB has broken new ground as the first company to engage in regulatory studies aimed at this severe progressive myoclonic epilepsy.

 

The Phase III clinical programme for Rikelta(TM) is ongoing as adjunctive therapy in patients with refractory partial-onset epilepsy. Results are expected in the third quarter 2009.

 

A proof of concept trial (Phase IIa) with lacosamide in fibromyalgia is on track for first results to be reported by the end of June this year.