BRUSSELS, BELGIUM--(Marketwire - April 30, 2009) -
* Earnings performance in-line with company expectations but revenue declines * New product launches on track * SHAPE programme continues to focus on core priorities and streamlining the organisation * Cimzia® response letter on rheumatoid arthritis submitted to U.S. FDA * Outlook 2009: revenue between EUR 3.1-3.3 billion, recurring EBITDA greater than EUR 680 million, net profit to exceed EUR 130 million
UCB announced today its interim report for the first quarter of 2009.
“In the first three months of 2009, UCB has made further progress in focusing its resources and organisation on its core priorities in severe diseases of the central nervous system and immunology. We are preparing to launch Vimpat® in adjunctive therapy for epilepsy in the U.S. and in additional European countries, Cimzia® in rheumatoid arthritis in the U.S. and in Europe, and Neupro® in Parkinson’s disease and restless legs syndrome in Europe”, said Roch Doliveux, CEO of UCB.
In the period from January to March 2009, UCB’s revenue decreased compared to the first three months in 2008 due to a lower net sales contribution from the U.S. market. Recurring EBITDA and net profit performance were in line with the company’s expectation.
In the U.S. market, net sales of the Keppra® (levetiracetam) franchise decreased following loss of exclusivity. Net sales of the anti-tussive, Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex), decreased compared to the same period last year due to a weak cough and cold season. The attention deficit and hyperactivity disorder product, Metadate™ CD (methylphenidate), however, continued to grow strongly in the U.S. market.
Key products in Europe and in the rest of the world outside the U.S. were Keppra® which continued to show strong sales growth and the allergy product, Zyrtec® (cetirizine), in Japan which is growing strongly because of a more severe pollen season.
New product launches
Cimzia® (certolizumab pegol) roll-out in the U.S. for the treatment of Crohn’s disease continues with over 6 200 patients being prescribed the product since launch in April 2008.
Keppra® XR, an extended release formulation of levetiracetam, was launched at the end of September 2008 in the U.S. and continues to gain market share at a rate above the original launch of Keppra® in the U.S.
The European market introduction of Vimpat® (lacosamide) is ongoing with more than 5 000 patients already benefiting from the drug and the launch outperforming the two most recent anti-epileptic drug launches. Vimpat® is now launched in Germany, UK, Austria, Greece, Denmark, Sweden, Netherlands, and more European countries will follow.
SHAPE
UCB continued to focus its organisation and resources on its core products and geographies, in particular on its products and development projects for severe diseases in the central nervous system (CNS) and immunology. In the first quarter of 2009, UCB concluded a transaction with GlaxoSmithKline for the divestiture of selected smaller emerging markets. UCB also divested Equasym™ IR/XL (methylphenidate)to Shire and Somatostatine-UCB® to Eumedica. All these transactions have now closed and UCB will publish further financial details in its half-year 2009 report, due 31st July, 2009.
At the end of March 2009, UCB had achieved more than 80% of its original 17% (or 2 000 positions) worldwide work force reduction target set in August 2008.
Development pipeline update
Following the receipt of a Complete Response Letter in January 2009, UCB recently submitted the additional safety update on Cimzia® in rheumatoid arthritis requested by the Food and Drug Administration (FDA).
UCB expects to make Vimpat® available in the U.S. during the second quarter of 2009. In October 2008, the FDA approved Vimpat® as adjunctive therapy for adults with partial-onset seizures and also proposed that Vimpat® be designated as a Schedule V drug. As a result, Vimpat® is undergoing the normal process to confirm drug scheduling with the U.S. Drug Enforcement Agency (DEA). U.S. drug schedules range from Schedule I to Schedule V with Schedule V drugs considered to have the lowest potential for abuse.
UCB is working with the regulatory authorities to make Neupro® (rotigotine) available again to patients suffering from Parkinson’s disease (including new patients) in Europe, and to launch the restless legs syndrome indication in Europe, during the second quarter of 2009. A complete cold-chain storage and distribution system which minimises the development of crystals on Neupro® patches was successfully implemented in Europe in September 2008. A dialogue with the FDA to resolve the U.S. out-of-stock situation of Neupro® is ongoing.
Toviaz® (fesoterodine fumarate) was launched by Pfizer in the U.S. in the first week of April for the treatment of overactive bladder, following approval in the U.S. in October 2008. In Europe, Toviaz® is also approved and was launched by Pfizer mid-2008. UCB is entitled to receive royalties on the combined sales of Toviaz® and Pfizer’s tolterodine product franchise.
Earlier this week, UCB announced first results from Phase III brivaracetam studies in epilepsy. One study met its primary efficacy endpoint while the second study did not meet its primary efficacy endpoint. A third safety and tolerability study confirmed brivaracetam was well tolerated. Further analysis will be conducted and regulatory authorities will be consulted to determine next steps to bring brivaracetam to patients. During the third quarter of 2009, UCB expects to see first Phase IIb results for epratuzumab in systemic lupus erythematosus (SLE).
Financial outlook 2009
Taking into consideration the trends seen in the first quarter of 2009, full year revenue is expected to reach between EUR 3.1-3.3 billion.
Recurring EBITDA is expected to end the year greater than EUR 680 million.
Net profit, as reported, is expected to exceed EUR 130 million for the full year 2009, excluding the capital gains resulting from the already-announced divestitures concluded in the first quarter of 2009.
For further information Antje Witte, Corporate Communications & Investor Relations, UCB T +32.2.559.9414, antje.witte@ucb.com Richard Simpson, Investor Relations, UCB T+32.2.559.9494, richard.simpson@ucb.com Michael Tuck-Sherman, Investor Relations, UCB T +32.2.559.9712, michael.tuck-sherman@ucb.com Nancy Nackaerts, External Communications, UCB T +32 2 559 9264, nancy.nackaerts@ucb.com
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialisation of innovative medicines with a focus on the fields of the central nervous system and immunology disorders. Employing approximately 10 000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different 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, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
For the pdf-version of this press release, please click on the link below:
Interim report Q1 2009: http://hugin.info/133973/R/1309851/302783.pdf
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