Slow Start but Outlook 2013 and Growth Prospects Confirmed
Brussels (Belgium), 25 April 2013 – 07:00 (CEST) – regulated information
UCB announced today its interim report for the first three months of 2013.
"UCB is on track for growth. The start in the first three months of 2013 shows solid growth of our core medicines, Cimzia®, Vimpat® and Neupro® as well as in emerging markets", said Roch Doliveux, CEO of UCB. "At the same time as we are facing the remaining post exclusivity impacts on Keppra® we are facing strong seasonal effects due to the continued cold winter, affecting our allergy franchise. We are pleased with our pipeline performance, which includes positive phase 3 results in the U.S. with Vimpat® to treat epilepsy in monotherapy and a new project joining our pipeline – tozadenant in Parkinsons' disease."
Total revenue in the first three months of 2013 reached EUR 799 million (-9%;
-7% at constant exchange rates) due to the delayed allergy season and strong Keppra® erosion, partly compensated by the solid growth of Cimzia®, Vimpat® and Neupro®.
Total revenue 2013 is anticipated at approximately EUR 3.4 billion. Recurring EBITDA is expected at approximately EUR 680-710 million. Core earnings per share of EUR 1.90-2.05 are expected based on 179.3 million weighted average shares outstanding.
Continued growth of core medicines
In the first three months of 2013, UCB’s core medicines Cimzia®, Vimpat® and Neupro® delivered double digit growth reaching combined sales of EUR 247 million, +23% at actual exchange rates; +24% at constant exchange rates (CER) compared with the first three months in 2012.
Cimzia® (certolizumab pegol) for Crohn’s disease (CD) and rheumatoid arthritis (RA) reached net sales of EUR 122 million (+25%; +27% CER). Net sales in North America increased to EUR 76 million, plus 13% (+14% CER) while Europe accelerated to EUR 36 million, plus 31% (+32% CER). In the 'rest of the world,' Cimzia® reported net sales of EUR 10 million, after EUR 2 million in the first three months 2012.
Vimpat® (lacosamide) for adjunctive therapy of epilepsy showed net sales of EUR 88 million (+15%; +16% CER). In North America, net sales were EUR 66 million, up 17% (+17% CER), while Europe reported net sales of EUR 20 million (+13%; +13% CER). In 'rest of the world', net sales were stable at EUR 2 million.
Neupro® (rotigotine), the patch for Parkinson’s disease (PD) and restless legs syndrome (RLS) grew by 36% (+37% CER) reaching net sales of EUR 36 million. Net sales in North America reached EUR 6 million after the launch in summer 2012. Growth in Europe was plus 11% to EUR 29 million. In 'rest of the world' net sales were EUR 2 million after EUR 1 million in the first three months of 2012.
Net sales of the anti-epileptic drug Keppra® (levetiracetam) decreased by 23%
(-22% CER) during the first three months of 2013 to EUR 171 million. The post exclusivity erosion continues both, in the U.S. (-17%) and in Europe (-37%) where it is accelerating. In other regions, E Keppra® showed double digit growth.
Central nervous system (CNS) R&D update:
Vimpat® (lacosamide) generated positive results in the U.S. Phase 3 monotherapy study: top-line results demonstrate that the conversion to lacosamide monotherapy study met its primary endpoint. Submission to U.S. regulatory authority is planned in the second half of this year.
UCB's CNS partner in Japan, Otsuka Pharmaceutical has launched Neupro® for the treatment of PD and RLS. In December 2012, Neupro® was approved in Japan.
All other clinical development projects in CNS are on track: brivaracetam as adjunctive therapy for the treatment of partial onset seizures in adults with epilepsy, Vimpat® for monotherapy in the EU, for PGTCS, paediatric adjunctive therapy as well as adjunctive therapy in adult patients with partial-onset seizures in Asia.
Immunology R&D update:
The regulatory filings for two new indications for Cimzia® for the treatment of active psoriatic arthritis and active axial spondyloarthritis have been accepted and are now under review by both agencies as well as in further regions. By the end of 2012, UCB submitted the two new regulatory filings to the U.S. and EU regulatory agencies to extend the marketing authorization for Cimzia®.
In Japan, UCB and its partner Astellas have launched Cimzia® for the treatment of adult patients with rheumatoid arthritis. In December 2012, Cimzia® was approved in Japan
Expanding its pipeline, UCB initiated a phase 1 study to assess the new mechanism of action UCB4940, as a new option for the treatment of immunological diseases.
The other clinical development projects in immunology, Cimzia® ExxelerateTM and C-EarlyTM, the phase 3 programs romosozumab in post-menopausal osteoporosis (PMO) and epratuzumab in systemic lupus erythematosus (SLE) and also CDP7657 in SLE in phase 1 are advancing.
For further information
Antje Witte, Investor Relations UCB
T +32.2.559.9414, firstname.lastname@example.org
France Nivelle, Communications UCB
T +32.2.559.9178, email@example.com
Laurent Schots, Media Relations, UCB
T +32.2.559.9264, firstname.lastname@example.org
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approx. 9 000 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially 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, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
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