UCB Interim Report for the first nine months of 2012
Brussels (Belgium), 29 October 2012 – 7:00 AM (CET) - regulated information - UCB announced today its interim report for the first nine months of 2012.
"In the first nine months, Cimzia®, Vimpat® and Neupro® reached more than 382 000 patients with a strong growth of 50% net sales of EUR 665 million. UCB has now reached the inflection point where net sales of our new core medicines are higher than those of the Keppra® franchise – the 'cross-over'," said Roch Doliveux, Chief Executive Officer of UCB. "This performance confirms our ambition to reach more than 1.5 million patients with Cimzia®, Vimpat® and Neupro®, with a combined peak sales target of at least EUR 3.1 billion in the second half of this decade."
Revenue in the first nine months of 2012 increased by 5%* compared with the previous interim period to EUR 2 565 million (stable at constant exchange rates) because of the strong growth performance of the core medicines Cimzia®, Vimpat® and Neupro® as well as E Keppra® in Japan. Underlying profitability (recurring EBITDA) and net profit performance meet the company's expectations and are in-line with the financial outlook for 2012.
Growth performance in the first nine months 2012
Cimzia® (certolizumab pegol) for rheumatoid arthritis (RA) and Crohn’s disease (CD) reached net sales of EUR 334 million, 51%* higher than last interim period (+41% at constant exchange rates (CER)). Net sales in North America accelerated to EUR 231 million, plus 42%* (30% CER) while Europe grew a solid 70%* to EUR 95 million (68% CER). In the 'rest of the world,' Cimzia® reported net sales of EUR 9 million (+197%*).
The anti-epileptic medicine, Vimpat® (lacosamide) achieved global net sales of EUR 237 million (+54%*; +44% CER). In North America, net sales were EUR 177 million, up 60%* (+46% CER), while Europe reported net sales of EUR 56 million (+35%*; +34% CER). In 'rest of the world', net sales increased 171%* to EUR 5 million.
Neupro® (rotigotine), a patch for Parkinson’s disease and restless legs syndrome, increased net sales by 33%* to EUR 93 million (+32% CER) driven by accelerated growth in Europe (plus 23%* to EUR 84 million) and since mid-July this year by a strong launch in the United States with net sales of EUR 6 million or USD 8 million.
Keppra® (levetiracetam), for epilepsy, achieved net sales of EUR 652 million, a 13%* decline (-16% CER). The continued post-patent expiry erosion in North America (EUR 176 million; -8%*; -16% CER) and the increasing post-patent expiry erosion in Europe (EUR 356 million; -26%*) contrasts with strong performance in the 'rest of world' (+57%*) reaching EUR 120 million, supported by the growth of E Keppra® in Japan.
R&D update central nervous system (CNS)
In January, the Vimpat® open-label pilot Phase 2 study for adjunctive therapy in primary generalised tonic-clonic seizures (PGTCS) showed positive results. It will now move into Phase 3 development for PGTCS.
In April, Neupro® received U.S. regulatory approval. The room temperature stable patch is now approved for early and advanced Parkinson’s disease (PD) as well as restless legs syndrome (RLS). Neupro® is available for patients in the U.S. since July 2012.
In August, the room temperature stable patch was approved in the European Union for early and advanced PD as well as RLS.
All other clinical development projects in epilepsy are progressing: brivaracetam for adjunctive therapy, Vimpat® for monotherapy in U.S. and Europe as well as paediatric adjunctive therapy, and UCB0942 in phase 1.
R&D update immunology
In January, UCB filed certolizumab pegol (Cimzia®) for marketing authorisation with the Japanese Ministry of Health, Labour and Welfare (MHLW). UCB and Astellas Pharma Inc. have agreed to co-develop and co-promote certolizumab pegol in Japan.
In February and April respectively, the Phase 3 trials for Cimzia® in psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) including ankylosing spondylitis (AS) reported first positive results. Submissions to regulatory authorities for these indications are planned by the end of 2012.
In March, for Cimzia® the Phase 3 program in juvenile rheumatoid arthritis, (Juvenile Idiopathic Arthritis, JIA) started as scheduled. First results are expected in the second half of 2014.
In April, romosozumab (sclerostin antibody; CDP7851/AMG 785) phase 3 clinical trial program started for the treatment of postmenopausal osteoporosis (PMO). Initial results from this program are expected by the end of 2015.
First results for CDP7851/AMG785 from the phase 2 program in fracture healing are expected in the first half of 2013.
In September, UCB announced top-line phase 2 results for olokizumab in rheumatoid arthritis. This study met its primary endpoint of demonstrating a significant reduction in the disease activity score at week 12. However, the current data do not suggest sufficient differentiation potential versus tocilizumab. UCB will not progress the program internally into phase 3, and is now exploring options for olokizumab including partnering.
For epratuzumab in systemic lupus erythematosus (SLE), four year safety and efficacy data from of a phase 2 open-label study in patients with moderate to severe SLE are being presented at upcoming ACR (American College of Rheumatology) Annual Meeting in Washington, D.C., November 9-14, 2012. First results from the on-going phase 3 program are expected in the first half of 2014.
The other clinical development projects in immunology, namely Cimzia® ExxelerateTM and C-EarlyTM and CDP7657 in SLE (phase 1) are advancing.
Outlook 2012 confirmed
UCB expects its financial results in 2012 to be driven by the continued growth of Cimzia®, Vimpat® and Neupro® as well as by post-exclusivity expiry erosion for Keppra®. Revenue 2012 is anticipated to exceed EUR 3.2 billion, recurring EBITDA in the range of EUR 630-660 million and core earnings per share at approximately EUR 1.70 – based on 179 million shares outstanding.
For further information
Antje Witte, Investor Relations UCB
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Laurent Schots, Media Relations, UCB
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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 more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. 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.
* Variance at actual rates versus the first half 2011
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