Brussels (Belgium), 30 October 2018 – 7:00 am (CET) – regulated information –
- Revenue reached € 3.4 billion (+3%; +6% CER)
- Strong growth of UCB’s five main products reached € 2.8 billion (+6%; +12% CER)
- R&D update: Cimzia® filed for non-radiographic axial spondyloarthritis (nr-axSpA) in the U.S.; Keppra® approved as monotherapy for epilepsy in China; rozanolixizumab achieved positive results and proof-of-concept in myasthenia gravis
- Financial outlook 2018 confirmed: Revenue expected to reach € 4.5 - 4.6 billion, recurring EBITDA1 should reach € 1.3 - 1.4 billion, Core EPS of € 4.30 - 4.70
Revenue for the first nine months of 2018 reached € 3.4 billion, +3% at actual and +6% at constant exchange rates (CER). Adjusted by the one-time other revenue in Q1 2017 of € 56 million for out-licensing the OTC-allergy drug Xyzal® (levoceterizine), revenue grew by 5% (+8% CER).
Core driver of the continued growth are UCB's main products - Cimzia®, Vimpat®, Keppra®, Briviact® and Neupro® - with combined net sales of € 2 780 million, +6% actual (+12% CER).
Financial outlook 2018 confirmed
2018 revenue is expected to reach € 4.5 – 4.6 billion. Recurring EBITDA in the range of
€ 1.3 – 1.4 billion. Core earnings per share are therefore expected in the range of € 4.30 – 4.70 based on an average of 188 million shares outstanding.
Key events: In September, in line with its strategic focus, UCB sold its subsidiary “Innere Medizin”. “Innere Medizin” has been successfully promoting pharmaceutical products in Germany for many years, mainly in the internal medicine area for cardiovascular and respiratory diseases. Financial terms of the transaction were not disclosed.
R&D update – Neurology: In April, UCB agreed to acquire midazolam nasal spray from Proximagen and closed on the acquisition in June. This nasally administered investigational midazolam formulation is intended as a rescue treatment of acute repetitive seizures in patients with epilepsy. The new drug application was accepted for filing by the FDA in August, following previous orphan drug status and fast-track designation.
In July, positive phase 2 results were achieved for Briviact® (brivaracetam) in acute repetitive seizures.
UCB pioneered with the extrapolation concept in China: in March 2018 UCB filed Keppra® (levetiracetam) for monotherapy of partial onset epilepsy seizures based on extrapolation from adjunctive therapy with sound scientific rationale and was approved in August. Launch preparations are ongoing. In September, UCB submitted Vimpat® (lacosamide) IV and oral formulation for the adjunctive therapy of partial onset epilepsy seizures in children above 4 years and for adults, based on extrapolation.
In October, UCB announced positive results from a phase 2 study with a novel, subcutaneous FcRn (neonatal Fc receptor) monoclonal antibody, rozanolixizumab, in patients with myasthenia gravis (MG), achieving proof-of-concept. These results support the acceleration of rozanolixizumab development with a confirmatory study in MG starting in the second half of 2019.
Immunology: In September, Cimzia® (certolizumab pegol) was submitted to the U.S. regulatory authorities for non-radiographic axial spondyloarthritis (nr-axSpA) and was accepted for filing in October. In May this year, UCB announced positive topline results from a Phase 3 placebo controlled study to investigate the efficacy of Cimzia® on the signs and symptoms of active axSpA in patients without x-ray evidence of ankylosing spondylitis (AS) - the first phase 3 study to follow nr-axSpA patients for 52 weeks.
In August, the Japanese authorities approved the Cimzia® AutoClick® device.
In September, the label update for Cimzia® in pregnancy and breastfeeding was approved in Japan. Also in September and in Japan, positive phase 3 results were achieved for Cimzia® in patients with psoriasis and psoriatic arthritis.
In October, UCB and its partner Biogen announced top-line results from a Phase 2b study with dapirolizumab pegol (DZP) in moderately-to-severely active systemic lupus erythematosus (SLE). The primary endpoint of the study to demonstrate a dose response at 24 weeks on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) was not met (p=0.06). The study did demonstrate consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with DZP compared with placebo. UCB and Biogen continue to further evaluate these data while assessing potential next steps.
All other clinical development programs are continuing as planned.
1 EBITDA = Earnings Before Interest, Taxes, Depreciation and Amortization charges
CER = constant exchange rates; All figures are unaudited.
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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 7 500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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