UCB First Nine Months Interim Report 2017: Strong 9 months performance allows for increase of 2017 financial outlook
Brussels (Belgium), 20 October 2017 – 7:00 (CEST) – regulated information –
- Revenue increased to € 3.3 billion, by 9%; main products grew by 15% to € 2.6 billion
- R&D update: Briviact® approved as monotherapy in the U.S. Vimpat® approved as monotherapy in Japan and for children as add-on therapy in the EU.
- Financial outlook 2017 increased: Now revenue expected between €4.4 - 4.5bn. REBITDA between €1.25 - 1.35bn, Core EPS between €4.10 – 4.50
Revenue for the first nine months of 2017 increased to € 3.3 billion, by 9% at actual and at constant exchange rates (CER). Adjusted by product divestitures in 2016, the revenue growth was 14%.
Core driver of the continued growth are UCB's main products, Cimzia®, Vimpat®, Keppra®, Briviact® and Neupro® with combined net sales of € 2.6 billion, a plus of 15%.
Financial outlook 2017 increased - UCB now expects 2017 revenue to reach € 4.4. - 4.5 billion; recurring EBITDA1 should increase to €1.25 – 1.35 billion. Core earnings per share are expected in the range of € 4.10 – 4.50 based on an expected average of 188 million shares outstanding.
In July, UCB and its partner Dermira submitted a marketing application to EU and U.S. regulatory authorities for Cimzia® (certolizumab pegol) in psoriasis which were accepted for filing in August and October, respectively.
In July, bimekizumab demonstrated positive results in a Phase 2b study in patients with psoriasis. Up to 79% of patients achieved at least 90% skin clearance at week 12 (primary endpoint), and up to 60% of patients achieved complete skin clearance at week 12, a secondary efficacy endpoint.
UCB advances the phase 3 clinical development program in psoriasis with the first study scheduled to start by the end of the year.
Phase 2b clinical trials with bimekizumab in psoriatic arthritis and ankylosing spondylitis are ongoing with first results now expected earlier, in Q1 2018.
In August, the Japanese health authorities approved Vimpat® (lacosamide) for use as monotherapy for partial-onset seizure in adult patients with epilepsy.
In September, the European Medicines Agency approved Vimpat® for the treatment of epilepsy in children from four to sixteen years of age.
In July, UCB filed a marketing authorization in the EU for Briviact® (brivaracetam) for children with epilepsy of four years of age and older, for the adjunctive treatment of partial-onset seizures and with the U.S. authorities for the monotherapy and adjunctive treatment.
In September, in the U.S., Briviact® was approved as monotherapy for partial-onset (focal) seizures.
In July, the U.S. authorities issued a Complete Response Letter for the Biologics License Application for EVENITY™ (romosozumab) as a treatment for postmenopausal women with osteoporosis. This request will be addressed in the form of a resubmission within the timeline of the complete response letter, which is an extension of the current review in the U.S. All phase 3 data being evaluated to ensure most comprehensive view and understanding of what was observed with respect to the cardiovascular signal in ARCH will be included in the resubmission.
All other clinical development programs are continuing as planned.
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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 € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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