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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.
R&D update 
 
Immunology 
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. 
 
Neurology
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. 
 
Bone 
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. 
 
For further information, UCB:
 
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
 
Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 
 
Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
 
Laurent Schots 
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com 
 
About UCB
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
 
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. 
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document 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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