UCB First Three Months Interim Report 2017: UCB with a good start into 2017 | UCB
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UCB First Three Months Interim Report 2017: UCB with a good start into 2017

Brussels (Belgium), 24 April 2017 – 7:00 (CEST) – regulated information 

  • Revenue increased to € 1.12 billion, by 15%; main products grew by 20% to € 853 million 
  • R&D update: Phase 3 study for Japan started evaluating Cimzia® (certolizumab pegol) in psoriasis and psoriatic arthritis; Vimpat® (lacosamide) in the U.S. filed for children (> 4yrs); phase 2a study started with rozanolixizumab (UCB7665) in myasthenia gravis (MG)
  • Financial outlook 2017 confirmed 

Revenue for the first three months of 2017 increased to € 1.12 billion, by 15% at actual and 14% at constant exchange rates (CER). This was supported by the one-time other revenue of € 56 million recognized in February 2017 for out-licensing of the OTC-allergy drug Xyzal® (levoceterizine). Core driver of the continued growth are UCB's main products, Cimzia®, Vimpat®, Keppra®, Briviact® and Neupro® with combined net sales of € 853 million, a plus of 20%. 


R&D update 

In January 2017, UCB and its partner Dermira announced positive topline results from CIMPACT, a Phase 3, placebo- and active-controlled clinical trial evaluating Cimzia® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This completed the positive results from CIMPASI-2 and CIMPASI-1 in Q4 2016. The submissions of marketing applications to regulatory authorities are expected in Q3 2017.

In February 2017, to support line extension for Japan, a phase 3 study evaluating Cimzia® in adult patients with psoriasis and psoriatic arthritis started with first results expected in Q4 2018.

In March 2017, the FDA (U.S. Food and Drug Administration) issued a complete response letter in connection with the review of a proposed new indication for Cimzia® to treat polyarticular juvenile idiopathic arthritis (pJIA). The FDA letter concerns the reliability of the submitted pharmacokinetic data. UCB is working with both the FDA and the third party bioanalytical laboratory concerned to work on the issue and to agree on next steps to bring Cimzia® to juvenile patients. This does not affect any other program with Cimzia®.

In January 2017, UCB filed a supplemental New Drug Application with the U.S. authorities for Briviact® (brivaracetam) as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

In February, the phase 2a study with padsevonil (UCB0942) - aimed at highly drug resistant epilepsy patients, who failed four anti-epileptic drugs and have at least four seizures/week - showed positive top line results and will progress into further development. Detailed results will be presented at future scientific meetings.

In March, Vimpat® (lacosamide) filing has been accepted by the U.S. FDA for pediatric patients living with partial-onset epilepsy at four years and older, based on extrapolation of data. For this pediatric group, filing is under review by the European authority.

Also in March, Vimpat® in a phase 3 study achieved positive results as adjunctive therapy in patients with epilepsy (partial-onset seizure; ≥ 4 to <17 years of age). Detailed results will be presented at future scientific meetings and will be submitted to regulatory authorities 

In March, a phase 2a study started with rozanolixizumab (UCB7665) in myasthenia gravis (MG), a rare, debilitating neurological auto-immune disease. First results are expected in Q2 2018.

All other clinical development programs are continuing as planned. 

For further information 
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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