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UCB — Interim / Quarterly Report 2015
Oct 28, 2015
4017_iss_2015-10-28_40222f8c-9f19-430d-aed1-281c856697f9.pdf
Interim / Quarterly Report
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Brussels (Belgium), 28 October 2015 – 7:00 (CET) – regulated information – UCB Interim Report for the first 9 months of 2015:
Strong growth of core medicines – continued growth of the pipeline
- Revenue up 19%* to € 2 864 million, +12% CER1 .
- Cimzia® , Vimpat® and Neupro® combined net sales of € 1 469 million, +41% or +24% CER1 . Keppra® net sales of € 565 million (+12%; +2% CER1 )
- R&D update: Phase 3 in EU for Vimpat® as monotherapy with positive results; U.S. Phase 3 for Cimzia® in non-radiographic axial spondyloarthritis started; bimekizumab with positive topline results in psoriatic arthritis
- Financial outlook 2015 updated: Revenue expected at approximately € 3.75 billion, rEBITDA now expected about € 800 million, Core EPS in the range of € 2.00-2.10.
"We are pleased with UCB's performance in 2015. Our patient value strategy is on its way to deliver superior value to patients: Already today, we are serving many more patients living with neurological or immunological diseases," said Jean-Christophe Tellier, CEO UCB. "Our core medicines continue their strong growth path and our pipeline continues to grow and to deliver results."
Financial outlook 2015 updated:
The continued growth of Cimzia® , Vimpat® , Neupro® is driving overall company growth; 2015 revenue should reach approximately € 3.75 billion. Due to favorable currency effects, less pre-marketing costs and efficiency gains within the organization, recurring EBITDA is now expected to reach about € 800 million. Core earnings per share (EPS) are expected in the range of € 2.00-2.10 based on an average of 192.5 million shares outstanding.
Revenue in the first nine months of 2015 reached € 2 864 million, an increase of 19%* driven by the strong growth of Cimzia® , Vimpat® and Neupro® with combined net sales of € 1 469 million, while Keppra® reached € 565 million.
| $\epsilon$ million | 9M 2015 | 9M 2014 | Actual | CER |
|---|---|---|---|---|
| Revenue | 2 8 6 4 | 2 4 0 2 | 19% | 12% |
| Net sales CVN | 1 4 6 9 | 1 0 4 4 | 41% | 24% |
| Immunology / Cimzia ® | 775 | 561 | 38% | 21% |
| Neurology | 1 259 | 988 | 27% | 14% |
| Vimpat® | 495 | 335 | 48% | 28% |
| Neupro® | 199 | 148 | 34% | 27% |
| Keppra® | 565 | 504 | 12% | 2% |
* 2014 revenue have been restated reflecting the treatment of Kremers Urban as discontinued operation. 1 CER = constant exchange rates All figures are unaudited
R&D update
In July, UCB0942 (PPSI), a small molecule in development for highly drug resistant epilepsy, started the Phase 2 proof of concept study; first results are expected Q4 2016.
In July and August, Vimpat® (lacosamide) and Neupro® (rotigotine) were filed with the Chinese regulatory authorities for the treatment of epilepsy and Parkinson's disease respectively.
In August, a Phase 1 study with UCB1332/NPT200-11, a small molecule disease modifying treatment option for people living with Parkinson's disease, started. In January 2015, Neuropore and UCB entered into world-wide collaboration to develop and commercialize NPT200-11 in all indications.
In August in Brazil, Keppra® (levetiracetam) was approved in the treatment of epilepsy and should be available as a new treatment option for epilepsy patients in Brazil in the first quarter of 2016.
In October, the Phase 3 study in EU for Vimpat® (lacosamide) as monotherapy in the treatment of partial-onset seizures in adults with epilepsy generated positive results. Submission to the European authorities is planned in the first half of 2016. In the U.S. Vimpat® monotherapy is available to patients with partial onset seizures since September 2014.
In July, UCB announced that the Phase 3 studies for epratuzumab in systemic lupus erythematosus (SLE) did not meet the primary clinical efficacy endpoints. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significantly higher than those who received placebo in addition to standard therapy. A high level review of the safety data did not identify any new safety concerns.
In September, UCB initiated a Phase 3 study for the U.S. to assess the efficacy and safety of Cimzia® (certolizumab pegol) in the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA). First headline results are expected in 2018.
In October, UCB6673 for immunotherapy entered into phase 1. This is from collaboration with the King's College London as part of UCB's continued strategy to innovate in drug discovery and early development by building scientific super networks and thereby convert innovative scientific discoveries into health improvements for patients.
In October, for bimekizumab (UCB4940) the learn phase exploratory development study in psoriatic arthritis yielded positive topline results, supporting UCB's hypothesis that targeting both ligands, IL-17A and IL-17F translates into potentially improved clinical patient benefit. These topline results will be followed by full analyses and will be submitted for presentation at an upcoming scientific meeting. UCB is now preparing the next development Phase 2b, planned to start in 2016.
All other clinical development programs are continuing as planned.
Cimzia® (certolizumab pegol) for inflammatory TNF mediated diseases, net sales reached € 775 million, +38%, supported by continuously broadened access to patients living with inflammatory TNF mediated diseases. Cimzia® net sales in Japan are reflecting the order pattern of UCB's partner which is normalizing going forward; the in-market performance shows a continued strong growth trend (> +30%).
| $\epsilon$ million | 9M 2015 | 9M 2014 | Actual | CER |
|---|---|---|---|---|
| U.S. | 373 | 237 | 57% | 30% |
| Europe | 98 | 81 | 21% | 20% |
| International markets | 23 | 17 | 37% | 34% |
| Total Vimpat® | 495 | 335 | 48% | 28% |
Vimpat® (lacosamide) for epilepsy recorded net sales of € 495 million, an increase of 48%. Since September 2014 Vimpat® is available in the U.S. for monotherapy treatment of partial onset seizures.
| $\epsilon$ million | 9M 2015 | 9M 2014 | Actual | CER 1 |
|---|---|---|---|---|
| U.S. | 56 | 30 | 87% | 54% |
| Europe | 110 | 102 | 8% | 7% |
| Japan | 26 | 12 | >100% | >100% |
| International markets | 8 | 5 | 47% | 44% |
| Total Neupro® | 199 | 148 | 34% | 27% |
Neupro® (rotigotine), the patch for Parkinson's disease and restless legs syndrome, reached net sales of € 199 million, +34%.
| $\epsilon$ million | 9M 2015 | 9M 2014 | Actual | CER |
|---|---|---|---|---|
| U.S. | 189 | 148 | 28% | 5% |
| Europe | 186 | 204 | $-9%$ | $-10%$ |
| Japan | 68 | 53 | 28% | 23% |
| International markets | 122 | 100 | 23% | 11% |
| Total Keppra® | 565 | 504 | 12% | 2% |
Keppra® (levetiracetam) for epilepsy net sales were € 565 million, up by 12%. In the U.S., Keppra® net sales benefited from short supply in the market and showed strong growth in international markets.
For further information
Investor Relations
Antje Witte, Investor Relations, UCB
Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, [email protected]
Corporate Communications
France Nivelle, Global Communications, UCB T +32.2.559.94.14, [email protected] T +32.2.559.9178, [email protected] Laurent Schots, Media Relations, UCB T+32.2.559.92.64, [email protected]
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 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. 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.