Publicado 28/02/2019 20:06CET
- Comunicado -

UCB Full Year Report 2018: 2018 Marks the Fifth Consecutive Year of Profitable Growth, Intensifying Investment in UCB's

- - Revenue reached EUR 4.6 billion: +2%, +5% CER(1); net sales increased to EUR 4.4 billion: +5%, +8% CER, driven by core products (+6%, +10% CER)

- Underlying profitability (rEBITDA) increased to EUR 1 398 million: 2%, +5% CER

- R&D update: Evenity() approved in Japan; Vimpat() approved in China

- Financial outlook for 2019: Revenue expected in the range of EUR 4.6 - 4.7 billion, recurring EBITDA(2) in the range of 27% - 29% of revenue, reflecting higher R&D investments

BRUSSELS, Feb. 28, 2019 /PRNewswire/ -- "We are confident for the future growth of UCB based on strong delivery in 2018, marking the fifth year of profitable growth in a row and a new blockbuster for UCB, Vimpat()," said Jean-Christophe Tellier, CEO UCB. "We are expecting Cimzia() to reach EUR 1.7 billion net sales by 2024 and Vimpat() should reach 1.4 billion by 2022. Our strong late stage pipeline currently offers six potential product launches in the next five years. Based on our solid foundation we will as planned accelerate our investments in future growth drivers."

Core product net sales

Revenue for 2018 reached EUR 4.63 billion, +2% at actual and +5% at constant exchange rates (CER). Net sales went up by 5% (+8% CER) to EUR 4.41 billion, driven by the continued growth of UCB's five core products, with combined net sales of EUR 3.8 billion (+6%; +10% CER), representing 82% of UCB's revenue.

Underlying profitability (rEBITDA(2)) improved by 2% (+5% CER) to EUR 1 398 million - thanks to core product growth and despite higher R&D expense.

Profit of the Group, supported by a tax rate of 19.7%, increased to EUR 823 million - of which EUR 800 million (+6%; +10% CER) is attributable to the UCB shareholders. The Board of directors of UCB proposes a dividend of EUR1.21 per share (gross), +2.5%.

UCB's financial results FY 2018:

EUR million FY 2018 FY 2017 Act CER Revenue 4 632 4 530 2% 5% Net sales 4 412 4 182 5% 8% rEBITDA(2) 1 398 1 375 2% 5% Number of shares (m) 188 188 Core EPS(3) (EUR) 4.78 4.82 -1% 3% Dividend per share (EUR) 1.21 1.18 2.5%

Latest R&D update

Neurology -

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 rozanolixizumab development with a confirmatory study in MG starting in Q2 2019.

In December, Vimpat() (lacosamide) was approved in China as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent patients 16 years of age and older with epilepsy. In January 2019, Vimpat() was approved in Japan for the treatment of partial onset seizures in children 4 years of age and older. In addition, two new formulations have been approved, IV (intravenous) and dry syrup.

At the end of 2018, one phase 1 project in neurology, UCB3491, was terminated due to lack of patients for recruitment - driven by sufficient standard of care.

In December, Keppra() (levetiracetam) for monotherapy of epilepsy as well as an updated pregnancy language was submitted to the U.S. authorities. The application was accepted for filing by the FDA in January 2019. The Keppra() pregnancy label has been approved in the EU in April 2018.

Immunology -

In October, UCB and its partner Biogen announced top-line results from a Phase 2b study with dapirolizumab pegol in moderately-to-severely active systemic lupus erythematosus. While the primary endpoint of the study 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 dapirolizumab pegol compared with placebo. UCB and Biogen continue to further evaluate these data while assessing potential next steps.

At the end of 2018, the phase 1 project UCB6673 was returned to the partner - due to prioritization within the UCB pipeline.

In September and in Japan, positive phase 3 results were achieved for Cimzia() (certolizumab pegol) in patients with psoriasis and psoriatic arthritis. Submission to the Japanese agency took place in January 2019.

Bone --

Early January 2019, UCB and Amgen announced the approval of Evenity() (romosozumab) in Japan. Evenity() is approved to reduce the risk of fractures and increase bone mineral density in men and post-menopausal women with osteoporosis at high risk of fracture. One week later, the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted positively for the approval of romosozumab. While the FDA is not bound by the Advisory Committee's recommendations, it takes the advice into consideration when making its decision.

All other clinical development programs are continuing as planned.

ImmunologyCimzia() (certolizumab pegol) for patients living with autoimmune and inflammatory TNF mediated diseases, net sales went up to EUR 1.4 billion, driven by continued, sustainable growth in all regions at constant exchange rates. In 2018, in the EU and the U.S., the Cimzia() label was enhanced with data in pregnancy and breastfeeding. In addition, Cimzia was launched for adults with moderate-to-severe plaque psoriasis.

Net sales

EUR million FY 2018 FY 2017 Act CER U.S. 896 918 -2% 2% Europe 400 370 8% 8% International markets 150 136 10% 19% Total Cimzia(R) 1 446 1 424 2% 5%

Neurology: UCB's epilepsy franchise reached net sales of EUR 2.0 billion, a plus of 10%.

Vimpat (lacosamide) with net sales of EUR 1.1 billion, is reaching more and more people living with epilepsy, marking a new blockbuster for UCB and showing strong, double-digit growth in all regions.

EUR million FY 2018 FY 2017 Act CER U.S. 822 746 10% 15% Europe 206 177 16% 17% International markets 70 53 33% 42% Total Vimpat(R) 1,099 976 13% 17%

Keppra (levetiracetam) for epilepsy, reported net sales of EUR 790 million. The evolution reflects the established brand and the maturity of the product while showing good growth in international markets.

EUR million FY 2018 FY 2017 Act CER U.S. 221 232 -5% 0% Europe 216 235 -8% -8% International markets 352 311 13% 19% Total Keppra(R) 790 778 2% 5%

Briviact (brivaracetam), is being made available to more and more patients and reached net sales of EUR 142 million. In 2018, Briviact was approved in the U.S. and the EU for young patients from 4 years of age.

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