Publicado 25/02/2021 07:00CET

UCB Full Year Report 2020: UCB - sustaining growth, now and into the future (1)

· Revenue increased to EUR 5.3 billion (+9%, +8% CER[1]) net sales to EUR 5.1 billion (+8%, +7% CER)

· Underlying profitability (adj. EBITDA[2]) was EUR 1.4 billion (+1%, -4% CER) or 27% of revenue

· R&D update: bimekizumab filed with FDA and EMA for psoriasis; timelines for late stage pipeline confirmed - despite pandemic

· Financial outlook for 2021: Revenue expected to reach EUR 5.45 - 5.65 billion, adjusted EBITDA[2] 27 - 28% of revenue, Core EPS[3] of EUR 5.60 - 6.10 expected

· Outlook 2025: revenue of at least EUR 6 billion and adj. EBITDA margin in the low to mid-thirties

BRUSSELS, Feb. 25, 2021 /PRNewswire/ -- "We are very impressed by our employees and partners for their resilience and achievements during 2020. Together we continued to serve patients, took good care of each other and joined forces in the global response to COVID-19. 2020 was another year with good performance in execution of our patient value strategy, ensuring sustained growth for the company also in the longer term," said Jean-Christophe Tellier, CEO UCB. "For the first time we share our growth ambition for 2025, despite upcoming patent expirations. Based on our strong portfolio and the promising late-stage pipeline, we aim to lead in specific populations by 2025, creating value for patients now and into the future. Also, we made progress in the sustainability areas that are critical to our long-term success and our contribution to society." []

UCB's 2020 financial results

2020 revenue reached EUR 5.3 billion (+9%; +8% at CER). Net sales went up by 8% to EUR 5.1 billion (+7% CER), driven by the sustained growth of UCB's key products.

Underlying profitability (adjusted EBITDA(2)) reached EUR 1.4 billion (+1%; -4% CER) reflecting higher investments into the future of UCB, namely product launches and product development.

Driven by other expenses, profit was to EUR 761 million (-7%, -14%) of which EUR 732 million (-7%; -15% CER) is attributable to the UCB shareholders. Core EPS[3] were EUR 5.36 after EUR 5.20 in 2019.

The Board of Directors of UCB proposes a dividend of EUR 1.27 per share (gross), +2%.

Acquisitions and agreements

In October 2020, UCB acquired a new campus located in Windlesham, Surrey for its U.K. operations supporting cutting-edge research and development, early manufacturing and commercialization of medicines. The acquisition reflects UCB's commitment to retain the U.K. as one of its three global hubs for research and development, alongside Belgium and the U.S.

In November 2020, UCB acquired Handl Therapeutics, a rapidly growing and transformative gene therapy company based in Leuven, Belgium and entered into a new collaboration with Lacerta Therapeutics, a Florida based clinical stage gene therapy company. The new acquisition and collaboration will together serve to rapidly accelerate UCB's ambition in gene therapy.

Regulatory approvals

Vimpat(®) (lacosamide) - In October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a license extension for the anti-epileptic drug Vimpat® as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in adults, adolescents and children from 4 years of age with idiopathic generalized epilepsy - approved in the European Union in December 2020. In November 2020, the U.S. Food and Drug Administration (FDA) has approved Vimpat(®) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older and Vimpat(® )injection for intravenous use in children four years of age and older.

R&D update

Bimekizumab - In September 2020, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. In July 2020, the Phase 3b study BE RADIANT, comparing bimekizumab to Cosentyx(®) (secukinumab) for the treatment of adults with moderate-to-severe plaque psoriasis, met all co- primary and ranked secondary endpoints, achieving significantly greater efficacy than secukinumab.

Dapirolizumab pegol: in August 2020, UCB and its partner, Biogen, included the first patients into the Phase 3 program with dapirolizumab pegol in patients with active systemic lupus erythematosus (SLE) despite standard-of-care treatment. First headline results are expected in H1 2024.

Rozanolixizumab: UCB is focusing its resources to new patient populations with autoantibody mediated neuro-inflammation and high unmet medical need. With these patients potentially benefitting from rozanolixizumab, UCB is preparing the start of two clinical programs already during 2021 - next to the ongoing Phase 3 studies in generalized myasthenia gravis (gMG) and immune thrombocytopenia (ITP). People living with chronic inflammatory demyelinating polyneuropathy (CIDP) are a heterogenous and complex patient population, with approximately only 30% having detectable autoantibodies. While the Phase 2a study in CIDP patients supports the conduct of a confirmatory clinical study, UCB decided to prioritize autoantibody mediated neuro-inflammation indications over CIDP.

Bepranemab (UCB0107) Initiation of a Phase 2 study in Alzheimer's disease (AD) is planned for mid-2021, following the partnership agreement with Roche/Genentech. This will allow to evaluate the potential of bepranemab in a tau-mediated disease and subsequently explore options in different tauopathy populations, including progressive supranuclear palsy (PSP).

In context with the pandemic, there are no changes to the expected timelines for the late stage pipeline projects.

Net sales break-down by core product

Cimzia(®)(certolizumab pegol) - EUR1799 million (+5% Act, +7% CER): for people living with autoimmune and inflammatory TNF mediated diseases, driven by continued growth in the U.S. and stable net sales in Europe despite volume growth, reflecting the competitive landscape. Strong growth contributors were new patient populations in psoriasis and psoriatic arthritis

Vimpat(®)(lacosamide) - EUR1072 million (+10% Act, +12 CER), continues to reach more and more people living with epilepsy, reflected in strong growth in all regions.

Keppra(®)(levetiracetam) - EUR788 million (+2% Act, +5% CER), for patients living with epilepsy, the continued generic erosion in the U.S. has been compensated by recovery from a local, one-time rebate adjustment in 2019 in Europe and continued growth in international markets including in Japan where the UCB team took over distribution of E Keppra(®) from partner Otsuka in October 2020.

Briviact(®)(brivaracetam) - EUR288 million (+31% Act, +33% CER), for people living with epilepsy, is driven by significant growth in all regions Briviact(®) is available to patients. Briviact(®) has a different mode of action from Vimpat(®) and differentiates from Keppra(®)

Neupro(®)(rotigotine) - EUR319 million (-2% Act, -1% CER), the patch for Parkinson's disease, was almost stable in a competitive market environment

Nayzilam(®) (midazolam) Nasal Spray(CIV), a nasal rescue treatment for epilepsy seizure clusters in the U.S. is successfully launched since December 2019 and reached net sales of EUR 26 million.