BRUSSELS, Feb. 20, 2020 /PRNewswire/ -- 7:00 (CET) - regulated information -
-- Revenue reached EUR 4.9 billion (+6%, +7% CER()) net sales increased
to EUR 4.7 billion (+6%)
-- Underlying profitability (rEBITDA()) was EUR 1.4 billion (+2%, +11%
CER) or 29.1% of revenue
-- R&D update: bimekizumab with three positive Phase 3 results in psoriasis
and a new Phase 3 program in hidradenitis suppurativa started;
Cimzia(®) with approvals in China and Japan
-- Financial outlook for 2020: Revenue expected to reach EUR 5.05 - 5.15
billion, rEBITDA() 28 - 29% of revenue, Core EPS() of EUR 4.80 -
-- New peak sales guidance for Cimzia(®) EUR 2.0 bn by 2024 and for
Vimpat(®) EUR 1.5 bn by 2022
-- New Composition of UCB's Executive Committee in 2020
"2019 was a year of strong delivery and growth. Hence, we have updated the peak sales guidance for Cimzia® and Vimpat® and we continue to accelerate our investments into future growth drivers," said Jean-Christophe Tellier, CEO UCB. "Based on our promising late-stage pipeline and the pending Ra Pharma acquisition, we could potentially launch up to 7 products by 2025 to create patient value for specific populations now and into the future. Also, we focus on four sustainability areas that are critical to our long-term success and our contribution to society."
Revenue for 2019 reached EUR 4.9 billion (+6%; +7% at CER). Net sales went up by 6% to EUR 4.7 billion (+7% CER), driven by the strong double-digit growth of UCB's key franchises: immunology and epilepsy.
Underlying profitability (rEBITDA( )) reached EUR 1.4 billion (+2%; +11% CER) with higher net sales overcompensating increased expenses for product launches and product development.
Profit was to EUR 817 million of which EUR 792 million (-1%; +15% CER) is attributable to the UCB shareholders.
Core EPS() were EUR 5.20 after EUR 4.78 in 2018.
The Board of Directors of UCB proposes a dividend of EUR 1.24 per share (gross), +2%.
In June, the Phase 3 study started in patients with myasthenia gravis with rozanolixizumab. First headline results are expected in H1 2021.
In January 2020, the Phase 3 study in patients with immune thrombocytopenia (ITP) started, first headline results are expected in H 2 2022.
In September, new data from a Phase 1 study indicated that UCB0107 anti-Tau was well tolerated with an acceptable safety profile. UCB aims to initiate an adequate and well controlled study in Q2 2020. UCB0107 is currently being investigated as a potential treatment for patients with tauopathies, initially focusing on progressive supranuclear palsy.
In October, Keppra(®) (levetiracetam) was approved, in the U.S., for monotherapy in partial onset seizures. The new indication is intended for the use of Keppra(®) as mono-therapy in treatment of partial-onset seizures in patients one month of age and older and with an updated labeling to comply with the Pregnancy and Lactation Labeling Rule. An important driver for this submission was adding patient value, especially for pregnant women or women of childbearing age.
In December, UCB launched Nayzilam(®) (midazolam) Nasal Spray (CIV), the first and only nasal rescue treatment for seizure clusters in the U.S. Nayzilam(®) nasal spray was approved in the U.S. in May 2019.
In July, Cimzia(®) (certolizumab pegol) was approved in combination with methotrexate for the treatment of moderate to severe, active rheumatoid arthritis in adult patients in China.
In December, Cimzia(®) was approved for the treatment of psoriasis and psoriatic arthritis in Japan.
During the course of the fourth quarter 2019, UCB reported positive results for three Phase 3 studies with bimekizumab in psoriasis:
-- In October, the study BE VIVID, evaluating the efficacy and safety of
bimekizumab in adults with moderate-to-severe chronic plaque psoriasis
met all primary and ranked secondary endpoints, including significantly
greater efficacy compared to ustekinumab.
-- In November, the study BE READY, evaluating the efficacy and safety of
bimekizumab versus placebo in adults with moderate-to-severe chronic
plaque psoriasis, met all primary and ranked secondary endpoints.
-- In December, the study BE SURE, comparing bimekizumab to adalimumab for
the treatment of adults with moderate-to-severe plaque psoriasis, met
all co-primary and ranked secondary endpoints, achieving significantly
greater efficacy than adalimumab.
UCB plans to submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in mid-2020.
In addition, based on a positive proof-of-concept study, UCB decided to move into late stage development with bimekizumab in moderate to severe hidradenitis suppurativa (HS), a severe inflammatory skin disease, affecting predominantly women. The Phase 3 program BE HEARD starts in Q1 2020. First headline results are expected in H1 2023.
Evenity(®) (romosozumab) is now approved in Japan, the U.S., South Korea, Canada and Australia as well as in the EU.
In October, following re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization.
Evenity(®) was approved by the EMA in December for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
Net sales break-down by core product()
Cimzia(®) (certolizumab pegol) for patients living with autoimmune and inflammatory TNF mediated diseases, net sales increased to more than EUR 1.7 billion, driven by continued, sustainable growth in all regions. Growth is also driven by new patient populations like women of childbearing age and people living with non-radio-graphic axial spondyloarthritis and with psoriasis
Neurology: UCB's epilepsy franchise reached net sales of EUR 2.3 billion, a plus of 12%.
Vimpat® (lacosamide), with net sales of more than EUR 1.3 billion, shows continued double-digit strong growth in all regions thanks to reaching more and more people living with epilepsy.
Keppra(®) (levetiracetam) for epilepsy, reported net sales of EUR 770 million, reflecting both, the strong, trusted brand and the maturity of the product. In the U.S. net sales were impacted by generic competition. In Europe, Keppra® net sales were affected by a local, one-time rebate adjustment in the first half 2019
Briviact(®) (brivaracetam), reached net sales of EUR 221 million. This is driven by significant, continuous growth in all regions where Briviact® is now available to patients
Neupro(®) (rotigotine), the patch for Parkinson's disease, showed a slight decrease of net sales to EUR 319 million. Smaller declines in the U.S. -due to the generic market environment - and Europe were almost compensated by good growth in international markets.
2019 FY financial highlights()
In 2019, revenue and net sales increased by 6% (+7% CER) to EUR 4 913 million and to EUR 4 680 million (+6%; +7% CER) respectively. Net sales before "designated hedging reclassified to net sales" went up by 11% (+7% CER) to EUR4 784 million. Adjusted for divestitures in 2018, mainly "Innere Medizin"/Germany and the iron supplement Niferex(® )in Q1 2019, and before 'designated hedges reclassified to net sales' growth was +13% (+9% CER). This growth was driven by the continued strong positive performance of UCB's core products.
Royalty income and fees decreased to EUR 78 million from EUR 92 million. Other revenue increased to EUR 155 million after EUR 128 million.
Gross profit reached EUR 3 645 million, with a plus of 6% in-line with the net sales growths and reflecting a stable gross margin compared to 2018.
Operating expenses reached EUR 2 527 million (+9%; +6% CER) reflecting 15% higher marketing and selling expenses of EUR 1 108 million - driven by the launch of Cimzia(®) in psoriasis in the U.S. and Europe and in active non-radiographic axial spondyloarthritis (nr-axSpA) in the U.S. as well as launch preparations for Evenity(®) in Europe, 10% higher research and development expenses of EUR 1 272 million - driven by higher R&D investments and resulting in a R&D ratio of 26% in 2019 after 25% in 2018 and 8% higher general and administrative expenses of EUR 195 million, mainly in connection with the new organization model implemented in 2019. Other operating income was EUR 48 million after expenses of EUR 24 million in 2018. The income is composed of investment grants, gain on divestiture, release of provisions and income from the collaboration with Amgen in connection with Evenity(®). This resulted in an operating expense ratio (in relation to revenue) of 51% after 50% in 2018.
Underlying operational profitability - rEBITDA() - reached EUR 1 431 million a plus of 2% (+11% CER) with higher net sales overcompensating increased expenses for product launches and product development. The rEBITDA ratio for 2019 (in % of revenue) reached 29.1%, from 30.2% in 2018.
Total impairment, restructuring and other income/expenses (formerly called "non-recurring") were expenses of EUR 50 million after an income of EUR 4 million in 2018. In 2019, this includes mainly restructuring expenses, but also legal and litigation costs, partially offset with income resulting from gain on the divestitures. In 2019, UCB strengthened its operating model to ensure maximum agility to meet the growth expectations for the years ahead, hence the restructuring expenses.
Net financial expenses increased by 15% to EUR 107 million.
Income tax expenses were EUR 146 million compared to EUR 200 million in 2018. The effective tax rate of 15% is driven by the higher group revenue and the increasing impact of R&D related tax deductions in key countries.
Profit amounted to EUR 817 million (after EUR 823 million), of which EUR 792 million (after EUR 800 million) is attributable to UCB shareholders and EUR 25 million (after EUR 23 million) to non-controlling interests.
Core earnings per share, which reflect profit attributable to UCB shareholders, adjusted for the after-tax impact of impairment, restructuring, other operating income/expenses, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached EUR 5.20 after EUR 4.78 based on 187 million weighted average shares outstanding.
Dividend - The Board of Directors of UCB proposes a dividend of EUR1.24 per share (gross), +2%.
Outlook 2020 - For 2020, UCB is aiming for revenues in the range of EUR 5.05 - 5.15 billion - thanks to the current core product growth and new patient populations being served. UCB will continue to advance its strong development pipeline to offer potential new solutions for patients and complement with external opportunities. Hence, the underlying profitability, rEBITDA(6), in the range of 28-29% of revenue will reflect the high R&D investment level. Core earnings per share are therefore expected in the range of EUR 4.80 - 5.20 based on an average of 187 million shares outstanding. The figures for the outlook 2020 as mentioned are calculated on the same basis as the actual figures for 2019. The 2020 outlook will be updated upon closing of the planned Ra Pharma acquisition.
New Composition of UCB's Executive Committee in 2020
Six consecutive years of growth have underscored UCB's robust performance over time. UCB is poised to further accelerate and expand to deliver on its Patient Value ambition, potentially launching six or seven new products by 2025.
"To support our ambition, we evolved our organization and ways of working to ensure we become more agile and collaborate more transversally across our organization. We believe this evolved organization will increase our operational clarity and efficiency, and will set us up for truly patient-value focused launches," said Jean-Christophe Tellier, CEO of UCB
This evolution is reflected in the new composition of the UCB Executive Committee which became smaller, with more transversal roles across businesses and regions, and with more focus on the company's core activity areas.
Since 1 February 2020 the new composition of the Executive Committee of UCB is as follows:
-- Jean-Christophe Tellier, Chief Executive Officer
-- Emmanuel Caeymaex, Executive Vice President Immunology Solutions & Head
-- Jean-Luc Fleurial, Executive Vice President & Chief Human Resources
-- Iris Löw-Friedrich, Executive Vice President & Chief Medical Officer
-- Kirsten Lund-Jurgensen, Executive Vice President, Supply & Technology
-- Dhaval Patel, Executive Vice President & Chief Scientific Officer
-- Bill Silbey, Executive Vice-President & General Counsel
-- Detlef Thielgen, Executive Vice President, Chief Financial Officer &
-- Charl van Zyl, Executive Vice President Neurology Solutions & Head of
Alexander Moscho, Pascale Richetta, Bharat Tewarie and Jeff Wren have left the Executive Committee and UCB is very thankful for their past contributions. Bill Silbey and Kirsten Lund-Jurgensen joined the Executive Committee in 2019.
Furthermore, UCB announced in July 2019 that the company's Chief Financial Officer, Detlef Thielgen, will be transitioning out of UCB in H1 2020. A search for a successor is ongoing.
Further information about UCB's Executive Committee are available on UCB website: https://www.ucb.com/investors/UCB-Governance#book-CMP_B_55790 [https://www.ucb.com/investors/UCB-Governance#book-CMP_B_55790]
Find the FY financial reports on UCB website: http://www.ucb.com/investors/Download-center [http://www.ucb.com/investors/Download-center]
Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00 (GMT) / 14.00 (CET).
Details are available on https://www.ucb.com/investors/UCB-financials/Full-year-financial-results [https://www.ucb.com/investors/UCB-financials/Full-year-financial-results]
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 7 600 people in approximately 40 countries, the company generated revenue of EUR 4.9 billion in 2019. UCB is listed on Euronext Brussels . Follow us on Twitter: @UCB_news
Forward looking statements
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 CER = constant exchange rates
 rEBITDA = recurring Earnings Before Interest, Taxes, Depreciation and Amortization charges
 Core EPS = core earnings per share
 Due to rounding, some financial data may not add up in the tables.
 Due to rounding, some financial data may not add up in the tables.
 rEBITDA = recurring Earnings Before Interest, Taxes, Depreciation and Amortization charges
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