BRUSSELS, Feb. 20, 2020 /PRNewswire/ -- 7:00 (CET) –
regulated information –
- Revenue reached € 4.9 billion (+6%, +7% CER[1]) net
sales increased to € 4.7 billion (+6%)
- Underlying profitability (rEBITDA[2]) was € 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 € 5.05 –
5.15 billion,
rEBITDA[2] 28 - 29% of revenue, Core EPS[3]
of € 4.80 – 5.20 expected
- New peak sales guidance for Cimzia® € 2.0 bn by
2024 and for Vimpat® € 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 € 4.9 billion (+6%; +7% at
CER). Net sales went up by 6% to € 4.7 billion
(+7% CER), driven by the strong double-digit growth of UCB's key
franchises: immunology and epilepsy.
Underlying profitability
(rEBITDA[2] ) reached
€ 1.4 billion (+2%; +11% CER) with higher net sales
overcompensating increased expenses for product launches and
product development.
Profit was to € 817 million of which
€ 792 million (-1%; +15% CER) is attributable to the UCB
shareholders.
Core EPS[3] were € 5.20 after
€ 4.78 in 2018.
The Board of Directors of UCB proposes a dividend of € 1.24 per
share (gross), +2%.
R&D update
Neurology
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.
Immunology
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[4]
Immunology
Cimzia® (certolizumab pegol) for patients
living with autoimmune and inflammatory TNF mediated diseases, net
sales increased to more than € 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 € 2.3 billion, a plus of 12%.
Vimpat® (lacosamide), with net sales of more than € 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 € 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
€ 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 € 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[5]
In 2019, revenue and net sales increased by 6% (+7% CER)
to € 4 913 million and to € 4 680 million (+6%;
+7% CER) respectively. Net sales before "designated hedging
reclassified to net sales" went up by 11% (+7% CER) to €4 784
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 € 78 million from € 92
million. Other revenue increased to € 155 million after €
128 million.
Gross profit reached € 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 € 2 527 million
(+9%; +6% CER) reflecting 15% higher marketing and selling expenses
of € 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 € 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 € 195 million, mainly in connection with the new
organization model implemented in 2019. Other operating income was
€ 48 million after expenses of € 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[6] - reached € 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
€ 50 million after an income of € 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 € 107
million.
Income tax expenses were € 146 million
compared to € 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 € 817 million (after
€ 823 million), of which € 792 million (after € 800
million) is attributable to UCB shareholders and € 25 million
(after € 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 € 5.20 after € 4.78 based on 187 million
weighted average shares outstanding.
Dividend - The Board of Directors of UCB proposes a
dividend of €1.24 per share (gross), +2%.
Outlook 2020 - For 2020, UCB is aiming for revenues
in the range of € 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,
rEBITDA6, 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 € 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 of US
- Jean-Luc Fleurial, Executive
Vice President & Chief Human Resources Officer
- Iris Löw-Friedrich, Executive Vice President & Chief
Medical Officer
- Kirsten Lund-Jurgensen,
Executive Vice President, Supply & Technology Solutions
- Dhaval Patel, Executive Vice
President & Chief Scientific Officer
- Bill Silbey, Executive
Vice-President & General Counsel
- Detlef Thielgen, Executive Vice President, Chief Financial
Officer & Corporate Development
- Charl van Zyl, Executive Vice
President Neurology Solutions & Head of EU/International
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
Find the FY financial reports on UCB website:
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
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
7 600 people in approximately 40 countries, the company
generated revenue of € 4.9 billion in 2019. UCB is listed on
Euronext Brussels (symbol: UCB). Follow us on Twitter:
@UCB_news
Forward looking statements
This press release contains forward-looking statements including,
without limitation, statements containing the words "believes",
"anticipates", "expects", "intends", "plans", "seeks", "estimates",
"may", "will", "continue" and similar expressions. These
forward-looking statements are based on current plans, estimates
and beliefs of management. All statements, other than statements of
historical facts, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
information, expected legal, arbitration, political, regulatory or
clinical results or practices and other such estimates and results.
By their nature, such forward-looking statements are not guarantees
of future performance and are subject to known and unknown risks,
uncertainties and assumptions which might cause the actual results,
financial condition, performance or achievements of UCB, or
industry results, to differ materially from those that may be
expressed or 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 or
within expected timing, 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, safety, quality, data integrity or
manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology
systems, product liability claims, challenges to patent protection
for products or product candidates, competition from other products
including biosimilars, 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. There is no guarantee that new product candidates will
be discovered or identified in the pipeline, or that new
indications for existing products will be developed and approved.
Movement from concept to commercial product is uncertain;
preclinical results do not guarantee safety and efficacy of product
candidates in humans. So far, the complexity of the human body
cannot be reproduced in computer models, cell culture systems or
animal models. The length of the timing to complete clinical trials
and to get regulatory approval for product marketing has varied in
the past and UCB expects similar unpredictability going forward.
Products or potential products which are the subject of
partnerships, joint ventures or licensing collaborations may be
subject to disputes between the partners or may prove to be not as
safe, effective or commercially successful as UCB may have believed
at the start of such partnership. UCB' efforts to acquire other
products or companies and to integrate the operations of such
acquired companies may not be as successful as UCB may have
believed at the moment of acquisition. Also, UCB or others could
discover safety, side effects or manufacturing problems with its
products and/or devices after they are marketed. The discovery of
significant problems with a product similar to one of UCB's
products that implicate an entire class of products may have a
material adverse effect on sales of the entire class of affected
products. Moreover, sales may be impacted by international and
domestic trends toward managed care and health care cost
containment, including pricing pressure, political and public
scrutiny, customer and prescriber patterns or practices, and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and reimbursement
activities and outcomes. Finally, a breakdown, cyberattack or
information security breach could compromise the confidentiality,
integrity and availability of UCB's data and systems.
Given these uncertainties, you should not place undue reliance
on any of such forward-looking statements. There can be no
guarantee that the investigational or approved products described
in this press release will be submitted or approved for sale or for
any additional indications or labelling in any market, or at any
particular time, nor can there be any guarantee that such products
will be or will continue to be commercially successful in the
future.
UCB is providing this information, including forward-looking
statements, only as of the date of this press release and expressly
disclaims any duty to update any information contained in this
press release, either to confirm the actual results or to report or
reflect any change in its forward-looking statements with regard
thereto or any change in events, conditions or circumstances on
which any such statement is based, unless such statement is
required pursuant to applicable laws and regulations.
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.
[1] CER = constant exchange rates
[2] rEBITDA = recurring Earnings Before
Interest, Taxes, Depreciation and
Amortization charges
[3] Core EPS = core earnings per share
[4] Due to rounding, some financial data may not add up in
the tables.
[5] Due to rounding, some financial data may not add up in the
tables.
[6] rEBITDA = recurring Earnings Before Interest, Taxes,
Depreciation and Amortization charges
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SOURCE UCB