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** First half 2021 with sustainable performance =E2=80=93 delivering on UCB=
=E2=80=99s strategy and guidance
------------------------------------------------------------
=C2=B7 Revenue increased to =E2=82=AC 2.8 billion (+7%; +11% CER^1) net sal=
es to =E2=82=AC 2 651 million (+6%; +11% CER)
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 843 million (=
+8%; +16% CER) or 30% of revenue
=C2=B7 All clinical development programs on track with 6 phase 3 studies to=
read out as planned
=C2=B7 R&D update: bimekizumab with positive CHMP opinion for psoriasis and=
phase 3 read-out for hidradenitis suppurativa (HS) moved to 2022; two new =
study starts for rozanolixizumab and a phase 2 started with bepranemab in A=
lzheimer=E2=80=99s Disease
=C2=B7 Financial guidance for 2021 unchanged: Revenue expected to reach =E2=
=82=AC 5.45 - 5.65 billion, adjusted EBITDA^2 27 - 28% of revenue, Core EPS=
^3 of =E2=82=AC 5.60 - 6.10
UCB Half Year Report 2021, Brussels (Belgium), 29 July 2021 =E2=80=93 7:00 =
(CEST) =E2=80=93 regulated information =E2=80=93=C2=A0
Jean-Christophe Tellier, CEO UCB commented: =E2=80=9CWe are very satisfied =
with the ongoing performance of UCB =E2=80=93 we are delivering on our ambi=
tious targets and strategy. We are thankful to our employees and partners f=
or their agility managing the new and changing environment. The coming mont=
hs will be marked by the expected launch of bimekizumab for people living w=
ith psoriasis backed by three superiority studies as well as in total six p=
hase 3 study read-outs from our late-stage pipeline. Our progress on sustai=
nability, namely in quality and risk, is recognized by top rankings like IS=
S ESG, MSCI and Sustainalytics. We are very confident in our late stage pip=
eline, our ability to lead in five patient populations in 2025 and to deliv=
er on our short- and long-term guidance.=E2=80=9D=C2=A0
UCB=E2=80=99s HY 2021 financial results & Core product net sales:
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HY 2021 revenue reached =E2=82=AC 2.8 billion (+7%; +11% CER). Net sales we=
nt up by 6% to =E2=82=AC 2 651million (+11% CER), driven by the sustainable=
growth of UCB=E2=80=99s key products.=C2=A0
Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 843 million =
(+8%; +16% CER) integrating high investments into the future of UCB, namely=
product launches and product development.=C2=A0
Driven by lower other expenses, profit increased to =E2=82=AC 571 million (=
+47%; +60% CER) of which the full amount is attributable to UCB shareholder=
s. Core EPS^3=C2=A0were =E2=82=AC 3.40 after =E2=82=AC 2.77 in HY 2020.
Regulatory and R&D update=C2=A0
Bimekizumab - In June, the European Medicines Agency=E2=80=99s Committee fo=
r Medicinal Products for Human Use (CHMP) has adopted a positive opinion re=
commending granting a marketing authorization for bimekizumab, for the trea=
tment of moderate to severe plaque psoriasis in adults. The European Commis=
sion is expected to deliver its decision on the marketing authorization of =
bimekizumab, under the trade name Bimzelx^=C2=AE, by end of summer 2021. Re=
gulatory reviews are also underway in the U.S., the UK, Japan, Australia an=
d Canada. Subject to respective approvals, UCB will bring bimekizumab to pa=
tients starting in the second half 2021.
Bimekizumab - The ongoing Phase 3 program in moderate to severe hidradeniti=
s suppurativa (HS), a chronic, inflammatory, and debilitating follicular sk=
in disease, showed accelerated patient recruitment, hence the first headlin=
e results are now expected before the end of 2022. First headline results f=
rom the phase 3 studies for the treatment of psoriatic arthritis, ankylosin=
g spondylitis and non-radiographic axial spondyloarthritis are expected as =
planned in Q4 2021.
Rozanolixizumab - first headline results from the phase 3 study for the tre=
atment of myasthenia gravis are expected as planned in Q1 2022.
Maintaining UCB=E2=80=99s focus on autoantibody-mediated neuroinflammation,=
UCB is investigating two additional patient populations:=C2=A0
(i) people living with autoimmune encephalitis (AIE) =E2=80=93 a rare and s=
erious medical condition, in which the immune system attacks the brain =E2=
=80=93 leading to epileptic seizures, movement disorders as well as cogniti=
ve decline in some patients. There is no therapy approved for AIE. The phas=
e 2a study in AIE starts in Q3 2021; first topline results are expected in =
H1 2024.
(ii) people living with myelin oligodendrocyte glycoprotein (MOG)-antibody =
disease =E2=80=93 a rare autoimmune inflammatory demyelinating disorder of =
the central nervous system caused by autoantibodies that target the MOG pro=
tein =E2=80=93 leading to temporal functional blindness, muscle weakness, b=
ladder dysfunction, sensory loss, and/or pain. There is no approved therapy=
for MOG-antibody disease. The Phase 3 study will start in Q4 2021.=C2=A0
UCB decided to prioritize these autoantibody mediated neuroinflammatory ind=
ications over chronic inflammatory demyelinating polyneuropathy (CIDP) repr=
esenting a heterogenous and complex patient population, with approximately =
only 30% of patients having detectable autoantibodies. Following this strat=
egic decision, results of the phase 2a study in CIDP will be presented duri=
ng an upcoming scientific meeting. =C2=A0
Zilucoplan - first headline results from the phase 3 study for the treatmen=
t of myasthenia gravis are expected as planned in Q4 2021.
Zilucoplan was tested in a proof of concept (phase 2a) study in immune-medi=
ated necrotizing myopathy (IMNM): The results of this study indicate that c=
omplement activation is not relevant in the disease biology of IMNM. UCB de=
cided to not move forward with its IMNM development program. The results in=
IMNM do not affect UCB=E2=80=99s confidence in zilucoplan for other indica=
tions with complement activation as a key disease mechanism.=C2=A0
Bepranemab (UCB0107) - in Q2 2021 a Phase 2 study started investigating the=
efficacy and safety of bepranemab in patients with early Alzheimer=E2=80=
=99s disease in partnership with Roche/Genentech. First headline results ar=
e expected in H1 2025.
UCB0599 - is a small molecule that prevents the pathological misfolding and=
accumulation of alpha-synuclein, a protein which plays a key role in Parki=
nson=E2=80=99s disease (PD) pathology. Inhibition of alpha-synuclein misfol=
ding has the potential to slow down the progression of PD. UCB0599 belongs =
to a series of molecules discovered by Neuropore, which were in-licensed by=
UCB in 2014. In April, a phase 2a study started with UCB0599 for study par=
ticipants with early-stage PD. First headline results are expected in H2 20=
23.
All other clinical development programs are continuing as planned. In the f=
irst six months of 2021, the timelines for UCB=E2=80=99s clinical developme=
nt program have not experienced any material delays due to COVID-19. UCB co=
ntinues to monitor the impact of COVID-19 on all ongoing clinical trials an=
d will implement changes as necessary.
Net sales break-down by core product^4
Cimzia^=C2=AE (certolizumab pegol) for people living with autoimmune and in=
flammatory TNF mediated diseases, outperformed the anti-TNF market and was =
driven by continued growth in the U.S. and strong growth in international m=
arkets, reaching more patients.
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Vimpat^=C2=AE (lacosamide), continues to reach more and more people living =
with epilepsy, reflected in strong growth at CER in all regions. Internatio=
nal markets were impacted by order patterns for Japan.=C2=A0
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=C2=A0
Keppra^=C2=AE (levetiracetam) for patients living with epilepsy. The contin=
ued generic erosion in the U.S. and Europe has been overcompensated by the =
performance in Japan. UCB took over distribution of E Keppra^=C2=AE from pa=
rtner Otsuka in October 2020 and now books the in-market net sales. Generic=
entries to the Japanese market are expected in Q4 2021.
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Briviact^=C2=AE (brivaracetam), for people living with epilepsy, is driven =
by significant growth in all regions Briviact^=C2=AE is available to patien=
ts. Briviact^=C2=AE has a different mode of action from Vimpat^=C2=AE and d=
ifferentiates from Keppra^=C2=AE.
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Neupro^=C2=AE (rotigotine), the patch for Parkinson=E2=80=99s disease, with=
good growth in the U.S. at CER in a competitive market environment and str=
ong growth in international markets including Japan.
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Nayzilam^=C2=AE (midazolam) Nasal Spray^CIV, a nasal rescue treatment for e=
pilepsy seizure clusters in the U.S. was successfully launched during 2020,=
despite the pandemic, and reached net sales of =E2=82=AC 21 million in the=
first six months 2021 after =E2=82=AC 11 million in HY 2020.
Evenity^=C2=AE (romosozumab) for the treatment of severe osteoporosis in po=
stmenopausal women at high risk of fracture, had its first European launch =
in March 2020, and reported net sales of =E2=82=AC 4 million in the first s=
ix months 2021 (after =E2=82=AC 1 million in HY 2020) - impacted by the pan=
demic which significantly impedes outreach to new patient populations. Even=
ity^=C2=AE is being launched successfully globally by Amgen, Astellas and U=
CB since 2019, with net sales outside Europe reported by the partners.
2021 HY financial highlights^5=C2=A0
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Revenue in the first six months 2021 increased by 7% (+11% CER) to =E2=82=
=AC 2 778 million and net sales increased by 6% (+11% CER) to =E2=82=AC 2 6=
51 million. Net sales before =E2=80=9Cdesignated hedging reclassified to ne=
t sales=E2=80=9D were =E2=82=AC 2 611 million with a plus of 4% (+11% CER).=
This growth was driven by the resilient UCB product portfolio =E2=80=93 de=
spite the pandemic. The change of distribution model for E-Keppra^=C2=AE in=
Japan supported the net sales growth. Adjusted for this impact, net sales =
would have increased by +7% CER.
Royalty income and fees were =E2=82=AC 40 million, plus 7% and other revenu=
e went up by 9% to =E2=82=AC 87 million due to milestones and other payment=
s from R&D partners.=C2=A0
Gross profit reached =E2=82=AC 2 089 million, with a plus of 9% (+14% CER) =
and reflecting an improved gross margin of 75% compared to the first six mo=
nths 2020 with 74%.
Operating expenses increased to =E2=82=AC 1 407 million (+7%; +11% CER) ref=
lecting=C2=A0
=C2=B7 7% higher marketing and selling expenses of =E2=82=AC 606 million - =
driven by the ongoing launches of Cimzia^=C2=AE (new indication and regiona=
l expansion), Nayzilam^=C2=AE, and Evenity^=C2=AE and especially launch pre=
parations for bimekizumab for people living with psoriasis, zilucoplan and =
rozanolixizumab in myasthenia gravis=C2=A0
=C2=B7 9% higher research and development expenses of =E2=82=AC 753 million=
reflecting the investments in UCB=E2=80=99s progressing pipeline encompass=
ing five late-stage assets which all are on track. This includes activities=
to ensure patient safety and recruitment managing the effects of the pande=
mic. The R&D ratio reached 27% in the first six months of 2020 after 26% in=
the first six months 2020.=C2=A0
=C2=B7 4% higher general and administrative expenses of =E2=82=AC 98 millio=
n, reflecting a similarly low-cost level like in the first six months 2020 =
due to the COVID-19 pandemic.
=C2=B7 operating income of =E2=82=AC 50 million after =E2=82=AC 41 million =
in 2020 - driven by an income of =E2=82=AC 55 million in connection with th=
e commercialization of Evenity^=C2=AE in collaboration with Amgen, partly c=
ompensated by other operating expenses.
Underlying operational profitability =E2=80=93 adjusted EBITDA^7 =C2=A0=E2=
=80=93 went up to =E2=82=AC 843 million (+8%; +16% CER) driven by continued=
revenue growth and higher operating expenses, reflecting the investments i=
nto the future of UCB, namely into product launches and clinical developmen=
t. The adjusted EBITDA ratio for the first six months 2021 (in % of revenue=
) was stable at 30% compared to the first six months of 2020.
Total impairment, restructuring and other income/expenses were expenses of =
=E2=82=AC 4 million. In the first six months 2020, the expenses were =E2=82=
=AC 95 million and included fees related to the acquisitions of Ra Pharma a=
nd Engage Therapeutics as well as restructuring expenses, partially offset =
with income resulting from gain on the divestiture of non-core products.
Net financial expenses went down to =E2=82=AC 35 million from =E2=82=AC 61 =
million, mainly due to lower hedging costs and lower interest expenses.
Income tax expenses were =E2=82=AC 76 million compared to =E2=82=AC 70 mill=
ion in June 2020. The average effective tax rate was 12% compared to 15% in=
June 2020, supported by R&D related incentives in key jurisdictions.
Profit amounted to =E2=82=AC 571 million, of which the full amount is attri=
butable to UCB shareholders as the contributions to non-controlling interes=
ts have expired end 2020. Driven by strong revenue and EBITDA growth as wel=
l as significantly lower restructuring expenses, lower financial expenses a=
nd taxes. For the first six months of 2020, profit was =E2=82=AC 388 millio=
n of which =E2=82=AC 363 million were attributable to UCB shareholders and =
=E2=82=AC 25 million to non-controlling interests.
Core earnings per share, which reflect profit attributable to UCB sharehold=
ers, adjusted for the after-tax impact of to be adjusted items, the financi=
al one-offs, the after-tax contribution from discontinued operations and th=
e net amortization of intangibles linked to sales, reached =E2=82=AC 3.40 a=
fter =E2=82=AC 2.77 based on stable 189 million weighted average shares out=
standing.
Guidance 2021 unchanged: For 2021, UCB is aiming for revenues in the range =
of =E2=82=AC 5.45 - 5.65 billion thanks to the current core product growth =
and new patient populations being served, based on current assessment of th=
e ongoing pandemic. UCB will continue to advance its late-stage development=
pipeline and prepare upcoming launches to offer potential novel solutions =
for patients.=C2=A0
Underlying profitability, adjusted EBITDA, is expected in the range of 27 -=
28% of revenue, reflecting high R&D and marketing & sales investment level=
s. Core earnings per share are therefore expected in the range of =E2=82=AC=
5.60 - 6.10 based on an average of 189 million shares outstanding. The fig=
ures for the guidance 2021 as mentioned are calculated on the same basis as=
the actual figures for 2020.=C2=A0
Guidance for 2025 unchanged: UCB shares its growth ambition for 2025 - desp=
ite upcoming patent expirations: Based on the strong product portfolio and =
the promising late-stage pipeline assets, UCB aims to lead in specific popu=
lations by 2025, creating value for patients now and into the future. Reven=
ue in 2025 are expected to reach at least =E2=82=AC 6 billion and the under=
lying profitability (adjusted EBITDA) should reach the low to mid-thirties =
in percent of revenue.
Guidance 2021 & 2025: Based on UCB=E2=80=99s current assessment of the Covi=
d-19 pandemic, UCB remains confident in the fundamental underlying demand f=
or its products in the short-term and its prospects for long-term growth. U=
CB will continue to closely follow evolving COVID-19 pandemic and its conse=
quences to the business environment diligently to assess potential near- an=
d mid-term challenges.
Find the financial reports on UCB website: http://www.ucb.com/investors/Dow=
nload-center=C2=A0
Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00=
(BST) / 14.00 (CET).
Details are available on https://www.ucb.com/investors/UCB-financials/Half-=
year-financial-results
For further information=C2=A0
Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
T +32.2.559.94.14 antje.witte@ucb.com
Julien Bayet
T: +32.2.559.95.80 Julien.bayet@ucb.com
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
=C2=A0
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With more than 7 600 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 5.3=
billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news
Forward looking statements=C2=A0
This press release contains forward-looking statements including, without l=
imitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =E2=
=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=E2=
=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestimate=
s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu=
e=E2=80=9D and similar expressions. These forward-looking statements are ba=
sed on current plans, estimates and beliefs of management. All statements, =
other than statements of historical facts, are statements that could be dee=
med 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 kno=
wn and unknown risks, uncertainties and assumptions which might cause the a=
ctual 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: the globa=
l spread and impact of COVID-19, changes in general economic, business and =
competitive conditions, the inability to obtain necessary regulatory approv=
als or to obtain them on acceptable terms or within expected timing, costs =
associated with research and development, changes in the prospects for prod=
ucts in the pipeline or under development by UCB, effects of future judicia=
l decisions or governmental investigations, safety, quality, data integrity=
or manufacturing issues; potential or actual data security and data privac=
y breaches, or disruptions of our information technology systems, product l=
iability claims, challenges to patent protection for products or product ca=
ndidates, 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 d=
iscovered or identified in the pipeline, or that new indications for existi=
ng products will be developed and approved. Movement from concept to commer=
cial product is uncertain; preclinical results do not guarantee safety and =
efficacy of product candidates in humans. So far, the complexity of the hum=
an body cannot be reproduced in computer models, cell culture systems or an=
imal models. The length of the timing to complete clinical trials and to ge=
t regulatory approval for product marketing has varied in the past and UCB =
expects similar unpredictability going forward. Products or potential produ=
cts which are the subject of partnerships, joint ventures or licensing coll=
aborations may be subject to disputes between the partners or may prove to =
be not as safe, effective or commercially successful as UCB may have believ=
ed at the start of such partnership. UCB=E2=80=99 efforts to acquire other =
products or companies and to integrate the operations of such acquired comp=
anies may not be as successful as UCB may have believed at the moment of ac=
quisition. Also, UCB or others could discover safety, side effects or manuf=
acturing problems with its products and/or devices after they are marketed.=
The discovery of significant problems with a product similar to one of UCB=
=E2=80=99s products that implicate an entire class of products may have a m=
aterial adverse effect on sales of the entire class of affected products. M=
oreover, 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 practice=
s, and the reimbursement policies imposed by third-party payers as well as =
legislation affecting biopharmaceutical pricing and reimbursement activitie=
s and outcomes. Finally, a breakdown, cyberattack or information security b=
reach could compromise the confidentiality, integrity and availability of U=
CB=E2=80=99s data and systems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
ly 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-lookin=
g statements with regard thereto or any change in events, conditions or cir=
cumstances on which any such statement is based, unless such statement is r=
equired pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n 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 jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.
=C2=A0
Footnotes:
1.
CER =3D constant exchange rates
2. adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation a=
nd Amortization charges.=C2=A0
3. Core EPS =3D 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.=C2=A0
6. For the net financial debt, the reporting date for comparative period is=
31 December 2020.
7. adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation a=
nd Amortization charges.=C2=A0
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