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** 2021 =E2=80=93 Delivering on UCB=E2=80=99s Strategy and Commitments
------------------------------------------------------------
=C2=B7 Unprecedented string of 6 positive Phase 3 study results: bimekizuma=
b in psoriatic arthritis and across the full spectrum of axial spondyloarth=
ritis (axSpA); both, rozanolixizumab and zilucoplan in generalized myasthen=
ia gravis (gMG)
=C2=B7 Revenue increased to =E2=82=AC 5.78 billion (+8%; +10% CER^1), net s=
ales to =E2=82=AC 5.47 billion (+8%; +11% CER)
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 1.64 billion =
(+14%; +21% CER), 28% of revenue
=C2=B7 Financial guidance for 2022: Revenue expected to reach =E2=82=AC 5.1=
5 - 5.4 billion, adjusted EBITDA2 26 - 27% of revenue, Core EPS^3 of =E2=82=
=AC 4.80 - 5.30 =C2=A0
=C2=A0
UCB Full-Year Report 2021, Brussels (Belgium), 24 February 2022 =E2=80=93 7=
:00 (CET) =E2=80=93 regulated information
Jean-Christophe Tellier, CEO UCB says: =E2=80=9CWe are very satisfied with =
the continued performance of UCB =E2=80=93 we reached more than 3.7 million=
patients. We are entering a transition phase, to be followed by accelerate=
d company growth, from a position of strength =E2=80=93 also underlined by =
six very positive Phase 3 study read-outs from our late-stage pipeline. We =
thank our employees and partners for their great contributions. The coming =
months will be marked by expected impacts from the loss of exclusivity for =
E KEPPRA^=C2=AE in Japan since January, for VIMPAT^=C2=AE in the U.S. in Ma=
rch and the EU in September. We are confident to bring BIMZELX^=C2=AE to pe=
ople living with psoriasis in the U.S. based on a regulatory decision expec=
ted within the first half this year. We continue to make progress towards o=
ur extra-financial targets, also recognized by key ESG ratings. We are very=
confident in our strong growth ahead and our ability in creating value for=
all stakeholders =E2=80=93 now and into the future.=E2=80=9D
UCB Full-Year Report 2021, Brussels (Belgium), 24 February 2022 =E2=80=93 7=
:00 (CET) =E2=80=93 regulated information
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1 CER =3D constant exchange rates
2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation an=
d Amortization charges
3 Core EPS =3D core earnings per share
FY 2021 revenue reached =E2=82=AC 5.78 billion (+8%; +10% CER^1). Net sales=
went up by 8% to =E2=82=AC 5.47 billion (+11% CER^1), driven by the contin=
ued growth of UCB=E2=80=99s product portfolio.
Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 1.64 billion=
(+14%; +21% CER^1) reflecting higher revenue, higher marketing and selling=
=E2=80=93 due to upcoming launches =E2=80=93 slightly higher research and =
development expenses and a strong increase in other operating income due to=
Evenity^=C2=AE (romosozumab).
Profit increased to =E2=82=AC 1 058 million (+39%; +51% CER^1). Core EPS^3 =
were =E2=82=AC 6.49 after =E2=82=AC 5.36 in 2020. The Board of Directors of=
UCB proposes a dividend of =E2=82=AC 1.30 per share (gross), +2%.
Regulatory and R&D update
BIMZELX^=C2=AE (bimekizumab) - In August 2021, BIMZELX^=C2=AE (bimekizumab)=
was approved in the European Union for the treatment of moderate to severe=
plaque psoriasis in adults who are candidates for systemic therapy. In Aug=
ust, BIMZELX^=C2=AE also received its marketing authorization in Great Brit=
ain.
On October 15, 2021, the U.S. Food and Drug Administration (FDA) deferred t=
he Prescription Drug User Fee Act (PDUFA) date for bimekizumab. The FDA ind=
icated that they were unable to finish the current review cycle due to COVI=
D-19-related restrictions on travel. UCB is expecting an FDA decision in th=
e first half of 2022.
In January and February 2022, BIMZELX^=C2=AE was approved in Japan and Cana=
da respectively.
In an unprecedented string of events, UCB announced positive topline result=
s of four Phase 3 readouts towards the end of 2021 and early 2022. The safe=
ty profile of bimekizumab in all four studies was consistent with safety fi=
ndings seen in previous studies with no new observed safety signals:=C2=A0
=C2=B7 Two positive study results for bimekizumab in psoriatic arthritis (b=
iologic disease-modifying anti-rheumatic drug-na=C3=AFve patients and patie=
nts with inadequate response or intolerant to anti-TNF treatment). Both stu=
dies in the treatment of adults with active psoriatic arthritis met the pri=
mary and all ranked secondary endpoints with statistically significant and =
clinically meaningful results.
=C2=A0
=C2=B7 Positive results of two Phase 3 studies evaluating bimekizumab acros=
s the full spectrum of axial spondyloarthritis (axSpA), which includes both=
radiographic (also known as ankylosing spondylitis or AS) and non-radiogra=
phic (nr)-axSpA. Both studies met the primary and all ranked secondary endp=
oints with statistically significant and clinically meaningful results, sup=
porting that bimekizumab improved outcomes in patients across the full dise=
ase spectrum of axSpA.
The ongoing Phase 3 program with bimekizumab in moderate to severe hidraden=
itis suppurativa (HS), a chronic, inflammatory, and debilitating follicular=
skin disease, showed an accelerated patient recruitment, hence, the first =
topline results are now projected for H2 2022.
1 CER =3D constant exchange rates
2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation an=
d Amortization charges
3 Core EPS =3D core earnings per share
Rozanolixizumab - a subcutaneously infused monoclonal antibody targeting th=
e neonatal Fc receptor (FcRn), showed positive topline results from the Pha=
se 3 study in patients with generalized myasthenia gravis (gMG). The study =
met the primary and all secondary endpoints with statistically significant =
and clinically meaningful results. Rozanolixizumab was well-tolerated with =
no new observed safety signals. Maintaining UCB=E2=80=99s focus on autoanti=
body-mediated neuroinflammation, UCB announced investigating two additional=
patient populations using its rozanolixizumab platform:=C2=A0
=C2=B7 People living with autoimmune encephalitis (AIE) =E2=80=93 a rare an=
d serious medical condition, in which the immune system attacks the brain =
=E2=80=93 leading to epileptic seizures, movement disorders as well as cogn=
itive decline in some patients. There is no therapy approved for AIE. The p=
hase 2a study in AIE started in Q3 2021; first topline results are expected=
in H1 2024.
=C2=A0
=C2=B7 People living with myelin oligodendrocyte glycoprotein (MOG)-antibod=
y disease =E2=80=93 a rare autoimmune inflammatory demyelinating disorder o=
f the central nervous system caused by autoantibodies that target the MOG p=
rotein =E2=80=93 leading to temporal functional blindness, muscle weakness,=
bladder dysfunction, sensory loss, and/or pain. There is no approved thera=
py for MOG-antibody disease. The Phase 3 study started in Q4 2021; first to=
pline results are expected H2 2024.=C2=A0
Zilucoplan - a self-administered, subcutaneous peptide inhibitor of complem=
ent component 5 (C5 inhibitor), reported positive topline results from the =
Phase 3 study in patients with generalized myasthenia gravis (gMG). The stu=
dy met the primary and all key secondary endpoints with statistically signi=
ficant and clinically meaningful results. Zilucoplan was well-tolerated wit=
h no new observed safety signals.
STACCATO^=C2=AE Alprazolam - an investigational drug-device combination usi=
ng Staccato^=C2=AE delivery technology with alprazolam, a benzodiazepine, t=
hat has the potential to be the first rescue treatment to be administered b=
y a patient or caregiver in an out-patient setting to rapidly (within 90 se=
conds) terminate an active epileptic seizure. The Phase 3 trial to assess t=
he efficacy and safety in study participants with stereotypical prolonged s=
eizures started in Q4 2021 and topline results are expected in H1 2024.
UCB0599 - In collaboration with UCB's new partner Novartis a Phase 2a study=
with UCB0599 for study participants with early-stage PD started, first top=
line results are expected in H2 2023.
All other clinical development programs are continuing as planned. In 2021,=
the timelines for UCB=E2=80=99s clinical development program have not expe=
rienced any material delays due to COVID-19. UCB continues to monitor the i=
mpact of COVID-19 on all ongoing clinical trials and will implement changes=
as necessary.=C2=A0
Net sales break-down by product
Due to rounding, some financial data may not add up in the tables.=C2=A0
CIMZIA^=C2=AE (certolizumab pegol) reached 170 000 people living with infla=
mmatory TNF-mediated diseases, driven by continued growth in the U.S. =E2=
=80=93 despite a reimbursement decrease since July, overcompensated by a vo=
lume increase =E2=80=93 and a slight decline in Europe, reflecting the mand=
ated price decrease in Germany in April and a strong growth in other market=
s.
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VIMPAT^=C2=AE (lacosamide) was accessed by over 800 000 people living with =
epilepsy and showed strong growth in all regions, reaching the expected pea=
k sales of at least =E2=82=AC 1.5bn, ahead of the loss of exclusivity in 20=
22 in the U.S. and Europe.
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KEPPRA^=C2=AE (levetiracetam) reached over 2 million people living with epi=
lepsy. The continued generic erosion in the U.S. and Europe has been overco=
mpensated by the performance in Japan, where UCB took over distribution of =
E Keppra^=C2=AE from partner Otsuka in October 2020. Generic entries to the=
Japanese market occurred early 2022.
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BRIVIACT^=C2=AE (brivaracetam), was used by 140 000 people living with epil=
epsy and showed significant growth in all regions. Briviact^=C2=AE has a di=
fferent mode of action from Vimpat=C2=AE and differentiates from Keppra^=C2=
=AE.
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NEUPRO^=C2=AE (rotigotine), the patch for Parkinson=E2=80=99s disease and r=
estless legs syndrome, used by 385 000 patients, recorded stable net sales =
in a competitive market environment.
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NAYZILAM^=C2=AE (midazolam) Nasal SprayCIV, a nasal rescue treatment for ep=
ilepsy seizure clusters in the U.S. (launched since December 2019) reached =
over 50 000 patients.
EVENITY^=C2=AE (romosozumab) since launch globally reached more than 200 00=
0 women living with severe postmenopausal osteoporosis at high risk of frac=
ture. It had its first European launch in March 2020 impacted by the pandem=
ic. Evenity^=C2=AE is being launched successfully globally by Amgen, Astell=
as and UCB since 2019, with net sales outside Europe reported by the partne=
rs.
BIMZELX^=C2=AE (bimekizumab) for people living with psoriasis had a well-re=
ceived launch in autumn in Germany, the UK, Sweden and the Netherlands. Rep=
orted net sales were =E2=82=AC 4 million. In January 2022, Bimzelx=C2=AE wa=
s approved in Japan and in February in Canada. The regulatory review in the=
U.S. is ongoing, the FDA inspections were conducted at the manufacturing s=
ites, a regulatory decision is expected within the first half of 2022.
2021 FY financial highlights
Due to rounding, some financial data may not add up in the tables.
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Revenue in 2021 went up by 8% (+10% CER^1) to =E2=82=AC 5 777 million and n=
et sales increased by 8% (+11% CER^1) to =E2=82=AC 5 471 million. This was =
driven by the continuous growth of UCB=E2=80=99s product portfolio =E2=80=
=93 driving company growth. One product was added to the UCB portfolio: In =
September, UCB launched BIMZELX^=C2=AE (bimekizumab) for the treatment of m=
oderate to severe plaque psoriasis in Germany, the UK, Sweden and the Nethe=
rlands.
Royalty income and fees were =E2=82=AC 79 million (-18%; -15% CER^1) and ot=
her revenue went up by 14% (+14% CER^1) to =E2=82=AC 227 million due to mil=
estones and other payments from R&D partners.=C2=A0
Gross profit reached =E2=82=AC 4 339 million with a plus of 9% (+12% CER^1)=
and reflecting an improved gross margin of 75.1% compared to 2020 with 74.=
5%.=C2=A0
Operating expenses increased to =E2=82=AC 3 021 million (+4%; +5% CER^1) re=
flecting:
=C2=B7 10% higher marketing and selling expenses of =E2=82=AC 1 346 million=
=E2=80=93 driven by launches and pre-launch activities,=C2=A0
=C2=A0
=C2=B7 4% higher research and development expenses of =E2=82=AC 1 629 milli=
on reflecting the investments in UCB=E2=80=99s progressing pipeline encompa=
ssing five late-stage assets and ongoing earlier stage research. The R&D ra=
tio reached 28% in 2021 after 29% in 2020,
=C2=B7 6% higher general and administrative expenses of =E2=82=AC 208 milli=
on, driven by implementation expenses for improved value-focused allocation=
of resources and share based payments valuation,
=C2=B7 significantly higher other operating income of =E2=82=AC 162 million=
after =E2=82=AC 95 million in 2020 - driven by an income of =E2=82=AC 151 =
million (+57%) reflecting the net contribution from Amgen in connection wit=
h the commercialization of EVENITY^=C2=AE.
Underlying operational profitability =E2=80=93 adjusted EBITDA^2 =E2=80=93 =
went up to =E2=82=AC 1 641 million (+14%; +21% CER^1) driven by continued r=
evenue growth and moderately growing operating expenses, reflecting the inv=
estments into the future of UCB, namely into product launches and clinical =
development. The adjusted EBITDA ratio for 2021 (in % of revenue) reached 2=
8%, after 27% in 2020.
Total impairment, restructuring and other income/expenses were expenses of =
=E2=82=AC 34 million. In 2020, the expenses were =E2=82=AC 122 million whic=
h was mainly driven by fees related to acquisitions, which did not reoccur =
in 2021.
Net financial expenses went down to =E2=82=AC 58 million from =E2=82=AC 93 =
million, mainly due to lower hedging costs and lower interest expenses.
Income tax expenses were =E2=82=AC 170 million compared to =E2=82=AC 119 mi=
llion in 2020. The average effective tax rate was 14% compared to 13% in 20=
20.
Profit amounted to =E2=82=AC 1 058 million (+39%; +51% CER^1), of which the=
full amount is attributable to UCB shareholders as the contributions to no=
n-controlling interests have expired at the end of 2020. The growth was dri=
ven by strong revenue and EBITDA growth as well as lower other expenses and=
lower financial expenses. For 2020, profit was =E2=82=AC 761 million of wh=
ich =E2=82=AC 732 million were attributable to UCB shareholders and =E2=82=
=AC 29 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 6.49 a=
fter =E2=82=AC 5.36 in 2020, based on stable 189 million weighted average s=
hares outstanding.
Dividend - The Board of Directors of UCB proposes a dividend of =E2=82=AC1.=
30 per share (gross), +2%.
Guidance 2022: For 2022, UCB is aiming for revenues in the range of =E2=82=
=AC 5.15 - 5.4 billion based on continued core product growth and taking in=
to account estimated impacts from the loss of exclusivity for VIMPAT^=C2=AE=
in the U.S. (March 2022) and Europe (September 2022), E KEPPRA^=C2=AE in J=
apan (January 2022) as well as the U.S. launch of BIMZELX^=C2=AE (bimekizum=
ab) for people living with psoriasis =E2=80=93 the regulatory review in the=
U.S. is ongoing, with a decision expected in the first half of 2022.=C2=A0
UCB will continue to invest into research and development to advance its la=
te-stage development pipeline and prepare upcoming launches to offer potent=
ial new solutions for patients. Underlying profitability, adjusted EBITDA, =
is expected in the range of 26 - 27% of revenue, reflecting the continued h=
igh R&D and marketing & selling investment levels. Core earnings per share =
are therefore expected in the range of =E2=82=AC4.80 - =E2=82=AC5.30 per sh=
are =E2=80=93 based on an average of 189 million shares outstanding.
The figures for the financial guidance 2022 as mentioned above are calculat=
ed on the same basis as the actual figures for 2021; they will be updated u=
pon closing of the planned Zogenix, Inc. acquisition (https://www.ucb.com/s=
tories-media/Press-Releases/article/UCB-to-acquire-Zogenix) .
Guidance for 2025 unchanged: UCB shares its growth ambition for 2025 =E2=80=
=93 despite upcoming patent expirations: Based on the strong product portfo=
lio and the promising late-stage pipeline assets, UCB aims to lead in five =
specific populations by 2025, creating value for patients now and into the =
future. Revenue in 2025 is expected to reach at least =E2=82=AC 6 billion a=
nd the underlying profitability (adjusted EBITDA) should reach the low to m=
id-thirties in percent of revenue.
Guidance 2022 & 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=
(GMT) / 14.00 (CET)
Details are available on https://www.ucb.com/investors/UCB-financials/Full-=
year-financial-results=C2=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.9414
antje.witte@ucb.com
Julien Bayet
T: +32 2 559 9580
julien.bayet@ucb.com
Global Communications
Laurent Schots, Media Relations
T+32.2.559.9264
Laurent.schots@ucb.com
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 approximately 8 600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Fol=
low 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.
GenericFile
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