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** Strong first six months =E2=80=93 UCB with continued delivery and strong=
resilience
------------------------------------------------------------
=C2=B7 Revenue increased to =E2=82=AC 2.93 billion (+5%; +3% CER^1), net sa=
les to =E2=82=AC 2.70 billion (+2%; 0% CER) =E2=80=93 impacted by generic e=
rosion to Vimpat/U.S. and E Keppra/Japan
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 814 million (=
-3%; -2% CER),=C2=A028% of revenue =E2=80=93 impacted by Zogenix inclusion =
since March
=C2=B7 Strong clinical pipeline: two additional phase 3 projects, developme=
nt of rozanolixizumab in ITP de-prioritized
=C2=B7 Financial guidance for 2022* confirmed: Revenue expected in the rang=
e of =E2=82=AC 5.3 - 5.4 billion, adjusted EBITDA^2 in the range 21 - 22 % =
of revenue, Core EPS^3 in the range of =E2=82=AC 3.70 - 4.00 =C2=A0
UCB HY-Year Report 2022, Brussels (Belgium), 28 July 2022 =E2=80=93 7:00 (C=
EST) =E2=80=93 regulated information
Jean-Christophe Tellier, CEO UCB says: =E2=80=9CWe had a strong first half =
2022, delivered good product growth and strong regional launches of BIMZELX=
^=C2=AE, which received great feedback from people living with psoriasis. A=
s expected, we=E2=80=99re seeing the impacts from the loss of exclusivity f=
or E KEPPRA^=C2=AE in Japan and VIMPAT^=C2=AE in the U.S. We are confident =
to bring BIMZELX^=C2=AE to people living with psoriasis in the U.S. followi=
ng our submission of the response to the complete response letter by the en=
d of 2022. We are looking forward to our strong long-term growth ahead and =
our ability in creating value for all stakeholders, now and into the future=
- also driven by the new product launches currently under preparation serv=
ing people living with psoriasis, psoriatic arthritis, across the full spec=
trum of axial spondyloarthritis and generalized myasthenia gravis.=E2=80=9D
UCB=E2=80=99s HY 2022 financial results & core product net sales
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^1 CER =3D constant exchange rates
^2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation a=
nd Amortization charges
^3 Core EPS =3D core earnings per share
*As communicated on 24 June 2022
In the first six months 2022, revenue reached =E2=82=AC 2 925 million (+5%;=
+3% CER1). Net sales went up by 2% to =E2=82=AC 2 705 million (0% CER^1), =
driven by the continued growth of UCB=E2=80=99s product portfolio, namely C=
IMZIA^=C2=AE and BRIVIACT^=C2=AE, and by the addition of FINTEPLA^=C2=AE. R=
oyalty income and fees increased from =E2=82=AC 40 million to =E2=82=AC 45 =
million. Other revenue benefitted from continued payments from R&D and lice=
nsing partners, including a one-time amount of =E2=82=AC 70 million from sa=
le of intellectual property rights, reaching =E2=82=AC 175 million after =
=E2=82=AC 87 million.=C2=A0
Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 814 million =
(-3%; -2% CER^1) reflecting higher revenue and higher operating expenses dr=
iven by the Zogenix acquisition and the ongoing and coming launches =E2=80=
=93 partly compensated by a strong increase in other operating income in co=
nnection with EVENITY^=C2=AE (romosozumab).
Profit decreased to =E2=82=AC 399 million (-30%; -25% CER^1) also due to th=
e higher amortization charges and fees in connection with the Zogenix acqui=
sition. Core EPS^3 were =E2=82=AC 3.15 after =E2=82=AC 3.40 in the first si=
x months 2021.=C2=A0
^1 CER =3D constant exchange rates
^2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation a=
nd Amortization charges
^3 Core EPS =3D core earnings per share
Regulatory and R&D update
BIMZELX^=C2=AE (bimekizumab) - In January and February 2022, BIMZELX^=C2=AE=
was approved in Japan and Canada respectively. In March 2022, BIMZELX^=C2=
=AE was approved in Australia.=C2=A0
In May 2022, UCB announced that the U.S. Food and Drug Administration (FDA)=
has issued a Complete Response Letter (CRL) regarding the Biologics Licens=
e Application (BLA) for bimekizumab for the treatment of adults with modera=
te to severe plaque psoriasis. The letter indicates that the FDA could not =
approve the application in its current form and that certain pre-approval i=
nspection observations of UCB's manufacturing site in Belgium must be resol=
ved before approval of the application. The CRL is not related to efficacy =
nor to safety of bimekizumab. UCB is working with the U.S. FDA to address a=
nd resolve the pre-approval inspection observations and bring this potentia=
l treatment option for moderate to severe plaque psoriasis to patients in t=
he U.S. UCB aims to submit the response to the bimekizumab CRL to the U.S. =
FDA by the end of 2022.
In March 2022, FINTEPLA^=C2=AE (fenfluramine) oral solution was approved in=
the U.S. for the treatment of seizures associated with Lennox-Gastaut synd=
rome (LGS) in patients two years of age and older. Additionally, the U.S. F=
DA has granted pediatric exclusivity for the product. It is already approve=
d for the treatment of seizures associated with Dravet syndrome in patients=
two years of age and older in the U.S., Europe and the UK.=C2=A0
Following the acquisition of Zogenix UCB decided to continue with the devel=
opment of the Phase 3 with fenfluramine in CDKL5 deficiency disorder (CDD).=
The Phase 3 program evaluates efficacy and safety as an adjunctive therapy=
in patients 1 to 35 years of age with CDD and uncontrolled seizures. First=
topline results are expected in H2 2024. CDD is a rare developmental epile=
ptic encephalopathy caused by mutations in the CDKL5 gene. In June 2022, th=
e FDA granted orphan drug designation to FINTEPLA^=C2=AE to treat CDD.
Following the acquisition of Zogenix, UCB sees a high unmet medical need to=
continue with the development of MT1621 (nucleoside therapy) in Thymidine =
Kinase 2 deficiency (TK2d). TK2d is an ultra-rare debilitating=C2=A0and lif=
e-threatening (often fatal) genetic mitochondrial disorder and causes progr=
essive and severe muscle weakness. Given the high unmet need, no approved t=
herapies, and MT1621 considered to change the disease trajectory, UCB has a=
n opportunity to create pivotal patient value. The clinical development pro=
gram is complete. UCB is currently engaged in discussions with regulatory a=
gencies to validate the global submission strategy. The target submission p=
rojections are aimed for 2023.=C2=A0
Rozanolixizumab - UCB decided to de-prioritize the development of rozanolix=
izumab in immune thrombocytopenia (ITP). Since UCB took the decision to pro=
gress the rozanolixizumab ITP development program to Phase 3 in 2019, the t=
reatment landscape for people living with ITP has significantly evolved. Ne=
w targeted therapies, offering multiple opportunities to transform the care=
and management of ITP, are now available or in late-stage development. Thi=
s evolution looks set to address many of the significant unmet needs faced =
by the ITP patient community. Taking these factors into account, UCB will n=
ot progress with the rozanolixizumab ITP development program. This allows U=
CB to reallocate resources to areas with higher unmet medical needs. All ot=
her rozanolixizumab programs continue as planned.
All other clinical development programs are continuing as planned. In 2022,=
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), for people living with inflammatory TNF=
-mediated diseases, went up by 14% (+7% CER), outperforming the anti-TNF ma=
rket based on strong differentiation and driven by continued growth in all =
markets, namely in the U.S. and strong growth in international markets, rea=
ching more patients.
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VIMPAT^=C2=AE (lacosamide) for people living with epilepsy showed net sales=
of =E2=82=AC 744 million. After strong growth in the U.S. in the beginning=
of the year, the expected generic erosion in the U.S. since end of March i=
mpacted the performance in the U.S., compensated by continued good growth i=
n Europe and international markets.
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KEPPRA^=C2=AE (levetiracetam) available for people living with epilepsy rep=
orted 22% lower net sales. The generic erosion in Japan started early Janua=
ry this year and was stronger than expected due to multiple generics and go=
vernmental support for generic levetiracetam.
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BRIVIACT^=C2=AE (brivaracetam), used by people living with epilepsy showed =
continued, significant growth in all regions Briviact^=C2=AE is available t=
o patients. Briviact^=C2=AE has a different mode of action from Vimpat^=C2=
=AE and differentiates from Keppra^=C2=AE.=C2=A0
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NEUPRO^=C2=AE (rotigotine), the patch for Parkinson=E2=80=99s disease and r=
estless legs syndrome, recorded declining net sales in the U.S. and interna=
tional markets, namely Japan, and stable net sales in Europe =E2=80=93 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 =
net sales of =E2=82=AC 36 million after =E2=82=AC 21 million.
FINTEPLA^=C2=AE (fenfluramine) is now part of the UCB epilepsy portfolio th=
anks to the completed acquisition of Zogenix, Inc. in early March. FINTEPLA=
^=C2=AE is approved for seizures associated with rare epileptic syndromes, =
Dravet (since mid-2020) and Lennox-Gastaut syndrome (since late March 2022)=
, providing new treatment options for patients and families living with the=
se rare syndromes that are particularly challenging to treat. Net sales (Ma=
rch - June) were =E2=82=AC 35 million. The integration of Zogenix is ongoin=
g and expected to be completed as planned by the end of 2022.
BIMZELX^=C2=AE (bimekizumab) for people living with psoriasis is being laun=
ched in Europe and the UK since autumn last year and in Japan and Canada mo=
st recently this year. Reported net sales were =E2=82=AC 10 million after =
=E2=82=AC 4 million in the second half 2021.=C2=A0
For the U.S., UCB received a complete response letter (CRL) from the U.S. F=
ood and Drug Administration (FDA). The letter indicates that the FDA cannot=
approve the application in its current form. The CRL states that certain p=
re-approval inspection observations must be resolved before approval of the=
application. UCB will address all observations and questions noted in the =
CRL and is fully confident in the quality of its manufacturing process. UCB=
aims to submit the response to the CRL to the FDA by the end of 2022.
EVENITY^=C2=AE (romosozumab) for the treatment of severe osteoporosis in po=
stmenopausal women at high risk of fracture is being successfully launched =
in Europe since March 2020 and reported net sales of =E2=82=AC 9 million. E=
VENITY^=C2=AE is being launched successfully globally by Amgen, Astellas an=
d UCB since 2019, with net sales outside Europe reported by the partners.
2022 HY financial highlights
Due to rounding, some financial data may not add up in the tables.
For the net financial debt, the reporting date for comparative period is 31=
December 2021
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The statutory auditor has issued an unqualified review report dated 27 July=
2022 on the company=E2=80=99s condensed consolidated interim financial sta=
tements as of and for the six-month period ended 30 June 2022, and has conf=
irmed that the accounting data reported in the press release is consistent,=
in all material respects, with the accounts from which it has been derived=
.
Revenue in the first six months 2022 went up by 5% (+3% CER^1) to =E2=82=AC=
2 925 million and net sales reached =E2=82=AC 2 705 million (+2%; 0% CER1)=
. This was driven by the continued growth of UCB=E2=80=99s product portfoli=
o, namely CIMZIA^=C2=AE and BRIVIACT^=C2=AE, BIMZELX^=C2=AE being launched =
now in Europe, the UK, Japan and Canada and by the addition of FINTEPLA^=C2=
=AE following the acquisition of Zogenix.=C2=A0
Royalty income and fees were =E2=82=AC 45 million (+12%; 1% CER^1). Other r=
evenue reached =E2=82=AC 175 million=C2=A0
(+> 100%; +97% CER1) due to milestones and other payments from R&D partners=
and include a one-time amount of =E2=82=AC 70 million from sale of intelle=
ctual property rights (olokizumab).=C2=A0
Gross profit was stable with =E2=82=AC 2 080 million (0%; -2% CER^1). The c=
ost of sales for products and services increased by the write-off of some c=
ommercial bimekizumab inventory after not being able to launch in the U.S. =
market. The gross margin was 71% after 75% - impacted by the addition of FI=
NTEPLA^=C2=AE amortization. If adjusted for =E2=80=9Camortization of intang=
ible assets linked to sales=E2=80=9D, the adjusted gross margin is 77% afte=
r 78% in the first six months of 2021.
Operating expenses increased to =E2=82=AC 1 529 million (+9%; +5% CER^1) re=
flecting:
=C2=B7 21% higher marketing and selling expenses of =E2=82=AC 730 million =
=E2=80=93 driven by launches and pre-launch activities: FINTEPLA^=C2=AE lau=
nch activities, BIMZELX^=C2=AE global launch activities and preparations, E=
VENITY^=C2=AE ongoing launch activities and global launch preparations for =
generalized myasthenia gravis.=C2=A0
=C2=B7 6% higher research and development expenses of =E2=82=AC 798 million=
reflecting the investments in UCB=E2=80=99s progressing pipeline encompass=
ing six late-stage assets and ongoing earlier stage research. The strategic=
decision to terminate the development in ITP lead to termination costs of =
=E2=82=AC 29 million. The R&D ratio remained stable at 27% in the first six=
months of 2022,
=C2=B7 18% higher general and administrative expenses of =E2=82=AC 115 mill=
ion, due to implementation expenses for improved value-focused allocation o=
f resources and the integration of Zogenix,
=C2=B7 significantly higher other operating income of =E2=82=AC 114 million=
after =E2=82=AC 50 million in the first half 2021 - driven by an income of=
=E2=82=AC 108 million (+96%) reflecting the net contribution from Amgen in=
connection with the commercialization of EVENITY^=C2=AE.
Underlying operational profitability =E2=80=93 adjusted EBITDA^2 =E2=80=93 =
reached =E2=82=AC 814 million (-3%; -2% CER^1) reflecting higher revenue an=
d higher operating expenses driven by the impacts from the Zogenix acquisit=
ion and the ongoing and coming launches. Partly compensated by the strong i=
ncrease in other operating income in connection with EVENITY^=C2=AE. The ad=
justed EBITDA ratio (in % of revenue) reached 28%, after 30% in the first s=
ix months of 2021.
Total impairment, restructuring and other income/expenses were expenses of =
=E2=82=AC 61 million. This was mainly due to fees related to the acquisitio=
n of Zogenix, Inc. and restructuring expenses. In the first six months 2021=
, the pre-tax expenses were =E2=82=AC 4 million and included mainly restruc=
turing expenses offset with the unwinding of cumulative currency translatio=
n adjustments.
Net financial expenses went down to =E2=82=AC 9 million from =E2=82=AC 35 m=
illion, mainly due to a one-time positive currency impact of =E2=82=AC 25 m=
illion.
Income tax expenses were =E2=82=AC 82 million, after =E2=82=AC 76 million. =
The average effective tax rate was 17% compared to 12% in the first six mon=
ths 2021. This is driven by the continued and sustainable use of R&D incent=
ives in line with UCB=E2=80=99s business activities overcompensated by the =
inability to launch bimekizumab in the U.S. in 2022.
Profit amounted to =E2=82=AC 399 million (-30%; -25% CER^1) also due to the=
higher amortization charges and fees in connection with the Zogenix acquis=
ition. The full amount is attributable to UCB shareholders as the contribut=
ions to non-controlling interests have expired at the end of 2020. Core EPS=
^3 were =E2=82=AC 3.15 after =E2=82=AC 3.40 in the first six months 2021.
Core earnings per share, which reflect profit attributable to UCB sharehold=
ers, adjusted for the after-tax impact of to be adjusted items and the net =
amortization of intangibles linked to sales, reached =E2=82=AC 3.15 based o=
n 190 million weighted average shares outstanding after =E2=82=AC 3.40 base=
d on 189 million in the first six months 2021. In the first six months of 2=
022, mainly amortization of intangible assets linked to sales and expenses =
in connection with the acquisition of Zogenix, Inc. needed to be adjusted.
UCB updated its financial guidance 2022 on 24 June 2022, which is confirmed=
:=C2=A0
UCB is aiming for revenues in the range of =E2=82=AC5.30 - 5.40 billion bas=
ed on continued core product growth and taking into account impacts from th=
e loss of exclusivity for VIMPAT^=C2=AE in the U.S. (since March) and Europ=
e (from September) and the strong generic competition to E KEPPRA^=C2=AE in=
Japan since January.=C2=A0
UCB continues to invest in research and development to advance its late-sta=
ge development pipeline and prepare for upcoming launches to offer potentia=
l new solutions for patients. Underlying profitability, adjusted EBITDA, is=
now expected in the range of 21 - 22% of revenue, also reflecting the cont=
inued research and development and marketing & selling investment levels. C=
ore earnings per share are therefore expected in the range of =E2=82=AC3.70=
- 4.00 per share =E2=80=93 based on an average of 189 million shares outst=
anding.
The figures for the updated financial guidance 2022 as mentioned above are =
calculated on the same basis as the actual figures for 2021; they have been=
extended by the consolidation of the acquisition of Zogenix, Inc.=C2=A0
Supported by solid multiple scenario planning and sustainable efficiency ge=
nerating initiatives in all areas of UCB - being introduced since Q4 2021 -=
UCB maintains its financial guidance for 2025. Revenue in 2025 is expected=
to reach at least =E2=82=AC 6 billion and the underlying profitability (ad=
justed EBITDA) should reach the low to mid-thirties in percent of revenue.
Based on UCB=E2=80=99s current assessment of the Covid-19 pandemic and othe=
r macroeconomic factors, UCB remains confident in the fundamental underlyin=
g demand for its products in the short-term and its prospects for long-term=
growth. UCB will continue to closely follow the evolving COVID-19 pandemic=
and other macroeconomic factors and its consequences to the business envir=
onment diligently to assess potential near- and mid-term challenges.
-----------------------------
Find the financial reports on UCB website: http://www.ucb.com/investors/Dow=
nload-center
Today, UCB will host a conference call/video webcast at 08.00 (EDT) / 13.00=
(BST) / 14.00 (CEST)
Details are available on https://www.ucb.com/investors/UCB-financials/Half-=
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 operating in 40 countries, the company generated revenue of =E2=82=AC 5.8=
billion in 2021. 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.
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HY 2022 Briviact Net Sales (https://mb.cision.com/Public/18595/3607782/ad13=
28e37f030f57_org.png) Image
HY 2022 Neupro Net Sales (https://mb.cision.com/Public/18595/3607782/aad0eb=
0136d31912_org.png) Image
HY 2022 Financial Highlights (https://mb.cision.com/Public/18595/3607782/a8=
b801462d163f39_org.png)
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