https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3D7PGj_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33-2Bzj-2BWEDmgK0o-2BT3JG9zuaKCCiFhl08DIH0jYTz2MJfv-2Bo5WFOyELD=
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wdl6ND3ks6NzKOIBqM9zs50dWqGuyRVausH353LZmHhxqMqwqklai-2FlR2GWDKMaH9kWtI8ycR=
N7HiOrR7BYvf7emKxtGvdnaAYrahtEFTpDe7qStA-3D
** UCB off to a Good Start into 2024 =E2=80=93 Progressing on its Growth Pa=
th for a Decade Plus
------------------------------------------------------------
=C2=B7 Update on innovation and growth at UCB into the year 2024 by the CEO=
at today=E2=80=99s AGM
=C2=B7 BIMZELX^=C2=AE now approved in 42 countries. Five fillings under rev=
iew by U.S. FDA=C2=A0
=C2=B7 Continued strong launch of BIMZELX^=C2=AE in the U.S. for the treatm=
ent of psoriasis=C2=A0
=C2=B7 Global launches of RYSTIGGO^=C2=AE and ZYLBRYSQ^=C2=AE for people li=
ving with generalized myasthenia gravis (gMG)
=C2=B7 Evolution of UCB=E2=80=99s Executive Committee=C2=A0
Brussels (Belgium), April 25, 2024 =E2=80=93 07:00 (CEST) =E2=80=93 UCB, a =
global biopharmaceutical company, today shares an update on its progress at=
its annual shareholder meeting (AGM).
=E2=80=9CWe are excited to share the progress on our growth path for a deca=
de plus,=E2=80=9D said Jean-Christophe Tellier, CEO of UCB. =E2=80=9CWe had=
a good start into the year 2024, tracking well towards our full year finan=
cial guidance. Our ongoing launches are getting positive feedback from pati=
ents and healthcare professionals. The positive prescription trends for BIM=
ZELX^=C2=AE are continuing nicely in all regions where approved and availab=
le for patients. Additionally, the first months of 2024 have been marked fo=
r BIMZELX =C2=AE by five fillings by the U.S. FDA, an approval in the EU, a=
nd of course the approval of RYSTIGGO=C2=AE in the EU=E2=80=9D.=C2=A0
Key Growth and Innovation updates
=C2=B7 BIMZELX^=C2=AE (bimekizumab-bkzx) with continued strong uptake in th=
e U.S. BIMZELX^=C2=AE, an IL-17A and IL-17F inhibitor, was approved in the =
U.S. in October 2023 for the treatment of moderate to severe plaque psorias=
is in adults who are candidates for systemic therapy or phototherapy.=C2=A0
=C2=A0=C2=A0https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUz=
lo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepaRvhrvvW4sMjIGkc1SyrJ0hRbZaa9O6KbIgXhPm=
mM5eikMtFZgjw6Y2CTa4Pp-2B6lGCQUMsz9XNQSIZn67FTBsqiLjz_2dCLUNbuBjhX746-2FvM6=
3L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQ=
eFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2Bzj-2BWEDmgK0o-2BT3JG9zuaKCCiFh=
l08DIH0jYTz2MJfv-2Bo5WFOyELD14x-2Bl6Nvu3PL0ymqwz-2BB9OmbslhBigepZrTOLrgJ6sq=
aPqDmsGKo2HtnI-2BDNEPqp1O8tYG4U1raycdfulryD4AV6a12fyVdMRDpiFLiWBeAfmLCLGroK=
2WltZdXsOTeTocvg0X4QoLvgJlJcB1oARkfDhRvR0yazSeFlbp1YoKnrkoh1pRpmj0-3D
BIMZELX^=C2=AE is now approved in 42 countries. Five fillings for BIMZELX^=
=C2=AE (bimekizumab-bkzx) by the U.S. FDA in 2024: applications in psoriati=
c arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ank=
ylosing spondylitis (AS), hidradenitis suppurativa (HS) and for the bimekiz=
umab-bkzx 2mL device presentations. In the U.S., the efficacy and safety of=
bimekizumab-bkzx in the treatment of PsA, nr-axSpA, AS, HS have not been e=
stablished and these are investigational indications only.
In March, UCB presented the BIMZELX^=C2=AE four-year psoriasis data at the =
world=E2=80=99s largest dermatology meeting, showing that the majority of a=
dult patients treated with bimekizumab-bkzx achieved deep and durable clini=
cal response through four years, with a consistent tolerability profile.
=E2=80=9CThese results, from the largest pool of Phase 3 data, closely foll=
ow the U.S. launch, and reinforce our belief that BIMZELX^=C2=AE has the po=
tential to transform the lives of people with moderate to severe plaque pso=
riasis" said Emmanuel Caeymaex, Executive Vice President, Immunology and U.=
S. Solutions at UCB.
Earlier this week, UCB received European Commission approval for BIMZELX^=
=C2=AE as the first IL-17A and IL-17F biologic for moderate to severe hidra=
denitis suppurativa.
=C2=B7 Approval of RYSTIGGO=C2=AE (rozanolixizumab) in the EU for the treat=
ment of adults with generalized myasthenia gravis (gMG). (January 2024). Ma=
rch 2024 has been marked by the launches of RYSTIGGO^=C2=AE in the EU and J=
apan and global launches of ZYLBRYSQ^=C2=AE (zilucoplan) for the treatment =
of adults with gMG.=C2=A0
=E2=80=9CWe are very pleased with RYSTIGGO=C2=AE's launch uptake in the U.S=
. Our targeted and customized outreach efforts are effectively connecting u=
s with those in need of our therapies. Meanwhile, following successful laun=
ch of ZILBRYSQ=C2=AE in the first quarter 2024, UCB is proud to continue it=
s support of the gMG community by offering a seamless patient experience wi=
th another innovative option,=E2=80=9D said Kimberly Moran, Head of U.S. Ra=
re Diseases.
UCB presented 17 abstracts at the 76th American Academy of Neurology (AAN) =
Annual Meeting, covering new data analyses for UCB=E2=80=99s generalized my=
asthenia gravis (gMG) treatments, including post hoc and open-label extensi=
on results for the approved treatments RYSTIGGO=C2=AE (rozanolixizumab) and=
ZILBRYSQ^=C2=AE (zilucoplan).=C2=A0
=C2=B7 In March, the Japanese Ministry of Health, Labour, and Welfare appro=
ved FINTEPLA=C2=AE=E2=96=BC (fenfluramine) oral solution for the treatment =
of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on ther=
apy to other anti-epileptic medicines for patients two years of age and old=
er.
=C2=B7 Evolution of UCB=E2=80=99s Executive Committee:=C2=A0
UCB has decided to evolve the structure of its Executive Committee to bette=
r align with its commitment to growth and innovation, and to better address=
the dynamic external landscape of the healthcare industry. The aim is to f=
urther capitalize on the solid foundation and legacy established over the y=
ears, while incorporating the necessary expertise and leadership to deliver=
on the next decade of growth and on our innovation.
These are the changes to UCB=E2=80=99s Executive Committee:
Fiona du Monceau will join the Executive Committee to serve as Executive Vi=
ce President Patient Evidence. As such she will be responsible for the late=
-stage clinical development of UCB=E2=80=99s new molecules, brand positioni=
ng and strategy, medical affairs and the interaction with key external stak=
eholders such as government regulators, patient organizations or public off=
icials. Fiona brings extensive expertise of the pharmaceutical industry and=
has a proven leadership track record.
Emmanuel Caeymaex, currently Executive Vice President and Head of Immunolog=
y and U.S., will serve as Chief Commercial Officer. In this new role he wil=
l spearhead all commercial activities for the group. Emmanuel=E2=80=99s lon=
gstanding tenure at UCB and proven commercial expertise positions him ideal=
ly for this new leadership role.
Prof. Dr. Iris L=C3=B6w-Friedrich, Executive Vice President, Head of Develo=
pment and UCB=E2=80=99s Chief Medical Officer, will be retiring from UCB. I=
ris is set to depart later in 2024, ensuring a seamless transition before s=
he embarks on new pursuits.
Dhavalkumar Patel, MD, PhD, Chief Scientific Officer, will be retiring from=
UCB at the end of June 2024. After a tenure of 7 years, he will pass the b=
aton to a member of his leadership team, Alistair Henry.=C2=A0
Alistair Henry, PhD, currently Head of UK Research, will join the Executive=
Committee to serve as Chief Scientific Officer. Alistair, who is a biophys=
icist (PhD, King=E2=80=99s College London) by background, has worked on mul=
tiple therapeutic programs through his 26 years at UCB including CIMZIA=C2=
=AE, EVENITY=C2=AE and BIMZELX=C2=AE. He has championed the use of advanced=
biophysical methodologies to support discovery and understanding of drugs =
and the biological systems they interact with. Alistair is renowned for his=
expertise and unwavering passion for both people and science.=C2=A0
All other members of the Executive Committee will remain in their roles.
=E2=80=9CI want to extend my deepest gratitude to Iris L=C3=B6w-Friedrich, =
our Executive Vice President and Chief Medical Officer, who has dedicated o=
ver 20 years of service to UCB. Iris has been an invaluable member of the U=
CB Executive team, and during her tenure she has demonstrated exceptional c=
ommitment, leadership and expertise which significantly contributed to wher=
e we stand today,=E2=80=9D =C2=A0said Jean-Christophe Tellier, UCB=E2=80=99=
s CEO. =E2=80=9CI also wish to recognize and thank Dhaval for his vision an=
d passion for science, which has laid a robust foundation for future innova=
tion at UCB. Research and Development is ingrained in UCB=E2=80=99s DNA, an=
d we will further build on the exceptional legacy Iris and Dhaval leave beh=
ind. We extend our best wishes to both of them in their future endeavors an=
d on behalf of the UCB Executive Committee, we are pleased to welcome Fiona=
and Alistair.=E2=80=9D
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com
Sahar Yazdian
T: +32 2 559 9137
email sahar.yazdian@ucb.com
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
About UCB=C2=A0
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 9,000 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
This press release may contain forward-looking statements including, withou=
t limitation, 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=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e 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 relea=
se. Important factors that could result in such differences include: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent 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 o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, 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 s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=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. UCB expressly disclaims any duty t=
o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
rcumstances on which any such statement is based, unless such statement is =
required 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
=C2=A0
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UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium
