UCB (EBR:UCB) UCB Media Room: Good Start into 2024 – Progressing on its Growth Path for a Decade Plus

Transparency directive : regulatory news

25/04/2024 07:01

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= 14x-2Bl6Nvu3PL0ymqwz-2BB9OmbslhBigepcgUYSvNzvhJusMh9oHbBUORWU-2BWvCpFgByRUV= 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 GenericFile UCB PR Update April 25 2024 ENG (https://u7061146.ct.sendgrid.net/ls/click?= upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepaRvhrvvW4sMjIGkc1S= yrJ0Zrx1r68ON7bkIvfBdkHr3Dqt9MsCJyyExuJ-2FbPBxLHE-3DcEd2_2dCLUNbuBjhX746-2F= vM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3M= TdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2Bzj-2BWEDmgK0o-2BT3JG9zuaKCC= iFhl08DIH0jYTz2MJfv-2Bo5WFOyELD14x-2Bl6Nvu3PL0ymqwz-2BB9OmbslhBigepeIpEKn0R= UHw7-2FT5Z9-2BWEHw8UYZxdvfmTZvvHoiDdNgItdBE7ZyXVWyT4ssYUB4eMK1S3mt8LxN3QvOT= pJfhrDfzri7nYiM-2Fs1Pl-2FxSHpMaoaYC-2BzeRqPNInXBq5E6XqTX-2FkRFVp0tPOicelIjv= 3toY-3D Image Chart 1 April 25 2024 (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001= .gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepaRvhrvvW4sMjIGkc1SyrJ0hRbZaa= 9O6KbIgXhPmmM5evWc09DkqhGgdcPLNxMqIfo-3DHwuu_2dCLUNbuBjhX746-2FvM63L9Hyn3Kn= TFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfI= xs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2Bzj-2BWEDmgK0o-2BT3JG9zuaKCCiFhl08DIH0jY= Tz2MJfv-2Bo5WFOyELD14x-2Bl6Nvu3PL0ymqwz-2BB9OmbslhBigepfkFVKQ5myC-2FE-2BSdr= r6iCaT5K9hCLe6sbp0tHlXxpfWGE4rXAxYinkRTS4HUnmlzPOn9JL9jtkOYxBjGYjGz8LevLUko= d7m-2BUaPEvhrazMjyC2wpWWS4mGqqSDKsIXk8boU6PNO-2FW-2BbMo0SHSy8Rp-2Fk-3D ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu= Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUNh5lkvBUpm3lW86SECaZsvQBH= VGxObJyzNdAE7H0XtYf-2FRSV-2B-2BqQ7xyoVjWaF-2FOKhVc5iVqQOuE6Je8A0kJzDhKTfqb4= 8ZJ6TH7Vy-2F5lm7HY-3DLQPZ_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33-2Bzj-2BWEDmgK0o-2BT3JG9zuaKCCiFhl08DIH0jYTz2MJfv-2Bo5WFOyELD= 14x-2Bl6Nvu3PL0ymqwz-2BB9OmbslhBigepS7VZOv8QeKBWYpWblWeaPL8kT8Yd2S3YErJYKhh= -2F1-2F6YZXE4JHyO4D3nkivNMOap6jE98e-2FCpeIMiXuC6xLmzoc9W6Pmc1htBdb-2Fg3mZYl= w7xIbBCXa2adYyjqTutBXAPOtMmaIprpaba5fhZj2Qaw-3D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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26/04/2024 20:00

UCB (EBR:UCB) UCB Media Room: Good Start into 2024 – Progressing on its Growth Path for a Decade Plus

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