Latest news with #BIMZELX
Yahoo
11-06-2025
- Business
- Yahoo
BIMZELX® (bimekizumab-bkzx) Three-Year Data at EULAR 2025 Showed Lasting Efficacy and Control of Inflammation in Psoriatic Arthritis and Axial Spondyloarthritis
Sustained symptom relief in patients with psoriatic arthritis: Achievement of the stringent ACR50 endpoint was sustained at three years by 53.2% and 55.2% of patients with psoriatic arthritis (PsA) naïve to biologics or who had an inadequate response to, or were intolerant of, tumor necrosis factor inhibitors, respectively†* Lasting improvements in physical function across the full spectrum of patients with axial spondyloarthritis: ASAS40, a composite endpoint, was sustained at three years by 60.4% and 60.1% of patients with non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS), respectively¥* Long-term inflammation control through three years: New data demonstrated consistent sustainability of efficacy across stringent clinical endpoints in PsA, nr-axSpA, and AS, showing potential to improve long-term outcomes and prevent structural damage Dual inhibition: BIMZELX® is the first and only approved medicine designed to selectively inhibit interleukin 17A (IL-17A) in addition to interleukin 17F (IL-17F) ATLANTA, June 11, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX® (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), which includes both non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and ankylosing spondylitits (AS). BIMZELX, a dual inhibitor of IL-17A and IL-17F,1 demonstrated sustained control of inflammation and deep efficacy in patients living with PsA and axSpA,2-5 chronic inflammatory diseases with considerable impact on physical and emotional wellbeing.6-7 Sustained symptom relief in patients with active psoriatic arthritis "A primary treatment goal in psoriatic arthritis is sustained control of inflammation to help prevent long-term, irreversible structural damage and to improve quality of life," said Professor Laure Gossec,‡ from the Sorbonne University Hospital, Paris, France. "These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients, with elimination of swollen joints in nearly sixty percent of patients and approximately half reaching minimal disease activity (MDA) at three years – both strong clinical responses that suggest real control of inflammation in PsA." In patients with active PsA, regardless of prior treatment experience, results from BE OPTIMAL, BE COMPLETE, and their open-label extension, BE VITAL, showed that BIMZELX delivered sustained efficacy across multiple stringent clinical endpoints for up to three years.2-3 At three years, 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints (SJC=0).†*2-3 Complete skin clearance, measured by Psoriasis Area and Severity Index [PASI]100, was sustained to three years by 61.9% and 67.5% of bDMARD-naïve and TNFi-IR patients, respectively.†*2-3 MDA, a comprehensive and clinically meaningful endpoint, was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively.†*2-3 Improvements in physical function across the full spectrum of patients with axial spondyloarthritis "Long-term data, showing that patients living with axSpA can maintain high levels of clinical response, are invaluable for informed treatment decisions. It's particularly compelling to see sustained responses with bimekizumab treatment at three years with stringent outcome measures like ASAS40 and low disease activity," said Professor Xenofon Baraliakos,‡ from the Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany. "These endpoints are key indicators of durable inflammation control in axSpA, and achieving this level of sustained disease management is likely to have a profound impact on patients' daily lives." Across patients with nr-axSpA and AS, data from two Phase 3 studies, BE MOBILE 1 and 2, and their combined open-label extension, BE MOVING, BIMZELX treatment demonstrated sustained clinical responses up to three years.4 Achievement of ASAS40 was sustained to three years by 60.4% and 60.1% of nr-axSpA and AS patients, respectively*, while 61.8% and 59.9% of nr-axSpA and AS patients, respectively, maintained Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (LDA <2.1) through three years.¥±4 Long-term inflammation control in patients with PsA and axSpA "Psoriatic arthritis and axial spondyloarthritis are serious, chronic inflammatory diseases that can have a great impact in the daily lives of patients and their families. The data presented at EULAR reinforce the role of bimekizumab to deliver deep, consistent, and sustained outcomes across a spectrum of PsA and axSpA," said Donatello Crocetta, Chief Medical Officer, UCB. "These data, alongside our other EULAR data presentations of dapirolizumab pegol§ in systemic lupus erythematosus and romosozumab in osteoporosis, reflect UCB's commitment to offering differentiated, science-driven solutions that meet the diverse and evolving needs of people living with rheumatic diseases." Across the three-year clinical trial data for PsA and axSpA, BIMZELX was generally well-tolerated and no new safety signals were observed.2-4 The most common treatment-emergent adverse events (TEAEs) over three years for both PsA and axSpA in these studies were SARS-CoV-2 (COVID-19) infection, nasopharyngitis, and upper respiratory tract infection.2-4 UCB will present 14 abstracts on PsA and axSpA at EULAR 2025 in Barcelona, Spain, June 11-14, and will complement other presentations from UCB in systemic lupus erythematosus and osteoporosis. These data, together with a dedication to advancing clinical research – including the ongoing head-to-head Phase 3b BE BOLD trial in psoriatic arthritis – underscore UCB's ambition to be a leader in rheumatology, commitment to advancing innovation, and focus on providing meaningful solutions across the spectrum of rheumatic diseases. †PsA data reported from BE OPTIMAL, BE COMPLETE, and their open-label extension (OLE), BE VITAL, for patients in the BKZ Total group (PBO/BKZ patients and BKZ-randomized patients). BE OPTIMAL (bDMARD-naïve) Week 52 and BE COMPLETE (TNFi-IR) Week 16 completers were eligible for the BE VITAL open-label extension.2-3 *mNRI: Modified non-responder imputation (binary). All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response, other reasons for missing data were calculated using multiple imputation (MI).2-4 ¥axSpA trials BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS) each comprised a 16-week, double-blind, placebo-controlled period and a 36-week maintenance period. All patients received subcutaneous BKZ 160 mg every 4 weeks (Q4W) from Week 16.4 At Week 52, eligible patients could enter the OLE, BE MOVING.4 Of 586 randomized patients (nr-axSpA: 254; AS: 332), 494 (84.3%) patients entered the OLE at Week 52.4 Data presented include patients originally randomized to placebo; all patients were treated with BKZ 160 mg Q4W from Week 16.4 ±Multiple imputation (MI). ‡co-author. §Dapirolizumab pegol is an investigational drug and is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide. Notes to Editors: ACR50: A 50% or greater improvement from baseline in American College of Rheumatology response criteria, including at least a 50% improvement in tender and swollen joint counts as well as 50% improvement in three additional criteria (physician global, patient global, patient pain, function, and CRP/erythrocyte sedimentation rate).8 This represents a stringent efficacy outcome in PsA9-10 ASAS40: Assessment of SpondyloArthritis International Society 40%, a composite endpoint covering a core set of domains that should be assessed in axSpA patients.11 This core set of domains includes physical function, morning stiffness, patient global assessment, and pain.11 In order to meet an ASAS40 response, three of the four domains should improve by at least 40% and a minimum of two units on a scale of 0 to 10. In the remaining domain, there should be no worsening of 20% and a minimum of 1 unit, on a 0 to 10 scale.11 TNFi-inadequate response (TNFi-IR): Patients with PsA who experience prior inadequate response or intolerance to tumor necrosis factor inhibitors3 bDMARD-naïve: Patients who had not previously taken a biologic disease-modifying antirheumatic drug (bDMARD)2 About Psoriatic Arthritis Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.12 Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.13 It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).14 The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, and depression.6 In PsA, uncontrolled active disease can lead to long-term, irreversible structural damage.15 About BE OPTIMAL and BE COMPLETE BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of psoriatic arthritis.16 The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16.16 BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous BIMZELX 160 mg every four weeks (Q4W) in patients with PsA; both studies were placebo-controlled to Week 16, after which placebo patients switched to BIMZELX.16 BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for BE VITAL open-label extension.16 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.7 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.7 axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).7 The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.7 Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis.7 The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults.17-18 Approximately half of all patients with axSpA are patients with nr-axSpA.7 axSpA onset usually occurs before the age of 45.7 Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.7 About BE MOBILE 1 and BE MOBILE 2BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of nr-axSpA and AS, respectively.19 The primary endpoint in both studies was the Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at Week 16.19 BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.19 In BE MOBILE 1 and BE MOBILE 2, patients were randomized to BIMZELX (160 mg Q4W; n=128 for BE MOBILE 1 and n=221 for BE MOBILE 2) or to placebo (n=126 for BE MOBILE 1 and n=111 for BE MOBILE 2).19 Patients initially randomized to placebo were switched to BIMZELX (160 mg Q4W) at Week 16.19 BE MOBILE 1 and BE MOBILE 2 Week 52 completers were eligible for BE MOVING open-label extension.20 About BIMZELX® (bimekizumab-bkzx) BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1,21-23 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).1,21-24 The approved indications for BIMZELX in the U.S. are:1 Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Suicidal Ideation and BehaviorBIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. InfectionsBIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical AbnormalitiesElevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel DiseaseCases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. ImmunizationsPrior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. Please see Important Safety Information below and full U.S. Prescribing Information at For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email: Brand Communications Nicole Herga T +1.773.960.5349 email: About UCB UCB, Brussels, Belgium ( is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed 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 known and unknown risks, uncertainties and assumptions which might cause the 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 release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, 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 discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment 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 one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, 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 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 security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB 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-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. Accessed June 2025. Gossec L, Coates L, McInnes I, et al. Bimekizumab, a dual inhibitor of IL-17A and IL 17F, demonstrated long-term safety and efficacy biologic DMARD naïve patients with active psoriatic arthritis: final 3-year results from the Phase 3 BE OPTIMAL study and its open label extension [abstract]. EULAR 2025. POS1294. McInnes I, Merola J, Coates L, et al. Dual inhibition of IL-17A and IL-17F with bimekizumab demonstrated long-term safety and efficacy in patients with active psoriatic arthritis and prior inadequate response to tumor necrosis factor inhibitors: final 3-year results from the Phase 3 BE COMPLETE study and its open-label extension [abstract]. EULAR 2025. POS0105. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab demonstrated sustained efficacy and safety across the full spectrum of axial spondyloarthritis: 3-year results from two Phase 3 studies and their open-label extension [abstract]. EULAR 2025. POS0788. Navarro-Compán V, Kiltz U, Mease P, et al. Sustained improvements with bimekizumab in pain, morning stiffness, fatigue, physical function and health-related quality of life in patients with axial spondyloarthritis: 3-year results from two Phase 3 studies [abstract]. EULAR 2025. #POS0921. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: A literature review from a global health systems perspective. P T. 2010;35(12):680–89. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319–30. Gladman DD, Mease PJ, Healy P, et al. Outcome measures in psoriatic arthritis. J Rheumatol. 2007;34(5):1159-66. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023:82(11);1404–14. Kerschbaumer A, Smolen JS, Ferreira RJO, et al. Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis. 2024;83(6):760-774. doi: 10.1136/ard-2024-225534. Landewé R, van Tubergen A. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015:17(7);47. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015:41(4);545–68. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735. doi: 10.1016/ Mease P, Armstrong A. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014:74(4);423–41. Kwok T, Sutton M, Cook R, et al. Musculoskeletal Surgery in Psoriatic Arthritis: Prevalence and Risk Factors. J Rheumatol. 2023:50(4);497–503. Mease PJ, Merola JF, Tanaka Y, et al. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012:64(6);905–10. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Disord. 2015:10(16);392. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024:83(2);199–213. Baraliakos X, Deodhar A, van der Heijde D, et al. Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies. Rheumatology (Oxford). 2025;64(6):3534-3546. doi: 10.1093/rheumatology/keaf009. Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomized withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973. US-BK-2500704Date of preparation: June 2025BIMZELX® is a registered trademark of the UCB Group of Companies©2025 UCB, Inc., Smyrna, GA 30080, All rights reserved. View original content to download multimedia: SOURCE UCB Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
04-03-2025
- Business
- Yahoo
UCB SA (UCBJF) (Q4 2024) Earnings Call Highlights: Strong Revenue Growth and Strategic ...
Revenue Growth: 17% increase, 19% at constant rate, reaching EUR6.150 billion. Net Sales: EUR5.6 billion, 15% growth, 17% at constant rate. Adjusted Gross Margin: Improved by 1.5 percentage points to 78.3%. Adjusted EBITDA: Increased by 9% to EUR1.476 billion, with a margin of 24%. Profit: EUR1.065 billion, compared to EUR343 million in 2023. Core EPS: EUR4.98 per share, a 19% increase from 2023. Key Growth Drivers: BIMZELX, FINTEPLA, RYSTIGGO, ZILBRYSQ, BRIVIACT, and EVENITY. BIMZELX Sales: Quadrupled to EUR607 million. FINTEPLA Growth: 50% year-over-year increase. BRIVIACT Sales: Grew by 19% to EUR686 million. CIMZIA Sales: Surpassed EUR2 billion for the third consecutive year. 2025 Revenue Guidance: Expected between EUR6.5 billion and EUR6.7 billion. 2025 EBITDA Margin Guidance: Expected to reach 30% of revenue. Warning! GuruFocus has detected 7 Warning Signs with UCBJF. Release Date: February 27, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. UCB SA (UCBJF) reported a significant revenue growth of 17% in 2024, with a 19% increase at constant rates, showcasing a strong recovery from the previous year's decline. The company's five key growth drivers collectively generated over EUR 1.3 billion in revenue, tripling their performance compared to the previous year. UCB SA's R&D success rate stands at 29%, significantly higher than the industry average of 8%, indicating strong innovation capabilities. The company achieved a positive Phase 3 trial for dapirolizumab pegol in lupus, marking it as only the third positive Phase 3 trial for this challenging disease. UCB SA's adjusted gross margin improved by 1.5 percentage points, driven by an enhanced product mix with higher-margin growth drivers. Despite the revenue growth, UCB SA faced a 23% increase in operating expenses, primarily due to significant investments in marketing and sales for new product launches. The company experienced pricing pressure on CIMZIA, with expected high single-digit to low double-digit declines in the US due to increased competition and pricing dynamics. UCB SA's adjusted EBITDA margin decreased to 24% from 25.7% in the previous year, reflecting increased marketing and sales expenses. The termination of the minzasolmin development program led to accelerated recognition of revenues and termination expenses, impacting R&D expenses. The company's effective tax rate was unusually low at 8%, influenced by the divestment of its mature neurology and allergy portfolio in China, which may not be sustainable in the future. Q: Can you provide insights into your approach to rebates and pricing for BIMZELX, especially in relation to first-line use in psoriasis? A: Emmanuel Caeymaex, Chief Commercial Officer, explained that BIMZELX is not intended to be limited to third-line use. The focus is on expanding access responsibly, balancing premium pricing with broader usage. The aim is to make BIMZELX a core medicine in dermatology and rheumatology, with a mix of coverage strategies to build volume and negotiate future access. Q: What gives you confidence in the IL-13, IL-17 bispecific for atopic dermatitis, and what are the next steps? A: Fiona du Monceau, Executive Vice President, Patient Evidence, highlighted the combination of IL-13 and IL-17 as a promising approach in immuno-inflammation. The results have validated their platform, and they are analyzing data to determine which patient populations will benefit most from this combination. Q: Why is the fibromyalgia program with RYSTIGGO being terminated despite positive results? A: Fiona du Monceau explained that although the primary endpoints were met, the results did not meet predefined criteria for progression. UCB is focusing its R&D resources on areas with the greatest potential return, such as the ongoing launch study for RYSTIGGO in other indications. Q: Can you discuss the current size and future potential of the US hidradenitis suppurativa (HS) market for BIMZELX? A: Emmanuel Caeymaex stated that the current US HS market is about 45,000 treated patients, with potential growth to 160,000 patients within a decade. BIMZELX is expected to play a significant role, with current access primarily for bio-experienced patients, and improvements anticipated over time. Q: What are your thoughts on the emerging competition in HS, particularly from Incyte's JAK inhibitor and MoonLake's sonelokimab? A: Emmanuel Caeymaex noted that while oral therapies like Incyte's JAK inhibitor have advantages, deep and sustained efficacy is crucial in HS. BIMZELX's rapid relief of pain and healing are key differentiators. MoonLake's sonelokimab shares a similar mode of action, but BIMZELX's established efficacy sets a high bar. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Associated Press
27-02-2025
- Business
- Associated Press
On Growth Path for a Decade plus: Strong Launch Execution driving Company Growth
Revenue in 2024 increased to € 6.15 billion, a plus of 17% (+19% CER1), Net sales were up by 15% to € 5.61 billion (+17% CER1) driven by a strong, triple- and double-digit growth performance of newly launched growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ® as well as solid contribution from CIMZIA® and BRIVIACT® reaching its peak sales two years ahead of target Underlying profitability (adj. EBITDA2) went up to € 1.48 billion, a plus of 9% (+18% CER1), 24.0% of revenue; Core EPS3 increased to € 4.98 R&D update: Doxecitine and doxribtimine in thymidine Kinase 2 deficiency filed in U.S. – with granted priority review - and in EU; 1st phase 3 with positive results for dapirolizumab pegol in systemic lupus erythematosus (SLE), 2nd phase 3 started; Phase 2a study in atopic dermatitis with UCB9741/galvokimig showed positive and convincing data Sustainability with significant improvement in patient access, CO2 reduction and ESG ratings Financial guidance for 2025: Revenue expected to grow to € 6.5-6.7 billion, adjusted EBITDA2 to reach 30% of revenue, Core EPS3 in the range of € 6.80-7.40 ATLANTA, Feb. 27, 2025 /PRNewswire/ -- UCB Full-Year Report 2024, Brussels (Belgium) – regulated information Jean-Christophe Tellier, CEO UCB says: 'Our 2024 performance demonstrates that we are progressing on our path of growth for a decade+ and underlines our unwavering commitment to ensuring people with severe diseases can live the best life that they can, as free as possible from challenges of disease. We are proud to reaching more than 3.1 million patients globally with severe immunological and neurological conditions. As a result of our continuous execution, our five growth drivers tripled their combined net sales to more than € 1.3 billion in 2024. For growth beyond the decade, we are reporting progress from our clinical pipeline where we are studying 9 innovative, potential medicines with expected news flow in 2025. In 2024, we improved access to our medicines and achieved SBTi validation for our Net Zero Targets. Our efforts were recognized by Sustainalytics ranking UCB first in Biotechnology and the Carbon Disclosure Project with an A- for climate and water security.' UCB's FY 2024 financial results Sandrine Dufour, CFO UCB says: '2024 has been a successful year, showcasing UCB's innovation and strong execution capabilities, resulting in robust financial performance and reaching the € 6 billion mark ahead of target. Once again, we have met our financial guidance. We will continue our growth trajectory by supporting product launches, investing in breakthrough innovations, and strategically positioning our portfolio for continuous growth. Our financial guidance for 2025 continues the growth trend and anticipates a like-for-like significant increase over 2024, considering the portfolio evolution in 2024 and confirms our 30% adjusted EBITDA margin ambition.' Regulatory and Clinical Pipeline Update UCB continuously innovates and strives to find new ways to deliver solutions to people living with severe immunological and neurological diseases, reflected in a clinical development pipeline encompassing now one phase 4 (post-approval) asset, one asset under regulatory review, four phase 3 projects, four phase 2 projects - addressing different patient populations. The updated timelines for UCB's clinical development program, also reflecting regulatory updates and pipeline progress since July 1, 2024, up to the publication date of this report, are shown below. For more information, please visit Regulatory Update In July 2024, UCB received National Medical Products Administration (NMPA) approval for BIMZELX® for treatment of ankylosing spondylitis (AS) in China, followed by an approval in September for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA). In November 2024, UCB and the biopharma company Bioray signed an agreement for commercialization of BIMZELX® in China, advancing access to patients. In August 2024, the European Commission granted marketing authorization for two 320 mg device presentations of BIMZELX®. The pre-filled syringe and pre-filled pen each contain 320 mg of bimekizumab in a volume of 2 mL and provide alternatives to the currently available 160 mg in a volume of 1 mL injection options. In September 2024, U.S. Food and Drug Administration (FDA) approved BIMZELX® for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). Bimekizumab-bkzx is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). These newly approved indications follow the first U.S. approval for BIMZELX® in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In September 2024, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved BIMZELX® for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). In October 2024, the FDA approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of BIMZELX®. These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. In November 2024, the FDA approved BIMZELX® for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). The milestone marks the fifth indication for bimekizumab-bkzx in the U.S. in 2024, underscoring UCB's commitment to raising standards of care across a range of IL-17 mediated diseases. In January 2025, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the 320 mg/2mL Autoinjector for BIMZELX®. Clinical Pipeline Update The phase 2a study with rozanolixizumab in severe fibromyalgia syndrome showed statistically significant superiority to placebo but did not meet predefined criteria for progression. The reduction in IgG levels and the safety profile were consistent with what was observed in the myasthenia gravis population. UCB decided not to pursue a Phase 3 program for rozanolixizumab in severe fibromyalgia and to terminate this program. UCB9741/ galvokimig - a bispecific investigational antibody designed to target IL-13 and IL-17A & IL-17 F, which are key mediators of inflammation. The phase 2a study in moderate-to-severe atopic dermatitis - a type of eczema, which is the most common inflammatory skin disease - showed positive and convincing proof-of-concept data – to be presented at an upcoming scientific meeting in 2025. UCB is evaluating the next steps in the development program. UCB1381/ donzakimig - a bispecific investigational antibody designed to target IL-13 and IL-22, a key mediator of inflammation and important in maintenance of skin barrier integrity. Recruitment for the Phase 2a study in atopic dermatitis (AtD) is progressing slower than anticipated, leading to an updated timeline with results now expected in the second half of 2025. Minzasolmin, a phase 2a investigational, oral small molecule, alpha-synuclein misfolding inhibitor, developed in partnership with Novartis for early Parkinson's disease, did not meet its primary and secondary clinical endpoints in the ORCHESTRA proof-of-concept study. No new safety risks were identified, and the program was terminated. The findings from this study have been submitted to an upcoming scientific meeting and will be submitted for publication in a peer-reviewed journal. The data generated to date will enhance understanding of alpha-synuclein misfolding inhibition and aid in the advancement of future treatments. Bepranemab showed encouraging phase 2a study results in early Alzheimer's disease providing first evidence of biological and clinical effect of a mid-domain tau-targeting disease-modifying therapy. In the full study population, the primary endpoint was not met, however in key secondary endpoints bepranemab showed positive results. In pre-defined patient subgroups, consistent treatment benefit was shown across multiple primary and secondary outcome measures. UCB is evaluating next steps in the development program. At the end of 2024, regulatory submissions of doxecitine and doxribtimine in thymidine Kinase 2 deficiency (TK2d) occurred as planned and were accepted in February 2025 for review by the European and U.S. authorities. In the U.S., the application has been granted a priority review, Breakthrough Therapy Designation and Rare Pediatric Disease Designation. Following the acquisition of Zogenix, Inc. in 2022, UCB continued the development of Doxecitine and Doxribtimine, a pyrimidine nucleoside potential therapy for patients with TK2d, a rare, progressive, debilitating and often life-threatening genetic mitochondrial disease characterized by progressive and severe muscle weakness. Worldwide, there is no approved treatment available. UCB expects regulatory feedback and potential approvals by the end of 2025. The phase 3 study to evaluate the efficacy and safety of bimekizumab in Chinese study participants with moderate to severe plaque psoriasis (PSO) reported positive results. All primary and secondary endpoints were met, and safety observations were generally consistent with previous bimekizumab PSO studies. Submission to the Chinese regulatory authorities is planned for H2 2025. Recruitment for the phase 3 study with Fenfluramine (5-HT agonist) in the treatment of CDKL5 deficiency disorder (CDD) has required more time than anticipated. CDD is a rare developmental epileptic encephalopathy with onset in early infancy caused by mutations in the CDKL5 gene. The main clinical symptoms are early-onset, intractable epilepsy and neurodevelopmental delay impacting cognitive, motor, speech, and visual function. The study is now fully recruited, and first headline results are expected in H1 2025. In November 2024, UCB and partner Biogen presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The safety profile of dapirolizumab pegol was generally consistent with previous studies. In December 2024, UCB and Biogen initiated the second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, with first headline results expected in 2028. In September, UCB started BE BOLD, a head-to-head post-approval Phase 4 study, comparing bimekizumab, an IL-17A and IL-17F inhibitor, with risankizumab, an IL-23 inhibitor, in the treatment of adults with active psoriatic arthritis (PsA). BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor. First headline results are expected in H2 2026. All other clinical studies are continuing as planned. Sustainability In 2024, patient access to reimbursement of UCB's medicines improved to 82% (from 68%) across all countries where UCB operates. UCB advanced the CO2 reduction efforts and achieved SBTi validation for its Net Zero Targets. This performance is recognized by various ESG ratings, with Sustainalytics ranking UCB first in the Biotechnology sector and the Carbon Disclosure Project awarding an A- score for both, climate and water security. Net sales break-down for UCB's five growth drivers, CIMZIA® and BRIVIACT® Due to rounding, some financial data may not add up in the tables BIMZELX® (bimekizumab) the first and only IL-17A & IL-17F inhibitor, is available to people living with psoriasis in 47 countries. It is also available to people living with active psoriatic arthritis (PsA), with active ankylosing spondylitis (AS) in more than 40 countries – the U.S. approval and launch occurred September 2024 - and active non-radiographic axial spondyloarthritis (nr-axSpA) in Europe and in Japan. BIMZELX® for people living with hidradenitis superativa was approved and launched in Europe (Germany, Austria) in April 2024, in September in Japan and in the U.S. in November 2024. More than 49 700 patients accessed the product by the end of 2024. FINTEPLA® (fenfluramine) reached over 7 600 patients and their families living with seizures associated with rare epileptic syndromes, offering a foundational therapy in Dravet Syndrome and a recognized option in Lennox-Gastaut Syndrome at the end of 2024. Partner Nippon Shinyaku in Japan books the in-market sales. FINTEPLA® was added to the UCB portfolio in March 2022. Following a settlement in a patent dispute in late 2023, UCB is now considering Q4 2033 as the loss of exclusivity in the U.S. € million 2024 2023 Act CER1 U.S. 294 201 46 % 46 % Europe 41 21 93 % 92 % Japan 2 1 >100% >100% International markets 2 3 -16 % -16 % Total Fintepla® 340 226 50 % 50 % RYSTIGGO® (rozanolixizumab-noli), a new treatment option for people living with generalized myasthenia gravis (gMG) providing rapid and durable efficacy, was launched in the U.S. in July 2023, in Japan late 2023 and Europe early 2024. RYSTIGGO® reached more than 1 200 people living with gMG by the end of 2024. € million 2024 2023 Act CER1 U.S. 184 19 >100% >100% Europe 8 - N/A N/A Japan 10 - N/A N/A International markets - - N/A N/A Total Rystiggo® 202 19 >100% >100% ZILBRYSQ® (zilucoplan) the first and only once-daily subcutaneous, targeted C5 complement inhibitor reached more than 560 people living with myasthenia gravis (gMG) by the end of 2024 and is being launched in the U.S., Europe and Japan since April 2024. € million 2024 2023 Act CER1 U.S. 56 - N/A N/A Europe 8 - N/A N/A Japan 8 - N/A N/A International markets - - N/A N/A Total Zilbrysq® 72 - N/A N/A EVENITY® (romosozumab) since launch globally reached more than 900 000 (2023: 600 000) women living with postmenopausal osteoporosis at high risk of fracture. Net sales in Europe increased by 71% to € 103 million (+71% CER) after € 60 million in 2023. EVENITY® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners. The worldwide net contribution from EVENITY® is recognized under 'Other operating income'. CIMZIA® (certolizumab pegol) reached more than 220 000 people living with inflammatory TNF mediated diseases. The net sales performance was driven by global volume growth (+5%), overcompensated by net price decline mainly in the U.S. market. Since February 2024 and in the U.S., CIMZIA® is no longer patent protected. The patent in Europe expired in October 2024 and will expire in Japan in 2026. There is no biosimilar competition, neither today nor expected near-term. € million 2024 2023 Act CER1 U.S. 1 289 1 364 -5 % -5 % Europe 436 428 2 % 1 % Japan 28 39 -26 % -20 % International markets 280 257 9 % 15 % Total Cimzia® 2 033 2 087 -3 % -2 % BRIVIACT® (brivaracetam) was used by over 232 000 people living with epilepsy and increased net sales to € 686 million, achieving its peak sales target of 'at least € 600 million' well before 2026. This is driven by continued growth in all regions where BRIVIACT® is available to patients. In June 2024, BRIVIACT® was approved in Japan as monotherapy and adjunctive therapy in the treatment of partial onset seizures. € million 2024 2023 Act CER1 U.S. 540 445 21 % 21 % Europe 120 110 10 % 9 % Japan 1 - N/A N/A International markets 24 21 14 % 16 % Total Briviact® 686 576 19 % 19 % 2024 FY financial highlights Due to rounding, some financial data may not add up in the tables. Actual1 Variance € million 2024 2023 Actual rates CER2 Revenue 6 152 5 252 17 % 19 % Net sales 5 613 4 867 15 % 17 % Royalty income and fees 78 77 1 % 1 % Other revenue 461 308 50 % 50 % Adjusted Gross Profit 4 819 4 033 19 % 22 % Gross Profit 4 400 3 545 24 % 27 % Marketing and selling expenses -2 075 -1 594 30 % 30 % Research and development expenses -1 781 -1 630 9 % 9 % General and administrative expenses - 272 - 230 18 % 18 % Other operating income/expenses (-) 564 566 0 % 0 % Adjusted EBIT 836 657 27 % 47 % Impairment, restructuring and other income/expenses (-) 488 - 53 >-100% >-100% EBIT (operating profit) 1 324 604 >100% >100% Net financial expenses (-) - 161 - 163 -1 % -2 % Profit before income taxes 1 163 441 >100% >100% Income tax expenses (-) - 98 - 98 0 % 4 % Profit from continuing operations 1 065 343 >100% >100% Profit/loss (-) from discontinued operations 0 0 N/A N/A Profit 1 065 343 >100% >100% Attributable to UCB shareholders 1 065 343 >100% >100% Adjusted EBITDA 1 476 1 349 9 % 18 % Capital expenditure (including intangible assets) 322 316 2 % Net debt (-) -1 454 -2 177 -33 % Operating cash flow from continuing operations 1 242 761 63 % Weighted average number of shares – non diluted (million) 190 190 0 % EPS (€ per weighted average number of shares – non diluted) 5.61 1.81 >100% >100% Core EPS (€ per weighted average number of shares – non diluted) 4.98 4.20 19 % 32 % 1 Due to rounding, some financial data may not add up in the tables included in this management report 2 CER = constant exchange rates 'The statutory auditor has issued an unqualified report with no emphasis of matter paragraph dated 26 February 2025 on the company's consolidated accounts as of and for the year ended 31 December 2024 and has confirmed that the accounting data reported in the accompanying press release is consistent, in all material respects, with the accounts from which it has been derived.' Revenue in 2024 increased to € 6 152 million (+17%; +19% CER1) and net sales went up to € 5 613 million (+15%; +17% CER1). This growth was driven by the strong, triple- and double-digit growth of UCB's growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ® as well as the solid performance from CIMZIA® and the strong contribution from BRIVIACT®, reaching its peak sales target of 'at least € 6oo million' well ahead of the 2026 target. Royalty income and fees were € 78 million (1%; 1% CER1) and other revenue went up by 50% (+50% CER1) to € 461 million driven by the successful completion of the sale of rights to two established brands for Europe and selected countries in Latin-America and Asia-Pacific in November 2024, leading to other revenue of € 157 million. Also, the termination of the partnership for minzasolmin (see above) lead to additional termination revenue of € 92 million (termination expenses are recognized in research and development expenses). Gross profit before 'amortization of intangible assets linked to sales' was € 4 819 million (+19%; +22% CER1) and showed an even better performance than the topline, reflecting the improved product mix. The adjusted gross margin reached 78.3% and improvement over 2023 when the adjusted grow margin was 76.8%. Gross profit after 'amortization of intangible assets linked to sales' reached € 4 400 million – with an improved gross margin of 71.5% after 67.5%. Operating expenses increased to € 3 564 million (+23%; +23% CER1) reflecting significantly higher marketing and selling expenses, moderately increased research and development expenses, higher general and administration expenses and a stable 'other operating income'. Also, the accounting effect of long-term incentives (LTI), driven by the strong share price performance, impacted the different operating expenses and increased the total operating expenses by € 82 million or 2.3% of the total operating expenses. Total operating expenses are consisting of: 30% higher marketing and selling expenses of € 2 075 million (+30% CER1) reflecting focused and significant investments behind the global launch activities for UCB's five growth drivers: Global BIMZELX® launch activities in up to five indications, global launch activities for FINTEPLA® in two indications, global RYSTIGGO® and ZILBRYSQ® launch activities for people living with generalized myasthenia gravis (gMG) and the ongoing expansion of EVENITY® in Europe, reaching more and more patients. 9% higher research and development expenses of € 1 781 million (+9% CER1) reflect the continued investments in UCB's innovative R&D pipeline with 10 different study programs encompassing today one phase 4 (post-approval) asset, one asset under regulatory review, four phase 3 projects, four phase 2 projects - addressing ten different patient populations - as well as ongoing earlier research activities. The R&D ratio reached 29% in 2024 after 31% in 2023 due to strong revenue growth. 18% higher general and administrative expenses of € 272 million (+18% CER) driven by one-time expenses and additional external resources for the new growth organization model implemented at UCB in summer 2024 and by the above-mentioned accounting effect of LTI. other operating income was stable at € 564 million following € 566 million in 2023 driven by the net contribution of € 481 million (+31%) from EVENITY®, compensating a significantly lower other operating income. EVENITY® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners. Hence, the net earnings contribution from outside Europe is reflected here. In 2023, the sale of a portfolio of established brands in Europe (€ 145 million) was reported as other operating income. In 2024, two established brands were sold, however reported as other revenue following the IFRS accounting standards. Underlying operational profitability – adjusted EBITDA2 – increased by 9% to € 1 476 million (+18% CER1) reflecting double-digit revenue growth and higher operating expenses. The adjusted EBITDA ratio for 2024 (in % of revenue) reached 24.0%, after 25.7% in 2023. Total impairment, restructuring and other income/expenses was an income of € 488 million driven by the successful closing of the divestment of UCB's mature neurology and allergy portfolio in China and the Zhuhai manufacturing facility, announced in November 2024. In 2023, UCB reported expenses of € 53 million. Net financial expenses reached € 161 million after € 163 million in 2023. Higher funding expenses were compensated by an increase of returns on cash investments and reduction of net foreign exchange losses. Income tax expenses remained stable at € 98 million. The average effective tax rate was 8% compared to 22% in 2023 impacted by the above-mentioned divestment in China - adjusted for this the effective tax rate would be 14% and includes the continued and sustainable use of R&D incentives and the recognition of deferred tax assets on losses. Driven by double-digit revenue growth, higher operating expenses reflecting the strong investments behind the launches and the significant contribution from the gain on disposals, the profit of the Group amounted to € 1 065 million after € 343 million (>100%; >100% CER1). Core earnings per share, adjusted for the after-tax impact of to be adjusted items, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached € 4.98 after € 4.20 in 2023 based on stable 190 million weighted average shares outstanding. Dividend – the Board of Directors of UCB proposes a dividend of €1.39 per share (gross), +2%. Financial Guidance 2025 - The year 2025 will be marked by ongoing global launches and in-market performance of the five growth drivers BIMZELX®, RYSTIGGO®, ZILBRYSQ®, FINTEPLA® and EVENITY®, supported by the solid performance of BRIVIACT® and despite expected pricing pressure for CIMZIA®. For 2025, UCB is aiming for an increase of revenues to the range of € 6.5 - € 6.7 billion representing a year over year like-for-like3 significant increase over 2024, considering the portfolio evolution in 2024. UCB will continue to invest behind launches around the globe to offer potential new solutions for people living with severe diseases and remains committed to invest into research and development advancing its early- and late-stage development pipeline. At the same time, UCB will continue to be cost disciplined and, as in the past, to actively manage the tail of its portfolio. Underlying profitability, adjusted EBITDA, is expected to reach 30% of revenue. Core earnings per share are expected in the range of € 6.80 – 7.40 per share – based on an average of 190 million shares outstanding. The figures for the financial guidance 2025 as mentioned above are calculated on the same basis as the actual figures for 2024. Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00 (GMT) / 14.00 (CET) For further information, contact UCB: About UCB UCB, Brussels, Belgium ( is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news Forward looking statements This document contains forward-looking statements, including, without limitation, statements containing the words 'potential', 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'continue' and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed 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 guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring, retention and compliance of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment 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 one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, 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 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 security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. SOURCE UCB
