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Since 2015, UCB has embarked on a very important change journey:

the Patient Value Strategy

Disclaimer

This web page contains 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 be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this web page.

Important factors that could result in such differences include but are not limited to: the global spread and impact of COVID-19, 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, 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. There can be no guarantee that the investigational or approved products potentially described in this web page 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. 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 web page, and do not reflect any potential impacts from the evolving COVID-19 pandemic, unless indicated otherwise. UCB continues to follow the development diligently to assess the financial significance of this pandemic to UCB. Information contained in this web page 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.

In the event of any differences between this web page and the Integrated Annual Report or Half Year Report, the information included in the Report shall prevail.

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The evolving COVID-19 pandemic is profoundly impacting our lives, and places tremendous strain on healthcare systems and society at large. Since the start of the crisis, UCB has taken measures to protect our colleagues around the world, to stand by patients, to help our communities and take our part in the global response to the pandemic. We know that it is our responsibility to help where we can make an impact.

 

 

Our Strategic Growth Path Towards 2025


 

Our Key Medicines

We bring solutions to people living with neurological or immunological diseases.

 

More about BIMZELX® (bimekizumab)

Launched in September 2021 in Europe and the U.K., in January 2022 in Japan, in February 2022 in Canada, filing in the U.S.

Indication:
Psoriasis

Loss of Exclusivity (indicative):
2032 in Europe, U.S. and Japan

BIMZELX® - prescribing information

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More about BRIVIACT® (brivaracetam)

Reaching 140 000 patients globally (Dec 2021)

Indication:
Epilepsy partial-onset seizure, also known as focal seizure

Loss of Exclusivity (indicative):
2026 in Europe & U.S.

Sales:
€ 355 million in 2021

Peak sales guidance:
≥ € 600 million by 2026

BRIVIACT® - prescribing information

 

 

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More about CIMZIA® (certolizumab pegol)

Reaching 170 000 patients globally (Dec 2021)

Indications:
Ankylosing spondylitis (AS); non-radiographic Axial Spondyloarthritis (nr-axSpA); Crohn's disease (CD); Psoriasis (PSO); Psoriatic arthritis (PsA); Rheumatoid arthritis (RA)

Loss of Exclusivity (indicative):
2024 in Europe & U.S.
2026 in Japan

Sales:
€ 1 841 million in 2021

Peak sales guidance:
≥ € 2 billion by 2024

AS - prescribing information
nr-axSpA - prescribing information
CD - prescribing information
PSO - prescribing information
PsA - prescribing information
RA - prescribing information

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More about EVENITY® (romosozumab)

Reached more than 200 000 patients globally since launch (Dec 2021)

Indication:
Osteoporosis

Loss of Exclusivity (indicative):
2031 in Europe, U.S. and Japan

Sales:
€ 10 million in 2021 in Europe
Net sales outside Europe reported by Amgen and Astellas

EVENITY® - prescribing information

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More about KEPPRA® (levetiracetam)

Reaching more than 2 million patients globally (Dec 2021)

Indications:
Epilepsy partial-onset seizures, also known as focal seizures; Epilepsy primary generalized tonic-clonic seizures; Epilepsy myoclonic seizures

Loss of Exclusivity:
U.S. - 2008
Europe - 2010
Japan - 2020

Sales:
€ 970 million in 2021

Peak sales:
€ 1.2 billion (2008)

KEPPRA® - prescribing information

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More about NAYZILAM® (midazolam nasal spray)

Reaching more than 50 000 patients in the U.S. (Dec 2021)

Indication:
Epilepsy seizure clusters

Loss of Exclusivity (indicative):
2028 in U.S.

Sales:
€ 57 million in 2021

NAYZILAM® - prescribing information

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More about NEUPRO® (rotigotine transdermal patch)

Reaching 385 000 patients globally (Dec 2021)

Indications:
Parkinson's disease (PD); Restless legs syndrome (RLS)

Loss of Exclusivity (indicative):
2021 in Europe & U.S.
2024 in Japan
2030 in Europe & U.S. (several reformulation patents)

Sales:
€ 307 million in 2021

Peak sales:
€ 321 million (2018)

PD - prescribing information
RLS - prescribing information

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More about VIMPAT® (lacosamide)

Reaching more than 800 000 patients globally (Dec 2021)

Indications:
Epilepsy partial-onset seizures, also known as focal seizures; Epilepsy primary generalized tonic-clonic seizures

Loss of Exclusivity (indicative):
2022 in Europe & U.S.
2024 in Japan

Sales:
€ 1 549 million in 2021

Peak sales guidance:
≥ € 1.5 billion by 2022
achieved in 2021

VIMPAT® - prescribing information

 

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Our Partnerships


 

Our Pipeline

In a challenging environment, our pipeline builds the basis of UCB’s sustainable long-term growth.

We continued to create value for patients, advancing our pipeline of potential solutions for severe diseases, expanding our capabilities by investing in state-of-the-art scientific platforms and medical advances, and further progress on our digital business transformation journey.

 

General information

All medicines must pass safety and efficacy tests if they are to be approved by regulators. This is done through a series of rigorous clinical studies, also referred to as clinical trials, research studies or medical research.

More information is available here.

Clinical studies index

UCB is committed to sharing information on studies and making study results publicly accessible. You will find below links to the clinical studies (Phase 2-4) of our main R&D projects.

More information about our clinical studies index and our position paper are available here.

Molecule
Modality
Therapeutic Area
Indication
Phase
1 2 3 Filing
Information
Bimekizumab
Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Immunology
Psoriasis
Available in EU, EEA, GB, Japan, Canada. Re-submission to US FDA end 2022
Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Immunology
Psoriatic arthritis
Starting submission Q3 2022
Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Immunology
Axial spondyloarthritis
Starting submission Q3 2022
Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Immunology
Hidradenitis suppurativa
Topline results H2 2022
Monoclonal antibody

Bimekizumab is an investigational humanized monoclonal IgG antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.

Zilucoplan
Macrocyclic peptide

Zilucoplan is an investigational macrocyclic peptide inhibitor of complement component 5 (C5). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis.

Neurology
Generalized myasthenia gravis
Starting submission Q3 2022
Macrocyclic peptide

Zilucoplan is an investigational macrocyclic peptide inhibitor of complement component 5 (C5). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis.

Rozanolixizumab
Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Neurology
Generalized myasthenia gravis
Starting submission Q3 2022
Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Neurology
Myelin oligodendrocyte glycoprotein (MOG) antibody disease
Topline results H2 2024
Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Neurology
Autoimmune encephalitis
Topline results H1 2024
Monoclonal antibody

Rozanolixizumab is an investigational humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and IgG, inhibiting IgG recycling and inducing the removal of pathogenic IgG autoantibodies.

Fintepla® (fenfluramine)
Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

Neurology
Lennox-Gastaut-syndrome
Launched in the US. Submitted in EU + other geographies
Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

Neurology
Dravet syndrome
Launched in the US and in EU. Submitted in other geographies
Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

Neurology
CDKL5
Topline results H2 2024
Small molecule

Fenfluramine is an investigational serotonin releasing agent, that has shown to stimulate multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor

MT1621
Small molecule

MT1621 is an investigational therapy that combines two small molecules, deoxycytidine (dC) and deoxythymidine (dT). It targets the underlying pathophysiology of Thymidine kinase 2 deficiency (TK2d) by restoring mitochondrial DNA (mtDNA) replication fidelity.

Neurology
Thymidine kinase 2 deficiency (TK2d)
Starting submissions in 2023
Small molecule

MT1621 is an investigational therapy that combines two small molecules, deoxycytidine (dC) and deoxythymidine (dT). It targets the underlying pathophysiology of Thymidine kinase 2 deficiency (TK2d) by restoring mitochondrial DNA (mtDNA) replication fidelity.

Dapirolizumab pegol
Monoclonal antibody

Dapirolizumab pegol is an investigational humanised monovalent pegylated Fab antibody fragment against the CD40 ligand (CD40L). Through interactions with its receptor, CD40, CD40L plays an important role in regulating interactions between T cells and other immune cells and thus affects several important functional events thought to be involved in autoimmune disease.

Dapirolizumab pegol is being co-developed with Biogen.

Immunology
Systemic lupus erythematosus
Topline results H1 2024
Monoclonal antibody

Dapirolizumab pegol is an investigational humanised monovalent pegylated Fab antibody fragment against the CD40 ligand (CD40L). Through interactions with its receptor, CD40, CD40L plays an important role in regulating interactions between T cells and other immune cells and thus affects several important functional events thought to be involved in autoimmune disease.

Dapirolizumab pegol is being co-developed with Biogen.

Staccato® (alprazolam)
Small molecule

STACCATO® alprazolam is an investigational drug-device combination using STACCATO® delivery technology with alprazolam, a benzodiazepine, that has the potential to be the first rescue treatment to be administered by a patient or caregiver in an out-patient setting to rapidly terminate (within 90 seconds) an ongoing seizure.

Neurology
Stereotypical prolonged seizures
Topline results H1 2024
Small molecule

STACCATO® alprazolam is an investigational drug-device combination using STACCATO® delivery technology with alprazolam, a benzodiazepine, that has the potential to be the first rescue treatment to be administered by a patient or caregiver in an out-patient setting to rapidly terminate (within 90 seconds) an ongoing seizure.

Bepranemab
Monoclonal antibody

Bepranemab is an investigational recombinant, humanised, full length IgG4 monoclonal anti-tau antibody with specificity for human tau protein.

Bepranemab is being co-developed with Roche/Genentech

Neurology
Alzheimer's disease
Topline results H1 2025
Monoclonal antibody

Bepranemab is an investigational recombinant, humanised, full length IgG4 monoclonal anti-tau antibody with specificity for human tau protein.

Bepranemab is being co-developed with Roche/Genentech

UCB0599
Small molecule

UCB0599 is an investigational small molecule that prevents the pathological misfolding and accumulation of alpha-synuclein, a protein which plays a role in Parkinson’s disease (PD) pathology. Inhibition of alpha-synuclein misfolding has the potential to slow down the progression of PD.

UCB0599 belongs to a series of molecules discovered by Neuropore, which were in-licensed by UCB in 2014.

UCB0599 is being co-developed with Novartis.

Neurology
Parkinson's disease
Topline results H2 2023
Small molecule

UCB0599 is an investigational small molecule that prevents the pathological misfolding and accumulation of alpha-synuclein, a protein which plays a role in Parkinson’s disease (PD) pathology. Inhibition of alpha-synuclein misfolding has the potential to slow down the progression of PD.

UCB0599 belongs to a series of molecules discovered by Neuropore, which were in-licensed by UCB in 2014.

UCB0599 is being co-developed with Novartis.

Questions?

Contact the IR team and we will do our best to help you!