Integrated Annual Report 2023
© UCB Biopharma SRL, 2024. All rights reserved. Date of preparation: February 2024 | GL-BK-2400010
UCB | UCB at a Glance
Integrated Annual Report 2023
Inspired by patients.
Driven by science.
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Integrated Annual Report 2023
Welcome to our Integrated
Annual Report 2023
UCB's 2023 Integrated Annual Report contains our performance in 2023, and provides a look at how we create value for those we care for - people living with severe diseases, employees, communities, the planet, and our shareholders - now and into the future.
About this report
The Integrated Annual Report 2023 includes the management report in accordance with article 12 of the Royal Decree of 14 November 2007 relating to the obligations of issuers of financial instruments admitted to trading on a regulated market in Belgium. All information required to be included in such management report pursuant to articles 3:6 and 3:32 of the Belgian Code of Companies and Associations (i.e. Corporate Governance Statement - Remuneration Report included - Business Performance Review and UCB's Statement on extra-financial information) is reported throughout all different sections of this Integrated Annual Report. With respect to extra- financial information, this Integrated Annual Report has been prepared inspired by the European Sustainability Reporting Standards (ESRS), as UCB goes through the journey of complying with the Corporate Sustainability Reporting Directive (CSRD). Selected extra-financial information indicated with Greek letter beta (β) is assured by PwC Bedrijfsrevisoren and the limited assurance report is located on page 292. Sustainability Accountability Standards Board (SASB) standards provided by the IFRS Foundation were also used as reference. In addition, we support the recommendation of the Task Force on Climate-Related Financial Disclosures (TCFD) and UCB's TCFD information can be found in this report and in more detail here.
UCB is in scope of the EU Taxonomy Regulation, as a listed company with more than 500 employees. Now that the the Environmental Delegated Act1 has come into force, adding the activities related to the manufacturing of pharmaceuticals and active pharmaceutical ingredients (APIs) to the scope of the taxonomy, new eligible activities are applicable for UCB as of this year. We will continue to monitor any future reporting obligations and their impact.
This document contains information on investigational drug products that have not been approved for any use by any authority in the world or information on new indications for approved products. The safety and efficacy of these investigational drug products or new indications has yet to be established. For approved drugs, prescribing information may vary from country to country.
1 Delegated acts are non-legislative acts adopted by the European Commission that serve to amend or supplement the non-essential elements of the legislation.
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UCB | UCB at a Glance
Contents
UCB at a Glance | 6 | Data and Reporting | 82 |
Letter to our stakeholders | 8 | Sustainability statement | 84 |
Key figures | 10 | General Disclosures | 84 |
Where we are | 12 | Basis for preparation | 84 |
Our purpose and strategy | 14 | Materiality Assessment | 85 |
Driving Sustainable Business in 2023 - Social | 88 | ||
Scientific Innovation | 18 | ||
Scientific innovation | 88 | ||
UCB's therapeutic focus | 22 | ||
Equitable Access to Medicine | 89 | ||
Neurology | 23 | ||
Health system resilience | 90 | ||
Immunology | 26 | ||
Patient safety | 91 | ||
How UCB creates value | 30 | ||
Product quality | 92 | ||
Corporate Governance | 32 | ||
Patient engagement | 93 | ||
UCB's Performance | 38 | Employee Health, Safety and Wellbeing | 94 |
Key highlights | 41 | Employee Diversity, Equity and Inclusion | 95 |
Regulatory updates and pipeline progress | 44 | Workers' rights and working conditions | 98 |
UCB's Business Execution in 2023 | 49 | Employee development | 99 |
Innovating for sustainable performance | 60 | Human Rights | 104 |
Access to Medicines | 62 | Human rights in the value chain | 105 |
Employee Health, Safety, and Wellbeing | 66 | Responsible sales and marketing | 106 |
Diversity, Equity, and Inclusion | 68 | Data privacy and security | 106 |
Health of the Planet | 70 | Driving Sustainable Business in 2023 - Environmental | 107 |
Ethical Business Practices | 75 | Climate crisis mitigation and adaptation | 107 |
Risk Management | 78 | Water extraction, consumption and discharge | 110 |
Pollution | 113 | ||
Circular economy | 114 | ||
EU Taxonomy Disclosure | 116 | ||
Driving Sustainable Business in 2023 - Governance | 126 | ||
Ethical business practices | 126 | ||
Political influence and advocacy | 128 | ||
Governance for suppliers | 129 | ||
Ethical use of technology | 129 |
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Integrated Annual Report 2023
Our Governance
Corporate Governance Statement
- Scope of reporting
- Capital and shares
- Shareholders and shareholders' structure
- Board of Directors and Board committees
- Executive Committee
- Diversity at Board and Executive Committee level
- Remuneration Report
- Main features of the internal control and
risk management systems of UCB
- Private investment transactions and trading in UCB shares
- External audit
- Information requested under article 34 of the Royal Decree of November 14, 2007
- Conflicts of interest - Application of article 7:96 of the Belgian Code of Companies and Associations
130 | Accounting for Value | 294 |
- 2023 UCB U.S. Sustainable Access
- and Pricing Transparency Report
133 | Glossary | 318 |
135 | Forward Looking Statement Integrated Annual Report | 320 |
139 | Report language | 321 |
147 | Availability of the Integrated Annual Report | 321 |
148 | Financial calendar | 321 |
152 | Contact | 321 |
185 |
186
187
188
193
Financials | 196 | |
2. | Consolidated financial statements | 198 |
3. | Notes to the consolidated financial statements | 203 |
4. | Responsibility statement | 279 |
5. | Statutory auditor's report | 280 |
6. Abbreviated statutory financial | ||
statements of UCB SA | 286 |
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UCB | UCB at a Glance
UCB
at a Glance
UCB's ambition is to transform the lives
of people living with severe diseases, allowing them to live the best life that they can - as free as possible from the challenges and uncertainty of disease.
That commitment comes to life in our research and development activities across neurology, immunology and other areas where our expertise, innovation and ambition align with unmet needs. We are committed to driving sustainable growth that allows us to make a positive impact on society, while reducing our impact on the planet.
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Integrated Annual Report 2023
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UCB | UCB at a Glance
Letter to our stakeholders
Dear reader, patients, colleagues, caregivers, shareholders, and representatives from communities where we live and work,
As a company inspired by patients and driven by science, we know that our future is inextricably linked to our ability to innovate and grow. Our mission is to transform the lives of people living with severe diseases, by translating scientific advances into differentiated medicines that raise standards of care and reach as many patients as possible.
Our work in 2023 embodied our purpose of creating value for patients now and into the future. Not only did our medicines touch the lives of more than 3.2 million patients around the world, but after an unprecedented series of successes driven by innovation, we have set ourselves up to deliver increasing value to patients, society, and shareholders in the years to come. This year did not pass without its challenges, such as the notable delay in bringing BIMZELX®▼ (bimekizumab) to the U.S., which saw UCB teams demonstrate unwavering resilience in their efforts to navigate a complex and extended regulatory review.
Inspired by patients, driven by science
Today, UCB stands at the start of an unparalleled launch cycle for our company. With 14 major regulatory approvals for UCB medicines across six patient populations and three continents, we are now able to provide more new, differentiated treatment options to people living with severe diseases. We were particularly thrilled with the United States Food and Drug Administration (FDA)'s approval of BIMZELX® for the treatment of adults living with moderate to severe plaque psoriasis1. Today, more than 18 0002 patients around the world have already been treated with BIMZELX®.
The phase of growth we are entering puts us in a strong position to continue to invest in innovation and provide a competitive return to our shareholders. At the same time, it allows us to present attractive opportunities for our employees, while offering continued support for the communities we live in and striving to reduce our environmental footprint.
Our ambition is to help people living with severe diseases live the lives they want to, and these new approvals give us an opportunity to do just that - providing patients with differentiated value. Through BIMZELX®, we offer the first and only IL-17A and IL-17F inhibitor in moderate to severe plaque psoriasis, now approved in 41 countries. An extensive clinical program, including three Phase 3 studies, demonstrated how BIMZELX® delivered superior levels of skin clearance compared to placebo, ustekinumab and adalimumab, and was generally well-tolerated3. BIMZELX® is also approved in the European Union4, Japan5 and Great Britain6 for adults living with psoriatic arthritis, ankylosing spondylitis and non- radiographic axial spondylarthritis.
Similarly, we are proud to be the first company to offer adult patients living with generalized myasthenia gravis the choice of two new targeted therapies. RYSTIGGO®▼ (rozanolixizumab) and ZILBRYSQ®▼ (zilucoplan), each with a distinct mechanism of action, embody our commitment to addressing unmet needs of the generalized myasthenia gravis community and those of other rare patient populations - where no two people will experience their disease in the same way.
Delivering value for our business and society
Just as we looked to create value in psoriatic arthritis and generalized myasthenia gravis, in 2023 we also drew from our strengths to provide solutions for adults living with osteoporosis, and for women of child-bearing age. EVENITY®▼ (romosozumab) holds around a third of the patient share in the bone-builder segment in most European countries and has positively impacted the lives of more than 600 000 people at high risk of fracture globally since launch with our partners in 2019 - reaching together global sales of more than US$ 1 billion in 2023. Similarly, CIMZIA® (certolizumab pegol) leads in the branded anti-TNF (Tumor Necrosis Factor) market in the EU and U.S. and remains a relevant treatment option for women with chronic rheumatic diseases looking to start or expand their family7. CIMZIA® is also a prominent treatment for adult patients with non-radiographic axial spondyloarthritis in the U.S., and has shown meaningful efficacy for patients with rheumatoid arthritis and high rheumatoid factor levels through a post-hoc analysis of the EXXELERATE study8.
- This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
- BIMZELX® Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis. Available at https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis. Last Accessed: December 2023.
- As of end of 2023.
-
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.
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, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.
Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
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Integrated Annual Report 2023
We are pleased to again deliver solid financial results, with 2023 being a year with good product growth and strong launches. As expected, we have seen the impact from the losses of exclusivity for two products start diminishing and thanks to the strong revenue performance of our medicines which are driving growth, we resumed to expand our revenue in the second half of the year, with an increase of almost
3% compared to the first half of the year. Continued smart resource allocation and a strong contribution from EVENITY® enabled us to invest in our product launches.
Revenue in 2023 was driven by the continued growth of UCB's core products portfolio - namely BRIVIACT®, NAYZILAM® and FINTEPLA® showed double digit growth compared to last year and CIMZIA® has shown stable performance and an increase at constant rates. EVENITY® as well as newly-launched BIMZELX® more than doubled net sales, performance that was over-compensated by the known effects of the loss of exclusivity for VIMPAT® in the U.S. and Europe and E KEPPRA® in Japan.
At the heart of our sustainable innovation efforts and successes were over 9 000 UCB employees, whom we continue to support by fostering a diverse, inclusive and engaging working environment. Simply put, we have a long-term view and we only succeed when everyone on our journey - patients, physicians, caregivers, the communities around us, and the planet - benefits too.
A runway to a decade of growth
The dedication of UCB employees is our biggest strength as we look to create value for patients and society in a new decade of growth. We showed determination to navigate a complex and extended FDA review for BIMZELX®. We have mostly absorbed the recent loss of exclusivity impacts, and we have delivered on our financial outlook despite headwinds.
In 2023, we were at an inflection point. Now, we have confidence in five drivers to fuel our future growth performance: EVENITY®, FINTEPLA®▼ (fenfluramine), BIMZELX®, RYSTIGGO®, and ZILBRYSQ®. These five medicines form the backbone of our
Today, UCB stands at the start of an unparalleled launch cycle for
our company, where our priority is to bring more new, differentiated
treatment options to people living with severe diseases.
Each day, we challenge ourselves to maximize our impact while upholding a business approach that spans generations. While we use our growth to continue to invest in innovation, we commit to doing so in a way that brings value for society and our shareholders and is respectful of the planet.
In 2023, we widened timely access for patients to our solutions across geographies, as measured by our Access Coverage Performance Index and our Time to Access Index. UCB's medicines are increasingly available to patients in low- and middle-income countries9 and we expanded our social business approach in India, Brazil and Rwanda to improve epilepsy care in underserved communities.
As the climate crisis continues to dominate the global risk landscape and impact us around the world, we made significant progress to decrease our emissions in line with our commitment to set net-zeroscience-based targets according to the Science-Based Targets Initiative. UCB- owned sites are now powered with 100% renewable electricity and close to 60% of our suppliers by emissions have science-based targets.
growth trajectory together with our continuous innovation efforts, which have produced a clinical development pipeline of twelve ongoing programs targeting ten different patient populations.
Eleven out of these twelve clinical programs are expected to report top-line results in 2024.
We stand by our 2025 financial guidance of achieving top-line revenue of at least € 6 billion. For 2024, UCB is aiming for an increase of revenues to the range of € 5.5 - € 5.7 billion taking into account the launches and the continued solid contribution from the existing product portfolio. As we move into a year of product launches, we are met with an opportunity to raise standards of care for the many people around the world living with severe immunological and neurological conditions. Our job is only done when they get to benefit from our scientific innovation. Seizing the opportunity in front of us is how we stay true to our purpose of transforming people's lives for the better, now and into the future.
Thank you to all of you - our shareholders and partners, our colleagues and their families - for being part of that journey.
Jean-Christophe Tellier, Chief Executive Officer
Jonathan Peacock, Chair of UCB's Board of Directors
- UCB Receives New European Commission Approvals for BIMZELX® (bimekizumab) for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis. Available at https://www.ucb. com/stories-media/Press-Releases/article/UCB-Receives-New-European-Commission-Approvals-for-BIMZELXRVbimekizumab-for-the-Treatment-of-Psoriatic-Arthritis-and-Axial- Spondyloarthritis. Last Accessed: December 2023.
- BIMZELX® (bimekizumab) Receives Approval in Japan for the Treatment of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis. Available at https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-bimekizumab-Receives-Approval-in-Japan-for-the-Treatment-of-Psoriatic-Arthritis-Non-radiographic-Axial-Spondyloarthritis-and-Ankylosing-Spondylitis. Last Accessed: February 2024.
- BIMZELX® United Kingdom SPC. Available at: https://www.medicines.org.uk/emc/product/12833/smpc/print. Last Accessed: February 2024.
- CIMZIA® should only be used during pregnancy if clinically needed.
- Post hoc analysis showed meaningful efficacy of certolizumab pegol for RA patients with high Rheumatoid Factor (RF) levels. Available at https://www.ucb.com/stories-media/Press-Releases/article/Post-hoc-analysis-showed-meaningful-efficacy-of-certolizumab-pegol-for-RA-patients-with-high-Rheumatoid-Factor-RF-levels. Last Accessed: February 2024.
- For example, CIMZIA® and VIMPAT® are available to patients in 14 and 12 low- and middle-income countries, commercialized by UCB or third-party distributors.
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UCB | UCB at a Glance
Key figures
>3.2 million
People have accessed
our solutions1
5 252
Revenue in € million
(2022: 5 517)
Sustainalytics | MSCI |
rating: | rating: |
17.3 | AA |
(2022: 16.8) | (2022: AA) |
As of December 2023
14
Major regulatory approvals
for UCB medicines
31%
R&D/revenue ratio
(2022: 30%)
ISS ESG | CDP rating: |
rating: | Water Security: B |
C+ | (2022: B) |
Climate Change: A- | |
(2022: C+) | (2022: B) |
1 For calculating 2023 patient numbers, UCB switched to an external source to facilitate auditability. 2023 patient numbers and year-over-year comparisons in this document are calculated using the Moving Annual Total (MAT) patients (Estimated Actual Treated) at the end of Q3 2023 as provided by a third-party, if not mentioned otherwise. The total patient number gathers people who have accessed the following solutions: BIMZELX®, BRIVIACT®, CIMZIA®, EVENITY®, FINTEPLA®, KEPPRA®, NAYZILAM®, NEUPRO® and VIMPAT®.
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UCB SA published this content on 04 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 March 2024 16:39:08 UTC.