UCB : Financial Reporting Document

REFINITIV STREETEVENTS

EDITED TRANSCRIPT

UCB.BR - Full Year 2022 Ucb SA Earnings Call

EVENT DATE/TIME: FEBRUARY 22, 2023 / 1:00PM GMT

REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us

©2023 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

FEBRUARY 22, 2023 / 1:00PM, UCB.BR - Full Year 2022 Ucb SA Earnings Call

C O R P O R A T E P A R T I C I P A N T S

Antje Witte UCB SA - Head of Investor Relations

Charl van Zyl UCB SA - Executive VP of Neurology Solutions & Head of EU/International

Emmanuel Caeymaex UCB SA - Executive VP of Immunology Solutions & Head of US

Iris Loew-Friedrich UCB SA - Executive VP, Chief Medical Officer and Head of Development & Medical Patient Value Practices Jean-ChristopheTellier UCB SA - CEO & Executive Director

Sandrine Dufour UCB SA - Executive VP & CFO

P R E S E N T A T I O N

Antje Witte - UCB SA - Head of Investor Relations

Welcome to the UCB Full Year 2022 Capital Market Call. My name is Antje here, and I'm heading Investor Relations at UCB. Before I introduce you to the agenda today and hand over to the speakers, I'd like to make two remarks. This video conference is being recorded. This presentation and the following Q&A session are covered by the disclaimer and safe harbor statement as stated on Slide two of the deck. Please kindly read this carefully. With this, I'd like to introduce you to our speakers today. We will start with our CEO, Jean-Christophe Tellier, followed by our Chief Medical Officer, Iris Loew-Friedrich and she will hand over to our Head of Neurology, Charl van Zyl, who will then turn it to the Head of Immunology, Emmanuel Caeymaex. And the conclusion will be done by our -- the financial conclusion will be done by our Chief Financial Officer, Sandrine Dufour. Jean-Christophe will then finally briefly conclude this presentation before we hand over to the Q&A session. For the Q&A session, please turn up your questions into the chat or if you prefer, e-mail it to me under [e-mail]. I will ask the question on your behalf to presenters. With this, I kindly hand over to Jean-Christophe, over to you.

Jean-ChristopheTellier - UCB SA - CEO & Executive Director

Thank you, Antje, and good morning, good afternoon, everyone. It's a pleasure to welcome you at our call, and thank you for your interest at UCB. Next slide, please. In a challenging year, UCB demonstrated resilience delivered strong results and is now ready to execute on the multiple launch ahead. As we communicated earlier, the result that you see here on the top of the slide is at the high end of the guidance, even a little bit above with revenues at EUR 5.5 billion and underlying profitability at EUR 1.6 billion. These strong results are built first on the success of our core growth drivers, such as Briviact in epilepsy or Cimzia, which have reached already two years ahead of the plan, peak sales of more than EUR 2 billion of revenue.

But there are also the consequences of the successful acquisitions and integrations of Zogenix, which gave us Fintepla, and Fintepla contributed already in 2022 to our growth and our revenue with an amount of EUR 116 million. Finally, the cost control rigor and discipline in our resource allocation, gave us the ability to protect the investments towards future launches while being able to deliver the results that you see here. And we are now ready to move full speed into the execution mode of the launches, as you can see on the bottom of the slide with the various indications for Bimzelx and the three new assets that we have already with fintepla or we will launch in Myasthenia Gravis.

The solid performance, the strength of the platform that we have built year after year as well as the confidence in the future give us the guidance that we share with you today of revenue expected between 5.15% and 5.35% and adjusted EBITDA between 22.5% and 23.5%. Next slide, please. Sustainable performance is also the result of progress on extra financial elements and a key component of that is to continue to ensure access to our solutions to a broader population of patients who need our solution. As you can see here, we have made good progress in all of the three indicators that we are continuously monitoring to evaluate our access for our medicine for the patients. These are, of course, key components as our objective is, of course, to deliver value for patients wherever they are.

Next slide. Sustainable performance is also the result and the consequences of other key financial elements such as the value for our people, the value for the community where we operate and the value for the planet. You can see here some of the key components of all of these three indicators

2

REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us

©2023 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

FEBRUARY 22, 2023 / 1:00PM, UCB.BR - Full Year 2022 Ucb SA Earnings Call

that we are monitoring year after year to make sure that we are integrating that into an overall performance evaluation. Both pillars, financial and extra financial are key for the long-term success of the company.

Next slide, please. So in a nutshell, continuing to focus on the patients' value that we want and aim to deliver following our objective of being inspired by patients and driven by science, with the strong platform that we have and the confidence in the future, we are ready to start a new phase of growth after years of transitions linked to the loss of exclusivity of certain of our products. And as you can see here, we have three products to launch in the neurology space, and we have new indications within the rheumatology and dermatology environment. We are very confident that with the good preparation that we have, we will be able to move full speed into this phase. And with that, I would like to thank you and hand over to Iris she will go deeper into these evolutions of the pipeline. Thank you.

Iris Loew-Friedrich - UCB SA - Executive VP, Chief Medical Officer and Head of Development & Medical Patient Value Practices

Yes. Thank you very much, Jean-Christophe. What a unique phase in UCB's history. We are so excited as we turn the many positive Phase III results of last year into regulatory submissions around the world. Finally, this high intensity of regulatory submissions and reviews will translate into many launches. We are very thrilled by the opportunity to make an impact on the life of so many patients.

Next slide, please. Just take a look at this slide and the abundance of regulatory events. In the middle bar, we cover our ongoing regulatory reviews in the U.S., European Union, and Japan, which we expect to translate into approval soon. At the bottom, you see the upcoming regulatory submissions. So, we have two huge waves rolling, covering four molecules and eight patient populations. Amongst them are bimzelx, bimekizumab in several indications, rozanolixizumab, and zilucoplan for patients living with generalized myasthenia gravis. And FINTEPLA for patients with Lennox-Gastaut syndrome just approved in Europe. So please, do enjoy with us the prospect of several expected approvals and launches every quarter and new submissions following on the heels of the approvals expected to lead to more approvals and more launches in the future. Can you imagine so many important events in such a short period of time?

Next slide, please. In addition, we are enjoying a very remarkable clinical stage pipeline with five Phase III development programs, four innovative Phase II programs, and new assets moving into Phase I. With that to wealth of opportunities, please allow me to focus on a few milestones. Following the very strong results in generalized myasthenia gravis, rozanolixizumab development is progressing in patient populations that have no proven specific treatment options and serious unmet needs. So, we are very hopeful that patients living with MOG autoantibody disease and patients living with LGI1 autoimmune encephalitis will benefit from rozanolixizumab in the future, based, of course, on the data that we are currently generating. These programs are ongoing as planned. We have added a study in severe fibromyalgia to the portfolio of new indications with rozanolixizumab. Nonclinical data suggest a role of autoantibodies in the disease biology of fibromyalgia. However, as always, please remember that proof-of-concept studies are there to explore novel mechanisms of action in unchartered therapeutic territory. So, with a completely open outcome.

To bring the benefit of FINTEPLA to patients with unmet medical needs, we are recruiting children with CDKL5 deficiency disorder into a Phase III study. These children are suffering from catastrophic seizures developmental delays and have no valid treatment opportunity today. The combination of doxecitine and doxribtimine, we abbreviated as doxTM. And you might remember that we previously referred to this combination as MT1621. So, doxTM ensures survival of patients suffering from ultrarare TK2 deficiency disorder. We have now reached alignment with FDA and EMA on the submission strategy for doxTM, so that regulatory submissions can commence and will commence in 2024.

Our Phase III program with dapirolizumab for people living with systemic lupus erythematosus and with Staccato Alprazolam for the acute termination of stereotypical prolonged epileptic seizures are ongoing as planned. Top line results for these two programs are expected in the first half of next year. Patient recruitment has been completed for our disease-modifying proof of concept studies in neurodegenerative diseases. With anti-tau antibody bepranemab in patients with mild Alzheimer's disease and with the small molecule alpha-synuclein misfolding inhibitor, UCB0599, in patients with early Parkinson's disease. We are now expecting top-line results in Q4 2024. Both are very comprehensive proof-of-concept studies now with dose-ranging embedded in both studies. 450 patients participate in each study, and we have 18 months observation period. That's actually really what it takes for proof of concept in neurodegeneration. And again, as recruitment is completed, we will have results in the end of next year.

3

REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us

©2023 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

FEBRUARY 22, 2023 / 1:00PM, UCB.BR - Full Year 2022 Ucb SA Earnings Call

In addition, I am very pleased to inform you that we have initiated two Phase I programs with two molecules with different mechanisms of action in atopic dermatitis. This illustrates that we have a growing number of promising preclinical molecules. We are able to replenish the pipeline from the very early stages while also delivering on our differentiation ambition.

Next slide, please. Let's focus for a moment on our two near-term opportunities to serve patients with generalized myasthenia gravis, gMG. Please remember that the unpredictability of exacerbations and the fluctuating nature of the disease belong to the most burdensome token of gMG. Planning activities of everyday life is impossible for patients because they never know when and how their disease will take control of their lives. In addition, patients are very severely impacted by fatigue, so badly that they often cannot get up in the morning, and fatigue preventing them from working and from participation in social activities. Walking, talking, and eating - all these basic activities can be massively impacted by gMG and contribute to patients severely reduced quality of life. So, what can we offer them?

Next slide, please. The MG-QoL 15r score is a widely recognized patient-reported outcome measure. The 15 questions cover all dimensions of gMG from walking, eating, to working, socializing, driving, well-being, and depression. It is a very patient-focused instrument. The graph illustrates the longitudinal course of the MG-QoL 15r over time in patients treated with zilucoplan, initially for 12 weeks versus placebo. Then the patients on placebo switched over to active and showed similar efficacy. For all patients, the profound improvement with zilucoplan continued throughout the entire treatment period. These are very meaningful results and very much in line with expectations from the mechanism of action. The data directly reflect the positive long-term impact of zilucoplan on relevant activities of daily living. And that's what truly matters to patients.

Next slide, please. Let's have a look at rozanolixizumab. MG-ADL is the primary endpoint of our registration study, and we have measured the difference from baseline to day 43, the end of the first 6-week treatment cycle. The overall results are very strong and robust. You know that already. These graphs illustrate now the two different patient populations in the study. Those who are positive for acetylcholine receptor antibodies on the left and those who are positive for MuSK antibodies on the right. The patients with MuSK autoantibodies represent about 15% of the overall gMG population. The efficacy in both patient populations is strong across both doses of rozanolixizumab tested. However, it is the first time ever that efficacy of this magnitude has been observed in patients who are most positive. And the efficacy is consistent across all efficacy parameters in the study with the largest number of MuSK-positive patients recruited to date. So, what you see is unprecedented efficacy of rozanolixizumab in a very relevant subpopulation.

Next slide, please. I mentioned before that debilitating fatigue is one of the key symptoms of gMG that has huge impact on patients' ability to function effectively. In UCB, together with patients and with experts from academia, we developed patient-reported outcome measures that explore the different types of fatigue. There's, of course, muscle fatigability that you would expect in a disease where the neuromuscular junction is affected. However, there's also physical fatigue, the deep lack of motivation and energy that is so frustrating for patients. And there is bulbar muscle weakness that results in inability to swallow in difficulties to articulate and to speak properly, in weak jaw and face muscles, impacting mimics and facial expression. All these are very critical factors contributing to quality of life. And you see in this graph, the profound impact that rozanolixizumab has on all three dimensions of fatigue, very visible during the 6-week treatment cycle. These are huge and very meaningful improvements uniquely demonstrated for rozanolixizumab, clearly indicating the promise of this treatment opportunity for people living with gMG. And with these prospects and attributes, I hand over the baton today and in the long term for successful launches to Charl. Charl, please, over to you.

Charl van Zyl - UCB SA - Executive VP of Neurology Solutions & Head of EU/International

Thank you, Iris, and also thank you, everyone, for joining today's call. Of course, it's my pleasure to share with you our progress in Neurology. And before we go deeper into some of the results, I want to leave you with two very important messages. The first one being leadership in epilepsy, in our view, is secured for the next decade. And of course, we are very pleased also with the progress we're making on preparing our launches in the space of myasthenia gravis that will roll out in the second half of this year.

So, if we go to the next slide and we go a bit deeper into the results. Of course, we are very pleased with the results that we see in epilepsy with strong growth that we see from Briviact and of course, Nayzilam that are important areas of protected spaces in our portfolio. So, strong growth against competition there and really foundational, of course, for our future growth in epilepsy. We have also, of course, gone through the loss of exclusivity of Vimpat and Keppra. We see a large component of that in a sense behind us as an effect of 2022. There will be a remainder of the loss of exclusivity in the first half of this year. And of course, we returned to growth more in the second half of this year as an enterprise. We've also

4

REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us

©2023 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

FEBRUARY 22, 2023 / 1:00PM, UCB.BR - Full Year 2022 Ucb SA Earnings Call

done some rigorous resource reallocation to, of course, our growth drivers in epilepsy, but also to prepare for the launches in myasthenia gravis. And of course, also very pleased with the progress we've made on the integration of Zogenix and the performance we see of FINTEPLA in the market, and I will speak more to that in short order.

So, very solid results, solid foundation, this transition we are going through, and very pleased, of course, with the growth that we see from our protected portfolio. If we go to the next slide. Again, I want to remind you of our very diversified strategic position, we, in a sense, have in neurology. We have a very core focus on epilepsy. And with the advance of science and the better understanding of the genetic pathways, we are seeing a greater movement into the spaces of rare epilepsies with the advances of science. And this is an area we will continue to explore and, of course, also be important component of our research focus in the future. The second important area of future growth will be a new space for us, of course, in the space of myasthenia gravis with neuroinflammation. But of course, there are other patient populations that Iris have mentioned that will, of course, expand our growth opportunity in this space.

In the third pillar of our strategy, neurodegeneration, where disease modification is a key component of outcome. Here, we have essentially partnered our great science with, of course, two important partnerships with Roche in Alzheimer's and with Novartis in Parkinson's. So, if we go to the next slide, I really want to build here a bit further on what leadership looks like in epilepsy. And of course, what you see here is a history of 20 years, the large number of patients we serve, the breadth of our clinical programs, the focus on publications. So, really a presence that we have built, a legitimacy that we have built over a significant time. Underpinning all of this leadership is essentially key components that I just want to highlight very briefly. A very compelling portfolio we have with Nayzilam, Briviact, and Fintepla being important growth drivers now going forward. Keppra and Vimpat, of course, facing loss of exclusivity but still serving a large volume and of population of patients. We have, of course, made very strategic and smart acquisitions with Zogenix and of course, with Engage Therapeutics that brought us Staccato Alprazolam into our pipeline.

In the space of discovery and early work on future spaces of rare epilepsies, we have engaged in different academic partnerships to continue to further our understanding of the space and potentiate our pipeline for the long term in the spaces of rare epilepsies, where there's still a high degree of unmet need. And in the broader sense, we also focused on how we can help patients with the overall disease management with very smart investments in digital health that essentially help patients to monitor seizures, but also in potential to be able to detect seizures in the future. So, this is a clear picture of our future in epilepsy and one that, of course, we were part of and very confident that we can continue to see this as a cornerstone for epilepsy and for UCB in the future.

If we now go to the next slide, I wanted to just build on what Iris had mentioned in terms of FINTEPLA. And here, you see the three core patient populations that will be the cornerstone of our future in FINTEPLA. And what makes us very confident in the ability to realize our peak sales and predict 800 million peak sales as we've done earlier this year. The common theme with all these patient populations is a high degree of uncontrolled state with a high frequency of seizures. The second important component that is, of course, very severe here is the risk of sudden death in epilepsy. So, the importance here of having a solution that is reducing seizures is, of course, key. And this is what we have in Fintepla. It's really establishing itself as a foundational therapy in Dravet. We are now launching Lennox-Gastaut and rolling that out as a new patient population where we see significant potential. And in CDKL5 deficiency, we are able to read out our results in Phase III in the first -- in the second half of 2024. So very important foundational elements, which make us very confident to predict an $800 million peak sales as we have stated earlier this year. So if we go to the next slide, I want to just spend a little bit of time on our preparation for myasthenia gravis with the launches that are coming up in the near term.

So, first of all, I think we started the year with great news. The priority review status for rozimab with the FDA. This is a clear signal of the quality of our submission and our data. And so of course, we are pleased with that accelerated review and, of course, accelerated launch potential as well. We are working across four key levers. There's, of course, a very high unmet need in this space, and we know others have entered. But with our targeted solutions, we see the potential to continue to address a large number of patients with high unmet need. We have a very differentiated portfolio with two assets that I will speak to in a short while that give us really the potential for patients to take control of their disease as opposed to the disease taking control of them. We are also working closely with sustainable access. We know this is important in the space. This is a chronic condition and how we can ensure that there is sufficient reimbursement and affordability for patients to have access to these medicines.

And finally, the patient experience is very important. This is a chronic condition, a lifelong condition and that relationship with our solutions and with the patient is very important, and we want to make this seamless for patients when they are on our treatments going forward. So, very pleased

5

REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us

©2023 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.