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1.2 Key events

1.2 Key events

1.2 Key events

There were several key events that have affected or will affect UCB financially:

Impact of COVID-19 pandemic

At UCB, we are directing our actions to support our partners in society. Our colleagues and the patients we serve are our first priority. We are also concerned about the impact of the pandemic on our communities. We have therefore prioritized our assistance to our employees, patients and our communities by:

  • Ensuring that our employees are safe and supported financially,

  • Keeping patients at the heart with availability and access to their UCB medicines as a priority,

  • Helping our local communities with targeted financial support and in-kind donations, and contribution to scaling up local diagnostic testing capabilities,

  • Giving extended payment terms to some vendors,

  • Joining forces on global response by leveraging our scientific expertise to contribute to research projects worldwide. We are acknowledging the long-term impact of the pandemic and have set up a global fund to understand and address the long-term effect of COVID-19 on vulnerable populations’ health.

These initiatives did not have a material impact on our financial situation.

UCB will continue to put measures in place in order to protect the health of its employees and stakeholders worldwide especially its patients, while remaining focused on ensuring business critical activities are properly maintained.

UCB is not considering applying for public support measures. UCB does not plan any renegotiation of major contracts.

For the current impact on financial performance, financial position and cash-flows (liquidity position and liquidity risk management strategy), impact on revenues, we refer to Note 2 of this financial report.

As the expected future impact of the COVID-19 pandemic on UCB’s financial performance, financial position and cash-flows is assessed as being low, no special or additional contingency measures are planned to mitigate the expected future impact of this pandemic.

Our existing risk management processes are comprehensive and therefore no material unaddressed risks or uncertainties were identified compared to the ones mentioned in the Risk Management section of the 2020 Integrated Annual Report.

1.2.1 Important agreements / initiatives

April 2020 – Closing of the Ra Pharma acquisition

In October 2019 UCB announced the agreement to acquire Ra Pharmaceuticals. On April 2, 2020 UCB announced that the acquisition of Ra Pharmaceuticals, Inc. has been successfully completed and Ra Pharma is now a wholly-owned subsidiary of UCB. The former Ra Pharma shareholders received US$ 48 in cash for each Ra Pharma share held at closing. (approximately US$ 2.3 billion /€ 2.1 billion. Total transaction value of approximately US$2.0 billion / € 1.9 billion (net of Ra Pharma cash).

This acquisition should enhance UCB’s leadership potential in myasthenia gravis by adding zilucoplan, a peptide inhibitor of complement component 5 (C5) currently in Phase 3, to the UCB pipeline alongside to UCB’s rozanolixizumab, an FcRn targeting antibody also in Phase 3. Zilucoplan is a novel investigational molecule also being evaluated in other complement-mediated diseases including amyotrophic lateral sclerosis (ALS) and immune-mediated necrotizing myopathy (IMNM). UCB will develop and, if approved, plans to launch zilucoplan worldwide, accelerating and diversifying company growth. The acquisition of Ra Pharma will also accelerate UCB’s long-term innovation capabilities through the addition of Ra Pharma’s proprietary ExtremeDiversity™ technology platform.

The acquisition is expected to be Core EPS accretive from 2024 onwards and to enable accelerated top and bottom line growth for UCB from 2024 onwards.

June 2020 – UCB acquires Engage Therapeutics: Staccato® Alprazolam

Engage Therapeutics, Inc. (Summit, N.J. (U.S.)), is a clinical-stage pharmaceutical company developing Staccato® Alprazolam for the rapid termination of an active epileptic seizure, for US$ 125 million in cash (subject to certain adjustments) and up to US$ 145 million in further potential milestone payments related to clinical development, submission and launch of Staccato® Alprazolam.

Staccato® Alprazolam is an investigational drug (Phase 2b) designed to be used as a single-use epileptic seizure rescue therapy that combines the Staccato® delivery technology with alprazolam, a benzodiazepine. It is a small, hand-held inhaler device designed for easy delivery of alprazolam with a single normal breath potentially providing a way for people with epilepsy and their caregivers to stop an active seizure. The Staccato® system rapidly vaporizes alprazolam to form an aerosol, with particle size designed for deep lung delivery to produce a rapid, systemic effect.

Engage Therapeutics acquired worldwide rights to Staccato® Alprazolam. in 2017 under a license agreement with Alexza Pharmaceuticals Inc., Mountain View, CA (U.S.). In connection with the acquisition, UCB has also entered into an updated license and related commercial supply agreement with Alexza, under which the parties will continue to collaborate in the development and commercialization of Staccato® Alprazolam.

July 2020 – UCB and Ferring Pharmaceuticals Inc. have entered into a co-promotion agreement

UCB and Ferring Pharmaceuticals Inc. have entered into a co-promotion agreement to commercialize the prefilled syringe formulation Cimzia® (certolizumab pegol) in the U.S. for the treatment of Crohn’s disease (CD). Ferring will take over marketing, sales promotion, and field medical affairs responsibilities. UCB will continue to be responsible for all product-related activities, including revenue recognition. UCB will continue to promote and to commercialize the lyophilized formulation of Cimzia® for all indications as well as the prefilled syringe formulation for the rheumatology and dermatology indications.

July 2020 – UCB announced an agreement with Roche and Genentech

UCB announced an agreement to enter into a worldwide, exclusive licence agreement with Roche and Genentech, a member of the Roche Group, for the global development and commercialization of bepranemab (UCB0107) in Alzheimer’s disease (AD). Bepranemab is an investigational monoclonal antibody drug being developed by UCB as a potential treatment for patients with tauopathies such as progressive supranuclear palsy (PSP) and Alzheimer’s disease.

UCB provides an exclusive, worldwide license to Roche and Genentech to develop and commercialize bepranemab in AD. In return, UCB receives an initial upfront payment of US $120 million. UCB will fund and perform a proof-of-concept study in AD and, upon availability of the results of that study, Genentech has the right to progress with the development or return full rights back to UCB. After Genentech’s decision to proceed with further clinical development, UCB will be eligible to receive further potential cost reimbursement, development and sales milestone payments as well as royalties with a total potential consideration approaching US $2 billion upon receipt of certain regulatory approvals and satisfying certain clinical and sales milestones.

October 2020 – UCB acquires a new campus for its UK operations

UCB acquires a new campus located in Windlesham, Surrey for its UK operations supporting cutting-edge research and development, early manufacturing and commercialization of medicines. The acquisition reflects UCB’s commitment to retain the U.K. as one of its three global hubs for research and development, alongside Belgium and the U.S. UCB’s projected investment in the U.K., including this site, will be more than £1 billion over five years and the transition to this new facility will support more than 650 high-value jobs in scientific research, translational medicine, clinical development, early manufacturing and commercial roles.

November 2020 – UCB acquires Handl Therapeutics

UCB acquires Handl Therapeutics, a rapidly growing and transformative gene therapy company based in Leuven, Belgium and enters into a new collaboration with Lacerta Therapeutics, a Florida based clinical stage gene therapy company. The new acquisition and collaboration will together serve to rapidly accelerate UCB’s ambition in gene therapy.

Founded in 2019, Handl Therapeutics BV has a vision to deploy the power of disease modifying in vivo gene therapy to treat complex neurodegenerative diseases through AAV capsid technology. Operating in a highly collaborative manner, Handl Therapeutics BV has built a strong international network to access global capabilities and expertise. To this end, it combines state of the art technology platforms and scientific advances licensed from KU Leuven (Belgium), Centre for Applied Medical Research (CIMA Universidad de Navarra, Spain), University of Chile (Chile) and King’s College London (UK) to address unmet medical needs. The Handl Therapeutics team will continue to be based in Leuven, Belgium, and will work very closely with UCB’s international research teams.

The new collaboration with Lacerta Therapeutics underlines UCB’s strategic focus in gene therapy to fulfil its Patient Value Ambition. These transactions build upon the strategic acquisition of Element Genomics, Inc. (acquired in 2018) that strengthened UCB’s genomics and epigenomics research platforms aiding the identification of novel drug targets.

Founded in 2017, and a spin-off from the University of Florida, Lacerta Therapeutics’ mission is to make AAV-based therapies available for all patients with rare and serious neurological disorders. The research collaboration and licensing agreement with UCB will focus on a central nervous system (CNS) disease with a high unmet need. Lacerta Therapeutics will lead research, preclinical activities and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing and clinical development. This new collaboration will allow UCB to access Lacerta Therapeutics’ expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases.

Regulatory update

January 2020 – Cimzia® (certolizumab pegol) was approved by the Japanese health authorities for the treatment of plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective. The approval makes Cimzia® the first Fc-free, PEGylated anti-TNF treatment option now available for these patients in Japan.

During the first quarter 2020, Vimpat® (lacosamide) CV for the adjunctive treatment of primary generalized tonic-clonic seizures (PGTCS) in study participants 4 years of age and older was filed with the U.S., EU and Japanese regulatory agencies. In October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a license extension for the anti-epileptic drug Vimpat® as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalized epilepsy – approved in the European Union in December 2020. In November 2020, the U.S. Food and Drug Administration (FDA) has approved Vimpat® as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older.

September 2020 – The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.

Pipeline progress

In March 2020, the evolving COVID-19 pandemic led UCB to pause new patient recruitment into ongoing clinical studies and to delay all new study starts. As from end-May 2020, UCB began to restart clinical study recruitment, including new study starts, at clinical trials sites that meet the restart criteria. This has led to some delays of UCB’s clinical studies.

The updated timelines for UCB’s clinical development program, also reflecting regulatory update and pipeline progress from January 1, 2020 up to the publication of date of this report, is shown below. UCB continues to monitor the impact of COVID-19 on all ongoing clinical trials and will implement changes as necessary.

Bimekizumab

In September 2020, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara® (ustekinumab) and Humira® (adalimumab) in achieving skin clearance at week 16.

In July 2020, the phase 3b study BE RADIANT, comparing bimekizumab to Cosentyx® (secukinumab) for the treatment of adults with moderate-to-severe plaque psoriasis, met all co- primary and ranked secondary endpoints, achieving significantly greater efficacy than secukinumab.

The Phase 3 programs in psoriatic arthritis (PsA) and ankylosing spondyloarthritis (AS) are ongoing with first results expected in Q4 2021.

Based on the positive proof-of-concept study, in February 2020, UCB decided to move into late stage development with bimekizumab also in moderate to severe hidradenitis suppurativa (HS), a severe inflammatory skin disease, affecting predominantly women (Phase 3 program BE HEARD). First headline results are expected in H1 2023.

Zilucoplan

With the successful completion of the Ra Pharma acquisition in April 2020, zilucoplan was added to UCB’s pipeline. Zilucoplan is a peptide inhibitor of complement component 5 (C5) currently in Phase 3 in general myasthenia gravis (gMG) with first results expected in Q4 2021 and currently in phase 2a in immune-mediated necrotizing myopathy (IMNM) with first results expected in H1 2021.

Zilucoplan is also being investigated in amyotrophic lateral sclerosis (ALS) by HEALEY ALS Platform Trial and in COVID-associated ARDS (acute respiratory distress syndrome) by University of Ghent (Belgium), the Medical Research Council (U.K.) and by COMMUNITY, a global platform trial for hospitalized patients with COVID-19 by COVID R&D Alliance (Amgen Inc., Takeda Pharmaceutical Co. Ltd. and UCB).

Rozanolixizumab

UCB is focusing its resources to new patient populations with autoantibody mediated neuro-inflammation and high unmet medical need. With these patients potentially benefitting from rozanolixizumab, UCB is preparing the start of two clinical programs already during 2021 – next to the ongoing Phase 3 studies in generalized myasthenia gravis (gMG) and immune throm-bocytopenia (ITP). People living with chronic inflammatory demyelinating polyneuropathy (CIDP) are a heterogenous and complex patient population, with approximately only 30% having detectable autoantibodies. While the phase 2a study in CIDP patients supports the conduct of a confirmatory clinical study, UCB decided to prioritize autoantibody mediated neuro-inflammation indications over CIDP.

Dapirolizumab pegol: in August 2020, UCB and its partner, Biogen, included the first patients into the Phase 3 program with dapirolizumab pegol in patients with active systemic lupus erythematosus (SLE) despite standard-of-care treatment. First headline results are expected in H1 2024.

Staccato® Alprazolam was added to UCB pipeline by the acquisition of Engage Therapeutics and designed to be used as a single-use epileptic seizure rescue therapy that combines the Staccato® delivery technology with alprazolam, a benzodiazepine. The Phase 3 program is expected to start in the second half of 2021.

Bepranemab (UCB0107): Initiation of a Phase 2 study in Alzheimer’s disease (AD) is planned for mid-2021, following the partnership agreement with Roche/Genentech. This will allow to evaluate the potential of bepranemab in a tau-mediated disease and subsequently explore options in different tauopathy populations, including progressive supranuclear palsy (PSP).

Padsevonil: Top-line results from ARISE, the first of two adequate and well-controlled studies, investigating the efficacy and safety of padsevonil for the treatment of observable focal-onset seizures in adults with drug-resistant epilepsy did not reach statistical significance for either of the primary end-points. Padsevonil was generally well-tolerated and its safety profile was consistent with that seen in earlier studies. Further analysis of the data led UCB to the decision to terminate the padsevonil program as it did not offer sufficient benefit for people living with epilepsy over existing anti-epileptic treatment options.

All other clinical development programs are continuing as planned.