Brussels (Belgium) regulated information inside information - UCB is updating its 2022 financial guidance factoring in the impact of the Zogenix acquisition, the complete response letter for bimekizumab in the U.S. and macro-economic conditions. UCB's foundation for growth is strong as demonstrated by recent positive clinical phase 3 study results which will lead to regulatory submissions starting next quarter. The company is confident in its ability to deliver value and growth for patients and all other stakeholders through its strong fundamental underlying performance. UCB reiterates its 2025 financial guidance.
Jean-Christophe Tellier, CEO UCB says: 'We aim to submit our response to the complete response letter by the end of the year - and are fully committed to bring bimekizumab as treatment option to people living with psoriasis in the U.S. We are updating our financial guidance, reflecting the most recent events and the current macro situation. UCB's underlying performance is solid, despite the impacts from the loss of exclusivity for E KEPPRA in Japan since January and for VIMPAT in the U.S. since March. We are very confident in our future launches and our strategic growth path ahead, supported by dynamic management and efficiency initiatives in all areas of UCB. Our drive to create value for patients, now and into the future, remains stronger than ever.'
Bimekizumab complete response letter response timing
UCB aims to submit the response to the bimekizumab complete response letter (CRL) to the U.S. Food and Drug Administration (FDA) by the end of 2022. UCB will address all observations and questions noted in the CRL and is fully confident in the quality of its manufacturing process. Upon receiving the response, the FDA will classify the response following the re-submission. A Class 1 re-submission would imply a 2-month review cycle by the FDA post the re-submission date, and a Class 2 re-submission would imply a 6-month review cycle post the re-submission date.
Updated financial guidance 2022
Zogenix acquisition
Following the close of the Zogenix, Inc. acquisition in early March 2022, the full integration process is nearly complete. This acquisition is now for the first time reflected in UCB's financial guidance. Together with the team from Zogenix, UCB is bringing FINTEPLA (fenfluramine) oral solution to patients and their families around the world living with Dravet Syndrome and Lennox-Gastaut Syndrome (LGS). FINTEPLA is available in the U.S and Europe to treat seizures associated with Dravet Syndrome. In June, UK's National Institute for Healthcare Excellence (NICE) issued a positive Final Appraisal Determination (FAD) recommending FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet Syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. Since late March 2022, FINTEPLA is approved in the U.S. for the treatment of Lennox-Gastaut Syndrome (LGS), in patients two years of age and older. The application review for LGS in the EU and other regions is ongoing.
The new financial guidance for 2022 takes into account the expected net sales contribution from FINTEPLA as well as the additional research and development, marketing and selling and other expenses, leading to a dilution of the UCB earnings, consistent with UCB's assessment at the time of the acquisition. The dilution to UCB's adjusted EBITDA guidance is expected around 2.5%-points in 2022. The acquisition is expected to be earnings accretive from 2023 onwards.
Bimekizumab complete response letter impact
UCB aims to submit the response to the bimekizumab complete response letter (CRL) to the U.S. Food and Drug Administration (FDA) by the end of 2022. Adjustments to the 2022 financial guidance removed the 2022 net sales contribution in the U.S., adjusted the expenses while ensuring that the expected launch is secured and reflect the gross profit and tax implications.
Since the second half of 2021, BIMZELX (bimekizumab) is available to people living with psoriasis in the European Union /European Economic Area, Great Britain, Japan, Canada and approved in Australia.
Macro environment adding up
Multiple external headwinds combined with a difficult macro-economic situation are leading to upward pressure on costs - like significantly higher than anticipated inflation including energy costs, the war in Ukraine including drug supply and donations to Ukraine. These were reflected in the new updated financial guidance for 2022.
Adjusted financial guidance for 2022
For 2022, UCB is now aiming for revenues in the range of EUR5.3 - 5.4 billion based on continued core product growth and taking into account impacts from the loss of exclusivity for VIMPAT in the U.S. (March) and Europe (September) and the strong generic competition to E KEPPRA in Japan since January.
UCB continues to invest in research and development to advance its late-stage development pipeline and prepare for upcoming launches to offer potential new solutions for patients. Underlying profitability, adjusted EBITDA, is now expected in the range of 21 - 22% of revenue, also reflecting the continued research and development and marketing & selling investment levels. Core earnings per share are therefore expected in the range of EUR3.70 - 4.00 per share - based on an average of 189 million shares outstanding.
The figures for the new financial guidance 2022 as mentioned above are calculated on the same basis as the actual figures for 2021; they have been extended by the consolidation of the acquisition of Zogenix, Inc.
UCB will publish its Half-Year Report 2022 on July 28, 2022.
2025 financial guidance -confirmed
Supported by solid multiple scenario planning and sustainable efficiency generating initiatives in all areas of UCB - being introduced since Q4 2021 - UCB maintains its financial guidance for 2025. Revenue in 2025 is expected to reach at least EUR 6 billion and the underlying profitability (adjusted EBITDA) should reach the low to mid-thirties in percent of revenue.
Based on UCB's current assessment of the Covid-19 pandemic, UCB remains confident in the fundamental underlying demand for its products in the short-term and its prospects for long-term growth. UCB will continue to closely follow the evolving COVID-19 pandemic and its consequences to the business environment diligently to assess potential near- and mid-term challenges.
Contact:
Investor
Antje Witte
T: +32.2.559.9414
E: antje.witte@ucb.com
ZOGENIX, INC. 
