2021 – Delivering on UCB's Strategy and Commitments

UCB Full-Year Report 2021, Brussels (Belgium), 24 February 2022 – 7:00 (CET) – regulated information

1 CER = constant exchange rates
2 adj. EBITDA = adjusted Earnings Before Interest, Taxes, Depreciation and Amortization charges
3 Core EPS = core earnings per share

FY 2021 revenue reached € 5.78 billion (+8%; +10% CER¹). Net sales went up by 8% to € 5.47 billion (+11% CER¹), driven by the continued growth of UCB’s product portfolio.

Underlying profitability (adjusted EBITDA²) reached € 1.64 billion (+14%; +21% CER¹) reflecting higher revenue, higher marketing and selling – due to upcoming launches – slightly higher research and development expenses and a strong increase in other operating income due to Evenity^® (romosozumab).

Profit increased to € 1 058 million (+39%; +51% CER¹). Core EPS³ were € 6.49 after € 5.36 in 2020. The Board of Directors of UCB proposes a dividend of € 1.30 per share (gross), +2%.

Regulatory and R&D update

BIMZELX^® (bimekizumab) - In August 2021, BIMZELX^® (bimekizumab) was approved in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In August, BIMZELX^® also received its marketing authorization in Great Britain.

On October 15, 2021, the U.S. Food and Drug Administration (FDA) deferred the Prescription Drug User Fee Act (PDUFA) date for bimekizumab. The FDA indicated that they were unable to finish the current review cycle due to COVID-19-related restrictions on travel. UCB is expecting an FDA decision in the first half of 2022.

In January and February 2022, BIMZELX^® was approved in Japan and Canada respectively.
In an unprecedented string of events, UCB announced positive topline results of four Phase 3 readouts towards the end of 2021 and early 2022. The safety profile of bimekizumab in all four studies was consistent with safety findings seen in previous studies with no new observed safety signals: 

• Two positive study results for bimekizumab in psoriatic arthritis (biologic disease-modifying anti-rheumatic drug-naïve patients and patients with inadequate response or intolerant to anti-TNF treatment). Both studies in the treatment of adults with active psoriatic arthritis met the primary and all ranked secondary endpoints with statistically significant and clinically meaningful results.
• Positive results of two Phase 3 studies evaluating bimekizumab across the full spectrum of axial spondyloarthritis (axSpA), which includes both radiographic (also known as ankylosing spondylitis or AS) and non-radiographic (nr)-axSpA. Both studies met the primary and all ranked secondary endpoints with statistically significant and clinically meaningful results, supporting that bimekizumab improved outcomes in patients across the full disease spectrum of axSpA.

The ongoing Phase 3 program with bimekizumab in moderate to severe hidradenitis suppurativa (HS), a chronic, inflammatory, and debilitating follicular skin disease, showed an accelerated patient recruitment, hence, the first topline results are now projected for H2 2022.

1 CER = constant exchange rates
2 adj. EBITDA = adjusted Earnings Before Interest, Taxes, Depreciation and Amortization charges
3 Core EPS = core earnings per share

Rozanolixizumab - a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn), showed positive topline results from the Phase 3 study in patients with generalized myasthenia gravis (gMG). The study met the primary and all secondary endpoints with statistically significant and clinically meaningful results. Rozanolixizumab was well-tolerated with no new observed safety signals. Maintaining UCB’s focus on autoantibody-mediated neuroinflammation, UCB announced investigating two additional patient populations using its rozanolixizumab platform: 

• People living with autoimmune encephalitis (AIE) – a rare and serious medical condition, in which the immune system attacks the brain – leading to epileptic seizures, movement disorders as well as cognitive decline in some patients. There is no therapy approved for AIE. The phase 2a study in AIE started in Q3 2021; first topline results are expected in H1 2024.
• People living with myelin oligodendrocyte glycoprotein (MOG)-antibody disease – a rare autoimmune inflammatory demyelinating disorder of the central nervous system caused by autoantibodies that target the MOG protein – leading to temporal functional blindness, muscle weakness, bladder dysfunction, sensory loss, and/or pain. There is no approved therapy for MOG-antibody disease. The Phase 3 study started in Q4 2021; first topline results are expected H2 2024. 

Zilucoplan - a self-administered, subcutaneous peptide inhibitor of complement component 5 (C5 inhibitor), reported positive topline results from the Phase 3 study in patients with generalized myasthenia gravis (gMG). The study met the primary and all key secondary endpoints with statistically significant and clinically meaningful results. Zilucoplan was well-tolerated with no new observed safety signals.

STACCATO^® Alprazolam - 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 (within 90 seconds) terminate an active epileptic seizure. The Phase 3 trial to assess the efficacy and safety in study participants with stereotypical prolonged seizures started in Q4 2021 and topline results are expected in H1 2024.

UCB0599 - In collaboration with UCB's new partner Novartis a Phase 2a study with UCB0599 for study participants with early-stage PD started, first topline results are expected in H2 2023.

All other clinical development programs are continuing as planned. In 2021, the timelines for UCB’s clinical development program have not experienced any material delays due to COVID-19. UCB continues to monitor the impact of COVID-19 on all ongoing clinical trials and will implement changes as necessary. 

Net sales break-down by product
Due to rounding, some financial data may not add up in the tables. 

CIMZIA^® (certolizumab pegol) reached 170 000 people living with inflammatory TNF-mediated diseases, driven by continued growth in the U.S. – despite a reimbursement decrease since July, overcompensated by a volume increase – and a slight decline in Europe, reflecting the mandated price decrease in Germany in April and a strong growth in other markets.

VIMPAT^® (lacosamide) was accessed by over 800 000 people living with epilepsy and showed strong growth in all regions, reaching the expected peak sales of at least € 1.5bn, ahead of the loss of exclusivity in 2022 in the U.S. and Europe.

KEPPRA^® (levetiracetam) reached over 2 million people living with epilepsy. The continued generic erosion in the U.S. and Europe has been overcompensated by the performance in Japan, where UCB took over distribution of E Keppra^® from partner Otsuka in October 2020. Generic entries to the Japanese market occurred early 2022.

BRIVIACT^® (brivaracetam), was used by 140 000 people living with epilepsy and showed significant growth in all regions. Briviact^® has a different mode of action from Vimpat® and differentiates from Keppra^®.

NEUPRO^® (rotigotine), the patch for Parkinson’s disease and restless legs syndrome, used by 385 000 patients, recorded stable net sales in a competitive market environment.

NAYZILAM^® (midazolam) Nasal SprayCIV, a nasal rescue treatment for epilepsy seizure clusters in the U.S. (launched since December 2019) reached over 50 000 patients.

EVENITY^® (romosozumab) since launch globally reached more than 200 000 women living with severe postmenopausal osteoporosis at high risk of fracture. It had its first European launch in March 2020 impacted by the pandemic. Evenity^® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners.

BIMZELX^® (bimekizumab) for people living with psoriasis had a well-received launch in autumn in Germany, the UK, Sweden and the Netherlands. Reported net sales were € 4 million. In January 2022, Bimzelx® was approved in Japan and in February in Canada. The regulatory review in the U.S. is ongoing, the FDA inspections were conducted at the manufacturing sites, a regulatory decision is expected within the first half of 2022.

2021 FY financial highlights
Due to rounding, some financial data may not add up in the tables.

Revenue in 2021 went up by 8% (+10% CER¹) to € 5 777 million and net sales increased by 8% (+11% CER¹) to € 5 471 million. This was driven by the continuous growth of UCB’s product portfolio – driving company growth. One product was added to the UCB portfolio: In September, UCB launched BIMZELX^® (bimekizumab) for the treatment of moderate to severe plaque psoriasis in Germany, the UK, Sweden and the Netherlands.

Royalty income and fees were € 79 million (-18%; -15% CER¹) and other revenue went up by 14% (+14% CER¹) to € 227 million due to milestones and other payments from R&D partners. 

Gross profit reached € 4 339 million with a plus of 9% (+12% CER¹) and reflecting an improved gross margin of 75.1% compared to 2020 with 74.5%. 

Operating expenses increased to € 3 021 million (+4%; +5% CER¹) reflecting:

• 10% higher marketing and selling expenses of € 1 346 million – driven by launches and pre-launch activities, 
• 4% higher research and development expenses of € 1 629 million reflecting the investments in UCB’s progressing pipeline encompassing five late-stage assets and ongoing earlier stage research. The R&D ratio reached 28% in 2021 after 29% in 2020,
• 6% higher general and administrative expenses of € 208 million, driven by implementation expenses for improved value-focused allocation of resources and share based payments valuation,
• significantly higher other operating income of € 162 million after € 95 million in 2020 - driven by an income of € 151 million (+57%) reflecting the net contribution from Amgen in connection with the commercialization of EVENITY^®.

Underlying operational profitability – adjusted EBITDA² – went up to € 1 641 million (+14%; +21% CER¹) driven by continued revenue growth and moderately growing operating expenses, reflecting the investments into the future of UCB, namely into product launches and clinical development. The adjusted EBITDA ratio for 2021 (in % of revenue) reached 28%, after 27% in 2020.

Total impairment, restructuring and other income/expenses were expenses of € 34 million. In 2020, the expenses were € 122 million which was mainly driven by fees related to acquisitions, which did not reoccur in 2021.

Net financial expenses went down to € 58 million from € 93 million, mainly due to lower hedging costs and lower interest expenses.

Income tax expenses were € 170 million compared to € 119 million in 2020. The average effective tax rate was 14% compared to 13% in 2020.

Profit amounted to € 1 058 million (+39%; +51% CER¹), of which the full amount is attributable to UCB shareholders as the contributions to non-controlling interests have expired at the end of 2020. The growth was driven by strong revenue and EBITDA growth as well as lower other expenses and lower financial expenses. For 2020, profit was € 761 million of which € 732 million were attributable to UCB shareholders and € 29 million to non-controlling interests.

Core earnings per share, which reflect profit attributable to UCB shareholders, adjusted for the after-tax impact of to be adjusted items, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached € 6.49 after € 5.36 in 2020, based on stable 189 million weighted average shares outstanding.

Dividend - The Board of Directors of UCB proposes a dividend of €1.30 per share (gross), +2%.
Guidance 2022: For 2022, UCB is aiming for revenues in the range of € 5.15 - 5.4 billion based on continued core product growth and taking into account estimated impacts from the loss of exclusivity for VIMPAT^® in the U.S. (March 2022) and Europe (September 2022), E KEPPRA^® in Japan (January 2022) as well as the U.S. launch of BIMZELX^® (bimekizumab) for people living with psoriasis – the regulatory review in the U.S. is ongoing, with a decision expected in the first half of 2022. 

UCB will continue to invest into research and development to advance its late-stage development pipeline and prepare upcoming launches to offer potential new solutions for patients. Underlying profitability, adjusted EBITDA, is expected in the range of 26 - 27% of revenue, reflecting the continued high R&D and marketing & selling investment levels. Core earnings per share are therefore expected in the range of €4.80 - €5.30 per share – based on an average of 189 million shares outstanding.

The figures for the financial guidance 2022 as mentioned above are calculated on the same basis as the actual figures for 2021; they will be updated upon closing of the planned Zogenix, Inc. acquisition.

Guidance for 2025 unchanged: UCB shares its growth ambition for 2025 – despite upcoming patent expirations: Based on the strong product portfolio and the promising late-stage pipeline assets, UCB aims to lead in five specific populations by 2025, creating value for patients now and into the future. Revenue in 2025 is expected to reach at least € 6 billion and the underlying profitability (adjusted EBITDA) should reach the low to mid-thirties in percent of revenue.

Guidance 2022 & 2025: 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 evolving COVID-19 pandemic and its consequences to the business environment diligently to assess potential near- and mid-term challenges.