HIGHLIGHTS

The growth of Lundbeck's strategic brands accelerated further with a growth of 31% (+20% in local currencies) in 2022, reaching DKK 12.1 billion, representing 67% of overall revenue.

• Brintellix[®]/Trintellix[®]: +21% reported to DKK 4,277 million (+13% in local currencies)
• Rexulti[®]/Rxulti[®]: +37% reported to DKK 3,890 million (+21% in local currencies)
• Abilify Maintena[®]: +22% reported to DKK 2,964 million (+16% in local currencies)
• Vyepti[®]: +104% reported to DKK 1,004 million (+80% in local currencies)

Total revenue increased by 12% (+7% in local currencies) to DKK 18,246 million, with all markets contributing strongly.

• United States: +22% reported to DKK 9,102 million (+7% in local currencies)
• International Markets: +13% reported to DKK 5,203 million (+6% in local currencies)
• Europe: +11% reported to DKK 4,252 million (+12% in local currencies)

Currency favorability on product sales continued to be partially offset by negative hedging effects of DKK 588 million while specific cost items were significantly impacted by exchange rates. The SG&A costs increased 13% of which the pure organic increase was 4%. The EBITDA margin improved from 22.8% in 2021 to 25.6% for 2022 despite increased investments in marketing and sales costs underpinning the launch of Vyepti in several markets during 2022.

• EBITDA: +25% reported to DKK 4,663 million
• EBIT: +42% reported to DKK 2,852 million
• Core EBIT: +18% reported to DKK 4,155 million
• EPS: +45% reported to DKK 1.93
• Core EPS: +28% reported to DKK 3.22

In line with our dividend policy, it is proposed to pay-out a dividend of DKK 0.58 per share or DKK 578 million which is an increase of 45% compared to 2021.

In connection with the corporate release, Lundbeck's President and CEO, Deborah Dunsire said:

"I am very pleased with our operational performance in 2022. We delivered our best ever revenue result and exceptional growth in profits. Our pipeline continues to progress according to our plans. In 2023, we look forward to continuing to grow our strategic brands and deliver solid results, at the same time we continue to invest into the continued global roll-out of Vyepti, the launch of brexpiprazole in Alzheimer's agitation and the launch of aripiprazole 2M RTU formulation."

Key figures:

[][][][][][]
DKK million FY 2022 FY 2021 Growth Q4 2022 Q4 2021 Growth
Core Revenue[1] 18,246  16,299  12% 4,680 4,053 15%
Core EBIT[1] 4,155  3,517  18% 783 544 44%
Core EPS[1],[2] 3.22  2.51  28% 0.61 0.42 45%
Core EBIT-margin[1] 22.8% 21.6% 16.7% 13.4%

Reported Revenue 18,246  16,299  12% 4,680 4,053 15%
EBITDA 4,663 3,720 25% 910 440 107%
Reported EBIT 2,852  2,010  42% 403 6 6,617%
Reported EPS[2] 1.93  1.33  45% 0.31 -
Reported EBIT-margin 15.6% 12.3% 8.6% 0.1%

1 For definition of the measures "Core Revenue", "Core EBIT", "Core EPS" and "Core EBIT-margin", see note 2 Core reporting.

2 The calculation of EPS is based on a share denomination of DKK 1 as a result of the share split completed on June 8, 2022. Comparative figures have been restated to reflect the change in trading unit from a nominal value of DKK 5 to DKK 1.  

 

In January 2023, Lundbeck announced the FDA acceptance and priority review of the sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia. The FDA target date (PDUFA date) for completion of the review is May 10, 2023.

Lu AG13909 is Lundbeck's first neurohormonal project and has entered clinical phase I in December 2022. Lu AG13909 is a humanized anti-adrenocorticotropic hormone (anti-ACTH) monoclonal antibody that blocks the binding of ACTH to the melanocortin 2 receptor in the adrenal glands, thereby decreasing the neurohormonal signaling of ACTH.

 

2023 GUIDANCE AND MID-TERM TARGETS

In 2023, Lundbeck will continue the global roll-out of Vyepti with around 15 launches. Additionally, Lundbeck plans to launch aripiprazole 2-month ready-to-use (RTU) long-acting injectable (LAI) for both treatment of schizophrenia and the maintenance treatment of bipolar I disorder and brexpiprazole for the significant unmet need for patients with agitation associated with Alzheimer's dementia, pending approvals by the relevant authorities later in 2023.

The financial guidance for 2023 reflects the expected investments needed for these important launches driving significant future growth. Lundbeck continues to expect strong growth for its strategic brands despite continued pricing pressure and loss of exclusivity in some geographies. Inflation will have a significantly higher impact in 2023 than seen in 2022. The financial guidance for 2023 is summarized below:

Financial guidance

DKK FY 2021 actual FY 2022 actual FY 2023 guidance
Revenue  16,299 million DKK 18,246 million DKK 19.4 - 20.0 billion
EBITDA 3,720 million DKK 4,663 million DKK 4.8 - 5.2 billion

 

Lundbeck is in a period with limited impact from major regional loss of exclusivity and anticipates solid growth of its strategic brands. We expect that in 2023 and 2024 there will be targeted investments behind the potential blockbuster opportunity for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia. Based on organic growth, we expect revenue to show a mid-single digit compound annual growth rate (CAGR) over the mid-term, (3-4 years). At the same time, we remain focused on driving efficiencies and being prudent in our spending. Based on these assumptions, we target an EBITDA-margin of 30-32% for the current business, excluding any business development activities, by the end of the mid-term period.