Key highlights

• United States: DKK 2,337 million (+22%; +16% CER)
• International Markets: DKK 1,499 million (+3%; +3% CER)
• Europe: DKK 1,174 million (+15%; +14% CER)

• Brintellix[®]/Trintellix[®]: DKK 1,077 million (+9%; +7% CER)
• Rexulti[®]/Rxulti[®]: DKK 1,060 million (+28%; +22% CER)
• Abilify Maintena[®]: DKK 785 million (+16%; +14% CER)
• Vyepti[®]: DKK 351 million (+106%; +97% CER)

Adjusted EBITDA[2] increased to DKK 1,845 million (+43%; +39% CER) and adjusted EBITDA margin reached 36.6% equivalent to an increase of 7.1 percentage points. Adjusted earnings per share (EPS) reached DKK 1.36 equivalent to an increase of 33%.

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

"I am very pleased with our operational performance in the first quarter. Lundbeck continues to show excellent growth driven by our strategic brands also driving profitability in the quarter. In the first quarter of 2023, Lundbeck delivered the highest quarterly revenue ever. I am delighted with the impact of our R&D transformation, delivering a positive Advisory committee vote for Rexulti in AAD, the on-time FDA approval for Abilify Asimtufii and the positive proof of concept for our novel PACAP-inhibitor."

Key figures:

[]
DKK million Q1 2023 Q1 2022 Change Change
(CER)
Revenue 5,044 4,372 15% 11%*
EBITDA 1,744 1,290 35% 31%
Adjusted EBITDA 1,845 1,290 43% 39%
EPS (DKK)[**] 0.89 0.41 117%
Adjusted EPS (DKK) 1.36 1.02 33%

* Revenue change at CER does not include effects from hedging.
** 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.

Recent events

On April 27, 2023, Lundbeck and Otsuka Pharmaceutical, Inc. (Otsuka) announced that FDA has approved the New Drug Application (NDA) for Abilify Asimtufii[®] (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. Abilify Asimtufii offers two months of sustained therapeutic concentrations with one dose.

On April 16, 2023, Lundbeck and Otsuka announced that the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease. The committees voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating agitation associated with dementia due to Alzheimer's disease with brexpiprazole outweigh its risks. If approved, brexpiprazole would be the first FDA-approved treatment indicated for the treatment of agitation associated with dementia due to Alzheimer's disease in the U.S. The FDA will address the feedback from the committee as it reviews the sNDA for brexpiprazole in advance of the May 10, 2023 Prescription Drug User Fee Act (PDUFA) target action date.

On April 19, 2023, Lundbeck announced headline results from the HOPE trial with the anti-PACAP ("`222"). `222 met its primary endpoint in migraine prevention; patients treated with this monoclonal antibody, had a statistically significantly greater reduction vs. placebo in the number of monthly migraine days from baseline to week 4 of treatment. The efficacy was consistent across multiple endpoints and '222 was well tolerated by the patients at the doses tested. The elimination of PACAP with `222 and thereby the interruption of its downstream signaling via a set of receptors, represents a new therapeutic possibility. The mode of action is distinct from the calcitonin gene-related peptide (CGRP) biology, which is targeted by the recently available migraine treatment drug class.

2023 Guidance

On February 7, 2023, Lundbeck communicated the financial guidance for 2023 focusing on revenue performance and, from the first quarter of 2023 and onwards, on adjusted EBITDA.

• Revenue expected at DKK 19.4 - 20.0 billion
• Adjusted EBITDA expected at DKK 5.1 - 5.5 billion (previous EBITDA expected at DKK 4.8 - 5.2 billion)

The previously communicated expected provision of approximately DKK 300 million for Vyepti inventory obsolescence is reflected in the Adjusted EBITDA guidance for 2023. Of the total expected provision, DKK 101 million has been recognized in the first quarter of 2023.

[1] Constant Exchange Rates (CER) previously denominated Local Currencies (LC).
[2] EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section 4 Notes, note 3 Adjusted EBITDA.