Key highlights

• United States: DKK 5,307 million (+11% CER; +11% DKK)
• Europe: DKK 2,517 million (+10% CER; +8% DKK)
• International Markets: DKK 2,795 million (+8% CER; +2% DKK)

• Rexulti®: DKK 2,381 million (+13% CER; +12% DKK)
• Brintellix®/Trintellix®: DKK 2,351 million (+11% CER; +9% DKK)
• Abilify Maintena®/Asimtufii: DKK 1,725 million (+9% CER; +9% DKK)
• Vyepti®: DKK 1,342 million (+78% CER; +77% DKK)

Adjusted EBITDA[2] increased to DKK 3,365 million (+5% CER; +1% DKK) reflecting the strong revenue growth across all strategic brands. Adjusted EBITDA margin reached 31.3% equivalent to a decrease of 2.1 percentage points due to higher raw material and manufacturing costs, increasing share of Vyepti® on cost of sales as well as unfavorable currency and hedging effects.

Adjusted earnings per share (EPS) reached DKK 2.64 (+7%).

Lundbeck's President and CEO, Charl van Zyl said:

"I am pleased to present an excellent performance for the first half of 2024, driven by the continued strong performance of our strategic brands allowing us to raise the guidance. I am particularly pleased with the performance of Vyepti® and Rexulti® as well as with the scientific innovation that we continue to drive with the aim of discovering new treatments for neuro-rare and neuro-specialty conditions. Recently, the FDA accepted the brexpiprazole PTSD submission and Lu AG13909 has advanced into the second investigational study with the initiation of a trial in Cushing's disease."

Key figures

[][]
DKK H1 H1 Change Change(DKK) Q2 Q2 Change Change(DKK)
million 2024 2023 (CER)[1] 2024 2023 (CER)[1]
Revenue 10,741 9,982 10% 8% 5,453 4,938 13% 10%
EBITDA 3,217 3,078 9% 5% 1,471 1,334 17% 10%
Adjusted 3,365 3,338 5% 1% 1,619 1,493 14% 8%
EBITDA
EPS 1.79 1.49 20% 0.78 0.60 30%
(DKK)
Adjusted 2.64 2.47 7% 1.26 1.11 14%
EPS
(DKK)

Recent events

On July 31, 2024, Lundbeck announced that in support of its Focused Innovator strategy aiming to create financial flexibility and reallocate resources to other growth opportunities, it has been agreed with Takeda Pharmaceutical Company Limited (Takeda) to modify the current collaboration in the U.S. from a co-promotion, cost-sharing, revenue-sharing, and royalty setup to a royalty-based model effective January 1, 2025. Consequently, effective from January 1, 2025, Lundbeck will cease all promotional efforts for Trintellix® (vortioxetine) in the U.S. This will enable Lundbeck to fully reallocate resources to other growth opportunities, including Rexulti® in the U.S. and thereby further accelerate growth for these products. As part of the agreement, Lundbeck will receive a fixed, undisclosed royalty rate based on net sales in the U.S. for 2025 and 2026. This agreement does not impact any other geographies where Trintellix® is marketed. The agreement is expected to have only a limited impact on revenue and adjusted EBITDA and will therefore not change the financial guidance for 2024 nor is it expected to change Lundbeck's mid-term targets as communicated in February 2023.

On June 25, 2024, Lundbeck and Otsuka Pharmaceutical Co., Ltd. announced the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025. If approved, brexpiprazole in combination with sertraline could represent an important advancement over the current standard of care for PTSD patients and their caregivers.

On June 19, 2024, it was announced that Lundbeck has explored a new area in neurohormonal dysfunctions by initiating a phase II trial using Lu AG13909 as a potential treatment for Cushing's disease, a serious condition which can have debilitating effects if left untreated. This marks a significant step in the advancement of Lundbeck's pipeline to deliver innovative solutions to serve areas of high unmet need. Earlier on June 3, 2024, Lundbeck presented the first in human trial of Lu AG13909 for the treatment for congenital adrenal hyperplasia (CAH), a rare debilitating disease with excess morbidity and mortality, at ENDO 2024 in Boston. The development of Lu AG13909, a first-in-class monoclonal antibody, demonstrates Lundbeck's ability to harness our industry-leading understanding of biology and disease pathways within brain health to lead to the innovation of breakthrough medicines in complex areas such as neuro-rare.

Financial guidance 2024 raised

On August 20, 2024, Lundbeck communicated that the full year revenue and adjusted EBITDA outlook at CER have been raised.

The revenue growth is expected to be 11% to 14% at CER, previously 7% to 10% at CER, when compared to revenue of the prior year excluding the effect from hedging. The adjusted EBITDA growth is expected to be 15% to 20% at CER, previously 10% to 16% at CER, when compared to adjusted EBITDA of the prior year excluding effects from hedging. Further details are available in section 2.8 Outlook.

Conference call

Tomorrow at 13.00 CET, Lundbeck will be hosting a conference call for the financial community. You can find dial-ins and a link for webcast online at www.lundbeck.com under the Investor section.
 

[1] Change at CER (Constant Exchange Rates) does not include effects from hedging.

[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.