Lundbeck continues solid operational performance with strong growth from strategic brands in Q3 2021

HIGHLIGHTS

Revenue reached DKK 12,246 million in the first nine months of 2021, a decline of 5% in local currencies primarily due to loss of exclusivity erosion on Northera^®. EBIT grew 29% compared to the same period in 2020 and reached DKK 2,004 million. EBIT margin reached 16.4%. EPS grew by 28% for the period, reaching DKK 6.64.

In aggregate, strategic brands grew 17% in local currencies reaching DKK 6,815 million in the first nine months of the year, representing 56% of total revenue. In the third quarter of 2021, all strategic brands have continued their double-digit growth. Based on trends in Trintellix and Rexulti in the U.S., there is a gradual uptick in new patient starts as the pandemic wanes, further supporting positive growth.

The newest product in the portfolio, Vyepti^®, continues to grow strongly since its launch in April 2020, reaching DKK 328 million in the first nine months of 2021 compared to DKK 42 million for the same period last year. Vyepti is approved in seven markets, commercially launched in two markets and regulatory review is ongoing in 14 markets including Europe.

Strategic brand performance:

• • Revenue of Abilify Maintena^®: DKK 1,810 million (up 7% in local currencies, 5% reported)
  • Revenue of Brintellix^®/Trintellix^®: DKK 2,565 million (up 16% in local currencies, 11% reported)
  • Revenue of Rexulti^®/Rxulti^®: DKK 2,112 million (up 13% in local currencies, 5% reported)
  • Revenue of Vyepti^®: DKK 328 million (up 731% in local currencies, 681% reported)

Market performance:

• • Revenue in North America: DKK 6,068 million (down 12% in local currencies, 17% reported)
  • Revenue in International Markets: DKK 3,281 million (up 5% in local currencies, 1% reported)
  • Revenue in Europe: DKK 2,608 million (up 4% in local currencies, 4% reported)

In connection with the financial report, Lundbeck’s President and CEO Deborah Dunsire said:

“I am very pleased with the results for the first nine months of the year. Our brands are continuing to perform well across all markets and delivering solid growth and Vyepti continues to have good uptake. Our transformed approach to R&D is showing results, with an expanding early- and mid-stage pipeline. The recent addition of an early stage CD40L inhibitor into our early-stage portfolio gives us a promising start to further develop our neuroimmunology platform. I see a strong future ahead of us.”

Key figures:

DKK million	9M 2021	9M 2020	Growth
Core Revenue*	12,246	13,397	(9%)
Core EBIT*	2,973	3,644	(18%)
Core EPS*	10.48	14.60	(28%)
Core EBIT margin*	24.3%	27.2%
Reported Revenue	12,246	13,397	(9%)
Reported EBIT	2,004	1,559	29%
Reported EPS	6.64	5.17	28%
Reported EBIT margin	16.4%	11.6%

*For definition of the measures “Core Revenue”, “Core EBIT”, “Core EBIT margin” and “Core EPS”, see note 5● Core reporting

The phase IIIb DELIVER-study with Vyepti, in patients with migraine that failed 2-4 prior treatments, met its primary endpoint of change from baseline in the number of monthly migraine days (MMDs), and also significantly more patients treated with Vyepti vs placebo had a 50%, or greater, reduction in MMDs.

Lundbeck has initiated a phase II PoC study for potential new treatment of multiple system atrophy (MSA) with Lu AF82422, which represents a novel approach for potential treatment of MSA, a condition with a high and urgent unmet medical need.

Lundbeck has received exclusive, worldwide rights to APB-A1 (now Lu AG22515), a differentiated anti-CD40 ligand (CD40L) antibody, ready for phase I testing in the beginning of 2022.

Core EBIT reached DKK 2,973 million and Core EBIT margin reached 24.3%. Profitability is benefitting from COVID-19 related cost avoidance but is also negatively impacted by Northera erosion on the revenue side.

The financial guidance for 2021 is maintained. Lundbeck expects revenue to reach DKK 16.3 – 16.6 billion. Core EBIT is expected to reach DKK 3.3 – 3.6 billion and EBIT to reach DKK 2.0 – 2.3 billion.