LEO Pharma Achieves 11% H1 Revenue Growth, Raises Annual Financial Forecast

In the first six months of 2024, LEO Pharma has shown significant progress by sticking to its strategic roadmap, with a focus on its dermatology portfolio as the main growth catalyst. The company reported an 11% revenue growth in constant exchange rates (CER) and achieved an EBITDA margin of 9% during this period. These figures illustrate LEO Pharma's steady path towards solid financial performance for the entire year, prompting a positive revision of its financial outlook.

LEO Pharma’s CEO, Christophe Bourdon, expressed satisfaction with the consistent and solid sales growth in the first half of 2024, highlighting that 100 million people globally are now benefiting from the company's innovative dermatological treatments. Dermatology revenue alone grew by 13% (CER). Bourdon attributed the improved earnings to the company's strategic actions, commercial success, and cost management efforts. He emphasized that the rest of 2024 will focus on preparing for the potential European launch of delgocitinib, expanding the pipeline, and maintaining strategic execution.

Key Financial Metrics for H1 2024:
- Revenue increased by 11% (CER) to DKK 6,375 million compared to DKK 5,797 million in H1 2023, with reported growth at 10%.
- Revenue from dermatology climbed by 13% (CER) to DKK 5,101 million, primarily driven by the strong performance of Adtralza®/Adbry® for atopic dermatitis (AD) and the core dermatology products.
- Adbry®/Adtralza® revenue surged by 84% (CER), with significant uptake across markets, particularly in North America.
- The core dermatology portfolio grew 5% (CER), driven mainly by products like Enstilar® and Protopic®.
- Revenue growth was noted across all regions: North America saw a 43% increase, Europe a 7% rise, and the Rest of the World a 6% (CER) growth. North America remains a crucial growth driver with revenue reaching DKK 1,022 million.
- Thrombosis revenue went up by 8% (CER), aided by European market sales and some extraordinary items, with underlying growth at 4%.
- Adjusted EBITDA reached DKK 599 million, up from DKK 488 million in H1 2023, resulting in a 9% EBITDA margin, supported by revenue growth and operational efficiencies.
- EBIT was a negative DKK 235 million, an improvement of DKK 99 million compared to H1 2023.
- Free cash flow recorded a net outflow of DKK 779 million, better than the DKK 2,035 million outflow in H1 2023.

Strategic Priorities:
LEO Pharma remains committed to its transformation into a global leader in medical dermatology, showing a robust track record in financial turnaround and sustained double-digit revenue growth. The company has established a commercial foundation and diverse product portfolio, positioning itself well for the planned launch of delgocitinib in Germany in the fourth quarter.

Notable Achievements:
- The Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending European approval of delgocitinib for adult patients with moderate to severe chronic hand eczema (CHE).
- Results from pivotal DELTA 1 and DELTA 2 trials with delgocitinib were published in The Lancet, one of the leading medical journals. These trials assessed the safety and efficacy of investigational delgocitinib cream in adults with moderate to severe CHE.
- LEO Pharma's U.S. business was bolstered by the FDA approval of the Adbry® 300 mg single-dose autoinjector for adults.
- Positive results from the Enstilar® phase 3 trial in China reinforce the company’s commitment to expanding its presence in the Chinese market.
- However, the phase 3 trial of TMB-001 in congenital ichthyosis did not show a statistically significant difference between active treatment and vehicle.

2024 Financial Outlook:
Given the robust sales performance in the first half of 2024, LEO Pharma has revised its full-year revenue growth outlook upwards to 9-11% (CER), previously 5-8%. The revised forecast is driven by strong performance in the U.S. and delayed impacts from price reforms and generic competition in select areas. Adjusted EBITDA margin outlook has also been revised upwards to a positive range of 6-8%. Despite improvements, the company still expects to report negative EBIT and net results for the full year of 2024. Risk factors include market growth assumptions and unexpected healthcare and pricing reforms.

About LEO Pharma:
LEO Pharma, headquartered in Denmark, is dedicated to advancing care for skin conditions. Founded in 1908 and majority-owned by the LEO Foundation, the company has a long history in dermatology research and development. LEO Pharma serves millions globally with a wide range of therapies and employs approximately 4,200 people worldwide. In 2023, the company generated net sales of DKK 11.4 billion.