H1 2024 financial highlights

• Revenue grew 11% (CER) to DKK 6,375 million (H1 2023: DKK 5,797 million). Reported growth was 10%.
• Dermatology revenue grew 13% (CER) to DKK 5,101 million (H1 2023: DKK 4,576 million), driven by strong growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core dermatology portfolio.
• Adbry®/Adtralza® revenue increased by 84% (CER) driven by continued uptake across markets, especially in North America.
• Core dermatology portfolio delivered growth of 5% (CER) across markets. Growth was largely driven by Enstilar® and Protopic®.
• Growth across all regions: North America up 43%, Europe up 7%, Rest of the World up 6% (CER). North America continues to be the key growth driver with revenue of DKK 1,022 million.
• Thrombosis revenue increased by 8% (CER) driven by sales across European markets and positively impacted by certain extraordinary items during H1 2024, with underlying growth being 4%.
• Adjusted EBITDA was DKK 599 million (H1 2023: DKK 488 million) corresponding to a EBITDA margin of 9%, benefiting from revenue growth and operational efficiencies.
• EBIT was negative DKK 235 million, which represents an improvement of DKK 99 million compared to H1 2023.
• Free cash flow for H1 2024 was a net outflow of DKK 779 million, improved compared to H1 2023 (H1 2023: DKK (2,035) million).

Progress on strategic priorities

• With a solid track record of delivering on the financial turnaround and consistent double-digit revenue growth, LEO Pharma remains fully committed to transforming the company into a global leader in medical dermatology.
• An established commercial platform with a diversified product portfolio, along with strong launch capabilities, is in place ahead of the planned launch of delgocitinib in Germany in Q4.
• Positive Committee for Medicinal Products for Human Use (CHMP) opinion recommending European approval of delgocitinib for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.
• Publication of results from pivotal DELTA 1 and DELTA 2 trials with delgocitinib in The Lancet, one of the most influential peer-reviewed medical periodicals in the world. The DELTA 1 and DELTA 2 trials investigated the safety and efficacy of investigational delgocitinib cream in adult patients with moderate to severe CHE.
• U.S. business strengthened with the FDA approval of Adbry® 300 mg single-dose autoinjector for adult patients.
• Successful Enstilar® phase 3 trial results in China confirms LEO Pharma’s commitment to expanding its presence in China.
• Phase 3 trial of TMB-001 in congenital ichthyosis did not show a statistically significant difference between active treatment and vehicle.

2024 financial outlook

• With our consistent increase in sales performance in H1 2024, LEO Pharma is revising its full-year revenue growth outlook upwards compared to what was shared on 3rd May 2024. Full-year revenue growth is now projected to be 9-11% in CER (before: 5-8%). The upwards revision is driven by stronger financial performance in the U.S. in addition to delayed impact from price reforms and generic competition in selected geographies.
• As a result of the solid first half year results, LEO Pharma is also revising its outlook upwards for adjusted EBITDA margin from a positive mid-single digit margin to a positive margin range of 6-8%.
• We continue to expect significant improvements in EBIT and net result relative to 2023, although still expecting to deliver both negative EBIT and net result for full year 2024.
• Potential changes in key assumptions for market growth and unexpected health care and pricing reforms are key risk factors, among others, which could change the outlook for the year.