Solid start to the year: 13% revenue growth driven by strong performance in dermatology

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Q1 2024 Trading Update (Unaudited): In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER). The dermatology portfolio saw accelerated growth in revenue of 16%. The acquisition of TMB-001 to the treatment of congenital ichthyosis added a late-stage asset to LEO Pharma’s medical dermatology pipeline, and delgocitinib for chronic hand eczema (CHE) is on track for its planned European launch in Q4 2024. Full-year outlook has been revised slightly upwards.

LEO Pharma - Ballerup Headquarters
LEO Pharma - Ballerup Headquarters

Q1 2024 financial highlights

  • Revenue grew 13% to DKK 3,064 million (Q1 2023: 2,763 million). Reported growth was 11%.
  • Dermatology revenue grew 16% to DKK 2,444 million (Q1 2023: 2,150 million), driven by growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core portfolio.
  • Adbry®/Adtralza® revenue increased by 90% driven by continued uptake across markets.
  • Core dermatology portfolio delivered growth of 9% across our Affiliate and Alliance markets. Growth largely driven by the Fucidin® Range, Enstilar® and Protopic® across our eczema, psoriasis and skin infection portfolios.
  • Growth across all regions: North America up 42%, Europe up 6%, Rest of the World up 15%. North America continues to be the key growth driver with revenue of DKK 439 million (Q1 2023: 313 million).

 Progress on strategic priorities

  • To advance the growth of our U.S. business, LEO Pharma added a late-stage asset to our medical dermatology pipeline by finalizing the strategic acquisition of TMB-001 to the treatment of congenital ichthyosis. In Q1 2024, patient recruitment was completed for the Phase III ASCEND trial.
  • The recent results of the successful DELTA FORCE-trial comparing delgocitinib to current standard of care, further confirms delgocitinib’s potential to become a key growth driver for the company and we will be investing additional resources in accelerating the launch of this potential treatment to patients.
  • Regulatory review of the marketing authorization application is pending in the EU, and based on the positive outcome of the DELTA clinical program, LEO Pharma is assessing ways to bring this potential treatment to other markets as well, including the U.S.
  • Adbry® (tralokinumab-ldrm) data from the ECZTEND trial was shared during the American Academy of Dermatology (AAD) Annual Meeting investigating the stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe AD.

“First quarter marks a solid start to 2024 with a 13% revenue growth and continued progress on our strategic priorities. I am pleased with the strong growth track record for our global dermatology portfolio, primarily driven by performance in North America. Furthermore, I am excited about the progress we are making in building evidence and bringing delgocitinib to the market to help patients with chronic hand eczema. The positive results from the recently completed head-to-head trial against current standard of care make us even more motivated to accelerate our efforts,” says CEO Christophe Bourdon.

2024 financial outlook

  • Following our strong Q1 2024 performance, we are revising our full-year revenue growth outlook upwards compared to what was shared in the Annual Report on 29th February 2024. Full-year revenue growth is now projected to be 5-8% in CER (before: 4-8%).
  • Potential changes in key assumptions for market growth and unexpected health care and pricing reforms are risk factors, among others, which could change the outlook for the year.

Sales performance

In Q1 2024, revenue grew 13% (CER) to DKK 3,064 million from DKK 2,763 million in the same period last year, corresponding to a reported growth in DKK of 11%. Dermatology revenue was a significant contributor with 16% in CER. While growth is attributed to the performance of both recently launched dermatology products Adtralza®/Adbry®, as well as core dermatology products, a part of growth was also attributable to timing of shipments especially in rest of world.

          Growth composition
(DKK million) Q1 2024 Q1 2023 FY 2023   CER growth Reported growth
Revenue by region            
Europe 1.698 1.588 6.375   6% 7%
North America 439 313 1.667   42% 40%
Rest of World 927 862 3.350   15% 7%
Total 3.064 2.763 11.392   13% 11%
             
Revenue by therapeutic area            
Dermatology            
  Psoriasis 1.012 951 3.813   9% 6%
  Skin Infection 432 416 1.771   6% 4%
  Eczema 836 639 2.900   34% 31%
  Acne/Rosacea 101 85 317   21% 18%
  Other Mature Dermatology 63 59 238   13% 6%
Total dermatology 2.444 2.150 9.039   16% 13%
Thrombosis 588 566 2.141   4% 4%
CMO* 32 47 212   (31)% (31)%
Total 3.064 2.763 11.392   13% 11%
*Contract manufacturing of divested products 

LEO Pharma expects to issue a company announcement on the financial performance and progress on strategic priorities in the first half of 2024 on 26 August 2024.

Ballerup, 3 May 2024,

LEO Pharma

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About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of approx. 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

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LEO Pharma announces topline results of phase 3 trial in China for Enstilar® (LEO 90100) demonstrating superiority in adult Chinese subjects with stable plaque psoriasis7.5.2024 20:00:00 CEST | Pressemeddelelse

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LEO Pharma announces positive phase 3 head-to-head data results from DELTA FORCE trial comparing delgocitinib cream with alitretinoin capsules in adults with severe chronic hand eczema (CHE)24.1.2024 08:00:00 CET | Pressemeddelelse

Delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules as its primary outcome measure. Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, health-related quality of life (HRQoL), and a lower number of treatment-emergent adverse events. DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.1 With only one treatment option currently approved for severe CHE and no approved optionsfor more moderate forms of the disease, there is a considerable unmet need for patients living with CHE.

LEO Pharma announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)30.10.2023 10:00:00 CET | Pressemeddelelse

Subjects who completed the 16-week twice-daily treatment regimen of delgocitinib cream or cream vehicle in the phase 3 DELTA 1 or DELTA 2 trials were offered to immediately enroll into the 36-week DELTA 3 extension trial.1 The DELTA 3 trial evaluated the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE.1 The long-term safety profile of delgocitinib cream was consistent with previous results from the DELTA 1 and 2 trials. Patients who entered the DELTA 3 trial after receiving delgocitinib cream in the DELTA 1 and DELTA 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.

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