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

Del

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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Flere pressemeddelelser fra LEO Pharma

LEO Pharma Presents Late-breaking Tralokinumab Data at EADV 2024 for Moderate-to-Severe Atopic Dermatitis (AD) in the Difficult-to-Treat Head and Neck Region27.9.2024 15:00:00 CEST | Pressemeddelelse

Real-world findings showed that subgroup of patients treated with Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) and with head and neck (H&N) atopic dermatitis (AD) at baseline reported presence of AD in that area in 52.1% of patients after nine months of treatment.(1) As part of one of LEO Pharma’s most extensive scientific programs at EADV to date, the late-breaking presentation examined interim data from the real-world TRACE study of adult AD patients who have been prescribed Adtralza/Adbry for up to nine months.(1) Additional posters presented interim results of the TRACE study on effectiveness of Adtralza/Adbry treatment through various physician and patient reported outcomes such as improvements in Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), itch, sleep disturbance and quality of life.(2,3)

LEO Pharma submits New Drug Application for Enstilar® for Adults with Plaque Psoriasis in China27.9.2024 12:30:00 CEST | Pressemeddelelse

LEO Pharma is seeking to expand the availability of Enstilar® (LEO 90100) to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). The NDA is supported by results from a phase 3 trial comparing the efficacy and safety of Enstilar with Daivobet® ointment in adult Chinese patients.(1,2) The Enstilar submission demonstrates LEO Pharma's commitment to providing additional treatment options for the estimated seven million adult patients living with plaque psoriasis in China.(3)

LEO Pharma Presents Late-Breaking Results from the Phase 2a Mechanism of Action Trial of Temtokibart and Dupilumab in Moderate-to-Severe Atopic Dermatitis at the 2024 EADV Annual Meeting26.9.2024 14:30:00 CEST | Pressemeddelelse

Results presented at the Late Breaker Session on September 26th at the European Dermatology Congress, European Academy of Dermatology & Venereology (EADV) 2024, showed that the investigational interleukin 22 receptor, alpha 1 (IL-22RA1) inhibitor temtokibart induced fast (Week 1) molecular responses(1) Markers of skin hydration (natural moisturizing factors) 2-pyrrolidone-5-carboxylic acid (PCA) and urocanic acid (UCA) were significantly improved from baseline at Week 1 in the temtokibart group (p<0.0001)(1) Both temtokibart and dupilumab led to comparable changes in eczema area and severity index (EASI) and itch numerical rating scale (NRS) at Week 16(1)

LEO Pharma Presents Late-Breaking Anzupgo® (delgocitinib) Cream Presentation at EADV 2024 Highlighting Results of Head-to-Head DELTA FORCE Trial in Chronic Hand Eczema (CHE)25.9.2024 15:45:00 CEST | Pressemeddelelse

The full DELTA FORCE results, the first of three Anzupgo® (delgocitinib) cream late-breaking presentations at the congress, demonstrated that topical treatment with delgocitinib cream had a significantly higher efficacy compared to oral alitretinoin capsules among adult patients with severe CHE.(1) Six other pieces of investigational delgocitinib cream research form part of LEO Pharma’s extensive scientific program at EADV 2024.(2-7) Remaining abstracts include post hoc analysis of the DELTA 1, 2, and 3 trials showing efficacy data for delgocitinib cream across five different CHE subtypes, clinician-reported real-world findings, large-scale patient prevalence data, and detailed analysis of patient biopsy samples.(2-7)

LEO Pharma Unveils Most Extensive EADV Program To Date with 5 Late Breaking Abstracts and 23 Posters Sharing Clinical and Real-World Data25.9.2024 10:00:00 CEST | Pressemeddelelse

LEO Pharma will demonstrate true leadership in medical dermatology by presenting one of its largest ever scientific programs to date at this year’s EADV congress, with 5 late-breaking presentations and 23 scientific posters in total.(1-28) New late-breaking Anzupgo® (delgocitinib) cream data will include the full results of the Phase 3 head-to-head DELTA FORCE trial, as well as a wide range of associated clinical and real-world findings on delgocitinib cream and moderate to severe chronic hand eczema (CHE).(1-6) Additional late-breaking data includes a presentation of Adtralza® (tralokinumab)/Adbry ® (tralokinumab-ldrm) interim data from the real-world TRACE study on the effectiveness of Adtralza/Adbry in adults with moderate to severe head and neck atopic dermatitis (AD).(27) Finally, a late-breaking presentation will discuss the first randomized trial comparing clinical and molecular effects of temtokibart and dupilumab in moderate to severe AD.(28)

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