LEO Pharma

The phase 3 trial DELTA CARE 1 will recruit up to 652 adult patients with lichen sclerosus (LS) to investigate the efficacy and safety of delgocitinib cream compared to cream vehicle.1 The study initiation in LS is part of LEO Pharma's ambition to explore Anzupgo (delgocitinib) creme in additional indications beyond Chronic Hand Eczema (CHE), investigating the potential of delgocitinib as treatment option in skin diseases with high unmet medical need. There are currently no approved treatments specifically indicated for LS in the U.S. or in Europe. Delgocitinib cream has been shown to inhibit the activity of all four JAKs,2,3 making it a potential treatment option for people living with LS disease.

Ballerup, Denmark, January 7, 2026 – LEO Pharma, a global leader in medical dermatology, announced today that CEO Christophe Bourdon will deliver a company update at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 9:00 AM PST. With over 60 years of specialist expertise in medical dermatology and more than 90 million patients served in 70+ markets, LEO Pharma is uniquely positioned in one of healthcare’s most attractive and underserved sectors. Backed by an unmatched portfolio combining category‑leading brands with first‑in‑class innovations, the company is redefining standards of care for patients with high unmet needs. Entering 2026, LEO Pharma builds on the strong momentum of recent years, marked by robust top-line growth, significant margin expansion, and a promising pipeline. Leveraging its unique global platform, the LEO Pharma is advancing innovation as the preferred partner in medical dermatology. The J.P. Morgan Healthcare Con

Marika Murto brings over 20 years of pharmaceutical expertise in product strategy, innovation, and business transformation Her appointment as SVP of Global Product Strategy will help unlock LEO Pharma’s portfolio potential, driving patient impact and supporting sustainable growth

LEO Pharma has submitted a label expansion application to EMA to expand Anzupgo® (delgocitinib) cream to adolescent patients (12–17 years) with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate – the application has been accepted for review. The application is supported by results from DELTA TEEN, a phase 3 trial investigating efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema (CHE).1 The label expansion submission for adolescent patients demonstrates LEO Pharma's commitment to investigating use within relevant sub-populations where treatments can help make a fundamental difference for patients with skin diseases.

The ADHAND trial evaluates the efficacy and safety of tralokinumab in adult patients living with atopic dermatitis with moderate-to-severe hand involvement,1 a high burden, high unmet need population.2 At Week 16, tralokinumab showed statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch and pain.3 The 32-week results of the ADHAND trial builds on the positive findings observed at Week 16.

Ballerup, Denmark, 6 November, 2025 - In the first nine months of 2025, LEO Pharma continued its robust revenue growth, with significantly improved profitability and free cash flow. As expected, growth accelerated in the third quarter, with the global rollout of Anzupgo® gaining further momentum after its September launch in the U.S. The 2025 financial outlook is updated to reflect the addition of Spevigo® to the portfolio, reinforcing LEO Pharma’s commitment to advancing innovation and expanding access to care. Highlights LEO Pharma’s revenue increased by 7% to DKK 10,064 million, and by 8% at constant exchange rates (CER), entirely driven by organic growth. The revenue growth was led by North America (+27% at CER), with Europe (+2% at CER) and Rest of World (+6% at CER) also contributing to the overall growth. Revenue from the Dermatology portfolio grew by 9% (CER), driven by the Strategic brands Adtralza®/Adbry® and Anzupgo®, which combined had a revenue increase of 41% (CER), in ad

The National Institute for Health and Care Excellence (NICE) has recommended the first-and-only topical treatment for adults in the United Kingdom specifically approved for moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 The Technology Appraisal Guidance (TAG) means NHS organisations in England and Wales must now make Anzupgo® ▼(delgocitinib) cream available for healthcare professionals to prescribe. CHE affects around 4.4 million2,3 adults in the UK, with 70% of those with severe forms reporting problems performing everyday activities4, and 58% saying it interferes with their ability to work5.

Sophie Lamle brings over 20 years of experience in the pharmaceutical industry, leading innovation, clinical development, and strategic transformation. Her appointment will further strengthen LEO Pharma’s Search & Develop innovation model, unlocking value with a focus on differentiated assets.

LEO Pharma is seeking to expand the availability of Anzupgo® (delgocitinib) cream to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA), which has been accepted for review for adult patients with moderate to severe chronic hand eczema. The NDA is supported by results from DELTA China, a phase 3 trial with Anzupgo in Chinese adults with moderate to severe chronic hand eczema (CHE)1 along with the full clinical program of delgocitinib, which includes data from DELTA 1,2 and 3, DELTA Force and DELTA Teen.2-7 The Anzupgo NDA submission demonstrates LEO Pharma's commitment to providing additional treatment options for patients living with skin diseases in China.

Adding Spevigo® is a significant step forward in LEO Pharma’s focused growth strategy, to accelerate and expand patients’ access to treatments for medical dermatological conditions, including generalized pustular psoriasis (GPP), a rare and severe skin condition Spevigo® (spesolimab) is a first-in-class IL-36R antagonist successfully developed and launched by Boehringer Ingelheim and approved globally for the treatment and prevention of GPP flares Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases

Late-breaking data from the ECZTEND trial show that patients with moderate-to-severe atopic dermatitis (AD), who responded to Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) at Week 16, maintained stable, optimal treatment outcomes for up to three years.1 Additional data presented at EADV from the real-world TRACE study further support the long-term use of tralokinumab, with sustained improvements in disease severity, quality of life, sleep, and work productivity observed over 12 months of treatment.2-4 Presented as part of LEO Pharma’s most ambitious scientific program to date at the 2025 EADV Congress, the tralokinumab data reinforce the company’s leadership in medical dermatology and its commitment to advancing innovation across its biologics’ portfolio.

The first late-breaking presentation was the phase 3 trial results for DELTA TEEN, showing delgocitinib cream had superior efficacy compared to cream vehicle and was generally well tolerated in adolescents, aged 12-17, with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 In a second late-breaking presentation, pooled data from five phase 2b and phase 3 trials of delgocitinib cream confirmed a consistent safety profile for the treatment of moderate to severe CHE in adults.2 Fifteen other pieces of delgocitinib cream research formed part of LEO Pharma’s most ambitious scientific program to date at EADV 2025.3-17

Results presented at EADV 2025 demonstrated that investigational agent temtokibart met its primary endpoint of percentage change in the Eczema Area and Severity Index (EASI) compared with placebo for the three highest doses (600 mg, 450 mg, and 300 mg).1 Significantly greater improvements in EASI were reported as early as Week 1 for temtokibart 450mg and 300mg, and Week 2 for 600mg, vs placebo; these results were maintained up to Week 32 in 600mg and 300mg arms, despite no treatment after Week 14.1 Safety analyses revealed that temtokibart was well-tolerated with no dose-dependent AEs, a low incidence of conjunctivitis, and no signal for herpes.1

For the second year in a row, LEO Pharma delivers its largest and most ambitious scientific programme ever at the 2025 European Academy of Dermatology and Venereology (EADV), setting a new standard by presenting an unprecedented volume of scientific content for the company, with 5 late-breaking presentations and 24 regular abstracts.1-29 LEO Pharma’s scientific programme at EADV 2025 spans multiple dermatological indications, mirroring the company’s strong commitment to addressing both the most prevalent chronic skin diseases and hard-to-treat conditions.1-29 Highlights from EADV 2025 includes exciting phase 3 data in biologic injectables as well as foam and cream formulations, illustrating the breadth of therapeutic approaches represented in LEO Pharma’s medical dermatology portfolio.1-29

Ballerup, Denmark, 18 August, 2025 - In H1 2025, LEO Pharma delivered robust growth and significantly improved profitability, enabling an increase to the financial outlook for sales growth and adjusted EBITDA margin in 2025 towards the upper-end of previously communicated expectations. In July, the FDA approval of Anzupgo® and partnership with Boehringer Ingelheim for SPEVIGO®, marked major strategic milestones demonstrating LEO Pharma’s commitment to advancing innovation in dermatology. Highlights LEO Pharma’s revenue increased by 6% year-on-year to DKK 6,789 million, and by 7% at constant exchange rates (CER) entirely driven by organic growth. The revenue growth was led by North America (+28% at CER), with Europe (+1% at CER) and Rest of World (+4% at CER) also contributing to the overall growth. Revenue from the Dermatology portfolio grew by 8% (CER) year-on-year, driven by the Strategic brands Adtralza®/Adbry® and Anzupgo®, which combined had a revenue increase of 51% (CER). Sales

ANZUPGO® (delgocitinib) cream now becomes the first and only FDA-approved treatment specifically approved for the treatment of adults living with moderate-to-severe chronic hand eczema (CHE) in the U.S.1 CHE affects approximately one in ten adults worldwide, yet previously, there has been no specific treatment FDA-approved for those living with the disease.2,3 The approval represents an important milestone for LEO Pharma’s expanding presence in the U.S. as it broadens its portfolio of dermatology treatments to address unmet needs.

Partnership will accelerate and broaden access to treatment for more patients with generalized pustular psoriasis (GPP), a rare and devastating skin condition LEO Pharma’s six decades of dermatology expertise and Boehringer’s global track record in bringing SPEVIGO® to over 40 countries will be combined to ensure continuous patient support Boehringer Ingelheim and LEO Pharma will closely cooperate to ensure a smooth transition of all operations

ADHAND is a phase 3b placebo-controlled clinical trial evaluating the efficacy and safety of tralokinumab in adult patients living with moderate-to-severe atopic dermatitis on the hands who are candidates for systemic therapy.1 The 16-week interim results of the ADHAND trial met the primary and all key secondary endpoints, showing statistically significant results compared to placebo. This analysis assessed outcomes up to Week 16, but the trial will continue through Week 32, with final results expected by the end of the year.

The phase 2a proof-of-concept trial will recruit up to 135 adult patients with mild to severe PPP to investigate the efficacy and safety of delgocitinib cream compared to cream vehicle. Delgocitinib cream has been shown to inhibit the activity of all four JAKs,(1,2) making it a potential therapeutic candidate for treating PPP.

A few weeks ago, LEO Pharma announced the appointment of a new EVP for Global People & Corporate Affairs (GPCA) – Helle Hedegaard Juhl will be joining LEO Pharma on July 1. She joins LEO Pharma, alongside recently appointed EVP for International Operations Frederik Kier, to strengthen the company’s leadership and support the next phase of LEO Pharma's strategic journey and transformation