LEO Pharma

NMPA approval of Enstilar® in China marks a significant milestone for LEO Pharma, expanding access to a new treatment option for the estimated 6.5 million adults living with plaque psoriasis in the world’s largest market measured by patient numbers.1 China represents a strategically important pillar in LEO Pharma’s long-term growth, and the approval strengthens the company’s position in medical dermatology by expanding its psoriasis portfolio in an exciting market for innovative treatments. Enstilar builds on LEO Pharma’s established leadership in topical psoriasis treatments, offering a clinically proven, foam-based formulation that has been widely adopted in more than 50 markets worldwide and is supported by robust phase 3 clinical data.2,3

The application is supported by positive data from the pivotal Phase 3 DELTA TEEN trial in the primary and key secondary endpoints.1 If approved, ANZUPGO will be the first treatment option specifically indicated for pediatric patients aged 12–17 living with moderate to severe chronic hand eczema (CHE).

U.S. RELEASE MADISON, N.J. – March 20, 2026 – LEO Pharma A/S, a global leader in medical dermatology, today announced it will present 17 scientific posters at the 2026 American Academy of Dermatology (AAD) Annual Meeting (March 27-31, Denver, Colorado), highlighting new real-world and clinical data across its medical dermatology portfolio and pipeline for inflammatory skin diseases. Key data to be presented by LEO Pharma at AAD 2026 include: ADBRY® (tralokinumab) 12‑month real‑world data from the TRACE study evaluating the safety and effectiveness of ADBRY among patients with atopic dermatitis (AD), including analyses in patients with hand and foot involvement and patients with skin of color.1-3 ANZUPGO® (delgocitinib) data evaluating outcomes with ANZUPGO cream 20 mg/g in adults with moderate-to-severe chronic hand eczema (CHE), including results across patients with and without prior systemic therapy exposure, further characterizing treatment response in this difficult-to-treat popul

Ballerup, Denmark, February 23, 2026 – LEO Pharma today announced that Kasper Fangel, CEO of ISS A/S, will be nominated for election as a member of the Board of Directors at the Annual General Meeting (AGM) on 25 February 2026 and subsequently appointed as Chair of the Audit Committee. A Danish national, Kasper Fangel has built a distinguished career in corporate leadership and finance. At ISS A/S, one of the world’s largest workplace experience and facility management companies, he has played a pivotal role in shaping strategy and delivering sustainable performance on a global scale - serving in various leadership roles, including CFO from 2020 and CEO since 2023. His extensive expertise in governance, financial oversight, capital allocation, and strategic execution will be a valuable asset to LEO Pharma’s Board as the company advances its journey of sustainable growth and innovation in medical dermatology. "We are delighted to welcome Kasper to the Board and as our new Chair of the A

Ballerup, Denmark, 18 February, 2026 – In 2025, LEO Pharma delivered a third consecutive year of double‑digit revenue growth (CER), at the upper end of guidance, and achieved a significant improvement in profitability, returning to positive net profit and free cash flow. The portfolio was strengthened by the launch of Anzupgo® in 10 additional markets, including the U.S., as well as the addition of Spevigo®. The pipeline was advanced through new late‑stage programs and strategic partnerships aimed at accelerating innovation. For 2026, revenue growth is expected to be 8-11% (CER), supporting further improvement in the adjusted EBITDA margin to 16-19%, alongside increased investments in innovation and LEO Pharma’s global platform. Financial highlights LEO Pharma’s revenue increased by 10% at constant exchange rates (CER) and by 8% in DKK to 13,499 million. Revenue growth was led by North America (+35% at CER), with Rest of World (+9% at CER) and Europe (+3% at CER) also contributing to t

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