LEO Pharma

Interim results from the German REACHED study provide the first real-world evidence on the effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema (CHE), with 28.6% of patients assessed as clear or almost clear after eight weeks of treatment, from none at baseline.1 New post hoc analyses from the phase 3 DELTA TEEN trial show greater reductions in daily HESD itch and pain scores with delgocitinib cream than with cream vehicle in adolescents aged 12-17 with moderate to severe CHE.2 In an oral presentation, new post hoc analyses from DELTA TEEN show that a higher proportion of adolescents reported no impact on quality of life at Week 16 with delgocitinib cream than with cream vehicle (27.0% vs 0%)3

New findings from a subgroup analysis of the 12-month TRACE study show that more than 70% of adults whose Atopic Dermatitis (AD) affected multiple high-burden areas – such as the head and neck, hands and feet, or genitals – had reduced involvement of those areas after 12 months of treatment with tralokinumab.1 New pre-specified and post hoc analyses from the phase 3 ADHAND trial show significantly greater improvements in quality of life, daily function and sleep at Week 16 with tralokinumab monotherapy than with placebo in adults with AD and moderate-to-severe hand involvement, with the two treatment groups separating within two weeks.2,3 In a post hoc analysis, adolescents aged 12-17 years treated across the phase 3 ECZTRA 6 trial and its ECZTEND extension, response rates remained high and stable through most of the extension period, and no new safety concerns were identified.5

LEO Pharma will present 28 accepted abstracts at the 2026 European Academy of Dermatology and Venereology Congress, taking place from 30 September to 3 October in Vienna, Austria. The EADV 2026 program reflects the strength and breadth of LEO Pharma’s portfolio, showcasing what’s now and what’s next in medical dermatology with new evidence across nine disease areas, six routes of administration and nine modes of action; including biologic injectables, topical formulations, and covering data across established dermatology brands and new innovation. The program underscores LEO Pharma’s continued commitment to advancing medical dermatology through evidence that addresses both highly prevalent chronic skin diseases and complex or rare, hard-to-treat conditions with significant unmet needs.

The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate. If approved by the European Commission, Anzupgo® would become the first therapy in the EU specifically approved for adolescents with moderate to severe chronic hand eczema, a patient population for whom there are currently no specifically approved treatment options. The positive CHMP opinion is supported by results from DELTA TEEN, a phase 3 trial investigating the efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema.1

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for dersimelagon for filing and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) date expected by the end of February 2027. LEO Pharma has successfully closed the acquisition of dersimelagon from Tanabe Pharma, strengthening its late-stage pipeline and further leveraging its global dermatology platform. Dersimelagon is an investigational, once-daily oral melanocortin 1 receptor (MC1R) agonist for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), two rare genetic skin diseases with significant unmet medical need.

Ballerup, Denmark, 18 August, 2026 – In H1 2026, LEO Pharma delivered strong revenue growth, driven by the dermatology portfolio, with an improved gross margin alongside significantly increased investments in commercial and innovation activities. In August, LEO Pharma agreed to acquire the global rights for dersimelagon, an investigational first-in-class oral therapy with potential launch in 2027. Together with the acquisition of Replay, announced in April 2026, the agreement further strengthens LEO Pharma’s pipeline in rare genetic skin diseases. Financial highlights LEO Pharma’s revenue increased by 7% to DKK 7,257 million, and by 10% at constant exchange rates (CER). The revenue growth was led by North America (38% at CER) and Rest of World (10% at CER), while sales in Europe (0% at CER) were broadly stable compared to H1 2025. Revenue from the Dermatology portfolio grew by 12% (CER), driven by the strategic brands Anzupgo®, Spevigo® and Adtralza®/Adbry®, which combined had a revenu

Acquisition adds dersimelagon to LEO Pharma’s rare dermatology pipeline, an investigational once-daily oral melanocortin 1 receptor (MC1R) agonist for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) that has completed Phase 3 development and for which a New Drug Application (NDA) has been submitted to U.S. Food and Drug Administration (FDA) for review in June 2026.1 Leverages LEO Pharma's six decades of dermatology expertise to advance innovation for patients with rare skin diseases through the addition of this oral late-stage asset, building on LEO Pharma’s recent acquisition of Replay and partnership with Boehringer Ingelheim for Spevigo® (spesolimab). EPP and XLP are rare, devastating lifelong genetic disorders that cause severe sunlight-induced skin pain, as well as rash, swelling, redness, burning sensations and, in some cases, liver damage.2,3 Under the terms of the agreement, LEO Pharma will acquire worldwide rights to dersimelagon from Tanabe Pharma for up

Henriette Mersebach will bring deep pharmaceutical R&D and innovation expertise to the Board

TRAPEDS-1 is a Phase 2 trial evaluating the pharmacokinetics and long-term safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis.1 The pharmacokinetic profile was as expected and consistent with what has previously been observed with tralokinumab. Tralokinumab was generally well tolerated for up to 172 weeks of treatment, with no new safety signals identified.

New data show that chronic hand eczema can disrupt working lives and school days, with many patients reporting sick leave from work and worsening of symptoms during everyday activities.1 Findings from the DELTA FORCE and DELTA TEEN phase 3 studies highlight the heavy burden of chronic hand eczema across the life course – from impaired work productivity in adults to an impact on school life in adolescents.1,2

LEO Pharma has achieved Science Based Targets initiative (SBTi) validation for its net-zero climate targets, including its ambition to reach net-zero greenhouse gas emissions by 2050, alongside near-term goals to reduce Scope 1 and 2 emissions by 63% and Scope 3 emissions by 37.5% by 2035 With its targets now validated, LEO Pharma is shifting from target-setting to implementation, advancing 15 prioritized initiatives in its Climate Transition Plan while emphasizing the connection between environmental health and patient care

LOQTORZI® (toripalimab) lanceres i kombination med standardkemoterapi i Danmark som en ny førstelinjebehandling til voksne patienter med recidiverende eller metastatisk nasopharyngeal cancer, som ikke kan behandles med kirurgi eller strålebehandling (R/M NPC).¹ LOQTORZI® har vist en dokumenteret overlevelsesgevinst og kan udgøre en potentiel ny standardbehandling for patienter med fremskreden R/M NPC.² Langtidsdata fra det kliniske JUPITER-02-studie viser, at LOQTORZI® i kombination med kemoterapi giver vedvarende og signifikante forbedringer i både samlet overlevelse (OS) og progressionsfri overlevelse (PFS) sammenlignet med kemoterapi alene¹, hvilket etablerer en ny behandlingsmulighed for patienter med R/M NPC Lanceringen styrker LEO Pharmas Critical Care-portefølje på hjemmemarkedet i Danmark og demonstrerer virksomhedens engagement i at bringe nye behandlinger til patienter – via en etableret specialiseret kommerciel platform til hospitaler.

Ballerup, Denmark, 5 May, 2026 – In Q1 2026, LEO Pharma delivered robust revenue growth, driven by the dermatology portfolio, and improved profitability while significantly increasing commercial investments to support the global roll-out of Anzupgo® and the addition of Spevigo® to the portfolio. LEO Pharma also made significant strategic progress and advanced innovation through the acquisition of Replay’s next-generation gene therapy platform targeting rare genetic skin diseases, the approval of Enstilar® in China and the continued late-stage development activities for Anzupgo®, including FDA acceptance for review in adolescents with chronic hand eczema. Financial highlights LEO Pharma’s revenue increased by 4% to DKK 3,521 million, and by 9% at constant exchange rates (CER). The revenue growth was led by North America (30% at CER) and Rest of World (13% at CER), whereas sales in Europe declined by 1% at CER. Revenue from the dermatology portfolio grew by 11% (CER), driven by the strat

Acquisition adds high-payload herpes simplex virus (HSV) gene therapy targeting genetic skin diseases to LEO Pharma’s pipeline and further expands the company’s presence in rare dermatology Combines LEO Pharma’s six decades of dermatology expertise with Replay’s next-generation gene therapy platform to advance innovation for patients with rare skin diseases The lead program targets dystrophic epidermolysis bullosa (DEB), a devastating genetic skin disease with significant unmet medical need.

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.