Delgocitinib

BALLERUP, Denmark--(BUSINESS WIRE)--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 addition to growth of 1% (CER) in the Established brands. Sales in the Critical Care portfolio declined by 1% (CER), affected by a reversal of sales discounts in the same period last year. Operating profit improved significantly, with adjusted EBITDA reaching DKK 2,105 million in 9M 2025, reflecting a margin of 21% (9M 2024: 8%), excluding the STAT6 partnership upfront payment from Gilead Sciences received in January and other non-recurring items. The improvement in adjusted EBITDA was driven by sales growth and reduced operating expenses. Net profit for 9M 2025 was DKK 2,036 million (9M 2024: negative DKK 1,262 million), including non-recurring items. Free cash flow was DKK 1,760 million for 9M 2025 (9M 2024: negative DKK 293 million), and net interest-bearing debt was reduced to DKK 9,423 million (YE 2024: DKK 11,115 million). Excluding M&A, free cash flow was DKK 815 million. In September, Anzupgo® (delgocitinib) cream was launched in the U.S. as the first and only topical pan‑JAK inhibitor for chronic hand eczema (CHE), supported by a more than 50% expansion of LEO Pharma’s U.S. sales force following FDA approval in July 2025. In October, Chinese authorities accepted the NDA filing for Anzupgo® to treat CHE in China. On 30 September, the transaction for Spevigo® (spesolimab) with Boehringer Ingelheim closed, granting LEO Pharma global development and commercialization rights for the first‑in‑class IL‑36R antagonist already approved for generalized pustular psoriasis. Leveraging LEO Pharma’s global dermatology platform, the transaction aims to accelerate and broaden access to Spevigo®, making it a strategic brand, alongside Adtralza®/Adbry® and Anzupgo®. For the 2025 outlook, group revenue growth is now expected to be 8-10% at CER (previously: 7-9%), and the adjusted EBITDA margin is now expected to be 15-17% (previously: 16-18%). The revised outlook reflects the consolidation of Spevigo® including ongoing development costs for the asset. Excluding Spevigo®, the outlook for organic revenue growth of 7-9% is unchanged. "Our momentum continues to build as the global rollout of Anzupgo® accelerates and the Spevigo® brand joins LEO Pharma. With three strategic brands now in our portfolio, we are entering a pivotal chapter in our growth journey – one where we are further investing in our global platform to unlock its full potential and enhance our ability to drive innovation for the benefit of patients worldwide.” CEO Christophe Bourdon. 9M 2025 Financial overview (DKK million) Q3 2025 Q3 2024 Growth 9M 2025 9M 2024 Growth Revenue 3,275 3,057 7% 10,064 9,432 7% Revenue growth at CER 10% 10% N.m. 8% 11% N.m. Adjusted EBITDA 649 181 259% 2,105 780 170% Adjusted EBITDA margin 20% 6% N.m. 21% 8% N.m. Net profit/(loss) for the period 59 (501) N.m. 2,036 (1,262) N.m. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder, the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

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 million 2,3 adults in the UK, with 70% of those with severe forms reporting problems performing everyday activities 4 , and 58% saying it interferes with their ability to work 5 . BALLERUP, Denmark--(BUSINESS WIRE)--GLOBAL RELEASE - NOT INTENDED FOR UK MEDIA LEO Pharma, a global leader in medical dermatology, today announced that the National Institute for Health and Care Excellence (NICE) has issued Technology Appraisal Guidance (TAG) recommending the reimbursement of Anzupgo® ▼(delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.1 Anzupgo® ▼ is now the first approved topical pan-Janus kinase (JAK) inhibitor treatment for this indication in England and Wales.1 CHE is a fluctuating inflammatory skin disease, characterised by persistent itch, pain, redness and irritation on the hands and wrists.6 The disease is diagnosed when these symptoms last more than three months, or when they return two or more times within a year.7,8 People can develop CHE due to a combination of factors, including a weakened skin barrier, ongoing inflammation, and changes in the skin’s microbiome.9 “The NICE recommendation marks a pivotal moment in the treatment of moderate to severe chronic hand eczema in the United Kingdom,” said Prof. Richard Warren, The University of Manchester and Northern Care Alliance NHS Foundation Trust. “There have been limited treatment options for these patients. This recommendation provides a new, evidence-based option - an important step for patients living with what can be a debilitating disease.” The NICE committee concluded that delgocitinib cream is an effective treatment for improving symptoms of CHE, based on robust clinical evidence from the DELTA 1, 2, 3 and DELTA FORCE trials.1 It advised that delgocitinib should be started and monitored by a healthcare professional with experience in diagnosing and treating CHE in secondary care.1 Clinicians should also consider how skin colour may influence the assessment of disease severity and make any adjustments needed.1 “This approval is a huge moment for the many people living with chronic hand eczema and for us at LEO Pharma,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland. “Delgocitinib is now the first NICE-approved topical treatment of its kind, and I am proud to be able to bring this innovation to patients. What’s especially encouraging is how NICE has recognised the need for equitable care, including how this condition shows up differently across skin tones. It’s a real step forward. At LEO Pharma, we’re committed to making a meaningful difference by listening, learning and continuing to deliver treatments that help improve lives.” The recommendation from NICE follows regulatory approvals of delgocitinib cream, among others including by the European Medicines Agency (EMA) in September 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024, and the U.S. Food and Drug Administration (FDA) in July 2025 for the treatment of moderate to severe Chronic Hand Eczema in adults. Notes to editors About Chronic Hand Eczema Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year.7,8 CHE is one of the most common skin diseases of the hands10 with a global prevalence rate of approximately 4.7%.2 In a substantial number of patients, HE can develop into a chronic disease.10 CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.6 CHE has been shown to cause psychological and functional burdens that impact patient quality of life,11 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.4 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.12 About Anzupgo® (delgocitinib) cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.13 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.9 Delgocitinib cream is currently approved in the European Union, Switzerland, Canada, Australia, South Korea, the United Arab Emirates, the UK and the U.S. for the treatment of moderate-to-severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialise delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. According to the final Technology Appraisal Guidance (TAG) issued by NICE, delgocitinib can be used in England and Wales, within its marketing authorisation, as an option to treat moderate to severe CHE in adults when topical corticosteroids have not worked or are not suitable.1 Delgocitinib should be started and monitored by a healthcare professional with experience in diagnosing and treating CHE in secondary care and healthcare professionals should consider how skin colour could affect the assessment of severity and make any adjustments needed.1 About the DELTA 1, 2 and 3 Trials The primary objective for the randomised, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of Anzupgo® (delgocitinib) cream 20 mg/g (2%) compared with cream vehicle in the treatment of adults with moderate to severe CHE.14 The primary endpoint of the trials was the Investigator’s Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores are 2 (mild), 3 (moderate), and 4 (severe).14 Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI). The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.14 Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 open-label, multi-site extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.15 About the DELTA FORCE Trial DELTA FORCE was a 24-week, randomised, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of Anzupgo® (delgocitinib) cream twice-daily with oral alitretinoin capsules once-daily in adult participants with severe CHE.16 The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.16 About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com. References National Institute for Health and Care Excellence. Final Appraisal Document – Delgocitinib: 1 Recommendations | Delgocitinib for treating moderate to severe chronic hand eczema | Guidance | NICE Apfelbacher C, et al. Br J Dermatol . 2025 May 19;192(6):1047-1054. Worldometers, United Kingdom Demographics. Accessed on 16.10.2025. United Kingdom Demographics 2025 (Population, Age, Sex, Trends) - Worldometer Cortesi PA, Contact Dermatitis . 2014;70(3):158-168. LEO Pharma UK. (2024, June). Chronic Hand Eczema (CHE) Patient Impact Report. LEO Pharma UK. https://www.leo-pharma.co.uk/our-responsibility/supporting-patients-and-patient-organisations/che-patient-impact-report MAT-73725 June 2024 Thyssen J, et al. Contact Dermatitis . 2022;86:357–78. Lynde C, et al. J Cutan Med Surg . 2010;14:267–284. Erratum in: J Cutan Med Surg. 2011;15:360. Diepgen TL, et al. J Dtsch Dermatol Ges . 2015;13(1):e1–22. Lee GR, et al. Dermatol Ther . 2019;e12840:1–12. Bissonnette R, et al. JEADV . 2010;24;1–20 Grant L, et al. Adv Ther . 2020;37(2):692-706. Voorberg AN, et al. Acta Derm Venereol . 2022;102:adv00626. Dubin C, et al. Ther Clin Risk Manag . 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021:17:233. Bissonnette R, et al. Lancet 2024;404:461-473. Gooderham M, et al. J Am Acad Dermatol . 2025;93(1):95-103. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://classic.clinicaltrials.gov/ct2/show/NCT05259722 . MAT-87405 November 2025