Latest news with #Anzupgo®
Business Wire
2 days ago
- Business
- Business Wire
LEO Pharma Delivers 7% Revenue Growth at CER in H1 2025 and Achieves Key Milestones Enabling Future Growth
BALLERUP, Denmark--(BUSINESS WIRE)--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 in the Critical Care portfolio (formerly called 'Thrombosis') declined by 3% (CER) year-on-year, affected by the reversal of sales discounts in the same period last year. Operating profit improved significantly, with adjusted EBITDA reaching DKK 1,456 million in H1 2025, reflecting a margin of 21% (H1 2024: 9%) excluding the STAT6 partnership upfront payment from Gilead received in January and other non-recurring items. Net profit for H1 2025 was DKK 1,977 million (H1 2024: negative DKK 761 million), including non-recurring items. Free cash flow was DKK 1,469 million for H1 2025 (H1 2024: negative DKK 779 million), and net interest-bearing debt was reduced to DKK 9,676 million (YE 2024: DKK 11,115 million). Excluding M&A, free cash flow was negative DKK 158 million driven by timing and non-recurring one-offs. On 23 July, LEO Pharma received FDA approval of Anzupgo® (delgocitinib) for the treatment of chronic hand eczema, enabling launch of the product in the U.S. by Q3 2025 as the first and only topical pan-JAK inhibitor. Additionally, LEO Pharma on 9 July announced positive interim results from the phase 3 ADHAND trial for Adtralza®/Adbry® (tralokinumab). On 14 July, LEO Pharma announced a partnership with Boehringer Ingelheim, granting LEO Pharma an exclusive global license for the development and commercialization of SPEVIGO® (spesolimab), a first-in-class IL-36R antagonist already approved and marketed for generalized pustular psoriasis (GPP). The partnership aims to accelerate and broaden access for patients by leveraging LEO Pharma's global dermatology platform. The transaction is expected to close in H2 2025 with SPEVIGO® set to become the third Strategic brand in LEO Pharma's portfolio, alongside Adtralza®/Adbry® and Anzupgo®. For the 2025 outlook, group revenue growth is now expected to be 7-9% at CER (previously: 6-9%) and the adjusted EBITDA margin is now expected to be 16-18% (previously: 15-18%). This reflects the FDA approval of Anzupgo® and year-to-date business performance. The outlook does not include any impact from the partnership for SPEVIGO®, pending closing of the transaction. LEO Pharma is in its strongest position in years – financially, strategically, and in terms of our portfolio and pipeline activities. The FDA approval of Anzupgo® represents a major step forward, and together with the addition of SPEVIGO® to our portfolio, we are further unlocking the value of our global platform, highlighting our commitment to driving innovation for patients.' CEO Christophe Bourdon. 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. Head-quartered 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
Business Wire
15-05-2025
- Business
- Business Wire
Three-month interim report (Q1) 2025 (Unaudited): LEO Pharma Delivers 9% Revenue Growth at Constant Exchange Rates and Doubles Adjusted EBITDA Margin to 16%
BALLERUP, Denmark--(BUSINESS WIRE)--In Q1, LEO Pharma continued its robust growth, driven by dermatology, and made significant strategic progress. This included expanding the launch of Anzupgo® to five markets, advancing innovation through the newly formed strategic partnership with Gilead for the STAT6 program, and significantly improving profitability with a return to a positive net profit. Q1 2025 highlights LEO Pharma's revenue increased by 10% year-on-year to DKK 3,373 million, and by 9% at constant exchange rates (CER). The revenue growth was led by North America (+45% at CER), with Europe (+2% at CER) and Rest of World (+5% at CER) also contributing to the overall growth. Dermatology portfolio revenue grew by 10% (CER) year-on-year, driven by the Strategic brands, Adtralza®/Adbry® and Anzupgo®, which together saw a revenue increase of 73% (CER). Sales in the Thrombosis portfolio declined by 1% (CER) year-on-year, negatively impacted by order timing. Operating profit improved significantly, with adjusted EBITDA reaching DKK 545 million in Q1 2025, reflecting a margin of 16% (Q1 2024: 8%) excluding the upfront payment from Gilead and other non-recurring items. Net profit for the quarter was DKK 1,742 million (Q1 2024: negative DKK 366 million), including non-recurring items. Free cash flow was positive DKK 1,386 million for Q1 2025 (Q1 2024: negative DKK 571 million), and net interest-bearing debt was reduced to DKK 9,750 million (YE 2024: DKK 11,115 million). Excluding one off M&A-related payments, free cash flow in Q1 2025 was negative DKK 241 million. In Q1, LEO Pharma reported positive results from the DELTA TEEN and DELTA China trials, marking the fifth and sixth consecutive successful phase 3 trials for delgocitinib (brand name: Anzupgo®) in chronic hand ezcema. Additionally, in January, LEO Pharma announced a strategic partnership with Gilead Sciences to accelerate the pre-clinical STAT6 program. The 2025 financial outlook for revenue growth of 6-9% (CER) and an adjusted EBITDA margin of 15-18% is unchanged and confirmed. "We have seen a good start to 2025, with encouraging progress in the ongoing launch of Anzupgo® and key milestones achieved for our innovation pipeline. A significant highlight is the acceleration of the STAT6 program through our new partnership with Gilead. Additionally, the return to a positive net result marks another key milestone for the quarter, as we continue to develop the foundations for LEO Pharma's long-term financial strength,' says Christophe Bourdon, CEO of LEO Pharma. Q1 2025 Financial overview 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
Yahoo
27-02-2025
- Health
- Yahoo
LEO Pharma Meets Primary Endpoint in Phase 3 DELTA China Trial with Anzupgo® (delgocitinib) Cream in Chinese Patients with Moderate to Severe Chronic Hand Eczema (CHE)
The phase 3 clinical trial investigated Anzupgo® in Chinese adults and adolescents (aged 12 and above) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 Upon completion of the double-blind treatment period, the trial met its primary endpoint with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.1 The safety profile and pharmacokinetics (PK) data remained consistent with previous trial findings, with Anzupgo generally well tolerated and with low systemic exposure.1 BALLERUP, Denmark, February 27, 2025--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results for the primary endpoint from the double-blind treatment period of the DELTA China trial. DELTA China is a phase 3 clinical trial with Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adults and adolescents (aged 12 and above) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks.1 A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.1 The results announced today cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of Anzupgo treatment and are an important milestone in the Chinese market as there are currently no approved treatment options specifically indicated for moderate to severe CHE in China.1 The primary endpoint for DELTA China was the Investigator's Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.1 Furthermore, the 16-week safety profile of Anzupgo was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.1 The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing.1 The results from this stage of the trial will be released at a later date. The primary objective of the study was to evaluate the efficacy of twice-daily applications of Anzupgo compared with cream vehicle in the treatment of Chinese subjects with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.1 "Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China," said Byron Yin, General Manager for LEO Pharma in China. "LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China." The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.2-5 "DELTA China demonstrates LEO Pharma's truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide," said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition." Currently, Anzupgo is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States. Detailed results from DELTA China are planned to be submitted for scientific presentation and publication at a later date. For more information on the DELTA China trial (NCT06004050) go to Notes to editors About Anzupgo® (delgocitinib) cream Anzupgo is currently approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo is under investigation in other markets, including the United States. Anzupgo® (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.6 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.7 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 commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About the DELTA China Trial DELTA China is a phase 3 trial to evaluate efficacy, safety, and pharmacokinetics (PK) (only adults) of twice-daily applications of Anzupgo in Chinese adults and adolescents (aged 12 and above) with moderate to severe CHE.1 The primary endpoint of the DELTA China trial was the Investigator's Global Assessment for CHE 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.1 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.8,9 HE is the most common skin disorder of the hands10 with a prevalence rate of approximately 4.7%.11 In a substantial number of patients, HE can develop into a chronic condition.10 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.12 CHE has been shown to cause psychological and functional burdens that impact patient quality of life,13 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.14 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.15 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 References National Library of Medicine (U.S.). Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema. Identifier: NCT06004050. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841 Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360. Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626. MAT- 80047 February 2025 View source version on Contacts Jes Broe FrederiksenGlobal Commercial Communication+45 53 60 59 48jebfe@ Jeppe IlkjærGlobal Corporate Communications+45 3050 2014JEILK@ Sign in to access your portfolio
