LEO Pharma

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

Three-month interim report (Q1) 2025 (Unaudited)

Ballerup, Denmark, 13 May 2025 -- At LEO Pharma, we have made significant progress on our transformation journey. With our strategy on the right track, we have reached a point on our journey that requires a focus on the long term and the profiles required to shape our future. In light of this, we are announcing the following changes to our Executive Management team: We will split the current Product Strategy and International Operations into two functions, and with this EVP Becki Morison will be leaving LEO Pharma, effective end of June 2025. Frederik Kier has been appointed as EVP, International Operations and will start at LEO Pharma on June 1, 2025. Frederik joins LEO Pharma from a position as Senior Vice President, Global Obesity Unit at Novo Nordisk. Frederik’s long career at Novo Nordisk spans commercial roles, including international experience as SVP Region Northwest Europe, and SVP Region AAMEO (Africa, Asia, Middle East and Oceania). Lisa Elliott, currently Vice President, Gl

Temtokibart achieved positive results for the primary endpoint for the 3 highest doses in a phase 2b clinical trial in adults with moderate-to-severe atopic dermatitis (AD) Temtokibart – also called LEO 138559 – is an investigational IL-22RA1 antagonist

LEO Pharma and the Parker Institute have entered a 3-year partnership with the objective to advance dermatology research. The collaboration will leverage the Parker Institute’s expertise in trial design, artificial intelligence, and SingleCell RNA sequencing and LEO Pharma’s global leadership in serving 90 million patients annually in medical dermatology to enhance understanding and treatment of skin diseases. This initiative reinforces LEO Pharma's commitment to unlock external innovation and drive standard of care improvement. Ballerup, Denmark, 14 April 2025 – LEO Pharma and the Parker Institute at Copenhagen University Hospital have formed an academic partnership to advance research and innovation in medical dermatology. This collaboration aims to produce high-quality research that enhances disease understanding and benefits patients. Furthermore, it aims to discover molecules that could potentially be integrated into broader pharmaceutical research and development efforts. “We are

The post hoc analysis investigated treatment responses in a patient subgroup with moderate to severe Chronic Hand Eczema (CHE) treated with delgocitinib cream for 16 weeks in the DELTA 1 2 phase 3 trials.(1) Late-breaking presentation showcased that delgocitinib cream produced a deep, consistent and/or maintained response in a subgroup of patients with moderate to severe Chronic Hand Eczema (CHE).(1) Separate data presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting evaluated systemic exposure in patients following high use of delgocitinib cream to treat moderate to severe CHE.(2)

At LEO Pharma’s Annual General Meeting 5 March 2025, Liisa Hurme, President and CEO of Orion Corporation, and Mark Levick, former EU medicines regulator and CEO of Alvotech, were elected as independent members of the Board of Directors. Liisa Hurme brings over 20 years of experience in the chemical and healthcare industries, with expertise in R&D, business development, global supply chains, and operations. She joined Orion Corporation in 1999 and became President and CEO in 2022. Liisa also chairs the Board at the Chemical Industry Federation of Finland and has served on various company and industry boards. She holds a doctorate in biochemistry from the University of Helsinki. Mark Levick is a former EU medicines regulator and CEO of Alvotech, a global biopharmaceutical company listed on the US NASDAQ. His expertise was gained through a successful career as a practicing specialist physician in Australia and the UK, before leading global R&D groups at GlaxoSmithKline and Novartis in the

Ballerup, Denmark, 26 February, 2025 – LEO Pharma delivered another year of strong progress in 2024, with both sales growth and adjusted EBITDA margin ahead of the initial outlook for the year, putting the company on track to meet its profitability targets and to achieve its long-term strategic objectives. “2024 was a year of strong progress for LEO Pharma with double-digit growth in sales and another year of significantly improved EBITDA. A major highlight in 2024 was the approval and launch of our pioneering innovative topical Anzupgo® for chronic hand eczema (CHE). Additionally, we have strengthened our pipeline and successfully implemented efficiency initiatives set to substantially further improve our financial performance in 2025 and return LEO Pharma to a positive net result. With our innovative portfolio demonstrating significant commercial potential, and by maintaining financial discipline, delivering consistent high growth, and building an attractive pipeline, we are creating

Partners form non-exclusive collaboration to expand research efforts and develop new treatments for Epidermolysis Bullosa (EB). The partnership leverages DEBRA Research’s focus on patient care and pharma experience and LEO Pharma’s extensive medical dermatology experience. Munich, Germany, and Ballerup, Denmark, 5 February 2025 – DEBRA Research GmbH, a non-profit organization dedicated to advancing research, advocacy, and support for those affected by Epidermolysis Bullosa (EB) and LEO Pharma, a global leader in medical dermatology, today announced a non-exclusive strategic partnership. This collaboration aims to enhance scouting capabilities and provide additional capacity to accelerate the development of life-changing therapies for EB. The partners are committed to driving transformative progress for EB patients and their families, and to deliver innovative medicines for this serious skin disease with no approved treatment options. “We are pleased to announce our non-exclusive partne

The phase 3 clinical trial (DELTA TEEN) with Anzupgo® in adolescents, aged 12-17, with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate, achieved primary and all key secondary endpoints compared to cream vehicle.(1) CHE can significantly affect the quality of life for adolescent patients.(2) There are currently no approved treatment options specifically indicated for moderate to severe CHE in the adolescent patient population.

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The Swiss Agency for Therapeutic Products, Swissmedic, has approved Anzupgo®, making it the first topical pan-Janus kinase (JAK) inhibitor specifically indicated for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to topical corticosteroids, or for whom potent to very potent topical corticosteroids are not advisable.(1) The approval will bring a new treatment option to approximately 4.7% of adults in Switzerland living with CHE, a condition with a high unmet need for which no specifically approved topical treatment was previously available.(2,3) In addition to the results of the DELTA 1,2 and 3 trials, the marketing approval is supported by the head-to-head DELTA FORCE trial of Anzupgo against oral alitretinoin capsules, the only other existing specifically approved treatment for severe CHE.(4-7)

LEO Pharma is excited to announce strategic leadership changes to bolster growth, further professionalize the organization, and strengthen its commitment to strategy and transformation. Kristian Sibilitz has been appointed as the new Executive Vice President (EVP) of Technical Development and Supply and will join the Global Leadership Team on December 1, 2024. Effective immediately, Jean Monin, EVP of Thrombosis, and Anne Jensen, Vice President (VP) of Strategy, will also join the Global Leadership Team. Additionally, Anders Monrad Rendtorff will join as the new head of Global Communications.

Q3 2024 Trading Update (Unaudited)

Efter Europa Kommissionens produktgodkendelse i september bliver Danmark det næste og kun andet land i verden, hvor LEO Pharma lancerer sit nyeste lægemiddel, Anzupgo® (delgocitinib) creme, efter lanceringen i Tyskland tidligere på måneden. (1) Anzupgo® creme er den første godkendte topikale behandling for voksne med moderat til svært kronisk håndeksem, hvor topikale kortikosteroider er utilstrækkelige eller uhensigtsmæssige. (1) Lanceringen giver en ny behandlingsmulighed for de mange voksne danskere, som lever med moderat til svært kronisk håndeksem, som er en af de mest udbredte kroniske inflammatoriske hudsygdomme, der rammer 4,7% af befolkningen. (2,3)

Following the recent European Commission (EC) approval, Germany has become the first country worldwide where Anzupgo will be made available.(1) Anzupgo is the first topical treatment specifically indicated for adults with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.(1) The launch brings a new treatment option for the estimated 3.9 million people in Germany living with CHE, a condition with a high unmet need for which no specifically approved topical treatment was previously available.(2,3)