LEO Pharma

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.

null

null

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)

A net-zero target is a natural continuation of our current commitments to run a sustainable business, LEO Pharma says.

Real-world findings showed that subgroup of patients treated with Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) and with head and neck (H&N) atopic dermatitis (AD) at baseline reported presence of AD in that area in 52.1% of patients after nine months of treatment.(1) As part of one of LEO Pharma’s most extensive scientific programs at EADV to date, the late-breaking presentation examined interim data from the real-world TRACE study of adult AD patients who have been prescribed Adtralza/Adbry for up to nine months.(1) Additional posters presented interim results of the TRACE study on effectiveness of Adtralza/Adbry treatment through various physician and patient reported outcomes such as improvements in Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), itch, sleep disturbance and quality of life.(2,3)

LEO Pharma is seeking to expand the availability of Enstilar® (LEO 90100) to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). The NDA is supported by results from a phase 3 trial comparing the efficacy and safety of Enstilar with Daivobet® ointment in adult Chinese patients.(1,2) The Enstilar submission demonstrates LEO Pharma's commitment to providing additional treatment options for the estimated seven million adult patients living with plaque psoriasis in China.(3)

Results presented at the Late Breaker Session on September 26th at the European Dermatology Congress, European Academy of Dermatology & Venereology (EADV) 2024, showed that the investigational interleukin 22 receptor, alpha 1 (IL-22RA1) inhibitor temtokibart induced fast (Week 1) molecular responses(1) Markers of skin hydration (natural moisturizing factors) 2-pyrrolidone-5-carboxylic acid (PCA) and urocanic acid (UCA) were significantly improved from baseline at Week 1 in the temtokibart group (p<0.0001)(1) Both temtokibart and dupilumab led to comparable changes in eczema area and severity index (EASI) and itch numerical rating scale (NRS) at Week 16(1)