LEO Pharma

LEO Pharma is seeking to expand the availability of Anzupgo® (delgocitinib) cream to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA), which has been accepted for review for adult patients with moderate to severe chronic hand eczema. The NDA is supported by results from DELTA China, a phase 3 trial with Anzupgo in Chinese adults with moderate to severe chronic hand eczema (CHE)1 along with the full clinical program of delgocitinib, which includes data from DELTA 1,2 and 3, DELTA Force and DELTA Teen.2-7 The Anzupgo NDA submission demonstrates LEO Pharma's commitment to providing additional treatment options for patients living with skin diseases in China.

Adding Spevigo® is a significant step forward in LEO Pharma’s focused growth strategy, to accelerate and expand patients’ access to treatments for medical dermatological conditions, including generalized pustular psoriasis (GPP), a rare and severe skin condition Spevigo® (spesolimab) is a first-in-class IL-36R antagonist successfully developed and launched by Boehringer Ingelheim and approved globally for the treatment and prevention of GPP flares Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases

Late-breaking data from the ECZTEND trial show that patients with moderate-to-severe atopic dermatitis (AD), who responded to Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) at Week 16, maintained stable, optimal treatment outcomes for up to three years.1 Additional data presented at EADV from the real-world TRACE study further support the long-term use of tralokinumab, with sustained improvements in disease severity, quality of life, sleep, and work productivity observed over 12 months of treatment.2-4 Presented as part of LEO Pharma’s most ambitious scientific program to date at the 2025 EADV Congress, the tralokinumab data reinforce the company’s leadership in medical dermatology and its commitment to advancing innovation across its biologics’ portfolio.

The first late-breaking presentation was the phase 3 trial results for DELTA TEEN, showing delgocitinib cream had superior efficacy compared to cream vehicle and was generally well tolerated in adolescents, aged 12-17, with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 In a second late-breaking presentation, pooled data from five phase 2b and phase 3 trials of delgocitinib cream confirmed a consistent safety profile for the treatment of moderate to severe CHE in adults.2 Fifteen other pieces of delgocitinib cream research formed part of LEO Pharma’s most ambitious scientific program to date at EADV 2025.3-17

Results presented at EADV 2025 demonstrated that investigational agent temtokibart met its primary endpoint of percentage change in the Eczema Area and Severity Index (EASI) compared with placebo for the three highest doses (600 mg, 450 mg, and 300 mg).1 Significantly greater improvements in EASI were reported as early as Week 1 for temtokibart 450mg and 300mg, and Week 2 for 600mg, vs placebo; these results were maintained up to Week 32 in 600mg and 300mg arms, despite no treatment after Week 14.1 Safety analyses revealed that temtokibart was well-tolerated with no dose-dependent AEs, a low incidence of conjunctivitis, and no signal for herpes.1

For the second year in a row, LEO Pharma delivers its largest and most ambitious scientific programme ever at the 2025 European Academy of Dermatology and Venereology (EADV), setting a new standard by presenting an unprecedented volume of scientific content for the company, with 5 late-breaking presentations and 24 regular abstracts.1-29 LEO Pharma’s scientific programme at EADV 2025 spans multiple dermatological indications, mirroring the company’s strong commitment to addressing both the most prevalent chronic skin diseases and hard-to-treat conditions.1-29 Highlights from EADV 2025 includes exciting phase 3 data in biologic injectables as well as foam and cream formulations, illustrating the breadth of therapeutic approaches represented in LEO Pharma’s medical dermatology portfolio.1-29

Ballerup, Denmark, 18 August, 2025 - 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

ANZUPGO® (delgocitinib) cream now becomes the first and only FDA-approved treatment specifically approved for the treatment of adults living with moderate-to-severe chronic hand eczema (CHE) in the U.S.1 CHE affects approximately one in ten adults worldwide, yet previously, there has been no specific treatment FDA-approved for those living with the disease.2,3 The approval represents an important milestone for LEO Pharma’s expanding presence in the U.S. as it broadens its portfolio of dermatology treatments to address unmet needs.

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