Leo Pharma has posted a strong set of financials for 2024, a year which saw the Danish drugmaker nail its three ambitions of increasing top-line growth, improving profitability and advancing in innovation, CEO Christophe Bourdon has told Scrip.
Revenues for the year rose by 9% to DKK12.45bn ($1.75bn), with the dermatology unit, which accounted for 80% of group sales, climbing 11% to just over DKK10.00bn. Driving that growth was Adtralza/Adbry (tralokinumab), Leo’s anti-IL-13 monoclonal antibody for atopic dermatitis licensed from AstraZeneca back in 2016.
Revenues of the drug, which was first approved in April 2021 and is now available in 20 markets, increased by 69% and while Leo does not disclose sales of individual products, growth of Adbry was particularly strong in the US. Bourdon said that in addition to exceeding guidance, “we have grown exactly where and how we wanted to,” and the US is now Leo’s largest market.
The strong performance of Adbry in the US is due in part to the “laser focus and clarity” shown by the Leo team on the ground to identify pockets of patients such as those with head and neck atopic dermatitis where, despite the use of other biologics, there is still a high unmet need, he noted. For these patients, Adbry has shown a clear benefit as revealed by the six years of real-world evidence Leo has generated on the therapy, Bourdon said, adding that “the awareness of the brand among US dermatologists is very strong” and a pre-filled pen had further strengthened uptake.
It is not just the US where Leo is on the rise and Bourdon insisted that “we are the leader in medical dermatology globally. We are serving more than 100 million patients across 70 countries and we are changing the standard of care. We are extremely credible.”
That credibility has been helped by Anzupgo (delgocitinib) which was approved for chronic hand eczema in September last year. The first-in-class topical pan-JAK inhibitor was launched in Germany and Denmark in the fourth quarter and marketing authorizations were also granted in the UK, Switzerland, and the United Arab Emirates.
Bourdon told Scrip that Leo expected to get a target date for the therapy from the US Food and Drug Administration for the third quarter of this year. Leo is also looking at other opportunities for Anzupgo and “while we are not disclosing the new indications right now, we are working at full speed to have at least two to three other indications with this incredible asset – we are getting increasingly confident it is a pipeline in a drug with significant growth potential.”
Changing Fortunes
Bourdon has led a significant turnaround in Leo’s fortunes since he took the reins in April 2021 which has been achieved while “remaining extremely disciplined on cost and capital allocation.” Adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA) were up by 43% year-over-year to DKK895m despite the investments in Anzupgo launch activities and the negative impact of foreign exchange rates and he noted that the adjusted EBITDA margin has risen from -17% in 2021 to 7% in 2024.
Revenues in 2025 are forecast to rise by 6%-9% at constant exchange rates, while adjusted EBITDA margin should be 15%-18%, excluding the DKK1.8bn upfront payment Leo banked from selling its preclinical oral signal transducer and activator of transcription 6 (STAT6) small-molecule inhibitors and targeted protein degraders for use in autoimmune and allergic diseases to Gilead Sciences earlier this year.
Under the terms of that deal, which could be worth up to $1.7bn plus tiered royalties, Leo kept hold of the global rights to STAT6 topical formulations in dermatology. Bourdon noted that the firm also had co-commercialization rights to the assets outside the US “and we’re not giving any crown jewels away. It was very important for me when we selected Gilead to really shape this partnership so that we at Leo could retain some significant benefit ... and the first weeks of collaboration have been very encouraging.”
The company, which is owned by the Leo Foundation (which holds over 75% of the shares) and private equity group Nordic Capital (which owns the rest), is also revisiting the possibility of going public. When Bourdon was appointed CEO, “an initial public offering was always an objective and ultimately, it is in the hand of shareholders. But if you look at the trajectory, how we closed 2024 and how we’re guiding for 2025, I’m getting increasingly confident that we are completely on track for an IPO in 2026.”
The year has started well for Leo, which has also inked a licensing deal for Shanghai Junshi Biosciences' PD-1 antibody toripalimab, and Bourdon is heading off to Orlando early next month for the American Academy of Dermatology meeting where the firm will have a strong presence. Three years ago, “the question was ‘Hey Leo, how do you plan to stay in the game?’ Now people are calling and saying, ‘Can we help? Can we do things together?’ Now it’s a lot of biotechs reaching out to us, and they see we are uniquely positioned to bring innovation globally. Things are moving in the right direction, full speed ahead, and I’m very confident about the future.”
