Delgocitinib

For the first time since 2018, dermatology-focused Leo Pharma projects that it could turn a profit this year. Its Wednesday guidance comes on the heels of a broad multiyear restructuring — a plan that focused on strengthening Leo’s balance sheet ahead of a potential IPO. And the pharma company should be on track to go public in 2026 if it becomes net profit positive and free cash flow positive this year, CEO Christophe Bourdon told Endpoints News in an interview. Leo also plans to ink dermatology deals this year, with a focus on in-licensing assets that have the potential to address a significant unmet need, Bourdon said. In January, it made a pact with Gilead to advance the Danish company’s early-stage pipeline of STAT6 inhibitors. The biotech’s troubles started in April 2021, when it was slapped with a CRL for its atopic dermatitis candidate, which was meant to compete with Sanofi and Regeneron’s Dupixent. The drug went on to secure approval in December that same year with the brand name Adbry. But when Bourdon joined the company in 2022, it was dealing with high launch costs for Adbry, on top of high R&D costs. It was also operating at an EBITDA in the minus double-digits. It has since been through a series of changes over several years: significant staff cuts , a two-way split in R&D operations that involved an executive reshuffle, and a $14 million acquisition of the rare skin disease company Timber Pharmaceuticals. And on Wednesday, Leo said it delivered a 7% in EBITDA last year. In 2024, sales of the company’s dermatology portfolio hit 10 billion Danish krone ($1.4 billion), which is a 12% rise from 2023, mainly driven by growth in the US. Its total revenues climbed 10% to DKK 12.5 billion ($1.76 billion), bolstered by cash from partnerships. “When I kicked off 2024, I committed to three things — grow the top line, advance innovation and improve the profitability of the organization,” Bourdon said. “We’ve nailed those three objectives.” The company secured EU approval for its chronic hand eczema drug Anzupgo in September. Launch activities for Anzupgo are underway in Germany and Denmark. The pan-JAK inhibitor is also under FDA review with a decision expected in the third quarter. There are no approved treatments for chronic hand eczema in the US. There are five million patients eligible for treatment with Anzupgo across the US and Europe, Bourdon said. Leo’s medical market access and commercial teams are ready for a US launch in the middle of the year, he added. Last month, Gilead licensed Leo’s preclinical oral STAT6 inhibitors and protein degraders for inflammatory diseases, including certain skin conditions. Leo received $250 million upfront, but the pact could be worth up to $1.7 billion when factoring in milestones, with Leo also eligible for tiered royalties on sales. Targeting STAT6 involves entering the nucleus of the cell and degrading complement to correct inflammatory pathways of disease, Bourdon said, adding the approach exemplifies the latest “wave of innovation” in dermatology. It also has potential applications in oncology, he said.

Incyte pulled $4.2 billion in full-year 2024 product revenues. Incyte’s ruxolitinib franchise, made up of blockbuster JAK inhibitor Jakafi and its topical counterpart Opzelura, have been the company’s driving focus for years. Now, with Jakafi approaching a 2028 patent cliff, Opzelura is gaining momentum as several expansion opportunities take shape.The 2021-approved Opzelura grew sales by 50% during 2024, reaching $508 million on the back of its two approved indications in atopic dermatitis and vitiligo. Included in the fourth quarter’s $162 million revenue haul is $24 million from sales outside of the U.S., where Opzelura’s European launch is seeing positive momentum, Incyte said on its earnings presentation Monday. Opzelura remains the only marketed topical JAK inhibitor, although Leo Pharma’s delgocitinib is vying for a nod in chronic hand eczema. Besides studies in prurigo nodularis and mild to moderate hidradenitis suppurativa, Incyte’s next move for Opzelura is an expected approval in pediatric atopic dermatitis in the second half of this year. An expansion into the 2- to 11-year-old age group would add 2 million to 3 million pediatric patients into the drug’s clutches, representing 10% to 15% of the total atopic dermatitis patient population at its peak, CEO Hervé Hoppenot said on a conference call Monday. As it stands, the “vast majority” of those patients’ disease remains uncontrolled, according to Hoppenot, leaving a significant market opportunity for Opzelura.Beyond that, the company is hopeful that the phase 3 data for its study of Opzelura in prurigo nodularis, expected to drop over the first half of this year, will meet the bar set by its successful phase 2 trial.In the phase 2, Opzelura helped patients achieve a significantly greater reduction in the amount of abscess and inflammatory nodules than those who used the vehicle control. If the phase 3 results are “anywhere near” what the phase 2 proved, the drug could be an important offering for patients who may have less severe disease than those that currently require a systemic medicine, R&D head Pablo Cagnoni, M.D., explained on the call.With the expansions taking shape, Incyte on Monday delivered its first revenue guidance expectations for Opzelura since its 2021 launch, forecasting 2025 sales of $630 million to $670 million. The range comes in slightly below current consensus of $678 million, according to William Blair. The sales estimates are backed by demand growth in its two approved indications, plus the potential launch in the pediatric atopic dermatitis population, Chief Financial Officer Christiana Stamoulis said.While the company is seeing an increase in the average number of patients that are sticking to their Opzelura treatment, it’s still an “area that is evolving” as Incyte continues to educate patients on how best to use the product, according to Stamoulis.Meanwhile, Jakafi continues to pick up the bulk of sales at Incyte and collected $773 million in fourth-quarter revenue, with polycythemia vera patients currently making up 35% of all Jakafi takers, Hoppenot mentioned. The company has a second chance to help Jakafi live on in a once-daily extended-release formulation. Incyte said the new formulation has met the bioequivalence criteria set by the FDA, and it plans to submit to the FDA by the end of the year after it wraps up the stability studies in hopes of a 2026 launch. The FDA had previously rejected the contender, dealing a blow to Incyte's proposed fixed-dose combinations of Jakafi with other once-daily novel agents.Elsewhere, Incyte is looking at a packed year with 18 key milestones expected to come, including four new product launches, three phase 3 study initiations, four pivotal readouts and seven proof-of-concept readouts.Along with the launch of newly approved chronic graft-versus-host disease drug Niktimvo, as well as potential expansions for Opzelura, lymphoma med Monjuvi and PD-1 inhibitor Zynyz, the company is gearing up for a key readout for its phase 3 povorcitinib asset in hidradenitis suppurativa during the first half of this year. Incyte sees “best-in-class efficacy” for povorcitinib, which is also being assessed in vitiligo and prurigo nodularis.