Incyte Corporation Q4 FY2025 earnings call

Management Statement and Operational Highlights

• 2025 Achievements: Business exceeded expectations on total sales, Jakafi sales, and core business sales ex-Jakafi. Pipeline transformed with multiple assets moving to late-stage development. Regulatory applications for Jakafi XR, Opsilor for moderate AD, and povastatinib for HS in Europe submitted.
• 2025 Revenue: Q4 revenues totaled $1.51 billion, up 28% versus prior year. Full year 2025 revenue totaled $5.14 billion, up 21% year over year. Core business ex-Jakafi expected to grow over 30% in 2026 and approach $3 to $4 billion by 2030.
• Pipeline Progress: 2026 plans include additional approvals, regulatory filings, pivotal data readouts, and trial initiations. Key late-stage pipeline assets with upcoming FDA filings and data readouts.

Segment Performance

• Jakafi: Fourth quarter sales were $828 million, an increase of 7% versus the prior year. Full year sales totaled $3.093 billion, representing an 11% increase year over year. Prescriptions increased 11% in the fourth quarter and 9% for the full year 2025. PV is expected to be the largest and fastest-growing indication in 2026.
• Opsalor: Net sales in the fourth quarter totaled $207 million, an increase of 28%, and full-year net sales were $678 million, up 33% versus 2024. Growth driven by increased penetration in US AD and vitiligo markets. Pediatric launch for Opsilor AD is off to a strong start.
• Hematology and Oncology: Net product sales in the fourth quarter were $187 million, up 121% compared to the prior year. Full-year '25 sales were $583 million, representing an 83% increase compared to 2024, driven by Niktimbo, Manjuli, and Zionis. Full-year guidance for the hematology business is $800 million to $880 million for 2026.

Guidance

• 2026 Revenue: Full-year revenue guidance of $4.77 billion to $4.94 billion, representing a 10% to 13% increase from prior year. Jakafi net revenue expected $3.22 billion to $3.27 billion, Opsalor $750 million to $790 million, hematology oncology $800 million to $880 million.
• Expenses: Total GAAP R&D and SG&A operating expenses expected $3.495 billion to $3.675 billion in 2026, a 4% increase versus prior year, driven by targeted investments in late-stage pipeline.

Risks

• Regulatory Uncertainties: Uncertainties around approval timelines for pipeline assets.
• Competitive Pressures: Competitor activity in market segments such as AD and oncology.
• Formulary and Pricing: Uncertainties in formulary access and potential pricing impacts on sales.

Question and Answer

Q: Marc Frahm from TD Cowen on CALAR pivotal programs and Opsalor pricing A: Pablo Cagnoni discussed CALAR pivotal programs strategy with FDA, and William Meury stated Opsalor pricing was about long-term formulary coverage, not competitive issues Q: Tazeen Ahmad from Bank of America on Opsalor uptake A: William Meury said AD growing near 20% YoY, vitiligo mid-teens, 60% AD and 40% vitiligo of Opsalor sales, pediatric launch annualizing $30 million Q: Michael Schmidt from Guggenheim Securities on Frontline PLBCL A: Pablo Cagnoni discussed IPI three to five patient group and Monjuvi's PFS benefit, Mohamed Issa added on first-line DLBCL opportunity Q: Eric Schmidt from Cantor Fitzgerald on 890 bispecific A: Pablo Cagnoni said additional data on 890 bispecific expected in 2026 with phase three study underway Q: Eric Lavington from Mizuho on Opsilura in PN and HS A: Steven Stein explained PN trial situation with two studies, one positive one negative, and no read-through to HS Q: Salveen Richter from Goldman Sachs on M. KLR bispecific A: Pablo Cagnoni discussed CALAR by CD three bispecific and V six seventeen F program, noting phase I data expected in 2027 Q: Jay Olson from Oppenheimer on PDAC trial design A: Steven Stein discussed phase III trial design in PDAC and potential for adjuvant/neoadjuvant studies Q: Madeline from William Blair on POVO in HS biologic-naive patients A: Steven Stein said POVO NDA submitted includes both pre-biologic and post-biologic populations Q: Parth from Morgan Stanley on nine eighty nine frontline MF readout A: Pablo Cagnoni said data on nine eighty nine in frontline MF expected later 2026 supporting first-line development Q: Brandon from Wolfe Research on Jakafi XR formulary access A: William Meury said had conversations with PBMs, XR expected to drive conversion in 2027 and beyond Q: Evan Seigerman from BMO Capital Markets on HS OPSILURA placebo response A: Steven Stein discussed managing placebo response in HS trials with larger study size and minimum abscess/nodule requirements Q: Derek Archila from Wells Fargo on Jakafi guide and PV penetration A: William Meury said no incremental XR revenue in 2026 guidance, Jakafi growth in high single digits, PV penetration potential Q: Brian Abrams from RBC Capital Markets on nine eighty nine subcu study A: Pablo Cagnoni discussed subcu formulation study bioavailability and dosing strategy, data expected later 2026 Q: Steven Willey from Stifel on mutant selective JAK inhibitor exposure target A: Pablo Cagnoni explained IC 35 target related to molecule selectivity, data expected in 2026 on o five a program Q: Srikripa Devarakonda from Truist Securities on provercitinib in asthma A: William Meury and Pablo Cagnoni discussed povastatin's potential in HS pre-biologic population and asthma phase II data outlook