Incyte (NASDAQ:INCY) executives highlighted stronger-than-expected 2025 commercial performance, an increasingly late-stage pipeline, and multiple regulatory milestones during the company’s fourth quarter and year-end 2025 financial results conference call.
2025 results exceeded expectations
Chief Executive Officer Bill presented a summary of 2025 performance, noting that the company “exceeded expectations” on total sales, Jakafi sales, and core business sales excluding Jakafi, while also moving “multiple assets from early to late-stage development.”
Sales for the company’s core business excluding Jakafi totaled $1.26 billion in 2025, representing a 53% increase versus 2024 and more than $400 million of growth. Bill said OPZELURA, Niktimvo, and MONJUVI were the largest contributors to that increase.
Key products: Jakafi, OPZELURA, and oncology/hematology portfolio
Jakafi delivered fourth quarter sales of $828 million (up 7%) and full-year sales of $3.093 billion (up 11%). Bill said prescriptions increased 11% in the fourth quarter and 9% for the full year despite competition, with demand up across all three indications. He added that polycythemia vera (PV) is expected to be the “largest and fastest growing indication” in 2026, citing an estimated PV penetration rate of about 30% compared with 60%–70% in frontline myelofibrosis (MF). Formulary coverage was described as “near-complete.”
For Jakafi XR, management expects an approval and launch “in the middle of 2026.” Bill said 2026 will primarily focus on formulary access and 2027 on conversion. In response to a question, management stated that the 2026 Jakafi guidance includes no incremental revenue from Jakafi XR. Executives also said they have had conversations with major pharmacy benefit managers and are targeting sufficient coverage to enable a 10%–30% conversion rate over time.
OPZELURA posted fourth quarter net sales of $207 million (up 28%) and 2025 net sales of $678 million (up 33%). Bill said growth was driven by higher penetration in U.S. atopic dermatitis (AD) and vitiligo, with prescriptions up 24% and 15%, respectively. The pediatric AD launch in the U.S. was described as off to a strong start, with sales “already annualizing around $30 million.” International vitiligo sales doubled to $130 million in 2025.
Management guided 2026 OPZELURA sales to $750 million–$790 million, with continued double-digit U.S. volume growth partially offset by price actions intended to expand formulary coverage and sustained double-digit international growth. Bill said the moderate AD launch in Europe is expected in the second half of 2026, with most benefits expected in 2027 and beyond. Addressing pricing, executives said the formulary-related price actions were not driven by competitive pressure, emphasizing a long-term approach and exclusivity “to the end of the next decade.”
Hematology and oncology products generated fourth quarter net sales of $187 million (up 121%) and full-year sales of $583 million (up 83%), driven by Niktimvo, MONJUVI, and ZYNYZ. Niktimvo ended its first year with $152 million in sales; management said it reached more than 1,400 patients with 13,000 infusions, with use primarily in fourth-line and increasing preference in third-line settings. MONJUVI sales increased 20% year-over-year, supported by a follicular lymphoma launch in mid-2025.
Pipeline and regulatory milestones: multiple pivotal trials and data catalysts
Chief Scientific Officer Pablo said 2025 pipeline progress included approvals for MONJUVI in follicular lymphoma, ZYNYZ in squamous cell anal carcinoma, and OPZELURA in pediatric AD, as well as submissions for Jakafi XR, OPZELURA, and povorcitinib. He also highlighted clinical data that advanced multiple programs, including Phase III registrational data for povorcitinib in hidradenitis suppurativa (HS) and early-stage results supporting pivotal development efforts across several oncology and MPN programs.
Management said it expects, by the end of 2026, to have 14 pivotal trials underway across seven assets, along with seven data readouts during the year. Late-stage expectations include FDA filing acceptance for povorcitinib in HS in the first quarter of 2026 and an sBLA submission for tafasitamab in first-line diffuse large B-cell lymphoma (DLBCL) in the first half of 2026.
- Povorcitinib (HS and other indications): The company submitted an NDA for HS and expects FDA acceptance in the first quarter of 2026; an MAA was submitted to the EMA in the fourth quarter of 2025. Executives described an opportunity in both pre-biologic patients (where they said there are no FDA-approved treatments) and post-biologic patients with partial responses to IL-17s and TNFs. Management said it is seeking a label covering both biologic-naïve and biologic-experienced populations, noting roughly one-third of trial patients had prior biologic exposure.
- OPZELURA (prurigo nodularis and HS): Pablo said development in prurigo nodularis (PN) has been paused after FDA feedback in January indicating an additional efficacy study would be required, following two Phase III studies where one met statistical significance and the other narrowly missed. Executives said there is “no read-through” to OPZELURA HS studies, which are ongoing with Phase III results expected later in 2026.
- MONJUVI/tafasitamab (frontline DLBCL): Management reiterated January data in which tafasitamab plus lenalidomide added to R-CHOP improved progression-free survival by 25% in newly diagnosed high-grade DLBCL patients with IPI 3–5, with no new safety signals observed. The company plans to present additional data at an upcoming medical congress, work on guideline inclusion, submit an sBLA in the first half of 2026, and said approval could come by early 2027.
- MPN programs (mutant CALR and JAK2 V617F): Pablo said Incyte plans to initiate Phase III studies for 989 in second-line CALR-positive essential thrombocythemia (mid-2026) and second-line myelofibrosis (second half of 2026), subject to regulatory alignment. A Phase I subcutaneous formulation study is planned for the first quarter of 2026. He also said Phase I data for the JAK2 V617F inhibitor program (058) are expected in the second half of 2026, and Phase I data for the mutant CALR x CD3 bispecific (784) are expected in 2027.
- Oncology programs (MSS colorectal cancer and pancreatic cancer): Pablo said a Phase III study for A90 (TGF-beta receptor 2 by PD-1 bispecific) in first-line MSS colorectal cancer began in December. For 734, a KRAS G12D inhibitor, management cited ASCO GI data showing a 37% overall response rate at the planned Phase III dose in a predominantly third-line and later PDAC population and said the program is on track to initiate a Phase III first-line PDAC trial in the first quarter of 2026.
2026 guidance: revenue growth and controlled spending
Management issued full-year 2026 revenue guidance of $4.77 billion–$4.94 billion. Product-level expectations include:
- Jakafi: $3.22 billion–$3.27 billion
- OPZELURA: $750 million–$790 million
- Hematology/oncology: $800 million–$880 million
Bill said core business sales excluding Jakafi are expected to be $1.57 billion–$1.69 billion, implying roughly 30% growth at the midpoint.
On expenses, management guided total GAAP R&D and SG&A operating expenses to $3.495 billion–$3.675 billion in 2026, with R&D expected to rise roughly 10% and SG&A expected to be “relatively flat” year-over-year due to reallocation, including G&A down about 10% and modestly higher sales and marketing to support planned launches. Cost of goods is expected to remain stable at 8%–9% of net sales.
Management focus: execution into 2026 and beyond
Executives framed 2026 as an “inflection point,” emphasizing execution across product launches, multiple Phase III programs, and business development as a potential “multiplier.” Bill said the company is focused on creating “the steepest possible growth curve post 2029” and emphasized plans to build a path to “replace Jakafi” over time.
About Incyte (NASDAQ:INCY)
Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company’s research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company’s flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
