On October 28, 2025 Incyte (Nasdaq:INCY) reported financial results for the third quarter of 2025 and provided a business update.
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"Our third-quarter results demonstrate strong growth across our product portfolio, with net product revenues increasing 19% year-over-year, which highlights the momentum in our business and effective commercial execution," said Bill Meury, President and Chief Executive Officer, Incyte. "We are taking a deliberate approach to pipeline prioritization. We are actively reviewing our R&D efforts and focusing on high-value programs that are scientifically differentiated, address unmet medical needs, and have the potential to significantly drive Incyte’s next phase of growth."
Third Quarter 2025 Results
•Total revenues: Total revenues were $1.37 billion, an increase of 20% compared to the third quarter of 2024, primarily driven by an increase in total net product revenues. Total net product revenue for the third quarter of 2025 was $1.15 billion, an increase of 19%. The increase was primarily related to patient demand for Jakafi (ruxolitinib) across all indications and strong uptake of the initial launch of Niktimvo (axatilimab-csfr).
•Cost of product revenues: GAAP and non-GAAP cost of product revenues were $99.0 million and $92.7 million, an increase of 15% and 16%, respectively, compared to the prior year period.
•Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $506.6 million and $467.0 million, a decrease of 12% and 11%, respectively, compared to the prior year period.
•Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $329.1 million and $308.0 million, an increase of 6% and 11%, respectively, compared to the prior year period.
•Cash, cash equivalents and marketable securities position: As of September 30, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.9 billion and $2.2 billion, respectively.
Full-year 2025 Financial Guidance
•The Company is raising its full-year 2025 net product revenue guidance to $4.23 – $4.32 billion to account for higher demand for Jakafi and other hematology and oncology marketed products. The update includes raised guidance for Jakafi to $3.050 – $3.075 billion, as well as other hematology and oncology marketed products to $550 – $575 million. The Opzelura (ruxolitinib) cream revenue guidance of $630 – $670 million is maintained.
•The Company reiterates its guidance for GAAP and non-GAAP cost of product revenues, R&D, and SG&A expenses for full year 2025, which reflects the continued investment in mid- and late-stage clinical development programs and commercial capabilities.
Key Business Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD)
•The Company is on track to submit ruxolitinib extended-release (XR) bioequivalence data to the U.S. Food and Drug Administration (FDA) in the fourth quarter.
•Results from the Phase 1 trial evaluating INCA033989, an investigational mutant calreticulin (mutCALR) selective monoclonal antibody, in mutCALR positive patients with myelofibrosis (MF) are expected in the second half of 2025. The Phase 1 results will include safety and efficacy data evaluating INCA033989 as a monotherapy in patients who are resistant, refractory or intolerant to JAK inhibitor treatment, as well as data evaluating INCA033989 as a combination therapy with ruxolitinib in patients who are exhibiting a suboptimal response to ruxolitinib monotherapy.
Hematology/Oncology
•In October, results from the Phase 1 trial evaluating INCA33890 (TGFBR2xPD-1 bispecific antibody) in solid tumors were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. In the trial, INCA33890 demonstrated a manageable tolerability profile and clinical efficacy across multiple tumors, including microsatellite stable colorectal cancer (MSS CRC) patients with and without active liver metastases. Based on these initial findings, the Company plans to initiate a registrational program evaluating INCA33890 in MSS CRC in 2026.
•Preliminary results from the Phase 1 trial evaluating INCB161734 (KRASG12D selective inhibitor) were presented at the ESMO (Free ESMO Whitepaper) Congress in October. In the trial, INCB161734 demonstrated a manageable safety profile and clinical efficacy in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) patients with a KRASG12D mutation. Evaluation of INCB161734 in PDAC patients as a monotherapy, and in combination with chemotherapy, is ongoing and will support potential future development efforts.
•A Phase 2 trial evaluating INCB123667 (CDK2i) in patients with platinum-resistant ovarian cancer (PROC) with Cyclin E1 overexpression was initiated in the third quarter.
•The Phase 3 study evaluating tafasitamab (Monjuvi) as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing, with data anticipated around year-end 2025.
Inflammation and Autoimmunity (IAI)
Ruxolitinib cream
▪In September, the FDA approved the supplemental New Drug Application (sNDA) for Opzelura for pediatric atopic dermatitis (AD). Opzelura is now indicated for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
▪In October, Phase 3 results from the TRuE-AD4 trial evaluating Opzelura in patients with moderate AD were presented at the International Symposium on Atopic Dermatitis (ISAD). Results from the study demonstrated that by Week 8, treatment with Opzelura significantly improved the clinical signs of AD, rapidly improved itch, improved quality of life measures and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
▪The Company anticipates filing a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by year-end 2025.
Povorcitinib
▪In September, longer-term data for povorcitinib were presented at the European Association of Dermatology and Venereology (EADV) which demonstrated continued clinically meaningful and statistically significant improvements in patients with active moderate to severe hidradenitis suppurativa (HS).
▪Regulatory submissions for povorcitinib in moderate to severe HS in the EU and the U.S. are anticipated by year end 2025 and early 2026, respectively.
▪Data from the Phase 3 studies evaluating povorcitinib in prurigo nodularis (PN) and vitiligo, as well as data from the Phase 2 proof-of-concept trial in asthma, are anticipated in 2026.
Corporate and Business Development Updates
▪The Company strengthened its executive leadership team through the appointment of Soni Basi as Executive Vice President and Chief Human Resources Officer and Dave Gardner as Executive Vice President and Chief Strategy Officer in the third quarter.
▪Based on ongoing pipeline prioritization efforts, the Company has paused further development of the INCA034460 (anti-CD122) and INCB57643 (BET inhibitor) programs, as well as the development of povorcitinib in chronic spontaneous urticaria (CSU).
▪The Company announced a strategic partnership with Enable Injections, Inc., to develop and commercialize specific assets in Incyte’s portfolio, including INCA033989, with Enable’s enFuse on-body delivery system. Under the terms of the agreement, Incyte will obtain a worldwide, exclusive license to use the enFuse technology with INCA033989 in essential thrombocythemia (ET) and MF, with the potential to expand to additional assets and indications.
2025 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months ended September 30, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
(Press release, Incyte, OCT 28, 2025, View Source [SID1234657068])