On July 29, 2025 Incyte (Nasdaq:INCY) reported 2025 second quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, JUL 29, 2025, View Source [SID1234654599]).

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"As I begin my tenure as CEO, I look forward to leading Incyte through its next phase of growth and value creation for patients, partners and shareholders. Our second quarter results reflect strong growth for Jakafi (ruxolitinib), Opzelura (ruxolitinib) cream and Niktimvo (axatilimab), positioning us well to deliver on our 2025 objectives," said Bill Meury, Chief Executive Officer, Incyte. "During the quarter, we achieved two regulatory milestones with the approvals of Zynyz (retifanlimab-dlwr) for squamous cell anal carcinoma and Monjuvi (tafasitamab-cxix) for follicular lymphoma, further expanding our ability to address patients’ needs. Continued progress and diversification of our portfolio, including advancements with povorcitinib and mutCALR, are strengthening the foundation for sustainable, long-term growth."

Key Commercial Highlights
Jakafi:
Net product revenues for the second quarter 2025 of $764 million (+8% Y/Y):
▪Net product revenue growth in the second quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand of 8% reflecting continued demand growth in all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2025.

Opzelura:
Net product revenues for the second quarter 2025 of $164 million (+35% Y/Y):
▪U.S. net product revenue of $132 million in the second quarter of 2025 increased 19% compared to the second quarter of 2024 driven by increased patient demand and refills in both atopic dermatitis (AD) and vitiligo. Opzelura inventory levels were within normal range at the end of the second quarter of 2025.
▪Ex-U.S. net product revenues of $32 million in the second quarter of 2025 were primarily driven by continued growth in sales in France, and the recent launches in Italy and Spain.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪In June 2025, data from the Phase 1 study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) were presented during a late-breaking session at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Milan, Italy. The data showed rapid and durable normalization of platelet counts across all dose levels and importantly, a reduction in peripheral blood mutCALR variant allele frequency (VAF) correlating with hematologic response. INCA033989 was well tolerated with a favorable safety profile with no dose limiting toxicities reported. Together, the data demonstrates the potential of INCA033989 for disease modification by directly inhibiting and eliminating oncogenic mutCALR cells, while sparing healthy cells and restoring normal blood cell production. The Phase 1 data in patients with myelofibrosis (MF) as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025.
▪A Phase 1 study evaluating JAK2V617Fi in MPNs is ongoing. Initial proof of concept data are anticipated in the first half of 2026.
▪A Phase 2 trial evaluating axatilimab (Niktimvo) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing.
▪A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing.
MPN and GVHD Programs Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3
INCA033989
(mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myeloproliferative Neoplasms (MPNs): Phase 1

Other Hematology/Oncology – key highlights
▪In May 2025, Zynyz was approved by the U.S. Food and Drug Administration (FDA) in combination with chemotherapy and as a single agent for the treatment of adult patients with advanced squamous cell carcinoma of the anal canal (SCAC). The Priority Review and FDA approval were based on data from two trials: the Phase 3 POD1UM-303/InterAACT2 and the Phase 2 POD1UM-202 trial. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a Japanese New Drug Application (J-NDA) for retifanlimab in advanced SCAC.
▪In June 2025, Monjuvi was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with rituximab and lenalidomide. The Priority Review and FDA approval were based on data from the pivotal Phase 3 inMIND trial.
▪Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
▪The Phase 3 study evaluating tafasitamab as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the second half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing. Initial proof of concept data for both studies are anticipated in the second half of 2025.
Heme/Oncology Programs Indication and status
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Retifanlimab (Zynyz)1
(PD-1)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1

1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪In April 2025, Incyte announced positive topline results from the Phase 3 (TRuE-AD4) study evaluating ruxolitinib cream in adult patients with moderate atopic dermatitis. The study met the co-primary endpoints at Week 8, with a statistically significant proportion of patients achieving both Investigator’s Global Assessment Treatment Success (IGA-TS) and EASI75, which is defined as a 75% or greater improvement in the Eczema Area Severity Index score from baseline. In addition, the study met all key secondary endpoints. Ruxolitinib cream was well tolerated with no new safety signals. The full dataset will be presented at an upcoming medical conference.
▪In June 2025, two Phase 3 studies (TRuE-HS2 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) were initiated and are ongoing.
▪In June 2025, the FDA extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date was extended by three months to September 19, 2025.

Povorcitinib (INCB54707)
▪Two Phase 3 studies (STOP-V1 and STOP-V2) evaluating povorcitinib versus placebo in patients with vitiligo are ongoing. The Phase 3 data are anticipated in 2026.
▪Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus placebo in patients with PN are ongoing. The Phase 3 data are anticipated in 2026.
▪A Phase 2 trial evaluating povorcitinib in asthma is ongoing. Data are anticipated in the second half of 2025.
IAI and Dermatology Programs Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3); sNDA under review in the U.S.
Hidradenitis suppurativa: Phase 3 (TRuE-HS1, TRuE-HS2)
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Chronic spontaneous urticaria: Phase 2
Asthma: Phase 2
INCA034460
(anti-CD122) Vitiligo: Phase 1

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

2025 Second Quarter Financial Results
The financial measures presented in this press release for the three and six months ended June 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.

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
Six Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
2025 2024 2025 2024
Net product revenues:
Jakafi $ 763,788 $ 705,973 8 % NA $ 1,473,200 $ 1,277,812 15 % NA
Opzelura 164,499 121,695 35 % 34 % 283,204 207,419 37 % 36 %
Iclusig 32,729 26,862 22 % 16 % 62,273 57,205 9 % 8 %
Pemazyre 22,192 20,269 9 % 8 % 40,632 37,945 7 % 7 %
Minjuvi/ Monjuvi 31,131 31,116 0 % (1 %) 60,682 54,990 10 % 10 %
Niktimvo 36,154 — NM NA 49,767 — NM NA
Zynyz 8,921 651 1,270 % NA 11,930 1,118 967 % NA
Total net product revenues 1,059,414 906,566 17 % 16 % 1,981,688 1,636,489 21 % 21 %
Royalty revenues:
Jakavi 109,714 99,317 10 % 7 % 201,859 188,912 7 % 8 %
Olumiant 33,482 31,702 6 % 4 % 64,282 62,291 3 % 5 %
Tabrecta 6,632 5,298 25 % NA 13,045 10,532 24 % NA
Other 1,287 876 47 % NM 2,553 1,424 79 % NM
Total royalty revenues 151,115 137,193 10 % 281,739 263,159 7 %
Total net product and royalty revenues 1,210,529 1,043,759 16 % 2,263,427 1,899,648 19 %
Milestone and contract revenues 5,000 — NM NM 5,000 25,000 (80 %) (80 %)
Total GAAP revenues $ 1,215,529 $ 1,043,759 16 % $ 2,268,427 $ 1,924,648 18 %

NM = not meaningful
NA = not applicable
1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results.
Product and Royalty Revenues Total net product revenues for the quarter ended June 30, 2025 increased 17% over the prior year comparative period. Total net product and royalty revenues for the quarter ended June 30, 2025 increased 16% over the prior year comparative period, primarily driven by the following:
•Jakafi net product revenue increased 8% versus the prior year comparable period, driven by an increase in paid demand of 8% reflecting continued demand growth in all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2025.
•Opzelura net product revenue increased 35% due to increased patient demand and refills in the U.S. in both AD and vitiligo, and increased contribution from ex-U.S. driven by continued uptake in France, and growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the second quarter of 2025.
•Niktimvo net product revenue reflects continued strong uptake of the product following its commercial launch during the first quarter of 2025.
•Zynyz net product revenue increase driven by the approval of the product in squamous cell anal carcinoma in the second quarter of 2025.

•Total royalty revenues for the quarter increased 10% versus the prior year comparable period, primarily driven by growth in Jakavi royalty revenue.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
June 30, %
Change Six Months Ended
June 30, %
Change
2025 2024 2025 2024
GAAP cost of product revenues $ 78,766 $ 76,634 3 % $ 151,954 $ 137,590 10 %
Non-GAAP cost of product revenues1
72,544 70,899 2 % 139,489 125,858 11 %
Contract dispute settlement (242,251) — NM (242,251) — NM
Non-GAAP contract dispute settlement2
— — NM — — NM
GAAP research and development 494,917 1,138,380 (57 %) 932,196 1,567,640 (41 %)
Non-GAAP research and development3
455,635 1,089,089 (58 %) 855,655 1,477,526 (42 %)
GAAP selling, general and administrative 331,022 305,982 8 % 656,713 606,238 8 %
Non-GAAP selling, general and administrative4
304,771 262,572 16 % 607,063 539,907 12 %
GAAP loss (gain) on change in fair value of acquisition-related contingent consideration 22,761 893 NM 34,333 437 NM
Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration — — NM — — NM
GAAP (profit) and loss sharing under collaboration agreements — — NM — (1,025) NM