Incyte Reports 2025 Second Quarter Financial Results and Provides Updates on Key Clinical Programs

– Total revenues of $1,216 million in the second quarter (Q2'25) (+16% Y/Y); total product revenues of $1,059 million in Q2'25 (+17%Y/Y)

– Jakafi^® (ruxolitinib) net product revenues of $764 million in Q2'25 (+8% Y/Y); raising full year 2025 guidance to a new range of $3,000 - $3,050 million [previously $2,950 - $3,000 million]

– Opzelura^® (ruxolitinib) cream net product revenues of $164 million in Q2'25 (+35% Y/Y)

– Niktimvo^™ (axatilimab-csfr) net product revenues of $36 million in the second quarter, demonstrating strong commercial execution; raising full year 2025 Other Oncology guidance to a new range of $500 - $520 million [previously $415 - $455 million]

– Zynyz^® (retifanlimab-dlwr) and Monjuvi^® (tafasitamab-cxix) approved by the U.S. FDA for the first line treatment of adult patients with advanced squamous cell carcinoma of the anal canal (SCAC) and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with rituximab and lenalidomide, respectively

– Bill Meury appointed as President and Chief Executive Officer effective June 26, 2025, upon the retirement of Hervé Hoppenot

Conference Call and Webcast Scheduled Today at 8:00 a.m. ET

WILMINGTON, Del.--(BUSINESS WIRE)--$INCY--Incyte (Nasdaq:INCY) today reports 2025 second quarter financial results, and provides a status update on the Company’s clinical development portfolio.

"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) 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.

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.

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.

Other

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.

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.

Financial Highlights

Revenue Details

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

Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended June 30, 2025 increased 3% and 2% respectively, compared to the same period in 2024, primarily driven by growth in net product revenues, the Niktimvo profit share and increased manufacturing related costs, partially offset by the impact of the contract dispute settlement with Novartis.

Contract dispute settlement In May 2025, Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. Under the settlement agreement, the royalty rate payable by Incyte on future net sales of Jakafi in the United Stated is reduced by 50% beginning January 1, 2025 and Incyte paid Novartis $280.0 million as the settlement of disputed royalties on net sales of Jakafi in the United States through December 31, 2024. The reduced royalty paid for the quarter ending March 31, 2025, was approximately $14.9 million. The difference of $242.2 million between the accrued royalties and the total amount paid by us to Novartis as disclosed above was recorded in contract dispute settlement on the condensed consolidated statement of operations for the three and six months ended June 30, 2025.

Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended June 30, 2025 decreased 57% and 58%, respectively, compared to the same period in 2024, primarily due to $691.9 million of expense relating to the Escient acquisition that occurred during the quarter ended June 30, 2024. Excluding the upfront consideration paid related to the Escient transaction and other upfront and milestone payments, research and development expenses for the quarter ended June 30, 2025 increased 8% compared to the same period in 2024 primarily driven by continued investment in our late stage development assets.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2025 increased 8% and 16%, respectively, compared to the same period in 2024, primarily due to increased legal costs relating to the Novartis contract dispute settlement and other matters and timing of consumer marketing activities. The 2024 Non-GAAP selling, general and administrative expenses exclude $21.5 million of expense relating to the Escient acquisition that occurred during the second quarter of 2024.

Other Financial Information

Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.

Operating income GAAP and Non-GAAP operating income for the three months ended June 30, 2025 increased 211% and 201%, respectively, compared to the same period in 2024, driven primarily by the aforementioned costs relating to the Escient acquisition in 2024, the Novartis contract dispute settlement in 2025 and growth in net product revenues.

Cash, cash equivalents and marketable securities position As of June 30, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively. The balance reflects the Novartis contract dispute settlement payment made during the second quarter of 2025, which offsets cash flows from operating activities.

2025 Financial Guidance

Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its revenue guidance for Jakafi to account for higher demand in the first half of 2025. Incyte is also raising its revenue guidance for other oncology products, to reflect the strength of the Niktimvo launch, higher demand for Zynyz in the first half of the year and the positive impact of foreign currency exchange rates. Incyte is updating its cost of product revenues guidance to reflect the reduction in the Jakafi royalty rate payable to Novartis, as a result of the contract dispute settlement. Furthermore, Incyte is updating its expense guidance for research and development to reflect the increase due to upfront and ongoing expenses related to new collaborations with Genesis and Biotheryx.

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