What Incyte (INCY) Said on Its Q3 Earnings Call

Key Points

• Strong quarterly growth: Incyte reported third-quarter revenue of $1.56 billion, up 14% year over year, while core-business sales excluding Jakafi rose 30% to $490 million. OPZELURA sales increased 36% to $255 million, helping offset more modest Jakafi growth.
• Raised full-year outlook: The company increased guidance for OPZELURA sales to $1.10 billion–$1.12 billion, hematology and oncology sales to $890 million–$910 million, and total net sales to $5.21 billion–$5.30 billion. Expenses included a $1.23 billion acquisition-related charge tied to Vega Therapeutics.
• Pipeline and regulatory progress: Incyte expects important data and regulatory milestones across myelofibrosis, colorectal cancer, dermatology and other programs, including first-line myelofibrosis data for INCA033989 by year-end and potential approvals for povorcitinib in hidradenitis suppurativa.

Incyte NASDAQ: INCY reported third-quarter revenue of $1.56 billion, up 14% from a year earlier, as growth in its dermatology and hematology-oncology products helped offset a more modest increase in Jakafi sales. The company also raised its full-year sales outlook for OPZELURA, hematology and oncology products, and total net sales while outlining progress across several late-stage pipeline programs.

Chief Executive Officer Bill Meury said the company’s strategy centers on expanding its core business beyond Jakafi while advancing a late-stage pipeline intended to support growth through and beyond the company’s anticipated 2029 transition.

“Every product grew year-over-year,” Meury said, adding that sales from the core business excluding Jakafi increased 37% from the prior-year period.

Sales Growth Led by OPZELURA and Core Brands

Total net sales were $1.32 billion in the quarter, also up 14% year-over-year. Jakafi franchise net sales rose 4% to $827 million. Underlying demand for Jakafi increased 12%, with growth across indications led by polycythemia vera, though reported sales growth reflected expected pricing dynamics, including the effect of the CMS GENEROUS Model, Meury said.

Incyte said formulary coverage for Jakafi XR is expected to exceed 80% by year-end. The company remains on track for approximately $50 million in full-year XR net sales and continues to target retention of 10% to 30% of the Jakafi business by 2029.

Core-business sales excluding Jakafi reached $490 million, up 30% year-over-year, supported by OPZELURA, NIKTIMVO, ZYNYZ and MONJUVI. Meury said Incyte sees the ex-Jakafi core business growing to between $3 billion and $4 billion by 2030.

OPZELURA net sales rose 36% to $255 million. On a pro forma basis that adjusts the prior-year quarter for a Medicaid line-extension settlement, OPZELURA sales increased 21%. U.S. sales totaled $208 million, up 45% from a year earlier.

Mohamed Issa, executive vice president and head of U.S. commercial, said pro forma U.S. OPZELURA growth was driven largely by demand, which grew 24% year-over-year. He said new-patient volume grew at twice the market rate across atopic dermatitis and vitiligo.

Guidance Raised as Expenses Reflect Vega Acquisition

Chief Financial Officer Suky Upadhyay said the company raised 2026 OPZELURA net-sales guidance to $1.10 billion to $1.12 billion and increased hematology and oncology sales guidance to $890 million to $910 million. Total net-sales guidance was raised to $5.21 billion to $5.30 billion.

Incyte maintained its full-year operating-expense guidance, with research and development and selling, general and administrative expenses expected near the midpoint of the previously stated range.

GAAP expenses totaled $2.27 billion, up 146% year-over-year, including a $1.23 billion in-process research and development expense tied to the closing of Incyte’s acquisition of Vega Therapeutics. Excluding the Vega-related expense, operating expenses increased 12%. The company ended the quarter with $3.9 billion in cash and cash equivalents.

Pipeline Updates Include MF, Oncology and Dermatology Programs

President and Global Head of R&D Pablo Cagnoni said Incyte expects to present first-line myelofibrosis data for INCA033989, its mutant CALR antibody, by year-end. The update is expected to include approximately 55 frontline patients, including patients treated with the therapy as a monotherapy and in combination with ruxolitinib.

The company’s pivotal second-line myelofibrosis study of 989 is focused on patients with Type 1 CALR mutations, which Cagnoni said represent more than 70% of CALR-mutated myelofibrosis cases. Incyte also plans to present preclinical data for a next-generation mutant CALR antibody and move that candidate into the clinic in early 2027.

In hematology, the FDA review of tafasitamab for first-line diffuse large B-cell lymphoma remains under way, with a decision expected in the first quarter of 2027. Incyte also expects results from a phase II study of axatilimab plus ruxolitinib in chronic graft-versus-host disease at a medical meeting early next year.

Vega’s lead therapy, latarcibart, is being studied in a pivotal phase III trial for von Willebrand disease, with top-line data expected in early 2029.

• For its KRAS G12D inhibitor, INCB161734, Incyte reported phase I response rates of 58% with gemcitabine and nab-paclitaxel and 81% with modified FOLFIRINOX in first-line pancreatic ductal adenocarcinoma.
• In heavily pretreated colorectal cancer, 734 plus cetuximab produced a 36% objective response rate. Incyte plans to initiate the phase III DAWN-302 study in previously treated colorectal cancer in the first half of 2027.
• Its TGF-beta receptor 2 by PD-1 bispecific antibody, INCA33890, showed a 71% objective response rate with FOLFOX and bevacizumab in first-line microsatellite-stable colorectal cancer in phase I data, according to the company.

Incyte said the phase III NEXERA-303 study of 890 in first-line metastatic microsatellite-stable colorectal cancer is under way, with top-line results expected in 2029.

The company also narrowed development plans for its CDK2 inhibitor, INCB123667. It will focus on first-line maintenance treatment in CCNE1-overexpressing ovarian cancer, halt additional site activation and future enrollment in the randomized phase III MAESTRA-2 study in platinum-resistant ovarian cancer, and continue the open-label phase II MAESTRA-1 trial.

Regulatory Milestones in Dermatology

During the quarter, the European Commission approved OPZELURA for adults with moderate atopic dermatitis, making it the first steroid-free topical JAK inhibitor available in Europe for that population, according to Incyte.

Meanwhile, povorcitinib received a positive CHMP opinion in Europe for adults with moderate-to-severe hidradenitis suppurativa who have had an inadequate response to anti-TNF therapy. Incyte expects a potential European approval by year-end and anticipates a U.S. decision in the first quarter of 2027.

The company also expects phase III readouts by year-end for ruxolitinib cream in mild-to-moderate hidradenitis suppurativa and povorcitinib in prurigo nodularis.

About Incyte (NASDAQ:INCY)

Incyte Corporation is a biopharmaceutical company that discovers, develops and commercializes medicines for oncology and inflammatory or autoimmune diseases. The company focuses on therapies that target specific biological pathways, including Janus kinase (JAK), fibroblast growth factor receptor (FGFR) and other mechanisms involved in cancer and immune-related conditions.

Its key products include Jakafi (ruxolitinib), a JAK inhibitor used in the United States for certain blood cancers and graft-versus-host disease; Opzelura (ruxolitinib cream), a topical treatment for atopic dermatitis and nonsegmental vitiligo; and Pemazyre (pemigatinib), an FGFR inhibitor approved for selected patients with cholangiocarcinoma and certain myeloid or lymphoid neoplasms.

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