Incyte Reports Third Quarter 2026 Financial Results and Provides Business Updates

Total revenue of $1.56 billion and total net sales of $1.32 billion in the third quarter of 2026, each an increase of 14% compared to the third quarter of 2025

Jakafi^®/Jakafi XR^™ (ruxolitinib) net sales of $827 million, an increase of 4% compared to the same period in 2025

Continued growth in core business (ex-Jakafi), with Opzelura^® (ruxolitinib) cream net sales of $255 million and Hematology and Oncology net sales of $235 million, an increase of 36% and 38%, respectively, versus the prior year period

Raising 2026 full year financial guidance for Opzelura net sales, Hematology and Oncology net sales and total net sales

Phase 1 data for INCB161734 and INCA033890 support an expanding GI Oncology development strategy, including multiple ongoing and planned registrational studies in 2027

Advancing multiple registrational programs in Hematology with Phase 3 studies underway or planned for INCA033989 in essential thrombocythemia (ET) and myelofibrosis (MF), and latarcibart in von Willebrand disease (VWD)

Phase 3 data expected by year-end for povorcitinib in prurigo nodularis (PN) and ruxolitinib cream in hidradenitis suppurativa (HS)

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WILMINGTON, Del.--(BUSINESS WIRE)--$INCY--Incyte (Nasdaq:INCY) today reported financial results for the third quarter of 2026 and provided a business update.

“Our third quarter was marked by strong commercial performance, meaningful pipeline progress and important regulatory achievements,” said Bill Meury, Chief Executive Officer, Incyte. “Net sales growth was strong in both the U.S. and internationally, creating a durable core business beyond Jakafi. At the same time, we are advancing a pipeline led by a CALR-targeted monoclonal antibody for myeloproliferative neoplasms, a novel Protein S modulator for von Willebrand disease, a KRAS G12D inhibitor for pancreatic and colorectal cancers and a TGFβR2×PD-1 bispecific antibody for colorectal cancer. Each represents a significant opportunity for Incyte, and together they give us multiple paths to growth beyond 2029. With important clinical, regulatory and commercial catalysts ahead, we are well positioned to create long-term value for patients and shareholders.”

Third Quarter 2026 Results

• Total revenue: Total revenue was $1.56 billion, an increase of 14% compared to the third quarter of 2025, primarily driven by an increase in total net sales across marketed products.
• Total net sales: Total net sales were $1.32 billion, an increase of 14% compared to the third quarter of 2025, driven by increased demand across marketed products.
  • Jakafi^®/Jakafi XR^™ (ruxolitinib) net sales of $827 million, an increase of 4% compared to the same period in 2025.
  • Opzelura^® (ruxolitinib) cream net sales of $255 million, an increase of 36% versus the prior year period.
  • Hematology and Oncology portfolio net sales of $235 million, an increase of 38% compared to the third quarter of 2025.
• Cost of sales: GAAP and non-GAAP cost of sales were $108.7 million and $102.2 million, respectively, representing 8% of total net sales.
• Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $1.79 billion and $1.75 billion, an increase of 254% and 274%, respectively, compared to the prior year period, primarily driven by a one-time $1.23 billion IPR&D expense related to the acquisition of Vega Therapeutics. Excluding the Vega IPR&D expense, GAAP research and development expenses increased 11% as compared to the same period in 2025 primarily driven by late-stage development efforts.
• Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $364.3 million and $339.1 million, an increase of 11% and 10%, respectively, compared to the prior year period.
• Cash, cash equivalents and marketable securities position: As of September 30, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $3.9 billion and $3.6 billion, respectively.

2026 Financial Guidance

Incyte is raising its full year 2026 net sales guidance for Opzelura to $1,100 - $1,120 million, Hematology and Oncology to $890 - $910 million and total net sales to $5,210 - $5,300 million to reflect continued strong performance across the portfolio. Incyte is reaffirming its full year 2026 guidance for all other categories.

Incyte’s guidance for the fiscal year 2026 is summarized below.

Key Business Updates

Hematology

INCA033989 (mutCALR)

• A Phase 3 study (EXCALIBUR-MF2) is expected to initiate by year end 2026, following positive End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) in the third quarter. The trial will evaluate INCA033989 versus best available therapy (BAT) in patients with CALR-mutated myelofibrosis (MF) who were previously treated with a JAK inhibitor.
• The registrational Phase 3 study (EXCALIBUR-ET2), evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy was initiated in mid-2026.
• Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve patients with MF are anticipated in the fourth quarter of 2026.

Latarcibart (formerly VGA039)

• The Phase 3 study (VIVID-6) evaluating once-monthly subcutaneous (SC) administration of latarcibart as bleeding prophylaxis in patients with all types of von Willebrand disease (VWD) is ongoing. Topline data from the VIVID-6 study are anticipated in early 2029.

Monjuvi/Minjuvi

• Global regulatory submissions for Monjuvi/Minjuvi as a treatment for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) are under regulatory review. The Company anticipates a potential approval and launch in the U.S. in the first quarter of 2027.

Niktimvo

• Results from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are expected to be presented at a medical meeting in the first quarter of 2027.

Oncology

INCB161734 (KRAS G12D)

• Data from the ongoing Phase 1 trial presented at the 2026 European Society for Medical Oncology (ESMO) Congress demonstrated high response rates and early evidence of durable clinical benefit with INCB161734 in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), further supporting its potential as a first-line treatment option.
• A Phase 3 study (DAWN-303) evaluating INCB161734 in combination with standard-of-care chemotherapy versus chemotherapy alone as a first-line treatment in patients with metastatic PDAC is ongoing, with topline data anticipated in 2028.
• A Phase 3 study evaluating INCB161734 as adjuvant therapy following surgical resection in patients with PDAC is expected to initiate in 2027.
• Data from the ongoing Phase 1 trial presented at ESMO demonstrated notable antitumor activity with INCB161734, both as monotherapy and in combination with cetuximab, in heavily pretreated metastatic colorectal cancer (CRC) patients, supporting further development in this patient population.
• A Phase 3 study (DAWN-302) evaluating INCB161734 in combination with cetuximab in patients with previously treated CRC is expected to initiate in the first half of 2027.

INCA33890 (TGFβR2xPD-1)^†

• Data from the ongoing Phase 1 trial presented at the 2026 ESMO Congress demonstrated encouraging clinical activity and a manageable safety profile of INCA33890 in combination with standard-of-care (SoC) chemotherapy and bevacizumab in first-line microsatellite-stable colorectal cancer (MSS CRC), supporting the ongoing Phase 3 study (NEXERA-303) and expansion of the program into earlier-stage disease.
• The Phase 3 study (NEXERA-303) evaluating INCA33890 in combination with SoC chemotherapy and bevacizumab as a first-line treatment in patients with MSS CRC is ongoing, with topline data anticipated in 2029.
• In October, a Phase 2 study (NEXERA-204) evaluating INCA33890 for the treatment of patients with circulating tumor DNA-positive stage II/III MSS CRC after curative resection and chemotherapy, was initiated.

INCB123667 (CDK2)

• As part of a strategic shift in focus toward the first-line maintenance ovarian cancer setting, enrollment in the Phase 3 study (MAESTRA-2) evaluating INCB123667 in patients with platinum-resistant ovarian cancer (PROC) was discontinued.
• A Phase 3 study (MAESTRA-3) evaluating INCB123667 in combination with bevacizumab as first-line maintenance therapy in patients with ovarian cancer is expected to initiate in the fourth quarter of 2026.
• Preliminary efficacy data from the ongoing Phase 1 trial evaluating INCB123667 in combination with bevacizumab in patients with recurrent epithelial ovarian cancer (rEOC) were presented as a rapid oral presentation at the 2026 ESMO Congress.

Inflammation and Autoimmunity (IAI)

Opzelura

• In July, the European Commission (EC) approved Opzelura for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. Opzelura is the first steroid-free topical JAK inhibitor approved in the European Union (EU) for adults with moderate AD. This approval represents Opzelura’s second approved indication in the EU.
• Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.

Povorcitinib

• In September, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of povorcitinib (Povofortay^®) for the treatment of active moderate to severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to, an anti-TNF therapy. A regulatory decision from the EC is anticipated in the fourth quarter of 2026.
• The New Drug Application (NDA) for povorcitinib as a treatment for patients with moderate to severe HS is under regulatory review and the Company anticipates a potential U.S. approval and launch in the first quarter of 2027.
• Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.
• Topline data from the Phase 2 proof-of-concept trial for povorcitinib in patients with asthma are anticipated by year-end 2026.

Corporate Updates

• In July, the Company completed its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC. The acquisition added latarcibart, a novel investigational monoclonal antibody in Phase 3 development for patients with VWD, to Incyte’s late-stage pipeline. Under the terms of the parties’ stock purchase agreement, Incyte acquired all outstanding shares of Vega Therapeutics for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones.
• In August, the Company entered into an agreement with the U.S. Centers for Medicare & Medicaid Services (CMS) intended to improve access to medicines for American patients while supporting continued U.S. biopharmaceutical innovation. Under the agreement, the Company will enable state Medicaid programs to access Jakafi and Jakafi XR at prices aligned with those in a defined group of other advanced, industrialized nations. Additionally, the Company expects that it will not be subject to certain future CMS pricing mandates, including the proposed GUARD and GLOBE models.

2026 Third Quarter Financial Results

The financial measures presented in this press release for the three and nine months ended September 30, 2026 and 2025 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 the Company’s 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

Net Sales and Royalty Revenues Total net sales and royalty revenue for the quarter ended September 30, 2026 increased 14% over the prior year comparable period.

• Total net sales for the quarter ended September 30, 2026 increased 14% over the prior year comparable period.
• Jakafi net sales increased 4% in the third quarter of 2026 versus the prior year comparable period to $827 million, primarily driven by a 12% increase in paid demand and growth across all indications. Jakafi inventory levels were within normal range at the end of the third quarter of 2026.
• Opzelura net sales increased 36% in the third quarter of 2026 versus the prior year comparable period to $255 million. Net growth was driven by increased patient demand in both AD and vitiligo and improvements in net pricing resulting from the Opzelura line extension settlement in the second quarter. Opzelura inventory levels were within normal range at the end of the third quarter of 2026.
• Hematology and oncology net sales increased 38% in the third quarter of 2026 versus the prior year comparable period to $235 million, driven by increased demand for Niktimvo, Zynyz and Monjuvi/Minjuvi.

Operating Expenses

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