Incyte — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue was $1.56 billion, a 14% increase compared to the third quarter of 2025.
• Total net sales were $1.32 billion, a 14% increase compared to the third quarter of 2025.
• Jakafi/Jakafi XR net sales were $827 million, a 4% increase compared to the prior year period.
• Opzelura net sales were $255 million, a 36% increase compared to the prior year period.
• Hematology and Oncology portfolio net sales were $235 million, a 38% increase compared to the prior year period.
• GAAP cost of sales was $108.7 million (8% of total net sales); Non-GAAP cost of sales was $102.2 million.
• GAAP Research and Development (R&D) expenses were $1.79 billion (up 254% YoY); Non-GAAP R&D expenses were $1.75 billion (up 274% YoY). Excluding the $1.23 billion Vega IPR&D expense, GAAP R&D increased 11%.
• GAAP Selling, General and Administrative (SG&A) expenses were $364.3 million (up 11% YoY); Non-GAAP SG&A expenses were $339.1 million (up 10% YoY).
• GAAP net loss was $784.8 million; Non-GAAP net loss was $730.8 million.
• GAAP diluted EPS was $(3.86); Non-GAAP diluted EPS was $(3.60).
• Cash, cash equivalents, and marketable securities totaled $3.9 billion as of September 30, 2026, compared to $3.6 billion as of December 31, 2025.

Guidance and Future Outlook:

• Raised 2026 full-year Opzelura net sales guidance to $1,100–$1,120 million (previously $1,050–$1,100 million).
• Raised 2026 full-year Hematology and Oncology net sales guidance to $890–$910 million (previously $860–$890 million).
• Raised 2026 full-year total net sales guidance to $5,210–$5,300 million (previously $5,130–$5,260 million).
• Reaffirmed 2026 guidance for Jakafi net sales ($3,220–$3,270 million), total GAAP R&D and SG&A operating expenses ($4,915–$4,995 million), and total Non-GAAP R&D and SG&A operating expenses ($4,625–$4,695 million).
• Phase 3 data expected by year-end for povorcitinib in prurigo nodularis and ruxolitinib cream in hidradenitis suppurativa.
• Phase 3 study for INCA033989 in essential thrombocythemia and myelofibrosis is expected to initiate by year-end 2026.
• Topline data for latarcibart (VIVID-6) anticipated in early 2029.
• Potential U.S. approval and launch for Monjuvi in newly diagnosed diffuse large B-cell lymphoma anticipated in Q1 2027.
• Potential U.S. approval and launch for povorcitinib in hidradenitis suppurativa anticipated in Q1 2027.

Business Segments and Product Lines:

• Hematology: INCA033989 (mutCALR) is in Phase 3 development for myelofibrosis and essential thrombocythemia; Phase 1 data anticipated in Q4 2026. Latarcibart is in Phase 3 for von Willebrand disease. Niktimvo results for chronic GVHD combination therapy expected in Q1 2027.
• Oncology: INCB161734 (KRAS G12D) showed high response rates in Phase 1 for pancreatic and colorectal cancers; Phase 3 studies ongoing or planned for 2027/2028. INCA33890 (TGFβR2×PD-1) showed encouraging activity in Phase 1 for colorectal cancer; Phase 3 study ongoing. INCB123667 (CDK2) enrollment discontinued for platinum-resistant ovarian cancer; Phase 3 study for first-line maintenance expected to initiate in Q4 2026.
• Inflammation and Autoimmunity: Opzelura received European Commission approval for moderate atopic dermatitis in adults. Topline results for Opzelura in hidradenitis suppurativa anticipated in Q4 2026. Povorcitinib received positive CHMP opinion for hidradenitis suppurativa; U.S. NDA under review.

Market and Competitive Landscape:

• Net sales growth was strong in both the U.S. and internationally.
• Opzelura growth driven by increased patient demand in atopic dermatitis and vitiligo, and improved net pricing from a line extension settlement.
• Hematology and Oncology growth driven by increased demand for Niktimvo, Zynyz, and Monjuvi/Minjuvi.
• Jakafi inventory levels were within normal range at the end of the third quarter of 2026.
• Opzelura inventory levels were within normal range at the end of the third quarter of 2026.

Risks and Challenges:

• GAAP operating loss was driven primarily by the $1.23 billion one-time IPR&D expense related to the Vega Therapeutics acquisition.
• R&D expenses increased significantly due to the Vega acquisition upfront consideration and continued late-stage development efforts.
• Forward-looking statements regarding clinical trial results, regulatory approvals, and commercial success involve risks including clinical trial enrollment, regulatory actions, and market acceptance.

Management Commentary and Tone:

• CEO Bill Meury described the quarter as marked by "strong commercial performance, meaningful pipeline progress and important regulatory achievements."
• Management highlighted the creation of a "durable core business beyond Jakafi" and noted multiple paths to growth beyond 2029.
• Management expressed confidence in the pipeline, citing a CALR-targeted monoclonal antibody, a Protein S modulator, a KRAS G12D inhibitor, and a TGFβR2×PD-1 bispecific antibody as significant opportunities.

Other Key Points:

• Completed acquisition of Vega Therapeutics in July for $1.25 billion; Star Therapeutics eligible for up to $750 million in additional sales milestone payments.
• Entered into an agreement with CMS in August to align Jakafi and Jakafi XR prices with other advanced industrialized nations and avoid certain future pricing mandates (GUARD and GLOBE models).
• Opzelura net sales for the nine months ended September 30, 2026, included a one-time $246 million benefit from the CMS agreement.
• Contract dispute settlement with Novartis in May 2025 reduced royalty rates on Jakafi in the U.S. by 50% starting January 1, 2025, and involved a $280 million payment for prior royalties.
• Enrollment in the Phase 3 MAESTRA-2 study for INCB123667 in platinum-resistant ovarian cancer was discontinued as part of a strategic shift to first-line maintenance.