On April 28, 2026 Incyte (Nasdaq:INCY) reported financial results for the first quarter of 2026 and provided a business update.

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"Our first quarter represented a strong start to 2026, driven by 20% year-over-year net sales growth and strong commercial execution," said Bill Meury, Chief Executive Officer, Incyte. "At the same time, we are making significant progress toward building a more durable, growth oriented portfolio with four anticipated product approvals and launches over the next 12 months, positive registrational data for povorcitinib in vitiligo and a late stage pipeline that now includes 10 Phase 3 studies underway, including the initiation of a pivotal trial of our G12D inhibitor in first line pancreatic ductal adenocarcinoma."

First Quarter 2026 Results
•Total revenue: Total revenue was $1.27 billion, an increase of 21% compared to the first quarter of 2025, primarily driven by an increase in total net sales.
•Total net sales: Total net sales for the first quarter of 2026 were $1.10 billion, an increase of 20% compared to the first quarter of 2025. The increase was primarily related to demand for Jakafi (ruxolitinib) across all indications, Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo, Niktimvo (axatilimab-csfr) in chronic graft versus host disease (GVHD), Monjuvi (tafasitamab-cxix) in follicular lymphoma (FL) and Zynyz (retifanlimab-dlwr) in squamous cell carcinoma of the anal canal (SCAC).
•Cost of sales: GAAP and non-GAAP cost of sales were $104.5 million and $98.3 million, an increase of 43% and 47%, respectively, compared to the prior year period.
•Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $515.9 million and $476.7 million, an increase of 18% and 19%, respectively, compared to the prior year period.
•Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $328.1 million and $304.1 million, an increase of 1% for both, respectively, compared to the prior year period.
•Cash, cash equivalents and marketable securities position: As of March 31, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $4.0 billion and $3.6 billion, respectively.

Key Business Updates
Hematology

Monjuvi/Minjuvi (tafasitamab)
•Data from the pivotal Phase 3 frontMIND trial evaluating tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) for the treatment of patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
◦Abstract Title: frontMIND: Phase 3 study of tafasitamab (Tafa) plus lenalidomide (Len) and R-CHOP for patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
◦Abstract Number: 7000
◦Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
◦Date and Time: May 30, 2026, 3:00-6:00 p.m. CDT

Niktimvo
•Data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026.

INCA033989 (mutCALR)
•The Company is on track to initiate a Phase 3 registrational study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy in mid-2026 following a successful end-of-phase meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026.
•Updated data from the ongoing Phase 1 trial in second-line ET and myelofibrosis (MF) patients are anticipated in mid-2026. Data from the cohort evaluating INCA033989 and INCA033989 in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026.
•A Phase 1 study evaluating the pharmacokinetics, safety and tolerability of INCA033989 as a subcutaneous (SC) administration in healthy adult participants was initiated and completed. The Company plans to initiate a Phase 1 study evaluating INCA033989 as a SC administration in mutCALR positive patients mid-year 2026.

INCB160058 (JAK2V617F)
•In the first quarter of 2026, the Company initiated dosing of the amorphous solid dispersion (ASD) formulation of INCB160058 in the Phase 1 trial. Data from the Phase 1 trial evaluating INCB160058 in patients with myeloproliferative neoplasms (MPNs) with a JAK2V617F mutation are anticipated in the second half of 2026.

Jakafi XR (ruxolitinib)
•The Company expects a regulatory decision in the U.S. and potential commercial launch in mid-2026.
Oncology
Zynyz
•In March, the Company announced that the European Commission (EC) approved Zynyz in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent SCAC. This marks the second indication in Europe for Zynyz, which was previously approved by the EC for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

INCB161734 (KRASG12D)
•The Company initiated a Phase 3 study (DAWN-303) evaluating INCB161734 as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) versus chemotherapy alone in the first quarter of 2026.
•Additional data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy as a first-line treatment in patients with metastatic PDAC are anticipated in the second half of 2026.

INCA33890 (TGFβR2xPD-1)
•The Phase 3 study evaluating INCA33890 in combination with standard-of-care chemotherapy and bevacizumab as a first-line treatment in patients with microsatellite stable colorectal cancer (MSS CRC) is ongoing.
•Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is expected in the second half of 2026.
Inflammation and Autoimmunity (IAI)
Opzelura
▪The Company expects a regulatory decision in the second half of 2026 following the submission of a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the EU.
▪Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Povorcitinib
▪Today the Company announced positive results from the Phase 3 program evaluating povorcitinib (30mg) in adult patients with nonsegmental vitiligo. In both Phase 3 studies (STOP-V1 and STOP-V2), povorcitinib achieved the primary endpoint of >75% reduction in Facial Vitiligo Area Scoring Index (F-VASI75) from baseline at Week 52.
•In STOP-V1, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 6.8% of placebo-treated patients at Week 52 (p<0.001). In STOP-V2, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 3.1% of placebo-treated patients at Week 52 (p<0.001). Across both studies, statistically significant and clinically meaningful differences were also observed in key secondary endpoint measures, including T-VASI50 at Week 52. The overall safety and tolerability profile of povorcitinib through 52 weeks is consistent with prior studies, with no new safety signals observed. We expect to share additional data from the Phase 3 program in the second half of 2026.

•The positive results from the Phase 3 STOP-V1 and STOP-V2 studies will support regulatory applications for povorcitinib in nonsegmental vitiligo planned for the first half of 2027.
▪The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the EU and the first quarter of 2027 in the U.S.
▪In March, 54-week data from the Phase 3 clinical studies (STOP-HS1 and STOP-HS2) evaluating povorcitinib in patients with moderate to severe HS were presented during the late-breaking research session at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
•In the studies, treatment with povorcitinib resulted in clinically meaningful and durable efficacy responses through Week 54. Across both STOP HS1 and STOP HS2, up to 71% of patients achieved HiSCR50, with improvements also observed at higher stringency thresholds, including up to 57% achieving HiSCR75 and up to 29% achieving HiSCR100. These responses were accompanied by consistent resolution across all three key types of inflammatory lesions including inflammatory nodules, abscesses and draining tunnels, as well as meaningful improvements in skin pain, fatigue and quality of life. The overall safety profile of povorcitinib through 54 weeks was consistent with previously reported data, and both doses were well tolerated.

▪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 asthma are anticipated in the second half of 2026.

Corporate Updates

▪Today the Company announced the appointment of Suketu (Suky) Upadhyay to Chief Financial Officer, effective May 4, 2026. Mr. Upadhyay most recently served as Executive Vice President and Chief Financial Officer of Zimmer Biomet. Prior to joining Zimmer Biomet, Mr. Upadhyay served as Senior Vice President of Global Financial Operations at Bristol Myers Squibb, where he was responsible for strategic and operational initiatives across BMS’s supply chain, commercial operations, R&D and business development.

▪In March, the Company announced the appointments of Pablo J. Cagnoni, M.D. to President, Incyte and Global Head of Research and Development, Steven Stein, M.D. to Executive Vice President, Chief Medical Officer and Head of Late-State Development and Mohamed Issa, Pharm.D. to Executive Vice President and Head of U.S. Commercial.

2026 First Quarter Financial Results
The financial measures presented in this press release for the three months ended March 31, 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 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

(Press release, Incyte, APR 28, 2026, View Source [SID1234664859])