THE MEDICI LIST

by Mike Gee

Medici List crest
Disclaimer: This is a simplified summary of a public company filing. See full disclaimer here.

INCYTE CORP

CIK: 8791691 Annual ReportLatest: 2026-02-10

10-K / February 10, 2026

Incyte

Overview

  • Incyte is a global biopharmaceutical company focused on the discovery, development, and commercialization of proprietary therapeutics.
  • Global headquarters: Wilmington, Delaware (discovery, clinical development, and commercial operations).
  • European headquarters: Morges, Switzerland; additional offices in Europe. Japanese headquarters: Tokyo. Canadian headquarters: Montreal.
  • Therapeutic focus: Hematology, Oncology, and Inflammation and Autoimmunity (IAI).

Commercial portfolio and indications

  • Hematology
    • JAKAFI (ruxolitinib) — United States
    • JAKAVI (ruxolitinib) — outside the United States via Novartis
    • ICLUSIG (ponatinib)
    • MONJUVI (tafasitamab-cxix) / MINJUVI (tafasitamab) for B‑cell malignancies
    • NIKTIMVO (axatilimab-csfr)
  • Oncology
    • PEMAZYRE (pemigatinib)
    • ZYNYZ (retifanlimab‑dlwr)
  • Inflammation and Autoimmunity
    • OPZELURA (ruxolitinib) cream
  • Commercial reach
    • Six compounds commercialized in the United States, three in Europe, and one in Japan.
    • Distribution through specialty pharmacies, wholesalers, and retail/hospital channels as appropriate.

Product and program highlights

  • JAKAFI / JAKAVI (ruxolitinib)
    • Approved in the U.S. for multiple indications including myelofibrosis (MF), polycythemia vera (PV), and graft‑versus‑host disease (GVHD); orphan drug status in multiple indications.
    • Novartis holds exclusive development and commercialization rights outside the U.S. for ruxolitinib (JAKAVI); Incyte retains U.S. rights for JAKAFI.
    • Ruxolitinib XR (once‑daily extended‑release): FDA issued a complete response letter in 2023; bioequivalence met in 2025; regulatory decision and potential launch anticipated mid‑2026.
  • ICLUSIG (ponatinib)
    • European operations acquired from ARIAD in 2016; EU indications include chronic myeloid leukemia (CML) and Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) with specified resistance or intolerance criteria.
  • MONJUVI / MINJUVI (tafasitamab)
    • Collaboration with MorphoSys followed by acquisition of exclusive global rights to tafasitamab.
    • FDA approval in 2020 for diffuse large B‑cell lymphoma (DLBCL) in combination with lenalidomide; EU approval for the same combination.
    • Regulatory updates on follicular lymphoma (FL) approvals in multiple regions reported for 2025/2026.
  • NIKTIMVO (axatilimab-csfr)
    • Exclusive worldwide collaboration with Syndax to develop and commercialize axatilimab.
    • U.S. launch for chronic GVHD began January 2025.
  • PEMAZYRE (pemigatinib)
    • Targets FGFR1–3; approvals for cholangiocarcinoma and myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangements.
    • Global approvals include China, EU, UK, and Japan (drug‑specific indications and dates documented in regulatory filings).
  • ZYNYZ (retifanlimab-dlwr)
    • PD‑1 antibody licensed from MacroGenics.
    • Approvals for Merkel cell carcinoma and squamous cell carcinoma of the anal canal; expansion activities in Europe and Japan ongoing.
  • Other development programs
    • INCB123667 (CDK2), INCB161734 (KRAS G12D), INCA33890 (TGFβR2xPD‑1), INCA033989 (mutCALR) and additional oncology and hematology candidates in mid‑ to late‑stage development, with ongoing trials and upcoming milestones.

Inflammation and Autoimmunity programs

  • OPZELURA (ruxolitinib) cream
    • Approved for mild‑to‑moderate atopic dermatitis (AD) in adults and children 12+; pediatric extension approved in 2025.
    • Phase 3 and regulatory activity underway for additional AD indications.
    • Hidradenitis suppurativa (HS) Phase 3 programs in progress, with topline data anticipated in 2026.
  • Povorcitinib (oral JAK1 inhibitor)
    • Evaluated for HS, nonsegmental vitiligo, prurigo nodularis, and asthma; multiple Phase 2/3 trials with data expected in 2026.
  • INCB00928 (zilurgisertib)
    • Phase 2 program in fibrodysplasia ossificans progressiva (FOP); Fast Track and orphan designations granted.

Commercial strategy and partnerships

  • Novartis: Outside U.S. development and commercialization rights to ruxolitinib (JAKAVI) and capmatinib (TABRECTA) in all indications; Incyte retains U.S. rights to JAKAFI and has options related to capmatinib in the U.S.
  • Lilly: Exclusive worldwide development and commercialization rights to baricitinib (OLUMIANT) for inflammatory and autoimmune diseases; agreement amendments include COVID‑19 and Type 1 diabetes expansions, with upfront and royalty adjustments.
  • Syndax: Exclusive worldwide rights to axatilimab outside the U.S.; co‑commercial rights in the U.S. for NIKTIMVO.
  • Incyte combines in‑house discovery with collaborations across academia and CROs to advance its pipeline.
  • Collaboration agreements include upfront payments, milestones, and royalties, with ongoing performance monitoring and contractual termination provisions.

Intellectual property and exclusivity

  • Incyte maintains a broad patent portfolio covering composition of matter, methods of use, and formulations for its marketed drugs and clinical candidates.
  • The company relies on patents, trade secrets, and regulatory data protection to preserve exclusivity, and manages ongoing or potential patent‑related litigation and settlements.

Global operations and manufacturing

  • Manufacturing primarily uses third‑party contract manufacturers.
  • Swiss bioplant facility supports MONJUVI/MINJUVI drug substance manufacturing; GMP license received in 2022. Drug substance became usable following regulatory approvals in Europe (2023) and the U.S. (2025).
  • Small molecules (JAKAFI, ICLUSIG, PEMAZYRE, OPZELURA) are produced by contract manufacturers; ruxolitinib phosphate sourced from multiple suppliers while some APIs are single‑ or limited‑source.
  • Supply strategy focuses on maintaining quality and continuity across a multi‑country supply chain, with attention to risks such as interruptions and raw material costs.

People and operating footprint

  • As of December 31, 2025, total employees: 2,844 (up from 2,617 at prior year‑end).
    • Research and development: 940
    • Medical affairs: 213
    • Sales and marketing: 975
    • Operations support and administrative roles: 716
  • Geographic distribution: approximately 70% in the United States/Canada; 27% in Europe; 3% in Asia.
  • Incyte states it is an Equal Opportunity Employer and highlights diversity, inclusion, and community programs.

Key takeaway

Incyte is a diversified, global biopharmaceutical company with marketed products across hematology, oncology, and inflammation/autoimmunity. The company operates a mix of in‑house and partnered development and commercialization activities, maintains a large, regionally distributed workforce, and uses third‑party manufacturing supplemented by a dedicated bioplant for certain biologics.

View Full 10-K DocumentEDGAR