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    INCY
    Earnings call· Jun 2026(Q2 FY26)

    INCYTE Q2 FY26 earnings call INCY

    Jul 28, 2026 Source

    Executive summary

    Incyte Q2 FY26 — Strong Growth Across Portfolio and Pipeline Advancement

    Incyte delivered a strong second quarter, showcasing broad-based growth across its commercial portfolio, including its cornerstone product Jakafi and rapidly expanding core business. The company also made significant strides in pipeline advancement, securing key regulatory milestones and strategically expanding its late-stage assets through business development. This quarter marks continued progress in Incyte's transition towards a diversified growth profile, reducing reliance on a single product and setting the stage for multiple future launches.

    Highlights

    5

    • Total net sales increased 40% year-over-year to $1.49 billion, driven by strong demand and a one-time non-cash benefit.

    • Core business (excluding Jakafi) sales grew 127% year-over-year to $671 million, or 44% excluding the one-time Opzelura benefit.

    • Jakafi sales were $817 million, up 7% year-over-year, with prescription demand increasing 9% across all indications.

    • Opzelura sales reached $450 million, including a $246 million one-time non-cash benefit, with U.S. sales (excluding benefit) up 22% to $161 million and prescriptions up 26% year-over-year.

    • Hematology and Oncology net sales grew 69% to $222 million, with Niktimvo up 67%, Monjuvi up 72%, and Zynyz up 4x year-over-year.

    Concerns

    1

    • Discontinuation of 058 development, a lead asset in the JAK2 V617F targeted pipeline, due to lack of differentiated profile.

    Guidance & targets

    11
    CategoryTargetConfidence
    Total Net Sales
    $5.13 billion to $5.26 billion
    high materiality
    High
    Opzelura Net Sales
    $1.05 billion to $1.10 billion
    high materiality
    High
    Hematology and Oncology Net Sales
    $860 million to $890 million
    medium materiality
    High
    GAAP R&D and SG&A Operating Expenses
    $4.915 billion to $4.995 billion
    medium materiality
    High
    Non-GAAP R&D and SG&A Operating Expenses
    $4.625 billion to $4.695 billion
    medium materiality
    High
    Jakafi XR Full Year Sales
    $40 million to $50 million
    low materiality
    High
    Jakafi XR Formulary Coverage
    50% to 70%
    low materiality
    High
    Core Business Net Sales (ex-Jakafi)
    $3 billion to $4 billion
    high materiality
    High
    Opzelura International Revenue Contribution
    Modest revenue contribution
    low materiality
    Medium
    Opzelura International Sales Potential
    2 to 3x international sales today
    medium materiality
    Medium
    COGS as % of Total Net Sales
    8% to 9%
    low materiality
    High

    Segment performance

    11
    SegmentRevenueYoYQoQMargin
    Total Company
    Total revenue driven by strong product sales.
    		$1.67 billion38%——
    Total Net Sales
    Increase driven by strong product demand and a one-time non-cash benefit of $246 million.
    Growth excluding one-time non-cash benefit: 17%
    		$1.49 billion40%——
    Jakafi
    Remains foundational to the company, with strong new patient starts and stable prescriber base.
    Prescription demand growth: 9% across all indications (MF, PV, GVHD)PV: largest growth driver
    		$817 million7%——
    Core Business (excluding Jakafi)
    Becoming an increasingly important part of Incyte's transition through the LOE period and for long-term growth.
    Growth excluding one-time Opzelura benefit: 44%
    		$671 million127%——
    Opzelura
    Largest contributor to the business outside of Jakafi.
    Net product sales: $204 millionOne-time non-cash benefit: $246 million (related to CMS agreement and Medicaid rebate litigation resolution)
    		$450 million———
    Opzelura (U.S.)
    Strong demand with prescriptions outpacing the overall market (21% growth). Resolution of CMS matter improved economics and gross-to-net profile.
    Prescription growth: 26% year-over-yearBranded topical NBRx volume capture: 46%
    		$161 million22%——
    Opzelura (International)
    Robust growth in vitiligo across markets.
    		$43 million34%——
    Hematology and Oncology
    Niktimvo, Monjuvi, and Zynyz were the biggest contributors to growth.
    		$222 million69%——
    Niktimvo
    Performance entirely volume growth based.
    New patients initiating therapy: >300 during the quarterTotal patients treated: >1,200Market share (third line plus): ~1/3
    		$60 million67%——
    Monjuvi
    Growth primarily driven by uptake in follicular lymphoma and international markets, including Japan launch.
    		$54 million72%——
    Zynyz
    Rapid and robust adoption in SEAC across markets, becoming the leading prescribed regimen in the U.S. in just 12 months post-launch.
    Market share (first-line SEAC in U.S.): >40%
    		$50 million4x——

    Operational metrics

    17
    Total Net Sales (ex-one-time benefit)
    $1.244 billion17% increase year-over-year
    Q2 FY26

    Total net sales excluding the one-time non-cash benefit from the CMS settlement.

    Opzelura Net Sales (U.S. ex-one-time benefit)
    $161 million22% increase versus Q2 FY25
    Q2 FY26

    U.S. Opzelura sales excluding the one-time non-cash benefit related to CMS agreement.

    Opzelura One-Time Non-Cash Benefit
    $246 million
    Q2 FY26

    Related to agreement with CMS and reversal of previously accrued balances associated with Medicaid rebate litigation.

    Opzelura Gross-to-Net Profile
    Improved from low 60s to high 50s
    Q2 FY26

    Resolution of CMS matter improved the economics of the business, resulting in a favorable change to average selling price and gross-to-net profile.

    Impact of CMS Settlement on U.S. Opzelura Net Sales (Q2)
    $15 million
    Q2 FY26

    Net impact after consideration of certain one-time prior year state-related liabilities.

    Expected Impact of CMS Settlement on U.S. Opzelura Net Sales (H2)
    $40 million to $50 million
    H2 FY26

    Expected impact on a go-forward basis for the second half of the year.

    GAAP Total Expenses
    $976 million42% increase compared to prior year
    Q2 FY26

    Total GAAP expenses for the quarter.

    GAAP Cost of Goods Sold
    $105 million
    Q2 FY26

    In line with expectations.

    GAAP R&D Expenses
    $517 million4% increase
    Q2 FY26

    GAAP R&D expenses for the quarter.

    GAAP SG&A Expenses
    $352 million6% increase
    Q2 FY26

    GAAP SG&A expenses for the quarter.

    Cash and Cash Equivalents
    $4.5 billion
    Q2 FY26

    Balance at the end of the quarter.

    Vega Acquisition Upfront Payment and Transaction Costs
    $1.27 billion
    FY26

    Reflected in the updated operating expense guidance.

    Latarcibart Phase III Development Costs
    $50 million
    H2 FY26

    Incremental costs related to the Vega acquisition.

    Latarcibart Annualized Bleeding Rate Reduction
    81%median reduction
    VIVID-3 study

    Demonstrated in the multi-dose VIVID-3 study across different VWD subtypes and bleeding types.

    G12D (734) Patient Data at ESMO
    Approximately 50 patientshalf with Genmab and half with FOLFIRINOX
    ESMO presentation

    Data to be presented at ESMO with a fair amount of maturity, showing efficacy and safety.

    989 Phase I Data (JAK ineligible cohort)
    Approximately 20 patients
    EHA presentation

    Showed strong SVR35 and TSS50 data.

    989 Phase I Data (Monotherapy and Combo)
    Between 50 and 60 patients
    Later this year

    Data update expected later this year to inform development path.

    Industry KPIs

    9
    MetricValueDetails
    Launch access metrics50% to 70%%
    Pipeline read out calendar10 data readoutsreadouts
    Product franchise net sales$817 millionUSD
    Regulatory approvals filingsJakafi XR approved (Q2 FY26)
    Peak long term sales guidance$3 billion to $4 billionUSD
    Therapeutic drug market share40%%
    Prescription volume new starts9% increase%
    Clinical trial efficacy safety data81% median reduction%
    Cumulative patients uptake since launch>1,200 patients treatedpatients

    Product announcements

    3
    ProductTypeDetails
    Jakafi XRlaunch
    Opzelura (moderate Atopic Dermatitis)launch
    Monjuvi (Japan)launch

    Deals & partnerships

    2
    Vega TherapeuticsAcquisition of Vega Therapeutics to add latarcibart, a novel prognose modulator in Phase III development for Von Willebrand disease.

    Strengthened hematology portfolio, expands most important therapeutic franchise, offers attractive risk-reward profile, and structured to preserve balance sheet flexibility. Closed in July.

    HalozymeGlobal collaboration and license agreement to evaluate the subcutaneous formulation of 989 using ENHANZE technology.

    Complements internal subcutaneous development efforts for 989 and provides additional flexibility to optimize administration profile for future commercial use.

    Risks & headwinds

    3
    Pricing and reimbursement environment for OpzeluraOngoing

    Dynamic environment

    Mitigation: Maintaining broad access and a disciplined gross-to-net profile remains a priority; effective commercial execution and continued focus on access and pricing dynamics.

    Attrition in pipeline developmentOngoing

    Not quantified

    Mitigation: Actively looking at potential business development opportunities that meet strategic and financial criteria; stopping investments if facts and circumstances change or performance is not as expected.

    JAK2 V617F targeted pipeline asset (058) differentiationQ2 FY26

    Discontinuation of development

    Mitigation: Prioritizing next-generation JAK2 V617F targeted assets that are progressing through IND-enabling studies, with preclinical data expected by year-end.

    What to watch in Q3 FY26

    5

    Opzelura International Launch Momentum

    Q3 FY26 / FY27
    CurrentModest revenue contribution in 2026
    TargetBuilding momentum through 2027 as additional countries launch and reimbursement expands

    Why it matters

    International expansion is an important long-term growth driver for the Opzelura franchise, with potential to deliver 2-3x current international sales.

    We expect modest revenue contribution in 2026 with momentum building through '27 as additional countries launch and reimbursement expands.

    Q&A highlights

    6

    What are the major questions awaiting resolution regarding the trial design for 989 in MF, specifically concerning endpoints (e.g., anemia composite) and dose selection for different patient types (Type 1 vs. Type 2)?

    Pablo Cagnoni explained that for MF, there are two regulatory paths: traditional endpoints (SVR35, TSS50) or an alternative incorporating novel endpoints like hemoglobin improvement and disease-modifying evidence, which 989 has shown. Discussions with the FDA are ongoing and constructive to reflect these benefits in trial design. The intention is to conduct a study in MF for all comers (Type 1 and non-Type 1) with differential dosing, starting with two different dose levels rather than escalation.

    “So when you put all that together, we thought and still believe it's important to have a constructive dialogue with the FDA to see how we can incorporate some of these endpoints that reflect the benefit patients received from 989 and that reflect the mechanism of action 989 that they need to be reflected in the clinical trial design.”

    asked by Marc Frahm · answered by Pablo Cagnoni

    2 min read6 chapters

    Detailed Narrative

    01

    Strategic Transition and Growth Drivers

    Incyte is actively transitioning from reliance on a single cornerstone product to a company with multiple growth drivers. This involves strengthening the core business, achieving regulatory milestones, advancing the pipeline to late-stage development, and strategically adding novel assets through business development. The company aims for its core business, excluding Jakafi, to reach $3 billion to $4 billion in net sales by 2030, supported by multiple products and near-term launches, leveraging its commercial capabilities for parallel product scaling.

    02

    Regulatory Milestones and Pipeline Progress

    The company achieved several key regulatory milestones, including the approval and launch of Jakafi XR and a positive CHMP opinion for Opzelura in moderate AD in Europe. Regulatory reviews are underway for povorcitinib in HS and Monjuvi in first-line DLBCL, with anticipated approvals and launches into early 2027. Multiple assets, including 989 in ET, 734 in PDAC, and 890 in CRC, have advanced into Phase III studies, with 10 data readouts expected in H2 2026, providing greater visibility into growth beyond 2029.

    03

    Business Development and Hematology Portfolio Expansion

    Incyte strengthened its hematology portfolio through the acquisition of Vega Therapeutics, adding latarcibart, a Phase III asset for Von Willebrand disease. This transaction aligns with Incyte's strategy for attractive risk-reward profiles and balance sheet flexibility. Latarcibart, a prognose modulator, demonstrated an 81% median reduction in annualized bleeding rate in the VIVID-3 study, with potential for once-monthly subcutaneous dosing, aiming to establish a new standard of care.

    04

    Opzelura Performance and CMS Settlement Impact

    Opzelura remains a significant contributor, generating $450 million in Q2 sales, including a $246 million one-time📎 non-cash benefit from a CMS settlement. U.S. sales, excluding this benefit, increased 22% year-over-year, driven by a 26% increase in prescriptions. The CMS resolution improved the business economics, leading to a favorable change in average selling price and gross-to-net profile, which is expected to translate prescription growth more efficiently into net sales going forward⏳.

    05

    Oncology Pipeline Updates and ESMO Presentations

    All three lead solid tumor programs (890, 734, 667) are progressing through pivotal development. The company plans to present comprehensive Phase I data for these assets at ESMO in October, including 734 in first-line pancreatic and late-line colorectal cancer, 890 in first-line and late-line colorectal cancer, and 667 in recurrent ovarian cancers. These presentations will offer significant insights into efficacy, safety, and competitive profiles, informing potential expansion into additional indications.

    06

    CALR Program and JAK2 V617F Strategy

    Incyte is advancing 989, a mutant CALR monoclonal antibody, in late-stage development for ET and MF, with a Phase III study underway in ET and planned for MF. The company is also developing a subcutaneous formulation of 989, including a collaboration with Halozyme. While discontinuing 058 for JAK2 V617F due to lack of differentiation, Incyte remains committed to this target with next-generation programs progressing through IND-enabling studies, with preclinical data expected by year-end.

    AI-generated summary of the company’s earnings call. Not investment advice.