Incyte Corporation (INCY) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary reflects strong financial guidance with raised revenue projections, significant product launches, and strategic pipeline development. The Q&A section further supports this with insights into growth prospects for key products like Opzelura and Monjuvi. Although there are concerns about expenses and some regulatory hurdles, the overall sentiment is positive, especially with raised guidance and strategic focus on high-value programs. The positive outlook on revenue growth and product pipeline suggests a positive stock price movement.
Key Financial Performance
Fourth Quarter Revenue $1.51 billion, up 28% year-over-year. Driven by strong commercial performance and an increase in milestone and contract revenue.
Full Year Revenue $5.14 billion, up 21% year-over-year. Driven by strong commercial performance and an increase in milestone and contract revenue.
Fourth Quarter Net Sales $1.22 billion, up 20% year-over-year. Growth was broad-based with nearly every product contributing meaningfully.
Full Year Net Sales $4.35 billion, up 20% year-over-year. Exceeded expectations and guidance.
Core Business Sales (Excluding Jakafi) $1.26 billion, up 53% year-over-year. Growth driven by products like Opzelura, NiktimVo, and Monjuvi.
Jakafi Fourth Quarter Sales $828 million, up 7% year-over-year. Growth driven by increased prescriptions and demand across all indications.
Jakafi Full Year Sales $3.093 billion, up 11% year-over-year. Growth driven by increased prescriptions and demand across all indications.
Opzelura Fourth Quarter Net Sales $207 million, up 28% year-over-year. Growth driven by increased penetration in U.S. AD and vitiligo markets.
Opzelura Full Year Net Sales $678 million, up 33% year-over-year. Growth driven by increased penetration in U.S. AD and vitiligo markets, and strong pediatric launch.
Hematology and Oncology Products Fourth Quarter Sales $187 million, up 121% year-over-year. Growth driven by Niktimvo, Monjuvi, and Zynyz.
Hematology and Oncology Products Full Year Sales $583 million, up 83% year-over-year. Growth driven by Niktimvo, Monjuvi, and Zynyz.
GAAP R&D Expenses (Quarter) $611 million, up 31% year-over-year. Driven by continued investment in late-stage development assets.
GAAP R&D Expenses (Year) $2.05 billion, up 8% year-over-year. Driven by continued investment in late-stage development assets.
GAAP SG&A Expenses (Quarter) $390 million, up 19% year-over-year. Driven by costs associated with U.S. oncology product launches and timing of other expenses.
GAAP SG&A Expenses (Year) $1.38 billion, up 11% year-over-year. Driven by costs associated with U.S. oncology product launches and timing of other expenses.
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Operating Highlights
Pipeline Maturity: Incyte moved multiple assets from early to late-stage development, including treatments for MPNs, pancreatic cancer, colorectal cancer, and HS.
Regulatory Submissions: Applications for Jakafi XR, Opzelura for moderate AD, and povorcitinib for HS in Europe were submitted.
Product Launches: Jakafi XR is expected to launch in mid-2026, and povorcitinib has the potential to be the first FDA-approved oral treatment for HS.
Revenue Growth: Fourth-quarter revenue reached $1.51 billion, up 28% year-over-year. Full-year revenue totaled $5.14 billion, a 21% increase.
Core Business Growth: Excluding Jakafi, core business sales grew 53% year-over-year, with products like Opzelura, NiktimVo, and Monjuvi driving growth.
International Expansion: Opzelura's international sales for vitiligo doubled to $130 million in 2025.
Operational Efficiency: Operating expenses increased by 11% year-over-year, while revenues grew by 19%, improving operating leverage and margins.
R&D Investment: R&D expenses increased by 8% year-over-year, focusing on late-stage development assets.
Strategic Growth: Incyte aims to double its business over time, with 14 pivotal trials across 7 assets planned for 2026.
Business Development: The company views business development as a multiplier to extend and strengthen its core operations.
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Risk or Challenges
Regulatory Risks: The company acknowledges that forward-looking statements are subject to risks and uncertainties, and actual results may differ materially. Regulatory approvals for key products like Jakafi XR, Opzelura, and povorcitinib are pending, and delays or rejections could impact growth projections.
Competitive Pressures: Despite strong performance, the company faces growing competition in the Jakafi market, which could impact its market share and revenue growth.
Pipeline Development Risks: The company is heavily reliant on its pipeline, with 14 pivotal trials underway. Any delays, failures, or negative data readouts could significantly impact future growth and revenue.
Economic and Market Conditions: Price actions to expand formulary coverage for products like Opzelura could offset growth, and economic uncertainties may affect international sales.
Strategic Execution Risks: The company is managing multiple product launches and Phase III trials simultaneously, which requires precise execution to avoid delays or mismanagement.
Supply Chain and Operational Risks: No explicit mention of supply chain disruptions, but the complexity of managing multiple product launches and trials could pose operational challenges.
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Guidance & Outlook
Core Business Growth: The core business, excluding Jakafi, is expected to grow over 30% in 2026 and has the potential to grow at a 15% to 20% 5-year CAGR, approaching $3 billion to $4 billion by 2030.
Jakafi Sales: Net sales for Jakafi are expected to be $3.22 billion to $3.27 billion in 2026, with prescriptions growing at a high single-digit rate, representing mid-single-digit sales growth compared to 2025. Approval and launch of Jakafi XR are anticipated in mid-2026, with a focus on formulary access in the second half of the year and conversion in 2027.
Opzelura Sales: Sales for Opzelura are projected to be $750 million to $790 million in 2026, representing a 15% increase at the midpoint. Growth is driven by double-digit volume growth in the U.S. for AD and vitiligo, as well as sustained international growth. Long-term aim is to nearly double the size of this business.
Hematology and Oncology Business: Full-year guidance for the hematology and oncology business is set at $800 million to $880 million for 2026, representing a 40% to 50% increase compared to 2025.
Pipeline and Product Launches: Four product launches are anticipated in late 2026 and early 2027, including Jakafi XR, Opzelura, Monjuvi, and povorcitinib. The pipeline is expected to support top-tier growth, with 14 pivotal trials underway across 7 assets by the end of 2026.
Povorcitinib Development: The NDA for povorcitinib in HS has been submitted, with FDA filing acceptance anticipated in Q1 2026. The drug has the potential to be the first FDA-approved oral treatment for HS, targeting both pre-biologic and post-biologic settings.
Regulatory and Clinical Milestones: Key regulatory and clinical milestones in 2026 include FDA filing acceptance for povorcitinib, sBLA submission for tafasitamab in first-line DLBCL, and data readouts from 7 pivotal trials. Phase III trials for CALR-positive ET and MF are expected to initiate in mid to late 2026.
Revenue Guidance: Full-year 2026 revenue guidance is set at $4.77 billion to $4.94 billion, representing a 10% to 13% increase from 2025. This includes specific guidance for Jakafi, Opzelura, and the hematology/oncology business.
Expense Outlook: Total GAAP R&D and SG&A operating expenses for 2026 are expected to be $3.495 billion to $3.675 billion, representing a 4% increase versus 2025. R&D expenses are projected to rise by 10%, while SG&A expenses remain relatively flat year-over-year.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What are the latest thoughts on designing Phase III trials for CALR pivotal programs, particularly regarding dosing strategies for different CALR mutations?
A:The company plans to discuss the dosing strategy with the FDA this quarter. They propose enrolling patients with all types of mutations and aim to address the differential potency of 989 across mutations. The primary endpoint will likely involve hematologic response, with discussions on timing for evaluation. An update will be provided later this year.
Q:What factors influenced Opzelura pricing adjustments, and how do competitive launches impact this?
A:The pricing adjustments were not due to competition but aimed at improving long-term formulary coverage for major PBMs. The company expects the impact on ASP in 2026 to roll off by 2027, with fewer discounts in the future.
Q:What is the uptake of Opzelura in current approved indications, and what are the sales projections?
A:The AD business is growing at almost 20% year-over-year, and the vitiligo business is growing in the mid-teens. Pediatric indications launched in 2025 are annualizing at $30 million. The business is expected to grow at a 10% CAGR over the next 5 years, with $300 million in incremental international revenue projected. Total sales could reach $700 million, with most growth driven by volume.
Q:How is Monjuvi positioned in the frontline DLBCL setting compared to POLIVY, and what are the implications of the trial's IPI eligibility criteria?
A:The trial focused on patients with IPI 3 to 5, a group with worse prognosis. Monjuvi is positioned as an addition to R-CHOP, unlike POLIVY, which replaces R-CHOP. The PFS benefit is competitive, and Monjuvi addresses a broader patient spectrum, including GCB DLBCL. The product is expected to contribute significantly to growth by 2029 and beyond.
Q:Will there be additional Phase I/II data for 890 in colorectal cancer in 2026, and does the pivotal study have an interim analysis?
A:Yes, additional data will be shared over the year. The Phase III study has been initiated, with over 200 global sites identified. The company will provide more clarity on timing as the year progresses.
Q:Why did the FDA recommend another Phase III trial for Opzelura in PN, and does this have any read-through to HS?
A:The FDA recommended another trial because one of the two Phase III studies was negative. The program is currently paused while the company decides on conducting another trial. There is no read-through to HS, where standard regulatory development is ongoing.
Q:What are the expectations for the mCALR bispecific and 617F programs?
A:The mCALR bispecific program is accelerating, with efficacy data expected next year. It is designed to target patients who do not respond to the CALR antibody. For the 617F program, the company is confident in its potential to deliver transformative effects in MPNs. Data from a new formulation will be available later this year.
Q:What are the plans for the KRAS G12D PDAC study, and how does the company view the competitive landscape?
A:The study will be a first-line trial in combination with chemotherapy regimens, focusing on time-to-event endpoints. The company sees this as a major opportunity in a space with limited competition and plans to expand the program to other tumor types and settings.
Q:What is the potential for RUX XR in the Jakafi guide, and what is the expected penetration in PV before LOE?
A:No incremental revenue from RUX XR is included in the 2026 guidance. The company expects Jakafi to grow in the high single digits through 2028. RUX XR could achieve a 10%-30% conversion rate, potentially adding $0.25 billion in revenue by 2029.
Q:What are the expectations for povorcitinib in asthma and its place in the therapeutic landscape?
A:The Phase II study aims to evaluate povorcitinib in patients with low eosinophilic asthma who do not respond to standard treatments. The company sees potential for the drug in prebiologic populations and will decide on next steps based on data later this year.
Q:Review of Unclear Management Responses
A:Management avoided directly answering questions about the specific volumes and injection times for the subcutaneous bioequivalence study for 989, citing the need for more data. They also provided limited clarity on the exact positioning of the mCALR bispecific in the treatment paradigm, stating it was too early to elaborate.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AD
CALR
DLBCL
ET
Europe
FDA
III trial
Monjuvi
Opzelura
PDAC
PN
Pablo
Phase III
STOP
acceptance
alignment
bevacizumab
breadth
cancer
combination
core
digit
disease
endpoint
filing
frontline
hematology oncology
increase sale
indication
launch
lenalidomide
line MF
maturity
outlook
patient
povorcitinib
sBLA
sale increase
setting
steroid
study
tafasitamab
therapy
trial line
INCY Transcript
Incyte Corporation (INCY) Q4 2025 Earnings Call Transcript
Positive2-10
The earnings call summary reflects strong financial guidance with raised revenue projections, significant product launches, and strategic pipeline development. The Q&A section further supports this with insights into growth prospects for key products like Opzelura and Monjuvi. Although there are concerns about expenses and some regulatory hurdles, the overall sentiment is positive, especially with raised guidance and strategic focus on high-value programs. The positive outlook on revenue growth and product pipeline suggests a positive stock price movement.
Incyte Corporation (INCY) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
National Bank of Canada (NA:CA) Q4 2025 Earnings Call Transcript
Positive12-3
The earnings call reveals raised revenue guidance for key products, with expectations of 14%-17% growth in net product revenues and a focus on operating margin expansion. The company plans over 10 product launches by 2030, indicating strong future growth potential. Positive developments in product pipelines and strategic capital allocation further support a positive outlook. The Q&A section highlighted robust strategies and growth drivers, with management addressing concerns effectively. Overall, the combination of strong guidance, strategic priorities, and effective management responses suggests a positive stock price movement.
Incyte Corporation (INCY) Presents at Evercore 8th Annual Healthcare Conference Transcript
Neutral12-3
INCY Slides
INCY Report
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