WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) date for the FDA decision is August 28, 2024. The BLA is supported by positive data from the AGAVE-201 trial ...

The unpredictability of the biotech sector, highlights the inherent risks involved in certain biotech stocks to sell.2023 was a rough year for the market, marked by a 10% plunge in the SPDR S&P Biotech ETF (XBI), alongside widespread layoffs and fundraising challenges. Moreover, despite forecasts pointing to a potential rebound in 2024, the biotech industry is struggling to adapt post-pandemic. For many biotech firms, securing private funding and launching successful IPOs remains a daunting task.Furthermore ...

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) announced today that it will present at the Cowen 44th Annual Health Care Conference on Monday, March 4, 2024 at 9:50 a.m. (EST) in Boston. The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, deve ...

Incyte Corporation (INCY) reported fourth-quarter 2023 adjusted earnings of $1.06 per share, which missed the Zacks Consensus Estimate of $1.21. The company had recorded earnings of 62 cents per share in the year-ago quarter.Total revenues in the reported quarter were $1.01 billion, which grew 9.3% year over year, driven by the sustained performance of the lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) on strong launch and demand. The top line, however, marginally missed the ...

Incyte Corporation (NASDAQ:INCY) Q4 2023 Earnings Conference Call February 13, 2024 8:00 AM ET Company Participants Ben Strain - Associate Vice President, Investor Relations Hervé Hoppenot - Chief Executive Officer Barry Flannelly - General Manager, North America Pablo Cagnoni - President, Head of Research & Development Steven Stein - Chief Medical Officer Christiana Stamoulis - Chief Financial Officer Conference Call Participants Kripa Devarakonda - Truist Securities Andrew Berens - Leerink Michael Schmidt ...

Incyte (INCY) reported $1.01 billion in revenue for the quarter ended December 2023, representing a year-over-year increase of 9.4%. EPS of $1.06 for the same period compares to $0.62 a year ago.The reported revenue represents a surprise of -0.74% over the Zacks Consensus Estimate of $1.02 billion. With the consensus EPS estimate being $1.21, the EPS surprise was -12.40%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine the ...

Incyte (INCY) came out with quarterly earnings of $1.06 per share, missing the Zacks Consensus Estimate of $1.21 per share. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -12.40%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $1.09 per share when it actually produced earnings of $1.10, delivering a surprise of 0.92%.Over the last four quarters, the compa ...

| --- | --- | --- | --- | --- | --- | |------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | 2023 Fourth Quarter & Full-Year | | | | | | | Financial and Corporate Update February 13 th , 2024 | | | | | | Fourth Quarter & FY 2023 Earnings Call Agenda | --- | --- | |-----------------------|----------------------------------------------------------| | Introduction | Ben Strain \nHead of Investor Relations | | | | | Key Highli ...

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2023 fourth quarter financial results, provides 2024 financial guidance and provides a status update on the Company’s research and development portfolio. "We delivered a strong 2023 with total net product and royalty revenues of $3.7 billion, increasing 14% versus 2022. In the fourth quarter, we achieved for the first time, a new milestone of $1 billion in total quarterly revenues, driven by the continued growth of Jakafi® (ruxolitinib ...

Financial Performance - Total revenues for 2023 reached $3,695,649, an increase of 8.8% from $3,394,635 in 2022[441]. - Product revenues, net, increased to $3,165,168 in 2023, up 15.1% from $2,746,897 in 2022[441]. - Net income for 2023 was $597,599, representing a 75.5% increase compared to $340,660 in 2022[441]. - Total assets increased to $6,782,107 in 2023, up 16.1% from $5,840,984 in 2022[438]. - Total stockholders' equity grew to $5,189,837 in 2023, an increase of 18.7% from $4,370,119 in 2022[438]. - Cash and cash equivalents increased to $3,213,376 in 2023, up 8.9% from $2,951,422 in 2022[438]. - The company reported a basic net income per share of $2.67 for 2023, compared to $1.53 for 2022, reflecting a 74.5% increase[441]. - Net cash provided by operating activities decreased to $496,487 in 2023 from $969,941 in 2022, a decline of 48.9%[448]. - Income taxes paid in 2023 amounted to $378,206, significantly higher than $136,242 in 2022, an increase of 177.5%[448]. Research and Development - The company expects to continue incurring significant expenses in drug discovery and development, which may hinder sustained profitability in the future[313]. - Anticipated increases in drug discovery and development expenditures are linked to preclinical tests and clinical trials required for regulatory approval[314]. - Research and development expenses rose to $1,627,594 in 2023, a slight increase of 2.7% from $1,585,936 in 2022[441]. - The company plans to continue investing in research and development to drive future growth and innovation[441]. - Research and development costs are expensed as incurred, including salaries, stock-based compensation, and clinical trial costs[492]. Revenue Recognition and Product Sales - The company recognizes product revenues at a point in time once performance obligations are satisfied, including sales of JAKAFI, OPZELURA, PEMAZYRE, and ZYNYZ in the U.S.[474]. - Revenue recognition for product sales is net of allowances for customer credits, including estimated rebates, chargebacks, discounts, and returns[475]. - The company assesses collectability based on customer payment history and creditworthiness when recognizing revenue[473]. - Allowances for rebates are based on statutory discount rates and expected utilization, with accruals reflecting estimates of amounts owed after product dispensing[477]. - The company maintains an accrual for chargebacks based on estimated contractual discounts on inventory levels in the distribution channel[480]. Intellectual Property and Legal Risks - The company may face risks related to intellectual property, including potential litigation and challenges to patent validity, which could disrupt drug development efforts[326]. - The effectiveness of the company's patent portfolio may be impacted by changes in patent laws, potentially reducing the duration and value of patent protection[334]. - The Supreme Court ruling on patent settlements may create uncertainty and complicate future patent litigation settlements[336]. - International patent protection is uncertain and costly, with potential substantial costs associated with opposition proceedings in foreign countries[337]. Financial Liabilities and Capital Needs - Future capital needs may arise, and the company may face limitations on research and development efforts if unable to raise sufficient funds[317]. - The company may need to raise additional capital in the future, which could be dilutive to existing shareholders and may involve unfavorable terms[318]. - Total accrued and other current liabilities as of December 31, 2023, amounted to $935.6 million, an increase from $701.1 million in 2022[575]. Data Security and IT Risks - The company faces significant risks related to data security breaches, which could lead to loss of confidential information and reputational harm[340]. - The company is continuously enhancing its IT systems, which involves inherent costs and risks, including potential delays and errors in critical business information[339]. - The company’s business operations are increasingly dependent on complex IT systems, making them vulnerable to various risks including cyber-attacks and natural disasters[338]. - The company is subject to potential fines under the General Data Protection Regulation in the EU, which can reach up to €20 million or 4% of annual global revenue for noncompliance[342]. Investments and Marketable Securities - As of December 31, 2023, marketable securities totaled $442.7 million, primarily composed of U.S. government securities[424]. - The company made purchases of marketable securities totaling $456,020 in 2023, compared to $79,860 in 2022, an increase of 471.5%[448]. - The fair market value of the company's long-term investment in Agenus Inc. was $10.0 million and $29.0 million as of December 31, 2023, and 2022, respectively[537]. - The fair market value of the company's long-term investment in Merus was $110.1 million and $54.9 million as of December 31, 2023, and 2022, respectively[542]. Stock Compensation and Employee Benefits - The total stock compensation expense recorded for the years ended December 31, 2023, 2022, and 2021 was $215.9 million, $188.4 million, and $183.0 million, respectively[588]. - The company granted 3,576,242 RSUs and 300,512 PSUs in 2023, with a balance of 7,165,342 shares subject to outstanding awards as of December 31, 2023[586]. - The company recorded stock compensation expense of $126.7 million for research and development in 2023, compared to $112.5 million in 2022[588]. - The total compensation cost of RSUs granted but not yet vested as of December 31, 2023, was $235.4 million, expected to be recognized over 1.7 years[591].