• Total Revenue: $4.2 billion for 2024, a 15% increase from 2023.
• Jakafi Net Sales: $2.8 billion in 2024, up 8% year-over-year.
• Opzelura Revenue: $508 million in 2024, a 50% increase from 2023.
• Q4 2024 Revenue: $1.2 billion, up 16% from Q4 2023.
• Cash Position: $2.2 billion at the end of 2024, with no debt.
• Share Repurchase: Completed $2 billion share repurchase in 2024.
• Jakafi Q4 Revenue: $773 million, an 11% increase year-over-year.
• Opzelura Q4 Revenue: $162 million, a 48% increase year-over-year.
• Royalty Revenues: $159 million in Q4 2024, up 6% from Q4 2023.
• R&D Expenses: $466 million in Q4 2024, a 5% increase from Q4 2023.
• SG&A Expenses: $327 million in Q4 2024, an 11% increase year-over-year.
• 2025 Jakafi Revenue Guidance: $2.925 billion to $2.975 billion.
• 2025 Opzelura Revenue Guidance: $630 million to $670 million.
• 2025 Other Oncology Products Revenue Guidance: $415 million to $455 million.
• 2025 R&D Expense Guidance: $1.93 billion to $1.96 billion.
• 2025 SG&A Expense Guidance: $1.28 billion to $1.31 billion.

• Warning! GuruFocus has detected 3 Warning Sign with INCY.

Release Date: February 10, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Incyte Corp (NASDAQ:INCY) reported a 15% increase in total revenues for 2024, reaching $4.2 billion, demonstrating steady growth since 2020.
• Jakafi net sales grew by 8% to $2.8 billion in 2024, with growth across all indications, particularly in polycythemia vera (PV).
• Opzelura showed strong momentum with a 50% increase in revenue to $508 million, driven by new patients and refills in atopic dermatitis (AD) and vitiligo.
• The company completed a $2 billion share repurchase in 2024, maintaining a strong balance sheet with $2.2 billion in cash and no debt.
• Incyte Corp (NASDAQ:INCY) anticipates four new product launches in 2025, including Niktimvo, which is expected to contribute significantly to revenue growth.

Negative Points

• The company faces risks and uncertainties that could cause actual results to differ materially from forward-looking statements.
• Incyte Corp (NASDAQ:INCY) anticipates lower net pricing for Jakafi due to IRA-imposed price increase caps and continued growth in 340B volumes.
• Operating expenses increased, with GAAP R&D expenses rising by 5% in Q4 2024 and 14% for the full year, driven by late-stage development investments.
• SG&A expenses increased by 11% year-over-year in Q4 2024, partly due to Monjuvi-related sales and marketing expenses.
• The company expects typical Q1 dynamics to impact Opzelura net product revenue, with Q1 2025 expected to be lower than the previous quarter.

Q & A Highlights

Q: Can you set some expectations for the upcoming Phase 3 in prurigo nodularis for Opzelura, given there's no topical therapies available? A: Pablo Cagnoni, President, Head of Research and Development, stated that the Phase 3 data for prurigo nodularis is expected in the first half of the year. The clinical bar is set based on Phase 2 data, focusing on improvements in global assessment of itching and WNRS endpoint. If the Phase 3 results are similar to Phase 2, Opzelura could be a significant addition for patients with prurigo nodularis.

Q: How did you arrive at the guidance for Opzelura's calendar year, and what are your expectations for the HS data? A: Christiana Stamoulis, CFO, explained that the guidance of $630 million to $670 million reflects 24% to 32% year-over-year growth, driven by demand in AD and vitiligo, potential pediatric AD launch, and increased European contribution. For HS data, Pablo Cagnoni emphasized the importance of statistical significance for HiSCR 50 at week 12, with expectations to replicate Phase 2 results for a competitive profile.

Q: What is the process for patients to benefit from the IRA out-of-pocket cap, and when will it impact sales? A: Christiana Stamoulis noted that the out-of-pocket cap is reduced to $2,000, with an option for equal payments throughout the year. The process may take time for patients to navigate, so immediate benefits may not be seen, but continued benefits are expected as in 2024.

Q: Are you seeking a label for biologic-naive patients in the Phase 3 trials for povo in HS, and how are the trials powered? A: Pablo Cagnoni confirmed that the trials stratify patients by prior biologic exposure, and data will be analyzed accordingly. The studies are powered based on assumptions around primary and key secondary endpoints, with labeling discussions to follow based on data.

Q: What are the expectations for the mutant-CALR and JAK2V617F proof-of-concept data, and what are the success criteria? A: Pablo Cagnoni expects substantive data at different dose levels for mutant-CALR, focusing on traditional endpoints and early evidence of allele reduction. For JAK2V617F, similar endpoints are anticipated, with updates expected later in the year.

Q: How will you disclose data from the STOP-HS1 and 2 Phase 3 trials for povo, and any updates on the X2 program for CSU? A: Pablo Cagnoni stated that data will be disclosed via press release and likely a call with the investment community. For the X2 program, updates will be provided later in the year as evaluations continue.

Q: What are the commercialization plans for ruxolitinib XR, and the timeline for a fixed-dose combination with the BET inhibitor? A: Herve Hoppenot, CEO, mentioned that ruxolitinib XR is expected to be commercialized in 2026, with a focus on transitioning patients to once-a-day dosing. The combination with the BET inhibitor depends on further data and portfolio evolution.

Q: Can you discuss the potential impact of upcoming competitor readouts on povo in HS, and how you view your value proposition? A: Pablo Cagnoni believes that povo has a competitive profile based on Phase 2 data, with strong efficacy and safety. The company is confident in its positioning against biologics and other competitors in the HS market.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.