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INCYTE CORP (INCY)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 total GAAP revenue was $1,178.7M (+16% YoY) with GAAP diluted EPS of $1.02 and Non-GAAP diluted EPS of $1.43, reflecting strong execution across Jakafi and Opzelura and increased Monjuvi contribution .
  • Management issued 2025 guidance: Jakafi $2,925–$2,975M, Opzelura $630–$670M, Other Oncology $415–$455M; COGS 8.5–9.0% (GAAP), R&D $1,930–$1,960M, SG&A $1,280–$1,310M, with non-GAAP ranges provided; catalysts include four launches and four pivotal readouts in 2025 .
  • Sequential momentum: Q2→Q3→Q4 revenues rose from $1,043.8M to $1,137.9M to $1,178.7M; GAAP operating income improved from a Q2 loss to $146.1M in Q3 and $301.5M in Q4 as one-time acquisition/milestone costs rolled off .
  • Management highlighted PV as the fastest-growing Jakafi indication (35% of patients) and reiterated Opzelura’s ex-U.S. uptake and expected Q1 seasonality; ruxolitinib XR achieved bioequivalence, with FDA submission by year-end 2025 .

What Went Well and What Went Wrong

  • What Went Well

    • “We delivered another strong year… total revenues growing 15% versus 2023 to reach $4.2 billion” and diversified with Opzelura growth; ended 2024 with $2.2B in cash and no debt .
    • Jakafi: Q4 net product revenue +11% YoY to $773M, paid demand +14%; PV strength with 35% of patients, anticipating continued growth in 2025 .
    • Opzelura: Q4 net product revenue $162M (+48% YoY), $24M ex-U.S. in Q4; FY 2024 $508M (+50% YoY); expanding reimbursement in Europe and pediatric AD sNDA filed, approval anticipated H2’25 .
  • What Went Wrong

    • FY 2024 GAAP operating income fell sharply (to $61.4M) due to Escient-acquisition IPR&D ($679.4M), $38.0M related compensation/severance, and $100M MacroGenics milestone; GAAP net income dropped to $32.6M .
    • COGS rate expected higher in 2025 (8.5–9.0%) driven by manufacturing costs and Niktimvo U.S. profit share accounting in COGS .
    • Medicare Part D redesign complexities may delay immediate benefit from $2,000 OOP cap, while 340B growth offsets some gross-to-net savings for Jakafi .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total GAAP Revenues ($USD Thousands)$1,043,759 $1,137,871 $1,178,698
GAAP Operating Income ($USD Thousands)$(478,130) $146,085 $301,513
Non-GAAP Operating Income ($USD Thousands)$(378,801) $255,236 $376,265
GAAP Net Income ($USD Thousands)$(444,601) $106,456 $201,212
Non-GAAP Net Income ($USD Thousands)$(396,132) $209,651 $281,353
GAAP Diluted EPS ($USD)$(2.04) $0.54 $1.02
Non-GAAP Diluted EPS ($USD)$(1.82) $1.07 $1.43
MetricQ4 2023Q4 2024
Total GAAP Revenues ($USD Thousands)$1,013,341 $1,178,698
GAAP Diluted EPS ($USD)$0.89 $1.02
Non-GAAP Diluted EPS ($USD)$1.06 $1.43
GAAP Operating Income ($USD Thousands)$187,270 $301,513
Non-GAAP Operating Income ($USD Thousands)$267,702 $376,265

Segment/Product and Royalty Breakdown

Metric ($USD Thousands)Q2 2024Q3 2024Q4 2024
Jakafi Net Product Revenues$705,973 $741,181 $773,114
Opzelura Net Product Revenues$121,695 $139,272 $161,602
Iclusig Net Product Revenues$26,862 $29,745 $27,369
Pemazyre Net Product Revenues$20,269 $20,661 $23,142
Minjuvi/Monjuvi Net Product Revenues$31,116 $31,439 $32,807
Zynyz Net Product Revenues$651 $694 $1,373
Total Net Product Revenues$906,566 $962,992 $1,019,407
Jakavi Royalty Revenues$99,317 $115,741 $114,187
Olumiant Royalty Revenues$31,702 $34,796 $38,485
Tabrecta Royalty Revenues$5,298 $5,928 $6,286
Pemazyre Royalty Revenues$876 $414 $333
Total Royalty Revenues$137,193 $156,879 $159,291
Milestone & Contract Revenues$0 $18,000 $0
Total GAAP Revenues$1,043,759 $1,137,871 $1,178,698

KPIs

KPIQ2 2024Q3 2024Q4 2024
Jakafi Paid Demand Growth (YoY)+9% N/A+14%
Jakafi Total Demand Growth (YoY)+10% +9%
Jakafi Patient Mix – PV Share35% of patients
Opzelura ex-U.S. Net Product Revenue ($USD Thousands)$11,000 $20,000 $24,000

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Jakafi Net Product RevenuesFY 2025N/A$2,925–$2,975M New
Opzelura Net Product RevenuesFY 2025N/A$630–$670M New
Other Oncology Net Product RevenuesFY 2025N/A$415–$455M New
GAAP Cost of Product RevenuesFY 2025N/A8.5%–9.0% of net product revenues New
Non-GAAP Cost of Product RevenuesFY 2025N/A7.5%–8.0% of net product revenues New
GAAP R&D ExpensesFY 2025N/A$1,930–$1,960M New
Non-GAAP R&D ExpensesFY 2025N/A$1,780–$1,805M New
GAAP SG&A ExpensesFY 2025N/A$1,280–$1,310M New
Non-GAAP SG&A ExpensesFY 2025N/A$1,160–$1,185M New

Note: Management clarified 2025 COGS increase due to manufacturing costs and Niktimvo profit-sharing accounting in COGS .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Opzelura adoption and ex-U.S. rampEU reimbursement expanding; ex-U.S. $11M in Q2 Ex-U.S. $20M; strong YoY growth Ex-U.S. $24M; 2025 guidance $630–$670M; Q1 seasonality caution Accelerating outside U.S.; seasonal Q1 dip expected
Jakafi PV-driven growthPaid demand +9% Growth across indications PV now 35% of patients; paid demand +14% in Q4 PV becoming largest contributor
Medicare Part D/IRA impactOOP cap at $2,000; process may delay immediate benefit; gross-to-net savings offset by 340B Policy transition headwind/offsets
Povorcitinib HS readout expectationsPhase 3 ongoing; data flow plans HS data anticipated; program advancing Significant/clinically meaningful HiSCR50 at week 12 targeted; safety profile emphasized Readout in H1 2025; efficacy focus
Ruxolitinib XRXR study enrolling Data anticipated H1 2025 Bioequivalence achieved (AUC, Cmin); FDA submission by year-end 2025 Milestone achieved; toward 2026 commercialization
Niktimvo (axatilimab)FDA approvals in Q2/Q3 updates Approved and highlighted Launch underway; profit-sharing affects COGS Commercialization started

Management Commentary

  • Hervé Hoppenot: “We delivered another strong year… total revenues growing 15% versus 2023 to reach $4.2 billion… we saw strong growth from our non-Jakafi revenue, primarily driven by Opzelura… We ended 2024 with $2.2 billion in cash and no debt” .
  • Pablo Cagnoni: “Bioequivalency… ruxolitinib 55 mg extended release… once-a-day formulation… bioequivalent to twice a day ruxolitinib… plan to submit for approval by the end of the year once stability studies are completed” .
  • Christiana Stamoulis: “Q4 revenues of $1.2 billion, up 16%… driven by demand growth for Jakafi and Opzelura… increased revenue contribution from Monjuvi” .
  • Hervé Hoppenot: “PV… now accounting for 35% of the patients on Jakafi… we expect PV to become the largest contributor… supported by MAGIC PV study” .

Q&A Highlights

  • Opzelura guidance drivers and seasonality: 2025 guidance implies 24–32% YoY growth, driven by U.S. AD/vitiligo demand, potential pediatric AD launch, and Europe; Q1 revenue expected below Q4 due to deductibles and seasonality .
  • Povorcitinib HS endpoints: Focus on HiSCR50 at week 12; aim for statistically significant and clinically meaningful effects across HiSCR levels and pain; Phase III design aligns with Phase II efficacy profile, with antibiotic-use rules consistent across trials .
  • Medicare Part D redesign: $2,000 OOP cap may take time for patients to realize; expected savings in Part D offset by 340B growth; gross-to-net considerations persist .
  • Ruxolitinib XR commercialization: Submission by year-end 2025; commercialization targeted for 2026, providing ~2.5-year window before first twice-daily generic (2029) .
  • BET inhibitor and frontline strategy: Advancing as monotherapy post-Jakafi in MF; additional data needed for first-line combo path with Jakafi .

Estimates Context

  • S&P Global consensus estimates for Q4 2024 revenue/EPS were unavailable at the time of this analysis due to data access limits. As a result, beat/miss versus Wall Street consensus cannot be assessed at this time.
  • Where estimates materially inform trading decisions (e.g., EPS surprises), consider revisiting when S&P Global data are accessible.

Key Takeaways for Investors

  • Revenue momentum with sequential growth Q2→Q3→Q4 and strong YoY EPS expansion in Q4 reflects demand strength and reduced one-time expense drag .
  • Jakafi’s PV-driven expansion (35% mix, paid demand +14%) positions FY 2025 growth of 5–7% YoY, but monitor IRA price caps and 340B impacts on net pricing and gross-to-net .
  • Opzelura’s ex-U.S. uptake (Germany/France; expanding to Italy/Spain) plus potential pediatric AD approval underpins 2025 guidance; plan for Q1 seasonality and adherence initiatives to drive refill behavior .
  • Pipeline catalysts are near-term and numerous: povorcitinib HS pivotal readouts (H1’25), rux XR submission (YE’25), and potential approvals for tafasitamab FL and retifanlimab SCAC (H2’25), supporting diversification .
  • COGS expected to step-up in 2025 due to Niktimvo profit share; R&D/SG&A investments remain elevated but targeted as programs mature—monitor operating leverage progression .
  • Cash of ~$2.16B at year-end provides strategic flexibility post $2B buyback and Escient acquisition; balance sheet supports launch readiness and clinical milestones .
  • Near-term trading: watch HS/topical PN data and any 2025 guidance updates; medium-term thesis: execution on launches/readouts and Opzelura adherence/ex-U.S. ramp key to de-risk revenue diversification .