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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
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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 .
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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
Segment/Product and Royalty Breakdown
KPIs
Guidance Changes
Note: Management clarified 2025 COGS increase due to manufacturing costs and Niktimvo profit-sharing accounting in COGS .
Earnings Call Themes & Trends
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 .