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IT

Intra-Cellular Therapies, Inc. (ITCI)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 CAPLYTA net product sales were $199.22M, up 51% year over year; diluted EPS was -$0.16, improving from -$0.29 in Q4 2023 .
  • Against third-party consensus, revenue was below MarketBeat ($205.08M) and EPS missed (-$0.08), while revenue topped Zacks ($193M) but EPS missed (-$0.05); S&P Global consensus was unavailable due to mapping limitations. Bolded: Revenue miss vs MarketBeat, EPS miss vs MarketBeat/Zacks (, ).
  • FDA accepted lumateperone sNDA for adjunctive MDD; company began a sales force expansion in Q1 2025 ahead of potential approval, and ended 2024 with ~$1.0B in cash/investments .
  • Prior quarters (Q2/Q3 2024) showed strong CAPLYTA growth and successive raises to FY 2024 sales guidance ($650–$680M in Q2, then $665–$685M in Q3), setting the trajectory into Q4 .

What Went Well and What Went Wrong

What Went Well

  • Strong Q4 top-line: CAPLYTA net sales grew 51% YoY to $199.22M, capping FY 2024 net sales of $680.50M (+47% YoY) .
  • Regulatory progress: “The FDA has accepted for review the sNDA for lumateperone… adjunctive treatment of MDD,” supported by two positive Phase 3 studies (501, 502) .
  • Management strategic confidence: “We believe CAPLYTA represents at least a $5 billion opportunity within the next 10 years” (Sharon Mates), with expanded primary care reach and pipeline momentum .

What Went Wrong

  • Continued losses (though improved YoY): Q4 net loss of -$16.89M and diluted EPS -$0.16; cost base rose with SG&A/R&D spend tied to commercial and clinical scale-up .
  • Expense pressure: FY 2024 SG&A grew to $504.49M (vs $409.86M FY 2023) and R&D to $236.12M (vs $180.14M), reflecting commercialization and multi-program advancement .
  • Estimates context: Relative to some third-party consensus sources, EPS missed and revenue was mixed (beat vs Zacks, miss vs MarketBeat), highlighting variance in Street expectations (, ).

Financial Results

Headline metrics vs prior periods and third-party estimates

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($USD Millions)$161.39 $175.38 $199.22
Net Loss ($USD Millions)-$16.22 -$26.32 -$16.89
Diluted EPS ($USD)-$0.16 -$0.25 -$0.16
EBIT (Loss from operations, $USD Millions)-$27.72 -$38.85 -$29.20
EBIT Margin %-17.2% (calc from )-22.2% (calc from )-14.7% (calc from )
Net Income Margin %-10.0% (calc from )-15.0% (calc from )-8.5% (calc from )

Actual vs third-party consensus (Q4 2024)

SourceRevenue ($USD Millions)EPS ($USD)
Actual$199.22 -$0.16
MarketBeat Consensus$205.08 -$0.08
Zacks/Yahoo Consensus$193.00 -$0.05

Segment/KPI details

MetricQ2 2024Q3 2024Q4 2024
CAPLYTA Net Product Sales ($USD Millions)$161.28 $175.16 $199.22
Grant Revenue ($USD Millions)$0.11 $0.22 $0.00
Total Prescriptions YoY Growth (%)36% 38% N/A (not disclosed)
Cash, Cash Equivalents, Investment Securities, Restricted Cash ($USD Billions, period-end)$1.025 ~$1.0 ~$1.0

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CAPLYTA Net Product SalesFY 2024$650–$680M $665–$685M Raised
SG&A ExpenseFY 2024$480–$510M $490–$510M Narrowed higher floor
R&D ExpenseFY 2024$210–$230M $220–$230M Raised floor

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
MDD sNDA/label expansionPlan to file sNDA in H2’24; robust Phase 3 efficacy (MADRS LS mean diff: -4.9/-4.5; effect sizes 0.61/0.56) On track to submit; successful pre-sNDA meeting FDA accepted lumateperone sNDA for adjunctive MDD Advancing (acceptance)
Commercial expansion (Primary Care)Announced ~150 rep expansion in Q3; target >500 reps Completed ~150 rep expansion; second expansion planned for 2025 Commenced additional expansion in Q1 2025 ahead of potential MDD approval Scaling up
CAPLYTA growth and TAMStrong Q2 Rx growth; FY sales guide raised “$5B opportunity within 10 years” positioning across mood disorders Q4 sales +51% YoY; FY 2024 $680.5M (+47% YoY) Sustained growth
Pricing/IRA dynamicsSpecified Small Manufacturer Exception noted; minimal Phase-in rebates impact near term Moderate improvements in net selling price contemplated; IRA impact embedded (long-term) No incremental update in PR; framework unchanged Neutral / monitored
Pipeline (1284, LAI, pediatrics)Initiated Phase 2 (GAD, AD psychosis); Phase 3 pediatric, mania, LAI plans Ongoing Phase 3 mania; LAI Phase 1 started; 1284 studies ongoing 10 late-stage trials initiated in 2024; ongoing pediatric ASD Phase 3s; 1284 programs advancing Broadening execution
Corporate/StrategicCFO transition to Narula Sales force build, market research confidence Pending J&J transaction referenced in forward-looking statements ; J&J highlighted planned acquisition (Jan-2025) ()Potential strategic catalyst

Management Commentary

  • “Based on this continued strong performance, we are raising our 2024 full year net sales guidance range to $665 million to $685 million.” (Sharon Mates, Q3) .
  • “CAPLYTA represents at least a $5 billion opportunity within the next 10 years… driven by bipolar depression and MDD, and to a lesser extent, schizophrenia.” (Sharon Mates, Q3) .
  • “We expect our gross to net percentage to remain in mid-30s for the fourth quarter.” (Sanjeev Narula, Q3) .
  • “We are going to be presenting at ACNP different aspects of the studies 501, 502 and also the open-label Study 503.” (Suresh Durgam, Q3) .

Q&A Highlights

  • Long-term TAM: Management outlined a $5B sales vision, with rigorous market research supporting leading share in adjunctive MDD and continued gains in bipolar depression .
  • Launch/field dynamics: Primary care expansion (~150 reps in Q3; further expansion planned in 2025) aims to optimize share of voice and uptake across mood disorders .
  • LAI impact: Near-term limited impact expected; oral CAPLYTA remains favored given safety/tolerability profile .
  • IRA/pricing: Assumes moderate net price improvements; IRA considerations embedded, with specified small manufacturer exception mitigating near-term rebate effects .

Estimates Context

  • S&P Global consensus estimates were unavailable due to CIQ mapping limitations for ITCI.
  • Third-party estimates varied: MarketBeat implied a revenue miss ($199.22M vs $205.08M) and EPS miss (-$0.16 vs -$0.08) (). Zacks/Yahoo showed a revenue beat ($199.22M vs $193.00M) and EPS miss (-$0.16 vs -$0.05) ().
  • Given dispersion in non-SPGI estimates, we expect Street models to adjust for stronger-than-expected CAPLYTA demand, higher SG&A from sales force expansion, and timing of a potential MDD label.

Key Takeaways for Investors

  • Q4 delivered strong top-line growth with improving margins sequentially (EBIT margin -22.2% to -14.7%), underpinned by CAPLYTA momentum; continued investment tempers near-term profitability .
  • Regulatory catalyst: sNDA acceptance for adjunctive MDD and active physician education should support a 2025 launch trajectory if approved; commercial scale-up underway .
  • Guidance execution credibility: Successive FY 2024 guidance raises (Q2→Q3) were matched by delivery into Q4, reinforcing demand durability in bipolar depression and prescriber base expansion .
  • Strategic optionality: The J&J planned acquisition provides an external validation of the franchise and potential acceleration in penetration/geographies; transaction referenced by both parties ().
  • Near-term trading lens: Results versus estimates depend on source; narrative catalysts include MDD label progress, field expansion impact, and any transaction developments—expect volatility around regulatory/timing milestones (, ).
  • Medium-term thesis: Broader mood disorders positioning (bipolar I/II, adjunctive MDD), favorable tolerability, and pediatric/LAI/1284 pipeline create multi-year growth vectors, albeit with ongoing SG&A/R&D investment requirements .

Notes:

  • Primary source documents for Q4 2024: 8-K 2.02 press release and condensed financials .
  • Prior quarter sources: Q3 2024 8-K/press release and transcript ; Q2 2024 8-K/press release and transcript .
  • Q4 2024 earnings call transcript was not available via our document tool; commentary references Q2/Q3 calls and the Q4 press release .