Intra-Cellular Therapies, Inc. (ITCI)·Q1 2024 Earnings Summary

Executive Summary

• Q1 2024 was a strong growth quarter: CAPLYTA net product sales rose 53% year over year to $144.8M and total revenues were $144.9M; net loss narrowed to $15.2M and EPS improved to -$0.16, driven primarily by prescription demand despite first‑quarter seasonality and the Change Healthcare cyberattack disruption .
• Guidance was reiterated: FY2024 CAPLYTA net product sales of $645–$675M, SG&A $450–$480M, and R&D $215–$240M, signaling confidence in sustained demand and execution .
• Strategic highlight: robust positive Phase 3 Study 501 (adjunctive MDD) results (MADRS LS mean difference -4.9; p<0.0001; ES=0.61) with additional safety/tolerability data; topline results from Study 502 expected late Q2 2024 and sNDA targeted for 2H 2024 .
• Key catalysts: imminent Study 502 readout and potential 2H24 sNDA filing for adjunctive MDD; continued DTC campaign rollout; strong market access (>99% Medicare/Medicaid, ~90% commercial) and expanding prescriber base (>39k) .

What Went Well and What Went Wrong

What Went Well

• CAPLYTA commercial momentum: Total prescriptions up 39% YoY in Q1; prescriber base surpassed 39,000 with robust DTC and sales execution (“we are well positioned for continued growth”) .
• Adjunctive MDD efficacy: Study 501 met primary and key secondary endpoints with robust effect sizes; safety and tolerability favorable, including metabolic parameters comparable to placebo (“significant step towards our goal…first‑choice treatment across mood disorders”) .
• Balance sheet strengthened: $477.4M cash/investments at 3/31; April public offering generated ~$543M net proceeds; no debt, supporting pipeline and potential BD opportunities .

Management quotes:

• “We continued to deliver strong growth for CAPLYTA … achieved a significant milestone in our adjunctive MDD program with positive Phase 3 Study 501 results.” — Dr. Sharon Mates .
• “CAPLYTA’s strong performance continued in Q1 … robust year‑over‑year growth in total prescriptions of 39%.” — Mark Neumann .

What Went Wrong

• Seasonality and external disruption: First‑quarter seasonal headwinds and industry disruption from the Change Healthcare cyberattack, though demand remained the primary revenue driver .
• Operating expense intensity: SG&A rose to $113.1M (+14% YoY) and R&D to $42.8M (+13% YoY), reflecting continued commercialization and pipeline investments .
• Estimates comparison: S&P Global consensus estimates were unavailable for ITCI, limiting external beat/miss assessment for Q1 [GetEstimates error].

Financial Results

Revenue, EPS, and Margins vs Prior Periods

Notes: Gross Margin (%) = (Total Revenues − Cost of Product Sales) / Total Revenues; Net Income Margin (%) = Net Loss / Total Revenues. All inputs cited from company filings.

Segment Breakdown

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are reiterating guidance for full year CAPLYTA net sales between $645 million and $675 million.” — Dr. Sharon Mates .
• “CAPLYTA’s growth continues to be driven by strong uptake in bipolar depression … and steady growth in schizophrenia.” — Mark Neumann .
• “We are in a strong financial position … approximately $477.4 million in cash … April 2024 offering ~$575 million gross proceeds … no debt.” — Dr. Sharon Mates .
• “Study 501 demonstrated a robust effect … MADRS LS mean difference -4.9 vs placebo; p<0.0001; ES=0.61 … favorable safety and tolerability.” — Company press release .

Q&A Highlights

• Business development capacity: Management is evaluating marketed or late‑stage assets; prefers staggering launches to maintain focus on CAPLYTA but has capacity to handle two launches .
• MDD filing timeline: Q3 filing “aggressive” but doable; aim remains 2H24 pending Study 502 data .
• Prescriber dynamics and DTC impact: Expect continued contribution from added reps and refreshed DTC campaign over 2024 .
• Inventory/gross‑to‑net: Revenue primarily driven by scripts; inventory not quantified; 2024 gross‑to‑net expected in mid‑30s (vs low‑30s in 2023) .
• PD (lenrispodun) study timelines: Enrollment slower than expected; topline remains in 2025; measuring motor, cognition, and inflammatory biomarkers .

Estimates Context

• S&P Global Wall Street consensus for ITCI was unavailable due to a CIQ mapping issue; therefore, beat/miss analysis vs consensus could not be performed. Values would normally be retrieved from S&P Global (Capital IQ).

Key Takeaways for Investors

• Commercial execution remains robust: CAPLYTA prescriptions up 39% YoY in Q1; prescribers >39k; broad payer access (>99% Medicare/Medicaid; ~90% commercial) supports sustained growth .
• Profitability trajectory improving: Net loss narrowed to $15.2M and net loss margin improved to -10.5% from -21.6% in Q4, aided by strong revenue growth and stable COGS .
• Adjunctive MDD is the near‑term catalyst: 501 positive; 502 topline due late Q2; potential sNDA in 2H24 could expand TAM meaningfully into MDD .
• Marketing and access tailwinds: New DTC campaign and prior Medicare Part D improvements should benefit 2024 demand; GTN moving to mid‑30s suggests evolving payer mix to monitor .
• Strong balance sheet and optionality: $477.4M cash at quarter‑end plus ~$543M net proceeds in April offering; no debt; capacity for BD and pipeline investment .
• Pipeline breadth beyond CAPLYTA: LAI, pediatric programs, ITI‑1284 (GAD/AD psychosis/agitation), PDE1 (PD), ITI‑1500 (non‑hallucinogenic psychedelics) provide medium‑term optionality .
• Near‑term trading considerations: Watch for Study 502 timing and strength of data, any guidance updates post‑readout, and script trends as DTC campaign scales; estimates context unavailable this quarter limits consensus beat/miss framing .

Citations:
All quantitative and qualitative statements are sourced from ITCI’s Q1 2024 8‑K and press release , Q1 2024 earnings call transcript , Q4 2023 8‑K and transcript , Q3 2023 8‑K and transcript , and the April 16, 2024 adjunctive MDD Study 501 8‑K press release .