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IT

Intra-Cellular Therapies, Inc. (ITCI)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 total revenues were $161.4M, with CAPLYTA net product sales of $161.3M (+46% YoY), and net loss of $16.2M ($0.16 EPS); management raised FY2024 CAPLYTA sales guidance to $650–$680M, increased SG&A guidance to $480–$510M, and lowered R&D guidance to $210–$230M .
  • CAPLYTA prescriptions grew 36% YoY and 10% sequentially; the company is adding ~150 sales reps in Q3 to expand reach in primary care, with most impact expected in 2025 .
  • Positive Phase 3 results in MDD (Studies 501 and 502) underpin plans to submit an sNDA in 2H 2024; management emphasized robust efficacy, favorable safety, and early-onset benefit .
  • CMS Specified Small Manufacturer Exception status implies minimal Part D phase‑in rebates near term; CFO transition announced with Sanjeev Narula joining Aug 12, 2024 .

What Went Well and What Went Wrong

What Went Well

  • CAPLYTA continued strong uptake: net product sales reached $161.3M (+46% YoY); “We are very pleased with the strong performance of CAPLYTA during the second quarter” — Sharon Mates (CEO) .
  • MDD Phase 3 success: Lumateperone met MADRS primary endpoint with LS mean differences of −4.9 and −4.5 vs placebo, p<0.0001; key secondary endpoints (CGI‑S, QIDS‑SR) also positive; safety/metabolic changes similar to placebo .
  • Raised FY 2024 CAPLYTA sales guidance to $650–$680M; management highlighted durable demand and expanded primary care reach driving growth .

What Went Wrong

  • Profitability still negative: net loss was $16.2M and EPS $(0.16), reflecting continued investment and higher SG&A; loss from operations was $(27.7)M .
  • Operating expenses increased YoY: SG&A $121.6M and R&D $56.2M vs $101.0M and $49.8M in Q2 2023, tied to commercialization and pipeline progress; SG&A will rise further with sales force expansion .
  • Seasonality likely to temper Q3 momentum: management flagged typical summer seasonality with stronger Q4, guiding expectations accordingly .

Financial Results

Metric ($USD Millions except per-share)Q4 2023Q1 2024Q2 2024
Total Revenues$132.1 $144.9 $161.4
CAPLYTA Net Product Sales$131.5 $144.8 $161.3
Grant Revenue$0.6 $0.0 $0.1
Cost of Product Sales$10.7 $9.9 $11.4
SG&A Expense$104.7 $113.1 $121.6
R&D Expense$50.8 $42.8 $56.2
Loss from Operations$(34.1) $(21.0) $(27.7)
Interest Income$6.0 $6.1 $11.6
Net Loss$(28.6) $(15.2) $(16.2)
Basic & Diluted EPS ($)$(0.30) $(0.16) $(0.16)

Segment breakdown

Revenue Component ($USD Millions)Q4 2023Q1 2024Q2 2024
CAPLYTA Net Product Sales$131.5 $144.8 $161.3
Grant Revenue$0.6 $0.0 $0.1
Total Revenues$132.1 $144.9 $161.4

KPIs

KPIQ4 2023Q1 2024Q2 2024
CAPLYTA Total Prescriptions YoY Growth (%)55% 39% 36%
Sequential Prescription Growth (%)10% n/a10%
Cumulative Unique Prescribers (approx.)>36,000 >39,000 ~43,000
New First-Time Prescribers (quarter)n/a3,000–4,000 >3,600
Gross-to-Net (% guidance)Low 30s in Q4 Mid-30s full year guide Mid-30s expected rest of year

Estimates vs Actuals

MetricQ1 2024Q2 2024Q3 2024Q4 2024
Revenue Consensus Mean ($USD Millions)Unavailable via S&P GlobalUnavailable via S&P GlobalUnavailable via S&P GlobalUnavailable via S&P Global
Primary EPS Consensus Mean ($)Unavailable via S&P GlobalUnavailable via S&P GlobalUnavailable via S&P GlobalUnavailable via S&P Global

Note: Wall Street consensus from S&P Global was unavailable for ITCI (mapping error); as a result, beat/miss vs estimates cannot be determined for Q2 2024.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CAPLYTA Net Product Sales (GAAP)FY 2024$645–$675M $650–$680M Raised
SG&A Expense (GAAP)FY 2024$450–$480M $480–$510M Raised
R&D Expense (GAAP)FY 2024$215–$240M $210–$230M Lowered
Gross-to-Net (% commentary)FY 2024Mid-30s expected Mid-30s reaffirmed Maintained

Drivers: SG&A increase primarily reflects the sales force expansion in primary care; R&D lowered on updated program pacing; revenue guidance raised on prescription demand acceleration .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
CAPLYTA prescription momentum85% YoY Rx growth in 2023; 10% sequential growth in Q4; strong Q1 despite Change Healthcare disruption 36% YoY and 10% sequential Rx growth in Q2; demand cited as driver for raised sales guidance Accelerating
Primary care expansionTargeted high-volume PCPs; broader PCP push contemplated for MDD +150 reps in Q3 to expand PCP reach for bipolar depression; broader expansion to follow potential MDD approval Expanding
MDD label expansion planExpect top-line: 501 (Apr), 502 (late Q2); sNDA in 2H 2024; robust 501 efficacy Positive 501 and 502 results; sNDA preparation ongoing; safety profile favorable; early onset benefit Advancing
Pediatric programInitiated studies in ASD irritability and bipolar depression; open-label safety ongoing Plans to begin enrolling ASD studies in 2H 2024; ongoing pediatric bipolar and safety studies Continuing
Long-acting injectable (LAI)Phase 1 SAD done; new formulations to start 1H 2024 Commencing Phase 1 with several formulations shortly Progressing
CMS/IRA dynamicsImproved Medicare Part D coverage in Q4’23 CMS Specified Small Manufacturer Exception → minimal phase-in rebates through decade Supportive
Profitability pathNo profitability timeline; focus on growth and pipeline Reiterated focus on profitability with no specific timeline; strong cash and no debt Unchanged

Management Commentary

  • “We are very pleased with the strong performance of CAPLYTA during the second quarter and look forward to continued growth for the remainder of 2024.” — Sharon Mates, CEO .
  • “Both studies demonstrated robust efficacy…with a large separation versus placebo of 4.9 points in Study 501 and 4.5 points in Study 502…effect size of 0.61 and 0.56.” — Sharon Mates on MDD Phase 3 .
  • “To capitalize on this opportunity…we are expanding our sales force by approximately 150 representatives during the third quarter of this year.” — Mark Neumann, CCO .
  • “Our gross to net percentage…was in the mid‑30s and consistent with our guidance for the full year.” — Larry Hineline, CFO .
  • “We are in a strong financial position ending the second quarter with approximately $1.025 billion in cash, cash equivalents and investment securities, and we have no debt.” — Sharon Mates .

Q&A Highlights

  • Seasonality and script trajectory: Management expects typical summer softness in Q3 with stronger Q4; full-year guidance incorporates this pattern .
  • MDD launch planning and share-of-voice: Commercial strategy spans expanded field force, medical education, and DTC/digital presence to achieve competitive share-of-voice upon approval .
  • CMS exception impact: Specified Small Manufacturer Exception implies minimal phase-in rebates near term under IRA Part D redesign .
  • Sales force sizing: ~150 reps added in Q3 2024 (taking total field north of 500) to deepen PCP coverage; larger expansion likely in 2025 post-MDD approval .
  • Profitability: No explicit timeline; continued investment in commercialization and R&D with strong cash position and no debt .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 revenue and EPS were unavailable due to a mapping error; therefore, we cannot determine a beat/miss vs Wall Street for this quarter. The company raised FY 2024 sales guidance, which typically leads to upward estimate revisions for revenue and EPS models .

Key Takeaways for Investors

  • CAPLYTA growth remains robust, with raised FY revenue guidance and expanding prescriber base; primary care expansion is a near-term lever, with most impact visible in 2025 .
  • Phase 3 MDD success (two positive studies) positions CAPLYTA for a major label expansion; sNDA submission targeted for 2H 2024, supporting medium-term upside .
  • Operating expenses will rise near term (SG&A) due to sales force scaling; R&D guidance lowered as programs pace, but pipeline breadth (ITI‑1284, PDE1, LAI) continues to mature .
  • Seasonality suggests tempered Q3 scripts and stronger Q4; watch Rx trends and PCP rollout cadence for 2025 revenue reacceleration .
  • CMS exception reduces near-term IRA headwinds on rebates; market access remains broad (Medicare/Medicaid >99%, commercial ~90%) supporting adoption .
  • Strong balance sheet (~$1.025B cash/investments; no debt) enables continued investment and optionality in BD to leverage the expanding commercial footprint .
  • Execution focus: monitor sNDA filing timing, sales force on-boarding effectiveness, and medical conference disclosures (501/502 data) as catalysts for sentiment and estimate revisions .

Additional Documents Read

  • Q2 2024 Form 8‑K and Exhibit 99.1 earnings press release; Exhibit 99.2 CFO appointment press release .
  • Q2 2024 earnings call transcript –.
  • Q1 2024 Form 8‑K and press release; Q1 2024 earnings call transcript –.
  • Q4 2023 Form 8‑K and press release; Q4 2023 earnings call transcript –.