Executive Summary

Q3 revenue rose 39% year-over-year to $175.4M, driven by CAPLYTA net product sales of $175.2M (+39% YoY), while net loss was $26.3M; management raised 2024 CAPLYTA sales guidance to $665–$685M and narrowed OpEx ranges .
Prescriptions stayed strong: CAPLYTA total Rx +38% YoY and +9% QoQ; the company added ~150 primary care reps in Q3 to expand reach, with a second primary care expansion planned in 2025 to support a potential MDD indication .
Management characterized CAPLYTA as an at least $5B sales opportunity over the next 10 years across mood disorders, supported by robust Phase 3 adjunctive MDD data and a planned sNDA filing in Q4 2024; cash and investments were ~$1.0B at quarter-end, providing ample flexibility .
Key stock drivers: raised FY24 sales guidance, accelerating primary care build-out, imminent MDD sNDA, and management’s $5B long-term revenue framework; watch OpEx ramps (SG&A, R&D) as the pipeline and commercial footprint scale .

What Went Well and What Went Wrong

What Went Well

CAPLYTA demand remained robust: Q3 net product sales were $175.2M (+39% YoY) as total revenues reached $175.4M; total prescriptions rose 38% YoY and 9% QoQ, outpacing branded and overall antipsychotic markets .
FY24 outlook improved: CAPLYTA sales guidance raised to $665–$685M; SG&A and R&D ranges narrowed, reflecting visibility into spending as the sales force and pipeline scale .
Clear strategic ambition and confidence: “CAPLYTA represents at least a $5 billion opportunity within the next 10 years,” underpinned by mood disorder breadth and potential MDD label expansion; “we are on track to submit our sNDA…for MDD later this year” .

What Went Wrong

Loss widened YoY: Net loss was $26.3M vs. $24.3M a year ago as SG&A ($132.1M) and R&D ($66.8M) rose with sales force expansion and multiple late-stage studies (bipolar mania, pediatric, ITI-1284) .
Gross margin moderated sequentially: cost of product sales increased to $15.3M vs. $11.4M in Q2; calculated CAPLYTA gross margin dipped QoQ (see table) .
Consensus benchmarking unavailable: S&P Global consensus data could not be retrieved in our system for Q3, limiting formal beat/miss framing (see Estimates Context) [GetEstimates error noted].

Financial Results

Headline P&L vs Prior Periods and YoY

Metric	Q3 2023	Q1 2024	Q2 2024	Q3 2024
Total Revenues ($M)	$126.2	$144.9	$161.4	$175.4
CAPLYTA Net Product Sales ($M)	$125.8	$144.8	$161.3	$175.2
Net Loss ($M)	$(24.3)	$(15.2)	$(16.2)	$(26.3)
Diluted EPS ($)	$(0.25)	$(0.16)	$(0.16)	$(0.25)
vs S&P Global Consensus	N/A (Unavailable)	N/A (Unavailable)	N/A (Unavailable)	N/A (Unavailable)

Notes: S&P Global consensus unavailable in tool; see Estimates Context.

Margins (calculated from reported line items)

Margin	Q3 2023	Q1 2024	Q2 2024	Q3 2024
CAPLYTA Gross Margin %	92.7% (calc from $125.8M product sales and $9.1M cost )	93.2% (calc from $144.8M and $9.9M )	93.0% (calc from $161.3M and $11.4M )	91.3% (calc from $175.2M and $15.3M )
Net Income Margin %	(19.2)% (calc from $(24.3)M and $126.2M )	(10.5)% (calc from $(15.2)M and $144.9M )	(10.0)% (calc from $(16.2)M and $161.4M )	(15.0)% (calc from $(26.3)M and $175.4M )

Note: Margins are derived calculations based on cited product sales, cost of product sales, net loss, and total revenues.

Revenue Composition (segment-like disclosure)

Revenue Detail ($M)	Q3 2023	Q1 2024	Q2 2024	Q3 2024
CAPLYTA Net Product Sales	$125.8	$144.8	$161.3	$175.2
Grant Revenue	$0.4	$0.02	$0.11	$0.22
Total Revenues	$126.2	$144.9	$161.4	$175.4

KPIs and Operating Metrics

KPI	Q3 2024	Prior Reference
CAPLYTA Total Prescriptions	+38% YoY; +9% QoQ	Q2: +36% YoY; +10% QoQ
New First-time Prescribers Added	~4,000 in Q3; >49,000 cumulative since launch	~43,000 cumulative by Q2
Gross-to-Net	Mid-30s; expected mid-30s in Q4	Mid-30s in Q2; expected mid-30s for year
Sales Force Expansion	~150 reps added in Q3 for primary care	Planned second primary care expansion in 2025
Cash, Equivalents, Investments, Restricted Cash	~$1.0B at 9/30/24	$1.025B at 6/30/24

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
CAPLYTA Net Product Sales	FY 2024	$650–$680M	$665–$685M	Raised
SG&A Expense	FY 2024	$480–$510M	$490–$510M	Narrowed (upper maintained; lower raised)
R&D Expense	FY 2024	$210–$230M	$220–$230M	Narrowed (upper maintained; lower raised)

Context: Higher sales guidance underpinned by continued prescription demand and seasonal Q4 strength; some Q4 contribution from newly added primary care reps expected, with most impact in 2025 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2 2024)	Current Period (Q3 2024)	Trend
Adjunctive MDD sNDA	Study 501 positive; 502 readout planned; sNDA 2H24; Q3 filing “aggressive”	Successful pre-sNDA meeting; anticipate sNDA submission in Q4 2024; ACNP/other data presentations upcoming	Momentum increasing; execution milestone near
Primary Care Expansion	Expanding by ~150 reps in Q3 to broaden reach; 2025 expansion planned for MDD	150 reps added in Q3; second primary care expansion planned in 2025	Execution underway; broader rollout next year
Long-acting Injectable (LAI)	Phase 1 with several formulations to commence	Phase 1 single ascending dose study ongoing; do not expect major impact on oral franchise	Early clinical progress; modest near-term commercial relevance
ITI-1284 (GAD, AD psychosis/agitation)	Initiated large Phase 2 programs; designed as potential registration studies	Enrollment ongoing; program viewed as >$1B GAD opportunity; timelines conservative	Advancing; high unmet need positioning
Market/Policy (IRA)	CAPLYTA qualified for Specified Small Manufacturer Exception; minimal impact till late decade	No change; pricing assumptions moderate net price improvements over time	Stable policy footing
Long-term Outlook	Strong commercial and pipeline execution; cash >$1B	CAPLYTA at least $5B sales opportunity in 10 years across mood disorders	More explicit long-term target disclosed

Management Commentary

“CAPLYTA's growth trajectory continues…net sales of $175.2 million in the third quarter representing a 39% increase over the third quarter of 2023…we are raising our 2024 full year net sales guidance range to $665 million to $685 million” — Sharon Mates, CEO .
“We believe CAPLYTA represents at least a $5 billion opportunity within the next 10 years…primarily driven by bipolar depression and MDD” — Sharon Mates, CEO .
“Gross to net percentage in the quarter was in mid-30s…we’re raising CAPLYTA net product sales guidance range to $665 million to $685 million…cash and investment totaled $1 billion on September 30, 2024” — Sanjeev Narula, CFO .
“We recently completed an expansion of our sales force during Q3, adding 150 new sales representatives to leverage the growing opportunity with primary care physicians” — Mark Neumann, CCO .

Q&A Highlights

Long-term framework: Management unveiled a $5B 10-year CAPLYTA sales opportunity, with major contributions from bipolar depression and MDD; rationale supported by quantitative market research and robust MDD data .
Q4 trajectory and guidance math: Management expects typical seasonal strength plus some early effect from Q3 fielded reps; implied Q4 sequential growth of ~11% at guidance midpoint viewed as reasonable .
LAI expectations: Early-stage; penetration limited in schizophrenia (~5–10% of patients on LAIs). Minimal impact expected to the oral franchise given CAPLYTA’s tolerability and patient preference for oral therapy .
Competitive landscape: KarXT (schizophrenia) launch not expected to materially impact CAPLYTA; ITCI’s focus remains mood disorders where KarXT does not compete .
MDD data dissemination: Additional presentations planned (e.g., ACNP) including secondary endpoints and post-hoc analyses from Studies 501/502 .

Estimates Context

We attempted to pull S&P Global consensus for Q3 2024 (revenue, EPS, target price), but our system could not map the ticker to CIQ identifiers at this time; therefore, consensus comparisons are unavailable for this recap. We will update when S&P Global mapping is restored [GetEstimates error].

Key Takeaways for Investors

Demand-driven beat trajectory: CAPLYTA revenue growth remained strong (+39% YoY), with Rx growth outpacing the market; FY24 sales guidance was raised, reflecting durable demand and an expanding prescriber base .
Near-term catalyst: sNDA filing for adjunctive MDD in Q4 2024; label expansion could materially enlarge TAM (from ~50% to ~80% of antipsychotic scripts across schizophrenia/bipolar/MDD) and support 2025 acceleration .
Go-to-market leverage: 150 new primary care reps are in place; expect modest Q4 impact and greater 2025 contribution; a second primary care expansion is planned contingent on MDD approval .
Profitability trade-off: Net loss widened YoY as SG&A (sales force/marketing) and R&D (multiple late-stage programs) stepped up; investors should monitor OpEx intensity versus revenue scaling through 2025 .
Margin watch: Calculated CAPLYTA gross margin eased QoQ (91.3% vs. 93.0% in Q2) amid higher cost of sales; sustainability of mid-90%+ levels (typical for branded CNS) will be a point to track with mix/discounting dynamics .
Long-term thesis: Management’s $5B 10-year revenue ambition frames a multi-indication mood disorders franchise with optionality from LAI and ITI-1284; balance sheet (~$1.0B) supports execution without near-term financing .
Risk checks: Regulatory timing/label for MDD, execution of primary care expansion, competitive dynamics in mood disorders, and maintaining favorable gross-to-net in mid-30s as access broadens .

Additional Source Citations

Q3 2024 press release and 8-K financials, outlook, clinical updates .
Q3 2024 earnings call prepared remarks and Q&A .
Q2 2024 press release and 8-K (prior quarter baseline, guidance) .
Q2 2024 earnings call (commercial momentum, expansion plans) .
Q1 2024 press release and 8-K (baseline) .

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