Executive Summary

Q4 2024 EPS beat but revenue missed: EPS of $(3.57) vs S&P Global consensus $(6.94), while product revenue of $0.37M missed $0.72M; operating expenses declined sharply year over year, reflecting restructuring and lower R&D spend * . Values retrieved from S&P Global.
Clinical execution advanced: SERENITY At-Home Phase 3 reached 63% enrollment (127/200) across 24 sites; topline data expected in H2 2025, a key stock catalyst for potential at-home label expansion of IGALMI (BXCL501) .
Balance sheet and financing: Cash was $29.9M at 12/31/24, and a $14M equity raise brought cash to ~ $35M as of Mar 4, 2025, extending funding runway to progress SERENITY .
Regulatory/quality update: FDA closed a TRANQUILITY II trial site inspection (EIR “Voluntary Action Indicated”), supporting reliability of prior Phase 3 data, which helps underpin the Alzheimer’s agitation program .

What Went Well and What Went Wrong

What Went Well

SERENITY At-Home execution: 24 sites open; 127 patients enrolled (63% of target), with topline H2 2025—management emphasized the opportunity to address ~23M at‑home agitation episodes annually .
Operating expense discipline: Q4 R&D fell to $5.9M from $9.9M YoY; SG&A fell to $4.1M from $9.6M YoY, reflecting reprioritization and lower commercial spend .
Positive regulatory signal: FDA closed TRANQUILITY II site inspection with “Voluntary Action Indicated,” bolstering confidence in the Alzheimer’s agitation dataset supporting the In‑Care pivotal design .

Selected quotes:

“We are pleased that patient enrollment in our SERENITY At-Home pivotal Phase 3 trial is progressing well and that we have recently strengthened our cash position to further advance this important study.” — CEO Vimal Mehta
“Topline data [from SERENITY At‑Home] expected in the second half of 2025.”
The Company is “continuing to supply IGALMI…with minimal commercial support,” prioritizing development over commercialization .

What Went Wrong

Revenue miss and thin IGALMI traction: Q4 product revenue $366k vs $718k consensus*, with product revenue roughly flat YoY (Q4’23: $376k), reflecting minimal commercial support and timing dynamics seen in prior quarters * . Values retrieved from S&P Global.
Inventory reserve pressure: Q4 COGS included $778k of reserves for excess/obsolete inventory (vs $696k in Q4’23), keeping gross margins under pressure .
Liquidity and going-concern risk: Cash fell to $29.9M at year-end; company continues to note “substantial doubt” about ability to continue as a going concern among risk factors in forward-looking statements, despite subsequent $14M raise .

Financial Results

P&L and Cash (Quarterly)

Metric (USD, as reported)	Q2 2024	Q3 2024	Q4 2024
Product Revenues ($ Thousands)	$1,104	$214	$366
Cost of Goods Sold ($ Thousands)	$62	$1,170	$832
Inventory Reserve Charges in COGS ($ Thousands)	N/A	$1,200	$778
R&D Expense ($ Thousands)	$8,032	$5,101	$5,901
SG&A Expense ($ Thousands)	$9,450	$7,683	$4,094
Net Loss ($ Thousands)	$(8,299)	$(13,650)	$(10,859)
Cash & Cash Equivalents (Period-end, $ Thousands)	$56,271	$40,387	$29,854
Net Loss per Share (Basic & Diluted)	$(0.21)	$(0.32)	$(3.57)

Note: On Feb 6, 2025, BioXcel effected a 1‑for‑16 reverse split; per-share metrics reported for earlier quarters (e.g., Q2/Q3 2024) were originally disclosed pre‑split and may not be directly comparable to Q4’s presentation .

Q4 2024 vs Estimates (S&P Global)

Metric	Actual	Consensus	Surprise
Revenue ($)	$366,000	$718,260*	$(352,260)
EPS (Primary)	$(3.5627)	$(6.9436)*	+$3.381

Values marked with * are retrieved from S&P Global (Capital IQ). Values retrieved from S&P Global.

Segment Breakdown

Company reports a single product revenue line (IGALMI) and does not provide segment reporting .

KPIs and Operating Drivers

KPI	Q2 2024	Q3 2024	Q4 2024
SERENITY At‑Home: Sites Open	N/A	N/A	24
SERENITY At‑Home: Enrollment	N/A	N/A	127/200 (63%)
Topline Timing (SERENITY At‑Home)	N/A	N/A	H2 2025
TRANQUILITY II FDA Site Inspection	N/A	N/A	EIR “Voluntary Action Indicated” (inspection closed)
IGALMI Commercial Approach	Focused PMR and targeted clinics	Maintain IGALMI with minimal resources	Supply IGALMI with minimal commercial support

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
SERENITY At‑Home topline	H2 2025	Trial duration 9–12 months from Sept 2024 initiation; no specific date	Topline data expected in H2 2025	Maintained/clarified
TRANQUILITY In‑Care design/status	2025	FDA feedback received; protocol largely mirrors TRANQUILITY II; pilot at‑home cohort dropped	Plans developed following FDA feedback; moving forward on protocol	Maintained
IGALMI commercialization support	Ongoing	Maintain product with small footprint; targeted behavioral health clinics	Supply via existing channels with minimal commercial support	Maintained
Cash/Liquidity commentary	Near term	Cash $40.4M at 9/30/24	Cash $29.9M at 12/31/24; ~$35M after $14M equity financing (as of Mar 4, 2025)	Updated (post‑quarter financing)

Earnings Call Themes & Trends

(Note: No Q4 2024 earnings call transcript was available in the searched dataset; themes below compare Q2/Q3 to Q4 press disclosures.)

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
SERENITY At‑Home execution	FDA protocol feedback incorporated; make‑ready complete; SERENITY less complex/faster study	24 sites open; 127 patients enrolled (63%); topline H2 2025	Positive momentum
TRANQUILITY In‑Care plans	Protocol substantially similar to TRANQUILITY II; FDA aligned; focus on repeat‑dose efficacy	Post‑FDA feedback plans developed; inspection closure supports data reliability	Advancing
IGALMI commercialization	Target behavioral health clinics; PMR study positive; sequential revenue growth in Q2	Continue supply with minimal support; Q4 revenue modest	Focus remains on R&D
Regulatory/quality	—	FDA closed TRANQUILITY II site inspection (EIR “VAI”)	Positive
Funding/runway	Evaluating strategic financing, partnerships, monetization	$14M equity raise; cash ~ $35M on Mar 4, 2025	Incremental improvement
AI/technology positioning	Using AI to develop medicines (ongoing positioning)	Reiterated AI‑enabled drug re‑innovation strategy	Stable narrative

Management Commentary

“We believe that our SERENITY program presents an exciting opportunity to address a substantial unmet medical need — the 23 million episodes of bipolar and schizophrenia-related agitation that occur annually in the United States at home — and expand the market potential for our lead neuroscience asset BXCL501.” — Vimal Mehta, Ph.D., CEO .
“We are pleased that patient enrollment in our SERENITY At-Home pivotal Phase 3 trial is progressing well and that we have recently strengthened our cash position to further advance this important study.” — Vimal Mehta, Ph.D. .
“The Company is continuing to supply IGALMI…through existing distribution channels, with minimal commercial support.” .

Q&A Highlights

No Q4 2024 call transcript was available in the dataset searched; highlights below reference the Q3 2024 call for context:

SERENITY enrollment cadence and design: 26 sites planned; 9–12 month enrollment window; rescue meds allowed as a safety measure; tracking surrogate markers such as rescue use .
TRANQUILITY protocol feedback: Direct, actionable FDA feedback; at‑home pilot cohort removed from protocol design .
Funding and covenants: Management engaging stakeholders to strengthen balance sheet and reach data readouts; discussions with partners ongoing .
Inventory and COGS: Inventory write‑down discussed; sufficient product on hand for next couple of years; write‑down is non‑cash .

Estimates Context

Q4 2024: EPS actual $(3.5627) vs consensus $(6.9436)* (beat); revenue actual $366k vs consensus $718k* (miss); 5 estimates for both metrics *. Values retrieved from S&P Global.
Q3 2024 for context: EPS actual $(5.12) vs consensus $(8.74)* (beat); revenue actual $214k vs consensus $1.33M* (miss) *. Values retrieved from S&P Global.
Implications: Street revenue models may need to reflect ongoing minimal commercial support for IGALMI and inventory reserve effects; expense discipline is evident, but liquidity and going-concern language in disclosures remain important risk considerations for estimates .

Key Takeaways for Investors

The core near-term catalyst is SERENITY At‑Home topline in H2 2025; enrollment is 63% complete across 24 sites, keeping timelines on track .
Q4 delivered an EPS beat vs consensus but missed on revenue; beats are driven more by operating discipline and below‑the‑line items historically, while revenue remains modest under a minimal commercialization approach * . Values retrieved from S&P Global.
Operating expense reductions (R&D and SG&A) are durable following reprioritization; watch for any ramp as TRANQUILITY In‑Care initiates .
Liquidity improved post-quarter with a $14M raise to ~$35M cash, but risk disclosures still highlight going‑concern uncertainty; additional financing or partnerships could be a stock driver .
Regulatory risk eased slightly with FDA closure of the TRANQUILITY II site inspection (EIR “VAI”), supporting reliability of prior Alzheimer’s data and the In‑Care trial plan .
For trading, watch for: continued SERENITY enrollment updates, any TRANQUILITY initiation milestones, financing actions, and IGALMI utilization trends in behavioral health settings .

References:

Q4/FY 2024 earnings press release and financials
Q4 2024 8‑K (Item 2.02; Exhibit 99.1)
Q3 2024 press release, 8‑K, and call transcript
Q2 2024 press release and call transcript
Reverse stock split press release (EPS comparability)

S&P Global disclaimer: All values marked with * are retrieved from S&P Global (Capital IQ) consensus estimates.

BioXcel Therapeutics, Inc. (BTAI)·Q4 2024 Earnings Summary