BioXcel Therapeutics (BTAI) Q4 2025 earnings summary

Executive summary

• Submitted sNDA to FDA for IGALMI label expansion to at-home use for acute agitation in bipolar disorders and schizophrenia, with potential approval by year-end 2026.

• Advancing commercial launch plans for IGALMI in the at-home setting, supported by third-party market assessment indicating up to 86 million annual addressable episodes.

• Focused on expanding BXCL501 clinical programs, including Alzheimer's dementia and opioid withdrawal indications.

Financial highlights

• Net revenue from IGALMI was $256,000 for Q4 2025 (down from $366,000 in Q4 2024) and $642,000 for full-year 2025 (down from $2.3 million in 2024).

• Cost of goods sold for Q4 2025 was $32,000 (down from $832,000 in Q4 2024); full-year was $164,000 (down from $2.1 million in 2024), mainly due to lower inventory reserve charges.

• R&D expenses were $6.7 million for Q4 2025 (up from $5.9 million in Q4 2024) and $30.3 million for full-year 2025 (flat vs. $30.4 million in 2024).

• SG&A expenses were $3.8 million for Q4 2025 (down from $4.1 million in Q4 2024) and $20.5 million for full-year 2025 (down from $34.5 million in 2024), reflecting lower personnel and marketing costs.

• Operating loss was $10.3 million for Q4 2025 (vs. $10.5 million in Q4 2024); net loss was $12.5 million for Q4 2025 (vs. $10.9 million in Q4 2024).

• Full-year 2025 operating loss was $50.5 million (vs. $67.2 million in 2024); net loss was $69.9 million (vs. $59.6 million in 2024).

• Cash used in operations for 2025 was $57.6 million, down from $72.0 million in 2024; cash and equivalents totaled $28.8 million at year-end 2025.

Outlook and guidance

• sNDA timeline supports potential IGALMI at-home approval by year-end 2026.

• Commercial and launch plans for IGALMI at-home are advancing, with market research supporting a large addressable market.

• Continued focus on Alzheimer's dementia and opioid withdrawal programs.