BioXcel Therapeutics(BTAI) - 2024 Q4 - Annual Results

Clinical Trial Progress - Patient enrollment in the SERENITY At-Home pivotal Phase 3 trial has exceeded 60%, with 127 out of 200 patients enrolled, representing 63% of the required enrollment[5] - Topline data from the SERENITY At-Home trial is expected in the second half of 2025, which may support a potential sNDA submission for label expansion of IGALMI[1][3] Financial Performance - Net revenue from IGALMI for Q4 2024 was $366,000, a slight decrease from $376,000 in Q4 2023; for the full year 2024, net revenue was $2.3 million, up from $1.4 million in 2023[8] - Product revenues for the year ended December 31, 2024, were $2,266,000, compared to $1,380,000 for the year ended December 31, 2023, representing a 64.3% increase[31] Cost and Expenses - Cost of Goods Sold (COGS) for Q4 2024 was $832,000, compared to $714,000 in Q4 2023; for the full year 2024, COGS was $2.1 million, up from $1.3 million in 2023[9][10] - Research and Development (R&D) expenses for Q4 2024 were $5.9 million, down from $9.9 million in Q4 2023; for the full year 2024, R&D expenses totaled $30.4 million, significantly lower than $84.3 million in 2023[11] - Selling, General and Administrative (SG&A) expenses for Q4 2024 were $4.1 million, down from $9.6 million in Q4 2023; for the full year 2024, SG&A expenses were $34.5 million, compared to $83.4 million in 2023[12][13] - Total operating expenses for the year ended December 31, 2024, were $69,511,000, down from $173,162,000 for the year ended December 31, 2023, indicating a 60.1% reduction[31] - Research and development expenses for the year ended December 31, 2024, were $30,435,000, down from $84,326,000 for the year ended December 31, 2023, a reduction of 64.1%[31] - Selling, general and administrative expenses decreased to $34,492,000 for the year ended December 31, 2024, from $83,413,000 for the year ended December 31, 2023, a decline of 58.6%[31] Net Loss and Financial Position - BioXcel Therapeutics reported a net loss of $10.9 million for Q4 2024, an improvement from a net loss of $22.3 million in Q4 2023; for the full year 2024, the net loss was $59.6 million, down from $179.1 million in 2023[14] - The net loss for the year ended December 31, 2024, was $59,599,000, compared to a net loss of $179,053,000 for the year ended December 31, 2023, reflecting a 66.7% improvement[31] - The net loss per share for the year ended December 31, 2024, was $23.51, compared to $98.33 for the year ended December 31, 2023, a 76.1% improvement[31] - The company reported a loss from operations of $67,245,000 for the year ended December 31, 2024, compared to a loss of $171,782,000 for the year ended December 31, 2023, a 60.8% decrease[31] Cash Position - Cash and cash equivalents totaled $29.9 million as of December 31, 2024, a decrease from $65.2 million on December 31, 2023[15] - Cash and cash equivalents decreased to $29,854,000 as of December 31, 2024, from $65,221,000 as of December 31, 2023, a decline of 54.2%[31] - The company closed a $14 million equity financing, strengthening its cash position to approximately $35 million as of March 4, 2025[7] Liabilities and Going Concern - Total liabilities increased slightly to $131,439,000 as of December 31, 2024, from $130,210,000 as of December 31, 2023[31] - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern[31]