Amylyx(AMLX) - 2025 Q4 - Annual Results

Financial Performance - Net loss for Q4 2025 was $33.0 million, or $0.30 per share, compared to a net loss of $37.5 million, or $0.55 per share in Q4 2024; total net loss for 2025 was $144.7 million, or $1.53 per share, compared to $301.7 million, or $4.43 per share in 2024[10] - Product revenue for the year ended December 31, 2025, was $0, compared to a loss of $665 million in 2024[25] - Total operating expenses for the year ended December 31, 2025, were $153.3 million, a decrease from $402.1 million in 2024[25] - Net loss for the year ended December 31, 2025, was $144.7 million, compared to a net loss of $301.7 million in 2024[25] - Net loss per share for the year ended December 31, 2025, was $1.53, an improvement from $4.43 in 2024[25] - Loss from operations for the year ended December 31, 2025, was $153.3 million, compared to a loss of $314.7 million in 2024[25] - Other income for the year ended December 31, 2025, was $8.6 million, compared to $12.6 million in 2024[25] - Weighted-average shares used in computing net loss per share for 2025 were 94,565,567, compared to 68,142,158 in 2024[25] Expenses - Research and development expenses for Q4 2025 were $21.2 million, a decrease from $22.9 million in Q4 2024, and total R&D expenses for the year were $90.4 million, down from $104.1 million in 2024[8] - Selling, general, and administrative expenses for Q4 2025 were $15.4 million, compared to $17.1 million in Q4 2024, with total SG&A expenses for the year at $62.9 million, down from $114.3 million in 2024[9] - Total operating expenses for the year ended December 31, 2025, were $153.3 million, a decrease from $402.1 million in 2024[25] - Selling, general and administrative expenses for the year ended December 31, 2025, were $62.9 million, down from $114.3 million in 2024[25] - Cost of sales for the year ended December 31, 2025, was $5.9 million, compared to $118.7 million in 2024[25] Cash Position - Cash, cash equivalents, and short-term investments were $317.0 million as of December 31, 2025, down from $344.0 million at September 30, 2025; the company expects its cash runway to extend into 2028[11] Clinical Trials and Development - The Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH) has completed recruitment, with topline data expected in Q3 2026 and a potential commercial launch in 2027[4] - AMX0318 has been selected as a development candidate for PBH and other rare diseases, demonstrating favorable pharmacokinetic properties and high solubility[6] - The LUCIDITY trial will evaluate the efficacy and safety of avexitide in approximately 75 participants, with a primary outcome focused on reducing Level 2 and Level 3 hypoglycemic events[4] - The company presented early safety and tolerability data for AMX0114, an investigational treatment for ALS, showing it was generally well-tolerated in the first cohort of the Phase 1 LUMINA trial[6] - The company is preparing for a regulatory submission and building commercial infrastructure to support potential commercialization of avexitide in 2027[2] - Investigational New Drug (IND)-enabling studies for AMX0318 are underway, with an IND filing targeted for 2027[14]