Amylyx(AMLX) - 2024 Q4 - Annual Results

Financial Performance - Net loss for Q4 2024 was $37.5 million, or$ 0.55 per share, compared to a net income of $4.7 million, or$ 0.07 per share in Q4 2023; for the full year, net loss was $301.7 million, or$ 4.43 per share, compared to a net income of $49.3 million, or$ 0.70 per share in 2023[11] - Product revenue for the three months ended December 31, 2024, was $(665,000), compared to$ 108,449,000 in the same period of 2023, indicating a significant decrease[24] - The net loss for the year ended December 31, 2024, was $(301,743,000), compared to a net income of$ 49,271,000 in 2023, marking a substantial decline[24] - The company reported a basic net loss per share of $(0.55) for the three months ended December 31, 2024, compared to a profit of$ 0.07 in the same period of 2023[24] Expenses - Research and development expenses for Q4 2024 were $22.9 million, down from$ 44.9 million in Q4 2023, and total R&D expenses for the year were $104.1 million compared to$ 128.2 million in 2023[9] - Selling, general, and administrative expenses for Q4 2024 were $17.1 million, a decrease from$ 52.2 million in Q4 2023, with total SG&A expenses for the year at $114.3 million compared to$ 188.4 million in 2023[10] - Total operating expenses for the year ended December 31, 2024, were $402,102,000, up from$ 341,984,000 in 2023, reflecting an increase of approximately 17.5%[24] - Research and development expenses for the three months ended December 31, 2024, were $22,892,000, compared to$ 44,914,000 in the same period of 2023, showing a decrease of approximately 48.9%[24] Cash Position - Cash position at December 31, 2024, was $176.5 million, down from$ 234.4 million at September 30, 2024; the company raised $65.5 million in January 2025, extending the cash runway through the end of 2026[12] - Cash, cash equivalents, and marketable securities decreased to$ 176,501,000 as of December 31, 2024, down from $371,362,000 in 2023, a decline of approximately 52.5%[22] Clinical Trials and Development - The pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia is underway, with completion of recruitment expected in 2025 and topline data anticipated in the first half of 2026[5] - The LUCIDITY trial will evaluate the FDA-agreed-upon primary outcome of reducing hypoglycemic events through Week 16, with a total of approximately 75 participants[18] - Amylyx appointed Dan Monahan as Chief Commercial Officer to lead the commercialization strategy for avexitide, which is expected to launch in 2027 if approved[6] - The company began the Phase 1 LUMINA clinical trial of AMX0114 for ALS, with dosing expected to begin in March or April 2025[6] - Amylyx plans to share Week 48 data from the ongoing Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in the coming months[12] - The company anticipates the announcement of Week 48 data from the Phase 2 HELIOS trial of AMX0035 for the treatment of Wolfram syndrome in the near future[20] - Amylyx is currently conducting a Phase 3 trial of avexitide for PBH, with expectations regarding recruitment completion and topline data readout[20] - The company is exploring the potential of AMX0114 as a treatment for ALS, with an expected timeline for data readout forthcoming[20] Asset Position - As of December 31, 2024, total assets decreased to$ 193,634,000 from $517,454,000 in 2023, representing a decline of approximately 62.6%[22] - The company entered into a collaboration with Gubra A/S to develop a novel long-acting GLP-1 receptor antagonist, aiming to identify a lead development candidate for IND-enabling studies[6]