Amylyx Pharmaceuticals Reports $301.7 Million Net Loss for 2024 Following Product Withdrawal

Amylyx Pharmaceuticals, Inc. reported a net loss of $301.7 million for the year ended December 31, 2024, a significant decrease from the $49.3 million net income reported in 2023. This substantial change is primarily attributed to the voluntary discontinuation of marketing authorizations and market withdrawal of RELYVRIO/ALBRIOZA for ALS in April 2024, resulting in a $293.4 million decrease in product revenue, net. The company's cost of sales increased to $124.6 million in 2024, compared to $25.4 million in 2023, largely due to a $118.7 million charge related to inventory write-downs and losses on purchase commitments following the product withdrawal.

Operating expenses also saw a notable shift. Research and development expenses decreased by $24.1 million to $104.1 million in 2024, primarily due to reduced spending on AMX0035 for ALS, offset by increased spending on AMX0035 for PSP and the addition of avexitide following its acquisition from Eiger Pharmaceuticals, Inc. in July 2024. Selling, general, and administrative expenses decreased by $74.0 million to $114.3 million, mainly due to workforce reductions under the company's April 2024 restructuring plan. The restructuring also resulted in $22.9 million in restructuring expenses. The company had 123 full-time employees as of December 31, 2024.

Strategic developments during the year included the acquisition of substantially all assets related to avexitide from Eiger Pharmaceuticals. Amylyx also initiated recruitment for a pivotal Phase 3 clinical trial (LUCIDITY) for avexitide in post-bariatric hypoglycemia, with topline data anticipated in the first half of 2026. Additionally, the company initiated a Phase 2b/3 clinical trial (ORION) for AMX0035 in progressive supranuclear palsy and a Phase 1 trial (LUMINA) for AMX0114 in amyotrophic lateral sclerosis. Positive topline data from a Phase 2 trial of AMX0035 in Wolfram syndrome was also announced. The company is actively pursuing collaborations, including one with Gubra A/S for the development of a long-acting GLP-1 receptor antagonist.

Amylyx's cash, cash equivalents, and marketable securities totaled $176.5 million as of December 31, 2024, and increased to approximately $242 million following a January 2025 equity offering. The company anticipates that these funds, along with the proceeds from the offering, will be sufficient to meet its operating and capital expenditure requirements through 2026. However, the company acknowledges that this projection is based on assumptions and could change. The company also notes ongoing securities litigation and the potential for future litigation. The company is no longer considered an emerging growth company, and therefore is subject to increased regulatory reporting requirements.