Amylyx(AMLX) - 2024 Q4 - Annual Report

Financial Performance - Product revenue, net for the year ended December 31, 2024, was $87.4 million, a decrease of 77$380.8 million in 2023[506]. - Net loss for the year ended December 31, 2024, was $301.7 million, compared to a net income of$49.3 million in 2023, representing a 712% decline[505]. - Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $176.5 million, supplemented by net proceeds of$65.5 million from a January 2025 offering[490]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $176.5 million, with an accumulated deficit of$606.7 million[517]. - Net cash used in operating activities was $167.6 million in 2024, compared to a cash provided of$11.9 million in 2023, reflecting a change of $179.6 million[524][525]. - Net cash provided by investing activities decreased to$75.7 million in 2024 from $92.1 million in 2023, a decline of$16.4 million or 18%[529][530]. Operating Expenses - Total operating expenses increased by 18% to $402.1 million in 2024, compared to$342.0 million in 2023[505]. - Research and development expenses decreased by 19% to $104.1 million in 2024, down from$128.2 million in 2023[505]. - Selling, general and administrative expenses decreased by 39% to $114.3 million in 2024, compared to$188.4 million in 2023, following a restructuring plan that reduced the workforce by approximately 70%[502]. - Direct research and development expenses for AMX0035 - ALS dropped by $24.1 million (40$36.7 million, while expenses for AMX0035 - PSP increased by $10.5 million (164$16.9 million[510][511]. - Restructuring expenses amounted to approximately $22.9 million in 2024, including$21.9 million for employee severance and termination benefits[513]. Product Discontinuation - The RELYVRIO/ALBRIOZA product was discontinued in April 2024 following the failure of the Phase 3 PHOENIX trial to meet its primary and secondary endpoints[492]. - The company recorded approximately $118.7 million in charges related to inventory write-downs and losses on firm purchase commitments due to the discontinuation of RELYVRIO/ALBRIOZA[507]. Future Outlook - The company anticipates that existing cash and proceeds will be sufficient to meet operating and capital expenditure requirements through 2026[490]. - The company expects to finance near-term operations through existing cash and potential equity or debt financing, with no assurances of additional funding availability[519][523]. - The January 2025 Offering is expected to generate approximately$65.5 million in proceeds, which will support ongoing operations[516]. Accounting and Reporting - The company prepares its consolidated financial statements in accordance with U.S. GAAP, requiring estimates and judgments that affect reported amounts of assets and liabilities[534]. - Revenue recognition prior to the discontinuation of RELYVRIO®/ALBRIOZA™ involved significant estimates related to gross-to-net adjustments, which have not materially differed from actual activity to date[536]. - The company estimates accrued research and development expenses based on open contracts and service provider communications, with adjustments made as necessary[539]. - The estimate of accrued research and development expenses relies on timely reporting from third-party service providers, with no material adjustments to prior estimates reported[540]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[543].