Amylyx(AMLX) - 2024 Q2 - Quarterly Results

Financial Performance - Net product revenue for Q2 2024 was $(1.0) million, a significant decrease from $98.2 million in Q2 2023 due to the discontinuation of RELYVRIO and ALBRIOZA[5] - The company reported a net loss of $72.7 million, or $1.07 per share, for Q2 2024, compared to a net income of $22.1 million, or $0.31 per diluted share, in Q2 2023[5] - Product revenue for the three months ended June 30, 2024, was $1,023,000, a significant decrease from $98,216,000 in the same period of 2023, representing a decline of approximately 98.96%[27] - Net loss for the three months ended June 30, 2024, was $72,700,000, compared to a net income of $22,074,000 for the same period in 2023[27] - Total operating expenses for the six months ended June 30, 2024, were $286,036,000, compared to $151,496,000 for the same period in 2023, an increase of approximately 88.8%[27] Research and Development - Research and development expenses decreased to $23.3 million in Q2 2024 from $29.0 million in Q2 2023, primarily due to reduced payroll and clinical expenses[5] - Research and development expenses for the three months ended June 30, 2024, were $23,347,000, down from $29,044,000 in the same period of 2023, a decrease of approximately 19.5%[27] - The company is conducting the Phase 2b/3 ORION trial to assess the efficacy and safety of AMX0035 in patients with progressive supranuclear palsy (PSP)[17] - The company plans to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia (PBH) in Q1 2025, with topline data anticipated in 2026[1] - Updated data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome will be presented at ISPAD 2024, including data from all 12 participants at Week 24[1] - A multiple ascending dose clinical trial of AMX0114 in ALS is expected to begin in the second half of 2024[4] - The company plans to initiate discussions with regulatory authorities regarding the potential Phase 3 trial for AMX0035 for Wolfram syndrome[22] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $309.8 million as of June 30, 2024, down from $373.3 million at March 31, 2024, with a cash runway expected into 2026[5] - Cash, cash equivalents, and short-term investments decreased to $309,812,000 from $371,362,000, a decline of approximately 16.6%[26] Company Overview - Amylyx Pharmaceuticals is focused on developing treatments for neurodegenerative diseases, including ongoing clinical programs for ALS and Wolfram syndrome[21] - The company received Orphan Drug Designation from the European Commission for AMX0035 for the treatment of Wolfram syndrome[3] - Approximately 160,000 individuals in the U.S. are estimated to be affected by symptomatic PBH, highlighting a significant unmet medical need[1] Administrative Expenses - Selling, general and administrative expenses were $21.6 million in Q2 2024, down from $43.4 million in Q2 2023, reflecting a decrease in personnel costs and consulting services[6] - The company reported a total liabilities of $70,853,000 as of June 30, 2024, down from $84,022,000 at the end of 2023, a decrease of approximately 15.5%[26] - The weighted-average shares used in computing net loss per share for the three months ended June 30, 2024, were 68,024,929[27]