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Jun 30, 2024
Amylyx Q2 2024 Earnings Report
Amylyx's financial performance declined due to adjustments to gross-to-net revenue reserve estimates and the voluntary discontinuation of RELYVRIO® and ALBRIOZA™.
Key Takeaways
Amylyx Pharmaceuticals reported a net product revenue of $(1.0) million for Q2 2024, a significant decrease compared to $98.2 million in the same period of 2023. The company experienced a net loss of $72.7 million, or $1.07 per share, compared to a net income of $22.1 million, or $0.31 per diluted share, for the same period in 2023. However, the company acquired avexitide, a Phase 3-ready GLP-1 receptor antagonist, and is advancing its pipeline with multiple clinical trials planned.
Net product revenue was $(1.0) million due to adjustments to gross-to-net revenue reserve estimates, compared to $98.2 million for the same period in 2023.
Cost of sales were $7.4 million, primarily related to losses on firm purchase commitments for AMX0035.
Research and development expenses decreased to $23.3 million compared to $29.0 million in the same period of 2023.
Cash, cash equivalents, and short-term investments totaled $309.8 million at June 30, 2024, with a cash runway expected into 2026.
Amylyx
Amylyx
Forward Guidance
Amylyx is focused on advancing its pipeline, including avexitide and AMX0114, with key milestones expected in the coming quarters. The company anticipates initiating a Phase 3 program for avexitide in PBH in Q1 2025 and reporting interim data from the AMX0035 progressive supranuclear palsy program in mid-2025.
Positive Outlook
- Phase 3 program initiation in post-bariatric hypoglycemia (PBH) on track for Q1 2025.
- Company expects to present updated data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome at ISPAD 2024.
- Multiple ascending dose clinical trial of AMX0114 in people living with ALS planned to initiate in the second half of 2024.
- Topline data for avexitide in PBH is anticipated in 2026.
- Interim data from the ORION study of AMX0035 in progressive supranuclear palsy (PSP) continue to be expected in mid-2025.
Challenges Ahead
- Net product revenue was $(1.0) million for the three months ended June 30, 2024, as a result of adjustments to gross-to-net revenue reserve estimates.
- Company announced that it had started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO® and ALBRIOZA™ and remove the product from the market
- Net loss for the three months ended June 30, 2024 was $72.7 million, or $1.07 per share
- Cost of sales in the three months ended June 30, 2024 primarily relate to losses on firm purchase commitments under Amylyx’ commercial manufacturing supply agreements for AMX0035 that were established prior to the results from the Phase 3 PHOENIX trial.
- Restructuring expenses were $22.9 million for the three months ended June 30, 2024