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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.
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
Historical Earnings Impact
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