Amylyx Pharmaceuticals (AMLX) Q2 2024 earnings summary

Executive summary

• Expanded late-stage pipeline with the acquisition of avexitide, a Phase 3-ready GLP-1 receptor antagonist for PBH and congenital hyperinsulinism, both with FDA Breakthrough Therapy and Orphan Drug Designations; now holding three assets targeting orphan indications.

• Discontinued marketing of RELYVRIO/ALBRIOZA for ALS in the U.S. and Canada after Phase 3 PHOENIX trial failed endpoints; no significant product revenue expected going forward.

• Completed major restructuring, reducing workforce by ~70% and focusing resources on key clinical and preclinical programs, with cash runway into 2026.

• Pipeline includes avexitide (PBH, congenital HI), AMX0035 (Wolfram syndrome, PSP), and AMX0114 (ALS); multiple clinical milestones expected in 2024–2026.

• Announced interim Phase 2 HELIOS data for AMX0035 in Wolfram syndrome, showing improvements in glycemic control, beta cell function, and vision; updated data to be presented at ISPAD 2024.

Financial highlights

• Net product revenue was $(1.0) million for Q2 2024, down from $98.2 million in Q2 2023, due to adjustments for returns and discontinuation of RELYVRIO/ALBRIOZA.

• Cost of sales was $7.4 million in Q2 2024, mainly from estimated losses on firm commitments for discontinued products.

• R&D expenses were $23.3 million in Q2 2024, down from $29 million year-over-year, reflecting restructuring and lower clinical costs.

• SG&A expenses were $21.6 million in Q2 2024, down from $43.4 million year-over-year, due to lower payroll and consulting costs.

• Net loss for Q2 2024 was $72.7 million ($1.07 per share), including $22.9 million in restructuring charges.

Outlook and guidance

• Cash, cash equivalents, and short-term investments totaled $309.8 million at June 30, 2024; cash runway expected into 2026.

• Phase 3 avexitide program in PBH to initiate in Q1 2025, with topline data expected in 2026.

• HELIOS (Wolfram syndrome) topline data for all 12 participants at week 24 to be presented in fall 2024.

• ORION (PSP) interim analysis and data expected mid-2025.

• AMX0114 (ALS) multiple ascending dose clinical trial to begin before year-end 2024.