earnings
confidence high
sentiment positive
materiality 0.75
Amylyx reports Q2 net loss $54.1M; ALBRIOZA launched in Canada; FDA PDUFA Sept 29
Amylyx Pharmaceuticals, Inc.
2022-Q2 EPS reported
-$1.85
- Net loss of $54.1M ($0.93/sh) vs $21.9M ($3.41/sh) in Q2 2021; cash $206.7M at quarter end.
- ALBRIOZA (AMX0035) commercially launched in Canada on July 29, 2022 – first product launch.
- FDA Advisory Committee meeting for ALS NDA scheduled Sept 7, 2022; PDUFA action date Sept 29, 2022.
- EU MAA under review; EMA decision expected first half 2023, with launch prep underway.
- R&D expense $24.3M (up from $10.9M); G&A expense $30.0M (up from $7.7M) driven by commercial readiness.