earnings
confidence high
sentiment negative
materiality 0.70
Acadia cuts FY2021 NUPLAZID revenue guidance to $480-515M; FDA reiterates need for additional DRP studies
ACADIA PHARMACEUTICALS INC
2022-Q2 EPS reported
-$0.69
revenue$115,221,000
- 2Q21 net sales $115.2M (+5% YoY); net loss $43.9M ($0.27/share) vs $42.1M loss in 2Q20.
- FY2021 revenue guidance reduced to $480-515M from $510-550M due to pandemic and higher gross-to-net (~20%).
- FDA Type A meeting on pimavanserin for DRP: FDA insists on additional studies per subgroup but open to further discussion.
- GAAP R&D guidance lowered to $250-270M (prior $280-300M); SG&A guidance unchanged at $385-415M.
- Phase 3 LAVENDER (trofinetide for Rett syndrome) top-line expected Q4 2021; Phase 2 ACP-044 pain results also Q4 2021.