ACADIA Pharmaceuticals (ACAD) Q4 2022 earnings summary

Executive summary

• 2022 net product sales rose to $517.2M from $484.1M, while net loss widened to $216.0M from $167.9M, primarily amid higher R&D spending.

• NUPLAZID remained the sole commercial product in 2022; DAYBUE received FDA approval for Rett syndrome in March 2023, expanding the commercial portfolio to two first-and-only FDA-approved CNS therapies.

• Cash, cash equivalents and investments totaled $416.8M at year-end; management expected resources to fund planned operations for at least 12 months.

Financial highlights

• 2022 net product sales were $517.2M, up from $484.1M in 2021, primarily due to higher average gross selling price; 2021 sales were $441.8M.

• Net loss was $216.0M, or $1.34/share, versus $167.9M, or $1.05/share, in 2021; operating loss was $223.6M versus $170.4M.

• R&D expense rose to $361.6M from $239.4M; SG&A declined to $369.1M from $396.0M, including reduced NUPLAZID promotion spend and trofinetide launch preparation.

• Operating cash use was $114.0M, down from $125.7M; cash, cash equivalents and investments declined $103.9M to $416.8M.

Outlook and guidance

• Management expected cash, cash equivalents and investments to fund planned operations through at least the next 12 months; additional financing may be needed in the future.

• ADVANCE-2 enrollment was projected to finish in 2023, with top-line results expected in early 2024; a positive outcome could support an sNDA for pimavanserin in schizophrenia’s negative symptoms.

• ACP-204 Phase 1 completion was planned for H1 2023, with Phase 2 studies in Alzheimer’s disease psychosis expected later in 2023.

• DAYBUE was FDA-approved for Rett syndrome in March 2023; launch investment included field representatives, medical science liaisons and expanded patient-support services.