ACADIA Pharmaceuticals (ACAD) Q4 2019 earnings summary

Executive summary

• FY2019 delivered strong NUPLAZID growth, positive late-stage results in dementia-related psychosis and negative symptoms of schizophrenia, and progress across MDD and Rett syndrome programs.

• NUPLAZID remained the only marketed product, approved in the U.S. for hallucinations and delusions associated with Parkinson's disease psychosis.

Financial highlights

• 2019 net product sales were $339.1 million, up 52% YoY; higher unit sales, a higher average gross selling price and a $3.3 million Medicare accrual estimate benefit contributed to growth.

• Total operating expenses were $585.6 million; operating loss was $246.5 million and net loss was $235.3 million, or $1.60 per diluted share.

• R&D expense rose to $240.4 million from $187.2 million; SG&A increased to $325.6 million from $265.8 million, reflecting expanded development and commercial spending.

• Cost of product sales was $11.3 million, or 3% of net product sales, versus $12.4 million, or 6%, in 2018.

Outlook and guidance

• Planned DRP sNDA submission was summer 2020, with potential U.S. approval targeted around year-end 2020; a launch would require significant commercial and medical affairs expansion.

• CLARITY-2 results were expected in Q4 2020 and CLARITY-3 in Q1 2021; ADVANCE-2 was planned for summer 2020, and LAVENDER results were expected in 2021.

• Operating losses were expected to continue for the next few years as development and commercialization spending increases; cash resources were expected to fund planned operations through at least the next 12 months.