ACADIA Pharmaceuticals (ACAD) Q4 2016 earnings summary

Executive summary

• NUPLAZID (pimavanserin) received FDA approval on April 29, 2016, as the first and only approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis; U.S. launch began in May.

• Positive Phase II Alzheimer’s disease psychosis results and four clinical-trial starts broadened development across Alzheimer’s disease, schizophrenia and major depressive disorder.

• 2016 ended with $529.0 million in cash, cash equivalents and investments, supporting commercialization and pipeline investment.

Financial highlights

• FY2016 revenue was $17.331 million, including $17.327 million in NUPLAZID product sales; FY2015 revenue was $61,000.

• FY2016 operating loss was $272.815 million and net loss was $271.393 million, versus $164.612 million and $164.443 million, respectively, in FY2015.

• FY2016 basic and diluted loss per share was $2.34, compared with $1.63 in FY2015.

• R&D expense rose to $99.3 million from $73.9 million; SG&A rose to $186.5 million from $88.3 million, driven largely by clinical development and the product launch.

• FY2016 cost of product sales was $3.1 million, or 18% of net product sales; previously expensed zero-cost raw material did not materially affect product gross margins.

Outlook and guidance

• Cash and investments were expected to fund planned operations for at least the next 12 months; operating losses were expected to continue for at least the next few years.

• R&D and SG&A expenses were expected to increase as post-marketing studies, additional-indication trials and NUPLAZID commercial activities progressed.

• Phase III development for Alzheimer’s disease psychosis was planned for the second half of 2017.

• 2017 priorities included continued NUPLAZID commercialization and advancement of ongoing clinical studies.