ACADIA Pharmaceuticals (ACAD) Q4 2015 earnings summary

Executive summary

• 2015 centered on the U.S. regulatory review of NUPLAZID for Parkinson’s disease psychosis (PDP); the NDA received priority review, with a May 1, 2016 PDUFA goal date and an advisory committee meeting scheduled for March 29, 2016.

• Phase III Study -020 showed significant psychosis reduction without worsening motor function; the program remained pre-commercial, with launch preparations underway.

• Development broadened to pimavanserin in Alzheimer’s disease psychosis (Phase II), planned Alzheimer’s agitation studies, and evaluation of further schizophrenia opportunities.

Financial highlights

• 2015 collaborative revenue was $61K; no product sales had been generated. Revenue was primarily from collaboration payments and patent-cost reimbursements.

• Operating expenses were $164.7M, including $73.9M R&D, $88.3M G&A and a $2.5M Ipsen license fee; operating loss was $164.6M.

• Net loss was $164.4M, or $1.63 per basic and diluted share, versus $92.5M and $0.95 in 2014.

• Cash, cash equivalents and investment securities totaled $215.1M at Dec. 31, 2015, down from $322.5M; operating cash use was $121.8M.

Outlook and guidance

• R&D and G&A expenses were expected to rise as development continued and the commercial organization expanded; operating losses were expected for at least the next few years.

• Management expected existing cash resources to fund planned operations through at least the next 12 months; January 2016 offering proceeds added $281.6M net.

• Phase II Alzheimer’s psychosis enrollment was expected to complete around mid-2016, with top-line results in Q4 2016; an Alzheimer’s agitation Phase II study was planned for H1 2016.

• If approved, U.S. commercialization was planned through a specialty sales force of approximately 135 professionals, focused on physicians treating PDP.