Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.

“Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson’s disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development,” said Steve Davis, Chief Executive Officer. “In 2021, we are focused on delivering continued growth of NUPLAZID, the upcoming potential approval and launch of pimavanserin for dementia-related psychosis and advancing our business development strategy.”

Company Highlights

• Upcoming PDUFA (Prescription Drug User Fee Act) date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.

• Top-line results from Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome expected in the fourth quarter of 2021.

• Two Phase 2 clinical studies evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic, in acute and chronic pain to commence in first half of 2021. A bunionectomy study is expected to initiate in the first quarter of 2021 and an osteoarthritis study is expected to initiate in the second quarter of 2021.

• In November 2020, the FDA approved a label update to allow the NUPLAZID capsule to be sprinkled on certain foods. This is an important feature for patients who take oral medications and may have difficulty swallowing; a potential issue for Parkinson’s disease patients and in the elderly in general.

• Kathie Bishop, Ph.D., joined Acadia as Senior Vice President, Head of Rare Disease and Diann Potestio joined Acadia as Senior Vice President, Market Access, Reimbursement and Channel Strategy.

Financial Results

Revenue
Net sales of NUPLAZID^® (pimavanserin) were $121.0 million for the fourth quarter of 2020, an increase of 23% as compared to $98.3 million reported for the fourth quarter of 2019. For the years ended December 31, 2020 and 2019, Acadia reported net product sales of $441.8 million and $339.1 million, respectively, an increase of 30% year-over-year.

Research and Development
Research and development expenses for the fourth quarter of 2020 were $62.1 million, compared to $57.5 million for the same period of 2019. For the years ended December 31, 2020 and 2019, research and development expenses were $319.1 million and $240.4 million, respectively. The increase in full year 2020 was primarily due to the upfront expenses of $52.8 million related to the acquisition of CerSci Therapeutics and a $10.0 million upfront payment to Vanderbilt University related to the license agreement and collaboration for novel therapeutic programs targeting muscarinic M1 receptors.

Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2020 were $120.8 million, compared to $91.9 million for the same period of 2019. For the years ended December 31, 2020 and 2019, selling, general and administrative expenses were $388.7 million and $325.6 million, respectively. This increase during the 2020 period as compared to 2019 was primarily due to increased advertising and promotional costs, dementia-related psychosis launch preparation expenses, as well as an increase in personnel and related costs.

Net Loss
For the fourth quarter of 2020, Acadia reported a net loss of $66.8 million, or $0.42 per common share, compared to a net loss of $53.0 million, or $0.34 per common share, for the same period in 2019. The net losses for the fourth quarters of 2020 and 2019 included $21.2 million and $19.8 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2020, Acadia reported a net loss of $281.6 million, or $1.79 per common share, compared to a net loss of $235.3 million, or $1.60 per common share, for the same period in 2019. The net losses for the years ended December 31, 2020 and 2019 included $84.4 million and $82.3 million, respectively, of non-cash stock-based compensation expense.

Cash and Investments
At December 31, 2020, Acadia’s cash, cash equivalents, and investment securities totaled $632.0 million, compared to $697.4 million at December 31, 2019.

2021 Financial Guidance

• Net sales guidance for NUPLAZID in Parkinson’s disease psychosis (PDP) of $510 to $550 million. As this is the potential launch year for dementia-related psychosis (DRP), the Company is not including revenue projections for DRP in 2021 net sales guidance.

• GAAP R&D guidance of $300 to $320 million reflects the