Acadia Pharmaceuticals Inc. ( ACAD Quick Quote ACAD - Free Report) reported a first-quarter 2023 loss of 27 cents per share, wider than the Zacks Consensus Estimate of a loss of 21 cents and our estimate of a loss of 26 cents per share. In the year-ago quarter, the company incurred a loss of 70 cents per share.
Total revenues comprised net sales of Nuplazid (pimavanserin) in the first quarter as Acadia’s second-marketed drug, Daybue (trofinetide) was launched in April 2023 in the U.S. market. Revenues from Nuplazid sales increased 3% year over year to $118.5 million in the first quarter, missing the Zacks Consensus Estimate of $122 million. Nuplazid sales decreased 13.2% sequentially in the first quarter.
Nuplazid sales in the first quarter were driven by an increase in new patient starts across both specialty pharmacy and specialty distribution channels. Year-over-year demand was up approximately 2% in the reported quarter.
Total revenues were lower than our estimate of $121.7 million in the reported quarter.
Nuplazid is an FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis (PDP).
Shares of Acadia have shot up 28% in the past year compared with the
industry’s 0.2% rise. Image Source: Zacks Investment Research Quarter in Detail
Research and development (R&D) expenses in the quarter were $69.1 million, down 46.4% year over year, owing to a $60 million upfront payment made for collaboration with Stoke Therapeutics, which was recorded in the first quarter of 2022.
Selling, general and administrative (SG&A) expenses were $101.2 million, up 4.7% year over year. The expense remained relatively steady year over year due to a reduction in spending in the PDP commercial franchise, which was offset by investments in the Daybue launch.
Acadia had cash, cash equivalents and investments worth $402.9 million as of Mar 31, 2023 compared with $416.8 million as of Dec 31, 2022.
2023 Financial Guidance Reaffirmed
Acadia expects Nuplazid net sales in the range of $520-$550 million for 2023.
The company expects R&D expenses in the $235-$255 million range, while SG&A expenses are expected to be in the range of $360-$380 million in 2023.
Acadia’s second product, Daybue,
was approved by the FDA in March 2023 for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Acadia also received a Rare Pediatric Disease Priority Review Voucher from the FDA, along with the approval of Daybue, which can be used to obtain priority review for a subsequent application.
Daybue was made available in the U.S. market in April 2023.
Acadia is currently evaluating pimavanserin in the phase III ADVANCE-2 study for treating negative symptoms of schizophrenia. The company expects to complete enrollment in the study around mid-year, announcing top-line results from the same in early 2024.
Acadia is also developing ACP-204 as a potential treatment for Alzheimer’s disease psychosis. In the reported quarter, the company completed phase I development of ACP-204, witnessing a favorable safety and tolerability profile. Acadia was also able to identify the doses to be evaluated in the phase II study of ACP-204. The company is currently planning to meet with the FDA to discuss further clinical development plans for the candidate.
Zacks Rank and Stocks to Consider
Acadia currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are
Allogene Therapeutics ( ALLO Quick Quote ALLO - Free Report) , Anixa Biosciences ( ANIX Quick Quote ANIX - Free Report) and ADMA Biologics, Inc. ( ADMA Quick Quote ADMA - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 17.6%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Therapeutics’ 2023 loss per share has narrowed from 62 cents to 43 cents. In the past year, shares of Anixa Therapeutics have increased by 20.7%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 24.04%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 14 cents. In the past year, shares of ADMA Biologics have increased by 117.4%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.