Acadia Pharmaceuticals Inc. ACAD reported a fourth-quarter 2021 loss of 27 cents per share, wider than the Zacks Consensus Estimate of a loss of 24 cents. In the year-ago quarter, the company incurred a loss of 42 cents per share.

Total revenues, comprising net sales of Acadia's only marketed drug Nuplazid (pimavanserin), increased 8% year over year to $130.8 million for the fourth quarter, driven by Nuplazid volume growth. The top line, however, missed the Zacks Consensus Estimate of $135 million. Nuplazid sales fell below market expectation in the reported quarter.

Nuplazid is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis.

Shares of Acadia were down 7.7% in after-market trading on Monday, following the weaker-than-expected earnings announcement. The stock has plunged 46.1% in the past year compared with the industry’s 36.6% decline.

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Full-Year Results

For 2021, Acadia generated total revenues of $484.1 million compared with $441.8 million recorded in 2020.

For the year, the company reported a loss of $1.05 per share compared with a net loss of $1.79 per share in 2020.

Quarter in Detail

Research and development (R&D) expenses were $67.1 million for the quarter, up 8.1% from the year-ago quarter.

Selling, general and administrative (SG&A) expenses were $105.8 million, down 12.4% year over year.

As of Dec 31, 2021, Acadia had cash, cash equivalents and investments worth $520.7 million compared with $540.3 million as of Sep 30, 2021.

2022 Guidance

Acadia expects Nuplazid net sales of $510-$560 million for 2022. The Zacks Consensus Estimate for the metric is pegged at $557.9 million.

The company expects R&D expenses of $355-$375 million, while SG&A expenses are expected to be $360-$380 million in 2022.

Pipeline Updates

In February 2022, Acadia resubmitted the supplemental new drug application (“sNDA”) to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.

The FDA had issued a complete response letter (“CRL”) to the sNDA for Nuplazid in April 2021.

Acadia has other promising pipeline candidates that are progressing well.

In December 2021, the company announced positive top-line data from the phase III Lavender study, which evaluated the safety and efficacy of its pipeline candidate, trofinetide, for the treatment of Rett syndrome. The study met its co-primary endpoints.

Acadia expects to file a new drug application (“NDA”) for trofinetide to treat Rett syndrome around mid-2022.