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Acadia Pharmaceuticals Inc. (ACAD - Free Report) reported a second-quarter 2022 loss of 21 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. In the year-ago quarter, the company had incurred a loss of 27 cents per share.
Total revenues, comprising net sales of Acadia's only marketed drug, Nuplazid (pimavanserin), increased 17% year over year to $134.6 million in the second quarter, driven by Nuplazid demand growth. The top line surpassed the Zacks Consensus Estimate of $131 million. Nuplazid sales increased 16.5% sequentially 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 have plunged 28.8% in the year so far compared with the industry’s 18% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses were $75.6 million for the quarter, up 32.8% year over year, owing to increased costs related to pipeline development activities, especially ACP-044, ACP-319 and other early-stage pipeline candidates.
Selling, general and administrative (SG&A) expenses were $89.9 million, down 7.1% year over year, owing to reduced advertising and promotional costs as well as lower personnel expenses.
As of Jun 30, 2022, Acadia had cash, cash equivalents and investments worth $436.4 million compared with $446 million as of Mar 31, 2022.
2022 Guidance
Acadia updated the financial guidance for 2022.
The company now expects Nuplazid net sales in the range of $510-$540 million compared with the earlier projection of $510-$560 million for 2022. The Zacks Consensus Estimate for the metric is pegged at $530.98 million.
The company expects R&D expenses in the range of $340-$360 million compared with the $355-$375 million expected previously. SG&A expenses are expected to be $360-$380 million, unchanged from the previous guidance.
Pipeline Updates
Last week, Acadia received a complete response letter (“CRL”) from the FDA for its resubmitted supplemental new drug application (“sNDA”) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The latest CRL was expected, as in June 2022, the FDA’s Psychopharmacologic Drugs Advisory Committee (“PDAC”) voted (nine-three) against the sNDA for pimavanserin for treating hallucinations and delusions associated with ADP.
Earlier, the FDA had asked the committee for advice and recommendations regarding the evidence that pimavanserin is effective for the given indication.
We remind investors that the FDA issued a CRL to the Nuplazid sNDA in April 2021.
Acadia submitted a new drug application or NDA to the FDA seeking approval of its pipeline candidate, trofinetide, for the treatment of Rett syndrome in adults and pediatric patients aged two years and above in July 2022.
Along with the earnings release, Acadia announced that it has decided to discontinue the development of ACP-044, a novel orally-administered non-opioid analgesic, which was evaluated for treating acute and chronic pain. The company also decided to discontinue the development of another candidate ACP-319.
Acadia Pharmaceuticals Inc. Price, Consensus and EPS Surprise
Bio-Techne’s earnings estimates have been revised 0.2% upward for 2022 and 0.8% upward for 2023 in the past 60 days.
Earnings of Bio-Techne have surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. TECH delivered an earnings surprise of 3.30%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 0.6% for 2022 and 13.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics have surpassed estimates in two of the trailing four quarters and missed on the other two occasions. ATRA delivered an earnings surprise of -12.51%, on average.
Precision BioSciences’ loss per share estimates narrowed 5.7% for 2022 and 16.2% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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Acadia's (ACAD) Q2 Earnings & Revenues Surpass Estimates
Acadia Pharmaceuticals Inc. (ACAD - Free Report) reported a second-quarter 2022 loss of 21 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. In the year-ago quarter, the company had incurred a loss of 27 cents per share.
Total revenues, comprising net sales of Acadia's only marketed drug, Nuplazid (pimavanserin), increased 17% year over year to $134.6 million in the second quarter, driven by Nuplazid demand growth. The top line surpassed the Zacks Consensus Estimate of $131 million. Nuplazid sales increased 16.5% sequentially 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 have plunged 28.8% in the year so far compared with the industry’s 18% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses were $75.6 million for the quarter, up 32.8% year over year, owing to increased costs related to pipeline development activities, especially ACP-044, ACP-319 and other early-stage pipeline candidates.
Selling, general and administrative (SG&A) expenses were $89.9 million, down 7.1% year over year, owing to reduced advertising and promotional costs as well as lower personnel expenses.
As of Jun 30, 2022, Acadia had cash, cash equivalents and investments worth $436.4 million compared with $446 million as of Mar 31, 2022.
2022 Guidance
Acadia updated the financial guidance for 2022.
The company now expects Nuplazid net sales in the range of $510-$540 million compared with the earlier projection of $510-$560 million for 2022. The Zacks Consensus Estimate for the metric is pegged at $530.98 million.
The company expects R&D expenses in the range of $340-$360 million compared with the $355-$375 million expected previously. SG&A expenses are expected to be $360-$380 million, unchanged from the previous guidance.
Pipeline Updates
Last week, Acadia received a complete response letter (“CRL”) from the FDA for its resubmitted supplemental new drug application (“sNDA”) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The latest CRL was expected, as in June 2022, the FDA’s Psychopharmacologic Drugs Advisory Committee (“PDAC”) voted (nine-three) against the sNDA for pimavanserin for treating hallucinations and delusions associated with ADP.
Earlier, the FDA had asked the committee for advice and recommendations regarding the evidence that pimavanserin is effective for the given indication.
We remind investors that the FDA issued a CRL to the Nuplazid sNDA in April 2021.
Acadia submitted a new drug application or NDA to the FDA seeking approval of its pipeline candidate, trofinetide, for the treatment of Rett syndrome in adults and pediatric patients aged two years and above in July 2022.
Along with the earnings release, Acadia announced that it has decided to discontinue the development of ACP-044, a novel orally-administered non-opioid analgesic, which was evaluated for treating acute and chronic pain. The company also decided to discontinue the development of another candidate ACP-319.
Acadia Pharmaceuticals Inc. Price, Consensus and EPS Surprise
Acadia Pharmaceuticals Inc. price-consensus-eps-surprise-chart | Acadia Pharmaceuticals Inc. Quote
Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Bio-Techne Corporation (TECH - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and Precision BioSciences, Inc. (DTIL - 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.
Bio-Techne’s earnings estimates have been revised 0.2% upward for 2022 and 0.8% upward for 2023 in the past 60 days.
Earnings of Bio-Techne have surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. TECH delivered an earnings surprise of 3.30%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 0.6% for 2022 and 13.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics have surpassed estimates in two of the trailing four quarters and missed on the other two occasions. ATRA delivered an earnings surprise of -12.51%, on average.
Precision BioSciences’ loss per share estimates narrowed 5.7% for 2022 and 16.2% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.