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Acadia's (ACAD) Q3 Loss Narrower Than Expected, Revenues Miss
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Acadia Pharmaceuticals Inc. (ACAD - Free Report) reported a third-quarter 2022 loss of 17 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents. The loss was wider than our estimate of a loss of 16 cents per share. In the year-ago quarter, the company had incurred a loss of 9 cents per share.
Total revenues, comprising net sales of Acadia's only marketed drug, Nuplazid (pimavanserin), decreased 1% year over year to $130.7 million in the third quarter, missing the Zacks Consensus Estimate of $140 million. Nuplazid sales decreased 2.9% sequentially in the third quarter.
Nuplazid sales in the third quarter were driven by sequential demand growth of 2% and growth acceleration in the long-term care channel, which was offset by a reduction of in-channel inventory of approximately $7 million.
Total revenues were also lower than our estimate of $139 million 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 declined 31.8% in the year so far compared with the industry’s 21.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses in the quarter were $81.3 million, up 38.7% year over year, owing to increased costs related to pipeline development activities and a $10 million milestone payment accrued to Neuren Pharmaceuticals upon acceptance of the trofinetide new drug application (“NDA”) filing.
Selling, general and administrative (SG&A) expenses were $78.1 million, down 4.4% year over year, owing to reduced advertising and promotional costs.
As of Sep 30, 2022, Acadia had cash, cash equivalents and investments worth $436.6 million compared with $436.4 million as of Jun 30, 2022.
2022 Guidance
Acadia tightened its guidance for Nuplazid’s sales for 2022.
The company now expects Nuplazid’s net sales for 2022 in the $510-$520 million range compared with the earlier projection of $510-$540 million. The Zacks Consensus Estimate for the metric is pegged at $533.3 million while our estimate stands at $531.1 million.
The company now expects R&D expenses in the range of $345-$355 million compared with the $340-$360 million range expected previously. SG&A expenses are now expected to be $365-$375 million compared with $360-$380 million expected earlier.
Pipeline Updates
In September 2022, the FDA accepted for review Acadia's NDA seeking approval of its pipeline candidate, trofinetide, for the treatment of patients with Rett syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on Mar 12, 2023. ACAD submitted the NDA for trofinetide to treat Rett Syndrome in July 2022.
Upon potential approval, trofinetide can become the second approved drug in Acadia’s portfolio of marketed drugs and lend a significant boost to the company as well as lower its sole dependence on Nuplazid for revenues.
We remind investors that in August 2022, Acadia received a complete response letter from the FDA for its resubmitted supplemental new drug application (“sNDA”) for Nuplazid for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (“ADP”).
The FDA’s Psychopharmacologic Drugs Advisory Committee voted (9-3) against the sNDA for Nuplazid for treating hallucinations and delusions associated with ADP in June 2022.
Acadia is evaluating pimavanserin in the phase III ADVANCE-2 study for treating negative symptoms of schizophrenia. Enrollment in the study is expected to complete in mid-2023.
Acadia Pharmaceuticals Inc. Price, Consensus and EPS Surprise
Loss per share estimates for Akero Therapeutics narrowed 6.9% for 2022 and 4.8% for 2023 in the past 60 days.
Earnings of Akero Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. AKRO delivered an earnings surprise of 7.66% on average.
Loss per share estimates for Amarin narrowed 21% for 2022 and 50% for 2023 in the past 60 days.
Earnings of Amarin surpassed estimates in two of the trailing four quarters and missed on the other two occasions. AMRN delivered a negative earnings surprise of 14.29% on average.
Loss per share estimates for Atea Pharmaceuticals narrowed 10.9% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Atea Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. AVIR delivered a negative earnings surprise of 58.74% on average.
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Acadia's (ACAD) Q3 Loss Narrower Than Expected, Revenues Miss
Acadia Pharmaceuticals Inc. (ACAD - Free Report) reported a third-quarter 2022 loss of 17 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents. The loss was wider than our estimate of a loss of 16 cents per share. In the year-ago quarter, the company had incurred a loss of 9 cents per share.
Total revenues, comprising net sales of Acadia's only marketed drug, Nuplazid (pimavanserin), decreased 1% year over year to $130.7 million in the third quarter, missing the Zacks Consensus Estimate of $140 million. Nuplazid sales decreased 2.9% sequentially in the third quarter.
Nuplazid sales in the third quarter were driven by sequential demand growth of 2% and growth acceleration in the long-term care channel, which was offset by a reduction of in-channel inventory of approximately $7 million.
Total revenues were also lower than our estimate of $139 million 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 declined 31.8% in the year so far compared with the industry’s 21.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses in the quarter were $81.3 million, up 38.7% year over year, owing to increased costs related to pipeline development activities and a $10 million milestone payment accrued to Neuren Pharmaceuticals upon acceptance of the trofinetide new drug application (“NDA”) filing.
Selling, general and administrative (SG&A) expenses were $78.1 million, down 4.4% year over year, owing to reduced advertising and promotional costs.
As of Sep 30, 2022, Acadia had cash, cash equivalents and investments worth $436.6 million compared with $436.4 million as of Jun 30, 2022.
2022 Guidance
Acadia tightened its guidance for Nuplazid’s sales for 2022.
The company now expects Nuplazid’s net sales for 2022 in the $510-$520 million range compared with the earlier projection of $510-$540 million. The Zacks Consensus Estimate for the metric is pegged at $533.3 million while our estimate stands at $531.1 million.
The company now expects R&D expenses in the range of $345-$355 million compared with the $340-$360 million range expected previously. SG&A expenses are now expected to be $365-$375 million compared with $360-$380 million expected earlier.
Pipeline Updates
In September 2022, the FDA accepted for review Acadia's NDA seeking approval of its pipeline candidate, trofinetide, for the treatment of patients with Rett syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on Mar 12, 2023. ACAD submitted the NDA for trofinetide to treat Rett Syndrome in July 2022.
Upon potential approval, trofinetide can become the second approved drug in Acadia’s portfolio of marketed drugs and lend a significant boost to the company as well as lower its sole dependence on Nuplazid for revenues.
We remind investors that in August 2022, Acadia received a complete response letter from the FDA for its resubmitted supplemental new drug application (“sNDA”) for Nuplazid for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (“ADP”).
The FDA’s Psychopharmacologic Drugs Advisory Committee voted (9-3) against the sNDA for Nuplazid for treating hallucinations and delusions associated with ADP in June 2022.
Acadia is evaluating pimavanserin in the phase III ADVANCE-2 study for treating negative symptoms of schizophrenia. Enrollment in the study is expected to complete in mid-2023.
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 are Akero Therapeutics, Inc. (AKRO - Free Report) , Amarin Corporation plc (AMRN - Free Report) and Atea Pharmaceuticals, Inc. (AVIR - Free Report) , all sporting a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Akero Therapeutics narrowed 6.9% for 2022 and 4.8% for 2023 in the past 60 days.
Earnings of Akero Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. AKRO delivered an earnings surprise of 7.66% on average.
Loss per share estimates for Amarin narrowed 21% for 2022 and 50% for 2023 in the past 60 days.
Earnings of Amarin surpassed estimates in two of the trailing four quarters and missed on the other two occasions. AMRN delivered a negative earnings surprise of 14.29% on average.
Loss per share estimates for Atea Pharmaceuticals narrowed 10.9% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Atea Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. AVIR delivered a negative earnings surprise of 58.74% on average.