ACADIA Pharmaceuticals Inc.


ACAD

reported first-quarter 2021 loss of 42 cents per share, narrower than the Zacks Consensus Estimate of a loss of 53 cents. In the year-ago quarter, the company reported a loss of 57 cents.

Total revenues comprising net sales of ACADIA’s only marketed drug Nuplazid (pimavanserin) increased 18% year over year to $106.6 million in the first quarter. However, the top line missed the Zacks Consensus Estimate of $113 million.

Nuplazid is the first and the only FDA-approved treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. On the first-quarter conference call, management stated that sales of Nuplazid grew steadily year over year, driven by a strong performance in the office-based setting. However, Nuplazid sales were down 11.9% sequentially due to the ongoing COVID-19 pandemic adversity.

Shares of ACADIA have plunged 63.7% so far this year compared with the

industry’s

decrease of 6%.

Quarter in Detail

Research and development (R&D) expenses were $57 million in the quarter, down 21.4% from the year-ago period on decreased development costs related to Nuplazid label expansion studies.

Selling, general and administrative (SG&A) expenses rose 9.5% year over year to $111.7 million due to higher costs associated with the potential launch of Nuplazid for the dementia-related psychosis (DRP) indication.

As of Mar 31, 2021, ACADIA had cash, cash equivalents and investments worth $577.8 million compared with $632 million as of Dec 31, 2020.

2021 Guidance

ACADIA maintained the financial guidance it provided earlier this year. Nuplazid net sales are expected in the range of $510-$550 million for 2021. The Zacks Consensus Estimate for the metric stands at $532.7 million.

Meanwhile, the company lowered its expectation for R&D expenses to the range of $280-$300 band, which was earlier expected in within $300-$320 million. SG&A expense guidance for the full year is also decreased to $385-$415 million from the earlier projection of $560-$590 million.

Pipeline Updates

Several additional studies on Nuplazid targeting different central nervous system (CNS) indications are currently underway.

In April 2021, the FDA

issued

a complete response letter (CRL) to ACADIA’s supplemental new drug application (sNDA) seeking an approval for the label expansion of Nuplazid to treat hallucinations and delusions associated with DRP.

The CRL was issued as the regulatory body believes that it cannot approve the sNDA in its present form as it lacks statistical significance in some of the subgroups of dementia.

Earlier in March, the FDA identified deficiencies in the sNDA, seeking an approval for Nuplazid to address the DRP indication.

Other studies on Nuplazid include the phase III ADVANCE study for treating negative symptoms of schizophrenia. Nuplazid is also being evaluated in the phase III CLARITY study as an adjunctive treatment of major depressive disorder.

Meanwhile, ACADIA is evaluating a pipeline candidate named trofinetide in the phase III LAVENDER study for the treatment of Rett syndrome, a rare neurodevelopmental congenital CNS disorder for girls aged between five years and 20 years. Top-line data from the same is expected in the fourth quarter of 2021.

Additionally, in March 2021, ACADIA initiated a phase II study evaluating ACP-044, a novel orally administered non-opioid analgesic, for treating postoperative pain following bunionectomy surgery. The company also plans to begin another phase II study on ACP-044 in second-quarter 2021 for pain associated with osteoarthritis.

Zacks Rank and Stocks to Consider

ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include

ASLAN Pharmaceuticals Limited


ASLN

,

Allogene Therapeutics, Inc.


ALLO

and

Nabriva Therapeutics AG


NBRV

, 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


.

ASLAN Pharmaceuticals’ loss per share estimates have narrowed 26.3% for 2021 and 43.9% for 2022 over the past 60 days. The stock has surged 59% year to date.

Allogene Therapeutics’ loss per share estimates have narrowed 0.5% for 2021 and 1.2% for 2022 over the past 60 days. The stock has increased 13.7% year to date.

Nabriva Therapeutics’ loss per share estimates have narrowed 40.9% for 2021 and 45.3% for 2022 over the past 60 days.

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