ACADIA Pharmaceuticals Inc. (ACAD - Free Report) incurred first-quarter 2020 loss of 57 cents per share, wider than the Zacks Consensus Estimate of a loss of 46 cents but narrower than the year-ago loss of 59 cents.
Total revenues comprising net sales of the sole marketed drug Nuplazid (pimavanserin) rose 43% year over year to $90.1 million in the first quarter. However, the top line missed the Zacks Consensus Estimate of $93 million.
Notably, Nuplazid is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis.
Sales of Nuplazid grew steadily both year over year and sequentially. The drug has seen a strong uptake ever since its launch in 2016. On first-quarter conference call, management stated that a strong patient base is continuing treatment with Nuplazid. However, the current environment can pose a short-term negative impact on the rate of new patient growth.
ACADIA lowered its revenue guidance for 2020 by approximately 5% to incorporate the short-term adversity from the COVID-19 pandemic.
Shares of ACADIA were down 6.5% in after-hours trading on Thursday following the cut in revenue guidance. However, the stock has rallied 15.4% in the year so far compared with the industry’s increase of 3.8%.
Research and development (R&D) expenses were $72.6 million in the quarter, up 37.2% from the year-ago period due to higher development costs for the pipeline candidate trofinetide and an upfront payment made to Vanderbilt University.
Selling, general and administrative (SG&A) expenses rose 9.6% year over year to $102 million due to increased medical expense and higher personnel costs.
As of Mar 31, 2020, ACADIA had cash, cash equivalents and investments worth $651.4 million compared with $697.4 million as of Dec 31, 2019.
Compelled by the COVID-19 pandemic-related uncertainty, ACADIA lowered its 2020 revenue guidance by approximately 5%.
The company now expects total revenues in the range of $420-$450 million for the full year compared with the previous guidance of $440-$470 million. The Zacks Consensus Estimate for the metric stands at $445.9 million for the period.
Several additional studies on Nuplazid targeting different central nervous system (CNS) indications are currently underway. A potential label expansion will boost the sales of the drug in future quarters.
Nuplazid is being evaluated in the phase III HARMONY study for treating dementia-related psychosis (DRP). Management met the FDA authorities and is planning to file a supplemental new drug application later in the summer of 2020 seeking approval for Nupalzid to treat DRP. This will be a potential second indication for Nuplazid.
Other studies on Nupalzid include the phase II ADVANCE study for addressing schizophrenia’s negative symptoms. The company plans to initiate a second pivotal study, ADVANCE-2, on Nupalzid in the second half of 2020 for treating negative symptoms of schizophrenia. Meanwhile, the phase III CLARITY study is evaluating Nupalzid as an adjunctive treatment of major depressive disorder (MDD).
Apart from Nupalzid, ACADIA is evaluating its investigational candidate trofinetide in a late-stage study for the treatment of Rett syndrome, a rare neurodevelopmental congenital CNS disorder for girls aged between five and 20 years. In March 2020, the FDA granted Rare Pediatric Disease designation to trofinetide for the given indication.
In a separate press release, ACADIA announced that it has entered into a licensing and collaboration agreement with Vanderbilt University to develop/commercialize novel drug candidates targeting the muscarinic M1 receptor with potential to treat a range of CNS disorders.
ACADIA Pharmaceuticals Inc Price, Consensus and EPS Surprise
Zacks Rank & Stocks to Consider
ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Menlo Therapeutics Inc. (MNLO - Free Report) , Lineage Cell Therapeutics Inc (LCTX - Free Report) and Abeona Therapeutics Inc (ABEO - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Menlo Therapeutics’ loss per share estimates have narrowed 38.2% for 2020 and 66.7% for 2021 over the past 60 days.
Lineage Cell’s loss per share estimates have narrowed 5.6% for 2020 and 4.8% for 2021 over the past 60 days.
Abeona Therapeutics’ loss per share estimates have narrowed 21.1% for 2020 and 14.5% for 2021 over the past 60 days.
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