Needham & Company Affirms Acadia Pharma (ACAD) at 'Buy'; Says Initial Nuplazid Sales Affected by Sampling

August 5, 2016 8:19 AM EDT
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Needham & Company affirms Acadia Pharma (Nasdaq: ACAD) at Buy with a price target of $49 following Q2 results on Thursday night.

Analyst Alan Carr commented today, Acadia reported $97,000 in Nuplazid 2Q16 sales, compared to our $0.5M and consensus $0.1M estimates. Mgmt reported that extensive use of sampling programs significantly impacted sales. We expect this to continue into 3Q16 and have adjusted our estimates for 2016 accordingly. Nevertheless, mgmt reported positive anecdotal response from physicians and caregivers and noted launch is meeting internal expectations. Nuplazid was launched 5/31/16 for the treatment of Parkinson's Disease Psychosis (PDP). Our peak U.S. sales estimate in PDP is unchanged (up to ~$1B). Mgmt guided for top-line results from Phase 2 Alzheimer's Disease Psychosis (ADP) trial in 4Q16 (unch). A positive outcome may subsequently drive off-label use in this and several other dementia-related psychoses.

The company has called on 9,700 of target 12,000 physicians since launch. Medicare Part D plans are expected to complete formulary process by 90 days post-launch. Formulary process at private payers is expected to be completed by early 2017. Mgmt expects prior authorization to be most common restriction. To-date, most pts are Medicare Part D. Time to fill script is around 5-10 days.

Acadia previously announced a delay in planned 2Q16 MAA submission of Nuplazid due to EMA rejection of Pediatric Investigation Plan. Acadia had initially sought a waiver, but the EMA indicated a plan is still necessary. Mgmt guided for submission of a new plan in 3Q16. We believe an MAA could be submitted in early 2017, Carr noted.

For an analyst ratings summary and ratings history on Acadia Pharmaceuticals click here. For more ratings news on Acadia Pharmaceuticals click here.

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