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ACADIA Pharmaceuticals Reports Second Quarter 2017 Financial Results

SAN DIEGO--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced its unaudited financial results for the second quarter ended June 30, 2017.

“Our commercial efforts continue to drive strong financial performance with solid market uptake for NUPLAZID in patients with Parkinson’s disease psychosis,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “Following positive data from our Phase II study in Alzheimer’s disease psychosis and recently completed End-of-Phase II meeting with the FDA, we are excited to start our Phase III program in the next couple of months.”

During the second quarter of 2017, ACADIA generated $30.5 million of net product sales of NUPLAZID, which includes the one-time recognition of $3.6 million associated with the transition to the sell-in revenue recognition method of accounting from the sell-through method.

Starting with the second quarter of 2017, based on its determination it had sufficient volume of activity to reasonably estimate its allowances for rebates and chargebacks, ACADIA began to recognize revenue at the point of sale to its specialty pharmacy and specialty distributor partners, commonly referred to as the “sell-in” revenue recognition method. Previously, ACADIA had deferred the recognition of revenue until it obtained evidence that its specialty partners had dispensed the product to a patient or had sold the product to a government facility, long-term care pharmacy or in-patient hospital pharmacy. The $3.6 million one-time adjustment was deferred revenue as of March 31, 2017 and represents product held by specialty pharmacies and specialty distributors at such date.

For comparison purposes, the following table presents NUPLAZID’s pro forma quarterly net product sales under the sell-in method, if ACADIA had been able to reasonably estimate its allowances for rebates and chargebacks from the time of launch in May 2016.

Pro Forma Reconciliation of Sell-Through to Sell-In Method

(in millions) Three Months Ended
June 30, September 30, December 31, March 31, June 30,
2016 2016 2016 2017 2017
NUPLAZID net sales, as reported1 $ 0.1 $ 5.3 $ 12.0 $ 15.3 $ 30.5
Difference2 0.4 1.2 0.5 1.5 (3.6 )

Pro forma NUPLAZID net sales, sell-in method

$ 0.5 $ 6.5 $ 12.5 $ 16.8 $ 26.9

1

Includes the net sales as previously reported for the quarterly periods through March 31, 2017 utilizing the sell-through revenue recognition method.

2

Represents the impact of recognizing the deferred revenue at period-end, net of allowances for rebates and chargebacks, had the sales been recognized in the quarter which the product was delivered to the specialty pharmacies and distributors.

Recent Highlights

  • Conducted End-of-Phase II meeting with the FDA on the Alzheimer’s disease psychosis (AD Psychosis) program.
  • Abstract of Phase II data with pimavanserin for AD Psychosis was accepted for presentation at the Clinical Trials on Alzheimer’s Disease meeting in early November 2017.
  • Expanded penetration into the long-term care market with the deployment of an additional 25 long-term care specialists; ACADIA currently has approximately 155 total sales specialists.
  • NUPLAZID nominated for the 11th Annual Prix Galien Award for Best Pharmaceutical Agent.
  • ACADIA named to Forbes Magazine’s List of World’s Most Innovative Growth Companies.
  • Continue to advance broad clinical development program with ongoing studies in Alzheimer’s disease agitation, schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.

Financial Results

Revenue
Net product sales of NUPLAZID, which was first made available for prescription starting in May 2016, were $30.5 million for the three months ended June 30, 2017 compared to $0.1 million for the three months ended June 30, 2016. For the six months ended June 30, 2017 and 2016, ACADIA reported NUPLAZID net product sales of $45.8 million and $0.1 million, respectively.

Research and Development
Research and development expenses for the three months ended June 30, 2017 were $34.2 million, compared to $20.5 million for the same period of 2016. For the six months ended June 30, 2017 and 2016, research and development expenses were $69.6 million and $43.3 million, respectively. The increase in research and development expenses during the 2017 periods as compared to 2016 was primarily due to increased clinical...


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