ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders, announced its financial results for the fourth quarter and year ended December 31, 2014.
ACADIA reported a net loss of $28.4 million, or $0.28 per common share, for the fourth quarter of 2014, compared to a net loss of $12.0 million, or $0.13 per common share, for the fourth quarter of 2013. The net losses for the fourth quarters of 2014 and 2013 included $4.6 million and $2.2 million, respectively, in non-cash, stock-based compensation expense. For the year ended December 31, 2014, ACADIA reported a net loss of $92.5 million, or $0.95 per common share, compared to a net loss of $37.9 million, or $0.44 per common share, for 2013. The net losses for 2014 and 2013 included $16.0 million and $5.7 million, respectively, in non-cash, stock-based compensation expense.
At December 31, 2014, ACADIA’s cash, cash equivalents, and investment securities totaled $322.5 millioncompared to $185.8 million at December 31, 2013. This increase was primarily due to net proceeds from sales of equity securities, including $196.8 million raised in a public offering in March 2014, offset in part by cash used to fund ACADIA’s operations.
“Our accomplishments in 2014, highlighted by NUPLAZIDTM receiving Breakthrough Therapy designation from the FDA, our strengthened balance sheet, and our commercial preparations, set the stage for a promising 2015,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “Importantly, we continue to advance our Parkinson’s disease psychosis program towards registration and remain on track to submit our New Drug Application to the FDA in the first quarter of 2015.”
“We have an important year ahead of us as we continue to add to our commercial capabilities and prepare for the planned launch of NUPLAZID in the United States. We also plan to initiate studies with pimavanserin where new therapies are greatly needed, including schizophrenia and sleep disturbances in Parkinson’s patients, as well as continuing our ongoing Phase II study with pimavanserin in Alzheimer’s disease psychosis. Additionally, we will prepare a Marketing Authorization Application for NUPLAZID for submission in Europe. In all, 2015 will be a pivotal year for ACADIA as we advance NUPLAZID towards commercialization in the United States and broaden the program into additional neurological and psychiatric indications for which there are large unmet medical needs.”
Research and development expenses increased to $18.2 million for the fourth quarter of 2014, including$1.7 million in stock-based compensation, from $7.9 million for the comparable quarter of 2013, including$791,000 in stock-based compensation. This increase was primarily due to an increase of $7.8 million in external service costs associated with the development of pimavanserin. Increases in costs associated with ACADIA’s expanded research and development organization, including $1.5 million in increased personnel costs and $948,000 in increased stock-based compensation expense, also contributed to the quarter-over-quarter increase.
General and administrative expenses increased to $10.4 million for the fourth quarter of 2014, including$2.9 million in stock-based compensation, from $4.3 million for the comparable quarter of 2013, including$1.4 million in stock-based compensation. This increase was due to a $2.1 million increase in external service costs largely related to ACADIA’s commercial preparations for the planned launch of NUPLAZID. Also contributing to the quarter-over-quarter increase in general and administrative expenses was a $1.7 millionincrease in personnel expenses largely related to ACADIA’s preparations for the planned launch of NUPLAZID, as well as a $1.5 million increase in stock-based compensation expense.
ACADIA anticipates that the level of cash used in its operations will increase in future periods in order to fund its work related to the New Drug Application (NDA) submission and review and commercial activities for NUPLAZID, and its ongoing and planned development activities for pimavanserin for other indications. ACADIA currently expects that its cash, cash equivalents, and investment securities will be sufficient to fund its planned operations at least into the second half of 2016.
- FDA granted Breakthrough Therapy designation to NUPLAZID for the treatment of Parkinson’s disease psychosis (PDP).
- Conducted successful pre-NDA meetings with the FDA for NUPLAZID.
- FDA provisionally accepted the trade name “NUPLAZID”™ for pimavanserin.
- Presented caregiver burden data from Phase III PDP program at the 10th Annual International Congress of Non-Motor Dysfunctions in Parkinson’s Disease and Related Disorders.
- Continued to enroll patients in the ongoing Phase II study with pimavanserin in Alzheimer’s disease psychosis.
- Advanced commercial preparations for the planned launch of NUPLAZID, comprising extensive market research, foundational access and reimbursement research, national and regional scientific advisory boards, pricing analysis, sales force sizing, and adding to the leadership of the commercial team.
Business and Other
- Completed a public offering of common stock raising net proceeds of $196.8 million.
- Appointed Steve Davis as Executive Vice President, Chief Financial Officer and Chief Business Officer.
Shares of Acadia closed today at $37.78. ACAD has a 1-year high of $38.43 and a 1-year low of $15.64. The stock’s 50-day moving average is $33.40 and it’s 200-day moving average is $28.80.
On the ratings front, Acadia (NASDAQ: ACAD) has been the subject of a number of recent research reports. In a report released yesterday, H.C. Wainwright analyst Andrew Fein initiated coverage with a Buy rating on ACAD and a price target of $50, which implies an upside of 33.4% from current levels. Separately, on January 13, J.P. Morgan’s Cory Kasimov maintained a Buy rating on the stock .
ACADIA Pharmaceuticals Inc is in the business of development and commercialization of small molecule drugs for the treatment of central nervous system disorders.