AcelRx Pharmaceuticals reported financial results for the three and twelve months ended December 31, 2014. Net loss for Q4 was $13.8 million, or $0.32 basic and diluted net loss per share.
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This compares to $17.8 million net income, or $0.41 basic net income per share and $0.39 diluted net income per share, for the fourth quarter of 2013.
Net loss in the fourth quarter as compared to net income in the fourth quarter last year was primarily due to the receipt of a $30.0 million upfront payment under the collaboration agreement with Grunenthal, of which $27.4 million was recognized as revenue in the fourth quarter of 2013.
In the fourth quarter of 2014, operating expenses of $12.0 million increased by $4.4 million from $7.6 million in the fourth quarter of 2013, primarily due to research and development activities to support resubmission of the Zalviso NDA, and an increase in headcount and related expenses in preparation for the potential commercialization of Zalviso.
During the fourth quarter of 2014, AcelRx recognized $226,000 of previously deferred revenue under the collaboration agreement with Grunenthal.
During the fourth quarter of 2013, in addition to the $27.4 million in revenue recognized under the Grunenthal collaboration, AcelRx also recognized revenue of $237,000 resulting from reimbursement for work completed under a research grant from the U.S. Army for development of ARX-04. Work under this research grant was completed in the fourth quarter of 2013.
Research and development expenses for the fourth quarter 2014 were $7.3 million, compared to $4.3 million for the fourth quarter 2013. The increase was primarily due to activities to support the resubmission of the Zalviso NDA, build-out of the Medical Affairs team and continued development work on ARX-04.
General and administrative expenses were $4.7 million for the fourth quarter of 2014, compared to $3.3 million for the fourth quarter of 2013. The increase was primarily due to activities in support of the potential commercialization of Zalviso
Full year 2014 financial results
For the year ended December 31, 2014, AcelRx reported a net loss of $33.4 million, or $0.77 basic net loss per share and $0.91 diluted net loss per share, compared to $23.4 million net loss, or $0.59 basic and diluted net loss per share for 2013.
Revenue for 2014 was $5.2 million, including the receipt of a $5 million milestone payment from Grunenthal for the filing of the Marketing Authorization Application, or MAA, for Zalviso in Europe. Revenue for 2013 was $29.5 million mainly from the upfront payment received from Grunenthal for the collaboration agreement signed in December 2013.
Research and development expenses for 2014 were $24.5 million, compared to $26.3 million for 2013. The decrease in research and development expense for 2014 was primarily due to a high level of activity associated with Phase 3 clinical studies of Zalviso in 2013.
General and administrative expenses were $18.3 million for 2014, compared to $9.9 million for 2013. The increase was primarily due to an increase in headcount, market research programs and other activities in preparation for the potential commercialization of Zalviso.
As of December 31, 2014, AcelRx had cash, cash equivalents and investments of $75.4 million, compared to $103.7 million at December 31, 2013.
The decrease in cash during the year was driven by cash used in operations and investing activities of $40.2 million, primarily offset by the $10 million drawdown of the second tranche of the loan agreement with Hercules and receipt of $1.9 million from the exercise of stock options and purchase of stock under the employee stock purchase plan. ■