"Assuming the closing of the financing, we believe we will be financially positioned to proceed with the direct commercialization of ILUVIEN in Germany, the United Kingdom and France, without needing to raise any additional funds," said Rick Eiswirth, Alimera's chief operating officer and chief financial officer. "We expect to begin shipping ILUVIEN to Europe in the fourth quarter of 2012 and generating revenue during the first quarter of 2013."
Second Quarter 2012 Financial Results
As of June 30, 2012, Alimera had cash, cash equivalents and investments of $22.3 million, compared to $33.6 million as of December 31, 2011. This cash and cash equivalents balance excludes any amounts to be received upon the closing of the Series A Preferred financing.
Research and development expenses for the second quarter of 2012 increased to $1.9 million, compared to $1.8 million for the second quarter of 2011. The majority of the company's research and development expenses incurred to date have been related to the development of ILUVIEN.
General and administrative expenses in the second quarter of 2012 were $1.5 million, compared to $1.9 million in the second quarter of 2011.
Marketing expenses in the second quarter of 2012 were $1.1 million, compared to $1.3 million for the second quarter of 2011. Marketing expenses in the second quarter of 2012 were used primarily for assessing the commercial opportunity of, and developing market awareness and launch plans for, ILUVIEN in Europe.
Net loss for the quarter ended June 30, 2012 was $4.7 million, or $0.15 per common share, compared with a net loss of $5.2 million, or $0.17 per common share, for the quarter ended June 30, 2011. Net loss per share was based on 31,430,651 weighted average shares outstanding for the second quarter of 2012 and 31,354,243 weighted average shares outstanding for the second quarter of 2011.
Alimera met with the U.S. Food and Drug Administration (FDA) in June 2012 to discuss the FDA's November 2011 Complete Response Letter (CRL) regarding Alimera's New Drug Application (NDA) for ILUVIEN for the treatment of diabetic macular edema (DME). Based on that meeting, Alimera intends to resubmit its NDA for ILUVIEN. Using data from its two previously completed pivotal Phase III clinical trials (FAME™ Study), the resubmission will focus on the population of patients with chronic DME considered insufficiently responsive to available therapies, the same indication for which marketing approval for ILUVIEN has been granted in various European Union countries. Alimera also expects to continue enrollment of patients in the physician utilization study of the ILUVIEN inserter that was temporarily suspended after the issuance of the CRL.