Alimera Sciences, Inc., (Nasdaq:ALIM), ("Alimera"), today announced financial results for the second quarter ended June 30, 2010 and provided an update on progress toward achieving its 2010 goals.
"We are pleased that we successfully achieved our regulatory submission goals for our lead product candidate, Iluvien® for the treatment of diabetic macular edema (DME). On the 28th of June, we submitted a New Drug Application to the U.S. Food and Drug Administration (FDA). We have requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year," said Dan Myers, President and Chief Executive Officer of Alimera. "Assuming a positive response from the FDA, we anticipate launching Iluvien® as early as the first quarter of 2011."
"We submitted Iluvien to European regulatory authorities for the treatment of DME during the week of July 5th. A Marketing Authorization Application (MAA) was presented to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and applications have been submitted to Austria, France, Germany, Italy, Portugal and Spain," said Mr. Myers.
There are currently no ophthalmic drug therapies approved in the United States for the treatment of DME. Alimera estimates that there are more than 300,000 new cases of DME annually and data shows that diabetic retinopathy causes 12,000 to 24,000 new cases of blindness each year in the United States alone. The Company estimates that the addressable market for Iluvien® could reach $1 billion per year.
Financial Highlights
Net loss for the quarter ended June 30, 2010 was $4.8 million, or $0.20 per common share, compared with a net loss of $8.1 million, or $5.46 per common share, for the quarter ended June 30, 2009.
Included in Alimera's results for the second quarter of 2010 was a gain of $380,000 associated with the decrease in the fair value of the conversion feature of Alimera's preferred stock, compared with an expense of $1.1 million recognized in the second quarter of 2009 in connection with an increase in the fair value of the preferred stock conversion feature. The changes in fair value are primarily attributable to changes in the estimated fair value of Alimera's common stock. In connection with the Company's IPO in April 2010, all of its preferred stock was converted to common stock and the liability associated with the conversion feature of its preferred stock was eliminated.
Research and development expenses for the quarter ended June 30, 2010 totaled $4.1 million, compared to $3.8 million for the second quarter of 2009. General and administrative expenses were $1.2 million for the second quarter of 2010, compared to $0.8 million for the second quarter of 2009. Marketing expenses were $0.4 million for the second quarter of 2010, compared to $0.2 million for the second quarter of 2009.
As of June 30, 2010, Alimera had cash, cash equivalents and investments of $60.2 million, compared to $4.9 million as of December 31, 2009.
Financial Outlook
Alimera anticipates that it will incur research and development expenses of approximately $11.6 million and $1.8 million during 2010 and 2011, respectively, to complete the clinical development and registration of Iluvien® for DME. Upon approval of Iluvien® by the FDA, Alimera will owe an additional milestone payment of $25.0 million to pSivida.
The Company anticipates significant increases in marketing and selling expenses as Alimera hires additional personnel and establishes sales and marketing capabilities in anticipation of the commercialization of Iluvien®. Alimera intends to market and sell Iluvien® to the approximately 1,600 retinal specialists practicing in the approximately 900 retina centers across the United States and Canada.
Alimera believes its current cash, cash equivalents and investments are sufficient to fund operations through the projected commercialization of Iluvien® and the expected generation of revenue in 2011.
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