IGI Labs (IG) Tops Q2 EPS by 4c

IGI Labs (NYSE: IG) reported Q2 EPS of ($0.04), $0.04 better than the analyst estimate of ($0.08). Revenue for the quarter came in at $8.9 million versus the consensus estimate of $7.63 million.

IGI Labs reaffirmed FY2015 guidance.

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "We are pleased with our steady progress this quarter. On the regulatory front, we received the FDA's final approval for our diclofenac sodium 1.5% topical solution earlier this month. We also added another six ANDA submissions during fiscal 2015, including the submission filed today. While there have been some changes in the econazole market earlier this quarter, we have regained market share for that product again over the last two months." Mr. Grenfell-Gardner continued, "Our long-term vision continues to focus on the creation of a diversified product portfolio, built around our topical, injectable, complex and ophthalmic, or TICO, strategy. During the second quarter, we submitted a Prior Approval Supplement to the FDA for our first injectable product, and we are working hard to target the launch of that product before the end of 2015."

Mr. Grenfell-Gardner concluded, "As of today, we have twenty-eight ANDAs pending with the FDA. Based on May 2015 IMS Health data, the addressable market for our pipeline of such twenty-eight ANDAs is estimated at $1.2 billion. We continue to see positive momentum in our correspondence with the FDA with regard to applications filed after October 1, 2014, or the third year after implementation of the Generic Drug User Fee Amendments of 2012. We are committed to responding effectively to the FDA's accelerated deadlines for applications currently under review, so we plan to submit up to a further fourteen ANDAs with the FDA this year, for a total of up to twenty new topical submissions in 2015."

For earnings history and earnings-related data on IGI Labs (IG) click here.

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