IGI Laboratories, Inc. (NYSEMKT:IG) Submits Second ANDA To U.S. FDA

IGI Laboratories, Inc. (NYSEMKT:IG) submitted its second ANDA to the U.S. FDA of 2015, which brings its total number of submissions pending with FDA to twenty-four. Jason Grenfell-Gardner, the President and CEO said that the management believes the ANDA filed has large addressable market of almost $50 million. The figures are based on February data from IMS Health.

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The market

The existing pipeline of twenty-four submissions now has a total addressable market of more than $702 million. The company operates in a specialty generic pharmaceutical industry and plans to become a leading company in the industry.

The disappointments

The submission news was followed by the disappointing financial numbers of first quarter. The shares of IGI declined more than 30% after it posted its first quarter results. The total revenue came at $10.7 million, missing analysts’ estimates of $1.7 million.

The outlook

In addition, the CEO revised outlook for the second-quarter. The sales of its econazole nitrate cream are expected to drop markedly in the second quarter. It indicates that the estimated revenues for 2Q will be in a range of $7 million to $8 million. The market, by contrast, had 2Q revenue pegged at around $14 million.

The future ahead

IGI Laboratories, Inc. (NYSEMKT:IG) has posted strong performance in the past two years. At one point, the shares traded as high as $12 per share but due to older products portfolio and other operational problems, the shares have declined back to earth. In the near term, IGI management is keeping its hopes on the company’s collection of ANDAs submitted with the U.S. Food and Drug Administration to create value for shareholders. The estimated potential revenues of $702 million can give a complete makeover to the company. Unfortunately, it will be a long wait for the company as the review is expected to take more than two years.

About the Author

Adam is a staff reporter for US Markets Daily Publications & Media, covering foreign affairs and domestic policy.

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