ANI Pharma's Purified Cortrophin Gel Scores FDA Approval; Q3 Earnings Beat Estimates

ANI Pharmaceuticals Inc ANIP has reported Q3 sales of $52.1 million, down 1.7% Y/Y, better than the consensus of $49.70 million.
The company achieved an adjusted EPS of $1.01 compared to $0.97 posted a year ago, well ahead of the consensus of $0.70.
Net revenues for generic pharmaceutical products were $35.1 million, a decrease of 6.8%Y/Y due to lower sales of Erythromycin Ethylsuccinate (EES), Methazolamide, Penicillamine, and Vancomycin and lower average selling prices tempered by increased volumes among generic products.
Net revenues for branded pharmaceutical products increased 15.3% to $14.3 million due in part to higher volumes tempered by a shift in mix towards brand products with lower average selling prices.
Contract manufacturing revenues were $2.4 million, +10.7%.
The cost of sales increased by $4.3 million to $24.4 million, primarily due to $2.2 million in cost of sales representing the excess of fair value over the cost of inventory acquired in the Sandoz Inc asset acquisition.
The FDA has also approved ANI's supplemental marketing application for Purified Cortrophin Gel for certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome.
The company plans a full-scale Cortrophin Gel launch in Q1 of 2022.
ANI acquired the NDA for Cortrophin Gel from Merck & Co Inc MRK in 2016.
Price Action: ANIP shares closed 49.52% higher at $55.89 on Monday.

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