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Sarepta's Loss Widens 59% as it Prepares Eteplirsen For a New Drug Application Filing

Duchenne muscular dystrophy-focused biopharmaceutical company Sarepta Therapeutics (NASDAQ: SRPT  ) reported its first-quarter results before the opening, telling the tale of a widening loss but a number of new regulatory moves on the horizon.

For the quarter, Sarepta reported a 36% increase in total revenue to $6.1 million as it recognized more revenue tied to the Marburg portion of its July 2010 government contract. Sarepta also received a boost from an exon 53-skipping therapeutic program, which receives support in the form of development cost reimbursement per its EU SKIP-NMD agreement.

Costs for the quarter, due to Sarepta's pipeline expansion and the company bringing on new personnel, jumped to $31.2 million from $19.9 million in the prior year period. Net loss, on an adjusted basis, widened by 59% to $20.7 million, or $0.55 per share, from the $13 million loss, or $0.41 per share, reported in Q1 2013. On GAAP basis its loss actually shrank by $13.8 million, but this was primarily due to a favorable change in warrant value.

Sarepta ended the quarter with $233.1 million in cash, cash equivalents, short investments and restricted investments, compared to $264.9 million as of the sequential fourth quarter.

Looking ahead, Sarepta laid the groundwork for its next regulatory and corporate development steps. It plans to file a new drug application in the U.S. for eteplirsen before the end of the year, and anticipates submitting investigational new drug applications for two Duchenne muscular dystrophy candidates sometime in the third quarter. Sarepta also plans to seek guidance in the EU later this year as to what it will need to get eteplirsen authorized in that region.

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Sean Williams

A Fool since 2010, and a graduate from UC San Diego with a B.A. in Economics, Sean specializes in the healthcare sector and in investment planning topics. You'll usually find him writing about Obamacare, marijuana, developing drugs, diagnostics, and medical devices, Social Security, taxes, or any number of other macroeconomic issues.

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