Sarepta Therapeutics Announces First Quarter 2013 Financial Results and Recent Corporate Developments

CAMBRIDGE, MA--(Marketwired - May 9, 2013) - Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today reported financial results for the three months ended March 31, 2013, and provided an update of recent corporate developments.

"We are encouraged by our initial interactions with the U.S. Food and Drug Administration regarding a potential accelerated approval regulatory path for eteplirsen for the treatment of Duchenne muscular dystrophy, and we are finalizing a response to the FDA's request for more data to help us determine the feasibility of this pathway," said Chris Garabedian, president and chief executive officer of Sarepta Therapeutics. "In parallel, we continue to advance the clinical, regulatory, and manufacturing activities for eteplirsen and our additional DMD product candidates to build a successful franchise in this important disease area."

Financial Results

For the first quarter of 2013, Sarepta reported a Non-GAAP operating loss of $13.3 million, compared to a Non-GAAP operating loss of $6.1 million for the first quarter of 2012. The incremental loss is primarily the result of a $6.7 million decrease in government contract revenues as well as a $0.5 million increase in operating expenses.

On a GAAP basis, the operating loss for the first quarter of 2013 was $15.4 million (including $2.1 million of stock-based employee compensation expense and restructuring expense), compared with an operating loss of $6.9 million for the first quarter of 2012 (including $0.8 million of stock-based employee compensation expense and restructuring expense). The incremental loss is the result of a $6.7 million decrease in government contract revenues and a $1.8 million increase in operating expenses.

Revenue for the first quarter of 2013 was $4.5 million, down from $11.2 million for the first quarter of 2012. The $6.7 million decrease was due to the August 2012 stop-work-order and subsequent termination for convenience of the Ebola portion of the Ebola-Marburg U.S. government contract due to a lack of available U.S. government funding. The Ebola termination did not impact the Marburg portion of the contract. Revenues from the Marburg portion of the contract also decreased during the first quarter of 2013 due to the timing of activities throughout the normal progression of the contract. These decreases were partially offset by revenue from the intramuscular administration (IM) contract with the U.S. government for the Marburg virus that started in August 2012.

Non-GAAP research and development expenses were $13.0 million for the first quarter of 2013, compared to $14.5 million for the first quarter of 2012, a decrease of $1.5 million. GAAP research and development expenses were $13.8 million for the first quarter of 2013 (including $0.8 million of stock-based employee compensation expense and restructuring expense), compared to $14.8 million for the first quarter of 2012 (including $0.3 million of stock-based employee compensation expense and restructuring expense), a decrease of $1.0 million.

Non-GAAP general and administrative expenses were $4.8 million for the first quarter of 2013, compared to $2.8 million for the first quarter of 2012, an increase of $2.0 million. GAAP general and administrative expenses were $6.1 million for the first quarter of 2013 (including $1.3 million of stock-based employee compensation expense and restructuring expense), compared to $3.3 million for the first quarter of 2012 (including $0.5 million of stock-based employee compensation expense and restructuring expense), an increase of $2.8 million.

The increased operating expenses were primarily caused by corporate growth as the Company continues the development of its programs in Duchenne muscular dystrophyand infectious diseases.

The Non-GAAP net loss for the first quarter of 2013 was $13.0 million, or $0.41 per share, compared to a net loss from the first quarter of 2012 of $6.0 million, or $0.27 per share. On a GAAP basis, the net loss for the first quarter of 2013 was $42.1 million, or $1.32 per share, compared to a net loss from the first quarter of 2012 of $17.7 million, or $0.78 per share.

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Sarepta Therapeutics Announces First Quarter 2013 Financial Results and Recent Corporate Developments