Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today reported financial results for the three months ended March 31, 2014, and provided an update of recent corporate developments.
“The path toward an NDA filing and a potential accelerated approval of eteplirsen has been laid out for us and we are busy preparing for the important clinical and regulatory milestones toward achieving this goal,” said Chris Garabedian, president and chief executive officer of Sarepta. “We are also preparing to advance our broader DMD program beyond eteplirsen in the U.S., and will begin the global clinical development program on our next exon-skipping drugs, as well as seek EMA guidance on requirements for a potential eteplirsen submission in the EU, later this year.”
For the first quarter of 2014, Sarepta reported a non-GAAP net loss of $20.7 million, or $0.55 per share, compared to a non-GAAP net loss of $13.0 million for the first quarter of 2013, or $0.41 per share. The incremental loss is primarily the result of an increase of $9.1 million in non-GAAP operating expenses due to corporate growth, offset by an increase of $1.6 million in contract revenue.On a GAAP basis, the net loss for the first quarter of 2014 was $28.3 million, or $0.75 per share (including $4.4 million of stock-based compensation and restructuring expenses), compared with a net loss of $42.1 million for the first quarter of 2013, or $1.32 per share (including $2.1 million of stock-based compensation and restructuring expenses). The decrease in net loss is primarily due to a decrease of $23.7 million in loss on change in warrant valuation and an increase of $1.6 million in contract revenue offset by an increase of $11.3 million in operating expenses. The fluctuation in the fair value of the Company’s outstanding warrant liability is primarily affected by the fluctuation of the Company’s stock price during each financial reporting period.