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.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2949418, ~/Articles/ArticleHandler.aspx, 11/26/2014 4:59:11 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement