Sarepta Therapeutics, Inc. (SRPT - Analyst Report) reported a loss of $1.49 per share in the first quarter of 2015, significantly wider than the Zacks Consensus Estimate of a loss of $1.00 and the year-ago loss of $0.63.
The company did not generate any revenues in the first quarter of 2015 while the year-ago period reflected revenues of $6.1 million. The lack of revenues in the reported quarter reflects the Jul 2014 expiration of the Marburg portion of the company’s Ebola-Marburg U.S. government contract. As per the Zacks Consensus Estimate, the company was expected to record revenues of $1 million in the reported quarter.
Other Details
Research and development expenses soared 87.3% year over year to $39.2 million. General and administrative expenses also shot up 120.3% year over year to $22.7 million.
On the first quarter call, Sarepta’s newly appointed CEO, Edward Kaye, informed that the company is on track to file a new drug application for eteplirsen in the U.S. in mid-15, pending discussions with the FDA scheduled for the second quarter of 2015.
We remind investors that the company is evaluating eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). Sarepta had received an updated guidance from the FDA regarding eteplirsen last October.
Sarepta plans to present additional data to the European Medicines Agency once data compilation for the FDA is complete. Thereafter, the company plans to seek approval for eteplirsen in the EU.
Meanwhile, Sarepta continues to progress on additional studies on eteplirsen and other exon skipping pipeline candidates for DMD. Two new studies on eteplirsen are currently enrolling patients – one a confirmatory study (PROMOVI) in ambulatory patients and the other (study 4658-204) in advanced-stage patients including patients who are non-ambulant.
The exon-53 study (on SRP-4053) has commenced in Europe. The company expects to completed enrollment in this study by the end of 2015.
In addition to this, another confirmatory study 4045-301 including both patients amenable to either exon 45 skipping or exon 53 skipping is on track for initiation in the U.S. by mid-15 while EU enrollment is planned for late 2015 or early 2016.
Our Take
Sarepta’s first-quarter results were disappointing with the company reporting a wider-than- expected loss and no revenues. Eteplirsen, if developed successfully, would be able to capture a major share of this orphan disease market. However, we note that several companies including BioMarin (BMRN - Analyst Report) are working on bringing DMD treatments to the market. BioMarin has already completed its rolling NDA submission for its DMD candidate, drisapersen.
Sarepta currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. (ALIOF - Snapshot Report) and Gilead Sciences Inc. (GILD - Analyst Report). Both hold a Zacks Rank #1 (Strong Buy).
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