Synageva BioPharma Corp. ( GEVA ) reported first quarter 2014 loss of $1.16 per share, wider than the year-ago loss of 54 cents per share, but narrower than the Zacks Consensus Estimate of a loss of $1.19 per share.
First quarter revenues decreased 69.1% from the year-ago quarter to $1.6 million, missing the Zacks Consensus Estimate of $2 million.
Quarterly Details
In the reported quarter, Synageva earned royalties from Roche ( RHHBY ) on Fuzeon and collaboration and license revenues from its partners.
R&D expenses increased 108.9% year over year to $27.9 million. SG&A expenses increased 73.4% year over year to $9.8 million.
Pipeline Update
Synageva's lead candidate, sebelipase alfa, is in a phase III study (ARISE) for the treatment of lysosomal acid lipase deficiency (LAL deficiency) in children and adults. The company continues to expect top-line results from the study in the third quarter of 2014. By the end of the first quarter of 2015, Synageva expects to file a Biologic License Application (BLA) for sebelipase alfa for this indication to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA).
Meanwhile, the company intends to initiate a study on SBC-103 by mid-2014. SBC-103 will be evaluated as an enzyme replacement therapy for mucopolysaccharidosis type IIIB (MPS IIIB). SBC-103 has orphan drug status in the U.S. and the EU.
2014 Guidance Maintained
Synageva expects net operating loss in the range of $190 million to $205 million in 2014. The company continues to invest in its pipeline and expand its global, commercial and medical infrastructure.
Synageva currently carries a Zacks Rank #4 (Sell). We expect investor focus to remain on data from the ARISE study.
Some better-ranked stocks in the biotech sector include Alexion Pharmaceuticals, Inc. ( ALXN ) and Gilead Sciences Inc. ( GILD ). Both carry a Zacks Rank #1 (Strong Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis Report
SYNAGEVA BIOPHM (GEVA): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
