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.
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.
Synageva’s lead candidate, sebelipase alfa, is in a phase III study (ARIS) 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.TO).
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.