Synageva BioPharma Corp. (GEVA) reported fourth quarter 2013 loss of $1 per share, wider than the year-ago loss of 62 cents per share, but narrower than the Zacks Consensus Estimate of a loss of $1.02 per share.
Fourth quarter revenues were $3.5 million, down 28.8% from the year-ago quarter. Revenues, however, surpassed the Zacks Consensus Estimate of $2 million.
Synageva reported a full-year loss of $3.40 per share, wider than the year-ago loss of $1.90 per share and the Zacks Consensus Estimate of a loss of $3.37 per share.
Revenues decreased 10.6% in 2013 to $13.4 million from the previous year. Revenues, however, surpassed the Zacks Consensus Estimate of $12 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 95% year over year to $25.2 million. SG&A expenses increased 39.7% year over year to $8.9 million.
Synageva expects a net operating loss of $190 million − $205 million in 2014 as it continues to invest in its pipeline and expands its global, commercial and medical infrastructure.
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. Top-line results should be out in the third quarter of 2014.
By the end of the first quarter of 2015, the company expects to file a Biologic License Application (:BLA) for sebelipase alfa 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 commence a study on SBC-103 by mid-2014. SBC-103 will be evaluated as an enzyme replacement therapy for mucopolysaccharidosis type IIIB (MPS IIIB).
Synageva currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on thye ARISE data.