Synageva BioPharma Corp. GEVA reported first quarter 2015 loss of $1.63 per share, wider than the year-ago loss of $1.16 per share, but narrower than the Zacks Consensus Estimate of a loss of $1.71 per share. Lower revenues and higher costs led to the wider year over year loss.
First quarter revenues decreased 41.6% from the year-ago quarter to $0.9 million, missing the Zacks Consensus Estimate of $1 million.
In the reported quarter, Synageva’s revenues comprised entirely of royalties earned on Fuzeon.
Research & development (R&D) expenses shot up 37.1% year over year to $38.2 million. Selling, general & administration (SG&A) expenses increased 121% year over year to $21.7 million.
Synageva’s lead candidate, Kanuma is currently under regulatory review in the U.S., Europe and Mexico for the treatment of lysosomal acid lipase deficiency (LAL deficiency). The company expects a response from the FDA regarding the approval status of Kanuma by Sep 8, 2015.
Synageva plans to submit a marketing application for Kanuma in Japan this year. The company is simultaneously conducting additional studies on Kanuma to expand the clinical experience of the candidate in LAL deficiency.
Meanwhile, preliminary phase I/II data on SBC-103, which is being developed for the treatment of mucopolysaccharidosis IIIB (Sanfilippo B syndrome), should be out during the second half of this year.
2014 Outlook Reiterated
For 2015, Synageva continues to expect total operating expenses in the range of $280 million to $295 million as it continues to invest in its pipeline and expand its global, commercial and medical infrastructure.