Synageva BioPharma Corp.
(“Synageva”) (NASDAQ:GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today reported first quarter 2014 financial results, and provided other business updates.
First Quarter 2014 Financial Results
For the quarter ended March 31, 2014, Synageva reported a net loss of $36.4 million compared to a net loss of $14.5 million for the corresponding quarter of the prior year. Revenue of $1.6 million for the quarter ended March 31, 2014 primarily consisted of $1.5 million of Fuzeon royalties from Roche, as well as revenue of $0.1 million from collaborations. Total costs and expenses for the quarter ended March 31, 2014, including research and development expenses, selling, general and administrative expenses, and amortization of developed technology, totaled $38.1 million. This compares to total costs and expenses for the first quarter of 2013 of $19.7 million. Synageva had cash, cash equivalents and short-term investments totaling $575.2 million on March 31, 2014.
Synageva reiterates its previous net loss guidance of between $190 and $205 million for 2014. The net loss is primarily due to investments supporting the global clinical development program for sebelipase alfa, development of SBC-103, expansion of the global clinical, medical affairs and commercial infrastructure, expansion of manufacturing capabilities, as well as advancement of other preclinical pipeline programs.
Sebelipase alfa and SBC-103
Synageva continues to plan to report top-line results from the Phase 3 ARISE trial with sebelipase alfa in children and adults with LAL Deficiency during the third quarter of 2014. Following this, the company continues to plan to complete submission of a Biologic License Application (BLA) to the U.S. Food & Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sebelipase alfa for the treatment of LAL Deficiency by the end of the first quarter of 2015. Synageva plans to initiate clinical trial sites for SBC-103 in patients with mucopolysaccharidosis IIIB (MPS IIIB) mid this year.