Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today reported 2013 full year financial results and provided 2014 goals, other key objectives, and financial guidance. Synageva’s management team will host a conference call today at 4:30 p.m. EST to review the financial results and provide a general business update. To participate in today’s call by telephone, please dial (877) 445-4603 for U.S. callers or (443) 295-9270 for international callers. In addition, the conference call will be webcast live from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at www.synageva.com.
2013 Full Year Financial Results
For the year ended December 31, 2013, Synageva reported a net loss of $95.5 million compared to a net loss of $42.9 million for the corresponding period of the prior year.
Revenue for the full year ended December 31, 2013 of $13.4 million included $7.0 million of Fuzeon royalties from Roche, as well as revenue of $6.3 million from collaborations. Total costs and expenses for the full year 2013, including research and development (R&D) expenses, sales, general and administrative (SG&A) expenses, and amortization of developed technology, totaled $109.3 million. This compares to total costs and expenses for the full year 2012 of $58.0 million.Synageva had cash, cash equivalents and short-term investments totaling $408.7 million on December 31, 2013, compared with cash, cash equivalents and short-term investments totaling $219.0 million on December 31, 2012. 2014 Financial Outlook Synageva currently expects a net loss 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. Recent Company Highlights:
- Initiated and completed enrollment of 66 children and adults with lysosomal acid lipase deficiency (LAL Deficiency) in the ARISE Phase 3 trial with sebelipase alfa
- Completed the target enrollment in the Phase 2/3 trial in infants with LAL Deficiency and provided initial results
- Presented 90-week data from the ongoing Phase 1/2 extension study of sebelipase alfa in adults with LAL Deficiency
- Expansions to the global clinical, medical affairs and commercial infrastructure to further enhance disease awareness and identify more patients with LAL Deficiency
- Completed construction on an additional commercial-scale manufacturing facility to further supply protein therapeutics for lead programs
- Strengthened balance sheet as a result of completing follow-on offerings in January and September 2013, resulting in $281 million of net proceeds
- 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
- 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
- Continue global disease awareness programs to support identification of more infants, children and adults with LAL Deficiency
- Initiate a clinical trial with SBC-103 in mucopolysaccharidosis IIIB (MPS IIIB) during mid-2014
- Advance two additional programs into clinical trials by the end of 2016