Onyx reports Q1 loss of $14.2m

Onyx Pharmaceuticals has reported a non-GAAP* net loss of $14.2m, or $0.23 per diluted share, for the first quarter 2011 compared with a non-GAAP net loss of $1.5m, or $0.02 per diluted share, for the same period last year. 

On a GAAP basis, Onyx reported a net loss of $49.2m, or $0.78 per diluted share, for Q1 2011 compared to a net loss of $12.0m, or $0.19 per diluted share, for the same period in 2010. 

Global sales of the company's chemotherapy drug Nexavar (sorafenib), which is produced in collaboration with Bayer HealthCare Pharmaceuticals, increased in Q1 2011 by 10 per cent to $235.5m compared with the same period last year. Higher net sales of Nexavar also contributed to Onyx reporting an increase in revenue from collaboration, which was reported at $67.1m for the first quarter of 2011.

"2011 is a pivotal year of execution and growth for Onyx as we prepare to deliver a number of significant near-term milestones," said Dr N Anthony Coles, president and CEO of Onyx. "The NDA [New Drug Application] for carfilzomib in relapsed and refractory multiple myeloma is on track for filing; our phase III confirmatory trials, ASPIRE and FOCUS, are enrolling patients; and ONX 0912, our next generation proteasome inhibitor, is expected to advance to phase II. Importantly, we are ramping up our preparation for the commercialisation of carfilzomib, in anticipation of a potential US launch next year."

Onyx reported an increase in operating expenses for Q1 2011, when compared with the same period in 2010. This was due in part to investments in phase III developments and a $12.7m non-cash expense related to the remaining balance of the funding provided to S*BIO in May 2010.

The company also experienced higher selling, general and administrative expenses primarily due to planned increases in employee headcount and related costs, legal costs, pre-launch costs for carfilzomib and increased facilities-related costs.

*Non-GAAP net loss excludes, among other items, adjustments to contingent consideration expense in connection with Onyx's acquisition of Proteolix or Proteolix employee stock-based compensation expense; non-cash imputed interest expense related to the application of Accounting Standards Codification (ASC) 470-20 and charges associated with the restructuring of Onyx's development, collaboration, option and licence agreement with S*BIO Pte Ltd., or S*BIO.