Princeton, N.J.-based Pharmasset, a clinical stage pharma company that discovers, develops and commercializes drugs to treat viral infections, reported a net loss of $91.2 million, or $1.25 per share, for the fiscal year ended September 30, 2011, compared to a net loss of $66.1 million, or $1.07 per share for fiscal 2010. Revenues were $0.9 million for fiscal year 2011, compared to $1.0 million for fiscal 2010. Revenues during each fiscal year primarily consist of amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue. 

Total costs and expenses for the fiscal year were $92.5 million, compared to $64.7 million for fiscal 2010. The increase in operating expenses was primarily the result of increased clinical development costs associated with the initiation and ongoing conduct of the phase II ELECTRON and ATOMIC studies, as well as the advancement of PSI-938 in NUCLEAR and the large phase IIb QUANTUM study.

At fiscal year end Pharmasset held $166.5 million in cash and cash equivalents and used $21.7 million of cash and cash equivalents during the fourth quarter of fiscal 2011.

"In 2011, we have made significant advances with our HCV nucleotide analogs," said Schaefer Price, President and CEO. "Encouraging data in combination with PSI-7977's good safety profile and high barrier to resistance have enabled us to rapidly initiate the first interferon-free phase III program in the industry. We are excited to pursue an interferon-free regimen in phase III, since interferon intolerability keeps most patients from being treated for their HCV. We anticipate filing for marketing approval in the U.S. and Europe in the second half of 2013 and hope to be the first to introduce an interferon-free regimen in the marketplace."

Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection.