pSivida Q4 loss rises on phase III trial spending

pSivida (ASX:PVA) reported a net loss for FY13 of US$11.9 million ($12.7 million), on revenues of US$2.1 million.

While the loss for the year was a significant reduction on the US$24.9 loss from FY12, that year’s results included a US$14.8 million impairment charge.

This impairment charge was a consequence of the US FDA’s rejection of marketing partner Alimera’s application for intravitreal insert Iluvien in diabetic macular edema in late 2011, and the subsequent significant decline in pSivida’s market cap.

Revenues were down from US$3.5 million, but FY12’s result likewise included a $1.1 million one-off payment resulting from the termination of a licensing agreement.

For the fiscal fourth quarter, pSivida’s net loss grew 69.5% to $3.9 million, due largely to costs associated with initiating the company’s phase III trial of Medidur - the same insert used in Iluvien - to treat posterior uveitis. This trial commenced in July.

Because the micro-inserts are the same, the FDA has granted pSivida permission to use much of the data from the Iluvien trials to support its posterior uveitis application.

“This should shorten and simplify the regulatory process,” pSivida CEO Dr Paul Ashton said. “Uveitis is the third leading cause of blindness in the US.”

pSivida (ASX:PVA) shares were trading 3.57% higher at $4.23 as of around 1.30 pm on Thursday.