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Biodel Reports First Quarter Fiscal Year 2013 Financial Results

DANBURY, Conn., Feb. 12, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today reported financial results for the first fiscal quarter ended December 31, 2012.

Highlights since first fiscal quarter:
  • Reported positive top line data from Phase 1 clinical trial of two Humalog ®-based ultra-rapid-acting formulations, BIOD-238 and BIOD-250.
  • Phase 2 clinical trial of BIOD-123, an ultra-rapid-acting formulation of recombinant human insulin (RHI), enrolling according to schedule; top line data expected in the third calendar quarter of 2013.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are pleased to have demonstrated that we can produce an insulin analog-based formulation with an ultra-rapid-acting absorption profile similar to what we've observed with our RHI-based formulations. Equally important is replicating our achievement of improved absorption in a formulation with injection site tolerability similar to that of Humalog ®. Demonstrating the broad utility of our technology across a number of different insulin molecules has expanded our strategic options as we look ahead to the Phase 2 data for BIOD-123."

First Quarter Financial Results

Biodel reported a net loss for the three months ended December 31, 2012 of $3.7 million, or $0.26 per share, compared to a net loss of $4.5 million, or $0.47 per share, for the same period in the prior year.

Research and development expenses, net of $196 thousand of grant revenue, were $4.5 million for the three months ended December 31, 2012, compared to $2.4 million for the same period in the prior year. The increase in research and development expenses was primarily attributable to ongoing clinical trials.

General and administrative expenses were $1.4 million for the three months ended December 31, 2012, compared to $2.0 million for the same period in the prior year. The decrease in general and administrative expenses was primarily attributable to a decrease in stock based compensation expense.

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