Biodel Reports Third Quarter Fiscal Year 2012 Financial Results

GlobeNewswire

Wednesday, August 8th 2012

DANBURY, Conn., Aug. 8, 2012 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today reported financial results for the third fiscal quarter ended June 30, 2012.

Highlights since beginning of third fiscal quarter

Completion of $18.5 million financing with institutional investors.
Obtained exclusive license to Aegis Therapeutics' technologies for development and commercialization of glucagon pharmaceutical formulations.
Liquid formulation of glucagon for the treatment of severe hypoglycemia remains on track for projected NDA submission in early 2014.
Presented positive Phase 1 clinical data at the American Diabetes Association 72^nd Scientific Sessions for lead recombinant human insulin-based ultra-rapid-acting candidates BIOD-123 and BIOD-125; BIOD-123 on track for advancement into Phase 2 clinical trial this quarter with top line data projected for third calendar quarter of 2013.
Analog-based ultra-rapid-acting insulin remains on target for top line Phase 1 data in first calendar quarter of 2013.
Awarded NIH grant of $582,473 to develop concentrated ultra-rapid-acting insulin formulations for use in artificial pancreas.
Regained compliance with NASDAQ minimum bid price listing requirement.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We have continued to build on our momentum by achieving milestones that keep us on track to generate top line Phase 1 data for our analog-based ultra-rapid-acting insulin in the first calendar quarter of 2013, generate top line Phase 2 safety and efficacy data for BIOD-123 in the third calendar quarter of 2013 and submit an NDA for a liquid formulation of glucagon for the treatment of severe hypoglycemia in early 2014. The recent financing extends our runway and enables us to reach all of these value building milestones without the need for additional financing."

Third Quarter Financial Results

Biodel reported a net loss for the three months ended June 30, 2012 of $6.1 million, or $0.52 per share, compared to a net loss of $4.0 million, or $0.48 per share, for the same period in the prior year.

Research and development expenses were $3.0 million for the three months ended June 30, 2012, compared to $2.9 million for the same period in the prior year.

General and administrative expenses were $1.8 million for the three months ended June 30, 2012, compared to $2.4 million for the same period in the prior year. The decrease in general and administrative expenses was primarily attributable to lower stock-based compensation expense.

Expenses for the three months ended June 30, 2012 and 2011 included costs of $0.3 million and $1.3 million, respectively, in stock-based compensation expense related to options granted to employees and non-employee directors. In addition, the results for the three months ended June 30, 2012 and 2011 included an increase of $1.4 million and a decrease of $1.4 million, respectively, in the fair value of the company's common stock warrant liability.

Biodel did not recognize any revenue during the three months ended June 30, 2012 or 2011.

On June 11, 2012, the company effected a one-for-four reverse split of its outstanding common stock and fixed on a post-split basis the number of authorized shares of its common stock at 25,000,000 (reduced from 100,000,000 authorized shares). As a result of the reverse stock split, each share of the company's common stock outstanding at the effective time was automatically changed into one-quarter of a share of common stock. Also as a result of the reverse stock split, the number of shares of common stock subject to outstanding options restricted stock units and warrants issued by the company and the number of shares reserved for future issuance under the company's stock plans were reduced by a factor of four.

On June 27, 2012, the company completed a private placement of an aggregate of 4,250,020 shares of the company's common stock, 3,605,607 shares of the company's series B convertible preferred stock and warrants to purchase an aggregate of 2,749,469 shares of its common stock at an exercise price of $2.66 per share. The company received net proceeds, after deducting placement agents' fees and other transaction expenses, of approximately $17.2 million from the 2012 private placement.

At June 30, 2012, Biodel had cash and cash equivalents of $43.7 million and 14.0 million and 5.4 million shares of common stock and convertible preferred stock outstanding, respectively.

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