Biodel Q3 Loss Narrower than Expected, Gives Pipeline Update


Biodel Inc. (BIOD), which had incurred a wider-than-expected loss in each of the last two quarters, reported a narrower-than-expected loss in the third quarter of fiscal 2014 report (ended Jun 30, 2014) earlier this week.

Biodel reported a loss of 15 cents per share, narrower than the year-ago loss of 66 cents per share and the Zacks Consensus Estimate of a loss of 26 cents per share.

Biodel did not generate any revenues in the reported quarter and in the year-ago quarter.

Quarter in Detail

Research & development expenses increased 4.4% to $3.6 million. This increase was primarily driven by expenses related to the development of the Glucagon Emergency Management (GEM.V) product.

General & administrative expenses decreased 23.8% to $1.3 million.

Apart from announcing earnings results, Biodel announced positive results from a phase II study (3-152) on BIOD-531, the company’s lead candidate for an ultra-rapid-acting insulin formulation. The company is working with the FDA on the pivotal trial design.

The study demonstrated superiority to Eli Lilly & Company’s (LLY) Humulin R U-500 and Humalog Mix 75/25 on post prandial glucose control following two standardized meals in patients with type 2 diabetes with moderate insulin resistance.

Meanwhile, Biodel is planning to expand the scope of the study 3-151 on BIOD-531 and it expects to complete the modified study in the fourth quarter of 2014.

The company announced positive results from a human factor study evaluating the successful handling of its GEM device with limited to no training. The final pivotal study is expected to complete in the third quarter of 2015.

Biodel intends to file for a New Drug Application for the device in late 2015. 

Biodel carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Endo International plc (ENDP) and Avanir Pharmaceuticals, Inc. (AVNR). While Endo International carries a Zacks Rank #1 (Strong Buy), Avanir holds a Zacks Rank #2 (Buy).

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