Biodel Inc.’s (BIOD) shares were down 3.5% immediately after the company reported second quarter fiscal 2014 report. Overall, shares are down 6.9% since the company released second quarter results.
The company reported a loss of 29 cents per share, narrower than the year-ago loss of 37 cents but wider than 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.
The Quarter in Detail
R&D expenses increased 43.5% to $4.3 million. This increase was primarily driven by expenses related to the development of Glucagon Emergency Management (GEM.V) program.
G&A expenses decreased 20.4% to $1.7 million.
Biodel started dosing patients with BIOD-531 in the first of two planned phase II meal studies (Study 3-151 and Study 3-152). The study will assess its benefits on post prandial control of glucose in diabetic patients. Results should be out in the fourth quarter of calendar 2014.
Biodel received the U.S. Food and Drug Administration’s (:FDA) feedback on the design of a proposed phase III study necessary for the approval of BIOD-531. Biodel requested the agency to help in defining the toxicology requirements in the study on BIOD-531. A response from the FDA is expected in the third quarter of calendar 2014.
Meanwhile, Biodel finished dosing in rats in an ongoing GLP toxicology study for the development of the GEM device as a rescue treatment of severe hypoglycemia. Results should be out by the third quarter of calendar 2014. The company plans to conduct at least two studies on the GEM device in human patients in 2014. Biodel intends to file a new drug application (:NDA) for the device in late 2015.
In the reported quarter, Biodel entered into agreements with companies like HEC Pharm and Emergent BioSolutions, Inc. (EBS). Biodel signed a long-term commercial manufacturing agreement with Emergent BioSolutions for the sale and finish of Biodel's GEM device. Recently, the company signed a research supply and technology development agreement with HEC Pharm for ultra-rapid-acting insulin aspart.
Biodel carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Cardiome Pharma Corp. (CRME) and Avanir Pharmaceuticals, Inc. (AVNR). While Cardiome carries a Zacks Rank #1 (Strong Buy), Avanir holds a Zacks Rank #2 (Buy).
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