Biodel (BIOD) Misses Q1 EPS by 3c
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Operating loss before tax provision (benefit): -3.09M
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Biodel (NASDAQ: BIOD) reported Q1 EPS of ($0.20), $0.03 worse than the analyst estimate of ($0.17).
At December 31, 2014, Biodel had cash and cash equivalents of $19.7 million and 23.5 million shares of common stock outstanding.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are off to a great start in 2015. In early January we announced positive data from Study 3-151, a Phase 2a Meal Study of BIOD-531, our concentrated ultra-rapid-acting insulin candidate, in diabetes patients who have significant insulin resistance and who are using greater than 150 units of insulin per day or greater than 100 units in a single injection. The positive data from Study 3-151 comes on the heels of the previously announced Phase 2a meal study data from Study 3-152, which demonstrated superiority of BIOD-531 versus Humalog® Mix 75/25 and Humulin® R U-500 in diabetes patients who have moderate insulin resistance. In addition to showing superiority in post meal glucose control against marketed insulin comparators, BIOD-531's unique profile has shown flexibility in dosing both pre and post meal. We are initiating studies to complete the toxicology and chemistry, manufacturing and controls requirements for pivotal trials while at the same time initiating a multi-dose, Phase 2b trial comparing BIOD-531 to Humalog® Mix 75/25 in type 2 diabetes patients with moderate insulin resistance. In addition, we continue to advance the GEM program and remain on target to announce the top line results of the Phase 1 proof-of-concept study towards the end of this calendar quarter."
For earnings history and earnings-related data on Biodel (BIOD) click here.
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