Biodel Reports Second Quarter Fiscal Year 2011 Financial Results
4:00 pm ET 05/05/2011 - PR Newswire
DANBURY, Conn., May 5, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today reported financial results for the quarter ended March 31, 2011.
Second Quarter Fiscal Year 2011 Financial Results
Biodel reported a net loss for the three months ended March 31, 2011 of $5.4 million, or $0.21 per share, compared to a net loss of $10.4 million, or $0.44 per share, for the same period in the prior year.
Research and development expenses were $2.9 million for the three months ended March 31, 2011, compared to $7.0 million for the same period in the prior year. The decrease of $4.1 million in expenses was primarily attributed to non-recurring events that occurred in the previous fiscal year including the conclusion of the Linjeta™ Phase 3 extension trials in February 2010 at a cost of $2.1 million; recombinant human insulin purchased at a cost of $1 million; professional fees of $0.7 million related to the 120 day safety report filing of Linjeta™ and follow-on questions from the FDA, and pen development costs of $0.4 million.
General and administrative expenses totaled $2.3 million for the three months ended March 31, 2011, compared to $3.4 million for the same period in the prior year. The decrease in general and administrative expenses was attributable to a decrease in personnel costs of $0.7 million as a result of lower headcount from 2010, and savings of $0.4 million in professional fees due to cost cutting measures.
Expenses for the three months ended March 31, 2011 and 2010 included $2.6 million in stock-based compensation expense related to options granted to employees and non-employee directors.
Biodel did not recognize any revenue during the three months ended March 31, 2011 or 2010.
At March 31, 2011, Biodel had cash and cash equivalents of $17.6 million and 26.5 million shares outstanding.
Business Review
•Biodel has selected two new recombinant human insulin-based formulation candidates, BIOD-105 and BIOD-107, for clinical development as ultra-rapid-acting mealtime insulins for the treatment of diabetes. Following recent discussions with the U.S. Food and Drug Administration, Biodel now plans to accelerate the timelines for clinical testing of these new formulations.
•Biodel has initiated a Phase 1 trial of BIOD-105 and BIOD-107 in a double-blind, three-period cross-over study in patients with Type 1 diabetes. This trial will evaluate the pharmacokinetic, pharmacodynamic and injection site tolerability profiles of the two experimental insulins relative to Humalog® when delivered by subcutaneous injection.
•In parallel with the Phase 1 clinical trial of BIOD-105 and BIOD-107 described above, investigators at Oregon Health and Sciences University will soon initiate a similar comparative study evaluating the use of these formulations and Humalog® when delivered by insulin pumps. The results of the two Phase 1 trials will be used to select the best formulation for Phase 2 clinical testing, planned to initiate later this year and Phase 3 clinical testing planned to initiate in 2012.
•Biodel recently named Dr. Brian Pereira as chairman of the company's board of directors. Dr. Pereira has been a board member since November 2007 and, as an experienced biotechnology executive, brings invaluable expertise to the company. Former chairman Dr. Charles Sanders will remain a member of Biodel's board.
Conference Call and Webcast Information
Biodel's senior management will host a conference call on May 5, 2011, beginning at 4:30 pm Eastern Daylight Saving Time, to discuss these results and provide a company update. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 1-877-303-8028 (United States) or 1-760-536-5167 (international). To access the call by live audio webcast, please log on to the investor section of the company's website at www.biodel.com. An archived version of the audio webcast will be available at Biodel's website.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com.
