DANBURY, Conn., Dec. 6, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today reported financial results for the fourth quarter ended September 30, 2011.
Fourth Quarter Operating Highlights
During Biodel’s fourth quarter of fiscal year 2011, the company:
- Selected a new lead candidate formulation of ultra-rapid-acting recombinant human insulin, or RHI, for a Phase 1 clinical trial;
- Extended an agreement with a pharmaceutical company for the supply of an insulin analog as the active pharmaceutical ingredient, or API, to be used in the clinical development of ultra-rapid-acting insulin candidates;
- Continued pipeline development with advances in liquid stabilized glucagon program; and
- Conserved cash by instituting cost cutting measures to maintain cash runway through the second calendar quarter of 2013.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “The focus and execution of our team has allowed us to rapidly advance a new ultra-rapid-acting recombinant human insulin formulation, which will be in the clinic next quarter. Furthermore, we are encouraged by having secured insulin analog supply for our clinical program. The goal of the new formulations is to mimic the pharmacokinetic and pharmacodynamic profiles seen in Linjeta while improving tolerability. Continued focus and prudent use of resources will allow us to develop a new generation of ultra-rapid-acting insulin product candidates, leverage other promising candidates in our pipeline and build value for shareholders.”
Fourth Quarter Financial Results
Biodel reported a net profit of $4.1 million, or basic earnings per share of $0.11 or a diluted earnings per share of $0.10, which includes an $8.7 million decrease in warrant liability for the quarter ended September 30, 2011, compared to a net loss of $8.1 million, or $0.31 per share basic and diluted, which includes a $1.3 million increase in its warrant liability for the same period in 2010. For fiscal year 2011 Biodel had a net loss of $10.6 million, or $0.34 per share basic and diluted, which includes a $12.6 million decrease in its warrant liability, compared to a net loss of $38.3 million, or $1.58 per share basic and diluted, which includes a $1.3 million increase in its warrant liability for fiscal year 2010.
Research and development expenses during the quarter ended September 30, 2011 were $2.6 million compared to $4.5 million for the same period in 2010, and for fiscal year 2011 were $13.9 million compared to $26.2 million for fiscal year 2010. The decrease in research and development expenses was primarily attributed to reductions in clinical and regulatory expenses.
General and administrative expenses were $2.1 million during the quarter ended September 30, 2011 compared to $2.4 million for the same period in 2010. General and administrative expenses for fiscal year 2011 were $9.3 million compared to $11.0 million for fiscal year 2010. The decrease was primarily attributable to lower personnel costs.
Biodel did not recognize any revenue during the quarters ended September 30, 2010 or 2011.
At September 30, 2011, Biodel had cash and cash equivalents of $38.7 million and 38.6 million shares of common stock outstanding.
Conference Call and Webcast Information
Biodel’s senior management will host a conference call on December 6, 2011 beginning at 4:30 pm Eastern 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) 303-8025 (United States) or +1 (760) 536-5162 (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 on 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.
