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Weekly UpdatesBiodel Inc. (Nasdaq: BIOD), Danbury, Conn., has reported financial results for the fourth quarter and fiscal year ended September 30, 2008 and reviewed recent corporate activities and plans.
Fourth Quarter and Full Year 2008 Financial Results
Biodel reported a net loss for the fourth quarter ended September 30, 2008 of $12.7 million, or $0.53 per share, as compared to a net loss of $8.4 million, or $0.42 per share, for the comparable period in the prior year. Net loss applicable to common stockholders for the year ended September 30, 2008 was $43.4 million, or $1.94 per share, as compared to $27.0 million, or $1.76 per share for the year ended September 30, 2007.
Research and development expenses were $11.0 million for the three months ended September 30, 2008, compared to $7.1 million for the same period in the prior year. For the 2008 fiscal year, research and development expenses were $32.6 million, compared to $15.9 million for 2007. The increase in quarterly and annual expenses was primarily due to costs related to Biodel's two pivotal Phase III clinical trials and ongoing extension clinical trials for VIAject, including $7.8 million related to increased clinical trial expenses in 2008; $3.3 million related to increased manufacturing expenses in 2008 for the process development, scale-up and manufacture of commercial batches of VIAject to support the company's clinical trials and regulatory submissions; and $2.6 million related to increased personnel costs, stock-based compensation expenses and consulting fees. Research and development expenses for the year ended September 30, 2008 include $1.3 million in stock-based compensation expense related to options granted to employees and $0.2 million in stock-based compensation expense related to options granted to non-employees. General and administrative expenses totaled $3.0 million for the three months ended September 30, 2008, compared to $2.3 million for the same period in the prior year. General and administrative expenses totaled $14.8 million for the year ended September 30, 2008, compared to $8.4 million for the comparable period in the prior year.
Biodel did not recognize any revenue during 2008 and 2007. At the end of fiscal year 2008, Biodel had cash, cash equivalents and marketable securities of $90.3 million and 23.7 million shares outstanding.
Business Review
In September 2008, the company announced results from a preliminary analysis of the data from two pivotal Phase III clinical trials comparing VIAject to Humulin R in patients with Type 1 and Type 2 diabetes. In the Type 2 trial, the company found that VIAject was comparable to Humulin R in terms of blood glucose control, when measured by the mean change in patients' HbA1c levels. Additionally, the company reported that Type 2 patients receiving VIAject, when compared to those receiving Humulin R, experienced fewer mild and moderate, or non-severe, hypoglycemic events and gained weight at a lower rate. In the Type 1 trial, the company found that VIAject was comparable to Humulin R in terms of blood glucose control among patients in the United States and Germany. However, when HbA1c data from patients in India were included in the analysis, change in HbA1c favored the Humulin R treatment group. Data from India was shown to be statistically different (treatment by country interaction, p=0.007) which, in the company's view, made these data not comparable to the data collected in the United States and Germany. The company also reported that Type 1 patients receiving VIAject, when compared to those receiving Humulin R, experienced fewer severe hypoglycemic events and lost weight instead of gaining weight. The finding regarding weight was progressive, with patients receiving VIAject continuing to lose weight and patients receiving Humulin R continuing to gain weight over the course of treatment. Accordingly, Biodel believes VIAject may be a safer form of mealtime insulin therapy than is currently available to patients with Type 1 or Type 2 diabetes.
Biodel expects to meet with officials from the U.S. Food and Drug Administration's Division of Metabolic and Endocrine Drug Products by the end of January 2009 to discuss the submission of a new drug application (NDA) for VIAject based on the results of the company's two pivotal Phase III clinical trials. Biodel is conducting ongoing analyses of all data from both trials that the company expects to complete prior to meeting with the FDA. After meeting with the FDA, the company plans to conduct at least one new clinical trial of VIAject in patients with Type 1 diabetes. The determination of whether to submit the NDA prior to or after the new trial will depend on the results of ongoing analyses, expert consultation and regulatory feedback. If Biodel submits the NDA after the completion of the additional trial, the submission would likely be filed no earlier than the second calendar quarter of 2010; if Biodel does not, it intends to submit the NDA by the end of the second calendar quarter of 2009. The company expects to provide an update on its plans by the end of the first calendar quarter of 2009.
Recently, the company reported positive effects of VIAjectTM on microvascular function in patients with Type 2 diabetes which were superior to results seen with regular human insulin and insulin lispro. VIAjectTM was found to be the most effective of the three insulins in improving microvasular blood flow and endothelial function and reducing postprandial oxidative stress. The findings were presented at the Eighth Annual Diabetes Technology Meeting in Bethesda, MD.
During fiscal year 2008, Biodel also raised net proceeds of $46.8 million from the sale of 3.26 million shares of common stock at $15.50 per share.
Upcoming Events During calendar year 2009, the company plans to:
Meet with the FDA and finalize the company's regulatory strategy for submission of an NDA for VIAject (1st calendar quarter)
Complete and announce results of a study testing the bioequivalence of four different formulations of VIAject in approximately 40 patients with Type 1 diabetes (1st calendar quarter)
Initiate another study of VIAject in patients with Type 1 diabetes (2nd/3rd calendar quarter)
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed using VIAdelTM technology, which reformulates existing FDA-approved peptide drugs.
For more information, visit http://www.Biodel.com or call 617/583-1308.
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