Message #3 From:
NewsBot Date: August 14, 2008 10:22:06 AM
BIOD Stock: Biodel Inc. Reports Third Quarter Fiscal Year 2008 Financial Results
Biodel Inc. (Nasdaq: BIOD stock) today reported financial results for its
third quarter ended June 30, 2008. The net loss for the quarter was
$10.1 million or $0.43 per share.
"Our third quarter financial results reflect recent clinical activities
including the completion of dosing in our two pivotal Phase III trials
of VIAject™ in July, the report of interim
results from secondary endpoints of these trials and our preparations
for analysis of the full data set from these trials later this year,"
stated Solomon Steiner, Ph.D., chief executive officer and chairman of
Biodel. "Interim results from these trials have been encouraging. We
look forward to receiving the final results of both studies later this
year, which we hope will confirm the advantages of VIAject’s
ultra-rapid-acting insulin and support our plan to file a 505(b)2 New
Drug Application for this important product candidate.”
Business Highlights
In July, Biodel completed dosing of its two pivotal Phase III clinical
trials of VIAject™ in patients with Type 1
and Type 2 diabetes. The company expects to report top line results
from these pivotal trials within the next six weeks.
The European Association for the Study of Diabetes (EASD) released two
abstracts which will be presented at its Annual Meeting on September
9, 2008 in Rome, Italy. These abstracts highlight results from a
January 2008 interim analysis of secondary end points for the company’s
pivotal Phase III trials for VIAject™. The
interim analysis showed a statistically significant difference in
weight changes and daily meal-time (prandial) dose reductions in
patients with Type 1 and Type 2 diabetes using VIAject™
compared to Humulin® R. The interim analysis
also showed statistically significant reductions in mild and moderate
hypoglycemic events in patients with Type 1 and Type 2 diabetes using
VIAject™ compared to Humulin®
R.
Biodel entered into a supply agreement with Organon on July 7, 2008 to
purchase specified quantities of recombinant human insulin for use in
the company’s VIAdel™
insulin formulations. The company believes that its current supplies
of insulin, together with the quantities of insulin that Organon has
agreed to supply, will be sufficient to complete the company’s
current and anticipated clinical trials of VIAject™
and support the company’s needs for
approximately three years following the commercial launch of VIAject™.
Positive findings from Phase I and II glucose clamp studies of VIAject™
were published in recent issues of the journals Diabetologia (Steiner
et al., Diabetologia, 2008) and Journal of Diabetes Science and
Technology (Hompesch et al., J. of Diabetes Science and Technology,
July 2008).
Biodel named Alan Krasner, M.D., its chief medical officer, effective
May 27, 2008. Dr. Krasner joined Biodel from Pfizer Global Research
and Development where he was director of the department of clinical
research, metabolic diseases. Former chief medical officer Dr. Andreas
Pfuetzner remains on Biodel's management team as the company's Senior
Vice President of Medical Affairs in Europe and as a member of the
company's scientific advisory board.
Biodel appointed Barry Ginsberg, M.D., Ph.D., to its board of
directors in June 2008. Dr. Ginsberg is the chief executive officer of
Diabetes Technology Consultants, which advises Fortune 500 companies
on the field of diabetes.
Biodel was added to the NASDAQ Biotechnology Index, effective May 19,
2008.
Financial Results for Three Months Ended
June 30, 2008
Biodel reported no revenue during the three months ended June 30, 2008
and June 30, 2007.
Biodel reported a net loss for the three months ended June 30, 2008 of
$10.1 million, or $0.43 per share, compared to a net loss of $5.3
million, or $0.30 per share, for the comparable period in the prior
year. Net loss for the quarter ended June 30, 2008 includes $1.9 million
of stock-based compensation expenses.
Research and development expenses were $6.9 million for the three months
ended June 30, 2008, compared to $2.6 million for the comparable period
in the prior year. The increase in quarterly expenses was primarily due
to a $1.3 million increase related to the pivotal Phase III clinical
trial program evaluating VIAject™, $1.5
million related to increased manufacturing expenses for the process
development, scale-up and manufacture of commercial batches of VIAject™
to support our clinical trials and regulatory submissions and $0.8
million in personnel-related expenses.
General and administrative expenses totaled $4.2 million for the three
months ended June 30, 2008, compared to $3.3 million for the comparable
period in the prior year. The increase for the quarter was primarily
attributable to $0.7 million in personnel-related expenses and $0.5
million in professional fees. The increase was offset by a decrease of
$0.9 million in stock-based compensation expenses. The three-months
ended June 30, 2007 included $1.7 million in stock-based compensation
expense related to options granted to the board of directors in May 2007.
Financial Results for Nine Months Ended
June 30, 2008
Biodel reported no revenue during the nine months ended June 30, 2008
and June 30, 2007.
Biodel reported a net loss applicable to common stockholders for the
nine months ended June 30, 2008 of $30.7 million, or $1.40 per share,
compared to a net loss applicable to common stockholders of $18.6
million, or $1.43 per share, for the comparable period in the prior
year. Net loss applicable to common stockholders for the nine months
ended June 30, 2008 includes $6.1 million of stock-based compensation
expenses. Net loss applicable to common stockholders for the nine months
ended June 30, 2007 included a $4.5 million deemed dividend charge.
Research and development expenses were $21.5 million for the nine months
ended June 30, 2008, compared to $8.9 million for the comparable period
in the prior year. The increase in expenses was primarily due to a $6.9
million increase related to the pivotal Phase III clinical trial program
evaluating VIAject™, a $1.4 million increase
related to increased manufacturing expenses for the process development,
scale-up and manufacture of commercial batches of VIAject™
to support the company's clinical trials and regulatory submissions, and
$2.2 million in personnel-related expenses.
General and administrative expenses totaled $11.8 million for the nine
months ended June 30, 2008, compared to $6.1 million for the comparable
period in the prior year. The increase was primarily attributable to
$3.7 million in personnel-related expenses and $0.8 million in
professional fees. Personnel-related expenses includes $4.7 million in
stock-based compensation expenses, and $1.1 million in stock-based
compensation and salary and benefits continuation charges related to the
severance agreement with the company's former chief financial officer.
The stock-based compensation expense includes $0.9 million of
stock-based compensation charges for options awarded to a newly
appointed board member.
At the end of the third quarter 2008, Biodel had $101.9 million in cash,
cash equivalents and marketable securities and 23.7 million shares
outstanding.
Conference Call and Webcast Information
Biodel's senior management team will host a conference call on
Wednesday, August 6, 2008 at 4:45 p.m. Eastern Time to discuss these
financial 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 1-877-675-4750 (United States)
or 1-719-325-4874 (international). To access the call by live Webcast,
please log on to the Investor section of Biodel's Web site at www.biodel.com.
An archived version of the Webcast will be available at Biodel's Web
site.
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 by using VIAdel™
technology, which reformulates existing FDA- approved peptide drugs. The
company's lead product candidate, VIAject™,
is an ultra rapid-acting injectable meal-time insulin in development for
use by patients with Type 1 or Type 2 diabetes. VIAject™
has been tested in two pivotal Phase III clinical trials. Biodel's
pipeline also includes VIAtab™, a sublingual
tablet formulation of insulin in the Phase I stage of clinical testing,
and two pre-clinical osteoporosis product candidates. For further
information regarding Biodel, please visit the company's Web site at www.biodel.com.
Safe Harbor
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, including
statements regarding our strategy, future operations, future clinical
trial results, future financial position, future revenues, projected
costs, prospects, plans and objectives of management are forward-looking
statements. The words "anticipates," "believes," "could," "estimates,"
"expects," "intends," "may," "plans," "potential," "predicts,"
"projects," "should," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. The
company's forward-looking statements are subject to a number of known
and unknown risks and uncertainties that could cause actual results,
performance or achievements to differ materially from those described or
implied in the forward-looking statements, including, but not limited
to, our ability to secure FDA approval for our product candidates under
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our
ability to market, commercialize and achieve market acceptance for
product candidates developed using our VIAdel™
technology; the progress or success of our research, development and
clinical programs, the initiation and completion of our clinical trials,
the timing of the interim analyses and the timing or success of our
product candidates, particularly VIAject™ and
VIAtab™; our ability to secure additional
patents for VIAject™ and our other product
candidates; our ability to protect our intellectual property and operate
our business without infringing upon the intellectual property rights of
others; our estimates of future performance; our ability to enter into
collaboration arrangements for the commercialization of our product
candidates and the success or failure of those collaborations after
consummation, if consummated; the rate and degree of market acceptance
and clinical utility of our products; our commercialization, marketing
and manufacturing capabilities and strategy; our estimates regarding
anticipated operating losses, future revenues, capital requirements and
our needs for additional financing; and other factors identified in our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008. The
company disclaims any obligation to update any forward-looking
statements as a result of events occurring after the date of this press
release.
