Biodel Reports Third Quarter Fiscal Year 2009 Financial Results

Third Quarter Fiscal Year 2009 Financial
Results

Biodel reported a net loss for the quarter ended June 30, 2009 of $11.1
million, or $0.47 per share, compared to a net loss of $10.1 million, or
$0.43 per share, for the comparable period in the prior year.

Research and development expenses were $8.0 million for the three months
ended June 30, 2009, compared to $6.9 million for the same period in the
prior year. The increase in quarterly expenses was primarily due to
costs related to the purchase of recombinant human insulin to build
commercial supply inventory for VIAject(R) and a slight increase in
personnel expenses related to stock-based compensation. These increases
were offset by reductions in certain clinical and manufacturing expenses.

General and administrative expenses totaled $2.7 million for the three
months ended June 30, 2009, compared to $4.2 million for the same period
in the prior year. The decrease in general and administrative expenses
was attributable to reductions in stock-based compensation, professional
fees and travel expenses.

Expenses for the three months ended June 30, 2009 and 2008 include $1.3
million and $1.9 million, respectively, in stock-based compensation
expense related to options granted to employees and non-employees.

Biodel did not recognize any revenue during the third quarter of fiscal
years 2009 or 2008.

At the end of June 2009, Biodel had cash, cash equivalents and
marketable securities of $64.6 million and 23.8 million shares
outstanding.

VIAject(R) Update

During the quarter, Biodel continued its work to prepare a new drug
application (NDA) for submission to the U.S. Food and Drug
Administration by the end of calendar year 2009 for approval to market
VIAject(R) for the treatment of diabetes. The NDA will be based upon
results from multiple pharmacokinetic, pharmacodynamic and standardized
meal studies as well as the two completed Phase 3 studies of VIAject(R) in
patients with Type 1 and Type 2 diabetes. Biodel is now preparing its
NDA submission and initiating studies designed to further differentiate
the therapeutic potential of VIAject(R) from existing
rapid-acting prandial insulins.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on August 7, 2009
beginning at 9 am Eastern Daylight 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 1-877-591-4949 (United States) or 1-719-325-4889
(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 endocrine
disorders, such as diabetes and osteoporosis. Biodel's product
candidates are developed using VIAdel(TM) technology, which
reformulates existing FDA-approved peptide drugs. For further
information regarding Biodel, please visit the company's website at www.Biodel.com.

Safe Harbor Statement

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements represent our management's judgment regarding
future events. 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 have our VIAject(R) NDA accepted
for filing by the FDA; our ability to secure FDA approval for VIAject(R)
and our other 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(TM) technology, particularly VIAject(R); the
progress or success of our research, development and clinical programs
and the initiation and completion of our clinical trials; the FDA's
findings regarding data anomalies observed in India in our Phase III
clinical trial of VIAject(R) for patients with Type 1 diabetes;
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, 2009. The
company disclaims any obligation to update any forward-looking
statements as a result of events occurring after the date of this press
release.

BIOD-G

Biodel Inc.
(A Development Stage Company)
Condensed Balance Sheets
(in thousands, except share and per share amounts)
                                                                September 30,     June 30,
                                                                2008              2009
                                                                                  (unaudited)
ASSETS
Current:
Cash and cash equivalents                                       $      64,731     $     63,567
Marketable securities, available for sale                              25,552           1,000
Taxes receivable                                                       1,988            580
Prepaid and other assets                                               1,130            497
Total current assets                                                   93,401           65,644
Property and equipment, net                                            3,931            3,461
Intellectual property, net                                             59               57
Other assets                                                           120              --
Total assets                                                    $      97,511     $     69,162
LIABILITIES AND STOCKHOLDERS' EQUITY
Current:
Accounts payable                                                $      813        $     273
Accrued expenses:
Clinical trial expenses                                                4,163            6,472
Payroll and related                                                    1,420            1,216
Accounting and legal fees                                              509              432
Severance expense                                                      268              267
Other                                                                  839              624
Income taxes payable                                                   1,012            37
Total current liabilities                                              9,024            9,321
Commitments
Stockholders' equity:
Preferred stock, $0.01 par value; 50,000,000 shares authorized         --               --
Common stock, $0.01 par value; 100,000,000 shares authorized;          237              238
23,698,558 and 23,796,587 shares issued and outstanding
Additional paid-in capital                                             171,506          175,598
Accumulated other comprehensive (loss) income                          (62     )        --
Deficit accumulated during the development stage                       (83,194 )        (115,995 )
Total stockholders' equity                                             88,487           59,841
Total liabilities and stockholders' equity                      $      97,511     $     69,162

Biodel Inc.
(A Development Stage Company)
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
                                                                                                                                     December 3, 2003
                                                          Three Months Ended                     Nine Months Ended                   (inception) to
                                                          June 30,                               June 30,                            June 30,
                                                          2008                2009               2008              2009              2009
Revenue                                                   $   --              $   --             $  --             $  --             $        --
Operating expenses:
Research and development                                      6,884               7,991             21,525            24,387                  82,113
General and administrative                                    4,161               2,692             11,836            8,408                   34,059
Total operating expenses                                      11,045              10,683            33,361            32,795                  116,172
Other (income) and expense:
Interest and other income                                     (390       )        (54        )      (2,174     )      (374       )            (5,477   )
Interest expense                                              --                  --                --                --                      78
Loss on settlement of debt                                    --                  --                --                --                      627
Operating loss before tax provision (benefit)                 (10,655    )        (10,629    )      (31,187    )      (32,421    )            (111,400 )
Tax provision (benefit)                                       (544       )        519               (491       )      380                     (465     )
Net loss                                                      (10,111    )        (11,148    )      (30,696    )      (32,801    )            (110,935 )
Charge for accretion of beneficial conversion rights          --                  --                --                --                      (603     )
Deemed dividend -- warrants                                   --                  --                --                --                      (4,457   )
Net loss applicable to common stockholders                $   (10,111    )    $   (11,148    )   $  (30,696    )   $  (32,801    )   $        (115,995 )
Net loss per share -- basic and diluted                   $   (0.43      )    $   (0.47      )   $  (1.40      )   $  (1.38      )
Weighted average shares outstanding -- basic and diluted      23,653,956          23,759,675        21,959,335        23,727,833

SOURCE: Biodel Inc.

The Trout Group LLC 
Seth D. Lewis, +1-617-583-1308

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