Biodel Reports Fourth Quarter Fiscal Year 2012 Financial Results

Biodel Reports Fourth Quarter Fiscal Year 2012 Financial Results

Conference Call and Audio Webcast Will be Held Today, December 18th, at 8:00
a.m. ET

DANBURY, Conn., Dec. 18, 2012 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the fourth fiscal quarter ended September
30, 2012.

Highlights of fourth fiscal quarter:

  *Initiated Phase 2 clinical trial of BIOD-123, an ultra-rapid-acting
    formulation of recombinant human insulin (RHI); top line data expected in
    the third calendar quarter of 2013.
  *Initiated Phase 1 clinical trial of BIOD-238 and BIOD-250, two
    ultra-rapid-acting formulations of an insulin analog; top line data
    expected in the first calendar quarter of 2013.
  *Awarded two NIH grants totaling approximately $1.16MM to develop novel and
    stable glucagon and concentrated ultra-rapid-acting insulin formulations
    for use in an artificial pancreas.
  *Prioritized liquid glucagon program to develop room temperature
    presentations.
  *Hosted research and development seminar featuring independent diabetes
    experts describing unmet medical needs and therapeutic developments
    related to Biodel's ultra-rapid-acting insulin and glucagon programs.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"We are pleased to be on track to generate top line Phase 1 data for two
ultra-rapid-acting insulin analog-based formulations in the first calendar
quarter of 2013 and to generate top line Phase 2 safety and efficacy data for
RHI-based BIOD-123 in the third calendar quarter of 2013. We believe that our
decision to shift our focus to developing a room temperature glucagon
presentation presents the best opportunity to achieve a more competitive
product."

Fourth Quarter Financial Results

Biodel reported a net loss for the three months ended September 30, 2012 of
$5.9 million, or $0.42 per share, compared to net income of $4.1 million, or
$0.43 per share, for the same period in the prior year. The results for the
three months ended September 30, 2012 and 2011 included an increase of $0.2
million and a decrease of $8.7 million, respectively, in the fair value of the
company's common stock warrant liability.

Research and development expenses, net of $88 thousand of grant revenue, were
$4.5 million for the three months ended September 30, 2012, compared to $2.6
million for the same period in the prior year. The increase in research and
development expenses was primarily attributable to clinical trials.

General and administrative expenses were $1.2 million for the three months
ended September 30, 2012, compared to $2.1 million for the same period in the
prior year. The decrease in general and administrative expenses was primarily
attributable to lower stock-based compensation expense.

Expenses for the three months ended September 30, 2012 and 2011 included costs
of $0.3 million and $1.0 million, respectively, in stock-based compensation
expense related to options granted to employees and non-employee directors.

Aside from research and development grants, Biodel did not recognize any
revenue during the three months ended September 30, 2012 or 2011.

At September 30, 2012, Biodel had cash and cash equivalents of $39.1 million
and 14.2 million shares of common stock outstanding.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on December 18, 2012
beginning at 8:00 a.m. 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) 303-8028 (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 on Biodel's website. Interested parties may also access an
audio replay by dialing (855) 859-2056 (US) or (404) 537-3406 (International)
and entering conference ID number 73281904.

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.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements about future activities related to the clinical
development plans for the company's drug candidates, including the potential
timing, design and outcomes of clinical trials; and the company's ability to
develop and commercialize product candidates. 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, the success of our product
candidates, particularly our proprietary formulations of injectable insulin
that are designed to be absorbed more rapidly than the "rapid-acting" mealtime
insulin analogs presently used to treat patients with Type 1 and Type 2
diabetes and our liquid glucagon formulation that is intended to treat
patients experiencing severe hypoglycemia; our ability to successfully
complete a Phase 2 clinical trial of a proprietary insulin formulation in a
timely manner, and the outcome of that trial; our ability to conduct pivotal
clinical trials, other tests or analyses required by the U.S. Food and Drug
Administration, or FDA, to secure approval to commercialize a proprietary
formulation of injectable insulin or a liquid formulation of glucagon; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a liquid formulation of
glucagon; our ability to secure approval from theFDAfor our product
candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act; the progress, timing or success of our research, development and clinical
programs, including any resulting data analyses; our ability to develop and
commercialize a proprietary formulation of injectable insulin that may be
associated with less injection site discomfort than Linjeta™ (formerly
referred to as VIAject®), which is the subject of a complete response letter
we received from theFDA; our ability to enter into collaboration arrangements
for the commercialization of our product candidates and the success or failure
of any such collaborations into which we enter, or our ability to
commercialize our product candidates ourselves; our ability to protect our
intellectual property and operate our business without infringing upon the
intellectual property rights of others; the degree of clinical utility of our
product candidates; the ability of our major suppliers to produce our products
in our final dosage form; our commercialization, marketing and manufacturing
capabilities and strategies; our ability to accurately estimate anticipated
operating losses, future revenues, capital requirements and our needs for
additional financing; and other factors identified in our most recent report
on Form 10-Q for the quarter endedJune 30, 2012. The company disclaims any
obligation to update any forward-looking statements as a result of events
occurring after the date of this press release.


Biodel Inc.
(A Development Stage Company)
Balance Sheets
(In thousands, except share and per share amounts)

                                                          September 30,
                                                          2011      2012
ASSETS
Current:                                                            
Cash and cash equivalents                                  $ 38,701  $ 39,050
Restricted cash                                            60        60
Taxes receivable                                           35        34
Grant receivable                                           —         88
Other receivable                                           1         9
Prepaid and other assets                                   399       295
Total current assets                                       39,196    39,536
Property and equipment, net                                2,253     1,552
Intellectual property, net                                 49        46
Long term other assets                                     7         —
Total assets                                               $ 41,505  $ 41,134
                                                          
LIABILITIES AND STOCKHOLDERS' EQUITY
Current:                                                            
Accounts payable                                           $ 222     $ 285
Accrued expenses:                                                   
Clinical trial expenses                                    763       488
Payroll and related                                        1,118     1,248
Accounting and legal fees                                  191       244
Severance                                                  688       141
Other                                                      205       273
Income taxes payable                                       103       101
Total current liabilities                                  3,290     2,780
Common stock warrant liability                             996       7,338
Severance payable, long term portion                       142       —
Total liabilities                                          4,428     10,118
Commitments                                                         
Stockholders' equity:                                               
Convertible preferred stock, $.01 par value; 50,000,000
shares authorized, 1,813,944 and 5,419,551 issued and      18        54
outstanding
Common stock, $.01 par value; 25,000,000 shares
authorized; 9,661,868 and 14,174,545 issued and            96        142
outstanding
Additional paid-in capital                                 212,309   226,913
Deficit accumulated during the development stage           (175,346) (196,093)
Total stockholders' equity                                 37,077    31,016
Total liabilities and stockholders' equity                 $ 41,505  $ 41,134



Biodel Inc.
(A Development Stage Company)
Statements of Operations
(In thousands, except share and per share amounts)

                             Year Ended September 30,          
                                                                December 3,
                                                                2003
                             2010       2011        2012       (Inception) to
                                                                September 30,
                                                                2012
Revenue                       $ —        $ —         $ —        $ —
Operating expenses:                                          
Research and development      26,177     13,901      12,571     142,700
Grant revenue                 —          —           (88)       (88)
General and administrative    10,980     9,321       6,816      63,762
Total operating expenses      37,157     23,222      19,299     206,374
Other (income) and expense:                                  
Interest and other income     (17)       (60)        (80)       (5,646)
Interest expense              —          —           —          78
Adjustments to fair value of
common stock warrant          1,254      (12,611)    1,510      (9,847)
liability
Loss on settlement of debt    —          —           —          627
Loss before tax provision     (38,394)   (10,551)    (20,729)   (191,586)
(benefit)
Tax provision (benefit)       (104)      41          18         (553)
Net loss                      (38,290)   (10,592)    (20,747)   (191,033)
Charge for accretion of       —          —           —          (603)
beneficial conversion rights
Deemed dividend — warrants    —          —           —          (4,457)
Net loss applicable to common $ (38,290) $ (10,592) $ (20,747) $ (196,093)
stockholders
Net loss per share — basic    $ (6.34)   $ (1.36)    $ (1.91)   
and diluted
Weighted average shares
outstanding — basic and       6,040,467  7,788,741   10,882,688 
diluted

BIOD-G

CONTACT: Seth D. Lewis, +1-646-378-2952
 
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