Biodel Reports First Quarter Fiscal Year 2013 Financial Results

Biodel Reports First Quarter Fiscal Year 2013 Financial Results

Conference Call and Audio Webcast Will be Held Today, February 12th, at 5:00
p.m. ET

DANBURY, Conn., Feb. 12, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the first fiscal quarter ended December
31, 2012.

Highlights since first fiscal quarter:

  *Reported positive top line data from Phase 1 clinical trial of two
    Humalog^®-based ultra-rapid-acting formulations, BIOD-238 and BIOD-250.
  *Phase 2 clinical trial of BIOD-123, an ultra-rapid-acting formulation of
    recombinant human insulin (RHI), enrolling according to schedule; top line
    data expected in the third calendar quarter of 2013.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"We are pleased to have demonstrated that we can produce an insulin
analog-based formulation with an ultra-rapid-acting absorption profile similar
to what we've observed with our RHI-based formulations. Equally important is
replicating our achievement of improved absorption in a formulation with
injection site tolerability similar to that of Humalog^®. Demonstrating the
broad utility of our technology across a number of different insulin molecules
has expanded our strategic options as we look ahead to the Phase 2 data for
BIOD-123."

First Quarter Financial Results

Biodel reported a net loss for the three months ended December 31, 2012 of
$3.7 million, or $0.26 per share, compared to a net loss of $4.5 million, or
$0.47 per share, for the same period in the prior year.

Research and development expenses, net of $196 thousand of grant revenue, were
$4.5 million for the three months ended December 31, 2012, compared to $2.4
million for the same period in the prior year. The increase in research and
development expenses was primarily attributable to ongoing clinical trials.

General and administrative expenses were $1.4 million for the three months
ended December 31, 2012, compared to $2.0 million for the same period in the
prior year. The decrease in general and administrative expenses was primarily
attributable to a decrease in stock based compensation expense.

Expenses for the three months ended December 31, 2012 and 2011 included costs
of $0.5 million and $0.8 million, respectively, in stock-based compensation
expense related to options granted to employees and non-employee directors. In
addition, the results for the three months ended December 31, 2012 and 2011
included a decrease of $2.2 million and an increase of $0.1 million,
respectively, in the fair value of the company's common stock warrant
liability.

Aside from research and development grants in 2012, Biodel did not recognize
any revenue during the three months ended December 31, 2012 or 2011.

At December 31, 2012, Biodel had cash and cash equivalents of $34.3 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 February 12, 2013
beginning at 5:00 p.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 97322985.

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 the FDA for 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 the FDA; 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-K for the year ended September 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)
Consolidated Condensed Balance Sheets
(in thousands, except share and per share amounts)
                                                                
                                                   September 30, December 31,
                                                   2012          2012
                                                                (unaudited)
ASSETS                                                           
Current:                                                         
Cash and cash equivalents                           $ 39,050      $ 34,278
Restricted cash                                     60            60
Taxes receivable                                    34            34
Grant receivable                                    88            284
Other receivables                                   9             —
Prepaid and other assets                            295           1,116
                                                                
Total current assets                                39,536        35,772
Property and equipment, net                         1,552         1,473
Intellectual property, net                          46            45
                                                                
Total assets                                        $ 41,134      $ 37,290
                                                                
LIABILITIES AND STOCKHOLDERS' EQUITY                             
Current:                                                         
Accounts payable                                    $ 285         $ 1,129
Accrued expenses:                                                
Clinical trial expenses                             488           2,158
Payroll and related                                 1,248         499
Accounting and legal fees                           244           230
Severance                                           141           —
Other                                               273           173
Income taxes payable                                101           93
                                                                
Total current liabilities                           2,780         4,282
                                                                
Common stock warrant liability                      7,338         5,110
                                                                
Total liabilities                                   10,118       9,392
Commitments                                                      
Stockholders' equity:                                            
Convertible Preferred stock, $.01 par value;
50,000,000 shares authorized, 5,419,551 issued and  54            54
outstanding
Common stock, $.01 par value; 62,500,000 shares
authorized; 14,174,545 and 14,177,220 issued and    142           142
outstanding
Additional paid-in capital                          226,913       227,464
Deficit accumulated during the development stage    (196,093)     (199,762)
                                                                
Total stockholders' equity                          31,016        27,898
                                                                
Total liabilities and stockholders' equity          $ 41,134      $ 37,290
                                                                


Biodel Inc.
(A Development Stage Company)
Consolidated Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
                                                              
                                                              December 3,
                                                              2003
                                          Three Months Ended   (inception) to
                                          December 31,         December 31,
                                          2011      2012       2012
Revenue                                    $ —      $ —       $ —
                                                             
Operating expenses:                                           
Research and development                   2,353     4,735      147,435
Government grant                           —         (196)      (284)
General and administrative                 2,020     1,370      65,132
                                                             
Total operating expenses                   4,373     5,909      212,283
Other (income)and expense:                                   
Interest and other income                  (24)      (16)       (5,662)
Interest expense                           —         —          78
Adjustment to fair value of common stock   145       (2,228)    (12,075)
warrant liability
Loss on settlement of debt                 —         —          627
                                                             
Loss before tax provision (benefit)        (4,494)   (3,655)    (195,251)
Tax provision (benefit)                    7         4          (549)
                                                             
Net loss                                   (4,501)   (3,669)    (194,702)
Charge for accretion of beneficial         —         —          (603)
conversion rights
Deemed dividend — warrants                 —         —          (4,457)
                                                             
Net loss applicable to common stockholders $ (4,501) (3,669)    $ (199,762)
                                                             
Net loss per share — basic and diluted     $ (0.47)  (0.26)     
                                                             
Weighted average shares outstanding —      9,673,529 14,176,057 
basic and diluted

BIOD-G

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