Biodel Reports Fourth Quarter Fiscal Year 2013 Financial Results

Biodel Reports Fourth Quarter Fiscal Year 2013 Financial Results

Conference Call and Audio Webcast Will be Held Today, December 18th, at 5:00
p.m. ET

DANBURY, Conn., Dec. 18, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the fourth fiscal quarter ended September
30, 2013.

Portfolio highlights since last fiscal quarter:

  *Executed long-term commercial supply agreement with BD (Becton, Dickinson
    and Company) for worldwide exclusive rights to the ultra-portable and
    proprietary Uniject™ device for the delivery of liquid glucagon to treat
    severe hypoglycemia.
  *Manufactured engineering batch of BIOD-961 glucagon formulation for the
    EZMix™ auto-reconstitution device in preparation for initiation of
    IND-enabling toxicology studies.
  *Presented preclinical glucagon formulation data at Diabetes Technology
    Meeting demonstrating commercially viable pharmacokinetic and
    pharmacodynamic profiles comparable to glucagon products marketed by Eli
    Lilly and Novo Nordisk.
  *Reported positive top-line data from Phase 2 clinical trial of
    ultra-rapid-acting insulin candidate BIOD-123 and requested meeting with
    FDA.
  *Improved stability of analog-based ultra-rapid-acting insulin
    formulations.
  *Initiated Phase 1 clinical trial of concentrated ultra-rapid-acting
    insulin candidate BIOD-531.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"I am pleased with the progress we have made across our rapidly progressing
portfolio of innovative therapies for the treatment of diabetes. We look
forward to delivering on several key milestones in 2014 including reporting
top-line data from the BIOD-531 Phase 1 trial in the next calendar quarter,
identifying analog-based ultra-rapid-acting insulin candidates and initiating
pivotal trials on our glucagon program in the second half of 2014."

Fourth Quarter Financial Results

Biodel reported a net loss for the three months ended September 30, 2013 of
$0.8 million, or $0.04 per share of common stock, compared to a net loss of
$5.9 million, or $0.42 per share of common stock, for the same period in the
prior year.

Research and development expenses were $2.9 million for the three months ended
September 30, 2013, compared to $4.6 million for the same period in the prior
year. The decrease in research and development expenses was primarily
attributable to the completion of our Phase 2 clinical trial of BIOD-123.

General and administrative expenses were $1.7 million for the three months
ended September 30, 2013, compared to $1.2 million for the same period in the
prior year.

Expenses for the three months ended September 30, 2013 and 2012 included costs
of $0.3 million each in stock-based compensation expense related to options
and restricted stock units granted to employees and our non-employee
directors.

Biodel did not recognize any revenue during the three months ended September
30, 2013 or 2012.

At September 30, 2013, Biodel had cash and cash equivalents of $39.8 million
and 21.1 million shares of common stock outstanding.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on December 18, 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 13631899.

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. Biodel's
product candidates are developed by applying proprietary technologies to
existing drugs in order to improve their therapeutic profiles. More
information aboutBiodelis available atwww.biodel.com.

Biodel Inc.
(A Development Stage Company)
                                                                   
Balance Sheets
(In thousands, except share and per share amounts)
                                                                   
                                                          September 30,
                                                          2012      2013
ASSETS                                                              
Current:                                                            
Cash and cash equivalents                                  $39,050 $39,781
Restricted cash                                            60        -
Taxes receivable                                           34        6
Grant receivable                                           88        26
Other receivable                                           9         -
Prepaid and other assets                                   295       264
Total current assets                                       39,536    40,077
Property and equipment, net                                1,552     1,031
Intellectual property, net                                 46        43
Long term other assets                                     —         -
Total assets                                               $41,134 $41,151
LIABILITIES AND STOCKHOLDERS' EQUITY                                
Current:                                                            
Accounts payable                                           $285    $246
Accrued expenses:                                                   
Clinical trial expenses                                    488       181
Payroll and related                                        1,248     1,139
Accounting and legal fees                                  244       226
Severance                                                  141       255
Other                                                      273       319
Income taxes payable                                       101       75
Total current liabilities                                  2,780     2,441
Common stock warrant liability                             7,338     6,121
Severance payable, long term portion                       —         26
Total liabilities                                          10,118    8,588
Commitments                                                         
Stockholders' equity:                                               
Convertible preferred stock, $.01 par value; 50,000,000
shares authorized, 5,419,551 and 1,950,000 issued and      54        19
outstanding
Common stock, $.01 par value; 62,500,000 shares
authorized; 14,174,545 and 21,070,824 issued and           142       211
outstanding
Additional paid-in capital                                 226,913   247,761
Deficit accumulated during the development stage           (196,093) (215,428)
Total stockholders' equity                                 31,016    32,563
Total liabilities and stockholders' equity                 $41,134 $41,151


Biodel Inc.
(A Development Stage Company)
                                                              
Statements of Operations
(In thousands, except share and per share amounts)
                                                              
                                                              December
                                                              3,
                                                              2003
                             Year Ended September 30,            (Inception)
                                                                to
                                                              September
                                                              30,
                             2011        2012        2013        2013
Revenue                       $ —         $ —         $ —         $ —
Operating expenses:                                            
Research and development      13,597      12,315      14,296      155,400
Government grants             —           (88)        (546)       (634)
General and administrative    9,625       7,072       6,843       72,201
Total operating expenses      23,222      19,299      20,593      226,967
Other (income) and expense:                                    
Interest and other income     (60)        (80)        (56)        (5,702)
Interest expense              —           —           —           78
Adjustments to fair value of
common stock warrant          (12,611)    1,510       (1,217)     (11,064)
liability
Loss on settlement of debt    —           —           —           627
Loss before tax provision     (10,551)    (20,729)    (19,320)    (210,906)
(benefit)
Tax provision (benefit)       41          18          15          (538)
Net loss                      (10,592)    (20,747)    (19,335)    (210,368)
Charge for accretion of       —           —           —           (603)
beneficial conversion rights
Deemed dividend — warrants    —           —           —           (4,457)
Net loss applicable to common $(10,592) $(20,747) $(19,335) $(215,428)
stockholders
Net loss per share — basic    $(1.36)   $(1.91)   $(1.24)   
and diluted*
Weighted average shares
outstanding — basic and       7,788,741   10,882,688  15,650,538  
diluted*
____________                                                   
* Restated for a one for four (1:4) reverse stock split effective on June 11,
2012.

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 glucagon presentation that is intended to treat patients
experiencing severe hypoglycemia; our ability to conduct pivotal clinical
trials, other tests or analyses required by theU.S. Food and Drug
Administration, orFDA, to secure approval to commercialize a proprietary
formulation of injectable insulin or a stable glucagon presentation; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a stable glucagon
presentation; 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, 2013. 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

CONTACT: John Graziano, +1 (646) 378 2942
 
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