Biodel Reports Third Quarter Fiscal Year 2013 Financial Results

Biodel Reports Third Quarter Fiscal Year 2013 Financial Results

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

DANBURY, Conn., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the third fiscal quarter ended June 30,

Portfolio highlights since last fiscal quarter:

  *Completed dosing and all scheduled follow-up visits for patients in the
    Phase 2 clinical trial of BIOD-123, the company's lead candidate for an
    ultra-rapid-acting insulin formulated with recombinant human insulin
    (RHI); top-line data expected in the third calendar quarter of 2013.
  *Acquired worldwide exclusive rights to a proprietary auto-reconstitution
    technology for use with glucagon, enabling the development of a customized
    device for the rescue treatment of severe hypoglycemia; lead candidate
    formulation selected and an NDA submission is anticipated in 2015.
  *Raised $19.3 million in net proceeds from a public offering and related
    underwriters' over-allotment option.
  *Added to the Russell Microcap Index.
  *Presented Phase 1 clinical data for ultra-rapid-acting insulin
    lispro-based formulations and preclinical data for concentrated
    ultra-rapid-acting RHI-based formulations at the American Diabetes
    Association (ADA) 73rd Scientific Sessions.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"In addition to completing the treatment segment of our Phase 2 clinical trial
of BIOD-123, in this past quarter we acquired a proprietary delivery
technology for glucagon and presented promising data at ADA from both our
ultra-rapid-acting insulin analog and concentrated insulin formulation
programs. I am gratified by our progress in building a company with a broad
portfolio of novel therapeutics to treat diabetes, each serving a distinct
unmet need. We are thankful for the endorsement of both new and existing
investors in our recent successful financing and look forward to reporting
top-line data from the BIOD-123 Phase 2 trial this quarter."

Third Quarter Financial Results

Biodel reported a net loss for the three months ended June 30, 2013 of $9.6
million, or $0.66 per share of common stock, compared to a net loss of $6.1
million, or $0.52 per share of common stock, for the same period in the prior

Research and development expenses were $3.6 million for the three months ended
June 30, 2013, compared to $3.0 million for the same period in the prior year.
The increase in research and development expenses was primarily attributable
to expenses associated with our ongoing Phase 2 clinical trial of BIOD-123.

General and administrative expenses were $1.7 million for the three months
ended June 30, 2013, compared to $1.8 million for the same period in the prior

Expenses for the three months ended June 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 June 30,
2013 or 2012.

At June 30, 2013, Biodel had cash and cash equivalents of $42.4 million and
18.9 million shares of common stock outstanding.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on August 12, 2013
beginning at 5:00 p.m. 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) 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 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 24718917.

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 about Biodel is available at 

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 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 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 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-Q for the
quarter ended March 31, 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.

Biodel Inc.
(A Development Stage Company)
Consolidated Condensed Balance Sheets
(in thousands, except share and per share amounts)
                                                    September 30, June 30,
                                                     2012          2013
Cash and cash equivalents                            $39,050     $42,382
Restricted cash                                      60            60
Taxes receivable                                     34            18
Grant receivable                                     88            25
Other receivables                                    9             —
Prepaid and other assets                             295           688
Total current assets                                 39,536        43,173
Property and equipment, net                          1,552         1,157
Intellectual property, net                           46            44
Total assets                                         $41,134     $44,374
LIABILITIES AND STOCKHOLDERS' EQUITY                              
Accounts payable                                     $285        $240
Accrued expenses:                                                 
Clinical trial expenses                              488           199
Payroll and related                                  1,248         1,064
Accounting and legal fees                            244           263
Severance                                            141           286
Other                                                273           432
Income taxes payable                                 101           75
Total current liabilities                            2,780         2,559
Common stock warrant liability                       7,338         9,657
Other long term liabilities                          —             57
Total liabilities                                    10,118        12,273
Stockholders' equity:                                             
Convertible Preferred stock, $.01 par value;
50,000,000 shares authorized, 5,419,551 and          54            52
5,242,587 issued and outstanding
Common stock, $.01 par value; 62,500,000 shares
authorized; 14,174,545 and 18,902,691 issued and     142           189
Additional paid-in capital                           226,913       246,473
Deficit accumulated during the development stage     (196,093)     (214,613)
Total stockholders' equity                           31,016        32,101
Total liabilities and stockholders' equity           $41,134     $44,374

Biodel Inc.
(A Development Stage Company)
Consolidated Condensed Statements of Operations
(in thousands, except share and per share amounts)
                                                                  December 3,
                      Three Months Ended    Nine Months Ended     2003
                     June 30,              June 30,              (inception)
                                                                  June 30,
                     2012       2013       2012       2013       2013
Revenue               $ —        $ —        $ —        $ —        $ —
Operating expenses:                                           
Research and          2,956      3,568      7,952      11,346     154,046
Government grant      —          (25)       —          (249)      (337)
General and           1,776      1,674      5,626      5,140      68,902
Total operating       4,732      5,217      13,578     16,237     222,611
Other (income) and                                            
Interest and other    (15)       (11)       (56)       (39)       (5,685)
Interest expense      —          —          —          —          78
Adjustment to fair
value of common stock 1,355      4,431      1,354      2,319      (7,528)
warrant liability
Loss on settlement of —          —          —          —          627
Loss before tax       (6,072)    (9,637)    (14,876)   (18,517)   (210,103)
provision (benefit)
Tax provision         (21)       (6)        (8)        3          (550)
Net loss              (6,051)    (9,631)    (14,868)   (18,520)   (209,553)
Charge for accretion
of beneficial         —          —          —          —          (603)
conversion rights
Deemed dividend —     —          —          —          —          (4,457)
Net loss applicable
to common             $(6,051)  $(9,631)  $(14,868) $(18,520) $(214,613)
Net loss per share —  $ (0.52)   $ (0.66)   $ (1.44)   $ (1.29)   
basic and diluted
Weighted average
shares outstanding —  11,600,003 14,573,110 10,320,558 14,311,875 
basic and diluted


CONTACT: Seth D. Lewis, +1-646-378-2952
Press spacebar to pause and continue. Press esc to stop.