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Biodel Reports First Quarter Fiscal Year 2014 Financial Results

Biodel Reports First Quarter Fiscal Year 2014 Financial Results

Conference Call and Audio Webcast Will be Held Today, February 6th, at 5:00
p.m. ET

DANBURY, Conn., Feb. 6, 2014 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the first fiscal quarter ended December
31, 2013.

Portfolio highlights since last fiscal quarter:

  *Completed dosing in Study 3-150, a Phase 1 clinical trial comparing
    Biodel's proprietary insulin formulation, BIOD-531, to the marketed
    products Humulin^® R U-500 and Humalog^® Mix 75/25.
  *Continued progress on the glucagon rescue EZMix™ GEM program, including
    completion of dose ranging safety studies in preparation for initiation of
    GLP toxicology study in the 1^st calendar quarter, with projected near
    term milestones including an IND filing in the 3^rd calendar quarter and
    initiation of pivotal trial in the 4^th calendar quarter of 2014.
  *Presenting "Novel Formulations to Modify Mealtime Insulin Kinetics" in the
    Mealtime Insulin Industry Session at the 7th International Conference on
    Advanced Technologies & Treatments for Diabetes in Vienna, Austria,
    February 7, 2014.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"With the continued advancement of BIOD-531 and the GEM program, Biodel's
portfolio has expanded beyond our historical focus on ultra-rapid-acting
prandial insulins. The diversified nature of our portfolio requires a tailored
development and commercialization strategy. To optimize the risk-adjusted
return across the portfolio, we intend to fund the more expensive and higher
risk ultra-rapid-acting prandial insulin programs to critical inflection
points, such as proof-of-concept, thereby giving us the opportunity for
significant upside upon a possible partnership, while minimizing funding
requirements. Programs with shorter timelines, lower risk profiles, and lower
development cost, such as GEM, will be funded through an NDA, allowing us to
realize more of the upside. We look forward to reporting on key milestones in
2014, such as the pending BIOD-531 Phase 1 data and the initiation of the GEM
pivotal study, as we execute upon this strategy."

First Quarter Financial Results

Biodel reported a net loss for the three months ended December 31, 2013 of
$2.4 million, or $0.12 per share of common stock, compared to a net loss of
$3.7 million, or $0.26 per share of common stock, for the same period in the
prior year.

Research and development expenses were $3.7 million for the three months ended
December 31, 2013, compared to $4.7 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 $1.4 million for the three months
ended December 31, 2013, compared to $1.4 million for the same period in the
prior year.

Expenses for the three months ended December 31, 2013 included costs of $0.3
million, compared to $0.5 million for the same period in the prior year, 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 December
31, 2013 or 2012.

At December 31, 2013, Biodel had cash and cash equivalents of $35.2 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 February 6, 2014
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 49156436.

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 www.biodel.com.

Biodel Inc.
(A Development Stage Company)
Consolidated Condensed Balance Sheets
(in thousands, except share and per share amounts)
                                                                 
                                                        September December
                                                         30,       31,
                                                        2013      2013
                                                                 (unaudited)
ASSETS                                                            
Current:                                                          
Cash and cash equivalents                                $39,781 $35,241
Taxes receivable                                         6         6
Grant receivable                                         26        97
Prepaid and other assets                                 264       725
Total current assets                                     40,077    36,069
Property and equipment, net                              1,031     883
Intellectual property, net                               43        42
Total assets                                             $41,151 $36,994
                                                                 
LIABILITIES AND STOCKHOLDERS' EQUITY                              
Current:                                                          
Accounts payable                                         $246    $1,788
Accrued expenses:                                                 
Clinical trial expenses                                  181       257
Payroll and related                                      1,139     491
Accounting and legal fees                                226       160
Severance                                                255       162
Other                                                    319       173
Income taxes payable                                     75        3
Total current liabilities                                2,441     3,034
Common stock warrant liability                           6,121     3,535
Other long term liabilities                              26        —
Total liabilities                                        8,588     6,569
Commitments                                                       
Stockholders' equity:                                             
Convertible Preferred stock, $.01 par value; 50,000,000
shares authorized, 1,950,000 and 1,950,000 issued and    19        19
outstanding
Common stock, $.01 par value; 62,500,000 shares
authorized; 21,070,824 and 21,075,870 issued and         211       211
outstanding
Additional paid-in capital                               247,761   248,066
Deficit accumulated during the development stage         (215,428) (217,871)
Total stockholders' equity                               32,563    30,425
Total liabilities and stockholders' equity               $41,151 $36,994


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,
                                         2012       2013       2013
Revenue                                   $ —        $ —        $ —
Operating expenses:                                           
Research and development                  4,676      3,741      159,141
Government grant                          (196)      (97)       (731)
General and administrative                1,429      1,396      73,597
Total operating expenses                  5,909      5,040      232,007
Other (income) and expense:                                   
Interest and other income                 (16)       (16)       (5,718)
Interest expense                          —          —          78
Adjustment to fair value of common stock  (2,228)    (2,586)    (13,650)
warrant liability
Loss on settlement of debt                —          —          627
Loss before tax provision (benefit)       (3,665)    (2,438)    (213,344)
Tax provision (benefit)                   4          5          (533)
Net loss                                  (3,669)    (2,443)    (212,811)
Charge for accretion of beneficial        —          —          (603)
conversion rights
Deemed dividend — warrants                —          —          (4,457)
Net loss applicable to common             $(3,669) $(2,443) $(217,871)
stockholders
Net loss per share — basic and diluted    $(0.26)  $(0.12)  
Weighted average shares outstanding —     14,176,057 21,073,676 
basic and diluted

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-K for the fiscal year endedSeptember 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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