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Biodel Reports Second Quarter Fiscal Year 2013 Financial Results



Biodel Reports Second Quarter Fiscal Year 2013 Financial Results

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

DANBURY, Conn., May 8, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the second fiscal quarter ended March 31,
2013.

Portfolio highlights since last fiscal quarter:

  * Selected BIOD-531 as lead concentrated ultra-rapid-acting insulin product
    candidate. BIOD-531 is a formulation of recombinant human insulin (RHI)
    designed to compete in multiple insulin market segments.
  * Phase 2 clinical trial of RHI-based ultra-rapid-acting formulation
    BIOD-123 completed enrollment and more than fifty percent of subjects have
    finished the study; 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 report progress across the breadth of our portfolio of
pipeline product candidates. Enrollment is fully complete in our Phase 2
clinical trial of RHI-based ultra-rapid-acting insulin BIOD-123 and more than
half of the subjects have finished the study. We remain on track to report top
line data in the third calendar quarter of 2013. On the research front, our
new concentrated insulin candidate BIOD-531 has demonstrated an
ultra-rapid-acting onset and basal duration profile in diabetic swine which
could offer medical practitioners a novel therapeutic to improve prandial
coverage while maintaining basal coverage in both severely insulin resistant
patients and patients who use premixed insulins. We look forward to
progressing BIOD-531 into clinical trials."

Second Quarter Financial Results

Biodel reported a net loss for the three months ended March 31, 2013 of $5.2
million, or $0.37 per share of common stock, compared to a net loss of $4.3
million, or $0.45 per share of common stock, for the same period in the prior
year.

Research and development expenses were $3.0 million for the three months ended
March 31, 2013, compared to $2.6 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 $2.1 million for the three months
ended March 31, 2013, compared to $1.8 million for the same period in the
prior year.

Expenses for the three months ended March 31, 2013 and 2012 included costs of
$0.4 million and $0.3 million, respectively, in stock-based compensation
expense related to options and RSU's granted to employees and our non-employee
directors.

Biodel did not recognize any revenue during the three months ended March 31,
2013 or 2012.

At March 31, 2013, Biodel had cash and cash equivalents of $28.0 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 May 8, 2013
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 57651588.

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 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 December 31, 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, March 31,
                                                     2012          2013
                                                                   (unaudited)
                                                                    
ASSETS                                                              
Current:                                                            
Cash and cash equivalents                            $39,050       $27,901
Restricted cash                                      60            60
Taxes receivable                                     34            34
Grant receivable                                     88            29
Other receivables                                    9             —
Prepaid and other assets                             295           953
                                                                    
Total current assets                                 39,536        28,977
Property and equipment, net                          1,552         1,314
Intellectual property, net                           46            45
                                                                    
Total assets                                         $41,134       $30,336
                                                                    
LIABILITIES AND STOCKHOLDERS' EQUITY                                
Current:                                                            
Accounts payable                                     $285          $312
Accrued expenses:                                                   
Clinical trial expenses                              488           111
Payroll and related                                  1,248         790
Accounting and legal fees                            244           239
Severance                                            141           286
Other                                                273           130
Income taxes payable                                 101           97
                                                                    
Total current liabilities                            2,780         1,965
                                                                    
Common stock warrant liability                       7,338         5,226
Other long term liabilities                          —             122
                                                                    
Total liabilities                                    10,118        7,313
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 14,201,997 issued and     142           142
outstanding
Additional paid-in capital                           226,913       227,809
Deficit accumulated during the development stage     (196,093)     (204,982)
                                                                    
Total stockholders' equity                           31,016        23,023
                                                                    
Total liabilities and stockholders' equity           $41,134       $30,336

 
 
Biodel Inc.
(A Development Stage Company)
Consolidated Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
 
                                                                December 3,
                      Three Months Ended   Six Months Ended     2003
                      March 31,            March 31,            (inception) to
                                                                March 31,
                      2012      2013       2012      2013       2013
Revenue               $—        $—         $—        $—         $—
                                                                 
Operating expenses:                                              
Research and          2,643     3,044      4,996     7,778      150,478
development
Government grant      —         (29)       —         (224)      (312)
General and           1,830     2,096      3,851     3,466      67,228
administrative
                                                                 
Total operating       4,473     5,111      8,847     11,020     217,394
expenses
Other (income) and                                               
expense:
Interest and other    (17)      (12)       (41)      (28)       (5,674)
income
Interest expense      —         —          —         —          78
Adjustment to fair
value of common stock (146)     116        (1)       (2,112)    (11,959)
warrant liability
Loss on settlement of —         —          —         —          627
debt
                                                                 
Loss before tax       (4,310)   (5,215)    (8,805)   (8,880)    (200,466)
provision (benefit)
Tax provision         6         5          13        9          (544)
(benefit)
                                                                 
Net loss              (4,316)   (5,220)    (8,818)   (8,889)    (199,922)
Charge for accretion
of beneficial         —         —          —         —          (603)
conversion rights
Deemed dividend —     —         —          —         —          (4,457)
warrants
                                                                 
Net loss applicable
to common             $(4,316)  $(5,220)   $(8,818)  $(8,889)   $(204,982)
stockholders
                                                                 
Net loss per share —  $(0.45)   $(0.37)    $(0.91)   $(0.63)     
basic and diluted
                                                                 
Weighted average
shares outstanding —  9,688,559 14,182,451 9,681,135 14,179,219  
basic and diluted
                                                                 

BIOD-G

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