Biodel Reports Third Quarter Fiscal Year 2014 Financial Results

Biodel Reports Third Quarter Fiscal Year 2014 Financial Results 
Conference Call and Audio and Visual Webcast Will Be Held Today,
August 11th, at 5:00 p.m. EST 
DANBURY, CT  -- (Marketwired) -- 08/11/14 --  Biodel Inc. (NASDAQ:
BIOD) today reported financial results for the third fiscal quarter
ended June 30, 2014.  
Portfolio highlights since last fiscal quarter:  


 
--  Announcement of positive top line data from Study 3-152, a Phase 2a
    clinical trial comparing Biodel's proprietary concentrated insulin
    formulation BIOD-531 to Humalog® Mix 75/25 and Humulin® R U-500 in
    patients with type 2 diabetes with moderate insulin resistance; BIOD-531
    demonstrated superiority over both comparators with respect to lower
    glucose responses following standardized meal challenges. 
--  Continued progress on the glucagon rescue Glucagon Emergency Management
    (GEM) program, including filing an IND and completion of a formative
    human factors study demonstrating successful usage of the auto-
    reconstitution device with little to no training; initiation of clinical
    trial and manufacture of commercial registration lots planned for
    calendar 4Q14. 
--  Presentation of four abstracts at the 74th Scientific Sessions of the
    American Diabetes Association in San Francisco, California, June 13-17,
    2014 and acceptance of two abstracts for presentation at the 50th Annual
    Meeting of the European Association for the Study of Diabetes in Vienna,
    Austria, September 16-19, 2014.
--  Implementation of an at-the-market facility for the sale of up to $14
    million of the company's common stock and an equity purchase commitment
    for an additional $15 million of the company's common stock.

 
Dr. Errol De Souza, president and chief executive officer of Biodel,
stated: "We have made rapid progress in achieving multiple
significant milestones in all of our programs this quarter. On the
heels of impressive Phase 1 results earlier this year, we rapidly
advanced BIOD-531 into multiple Phase 2 trials and are pleased to
report that BIOD-531 demonstrates superiority versus Humalog® Mix
75/25 and Humulin® R U-500 prandial/basal insulin on postprandial
glucose responses. This morning we announced positive data from the
BIOD-531 Study 3-152 meal study and are working with the FDA to get
agreement on pivotal trial design and look forward to updating you on
the further advancement of BIOD-531. We continue to advance the GEM
program with the filing of the IND and finalizing the design of the
device in anticipation of manufacturing registration lots towards the
end of the year. We look forward to reporting on additional key
milestones in 2014, such as the results of our second meal study with
BIOD-531 and the initiation of a GEM clinical study."   
Third Quarter Financial Results  
Biodel reported a net loss for the three months ended June 30, 2014
of $3.2 million, or $0.15 per share of common stock, compared to a
net loss of $9.6 million, or $0.66 per share of common stock, for the
same period in the prior year.  
Research and development expenses were $3.6 million for the three
months ended June 30, 2014, compared to $3.5 million for the same
period in the prior year. This increase is primarily due to expenses
associated with the development of our GEM product.  
General and administrative expenses were $1.3 million for the three
months ended June 30, 2014, compared to $1.8 million for the same
period in the prior year.  
Expenses for the three months ended June 30, 2014 included costs of
$0.1 million, compared to $0.3 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
June 30, 2014 or 2013.   
At June 30, 2014, Biodel had cash and cash equivalents of $24.5
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 August 11,
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) 407-7181 (Toll-Free US & Canada) or +1
(201) 689-8047 (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. Please note that the company has included
supplemental slides in the webcast related to its Third Quarter
results which will also be available in the "Webcasts" section of the
company website after the call. An archived version of the audio
webcast will be available on Biodel's website or by dialing +1 (877)
660-6853 (Toll Free US & Canada) or +1 (201) 612-7415 (International)
and entering conference ID number 13588552. 
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.                                 
                   Consolidated Condensed Balance Sheets                    
             (in thousands, except share and per share amounts)             
                                                                            
 

 
                                             September 30,      June 30,    
                                                  2013            2014      
                                         ------------------  ---------------
                                                               (unaudited)  
                 ASSETS                                                     
Current:                                                                    
  Cash and cash equivalents                 $       39,781   $       24,480 
  Income taxes receivable                                6                2 
  Grants receivable                                     26              227 
  Prepaid and other assets                             264              394 
                                         ------------------  ---------------
                                                                            
    Total current assets                            40,077           25,103 
  Property and equipment, net                        1,031              604 
  Intellectual property, net                            43               41 
                                         ------------------  ---------------
    Total assets                            $       41,151   $       25,748 
                                         ==================  ===============
                                                                            
  LIABILITIES AND STOCKHOLDERS' EQUITY                                      
Current:                                                                    
  Accounts payable                          $          246   $          374 
  Accrued expenses:                                                         
    Clinical trial expenses                            181              132 
    Payroll and related                              1,139              991 
    Accounting and legal fees                          226              170 
    Severance                                          255               31 
    Other                                              319              266 
  Income taxes payable                                  75                - 
                                         ------------------  ---------------
                                                                            
    Total current liabilities                        2,441            1,964 
                                                                            
  Common stock warrant liability                     6,121            2,413 
  Other long term liabilities                           26                - 
                                         ------------------  ---------------
                                                                            
    Total liabilities                                8,588            4,377 
                                         ------------------  ---------------
Commitments                                                                 
  Stockholders' equity:                                                     
  Convertible Preferred stock, $.01 par                                     
   value; 50,000,000 shares authorized,                                     
   1,950,000 and 1,950,000 issued and                                       
   outstanding                                          19               19 
  Common stock, $.01 par value;                                             
   62,500,000 shares authorized;                                            
   21,070,824 and 21,119,722 issued and                                     
   outstanding                                         211              211 
  Additional paid-in capital                       247,761          248,414 
  Accumulated deficit                             (215,428)        (227,273)
                                         ------------------  ---------------
                                                                            
    Total stockholders' equity                      32,563           21,371 
                                         ------------------  ---------------
                                                                            
    Total liabilities and stockholders'                                     
     equity                                 $       41,151   $       25,748 
                                         ==================  ===============
 

 
                                                                            
                                                                            
                                Biodel Inc.                                 
               Consolidated Condensed Statements of Operations              
              (in thousands, except share and per share amounts)            
                                 (unaudited)                                
                                                                            
 

 
                             Three Months Ended        Nine Months Ended    
                                  June 30,                 June 30,         
                         ------------------------- -------------------------
                             2013         2014         2013         2014    
                         ------------ ------------ ------------ ------------
Revenue                  $         -  $         -  $         -  $         - 
                         ------------ ------------ ------------ ------------
                                                                            
Operating expenses:                                                         
  Research and                                                              
   development                 3,474        3,628       11,115       11,626 
  Government grant               (25)        (227)        (249)        (531)
  General and                                                               
   administrative              1,768        1,348        5,371        4,475 
                         ------------ ------------ ------------ ------------
                                                                            
Total operating expenses       5,217        4,749       16,237       15,570 
Other (income) and                                                          
 expense:                                                                   
  Interest and other                                                        
   income                        (11)         (11)         (39)         (40)
  Adjustment to fair                                                        
   value of common stock                                                    
   warrant liability           4,431       (1,548)       2,319       (3,708)
                         ------------ ------------ ------------ ------------
                                                                            
Loss before tax                                                             
 provision (benefit)          (9,637)      (3,190)     (18,517)     (11,822)
Tax provision (benefit)           (6)          14            3           23 
                         ------------ ------------ ------------ ------------
                                                                            
Net loss                 $    (9,631) $    (3,204) $   (18,520) $   (11,845)
                         ============ ============ ============ ============
                                                                            
Net loss per share --                                                       
 basic and diluted       $     (0.66) $     (0.15) $     (1.29) $     (0.56)
                         ============ ============ ============ ============
                                                                            
Weighted average shares                                                     
 outstanding -- basic                                                       
 and diluted              14,573,110   21,118,375   14,311,875   21,100,903 
                         ============ ============ ============ ============

 
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 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 Linjetaâ„¢ (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 first fiscal quarter ended December 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. 
BIOD-G 
CONTACT: 
John Graziano
+1 (646) 378 2942
 
 
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