Biodel Reports Third Quarter Fiscal Year 2014 Financial Results

NEWS RELEASE TRANSMITTED BY Marketwired 
FOR: Biodel, Inc. 
NASDAQ SYMBOL: BIOD 
AUGUST 11, 2014 
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 - August 11, 2014) -  Biodel Inc. (NASDAQ: BIOD)
today reported financial results for the third fiscal quarter ended June 30,
2014.  
Portfolio highlights since last fiscal quarter:  
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--  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. 
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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.  
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Biodel Inc.                                  
Consolidated Condensed Balance Sheets                     
(in thousands, except share and per share amounts)              
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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  
==================  =============== 
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Biodel Inc.                                  
Consolidated Condensed Statements of Operations               
(in thousands, except share and per share amounts)             
(unaudited)                                 
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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  
============ ============ ============ ============ 
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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 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 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 
-30-
FOR FURTHER INFORMATION PLEASE CONTACT: 
CONTACT: 
John Graziano
+1 (646) 378 2942 
INDUSTRY:  Pharmaceuticals and Biotech - Biotech, Pharmaceuticals and Biotech -
Drugs, Pharmaceuticals and Biotech - Trials 
SUBJECT:  ERN 
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-0- Aug/11/2014 20:05 GMT
 
 
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