Biodel Reports Fourth Quarter and Fiscal Year 2015 Financial Results

DANBURY, CT -- (Marketwired) -- 12/17/15 --

Biodel Inc. (NASDAQ: BIOD) today reported financial results for the fourth fiscal quarter and year-ended September 30, 2015. Additionally, the Company announced that its Board of Directors has approved a plan to explore strategic alternatives to further realize value from its pipeline assets and to preserve the Company's significant cash balance. As part of this plan, enrollment in BIOD-531 Study 3-157 is being suspended and the Company will retain an advisor to assist in this process of evaluating its strategic alternatives.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "The impact of the delay of the timelines for filing the NDA for the Glucagon Emergency Management product candidate on our stock price has necessitated us to commence a review our strategic alternatives while at the same time extending our cash runway. While this is a difficult decision, we believe it offers the best opportunity to maximize shareholder value from our clinical assets and cash resources. I look forward to being able to update our investors on the process in the coming months."

Fourth Quarter Financial Results

Biodel reported a net loss of $3.2 million and $18.7 million, or $0.05 and $0.46 per share for the quarter and twelve month period ended September 30, 2015, respectively. These results compare to a net loss of $2.3 million and $14.1 million, or $0.10 and $0.66 per share for the quarter and twelve month period ended September 30, 2015, respectively.

Biodel did not recognize any revenue during the quarter and twelve month period ended September 30, 2015 or 2014. 

At September 30, 2015, Biodel had cash and cash equivalents of $40.8 million and 62.2 million shares of common stock outstanding.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on December 17, 2015 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 (United States) 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. An archived version of the audio webcast will be available on Biodel's website. Interested parties may also access an audio replay by dialing (877) 660-6853 (US) or (201) 612-7415 (International) and entering conference ID number 13588552.

Biodel Inc.

Consolidated Balance Sheets
(In thousands, except share and per share amounts)

                                                         September 30,      
                                                  --------------------------
                                                      2014          2015    
                                                  ------------  ------------
                                  ASSETS                                    
  Current:                                                                  
    Cash and cash equivalents                      $   24,588    $   40,845 
    Prepaid and other assets                              316           262 
                                                  ------------  ------------
        Total current assets                           24,904        41,107 
    Property and equipment, net                           481           280 
    Intellectual property, net                             40            37 
                                                  ------------  ------------
        Total assets                               $   25,425    $   41,424 
                                                  ============  ============
                    LIABILITIES AND STOCKHOLDERS' EQUITY                    
  Current:                                                                  
    Accounts payable                               $      172    $      421 
    Accrued expenses:                                                       
      Clinical trial expenses                             214             1 
      Payroll and related                                 958           863 
      Accounting and legal fees                           131           289 
      Other                                               141           234 
        Total current liabilities                       1,616         1,808 
                                                  ------------  ------------
    Common stock warrant liability                      1,014             5 
    Other long term liabilities                             -            54 
                                                  ------------  ------------
        Total liabilities                               2,630         1,867 
  Commitments                                                               
    Stockholders' equity:                                                   
    Convertible preferred stock, $.01 par value;                            
     50,000,000 shares authorized, 1,950,000 and                            
     1,909,410 issued and outstanding                      19            19 
    Common stock, $.01 par value; 200,000,000                               
     shares authorized; 23,079,543 and                                      
     62,151,202 issued and outstanding,                                     
     respectively                                         231           622 
    Additional paid-in capital                        252,104       287,212 
    Accumulated deficit                              (229,559)     (248,296)
                                                  ------------  ------------
        Total stockholders' equity                     22,795        39,557 
                                                  ------------  ------------
Total liabilities and stockholders' equity         $   25,425    $   41,424 
                                                  ============  ============
                                                                            

Biodel Inc.

Consolidated Statements of Operations
(In thousands, except share and per share amounts)

                                                          September 30,     
                                                      ----------------------
                                                         2014        2015   
                                                      ----------  ----------
  Revenue                                             $       -   $       - 
                                                      ----------  ----------
  Operating expenses:                                                       
    Research and development                             14,194      13,365 
    Government grants                                      (531)          - 
    General and administrative                            5,598       6,402 
                                                      ----------  ----------
        Total operating expenses                         19,261      19,767 
  Other expense/(income):                                                   
  Interest and other income                                 (49)        (52)
  Adjustments to fair value of common stock warrant                         
   liability                                             (5,107)     (1,009)
  Loss on fixed asset                                         -           2 
                                                      ----------  ----------
  Loss before tax provision                             (14,105)    (18,708)
  Tax provision                                              26          29 
                                                      ----------  ----------
  Net loss                                            $ (14,131)  $ (18,737)
                                                      ==========  ==========
  Net loss per share - basic and diluted              $   (0.66)  $   (0.46)
                                                      ==========  ==========
  Weighted average shares outstanding - basic and      21,404,2    41,017,8 
   diluted                                                   58          55 
                                                      ==========  ==========
                                                                            

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.

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 Biodel's product candidates, potential timing, design and outcomes of clinical trials and Biodel's ability to develop and commercialize its product candidates. Forward-looking statements represent Biodel's management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel's 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. Biodel'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 progress, timing or success of Biodel's research and development and clinical programs for Biodel's product candidates; Biodel's ability to conduct the development work necessary to finalize the formulation and design of Biodel's auto-reconstitution glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate; Biodel's ability to engage a strategic partner in the further development of Biodel's prandial ultra-rapid-acting insulin formulations, including BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient, and Biodel's insulin analog-based formulations; the success of Biodel's formulation development work to improve the stability of Biodel's newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations; the results of Biodel's real-time stability programs for Biodel's RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and Biodel's ability to accurately project long term stability on the basis of accelerated testing; Biodel's ability to accurately anticipate technical challenges that the company may face in the development of Biodel's ultra-rapid-acting RHI- and insulin analog-based product candidates or Biodel's glucagon rescue product candidates; Biodel's ability to secure approval by the FDA for Biodel's product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; Biodel's ability to enter into collaboration arrangements for the commercialization of Biodel's product candidates and the success or failure of any such collaborations into which the company enters, or Biodel's ability to commercialize its product candidates on its own; Biodel's ability to enforce Biodel's patents for Biodel's product candidates and Biodel's ability to secure additional patents for Biodel's product candidates; and other factors identified in our most recent annual report on Form 10-K for the fiscal year ended September 30, 2014 and other subsequent filings with the Securities and Exchange Commission. 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

Source: Biodel Inc.

   CONTACT: Clayton RobertsonTrout Group +1 (646) 378 2964

Source: Biodel, Inc.

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