EX-99.1 2 y81947exv99w1.htm EX-99.1` exv99w1
Exhibit 99.1
Biodel Reports First Quarter Fiscal Year 2010 Financial Results
Conference Call Today at 4:30 PM EST
DANBURY, Conn., February 4, 2010 – Biodel Inc. (Nasdaq: BIOD) today reported financial results for the first fiscal quarter ended December 31, 2009.
First Quarter Financial Results
Biodel reported a net loss for the quarter ended December 31, 2009 of $11.1 million, or $0.47 per share, compared to a net loss of $10.0 million, or $0.42 per share, for the quarter ended December 31, 2008.
Research and development expenses were $8.8 million for the three months ended December 31, 2009, compared to $8.0 million for the same period in the prior year. The increase in research and development expenses was primarily due to regulatory, personnel and consulting expenses which were offset by reductions in clinical fees as patients completed the Phase 3 extension trials for VIAject®.
General and administrative expenses totaled $2.4 million for the three months ended December 31, 2009, compared to $2.3 million for the same period in the prior year. The increase in general and administrative expenses was primarily attributable to increased personnel costs.
Expenses for the quarter ended December 31, 2008 and 2009 include $1.2 million and $1.3 million, respectively, in stock-based compensation expense related to options and restricted stock units granted to employees and non-employees.
Biodel did not recognize any revenue during the quarter ended December 31, 2008 or 2009.
At December 31, 2009, Biodel had cash and cash equivalents of $39.6 million and approximately 23.9 million shares of common stock outstanding.
Business Review
In December 2009, Biodel submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market VIAject® as a treatment for diabetes. We expect a decision from the FDA as to whether to accept the NDA for review by early March. Biodel is continuing to work with Wockhardt Ltd. to develop a disposable injection pen for use with VIAject®, which Biodel plans to submit to the FDA as a supplement to the NDA.
As part of Biodel’s ongoing development and commercialization efforts, the company recently presented the results of the VIAject® clinical program to advisory boards comprised of payors, physicians and medical opinion leaders. Biodel plans to present its clinical findings at the Advanced Technologies & Treatments for Diabetes in Basel Switzerland this February.

 


 

Additional abstracts on Biodel’s product candidates have been submitted to other professional societies, including the American Diabetes Association, and will be announced after they have been accepted for presentation.
Recently, Biodel conducted a review of its research and development programs and determined that it will focus on products to treat diabetes and discontinue its work in osteoporosis. The company’s product development pipeline now reflects this shift in strategy and, in addition to VIAject®, includes four diabetes product candidates: a sublingual prandial insulin (VIAtab™); a customized basal insulin; a smart basal insulin; and a stable glucagon.
Conference Call and Webcast Information
Biodel’s senior management will host a conference call on February 4, 2010 beginning at 4:30 p.m. Eastern Standard 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 1-888-812-8595 (United States) or 1-913-312-0957 (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 at Biodel’s website.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders such as diabetes. Biodel’s product candidates are developed using VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. For further information regarding Biodel, please visit the company’s website 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. 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, our ability to have our VIAject® NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject® and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel technology, particularly

 


 

VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA’s findings regarding data anomalies observed in India in our Phase 3 clinical trial of VIAject® for patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Annual Report on Form 10-K for the year ended September 30, 2009. 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)
Balance Sheets
(in thousands, except share and per share amounts)
                 
    September 30,     December 31,  
    2009     2009  
            (unaudited)  
ASSETS
               
Current:
               
Cash and cash equivalents
  $ 54,640     $ 39,551  
Taxes receivable
    752       759  
Other receivables
          1,406  
Prepaid and other assets
    482       1,030  
 
           
 
               
Total current assets
    55,874       42,746  
Property and equipment, net
    3,695       3,490  
Intellectual property, net
    56       55  
 
           
 
               
Total assets
  $ 59,625     $ 46,291  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current:
               
Accounts payable
  $ 1,007     $ 1,613  
Accrued expenses:
               
Clinical trial expenses
    5,647       1,288  
Regulatory
    359       1,214  
Payroll and related
    1,117       614  
Accounting and legal fees
    325       292  
Severance
    183       96  
Other
    284       199  
Income taxes payable
    165       155  
 
           
 
               
Total current liabilities
    9,087       5,471  
Commitments
               
Stockholders’ equity:
               
Preferred stock, $.01 par value; 50,000,000 shares authorized, none outstanding
           
Common stock, $.01 par value; 100,000,000 shares authorized; 23,803,672 and 23,883,612 issued and outstanding
    238       239  
Additional paid-in capital
    176,764       178,193  
Deficit accumulated during the development stage
    (126,464 )     (137,612 )
 
           
 
               
Total stockholders’ equity
    50,538       40,820  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 59,625     $ 46,291  
 
           

 


 

Biodel Inc.
(A Development Stage Company)
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,  
    2008     2009     2009  
Revenue
  $     $     $  
Operating expenses:
                       
Research and development
    8,035       8,754       98,805  
General and administrative
    2,281       2,417       39,062  
 
                 
 
                       
Total operating expenses
    10,316       11,171       137,867  
 
                 
 
                       
Other (income) and expense:
                       
Interest and other income
    (242 )     (5 )     (5,494 )
Interest expense
                78  
Loss on settlement of debt
                627  
 
                 
 
                       
Operating loss before tax benefit
    (10,074 )     (11,166 )     (133,078 )
Tax benefit
    (50 )     (18 )     (526 )
 
                 
 
                       
Net loss
    (10,024 )     (11,148 )     (132,552 )
Charge for accretion of beneficial conversion rights
                (603 )
Deemed dividend — warrants
                (4,457 )
 
                 
 
                       
Net loss applicable to common stockholders
  $ (10,024 )   $ (11,148 )   $ (137,612 )
 
                 
 
                       
Net loss per share — basic and diluted
  $ (0.42 )   $ (0.47 )        
 
                   
 
                       
Weighted average shares outstanding — basic and diluted
    23,706,148       23,848,855          
 
                   
          BIOD-G
          Contact:
          The Trout Group LLC
          Seth D. Lewis, +1 617-583-1308