-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VfA2Nmcyt1mYEwuAKCU+Fn2BDgqpiTmoPKctNxO5uk0mBdwkTKehLJO++Ghyj9tR 9vhXbtiA+hgC2h7WlghN1w== 0000950123-07-012808.txt : 20070919 0000950123-07-012808.hdr.sgml : 20070919 20070919173023 ACCESSION NUMBER: 0000950123-07-012808 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070919 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070919 DATE AS OF CHANGE: 20070919 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biodel Inc CENTRAL INDEX KEY: 0001322505 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33451 FILM NUMBER: 071125374 BUSINESS ADDRESS: STREET 1: 6 CHRISTOPHER COLUMBUS AVE CITY: DANBURY STATE: CT ZIP: 06810 BUSINESS PHONE: 203-798-3603 MAIL ADDRESS: STREET 1: 6 CHRISTOPHER COLUMBUS AVE CITY: DANBURY STATE: CT ZIP: 06810 8-K 1 y39891e8vk.htm FORM 8-K 8-K
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): September 19, 2007
BIODEL INC.
(Exact name of registrant as specified in its charter)
Commission File Number 001-33451
     
Delaware
(State or other jurisdiction of incorporation or organization)
  90-0136863
(IRS Employer Identification Number)
     
6 Christopher Columbus Avenue
Danbury, Connecticut

(Address of principal executive offices)
  06810
(Zip code)
(203) 798-3600
(Registrant’s telephone number, including area code)
Not Applicable
 
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 2.02   Results of Operations and Financial Condition.
     The disclosure set forth in Item 4.02 is incorporated by reference.
Item 4.02   Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review.
     During a meeting of the Audit Committee (the “Committee”) of the Board of Directors of Biodel Inc. (the “Company”) held on September 19, 2007, the Committee and the Company’s management concluded that the Company’s unaudited interim financial statements as of June 30, 2007 and for the three- and nine-month periods then ended, as contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007, filed on August 1, 2007 (the “June 2007 10-Q”), should no longer be relied upon as a result of an error in the Company’s accounting for stock options that the Company granted pursuant to its 2005 Non-Employee Directors’ Stock Option Plan (the “Plan”) upon the effectiveness of the registration statement related to the Company’s initial public offering.
     On May 10, 2007, under the Plan, the Company granted options to purchase an aggregate of 200,000 shares of common stock at an exercise price of $15.00 per share (which was the price per share to the public in the Company’s initial public offering). Pursuant to the Plan, all of the options were fully vested on the date of grant. Accordingly, the Company should have recorded non-cash share-based compensation expense of $1,698,000 relating to these options. The Company recorded non-cash share-based compensation expense related to these options as if the options were to vest over a two-year period, as had been the case with earlier option grants to the Company’s non-employee directors. Accordingly, in the third quarter of 2007, the Company recorded only $70,750 of share-based compensation expense related to these options and the Company would have recorded the remaining $1,627,250 of previously disclosed unamortized expense ratably over such two-year period.
     As a result, the Company is restating the previously filed unaudited financial statements contained in the June 2007 10-Q. Specifically, the Company will record additional non-cash share-based compensation expense of $1,627,250 for the three- and nine-month periods ended June 30, 2007. The effects of this restatement on the Company’s balance sheet as of June 30, 2007 and statements of operations for the three- and nine-month periods then ended are summarized below:
                 
    Previously        
    Reported     As Restated  
    (in thousands, except per share data)  
Three months ended June 30, 2007
               
 
               
Statement of Operations:
               
General and administrative expense
  $ 1,649     $ 3,276  
Net loss applicable to common stockholders
    (3,688 )     (5,295 )
Net loss per share
    (0.21 )     (0.30 )

2


 

                 
Nine months ended June 30, 2007
               
 
               
Statement of Operations:
               
General and administrative expense
  $ 4,475     $ 6,102  
Net loss applicable to common stockholders
    (17,005 )     (18,632 )
Net loss per share
    (1.31 )     (1.43 )
 
               
June 30, 2007
               
 
               
Balance Sheet:
               
Additional paid-in capital
  $ 114,584     $ 116,211  
Deficit accumulated during development stage
    (29,833 )     (31,460 )
     The restated financial statements will be included in an amended June 2007 10-Q, which the Company expects to file promptly following the filing of this Current Report on Form 8-K.
     The Company’s management and the Committee have discussed this matter with BDO Seidman, LLP, the Company’s independent registered public accounting firm.
     On September 19, 2007, the Company issued a press release concerning this matter, a copy of which is attached to this Report as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01   Financial Statements and Exhibits
(d) Exhibits
          99.1 Press Release dated September 19, 2007

3


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  BIODEL INC.
 
 
Date: September 19, 2007  By:   /s/ F. Scott Reding    
    F. Scott Reding   
    Chief Financial Officer   
 

4


 

EXHIBIT INDEX
     
Exhibit No.   Description
 
   
99.1
  Press Release dated September 19, 2007

 

EX-99.1 2 y39891exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

Exhibit 99.1
Biodel to Amend June 30, 2007 10-Q to
Correct Non-Cash Share-Based Compensation Expense
     DANBURY, Conn., September 19, 2007 — Biodel Inc. (Nasdaq: BIOD) today announced that it will amend its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007 to correct the manner in which the Company recorded non-cash share-based compensation expense arising from stock options granted to non-employee directors at the time of the Company’s initial public offering. The amendment will increase share-based compensation expense and is solely non-cash in nature.
     On May 10, 2007, the Company granted options to purchase an aggregate of 200,000 shares of common stock at an exercise price of $15.00 (which was the price per share to the public in the Company’s initial public offering). Pursuant to the terms of the Company’s 2005 Non-Employee Directors’ Stock Option Plan, all of the options were fully vested on the date of grant. Accordingly, the Company should have recorded non-cash share-based compensation expense of approximately $1.7 million. The Company recorded non-cash share based compensation expense related to these options as if the options were to vest over a two-year period, as had been the case with earlier option grants to the Company’s non-employee directors. Accordingly, in the third quarter of 2007, the Company only recorded approximately $0.1 million of share-based compensation expense related to these options and the Company would have recorded the remaining $1.6 million of previously disclosed unamortized expense ratably over such two-year period.
     As a result, the Company will file amended unaudited financial statements to record additional non-cash share-based compensation expense of approximately $1.6 million for the three- and nine-month periods ended June 30, 2007. The effect of this amendment will be to increase the Company’s general and administrative expenses and net loss applicable to common stockholders for these periods by $1.6 million from the previously reported amounts. In addition, the Company’s net loss per share for the three months ended June 30, 2007 will increase from $(0.21) to $(0.30) and the Company’s net loss per share for the nine months ended June 30, 2007 will increase from $(1.31) to $(1.43). This amendment will have no effect on the Company’s cash balances or other capital resources.
     The Company expects to file an amended Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007 as promptly as practicable.
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 and osteoporosis. Biodel’s product candidates are developed by using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs. The Company’s lead product candidate, VIAject™, is a rapid-acting injectable meal-time insulin for use by patients with Type 1 or Type

 


 

2 diabetes. VIAject™ is currently being tested in two pivotal Phase III clinical trials. Biodel’s pipeline also includes VIAtab™, a sublingual tablet formulation of insulin in Phase I clinical trials and two osteoporosis product candidates in pre-clinical studies. For further information regarding Biodel, please visit the Company’s website.
Safe Harbor
     This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other then statements of historical facts, including statements regarding our strategy, future operations, 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 secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drugs and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject™ and VIAtab™; our ability to secure patents for VIAject™ and our other product candidates; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
Contact
     Investors should contact Clay A. Kramer, ckramer@burnsmc.com, or Media, Carney Noensie, cnoensie@burnsmc.com, both of Burns McClellan, Inc., +1-212-213-0006, for Biodel Inc.

 

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