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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): October 24, 2005
MannKind Corporation
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation)
  000-50865
(Commission File Number)
  13-3607736
(IRS Employer
Identification No.)
     
28903 North Avenue Paine
Valencia, California

(Address of principal executive offices)
   
91355
(Zip Code)
Registrant’s Telephone Number, Including Area Code: (661) 775-5300
N/A
(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 (see General Instruction A.2. below):
 
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨ 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
On October 24, 2005, MannKind Corporation issued a press release announcing its financial results for the third quarter of 2005. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The information in this Current Report is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits. The following exhibit is filed herewith:
     
99.1
  Press Release of MannKind Corporation dated October 24, 2005, reporting MannKind’s financial results for the third quarter of 2005.

 


 

SIGNATURE
     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.
         
  MANNKIND CORPORATION
 
 
  By:   /s/ Richard L. Anderson    
    Name:   Richard L. Anderson   
Dated: October 24, 2005    Title:   Chief Financial Officer   

 


 

         
EXHIBIT INDEX
     
Number   Description
99.1
  Press Release of MannKind Corporation dated October 24, 2005, reporting MannKind’s financial results for the third quarter of 2005.

 

exv99w1
 

EXHIBIT 99.1
(MannKind Corporation Logo)
     
Company Contact:
  Investor Relations:
Dick Anderson
  Julie Huang
Chief Financial Officer
  Financial Dynamics
661-775-5302
  212-850-5628
danderson@mannkindcorp.com
  Julie.Huang@fd.com
MANNKIND CORPORATION REPORTS THIRD QUARTER FINANCIAL RESULTS
Conference Call to Begin Today at 9:00 a.m. ET
VALENCIA, Calif. (October 24, 2005) – MannKind Corporation (Nasdaq NM: MNKD) today reported financial results for the third quarter and nine months ended September 30, 2005.
For the third quarter of 2005, total operating expenses were $32.9 million, compared with $20.5 million for the third quarter of 2004. Research and development (R&D) expenses increased by $12.7 million to $24.5 million for the third quarter of 2005 compared to the third quarter of 2004, primarily due to increased costs associated with the Company’s expanded clinical development program for Technosphere® Insulin, which is currently in Phase 3 clinical trials in the U.S. and Europe. General and administrative (G&A) expenses decreased by $0.3 million to $8.4 million for the third quarter of 2005 compared to the third quarter of 2004.
The net loss applicable to common stockholders for the third quarter of 2005 was $31.7 million, or $0.73 per share based on 43.5 million shares outstanding, compared with a net loss applicable to common stockholders of $39.4 million, or $1.40 per share based on 28.1 million shares outstanding, for the third quarter of 2004.
For the first nine months of 2005, operating expenses totaled $83.1 million, compared with $55.5 million in the first nine months of 2004. R&D expenses were $66.8 million for the first nine months of 2005, up $27.9 million from the first nine months of 2004, primarily related to the expansion of clinical trials of the Technosphere Insulin program. G&A expenses decreased by $0.2 million to $16.3 million for the first nine months of 2005 as compared to the first nine months of 2004.
The net loss applicable to common stockholders for the first nine months of 2005 was $81.0 million, or $2.23 per share based on 36.4 million shares outstanding, compared with a net loss applicable to common stockholders of $74.7 million, or $3.29 per share based on 22.7 million shares outstanding, for the first nine months of 2004.

 


 

“We successfully completed one of the largest equity placements in our sector this year. As well, our Technosphere Insulin (TI) System continues to gain recognition for being unlike any other inhaled insulin therapy in registration or under development,“ said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “With a strengthened balance sheet and operating team, management continues to advance and execute its clinical development program for TI. We are currently completing database lock on the results of our TI European Phase 2b trial (005) and intend to announce the results in the next few months.”
Financing Transaction
On August 5, 2005, MannKind completed a $175 million private placement of newly issued shares of common stock and the concurrent issuance of warrants for the purchase of additional shares of common stock. Net proceeds will be used primarily to fund the development of the Technosphere Insulin System.
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Daylight Time. To participate in the call please dial (888) 282-8353 or listen to the call on the Internet at www.mannkindcorp.com. A telephone replay will be accessible for approximately 48 hours following completion of the call by dialing (888) 568-0414 and entering conference number 2891046. The web site replay will be available for fourteen days.
Presenting from the Company will be:
     –   Chairman and Chief Executive Officer, Alfred Mann
     –   President and Chief Operating Officer, Hakan Edstrom
     –   Corporate Vice President and Chief Financial Officer, Dick Anderson
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKind’s clinical trials and product candidates that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of clinical trials, the risk that future safety and efficacy studies may not confirm our past clinical results, risks related to intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, risks related to manufacturing the Company’s lead product candidate, risks related to competition from other pharmaceutical or biotechnology companies, risks related to the Company’s ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company’s operations, risks related to the Company’s ability to meet milestones and

 


 

other risks detailed in MannKind’s filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2004 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this news release.
(Tables to follow)

 


 

MannKind Corporation
Consolidated Statements of Operations
(Unaudited)
                                 
(In thousands, except per share            
amounts)   Three Months Ended     Nine Months Ended  
    September 30,     September 30,     September 30,     September 30,  
    2005     2004     2005     2004  
Revenue
  $     $     $     $  
 
                       
Operating expenses:
                               
Research and development
    24,466       11,790       66,758       38,901  
General and administrative
    8,396       8,713       16,318       16,552  
 
                       
Total operating expenses
    32,862       20,503       83,076       55,453  
 
                       
Loss from operations
    (32,862 )     (20,503 )     (83,076 )     (55,453 )
Other income (expense)
    (29 )     37       (8 )     112  
Interest income
    1,161       278       2,038       499  
 
                       
Loss before provision for income taxes
    (31,730 )     (20,188 )     (81,046 )     (54,842 )
Income taxes
                (1 )      
 
                       
Net loss
    (31,730 )     (20,188 )     (81,047 )     (54,842 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock
          (19,210 )           (19,822 )
Accretion on redeemable preferred stock
                      (60 )
 
                       
Net loss applicable to common stockholders
  $ (31,730 )   $ (39,398 )   $ (81,047 )   $ (74,724 )
 
                       
Net loss per share applicable to common stockholders — basic and diluted
  $ (0.73 )   $ (1.40 )   $ (2.23 )   $ (3.29 )
 
                       
Shares used to compute basic and diluted net loss per share applicable to common stockholders
    43,460       28,051       36,373       22,687  
 
                       

 


 

MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)

(in thousands)
                 
    September 30,     December 31,  
    2005     2004  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 69,238     $ 78,987  
Marketable securities
    113,166       11,546  
Restricted cash
    18       583  
State research and development tax credit exchange receivable – current
    1,233       1,500  
Prepaid expenses and other current assets
    3,451       3,265  
 
           
Total current assets
    187,106       95,881  
Property and equipment – net
    71,387       66,511  
State research and development tax credit exchange receivable - - net of current portion
    1,249       1,030  
Other assets
    282       61  
 
           
Total
  $ 260,024     $ 163,483  
 
           
Liabilities and Stockholders’ Equity
               
Current liabilities
  $ 18,960     $ 13,044  
Other liabilities
    36       76  
Stockholders’ equity
    241,028       150,363  
 
           
Total
  $ 260,024     $ 163,483  
 
           
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