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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): May 5, 2006
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))
 
 

 


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Item 2.02 Results of Operations and Financial Condition
Item 9.01 Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
Exhibit 99.1


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Item 2.02 Results of Operations and Financial Condition
On May 5, 2006, MannKind Corporation issued a press release announcing its financial results for the first quarter of 2006. 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 furnished herewith:
     
99.1
  Press Release of MannKind Corporation dated May 5, 2006, reporting MannKind’s financial results for the first quarter of 2006.

 


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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   
    Title:   Chief Financial Officer   
 
Dated: May 5, 2006

 


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EXHIBIT INDEX
     
Number   Description
99.1
  Press Release of MannKind Corporation dated May 5, 2006, reporting MannKind’s financial results for the first quarter of 2006.

 

exv99w1
 

EXHIBIT 99.1
(MANNKIND LOGO)
     
Company Contact:
  Financial Dynamics:
Dick Anderson
  Julie Huang (investors)
Chief Financial Officer
  Robert Stanislaro (media)
661-775-5302
  212-850-5600
danderson@mannkindcorp.com
  mnkd@fd-us.com
MANNKIND CORPORATION REPORTS FIRST QUARTER FINANCIAL RESULTS
- - Conference Call to Begin Today at 9:00 a.m. ET -
VALENCIA, Calif., May 5, 2006 — MannKind Corporation (Nasdaq NM: MNKD) today reported financial results for the three months ended March 31, 2006.
For the first quarter of 2006, total operating expenses were $45.1 million, compared with $22.6 million for the first quarter of 2005. Research and development (R&D) expenses increased by $17.3 million to $36.0 million for the first quarter of 2006 compared to the first quarter of 2005, 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 increased by $5.1 million to $9.1 million for the first quarter of 2006 compared to the first quarter of 2005 primarily due to an increase in stock compensation expense and increased consulting and various other general and administrative expenses, such as legal and accounting fees.
The net loss applicable to common stockholders for the first quarter of 2006 was $43.6 million, or $0.87 per share based on 49.8 million shares outstanding, compared with a net loss applicable to common stockholders of $22.2 million, or $0.68 per share based on 32.8 million shares outstanding, for the first quarter of 2005.
Cash, cash equivalents and marketable securities were $102.6 million at March 31, 2006 and $145.6 million at December 31, 2005.
“In first quarter of 2006, we announced the initiation of two pivotal Phase 3 clinical trials of Technosphere Insulin in patients with type 1 and type 2 diabetes,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “We expect to initiate our last pivotal trial shortly.”
Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation added, “In April we announced the results of a study that demonstrated that patients with type 1 diabetes using Technosphere Insulin can achieve much lower post meal glucose excursions and comparable levels of HbA1c as patients

 


 

treated with an injected rapid-acting insulin analog. Our study also found that patients using Technosphere Insulin experienced some weight loss in contrast to the weight gain experienced by patients using the injected rapid-acting insulin analog. Furthermore, after twelve weeks of treatment, pulmonary function did not differ between the two patient groups and there were no incidents of severe hypoglycemia.”
Conference Call
MannKind management will host a conference call to discuss the first quarter results today at 9:00 a.m. Eastern Time. To participate in the call please dial (888) 566-5775 or (210) 839-8503. To listen to the call via the Internet please visit www.mannkindcorp.com. A telephone replay will be accessible for approximately 48 hours following completion of the call by dialing (800) 234-3897 or (402) 220-9689 and entering passcode “MNKD”. 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
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Its lead investigational product candidate, the Technosphere® Insulin System, is currently in phase 3 clinical trials in the U.S. and Europe to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.
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, 2005 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 March 31,  
    2006     2005  
Revenue
  $ 100     $  
 
           
                 
Operating expenses:
               
Research and development
    35,950       18,696  
General and administrative
    9,138       3,951  
 
           
Total operating expenses
    45,088       22,647  
 
           
Loss from operations
    (44,988 )     (22,647 )
Other income
    50       14  
Interest income
    1,380       472  
 
           
Loss before provision for income taxes
    (43,558 )     (22,161 )
Income taxes
    (1 )     (1 )
 
           
                 
Net loss applicable to common stockholders
  $ (43,559 )   $ (22,162 )
 
           
                 
Net loss per share applicable to common stockholders — basic and diluted
  $ (0.87 )   $ (0.68 )
 
           
                 
Shares used to compute basic and diluted net loss per share applicable to common stockholders
    49,787       32,764  
 
           

 


 

MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)

(in thousands)
                 
    March 31,     December 31,  
Assets   2006     2005  
Current assets:
               
Cash and cash equivalents
  $ 45,889     $ 56,037  
Marketable securities
    56,700       89,597  
State research and development tax credit exchange receivable — current
    1,044       1,194  
Prepaid expenses and other current assets
    5,907       3,044  
 
           
Total current assets
    109,540       149,872  
Property and equipment — net
    80,289       76,183  
State research and development tax credit exchange receivable — net of current portion
    1,875       2,031  
Other assets
    287       285  
 
           
Total
  $ 191,991     $ 228,371  
 
           
Liabilities and Stockholders’ Equity
               
Current liabilities
  $ 24,257     $ 21,365  
Other liabilities
    24       29  
Stockholders’ equity
    167,710       206,977  
 
           
Total
  $ 191,991     $ 228,371  
 
           
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