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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 6, 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 May 6, 2005, MannKind Corporation issued a press release announcing its financial results for the first 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 May 6, 2005, reporting MannKind’s financial results for the first 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   
    Title:   Chief Financial Officer   
 

Dated: May 6, 2005

 


 

EXHIBIT INDEX

     
Number   Description
99.1
  Press Release of MannKind Corporation dated May 6, 2005, reporting MannKind’s financial results for the first quarter of 2005.

 

exv99w1
 

Exhibit 99.1

(MANNKIND CORPORATION LOGO)

Company Contact:
Dick Anderson
Chief Financial Officer
661-775-5302
danderson@mannkindcorp.com

MANNKIND CORPORATION REPORTS FIRST QUARTER FINANCIAL RESULTS

Conference Call to Begin Today at 9:00 a.m. EDT

VALENCIA, Calif. (May 6, 2005) – MannKind Corporation (Nasdaq NM: MNKD) today reported financial results for the three months ended March 31, 2005.

For the first quarter of 2005, total operating expenses were $22.6 million, compared with $16.6 million for the first quarter of 2004. Research and development (R&D) expenses increased by $5.9 million to $18.7 million, primarily due to increased costs associated with the Company’s expanded clinical trials and related support for its Technosphere® Insulin program. General and administrative (G&A) expenses increased by $0.2 million to $4.0 million.

The net loss applicable to common stockholders for the first quarter of 2005 was $22.2 million, or $0.68 per share based on 32.8 million shares outstanding, compared with a net loss applicable to common stockholders of $17.1 million, or $0.86 per share based on 20.0 million shares outstanding, for the first quarter of 2004. The first quarter 2004 share count reflects the completion of an offering of Series C convertible preferred stock in that quarter and the first quarter of 2005 share count reflects the initial public offering of common stock during the third quarter of 2004.

Cash, cash equivalents and marketable securities were $67.0 million at March 31, 2005 and $90.5 million at December 31, 2004.

Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation, stated, “The increased spending levels this past quarter reflect our significantly higher activity levels within the clinical and regulatory areas. In Europe, we expect to complete our final Phase 2b trial in the third quarter and are enrolling patients in our Phase 3 trial program. In the United States, the FDA conducted a Special Protocol Assessment of a proposed Phase 3 study to assess the long-term safety of the Technosphere® Insulin System in type 1 and type 2 diabetes. This review is now complete, clearing the way for us to initiate this pivotal trial by mid-year, as planned.”

 


 

MannKind Corporation also announced that Dr. Wendell Cheatham, a Corporate Vice President, is no longer employed by the Company. Mr. Edstrom has assumed Dr. Cheatham’s management responsibilities while the Company completes its search for a senior executive to lead its development operations.

Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation, added, “As we move forward, we need exceptional discipline and focus on our Phase 3 clinical program. We recently performed an in-depth organizational review of our clinical and regulatory functions, and have reorganized and structured these groups to better ensure the successful and timely completion of our pivotal trials, both in the United States and in Europe. We have assembled an experienced clinical and regulatory team, led by vice presidents of medical affairs, clinical operations and worldwide regulatory affairs. We are continuing to expand our clinical staff through the recruitment of experienced personnel to manage our contract research organizations, data management and clinical operations. We continue to strengthen our organization and are seeking several additional key executives to enable us to realize the potential of our 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) 463-4383 from the U.S. or Canada, or (706) 679-5355 from outside the U.S. or Canada, or listen to the call on the Internet at www.mannkindcorp.com. A telephone replay will be available for 48 hours following completion of the call by dialing (800) 642-1687 (toll-free) or (706) 645-9291, and entering reservation number 5915237. The web site replay will be available for 14 days.

About MannKind Corporation
MannKind focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. The Company is currently in Phase 3 clinical trials of its lead product, the Technosphere® Insulin System, in Europe to study its potential for the treatment of diabetes. This System consists of a proprietary dry powder Technosphere® formulation of insulin that is inhaled into the deep lung using the Company’s MedTone™ inhaler. MannKind believes that the performance characteristics, unique kinetics, convenience and ease of use of the Technosphere® Insulin System may have the potential to change the way diabetes is treated. 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, intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, manufacturing the Company’s lead product candidate, competition from other pharmaceutical or biotechnology companies, the Company’s ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company’s operations, 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. 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 data)   Three Months Ended  
    March 31,     March 31,  
    2005     2004  
 
Revenue
  $     $  
 
           
 
OPERATING EXPENSES:
               
Research and development
    18,696       12,799  
General and administrative
    3,951       3,769  
 
           
Total operating expenses
    22,647       16,568  
 
           
Loss from operations
    (22,647 )     (16,568 )
 
           
Other income
    14       54  
Interest income
    472       105  
 
           
Loss before provision for income taxes
    (22,161 )     (16,409 )
Income taxes
    (1 )      
 
           
Net loss
    (22,162 )     (16,409 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock
          (612 )
Accretion on redeemable preferred stock
          (64 )
 
           
Net loss applicable to common stockholders
  $ (22,162 )   $ (17,085 )
 
           
Net loss per share:
               
Basic and diluted
  $ (0.68 )   $ (0.86 )
 
           
Shares used to compute basic and diluted net loss per share:
               
Basic and diluted
    32,764       19,975  
 
           

 


 

MannKind Corporation
Consolidated Balance Sheet Highlights

(in thousands)

                 
    March 31,     December 31,  
Assets   2005     2004  
    (unaudited)          
Current Assets
               
Cash and Cash Equivalents
  $ 22,089     $ 78,987  
Marketable Securities
    44,958       11,546  
Restricted Cash
    585       583  
State Research and Development Tax Credit Exchange Receivable – Current
    1,500       1,500  
Prepaid Expenses and Other Current Assets
    3,027       3,265  
 
           
 
Total Current Assets
    72,159       95,881  
 
Property and Equipment — at cost, net
    67,999       66,511  
 
State Research and Development Tax Credit Exchange Receivable - - Net of Current Portion
    1,396       1,030  
Other Assets
    203       61  
 
           
 
Total Assets
  $ 141,757     $ 163,483  
 
           
 
Liabilities and Stockholders’ Equity
               
 
Current Liabilities
  $ 14,086     $ 13,044  
 
Other Liabilities
    48       76  
 
Stockholders’ Equity
    127,623       150,363  
 
           
 
Total Liabilities and Stockholders’ Equity
  $ 141,757     $ 163,483  
 
           

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