e8vk
 
 
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): November 5, 2008
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):
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
On November 5, 2008, MannKind Corporation issued a press release announcing its financial results for the third quarter of 2008. 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 November 5, 2008, reporting MannKind’s financial results for the third quarter of 2008.

 


 

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/ Matthew J. Pfeffer    
    Name:   Matthew J. Pfeffer   
    Title:   Corporate Vice President and Chief Financial Officer   
 
Dated: November 5, 2008

 


 

EXHIBIT INDEX
     
Number   Description
 
   
99.1
  Press Release of MannKind Corporation dated November 5, 2008, reporting MannKind’s financial results for the third quarter of 2008.

 

exv99w1
Exhibit 99.1
(MANNKIND LOGO)
Company Contact:
Matthew Pfeffer
Chief Financial Officer
661-295-4784
mpfeffer@mannkindcorp.com
MANNKIND CORPORATION REPORTS THIRD QUARTER FINANCIAL RESULTS
– Conference Call Today at 9:00 a.m. EST –
VALENCIA, Calif., November 5, 2008 — MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter ended September 30, 2008.
For the third quarter of 2008, total operating expenses were $69.1 million, compared to $75.6 million for the third quarter of 2007, primarily attributable to the $9.2 million reduction in research and development (R&D) expenses which totaled $55.6 million for this quarter compared to $64.8 million for the same quarter in 2007. The decrease in R&D expenses for the three months ended September 30, 2008 as compared to the same period in the prior year was primarily due to decreased costs associated with the clinical development of AFRESA™ (formerly identified as the Technosphere Insulin System) and the related manufacturing costs associated with clinical trial materials, partially offset by increased stock-based compensation expense and increased facilities-related expenses. General and administrative (G&A) expenses increased by $2.7 million to $13.4 million for the third quarter of 2008 compared to the third quarter of 2007. G&A expenses for the three months ended September 30, 2008 increased as compared to the same period in the prior year primarily due to increased employee-related and consulting expenses and increased stock-based compensation expense.
For the first nine months of 2008, operating expenses totaled $224.0 million, compared to $228.3 million in the first nine months of 2007. R&D expenses for the first nine months were $181.7 million, compared to $190.1 million in 2007. The decrease in R&D expenses for the nine months ended September 30, 2008, as compared to the same period in the prior year was primarily due to decreased costs associated with the clinical development of AFRESA and the related manufacturing costs associated with clinical trial materials, partially offset by increased stock-based compensation expense and increased facilities-related expenses. G&A expenses increased by $4.2 million to $42.4 million for the first nine months of 2008 as compared to the same period in 2007. G&A expenses for the nine months ended September 30, 2008 increased as compared to the same period in the prior year primarily due to increased employee-related and

 


 

consulting expenses and increased stock-based compensation expense, offset by decreased professional fees.
We anticipate that our R&D expenses associated with AFRESA will continue to decline as we close out our pivotal clinical studies and complete preparations for the filing of our New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”). We expect G&A expenses, other than non-cash stock-based compensation expense, to remain constant in the future.
The net loss for the third quarter of 2008 was $68.5 million, or $0.67 per share, based on 101.6 million weighted average shares outstanding. This compares to a net loss of $73.0 million, or $0.99 per share, based on 73.5 million weighted average shares outstanding for the third quarter of 2007.
The net loss for the first nine months of 2008 was $219.7 million, or $2.17 per share based on 101.5 million shares outstanding, compared with a net loss of $218.2 million, or $2.97 per share based on 73.4 million shares outstanding, for the first nine months of 2007.
Cash and cash equivalents and marketable securities were $95.2 million at September 30, 2008, $180.5 million at June 30, 2008, and $368.3 million at December 31, 2007.
“MannKind has made great progress this quarter,” commented Alfred Mann, Chairman and Chief Executive Officer. “Our pivotal trials are completed and we are well along in preparation of the AFRESA NDA submission to the FDA. We have completed and dedicated our new manufacturing facility and equipped it with the first stage of the modular production systems that will be used to supply commercial product. The emerging data support our belief that AFRESA will be a very important prandial insulin for most people with type 1 and type 2 diabetes. We will soon be ready to reinitiate discussions with potential partners.”
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Time. To participate in the call please dial (888) 677-5721 or (210) 839-8507. To listen to the call via the Internet please visit http://www.mannkindcorp.com. The web site replay will be available for fourteen days. A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (866) 411-1707 or (203) 369-0654 and entering conference number 4423761.
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 Matthew Pfeffer

 


 

    Corporate Vice President and Chief Scientific Officer Peter Richardson
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its pipeline includes AFRESA, which has completed Phase 3 clinical trials, and MKC253, which is currently in phase 1 clinical trials. Both of these investigational products are being evaluated for their safety and efficacy in the treatment of diabetes. MannKind maintains a website at https://www.mannkindcorp.com to which MannKind regularly posts copies of its press release as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to email alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKind’s expected R&D and G&A expenses, clinical trials, product candidates, regulatory submissions, manufacturing facility and partnership opportunities 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, difficulties or delays in seeking or obtaining regulatory approval, the manufacture of AFRESA, competition from other pharmaceutical or biotechnology companies, MannKind’s ability to enter into any collaborations or strategic partnerships, intellectual property matters, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2007 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 press release.
(Tables to follow)

 


 

MANNKIND CORPORATION
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands except per share data)
                                         
                                    Cumulative  
                                    period from  
                                    February 14,  
                                    1991 (date of  
    Three months ended     Nine months ended     inception) to  
    September 30,     September 30,     September 30,  
    2008     2007     2008     2007     2008  
 
                                       
Revenue
  $     $     $ 20     $ 10     $ 2,988  
 
                             
Operating expenses:
                                       
Research and development
    55,645       64,825       181,665       190,093       928,705  
General and administrative
    13,435       10,744       42,365       38,207       232,864  
In-process research and development costs
                            19,726  
Goodwill impairment
                            151,428  
 
                             
Total operating expenses
    69,080       75,569       224,030       228,300       1,332,723  
 
                             
Loss from operations
    (69,080 )     (75,569 )     (224,010 )     (228,290 )     (1,329,735 )
Other income (expense)
    (7 )     62       (7 )     158       (1,888 )
Interest expense on note payable to principal stockholder
                            (1,511 )
Interest expense on senior convertible notes
    (124 )     (778 )     (585 )     (2,824 )     (4,215 )
Interest income
    715       3,238       4,858       12,779       36,590  
 
                             
Loss before provision for income taxes
    (68,496 )     (73,047 )     (219,744 )     (218,177 )     (1,300,759 )
Income taxes
                            (24 )
 
                             
Net loss
    (68,496 )     (73,047 )     (219,744 )     (218,177 )     (1,300,783 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock
                            (22,260 )
Accretion on redeemable preferred stock
                            (952 )
 
                             
Net loss applicable to common stockholders
  $ (68,496 )   $ (73,047 )   $ (219,744 )   $ (218,177 )   $ (1,323,995 )
 
                             
Net loss per share applicable to common stockholders — basic and diluted
  $ (0.67 )   $ (0.99 )   $ (2.17 )   $ (2.97 )        
 
                               
Shares used to compute basic and diluted net loss per share applicable to common stockholders
    101,647       73,520       101,495       73,444          
 
                               

 


 

MANNKIND CORPORATION
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
                 
    September 30, 2008     December 31, 2007  
 
               
ASSETS
 
               
Current assets:
               
Cash and cash equivalents
  $ 31,582     $ 368,285  
Marketable securities
    63,651        
State research and development credit exchange
          831  
Prepaid expenses and other current assets
    7,709       9,596  
 
           
Total current assets
    102,942       378,712  
Property and equipment — net
    225,515       162,683  
State research and development credit exchange receivable — net of current portion
    2,625       1,500  
Other assets
    550       548  
 
           
Total
  $ 331,632     $ 543,443  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
               
Current liabilities:
               
Accounts payable
  $ 19,992     $ 35,463  
Accrued expenses and other current liabilities
    36,087       32,095  
 
           
Total current liabilities
    56,079       67,558  
Senior convertible notes
    112,128       111,761  
Other liabilities
          24  
 
           
Total liabilities
    168,207       179,343  
 
           
Commitments and contingencies
               
Stockholders’ equity:
               
Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding at September 30, 2008 and December 31, 2007
           
Common stock, $0.01 par value — 150,000,000 shares authorized; 101,710,590 and 101,380,823 shares issued and outstanding at September 30, 2008 and December 31, 2007, respectively
    1,017       1,014  
Additional paid-in capital
    1,463,191       1,444,125  
Deficit accumulated during the development stage
    (1,300,783 )     (1,081,039 )
 
           
Total stockholders’ equity
    163,425       364,100  
 
           
Total
  $ 331,632     $ 543,443