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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 


 

FORM 10-Q

 


 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2004

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from              to             

 

Commission File Number: 0-10736

 


 

MGI PHARMA, INC.

(Exact name of registrant as specified in its charter)

 


 

Minnesota   41-1364647

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. employer

identification number)

5775 West Old Shakopee Road

Suite 100

Bloomington, Minnesota 55437

  (952) 346-4700
(Address of principal executive offices and zip code)   (Registrant’s telephone number, including area code)

 

Indicate by check mark, whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Common Stock, $.01 par value   70,920,709 shares
(Class)   (Outstanding at November 2, 2004)

 



Table of Contents

MGI PHARMA, INC.

 

FORM 10-Q INDEX

 

    Page
Number


PART I. FINANCIAL INFORMATION

   

Item 1. Financial Statements (Unaudited)

   

Condensed Consolidated Balance Sheets – September 30, 2004 and December 31, 2003

  3

Condensed Consolidated Statements of Operations – Three and Nine Months Ended September 30, 2004 and 2003

  5

Condensed Consolidated Statements of Cash Flows – Three and Nine Months Ended September 30, 2004 and 2003

  6

Notes to Condensed Consolidated Financial Statements

  7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

  21

Item 3. Quantitative and Qualitative Disclosures About Market Risk

  46

Item 4. Controls and Procedures

  46

PART II. OTHER INFORMATION

   

Item 6. Exhibits

  47

SIGNATURES

  49

 

2


Table of Contents

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

MGI PHARMA, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(unaudited)

 

     September 30,
2004


   December 31,
2003


ASSETS

             

Current assets:

             

Cash and cash equivalents

   $ 211,454,358    $ 116,570,518

Short-term marketable investments

     37,159,989      23,362,898

Restricted marketable investments

     5,907,578      —  

Receivables, less contractual and bad debt allowances of $12,289,976 and $3,315,399

     82,053,150      6,223,964

Inventories

     5,183,056      7,437,550

Prepaid expenses

     918,471      922,070
    

  

Total current assets

     342,676,602      154,517,000

Equipment, furniture and leasehold improvements, at cost less accumulated depreciation of $3,656,725 and $3,041,360

     2,673,334      2,828,602

Restricted cash

     600,000      —  

Long-term marketable investments

     63,312,428      37,819,837

Restricted marketable investments, less current portion

     8,387,578      —  

Debt issuance costs, less accumulated amortization of $677,956 and $10,799

     7,457,517      39,044

Long-term equity investment

     911,512      3,646,052

Intangible assets, at cost less accumulated amortization of $4,697,773 and $3,667,412

     8,536,097      5,653,457

Other assets

     71,250      54,206
    

  

Total assets

   $ 434,626,318    $ 204,558,198
    

  

 

(Continued)

 

3


Table of Contents

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

Page 2

 

     September 30,
2004


    December 31,
2003


 

LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 9,660,130     $ 4,039,139  

Accrued expenses

     34,528,962       21,632,345  

Deferred revenue

     245,000       245,000  

Current portion of long-term debt

     327,865       —    

Other current liabilities

     15,599,780       28,910  
    


 


Total current liabilities

     60,361,737       25,945,394  
    


 


Noncurrent liabilities:

                

Senior subordinated convertible notes, face value of $348,000,000 and $21,000,000, net of unamortized discount of $87,828,240 as of September 30, 2004 and unamortized warrant costs of $1,322,244 as of December 31, 2003.

     260,171,760       19,677,756  

Long-term debt

     2,376       —    

Deferred revenue

     2,029,009       2,196,250  

Other noncurrent liabilities

     1,452,816       128,636  
    


 


Total noncurrent liabilities

     263,655,961       22,002,642  
    


 


Total liabilities

     324,017,698       47,948,036  
    


 


Stockholders’ equity:

                

Preferred stock, 10,000,000 authorized and unissued shares

     —         —    

Common stock, $.01 par value, 140,000,000 authorized shares, 70,798,764 and 63,393,964 issued and outstanding shares

     707,988       633,940  

Additional paid-in capital

     416,233,303       377,347,640  

Unearned compensation

     (3,944,688 )     (24,129 )

Accumulated other comprehensive income

     2,838,289       —    

Accumulated deficit

     (305,226,272 )     (221,347,289 )
    


 


Total stockholders’ equity

     110,608,620       156,610,162  
    


 


Total liabilities and stockholders’ equity

   $ 434,626,318     $ 204,558,198  
    


 


 

See accompanying notes to condensed consolidated financial statements.

 

4


Table of Contents

MGI PHARMA, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(unaudited)

 

    

Three Months Ended

September 30,


   

Nine Months Ended

September 30,


 
     2004

    2003

    2004

    2003

 

Revenues:

                                

Sales

   $ 54,905,028     $ 14,092,004     $ 127,600,556     $ 28,763,991  

Licensing

     644,650       7,109,046       2,757,093       9,065,641  
    


 


 


 


       55,549,678       21,201,050       130,357,649       37,829,632  
    


 


 


 


Costs and expenses:

                                

Cost of sales

     18,209,841       3,032,146       39,976,480       5,347,424  

Selling, general and administrative

     20,275,737       14,545,515       54,423,574       34,747,146  

Research and development

     22,952,509       15,223,561       36,001,009       22,855,816  

Acquired in-process research and development

     83,094,066       —         83,094,066       —    
    


 


 


 


       144,532,153       32,801,222       213,495,129       62,950,386  
    


 


 


 


Loss from operations

     (88,982,475 )     (11,600,172 )     (83,137,480 )     (25,120,754 )

Interest income

     1,761,171       429,193       3,951,835       848,417  

Interest expense

     (1,754,019 )     (249,391 )     (4,233,338 )     (748,172 )
    


 


 


 


Loss before taxes

     (88,975,323 )     (11,420,370 )   $ (83,418,983 )   $ (25,020,509 )

Provision for income taxes

     (310,000 )     —         (460,000 )     —    
    


 


 


 


Net loss

   $ (89,285,323 )   $ (11,420,370 )   $ (83,878,983 )   $ (25,020,509 )
    


 


 


 


Net loss per common share:

                                

Basic

   $ (1.26 )   $ (0.20 )   $ (1.20 )   $ (0.47 )

Assuming dilution

   $ (1.26 )   $ (0.20 )   $ (1.20 )   $ (0.47 )

Weighted average number of common shares outstanding:

                                

Basic

     70,689,093       57,374,528       69,722,866       52,976,546  

Diluted

     70,689,093       57,374,528       69,722,866       52,976,546  

 

See accompanying notes to condensed consolidated financial statements.

 

5


Table of Contents

MGI PHARMA, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(unaudited)

 

     Nine Months Ended September 30,

 
     2004

    2003

 

OPERATING ACTIVITIES:

                

Net loss

   $ (83,878,983 )   $ (25,020,509 )

Adjustments to reconcile net loss to net cash used in operating activities:

                

Acquired in-process research and development

     83,094,066       —    

Depreciation and intangible amortization

     1,937,481       1,617,550  

Benefit plan contribution

     675,733       397,078  

Amortization of non-cash financing charges

     790,406       272,340  

Employee stock compensation expense

     729,917       83,620  

Deferred rent

     7,202       22,395  

Noncash consulting payments

     25,000       17,500  

Other

     (2,864 )     —    

Change in operating assets and liabilities (net of acquisitions):

                

Receivables

     (74,422,866 )     (5,400,055 )

Inventories

     2,254,494       (258,080 )

Prepaid expenses

     173,973       (807,430 )

Accounts payable and accrued expenses

     17,278,776       4,627,291  

Deferred revenue

     (183,750 )     (7,325,722 )

Other current liabilities

     15,570,870       300,756  
    


 


Net cash used in operating activities

     (35,950,545 )     (31,473,266 )
    


 


INVESTING ACTIVITIES:

                

Purchase of held-to-maturity investments

     (78,835,853 )     (45,242,384 )

Maturity of held-to-maturity investments

     69,519,000       5,063,407  

Purchase of available for sale equity securities

     (24,400,000 )     —    

Purchases of certain net assets in connection with acquisitions, net of cash acquired

     (86,051,411 )     —    

Purchase of equipment, furniture and leasehold improvements

     (577,996 )     (700,003 )

Other

     —         2,343  
    


 


Net cash used in investing activities

     (120,346,260 )     (40,876,637 )
    


 


FINANCING ACTIVITIES:

                

Proceeds from issuance of shares, net

     —         168,581,477  

Payment of deposit payable

     —         (4,300,000 )

Restricted marketable securities held by trustee for debt service

     (14,295,156 )     —    

Issuance of shares under stock plans

     9,589,514       10,055,708  

Proceeds of debt offering

     260,171,760       —    

Issuance costs of debt offering

     (8,135,473 )     —