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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 March 31, 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


 

35,216,321 shares


(Class)

  (Outstanding at May 5, 2004)

 



Table of Contents

MGI PHARMA, INC.

 

FORM 10-Q INDEX

 

     Page
Number


PART I. FINANCIAL INFORMATION

    

Item 1. Financial Statements (Unaudited)

    

Balance Sheets – March 31, 2004 and December 31, 2003

   3

Statements of Operations – Three Months Ended March 31, 2004 and 2003

   5

Statements of Cash Flows – Three Months Ended March 31, 2004 and 2003

   6

Notes to Financial Statements

   7

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

   14

Item 3. Quantitative and Qualitative Disclosures About Market Risk

   35

Item 4. Controls and Procedures

   35

PART II. OTHER INFORMATION

    

Item 2. Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities

   36

Item 5. Other Information

   37

Item 6. Exhibits and Reports on Form 8-K

   38

SIGNATURES

   40

 

2


Table of Contents

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

MGI PHARMA, INC.

 

BALANCE SHEETS

 

(unaudited)

 

    

March 31,

2004


   December 31,
2003


ASSETS

             

Current assets:

             

Cash and cash equivalents

   $ 347,264,002    $ 116,570,518

Short-term marketable investments

     22,153,916      23,362,898

Restricted marketable investments

     5,816,589      —  

Receivables, less contractual allowances and bad debt of $5,487,410 and $3,315,399

     24,109,171      6,223,964

Inventories

     5,998,105      7,437,550

Prepaid expenses

     940,691      922,070
    

  

Total current assets

     406,282,474      154,517,000

Equipment, furniture and leasehold improvements, at cost less accumulated depreciation of $3,331,403 and $3,041,360

     2,799,805      2,828,602

Long-term marketable investments

     31,319,141      37,819,837

Restricted marketable investments, less current portion

     11,264,397      —  

Debt issuance costs, less accumulated amortization of $96,168 and $10,799

     7,982,054      39,044

Long-term equity investment

     3,646,052      3,646,052

Intangible assets, at cost less accumulated amortization of $4,008,866 and $3,667,412

     5,312,004      5,653,457

Other assets

     54,206      54,206
    

  

Total assets

   $ 468,660,133    $ 204,558,198
    

  

 

(Continued)

 

3


Table of Contents

BALANCE SHEETS

(Unaudited)

Page 2

 

    

March 31,

2004


    December 31,
2003


 

LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 5,121,429     $ 4,039,139  

Accrued expenses

     16,350,304       21,632,345  

Deferred revenue

     245,000       245,000  

Other current liabilities

     633,032       28,910  
    


 


Total current liabilities

     22,349,765       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 March 31, 2004 and unamortized warrant costs of $1,322,244 as of December 31, 2003.

     260,171,760       19,677,756  

Deferred revenue

     2,135,000       2,196,250  

Other noncurrent liabilities

     133,288       128,636  
    


 


Total noncurrent liabilities

     262,440,048       22,002,642  
    


 


Total liabilities

     284,789,813       47,948,036  
    


 


Stockholders’ equity:

                

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

     —         —    

Common stock, $.01 par value, 70,000,000 authorized shares, 35,143,134 and 31,696,982 issued and outstanding shares

     351,431       316,970  

Additional paid-in capital

     408,023,319       377,664,610  

Unearned compensation - restricted stock

     (11,496 )     (24,129 )

Accumulated deficit

     (224,492,934 )     (221,347,289 )
    


 


Total stockholders’ equity

     183,870,320       156,610,162  
    


 


Total liabilities and stockholders’ equity

   $ 468,660,133     $ 204,558,198  
    


 


 

See accompanying notes to financial statements.

 

4


Table of Contents

MGI PHARMA, INC.

 

STATEMENTS OF OPERATIONS

 

(Unaudited)

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Revenues:

                

Sales

   $ 25,833,634     $ 6,142,787  

Licensing

     1,035,536       615,961  
    


 


       26,869,170       6,758,748  
    


 


Costs and expenses:

                

Cost of sales

     7,283,384       770,881  

Selling, general and administrative

     17,464,875       8,817,980  

Research and development

     5,015,677       3,459,569  

Amortization

     341,454       295,494  
    


 


       30,105,390       13,343,924  
    


 


Loss from operations

     (3,236,220 )     (6,585,176 )

Interest income

     815,193       206,628  

Interest expense

     (724,618 )     (249,391 )
    


 


Net loss

   $ (3,145,645 )   $ (6,627,939 )
    


 


Net loss per common share:

                

Basic

   $ (0.09 )   $ (0.26 )

Assuming dilution

   $ (0.09 )   $ (0.26 )

Weighted average number of common shares outstanding:

                

Basic

     34,272,729       25,320,138  

Diluted

     34,272,729       25,320,138  

 

See accompanying notes to financial statements.

 

5


Table of Contents

MGI PHARMA, INC.

 

STATEMENTS OF CASH FLOWS

 

(Unaudited)

 

     Three Months Ended March 31,

 
     2004

    2003

 

OPERATING ACTIVITIES:

                

Net loss

   $ (3,145,645 )   $ (6,627,939 )

Adjustments for non-cash items:

                

Depreciation and intangible amortization

     637,006       513,204  

Benefit plan contribution

     208,736       143,313  

Amortization of non-cash financing charges

     208,618       91,891  

Amortization of restricted stock expense

     12,254       39,617  

Deferred rent

     4,651       9,716  

Noncash consulting payments

     7,500       5,000  

Other

     2,749       —    

Change in operating assets and liabilities:

                

Receivables

     (17,885,207 )     (104,652 )

Inventories

     1,439,445       297,063  

Prepaid expenses

     (18,621 )     (921,782 )

Accounts payable and accrued expenses

     (3,513,610 )     (1,553,951 )

Deferred revenue

     (61,250 )     (198,596 )

Other current liabilities

     604,122       190,197  
    


 


Net cash used in operating activities

     (21,499,252 )     (8,116,919 )
    


 


INVESTING ACTIVITIES:

                

Purchase of investments

     (32,421,932 )     —    

Maturity of investments

     40,131,610       3,089,679  

Purchase of equipment, furniture and leasehold improvements

     (269,505 )     (123,331 )
    


 


Net cash provided by investing activities

     7,440,173       2,966,348  
    


 


FINANCING ACTIVITIES:

                

Restricted marketable securities held by trustee for debt service

     (17,080,986 )     —    

Issuance of shares under stock plans

     5,890,011       101,786  

Proceeds of debt offering

     260,171,760       —    

Issuance costs of debt offering

     (8,078,222 )     —    

Issuance of shares through stock purchase warrant exercise

     3,850,000       —    
    


 


Net cash provided by financing activities

     244,752,563       101,786  
    


 


Increase (decrease) in cash and cash equivalents

     230,693,484       (5,048,785 )

Cash and cash equivalents at beginning of period

     116,570,518       52,933,393  
    


 


Cash and cash equivalents at end of period

   $ 347,264,002     $ 47,884,608  
    


 


Supplemental disclosure of cash information:

                

Cash paid for interest

   $ 0     $ 0  

 

See accompanying notes to financial statements.

 

6


Table of Contents

MGI PHARMA, INC.

 

NOTES TO FINANCIAL STATEMENTS

(Unaudited)

 

(1) Basis of Presentation

 

In the opinion of management, the accompanying Unaudited Financial Statements (“financial statements”) of MGI PHARMA, INC. (“MGI” or “Company”) have been prepared on a consistent basis with the December 31, 2003 audited financial statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly present the information set forth therein. The financial statements have been prepared in accordance with the regulations of the SEC, and, therefore, omit certain information and footnote disclosure necessary to present the statements in accordance with generally accepted accounting principles. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003, which was filed with the SEC on February 24, 2004. Certain amounts reported in previous periods have been reclassified to conform to the current period presentation. The results of operations for the first three months of 2004 are not necessarily indicative of the results to be expected for the entire fiscal year.

 

Accounting Policies:

 

In preparing the financial statements in conformity with accounting principles generally accepted in the United States of America, management must make decisions that impact the reported amounts and the related disclosures. Such decisions include the selection of the appropriate accounting principles to be applied and the assumptions on which to base accounting estimates. In reaching such decisions, management applies judgments based on its understanding and analysis of the relevant circumstances, historical experience, and actuarial valuations. Actual amounts could differ from those estimated at the time the financial statements are prepared. Note 1 to the financial statements in the Company’s Annual Report on Form 10-K provides a summary of the significant accounting policies followed in the preparation of the financial statements. Other footnotes in the Company’s Annual Report on Form 10-K describe various elements of the financial statements and the assumptions made in determining specific amounts.

 

Recent Accounting Pronouncements:

 

FIN 46, “Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51,” requires companies to consolidate certain types of variable interest entities. A variable interest entity is an entity that has inadequate invested equity at risk to meet expected future losses, or whose holders of the equity investments lack any of the following three characteristics: (i) the ability to make decisions about the entity’s activities; (ii) the obligation to absorb the entity’s losses if they occur; (iii) the right to receive the entity’s future returns if they occur. The provisions of the interpretation are effective for financial statements issued for the first period ending after December 15, 2003, or March 15, 2004, depending on the nature of the variable interest entity. The adoption of FIN46 did not have any impact on our financial position or results of operations.

 

7


Table of Contents

(2) Stock Incentive Plans

 

Under stock incentive plans, designated persons (including officers, directors, employees and consultants) have been or may be granted rights to acquire our common stock. These rights include stock options and other equity rights. At March 31, 2004, shares issued and shares available under stock incentive plans are as follows:

 

     Shareholder
Approved
Plans


   Other
Plans


  

Total

For All
Plans


Shares issuable under outstanding options

     3,973,538      20,308      3,993,846

Shares available for future issuance

     290,146      —        290,146
    

  

  

Total

     4,263,684      20,308      4,283,992
    

  

  

Average exercise price for outstanding options

   $ 17.38    $ 10.47    $ 17.35

 

We apply the intrinsic value method described in Accounting Principles Board (APB) Opinion No. 25 in accounting for the issuance of stock options to employees and directors. Accordingly, as all grants are made at or above market price, no compensation expense has been recognized in the financial statements. Had we determined compensation cost based on fair value at the grant date for our stock options and the fair value of the discount related to the employee stock purchase plan under SFAS 123, our net loss would have been reported as follows:

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Net loss, as reported

   $ (3,145,645 )   $ (6,627,939 )

Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards

     (3,097,722 )     (1,244,286 )
    


 


Pro forma net loss

   $ (6,243,367 )   $ (7,872,225 )