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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, 2003
    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: 0-20772

QUESTCOR PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)
CALIFORNIA   33-0476164
(State or other jurisdiction
of incorporation or organization)
  (I.R.S. Employer
Identification No.)

3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)

     REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700

     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 prior 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 Registrant is an accelerated filer (as defined in Rule 12B-2 of the Act). Yes [  ] No [x]

     At November 6, 2003 there were 44,379,058 shares of the Registrant’s common stock, no par value per share, outstanding.

 


TABLE OF CONTENTS

ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED SEPTEMBER 30, 2003 FINANCIAL STATEMENTS
Independent Accountants’ Review Report
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
ITEM 5. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
SIGNATURES
Exhibit Index
Exhibit 10.30
Exhibit 10.31
Exhibit 15.1
Exhibit 31
Exhibit 32


Table of Contents

QUESTCOR PHARMACEUTICALS, INC.

FORM 10-Q

TABLE OF CONTENTS

             
        Page
       
    PART I. FINANCIAL INFORMATION       3
Item 1   Financial Statements and Notes (Unaudited)       3
    Condensed Consolidated Balance Sheets—September 30, 2003 and December 31, 2002       3
    Condensed Consolidated Statements of Operations—for the three and nine months ended September 30, 2003 and 2002       4
    Condensed Consolidated Statements of Cash Flows—for the nine months ended September 30, 2003 and 2002       5
    Notes to Condensed Consolidated Financial Statements       6
    Independent Accountants’ Review Report       14
Item 2   Management’s Discussion and Analysis of Financial Condition and Results of Operations       15
Item 3   Quantitative and Qualitative Disclosures about Market Risk       22
Item 4   Controls and Procedures       22
    PART II. OTHER INFORMATION       22
Item 1   Legal Proceedings       22
Item 2   Changes in Securities and Use of Proceeds       22
Item 3   Defaults Upon Senior Securities       23
Item 4   Submission of Matters to a Vote of Security Holders       23
Item 5   Other Information       23
Item 6   Exhibits and Reports on Form 8-K       23
Signatures           24

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ITEM 1. FINANCIAL STATEMENTS

QUESTCOR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARES)

                         
            September 30,   December 31,
            2003   2002
           
 
            (Unaudited)   (Note 1)
       
ASSETS
               
Current assets:
               
   
Cash and cash equivalents
  $ 2,284     $ 6,156  
   
Short-term investments
    2,537       1,350  
   
Accounts receivable, net of allowances of $75 at September 30, 2003 and $49 at December 31, 2002
    2,144       1,590  
   
Inventories, net
    1,087       391  
   
Prepaid expenses and other current assets
    589       979  
 
   
     
 
     
Total current assets
    8,641       10,466  
Property and equipment, net
    657       585  
Purchased technology, net
    13,994       382  
Goodwill and other indefinite lived intangible assets
    479       479  
Deposits and other assets
    832       854  
 
   
     
 
     
Total assets
  $ 24,603     $ 12,766  
 
   
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
   
Accounts payable
  $ 1,025     $ 1,230  
   
Accrued compensation
    519       794  
   
Other accrued liabilities
    1,058       1,205  
   
Payable relating to product acquisition
    2,183        
   
Short-term debt and current portion of long-term debt
    153       218  
   
Current portion of capital lease obligations
          1  
 
   
     
 
     
Total current liabilities
    4,938       3,448  
Convertible debentures, (face amount of $4,000), net of deemed discount of $721 at September 30, 2003 and $1,092 at December 31, 2002
    3,279       2,908  
Other non-current liabilities
    928       833  
Commitments and Contingencies
               
Preferred stock, no par value, 7,500,000 shares authorized; 2,155,715 Series A shares issued and outstanding at September 30, 2003 and December 31, 2002 (aggregate liquidation preference of $10,000 at September 30, 2003 and December 31, 2002)
    5,081       5,081  
Stockholders’ equity:
               
   
Preferred stock, no par value, 10,000 Series B shares issued and outstanding at September 30, 2003, net of issuance costs (aggregate liquidation preference of $10,000 at September 30, 2003)
    9,178        
   
Common stock, no par value, 105,000,000 shares authorized; 44,342,808 and 38,676,592 shares issued and outstanding at September 30, 2003 and December 31, 2002, respectively
    84,263       77,528  
   
Deferred compensation
    (20 )     (22 )
   
Accumulated deficit
    (83,044 )     (76,968 )
   
Accumulated other comprehensive loss
          (42 )
 
   
     
 
     
Total stockholders’ equity
    10,377       496  
 
   
     
 
     
Total liabilities and stockholders’ equity
  $ 24,603     $ 12,766  
   
 
   
     
 

See accompanying notes.

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QUESTCOR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

                                     
        Three Months Ended   Nine Months Ended
        September 30,   September 30,   September 30,   September 30,
        2003   2002   2003   2002
       
 
 
 
Revenues:
                               
 
Net product sales
  $ 3,943     $ 3,772     $ 9,185     $ 10,885  
 
Grant and royalty revenue
    24       26       58       158  
 
Technology revenue
                250       250  
 
Services revenue from a related party
          50             150  
 
 
   
     
     
     
 
   
Total revenues
    3,967       3,848       9,493       11,443  
 
 
   
     
     
     
 
Operating costs and expenses:
                               
 
Cost of product sales
    796       881       2,620       2,243  
 
Selling, general and administrative
    2,630       2,892       7,950       8,666  
 
Research and development
    590       582       1,912       1,692  
 
Depreciation and amortization
    441       262       822       921  
 
 
   
     
     
     
 
   
Total operating costs and expenses
    4,457       4,617       13,304       13,522  
 
 
   
     
     
     
 
Loss from operations
    (490 )     (769 )     (3,811 )     (2,079 )
Non-cash amortization of deemed discount on convertible debentures
    (130 )     (130 )     (391 )     (305 )
Interest income (expense), net
    (18 )     (11 )     (32 )     3  
Other income (expense), net
    5       (151 )     (75 )     (261 )
Rental income, net
    57       66       194       212  
 
 
   
     
     
     
 
Net loss
    (576 )     (995 )     (4,115 )     (2,430 )
Non-cash deemed dividend related to beneficial conversion feature of Series B Preferred Stock
                1,394        
Dividends on Series B Preferred Stock
    200             567        
 
 
   
     
     
     
 
Net loss applicable to common stockholders
  $ (776 )   $ (995 )   $ (6,076 )   $ (2,430 )
 
 
   
     
     
     
 
Shares used in computing basic and diluted net loss per share applicable to common stockholders
    44,275       38,632       40,987       38,317  
 
 
   
     
     
     
 
Basic and diluted net loss per share applicable to common stockholders
  $ (0.02 )   $ (0.03 )   $ (0.15 )   $ (0.06 )
 
 
   
     
     
     
 

See accompanying notes.

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QUESTCOR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(IN THOUSANDS)

                   
      Nine Months Ended
     
      September 30,   September 30,
      2003   2002
     
 
OPERATING ACTIVITIES
               
Net loss
  $ (4,115 )   $ (2,430 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
 
Stock-based compensation expense
    40       311  
 
Amortization of deemed discount on convertible debentures
    391       305  
 
Amortization of deferred compensation
    44        
 
Depreciation and amortization
    822       921  
 
Other-than-temporary loss on investment
    51       367  
 
Deferred rent expense
    29       (77 )
 
Loss on the sale of investments
    14        
 
(Gain)/loss on the sale of equipment, net
    9       (37 )
Changes in operating assets and liabilities:
               
 
Accounts receivable
    (554 )     260  
 
Inventories
    (631 )     (340 )
 
Prepaid expenses and other current assets
    366       (523 )
 
Accounts payable
    (205 )     275  
 
Accrued compensation
    (275 )     192  
 
Other accrued liabilities
    (147 )     536  
 
Other non-current liabilities
    67        
 
   
     
 
Net cash flows used in operating activities
    (4,094 )     (240 )
 
   
     
 
INVESTING ACTIVITIES
               
Purchase of property and equipment
    (307 )     (323 )
Purchase of short-term investments
    (3,029 )      
Acquisition of purchased technology
    (12,113 )      
Proceeds from maturities and sales of short-term investments
    1,818        
Proceeds from sale of property and equipment
    23       51  
Decrease in other assets
    2       142  
 
   
     
 
Net cash flows used in investing activities
    (13,606 )     (130 )
 
   
     
 
FINANCING ACTIVITIES
               
Issuance of common stock, net of issuance costs
    5,058       557  
Issuance of Series B preferred stock and warrants, net of issuance costs
    9,404        
Issuance of convertible debentures
          4,000  
Short-term borrowings
    465       1,172  
Repayment of note payable to bank
          (5,000 )
Repayment of short-term and long-term debt
    (531 )     (1,296 )
Payment of Series B preferred stock dividends
    (567 )      
Repayments of capital lease obligations
    (1 )     (43 )
 
   
     
 
Net cash flows provided by/(used in) financing activities
    13,828       (610 )
 
   
     
 
Decrease in cash and cash equivalents
    (3,872 )     (980 )
Cash and cash equivalents at beginning of period
    6,156       10,183  
 
   
     
 
Cash and cash equivalents at end of period
  $ 2,284     $ 9,203  
 
   
     
 
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
               
 
Cash paid for interest
  $ 250     $ 150  
 
   
     
 
 
Amount payable relating to product acquisition
  $ 2,183     $  
 
   
     
 

See accompanying notes.

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Table of Contents

QUESTCOR PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED SEPTEMBER 30, 2003 FINANCIAL STATEMENTS

(UNAUDITED)

1. BASIS OF PRESENTATION

     Questcor Pharmaceuticals, Inc. (the “Company”) is a specialty pharmaceutical company that acquires, develops, markets and sells brand name prescription drugs through a U.S. direct sales force and overseas distributors. The Company focuses on the treatment of conditions, including central nervous system (“CNS”) diseases and gastroenterological disorders which are served by a concentrated group of physicians, such as neurologists and gastroenterologists. The Company’s strategy is to acquire pharmaceutical products that it believes have sales growth potential, are promotionally responsive to a focused, targeted sales and marketing effort and complement the Company’s existing products. In addition, through corporate collaborations, the Company intends to develop new patented intranasal formulations of previously FDA approved drugs. The Company currently markets five products in the U.S.: HP Acthar® Gel (“Acthar”), an injectable drug that is approved for the treatment of certain CNS disorders with an inflammatory component including the treatment of flares associated with Multiple Sclerosis (“MS”) and is commonly used in treating patients with infantile spasm; Nascobal®, the only prescription nasal gel used for the treatment of various Vitamin B-12 deficiencies; Ethamolin®, an injectable drug used to treat enlarged weakened blood vessels at the entrance to the stomach that have recently bled, known as esophageal varices; Glofil®-125, which is an injectable agent that assesses how well the kidney is working by measuring glomerular filtration rate, or kidney function; and VSL#3™, a patented probiotic marketed as a dietary supplement to promote normal gastrointestinal function. Probiotics are living organisms in food and dietary supplements, which, upon ingestion in certain numbers, improve the health of the host beyond their inherent basic nutrition. Due to minimal demand and increasing production costs, the Company discontinued marketing and selling Inulin in Sodium Chloride on September 30, 2003. On June 17, 2003, the Company acquired Nascobal®, a nasal gel formulation of Cyanocobalamin USP (Vitamin B-12), from Nastech Pharmaceutical Company, Inc. (“Nastech”). The Company began distributing Nascobal in July 2003. The Company markets Nascobal for patients with severe deficiencies of Vitamin B-12 associated with MS and Crohn’s Disease as these patients are at high risk of developing severe deficiencies of Vitamin B-12 due to a compromised ability to absorb Vitamin B-12 through the gastrointestinal system. In June 2002, the Company signed a license agreement with Fabre Kramer Pharmaceuticals, Inc., whereby Fabre Kramer will manage and provide funding for the clinical development programs for Hypnostat™ (an intranasal triazolam for the treatment of insomnia) and Panistat™ (an intranasal alprazolam for the treatment of panic disorders).

     The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States and applicable Securities and Exchange Commission regulations for interim financial information. These financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. The unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002, as filed on March 26, 2003 with the Securities and Exchange Commission. The accompanying balance sheet at December 31, 2002 has been derived from the audited financial statements at that date. In the opinion of the Company’s management, all adjustments (consisting of normal recurring adjustments) considered necessary for the fair presentation of interim financial information have been included. Operating results for the interim periods presented are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. Certain amounts in the prior quarter’s financial statements have been reclassified to conform with the current quarter’s presentation. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.

2. RECENTLY ISSUED ACCOUNTING STANDARDS

     In May 2003, the FASB issued SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity.” This Statement establishes new standards for how an issuer classifies and measures certain financial instruments with characteristics of both liabilities and equity. It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). This Statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The adoption of SFAS No. 150 on July 1, 2003 did not have a material impact on the Consolidated Financial Statements.

     In November 2002, the Emerging Issues Task Force (or EITF) of the Financial Accounting Standards Board (or FASB) issued EITF 00-21, “Revenue Arrangements with Multiple Deliverables,” which addresses certain aspects of the accounting for arrangements that involve the delivery or performance of multiple products, services and/or rights to use assets. Under EITF 00-21, revenue arrangements with multiple deliverables should be divided into separate units of accounting if the deliverables meet certain criteria, including whether the fair value of the delivered items can be determined and whether there is evidence of fair value of the undelivered items. In addition, the consideration should be allocated among the separate units of accounting based on their fair values, and the applicable revenue recognition criteria should be considered separately for each of the separate units of accounting. EITF 00-21

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is effective for revenue arrangements the Company enters into after June 30, 2003. The adoption of EITF 00-21 did not have a material impact on the Consolidated Financial Statements as of September 30, 2003. The Company will evaluate the impact of EITF 00-21 on future revenue arrangements it enters into.

3. STOCK-BASED COMPENSATION

     The Company generally grants stock options to its employees for a fixed number of shares with an exercise price equal to the fair value of the shares on the date of grant. As allowed under Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”), the Company has elected to follow Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” and related interpretations in accounting for stock awards to employees. Accordingly, no compensation expense is recognized in the Company’s financial statements in connection with stock options granted to employees with exercise prices not less than fair value. Deferred compensation for options granted to employees is determined as the difference between the fair value of the Company’s common stock on the date options were granted and the exercise price. For purposes of disclosures pursuant to SFAS 123, as amended by Statement of Financial Accounting Standards No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure”, the estimated fair value of options is amortized to expense over the options’ vesting periods.

     Compensation expense for options granted to non-employees has been determined in accordance with SFAS 123 and EITF 96-18, “Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in conjunction with Selling Goods or Services”, as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Compensation expense for options granted to non-employees is periodically re-measured as the underlying options vest.

     The following table illustrates the effect on net loss per common share if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):

                                   
      Three months ended September 30,   Nine months ended September 30,
     
 
      2003   2002   2003   2002
     
 
 
 
Net loss applicable to common stockholders as reported
  $ (776 )   $ (995 )   $ (6,076 )   $ (2,430 )
 
Add: Stock-based employee compensation expense included in reported net loss
    37       2       51       9  
 
Deduct: Total stock-based employee compensation expense determined under fair value method for all awards
    (343 )     (303 )     (1,010 )     (1,076 )
 
   
     
     
     
 
Net loss applicable to common stockholders, pro forma
  $ (1,082 )   $ (1,296 )   $ (7,035 )   $ (3,497 )
 
   
     
     
     
 
Basic and diluted net loss per share applicable to common stockholders:
                               
 
As reported
  $ (0.02 )   $ (0.03 )   $ (0.15 )   $ (0.06 )