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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

     
[X]
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2004
 
   
[   ]
  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: 0-13976

AKORN, INC.

(Exact Name of Registrant as Specified in its Charter)

     
LOUISIANA   72-0717400
(State or Other Jurisdiction of   (I.R.S. Employer
Incorporation or Organization)   Identification No.)
     
2500 MILLBROOK DRIVE    
BUFFALO GROVE, ILLINOIS   60089
(Address of Principal Executive Offices)   (Zip Code)

(847) 279-6100

(Registrant’s telephone number)

     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 Exchange Act Rule 12b-2).

Yes [   ] No [X]

     At August 10, 2004 there were 20,612,684 shares of common stock, no par value, outstanding.



 


         
    Page
PART I. FINANCIAL INFORMATION
       
ITEM 1. Financial Statements (Unaudited)
       
Condensed Consolidated Balance Sheets-June 30, 2004 and December 31, 2003
    3  
Condensed Consolidated Statements of Operations-Three and six months ended June 30, 2004 and 2003
    4  
Condensed Consolidated Statements of Cash Flows-Six months ended June 30, 2004 and 2003
    5  
Notes to Condensed Consolidated Financial Statements
    6  
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
    18  
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
    28  
ITEM 4. Controls and Procedures
    28  
PART II. OTHER INFORMATION
       
ITEM 1. Legal Proceedings
    29  
ITEM 2. Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities
    31  
ITEM 3. Defaults Upon Senior Securities
    31  
ITEM 4. Submission of Matters to a Vote of Security Holders
    31  
ITEM 5. Other Information
    31  
ITEM 6. Exhibits and Reports on Form 8-K
    31  
 Waiver and Modification of Bank Covenants
 Certification of Chief Executive Officer
 Certification of Chief Financial Officer
 906 Certification of Chief Executive Officer
 906 Certification of Chief Financial Officer

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AKORN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
(UNAUDITED)
                 
    JUNE 30,   DECEMBER 31,
    2004
  2003
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $     $ 218  
Trade accounts receivable (less allowance for doubtful accounts of $722 and $609, respectively)
    4,489       1,626  
Inventories
    8,803       7,807  
Prepaid expenses and other current assets
    803       944  
 
   
 
     
 
 
TOTAL CURRENT ASSETS
    14,095       10,595  
OTHER ASSETS
               
Intangibles, net
    10,372       12,872  
Investment in Novadaq Technologies, Inc.
    713       713  
Other
    627       1,328  
 
   
 
     
 
 
TOTAL OTHER ASSETS
    11,712       14,913  
PROPERTY, PLANT AND EQUIPMENT, NET
    32,992       33,907  
 
   
 
     
 
 
TOTAL ASSETS
  $ 58,799     $ 59,415  
 
   
 
     
 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Current installments of long-term debt
  $ 6,294     $ 4,156  
Trade accounts payable
    6,279       5,411  
Accrued compensation
    900       510  
Accrued expenses and other current liabilities
    1,521       1,882  
 
   
 
     
 
 
TOTAL CURRENT LIABILITIES
    14,994       11,959  
Long-term debt, less current installments
    12,805       13,777  
Redeemable Preferred Stock, $1.00 par value—5,000,000 shares authorized, 268,831 and 257,172 shares issued and outstanding as of June 30, 2004 and December 31, 2003, respectively
    22,181       21,132  
OTHER LONG-TERM LIABILITIES
    1,431       1,156  
 
   
 
     
 
 
TOTAL LIABILITIES
    51,411       48,024  
COMMITMENTS AND CONTINGENCIES
               
SHAREHOLDERS’ EQUITY
               
Common stock, no par value—40,000,000 shares authorized, 20,507,756 and 19,825,296 shares issued and outstanding at June 30, 2004 and December 31, 2003, respectively
    26,748       25,506  
Warrants to acquire common stock
    13,278       13,724  
Accumulated deficit
    (32,638 )     (27,839 )
 
   
 
     
 
 
TOTAL SHAREHOLDERS’ EQUITY
    7,388       11,391  
 
   
 
     
 
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 58,799     $ 59,415  
 
   
 
     
 
 

See notes to condensed consolidated financial statements.

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AKORN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
                                 
    THREE MONTHS ENDED   SIX MONTHS ENDED
    JUNE 30,
  JUNE 30,
    2004
  2003
  2004
  2003
Revenues
  $ 11,076     $ 8,840     $ 22,736     $ 21,622  
Cost of sales
    7,757       8,305       15,398       15,243  
 
   
 
     
 
     
 
     
 
 
GROSS PROFIT
    3,319       535       7,338       6,379  
Selling, general and administrative expenses
    3,254       3,610       6,150       7,773  
Amortization and write-down of intangibles
    1,877       344       2,560       699  
Research and development expenses
    383       362       712       835  
 
   
 
     
 
     
 
     
 
 
TOTAL OPERATING EXPENSES
    5,514       4,316       9,422       9,307  
 
   
 
     
 
     
 
     
 
 
OPERATING LOSS
    (2,195 )     (3,781 )     (2,084 )     (2,928 )
Interest expense
    (1,386 )     (612 )     (2,713 )     (1,257 )
 
   
 
     
 
     
 
     
 
 
LOSS BEFORE INCOME TAXES
    (3,581 )     (4,393 )     (4,797 )     (4,185 )
Income tax provision (benefit)
    2       (196 )     2       (171 )
 
   
 
     
 
     
 
     
 
 
NET LOSS
  $ (3,583 )   $ (4,197 )   $ (4,799 )   $ (4,014 )
 
   
 
     
 
     
 
     
 
 
NET LOSS PER SHARE:
                               
BASIC AND DILUTED
  $ (0.18 )   $ (0.21 )   $ (0.24 )   $ (0.20 )
 
   
 
     
 
     
 
     
 
 
SHARES USED IN COMPUTING NET LOSS PER SHARE:
                               
BASIC AND DILUTED
    20,190       19,723       20,038       19,705  
 
   
 
     
 
     
 
     
 
 

See notes to condensed consolidated financial statements.

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AKORN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
                 
    SIX MONTHS
    ENDED JUNE 30,
    2004
  2003
OPERATING ACTIVITIES
               
Net loss
  $ (4,799 )   $ (4,014 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    2,768       2,228  
Write-down of long lived assets
    1,849        
Amortization of debt discounts
    478       500  
Non-cash expenses related to preferred stock
    1,049        
Changes in operating assets and liabilities:
               
Accounts receivable
    (2,863 )     1,865  
Inventories
    (996 )     635  
Prepaid expenses and other current assets
    141       (568 )
Trade accounts payable
    868       415  
Accrued expenses and other liabilities
    304       (449 )
 
   
 
     
 
 
NET CASH USED IN OPERATING ACTIVITIES
    (1,201 )     612  
INVESTING ACTIVITIES
               
Purchase of intangible asset
    (60 )      
Purchases of property, plant and equipment
    (441 )     (903 )
 
   
 
     
 
 
NET CASH USED IN INVESTING ACTIVITIES
    (501 )     (903 )
FINANCING ACTIVITIES
               
Repayment of long-term debt
    (1,335 )     (155 )
Net borrowings under lines of credit
    2,127       12  
Proceeds under stock option and stock purchase plans
    692       70  
 
   
 
     
 
 
NET CASH PROVIDED BY FINANCING ACTIVITIES
    1,484       (73 )
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
    (218 )     (364 )
Cash and cash equivalents at beginning of period
    218       364  
 
   
 
     
 
 
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ (0 )   $ (0 )
 
   
 
     
 
 
Amount paid for interest (net of capitalized interest)
  $ 308     $ 797  
Amount refunded for income taxes
    38        

See notes to condensed consolidated financial statements.

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AKORN, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

NOTE A – BUSINESS AND BASIS OF PRESENTATION

     Business: Akorn, Inc. and its wholly owned subsidiary, Akorn (New Jersey), Inc. (collectively, the “Company”) manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas such as ophthalmology, rheumatology, anesthesia and antidotes, among others. Customers, including physicians, optometrists, wholesalers, hospitals and other pharmaceutical companies, are served primarily from three operating facilities in the United States.

     Basis of Presentation: The Company’s losses from operations in recent years and working capital deficiencies, together with the need to successfully resolve its ongoing compliance matters with the Food and Drug Administration (“FDA”), have raised substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business although the report of our independent auditors as of and for the year ended December 31, 2003 expressed substantial doubt as to the Company’s ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

     On October 7, 2003, a significant threat to the Company’s ability to continue as a going concern was resolved when the Company consummated a transaction with a group of investors that resulted in the extinguishment of the Company’s then outstanding senior bank debt in the amount of approximately $37,731,000 in exchange for shares of the Company’s Series A 6% Participating Convertible Preferred Stock, warrants to purchase shares of the Company’s common stock, subordinated promissory notes in the aggregate amount of $2,767,139 and cash in the amount of $5,473,862 which was obtained from a new credit facility obtained by the Company. For more information regarding this transaction, see Note H — “Financing Arrangements.”

     As of June 30, 2004, the Company had approximately $1.3 million of undrawn availability under its new line of credit. The Company believes that the new line of credit, together with cash generated from operations, will be sufficient to meet the cash requirements for operating the Company’s business for the next twelve months, although there can be no assurance of this sufficiency. At this time, the Company is exploring opportunities to raise additional capital to fund future growth opportunities.

     Although the Company has refinanced its debt on a long-term basis as described above, it continues to be subject to financial covenants under the new debt and to ongoing FDA compliance matters that could have a material adverse effect on the Company. See Note L — “Commitments and Contingencies” for further description of these matters. The Company is working with the FDA to favorably resolve such compliance matters and has submitted to the FDA and continues to implement a plan for comprehensive corrective actions at its Decatur, Illinois facility. The FDA completed inspection of the Decatur facility on April 7, 2004. The Company has responded to the findings from this inspection and has been meeting with the FDA to discuss these responses and the status of the Decatur facility. As a result of these meetings, the Company will be subject to a confirmatory inspection to verify the Company’s corrective actions on the previous inspection. The result of the last inspection remains open, pending this confirmatory inspection. The confirmatory inspection is anticipated to occur in the fourth quarter of 2004. The management of the Company believes that the Company will successfully resolve these compliance matters with the FDA. However, there can be no guarantee that the FDA matters will be successfully resolved.

     The Company has added key management personnel, including the hiring of a new chief financial officer in June 2004 along with additional personnel in critical areas. Management has reduced the Company’s cost structure, improved the Company’s processes and systems, and implemented strict controls over capital spending. Management believes these activities will improve the Company’s results of operations, cash flow from operations and its future prospects.

     As a result of all of the factors cited in the preceding paragraphs, management believes that the Company should be able to sustain its operations and continue as a going concern. However, the ultimate outcome of this uncertainty cannot be presently determined and, accordingly, there remains substantial doubt as to whether the Company will be able to continue as a going concern.

     Consolidation: The accompanying unaudited condensed consolidated financial statements include the accounts of Akorn, Inc. and Akorn (New Jersey) Inc. Intercompany transactions and balances have been eliminated in consolidation. These financial statements

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have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and accordingly do not include all the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements.

     Adjustments: In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included in these financial statements. Operating results for the three-month and six-month periods ended June 30, 2004 are not necessarily indicative of the results that may be expected for a full year. For further information, refer to the consolidated financial statements and footnotes for the year ended December 31, 2003, included in the Company’s Annual Report on Form 10-K.

NOTE B — USE OF ESTIMATES

     The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. Significant estimates and assumptions for the Company relate to the allowance for doubtful accounts, the allowance for chargebacks, the allowance for rebates, the reserve for slow-moving and obsolete inventory, the allowance for product returns, the carrying value of intangible assets and the carrying value of deferred income tax assets.

NOTE C — STOCK BASED COMPENSATION

     The Company applies APB Opinion No. 25 “Accounting for Stock Issued to Employees” in accounting for options granted to its employees under its stock option programs and applies Statement of Financial Accounting Standards No. 123 “Accounting for Stock Issued Employees” (“SFAS 123”) for disclosure purposes only. The SFAS 123 disclosures include pro forma net income (loss) and earnings (loss) per share as if the fair value-based method of accounting had been used.

     If compensation for employee options had been determined based on SFAS 123, the Company’s pro forma net income (loss) and pro forma net income (loss) per share for the three and six months ended June 30, would have been as follows:

                                 
    Three Months ended June 30
  Six Months ended June 30
    2004
  2003
  2004
  2003
Net loss, as reported
  $ (3,583 )   $ (4,197 )   $ (4,799 )   $ (4,014 )
Add stock-based employee compensation expense included in reported net income
                       
Deduct total stock-based employee compensation expense determined under fair-value-based method for all awards
    (54 )     3       (517 )     (86 )
 
   
 
     
 
     
 
     
 
 
Pro forma net loss
  $ (3,637 )   $ (4,194 )   $ (5,316 )   $ (4,100 )
 
   
 
     
 
     
 
     
 
 
Basic and diluted loss per share of common stock
                               
Basic and diluted as reported
  $ (0.18 )   $ (0.21 )   $ (0.24 )   $ (0.20 )
Basic and diluted pro forma
  $ (0.18 )   $ (0.21 )   $ (0.24 )   $ (0.21 )

NOTE D — REVENUE RECOGNITION

     The Company recognizes product sales for its ophthalmic and injectable business segments upon the shipment of goods for customers whose terms are FOB shipping point. The Company has certain customers whose terms are FOB destination point and recognizes revenue upon delivery of the product to these customers. Revenue is recognized when all obligations of the Company have been fulfilled and collection of the related receivable is probable.

     The Contract Services segment, which produces products for third party customers, based upon their specifications, at a pre-determined price, also recognizes sales upon the shipment of goods or upon delivery of the product as appropriate. Revenue is recognized when all obligations of the Company have been fulfilled and collection of the related receivable is probable.

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     Provision for estimated doubtful accounts, chargebacks, rebates, discounts and product returns is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.

NOTE E — ACCOUNTS RECEIVABLE ALLOWANCES

     The nature of the Company’s business inherently involves, in the ordinary course, significant amounts and substantial volumes of transactions and estimates relating to allowances for doubtful accounts, product returns, chargebacks, rebates and discounts given to customers. This is a natural circumstance of the pharmaceutical industry and not specific to the Company and inherently lengthens the collection process. Depending on the product, the end-user customer, the specific terms of national supply contracts and the particular arrangements with the Company’s wholesaler customers, certain rebates, chargebacks and other credits are deducted from the Company’s accounts receivable. The process of claiming these deductions depends on wholesalers reporting to the Company the amount of deductions that were earned under the respective terms with end-user customers (which in turn depends on which end-user customer, with different pricing arrangements might be entitled to a particular deduction). This process can lead to “partial payments” against outstanding invoices as the wholesalers take the claimed deductions at the time of payment.

     Unless otherwise noted, the provisions and allowances for the following customer deductions are reflected in the accompanying financial statements as reductions of revenues and trade accounts receivable, respectively.

Chargebacks and Rebates

     The Company enters contractual agreements with certain third parties such as hospitals and group-purchasing organizations to sell certain products at predetermined prices. The parties have elected to have these contracts administered through wholesalers that buy the product from the Company. When a wholesaler sells products to one of the third parties that is subject to a contractual price agreement, the difference between the price paid to the Company by the wholesaler and the price under contract is charged back to the Company by the wholesaler. The Company tracks sales and submitted chargebacks by product number for each wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product. The Company reduces gross sales and increases the chargeback allowance by the estimated chargeback amount for each product sold to a wholesaler. The Company reduces the chargeback allowance when it processes a request for a chargeback from a wholesaler. Actual chargebacks processed can vary materially from period to period.

     Management obtains certain wholesaler inventory reports to aid in analyzing the reasonableness of the chargeback allowance. The Company assesses the reasonableness of its chargeback allowance by applying the product chargeback percentage based on historical activity to the quantities of inventory on hand per the wholesaler inventory reports and an estimate of in-transit inventory that is not reported on the wholesaler inventory reports at the end of the period. In the first quarter of 2004, the Company obtained more precise information from the wholesalers to estimate the amount of in-transit inventory, which lowered its estimate of in-transit inventory. This resulted in the Company recognizing approximately $500,000 less in chargeback expense in the first quarter of 2004. The Company intends to use this new information on a going forward basis as a more accurate estimate of in-transit inventory. Additionally, in the second quarter of 2004, the Company, in accordance with its policy, reduced its estimate of the percentage amount of wholesaler inventory that will ultimately be sold to a third party that is subject to a contractual price agreement. This reduction was made in reaction to a six quarter trend of such sales being below the Company’s previous estimates, thereby confirming that the reduced percentage was other than temporary. This estimate change resulted in approximately $480,000 less in chargeback expense in the second quarter of 2004. The Company intends to use this revised estimate on a going forward basis until historical trends indicate that additional revisions should be made. Also, the Company does not expect any other significant changes in its chargeback estimates during 2004.

     Similarly, the Company maintains an allowance for rebates related to contract and other programs with certain customers. Rebate percentages vary by product and by volume purchased by each eligible customer. The Company tracks sales by product number for each eligible customer and then applies the applicable rebate percentage, using both historical trends and actual experience to estimate its rebate allowance. The Company reduces gross sales and increases the rebate allowance by the estimated rebate amount when the Company sells its products to its rebate-eligible customers. The Company reduces the rebate allowance when it processes a customer request for a rebate. At each balance sheet date, the Company analyzes the allowance for rebates against actual rebates processed and makes necessary adjustments as appropriate. Actual rebates processed can vary materially from period to period.

     The recorded allowances reflect the Company’s current estimate of the future chargeback and rebate liability to be paid or credited to the wholesaler under the various contracts and programs. For the three month periods ended June 30, 2004 and 2003, the Company

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recorded chargeback and rebate expense of $3,575,000 and $3,543,000, respectively. For the six months ended June 30, 2004 and 2003, the Company recorded chargeback and rebate expense of $6,420,000 and $6,305,000, respectively. The allowance for chargebacks and rebates was $3,666,000 and $4,804,000 as of June 30, 2004 and December 31, 2003, respectively.

Product Returns

     Certain of the Company’s products are sold with the customer having the right to return the product within specified periods and guidelines for a variety of reasons, including but not limited to pending expiration dates. Provisions are made at the time of sale based upon tracked historical experience, by customer in some cases. In evaluating month-end allowance balances, the Company considers actual returns to date that are in process, the expected impact of product recalls and the wholesaler’s inventory information to assess the magnitude of unconsumed product that may result in a product return to the Company in the future. Actual returns processed can vary materially from period to period. For the three month periods ended June 30, 2004 and 2003, the Company recorded a provision for product returns of $387,000 and $640,000, respectively. For the six month period ending June 30, 2004 and 2003, the Company recorded a provision for product returns of $1,182,000 and $1,337,000, respectively. The allowance for potential product returns was $1,283,000 and $1,077,000 at June 30, 2004 and December 31, 2003, respectively.

Doubtful Accounts

     Provisions for doubtful accounts, which reflect trade receivable balances owed to the Company that are believed to be uncollectible, are recorded as a component of selling, general and administrative expense. In estimating the allowance for doubtful accounts, the Company has:

  Identified the relevant factors that might affect the accounting estimate for allowance for doubtful accounts, including: (a) historical experience with collections and write-offs; (b) credit quality of customers; (c) the interaction of credits being taken for discounts, rebates, allowances and other adjustments; (d) balances of outstanding receivables, and partially paid receivables; and (e) economic and other exogenous factors that might affect collectibility (e.g., bankruptcies of customers, factors that affect particular distribution channels).

  Accumulated data on which to base the estimate for allowance for doubtful accounts, including: (a) collections and write-offs data; (b) information regarding current credit quality of customers; and (c) other information such as buying patterns and payment patterns, particularly in respect to major customers.

  Developed assumptions reflecting management’s judgments as to the most likely circumstances and outcomes, regarding, among other matters: (a) collectibility of outstanding balances relating to “partial payments;” (b) the ability to collect items in dispute (or subject to reconciliation) with customers; and (c) economic factors that might affect collectibility of outstanding balances — based upon information available at the time.

     For the three month periods ending June 30, 2004 and 2003, we recorded a net benefit for doubtful accounts of $65,000 and $342,000, respectively, as recoveries and reduced reserve requirements exceeded write-offs and newly identified collectibility concerns. For the six months ending June 30, 2004 and 2003, we recorded a net benefit for doubtful accounts of $427,000 and $348,000, respectively. The allowance for doubtful accounts was $722,000 and $609,000 as of June 30, 2004 and December 31, 2003, respectively. As of June 30, 2004, we had a total of $976,000 of past due gross accounts receivable. Included in this total is a credit balance of $243,000, which represents wholesaler chargeback deductions that are over 60 days past due. We perform monthly a detailed analysis of the receivables due from our wholesaler customers and provides a specific reserve against known uncollectible items for each of the wholesaler customers. We also include in the allowance for doubtful accounts an amount that we estimate to be uncollectible for all other customers based on a percentage of the past due receivables. The percentage reserved increases as the age of the receivables increases. Of the recorded allowance for doubtful accounts of $722,000, the portion related to major wholesaler customers is $466,000 with the remaining $256,000 reserve for all other customers.

Discounts

     Cash discounts are available to certain customers based on agreed upon terms of sale. The Company evaluates the discount reserve balance against actual discounts taken. For the three month periods ended June 30, 2004 and 2003, the Company recorded a provision for cash discounts of $139,000 and $155,000, respectively. For the six months ending June 30, 2004 and 2003, the Company recorded a provision for cash discounts of $331,000 and $358,000, respectively. The allowance for discounts was $152,000 and $94,000 as of June 30, 2004 and December 31, 2003, respectively.

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NOTE F – INVENTORIES

     The components of inventories are as follows (in thousands):

                 
    JUNE 30,   DECEMBER 31,
    2004
  2003
Finished goods
  $ 3,809     $ 3,510  
Work in process
    1,652       1,385  
Raw materials and supplies
    3,342       2,912  
 
   
 
     
 
 
 
  $ 8,803     $ 7,807  
 
   
 
     
 
 

     Inventory at June 30, 2004 and December 31, 2003 is reported net of reserves for slow-moving, unsaleable and obsolete items of $904,000 and $917,000, respectively, primarily related to finished goods. For the three month periods ended June 30, 2004 and 2003, the Company recorded a provision of $382,000 and $239,000, respectively. For the six months ended June 30, 2004 and 2003, the Company recorded a provision of $685,000 and $408,000, respectively.

NOTE G — PROPERTY, PLANT AND EQUIPMENT

     Property, plant and equipment consists of the following (in thousands):

                 
    JUNE 30,   DECEMBER 31,
    2004
  2003
Land
  $ 396     $ 396  
Buildings and leasehold improvements
    9,319       8,890  
Furniture and equipment
    27,439       27,117  
Automobiles
    55       55  
 
   
 
     
 
 
 
    37,209       36,458  
Accumulated depreciation
    (22,991 )     (21,636 )
 
   
 
     
 
 
 
    14,218       14,822  
Construction in progress
    18,774       19,085  
 
   
 
     
 
 
 
  $ 32,992     $ 33,907  
 
   
 
     
 
 

     Construction in progress primarily represents capital expenditures related to the Company’s Lyophilization project that is intended to enable the Company to perform processes in-house that are currently being performed by a sub-contractor. The Company capitalized interest expense related to the Lyophilization project of $83,000 and $306,000 during the three-month periods ended June 30, 2004 and 2003, respectively. For the six month periods ended June 30, 2004 and 2003, the Company capitalized interest expense related to the Lyophilization project of $173,000 and $602,000, respectively. Subject to the Company’s ability to generate sufficient operating cash flow or obtain new financing for future operations and capital expenditures, the Company anticipates completion of the lyophilization project (principally including validation testing of the process as of June 30, 2004) in the first half of 2005. Future costs are estimated to be $1.0 million excluding capitalized interest. The Company can make no assurances that it will be able to complete this project within its estimated timeframe, or at all, or that material impairment charges will not be required if such completion does not occur as anticipated.

NOTE H — FINANCING ARRANGEMENTS

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     The Company’s long-term debt consists of (in thousands):

                 
    June 30,   December 31,
    2004
  2003
Credit Agreement with LaSalle Bank:
               
Line of Credit
  $ 3,627     $ 1,500  
Term Loans
    5,245       6,415  
Convertible subordinated debentures
    5,000       5,000  
Mortgages payable
    1,468       1,623  
Promissory note to NeoPharm, Inc.
    3,250       3,250  
2003 Subordinated Notes
    2,767       2,767  
 
   
 
     
 
 
 
    21,357       20,555  
Less unamortized discount on debt
    2,258       2,622  
Less current portion
    6,294       4,156  
 
   
 
     
 
 
Long-term debt
  $ 12,805     $ 13,777  
 
   
 
     
 
 

     In December 1997, the Company entered into a $15,000,000 revolving credit agreement with The Northern Trust Company (“Northern Trust”), which was increased to $25,000,000 on June 30, 1998 and to $45,000,000 on December 28, 1999. Borrowings under this credit agreement were secured by substantially all of the assets of the Company and bore floating interest rates that were 7.25% at June 30, 2003.

     The Company went into default under the Northern Trust credit agreement in 2002 and thereafter operated under an agreement under which Northern Trust would agree to forbear from exercising its remedies (the “Forbearance Agreement”) and the Company acknowledged its then-current default. The Forbearance Agreement provided for additional borrowings and was extended on numerous occasions in 2003.

     On October 7, 2003, a group of investors (the “Investors”) purchased all of the Company’s then outstanding senior bank debt from Northern Trust, a balance of $37,731,000, at a discount and exchanged such debt with the Company (the “Exchange Transaction”) for (i) 257,172 shares of Series A 6.0% Participating Convertible Preferred Stock of the Company (“Preferred Stock”), (ii) subordinated promissory notes in the aggregate principal amount of approximately $2,767,139 (the “2003 Subordinated Notes”), (iii) warrants to purchase an aggregate of 8,572,400 shares of the Company’s common stock with an exercise price of $1.00 per share (“Exchange Warrants”), and (iv) $5,473,862 in cash from the proceeds of the term loan under the New Credit Facility described in a following paragraph. The 2003 Subordinated Notes and cash were issued by the Company to (a) The John N. Kapoor Trust dtd 9/20/89 (the “Kapoor Trust”), the sole trustee and sole beneficiary of which is Dr. John N. Kapoor, the Company’s Chairman of the Board of Directors and the holder of a significant stock position in the Company, (b) Arjun Waney, a newly-elected director and the holder of a significant stock position in the Company, and (c) Argent Fund Management Ltd., for which Mr. Waney serves as Chairman and Managing Director and 51% of which is owned by Mr. Waney. The Company also issued to the holders of the 2003 Subordinated Notes warrants to purchase an aggregate of 276,714 shares of common stock with an exercise price of $1.10 per share.

     As a result of the Exchange Transaction, the Company recorded transaction costs of approximately $3.1 million. The transaction costs consisted principally of cash and securities owed to restructuring and investment banking professionals that provided services directly related to the extinguishment of the Northern Trust debt.

     In accounting for the Exchange Transaction, the Company first reduced the carrying amount of the Northern Trust debt by the cash paid to Investors. The remaining carrying value was then allocated among the three securities issued to fully extinguish the debt based on the relative fair values of those securities. Accordingly, the Preferred Stock, the 2003 Subordinated Notes and the Exchange Warrants were initially recorded at $20,874,000, $2,046,000 and $9,337,000, respectively, before, in the case of the 2003 Subordinated Notes, the discount described below and before, in the case of the securities, related issuance costs of $480,000. The fair value of the Exchange Warrants was estimated by the Company using the same method and estimates as described for the warrants issued with the 2003 Subordinated Notes. All unexercised warrants expire on October 7, 2006.

     Simultaneously with the consummation of the Exchange Transaction, the Company entered into a credit agreement with LaSalle Bank National Association (“LaSalle Bank”) providing the Company with a $7,000,000 term loan and a revolving line of credit of up to $5,000,000 to provide for working capital needs (collectively, the “New Credit Facility”) secured by substantially all of the assets of the Company. The obligations of the Company under the New Credit Facility have been guaranteed by the Kapoor Trust and Arjun Waney. In exchange for this guaranty, the Company issued additional warrants (“Guarantee Warrants”) to purchase 880,000 and 80,000 shares of common stock to the Kapoor Trust and Arjun Waney, respectively, and has agreed to issue to each of them, on each

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anniversary of the date of the consummation of the Exchange Transaction, warrants to purchase an additional number of shares of common stock equal to 0.08 multiplied by the principal dollar amount of the Company’s indebtedness then guaranteed by them under the New Credit Facility. The warrants issued in exchange for these guarantees have an exercise price of $1.10 per share.

     The New Credit Facility with LaSalle Bank consists of a $5,500,000 term loan A, a $1,500,000 term loan B (collectively, the “Term Loans”) as well as a revolving line of credit of up to $5,000,000 (the “Revolver”) secured by substantially all of the assets of the Company. The New Credit Facility matures on October 7, 2005. The Term Loans bear interest at prime plus 1.75% (5.75% at June 30, 2004) and require principal payments of $195,000 per month commencing October 31, 2003, with the payments first to be applied to term loan B. The Revolver bears interest at prime plus 1.50% (5.50% as of June 30, 2004). Availability under the Revolver is determined by the sum of (i) 80% of eligible accounts receivable, (ii) 30% of raw material, finished goods and component inventory excluding packaging items, not to exceed $2,500,000 and (iii) the difference between 90% of the forced liquidation value of machinery and equipment ($4,092,000 as of August 18, 2003) and the sum of $1,750,000 and the outstanding balance under term loan B. The availability as of June 30, 2004 was $1,323,000. The New Credit Facility contains certain restrictive covenants including but not limited to certain financial covenants such as minimum EBITDA levels, Fixed Charge Coverage Ratios, Senior Debt to EBITDA ratios and Total Debt to EBITDA ratios. We had negotiated an amendment to the New Credit Facility effective December 31, 2003 to clarify certain covenant computations and waive certain technical violations. Certain financial covenants were further amended and the time for compliance with certain non-financial covenants was extended under an amendment entered into with LaSalle Bank on August 13, 2004. The New Credit Facility also contains subjective covenants providing that the Company would be in default if, in the judgment of the lenders, there is a material adverse change in the financial condition of the Company. Because the New Credit Facility also requires the Company to maintain its deposit accounts with LaSalle, the existence of these subjective covenants, pursuant to EITF Abstract No. 95-22, requires that the Company classify outstanding borrowings under the Revolver as a current liability.

     In 2001, the Company entered into a $5,000,000 convertible subordinated debt agreement with the Kapoor Trust (“Trust Agreement”). Under the terms of the Trust Agreement, the convertible subordinated debt bears interest at prime plus 3.0% (7.0% as of June 30, 2004), is due on December 20, 2006 and was issued with detachable warrants to purchase approximately 1,667,000 shares of common stock. Interest cannot be paid on the convertible subordinated debt until the repayment of all amounts under the New Credit Facility. The convertible feature of the convertible subordinated debt, as amended, allows the Kapoor Trust to immediately convert the subordinated debt plus interest into common stock of the Company, at a price of $2.28 per share of common stock for Tranche A and $1.80 per share of common stock for Tranche B.

     The Company, in accordance with APB Opinion No. 14, recorded the convertible subordinated debt and related warrants as separate securities. Furthermore, in accordance with Emerging Issues Task Force (“EITF”) Abstract No. 00-27, the Company has also computed and recorded a separate amount related to the “intrinsic” value of the conversion option related to the debt. The resultant debt discount of $3,024,000, equivalent to the value assigned to the warrants and the “intrinsic” value of the convertible debt, is being amortized and charged to interest expense over the life of the subordinated debt. Additionally, as the accrued interest on the convertible subordinated debt is also convertible into common stock, it may also result in separately recordable beneficial conversion amounts. Such amounts would be recorded if the price of the Company’s common stock is higher than the conversion rate when the interest is accrued. In the second quarter 2004, the Company reclassified approximately $105,000 of debt to equity in recognition of the beneficial conversion on the convertible subordinated debt.

     In December 2001, the Company entered into a $3,250,000 five-year loan with NeoPharm, Inc. (“NeoPharm”) to fund the Company’s efforts to complete its lyophilization facility located in Decatur, Illinois. The note was executed in conjunction with a Processing Agreement that provides NeoPharm with the option of securing at least 15% of the capacity of the Company’s lyophilization facility each year. Dr. John N. Kapoor, the Company’s chairman holds a substantial stock position in NeoPharm as well as in the Company. In September 30, 2003, the Company defaulted under the NeoPharm Promissory Note as a result of its failure to remove all FDA warning letter sanctions related to the Company’s Decatur, Illinois facility by June 30, 2003. The Company also defaulted under the Trust Agreement as a result of a cross-default to the NeoPharm Promissory Note.

     In connection with the Exchange Transaction, the Kapoor Trust and NeoPharm waived all existing defaults under their respective agreements and entered into amended agreements dated October 7, 2003. Interest under the NeoPharm Note accrues at 1.75% above LaSalle Bank’s prime rate (5.75% as of June 30, 2004). Interest payments under both agreements are currently prohibited under the terms of a subordination arrangement with LaSalle. The amended NeoPharm Note also requires the Company to make quarterly payments of $150,000 beginning on the last day of the calendar quarter during which all indebtedness under the New Credit Facility has been paid. All remaining amounts owed under the amended NeoPharm Note are payable at maturity on December 20, 2006. The Kapoor Trust amendment did not change the interest rate or the maturity date of the loans under the Trust Agreement.

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     As part of the Exchange Transaction, the Company issued the 2003 Subordinated Notes to the Kapoor Trust, Arjun Waney and Argent Fund Management, Ltd. The 2003 Subordinated Notes mature on April 7, 2006 and bear interest at prime plus 1.75% (5.75% as of June 30, 2004), but interest payments are currently prohibited under the terms of a subordination arrangement between LaSalle and the Note Holders. The 2003 Subordinated Notes are subordinated to the New Credit Facility and the amended NeoPharm Note but senior to the Trust Agreement. The Company also issued to the holders of the 2003 Subordinated Notes warrants to purchase an aggregate of 276,714 shares of common stock with an exercise price of $1.10 per share. All unexercised subordinated debt warrants expire on October 7, 2006. The Company, in accordance with APB Opinion No. 14, recorded the initial issuance of the 2003 Subordinated Notes and related warrants as separate securities. The fair value of the subordinated note warrants was estimated on the date of issuance using the modified Black-Scholes option pricing model with the following assumptions: (i) dividend yield of 0%, (ii) expected volatility of 127.5%, (iii) risk free rate of 2.19%, and (iv) expected life of 3 years. As a result, the Company assigned a value of $336,000 to subordinated note warrants and recorded this amount in shareholders’ equity and as a discount, along with the spread between the face value of the debt and its initial recorded value as described above, on the 2003 Subordinated Notes. Related debt discount amortization for the three and six month periods ended June 30, 2004 was $88,000 and $176,000, respectively.

     In June 1998, the Company entered into a $3,000,000 mortgage agreement with Standard Mortgage Investors. The principal balance is payable over 10 years, with the final payment due in June 2007. The mortgage note bears an interest rate of 7.375% and is secured by the real property located in Decatur, Illinois.

     As part of the Exchange Transaction, the Company recorded $1,627,000 as deferred financing costs, including the value of the Guarantee Warrants. This amount is being amortized as a component of interest expense over the life of the related debt or guarantee. Amortization for the three and six months ended June 30, 2004 was $349,000 and $698,000, respectively.

     During the second quarter, as allowed under the provisions of the exchange warrants, 416,667 warrants were exercised on a cashless basis for 297,619 shares of commons stock.

Note I — Preferred Stock

     The Preferred Stock accrues dividends at a rate of 6.0% per annum, which rate is fully cumulative, accrues daily and compounds quarterly. While the dividends could be paid in cash at the Company’s option, such dividends are currently being deferred and added to the Preferred Stock balance. In January 2004, 3,686 additional shares of Preferred Stock were issued representing the dividends earned through December 31, 2003. In April 2004 and July 2004, 3,956 and 4,017 shares, respectively of additional shares of Preferred Stock were issued representing the dividends earned year-to-date through June 30, 2004. All shares of Preferred Stock have liquidation rights in preference over junior securities, including the common stock, and have certain antidilution protections. The Preferred Stock and unpaid dividends are convertible at any time into a number of shares of common stock equal to the quotient obtained by dividing (x) $100 per share plus any accrued but unpaid dividends on that share by (y) $0.75, as such numbers may be adjusted from time to time pursuant to the terms of the Articles of Amendment. All shares of Preferred Stock shall convert to shares of common stock on the earlier to occur of (i) October 8, 2006 and (ii) the date on which the closing price per share of common stock for at least 20 consecutive trading days immediately preceding such date exceeds $4.00 per share. Until the Company’s shareholders approved certain provisions regarding the Preferred Stock (the ‘Stockholders Approval’), which occurred in July 2004, the Preferred Stock was also mandatorily redeemable in October 2011.

     Holders of Preferred Stock have full voting rights, with each holder entitled to a number of votes equal to the number of shares of common stock into which its shares can be converted. Holders of Preferred Stock and common stock shall vote together as a single class on all matters submitted to a shareholder vote, except in cases where a separate vote of the holders of Preferred Stock is required by law or by the Articles of Amendment. The Articles of Amendment provide that the Company cannot take certain actions, including (i) issuing additional Preferred Stock or securities senior to or on par with the Preferred Stock, (ii) amending the Company’s Articles of Incorporation or By-laws to alter the rights of the Preferred Stock, (iii) effecting a change of control or (iv) effecting a reverse split of the Preferred Stock, without the approval of the holders of 50.1% of the Preferred Stock.

     Immediately after the Exchange Transaction, the Investors held approximately 75% of the aggregate voting rights represented by outstanding shares of common stock and Preferred Stock. After the Exchange Transaction and assuming the exercise of all outstanding conversion rights, warrants and options to acquire common stock, the Investors would hold approximately 77% of the common stock, on a fully-diluted basis. Prior to the Exchange Transaction, the Investors held approximately 35% of the outstanding voting securities and would have held approximately 42% of the common stock on a fully-diluted basis.

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     The initially recorded amount of the Preferred Stock, as described in Note H, was $5,174,000 below its stated value. The Company, up through the Stockholders Approval date, had been accreting this difference over the time period from issuance to the mandatory redemption date in October 2011. Accretion for the three and six month periods ended June 30, 2004 was $161,000 and $323,000, respectively.

     Pursuant to FASB No. 150 — “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity,” as amended, the Preferred Stock was originally reflected as a liability because of its mandatory redemption feature. That characterization remained as of June 30, 2004. As such, accretion as described above and dividends have been reflected as interest expense in the statement of operations through July 2004. As a result of the Stockholders Approval, the July 2004 carrying value of the Preferred Stock was reclassified into shareholders’ equity and future accretion and dividends will be reflected as adjustments to retained earnings and will also impact income (loss) available to common stockholders. Additionally, and in accordance with EITF Abstract No. 00-27, the Company will also record in July 2004 the value of the conversion option imbedded at issuance in each share of Preferred Stock, subject to limitations described in the EITF. That value, approximately $21 million, will reduce the carrying value of the Preferred Stock to near $1 million with the offsetting increase to Common Stock. The carrying value of the Preferred Stock will then be adjusted to its full aggregated stated value, plus unpaid dividends (approximately $28 million), with a charge directly to retained earnings. That charge will not impact net earnings for the third quarter, but will substantially reduce earnings available to common stockholders and earnings per share for that period.

NOTE J — EARNINGS PER COMMON SHARE

     Basic net income (loss) per common share is based upon weighted average common shares outstanding. Diluted net income (loss) per common share is based upon the weighted average number of common shares outstanding, including the dilutive effect of stock options, warrants and convertible debt using the treasury stock and if converted methods. However, for the three and six month periods ended June 30, 2004 and 2003, the assumed exercise or conversion of any of these securities would be anti-dilutive; and, accordingly, diluted loss per share equals basic loss per share for each period.

     The number of shares subject to warrants, options and conversion rights excluded in each period is reflected in the following table.

                                 
    THREE MONTHS ENDED JUNE 30,
  SIX MONTHS ENDED JUNE 30,
    2004
  2003
  2004
  2003
Shares subject to warrants, convertible debt and convertible preferred stock
    (417 )     48       12,309       4,474  
Shares subject to options
    (449 )     183       2,666      <