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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 September 30, 2004


Commission file number 0-31475

ANDRX CORPORATION

(Exact name of registrant as specified in its charter)
     
Delaware
(State or other jurisdiction of incorporation or
organization)
  65-1013859
(I.R.S. Employer
Identification No.)
     
4955 Orange Drive
Davie, Florida

(Address of principal executive offices)
  33314
(Zip Code)

(954) 584-0300
(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 twelve 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:

x  YES          o NO

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

x  YES          o NO

The approximate number of shares outstanding of the issuer’s common stock as of November 1, 2004 is 72,870,000.



 


         
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 EXHIBIT 10.85 FORM OF STOCK OPTION AGREEMENT
 EXHIBIT 31.1 CERTIFICATION OF CEO RULE 13a-15(e)
 EXHIBIT 31.2 CERTIFICATION OF CFO RULE 13a-15(e)
 EXHIBIT 32 CERTIFICATION OF CEO & CFO SECTION 906

This Form 10-Q contains trademarks held by Andrx Corporation and third parties.

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ANDRX CORPORATION AND SUBSIDIARIES

PART I
FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

Andrx Corporation and Subsidiaries

Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
                 
    September 30,   December 31,
    2004
  2003
    (Unaudited)        
ASSETS
               
Current assets
               
Cash and cash equivalents
  $ 113,655     $ 110,248  
Investments available-for-sale, at market value
    125,242       94,875  
Accounts receivable, net of allowance for doubtful accounts of $5,541 and $7,734 at September 30, 2004 and December 31, 2003, respectively
    133,509       138,849  
Inventories
    244,795       209,910  
Deferred income tax assets, net
    56,904       65,153  
Prepaid and other current assets
    22,987       29,790  
 
   
 
     
 
 
Total current assets
    697,092       648,825  
Property, plant and equipment, net
    279,188       239,173  
Goodwill
    33,981       33,981  
Other intangible assets, net
    12,318       13,721  
Other assets
    19,405       22,746  
 
   
 
     
 
 
Total assets
  $ 1,041,984     $ 958,446  
 
   
 
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities
               
Accounts payable
  $ 172,045     $ 149,762  
Accrued expenses and other liabilities
    150,770       144,241  
 
   
 
     
 
 
Total current liabilities
    322,815       294,003  
Deferred income tax liabilities
    31,052       28,933  
Obligations under capital leases and other obligations
    11,895       12,609  
 
   
 
     
 
 
Total liabilities
    365,762       335,545  
 
   
 
     
 
 
Commitments and contingencies
               
Stockholders’ equity
               
Convertible preferred stock; $0.001 par value, 1,000,000 shares authorized; none issued and outstanding
           
Common stock; $0.001 par value, 200,000,000 shares authorized; issued and outstanding 72,826,000 shares and 72,332,000 shares at September 30, 2004 and December 31, 2003, respectively
    73       72  
Additional paid-in capital
    503,876       498,366  
Restricted stock units, net
    (4,660 )     (7,761 )
Retained earnings
    177,122       132,215  
Accumulated other comprehensive income (loss), net of income taxes
    (189 )     9  
 
   
 
     
 
 
Total stockholders’ equity
    676,222       622,901  
 
   
 
     
 
 
Total liabilities and stockholders’ equity
  $ 1,041,984     $ 958,446  
 
   
 
     
 
 

The accompanying notes to unaudited condensed consolidated financial statements are an integral
part of these condensed consolidated balance sheets.

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Andrx Corporation and Subsidiaries

Unaudited Condensed Consolidated Statements of Income
(in thousands, except share and per share amounts)
                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Revenues
                               
Distributed products
  $ 158,123     $ 168,334     $ 494,945     $ 484,457  
Andrx products
    106,050       74,489       319,293       199,600  
Licensing and royalties
    8,033       9,588       40,657       73,655  
Other
    80       2,688       150       6,942  
 
   
 
     
 
     
 
     
 
 
Total revenues
    272,286       255,099       855,045       764,654  
 
   
 
     
 
     
 
     
 
 
Operating expenses
                               
Cost of goods sold
    190,222       170,196       588,398       500,922  
Selling, general and administrative
    54,867       55,055       158,263       168,747  
Research and development
    9,995       12,729       32,498       38,553  
Litigation settlements and other charges
                7,800       7,500  
 
   
 
     
 
     
 
     
 
 
Total operating expenses
    255,084       237,980       786,959       715,722  
 
   
 
     
 
     
 
     
 
 
Income from operations
    17,202       17,119       68,086       48,932  
Other income (expense)
                               
Equity in earnings of joint ventures
    1,286       1,907       3,553       3,531  
Interest income
    1,221       503       2,658       1,600  
Interest expense
    (675 )     (661 )     (1,867 )     (1,957 )
Gain on sales of assets
          191             773  
 
   
 
     
 
     
 
     
 
 
Income before income taxes
    19,034       19,059       72,430       52,879  
Provision for income taxes
    7,233       7,318       27,523       20,305  
 
   
 
     
 
     
 
     
 
 
Net income
  $ 11,801     $ 11,741     $ 44,907     $ 32,574  
 
   
 
     
 
     
 
     
 
 
Net income per share:
                               
Basic
  $ 0.16     $ 0.16     $ 0.62     $ 0.45  
 
   
 
     
 
     
 
     
 
 
Diluted
  $ 0.16     $ 0.16     $ 0.61     $ 0.45  
 
   
 
     
 
     
 
     
 
 
Weighted average shares of common stock outstanding:
                               
Basic
    72,809,000       71,981,000       72,690,000       71,820,000  
 
   
 
     
 
     
 
     
 
 
Diluted
    73,487,000       72,839,000       73,581,000       72,517,000  
 
   
 
     
 
     
 
     
 
 

The accompanying notes to unaudited condensed consolidated financial statements are an integral part of these
unaudited condensed consolidated statements.

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Andrx Corporation and Subsidiaries

Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
                 
    Nine Months Ended
    September 30,
    2004
  2003
Cash flows from operating activities:
               
Net income
  $ 44,907     $ 32,574  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Depreciation and amortization
    25,296       20,068  
(Recoveries of) provision for doubtful accounts
    (552 )     5,673  
Gain on sales of assets
          (773 )
Impairment charges
    18,035       8,177  
Compensation expense on amortization of restricted stock units
    1,087       1,086  
Equity in earnings of joint ventures
    (3,553 )     (3,531 )
Deferred income tax provision
    27,523        
Income tax benefits on exercises of stock options and restricted stock units
    1,949       1,252  
Changes in operating assets and liabilities:
               
Accounts receivable
    5,892       8,994  
Inventories
    (34,885 )     (33,048 )
Income tax refunds
    639       51,695  
Prepaid and other assets
    8,900       (3,003 )
Accounts payable and accrued expenses and other liabilities
    7,247       46,300  
 
   
 
     
 
 
Net cash provided by operating activities
    102,485       135,464  
 
   
 
     
 
 
Cash flows from investing activities:
               
Purchases of investments available-for-sale, net
    (30,686 )     (20,275 )
Purchases of property, plant and equipment
    (73,187 )     (29,285 )
Acquisition of brand product rights
    (5,000 )      
Distributions from joint ventures
    4,279       4,111  
Proceeds from sale of assets
          250  
 
   
 
     
 
 
Net cash used in investing activities
    (104,594 )     (45,199 )
 
   
 
     
 
 
Cash flows from financing activities:
               
Proceeds from issuances of common stock in connection with exercises of stock options
    5,048       2,289  
Proceeds from issuances of common stock in connection with the employee stock purchase plan
    1,140       879  
Principal payments on capital lease obligations
    (672 )     (621 )
 
   
 
     
 
 
Net cash provided by financing activities
    5,516       2,547  
 
   
 
     
 
 
Net increase in cash and cash equivalents
    3,407       92,812  
Cash and cash equivalents, beginning of period
    110,248       35,521  
 
   
 
     
 
 
Cash and cash equivalents, end of period
  $ 113,655     $ 128,333  
 
   
 
     
 
 
Supplemental disclosure during the period for:
               
Interest paid
  $ 1,196     $ 968  
 
   
 
     
 
 
Income tax refunds received
  $ 639     $ 51,695  
 
   
 
     
 
 
Supplemental disclosure of non-cash investing and financing activities:
               
Assets acquired through capital leases
  $     $ 1,234  
 
   
 
     
 
 
Acquisition of CTEX Pharmaceuticals, Inc., adjustment
  $ (518 )   $  
 
   
 
     
 
 
(Termination) issuance of restricted stock units, net
  $ (2,014 )   $ 3,309  
 
   
 
     
 
 
Reclassification of amounts held-for-sale, net
               
Assets
          $ 6,169  
 
           
 
 
Liabilities
          $ 2,254  
 
           
 
 
The accompanying notes to unaudited condensed consolidated financial statements are an integral
part of these unaudited condensed consolidated statements.

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Andrx Corporation and Subsidiaries

Notes to Unaudited Condensed Consolidated Financial Statements
September 30, 2004

(in thousands, except share and per share amounts)

1. GENERAL

     The accompanying unaudited condensed consolidated financial statements for each period include the consolidated balance sheets, statements of income and cash flows of Andrx Corporation and subsidiaries (“Andrx” or the “Company”). All significant intercompany items and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States have been omitted pursuant to the SEC’s rules and regulations. However, management believes that the disclosures contained herein are adequate to make the information presented not misleading. In the opinion of management, the unaudited condensed consolidated financial statements reflect all material adjustments (which include normal recurring adjustments) necessary to present fairly the Company’s unaudited financial position, results of operations and cash flows. The unaudited results of operations for the three and nine months ended September 30, 2004, and cash flows for the nine months ended September 30, 2004, are not necessarily indicative of the results of operations or cash flows that may be expected for the remainder of 2004. The unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes thereto included in Andrx’s Annual Report on Form 10-K for the year ended December 31, 2003, and its quarterly reports on Form 10-Q for the quarters ended March 31, 2004 and June 30, 2004. The December 31, 2003 Consolidated Balance Sheet included herein was extracted from the December 31, 2003 Audited Consolidated Balance Sheet included in the Company’s 2003 Annual Report on Form 10-K.

     SIGNIFICANT ACCOUNTING POLICIES

     The preparation of these interim financial statements requires Andrx to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. Andrx bases its estimates on, among other things, currently available information, its historical experience and on various assumptions, which together form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although Andrx believes that these assumptions are reasonable under the circumstances, estimates would differ if different assumptions were utilized and these estimates may prove in the future to have been inaccurate. Since December 31, 2003, none of the critical accounting policies, or Andrx’s application thereof, as more fully described in Andrx’s Annual Report on Form 10-K for the year ended December 31, 2003, has significantly changed. Certain critical accounting policies have been presented below due to the significance of related transactions during the three and nine months ended September 30, 2004.

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     Revenue Recognition

     Andrx’s distributed product revenues are revenues derived from the sale of pharmaceutical products purchased from third parties, including generic products sold on behalf of Andrx’s unconsolidated joint ventures. Andrx product revenues include Andrx’s generic and brand product revenues. Andrx generic product revenues are revenues derived from the sale of generic products either manufactured by Andrx pursuant to an Andrx Abbreviated New Drug Application (“ANDA”) or sold with an Andrx New Drug Code (“NDC”), excluding generic products sold on behalf of Andrx’s unconsolidated joint ventures. Andrx brand product revenues are revenues derived from the sale of branded products either manufactured by Andrx pursuant to an Andrx New Drug Application (“NDA”) or sold with an Andrx NDC.

     Revenues from Andrx’s distributed and generic products and the related cost of goods sold are recognized at the time the product is accepted by Andrx’s customers.

     Revenues from Andrx’s brand products are recognized after products are accepted by customers and are based on Andrx’s estimate of when such products will be pulled through the distribution channel, taking into account, among other things, historical prescription data provided by external independent sources, projected prescription data, incentives granted to customers, customers’ right of return, competing product introductions and Andrx’s brand product inventory levels in the distribution channel, all of which the Company periodically evaluates. As a result, $3,135 and $5,722 of deferred revenue was included in the September 30, 2004 Unaudited Condensed Consolidated Balance Sheet and the December 31, 2003 Consolidated Balance Sheet, respectively.

     Allowances against sales for estimated returns, chargebacks, rebates and other sales allowances are established by Andrx concurrently with the recognition of revenue. These allowances are established based upon consideration of a variety of factors, including, but not limited to, customers’ right of return, historical returns, chargebacks and rebates by product type, the number and timing of competitive products approved for sale, both historical and projected, the estimated size of the market for the product, estimated customer inventory levels by product, current and projected economic conditions and anticipated future product pricing. Actual product returns, chargebacks, rebates and other sales allowances incurred are dependent upon future events. Andrx periodically monitors the factors that influence sales returns and allowances and makes adjustments to these provisions when Andrx believes that actual product returns, chargebacks, rebates and other sales allowances may differ from established allowances. If conditions in future periods change, revisions to previous estimates may be required, potentially in significant amounts. Changes in the level of provisions for estimated sales returns, chargebacks, rebates and other sales allowances will affect revenues.

     The pharmaceutical industry practice is generally to allow customers to return or exchange purchased goods.

     In the generic pharmaceutical industry, the practice of allowing customers to return or exchange purchased goods has resulted in generic manufacturers generally issuing inventory credits (also known as shelf-stock adjustments) to customers based on the customers’ existing inventory following decreases in the market price of the related generic pharmaceutical product. The determination to grant an inventory credit to a customer following a price decrease is generally at the Company’s discretion, and not pursuant to contractual arrangements with customers. Shelf-stock adjustments may occur frequently, potentially in significant amounts. As Andrx accrues an estimate for sales allowances in the same period the sale is recognized, the level of provisions for estimated shelf-stock adjustments affects revenues from sales of its generic products. In order to make such an accrual, Andrx makes significant accounting estimates, including estimates of the quantities sold by customers, product still on customers’ shelves and price declines that have occurred and may occur before the products pull through the distribution channel. Andrx periodically reviews and, as necessary, adjusts such

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estimates. As a result, if conditions in future periods change, revisions to previous estimates may be required, potentially in significant amounts.

     In Andrx’s brand business, the Company makes significant estimates for sales returns and allowances, which are dependent on Andrx’s ability to promote to physicians, create demand for its products, pull products through the distribution channel, future levels of prescriptions for its products and Andrx’s brand product inventory levels in the distribution channel. It is a common pharmaceutical industry practice for brand manufacturers to offer customers, among other things, buy-in allowances on initial purchases prior to promotion activities by the manufacturer. In addition, Andrx conducts a significant amount of its sales with a limited number of large pharmaceutical wholesalers and warehousing pharmacy chains that have a right to return or exchange product they purchased. During the three and nine months ended September 30, 2004, approximately 63% and 68%, respectively, of Andrx’s brand product shipments were made to three customers. As there are a limited number of large customers and Andrx does not have a substantial and therapeutically unique brand product line, these customers exert significant leverage on Andrx relative to, among other things, product returns and other concessions. Andrx periodically reviews its estimates for sales returns and allowances, and if conditions change in future periods, revisions to previous estimates may be required, potentially in significant amounts.

     Andrx sometimes enters into collaborative agreements where the other parties market the Company’s products. In these instances, Andrx recognizes revenue based on information supplied by the other parties related to shipment of the product to and acceptance by customers, less estimates for sales returns and allowances. Andrx receives periodic reports by the other parties that support the amount of revenue Andrx recognizes, and amounts recognized are then compared to the cash subsequently remitted to the Company. The revenues Andrx reports are subject to several estimates, similar to those the Company experiences with the sales of its products. Andrx periodically monitors the factors that influence sales returns and allowances and conducts inquiries of the other parties regarding these estimates. Such estimates are revised as changes become known.

     Licensing and royalties revenues are recognized when the obligations associated with the earning of the licensing or royalty revenue have been satisfied. The Company reviews each contract, and if appropriate, defers up-front and milestone payments, whether or not they are refundable, and recognizes such amounts over future periods after services have been rendered or delivery has occurred and the amounts are fixed or determinable (see Notes 7 and 11).

     Impairment or Disposal of Long-Lived Assets

     The Company utilizes the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” which requires that long-lived assets be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company periodically evaluates whether events and circumstances have occurred that may warrant revision of the estimated useful life of its long-lived assets or whether the remaining balance of long-lived assets should be evaluated for possible impairment. The Company uses an estimate of the related undiscounted cash flows over the remaining life of the long-lived assets to determine whether impairment has occurred. Fair value, as determined by appraisal or discounted cash flow analysis, is compared to the carrying value in calculating any impairment (see Notes 5 and 6).

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     DIVESTITURES

     Andrx divested its Massachusetts aerosol manufacturing operation and its Physicians’ Online (“POL”) web portal in October and December 2003, respectively. For the three and nine months ended September 30, 2003, other revenues included $2,688 and $6,817, respectively, from these divested operations (see Note 4).

     RECLASSIFICATIONS

     Certain prior period amounts have been reclassified to conform to the current period presentation.

     STOCK-BASED COMPENSATION

     The Company accounts for its stock-based compensation plans under the recognition and measurement principles of Accounting Principles Board Opinion (“APB”) No. 25 and related interpretations. Stock options granted under those plans are to employees and other eligible participants with an exercise price equal to the market value of the underlying common stock on the date of grant. Accordingly, no employee compensation expense for stock options is reflected in the Unaudited Condensed Consolidated Statements of Income. For restricted stock unit grants, the fair value on the date of the grant is fixed and is amortized on a straight-line basis over the related period of service. Such amortization expense is included in selling, general and administrative (“SG&A”) expenses.

     The following table summarizes the pro forma consolidated results of operations of Andrx as though the provisions of the fair value based method of accounting for employee stock option compensation of SFAS No. 123 had been used:

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net income as reported
  $ 11,801     $ 11,741     $ 44,907     $ 32,574  
Add: stock-based employee compensation expense included in reported net
                               
income, net of related tax effect
    250       262       674       673  
Deduct: total stock-based employee compensation expense determined under the fair value based method for all awards, net of related tax effect
    (3,623 )     (6,248 )     (10,779 )     (17,620 )
 
   
 
     
 
     
 
     
 
 
Pro forma net income
  $ 8,428     $ 5,755     $ 34,802     $ 15,627  
 
   
 
     
 
     
 
     
 
 
Basic net income per common share
                               
As reported
  $ 0.16     $ 0.16     $ 0.62     $ 0.45  
 
   
 
     
 
     
 
     
 
 
Pro forma
  $ 0.12     $ 0.08     $ 0.48     $ 0.22  
 
   
 
     
 
     
 
     
 
 
Diluted net income per common share
                               
As reported
  $ 0.16     $ 0.16     $ 0.61     $ 0.45  
 
   
 
     
 
     
 
     
 
 
Pro forma
  $ 0.12     $ 0.08     $ 0.48     $ 0.22  
 
   
 
     
 
     
 
     
 
 

     The fair value of Andrx stock options issued was estimated using the Black-Scholes option pricing model and the following assumptions:

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Risk-free interest rate
    3.6 %     3.0 %     3.0 %     3.0 %
Expected life of options (years)
    6.0       6.0       5.9       5.5  
Expected volatility
    82 %     76 %     83 %     88 %
Dividend yield
                       

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     The range of fair values per share of Andrx options as of the respective dates of grant was $19.80, and $10.89 to $21.60, for stock options granted during the three and nine months ended September 30, 2004, respectively, and $12.34 to $15.03 and $3.81 to $23.49, for stock options granted during the three and nine months ended September 30, 2003, respectively.

     The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, the Black-Scholes model, like all option valuation models, requires highly subjective assumptions including the expected stock price volatility. As the Company’s employee stock options have characteristics significantly different than those of traded options, and changes in the assumptions can materially affect the fair value estimate, in management’s opinion, the option pricing models do not necessarily provide a reliable measure of the fair value of its employee stock options.

     RECENT ACCOUNTING PRONOUNCEMENTS

     Variable Interest Entities

     In January 2003, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 46, “Consolidation of Variable Interest Entities” (“FIN No. 46”), which is intended to clarify the application of Accounting Research Bulletin No. 51, Consolidated Financial Statements, to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support. In December 2003, the FASB issued a revision to FIN No. 46, which partially delayed its effective date for public companies until the period ending after March 15, 2004, but permitted earlier adoption for some or all of their investments. FIN No. 46 requires a company to consolidate variable interest entities (“VIEs”), if that company is the primary beneficiary of the variable interest (or combination of variable interests) that will absorb a majority of the entity’s expected losses, receive a majority of the entity’s expected returns or both. Since Andrx does not have any VIEs, the adoption of FIN No. 46 for the year ended December 31, 2003, and the nine month period ended September 30, 2004, did not have an impact on Andrx’s consolidated financial statements.

     Revenue Recognition

     In December 2003, the SEC published Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition.” This SAB updates portions of the SEC staff’s interpretative guidance provided in SAB 101 and included in Topic 13 of the Codification of Staff Accounting Bulletins. SAB 104 deletes interpretative material no longer necessary, and conforms the interpretative material retained, because of pronouncements issued by the FASB’s Emerging Issues Task Force (“EITF”) on various revenue recognition topics, including EITF 00-21, “Revenue Arrangements with Multiple Deliverables” and EITF 99-19, “Reporting Revenue Gross as Principal Versus Net as an Agent”. SAB 104 also incorporates into the SAB codification of certain sections of the SEC staff’s “Revenue Recognition in Financial Statements — Frequently Asked Questions and Answers” (“FAQ”). To the extent not incorporated into the SAB codification, the SEC staff’s FAQ on SAB 101 (Topic 13) has been rescinded. Adoption of the provisions of SAB 104 did not have a significant impact on the Company’s consolidated financial statements.

2. COLLABORATIVE ARRANGEMENTS

     Andrx has entered into an agreement with Genpharm, Inc. (“Genpharm”) whereby the Company has the exclusive rights to either market Genpharm’s generic versions of Paxil® (paroxetine hydrochloride) 10mg, 20mg, 30mg, and 40mg tablets or Andrx’s own ANDA product(s) in the United States, in exchange for a royalty based on net profits, as defined. In May 2004, Andrx launched all four strengths of Genpharm’s generic Paxil product (see Note 11).

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     Andrx has a collaborative arrangement with L. Perrigo Company (“Perrigo”) whereby the Company agreed to manufacture and supply Perrigo with Andrx’s generic versions of Claritin-D® 12, Claritin-D® 24 and Claritin® RediTabs, and Perrigo agreed to market such products as “store-brand”, over-the-counter (“OTC”) products. Perrigo launched Andrx’s OTC generic version of Claritin-D 24 in June 2003 and Andrx’s OTC generic version of Claritin RediTabs in January 2004. Under the terms of the arrangement, Andrx manufactures and Perrigo packages and markets these “store-brand” products, and the parties share net profits, as defined, from product sales.

3. EARNINGS PER SHARE

     For the three and nine months ended September 30, 2004 and 2003, the shares used in computing basic net income per share are based on the weighted average shares of common stock outstanding, including the vested portion of restricted stock units. Diluted per share calculations included weighted average shares of common stock outstanding, including the vested portion of restricted stock units, during the three and nine months ended September 30, 2004 and 2003, respectively, plus dilutive common stock equivalents, computed using the treasury stock method. The Company’s common stock equivalents consist of stock options and the unvested portion of restricted stock units.

     A reconciliation of the denominators of basic and diluted earnings per share of common stock is as follows:

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Basic weighted average shares of common stock outstanding
    72,809,000       71,981,000       72,690,000       71,820,000  
Effect of dilutive items:
                               
Stock options and unvested restricted stock units
    678,000       858,000       891,000       697,000  
 
   
 
     
 
     
 
     
 
 
Diluted weighted average shares of common stock outstanding
    73,487,000       72,839,000       73,581,000       72,517,000  
 
   
 
     
 
     
 
     
 
 
Anti-dilutive weighted average common stock equivalents
    4,454,000       4,119,000       2,844,000       5,001,000  
 
   
 
     
 
     
 
     
 
 

4. INVENTORIES AND COST OF GOODS SOLD

     Inventories consist of the following:

                 
    September 30,   December 31,
    2004
  2003
Raw materials
  $ 37,539     $ 40,387  
Work in process
    14,562       20,913  
Finished goods
    192,694       148,610  
 
   
 
     
 
 
 
  $ 244,795     $ 209,910  
 
   
 
     
 
 

     As of September 30, 2004, the Company had approximately $8,378 in inventories relating to products pending launch while the Company awaits receipt of final Food and Drug Administration (“FDA”) marketing approval (see Note 11).

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     The following table summarizes charges to cost of goods sold associated with production related write-offs, impairment charges, and under-utilization and inefficiencies related to the manufacture of the Company’s products and product candidates:

                                 
    Three Months   Nine Months
    Ended September 30,
  Ended September 30,
    2004
  2003
  2004
  2003
Production related write-offs
  $ 6,470     $ 2,437     $ 20,857     $ 12,759  
Impairment charges:
                               
North Carolina facility (see Note 5)
                14,535        
Entex product rights (see Note 6)
                3,500        
Massachusetts aerosol facility
                      5,183  
Massachusetts aerosol inventory
                      2,994  
Under-utilization and inefficiencies of manufacturing operations:
                               
Florida facilities
    1,698       763       4,051       2,718  
North Carolina facility
    529       318       2,599       1,094  
Massachusetts aerosol facility
          1,571             4,264