UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
| 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
(Registrants 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 issuers 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.
1
ANDRX CORPORATION AND SUBSIDIARIES
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
Andrx Corporation and Subsidiaries
| 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.
2
Andrx Corporation and Subsidiaries
| 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.
3
Andrx Corporation and Subsidiaries
| 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 | ||||||
4
Andrx Corporation and Subsidiaries
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 SECs 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 Companys 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 Andrxs 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 Companys 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 Andrxs application thereof, as more fully described in Andrxs 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.
5
Revenue Recognition
Andrxs distributed product revenues are revenues derived from the sale of pharmaceutical products purchased from third parties, including generic products sold on behalf of Andrxs unconsolidated joint ventures. Andrx product revenues include Andrxs 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 Andrxs 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 Andrxs distributed and generic products and the related cost of goods sold are recognized at the time the product is accepted by Andrxs customers.
Revenues from Andrxs brand products are recognized after products are accepted by customers and are based on Andrxs 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 Andrxs 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 Companys 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
6
estimates. As a result, if conditions in future periods change, revisions to previous estimates may be required, potentially in significant amounts.
In Andrxs brand business, the Company makes significant estimates for sales returns and allowances, which are dependent on Andrxs ability to promote to physicians, create demand for its products, pull products through the distribution channel, future levels of prescriptions for its products and Andrxs 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 Andrxs 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 Companys 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).
7
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 |
| | | | ||||||||||||
8
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 Companys 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 managements 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 entitys expected losses, receive a majority of the entitys 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 Andrxs 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 staffs 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 FASBs 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 staffs Revenue Recognition in Financial Statements Frequently Asked Questions and Answers (FAQ). To the extent not incorporated into the SAB codification, the SEC staffs FAQ on SAB 101 (Topic 13) has been rescinded. Adoption of the provisions of SAB 104 did not have a significant impact on the Companys 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 Genpharms generic versions of Paxil® (paroxetine hydrochloride) 10mg, 20mg, 30mg, and 40mg tablets or Andrxs 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 Genpharms generic Paxil product (see Note 11).
9
Andrx has a collaborative arrangement with L. Perrigo Company (Perrigo) whereby the Company agreed to manufacture and supply Perrigo with Andrxs 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 Andrxs OTC generic version of Claritin-D 24 in June 2003 and Andrxs 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 Companys 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).
10
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 Companys 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 | ||||||||||||