SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2003
Commission File Number 1-1136
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
incorporation or organization)
345 Park Avenue, New York, N.Y. 10154
(Address of principal executive offices)
Telephone: (212) 546-4000
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No ¨
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
At June 30, 2003, there were 1,938,600,305 shares outstanding of the Registrant’s $.10 par value Common Stock.
INDEX TO FORM 10-Q
June 30, 2003
PART I - FINANCIAL INFORMATION
Item 1.
Financial Statements (unaudited):
Consolidated Balance Sheet at June 30, 2003 and December 31, 2002
Consolidated Statement of Earnings, Comprehensive Income and Retained Earnings for the three and six months ended June 30, 2003 and 2002
Consolidated Statement of Cash Flows for the six months ended June 30, 2003 and 2002
Notes to Consolidated Financial Statements
Report of Independent Auditors
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Item 4.
Controls and Procedures
PART II - OTHER INFORMATION
Legal Proceedings
Submission of Matters to a Vote of Security Holders
Item 6.
Exhibits and Reports on Form 8-K
Signatures
2
CONSOLIDATED BALANCE SHEET
June 30,
2003
December 31,
2002
ASSETS
Current Assets:
Cash and cash equivalents
Time deposits and marketable securities
Receivables, net of allowances $169 and $129
Inventories:
Finished goods
Work in process
Raw and packaging materials
Consignment inventory
Total Inventories
Prepaid expenses
Total Current Assets
Property, plant and equipment
Less: Accumulated depreciation
Goodwill
Intangible assets, net
Other assets
Total Assets
LIABILITIES
Current Liabilities:
Short-term borrowings
Deferred revenue on consigned inventory
Accounts payable
Dividends payable
Accrued litigation settlements
Accrued expenses
Accrued rebates and sales returns
U.S. and foreign income taxes payable
Total Current Liabilities
Other liabilities
Long-term debt
Total Liabilities
Commitments and contingencies
STOCKHOLDERS’ EQUITY
Preferred stock, $2 convertible series:
Authorized 10 million shares; issued and outstanding 8,248 in 2003 and 8,308 in 2002, liquidation value of $50 per share
Common stock, par value of $.10 per share:
Authorized 4.5 billion shares; issued 2,200,901,569 in 2003 and 2,200,823,544 in 2002
Capital in excess of par value of stock
Other accumulated comprehensive loss
Retained earnings
Less cost of treasury stock - 262,301,264 common shares in 2003 and 263,994,580 in 2002
Total Stockholders’ Equity
Total Liabilities and Stockholders’ Equity
The accompanying notes are an integral part of these financial statements.
3
CONSOLIDATED STATEMENT OF EARNINGS,
COMPREHENSIVE INCOME AND RETAINED EARNINGS
(UNAUDITED)
EARNINGS
Net Sales
Cost of products sold
Marketing, selling and administrative
Advertising and product promotion
Research and development
Acquired in-process research and development
Gain on sales of businesses/product lines
Provision for restructuring and other items, net
Litigation settlement (income) charge
Other (income) expense, net
Earnings from Continuing Operations Before Minority Interest and Income Taxes
Provision for income taxes
Minority interest, net of taxes(1)
Earnings from Continuing Operations
Discontinued Operations:
Net gain on disposal
Net Earnings
Earnings Per Common Share
Basic
Diluted
Average Common Shares Outstanding
Dividends declared per Common Share
4
COMPREHENSIVE INCOME AND RETAINED EARNINGS (Continued)
COMPREHENSIVE INCOME
Other Comprehensive Income (Loss):
Foreign currency translation, net of tax expense of $70 and tax benefit of $1 for the three months ended June 30, 2003 and 2002, respectively; and net of tax expense of $27 and tax benefit of $11 for the six months ended June 30, 2003 and 2002, respectively
Increase in market value of investments, net of tax of $2 and $1 for the three months and six months ended June 30, 2003, respectively
Deferred gains (losses) on derivatives qualifying as hedges, net of tax benefit of $25 and tax expense of $12 for the three months ended June 30, 2003 and 2002, respectively; and net of tax benefit of $54 and tax expense of $8 for the six months ended June 30, 2003 and 2002, respectively
Total Other Comprehensive Income (Loss)
Comprehensive Income
RETAINED EARNINGS
Retained Earnings, January 1
Cash dividends declared
Retained Earnings, June 30
5
CONSOLIDATED STATEMENT OF CASH FLOWS
Cash Flows From Operating Activities:
Net earnings
Depreciation
Amortization
Litigation settlement charge
Provision for restructuring and other items
Gain on sales of businesses/product lines (including discontinued operations)
Other operating items
Receivables
Inventories
Litigation settlement payments
Accounts payable and accrued expenses
Income taxes
Product liability
Insurance recoverable
Pension contribution to the U.S. retirement income plan
Other assets and liabilities
Net Cash Provided by (Used In) Operating Activities
Cash Flows From Investing Activities:
Proceeds from sales of time deposits and marketable securities
Purchases of time deposits and marketable securities
Additions to property, plant and equipment
Investment in ImClone
Proceeds from product divestitures
Business acquisitions (including purchase of trademarks/patents)
DuPont acquisition costs and liabilities
Other, net
Net Cash Used in Investing Activities
Cash Flows From Financing Activities:
Long-term debt borrowings
Long-term debt repayments
Issuances of common stock under stock plans
Purchases of treasury stock
Dividends paid
Net Cash Used in Financing Activities
Effect of Exchange Rates on Cash
Increase (Decrease) in Cash and Cash Equivalents
Cash and Cash Equivalents at Beginning of Period
Cash and Cash Equivalents at End of Period
6
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1: Basis of Presentation and New Accounting Standards
Bristol-Myers Squibb Company (the Company) prepared these unaudited consolidated financial statements following the requirements of the Securities and Exchange Commission (SEC) and U.S. generally accepted accounting principles (GAAP) for interim reporting. Under those rules, certain footnotes and other financial information that are normally required by GAAP for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Form 10-Q. These consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial position at June 30, 2003 and December 31, 2002, and the results of its operations and cash flows for the six months ended June 30, 2003 and June 30, 2002. These consolidated financial statements should be read in conjunction with the consolidated financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002 (2002 Form 10-K). PricewaterhouseCoopers LLP, the Company’s independent accountants, have performed a review of the unaudited consolidated financial statements included in this Form 10-Q, and their review report thereon accompanies this Form 10-Q.
Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated interim financial statements may not be the same as those for the full year.
The Company recognizes revenue for sales upon shipment of product to its customers, except in the case of certain transactions with its U.S. pharmaceuticals wholesalers which are accounted for using the consignment model. Under GAAP, revenue is recognized when substantially all the risks and rewards of ownership have transferred. In the case of sales made to wholesalers (1) as a result of incentives, (2) in excess of the wholesaler’s ordinary course of business inventory level, (3) at a time when there was an understanding, agreement, course of dealing or consistent business practice that the Company would extend incentives based on levels of excess inventory in connection with future purchases and (4) at a time when such incentives would cover substantially all, and vary directly with, the wholesaler’s cost of carrying inventory in excess of the wholesaler’s ordinary course of business inventory level, substantially all the risks and rewards of ownership do not transfer upon shipment and, accordingly, such sales are accounted for using the consignment model. The determination of when, if at all, sales to a wholesaler meet the foregoing criteria involves evaluation of a variety of factors and a number of complex judgments. Under the consignment model, the Company does not recognize revenue upon shipment of product. Rather, upon shipment of product the Company invoices the wholesaler, records deferred revenue at gross invoice sales price and classifies the inventory held by the wholesalers as consignment inventory at the Company’s cost of such inventory. The Company recognizes revenue when the consignment inventory is no longer subject to incentive arrangements but not later than when such inventory is sold through to the wholesalers’ customers, on a first-in first-out (FIFO) basis.
Revenues are reduced at the time of sale to reflect expected returns that are estimated based on historical experience. Additionally, provision is made at the time of sale for all discounts, rebates and estimated sales allowances based on historical experience updated for changes in facts and circumstances, as appropriate. Such provision is recorded as a reduction of revenue.
In addition, the Company includes alliance revenue in net sales. The Company has agreements to promote pharmaceuticals discovered by other companies. Alliance revenue is based upon a percentage of the Company’s co-promotion partners’ net sales and is earned when the co-promotion partners ship the related product and title passes to their customer.
The preparation of financial statements in conformity with GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant assumptions are employed in estimates used in determining values of intangible assets, restructuring charges and accruals, sales rebate and return accruals, legal contingencies and tax assets and tax liabilities, as well as in estimates used in applying the revenue recognition policy and accounting for retirement and postretirement benefits (including the actuarial assumptions). Actual results could differ from the estimated results.
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Note 1: Basis of Presentation and New Accounting Standards (Continued)
In January 2003, the Financial Accounting Standards Board (FASB) issued Interpretation No. 46, Consolidation of Variable Interest Entities (FIN 46). FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entity’s activities or entitled to receive a majority of the entity’s residual returns or both. FIN 46 also requires disclosures about variable interest entities that a company is not required to consolidate but in which it has a significant variable interest. The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003 and to existing entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. Based on its assessment of FIN 46, the Company has concluded that there are currently no variable interest entities in relation to the Company.
In accordance with SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, the following table summarizes the Company’s results on a pro forma basis as if it had recorded compensation expense based upon the fair value at the grant date for awards under these plans consistent with the methodology prescribed under SFAS No. 123, Accounting for Stock-Based Compensation, for the three and six months ended June 30, 2003 and 2002:
(dollars in millions, except per share data)
Net Earnings:
As reported
Deduct : Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects
Pro forma
Basic earnings per share:
Diluted earnings per share:
In November 2002, the FASB issued Interpretation No. 45, Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45). FIN 45 requires a guarantor to recognize a liability at the inception of the guarantee for the fair value of the obligation undertaken in issuing the guarantee and include more detailed disclosure with respect to guarantees. The types of contracts the Company enters into that meet the scope of this interpretation are financial and performance standby letters of credit on behalf of wholly-owned subsidiaries. FIN 45 is effective for guarantees issued or modified after December 31, 2002. The initial adoption of this accounting pronouncement did not have a material effect on the Company’s consolidated financial statements.
8
In November 2002, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. EITF No. 00-21 provides guidance on how to determine when an arrangement that involves multiple revenue-generating activities or deliverables should be divided into separate units of accounting for revenue recognition purposes, and if this division is required, how the arrangement consideration should be allocated among the separate units of accounting. The guidance in the consensus is effective for revenue arrangements entered into in the fiscal periods beginning after June 15, 2003. The initial adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements.
In June 2001, the FASB issued SFAS No. 143, Accounting for Asset Retirement Obligations. Under SFAS No. 143, the fair value of a liability for an asset retirement obligation must be recognized in the period in which it is incurred if a reasonable estimate of fair value can be made. The associated asset retirement costs are capitalized as part of the carrying amount of the long-lived asset. The provisions of SFAS No. 143 are effective for financial statements for fiscal years beginning after June 15, 2002. The initial adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
Note 2: Restructuring and Other Items
In the second quarter of 2003, the Company recorded $25 million of charges related to the rationalization of manufacturing facilities, and $4 million related to relocation expenses. The charges related to the rationalization of its manufacturing facilities include $13 million related to termination benefits for workforce reductions of approximately 430 manufacturing employees in the Pharmaceutical segment and downsizing and streamlining of worldwide manufacturing operations, $10 million of accelerated depreciation for certain manufacturing facilities in North America expected to be closed by the end of 2006, of which $6 million is recorded in cost of products sold and $4 million is recorded in other income (expense), $1 million for asset impairments recorded in cost of products sold and $1 million for retention benefits. The charge of $25 million was offset by an adjustment to prior period restructuring reserves of $24 million due to higher than anticipated recovery on assets previously written off as restructuring, and a reduction of estimated separation expenses. In addition, the Company recorded $11 million of income related to a reduction of estimated divestiture liabilities.
In the first quarter of 2003, the Company recorded a pre-tax charge of $12 million, related to termination benefits for workforce reductions of approximately 340 manufacturing employees in the Pharmaceuticals segment and downsizing and streamlining of worldwide manufacturing operations. In addition, the Company recorded $10 million in cost of products sold for asset impairments and $4 million in other (income) expense for accelerated depreciation of certain manufacturing facilities in North America expected to be closed by the end of 2004.
In the second quarter of 2002, the Company recorded a pretax charge of $57 million related to termination benefits for workforce reductions and downsizing and streamlining of worldwide operations. Of this charge, $30 million related to employee termination benefits for approximately 540 employees. The remaining $27 million related to asset write-downs for the closure of a manufacturing facility in Puerto Rico and other related expenses. Severance actions resulted from efforts to rationalize and consolidate manufacturing and downsize and streamline operations. In addition, $2 million of inventory associated with the plans described above was included in cost of products sold. The $57 million charge was offset by an adjustment to prior period restructuring liabilities of $47 million due to higher than anticipated proceeds from the sale of exited businesses and $8 million due to lower than expected separation payments.
In the first quarter of 2002, an adjustment to prior year reserves of $1 million was made to reflect reduced estimates of separation costs.
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Note 2: Restructuring and Other Items (Continued)
Restructuring charges and spending against accrued liabilities associated with prior and current actions are as follows:
Employee
Termination
Liability
Other Exit Cost
Balance at December 31, 2001
Charges
Spending
Changes in estimate
Balance at December 31, 2002
Balance at June 30, 2003
10
Note 3: Earnings Per Share
Basic earnings per common share are computed using the weighted-average number of shares outstanding during the year. Diluted earnings per common share are computed using the weighted-average number of shares outstanding during the year, plus the incremental shares outstanding assuming the exercise of dilutive stock options. The computations for basic earnings per common share and diluted earnings per common share are as follows:
Six Months Ended
Basic:
Diluted:
Incremental Shares Outstanding Assuming the Exercise of Dilutive Stock Options
Weighted-average shares issuable upon the exercise of stock options, which were not included in the diluted earnings per share calculation because they were not dilutive, were 117 million for the three and six month periods ended June 30, 2003 and 119 million for the three and six month periods ended June 30, 2002.
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Note 4: Goodwill
The changes in the carrying amount of goodwill for the year ended December 31, 2002 and the six months ended June 30, 2003, were as follows:
Pharmaceuticals
Segment
Nutritionals
Other
Healthcare
Balance as of December 31, 2001
Purchase accounting adjustments related to recent acquisitions:
Change in exit cost estimate
Purchase price and allocation adjustments
Balance as of December 31, 2002 and June 30, 2003
In accordance with SFAS No. 142, which the Company adopted in January 2002, goodwill was tested for impairment upon adoption of the standard and is required to be tested annually thereafter. The Company completed the assessment upon adoption, which indicated no impairment of goodwill. The Company uses a two-step process in testing for goodwill impairment. The first step is to identify a potential impairment, and the second step measures the amount of the impairment loss, if any. Goodwill is deemed to be impaired if the carrying amount of a reporting unit’s goodwill exceeds its estimated fair value. The Company has completed its 2003 annual goodwill impairment assessment, which indicated no impairment of goodwill.
Note 5: Intangible Assets
As of June 30, 2003 and December 31, 2002, intangible assets consisted of the following:
Patents / Trademarks
Licenses
Technology
Accumulated Amortization
Net Carrying Amount
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Note 5: Intangible Assets (Continued)
Amortization expense for intangible assets (the majority of which is included in cost of products sold) for the three months ended June 30, 2003 and 2002 was $59 million and $67 million, respectively, and for the six months ended June 30, 2003 and 2002 was $118 million and $133 million, respectively. Expected amortization expense through 2008 related to the current balance of intangible assets is as follows:
For the year ended December 31, 2003
For the year ended December 31, 2004
For the year ended December 31, 2005
For the year ended December 31, 2006
For the year ended December 31, 2007
For the year ended December 31, 2008
Note 6: Alliances and Investments
ImClone
The Company has a commercialization agreement that expires in 2018 with ImClone, a biopharmaceutical company focused on developing targeted cancer treatments, for the codevelopment and copromotion of ERBITUX* in the U.S., Canada and Japan. In accordance with the terms of the agreement, the Company paid ImClone $200 million, of which $140 million was paid in March 2002 and $60 million was paid in March 2003. The Company will also pay ImClone $250 million upon approval of the initial indication and an additional $250 million if a second indication is approved. Under the agreement, ImClone will receive a distribution fee based on a flat rate of 39% of product revenues in North America.
With respect to the $200 million of milestone payments the Company paid ImClone, $160 million was expensed in the first quarter of 2002 as acquired in-process research and development, and $40 million was recorded as an additional equity investment to eliminate the income statement effect of the portion of the milestone payment for which the Company has an economic claim through its ownership interest in ImClone.
On April 9, 2003, ImClone announced that due to the delay in filing its 2002 Form 10-K, it had failed to comply with certain filing requirements under Nasdaq listing qualification rules and its securities could be delisted from The Nasdaq National Market. Subsequent to this statement, ImClone filed its 2002 Form 10-K and 2003 Form 10-Q for the first quarter, and announced that its stock is eligible for continued listing on the Nasdaq National Market.
In the second quarter of 2003, the Company recorded a $3 million net loss for its share of ImClone’s losses. This amount includes an adjustment of $7 million of income to the $12 million net loss contingency the Company recorded in the first quarter of 2003, related to ImClone’s restatement of 2001 results and final reporting of 2002 full year and 2003 first quarter results. For the six months ended June 30, the Company has recorded a net loss of $26 million for its share of ImClone’s losses.
In the third quarter of 2002, the Company recorded a pre-tax charge of $379 million for an other than temporary decline in the market value of ImClone based on the decline in value of ImClone’s shares during 2002. The fair value of the equity investment in ImClone used to record the impairment was based on the market value of ImClone shares on September 30, 2002.
As of June 30, 2003, the Company’s total equity investment in ImClone was $77 million and the market value of the Company’s investment in ImClone was approximately $460 million. On a per share basis, the carrying value of the ImClone investment and the closing market price of the ImClone shares as of June 30, 2003 were $5.33 and $31.97, respectively.
13
Note 6: Alliances and Investments (Continued)
Sanofi-Synthelabo
In 1997, the Company entered into a codevelopment and comarketing agreement with Sanofi-Synthelabo (Sanofi) for two products: AVAPRO/AVALIDE* (irbesartan), an angiotensin II receptor antagonist indicated for the treatment of hypertension, and PLAVIX* (clopidogrel), a platelet inhibitor. The worldwide alliance operates under the framework of two geographic territories: one in the Americas and Australia and the other in Europe and Asia. Two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished product to the individual countries. At the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place.
The Company acts as the operating partner for the territory covering the Americas (principally the U.S., Canada, Puerto Rico, and Latin American countries) and Australia and owns the majority financial controlling interest in this territory. As such, the Company consolidates all country partnership results for this territory and records Sanofi’s share of the results as a minority interest expense, net of taxes, amounting to $63 million and $52 million for the three months ended June 30, 2003 and 2002, respectively, and $110 million and $117 million for the six months ended June 30, 2003 and 2002, respectively. For the three months ended June 30, 2003 and 2002, the Company recorded sales in this territory and in comarketing countries of $727 million and $576 million, respectively, and $1,310 million and $1,176 million for the six months ended June 30, 2003 and 2002, respectively.
Sanofi acts as the operating partner for the territory covering Europe and Asia and owns the majority controlling interest in this territory. The Company accounts for the investment in partnership entities in this territory under the equity method and records its share of the results as net income from unconsolidated affiliates (included in minority interest, net of taxes). The Company recorded its share of equity earnings in this territory of $44 million and $19 million for the three months ended June 30, 2003 and 2002, respectively, and $75 million and $39 million for the six months ended June 30, 2003 and 2002, respectively.
In 2001, the Company and Sanofi formed an alliance for the copromotion of irbesartan, as part of which the Company contributed the irbesartan distribution rights in the United States and Sanofi paid the Company $350 million. The Company accounts for this transaction as a sale of an interest in a license and defers and amortizes the $350 million into income over the expected useful life of the license, which is approximately eleven years. The Company amortized into other income $8 million in each of the three-month periods ended June 30, 2003 and 2002 and $16 million in each of the six-month periods ended June 30, 2003 and 2002.
Otsuka
The Company has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote ABILIFY* (aripiprazole) for the treatment of schizophrenia. The Company began copromoting the product with Otsuka in the U.S. and Puerto Rico in November 2002. The Company will also copromote the product in several European countries after receiving marketing approval from the European authorities. The Company records alliance revenue for its 65% share of the net sales in these copromotion countries and records all of its expenses related to the product. The Company also has an exclusive right to sell ABILIFY* in a number of countries in Europe, Latin America, and Asia. In these countries, the Company records 100% of the net sales. The Company recognized alliance revenue, which is included in net sales, of $65 million for the three months ended June 30, 2003 and $102 million for the six months ended June 30, 2003.
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Note 7: Divestitures and Discontinued Operations
Divestitures
During the first quarter of 2002, the Company completed the sale of two branded products resulting in a pretax gain of $30 million.
Discontinued Operations
Discontinued operations in the six months ended June 30, 2002 consisted of an after-tax adjustment of $14 million to increase the gain on the sale of Clairol as a result of lower than expected post-closing costs.
Note 8: Business Segments
The Company has three reportable segments - Pharmaceuticals, Nutritionals, and Other Healthcare. The Pharmaceuticals segment is comprised of the global pharmaceutical and international (excluding Japan) consumer medicines businesses. The Nutritionals segment consists of Mead Johnson Nutritionals, primarily an infant formula business. The Other Healthcare segment consists of the ConvaTec, Medical Imaging, and Consumer Medicines (U.S. and Japan) businesses.
Other Healthcare
Total Segments
Corporate/Other
Continuing Operations
Included in earnings from continuing operations before minority interest and income taxes of each segment is a cost of capital charge. The elimination of the cost of capital charge is in Corporate/Other. Corporate/Other principally consists of interest expense, interest income, certain administrative expenses and allocations to the segments. In the six months ended June 30, 2003, Pharmaceuticals and Corporate/Other include the following items: Pharmaceuticals – $21 million of income from a vitamins litigation settlement, $14 million of accelerated depreciation expense for facilities expected to be closed by the end of 2006, $11 million of asset impairment charges, $4 million of relocation expenses, and $1 million of retention benefits; Corporate/Other – $41 million of income from litigation settlements and the reimbursement of patent defense costs, $11 million of income related to the revision of estimates of certain divestiture liabilities, and $24 million of income related to adjustments of prior period restructuring reserves partially offset by expense of $25 million related to termination benefits for workforce reductions and downsizing and streamlining of worldwide manufacturing operations.
15
Note 8: Business Segments (Continued)
In the six months ended June 30, 2002, Pharmaceuticals and Corporate/Other include the following items: Pharmaceuticals – $160 million of in-process research and development charges related to milestone payments to ImClone; Corporate/Other – $90 million of expense for BUSPAR litigation and a $30 million gain on the sale of two branded products.
Note 9: Other (Income) Expense
The components of other (income) expense are:
Interest expense
Interest income
Foreign exchange transaction losses
Other (Income)/Expense, net
Interest expense in 2003 and 2002 is primarily related to the $5.0 billion debt issuance in conjunction with the DuPont and ImClone transactions. In 2003, interest expense also relates to floating rate swap and commercial paper expense. Interest income in 2003 is primarily related to fixed rate swap and investment income.
Note 10: Litigation Matters
Various lawsuits, claims, proceedings and investigations are pending against the Company and certain of its subsidiaries. In accordance with SFAS No. 5, Accounting for Contingencies, the Company records accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters involve antitrust, securities, patent infringement, ERISA, pricing practices and product liability.
The impact of any one of a number of the pending lawsuits, claims, proceedings and investigations described below could be material if the Company were not to prevail in final, non-appealable determinations of the applicable matter. In view of the inherent difficulty of predicting the outcome of legal matters, particularly where the claimants seek very large or indeterminate damages or where the cases involve complex issues and a large number of parties, the Company is unable to predict the outcome of these matters, and cannot reasonably estimate the possible loss or range of loss with respect to these matters. Management believes that during the next few years the aggregate impact of these matters is reasonably likely to be material to the Company’s results of operations and cash flow and may be material to its financial condition and liquidity. With the exception of the accruals for the TAXOL® and BUSPAR litigation matters and the product liability matters described below, the Company has not established reserves for these lawsuits, claims, proceedings and investigations. There can be no assurance that there will not be an increase in scope of these matters or that any future lawsuits, claims, proceedings or investigations will not be material.
The most significant of the Company’s litigation matters are described below:
TAXOL® LITIGATION
In 1997 and 1998, the Company filed several lawsuits asserting that a number of generic drug companies infringed its patents covering methods of administering paclitaxel when they filed Abbreviated New Drug Applications seeking regulatory
16
Note 10: Litigation Matters (Continued)
approval to sell paclitaxel. These actions were consolidated for discovery in the U.S. District Court for the District of New Jersey (District Court). The Company did not assert a monetary claim against any of the defendants, but sought to prevent the defendants from marketing paclitaxel in a manner that violates its patents. The defendants asserted that they did not infringe the Company’s patents and that these patents are invalid and unenforceable.
In early 2000, the District Court invalidated most claims of the Company’s patents at issue. On April 20, 2001, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s summary judgment of the invalidity of all but two claims of the patents at issue. Those two claims relate to the low-dose, three-hour administration of paclitaxel in which the patient is given a specified regimen of premedicants before the administration of paclitaxel. The appellate court remanded those two claims to the District Court for further proceedings. In 2001, the Company filed an additional patent infringement suit against another company seeking to market generic paclitaxel.
In September 2000, one of the defendants received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for paclitaxel and is marketing the product. The FDA has since announced additional final approvals and sales of additional generic products have begun.
Some of the defendants asserted counterclaims seeking damages for alleged antitrust and unfair competition violations. The Company believed its patents were valid when it filed the suits, and the counterclaims asserted were believed to be without merit. The lawsuits with all defendants who asserted counterclaims have been settled, with the defendants agreeing to drop all claims relating to paclitaxel and the Company granting licenses to them under certain paclitaxel patent rights.
Since the filing of the initial patent infringement suits, seven private actions have been filed by parties alleging antitrust, consumer protection and similar claims relating to the Company’s actions to obtain and enforce patent rights. The most recent of the seven private actions was brought in March 2003 by a purported competitor alleging antitrust claims relating to the Company’s actions to obtain and enforce patent rights, an alleged conspiracy to block the entry of generic paclitaxel into the market and the alleged restriction of the supply of TAXOL® raw materials. The plaintiffs seek declaratory judgment, damages (including treble and/or punitive damages where allowed), restitution, disgorgement, equitable relief and injunctive relief. In June 2002, a group of 32 state attorneys general, the District of Columbia, Puerto Rico and the Virgin Islands brought similar claims. In April 2003, the states amended their complaint to add 18 states, Guam, Mariana Islands and American Samoa as plaintiffs. In September 2000, the Federal Trade Commission (FTC) initiated an investigation relating to paclitaxel.
On January 7, 2003, the Company announced that it reached agreements in principle that would settle substantially all antitrust litigation surrounding TAXOL®. The amount of these TAXOL® antitrust settlements was $135 million, the full amount of which was recognized in the third quarter of 2002. The $135 million includes settlements of two class actions (which cover wholesalers and healthcare service providers who purchased TAXOL® from the Company, and insurers), as well as the states’ litigation (which covers the states and territories of the U.S. and consumers resident in those states and territories). Certain entities filed or threatened to file actions separate from the class actions. The Company has entered into settlement agreements with certain of those entities and is in discussions with certain others. The class actions and the states’ action require court approval and are subject to the rights of class members to opt out of the settlements. The supervising court has granted preliminary approval of the two class action settlements and the settlement of the states’ action. Final approval hearings are scheduled for the second half of 2003. Whether final approval will be granted cannot be predicted with certainty at this time.
The Company reached agreement with the FTC on the terms of a consent order resolving the FTC’s investigation, which was approved by the FTC commissioners and is in effect until April 14, 2013.
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Other than with respect to the above mentioned proposed settlements, it is not possible at this time reasonably to assess the final outcome of these lawsuits or reasonably to estimate the possible loss or range of loss with respect to these lawsuits. If the proposed settlements do not become final or do not resolve all TAXOL®-related antitrust, consumer protection and similar claims, and if the Company were not to prevail in final, non-appealable determinations of ensuing litigation, the impact could be material.
BUSPAR LITIGATION
On November 21, 2000, the Company obtained a patent, (‘365 patent), relating to a method of using BUSPAR or buspirone. The Company timely submitted information relating to the ‘365 patent to the FDA for listing in an FDA publication commonly known as the “Orange Book”, and the FDA thereafter listed the patent in the Orange Book.
Delisting and Patent Suits. Generic-drug manufacturers sued the FDA and the Company to compel the delisting of the ‘365 patent from the Orange Book. Although one district court declined to order the delisting of the ‘365 patent, another ordered the Company to cause the delisting of the patent from the Orange Book. The Company complied with the court’s order but appealed the decision to the United States Court of Appeals for the Federal Circuit. The appellate court reversed the district court that ordered the delisting. Concurrently, the Company sought to enforce the ‘365 patent in actions against two generic drug manufacturers.
Antitrust Suits. Following the delisting of the ‘365 patent from the Orange Book, a number of purchasers of buspirone and several generic drug makers filed lawsuits against the Company alleging that it improperly triggered statutory marketing exclusivity. The plaintiffs claimed that this was a violation of antitrust, consumer protection and other similar laws. The attorneys general of 35 states, Puerto Rico and the District of Columbia also filed suit against the Company with parallel allegations. The plaintiffs have amended their allegations to include charges that a 1994 agreement between the Company and a generic company improperly blocked the entry of generic buspirone into the market. Plaintiffs seek declaratory judgment, damages (including treble and/or punitive damages where allowed), disgorgement, equitable relief and injunctive relief. In addition, two antitrust suits brought by a number of health insurers remain pending in New Jersey Superior Court. The plaintiffs’ allegations and the relief sought are similar to those in the antitrust suits consolidated in the MDL proceeding.
Multidistrict Litigation (MDL) Proceedings. The Judicial Panel on MDL granted the Company’s motions to have all of the patent and antitrust cases consolidated in a single forum. The court before which the buspirone litigations are now pending issued two opinions dated February 14, 2002. In the first opinion, the court found that the ‘365 patent does not cover uses of buspirone and therefore is not infringed. In the second opinion, the court denied the Company’s motion to dismiss the federal antitrust and various state law claims. The second opinion allows the claims against the Company to proceed, except as to federal antitrust claims for damages accrued more than four years before the filing of the complaints.
Government Investigations. The FTC and a number of state attorneys general initiated investigations concerning the matters alleged in the antitrust suits and discussed above. The Company cooperated in these investigations. A number of attorneys general, but not all of them, filed an action against the Company, as noted above.
Proposed Settlements. On January 7, 2003, the Company announced that it reached agreements in principle that would settle substantially all antitrust litigation surrounding BUSPAR in the MDL proceeding. The amount of these BUSPAR settlements was $535 million, of which $35 million was recognized in the fourth quarter of 2001, $90 million was recognized in the first quarter of 2002, and $410 million was recognized in the third quarter of 2002. The $535 million includes settlements with generic drug manufacturers and chain drug stores, settlements of two class actions (which cover wholesalers, insurers and consumers in certain states), as well as the states’ litigation (which covers the states and territories of the U.S. and consumers resident in certain of those states and territories). Certain entities filed or threatened to file additional, separate actions. The Company has entered into settlement agreements with certain of those entities and is in discussions with certain others. The
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class actions and the states’ action require court approval and are subject to the rights of class members to opt out of the settlements. The supervising court has granted final approval to one of the class action settlements and preliminary approval of both the other class action settlement and the settlement of the states’ action. Final approval hearings for the two preliminarily approved settlements are scheduled for the fourth quarter of 2003. Whether final approval will be granted cannot be predicted with certainty at this time.
Other than with respect to the above mentioned proposed settlements of BUSPAR antitrust litigation, it is not possible at this time reasonably to assess the final outcome of these lawsuits or reasonably to estimate the possible loss or range of loss with respect to these lawsuits. If the proposed settlements do not become final or do not resolve all BUSPAR-related antitrust, consumer protection and similar claims, and if the Company were not to prevail in final, non-appealable determinations of ensuing litigation, the impact could be material.
VANLEV LITIGATION
In April, May and June 2000, the Company, its former chairman of the board and chief executive officer, Charles A. Heimbold, Jr., and its former chief scientific officer, Peter S. Ringrose, Ph.D., were named as defendants in a number of class action lawsuits alleging violations of federal securities laws and regulations. These actions have been consolidated into one action in the U.S. District Court for the District of New Jersey. The plaintiff claims that the defendants disseminated materially false and misleading statements and/or failed to disclose material information concerning the safety, efficacy and commercial viability of its product VANLEV during the period November 8, 1999 through April 19, 2000.
In May 2002, the plaintiff submitted an amended complaint adding allegations that the Company, its present chairman of the board and chief executive officer, Peter R. Dolan, its former chairman of the board and chief executive officer, Charles A. Heimbold, Jr., and its former chief scientific officer, Peter S. Ringrose, Ph.D., disseminated materially false and misleading statements and/or failed to disclose material information concerning the safety, efficacy, and commercial viability of VANLEV during the period April 19, 2000 through March 20, 2002. A number of related class actions, making essentially the same allegations, were also filed in the U.S. District Court for the Southern District of New York. These actions have been transferred to the U.S. District Court for the District of New Jersey. The plaintiff purports to seek compensatory damages, costs and expenses on behalf of shareholders.
It is not possible at this time reasonably to assess the final outcome of this litigation or reasonably to estimate the possible loss or range of loss with respect to this litigation. If the Company were not to prevail in final, non-appealable determinations of this litigation, the impact could be material.
PLAVIX* LITIGATION
The Company is part owner of an entity that is a plaintiff in two pending patent infringement lawsuits in the United States District Court for the Southern District of New York, entitled Sanofi-Synthelabo, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex Inc. and Apotex Corp., 02-CV-2255 (RWS) and Sanofi-Synthelabo, Sanofi-Synthelabo Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Dr. Reddy’s Laboratories, LTD., and Dr. Reddy’s Laboratories, Inc., 02-CV-3672 (RWS). The suits were initially based on U.S. Patent No. 4,847,265, which discloses and claims, among other things, the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX*, and on U.S. Patent No. 5,576,328, which discloses and claims, among other things, the use of clopidogrel to prevent a secondary ischemic event. The Company and its co-plaintiffs have elected to withdraw U.S. Patent No. 5,576,328
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from the litigation. Plaintiffs’ infringement position is based on defendants’ filing of their Abbreviated New Drug Applications with the FDA, seeking approval to sell generic clopidogrel prior to the expiration of the patents in suit.
It is not possible at this time reasonably to assess the final outcome of these lawsuits or reasonably to estimate the possible loss or range of loss with respect to these lawsuits. If patent protection for PLAVIX* were lost, the impact on the Company’s operations could be material.
OTHER SECURITIES MATTERS
During the period March through May 2002, the Company and a number of its current and former officers were named as defendants in a number of securities class action lawsuits alleging violations of federal securities laws and regulations. The plaintiffs variously alleged that the defendants disseminated materially false and misleading statements and failed to disclose material information concerning three different matters: (1) safety, efficacy and commercial viability of VANLEV (as discussed above), (2) the Company’s sales incentives to certain wholesalers and the inventory levels of those wholesalers, and (3) the Company’s investment in and relations with ImClone, and ImClone’s product, ERBITUX*. As discussed above, the allegations concerning VANLEV have been transferred to the U.S. District Court for the District of New Jersey and consolidated with the action pending there. The remaining actions have been consolidated and are pending in the U.S. District Court for the Southern District of New York. Plaintiffs filed a consolidated class action complaint on April 11, 2003 alleging a class period of October 19, 1999 through March 10, 2003. The consolidated class action complaint alleges violations of federal securities laws in connection with, among other things, the ImClone matter, as described above, and certain accounting issues, including issues related wholesaler inventory and sales incentives, the establishment of reserves, and accounting for certain asset and other sales. The plaintiffs seek compensatory damages, costs and expenses. On August 1, 2003, the Company moved to dismiss the consolidated class action complaint.
A number of the Company’s officers, directors and former directors were named as defendants in three shareholder derivative suits filed during the period October 2002 through May 2003 in the U.S. District Court for the Southern District of New York. The Company is a nominal defendant. All of the complaints name the Company’s independent auditors, PricewaterhouseCoopers LLP (PwC), as a defendant. The suits variously allege, among other things, violations of the federal securities laws and breaches of contract and fiduciary duty in connection with the Company’s sales incentives to certain wholesalers, the inventory levels of those wholesalers and its investment in ImClone and ImClone’s product, ERBITUX*, and, against PwC, malpractice. A number of the Company’s officers, directors and former officers were named as defendants in three shareholder derivative lawsuits filed during the period March 2003 through May 2003 in the U.S. District Court for the District of New Jersey. The Company is a nominal defendant. Two of the lawsuits also name PwC as a defendant. The lawsuits variously allege, among other things, violations of federal securities laws and breaches of fiduciary duty by the individual defendants in connection with the Company’s conduct concerning: safety, efficacy and commercial viability of VANLEV (as discussed above); the Company’s sales incentives to certain wholesalers and the inventory levels of those wholesalers; the Company’s investment in and relations with ImClone, and ImClone’s product ERBITUX*; alleged anticompetitive behavior in connection with BUSPAR and TAXOL®; and failure of the Board of Directors to supervise management and perform other duties. Two of the lawsuits allege malpractice by PwC. The plaintiffs seek restitution and rescission of certain officers’ and directors’ compensation and alleged improper insider trading proceeds; injunctive relief; fees, costs and expenses; and contribution and indemnification from PwC. In July 2003 the U.S. District Court for the District of New Jersey granted the Company’s motion to transfer two of the three shareholder derivative lawsuits that were filed in that court to the U.S. District Court for the Southern District of New York. Plaintiffs in the Third District of New Jersey lawsuit agreed to be bound by that decision and the court ordered that action transferred as well. Subsequently, the U.S. District Court for the Southern District of New York ordered all six federal shareholder derivative suits consolidated. The deadline for filing of the consolidated complaint has not been set. Two similar actions are pending in New York State court. Plaintiffs seek equitable relief, damages, costs and attorneys’ fees.
The SEC and the U.S. Attorney’s Office for the District of New Jersey are investigating the activities of the Company and certain current and former members of
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the Company’s management in connection with the wholesaler inventory issues referenced above and certain other accounting issues. As described below the Company cannot reasonably assess the final outcome of these investigations at this time. The Company is cooperating with both of these investigations. The Company’s own investigation is continuing.
It is not possible at this time reasonably to assess the final outcome of these litigations and investigations or reasonably to estimate the possible loss or range of loss with respect to these litigations and investigations. The Company is producing documents and actively cooperating with these investigations, which investigations could result in the assertion of civil and/or criminal claims against the Company and/or current or former members of the Company’s management. If the Company were not to prevail in final, non-appealable determinations of these litigations and investigations, the impact could be material.
ERISA LITIGATION
In December 2002 and the first quarter of 2003, the Company and others were named as defendants in five class actions brought under the Employee Retirement Income Security Act of 1974, as amended (ERISA) in the U.S. District Courts for the Southern District of New York and the District of New Jersey: Specifically, (i) Carrolin v. Bristol-Myers Squibb Co., et al., 02 CV 10129, was filed on December 20, 2002 in the Southern District of New York; (ii) Padovano v. Bristol-Myers Squibb Co., et al., 03 CV 0550, was filed on January 24, 2003 in the Southern District of New York; (iii) Barrett, et al. v. Bristol-Myers Squibb Co., et al., 03 CV 497, was filed on February 4, 2003 in the District of New Jersey; (iv) DeVoe v. Bristol-Myers Squibb Co., et al., 03 CV 1274, was filed on February 26, 2003 in the Southern District of New York; and (v) Krause, et al. v. Bristol-Myers Squibb Co., et al., 03 CV 1729, was filed on March 12, 2003 in the Southern District of New York. These actions have been consolidated in the Southern District of New York before Hon. Loretta A. Preska under the caption In re Bristol-Myers Squibb Co. ERISA Litigation, 02 CV 10129.
A Consolidated Complaint was filed in the Southern District of New York on April 30, 2003. The Consolidated Complaint is brought on behalf of five named plaintiffs and a putative class consisting of all participants in the Program and their beneficiaries for whose benefit the Savings Plan held and/or acquired Company stock at any time on or after January 1, 1999 (excluding the defendants, their heirs, predecessors, successors and assigns). The named defendants are the Company, the Bristol-Myers Squibb Company Savings Plan Committee (Committee), 13 individuals who presently serve on the Committee or who served on the Committee in the recent past, Charles A. Heimbold, Jr. and Peter R. Dolan (the past and present Chief Executive Officer, respectively, of the Company). The Consolidated Complaint generally alleges that the defendants breached their fiduciary duties under ERISA after January 1, 1999 by continuing to offer the Company Stock Fund and Company stock as investment alternatives under the Savings Plan; by, among other things, continuing to invest Company matching contributions in the Company Stock Fund and Company stock; and by failing to disclose that the investments in Company stock were (allegedly) imprudent. The Savings Plan’s purchases of Company stock after January 1, 1999 are alleged to have been transactions prohibited by ERISA. Finally, Defendants Heimbold and Dolan are alleged to have breached their fiduciary duties under ERISA by failing to monitor the actions of the Committee.
The litigations are at a very preliminary stage. The plaintiffs have indicated that they intend to file an amended complaint on August 14, 2003. There has not been any significant discovery. It is not possible at this time reasonably to predict the final outcome or reasonably to estimate the possible loss or range of loss with respect to the consolidated litigation. If the Company were not to prevail in final, non appealable determinations of these matters, the impact could be material.
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PRICING LITIGATION AND INVESTIGATION
The Company, together with a number of other pharmaceutical manufacturers, is a defendant in several private class actions and in actions brought by the Nevada and Montana Attorneys General and the County of Suffolk, New York that are pending in federal and state courts relating to the pricing of certain Company products. The federal cases (and many of the state cases, including both Attorneys General cases, which were removed to federal courts) were consolidated for pre-trial purposes under the caption In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456 before United States District Judge Patti B. Saris in the District of Massachusetts, Civ. Action No. 01-CV-12257-PBS (AWP Multidistrict Litigation). On September 6, 2002, several of the private plaintiffs in the AWP Multidistrict Litigation filed a Master Consolidated Class Action Complaint (Master Complaint), which superceded the complaints in their pre-consolidated constituent cases. Defendants moved to dismiss the Master Complaint and, in a decision dated May 12, 2003, the Court granted in part and denied in part the motion and gave plaintiffs leave to replead the dismissed portions.
On June 12, 2003, plaintiffs in the AWP Multidistrict Litigation served a proposed Amended Master Consolidated Complaint (Amended Master Complaint). On June 18, 2003, the Court granted plaintiffs’ motion for leave to file the Amended Master Complaint, but also set a briefing schedule on a proposed motion by defendants, including the Company, to dismiss the Amended Master Complaint for failure to state a cause of action. The Amended Master Complaint contains two sets of allegations against the Company. First, it alleges that the Company’s and many other pharmaceutical manufacturers’ reporting of prices for certain drug products (20 listed drugs in the Company’s case) had the effect of falsely overstating the Average Wholesale Price (“AWP”) published in industry compendia, which in turn improperly inflated the reimbursement paid to medical providers and others who prescribed and administered those products. Second, it alleges that the Company and certain other defendant pharmaceutical manufacturers conspired with one another in a program called the “Together Rx Card Program” to fix AWPs for certain drugs made available to consumers through the Program. The Amended Master Complaint asserts claims under the federal RICO and antitrust statutes and state consumer protection and fair trade statutes.
The Amended Master Complaint is brought on behalf of two main proposed classes, which are further divided into sub-classes: (1) all persons or entities who, from 1991 forward, (a) directly paid any portion of the price of a listed drug, which price was calculated with reference to AWP or (b) contracted with a pharmacy benefit manager to provide others with the drugs listed in the Amended Consolidated Complaint; and (2) all persons or entities who, from 2002 forward, paid or reimbursed any portion of the purchase price of a drug covered by the Together Rx Card Program based in whole or in part on AWP.
The Company and the other defendants intend to move to dismiss the Amended Master Complaint on the grounds it fails to state claims under the applicable statutes. It is anticipated that those motions will be heard by the Court on November 12, 2003. In the interim, the Court in the AWP Multidistrict Litigation has ruled that discovery should proceed on the limited claims and identified drugs against those defendant manufacturers that remain after the dismissal in part of the first Master Complaint.
The Nevada and Montana Attorneys General complaints assert claims similar to those in the Amended Master Complaint under state law, but also assert claims in the name of their respective States for alleged violations of state Medicaid fraud statutes. The Nevada and Montana Attorneys General moved to have their respective cases remanded to state court on the ground that there is no federal jurisdiction. On June 11, 2003, the Court ruled that the Nevada action should be remanded to state court on the ground that not all defendants had joined in the original removal petition. The Court retained jurisdiction over the Montana case. It is anticipated that defendants will move to dismiss that case on a motion schedule similar to that established for the Amended Master Complaint.
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Finally, the Company is a defendant in related state court proceedings commenced in New York, New Jersey, California, Arizona and Tennessee, and in one federal court proceeding commenced by the County of Suffolk, New York. The New York and New Jersey state court proceedings are currently stayed. The other proceedings have been transferred to the AWP Multidistrict Litigation for pre-trial purposes, although plaintiffs in the California, Arizona and Tennessee actions have sought to remand their cases to the state courts. No decision on these remand motions has yet been made. The County of Suffolk case alleges RICO claims similar to those contained in the first Master Complaint in the AWP Multidistrict Litigation on behalf of the County of Suffolk as a contributor to New York State’s Medicaid obligations. It is anticipated that the County of Suffolk will seek to amend its complaint based on the June 11, 2003 decision of the AWP Multidistrict Litigation and that defendants will make a motion to dismiss that amended complaint on a schedule similar to that set for the Montana Attorney General’s case.
These cases are at a very preliminary stage, and the Company is unable to assess the outcome and any possible effect on its business and profitability, or reasonably estimate possible loss or range of loss with respect to these cases. If the Company were not to prevail in final, non-appealable determinations of these litigations and investigations, the impact could be material.
The Company, together with a number of other pharmaceutical manufacturers, also has received subpoenas and other document requests from various government agencies seeking records relating to its pricing and marketing practices for drugs covered by Medicare and/or Medicaid. The requests for records have come from the United States Attorney’s Office for the District of Massachusetts, the Office of the Inspector General of the Department of Health and Human Services in conjunction with the Civil Division of the Department of Justice, and several states. In addition, a request for information has come from the House Committee on Energy & Commerce in connection with an investigation that the Committee is currently conducting into Medicaid best price issues.
On July 22, 2003, the Company announced that it had recently initiated an internal review of certain of its sales and marketing practices. That review focuses on whether these practices comply with applicable anti-kickback laws. It also includes an analysis of compliance with “Best Price” reporting requirements under the Medicaid program, and seeks to determine whether Medicaid rebates and pricing under certain other U.S. governmental programs which reference the Medicaid rebate program have been appropriate. Because the internal review is still in process, the Company cannot predict its outcome. The Company met with representatives of the U. S. Attorney’s Office for the District of Massachusetts to discuss the review and its plans for sharing the results of the review with that office. The Company subsequently received a subpoena from the U.S. Attorney’s Office relating to the subject matter of the review.
The Company is producing documents and actively cooperating with these investigations, which could result in the assertion of criminal and/or civil claims. The Company is unable to assess the outcome of, or to reasonably estimate the possible loss or range of loss with respect to, these investigations, which could include the imposition of fines, penalties, administrative remedies and/or liability for additional rebate amounts. If the Company were not to prevail in final, non-appealable determinations of these litigations and investigations, the impact could be material.
PRODUCT LIABILITY LITIGATION
The Company is a party to product liability lawsuits involving allegations of injury caused by the Company’s pharmaceutical and over-the-counter medications. The majority of these lawsuits involve certain over-the-counter medications containing phenylpropanolamine (PPA), or the Company’s SERZONE and STADOL NS prescription drugs. In addition to lawsuits, the Company also faces unfiled claims involving the same products.
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PPA. In May 2000, Yale University published the results of its Hemorrhagic Stroke Project which concluded that there was evidence of a suggestion that phenylpropanolamine (PPA) may increase the risk of hemorrhagic stroke in a limited population. In November 2000, the Food and Drug Administration (FDA) issued a Public Health Advisory and requested that manufacturers of PPA-containing products voluntarily cease manufacturing and marketing them. At that time, the only PPA-containing products manufactured or sold by the Company were COMTREX (liquigel formulation only) and NALDECON. On or about November 6, 2000, the Company, as did the other manufacturers of PPA containing products, discontinued the manufacture and marketing of PPA containing products and allowed customers to return any unused product that they had in their possession.
In January 2001, the Company was served with its first “PPA” lawsuit. The Company currently is a defendant in approximately 122 personal injury lawsuits, filed on behalf of approximately 1,158 plaintiffs, in federal and state courts throughout the U.S. The majority of these lawsuits involve multiple defendants. Among other claims, plaintiffs allege that PPA causes hemorrhagic and ischemic strokes, that the defendants were aware of the risk, failed to warn consumers and failed to remove PPA from their products. Plaintiffs seek compensatory and punitive damages. All of the federal cases have been transferred to the U.S. District Court for the Western District of Washington before U.S. District Judge Barbara Jacobs Rothstein, In re Phenylpropanolamine (PPA) Products Liability Litigation, MDL No. 1407. Judge Rothstein has denied all motions for class certification and there are no class action lawsuits pending against the Company in this litigation.
On June 18, 2003, Judge Rothstein issued a ruling effectively limiting the plaintiffs’ claims to hemorrhagic and ischemic strokes in men and women of all ages and in children. Rulings favorable for the defendants included the inadmissibility of expert testimony in cases alleging injuries occurring more than three days after ingestion of a PPA containing product and cases involving psychoses, seizures and cardiac injuries. The Company expects to be dismissed from a substantial number of cases in which its products were never used by the plaintiffs and where plaintiffs’ alleged injury occurred more than three days after ingestion of a PPA containing product or where a plaintiff suffered from cardiac injuries or psychoses.
SERZONE. SERZONE (nefazodone hydrochloride) is an antidepressant that was launched by the Company in May 1994 in Canada and in March 1995 in the U.S. In December 2001, the Company added a black box warning to its SERZONE label warning of the potential risk of severe hepatic events including possible liver failure and the need for transplantation. Within several months of the black box warning being added to the package insert for SERZONE, a number of lawsuits, including several class actions, were filed against the Company. Plaintiffs allege that the Company knew or should have known about the hepatic risks posed by SERZONE and failed to adequately warn physicians and users of the risks. They seek compensatory and punitive damages, medical monitoring, and refunds for the costs of purchasing Serzone.
At present, the Company has 126 lawsuits, on behalf of 1,657 plaintiffs, pending against it in federal and state courts throughout the U.S. Thirteen of these cases are pending in New York state court and have been consolidated for pretrial discovery. In addition, there are approximately 1,600 alleged, but unfiled, claims of injury associated with Serzone. In August 2002, the federal cases were transferred to the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin, In Re Serzone Products Liability Litigation, MDL 1477. Although discovery is still at a very early stage it appears that very few of these cases involve liver failure. In June 2003, Judge Goodwin dismissed the class claims in all but two of the class action complaints. Although a number of the class action complaints filed against the Company had sought the certification of one or more personal injury classes, the remaining class action complaints do not seek the certification of personal injury classes. On July 14, 2003, the court issued an order setting the hearing on class certification for July 21, 2004.
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STADOL NS. STADOL NS was approved in 1992 by the FDA as an unscheduled opioid analgesic nasal spray. In February 1995 the Company asked the FDA to schedule STADOL NS as a Schedule IV, low potential for abuse, drug due to post-marketing reports suggestive of inappropriate use of the product. On October 31, 1997, it became a Schedule IV drug. Since 1997, the Company has received a number of lawsuits involving STADOL. In late 2002, the number of filed suits increased due to newly passed tort reform legislation. Most, if not all, of the plaintiffs in these new suits had previously asserted claims against the Company for their alleged injuries. As a result of Mississippi tort reform that became effective on January 1, 2003, many claimants filed lawsuits prior to that date to avoid being subject to the new statute.
The Company currently is a party in 54 cases pending, on behalf of a total of approximately 928 plaintiffs, in federal and state courts throughout the U.S. Plaintiffs claim that the Company committed fraud on the FDA and wrongfully promoted STADOL NS as non-addictive. Further, plaintiffs allege that the Company failed to adequately warn of the addiction and dependency risk associated with the use of STADOL NS. In addition to these lawsuits, there are approximately 10,020 alleged and unfiled claims of which approximately 326 are active. The majority of the cases and claims are pending in Mississippi.
The Company intends to vigorously defend its product liability lawsuits and believes that the majority of these cases and claims are without merit. While it is not possible at this time to reasonably assess the final outcome of the Company’s pending product liability lawsuits and unfiled claims with certainty, management is of the opinion that the ultimate disposition of these matters should not have a material adverse effect on the Company’s financial position. The Company believes that it has adequate self-insurance reserves and commercially available excess insurance to cover potential loss related to its product liability cases and claims.
ENVIRONMENTAL MATTERS
In July 2003, the New Jersey Department of Environmental Protection (“NJDEP”) advised E.R. Squibb & Sons (“Squibb”), a wholly owned subsidiary of Bristol-Myers Squibb, that it believes Squibb violated the Clean Air Act by failing to comply with Prevention of Significant Deterioration (“PSD”) requirements in connection with its replacement of a gas turbine at its cogeneration facility at the New Brunswick, New Jersey facility in 1997. NJDEP also alleges that Squibb should have installed additional pollution control equipment at the facility pursuant to the New Jersey Air Pollution Control Act. Although NJDEP approved the cogeneration facility in 1997 and Squibb believes it demonstrated that it complied with PSD requirements, the NJDEP may nevertheless require the Company to take certain remedial steps, including performing another PSD analysis to determine if a permit is required, obtaining emissions credits, installing pollution control equipment and paying an administrative fine. Although discussions with the NJDEP are still preliminary and the agency has not yet made any specific financial demands, the Company believes that any capital expenditures, costs and/or penalties associated with this matter will not have a material impact on the consolidated financial condition or results of operations of the Company.
In May 2003, the Environmental Quality Board (“EQB”) of Puerto Rico issued a notice to Bristol-Myers Squibb alleging five violations of the Federal Resource Recovery and Conservation Act relating to recordkeeping or storage requirements for hazardous wastes at the Company’s facility in Humacao. Based on its prior dealings with EQB and the technical nature of the alleged violations, the Company believes that any penalties imposed will not be significant.
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Note 11: Comprehensive Income (Loss)
ForeignCurrency
Translation
Deferred
Loss on
Effective Hedges
MinimumPension
LiabilityAdjustment
Total
Other Accumulated
Comprehensive Loss
(dollars in millions)
Other comprehensive income (loss)
Note 12: Income Taxes
The effective income tax rate on earnings from continuing operations before minority interest and income taxes was reduced to 21.3% and 24.2% for the three and six months ended June 30, 2003, respectively, from 28.9% and 27.8% for the three and six months ended June 30, 2002, respectively, due to a revised estimate of the use of foreign tax credits relating mainly to the final implementation of the reorganization of the ownership structure of its non-U.S. subsidiaries as described below.
In 2002, the Company reorganized the structure of its ownership of many of its non-U.S. subsidiaries. The principal purpose of the reorganization was to facilitate the Company’s ability to efficiently deploy its financial resources outside the U.S. The Company believes that the reorganization transactions were generally tax-free both inside and outside the U.S. It is possible, however, that taxing authorities in particular jurisdictions could assert tax liabilities arising from the reorganization transactions or the operations of the reorganized subsidiaries. While it is not reasonably possible to predict whether any taxing authority will assert such a tax liability, the Company has established a reserve to cover this possibility. The Company would vigorously challenge any such assertion and believes that it would prevail but there can be no assurance of such a result. If the Company were not to prevail in final, non-appealable determinations, it is possible the impact could be material.
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To the Board of Directors
and Stockholders of
Bristol-Myers Squibb Company
We have reviewed the accompanying consolidated balance sheet of Bristol-Myers Squibb Company and its subsidiaries as of June 30, 2003 and the related consolidated statements of earnings, of comprehensive income and retained earnings for each of the three-and six-month periods ended June 30, 2003 and 2002 and statement of cash flows for each of the six-month periods ended June 30, 2003 and 2002. These financial statements are the responsibility of the Company’s management.
We conducted our review in accordance with standards established by the American Institute of Certified Public Accountants. A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with auditing standards generally accepted in the United States of America, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should be made to the accompanying consolidated interim financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.
We previously audited in accordance with auditing standards generally accepted in the United States of America, the consolidated balance sheet of Bristol-Myers Squibb Company as of December 31, 2002, and the related consolidated statements of earnings, of comprehensive income and retained earnings and of cash flows for the year then ended (not presented herein), and in our report dated March 26, 2003, included in the Company’s 2002 Form 10-K, we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying consolidated balance sheet as of December 31, 2002, is fairly stated in all material respects in relation to the consolidated balance sheet from which it has been derived.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Philadelphia, Pennsylvania
August 1, 2003
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Revenue Recognition Under the Consignment Model
The Company recognizes revenue for sales upon shipment of product to its customers, except in the case of certain transactions with its U.S. pharmaceuticals wholesalers that are accounted for using the consignment model. Under GAAP, revenue is recognized when substantially all the risks and rewards of ownership have transferred. The Company has determined that substantially all the risks and rewards of ownership do not transfer upon shipment for certain incentivized sales to two U.S. wholesalers, Cardinal Health, Inc. (Cardinal) and McKesson Corporation (McKesson) and, accordingly, such sales should be accounted for using the consignment model.
Under the consignment model, the Company does not recognize revenue upon shipment of product. Rather, upon shipment of product the Company invoices the wholesaler, records deferred revenue at gross invoice sales price and classifies the inventory held by the wholesalers as consignment inventory at the Company’s costs of such inventory. The Company recognizes revenue (net of discounts, rebates, estimated sales allowances and accruals for returns) when the consignment inventory is no longer subject to incentive arrangements but not later than when such inventory is sold through to the wholesalers’ customers, on a first-in first-out (FIFO) basis. For additional discussion of the Company’s revenue recognition policy, see Note 1, Basis of Presentation and New Accounting Standards, to the consolidated financial statements included in this Form 10-Q.
The Company determined that shipments of product to Cardinal and shipments of product to McKesson met the consignment model criteria set forth in the Company’s revenue recognition policy as of July 1, 1999 and July 1, 2000, respectively, and, continued through December 2002 for McKesson and February 2003 for Cardinal. Accordingly, the consignment model was required to be applied to such shipments. All shipments to McKesson in the first six months of 2003, other than those for the OTN business, and all shipments to Cardinal after February 2003 were accounted for as sales upon shipment.
The Company has determined that, although sales incentives were offered to other wholesalers and there was a buildup of inventories at such wholesalers in certain periods, the consignment model criteria set forth in the Company’s revenue recognition policy were not met. Accordingly, the Company recognized revenue when the products were shipped to these wholesalers. The Company estimates that, generally, in aggregate, the inventory of pharmaceutical products held by these other U.S. pharmaceutical wholesalers in excess of or below approximately one month of supply in the case of the Company’s exclusive products (including PLAVIX* and AVAPRO/AVALIDE*) and approximately two months in the case of the Company’s non-exclusive products, was in the range of approximately $100 million below this level of supply to $100 million in excess of this level of supply at June 30, 2003.
The Company’s estimates of inventories by wholesalers are based on the projected prescription demand-based sales for its products, as well as the Company’s analysis of third-party information, including information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and third-party market research data, and the Company’s internal information. The Company’s estimates are subject to inherent limitations of estimates that rely on third-party data, as certain third-party information was itself in the form of estimates, and reflect other limitations.
In April 2002, the Company disclosed a substantial buildup of wholesaler inventories in its U.S. pharmaceuticals business, and developed and subsequently undertook a plan to workdown in an orderly fashion these wholesaler inventory levels. To facilitate an orderly workdown, the Company’s plan included continuing to offer sales incentives, at reduced levels, to certain wholesalers. With respect to McKesson and Cardinal, the Company entered into agreements for an orderly workdown that provided for these wholesalers to make specified levels of purchases and for the Company to offer specified levels of incentives through the first quarter of 2003 for McKesson and the third quarter of 2003 for Cardinal. The Company expects that the orderly workdown of inventories of its pharmaceutical products held by all U.S. pharmaceuticals wholesalers will be substantially completed at or before the end of 2003.
The Company’s financial results and prior period and quarterly comparisons are affected by the buildup and orderly workdown of wholesaler inventories, as well as the application of the consignment model to certain sales to certain
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wholesalers. In addition, with respect to sales not accounted for using the consignment model, the Company’s financial results and prior period and quarterly comparisons are affected by fluctuations in the buying patterns of wholesalers, including the effect of incentives offered, and the corresponding changes in inventory levels maintained by these wholesalers. These wholesalers buying patterns and wholesaler inventory levels may not reflect underlying prescriber demand. The Company’s policy is to allow wholesalers to purchase product on a limited basis after a price increase at the pre-increase price. For information on U.S. pharmaceuticals prescriber demand, reference is made to the tables on pages 31 and 35, which sets forth a comparison of changes in net sales to the estimated total (both retail and mail order customers) prescription growth for certain of the Company’s U.S. pharmaceutical products for each of the three months and six months ended June 30, 2003 and 2002, respectively.
Three Months Results of Operations
Worldwide sales for the second quarter of 2003 increased 22% to $5,052 million from $4,127 million in 2002. This sales increase resulted from a 17% increase in volume, a 4% increase in foreign exchange and a 1% increase in price. Domestic sales increased 23% for the quarter, primarily as a result of continued strong prescription demand for key brands and the impact from the workdown of non-consignment wholesaler inventory in the second quarter of 2002. International sales increased 21%, including an 11% favorable foreign exchange impact. For the second quarter of 2003, $32 million of deferred revenue was reversed and recognized as sales (calculated net of sales discounts and rebates). The deferred revenue, recorded at gross invoice sales prices, related to the inventory of pharmaceutical products accounted for using the consignment model, was reduced to $110 million at June 30, 2003, compared to $174 million at March 31, 2003. The deferred revenue and consignment inventory recorded under the consignment model will continue to be reflected on the Company’s balance sheet until the related products are sold through to the wholesalers’ customers. The sell-through to the wholesalers’ customers is expected to be substantially complete by the end of 2003.
Second quarter 2003 earnings from continuing operations before minority interest and income taxes increased 61% to $1,165 million from $724 million in 2002 primarily as a result of higher sales. Net earnings from continuing operations increased 83% to $878 million in 2003 compared to $479 million in 2002. The effective income tax rate on earnings from continuing operations before minority interest and income taxes decreased to 21.3% in 2003 from 28.9% in 2002. Basic and diluted earnings per share from continuing operations each increased 80% to $.45 in 2003 from $.25 in 2002. Basic and diluted average shares outstanding for the second quarter were 1,937 million and 1,942 million, respectively, in 2003 compared to 1,937 million and 1,944 million, respectively, in 2002.
Business Segments
Sales for the Pharmaceuticals segment in the three months ended June 30, 2003 increased 28%, including a 5% favorable foreign exchange impact, to $4,192 million from $3,274 million in 2002. Domestic pharmaceutical sales increased 33% to $2,607 million in 2003 from $1,953 million in 2002, primarily due to increased sales of PRAVACHOL, PARAPLATIN, SUSTIVA and GLUCOVANCE*.
International sales for the Pharmaceuticals segment increased 20% to $1,585 million in 2003, including a 13% favorable foreign exchange impact, from $1,321 million in 2002. Sales in Europe and the Middle East increased 25%, including a 21% favorable foreign exchange impact, as a result of strong growth in PRAVACHOL, TAXOL®, VIDEX and Analgesic products. Japan realized sales growth of 21%, including a 10% favorable foreign exchange impact, led by growth in TAXOL® sales.
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Sales of selected products in the second quarter of 2003 were as follows:
30
The following table sets forth a comparison of reported net sales changes and the estimated total (for retail and mail order customers) prescription growth for certain of the Company’s U.S. pharmaceutical products. The estimated prescription growth amounts are based on third-party data. The Company’s estimates are subject to inherent limitations of estimates that rely on third-party data, or as described above. A significant portion of the Company’s domestic pharmaceutical sales is made to wholesalers. Where the change in reported net sales differs from prescription growth, this change in net sales may reflect wholesaler buying patterns and not reflect underlying prescriber demand.
% Change in
U.S. Net Sales
U.S. Prescriptions
PRAVACHOL
PLAVIX*
AVAPRO/AVALIDE*
ZERIT
SUSTIVA
GLUCOVANCE*
GLUCOPHAGE*XR
VIDEX/VIDEX EC
Earnings before minority interest and income taxes for the Pharmaceuticals segment increased to $939 million in the second quarter of 2003 from $468 million in 2002 primarily due to higher sales, with a favorable product mix, partially offset by increased advertising and product promotion spend on existing in-line products as well as spend to support new product launches.
Sales for the Nutritionals segment were $436 million for the three months ended June 30, 2003, a decrease of 7%, including a 1% unfavorable foreign exchange impact, from the prior year levels, as international sales increased 11%, including a 4% unfavorable foreign exchange impact, and U.S. sales decreased 22%. During the quarter, a $60 million charge to sales was recorded related to rebates issued under the Women, Infant and Children (WIC) program. The Company now accrues for rebates expected to be issued at the date of revenue recognition, rather than at the date the WIC coupons are issued. Mead Johnson continues to be the leader in the U.S. infant formula market. ENFAMIL, the Company’s largest-selling infant formula, had sales of $150 million, a decrease of 23% from the prior year. Sales of ENFAGROW, a children’s nutritional supplement, increased 31% to $38 million.
Earnings before minority interest and income taxes for the Nutritionals segment decreased to $50 million in 2003 from $124 million in 2002. This decrease is primarily due to a decrease in infant formula sales in the U.S., the discontinuance of a copromotion arrangement for CEFZIL with the Pharmaceuticals segment and a $60 million charge to sales that was recorded related to rebates issued under the WIC program. The Company now accrues for rebates expected to be issued at the date of revenue recognition, rather than at the date the WIC coupons are issued.
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Sales in the Other Healthcare segment increased 11%, including a 6% favorable foreign exchange impact, to $424 million. The Other Healthcare segment is comprised of the ConvaTec, Medical Imaging and Consumer Medicines (U.S. and Japan) businesses.
Earnings before minority interest and income taxes for the Other Healthcare segment increased to $101 million in 2003 from $95 million in 2002.
Expenses
Total expenses for the three months ended June 30, 2003, as a percentage of sales, decreased to 76.9% from 82.5% in 2002. During the second quarter of 2003 and 2002, the Company recorded several significant items that affected the comparability of the results of the periods presented herein:
Litigation settlement (1)
Restructuring and other items (2)
Income taxes/ (benefit) on items above
For additional information, see Note 2, Restructuring and Other Items, Note 6, Alliances and Investments, Note 7, Divestitures and Discontinued Operations, and Note 10, Litigation Matters, to the consolidated financial statements included in this Form 10-Q.
Cost of products sold, as a percentage of sales, was relatively flat year over year at 35.6% in 2003 and 35.5% in 2002. The 2003 cost of products sold included the impact of increased sales of high margin products, such as PRAVACHOL, PLAVIX* and PARAPLATIN, offset by increased sales of lower margin products from OTN.
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As a percentage of sales, marketing, selling and administrative expenses decreased to 20.9% in the second quarter of 2003 from 22.7% in 2002. Marketing, selling, and administrative expenses increased 13% to $1,058 million in 2003 from $937 million in 2002. This increase is primarily due to unfavorable foreign exchange in Europe combined with increased sales support in the Pharmaceuticals segment for new products in Europe and additional sales support for ABILIFY* and AVAPRO/AVALIDE* in the U.S., while the percentage decrease is due to increased sales. The percentage decrease in marketing, selling and administrative expense as a percentage of sales is largely due to the impact of inventory workdown in the second quarter of 2002.
Expenditures for advertising and promotion in support of new and existing products increased 21% to $418 million in 2003 from $345 million in 2002, primarily as a result of continued promotional support for ABILIFY*, PLAVIX*, PRAVACHOL and METAGLIP in the U.S.
Research and development expenditures increased 1% to $530 million in 2003 from $527 million in 2002. Pharmaceutical research and development spending remained constant in 2003 compared to 2002 and, as a percentage of pharmaceutical sales (excluding OTN sales), was 13.8% in the second quarter of 2003 and 17.9% in the second quarter of 2002. Pharmaceutical research and development activity for the quarter includes increased spending for new process development, offset by reductions in discovery spending. The Company continues to expect research and development spending levels for the full-year 2003 to be comparable to the 2002 level. The FDA granted marketing clearance for REYATAZ (atazanavir sulfate), a novel protease inhibitor also for the treatment of HIV disease in June 2003. REYATAZ is the first once-daily protease inhibitor approved by the FDA.
Restructuring programs were implemented in the second quarter of 2003 to downsize and streamline worldwide manufacturing operations. The programs include costs for the termination of approximately 430 manufacturing employees in the Pharmaceuticals segment. As a result of these actions, the Company expects the annual benefit to earnings from continuing operations before minority interest and income taxes to be approximately $12 million in future periods.
Other (income) expense, net increased to $143 million in the second quarter of 2003 from $126 million in the second quarter of 2002. Other (income) expense, net includes net interest expense of $66 million and $84 million for the three month periods ended June 30, 2003 and 2002, respectively.
The effective income tax rate on earnings from continuing operations before minority interest and income taxes was 21.3% compared with 28.9% in 2002 due to a revised estimate of the use of foreign tax credits relating mainly to the final implementation of the reorganization of the ownership structure of its non-U.S. subsidiaries. The principal purpose of the reorganization was to facilitate the Company’s ability to efficiently deploy its financial resources outside the U.S.
Six Months Results of Operations
Worldwide sales for the first six months of 2003 increased 11% to $9,763 million from $8,788 million in 2002. This sales increase resulted from a 5% increase in volume, a 4% increase in foreign exchange and a 2% increase in price. Domestic sales increased 7% and international sales increased 18%, including a 10% favorable foreign exchange impact. For the first six months of 2003, $287 million of deferred revenue was reversed and recognized as sales (calculated net of sales discounts and rebates). The deferred revenue, recorded at gross invoice sales prices, related to the inventory of pharmaceutical products accounted for using the consignment model, was reduced to $110 million at June 30, 2003, compared to $470 million at December 31, 2002. The deferred revenue and consignment inventory recorded under the consignment model will continue to be reflected on the Company’s balance sheet until the related products are sold through to the wholesalers’ customers. The sell-through to the wholesalers’ customers is expected to be substantially complete by the end of 2003.
For the six months ended June 30, 2003, earnings from continuing operations before minority interest and income taxes increased 15% to $2,240 million from $1,952 million in 2002. The increase was mainly driven by increased sales coupled with the $160 million of acquired in-process research and development expenses in 2002 which did not repeat in 2003, partially offset by an unfavorable product mix and increased investment in advertising and promotion spend as well as an increase in sales force expenses. Net earnings from continuing operations increased 24% to $1,639 million compared to $1,321 million in 2002. The effective income tax rate on earnings from continuing operations, before minority interest and
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income taxes decreased to 24.2% in 2003 from 27.8% in 2002. Basic earnings per share from continuing operations increased 25% to $.85 in 2003 from $.68 in 2002. Diluted earnings per share from continuing operations increased 24% to $.84 in 2003 from $.68 in 2002. Basic and diluted average shares outstanding for the second quarter were 1,936 million and 1,941 million, respectively, in 2003 compared to 1,936 million and 1,946 million, respectively, in 2002.
Sales for the Pharmaceuticals segment in the six months ended June 30, 2003 increased 14%, including a 4% favorable foreign exchange impact, to $8,098 million from $7,122 million in 2002. Domestic pharmaceutical sales increased 12% to $5,036 million in 2003 from $4,514 million in 2002, primarily due to increased sales of PRAVACHOL, GLUCOVANCE*, SUSTIVA and PARAPLATIN. International sales for the Pharmaceuticals segment increased 17% to $3,062 million in 2003, including an 11% favorable foreign exchange impact, from $2,608 million in 2002. Sales in Europe and the Middle East increased 21%, including an 18% favorable effect of foreign exchange. Strong growth in PRAVACHOL, TAXOL®, AVAPRO/AVALIDE*, SUSTIVA and PLAVIX* were partially offset by price declines in Germany and Italy. Japan realized sales growth of 20%, including an 11% favorable foreign exchange impact, led by growth in TAXOL® sales.
Sales of selected products for the six months ended June 30, 2003 were as follows:
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The following table sets forth a comparison of reported net sales changes and the estimated total (for retail and mail order customers) prescription growth for certain of the Company’s U.S. pharmaceutical products. The estimated prescription growth amounts are based on third-party data. A significant portion of the Company’s domestic pharmaceutical sales is made to wholesalers. Where the change in reported net sales differs from prescription growth, this change in net sales may reflect wholesaler buying patterns and not reflect underlying prescriber demand.
Earnings before minority interest and income taxes for the Pharmaceuticals segment increased to $1,826 million in 2003 from $1,414 million in 2002. The increase in earnings before minority interest and income taxes was driven by increased sales which were partially offset by unfavorable product mix and increased advertising and product promotion spend on new and existing in-line products.
Sales for the Nutritionals segment were $869 million for the six months ended June 30, 2003, a decrease of 6%, including a 2% unfavorable foreign exchange impact, from the prior year. International sales increased 8%, including a 4% unfavorable foreign exchange impact, and U.S. sales decreased 17%. Mead Johnson continues to be the leader in the U.S. infant formula market. ENFAMIL, the Company’s largest-selling infant formula, had sales of $311 million, a decrease of 17% from the prior year, primarily due to the charge recorded for Women, Infants and Children (WIC) accruals. Sales of ENFAGROW, a children’s nutritional supplement, increased 44% to $79 million.
Earnings before minority interest and income taxes for the Nutritionals segment decreased to $119 million in 2003 from $249 million in 2002. This decrease is primarily due to a decrease in infant formula sales in the U.S., the discontinuance of a copromotion arrangement for CEFZIL with the Pharmaceuticals segment and a $60 million charge to sales that was recorded related to rebates issued under the WIC program. The Company now accrues for rebates expected to be issued at the date of revenue recognition, rather than at the date the WIC coupons are issued.
Sales in the Other Healthcare segment increased 7%, including a 5% favorable foreign exchange impact, to $796 million. The Other Healthcare segment is comprised of the ConvaTec, Medical Imaging and Consumer Medicines (U.S. and Japan) businesses.
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Earnings before minority interest and income taxes for the Other Healthcare segment decreased to $155 million in 2003 from $183 million in 2002 primarily as a result of a decline in sales and increased sales incentives for EXCEDRIN QUICKTABS in the Consumer Medicines business.
Total expenses for the six months ended June 30, 2003, as a percentage of sales, decreased to 77.1% from 77.8% in 2002. During the first six months of 2003 and 2002, the Company recorded several significant items that affected the comparability of the results of the periods presented herein:
Cost of products sold, as a percentage of sales, increased to 35.7% in 2003 from 33.8% in 2002. This increase is primarily due to increased sales of lower margin products from OTN and a $60 million charge to sales recorded by the Nutritionals segment related to the Women, Infant and Children (WIC) program accrual, partially offset by increased sales of higher margin products such as PRAVACHOL, PARAPLATIN and SUSTIVA.
As a percentage of sales, marketing, selling and administrative expenses increased to 21.4% in the six months ended June 30, 2003 from 21.0% in 2002. Marketing, selling, and administrative expenses increased 13% to $2,090 million in 2003 from $1,849 million in 2002. This increase is primarily due to unfavorable foreign exchange in Europe combined with increased sales support in the Pharmaceuticals segment for new products in Europe and additional sales support for ABILIFY*, PRAVACHOL and AVAPRO/AVALIDE* in the U.S.
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Expenditures for advertising and promotion in support of new and existing products increased 29% to $782 million in 2003 from $604 million in 2002, primarily as a result of continued promotional support for ABILIFY*, METAGLIP, and PRAVACHOL in the U.S.
Research and development expenditures decreased 2% to $1,006 million in 2003 from $1,029 million in 2002. Pharmaceutical research and development spending decreased 3% from the prior year and, as a percentage of pharmaceutical sales (excluding OTN sales), was 13.5% in the six months ended June 30, 2003 and 15.8% in the six months ended June 30, 2002. The decline in spending is largely due to reductions in discovery spending, including the closure of a discovery facility in Wilmington, Delaware, and decreased spending for new process development. The Company continues to expect research and development spending levels for the full-year 2003 to be comparable to the 2002 level.
Restructuring programs were implemented in the first six months of 2003 to downsize and streamline worldwide manufacturing operations. The programs include costs for the termination of approximately 770 manufacturing employees in the Pharmaceuticals segment. As a result of these actions, the Company expects the annual benefit to earnings from continuing operations before minority interest and income taxes to be approximately $40 million in future periods.
Other (income) expense, net increased to $231 million in the six months ended June 30, 2003 from $165 million in the six months ended June 30, 2002. Other (income) expense, net includes net interest expense of $127 million and $159 million for the six month periods ended June 30, 2003 and 2002, respectively. In addition, 2003 includes a general product liability charge and 2002 includes income from the sale of certain minor assets.
The effective income tax rate on earnings from continuing operations before minority interest and income taxes was reduced to 24.2% in 2003 from 27.8% in 2002 due to a revised estimate of the use of foreign tax credits relating mainly to the final implementation of the reorganization of the ownership structure of its non-U.S. subsidiaries. The principal purpose of the reorganization was to facilitate the Company’s ability to efficiently deploy its financial resources outside the U.S. For a discussion of the recent reorganization of the structure of the ownership of non-U.S. subsidiaries and possible tax liability, which could be material, see Note 12: Income Taxes.
Financial Position
The Company had cash and cash equivalents of approximately $4.3 billion at June 30, 2003 as compared to $4. 0 billion at December 31, 2002. The Company continues to maintain a high level of working capital, amounting to $2.2 billion at June 30, 2003, increasing from $1.8 billion at December 31, 2002. Approximately $ 4.2 billion of the Company’s cash and cash equivalents at June 30, 2003 was held by our foreign subsidiaries, which the Company does not expect to repatriate in the foreseeable future. Repatriation of this cash to the U.S. would require additional tax provisions, which are not reflected in the Company’s consolidated financial statements. Due to the complexities in the tax laws and the assumptions that would have to be made, it is not practicable to estimate the amounts of the income taxes that would have to be provided.
Short-term borrowings were $1,902 million at June 30, 2003, compared with $1,379 million at December 31, 2002, primarily as a result of the issuance of commercial paper.
Long-term debt increased to $6.4 billion at June 30, 2003 from $6.3 billion at December 31, 2002. In July 2003, Standard & Poor’s lowered its corporate credit and senior unsecured debt rating on the Company to AA- from AA. In addition, Standard & Poor’s affirmed its A-1+ short term corporate credit and commercial paper rating. In April 2003, Moody’s Investors Service reduced the Company’s long-term credit rating from Aa2 to A1. In March 2003, Moody’s confirmed the Prime-1 short-term credit rating for the Company.
Net cash provided by operating activities was $1,312 million in the six months ended June 30, 2003 as compared to net cash used in operating activities of $680 million in 2002. The increase in cash provided by operating activities in 2003 compared to 2002 is mainly attributable to income tax outflows in 2002 of $1,547 million, which primarily related to the payment of taxes on the gain arising from the sale of the Clairol business.
During the six months ended June 30, 2003, the Company did not purchase any of its common stock. During the six months ended June 30, 2002, the Company purchased 3.1 million shares of its common stock at a cost of $117 million.
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For each of the three and six month periods ended June 30, 2003 and 2002 dividends declared per common share were $.280 and $.560, respectively.
Retirement Benefits
For a discussion of the Company’s retirement benefits, see Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s 2002 Form 10-K.
Critical Accounting Policies
For a discussion of the Company’s critical accounting policies, see Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in the Company’s 2002 Form 10-K.
Outlook
The Company expects to have both growth opportunities and continued exclusivity challenges over the next several years. During this period, exclusivity losses are expected to amount in each year to approximately $1 billion dollars per year in net sales. The Company expects these exclusivity losses will be more or less offset by growth in revenues resulting from growth of the Company’s in-line products, including PLAVIX*, AVAPRO/AVALIDE* and SUSTIVA, growth of recently launched exclusive products, ABILIFY* and REYATAZ, and by the introduction of late stage pipeline products that may be approved within the next six to thirty-six months such as ERBITUX*, CTLA4-Ig and Entecavir. After the impact of the loss of exclusivity of PRAVACHOL in the U.S., the Company will have several years of minimal exclusivity loss impact. External development and licensing will remain important elements of the Company’s strategy, but the potential impact is not built in the Company’s plans.
The Company also expects profit challenges that include changes in product mix, as many of the Company’s products losing exclusivity carry higher margins than the Company’s in-line products that are expected to grow sales. Other profit challenges include, adequately investing in marketing and sales spend to support the Company’s in-line products and new product launches, the Company’s maturing pipeline opportunities and research and development.
The Company has historically reviewed and will continue to review its cost base. Decisions that may be taken as a result of these reviews may result in restructuring or other charges later this year or in future periods. At this time, the Company is not able to reasonably estimate the amount of such charges, if any.
The Company is committed to establishing leadership through focus on therapy areas characterized by significant medical opportunity, where the Company can bring to bear its particular expertise and establish leadership positions.
The Company and its subsidiaries are the subject of a number of significant pending lawsuits, claims, proceedings and investigations. For a discussion of these matters and their potential impact on the Company, see “Legal Proceedings” below.
Actual results may differ materially from the expectations described above. Some of the factors that could affect these expectations are described below in the statement of cautionary factors.
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Cautionary Factors that May Affect Future Results
This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements the Company makes from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “may”, “will”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, the Company’s goals, plans and projections regarding its financial position, results of operations, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings, and financial results which are based on current expectations that involve inherent risks and uncertainties, including factors that could delay, divert or change any of them in the next several years.
Although it is not possible to predict or identify all factors, they may include the following:
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Although the Company believes it has been prudent in its plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. The Company undertakes no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.
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The market risk disclosures have not materially changed from those appearing in the Company’s 2002 Form 10-K.
In the six months ended June 30, 2003, the Company purchased and sold $1,049 million notional amount of foreign exchange euro put options, sold an additional $516 million notional amount of put options (primarily the euro) that had been previously purchased in 2002, sold $2,789 million notional amount of forward contracts (primarily euro and Canadian dollar) and bought a net $355 million notional amount of Japanese yen forward contracts to partially hedge the exchange impact related to forecasted intercompany inventory purchases for up to the next 22 months.
Additionally, in the three and six months ended June 30, 2003, the Company executed several fixed to floating interest rate swaps to convert an additional $1.0 billion of the Company’s fixed rate debt to be paid in 2006 and 2011 to variable rate debt.
As of the end of the period covered by this Form 10-Q, the Company carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures (as defined in Rule 13a-15e or 15d-15e under the Securities Exchange Act of 1934.)
In making this evaluation the Company has considered the two “material weaknesses” (as defined under standards established by the American Institute of Certified Public Accountants) relating to its accounting and public financial reporting of significant matters and to its initial recording and management review and oversight of certain accounting matters, that were identified and communicated to the Company and its Audit Committee by the Company’s independent auditors in connection with their audits of the restatement of previously issued financial statements and the consolidated financial statements for the year ended December 31, 2002. The Company has also considered measures taken by the Company in the last year to strengthen control processes and procedures.
Based on this evaluation, the Company’s chief executive officer and chief financial officer concluded that as of the evaluation date, such disclosure controls and procedures were reasonably designed to ensure that information required to be disclosed by the Company in reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.
Other than as described above, since the evaluation date by the Company’s management of its internal controls over financial reporting, there have not been any change in the Company’s internal controls over financial reporting that has materially affected, or is reasonably likely to materially affect the Company’s internal controls over financial reporting.
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PART II OTHER INFORMATION
In 1997 and 1998, the Company filed several lawsuits asserting that a number of generic drug companies infringed its patents covering methods of administering paclitaxel when they filed Abbreviated New Drug Applications seeking regulatory approval to sell paclitaxel. These actions were consolidated for discovery in the U.S. District Court for the District of New Jersey (District Court). The Company did not assert a monetary claim against any of the defendants, but sought to prevent the defendants from marketing paclitaxel in a manner that violates its patents. The defendants asserted that they did not infringe the Company’s patents and that these patents are invalid and unenforceable.
Since the filing of the initial patent infringement suits, seven private actions have been filed by parties alleging antitrust, consumer protection and similar claims relating to the Company’s actions to obtain and enforce patent rights. The most recent of the seven private actions was brought in March 2003 by a purported competitor alleging antitrust claims relating to the Company’s actions to obtain and enforce patent rights, an alleged conspiracy to block the entry of generic paclitaxel into the market and the alleged restriction of the supply of TAXOL® raw materials. The plaintiffs seek declaratory judgment, damages (including treble and/or punitive damages where allowed), restitution, disgorgement, equitable relief and injunctive relief. In June 2002, a group of 32 state attorneys general, the District of Columbia, Puerto Rico and the Virgin Islands
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brought similar claims. In April 2003, the states amended their complaint to add 18 states, Guam, Mariana Islands and American Samoa as plaintiffs. In September 2000, the Federal Trade Commission (FTC) initiated an investigation relating to paclitaxel.
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Proposed Settlements. On January 7, 2003, the Company announced that it reached agreements in principle that would settle substantially all antitrust litigation surrounding BUSPAR in the MDL proceeding. The amount of these BUSPAR settlements was $535 million, of which $35 million was recognized in the fourth quarter of 2001, $90 million was recognized in the first quarter of 2002, and $410 million was recognized in the third quarter of 2002. The $535 million includes settlements with generic drug manufacturers and chain drug stores, settlements of two class actions (which cover wholesalers, insurers and consumers in certain states), as well as the states’ litigation (which covers the states and territories of the U.S. and consumers resident in certain of those states and territories). Certain entities filed or threatened to file additional, separate actions. The Company has entered into settlement agreements with certain of those entities and is in discussions with certain others. The class actions and the states’ action require court approval and are subject to the rights of class members to opt out of the settlements. The supervising court has granted final approval to one of the class action settlements and preliminary approval of both the other class action settlement and the settlement of the states’ action. Final approval hearings for the two preliminarily approved settlements are scheduled for the fourth quarter of 2003. Whether final approval will be granted cannot be predicted with certainty at this time.
The Company is part owner of an entity that is a plaintiff in two pending patent infringement lawsuits in the United States District Court for the Southern District of New York, entitled Sanofi-Synthelabo, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex Inc. and Apotex Corp., 02-CV-2255 (RWS) and Sanofi-Synthelabo, Sanofi-
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Synthelabo Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Dr. Reddy’s Laboratories, LTD., and Dr. Reddy’s Laboratories, Inc., 02-CV-3672 (RWS). The suits were initially based on U.S. Patent No. 4,847,265, which discloses and claims, among other things, the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX*, and on U.S. Patent No. 5,576,328, which discloses and claims, among other things, the use of clopidogrel to prevent a secondary ischemic event. The Company and its co-plaintiffs have elected to withdraw U.S. Patent No. 5,576,328 from the litigation. Plaintiffs’ infringement position is based on defendants’ filing of their Abbreviated New Drug Applications with the FDA, seeking approval to sell generic clopidogrel prior to the expiration of the patents in suit.
During the period March through May 2002, the Company and a number of its current and former officers were named as defendants in a number of securities class action lawsuits alleging violations of federal securities laws and regulations. The plaintiffs variously alleged that the defendants disseminated materially false and misleading statements and failed to disclose material information concerning three different matters: (1) safety, efficacy and commercial viability of VANLEV (as discussed above), (2) the Company’s sales incentives to certain wholesalers and the inventory levels of those wholesalers, and (3) the Company’s investment in and relations with ImClone, and ImClone’s product, ERBITUX*. As discussed above, the allegations concerning VANLEV have been transferred to the U.S. District Court for the District of New Jersey and consolidated with the action pending there. The remaining actions have been consolidated and are pending in the U.S. District Court for the Southern District of New York. Plaintiffs filed a consolidated class action complaint on April 11, 2003 alleging a class period of October 19, 1999 through March 10, 2003. The consolidated class action complaint alleges violations of federal securities laws in connection with, among other things, the ImClone matter, as described above, and certain accounting issues, including issues related to wholesaler inventory and sales incentives, the establishment of reserves, and accounting for certain asset and other sales. The plaintiffs seek compensatory damages, costs and expenses. On August 1, 2003 the Company moved to dismiss the consolidated class action complaint.
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The SEC and the U.S. Attorney’s Office for the District of New Jersey are investigating the activities of the Company and certain current and former members of the Company’s management in connection with the wholesaler inventory issues referenced above and certain other accounting issues. As described below the Company cannot reasonably assess the final outcome of these investigations at this time. The Company is cooperating with both of these investigations. The Company’s own investigation is continuing.
The Company, together with a number of other pharmaceutical manufacturers, is a defendant in several private class actions and in actions brought by the Nevada and Montana Attorneys General and the County of Suffolk, New York that are pending in federal and state courts relating to the pricing of certain Company products. The federal cases (and many of the state cases, including both Attorneys General cases, which were removed to federal courts) were consolidated for pre-trial purposes under the caption In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456 before United States District Judge Patti B. Saris in the District of Massachusetts, Civ. Action No. 01-CV-12257-PBS (AWP Multidistrict Litigation). On September 6, 2002, several of the private plaintiffs in the AWP Multidistrict Litigation filed a Master
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Consolidated Class Action Complaint (Master Complaint), which superceded the complaints in their pre-consolidated constituent cases. Defendants moved to dismiss the Master Complaint and, in a decision dated May 12, 2003, the Court granted in part and denied in part the motion and gave plaintiffs leave to replead the dismissed portions.
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PPA. In May 2000, Yale University published the results of its Hemorrhagic Stroke Project which concluded that there was evidence of a suggestion that phenylpropanolamine (PPA) may increase the risk of hemorrhagic stroke in a limited population. In November 2000, the Food and Drug Administration (FDA) issued a Public Health Advisory and requested that manufacturers of PPA containing products voluntarily cease manufacturing and marketing them. At that time, the only PPA-containing products manufactured or sold by the Company were COMTREX (liquigel formulation only) and NALDECON. On or about November 6, 2000, the Company, as did the other manufacturers of PPA-containing products, discontinued the manufacture and marketing of PPA-containing products and allowed customers to return any unused product that they had in their possession.
On June 18, 2003, Judge Rothstein issued a ruling effectively limiting the plaintiffs’ claims to hemorrhagic and ischemic strokes in men and women of all ages and in children. Rulings favorable for the defendants included the inadmissibility of expert testimony in cases alleging injuries occurring more than three days after ingestion of a PPA containing product and cases involving psychoses, seizures and cardiac injuries. The Company expects to be dismissed from a substantial number of
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cases in which its products were never used by the plaintiffs and where plaintiffs’ alleged injury occurred more than three days after ingestion of a PPA containing product or where a plaintiff suffered from cardiac injuries or psychoses.
SERZONE. SERZONE (nefazodone hydrochloride) is an antidepressant that was launched by the Company in May 1994 in Canada and in March 1995 in the U.S. In December 2001, the Company added a black box warning to its SERZONE label warning of the potential risk of severe hepatic events including possible liver failure and the need for transplantation. Within several months of the black box warning being added to the package insert for SERZONE, a number of lawsuits, including several class actions, were filed against the Company. Plaintiffs allege that the Company knew or should have known about the hepatic risks posed by SERZONE and failed to adequately warn physicians and users of the risks. They seek compensatory and punitive damages, medical monitoring, and refunds for the costs of purchasing Serzone
At present, the Company has 126 lawsuits, on behalf of 1,657 plaintiffs, pending against it in federal and state courts throughout the U.S. Thirteen of these cases are pending in New York state court and have been consolidated for pretrial discovery. In addition, there are approximately 1,600 alleged, but unfiled, claims of injury associated with Serzone In August 2002, the federal cases were transferred to the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin, In Re Serzone Products Liability Litigation, MDL 1477. Although discovery is still at a very early stage it appears that very few of these cases involve liver failure. In June 2003, Judge Goodwin dismissed the class claims in all but two of the class action complaints. Although a number of the class action complaints filed against the Company had sought the certification of one or more personal injury classes, the remaining class action complaints do not seek the certification of personal injury classes. On July 14, 2003, the court issued an order setting the hearing on class certification for July 21, 2004.
The Company currently is a party in 54 cases pending, on behalf of a total of approximately 928 plaintiffs, in federal and state courts throughout the U.S. Plaintiffs claim that the Company committed fraud on the FDA and wrongfully promoted STADOL NS as non-addictive. Further, plaintiffs allege that the Company failed to adequately warn of the addiction and dependency risk associated with the use of STADOL NS In addition to these lawsuits, there are approximately 10,020 alleged and unfiled claims of which approximately 326 are active. The majority of the cases and claims are pending in Mississippi.
In July 2003, the New Jersey Department of Environmental Protection (“NJDEP”) advised E.R. Squibb & Sons (“Squibb”), a wholly owned subsidiary of Bristol-Myers Squibb, that it believes Squibb violated the Clean Air Act by failing to comply with Prevention of Significant Deterioration (“PSD”) requirements in connection with its replacement of a gas turbine at its cogeneration facility at the New Brunswick, New Jersey facility in 1997. NJDEP also alleges that Squibb should have installed additional pollution control equipment at the facility pursuant to the New Jersey Air Pollution Control Act. Although NJDEP approved the cogeneration facility in 1997 and Squibb believes it demonstrated that it complied with PSD requirements, the NJDEP may nevertheless require the Company to take certain remedial steps, including
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performing another PSD analysis to determine if a permit is required, obtaining emissions credits, installing pollution control equipment and paying an administrative fine. Although discussions with the NJDEP are still preliminary and the agency has not yet made any specific financial demands, the Company believes that any capital expenditures, costs and/or penalties associated with this matter will not have a material impact on the consolidated financial condition or results of operations of the Company.
Item 4 of the Form 10-Q for the quarterly period ended March 31, 2003 is hereby incorporated by reference.
15.
31a.
31b.
32a.
32b.
On April 29, 2003, the Registrant filed a Form 8-K under Item 9 announcing its earnings for the first quarter of 2003. Attached as an exhibit to such Form 8-K is its press release dated April 29, 2003.
*Indicates, in this Form 10-Q, brand names of products which are registered trademarks not owned by the Company or its subsidiaries. ERBITUX is a trademark of ImClone Systems Incorporated; AVAPRO/AVALIDE and PLAVIX are trademarks of Sanofi-Synthelabo S.A.; GLUCOPHAGE, GLUCOPHAGE XR and GLUCOVANCE are trademarks of Merck Sante S.A.S., an associate of Merck KGaA of Darmstadt, Germany; and ABILIFY is a trademark of Otsuka Pharmaceutical Company, Ltd.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
(REGISTRANT)
Date: August 8, 2003
By:
/s/ Peter R. Dolan
Peter R. Dolan
Chairman of the Board and Chief Executive Officer
/s/ Andrew R. J. Bonfield
Andrew R. J. Bonfield
Senior Vice President and Chief Financial Officer
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