NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
7
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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:
Three Months Six Months
Ended June 30, Ended June 30,
(dollars in millions, except per share data) 2003 2002 2003 2002
Net Earnings:
As reported $ 878 $ 479 $ 1,639 $ 1,335
Deduct : Total stock-based employee compensation expense
determined under fair value based method for all awards,
net of related tax effects (45 ) (62 ) (71 ) (107 )
Pro forma $ 833 $ 417 $ 1,568 $ 1,228
Basic earnings per share:
As reported $ .45 $ .25 $ .85 $ .69
Pro forma .43 .22 .81 .63
Diluted earnings per share:
As reported .45 .25 .84 .69
Pro forma $ .43 $ .21 $ .81 $ .63
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
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1: Basis of Presentation and New Accounting Standards (Continued)
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.
9
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 Other Exit Cost
Liability Liability Total
(dollars in millions)
Balance at December 31, 2001 $ 243 $ 41 $ 284
Charges 71 38 109
Spending (155 ) (29 ) (184 )
Changes in estimate (92 ) (8 ) (100 )
Balance at December 31, 2002 67 42 109
Charges 25 - 25
Spending (39 ) (29 ) (68 )
Changes in estimate (2 ) (1 ) (3 )
Balance at June 30, 2003 $ 51 $ 12 $ 63
10
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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:
Three Months Ended Six Months Ended
June 30, June 30,
2003 2002 2003 2002
(in millions, except per share data)
Earnings from Continuing Operations $ 878 $ 479 $ 1,639 $ 1,321
Discontinued Operations:
Net gain on disposal - - - 14
Net Earnings $ 878 $ 479 $ 1,639 $ 1,335
Basic:
Average Common Shares Outstanding 1,937 1,937 1,936 1,936
Earnings from Continuing Operations $ .45 $ .25 $ .85 $ .68
Discontinued Operations:
Net gain on disposal - - - .01
Net Earnings $ .45 $ .25 $ .85 $ .69
Diluted:
Average Common Shares Outstanding 1,937 1,937 1,936 1,936
Incremental Shares Outstanding Assuming the Exercise of
Dilutive Stock Options 5 7 5 10
1,942 1,944 1,941 1,946
Earnings from Continuing Operations $ .45 $ .25 $ .84 $ .68
Discontinued Operations:
Net gain on disposal - - - .01
Net Earnings $ .45 $ .25 $ .84 $ .69
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.
11
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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:
Other
Pharmaceuticals Nutritionals Healthcare
Segment Segment Segment Total
(dollars in millions)
Balance as of December 31, 2001 $ 4,738 $ 191 $ 190 $ 5,119
Purchase accounting adjustments related to
recent acquisitions:
Change in exit cost estimate (165 ) - - (165 )
Purchase price and allocation adjustments (89 ) (1 ) - (90 )
Balance as of December 31, 2002 and June 30,
2003 $ 4,484 $ 190 $ 190 $ 4,864
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:
June 30, December 31,
2003 2002
(dollars in millions)
Patents / Trademarks $ 246 $ 214
Licenses 247 554
Technology 1,783 1,783
2,276 2,551
Accumulated Amortization 450 647
Net Carrying Amount $ 1,826 $ 1,904
12
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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:
(dollars in millions)
For the year ended December 31, 2003 $ 225
For the year ended December 31, 2004 201
For the year ended December 31, 2005 201
For the year ended December 31, 2006 198
For the year ended December 31, 2007 197
For the year ended December 31, 2008 192
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
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
14
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
Three Months Ended Six Months Ended
June 30, June 30,
Earnings from Earnings from
Continuing Continuing
Operations Operations
Before Minority Before Minority
Interest and Interest and
Net Sales Income Taxes Net Sales Income Taxes
(dollars in millions)
2003 2002 2003 2002 2003 2002 2003 2002
Pharmaceuticals $ 4,192 $ 3,274 $ 939 $ 468 $ 8,098 $ 7,122 $ 1,826 $ 1,414
Nutritionals 436 471 50 124 869 920 119 249
Other Healthcare 424 382 101 95 796 746 155 183
Total Segments 5,052 4,127 1,090 687 9,763 8,788 2,100 1,846
Corporate/Other - - 75 37 - - 140 106
Continuing Operations $ 5,052 $ 4,127 $ 1,165 $ 724 $ 9,763 $ 8,788 $ 2,240 $ 1,952
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
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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:
Three Months Six Months
Ended June 30, Ended June 30,
2003 2002 2003 2002
(dollars in millions)
Interest expense $ 123 $ 102 $ 244 $ 200
Interest income (57 ) (18 ) (117 ) (41 )
Foreign exchange transaction losses - 8 4 11
Other, net 77 34 100 (5 )
Other (Income)/Expense, net $ 143 $ 126 $ 231 $ 165
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
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
17
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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
18
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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 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.
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
19
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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
20
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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.
21
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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.
22
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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.
23
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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.
24
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 10: Litigation Matters (Continued)
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.
25
BRISTOL-MYERS SQUIBB COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 11: Comprehensive Income (Loss)
Minimum
Foreign Deferred Pension Total
Currency Available for Loss on Liability Other Accumulated
Translation Sale Securities Effective Hedges Adjustment Comprehensive Loss
(dollars in millions)
Balance at December 31,
2002 $ (930 ) $ - $ (44 ) $ (128 ) $ (1,102 )
Other comprehensive income
(loss) 195 5 (128 ) - 72
Balance at June 30, 2003 $ (735 ) $ 5 $ (172 ) $ (128 ) $ (1,030 )
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.
26
Report of Independent Auditors
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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