UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(X) Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 for the quarterly period
ended September 28, 2003
or
( ) Transition Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 for the for the transition
period from to
Commission file number 1-3215
JOHNSON & JOHNSON
(Exact name of registrant as specified in its charter)
NEW JERSEY 22-1024240
(State or other jurisdiction of (I.R.S. Employer
Incorporation or organization) Identification No.)
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
(Address of principal executive offices)
Registrant's telephone number, including area code (732) 524-0400
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 the number of shares outstanding of each of the
issuer's classes of common stock, as of the latest practicable
date.
On October 26, 2003, 2,968,142,947 shares of Common Stock,
$1.00 par value, were outstanding.
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Johnson & Johnson and Subsidiaries
Table of Contents
Page No.
Part I - Financial Information
Item 1. Financial Statements
Consolidated Balance Sheets
September 28, 2003 and December 29, 2002 3
Consolidated Statement of Earnings for the Fiscal
Quarters Ended September 28, 2003 and September 29, 2002 5
Consolidated Statement of Earnings for the Fiscal
Nine Months Ended September 28, 2003 and September 29, 2002 6
Consolidated Statements of Cash Flows for the Fiscal
Nine Months Ended September 28, 2003 and September 29, 2002 7
Notes to Consolidated Financial Statements 8
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations 24
Item 3. Quantitative and Qualitative Disclosures 30
About Market Risk
Item 4. Controls and Procedures 30
Part II - Other Information
Item 1. Legal Proceedings 31
Item 5. Other Information 35
Item 6. Exhibits and Reports on Form 8-K 36
Signatures 37
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PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
ASSETS
September 28, December 29,
Current Assets: 2003 2002
Cash and cash equivalents $ 3,850 $ 2,894
Marketable securities 4,998 4,581
Accounts receivable, trade, less
allowances for doubtful accounts
$190 (2002 - $191) 6,399 5,399
Inventories (Note 4) 3,739 3,303
Deferred taxes on income 1,486 1,419
Prepaid expenses and other
receivables 1,674 1,670
Total Current Assets 22,146 19,266
Marketable securities, non-current 120 121
Property, plant and equipment,
at cost 16,054 14,314
Less accumulated depreciation 6,809 5,604
9,245 8,710
Intangible assets, gross (Note 5) 14,099 11,355
Less accumulated amortization 2,420 2,109
Intangible assets, net 11,679 9,246
Deferred taxes on income 402 236
Other assets 3,067 2,977
Total Assets $ 46,659 $ 40,556
See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
LIABILITIES AND
SHAREHOLDERS' EQUITY
September 28, December 29,
2003 2002
Current Liabilities:
Loans and notes payable $2,024 $2,117
Accounts payable 3,660 3,621
Accrued liabilities 5,037 3,820
Accrued salaries, wages and
commissions 941 1,181
Taxes on income 1,120 710
Total Current Liabilities 12,782 11,449
Long-term debt 3,149 2,022
Deferred tax liability 884 643
Employee related obligations 2,263 1,967
Other liabilities 1,843 1,778
Total Liabilities 20,921 17,859
Shareholders' Equity:
Preferred stock - without par
value (authorized and unissued
2,000,000 shares) - -
Common stock- par value $1.00
per share (authorized
4,320,000,000 shares; issued
3,119,842,000 shares) 3,120 3,120
Note receivable from employee
stock ownership plan (18) (25)
Accumulated other comprehensive
income (Note 8) (728) (842)
Retained earnings 29,500 26,571
31,874 28,824
Less common stock held in treasury,
at cost (151,867,000 & 151,547,000
shares) 6,136 6,127
Total Shareholders' Equity 25,738 22,697
Total Liabilities and
Shareholders' Equity $46,659 $40,556
See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Figures)
Fiscal Third Quarter Ended
Sept. 28, Percent Sept. 29, Percent
2003 to Sales 2002 to Sales
Sales to customers
(Note 6) $10,455 100.0% $9,079 100.0%
Cost of products sold 2,980 28.5 2,611 28.7
Gross profit 7,475 71.5 6,468 71.3
Selling, marketing and
administrative expenses 3,428 32.8 3,006 33.1
Research & development
expense 1,177 11.3 952 10.5
Interest income (63) (0.6) (51) (0.5)
Interest expense, net of
portion capitalized 75 0.7 39 0.4
Other (income)/expense, net (91) (0.9) 129 1.4
4,526 43.3 4,075 44.9
Earnings before provision
for taxes on income 2,949 28.2 2,393 26.4
Provision for taxes on
income (Note 3) 877 8.4 668 7.4
Net Earnings $2,072 19.8% $1,725 19.0%
Net Earnings Per Share (Note 7)
Basic $ 0.70 $ 0.58
Diluted $ 0.69 $ 0.57
Cash Dividends Per Share $0.240 $0.205
Average Shares Outstanding
Basic 2,968.0 2,974.4
Diluted 3,008.3 3,026.7
See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Figures)
First Fiscal Nine Months Ended
Sept. 28, Percent Sept. 29, Percent
2003 to Sales 2002 to Sales
Sales to customers
(Note 6) $30,608 100.0% $26,895 100.0%
Cost of products sold 8,668 28.3 7,650 28.4
Gross profit 21,940 71.7 19,245 71.6
Selling, marketing and
administrative expenses 10,077 32.9 8,866 33.0
Research & development
expense 3,195 10.4 2,715 10.1
Purchased in-process
research & development 918 3.0 189 0.7
Interest income (145) (0.5) (201) (0.7)
Interest expense, net of
portion capitalized 164 0.6 117 0.4
Other (income)/expense, net (203) (0.6) 117 0.4
14,006 45.8 11,803 43.9
Earnings before provision
for taxes on income 7,934 25.9 7,442 27.7
Provision for taxes on
income (Note 3) 2,582 8.4 2,229 8.3
Net Earnings $5,352 17.5% $5,213 19.4%
Net Earnings Per Share (Note 7)
Basic $ 1.80 $ 1.73
Diluted $ 1.78 $ 1.70
Cash Dividends Per Share $0.685 $ 0.59
Average Shares Outstanding
Basic 2,968.0 3,006.9
Diluted 3,012.0 3,066.0
See Notes to Consolidated Financial Statements
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JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
Fiscal Nine Months Ended
Sept. 28, Sept. 29,
2003 2002
Cash Flows from Operations
Net Earnings $5,352 5,213
Adj. to reconcile net earnings to cash flows:
Depreciation and amortization of property
and intangibles 1,347 1,274
Purchased in-process research and
development 918 189
Accounts receivable reserves (31) (4)
Changes in assets and liabilities, net of
effects from acquisition of businesses:
increase in accounts receivable (679) (632)
increase in inventories (231) (149)
changes in other assets and liabilities 367 158
Net Cash Flows from Operating Activities 7,043 6,049
Cash Flows from Investing Activities
Additions to property, plant and equipment (1,472) (1,299)
Proceeds from the disposal of assets 334 139
Acquisition of businesses, net of cash
acquired (2,781) (466)
Purchases of investments (5,064) (4,423)
Sales of investments 4,673 5,338
Other (104) (129)
Net Cash Used by Investing Activities (4,414) (840)
Cash Flows from Financing Activities
Dividends to shareholders (2,033) (1,772)
Repurchase of common stock (941) (6,181)
Proceeds from short-term debt 1,633 2,441
Retirement of short-term debt (1,621) (461)
Proceeds from long-term debt 1,013 20
Retirement of long-term debt (108) (221)
Proceeds from the exercise of stock
options 240 283
Net Cash Used by Financing Activities (1,817) (5,891)
Effect of exchange rate changes on cash
and cash equivalents 144 85
Increase/(decrease) in cash and cash
equivalents 956 (597)
Cash and cash equivalents, beginning of
period 2,894 3,758
Cash and Cash Equivalents, End of Period $3,850 $3,161
Acquisition of Businesses
Fair value of assets acquired 3,096 535
Fair value of liabilities assumed (315) (69)
Net Cash Paid for Acquisitions $2,781 466
See Notes to Consolidated Financial Statements
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 - The accompanying unaudited interim financial
statements and related notes should be read in conjunction with
the Consolidated Financial Statements of Johnson & Johnson and
Subsidiaries (the "Company") and related notes as contained in
the Annual Report on Form 10-K for the fiscal year ended
December 29, 2002. The unaudited interim financial statements
include all adjustments (consisting only of normal recurring
adjustments) and accruals necessary in the judgment of management
for a fair presentation of such statements.
NOTE 2 - FINANCIAL INSTRUMENTS
As of September 28, 2003 the balance of deferred net losses on
derivatives included in accumulated other comprehensive income was
$179 million after tax. For additional information, see Note 8.
The Company expects that $179 million will be reclassified into
earnings over the next 12 months as a result of transactions that
are expected to occur over that period. The amount ultimately
realized in earnings will differ as foreign exchange rates change.
Realized gains and losses are ultimately determined by actual
exchange rates at maturity of the derivative. Transactions with
third parties will cause the amount in accumulated other
comprehensive income to affect net earnings. The maximum length
of time over which the Company is hedging is 15 months.
For the first fiscal nine months ended September 28, 2003 the
net impact of the hedges' ineffectiveness to the Company's
financial statements was insignificant. For the first fiscal nine
months ended September 28, 2003 the Company recorded a net gain of
$3 million (after tax) in the "other (income) expense, net"
category of the consolidated statement of earnings, representing
the impact of discontinuance of cash flow hedges because it is
probable that the originally forecasted transactions will not
occur by the end of the originally specified time period.
Refer to Note 8 for disclosures of movements in Accumulated
Other Comprehensive Income.
NOTE 3 - INCOME TAXES
The effective income tax rates for the first fiscal nine months of
2003 and 2002 were 32.5% and 30.0%, respectively, as compared to
the U.S. federal statutory rate of 35%. The difference from the
statutory rate was primarily the result of subsidiaries
manufacturing in Ireland under an incentive tax rate effective
through the year 2010 and domestic subsidiaries operating in
Puerto Rico under a tax incentive grant expiring in 2014. The
increase in the effective tax rate for the first fiscal nine
months of 2003 compared with the same period a year ago is due to
acquisition related In-process Research and Development charges
that are non-deductible for tax purposes. For further details on
acquisitions, see Note 9.
NOTE 4 - INVENTORIES
(Dollars in Millions)
Sept. 28, 2003 Dec. 29, 2002
Raw materials and supplies $ 946 835
Goods in process 909 803
Finished goods 1,884 1,665
$ 3,739 3,303
-8-
NOTE 5 - INTANGIBLE ASSETS
Effective the beginning of fiscal year 2002 in accordance with
SFAS No. 142, the Company discontinued the amortization relating
to all existing goodwill and indefinite lived intangible assets.
Intangible assets that have finite useful lives continued to be
amortized over their useful lives. SFAS No. 142 requires that
goodwill and non-amortizable intangible assets be assessed
annually for impairment. The required initial assessment was
completed at June 30, 2002 and no impairment was determined. This
initial impairment assessment was updated in the fourth quarter of
2002 and no impairment was determined. Future impairment tests
will be performed in the fourth quarter, annually.
(Dollars in Millions)
Sept. 28, Dec. 29,
2003 2002
Goodwill-gross $6,065 $5,320
Less accumulated amortization 682 667
Goodwill - net 5,383 4,653
Trademarks (non-amortizable)- gross 1,086 1,021
Less accumulated amortization 133 138
Trademarks (non-amortizable)- net 953 883
Patents and trademarks 3,773 2,016
Less accumulated amortization 673 534
Patents and trademarks - net 3,100 1,482
Other amortizable intangibles - gross 3,175 2,998
Less accumulated amortization 932 770
Other intangibles - net 2,243 2,228
Total intangible assets - gross 14,099 11,355
Less accumulated amortization 2,420 2,109
Total intangibles - net $11,679 $9,246
Goodwill as of September 28, 2003 as allocated by segment of
business is as follows:
(Dollars in Millions)
Consumer Pharm Med. Dev. Total
& Diag.
Goodwill, net of
accumulated amortization
at December 29, 2002 $821 244 3,588 4,653
Acquisitions - 528 137 665
Translation & other 37 19 9 65
Goodwill at
September 28, 2003 $858 791 3,734 5,383
The weighted average amortization periods for patents and
trademarks and other intangible assets were 16 years and 18 years,
respectively. The amortization expense of amortizable intangible
assets for the first fiscal nine months of 2003 was $320 million
before tax and the estimated amortization expense for the five
succeeding years is approximately $480 million before tax, per
year, respectively.
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NOTE 6 - SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS
(Dollars in Millions)
Fiscal Third Quarter Ended
Sept. 28, Sept. 29, Amount Percent
2003 2002 Change Change
CONSUMER
Domestic $984 910 74 8.1%
International 857 751 106 14.1
Worldwide 1,841 1,661 180 10.8
PHARMACEUTICAL
Domestic 3,285 2,939 346 11.8
International 1,550 1,338 212 15.8
Worldwide 4,835 4,277 558 13.0
MED DEVICES & DIAG
Domestic 2,145 1,740 405 23.3
International 1,634 1,401 233 16.6
Worldwide 3,779 3,141 638 20.3
TOTAL
Domestic 6,414 5,589 825 14.8
International 4,041 3,490 551 15.8
Worldwide $10,455 9,079 1,376 15.2%
% OF TOTAL COMPANY
Consumer 17.6% 18.3%
Pharmaceutical 46.3 47.1
Med. Dev. & Diag. 36.1 34.6
Total 100.0% 100.0%
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SALES BY SEGMENT OF BUSINESS
(Dollars in Millions)
Fiscal Nine Months Ended
Sept. 28, Sept. 29, Amount Percent
2003 2002 Change Change
CONSUMER
Domestic $2,915 2,717 198 7.3%
International 2,536 2,196 340 15.5
Worldwide 5,451 4,913 538 11.0
PHARMACEUTICAL
Domestic 9,825 8,831 994 11.3
International 4,559 3,885 674 17.4
Worldwide 14,384 12,716 1,668 13.1
MED DEVICES & DIAG
Domestic 5,797 5,161 636 12.3
International 4,976 4,105 871 21.2
Worldwide 10,773 9,266 1,507 16.3
TOTAL
Domestic 18,537 16,709 1,828 10.9
International 12,071 10,186 1,885 18.5
Worldwide $30,608 26,895 3,713 13.8%
% OF TOTAL COMPANY
Consumer 17.8% 18.3%
Pharmaceutical 47.0 47.3
Med. Dev. & Diag. 35.2 34.4
Total 100.0% 100.0%
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OPERATING PROFIT BY SEGMENT OF BUSINESS
(Dollars in Millions)
Fiscal Third Quarter Ended
Sept. 28, Sept. 29, Percent
2003 2002 Change
Consumer $ 364 337 8.0%
Pharmaceutical(1) 1,751 1,455 20.3
Med. Dev. & Diag. 931 677 37.5
Segments Total 3,046 2,469 23.4
Expenses not allocated
to segments (97) (76)
Worldwide Total $ 2,949 2,393 23.2%
Fiscal Nine Months Ended
Sept. 28, Sept. 29, Percent
2003 2002 Change
Consumer $ 1,148 990 16.0%
Pharmaceutical(2) 4,702 4,696 0.1
Med. Dev. & Diag. (3) 2,332 1,902 22.6
Segments Total 8,182 7,588 7.8
Expenses not allocated
to segments (248) (146)
Worldwide Total $ 7,934 7,442 6.6%
(1) Includes $150 million of charges related to the outcome of an
arbitration proceeding in the fiscal third quarter of 2002.
(2) Includes $737 million and $150 million of In-process Research
and Development (IPR&D) charges related to acquisitions for the
first fiscal nine months of 2003 and 2002, respectively. Also
included are $150 million of charges related to the outcome of an
arbitration proceeding in the first fiscal nine months of 2002.
(3) Includes $181 million and $39 million of IPR&D charges
related to acquisitions for the
first fiscal nine months of 2003 and 2002, respectively.
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SALES BY GEOGRAPHIC AREA
(Dollars in Millions)
Fiscal Third Quarter Ended
Sept. 28, Sept. 29, Percent
2003 2002 Change
U.S. $ 6,414 5,589 14.8%
Europe 2,241 1,901 17.9
Western Hemisphere
excluding U.S. 576 505 14.1
Asia-Pacific, Africa 1,224 1,084 12.9
International Total 4,041 3,490 15.8
Worldwide Total $10,455 9,079 15.2%
Fiscal Nine Months Ended
Sept. 28, Sept. 29, Percent
2003 2002 Change
U.S. $18,537 16,709 10.9%
Europe 6,909 5,589 23.6
Western Hemisphere
excluding U.S. 1,603 1,506 6.4
Asia-Pacific, Africa 3,559 3,091 15.1
International Total 12,071 10,186 18.5
Worldwide Total $30,608 26,895 13.8%
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NOTE 7 - EARNINGS PER SHARE
The following is a reconciliation of basic net earnings per share
to diluted net earnings per share for the fiscal third quarters
ended September 28, 2003 and September 29, 2002.
(Shares in Millions)
Fiscal Third Quarter Ended
Sept. 28, Sept. 29,
2003 2002
Basic net earnings per share $0.70 0.58
Average shares outstanding - basic 2,968.0 2,974.4
Potential shares exercisable under
stock option plans 95.8 148.4
Less: shares which could be repurchased
under treasury stock method (70.4) (110.5)
Convertible debt shares 14.9 14.4
Adjusted average shares
outstanding - diluted 3,008.3 3,026.7
Diluted earnings per share $0.69 0.57
Diluted earnings per share calculation included the dilution
effect of convertible debt that was offset by the related decrease
in interest expense of $3 million after tax for each of the fiscal
third quarters ended September 28, 2003 and September 29, 2002,
respectively.
Diluted earnings per share excluded 125.0 million and 47.1
million shares related to options for the fiscal third quarters
ended September 28, 2003 and September 29, 2002, respectively as
the exercise price per share of these options was greater than the
average market value, resulting in an anti-dilutive effect on
diluted earnings per share.
The following is a reconciliation of basic net earnings per share
to diluted net earnings per share for the fiscal nine months ended
September 28, 2003 and September 29, 2002.
(Shares in Millions)
Fiscal Nine Months Ended
Sept. 28, Sept. 29,
2003 2002
Basic net earnings per share $1.80 1.73
Average shares outstanding - basic 2,968.0 3,006.9
Potential shares exercisable under
stock option plans 172.9 194.2
Less: shares which could be repurchased
under treasury stock method (143.8) (149.5)
Convertible debt shares 14.9 14.4
Adjusted average shares
outstanding - diluted 3,012.0 3,066.0
Diluted earnings per share $1.78 1.70
Diluted earnings per share calculation included the dilution
effect of convertible debt that was offset by the related decrease
in interest expense of $11 million and $9 million after tax each
for the first fiscal nine months ended September 28, 2003 and
September 29, 2002, respectively.
Diluted earnings per share excluded 47.9 million and 1.2 million
shares related to options for the first fiscal nine months ended
September 28, 2003 and September 29, 2002, respectively as the
exercise price per share of these options was greater than the
average market value, resulting in an anti-dilutive effect on
diluted earnings per share.
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NOTE 8 - ACCUMULATED OTHER COMPREHENSIVE INCOME
The total comprehensive income for the first fiscal nine months
ended September 28, 2003 was $5.5 billion, compared with $5.0
billion for the same period a year ago. Total comprehensive
income included net earnings, net unrealized currency gains and
losses on translation, net unrealized gains and losses on
available for sale securities, pension liability adjustments and
net gains and losses on derivative instruments qualifying and
designated as cash flow hedges. The following table sets forth
the components of accumulated other comprehensive income.
Foreign Unrld Pension Gains/ Total
Currency Gains/ Liab. (Losses) Accum.
Translation (Losses) Adj. on Deriv. Other
on Sec. & Hedg. Comp.
Inc/(Loss)
December 29, 2002 $ (707) (2) (33) (100) (842)
2003 nine months
gains/(losses)
Net change associated
to current period
hedging
transactions - - - (338) -
Net amount reclassed
to net earnings - - - 259* -
Net nine months
gains/(losses) 181 12 - (79) 114
September 28, 2003 $ (526) 10 (33) (179) (728)
Note: All amounts, other than foreign currency translation, are
net of tax. Foreign currency translation adjustments are not
currently adjusted for income taxes, as they relate to permanent
investments in non-US subsidiaries.
*Primarily offset by changes in value of the underlying
transactions.
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NOTE 9 - MERGERS & ACQUISITIONS
On January 29, 2003, Johnson & Johnson acquired certain assets of
Orquest, Inc., a privately held biotechnology company focused on
developing biologically based implants for orthopedic and spine
surgery. Orquest's principal product, HEALOS Bone Graft
Substitute, is designed to reduce the time and pain associated
with standard bone graft harvesting and represents a therapeutic
advance for patients requiring bone graft material for spine
fusion. The Company incurred a charge for In-process Research and
Development (IPR&D) of approximately $11 million before tax and $8
million after tax.
On February 10, 2003, Johnson & Johnson acquired OraPharma,
Inc., a specialty pharmaceutical company focused on the
development and commercialization of unique therapeutics.
OraPharma's initial product, ARESTIN, is the first locally
administered, time-released antibiotic encapsulated in
microspheres that effectively controls the germs that can cause
periodontal disease. The transaction was valued at approximately
$85 million, net of cash.
On March 28, 2003, Johnson & Johnson acquired 3-Dimensional
Pharmaceuticals, Inc., a company with a technology platform
focused on the discovery and development of potential new drugs in
early stage development for the treatment of cardiovascular
diseases, oncology and inflammation. The transaction was valued
at approximately $88 million, net of cash. The Company incurred
an IPR&D charge of approximately $7 million before and after tax.
On April 17, 2003, Johnson & Johnson acquired the CORTAID brand
anti-itch business, the #3 brand in the anti-itch treatment
segment of the first aid category. The transaction was valued at
approximately $37 million.
On April 29, 2003, Johnson & Johnson acquired Scios Inc., a
biopharmaceutical company with a marketed product for
cardiovascular disease and research projects focused on autoimmune
diseases. Scios was acquired to strengthen the Company's business
in key therapeutic areas and technology platforms. Scios' product
NATRECOR is a novel agent approved for congestive heart failure
and has several significant advantages over existing therapies.
The transaction was valued at approximately $2.4 billion, net of
cash, and the Company incurred a charge for IPR&D of $730 million
before and after tax. On a preliminary basis, the purchase price
was allocated to the tangible and identifiable intangible assets
acquired and liabilities assumed based on their estimated fair
values at the acquisition date. The excess of the purchase price
over the fair values of assets and liabilities acquired was
approximately $440 million and was allocated to goodwill. The
Company expects that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
On May 9, 2003, Johnson & Johnson acquired Inscope, an
intraluminal multiple clip applier technology. This transaction
was valued at $26 million.
On June 3, 2003, Johnson & Johnson acquired Link Spine Group,
Inc., a privately owned corporation that will provide the Company
with exclusive worldwide rights to the SB CHARITE Artificial Disc
for the treatment of spine disorders. Under the terms of the
agreement, the Company paid $325 million with contingent payments
due upon achievement of regulatory and other milestones and the
Company incurred a charge for IPR&D of $170 million before and
after tax. On a preliminary basis, the purchase price was
allocated to the tangible and identifiable intangible assets
acquired and liabilities assumed based on their estimated fair
values at the acquisition date. The excess of the purchase price
over the fair values of assets and liabilities acquired was
approximately $84 million and was allocated to goodwill. The
Company expects that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
The supplemental pro forma information for the current interim
period and the preceding year per SFAS No. 141, "Business
Combinations" and SFAS No. 142, "Goodwill and Other Intangible
Assets" are not provided as the impact of these aforementioned
acquisitions did not have a material effect on the Company's
results of operations, cash flows or financial position.
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NOTE 10 - PRO FORMA STOCK BASED COMPENSATION
At September 28, 2003, the Company had 26 stock-based employee
compensation plans. The Company accounted for those plans under
the recognition and measurement principles of Accounting Principle
Board Opinion No. 25 "Accounting for Stock Issued to Employees"
and its related Interpretations. Compensation costs were not
recorded in net income for stock options, as all options granted
under those plans had an exercise price equal to the market value
of the underlying common stock on the date of grant.
As required by SFAS No. 148, "Accounting for Stock-Based
Compensation - Transition and Disclosure - an amendment of FASB
Statement No. 123," the following table shows the estimated effect
on net income and earnings per share if the Company had applied
the fair value recognition provision of SFAS No. 123, "Accounting
for Stock-Based Compensation," to stock-based employee
compensation.
(Dollars in Millions)
Fiscal Third Fiscal Nine
Quarter Months
2003 2002 2003 2002
Net income as reported $ 2,072 1,725 $ 5,352 5,213
Less: compensation 87 85 262 242
expense (1)
Pro forma $ 1,985 1,640 $ 5,090 4,971
Earnings per share:
Basic - as reported $ 0.70 $ 0.58 $ 1.80 $ 1.73
- pro forma 0.67 0.55 1.71 1.65
Diluted - as reported $ 0.69 $ 0.57 $ 1.78 $ 1.70
- pro forma 0.66 0.54 1.70 1.62
(1) Determined under fair value based method for all awards, net
of tax.
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NOTE 11 - SCIOS DEBT GUARANTEE
In August 2002, Scios Inc. issued $150 million of 5.5% convertible
subordinated notes due August 15, 2009 through a private placement
to qualified institutional buyers. This debt became publicly
traded on January 10, 2002. Upon completion of the acquisition of
Scios Inc. in April 2003, Johnson & Johnson fully and
unconditionally guaranteed these convertible subordinated notes.
In accordance with SEC rules, the following presents condensed
consolidating financial information for Johnson & Johnson, Scios
Inc. from the date of acquisition and all other Johnson & Johnson
subsidiaries.
Consolidating Statement of Income
Quarter Ended September 28, 2003
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Sales to customers $ 48 - 10,407 - $10,455
Cost of products sold 24 - 2,956 - 2,980
Gross profit 24 - 7,451 - 7,475
Selling, marketing and
administrative expenses 27 148 3,253 - 3,428
Research expense 24 3 1,150 - 1,177
Interest (income)
expense, net 1 15 (4) - 12
Equity in net income/(loss)
of subsidiaries - 2,059 - (2,059) -
Other (income)
expense (2) (7) (82) - (91)
Corp. allocation - (233) 233 - -
Earnings before provision
for taxes on income (26) 2,133 2,901 (2,059) 2,949
Provision for taxes
on income 8 (61) (824) - (877)
Net earnings (loss) $(18) 2,072 2,077 (2,059) $ 2,072
Consolidating Statement of Income
Quarter Ended September 29, 2002
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Sales to customers $ - - 9,079 - $ 9,079
Cost of products sold - - 2,611 - 2,611
Gross profit - - 6,468 - 6,468
Selling, marketing and
administrative expenses - 105 2,901 - 3,006
Research expense - 2 950 - 952
Interest (income)
expense, net - 17 (29) - (12)
Equity in net income/(loss)
of subsidiaries - 1,676 - (1,676) -
Other (income)
expense - (14) 143 - 129
Corp. allocation - (168) 168 - -
Earnings before provision
for taxes on income - 1,734 2,335 (1,676) 2,393
Provision for taxes
on income - (9) (659) - (668)
Net earnings (loss) $ - 1,725 1,676 (1,676) $ 1,725
-18-
Consolidating Statement of Income
Nine Months Ended September 28, 2003
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Sales to customers $ 80 - 30,528 - $30,608
Cost of products sold 45 - 8,623 - 8,668
Gross profit 35 - 21,905 - 21,940
Selling, marketing and
administrative expenses 45 540 9,492 - 10,077
Research expense 39 7 3,149 - 3,195
Purchased in-process
research and development 730 - 188 - 918
Interest (income)
expense, net 2 26 (9) - 19
Equity in net income/(loss)
of subsidiaries - 5,336 - (5,336) -
Other (income)
expense (4) (29) (170) - (203)
Corp. allocation - (674) 674 - -
Earnings before provision
for taxes on income (777) 5,466 8,581 (5,336) 7,934
Provision for taxes
on income 9 (114) (2,477) - (2,582)
Net earnings (loss) $ (768) 5,352 6,104 (5,336) $ 5,352
Consolidating Statement of Income
Nine Months Ended September 29, 2002
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Sales to customers $ - - 26,895 - $26,895
Cost of products sold - - 7,650 - 7,650
Gross profit - - 19,245 - 19,245
Selling, marketing and
administrative expenses - 461 8,405 - 8,866
Research expense - 5 2,710 - 2,715
Purchased in-process
research and development - - 189 - 189
Interest (income)
expense, net - 5 (89) - (84)
Equity in net income/(loss)
of subsidiaries - 5,233 - (5,233) -
Other (income)
expense - (13) 130 - 117
Corp. allocation - (521) 521 - -
Earnings before provision
for taxes on income - 5,296 7,379 (5,233) 7,442
Provision for taxes
on income - (83) (2,146) - (2,229)
Net earnings (loss) $ - 5,213 5,233 (5,233) $ 5,213
-19-
Consolidating Balance Sheet
September 28, 2003
($ in millions)
Assets Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Current assets
Cash and cash equiv. $ 19 229 3,602 - $ 3,850
Marketable securities - - 4,998 - 4,998
Accounts receivable, trade,
less allowances for
doubtful accounts - - 6,399 - 6,399
Inventories 18 - 3,721 - 3,739
Other current assets 22 - 3,138 - 3,160
Total current assets 59 229 21,858 - 22,146
Property plant and
equipment, net 32 398 8,815 - 9,245
Intangible assets, net 1,916 16 9,747 - 11,679
Invest. In subsidiaries - 30,328 - (30,328) -
Intercompany loans
receivable 56 - 1,756 (1,812) -
Other assets 269 614 2,706 - 3,589
Total assets 2,332 31,585 44,882 (32,140) 46,659
Liabilities and Shareholders' Equity
Current liabilities
Loans and notes payable - 1,648 376 - 2,024
Accounts payable 9 360 3,291 - 3,660
Accrued liabilities 44 372 4,621 - 5,037
Accrued salaries, wages,
and commissions 9 9 923 - 941
Taxes on income - 463 657 - 1,120
Total current liabilities 62 2,852 9,868 - 12,782
Intercompany payables - 1,812 - (1,812) -
Other liabilities 719 3,314 4,106 - 8,139
Total liabilities 781 7,978 13,974 (1,812) 20,921
Shareholders' equity
Common stock - 3,120 - - 3,120
Other shareholders'
equity 1,551 22,618 28,777 (30,328) 22,618
Total shareholders'
equity 1,551 25,738 28,777 (30,328) 25,738
Total liabilities and
shareholders' equity $ 2,332 33,716 42,751 (32,140) $46,659
-20-
Consolidating Balance Sheet
September 29, 2002
($ in millions)
Assets Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Current assets
Cash and cash equivalents $ - 98 2,796 - $ 2,894
Marketable securities - - 4,581 - 4,581
Accounts receivable, trade,
less allowances for
doubtful accounts - - 5,399 - 5,399
Inventories - - 3,303 - 3,303
Other current assets - 112 2,977 - 3,089
Total current assets - 210 19,056 - 19,266
Property plant and
equipment, net - 359 8,351 - 8,710
Intangible assets, net - 16 9,230 - 9,246
Investment In subsidiaries - 27,798 - (27,798) -
Intercompany loans
receivable - - 2,947 (2,947) -
Other assets - 525 2,809 - 3,334
Total assets - 28,908 42,393 (30,745) 40,556
Liabilities and Shareholders' Equity
Current liabilities
Loans and notes payable - 1,652 465 - 2,117
Accounts payable - 347 3,274 - 3,621
Accrued liabilities - 233 3,587 - 3,820
Accrued salaries, wages,
and commissions - 14 1,167 - 1,181
Taxes on income - 157 553 - 710
Total current liabilities - 2,403 9,046 - 11,449
Intercompany payables - 1,707 1,240 (2,947) -
Other liabilities - 2,101 4,309 - 6,410
Total liabilities - 6,211 14,595 (2,947) 17,859
Shareholders' equity
Common stock - 3,120 - - 3,120
Other shareholders'
equity - 19,577 27,798 (27,798) 19,577
Total shareholders'
equity - 22,697 27,798 (27,798) 22,697
Total liabilities and
shareholders' equity $ - 28,908 42,393 (30,745) $40,556
-21-
Consolidating Statement of Cash Flows
Nine Months Ended September 28, 2003
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Net cash flows from
operations: $ 84 95 6,864 - $ 7,043
Cash flows from investing
activities:
Additions to property,
plant and equipment (22) (93) (1,357) - (1,472)
Proceeds from the
disposal of assets - - 334 - 334
Acquisition of businesses,
net of cash acquired - (2,781) - - (2,781)
Purchases of investments (131) - (4,933) - (5,064)
Sales of investments 131 - 4,542 - 4,673
Net proceeds from
intercompany accounts - 1,717 - (1,717) -
Decrease in investment
in subsiaries - 1,367 - (1,367) -
Other - - (104) - (104)
Net cash used by
investing activities (22) 210 (1,518) (3,084) (4,414)
Cash flows from
financing activities:
Dividends to shareholders - (2,033) - - (2,033)
Repurchase of common stock - (941) - - (941)
Proceeds from short-
term debt - 1,211 422 - 1,633
Retirement of short-
term debt - (1,214) (407) - (1,621)
Proceeds from long-
term debt - 1,000 13 - 1,013
Retirement of long-
term debt (43) - (65) - (108)
Proceeds from the
exercise of stock options - 240 - - 240
Capital infusion
from subsidiary - 1,563 - (1,563) -
Net capital distributions
from parent - - (2,930) 2,930 -
Net repayments of
intercompany accounts - - (1,717) 1,717 -
Net cash provided/(used) by
financing activities (43) (174) (4,684) 3,084 (1,817)
Effect of exchange rate
changes on cash and
cash equivalents - - 144 - 144
Increase/(decrease) in
cash and cash equivalents 19 131 806 - 956
Cash and cash equivalents,
beginning of period - 98 2,796 - 2,894
Cash and cash equivalents,
end of period $ 19 229 3,602 - $ 3,850
-22-
Consolidating Statement of Cash Flows
Nine Months Ended September 29, 2002
($ in millions)
Scios Johnson All Other Consolidating
Inc. & Johnson Subsidiaries Adjustments Worldwide
Net cash flows from
operations: $ - (101) 6,150 - $ 6,049
Cash flows from investing
activities:
Additions to property,
plant and equipment - (95) (1,204) - (1,299)
Proceeds from the
disposal of assets - - 139 - 139
Acquisition of businesses,
net of cash acquired - (466) - - (466)
Purchases of investments - - (4,423) - (4,423)
Sales of investments - - 5,338 - 5,338
Net proceeds from
intercompany accounts - 712 - (712) -
Decrease in investment
in subsiaries - 2,039 - (2,039) -
Other - - (129) - (129)
Net cash used by
investing activities - 2,190 (279) (2,751) (840)
Cash flows from
financing activities:
Dividends to shareholders - (1,772) - - (1,772)
Repurchase of common stock - (6,181) - - (6,181)
Proceeds from short-
term debt - 2,024 417 - 2,441
Retirement of short-
term debt - - (461) - (461)
Proceeds from long-
term debt - - 20 - 20
Retirement of long-
term debt - - (221) - (221)
Proceeds from the
exercise of stock options - 283 - - 283
Capital infusion
from subsidiary - 2,417 - (2,417) -
Net capital distributions
from parent - - (4,456) 4,456 -
Net repayments of
intercompany accounts - - (712) 712 -
Net cash provided/(used) by
financing activities - (3,229) (5,413) 2,751 (5,891)
Effect of exchange rate
changes on cash and
cash equivalents - - 85 - 85
Increase/(decrease) in
cash and cash equivalents - (1,140) 543 - (597)
Cash and cash equivalents,
beginning of period - 1,183 2,575 - 3,758
Cash and cash equivalents,
end of period $ - 43 3,118 - $ 3,161
-23-
NOTE 12 - LEGAL PROCEEDINGS
The information called for by this footnote is incorporated herein
by reference to Item 1 ("Legal Proceedings") included in Part II
of this Report on Form 10-Q.
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OPERATING RESULTS
Sales
Consolidated sales for the first fiscal nine months of 2003 were
$30.6 billion, exceeding sales for the first fiscal nine months of
2002 of $26.9 billion, by 13.8%, with 9.5% of the growth from
operations, and the remaining 4.3% due to a positive currency
impact. Domestic sales for the first fiscal nine months of 2003
were $18.5 billion, an increase of 10.9% over 2002 domestic sales
of $16.7 billion for the same period a year ago. Sales of
international subsidiaries grew to $12.1 billion, an increase of
18.5% over the same period a year ago, with operational sales
growth accounting for 7.3% of the reported growth and 11.2% due to
the positive impact of currency.
For the fiscal third quarter of 2003, worldwide sales were $10.5
billion, an increase of 15.2% over 2002 fiscal third quarter sales
of $9.1 billion with 11.7% of the growth from operations, and 3.5%
of the reported growth due to the positive impact of currency.
Sales by domestic companies were $6.4 billion in the fiscal third
quarter of 2003, which represented an increase of 14.8%.
International sales were $4.0 billion, which represented a total
increase of 15.8% over the same period a year ago, with 6.5% of
the growth from operations and the remaining 9.3% due to a
positive currency impact.
For geographic areas throughout the world, sales for the first
fiscal nine months of 2003 in Europe grew to $6.9 billion, an
increase of 23.6% over the same period a year ago, with
operational sales growth accounting for 5.5% of the reported
growth and 18.1% due to the positive impact of currency. Sales in
Asia-Pacific/Africa grew to $3.6 billion, an increase of 15.1%
over the same period a year ago, with operational sales growth
accounting for 7.8% of the reported growth and 7.3% due to the
positive impact of currency. Sales in the Western Hemisphere
(excluding the U.S.) grew to $1.6 billion, an increase of 6.4%
over the same period a year ago, with operational sales growth
accounting for 12.3% of the reported growth, offset by 5.9%
negative impact of currency.
For geographic areas throughout the world, sales for the fiscal
third quarter of 2003 in Europe grew to $2.2 billion, an increase
of 17.9% over the same period a year ago, with operational sales
growth accounting for 4.8% of the reported growth and 13.1% due to
the positive impact of currency. Sales in Asia-Pacific/Africa
grew to $1.2 billion, an increase of 12.9% over the same period a
year ago, with operational sales growth accounting for 7.4% of the
reported growth and 5.5% due to the positive impact of currency.
Sales in the Western Hemisphere (excluding the U.S.) grew to $0.6
billion, an increase of 14.1% over the same period a year ago,
with operational sales growth accounting for 11.3% of the reported
growth and 2.8% due to the positive impact of currency.
Consumer segment sales in the fiscal third quarter of 2003 were
$1.8 billion, an increase of 10.8% over the same period a year ago
with 7.4% of the increase resulting from operational growth and a
positive currency impact of 3.4%. Domestic sales increased by 8.1%
over the same period a year ago, with international sales gains of
14.1 % consisting of an operational sales growth of 6.4% and a
positive currency impact of 7.7%.
Consumer segment sales in the fiscal third quarter of 2003
achieved strong growth in the baby and kid's care products line,
and the AVEENO brand of skin care products. The Nutritionals
franchise had continued success with SPLENDA, the no-calorie
sweetener, with consistent growth in both the ingredient business
and the tabletop category. The women's health franchise had
positive growth led by K-Y Warming Liquid, launched earlier this
year, CAREFREE panty liners, and o.b. Tampon products. Wound Care
franchise results benefited from strong growth in the adhesive
bandage category, the acquisition of the CORTAID brand anti-itch
business in the fiscal second quarter of this year, and the
continued success of the COMPEED foot care line outside the US,
which was acquired in the fiscal fourth quarter of last year.
-24-
Pharmaceutical segment sales in the fiscal third quarter 2003
were $4.8 billion, an increase of 13.0% over the same period a
year ago with 9.7% of this change due to operational growth and
the remaining 3.3% increase related to the positive impact of
currency. The domestic Pharmaceutical sales increase was 11.8%.
International Pharmaceutical sales increased 15.8% which included
5.5% growth operationally, and 10.3% related to the positive
impact of currency.
Pharmaceutical segment sales growth reflects the strong
performance of TOPAMAX, an anti-epileptic medication; DURAGESIC, a
transdermal patch for chronic pain; REMICADE, a treatment for
rheumatoid arthritis and Crohn's disease, and ORTHO-EVRA, a
contraceptive patch. ACIPHEX/PARIET, a proton pump inhibitor that
is co-promoted with Eisai also contributed to the sales growth of
the fiscal third quarter of 2003. ACIPHEX will face new
competition from the OTC gastro-intestinal market in the fiscal
fourth quarter of 2003. There was also strong growth in the
various other brands, including REMINYL, CONCERTA, and DOXIL. The
addition of NATRECOR, resulting from the Scios acquisition in the
second fiscal quarter of this year, also had a positive impact.
PROCRIT (epoetin alfa) and EPREX (epoetin alfa) were adversely
affected by competition. Combined, PROCRIT and EPREX sales
declined 8.3% in the fiscal third quarter of 2003 as compared to
the same period a year ago with an operational decline of 11.7%
offset by a positive currency impact of 3.4%. This decline is the
net effect of strong market growth offset by a loss of market
share. However, sales of PROCRIT and EPREX in each fiscal quarter
of 2003 have stabilized, together averaging approximately $1
billion per quarter. The Company continues to implement programs
to improve its competitive position that include steps to ensure
that PROCRIT is priced competitively, as well as clinical
development programs which will provide comparative data with
competitive products.
Medical Devices & Diagnostics (MD&D) segment worldwide sales
for the fiscal third quarter of 2003 were $3.8 billion,
representing an increase of 20.3% over the same period a year ago
with operational sales growth of 16.3% and a positive currency
impact of 4.0%. Domestic sales were up 23.3% and the
international sales increase of 16.6% over the same period a year
ago included a 7.5% operational growth, and a positive currency
impact of 9.1%.
MD&D segment sales growth in the fiscal third quarter of 2003 was
achieved in several franchises including the strong growth in the
Cordis franchise due to sales of CYPHER, Cordis' drug-eluting
stent that was approved for the U.S. market on April 24, 2003.
Although there were numerous factors that affected the Company's
ability to satisfy the market demand for CYPHER, improvements in
the manufacturing process during the fiscal third quarter of 2003
enabled the improved availability of the CYPHER stent. The DePuy
franchise had double-digit growth in the joint reconstruction
category and in the trauma and Mitek line of sports medicine
products. Additionally, strong growth in the spinal category
continues to be achieved as the result of new product launches,
and the acquisition of Orquest, with its principal product HEALOS,
the bone graft substitute designed to enhance fusion. The Ethicon
Endo-Surgery franchise also reported solid growth with key drivers
from the endoscopy and mechanical business, particularly the
endocutter product line, which is the key product used in
performing bariatric surgical procedures. The Advanced
Sterilization Products line contributed to the strong sales growth
in the fiscal third quarter with the September launch of the
STERRAD 200 Sterilization System. In the Ethicon franchise, sales
were positively impacted by the use of synthetic absorbable
sutures and the growth in the use of cardiovascular sutures in
markets outside the U.S. The Vision Care franchise sales
increases were primarily a result of sales promotions for the
ACUVUE 2 products in the U.S. and continued sales growth of the 1-
DAY ACUVUE product in Japan.
Gross Profit
Gross profit for the fiscal third quarter of 2003 increased 15.6%
versus the fiscal third quarter of 2002 and increased 14.0% for
the first fiscal nine months of 2003 over the first fiscal nine
months of 2002. Gross profit increases reflect the impact of
continued cost improvements and efficiencies as well as the impact
of the mix of products within the Pharmaceutical segment. The
gross profit margin remained relatively unchanged for the fiscal
third quarter and first fiscal nine months of 2003 as compared to
the equivalent periods a year ago.
-25-
Selling, Marketing and Administrative Expenses
Selling, Marketing and Administrative (SM&A) expenses for the
fiscal third quarter of 2003 increased 14.0% over the third fiscal
quarter of 2002, and increased 13.7% for the first fiscal nine
months of 2003 over the same period a year ago. The SM&A expenses
as a percent to sales remained relatively unchanged for the fiscal
third quarter and first fiscal nine months of 2003 as compared to
the equivalent periods a year ago.
Research and Development
Research and development expenses as a percent to sales for the
fiscal third quarter of 2003 increased 0.8% to 11.3% over the
third fiscal quarter of 2002, and increased 0.3% to 10.4% for the
first fiscal nine months of 2003 over the same period a year ago.
Research and development expenses for the fiscal third quarter and
first fiscal nine months ended September 28, 2003 include fees and
milestone payments related to the licensing and development of
VELCADE. These fees and payments resulted from a
commercialization and development agreement the Company entered
into with Millenium Pharmaceuticals for commercial rights to
VELCADE outside of the United States.
In-Process Research & Development
In the fiscal second quarter of 2003, the Company recorded In-
process Research & Development (IPR&D) charges of $900 million
before and after tax related to acquisitions. These acquisitions
included Scios Inc., and Link Spine Group, Inc. Scios Inc., is a
biopharmaceutical company with a marketed product for
cardiovascular disease and research projects focused on auto-
immune diseases. The acquisition of Scios Inc. accounted for $730
million before and after tax of the IPR&D charges incurred in the
fiscal second quarter of 2003. Link Spine Group, Inc., was
acquired to provide the Company with exclusive worldwide rights to
the SB CHARITE Artificial Disc for the treatment of spine
disorders. The acquisition of Link Spine Group, Inc. accounted
for $170 million before and after tax of the IPR&D charges
incurred in the fiscal second quarter of 2003.
In the fiscal first quarter of 2003, the Company recorded IPR&D
charges of $18 million before tax and $15 million after tax
related to acquisitions. These acquisitions included Orquest,
Inc. and 3-Dimensional Pharmaceuticals, Inc. Orquest, Inc. is a
biotechnology company focused on developing biologically-based
implants for orthopedic spine surgery. The acquisition of
Orquest, Inc. accounted for $11 million before tax and $8 million
after tax of the IPR&D charges incurred in the fiscal first
quarter of 2003. 3-Dimensional Pharmaceuticals, Inc. is a company
with a technology platform focused on the discovery and
development of potential new drugs in early stage development for
the treatment of cardiovascular disorders, oncology and
inflammation. The acquisition of 3-Dimensional Pharmaceuticals,
Inc. accounted for $7 million before and after tax of the IPR&D
charges incurred in the fiscal first quarter of 2003.
Interest (Income) Expense
Interest income increased for the fiscal third quarter of 2003 by
$12 million to $63 million as compared to the same period a year
ago. Interest income in the fiscal third quarter of 2003 includes
interest income related to the recovery of a $40 million loan that
had been written off in a prior year. For the first fiscal nine
months of 2003 interest income decreased by $56 million to $145
million as compared to the same period a year ago. The decrease
is due primarily to the continuing decline in U.S. interest rates.
Interest expense increased for the fiscal third quarter of 2003
by $36 million to $75 million as compared to the same period a
year ago and for the first fiscal nine months of 2003 interest
expense increased by $47 million to $164 million as compared to
the same period a year ago. These increases are due to the
increase in long-term debt of approximately $1.0 billion
associated with the acquisition of Scios Inc.
-26-
Other (Income) Expense, Net
Other (income) expense included gains and losses related to the
sale and write-down of certain equity securities of Johnson &
Johnson Development Corporation, losses on the disposal of fixed
assets, currency gains & losses, minority interests, litigation
settlement expense, as well as, royalty income. For the fiscal
third quarter of 2003 net other income was $91 million, as
compared to a net other expense of $129 million in the same period
a year ago which represents an increase in net other income of
$220 million. The increase is primarily due to a 2002 expense of
$150 million, associated with the outcome of an arbitration
proceeding and the 2003 recovery of a $40 million loan that had
been written off in a prior year. For the first fiscal nine
months of 2003 net other income was $203 million, as compared to a
net other expense of $117 million in the same period a year ago
which represents an increase in net other income of $320 million.
The increase is primarily due to the sale of the Vascular Access
product line in the fiscal second quarter of 2003, the 2003
recovery of a $40 million loan that had been written off in a
prior year and a 2002 expense of $150 million associated with the
outcome of an arbitration proceeding
Operating Profit by Segment
The Consumer segment operating profit increased in the fiscal
third quarter and first fiscal nine months of 2003 by 8.0% and
16.0%, respectively. These improvements were due primarily to
volume growth, and leveraging of selling, promotion and
administrative expenses offset by increases in advertising.
The Pharmaceutical segment operating profit increased in the
fiscal third quarter of 2003 by 20.3% as compared to the same
period a year ago and remained relatively unchanged for the first
fiscal nine months of 2003 from the same period a year ago. The
Pharmaceutical segment operating profit was positively impacted in
both periods by volume growth, however the gains in the first
fiscal nine months were offset by the fiscal second quarter IPR&D
charges related to the acquisition of Scios Inc. Additionally,
the fiscal third quarter and first nine months of 2002 included
$150 million related to the outcome of an arbitration proceeding.
The Medical Devices & Diagnostics segment operating profit
increased in the fiscal third quarter and first fiscal nine months
of 2003 by 37.5% and 22.6%, respectively. These improvements
were due primarily to volume growth attributable to the impact of
the launch in the U.S. of the CYPHER stent. The improvement for
the first fiscal nine months of 2003 was partially offset by
acquisition related IPR&D incurred during the fiscal second
quarter of 2003.
The year-to-year increase in expenses not allocated to segments
for the fiscal third quarter and first fiscal nine months of 2003
was due primarily to financing expenses as previously discussed in
the Interest (Income) Expense section.
Provision For Taxes on Income
The effective income tax rates for the first fiscal nine months of
2003 and 2002 were 32.5% and 30.0%, respectively, as compared to
the U.S. federal statutory rate of 35%. The difference from the
statutory rate reflects lower tax rates resulting from
subsidiaries manufacturing in Ireland under an incentive tax rate
effective through the year 2010 and domestic subsidiaries
operating in Puerto Rico under a tax incentive grant expiring in
2014, partially offset by the impact of acquisition related IPR&D
charges, which are generally non-deductible for tax purposes.
Net Income and Earnings Per Share
Worldwide net earnings for the fiscal third quarter of 2003 were
$2.1 billion; diluted earnings per share for the same period were
$0.69 per share, representing a growth of 20.1% and 21.1%,
respectively versus the same period a year ago. For the first
fiscal nine months of 2003, worldwide net earnings and diluted
earnings per share were $5.4 billion and $1.78 per share,
increases of 2.7% and 4.7%, respectively versus the same period a
year ago. The growth rates of net earnings and earnings per share
for the first fiscal nine months were negatively impacted by the
increase in IPR&D charges incurred in conjunction with
acquisitions.
-27-
Cash Flows and Liquidity
Cash generated from operations and selected borrowings provided
the major sources of funds for the growth of the business,
including working capital, capital expenditures, acquisitions,
share repurchases, dividends and debt repayments. Cash and current
marketable securities were $8.8 billion at the end of the first
fiscal nine months of 2003 as compared with $7.5 billion at year-
end 2002. On August 1, 2002, the Company completed the stock
repurchase program that was announced on February 13, 2002 with
83,612,822 shares repurchased for an aggregate price of $5.0
billion.
Dividends
On July 22, 2003, the Board of Directors declared a regular cash
dividend of $0.24 per share, which was paid on September 9, 2003
to shareholders of record as of August 19, 2003. This represented
an increase of 17.1% from the fiscal third quarter of 2002
dividend. The Company expects to continue the practice of paying
regular cash dividends.
Financial Position & Capital Resources
Total Assets & Returns
Total assets increased $6.1 billion or 15.0% in the first fiscal
nine months of 2003 versus year-end 2002. Net intangible assets in
the first nine months of 2003 increased 26.3% over year-end 2002
and represented 25.0% of total assets versus 22.8% of total assets
at year-end 2002. The increase was primarily due to intangible
assets associated with acquisitions. Net property, plant and
equipment increased to $9.2 billion or 6.1% and represented 19.8%
of total assets versus 21.5% of total assets at year-end 2002.
Shareholders' equity per share at the end of the first fiscal nine
months of 2003 was $8.67 compared with $7.65 at year-end 2002, an
increase of 13.3%.
Financing & Market Risk
Total borrowings at the end of the first fiscal nine months of
2003 were $5.2 billion, an increase of $1.0 billion from year-end
2002. The increase was due primarily to the acquisition of Scios
Inc. for which the Company issued approximately $1.1 billion of
long-term debt during the fiscal second quarter of 2003. For the
first fiscal nine months of 2003, net cash (cash and current
marketable securities net of debt) was $3.7 billion. At year-end
2002, net cash (cash and current marketable securities net of
debt) was $3.3 billion. Total debt represented 16.7% of total
capital (shareholders' equity and total debt) for the first fiscal
nine months of 2003 and 15.4% of total capital at year-end 2002.
As of September 28, 2003, there were no material cash commitments.
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New Accounting Standards
In June 2001, the FASB issued SFAS No. 143, "Accounting for Asset
Retirement Obligations." The Company adopted this standard in 2003
that was effective for fiscal years beginning after June 15, 2002
and it has not had a material impact on the Company's results of
operations, cash flows or financial position. In June 2002, the
FASB issued SFAS No. 146, "Accounting for Costs Associated with
Exit or Disposal Activities" which was effective for exit or
disposal activities that are initiated after December 31, 2002.
The Company adopted SFAS No. 146 in the first quarter of 2003 and
it has not had a material effect on the Company's results of
operations, cash flows or financial position.
On November 25, 2002, the FASB issued FASB Interpretation No. 45
(FIN 45), "Guarantor's Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness of
Others, an interpretation of FASB Statements No. 5, 57 and 107 and
Rescission of FASB Interpretation No. 34." FIN 45 clarified the
requirements of FASB Statement No. 5, "Accounting for
Contingencies," relating to the guarantor's accounting for, and
disclosure of, the issuance of certain types of guarantees. The
disclosure requirements of FIN 45 are effective for financial
statements of interim or annual periods that end after December
15, 2002. The disclosure provisions have been implemented and no
disclosures were required for the fiscal third quarter and first
fiscal nine months of 2003. The provisions for initial recognition
and measurement are effective on a prospective basis for
guarantees that are issued or modified after December 31, 2002.
The Company's adoption of FIN 45 in 2003 has not had a material
effect on the Company's results of operations, cash flows or
financial position.
In January 2003, the FASB issued FIN 46, "Consolidation of
Variable Interest Entities - an interpretation of ARB No. 51,"
which addresses consolidation of variable interest entities. FIN
46 expanded the criteria for consideration in determining whether
a variable interest entity should be consolidated by a business
entity, and requires existing unconsolidated variable interest
entities (which include, but are not limited to, Special Purpose
Entities, or SPEs) to be consolidated by their primary
beneficiaries if the entities do not effectively disperse risks
among parties involved. This interpretation applied immediately to
variable interest entities created after January 31, 2003. The
adoption of this portion of FIN 46 has not had a material effect
on the Company's results of operation, cash flows or financial
position. This interpretation applies in the first fiscal year or
interim period beginning after December 15, 2003, to variable
interest entities in which an enterprise holds a variable interest
that is acquired before February 1, 2003. The Company has various
investments and arrangements, which may or may not be considered
variable interest, and is currently assessing the impact of this
standard on the results of operation, cash flows and financial
position of the Company.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains "forward-looking statements." Forward-
looking statements do not relate strictly to historical or current
facts and anticipate results based on management's plans that are
subject to uncertainty. Forward-looking statements may be
identified by the use of words like "plans," "expects," "will,"
"anticipates," "estimates" and other words of similar meaning in
conjunction with, among other things, discussions of future
operations, financial performance, the Company's strategy for
growth, product development, regulatory approvals, market position
and expenditures.
Forward-looking statements are based on current expectations of
future events. The Company cannot guarantee that any forward-
looking statement will be accurate, although the Company believes
that it has been reasonable in its expectations and assumptions.
Investors should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the Company's expectations and
projections. Investors are therefore cautioned not to place undue
reliance on any forward-looking statements. Furthermore, the
Company assumes no obligation to update any forward-looking
statements as a result of new information or future events or
developments.
The Company's Annual Report on Form 10-K for the fiscal year
ended December 29, 2002 contains, in Exhibit 99(b), a discussion
of various factors that could cause actual results to differ from
expectations. In furtherance of that discussion, the Company
notes that pending Federal Legislation, including Medicare drug
coverage legislation, a drug importation bill and amendments to
the Hatch-Waxman Act, could cause actual results to differ from
expectations. Exhibit 99 (b) from the Form 10-K is incorporated
in this filing by reference. The Company notes these factors as
permitted by the Private Securities Litigation Reform Act of 1995.
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ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
There has been no material change in the Company's assessment of
its sensitivity to market risk since its presentation set forth in
Item 7A, "Quantitative and Qualitative Disclosures About Market
Risk," in its Annual Report on Form 10-K for the fiscal year ended
December 29, 2002.
ITEM 4 - CONTROLS AND PROCEDURES
Disclosure Controls and Procedures. At the end of the fiscal
third quarter of 2003, the Company evaluated the effectiveness of
the design and operation of its disclosure controls and
procedures. The Company's disclosure controls and procedures are
the controls and other procedures that the Company has designed to
ensure that it records, processes, summarizes and reports in a
timely manner the information the Company must disclose in its
reports filed under the Securities Exchange Act. William C.
Weldon, Chairman and Chief Executive Officer, and Robert J.
Darretta, Executive Vice President and Chief Financial Officer,
reviewed and participated in this evaluation.
Based on this evaluation, Messrs. Weldon and Darretta concluded
that, as of the date of their evaluation, the Company's disclosure
controls and procedures were effective.
Internal Controls. During the period covered by this report,
there have not been any significant changes in the Company's
internal controls over financial reporting that could have
materially affected, or are reasonably likely to materially
affect, those internal controls.
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PART II - OTHER INFORMATION
ITEM 1 - LEGAL PROCEEDINGS
Product Liability Litigation
The Company is involved in numerous product liability cases in the
United States, many of which concern adverse reactions to drugs
and medical devices. The damages claimed are substantial, and
while the Company is confident of the adequacy of the warnings and
instructions for use which accompany such products, it is not
feasible to predict the ultimate outcome of litigation. However,
the Company believes that if any liability results from such
cases, it will be substantially covered by reserves established
under its self-insurance program and by commercially available
excess liability insurance.
One group of cases against the Company concerns the Janssen
Pharmaceutica Inc. product PROPULSID, which was withdrawn from
general sale and restricted to limited use in 2000. In the wake of
publicity about those events, numerous lawsuits have been filed
against Janssen, which is a wholly owned subsidiary of the
Company, and the Company regarding PROPULSID, in state and federal
courts across the country. There are approximately 500 such cases
currently pending, including the claims of approximately 6,000
plaintiffs. In the active cases, 445 individuals are alleged to
have died from the use of PROPULSID. These actions seek
substantial compensatory and punitive damages and accuse Janssen
and the Company of inadequately testing for and warning about the
drug's side effects, of promoting it for off-label use and of over
promotion. In addition, Janssen and the Company have entered into
agreements with various plaintiffs' counsel halting the running of
the statutes of limitations with respect to the potential claims
of a significant number of individuals while those attorneys
evaluate whether or not to sue Janssen and the Company on their
behalf.
In September 2001, the first ten plaintiffs in the Rankin case,
which comprises the claims of 155 PROPULSID plaintiffs, went to
trial in state court in Claiborne County, Mississippi. The jury
returned compensatory damage verdicts for each plaintiff in the
amount of $10 million, for a total of $100 million. The trial
judge thereafter dismissed the claims of punitive damages. On
March 4, 2002, the trial judge reduced these verdicts to a total
of $48 million, and denied the motions of Janssen and the Company
for a new trial. Janssen and the Company believe these verdicts,
even as reduced, are insupportable and have appealed. In the view
of Janssen and the Company, the proof at trial demonstrated that
none of these plaintiffss werewas injured by PROPULSID and that no
basis for liability existed.
In April 2002, a state court judge in New Jersey denied
plaintiffs' motion to certify a national class of PROPULSID users
for purposes of medical monitoring and refund of the costs of
purchasing PROPULSID. An effort to appeal that ruling has been
denied. In June 2002 the federal judge presiding over the
PROPULSID Multi-District Litigation in New Orleans, Louisiana
similarly denied plaintiffs' motion there to certify a national
class of PROPULSID users. Plaintiffs in the Multi-District
Litigation have said they are preserving their right to appeal
that ruling, and other complaints filed against Janssen and the
Company includes class action allegations, which could be the
basis for future attempts to have classes certified.
With respect to all the various PROPULSID actions against them,
Janssen and the Company dispute the claims in those lawsuits and
are vigorously defending against them except where, in their
judgment, settlement is appropriate. Janssen and the Company
believe they have adequate self-insurance reserves and
commercially available excess insurance with respect to these
cases. In communications to the Company, the excess insurance
carriers have raised certain defenses to their liability under the
policies and to date have declined to reimburse Janssen and the
Company for PROPULSID-related costs despite demand for payment.
However, in the opinion of the Company, those defenses are pro
forma and lack substance and the carriers will honor their
obligations under the policies either voluntarily or after
litigation.
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Affirmative Stent Patent Litigation
In patent infringement actions tried in Delaware federal court
in late 2000, Cordis Corporation, a subsidiary of Johnson &
Johnson, obtained verdicts of infringement and patent validity,
and damage awards, against Boston Scientific Corporation and
Medtronic AVE, Inc., based on a number of Cordis vascular stent
patents. On December 15, 2000, the jury in the damage action
against Boston Scientific returned a verdict of $324 million and
on December 21, 2000 the jury in the Medtronic AVE action returned
a verdict of $271 million. These sums represent lost profit and
reasonable royalty damages to compensate Cordis for infringement
but do not include pre or post judgment interest. In February 2001
a hearing was held on the claims of Boston Scientific and
Medtronic AVE that the patents at issue were unenforceable owing
to alleged inequitable conduct before the patent office.
In March and May 2002, the district judge issued post trial
rulings that confirmed the validity and enforceability of the main
Cordis stent patent claims but found certain other Cordis patents
unenforceable. Further, the district judge granted Boston
Scientific a new trial on liability and damages and vacated the
verdict against Medtronic AVE on legal grounds. On August 12,
2003, the Court of Appeals for the Federal Circuit found the trial
judge erred in vacating the verdict against Medtronic AVE and
remanded the case to the trial judge for further proceedings.
Medtronic AVE's motion for reconsideration by the panel and for
reconsideration by the full court was denied on October 3, 2003
and its request to stay the return of the mandate to the trial
court pending the filing of a request for a writ of certiorari to
the United States Supreme Court was denied on October 10, 2003.
Cordis filed motions before the trial court on October 14, 2003 to
reinstate the verdicts against both Medtronic AVE and Boston
Scientific and to award interest and enter injunctions against the
stent products at issue in those two cases (the GFX and Microstent
II stents of Medtronic AVE and the NIR stent of Boston Scientific)
and colorable variations thereof. It is expected that both
Medtronic AVE and Boston Scientific will resist reinstatement of
these verdicts and attempt to appeal to the Court of Appeals for
the Federal Circuit once judgments isare entered.
In January 2003, Cordis filed an additional patent infringement
action against Boston Scientific in Delaware federal court
accusing the Express II and TAXUS stents of infringing one of the
Cordis patents involved in the earlier actions against Boston
Scientific and Medtronic AVE. In February 2003, Cordis moved in
that action for a preliminary injunction seeking to bar the
introduction of the TAXUS stent based on that patent. A hearing
was held on that motion in July 2003 and a decision is expected at
any time. Cordis also has pending in Delaware federal court an
action accusing of infringement stent products introduced by
Medtronic AVE subsequent to the GFX and Microstent II products
subject to the earlier action referenced above.
In early June 2003, an arbitration panel in Chicago, in a
preliminary ruling, found in favor of Cordis in its arbitration
against ACS/Guidant involving infringement by ACS/Guidant of a
Cordis stent patent. On August 19, 2003, the panel confirmed that
ruling, rejecting the challenge of ACS/Guidant. Under the terms of
an earlier agreement between Cordis and ACS/Guidant, the
arbitration panel's ruling obligates ACS/Guidant to make a payment
of $425 million to Cordis in the fourth quarter of this year. No
additional royalties for ACS/Guidant's continued use of the
technology and no injunctions are involved.
Patent Litigation against various Johnson & Johnson Operating
Companies
The products of various Johnson & Johnson operating companies
are the subject of various patent lawsuits, which could
potentially affect the ability of those operating companies to
sell those products, or require the payment of past damages and
future royalties. The following patent lawsuits concern important
products of Johnson & Johnson operating companies: Boston
Scientific and Medinol Ltd. v. Cordis Corporation: This action,
filed in Delaware federal court in December 1999, charged
infringement by the BX VELOCITY and other Cordis stent products of
certain patents owned by Medinol and licensed by Boston
Scientific. The case was tried to a jury in September 2002 and
resulted in verdicts for Cordis of non-infringement and
invalidity, except with respect to a minor stent product as to
which the jury found infringement and awarded damages of $9
million. Medinol filed an appeal from this result, which is
scheduled to be argued before the Court of Appeal for The Federal
Circuit in December 2003. Medtronic AVE v. Cordis Corporation:
This action, filed in April 2002 in federal district court in
Texas and thereafter transferred to the federal district court in
Delaware, asserts certain patents owned by Medtronic AVE against
the Cordis BX VELOCITY stent, which is also the stent structure
used in the CYPHER drug eluting product. The federal district
court in Delaware has stayed this lawsuit pending the outcome of
arbitration between the parties on the issue of whether Cordis is
licensed under the patents asserted against it by Medtronic AVE.
Medtronic AVE has asked the court to reconsider that ruling. No
hearing date has been set for this arbitration.
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ACS/Guidant v. Cordis Corporation: This is an arbitration in which
ACS/Guidant has asserted its Lau patents against the Cordis BX
VELOCITY stent. In the event ACS/Guidant prevails, Cordis would
pay a pre-negotiated royalty with respect to past and future BX
VELOCITY sales; no injunction would be issued. The arbitration
hearings were concluded in October 2003 and a decision is expected
in the first quarter of 2004. Boston Scientific Corporation (BSC)
v. Cordis Corporation: This action, filed in Delaware federal
court in March 2003, asserts that the CYPHER drug-eluting stent
infringes several patents assigned to BSCBoston Scientific.
BSCBoston Scientific seeks damages and a permanent injunction and
in addition has moved for a preliminary injunction, a hearing on
which was held in late July 2003. Medinol Ltd. v. Cordis Europa NV
(Netherlands) and Medinol Ltd. v. Cordis Holding Belgium B.V.B.A.
and Janssen Pharmaceutica N.V. (Belgium): On July 3, 2003, the
Appeal Court of the Hague overturned a lower court and granted
Medinol, an Israeli stent manufacturer, a preliminary injunction
based on patent infringement prohibiting Cordis from making or
selling the BX VELOCITY and CYPHER stents in the Netherlands. The
injunction became effective on August 26, 2003. In Belgium,
Medinol has filed a patent infringement suit based on the same
patent it asserted in the Netherlands, and moved for a preliminary
injunction prohibitingseeking to prevent the defendants from
making or selling the BX VELOCITY and CYPHER stents there. Cordis
currently uses a Janssen Pharmaceutica facility in Belgium to coat
CYPHER stents with SIROLIMUS principally for the ex-US market. A
hearing on Medinol's preliminary injunction motion in Belgium was
heard in October. Rockey v. Cordis Corporation: This is an action
against Cordis by the heirs of Dr. Rockey concerning a patent he
licensed to Cordis in 1996, shortly before Cordis was acquired by
Johnson & Johnson. The plaintiffs assert that Dr. Rockey's patent,
which expires in 2005, covers all stent products ever marketed by
Cordis and seek a 10% past and future royalty on those sales.
Trial of the action, which is pending in federal court in Miami,
Florida, is scheduled for January 2004.
With respect to all of these matters, the Johnson & Johnson
operating company involved is vigorously defending against the
claims of infringement and disputing where appropriate the
validity and enforceability of the patent claims asserted against
it.
Litigation against filers of Abbreviated New Drug Applications
(ANDAs)
The following lawsuits are against generic firms that filed
Abbreviated New Drug Applications (ANDAs) seeking to market
generic forms of products sold by various subsidiaries of the
Company prior to expiration of the applicable patents covering
those products. These ANDAs typically include allegations of non-
infringement, invalidity and unenforceability of these patents. In
the event the subsidiary of the Company involved is not successful
in these actions, the firms involved will then introduce generic
versions of the product at issue resulting in very substantial
market share and revenue losses for the product of the Company's
subsidiary. Ortho-McNeil Pharmaceutical, Inc. and Daiichi, Inc. v.
Mylan Laboratories and Ortho-McNeil Pharmaceutical, Inc. and
Daiichi, Inc. v. Teva Pharmaceutical: These matters, the first of
which was filed in February 2002 in federal court in West Virginia
and the second in June 2002 in federal court in New Jersey,
concern the efforts of Mylan and Teva to invalidate and establish
non-infringement and unenforceability of the patent covering
LEVAQUIN levofloxacin tablets. The patent is owned by Daiichi and
exclusively licensed to Ortho-McNeil. Trial of the Mylan case
began on November 4, 2003, and will continue into December 2003.
No trial date has been set in the Teva matter. Ortho-McNeil
Pharmaceutical, Inc. and Daiichi v. Bedford Laboratories: This
matter was filed in federal district court in New Jersey in April
2003 and involves the effort of Bedford to invalidate and assert
non-infringement and unenforceability of the same Daiichi patent
on LEVAQUIN involved in the above proceedings. In this case,
however, Bedford is challenging the patent's application to its
products which it asserts are equivalent to LEVAQUIN injection pre-
mix and injection vials, rather than tablets. Janssen
Pharmaceutica Inc. and ALZA Corporation v. Mylan Laboratories:
This action, filed in federal district court in Vermont in January
2002, concerns Mylan's effort to invalidate and assert non-
infringement and unenforceability of ALZA's patent covering the
DURAGESIC product. Trial concluded in September 2003 and post-
trial briefing will be complete in November 2003. Janssen
Pharmaceutica N.V. v. Eon Labs Manufacturing: This action was
filed in federal court in the Eastern District of New York in
April 2001 and concerns Eon's effort to invalidate and establish
non-infringement of Janssen's patent covering SPORANOX
(itraconozole). No trial date has yet been scheduled.
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Ortho-McNeil Pharmaceutical, Inc. v. Kali Laboratories, Inc.:
This lawsuit was filed in federal court in New Jersey in November
2002 and concerns the attempt of Kali to invalidate and establish
non-infringement of Ortho-McNeil's patent covering ULTRACET
(tramadol-acetaminophen) tablets. No trial date has been set for
this case. ALZA Corporation v. Mylan Laboratories: This action was
filed in federal district court in West Virginia in May 2003 and
concerns Mylan's effort to invalidate and assert non-infringement
of an ALZA patent covering the DITROPAN XL product. Trial has been
scheduled for February 2005 in this case. ALZA Corporation v.
IMPAX Laboratories: This action was filed in federal court in
California in September 2003 and concerns Impax's effort to
invalidate and assert non-infringement of the same ALZA patent
covering DITROPAN XL involved in the above Mylan case. No trial
date has been set in this matter. Ortho-McNeil Pharmaceutical,
Inc. v. Barr Laboratories, Inc.: This action, filed in federal
district court in New Jersey in October 2003, concerns the effort
of Barr Laboratories to assert non-infringement, invalidity and
unenforceability of Ortho-McNeil's patent on ORTHO TRI-CYCLEN LO,
an oral contraceptive product.
With respect to all of the above matters, the Johnson & Johnson
operating company involved is vigorously defending the validity
and enforceability and asserting the infringement of its own or
its licensor's' patents.
Average Wholesale Price (AWP) Litigation
Johnson & Johnson and its pharmaceutical operating companies,
along with numerous other pharmaceutical companies, are defendants
in a series of lawsuits in state and federal courts involving
allegations that the pricing and marketing of certain
pharmaceutical products amounted to fraudulent and otherwise
actionable conduct because, among other things, the companies
allegedly reported an inflated Average Wholesale Price ("AWP") for
the drugs at issue. Most of these cases, both federal actions and
state actions removed to federal court, have been consolidated for
pre-trial purposes in a Multi-District Litigation (MDL) in federal
court in Boston, Massachusetts. The plaintiffs in these cases
include classes of private persons or entities that paid for any
portion of the purchase of the drugs at issue based on AWP, and
state government entities that made Medicaid payments for the
drugs at issue based on AWP.
Ethicon Endo-Surgery, Inc., a Johnson & Johnson operating company,
which markets endoscopic surgical instruments, and the Company,
are named defendants in a North Carolina state court class action
lawsuit alleging AWP inflation and improper marketing activities
against TAP Pharmaceuticals. Ethicon Endo-Surgery, Inc. is a
defendant based on claims that several of its former sales
representatives are alleged to have been involved in arbitrage of
a TAP drug. The allegation is that these sales representatives
persuaded certain physicians in states where the drug's price was
low to purchase from TAP excess quantities of the drug and then
resell it in states where its price was higher. Ethicon Endo-
Surgery, Inc. and the Company deny any liability for the claims
made against them in this case and are vigorously defending
against it. The trial judge recently certified a national class of
purchasers of the TAP product at issue and trial is likely in
2004.
Other
The New York State Attorney General's office and the Federal Trade
Commission issued subpoenas in January and February 2003 seeking
documents relating to the marketing of sutures and endoscopic
instruments by the Company's Ethicon, Inc. and Ethicon Endo-
Surgery, Inc. subsidiaries. The Connecticut Attorney General's
office also issued a subpoena for the same documents. These
subpoenas focus on the bundling of sutures and endoscopic
instruments in contracts offered to Group Purchasing Organizations
and individual hospitals in which discounts are predicated on the
hospital achieving specified market share targets for both
categories of products. The operating companies involved are
responding to the subpoenas.
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On June 26, 2003, the Company received a request for records and
information from the U.S. House of Representatives' Committee on
Energy and Commerce in connection with its investigation into
pharmaceutical reimbursements and rebates under Medicaid. The
Committee's request focuses on the drug REMICADE (infliximab),
marketed by the Company's Centocor, Inc. subsidiary. On July 2,
2003, Centocor received a request that it voluntarily provide
documents and information to the criminal division of the U.S.
Attorney's Office, District of New Jersey, in connection with its
investigation into various Centocor marketing practices. Both the
Company and Centocor are responding to these requests for
documents and information.
The Company is also involved in a number of other patent,
trademark and other lawsuits incidental to its business.
The ultimate legal and financial liability of the Company in
respect to all claims, lawsuits and proceedings referred to above
cannot be estimated with any certainty. However, in the opinion of
management, based on its examination of these matters, its
experience to date and discussions with counsel, the ultimate
outcome of these legal proceedings, net of liabilities already
accrued in the Company's consolidated balance sheet, is not
expected to have a material adverse effect on the Company's
consolidated financial position, although the resolution in any
reporting period of one or more of these matters could have a
significant impact on the Company's results of operations and cash
flows for that period.
ITEM 5 - OTHER INFORMATION
After a remand from the Federal Circuit Court of Appeals in
January 2003, a partial retrial was commenced in October and will
conclude in November 2003 in Boston, Massachusetts in the action
Amgen v. Transkaryotic Therapies, Inc. (TKT) and Aventis
Pharmaceutical, Inc. The matter is a patent infringement action
brought by Amgen against TKT, the developer of a gene-activated
EPO product, and Aventis, which holds marketing rights to the TKT
product, asserting that TKT's product infringes various Amgen
patent claims. TKT and Aventis dispute infringement and are
seeking to invalidate the Amgen patents asserted against them. No
decision from the October partial retrial has yet been issued. The
Amgen patents at issue in the case are exclusively licensed to
Ortho Biotech Inc. a Johnson & Johnson operating company, in the
U.S. for non-dialysis indications. Ortho Biotech Inc. is not a
party to the action.
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ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K
(A) Exhibits
Exhibit 31 - Certifications Pursuant to Rule 13a-14(a) Under
the Securities Exchange Act of 1934
Exhibit 32 - Certifications Furnished Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to section 906 of the
Sarbanes-Oxley Act of 2002.
(B) Reports on Form 8-K
A Form 8-K was furnished on July 18, 2003, under Item 9,
which included the Press Release for the period ended June
29, 2003. Also included in this filing are the unaudited
comparative supplementary sales data and condensed
consolidated statement of earnings for the fiscal second
quarter and six month period ended June 29, 2003.
A Form 8-K was furnished on October 14, 2003, under Item 12,
which included the Press Release for the period ended
September 28, 2003. Also included in this filing are the
unaudited comparative supplementary sales data and condensed
consolidated statement of earnings for the fiscal third
quarter and nine month period ended September 28, 2003.
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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.
JOHNSON & JOHNSON
(Registrant)
Date: November 11, 2003 By /s/ R.J. DARRETTA
R. J. DARRETTA
Executive Vice President and
Chief Financial Officer
Date: November 11, 2003 By /s/ S.J. COSGROVE
S. J. COSGROVE
Controller
(Chief Accounting Officer)
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