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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
|
[ X ] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 |
For the quarterly period ended March 31, 2005
or
|
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
For the transition period from to
Commission file number
1-1225
Wyeth
(Exact name of
registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
Five Giralda Farms, Madison, N.J.
(Address of principal executive offices) |
|
13-2526821
(I.R.S. Employer Identification No.)
07940 (Zip Code) |
Registrants telephone number,
including area code (973) 660-5000
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X
No
Indicate by check mark whether the
registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes X
No
The number of shares of Common Stock
outstanding as of the close of business on April 29, 2005:
|
Class
|
|
Number of
Shares Outstanding
|
|
|
Common Stock, $0.33-1/3 par value |
|
1,338,482,142 |
|
|
|
|
|
|
|
|
|
|
|
WYETH
INDEX
Page No.
|
|
|
|
|
|
Part I -
Part II -
Signature
Exhibit Index
|
Financial Information (Unaudited)
Item 1. Consolidated Condensed Financial Statements:
Consolidated Condensed Balance Sheets -
March 31, 2005 and December 31, 2004
Consolidated Condensed Statements of Operations -
Three Months Ended March 31, 2005 and 2004
Consolidated Condensed Statements of Changes in Stockholders'
Equity - Three Months Ended March 31, 2005 and 2004
Consolidated Condensed Statements of Cash Flows -
Three Months Ended March 31, 2005 and 2004
Notes to Consolidated Condensed Financial Statements
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Other Information
Item 1. Legal Proceedings
Item 6. Exhibits
|
|
2
3
4
5
6
7 - 19
20 - 42
43
43
44
44 - 50
51 - 52
53
EX-1
|
|
|
|
|
|
|
|
|
|
|
Items other than those listed above
have been omitted because they are not applicable.
1
Part I
Financial Information
WYETH
The consolidated condensed financial statements
included herein have been prepared by Wyeth (the Company), without audit, pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC). Certain information
and footnote disclosures normally included in financial statements prepared in accordance
with accounting principles generally accepted in the United States have been condensed or
omitted pursuant to such rules and regulations; however, the Company believes that the
disclosures are adequate to make the information presented not misleading. In the opinion
of management, the consolidated condensed financial statements reflect all adjustments,
including those that are normal and recurring, considered necessary to present fairly the
financial position of the Company as of March 31, 2005 and December 31, 2004, the results
of its operations, changes in stockholders equity and cash flows for the three
months ended March 31, 2005 and 2004. It is suggested that these consolidated condensed
financial statements and managements discussion and analysis of financial condition
and results of operations be read in conjunction with the financial statements and the
notes thereto included in the Companys 2004 Annual Report on Form 10-K and
information contained in Current Reports on Form 8-K filed since the filing of the 2004
Form 10-K.
We make available through our Company
Internet website, free of charge, our Company filings with the SEC as soon as reasonably
practicable after we electronically file them with, or furnish them to, the SEC. The
reports we make available include Annual Reports on Form 10-K, Quarterly Reports on Form
10-Q, Current Reports on Form 8-K, proxy statements, registration statements, and any
amendments to those documents. The Companys Internet website is
www.wyeth.com.
2
WYETH
CONSOLIDATED CONDENSED BALANCE SHEETS
(In Thousands Except Per Share Amounts)
(Unaudited)
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
| |
2005 |
|
2004 |
|
|
| |
| |
ASSETS | |
Cash and cash equivalents | |
$4,561,854 |
|
$4,743,570 |
|
Marketable securities | |
679,378 |
|
1,745,558 |
|
Accounts receivable less allowances | |
2,838,481 |
|
2,798,565 |
|
Inventories: | |
Finished goods | |
716,395 |
|
851,059 |
|
Work in progress | |
1,453,039 |
|
1,340,245 |
|
Materials and supplies | |
292,383 |
|
286,705 |
|
|
| |
| |
| |
2,461,817 |
|
2,478,009 |
|
Other current assets including deferred taxes | |
3,272,759 |
|
2,672,327 |
|
|
| |
| |
Total Current Assets | |
13,814,289 |
|
14,438,029 |
|
Property, plant and equipment | |
13,040,299 |
|
13,077,351 |
|
Less accumulated depreciation | |
3,601,419 |
|
3,553,001 |
|
|
| |
| |
| |
9,438,880 |
|
9,524,350 |
|
Goodwill | |
3,843,696 |
|
3,856,410 |
|
Other intangibles, net of accumulated amortization | |
(March 31, 2005-$148,685 and December 31, 2004-$166,827) | |
280,381 |
|
212,360 |
|
Other assets including deferred taxes | |
5,980,265 |
|
5,598,555 |
|
|
| |
| |
Total Assets | |
$33,357,511 |
|
$33,629,704 |
|
|
| |
| |
LIABILITIES | |
Loans payable | |
$1,518 |
|
$330,706 |
|
Trade accounts payable | |
799,214 |
|
949,251 |
|
Accrued expenses | |
6,883,973 |
|
7,051,557 |
|
Accrued taxes | |
264,848 |
|
204,028 |
|
|
| |
| |
Total Current Liabilities | |
7,949,553 |
|
8,535,542 |
|
Long-term debt | |
7,663,388 |
|
7,792,311 |
|
Accrued postretirement benefit obligations other than pensions | |
1,044,181 |
|
1,024,239 |
|
Other noncurrent liabilities | |
6,191,266 |
|
6,429,709 |
|
|
| |
| |
Total Liabilities | |
22,848,388 |
|
23,781,801 |
|
|
| |
| |
Contingencies and commitments (Note 5) | |
STOCKHOLDERS' EQUITY | |
$2.00 convertible preferred stock, par value $2.50 per share | |
39 |
|
40 |
|
Common stock, par value $0.33-1/3 per share | |
445,540 |
|
445,031 |
|
Additional paid-in capital | |
4,856,811 |
|
4,817,024 |
|
Retained earnings | |
4,889,074 |
|
4,118,656 |
|
Accumulated other comprehensive income | |
317,659 |
|
467,152 |
|
|
| |
| |
Total Stockholders' Equity | |
10,509,123 |
|
9,847,903 |
|
|
| |
| |
Total Liabilities and Stockholders' Equity | |
$33,357,511 |
|
$33,629,704 |
|
|
| |
| |
| |
The accompanying notes are an integral part of these consolidated condensed financial statements.
3
WYETH
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(In Thousands Except Per Share Amounts)
(Unaudited)
|
Three Months Ended March 31,
|
|
2005
|
2004
|
Net revenue |
|
$4,578,998 |
|
$4,014,789 |
|
|
| |
| |
Cost of goods sold | |
1,349,457 |
|
1,161,364 |
|
Selling, general and administrative expenses | |
1,452,681 |
|
1,354,210 |
|
Research and development expenses | |
607,957 |
|
705,302 |
|
Interest expense, net | |
29,999 |
|
26,932 |
|
Other income, net | |
(234,562 |
) |
(176,910 |
) |
|
| |
| |
Income before income taxes | |
1,373,466 |
|
943,891 |
|
Provision for income taxes | |
295,295 |
|
194,188 |
|
|
| |
| |
Net income | |
$1,078,171 |
|
$749,703 |
|
|
| |
| |
Basic earnings per share | |
$0.81 |
|
$0.56 |
|
|
| |
| |
Diluted earnings per share | |
$0.80 |
|
$0.55 |
|
|
| |
| |
Dividends paid per share of common stock | |
$0.23 |
|
$0.23 |
|
|
| |
| |
The accompanying notes are an integral part of these consolidated condensed financial statements.
4
WYETH
CONSOLIDATED CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
(In Thousands Except Per Share Amounts)
(Unaudited)
Three Months Ended March
31, 2005:
|
$2.00
Convertible
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
Capital
|
Retained
Earnings
|
Accumulated
Other
Comprehensive
Income
|
Total
Stockholders'
Equity
|
Balance at January 1, 2005 |
|
$40 |
|
$445,031 |
|
$4,817,024 |
|
$4,118,656 |
|
$467,152 |
|
$9,847,903 |
|
Net income | |
|
|
|
|
|
|
1,078,171 |
|
|
|
1,078,171 |
|
Currency translation adjustments | |
|
|
|
|
|
|
|
|
(155,820 |
) |
(155,820 |
) |
Unrealized gains on derivative contracts, net | |
|
|
|
|
|
|
|
|
22,310 |
|
22,310 |
|
Unrealized losses on marketable securities, net | |
|
|
|
|
|
|
|
|
(15,983 |
) |
(15,983 |
) |
|
|
|
|
|
|
| |
Comprehensive income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
928,678 |
|
|
|
|
|
|
|
| |
Cash dividends declared (1) | |
|
|
|
|
|
|
(307,268 |
) |
|
|
(307,268 |
) |
Common stock issued for stock options | |
|
|
431 |
|
30,228 |
|
|
|
|
|
30,659 |
|
Other exchanges | |
(1 |
) |
78 |
|
9,559 |
|
(485 |
) |
|
|
9,151 |
|
|
| |
| |
| |
| |
| |
| |
Balance at March 31, 2005 | |
$39 |
|
$445,540 |
|
$4,856,811 |
|
$4,889,074 |
|
$317,659 |
|
$10,509,123 |
|
|
| |
| |
| |
| |
| |
| |
| |
Three Months Ended March 31,
2004:
|
$2.00
Convertible
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
Capital
|
Retained
Earnings
|
Accumulated
Other
Comprehensive
Income
|
Total
Stockholders'
Equity
|
Balance at January 1, 2004 |
|
$42 |
|
$444,151 |
|
$4,764,390 |
|
$4,112,285 |
|
$(26,487 |
) |
$9,294,381 |
|
Net income | |
|
|
|
|
|
|
749,703 |
|
|
|
749,703 |
|
Currency translation adjustments | |
|
|
|
|
|
|
|
|
(58,817 |
) |
(58,817 |
) |
Unrealized gains on derivative contracts, net | |
|
|
|
|
|
|
|
|
9,170 |
|
9,170 |
|
Unrealized gains on marketable securities, net | |
|
|
|
|
|
|
|
|
2,449 |
|
2,449 |
|
|
|
|
|
|
|
| |
Comprehensive income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
702,505 |
|
|
|
|
|
|
|
| |
Cash dividends declared (2) | |
|
|
|
|
|
|
(306,604 |
) |
|
|
(306,604 |
) |
Common stock issued for stock options | |
|
|
167 |
|
13,181 |
|
|
|
|
|
13,348 |
|
Other exchanges | |
|
|
75 |
|
7,728 |
|
(165 |
) |
|
|
7,638 |
|
|
| |
| |
| |
| |
| |
| |
Balance at March 31, 2004 | |
$42 |
|
$444,393 |
|
$4,785,299 |
|
$4,555,219 |
|
$(73,685 |
) |
$9,711,268 |
|
|
| |
| |
| |
| |
| |
| |
| |
(1)
Includes the preferred stock cash dividend of $0.50 per share ($8 in the
aggregate) declared January 27, 2005 and payable on April 1, 2005.
(2)
Included the preferred stock cash dividend of $0.50 per share ($8 in the
aggregate) declared March 4, 2004 and paid on April 1, 2004.
The accompanying notes are an integral part of these consolidated condensed financial statements.
5
WYETH
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
|
Three Months
Ended March 31,
|
|
2005
|
2004
|
Operating Activities |
|
|
|
|
|
Net income
| |
$1,078,171 |
|
$749,703 |
|
Adjustments to reconcile net income to net cash
| |
provided by (used for) operating activities:
| |
Gains on sales of assets |
|
(155,712 |
) |
(132,480 |
) |
Depreciation and amortization |
|
166,353 |
|
147,394 |
|
Change in deferred income taxes |
|
138,088 |
|
17,964 |
|
Seventh Amendment security fund |
|
(1,250,000 |
) |
-- |
|
Diet drug litigation payments |
|
(289,593 |
) |
(98,643 |
) |
Changes in working capital, net |
|
(303,756 |
) |
(230,587 |
) |
Other items, net |
|
46,985 |
|
48,272 |
|
|
| |
| |
Net cash provided by (used for) operating activities |
|
(569,464 |
) |
501,623 |
|
|
| |
| |
Investing Activities |
|
Purchases of property, plant and equipment |
|
(213,030 |
) |
(291,583 |
) |
Proceeds from sales of assets |
|
170,959 |
|
228,836 |
|
Proceeds from sales and maturities of marketable securities |
|
1,067,199 |
|
182,800 |
|
Purchases of marketable securities |
|
(20,958 |
) |
(200,487 |
) |
|
| |
| |
Net cash provided by (used for) investing activities |
|
1,004,170 |
|
(80,434 |
) |
|
| |
| |
Financing Activities |
|
Repayments of long-term debt |
|
(328,187 |
) |
(1,500,000 |
) |
Other borrowing transactions, net |
|
(1,071 |
) |
(4,981 |
) |
Dividends paid |
|
(307,260 |
) |
(306,596 |
) |
Exercises of stock options |
|
30,659 |
|
13,348 |
|
|
| |
| |
Net cash used for financing activities |
|
(605,859 |
) |
(1,798,229 |
) |
|
| |
| |
Effect of exchange rate changes on cash and cash equivalents
| |
(10,563 |
) |
(1,414 |
) |
|
| |
| |
Decrease in cash and cash equivalents |
|
(181,716 |
) |
(1,378,454 |
) |
Cash and cash equivalents, beginning of period |
|
4,743,570 |
|
6,069,794 |
|
|
| |
| |
Cash and cash equivalents, end of period |
|
$4,561,854 |
|
$4,691,340 |
|
|
| |
| |
Supplemental Information |
|
Interest payments |
|
$157,833 |
|
$99,324 |
|
Income tax payments, net of refunds |
|
115,329 |
|
265,733 |
|
| |
The accompanying notes are an integral part of these consolidated condensed financial statements.
6
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Summary of
Significant Accounting Policies
|
The following policies are required interim updates to those disclosed in Footnote 1 of the
2004 Annual Report on Form 10-K: |
|
Stock-Based Compensation: The Company has four Stock Incentive Plans that it accounts for using
the intrinsic value method in accordance with APB Opinion No. 25, Accounting for Stock
Issued to Employees. All options granted under these plans have an exercise price
equal to the market value of the underlying common stock on the date of grant.
Accordingly, no stock-based employee compensation cost is reflected in net income other
than for the Companys restricted stock awards. The following table illustrates the
effect on net income and earnings per share if the Company had applied the fair value
recognition provisions of SFAS No. 123, Accounting for Stock-Based
Compensation as amended by SFAS No. 148, Accounting for Stock-Based Compensation
Transition and Disclosure, Amendment of SFAS No. 123, to stock-based
employee compensation: |
|
Three Months
Ended March 31,
|
(In thousands except per share amounts)
|
2005
|
2004
|
|
|
|
Net income, as reported |
|
$1,078,171 |
|
$749,703 |
|
Add: Stock-based employee compensation expense | |
included in reported net income, net of tax | |
4,477 |
|
2,493 |
|
Deduct: Total stock-based employee compensation | |
expense determined under fair value-based method | |
for all awards, net of tax |
|
(69,679 |
) |
(85,143 |
) |
|
| |
| |
Adjusted net income |
|
$1,012,969 |
|
$667,053 |
|
|
| |
| |
Earnings per share: |
|
Basic - as reported |
|
$0.81 |
|
$0.56 |
|
|
| |
| |
Basic - adjusted |
|
$0.76 |
|
$0.50 |
|
|
| |
| |
Diluted - as reported |
|
$0.80 |
|
$0.55 |
|
|
| |
| |
Diluted - adjusted |
|
$0.75 |
|
$0.49 |
|
|
| |
| |
|
|
|
On
December 16, 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123
(revised 2004), Share-Based Payment (Statement 123R). Statement 123R
replaces SFAS No. 123 and supersedes APB No. 25 and its related implementation guidance.
This Statement requires all share-based payments to employees, including grants of
employee stock options, to be recognized in the statement of operations as compensation
expense based on their fair values and over the vesting period of the award. Currently,
the Company provides the required pro forma expense effect of the grants in its footnote
disclosure. On April 14, 2005, the SEC approved a new
rule that, for public companies, delays the effective date of Statement 123R to annual,
rather than interim periods that begin after June 15, 2005. |
7
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
The
Company expects that the adoption of SFAS No. 123R will have a material impact on its
results of operations and earnings per share beginning in 2006. However, the Company has
not yet determined the impact of adopting SFAS No. 123R because of changes in the
Companys share-based compensation programs. |
|
Goodwill
and Other Intangibles: In accordance with SFAS No. 142, Goodwill and Other
Intangible Assets, the changes in the carrying amount of goodwill by reportable
segment for the three months ended March 31, 2005 are as follows: |
(In thousands)
|
Pharmaceuticals
|
Consumer Healthcare
|
Animal Health
|
Total
|
Balance at December 31, 2004 |
|
$2,728,565 |
|
$593,606 |
|
$534,239 |
|
$3,856,410 |
|
Currency translation adjustments |
|
(12,016 |
) |
(460 |
) |
(238 |
) |
(12,714 |
) |
|
| |
| |
| |
| |
|
|
|
|
|
Balance at March 31, 2005 |
|
$2,716,549 |
|
$593,146 |
|
$534,001 |
|
$3,843,696 |
|
|
| |
| |
| |
| |
8
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 2. Earnings per
Share
The
following table sets forth the computations of basic earnings per share and diluted
earnings per share:
|
Three Months
Ended March 31,
|
(In thousands except per share amounts)
|
2005
|
2004
|
Net income less preferred dividends |
|
$1,078,163 |
|
$749,695 |
|
Denominator: |
|
Weighted average common shares outstanding
| |
1,335,909 |
|
1,332,926 |
|
|
| |
| |
|
|
|
Basic earnings per share |
|
$0.81 |
|
$0.56 |
|
|
| |
| |
|
|
|
Numerator: |
|
Net income |
|
$1,078,171 |
|
$749,703 |
|
Interest expense on contingently convertible debt(1) | |
4,064 |
|
1,010 |
|
|
| |
| |
|
|
|
Net income, as adjusted |
|
$1,082,235 |
|
$750,713 |
|
|
| |
| |
|
|
|
Denominator: |
|
Weighted average common shares outstanding
| |
1,335,909 |
|
1,332,926 |
|
Common stock equivalents of outstanding stock | |
options, deferred contingent common stock | |
awards and convertible preferred stock(2) | |
4,344 |
|
4,817 |
|
Common stock equivalents of assumed conversion | |
of contingently convertible debt(1) | |
16,890 |
|
16,890 |
|
|
| |
| |
|
|
|
Total shares(2) |
|
1,357,143 |
|
1,354,633 |
|
|
| |
| |
|
|
|
Diluted earnings per share(1)(2) |
|
$0.80 |
|
$0.55 |
|
|
| |
| |
|
|
|
|
(1) |
Diluted
earnings per share reflects the impact of Emerging Issues Task Force Issue
No. 04-8 (EITF No. 04-8), Accounting Issues Related to Certain Features
of Contingently Convertible Debt and the Effect on Diluted Earnings
per Share, which requires the inclusion of the dilutive effect from
contingently convertible debt instruments with market price contingencies
in the calculation of diluted earnings per share (EPS). Accordingly,
interest expense on the Companys contingently convertible debt, net
of capitalized interest and taxes, is added back to reported net income,
and the additional common shares (assuming conversion) are included in
total shares outstanding for purposes of calculating diluted EPS. In
accordance with EITF No. 04-8, which is effective for all periods ending
after December 15, 2004 with restatement of previously reported diluted
EPS calculations, the 2004 first quarter diluted EPS has been restated to
reflect a $0.01 dilution as a result of the application of this Issue. |
|
(2) |
At
March 31, 2005 and 2004, approximately 100,446 and 107,070 of common shares,
respectively, related to options outstanding under the Companys
Stock Incentive Plans were excluded from the computation of diluted
earnings per share, as the effect would have been antidilutive. |
9
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 3.
Marketable
Securities
|
The
Company has marketable debt and equity securities, which are classified as either
available-for-sale or held-to-maturity, depending on managements investment
intentions at the time of purchase relating to these securities. |
|
The
cost, gross unrealized gains (losses) and fair value of available-for-sale and
held-to-maturity securities by major security type at March 31, 2005 and December 31, 2004
were as follows: |
(In thousands)
At March 31, 2005
|
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized (Losses)
|
Fair
Value
|
Available-for-sale: |
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$20,671 |
|
$ -- |
|
$(392 |
) |
$20,279 |
|
Commercial paper |
|
3,988 |
|
-- |
|
-- |
|
3,988 |
|
Certificates of deposit |
|
8,530 |
|
-- |
|
(11 |
) |
8,519 |
|
Corporate debt securities |
|
227,877 |
|
130 |
|
(509 |
) |
227,498 |
|
Mortgage-backed securities |
|
11,453 |
|
22 |
|
-- |
|
11,475 |
|
Other debt securities |
|
2,464 |
|
-- |
|
(10 |
) |
2,454 |
|
Equity securities |
|
48,264 |
|
8,305 |
|
(16,017 |
) |
40,552 |
|
Institutional fixed income fund |
|
341,128 |
|
9,831 |
|
(3,423 |
) |
347,536 |
|
|
| |
| |
| |
| |
Total available-for-sale |
|
664,375 |
|
18,288 |
|
(20,362 |
) |
662,301 |
|
|
| |
| |
| |
| |
Held-to-maturity: |
|
Commercial paper |
|
16,897 |
|
-- |
|
-- |
|
16,897 |
|
Other debt securities |
|
180 |
|
-- |
|
-- |
|
180 |
|
|
| |
| |
| |
| |
|
|
|
|
|
Total held-to-maturity |
|
17,077 |
|
-- |
|
-- |
|
17,077 |
|
|
| |
| |
| |
| |
|
|
|
|
|
|
|
$681,452 |
|
$18,288 |
|
$(20,362 |
) |
$679,378 |
|
|
| |
| |
| |
| |
(In thousands)
At December 31, 2004
|
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized (Losses)
|
Fair
Value
|
Available-for-sale: |
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$60,439 |
|
$ -- |
|
$(286 |
) |
$60,153 |
|
Commercial paper |
|
32,597 |
|
-- |
|
-- |
|
32,597 |
|
Certificates of deposit |
|
54,867 |
|
3 |
|
(52 |
) |
54,818 |
|
Corporate debt securities |
|
485,007 |
|
130 |
|
(528 |
) |
484,609 |
|
Asset-backed securities |
|
258,543 |
|
15 |
|
(166 |
) |
258,392 |
|
Mortgage-backed securities |
|
77,983 |
|
4 |
|
(67 |
) |
77,920 |
|
Other debt securities |
|
2,469 |
|
-- |
|
(12 |
) |
2,457 |
|
Equity securities |
|
48,264 |
|
8,998 |
|
(6,918 |
) |
50,344 |
|
Institutional fixed income fund |
|
531,929 |
|
16,713 |
|
-- |
|
548,642 |
|
|
| |
| |
| |
| |
Total available-for-sale |
|
1,552,098 |
|
25,863 |
|
(8,029 |
) |
1,569,932 |
|
|
| |
| |
| |
| |
Held-to-maturity: |
|
Commercial paper |
|
175,626 |
|
-- |
|
-- |
|
175,626 |
|
|
| |
| |
| |
| |
|
|
|
|
|
|
|
$1,727,724 |
|
$25,863 |
|
$(8,029 |
) |
$1,745,558 |
|
|
| |
| |
| |
| |
10
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
The
contractual maturities of debt securities classified as available-for-sale at March 31,
2005 were as follows: |
(In thousands)
|
Cost
|
Fair Value
|
Available-for-sale: |
|
|
|
|
|
Due within one year |
|
$112,400 |
|
$112,046 |
|
Due after one year through five years | |
146,022 |
|
145,576 |
|
Due after five years through 10 years | |
1,613 |
|
1,602 |
|
Due after 10 years |
|
14,948 |
|
14,989 |
|
|
| |
| |
|
|
|
|
|
$274,983 |
|
$274,213 |
|
|
| |
| |
|
All
held-to-maturity debt securities are due within one year and had aggregate fair values of
$17.1 million at March 31, 2005. |
Note 4.
Pensions and Other Postretirement Benefits
|
Net
periodic benefit cost for the Companys defined benefit plans for the three months
ended March 31, 2005 and 2004 (principally for the U.S.) was as follows: |
|
Pensions
|
Other Postretirement Benefits
|
|
Three Months
Ended March 31,
|
Three Months
Ended March 31,
|
(In thousands)
Components of Net Periodic Benefit Cost
|
2005
|
2004
|
2005
|
2004
|
Service cost |
|
$41,969 |
|
$35,371 |
|
$12,255 |
|
$11,145 |
|
Interest cost |
|
66,259 |
|
62,293 |
|
25,748 |
|
23,560 |
|
Expected return on plan assets |
|
(82,731 |
) |
(76,304 |
) |
-- |
|
-- |
|
Amortization of prior service cost |
|
2,146 |
|
2,843 |
|
(5,231 |
) |
(3,709 |
) |
Amortization of transition obligation |
|
287 |
|
(422 |
) |
-- |
|
-- |
|
Recognized net actuarial loss |
|
25,888 |
|
22,463 |
|
12,037 |
|
7,840 |
|
|
| |
| |
| |
| |
|
|
|
|
|
Net periodic benefit cost |
|
$53,818 |
|
$46,244 |
|
$44,809 |
|
$38,836 |
|
|
| |
| |
| |
| |
|
As
of March 31, 2005, $9.9 million and $24.7 million of contributions have been made in 2005
to the Companys defined benefit pension plans and other postretirement benefit
plans, respectively. The Company presently anticipates total contributions to be made
during 2005 to fund its defined benefit pension and other postretirement benefit plans
will approximate $200.0 million and $110.0 million, respectively. |
11
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 5.
Contingencies and Commitments
|
The
Company is involved in various legal proceedings, including product liability and
environmental matters, of a nature considered normal to its business. It is the
Companys policy to accrue for amounts related to these legal matters if it is
probable that a liability has been incurred and an amount is reasonably estimable. |
|
In
the opinion of the Company, although the outcome of any legal proceedings cannot be
predicted with certainty, the ultimate liability of the Company in connection with its
legal proceedings (other than the diet drug litigation discussed immediately below) will
not have a material adverse effect on the Companys financial position but could be
material to the results of operations or cash flows in any one accounting period. |
|
The
Company has been named as a defendant in numerous legal actions relating to the diet drugs
PONDIMIN (which in combination with phentermine, a product that was not
manufactured, distributed or sold by the Company, was commonly referred to as
fen-phen) or REDUX, which the Company estimated were used in the United
States, prior to their 1997 voluntary market withdrawal, by approximately 5.8 million
people. These actions allege, among other things, that the use of REDUX and/or
PONDIMIN, independently or in combination with phentermine, caused certain serious
conditions, including valvular heart disease and primary pulmonary hypertension (PPH). The
REDUX and PONDIMIN litigation is described in additional detail in the
Companys Annual Report on Form 10-K for the year ended December 31, 2004. |
|
On
October 7, 1999, the Company announced a nationwide class action settlement (the
settlement) to resolve litigation brought against the Company regarding the use of the
diet drugs REDUX or PONDIMIN. The settlement covered all claims arising out
of the use of REDUX or PONDIMIN, except for PPH claims, and was open to all
REDUX or PONDIMIN users in the United States. As originally designed, the
settlement was administered by an independent Settlement Trust and comprised of two
settlement funds. Fund A (with a value at the time of settlement of $1,000.0 million plus $200.0
million for legal fees) was created to cover refunds, medical screening costs, additional
medical services and cash payments, education and research costs, and administration
costs. Fund A has been fully funded by contributions by the Company. Fund B (which was to
be funded by the Company on an as-needed basis up to a total of $2,550.0 million) would
compensate claimants with significant heart valve disease depending upon their age and the
severity of their condition according to a five-level settlement matrix. The two funds
have now been combined into a single fund. Payments in connection with the nationwide
settlement were $96.0 million in the First Quarter of 2005. Payments may continue, if
necessary, until 2018. |
|
In
2004, the Company increased its reserves in connection with the REDUX and
PONDIMIN diet drug matters by $4,500.0 million, bringing the total of the charges
taken to date to $21,100.0 million. The $6,876.7 million reserve balance at March 31, 2005
represents managements best estimate, within a range of outcomes, of the aggregate
amount required to cover diet drug litigation costs, including payments in connection with
the nationwide settlement (as it would be amended by the proposed Seventh Amendment,
discussed below), initial opt outs, PPH claims, downstream opt out |
12
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
cases and the
Companys legal fees related to the diet drug litigation. The latest charge by the
Company takes into account the terms of the proposed Seventh Amendment, the Companys
settlement discussions with plaintiffs attorneys representing a number of
individuals who have opted out of the nationwide settlement, its experiences with the
downstream opt out cases that have been litigated or settled to date and its projected
expenses in connection with the diet drug litigation. However, due to the need for final
appellate court approval of the proposed Seventh Amendment, the preliminary status of the
Companys settlement discussions with attorneys representing certain downstream opt
out plaintiffs, the uncertainty of the Companys ability to consummate settlements
with the downstream opt out plaintiffs, the number and amount of any future verdicts that
may be returned in downstream opt out and PPH litigation, and the inherent uncertainty
surrounding any litigation, it is possible that additional reserves may be required in the
future and the amount of such additional reserves may be significant. |
|
The
Company intends to vigorously defend itself and believes it can marshal significant
resources and legal defenses to limit its ultimate liability in the diet drug litigation.
However, in light of the circumstances discussed above, it is not possible to predict the
ultimate liability of the Company in connection with its diet drug legal proceedings. It
is therefore not possible to predict whether, and if so when, such proceedings will have a
material adverse effect on the Companys financial condition, results of operations
and/or cash flows and whether cash flows from operating activities and existing and
prospective financing resources will be adequate to fund the Companys operations,
pay all liabilities related to the diet drug litigation, pay dividends, maintain the
ongoing programs of capital expenditures, and repay both the principal and interest on its
outstanding obligations without the disposition of significant strategic core assets
and/or reductions in certain cash outflows. |
|
Seventh Amendment to the Nationwide Settlement |
|
During
2004, the Company, counsel for the plaintiff class in the nationwide settlement and
counsel for certain individual class members negotiated a proposed Seventh Amendment to
the settlement agreement that would create a new claims processing structure, funding
arrangement and payment schedule for claims for compensation based on Levels I and II of
the five-level settlement matrix. These claims are the most numerous, but least serious,
of the claims filed for matrix benefits. The total number of currently filed Level I and
Level II claims posed the risk that the Settlement Trusts funds might be exhausted. |
|
On
March 15, 2005, United States District Judge Harvey Bartle III, the federal judge of the
United States District Court for the Eastern District of Pennsylvania overseeing the
settlement, approved the proposed Seventh Amendment as fair, adequate and
reasonable. Appeals from Judge Bartles decision have been filed with the
United States Court of Appeals for the Third Circuit. Briefing and argument of the appeals before the
Third Circuit has not yet been scheduled. If upheld
on appeal, the proposed Seventh Amendment would include the following key terms: |
13
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
o |
The
amendment would create a new Supplemental Fund, to be administered by a Fund
Administrator who will be appointed by the District Court and who will process most
pending Level I and Level II matrix claims; |
|
o |
After
District Court approval, the Company would make initial payments of up to $50.0 million
to facilitate the establishment of the Supplemental Fund and to begin reviewing claims.
Following affirmance by the Third Circuit of the District Courts approval and the
exhaustion of any further appellate review, the Company would make an initial payment of
$400.0 million to enable the Supplemental Fund to begin paying claims. The timing of
additional payments would be dictated by the rate of review and payment of claims by the
Fund Administrator. The Company would ultimately deposit a total of $1,275.0 million, net
of certain credits, into the Supplemental Fund; |
|
o |
All
participating matrix Level I and Level II claimants who qualify under the Seventh
Amendment, who pass the Settlement Funds medical review and who otherwise satisfy
the requirements of the settlement (Category One class members) would receive a pro rata
share of the $1,275.0 million Supplemental Fund, after deduction of certain expenses and
other amounts from the Supplemental Fund. The pro rata amount would vary depending upon
the number of claimants who pass medical review, the nature of their claims, their age
and other factors. A participating Category One class member who does not qualify for a
payment after such medical review would be paid $2,000 from the Supplemental Fund; |
|
o |
Participating
class members who might in the future have been eligible to file Level I and Level II
matrix claims (Category Two class members) would be eligible to receive a $2,000 payment
from the Trust; such payments would be funded by the Company apart from its other funding
obligations under the nationwide settlement; |
|
o |
If
the participants in the Seventh Amendment have heart valve surgery or other more serious
medical conditions on Levels III through V of the nationwide settlement matrix by the
earlier of 15 years from the date of their last diet drug ingestion or by December 31,
2011, they would remain eligible to submit claims to the existing Trust and be paid the
current matrix amounts if they qualify for such payments under terms modified by the
Seventh Amendment. In the event the existing Trust is unable to pay those claims, the
Company would guarantee payment; and |
|
o |
All
class members who participate in the Seventh Amendment would give up any further opt out
rights as well as the right to challenge the terms of and the binding effect of the
nationwide settlement. Final approval of the Seventh Amendment also would preclude any
lawsuits by the Trust or the Company to recover any amounts previously paid to class
members by the Trust, as well as terminate the Claims Integrity Program (discussed below)
as to all claimants who do not opt out of the Seventh Amendment. |
|
On
March 29, 2005, as collateral for the Companys financial obligations under the
Seventh Amendment, the Company established a security fund in the amount of $1,250.0
million. As of March 31, 2005, $660.0 million was included in Other current assets
|
14
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
including deferred taxes and $590.0 million was included in Other assets including
deferred taxes. The amounts in the security fund are owned by the Company and
will earn interest income for the Company while residing in the security fund. |
|
There
can be no assurance that the proposed Seventh Amendment will be upheld on appeal. If it is
upheld on appeal, only the claims of those class members who opted out of the Seventh
Amendment will be processed under the terms of the existing settlement agreement and under
the procedures that have been adopted by the Settlement Trust and the District Court. Less
than 5% of the class members who would be affected by the proposed Seventh Amendment
(approximately 1,900 of the Category One class members and approximately 5,100 of the
Category Two class members) elected to opt out of the Seventh Amendment and to remain
bound by the current settlement terms. Should the proposed Seventh Amendment not be upheld
on appeal, all of the pending and future matrix claims would be processed under the terms
of the existing settlement agreement. |
|
Nationwide Settlement Matrix Claims Data |
|
The
settlement agreement grants the Company access to claims data maintained by the Settlement
Trust. Based on its review of that data, the Company understands that, as of March 30,
2005, the Trust had recorded approximately 121,270 matrix claim forms. Approximately
33,285 of these forms were so deficient, incomplete or duplicative of other forms filed by
the same claimant that, in the Companys view, it is unlikely that a significant
number of these forms will result in further claims processing. |
|
The
Companys understanding of the status of the remaining approximately 87,985 forms,
based on its analysis of data received from the Trust through March 30, 2005, is as
follows. Approximately 24,635 of the matrix claims had been processed to completion, with
those claims either paid (approximately 3,975 payments, totaling $1.441 billion, had been
made to approximately 3,790 claimants), denied or in show cause proceedings (approximately
19,035) or withdrawn. Approximately 2,150 claims were in some stage of the 100% audit
process ordered in late 2002 by the District Court overseeing the national settlement. An
additional approximately 18,255 claims alleged conditions that, if true, would entitle the
claimant to receive a matrix award; these claims had not yet entered the audit process.
Another approximately 24,035 claims with similar allegations have been purportedly
substantiated by physicians or filed by law firms whose claims are now subject to the
outcome of the Trusts Claims Integrity Program.(1) Approximately 18,855
claim forms did not contain sufficient information even to assert a matrix claim, although
some of those claim forms could be made complete by the submission of additional
information and could therefore become eligible to proceed to audit in the future. The
remaining approximately 55 claims were in the data entry process and could not be
assessed. |
|
Challenges to the Nationwide Settlement |
|
Counsel
representing approximately 8,600 class members have filed a motion with the District Court
seeking a ruling that the nationwide settlement agreement is void. The motion asserts that
there was inadequate representation of the class when the settlement |
15
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
agreement was
negotiated, that the parties and their experts made mutual mistakes in projecting the
amount of money that would be needed to pay all valid claims, that the original notice to
the class was inadequate and that the Court had lacked subject matter jurisdiction over
some of the class members claims. The motion seeks an opportunity for all class
members to decide a second time whether or not to be included in the class and therefore
bound by the settlement agreement. The District Court had stayed briefing and
consideration of the motion pending its decision on approval of the proposed Seventh
Amendment, which as discussed above would preclude such claims on behalf of class members
who participate. A new schedule for briefing of the motion has not been set. |
|
Certain
class members also have filed a number of other motions and lawsuits attacking both the
binding effect of the settlement and the administration of the Trust, some of which have
been decided against class members and currently are on appeal. The Company cannot predict
the outcome of any of these motions or lawsuits. |
|
As
of March 31, 2005, approximately 62,000 individuals who had filed Intermediate or Back-End
opt out forms had pending lawsuits against the Company. The claims of approximately 48% of
the plaintiffs in the Intermediate and Back-End opt out cases served on the Company are
pending in Federal Court, with approximately 38% pending in State Courts. The claims of
approximately 14% of the Intermediate and Back-End opt out plaintiffs have been removed
from State Courts to Federal Court but are still subject to a possible remand to State
Court. In addition, a large number of plaintiffs have asked the U.S. Court of Appeals for
the Third Circuit to review and reverse orders entered by the Federal Court overseeing the
settlement which had denied the plaintiffs motions to remand their cases to State
Court. As of March 31, 2005, approximately 2,875 Intermediate or Back-End opt out
plaintiffs have had their lawsuits dismissed for procedural or medical deficiencies or for
various other reasons. |
|
The
claims of 13 class members who had taken advantage of the Intermediate and Back-End opt
out rights created in the nationwide settlement went to verdict from January 1 through
April 29, 2005. Three of those verdicts were returned in favor of plaintiffs, in the
aggregate amount of less than $50,000, at the close of the initial stage of a trial
bifurcated to consider medical causation and damages in the first phase and liability in
the second phase. A verdict in the amount of $50,000 was returned in favor of another
plaintiff in a similarly bifurcated trial. Those cases have since been settled. Seven of
the verdicts were defense verdicts in favor of the Company at the close of the initial
phase in similarly bifurcated trials. The remaining two verdicts involved cases in which
the jury initially found in favor of the plaintiffs for $5 million and $500,000
respectively, but subsequently found for the Company during the liability phase, thereby
negating the earlier damage finding. A number of additional cases were settled, dismissed
or adjourned during the first quarter of 2005. Additional Intermediate and Back-End opt
out trials are scheduled throughout 2005 and 2006. |
16
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
On
January 18, 2005, the Company and counsel representing certain downstream opt out
plaintiffs filed a motion with the District Court advising the Court that those parties
had developed a proposed process by which large numbers of the downstream opt out cases
might be negotiated and settled. The proposed process provides a methodology for valuing
different categories of claims and also provides a structure for individualized
negotiations between Wyeth and lawyers representing diet drug claimants. Counsel for more
than half of the plaintiffs with pending Intermediate and Back-End Opt Out lawsuits have
agreed to participate in the process and the Company is moving forward with settlement
discussions with those attorneys. However, the Company cannot predict the number of cases
that might be settled as a result of such a process. |
|
On
April 27, 2004, a jury in Beaumont, Texas hearing the case of Coffey, et al. v. Wyeth,
et al., No. E-167,334, 172nd Judicial District Court, Jefferson Cty., TX, returned a
verdict in favor of the plaintiffs for $113.4 million in compensatory damages and $900.0
million in punitive damages for the wrongful death of the plaintiffs decedent,
allegedly as a result of PPH caused by her use of PONDIMIN. On May 17, 2004, the
Trial Court entered judgment on behalf of the plaintiffs for the full amount of the
jurys verdict, as well as $4.2 million in pre-judgment interest and $188,737 in
guardian ad litem fees. On July 26, 2004, the Trial Court denied in their entirety the
Companys motions for a new trial or for judgment notwithstanding the verdict,
including the Companys request for application of Texas statutory cap on
punitive damage awards. The Company has filed an appeal from the judgment entered by the
Trial Court and believes that it has strong arguments for reversal or reduction of the
awards on appeal due to the significant number of legal errors made during trial and in
the charge to the jury and due to a lack of evidence to support aspects of the verdict. In
connection with its appeal, the Company was required by Texas law to post a bond in the
amount of $25.0 million. The Company filed its brief in support of the appeal on April 14,
2005. Oral argument is not expected until later in 2005. |
|
As
of April 15, 2005, the Company was a defendant in approximately 375 pending lawsuits in
which the plaintiff alleges a claim of PPH, alone or with other alleged injuries. Almost
all of these claimants must meet the definition of PPH set forth in the national
settlement agreement in order to pursue their claims outside of the national settlement
(payment of such claims, by settlement or judgment, would be made by the Company and not
by the Trust). Approximately 75 of these cases appear to be eligible to pursue a PPH
lawsuit under the terms of the national settlement. In approximately 10 of the 375 cases,
the Company expects the PPH claims to be voluntarily dismissed by the plaintiffs (although
they may continue to pursue other claims). In approximately 125 of these cases, the
Company has filed or expects to file motions under the terms of the national settlement to
preclude plaintiffs from proceeding with their PPH claims. For the balance of these cases,
the Company currently has insufficient medical information to assess whether or not the
plaintiffs meet the definition of PPH under the national settlement. The Company is aware
of approximately 10 additional PPH claims which are not currently the subject of a lawsuit
but which appear to meet the settlements PPH |
17
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
|
definition. The Company continues to
work toward resolving the claims of individuals who allege that they have developed PPH as
a result of their use of the diet drugs and intends to vigorously defend those PPH cases
that cannot be resolved prior to trial. |
|
(1) |
Pursuant
to its Claims Integrity Program, the Settlement Trust has required additional
information concerning matrix claims purportedly substantiated by 18 identified
physicians or filed by two law firms in order to determine whether to permit
those claims to proceed to the 100% audit process established by the District
Court. Based upon data obtained from the Trust, the Company believes that
approximately 24,035 matrix claims were purportedly substantiated by the 18
physicians and/or filed by the two law firms covered by the Claims Integrity
Program as of March 30, 2005. It is the Companys understanding that
additional claims substantiated by additional physicians or filed by additional
law firms might be subjected to the same requirements of the Claims Integrity
Program in the future. The ultimate disposition of any or all claims that are
subject to the Claims Integrity Program is at this time uncertain. Counsel for
certain claimants affected by the program have challenged the Trusts
authority to implement the Claims Integrity Program and to require completion
of the questionnaire before determining whether to permit those claims to
proceed to audit. While that motion was denied by the Court, additional
challenges to the Claims Integrity Program and to the Trusts matrix claim
processing have been filed. The Trust has also instituted civil litigation
alleging fraud on the part of two physicians who substantiated matrix claims.
As indicated above, following final judicial approval of the Seventh Amendment,
the Claims Integrity Program will be terminated as to all claimants who have
not opted out of the Seventh Amendment. |
18
WYETH
NOTES TO CONSOLIDATED
CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 6.
Company Data by Segment
|
The
Company has four reportable segments: Wyeth Pharmaceuticals (Pharmaceuticals), Wyeth
Consumer Healthcare (Consumer Healthcare), Fort Dodge Animal Health (Animal Health) and
Corporate. The Companys Pharmaceuticals, Consumer Healthcare and Animal Health
reportable segments are strategic business units that offer different products and
services. The reportable segments are managed separately because they manufacture,
distribute and sell distinct products and provide services that require differing
technologies and marketing strategies. The Companys Corporate segment is responsible
for the treasury, tax and legal operations of the Companys businesses and maintains
and/or incurs certain assets, liabilities, income, expense, gains and losses related to
the overall management of the Company which are not allocated to the other reportable
segments. |
|
Net Revenue
|
Income (Loss) Before Income Taxes
|
(In thousands) |
Three Months
Ended March 31,
|
Three Months
Ended March 31,
|
Segment
|
2005
|
2004
|
2005
|
2004
|
Pharmaceuticals(1) |
|
$3,717,469 |
|
$3,207,586 |
|
$1,238,532 |
|
$872,113 |
|
Consumer Healthcare |
|
616,790 |
|
588,351 |
|
121,140 |
|
109,458 |
|
Animal Health |
|
244,739 |
|
218,852 |
|
51,189 |
|
37,694 |
|
Corporate |
|
-- |
|
-- |
|
(37,395 |
) |
(75,374 |
) |
|
| |
| |
| |
| |
|
|
|
|
|
Total(2) |
|
$4,578,998 |
|
$4,014,789 |
|
$1,373,466 |
|
$943,891 |
|
|
| |
| |
| |
| |
|
(1) |
Pharmaceuticals
for the 2004 first three months included a first quarter charge of
$145,500 within Research and development expenses related to
the upfront payment to Solvay Pharmaceuticals in connection with the
co-development and co-commercialization of four neuroscience compounds,
most notably, bifeprunox, a late stage compound in Phase 3 development for
schizophrenia and other possible uses. |
|
(2) |
Income
before income taxes for the 2005 and 2004 first three months included
approximately $138,500 and $140,700, respectively, related to gains from
the divestiture of certain Pharmaceuticals and Consumer Healthcare
products. The 2005 divestitures included product rights to SYNVISC and
EPOCLER (in Brazil). The 2004 divestitures included product rights
to indiplon, DIAMOX (in Japan), and the Companys nutritionals products in
France. |
19
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
Item 2.
Results of Operations
|
Wyeth
is one of the worlds largest research-based pharmaceutical and health care products
companies and is a leader in the discovery, development, manufacturing and marketing of
pharmaceuticals, biologicals, vaccines, non-prescription medicines and animal health care.
The Company has four reportable segments: Wyeth Pharmaceuticals (Pharmaceuticals), Wyeth
Consumer Healthcare (Consumer Healthcare), Fort Dodge Animal Health (Animal Health) and
Corporate, which are managed separately because they manufacture, distribute and sell
distinct products and provide services which require differing technologies and marketing
strategies. These segments reflect how senior management reviews the business, makes
investing and resource allocation decisions, and assesses operating performance. |
|
Our
Pharmaceuticals segment, which provided 81% of our worldwide net revenue for the first
three months of 2005 and 80% for the first three months of 2004, manufactures, distributes
and sells branded human ethical pharmaceuticals, biologicals and nutritionals. Principal
products include neuroscience therapies, cardiovascular products, nutritionals,
gastroenterology drugs, anti-infectives, vaccines, oncology therapies, musculoskeletal
therapies, hemophilia treatments, immunology products and womens health care
products. These products are promoted and sold worldwide primarily to wholesalers,
pharmacies, hospitals, physicians, retailers and other human health care institutions. |
|
The
Consumer Healthcare segment, which provided approximately 14% of our worldwide net revenue
for the first three months of 2005 and 15% for the first three months of 2004,
manufactures, distributes and sells over-the-counter health care products, which include
analgesics, cough/cold/allergy remedies, nutritional supplements, and hemorrhoidal, asthma
and personal care items. These products generally are sold to wholesalers and retailers
and are promoted primarily to consumers worldwide through advertising. |
|
Our
Animal Health segment, which provided 5% of our worldwide net revenue for the first three
months of both 2005 and 2004, manufactures, distributes, and sells animal biological and
pharmaceutical products, including vaccines, pharmaceuticals, parasite control and growth
implants. These products are sold to wholesalers, retailers, veterinarians and other
animal health care institutions. |
|
The
Corporate segment is responsible for the treasury, tax and legal operations of the
Companys businesses. It maintains and/or incurs certain assets, liabilities, income,
expenses, gains and losses related to the overall management of the Company that are not
allocated to the other reportable segments. |
|
Wyeth
exhibited strong revenue growth for the 2005 first three months, achieving a 14% increase
in worldwide net revenue compared with the first three months of 2004. |
20
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Pharmaceuticals
had net revenue of $3,717.5 million for the 2005 first three months, representing growth
of 16% over the 2004 first three months, which was driven by the strong performance of
several key products: |
|
|
|
|
o
o
o
o
o
|
EFFEXOR (a neuroscience therapy) - up 12% to $868.5 million
PREVNAR (a vaccine) - up 126% to $391.1 million
ENBREL (a musculoskeletal therapy) - up 75% (internationally, where the Company has exclusive marketing rights)
to $237.0 million
ZOSYN/TAZOCIN (an infectious disease drug) - up 26% to $229.3 million
RAPAMUNE (an immunology product) - up 24% to $72.1 million
|
|
|
|
|
Collectively,
sales of these products increased 36% for the first three months of 2005 compared with the
first three months of 2004. |
|
In
September 2004, the U.S. Centers for Disease Control and Prevention (CDC) issued an
updated recommendation for the use of PREVNAR reinstating the full, four-dose
vaccination schedule. In August 2004, the European Medicines Agency (EMEA) and Committee
for Medicinal Products for Human Use (CHMP) announced a return to the normal dosing
schedule for PREVNAR in Europe. First quarter net revenue growth for PREVNAR
reflected a return to the full dose vaccination schedule, the resolution of manufacturing
issues that limited production and a catch-up of deferred doses from the 2004 first half
that resulted from supply constraints. |
|
Other
areas of revenue growth for the Pharmaceuticals segment for the 2005 first three months
included nutritionals, ZOTON, BENEFIX and rhBMP-2 and alliance
revenue predominantly from sales of ENBREL (in North America). |
|
PROTONIX
net revenue for the first three months of 2005 of $409.4 million was comparable with
the first three months of 2004. PROTONIX business is shifting from the more heavily
discounted Medicaid segment to the less heavily discounted third party managed care
segment. This trend is expected to continue throughout 2005 and, despite an anticipated
decline in the rate of overall prescription volume growth, it is expected to have a
positive impact on profitability. |
|
Growth
in EFFEXOR revenue is moderating, reflecting several factors. The antidepressant
category is maturing and growth overall has slowed. In addition, negative publicity
regarding antidepressants and increased concern about the use of these products in
children and adolescents have had an impact. In late 2004, the Food and Drug Administration
(FDA) directed all manufacturers of antidepressant medications to implement labeling
changes regarding the use of these agents and the risk of suicidality in children and
adolescents. In March 2005, we implemented these labeling changes. EFFEXOR has
never been recommended for use in children and continues to
be an appropriate and important therapy in treating adult patients with major
depressive disorder, generalized anxiety disorder and social anxiety disorder.
An indication for |
21
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
panic disorder, filed in the U.S.,
Canada and Europe in the second half of last year, is currently pending. |
|
In
July 2002, the National Institutes of Health (NIH) announced that it was discontinuing a
portion of its Womens Health Initiative (WHI) study assessing the value of
combination estrogen plus progestin therapy, and, in early March 2004, the portion of the
study addressing estrogen-only therapy also was discontinued. In March 2005, an
independent panel, meeting in conjunction with the NIH-sponsored conference on the
Management of Menopause-Related Symptoms, issued a statement supporting the use of
postmenopausal hormone therapy (HT) for the management of moderate to severe menopausal
symptoms and agreed that HT remains the most consistently effective therapy for treating
menopausal symptoms. We remain committed to womens health care and stand behind the
PREMARIN family of products as the standard of therapy to help women address
serious menopausal symptoms. We introduced low-dose versions of PREMARIN and
PREMPRO in 2003, launched a direct-to-consumer (DTC) advertising campaign
featuring PREMPRO 0.3 mg/1.5 mg in 2004, and launched a DTC advertising campaign
for PREMARIN in March 2005. Despite these efforts, sales of the PREMARIN
family of products declined from $265.9 million for the 2004 first quarter to $210.9
million for the 2005 first quarter; however, the launch of low-dose PREMARIN and
PREMPRO has helped to moderate the decrease in sales. The decline also reflects a
reduction of inventory levels in the wholesale channel in the 2005 first quarter. |
|
Both
Consumer Healthcare and Animal Health posted increases in net revenue for the 2005 first
quarter over the 2004 first quarter. Consumer Healthcare net revenue increased 5% for the
2005 first quarter primarily from increased sales of ROBITUSSIN, ADVIL and
CALTRATE brands. Animal Health net revenue increased 12% for the 2005 first
quarter, reflecting higher sales of companion animal and livestock products despite the
impact of the voluntary recall of PROHEART 6 in the U.S. market in September
2004. |
|
In
order for us to sustain the growth of our core group of products, we must continue to meet
the global demand of our customers. Two of our important core products, PREVNAR and
ENBREL, are biological products that are extremely complicated and difficult to
manufacture. We continue to seek to improve manufacturing processes and overcome
production issues. With respect to PREVNAR, during 2004, upgrades and improvements
were made to the Wyeth manufacturing facilities and additional vial filling capacity
became available through a third-party filler. Regulatory approval of pre-filled syringes
from another third-party filler for Europe has been received and launch of pre-filled
syringes in Europe is anticipated for mid-year 2005. Pre-filled syringes from Wyeth and
the third-party filler are expected, pending regulatory approval, to be launched in the
U.S. in early 2006. Overall, we expect to meet our 2005 PREVNAR production goal of
25 28 million doses. |
|
We
anticipate regulatory approval in 2005 for the production of ENBREL
at our Grange Castle, Ireland site as well as at Amgen Inc.s (Amgen)
BioNext facility in Rhode Island. |
22
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
This expected additional manufacturing capacity should
help ENBREL reach its full commercial potential, although, as is typical for new
biological manufacturing facilities, margins are expected to be affected during at least
the initial year of production. In late March 2005, ENBREL was launched for the
treatment of rheumatoid arthritis in Japan, where it is co-promoted by Wyeth and Takeda
Pharmaceutical Company, Limited (Takeda). Early in April 2005, we increased our ownership
from 60% to 70% in our joint venture with Takeda. |
|
We
have entered into inventory management agreements with the majority of our full-line
pharmaceutical wholesalers in the U.S., whereby the wholesalers have agreed to maintain
inventory at certain targeted levels in return for the opportunity to buy specific amounts
of product at pre-price increase prices whenever Wyeth implements a price increase. As a
result, we, along with our wholesaler partners, are able to manage product flow and
inventory levels in a way that more closely follows trends in prescriptions. Subsequent to
the execution of these inventory management agreements, our largest wholesale customers
have requested that we enter into revised agreements based on services performed. The
wholesalers have indicated they may discontinue purchasing Wyeths pharmaceutical
products upon expiration of the current inventory management agreements, which occurs in 2005,
unless we enter
into the new compensation arrangements. We are currently in discussions with these
wholesalers but cannot predict whether changes in the contractual arrangements will occur. |
|
Our
principal strategy for future success is based on research and development (R&D)
innovations, hence the significant increase in our R&D spending planned for 2005,
which we expect to reach about $2,700.0 million. We intend to leverage our breadth of
knowledge and resources across three scientific development platforms (traditional
pharmaceuticals, biologicals and vaccines) to produce first-in-class and best-in-class
therapies for significant unmet medical needs around the world. Late in 2004, we submitted
a global registration filing for TYGACIL, an innovative broad-spectrum I.V.
antibiotic for serious, hospital-based infections. In January 2005, this application was
given priority review status by the FDA in the United
States, which could lead to its approval and market introduction later in 2005. We also
plan to file New Drug Applications (NDA) for six additional products in the next 18
months. |
|
We
continue to address the challenges of the Companys diet drug litigation. As
discussed in more detail in Note 5 to our consolidated condensed financial statements, on
March 15, 2005, the proposed Seventh Amendment to the National Diet Drug Settlement was
approved as fair, adequate and reasonable. This is an important milestone not
only for the Seventh Amendment itself but also for the National Diet Drug Settlement in
general. The Seventh Amendment would create a new claims processing structure, funding
arrangement and payment schedule for matrix Level I or II claims, the least serious but
most numerous matrix claims in the Settlement. The amendment would ensure that these
claims are processed on a streamlined basis, while preserving funds in the existing Trust
for more serious claims. Several appeals have been filed challenging |
23
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
the approval of the
Seventh Amendment; however, briefing and argument on these appeals has not yet been
scheduled. |
|
In
January 2005, we announced that the Company was in discussions with plaintiffs
attorneys representing a number of individuals who have opted out of the National Diet
Drug Settlement on a proposed process for settling downstream opt out cases. The proposed
process provides a methodology for valuing different categories of claims and also
provides a structure for individualized negotiations between the Company and lawyers
representing diet drug claimants. To date, attorneys representing more than half of the
downstream opt out cases have agreed to participate in this process and we are proceeding
with the individual negotiations. Negotiations will take place with over one hundred
individual attorneys representing thousands of downstream opt out plaintiffs.
Documentation supporting the claims must be produced and reviewed and settlements of some
categories of claims will require individualized negotiations between that attorney and
the Company. As we move forward, additional attorneys may agree to participate in the
process and some who have previously agreed may decide to withdraw their participation. We
will continue to try those cases where attorneys are not willing to participate in this
settlement process. |
|
Generally,
we face the same difficult challenges that all research-based pharmaceutical companies are
confronting. Pressure from government agencies and consumers to lower prices either
through leveraged purchasing plans, importation or reduced reimbursement for prescription
drugs poses significant challenges for our Company. Health care providers and the general
public want more information about our products, and they want it delivered efficiently
and effectively. Regulatory burdens are increasing the demands on our Company, and they
increase both the cost and time it takes to bring new drugs to market. We also are faced
with the moderating rate of growth of some of our major products. We intend to embark on a
series of long-term initiatives throughout 2005 to address these changing conditions with
the objective of making Wyeth more efficient, more effective and more profitable so that
we may continue to thrive in this increasingly challenging pharmaceutical environment. |
24
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Worldwide
net revenue increased 14% for the 2005 first quarter compared with prior year levels and
was due to increases in the Pharmaceuticals, Consumer Healthcare and Animal Health
segments. Excluding the favorable impact of foreign exchange, worldwide net revenue
increased 12% for the 2005 first quarter. |
|
The
following table sets forth worldwide net revenue results by reportable segment together
with the percentage changes from the comparable period in the prior year: |
|
Net Revenue
|
|
|
Three Months
Ended March 31,
|
|
(Dollars in millions) Segment
|
2005
|
2004
|
% Increase
|
Pharmaceuticals |
|
$3,717.5 |
|
$3,207.6 |
|
16% |
|
Consumer Healthcare | |
616.8 |
|
588.3 |
|
5% | |
Animal Health | |
244.7 |
|
218.9 |
|
12% | |
|
| |
| |
| |
|
|
|
|
Total | |
$4,579.0 |
|
$4,014.8 |
|
14% | |
|
| |
| |
| |
|
Worldwide
Pharmaceuticals net revenue increased 16% for the 2005 first quarter. The increases in net
revenue were due primarily to higher sales of EFFEXOR XR, PREVNAR,
ENBREL (internationally), ZOSYN/TAZOCIN, RAPAMUNE, nutritionals,
ZOTON, BENEFIX and rhBMP-2. Higher sales of PREVNAR reflected
a return to the full dose vaccination schedule, the resolution of manufacturing issues
that limited production in 2004 and a catch-up of deferred doses from the 2004 first half
that resulted from supply constraints. Increases in net revenue were also attributable to
higher alliance revenue for the 2005 first quarter primarily as a result of higher sales
of ENBREL in North America. The increases in net revenue were offset, in part, by
lower sales of the PREMARIN family of products as a result of lower prescription
volume and a continued reduction of inventory levels in the wholesale channel. Excluding
the favorable impact of foreign exchange, worldwide Pharmaceuticals net revenue increased
14% for the 2005 first quarter. |
25
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
The
following table sets forth the significant worldwide Pharmaceuticals net revenue by
product for the three months ended March 31, 2005 compared with the same period in the
prior year: |
|
Three Months
Ended March 31,
|
(In millions)
|
2005
|
2004
|
EFFEXOR |
|
$868.5 |
|
$775.7 |
|
PROTONIX | |
409.4 |
|
410.5 |
|
PREVNAR | |
391.1 |
|
173.4 |
|
Nutritionals | |
254.5 |
|
215.8 |
|
ENBREL | |
237.0 |
|
135.0 |
|
ZOSYN / TAZOCIN | |
229.3 |
|
181.4 |
|
PREMARIN family | |
210.9 |
|
265.9 |
|
Oral Contraceptives | |
140.0 |
|
142.8 |
|
ZOTON | |
124.1 |
|
112.0 |
|
BENEFIX | |
88.9 |
|
74.5 |
|
RAPAMUNE | |
72.1 |
|
58.3 |
|
REFACTO | |
63.5 |
|
60.3 |
|
rhBMP-2 | |
51.6 |
|
23.1 |
|
Alliance revenue | |
196.0 |
|
149.4 |
|
Other | |
380.6 |
|
429.5 |
|
|
| |
| |
|
|
|
Total Pharmaceuticals | |
$3,717.5 |
|
$3,207.6 |
|
|
| |
| |
|
|
|
26
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Worldwide
Consumer Healthcare net revenue increased 5% for the 2005 first quarter reflecting
continued solid performance. The increases were attributable to a number of factors,
including growth in ROBITUSSIN, ADVIL and CALTRATE brands. Excluding
the favorable impact of foreign exchange, worldwide Consumer Healthcare net revenue
increased 3% for the 2005 first quarter. |
|
The
following table sets forth significant worldwide Consumer Healthcare net revenue by
product for the three months ended March 31, 2005 compared with the same period in the
prior year: |
|
Three Months
Ended March 31,
|
(In millions)
|
2005
|
2004
|
CENTRUM |
|
$140.8 |
|
$139.1 |
|
ADVIL | |
119.3 |
|
114.4 |
|
ROBITUSSIN | |
60.5 |
|
48.4 |
|
CALTRATE | |
45.0 |
|
40.0 |
|
ADVIL COLD & SINUS | |
36.3 |
|
30.2 |
|
SOLGAR | |
27.3 |
|
29.7 |
|
CHAPSTICK | |
26.6 |
|
26.3 |
|
DIMETAPP | |
20.2 |
|
20.1 |
|
ALAVERT | |
17.1 |
|
17.6 |
|
Other | |
123.7 |
|
122.5 |
|
|
| |
| |
|
|
|
|
|
|
Total Consumer Healthcare | |
$616.8 |
|
$588.3 |
|
|
| |
| |
27
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Worldwide
Animal Health net revenue increased 12% for the 2005 first quarter due primarily to
increases in sales of companion animal and livestock products despite the impact of the
voluntary recall of PROHEART 6 in the U.S. market in September 2004.
Excluding the favorable impact of foreign exchange, worldwide Animal Health net revenue
increased 10% for the 2005 first quarter. |
|
The
following table sets forth worldwide Animal Health net revenue by product category for the
three months ended March 31, 2005 compared with the same period in the prior year: |
|
Three Months
Ended March 31,
|
(In millions)
|
2005
|
2004
|
Livestock products |
|
$100.8 |
|
$83.7 |
|
Companion animal products | |
71.3 |
|
63.4 |
|
Equine products | |
45.7 |
|
47.9 |
|
Poultry products | |
26.9 |
|
23.9 |
|
|
| |
| |
|
|
|
Total Animal Health | |
$244.7 |
|
$218.9 |
|
|
| |
| |
28
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
The
following table sets forth the percentage changes in worldwide net revenue by reportable
segment and geographic area compared with the prior year, including the effect volume,
price and foreign exchange had on these percentage changes: |
|
% Increase (Decrease)
Three Months Ended March 31, 2005
|
|
Volume
|
Price
|
Foreign
Exchange
|
Total
Net Revenue
|
Pharmaceuticals |
|
|
|
|
|
|
|
|
|
United States | |
8% | |
2% | |
-- | |
10% | |
International | |
19% | |
1% | |
4% | |
24% | |
|
| |
| |
| |
| |
|
|
|
|
|
Total | |
12% | |
2% | |
2% | |
16% | |
|
| |
| |
| |
| |
|
|
|
|
|
Consumer Healthcare | |
United States | |
(1%) | |
1% | |
-- | |
-- | |
International | |
3% | |
4% | |
6% | |
13% | |
|
| |
| |
| |
| |
|
|
|
|
|
Total | |
-- | |
3% | |
2% | |
5% | |
|
| |
| |
| |
| |
|
|
|
|
|
Animal Health | |
United States | |
4% | |
5% | |
-- | |
9% | |
International | |
9% | |
2% | |
4% | |
15% | |
|
| |
| |
| |
| |
|
|
|
|
|
Total | |
6% | |
4% | |
2% | |
12% | |
|
| |
| |
| |
| |
|
|
|
|
|
Total | |
United States | |
6% | |
2% | |
-- | |
8% | |
International | |
16% | |
2% | |
4% | |
22% | |
|
| |
| |
| |
| |
|
|
|
|
|
Total | |
10% | |
2% | |
2% | |
14% | |
|
| |
| |
| |
| |
|
|
|
|
|
|
The
Company deducts certain items from gross revenue, which primarily consist of provisions
for product returns, cash discounts, chargebacks/rebates, customer allowances and consumer
sales incentives. The provision for chargebacks/rebates relates primarily to U.S. sales of
pharmaceutical products provided to wholesalers and managed care organizations under
contractual agreements or to certain governmental agencies that administer benefit
programs, such as Medicaid. While different programs and methods are utilized to determine
the chargeback or rebate provided to the customer, the Company considers both to be a form
of price reduction. Chargebacks/rebates are the only deductions from gross revenue that
are considered significant by the Company and approximated $612.7 million for the 2005
first quarter compared with $532.9 million for the 2004 first quarter. The increase in
chargebacks/rebates for the 2005 first quarter was due primarily to higher rebate rates
and increased volumes of PROTONIX in the managed care segment. |
|
Except
for chargebacks/rebates, provisions for each of the other components of sales deductions,
including product returns, are individually less than 2% of gross sales. The provisions
charged against gross sales for product returns for 2005 and 2004 were $56.9 million and
$75.7 million, respectively. |
29
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Cost
of goods sold, as a percentage of Net revenue, increased to 29.5% for the 2005
first quarter compared with 28.9% for the 2004 first quarter due primarily to higher
inventory and manufacturing losses in the Pharmaceuticals segment. The decrease in gross
margin was also due to higher royalty costs as a result of higher sales of ENBREL,
ZOTON and PREVNAR offset, in part, by an increase in alliance revenue. |
|
Selling,
general and administrative expenses increased 7% while Net revenue increased at
a rate of 14% for 2005 as compared with 2004. This difference is primarily attributable to
the significant increase in net revenue of PREVNAR and ENBREL, which
generally require lower promotional spending than mass-marketed Pharmaceuticals products.
In addition, net revenue of EFFEXOR also increased
significantly as compared with 2004 while promotional spending decreased. The 2005 first
quarter was also impacted by higher selling expenses related to an increase in sales force
in Japan to support the launch of ENBREL as well as pre-launch spending for
TYGACIL in the Pharmaceuticals segment. |
|
Research
and development expenses decreased 14% for the 2005 first quarter as compared with
2004 primarily due to the non-recurrence of the upfront payment and charge in the 2004
first quarter of $145.5 million made in connection with the agreement entered into between
the Company and Solvay to co-develop and co-commercialize four neuroscience compounds,
most notably, bifeprunox. The 2005 first three months also reflects the impact of lower
clinical grant spending in the Pharmaceuticals segment and higher other research operating
expenses (including higher chemicals and materials expenses). |
|
Interest Expense and Other Income |
|
Interest
expense, net for the three months ended March 31, 2005 and 2004 consisted of the
following: |
|
Three Months
Ended March 31,
|
(In millions)
|
2005
|
2004
|
Interest expense |
|
$90.1 |
|
$70.8 |
|
Interest income | |
(52.3 |
) |
(23.4 |
) |
Less: amount capitalized for | |
capital projects | |
(7.8 |
) |
(20.5 |
) |
|
| |
| |
|
|
|
Total interest expense, net | |
$30.0 |
|
$26.9 |
|
|
| |
| |
|
|
|
|
Interest
expense, net increased 12% for the 2005 first quarter due primarily to lower
capitalized interest and higher interest expense offset, in part, by higher interest
income. Weighted average debt outstanding during the 2005 first quarter was $7,912.8
million |
30
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
compared with the prior year level of $8,695.0 million. The impact of lower weighted
average debt outstanding on interest expense was offset by an increase in interest rates,
partially offset by an increase in interest income earned on higher cash balances in 2005
versus 2004. The lower capitalized interest resulted from reduced spending for long-term
capital projects in process. These projects include the expansion of existing
manufacturing facilities in Ireland and Puerto Rico. |
|
Other
income, net increased $57.7 million for the 2005 first quarter primarily as a result
of the sale of a nutritionals manufacturing facility and income received in connection
with a settlement regarding certain environmental issues. Other income, net was also
impacted by pre-tax gains from the divestiture of certain Pharmaceuticals and Consumer
Healthcare products of approximately $138.5 million and $140.7 million in the 2005 and
2004 first quarter, respectively. The 2005 divestitures included product rights to
SYNVISC and EPOCLER (in Brazil). The 2004 divestitures included product
rights to indiplon, DIAMOX (in Japan), and the Companys nutritionals products
in France. The sales, profits and net assets of these divested products, individually or
in the aggregate, were not material to either business segment or the Companys
consolidated financial position or results of operations. |
|
Income Before Income Taxes |
|
The
following table sets forth worldwide income before income taxes by reportable segment
together with the percentage changes from the comparable period in the prior year: |
|
Income Before Income Taxes
Three Months
Ended March 31,
|
(Dollars in millions)
Segment
|
2005
|
2004
|
% Increase
|
Pharmaceuticals(1) |
|
$1,238.5 |
|
$872.1 |
|
42% |
|
Consumer Healthcare | |
121.2 |
|
109.5 |
|
11% | |
Animal Health | |
51.2 |
|
37.7 |
|
36% | |
Corporate | |
(37.4 |
) |
(75.4 |
) |
50% | |
|
| |
| |
| |
|
|
|
|
Total(2) | |
$1,373.5 |
|
$943.9 |
|
46% | |
|
| |
| |
| |
|
(1) |
Pharmaceuticals
for the 2004 first three months included a first quarter charge of $145.5
within Research and development expenses related to the
upfront payment to Solvay in connection with the co-development and
co-commercialization of four neuroscience compounds. Excluding the upfront
payment from the 2004 first three months results, but including
Pharmaceuticals product divestiture gains discussed in footnote 2 below,
Pharmaceuticals income before income taxes increased 22%. |
|
(2) |
Income
before income taxes for the 2005 and 2004 first three months included
approximately $138.5 and $140.7, respectively, related to gains from the
divestiture of certain Pharmaceuticals and Consumer Healthcare products.
The 2005 divestitures included product rights to SYNVISC and EPOCLER (in
Brazil). The 2004 divestitures included product rights to indiplon, DIAMOX (in
Japan), and the Companys nutritionals products in France. |
31
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Worldwide
Pharmaceuticals income before income taxes for the 2005 first quarter increased 42%. The
increase for the 2005 first quarter was due primarily to higher net revenue and lower
selling and general expenses, as a percentage of net revenue, offset in part, by decreased
gross profit margins earned on worldwide sales of Pharmaceuticals products. The increase
in income before income taxes is also attributable to lower research and development
expenses primarily due to the non-recurrence of the upfront payment to Solvay. |
|
Worldwide
Consumer Healthcare income before income taxes for the 2005 first quarter increased 11%.
The increase for the 2005 first quarter was due primarily to higher net revenue, increased
gross profit margins earned on worldwide sales of Consumer Healthcare products and higher
other income, net related to product divestiture gains. |
|
Worldwide
Animal Health income before income taxes increased 36% for the 2005 first quarter due
primarily to higher net revenue and lower selling and general expenses offset in part, by
decreased gross profit margins earned on worldwide sales of Animal Health products. |
|
Corporate
expenses, net for the 2005 first quarter were $37.4 million compared with $75.4 million
for the 2004 first quarter. The decrease for the 2005 first quarter was due primarily to
higher other income, net related to the sale of a manufacturing facility and income
received in connection with a settlement regarding certain environmental issues. |
|
The
effective tax rates were 21.5% and 20.6% for the 2005 and 2004 first quarter,
respectively. Excluding certain items affecting comparability (as discussed below under
Consolidated Net Income and Diluted Earnings Per Share Results), the 2004
first quarter effective tax rate was 22.5%. |
|
Consolidated Net Income and Diluted Earnings Per Share Results |
|
Net
income and diluted earnings per share for the 2005 first quarter were $1,078.2 million and
$0.80, respectively, compared with net income and diluted earnings per share of $749.7
million and $0.55 in the prior year, increases of 44% and 45%, respectively. |
|
The
Companys management uses various measures to manage and evaluate the Companys
performance and believes it is appropriate to specifically identify certain significant
items included in net income and diluted earnings per share to assist investors with
analyzing ongoing business performance and trends. In particular, the Companys
management believes that comparisons between the 2005 and 2004 first three months results
of operations are influenced by the impact of the 2004 first quarter upfront payment of
$145.5 million ($94.6 million after-tax or $0.07 per share-diluted) to Solvay that is |
32
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
included in net income and diluted earnings per share. The significant upfront payment
related to the co-development and co-commercialization of the four neuroscience compounds
being developed with Solvay, which was immediately expensed and included in Research
and development expenses, has been identified by the Companys management when
evaluating the Companys performance. Isolating this item when reviewing the
Companys results provides a more appropriate view of operations for these accounting
periods. |
|
Excluding
the Solvay payment, the increases in net income and diluted earnings per share for the
2005 first quarter were due primarily to higher net revenue, lower selling, general and
administrative expenses, as a percentage of net revenue, and higher other income, net,
offset, in part, by higher cost of goods sold and higher research and development
spending. |
|
Gains
from product divestitures constitute an integral part of the Companys analysis of
divisional performance and are important to understanding changes in our reported net
income. Gains from product divestitures for the 2005 first three months were $138.5
million ($90.1 million after-tax or $0.07 per share-diluted) compared with $140.7 million
($92.5 million after-tax or $0.07 per share-diluted) for the 2004 first three months. |
|
Liquidity, Financial Condition and Capital Resources |
|
Cash
flows used for operating activities totaling $569.5 million during the 2005 first three
months were generated primarily by net earnings of $1,078.2 million, offset by the
establishment of the Seventh Amendment security fund of $1,250.0 million, payments of
$303.8 million for working capital requirements and payments of $289.6 million related to
the diet drug litigation (see Note 5 to the consolidated condensed financial statements).
The change in working capital, which used $303.8 million of cash as of March 31, 2005,
excluding the effects of foreign exchange, primarily consisted of a decrease in accounts
payable and accrued expenses of $263.7 million relating to timing of payments and an
increase in accounts receivable of $70.8 million relating to increased sales. The change
in working capital, which used $230.6 million of cash as of March 31, 2004, excluding the
effects of foreign exchange, primarily consisted of a decrease of accounts payable and
accrued expenses of $310.3 million relating to timing of payments, a decrease in accrued
taxes of $75.8 million due to timing of payments offset, in part, by a decrease in other
current assets of $101.4 million due to receipt of payments and a decrease in accounts
receivable of $79.8 million due to increased collections. |
|
During
the 2005 first three months, the Company received investment proceeds through the sales
and maturities of marketable securities of $1,067.2 million and the sales of assets
totaling $171.0 million. The proceeds from the sales and maturities of marketable
securities were primarily used to fund the Seventh Amendment security fund. In addition,
the Company used $213.0 million of cash for investments in property, plant and equipment
and $21.0 million of cash for purchases of marketable securities. The capital expenditures
made during the 2005 first three months were consistent with the |
33
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Companys commitment
to expand existing manufacturing and research and development facilities worldwide, and to
build new biotechnology facilities. |
|
The
Companys financing activities in the 2005 first three months included repayments of
debt totaling $328.2 million and dividend payments of $307.3 million. |
|
At
March 31, 2005, the Company had outstanding $7,664.9 million in total debt, which
consisted of notes payable and other debt. Maturities of the Companys obligations as
of March 31, 2005 are set forth below. |
(In millions)
|
Total
|
Less than
1 year
|
1-3 years
|
4-5 years
|
Over
5 years
|
Total debt |
|
$7,664.9 |
|
$1.5 |
|
$315.6 |
|
$1,597.1 |
|
$5,750.7 |
|
|
The
following represents the Companys credit ratings as of March 31, 2005 and as of May
5, 2005: |
|
Moody's
|
S&P
|
Fitch
|
Short-term debt
Long-term debt
Outlook
Last rating update
|
P-2
Baa1
Developing
February 8, 2005
|
A-1
A
Negative
December 8, 2003
|
F-2
A-
Negative
January 31, 2005
|
|
|
|
|
|
In
light of the circumstances discussed in Note 5 to the consolidated condensed financial
statements, including the unknown number of valid matrix claims and the unknown number and
merits of valid downstream opt outs, it is not possible to predict the ultimate liability
of the Company in connection with its diet drug legal proceedings. It is therefore not
possible to predict whether, and if so when, such proceedings will have a material adverse
effect on the Companys financial condition, results of operations and/or cash flows
and whether cash flows from operating activities and existing and prospective financing
resources will be adequate to fund the Companys operations, pay all liabilities
related to the diet drug litigation, pay dividends, maintain the ongoing programs of
capital expenditures, and repay both the principal and interest on its outstanding
obligations without the disposition of significant strategic core assets and/or reductions
in certain cash outflows. |
|
Certain Factors that May Affect Future Results |
|
Prempro / Premarin HT Studies |
|
In
July 2002, the hormone therapy (HT) subset of the WHI study, involving women who received
a combination of conjugated estrogens and medroxyprogesterone acetate (PREMPRO),
was stopped early (after the patients were followed in the study for an |
34
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
average of 5.2
years) because, according to the predefined stopping rule, certain increased risks
exceeded the specified long-term benefits. Additional analyses of data from the HT subset
of the WHI study were released during 2003, and further analyses of WHI data may be
released in the future. |
|
In
March 2004, the NIH announced preliminary findings from the estrogen-only arm of the WHI
study and stated that it had decided to stop the study because it believed that the
results would not likely change during the period until completion of the study in 2005
and that the increased risk of stroke seen in the treatment arm could not be justified by
what could be learned in an additional year of treatment. NIH concluded that estrogen
alone does not appear to affect (either increase or decrease) coronary heart disease and
did not increase the risk of breast cancer. In addition, NIH found an association with a
decrease in the risk of hip fracture. This increased risk of stroke was similar to the
increase seen in the HT subset of the WHI study. NIH also stated that analysis of
preliminary data from the separate Womens Health Initiative Memory Study (WHIMS)
showed an increased risk of probable dementia and/or mild cognitive impairment in women
age 65 and older when data from both the PREMARIN and PREMPRO arms were
pooled. The study also reported a trend toward increased risk of possible dementia in
women treated with PREMARIN alone. WHIMS data published in The Journal of the
American Medical Association (JAMA) in June 2004 and in a separate report published in
JAMA at the same time indicated that HT did not improve cognitive impairment and
may adversely affect it in some women. The Company is working with the FDA to update the
labeling for its HT products to include the latest data. |
|
The
Company operates in the highly competitive pharmaceutical and consumer health care
industries. PREMARIN, the Companys principal conjugated estrogens product
manufactured from pregnant mares urine, and related products PREMPRO and
PREMPHASE (which are single tablet combinations of the conjugated estrogens in
PREMARIN and the progestin medroxyprogesterone acetate) are the leaders in their
categories and contribute significantly to net revenue and results of operations.
PREMARINs natural composition is not subject to patent protection (although
PREMPRO has patent protection). PREMARIN, PREMPRO and PREMPHASE
are indicated for the treatment of certain menopausal symptoms. They also are approved
for the prevention of osteoporosis, a condition involving a loss of bone mass in
postmenopausal women. Their use for that purpose in women without symptoms should be
limited to cases where non-hormonal treatments have been seriously considered and
rejected. Estrogen-containing products manufactured by other companies have been marketed
for many years for the treatment of menopausal symptoms. During the past several years,
other manufacturers have introduced products for the treatment and/or prevention of
osteoporosis. New products containing different estrogens and/or different progestins from
those found in PREMPRO and PREMPHASE, utilizing various forms of delivery
and having many forms of the same indications, have been introduced. Some companies also
have attempted to obtain approval for generic versions of PREMARIN. |
35
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
These products,
if approved, would be routinely substitutable for PREMARIN and related products
under many state laws and third-party insurance payer plans. In May 1997, the FDA
announced that it would not approve certain synthetic estrogen products as generic
equivalents of PREMARIN given known compositional differences between the active
ingredient of these products and PREMARIN. Although the FDA has not approved any
generic equivalent to PREMARIN to date, PREMARIN will continue to be subject
to competition from existing and new competing estrogen and other products for its
approved indications and may be subject to generic competition from either synthetic or
natural conjugated estrogens products in the future. One other company had announced that
it had applied for FDA approval of a generic version of PREMARIN derived from the
same natural source, but that company has since announced the withdrawal of its
application. The Company cannot predict the timing or outcome of any efforts to seek FDA
approval for generic versions of PREMARIN. |
|
Two
of the Companys largest products, EFFEXOR XR and PROTONIX, are the
subject of pending patent litigation involving potential generic competition. In the case
of EFFEXOR XR, the Company has patent protection in the United States until at
least June 2008, when the patent covering the active ingredient in EFFEXOR,
venlafaxine, will expire. The pending litigation involves the infringement by a potential
generic competitor of the Companys patents relating to extended-release venlafaxine
that expire in 2017. In the event that the Company is not successful in this action,
EFFEXOR XR may face generic competition as early as June 2008.
In the case of PROTONIX, the Company and its partner, Altana, have patent protection until
at least July 2010, when the patent covering the active ingredient in PROTONIX,
pantoprazole, will expire. That patent is being asserted against a potential generic
competitor. In the event the Company is not successful in this action, PROTONIX
may face generic competition prior to July 2010. Although the Company believes that
its patents are valid and have been infringed, there can be no assurance as to the outcome
of these matters, which could materially affect future results of operations. |
|
Growth
in overall usage of antidepressants globally appears to be slowing for a
variety of reasons. In addition, the FDA has recommended new class labeling for
antidepressants that will, among other things, more prominently highlight the already
labeled risk of suicide in children and adolescents in a black box warning.
The Company already has implemented the labeling change for EFFEXOR. The FDA
also has requested that data regarding suicidality from clinical trials in adults be
re-examined using the same approach developed for evaluating the pediatric data. The
Company will respond to the FDAs request. |
|
In
addition, the regulatory authority in the United Kingdom recently has completed a review
of the safety and efficacy of the selective serotonin reuptake inhibitor class of
antidepressants as well as EFFEXOR. New class labeling for antidepressants as well
as restrictions on the use of EFFEXOR in the United Kingdom have been implemented.
The Company has appealed this decision to the United Kingdom Committee on the |
36
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Safety of
Medicines and the Committees decision is pending. The Company expects further
regulatory scrutiny of the drugs in this therapeutic area, including EFFEXOR. |
|
The Company cannot predict the level of impact
these issues may have on future global usage of EFFEXOR. |
|
The
proton pump inhibitor category is highly competitive. PROTONIX is subject to
discounting demands by managed care and state organizations and price competition from
generic omeprazole and other branded proton pump inhibitor products. This pricing pressure
may have an effect on future net sales. PROTONIX business is shifting from the more
heavily discounted Medicaid segment to the less heavily discounted third party managed
care segment. This trend is expected to continue throughout 2005 and, despite an
anticipated decline in the rate of overall prescription volume growth, it is expected to
have a positive impact on profitability. |
|
Market
demand for ENBREL continued to grow in the first quarter 2005 as net sales
increased 49% within North America and 76% outside North America when compared to first
quarter 2004 results. As this strong growth in demand continues, worldwide manufacturing
for ENBREL also continues to improve, and supply has remained unconstrained since
early 2004. Improvements in the existing Rhode Island and Boehringer Ingelheim
facilities performance, combined with the FDA approval of a second Boehringer
Ingelheim facility in June 2004 and the October 2004 FDA approval of a Genentech, Inc.
facility, were key contributors to the manufacturing capacity increases in 2004 and early
2005. While continued process improvements and the inclusion of Genentech material will
once again contribute to the supply of ENBREL in 2005, market demand has continued
to grow, and additional manufacturing supply will be required. |
|
The
anticipated approval of two new manufacturing facilities in 2005 will help to ensure
uninterrupted supply and support the continued growth of ENBREL. Wyeths
application for approval of its Grange Castle, Ireland, facility was filed with the
European Medicines Agency in January 2005 and approval is anticipated in mid 2005.
Additionally, Amgen expects the approval of a second facility in Rhode Island in 2005. |
|
As
a result of delays in product availability of PREVNAR due to a late 2003 shutdown
of the filling lines at the Companys Pearl River, New York, facility as well as
other manufacturing and testing issues, product availability was constrained in all
markets through the first half of 2004. During the first quarter of 2004, the Centers for
Disease Control and Prevention (CDC) issued interim recommendations to defer
administration of the third and fourth doses for healthy children. Due to increased
product availability, the CDC revised these recommendations in early July 2004 and again
in September 2004 to recommend that health care providers return to the four-dose schedule
for healthy children and initiate efforts to vaccinate those children who had the doses
deferred. |
37
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
In March of 2004, the European Agency for the Evaluation of Medicinal Products
issued interim dosing recommendations to reduce usage. In September 2004, these
recommendations were revised to reinstate pre-shortage recommendations. Capacity was
enhanced overall in 2004 due to internal improvements and the FDA approval of a
third-party filling facility in the second quarter of 2004. The Company exceeded its 2004
production goal of 20 23 million doses. Regulatory approval of pre-filled syringes
from another third-party filler for Europe has been received and launch of pre-filled
syringes in Europe is anticipated for mid-year 2005. Pre-filled syringes from Wyeth and
the third-party filler are expected, pending regulatory approval, to be launched in the
U.S. in early 2006. The Company expects to meet the 2005 PREVNAR production goal of
25 28 million doses. |
|
Management
continually reviews the Companys supply chain structure with respect to utilization
of production capacities as well as manufacturing efficiencies. Changes in product demand
periodically create capacity imbalances within the manufacturing network. When such
imbalances result in overcapacity, which management considers to be other than temporary,
the network is restructured to gain optimal efficiency and to reduce production costs. As
a result, additional restructuring charges may occur in future periods. |
|
The
Company continues to be in discussion with various regulatory authorities regarding
manufacturing process issues at certain of the Companys European manufacturing
sites. The Company is working with the authorities to resolve these issues but cannot
predict the outcome of those discussions and what impact these issues will have on supply
of the Companys products manufactured at these facilities. However, based on
information currently available, the Company believes the impact, if any, on its
consolidated statements of operations will not be material. |
|
Litigation and Contingent Liabilities |
|
The
Company is involved in various legal proceedings, including product liability and
environmental matters that arise from time to time in the ordinary course of business, the
most significant of which are described in the Companys Annual Report on Form 10-K
for the year ended December 31, 2004, interim Current Reports filed on Form 8-K, and this
Quarterly Report on Form 10-Q. These include allegations of injuries caused by drugs,
vaccines and over-the-counter products, including PONDIMIN (which in combination
with phentermine, a product that was not manufactured, distributed or sold by the Company,
was commonly referred to as fen-phen), REDUX, the prior formulation of
DIMETAPP, the prior formulation of ROBITUSSIN, PREMPRO and
PREMARIN and EFFEXOR, among others. In addition, the Company has
responsibility for environmental, safety and cleanup obligations under various local,
state and federal laws, including the Comprehensive Environmental Response, Compensation
and Liability Act, commonly known as Superfund. |
38
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
The
estimated costs that the Company expects to pay are accrued when the liability is
considered probable and the amount can be reasonably estimated (see Note 5 to the
consolidated condensed financial statements for a discussion of the costs associated with
the REDUX and PONDIMIN diet drug litigation). In many cases, future
environmental-related expenditures cannot be quantified with a reasonable degree of
accuracy. As investigations and cleanups proceed, environmental-related liabilities
are reviewed and adjusted as additional information becomes available. Prior to November
2003, the Company was self-insured for product liability risks with excess coverage on a
claims-made basis from various insurance carriers in excess of the self-insured amounts
and subject to certain policy limits. Effective November 2003, the Company became
completely self-insured for product liability risks. It is not possible to predict whether
any potential liability that might exceed amounts already accrued will have a material
adverse effect on the Companys financial condition, results of operations and/or
cash flows. |
|
Cautionary Statements Regarding Forward-Looking Information |
|
The
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. Forward-looking statements may appear in periodic reports
filed with the Securities and Exchange Commission (including the Companys Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q), in press releases, in the
Companys Annual Report to Stockholders and other reports to stockholders, and in
other communications made by the Company. These forward-looking statements can be
identified by their use of words such as anticipates, expects,
is confident, plans, could, will,
believes, estimates, forecasts, projects
and other words of similar meaning. These forward-looking statements address various
matters including: |
|
o |
Our
anticipated results of operations, liquidity position, financial condition and capital
resources; |
|
o |
The benefits
that we expect will result from our business activities and certain transactions we
announced or completed,
such as increased revenues, decreased expenses, and avoided expenses and expenditures; |
|
o |
Statements of our expectations, beliefs, future plans and strategies, anticipated
developments and other matters that are not historical facts; |
|
o |
The
accuracy of our estimates and assumptions utilized in our critical accounting policies; |
|
o |
The
timing and successfulness of research and development activities; |
|
o |
The
impact of competitive or generic products; |
|
o |
Economic
conditions, including interest rate and foreign currency exchange rate fluctuation; |
|
o |
Changes
in generally accepted accounting principles; |
39
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
o |
Any
changes in political or economic conditions due to the threat of terrorist activity
worldwide and related U.S. military action internationally; |
|
o |
Costs
related to product liability, patent protection, government investigations and
other legal proceedings; |
|
o |
Our
ability to protect our intellectual property, including patents; |
|
o |
The
impact of legislation or regulation affecting pricing, reimbursement or access,
both in the United States and internationally; |
|
o |
Impact
of managed care or health care cost-containment; |
|
o |
Increased
focus on privacy issues in countries around the world, including the United States and
the European Union; |
|
o |
Governmental
laws and regulations affecting our U.S. and international businesses, including tax
obligations and results of tax audits; |
|
o |
Environmental
liabilities; |
|
o |
The
future impact of presently known trends, including those with respect to product
performance and competition; |
|
o |
Anticipated
amounts of future contractual obligations and other commitments, including future minimum
rental payments
under non-cancelable operating leases and estimated future pension and other
postretirement benefit payments; |
|
o |
Anticipated
developments relating to sales of PREMPRO/PREMARIN family of products, PROTONIX,
EFFEXOR, ENBREL, and PREVNAR and ENBREL product supply; and |
|
o |
Expectations
regarding the impact of potential litigation relating to PREMPRO, PREMARIN,
ROBITUSSIN, DIMETAPP and EFFEXOR; the nationwide class action
settlement relating to REDUX and PONDIMIN; and additional litigation
charges related to REDUX and PONDIMIN. |
|
All
forward-looking statements address matters involving numerous assumptions, risks and
uncertainties, which may cause actual results to differ materially from those expressed or
implied by us in those statements. Accordingly, we caution you not to place undue reliance
on these forward-looking statements, which speak only as of the date on which they were
made. From time to time, we also may provide oral or written forward-looking statements in
other materials we release to the public. Additionally, we undertake no obligation to
publicly update or revise any forward-looking statements, whether as a result of new
information, future developments or otherwise. As permitted by the Private Securities
Litigation Reform Act of 1995, the Company is hereby filing the following cautionary
statements identifying important factors, which among others, could cause the
Companys actual results to differ materially from expected and historical results: |
|
Economic
factors over which we have no control such as changes in business and economic conditions,
including, but not limited to, inflation and fluctuations in interest rates, foreign
currency exchange rates and market value of our equity investments and any impacts of war
or terrorist acts; |
40
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Interruptions
of computer and communication systems including computer viruses, that could impair the
Companys ability to conduct business and communicate internally with its customers; |
|
Increasing
pricing pressures, both in and outside the United States, resulting from continued
consolidation among health care providers, rules and practices of managed care groups and
institutional and governmental purchasers, judicial decisions and governmental laws and
regulations relating to Medicare, Medicaid and health care reform, pharmaceutical
reimbursement and pricing in general; |
|
Competitive
factors, such as (i) new products developed by our competitors that have lower prices or
superior performance features or that are otherwise competitive with our current products;
(ii) technological advances and patents attained by our competitors; (iii) changes in
promotional regulations or practices; (iv) development of alternative therapies; (v)
potential generic competition for PREMARIN and for other health care products as
such products mature and patents or marketing exclusivity expire on such products; (vi)
problems with licensors, suppliers and distributors; (vii) business combinations among our
competitors and major customers; and (viii) ability to attract and retain management and
other key employees; |
|
Government
laws and regulations affecting U.S. and international operations, including (i) trade,
monetary and fiscal policies and taxes; (ii) price controls, or reimbursement or access
policies; (iii) drug importation legislation; (iv) changes in governments and legal
systems; and (v) regulatory approval processes affecting approvals of products and
licensing, including, without limitation, uncertainties of the FDA approval process that
may delay or prevent the approval of new products and result in lost market opportunity; |
|
Difficulties
and delays inherent in pharmaceutical research, product development, manufacturing and
commercialization, such as, (i) failure of new product candidates to reach market due to
efficacy or safety concerns, inability to obtain necessary regulatory approvals and the
difficulty or excessive cost to manufacture; (ii) the inability to identify viable new
chemical compounds; (iii) difficulties in successfully completing clinical trials; (iv)
difficulties in manufacturing complex products, particularly biological products, on a
commercial scale; (v) difficulty in gaining and maintaining market acceptance of approved
products; (vi) seizure or recall of products; (vii) the failure to obtain, the imposition
of limitations on the use of, or loss of patent and other intellectual property rights;
(viii) failure to comply with current Good Manufacturing Practices and other applicable
regulations and quality assurance guidelines that could lead to temporary manufacturing
shutdowns, product shortages and delays in product manufacturing; and (ix) other
manufacturing or distribution problems, including unexpected adverse events or
developments at any of the manufacturing facilities involved in the production of one or
more of the Companys principal products; |
41
Managements
Discussion and Analysis of Financial Condition
and Results of Operations
Three Months Ended
March 31, 2005
|
Difficulties
or delays in product manufacturing or marketing, including but not limited to, the
inability to build up production capacity commensurate with demand, the inability of our
suppliers to provide raw material, or the failure to predict market demand for or to gain
market acceptance of approved products; |
|
Unexpected
safety or efficacy concerns arising with respect to marketed products, whether or not
scientifically justified, leading to product recalls, withdrawals, regulatory action on
the part of the FDA (or foreign counterparts) or declining sales; |
|
Growth
in costs and expenses, changes in product mix, and the impact of any acquisitions or
divestitures, restructuring and other unusual items that could result from evolving
business strategies, evaluation of asset realization and organizational restructuring; |
|
Legal
difficulties, any of which can preclude or delay commercialization of products or
adversely affect profitability, such as (i) product liability litigation related to our
products including, without limitation, litigation associated with DIMETAPP,
ROBITUSSIN, PREMPRO, PREMARIN, EFFEXOR, and our former diet
drug products, REDUX and PONDIMIN; (ii) claims asserting violations of
antitrust, securities, or other laws; (iii) tax matters; (iv) intellectual property
disputes or changes in intellectual property legal protections and remedies; (v)
environmental matters, including obligations under the Comprehensive Environmental
Response, Compensation and Liability Act, commonly known as Superfund; and (vi) complying
with the consent decree with the FDA; |
|
Fluctuations
in buying patterns of major distributors, retail chains and other trade buyers which may
result from seasonality, pricing, wholesaler buying decisions or other factors; and |
|
Changes
in accounting standards promulgated by the Financial Accounting Standards Board, the
Emerging Issues Task Force, the Securities and Exchange Commission, and the American
Institute of Certified Public Accountants, which may require adjustments to our financial
statements. |
|
This
list should not be considered an exhaustive statement of all potential risks and
uncertainties. |
42
Item 3.
Quantitative and
Qualitative Disclosures about Market Risk
|
The
market risk disclosures appearing on page 79 and 80 of the Companys 2004 Annual
Report as incorporated by reference in the Form 10-K have not materially changed from
December 31, 2004. At March 31, 2005, the fair values of the Companys financial
instruments were as follows: |
|
|
Carrying
Value
|
Fair
Value
|
(In millions)
Description
|
Notional/ Contract Amount
|
Assets (Liabilities)
|
|
|
|
|
Forward contracts (1) |
|
$1,403.4 |
|
$(1.6 |
) |
$(1.6 |
) |
Option contracts(1) | |
1,285.8 |
|
(1.8 |
) |
(1.8 |
) |
Interest rate swaps | |
5,300.0 |
|
16.5 |
|
16.5 |
|
Outstanding debt (2) | |
7,648.4 |
|
(7,664.9 |
) |
(8,024.3 |
) |
|
(1) |
If
the U.S. dollar were to strengthen or weaken by 10%, in relation to all
hedged foreign currencies, the net payable on the forward contracts would
collectively decrease or increase by approximately $105.6. |
|
(2) |
If
the interest rates were to increase or decrease by one percentage point, the
fair value of the outstanding debt would decrease or increase by
approximately $656.6. |
|
The
estimated fair values approximate amounts at which these financial instruments could be
exchanged in a current transaction between willing parties. Therefore, fair values are
based on estimates using present value and other valuation techniques that are
significantly affected by the assumptions used concerning the amount and timing of
estimated future cash flows and discount rates that reflect varying degrees of risk. The
fair value of forward contracts, currency option contracts and interest rate swaps
reflects the present value of the contracts at March 31, 2005 and the fair value of
outstanding debt instruments reflects a current yield valuation based on observed market
prices as of March 31, 2005. |
Item 4.
Controls and Procedures
|
As
of March 31, 2005, the Company carried out an evaluation, under the supervision and with
the participation of the Companys management, including the Chief Executive Officer
and Chief Financial Officer, of the effectiveness of the design and operation of the
Companys disclosure controls and procedures (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that the Companys disclosure
controls and procedures are effective. During the 2005 first quarter, there were no
significant changes in the Companys internal control over financial reporting (as
such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that have
materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting. |
43
Part II Other
Information
Item 1.
Legal Proceedings
|
The
Company and its subsidiaries are parties to numerous lawsuits and claims arising out of
the conduct of its business, including product liability and other tort claims, the most
significant of which have been described in the Companys Annual Report on Form 10-K
for the year ended December 31, 2004 and items filed in Current Reports on Form 8-K in
2005. |
|
The
REDUX and PONDIMIN diet drug litigation is discussed in greater detail in
Note 5 to the consolidated condensed financial statements. |
|
Through
March 31, 2005, payments into the REDUX and PONDIMIN national settlement
funds, individual settlement payments, legal fees and other costs totaling $14,223.3
million were paid and applied against the litigation accrual. At March 31, 2005, $6,876.7
million of the litigation accrual remained. |
|
On
March 15, 2005, United States District Judge Harvey Bartle III, the federal judge of the
United States District Court for the Eastern District of Pennsylvania overseeing the
settlement, approved the proposed Seventh Amendment as fair, adequate and
reasonable. Appeals from Judge Bartles decision have been filed with the
United States Court of Appeals for the Third Circuit. Briefing and argument of the appeals before the
Third Circuit has not yet been scheduled. If upheld
on appeal, the proposed Seventh Amendment would include the following key terms: |
|
o |
The amendment would create a new Supplemental Fund, to be administered by a Fund
Administrator who will be appointed by the District Court and who will process most
pending Level I and Level II matrix claims; |
|
o |
After District Court approval, the Company would make initial payments of up to $50.0
million to facilitate the establishment of the Supplemental Fund and to begin reviewing
claims. Following affirmance by the Third Circuit of the District Courts approval
and the exhaustion of any further appellate review, the Company would make an initial
payment of $400.0 million to enable the Supplemental Fund to begin paying claims. The
timing of additional payments would be dictated by the rate of review and payment of
claims by the Fund Administrator. The Company would ultimately deposit a total of
$1,275.0 million, net of certain credits, into the Supplemental Fund; |
44
|
o |
All participating matrix Level I and Level II claimants who qualify under the Seventh
Amendment, who pass the Settlement Funds medical review and who otherwise satisfy
the requirements of the settlement (Category One class members) would receive a pro rata
share of the $1,275.0 million Supplemental Fund, after deduction of certain expenses and
other amounts from the Supplemental Fund. The pro rata amount would vary depending upon
the number of claimants who pass medical review, the nature of their claims, their age and
other factors. A participating Category One class member who does not qualify for a
payment after such medical review would be paid $2,000 from the Supplemental Fund; |
|
o |
Participating class members who might in the future have been eligible to file Level I and
Level II matrix claims (Category Two class members) would be eligible to receive a $2,000
payment from the Trust; such payments would be funded by the Company apart from its other
funding obligations under the nationwide settlement; |
|
o |
If the participants in the Seventh Amendment have heart valve surgery or other more
serious medical conditions on Levels III through V of the nationwide settlement matrix by
the earlier of 15 years from the date of their last diet drug ingestion or by December 31,
2011, they would remain eligible to submit claims to the existing Trust and be paid the
current matrix amounts if they qualify for such payments under terms modified by the
Seventh Amendment. In the event the existing Trust is unable to pay those claims, the
Company would guarantee payment; and |
|
o |
All class members who participate in the Seventh Amendment would give up any further opt
out rights as well as the right to challenge the terms of and the binding effect of the
nationwide settlement. Final approval of the Seventh Amendment also would preclude any
lawsuits by the Trust or the Company to recover any amounts previously paid to class
members by the Trust, as well as terminate the Claims Integrity Program (see Note 5 to the
consolidated condensed financial statements) as to all claimants who do not opt out of the
Seventh Amendment. |
|
There
can be no assurance that the proposed Seventh Amendment will be upheld on appeal. If it is
upheld on appeal, only the claims of those class members who opted out of the Seventh
Amendment will be processed under the terms of the existing settlement agreement and under
the procedures that have been adopted by the Settlement Trust and the District Court. Less
than 5% of the class members who would be affected by the proposed Seventh Amendment
(approximately 1,900 of the Category One class members and approximately 5,100 of the
Category Two class members) elected to opt out of the Seventh Amendment and to remain
bound by the current settlement terms. Should the proposed Seventh Amendment not be upheld
on appeal, all of the pending and future matrix claims would be processed under the terms
of the existing settlement agreement. |
|
As
of March 31, 2005, approximately 62,000 individuals who had filed Intermediate or Back-End
opt out forms had pending lawsuits against the Company. The claims of approximately 48% of
the plaintiffs in the Intermediate and Back-End opt out cases served on the Company are
pending in Federal Court, with approximately 38% pending in State Courts. The claims of
approximately 14% of the Intermediate and Back-End opt out plaintiffs have been removed
from State Courts to Federal Court but are still subject to a possible remand to State
Court. In addition, a large number of plaintiffs have asked the U.S. Court of Appeals for
the Third Circuit to review and reverse orders entered by the Federal Court overseeing the
settlement which had denied the plaintiffs motions to remand their cases to State
Court. As of March 31, 2005, approximately 2,875 Intermediate or Back-End opt out
plaintiffs have had their lawsuits dismissed for procedural or medical deficiencies or for
various other reasons. |
|
The
claims of 13 class members who had taken advantage of the Intermediate and Back-End opt
out rights created in the nationwide settlement went to verdict from |
45
|
January 1 through
April 29, 2005. Three of those verdicts were returned in favor of plaintiffs, in the
aggregate amount of less than $50,000, at the close of the initial stage of a trial
bifurcated to consider medical causation and damages in the first phase and liability in
the second phase. A verdict in the amount of $50,000 was returned in favor of another
plaintiff in a similarly bifurcated trial. Those cases have since been settled. Seven of
the verdicts were defense verdicts in favor of the Company at the close of the initial
phase in similarly bifurcated trials. The remaining two verdicts involved cases in which
the jury initially found in favor of the plaintiffs for $5.0 million and $500,000
respectively, but subsequently found for the Company during the liability phase, thereby
negating the earlier damage finding. A number of additional cases were settled, dismissed
or adjourned during the first quarter of 2005. Additional Intermediate and Back-End opt
out trials are scheduled throughout 2005 and 2006. |
|
On
January 18, 2005, the Company and counsel representing certain downstream opt out
plaintiffs filed a motion with the District Court advising the Court that those parties
had developed a proposed process by which large numbers of the downstream opt out cases
might be negotiated and settled. The proposed process provides a methodology for valuing
different categories of claims and also provides a structure for individualized
negotiations between Wyeth and lawyers representing diet drug claimants. Counsel for more
than half of the plaintiffs with pending Intermediate and Back-End Opt Out lawsuits have
agreed to participate in the process and the Company is moving forward with settlement
discussions with those attorneys. However, the Company cannot predict the number of cases
that might be settled as a result of such a process. |
|
On
April 27, 2004, a jury in Beaumont, Texas hearing the case of Coffey, et al. v. Wyeth,
et al., No. E-167,334, 172nd Judicial District Court, Jefferson Cty., TX, returned a
verdict in favor of the plaintiffs for $113.4 million in compensatory damages and $900.0
million in punitive damages for the wrongful death of the plaintiffs decedent,
allegedly as a result of PPH caused by her use of PONDIMIN. On May 17, 2004, the
Trial Court entered judgment on behalf of the plaintiffs for the full amount of the
jurys verdict, as well as $4.2 million in pre-judgment interest and $188,737 in
guardian ad litem fees. On July 26, 2004, the Trial Court denied in their entirety the
Companys motions for a new trial or for judgment notwithstanding the verdict,
including the Companys request for application of Texas statutory cap on
punitive damage awards. The Company has filed an appeal from the judgment entered by the
Trial Court and believes that it has strong arguments for reversal or reduction of the
awards on appeal due to the significant number of legal errors made during trial and in
the charge to the jury and due to a lack of evidence to support aspects of the verdict. In
connection with its appeal, the Company was required by Texas law to post a bond in the
amount of $25.0 million. The Company filed its brief in support of the appeal on April 14,
2005. Oral argument is not expected until later in 2005. |
|
As
of April 15, 2005, the Company was a defendant in approximately 375 pending lawsuits in
which the plaintiff alleges a claim of PPH, alone or with other alleged injuries. Almost
all of these claimants must meet the definition of PPH set forth in the national
settlement agreement in order to pursue their claims outside of the national settlement
(payment of such claims, by settlement or judgment, would be made by the |
46
|
Company and not
by the Trust). Approximately 75 of these cases appear to be eligible to pursue a PPH
lawsuit under the terms of the national settlement. In approximately 10 of the 375 cases,
the Company expects the PPH claims to be voluntarily dismissed by the plaintiffs (although
they may continue to pursue other claims). In approximately 125 of these cases, the
Company has filed or expects to file motions under the terms of the national settlement to
preclude plaintiffs from proceeding with their PPH claims. For the balance of these cases,
the Company currently has insufficient medical information to assess whether or not the
plaintiffs meet the definition of PPH under the national settlement. The Company is aware
of approximately 10 additional PPH claims which are not currently the subject of a lawsuit
but which appear to meet the settlements PPH definition. The Company continues to
work toward resolving the claims of individuals who allege that they have developed PPH as
a result of their use of the diet drugs and intends to vigorously defend those PPH cases
that cannot be resolved prior to trial. |
|
In
the product liability litigation involving PREMARIN and PREMPRO, the
Companys estrogen and estrogen/progestin therapies, respectively, a Writ of Summons
was recently filed in Stanway v. Wyeth Canada, Inc., et al., No. S87156, Sup. Ct.,
British Columbia, Canada, seeking class certification. From this abbreviated filing, it is
not clear whether the plaintiff seeks damages on behalf of British Columbia PREMARIN and
PREMPLUS users or all Canadian PREMARIN and PREMPLUS users. In Albertson, et al. v. Wyeth,
No. 002944, Ct. Comm. Pleas, Phil. Cty., PA, a putative statewide medical monitoring class
action, class certification was denied on May 2, 2005. In addition to the pending
class actions, the Company is defending approximately 3,325 individual actions and 170
multi-plaintiff actions in various courts for personal injuries including claims for
breast cancer, stroke, ovarian cancer and heart disease. Together, these cases assert
claims on behalf of approximately 5,280 women alleged injured by PREMPRO or
PREMARIN. |
|
In
the product liability litigation involving the Companys cough/cold products that
contained the ingredient phenylpropanolamine (PPA), the Company is currently a named
defendant in approximately 460 lawsuits on behalf of a total of approximately 725
plaintiffs. |
|
In
the product liability litigation alleging that the administration of one or more vaccines
containing thimerosal, a preservative used in certain vaccines manufactured and
distributed by the Company as well as by other vaccine manufacturers, causes severe
neurological damage, including autism, the Company is currently defending approximately
380 lawsuits in various state and federal courts involving approximately 2,350 plaintiffs,
approximately 950 of whom are vaccine recipients. |
|
In
the product liability litigation involving the veterinary product PROHEART 6, which
the Companys Fort Dodge Animal Health subsidiary voluntarily recalled from the
market in September 2004, a third PROHEART 6 putative statewide class action has
been filed. Plaintiffs in Higginbotham v. Fort Dodge Animal Health, et al., No. GIC
842886, Super. Ct., San Diego Cty., seek compensatory damages on the grounds that Fort
Dodge violated Californias Consumer Legal Remedies Act in the manufacture,
marketing, advertising, sale and distribution of PROHEART 6. |
47
|
In
the litigation in which plaintiffs allege that the defendant pharmaceutical companies
artificially inflated the Average Wholesale Price (AWP) of their drugs, an additional
government entity class action has been filed naming the Company as a defendant. Like the
other cases brought by various New York counties, County of Erie v. Abbott
Laboratories, Inc., et al., No. 2005-2439, Sup. Ct., Erie Cty., NY, includes claims
based on the federal RICO Act, the Social Security Act, New York Social Services Law and
New York General Business Law for damages suffered as a result of alleged overcharging for
prescription medication paid for by Medicaid. All of the government entity actions have
been removed to federal court and transferred to the U.S. District Court for the District
of Massachusetts where they are pending under the caption: In re: Pharmaceutical
Industry AWP Litigation, MDL 1456. By stipulation, no activity is occurring
in these matters pending the courts resolution of defendants motion to dismiss
in the County of Suffolk matter. The MDL judge dismissed certain counts of the
complaint and directed plaintiffs to make more definitive allegations against numerous
defendants (including the Company) against whom they had previously made only conclusory
allegations. Plaintiffs filed an amended complaint and the Company and numerous other
defendants again moved to dismiss. Recently, the court granted the motion, dismissing the
Company and eighteen other defendants. Plaintiffs have indicated that they intend to file
an Amended Master Complaint on behalf of approximately 43 additional New York counties. It
is not clear whether plaintiffs will again attempt to plead more specific allegations
against the Company and the other dismissed plaintiffs or simply proceed against the
remaining defendants. |
|
In
September 2002, Israel Bio-Engineering Project (IBEP) filed an action against Amgen,
Immunex, the Company and one of the Companys subsidiaries (Docket No. C02-6880 ER,
D.Ca.) alleging infringement of U.S. Patent 5,981,701, by the manufacture, offer for sale,
distribution and sale of ENBREL. IBEP is not the assignee of record of this patent,
but is alleging ownership. IBEP seeks an accounting of damages and of any royalties or
license fees paid to a third party and seeks to have the damages trebled on account of
alleged willful infringement. IBEP also seeks to require the defendants to take a
compulsory non-exclusive license. Under its agreement with Amgen for the promotion of
ENBREL, the Company has an obligation to pay a portion of the patent litigation
expenses related to ENBREL in the U.S. and Canada as well as a portion of any
damages or other monetary relief awarded in such patent litigation. Yeda Research and
Development Co., Ltd., the assignee of record of the patent, intervened in the case and
filed a summary judgment motion seeking a ruling that it is the owner of the patent. On
March 15, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed in part and
reversed in part the lower courts summary judgment ruling in favor of the defendants
that IBEP does not own the 701 Patent, and remanded the action to the lower court
for further proceedings. |
|
The
Company has received notifications from Teva Pharmaceuticals USA (Teva), Sandoz, Inc. and
Sun Pharmaceutical Advanced Research Centre Limited (Sun) that Abbreviated New Drug
Applications (ANDA) had been filed with the FDA seeking approval to market generic
pantoprazole sodium 20 mg and 40 mg delayed release tablets. Pantoprazole sodium is the
active ingredient used in PROTONIX. |
48
|
The Orange Book lists two patents in connection
with PROTONIX tablets. The first of these patents covers pantoprazole and expires
in July 2010. The other listed patent is a formulation patent and expires in December
2016. Wyeths licensing partner, Altana Pharma AG (Altana) is the owner of these
patents. In May 2004, Altana and the Company filed a lawsuit against Teva and Teva
Pharmaceutical Industries Ltd. in the U.S. District Court for the District of New Jersey,
Docket No. 2:04-CV-02355, alleging infringement of the patent expiring in 2010. On March
4, 2005, the Company received a second notification from Sun, indicating that Sun has now
certified that it believes that the patent expiring in 2010 is invalid, not infringed, or
unenforceable. On April 13, 2005, Altana and the Company filed a lawsuit against Sun
Pharmaceutical Industries Ltd. and Sun Pharmaceutical Advanced Research Centre Ltd. in the
U.S. District Court for the District of New Jersey, Docket No. 2:05-CV-05-01966-JLL-RJH,
alleging infringement of the patent expiring in 2010. The Company intends, and is informed
that Altana intends, to vigorously pursue the causes of action under these litigations. |
|
On
March 24, 2003, the Company filed suit in the United States District Court for the
District of New Jersey against Teva Pharmaceuticals, USA (Wyeth v. Teva Pharmaceuticals
USA, Inc., Docket No. 03-CV-1293 (KSH), U.S.D.C., D. N.J.) alleging that the filing of
an ANDA by Teva seeking FDA approval to market 37.5 mg, 75 mg, and 150 mg venlafaxine HC1
extended-release capsules infringes certain of the Companys patents. Venlafaxine HCl
is the active ingredient used in EFFEXOR XR. The patents involved in the
litigation relate to extended-release formulations of venlafaxine and/or methods of their
use. These patents expire in 2017. Teva has asserted that these patents are invalid and/or
not infringed. Under the 30-month stay provision of the Hatch-Waxman Act, any FDA approval
of Tevas ANDA cannot be made effective before August 2005 unless the court earlier
decides that the patents are invalid or not infringed. Teva has not, to date, made any
allegations as to the Companys patent covering the compound, venlafaxine.
Accordingly, Tevas ANDA may further not be approved until the expiration of that
patent, and its associated pediatric exclusivity period, on June 13, 2008. |
|
On
March 14, 2003, Aventis Pharma Deutschland (Aventis) and King Pharmaceuticals, Inc. filed
a patent infringement suit against Cobalt Pharmaceuticals (Cobalt) in the United States
District Court for the District of Massachusetts (Aventis Pharma Deutschland GmbH and
King Pharmaceuticals, Inc. v. Cobalt Pharmaceuticals Inc., Docket No. 03-10492JLT,
U.S.D.C., D. Mass.) alleging that Cobalt infringes an Aventis patent for ramipril, which
expires in October 2008, by filing an ANDA with the FDA seeking approval to market generic
1.25 mg, 2.5 mg, 5 mg, and 10 mg ramipril capsules. The Company co-promotes ALTACE
(ramipril) together with King Pharmaceuticals, Inc. Cobalt has alleged that this patent is
invalid. Under the 30-month stay provision of the Hatch-Waxman Act, any FDA approval of
Cobalts ANDA cannot be made effective before August 2005, unless the court earlier
finds the patent invalid or not infringed. |
|
Medtronic
Sofamor Danek (which is Wyeths licensee for certain products utilizing Wyeths
recombinant BMP-2 protein, in particular the INFUSE Bone Graft/LT-CAGE Lumbar Tapered
Fusing Device System) and the patent owner have agreed to settle Medtronic Sofamor
Danek, Inc. vs. Gary K. Michelson, M.D. and Karlin Technology, Inc., |
49
|
Civ. Action No.
01-2373 (U.S. District Court for the Western District of Tennessee) where a jury had found
Medtronic liable for $109.0 million in compensatory damages and $400.0 million in punitive
damages and found that INFUSE infringed U.S. patents 6,080,155, 6,270,498 and 6,210,412
and awarded royalties at a rate of 10%. The Company was not a party to that action and is
not liable for the damages awarded or for the additional royalties. The settlement, which
is subject to Hart-Scott-Rodino regulatory approval, provides that Medtronic will assume
ownership of the patents in suit. When the settlement has cleared Hart-Scott-Rodino
review, the action will be dismissed and the potential for the patent owner to obtain an
injunction as to Medtronics sales of INFUSE will be removed. |
|
In
the litigation alleging that the Company violated the antitrust laws through the use of
exclusive contracts and disguised exclusive contracts with managed care
organizations and pharmacy benefit managers concerning PREMARIN, the
J.B.D.L. Corp. v. Wyeth-Ayerst Pharmaceuticals, Inc., Civ. A. No. C-1-01-704,
U.S.D.C., S.D. Oh., and CVS Meridian, Inc. et al. v. Wyeth, Civil A. No.
C-1-03-781, U.S.D.C., S.D. Oh., actions are scheduled for trial in August 2005. The
Company has filed a motion for summary judgment in the J.B.D.L. and CVS Meridian
actions. Moreover, two actions by indirect purchasers, one of which is a certified
class action, are pending in California court (Blevins v. Wyeth-Ayerst Laboratories,
Inc. et al., Case No. 324380, Cal. Sup. Ct., San Francisco Cty., Cal. and Sullivan
v. Wyeth-Ayerst Laboratories, Inc., Case No. GIC796997, Cal. Sup. Ct., San Diego Cty.,
Cal.) and have been coordinated in San Francisco under JCCP No. 4389. |
|
In
the litigation alleging that the Company, along with other pharmaceutical manufacturers,
violated federal antitrust statutes and certain state laws by unlawfully agreeing to
engage in conduct to prevent U.S. consumers from purchasing defendants prescription
drugs from Canada, a motion by the Company and its co-defendants to dismiss the complaint
has been granted in part and denied in part by the Magistrate Judge hearing the matter. An
appeal to the District Court from this ruling is expected. In re Canadian Import
Antitrust Litigation, Civ. No. 04-2724, U.S.D.C., D. Minn. |
|
Additionally,
in the Clayworth v. Pfizer, et al., No. RG04172428, Calif. Super. Ct., Alameda
Cty., action, the trial court has dismissed both plaintiffs original complaint and
their Second Amended Complaint, with leave to amend. Plaintiffs have until May 6, 2005 to file a
Third Amended Complaint. |
|
The
Company intends to continue to defend all of the foregoing litigation vigorously. |
|
In
the opinion of the Company, although the outcome of any legal proceedings cannot be
predicted with certainty, the ultimate liability of the Company in connection with pending
litigation (other than the litigation involving REDUX and PONDIMIN, the
potential effects of which are discussed in Note 5 to the consolidated condensed financial
statements) will not have a material adverse effect on the Companys financial
position but could be material to the results of operations or cash flows in any one
accounting period. |
50
Item 6. Exhibits and
Reports on Form 8-K
(a)
Exhibits
Exhibit No.
Description
|
(10.1) |
Form
of Stock Option Agreement (transferable options). |
|
(10.2) |
Form
of Performance Share Award Agreement. |
|
(10.3) |
Form
of Restricted Stock Unit Award Agreement (3 year cliff vesting). |
|
(12) |
Computation
of Ratio of Earnings to Fixed Charges. |
|
(31.1) |
Certification
of disclosure as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
(31.2) |
Certification
of disclosure as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
(32.1) |
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
|
(32.2) |
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
51
(b)
Reports on Form 8-K
|
The
following Current Reports on Form 8-K were filed or furnished by the Company:
|
|
|
|
|
o
o
o
o
o
o
o
o
|
January 11, 2005 relating to the Company's diet drug litigation (Items 1.01 and 9.01 disclosure).
January 19, 2005 relating to the Company's diet drug litigation (Items 7.01 and 9.01 disclosure).
January 31, 2005 relating to furnishing the Company's earnings results for the 2004 fourth quarter and full year (Items 2.02 and 9.01 disclosure).
March 3, 2005 relating to departure of directors (Item 5.02 disclosure).
March 9, 2005 relating to 2004 cash bonuses, 2005 base salaries and restricted stock awards for certain executive officers (Item 1.01 disclosure).
March 21, 2005 relating to furnishing information on Wyeth's 2005 earnings guidance (Items 7.01 and 9.01 disclosure).
April 20, 2005 relating to furnishing Wyeth's earnings results for the 2005 first quarter (Items 2.02 and 9.01 disclosure).
April 22, 2005 relating to the adoption of the 2005 Stock Incentive Plan (Items 1.01 and 9.01 disclosure).
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52
Signature
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.
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Wyeth (Registrant)
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By /s/ Paul J. Jones
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Paul J. Jones |
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Vice President and Controller
(Duly Authorized Signatory and Chief Accounting Officer) |
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Date: May 6, 2005
53
Exhibit Index
Exhibit No.
Description
|
(10.1) |
Form
of Stock Option Agreement (transferable options). |
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(10.2) |
Form
of Performance Share Award Agreement. |
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(10.3) |
Form
of Restricted Stock Unit Award Agreement (3 year cliff vesting). |
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(12) |
Computation
of Ratio of Earnings to Fixed Charges. |
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(31.1) |
Certification
of disclosure as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
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(31.2) |
Certification
of disclosure as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
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(32.1) |
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
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(32.2) |
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
EX - 1