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 2002 Annual Report on Form 10-K:
Stock-Based Compensation: The Company has five Stock Incentive Plans
which it accounts for using the intrinsic value method in accordance
with APB Opinion No. 25, Accounting for Stock Issued to Employees. No
stock-based employee compensation cost is reflected in net income, as
all options granted under those plans have an exercise price equal to
the market value of the underlying common stock on the date of grant.
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,
to stock-based employee compensation:
Three Months Six Months
Ended June 30, Ended June 30,
-------------------- ------------------------
(In thousands except per share amounts) 2003 2002 2003 2002
------------------------------------------ -------- -------- ---------- ----------
Net income, as reported $864,405 $599,859 $2,142,287 $1,471,779
Deduct: total stock-based employee
compensation expense determined under
fair value-based method for all awards,
net of tax 73,178 78,745 155,553 140,710
-------- -------- ---------- ----------
Pro forma net income $791,227 $521,114 $1,986,734 $1,331,069
======== ======== ========== ==========
Earnings per share:
Basic - as reported $0.65 $0.45 $1.61 $1.11
======== ======== ========== ==========
Basic - pro forma $0.60 $0.39 $1.50 $1.00
======== ======== ========== ==========
Diluted - as reported $0.65 $0.45 $1.61 $1.10
======== ======== ========== ==========
Diluted - pro forma $0.59 $0.39 $1.49 $1.00
======== ======== ========== ==========
Goodwill and Other Intangibles: On January 1, 2002, the Company
adopted SFAS No. 142, Goodwill and Other Intangible Assets. With the
adoption of SFAS No. 142, goodwill is no longer being amortized but is
subject to at least an annual assessment for impairment by applying a
fair value-based test. The same applies to other intangibles that have
been determined to have indefinite useful lives. However, other
intangibles with finite lives will continue to be amortized. The
Company's other intangibles, which all have finite lives, are being
amortized over their estimated useful lives ranging from three to 10
years.
7
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
The changes in the carrying amount of goodwill by segment for the six
months ended June 30, 2003, are as follows:
Consumer
(In thousands) Pharmaceuticals Healthcare Total
-------------------------------- --------------- ---------- ----------
Balance at December 31, 2002 $3,155,403 $590,346 $3,745,749
Currency translation adjustments 49,360 1,335 50,695
---------- -------- ----------
Balance at June 30, 2003 $3,204,763 $591,681 $3,796,444
========== ======== ==========
Note 2. Issuance of Notes and Credit Facilities
Issuance of $1,800.0 Million of Notes:
On February 11, 2003, the Company issued $1,800.0 million of Notes.
The issuance consisted of two tranches of Notes, each of which pays
interest semiannually, as follows:
o $300.0 million 4.125% Notes due March 1, 2008 with interest
payments due on March 1 and September 1
o $1,500.0 million 5.25% Notes due March 15, 2013 with interest
payments due on March 15 and September 15
The interest rate payable on each of these tranches of Notes is
subject to an increase of 0.25 percentage points per level of
downgrade in the Company's credit rating by Moody's or S&P. There is
no adjustment to the interest rate payable on either series of Notes
for the first single-level downgrade in the Company's credit rating by
S&P. If Moody's or S&P subsequently were to increase the Company's
credit rating, the interest rate payable on each series of Notes is
subject to a decrease of 0.25 percentage points for each level of
credit rating increase. The interest rate payable for both series of
Notes cannot be reduced below the original coupon rate of either
series of Notes. However, the total adjustment to the interest rate
for either series of Notes cannot exceed two percentage points and the
interest rate in effect on March 15, 2006, for both series of Notes,
will become the effective interest rate until maturity. The Company
would incur a total of approximately $4.5 million of additional annual
interest expense for every 0.25 percentage point increase in the
interest rate.
The Company entered into two interest rate swaps with an aggregate
notional amount of $300.0 million relating to the $300.0 million
4.125% Notes and two interest rate swaps with an aggregate notional
amount of $1,500.0 million relating to the $1,500.0 million 5.25%
Notes whereby the Company effectively converted the fixed rate of
interest on these Notes to a floating rate, which is based on LIBOR.
8
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
New Credit Facility:
In March 2003, the Company's $3,000.0 million credit facility
terminated. Concurrent with this termination, the Company entered into
new credit facilities totaling $2,700.0 million. These credit
facilities are composed of a $1,350.0 million, 364-day facility and a
$1,350.0 million, three-year facility. The maturity date of any
borrowings under the $1,350.0 million, 364-day credit facility that
are outstanding upon its termination in February 2004 is extendible by
the Company for an additional year. The credit facilities contain
substantially identical financial and other covenants,
representations, warranties, conditions and default provisions as the
terminating facility.
At June 30, 2003, the Company had commercial paper outstanding of
$457.7 million, which is supported by the credit facilities identified
above and was classified as Long-term debt.
Note 3. 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 Company's 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.
The nationwide class action settlement to resolve litigation brought
against the Company regarding use of 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 received final judicial approval effective
January 3, 2002. In connection with the REDUX and PONDIMIN diet drug
matter, the Company has recorded litigation charges totaling $14,600.0
million. These charges are intended to cover the total amount required
to resolve all diet drug litigation, including anticipated funding
requirements for the nationwide class action settlement, anticipated
costs to resolve the claims of any members of the settlement class who
have exercised or in the future may exercise an intermediate or
back-end opt out right, costs to resolve the claims of primary
pulmonary hypertension (PPH) claimants and initial opt out claimants,
and administrative and litigation expenses.
During the 2003 first half, individual settlement payments, legal fees
and other costs totaling $248.4 million were paid and applied against
the litigation accrual. At June 30, 2003, $1,702.3 million of the
litigation accrual remained.
In December 2002, following a joint motion by the Company and
plaintiffs' counsel, the Court approved an amendment to the settlement
agreement which provided for the merger of Funds A and B into a
combined fund which will now cover all expenses and injury claims in
connection with the settlement. The effect of the merger is to
accelerate the spillover of the expected remainder in Fund A, which
will now be available to pay Fund B claims. The merger of the two
funds took place in January 2003. In February 2003, as required by the
amendment to the settlement agreement merging the two
9
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
settlement funds, an additional $535.2 million was added by the
Company to the security fund and such amount was recorded in Other
assets including deferred taxes. The Company established the security
fund as collateral for the Company's financial obligations under the
settlement. 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.
The Company continuously reviews its diet drug litigation reserve as
additional information becomes available with respect to claims both
inside and outside of the nationwide class action settlement. Within
the settlement, the number of individuals who have filed claims that
allege significant heart valve disease (known as matrix claims) has
been higher than had been anticipated. While the Company does not have
precise current information, the settlement trust has recorded
approximately 83,000 matrix-level claim forms to date and it is likely
that additional forms have been received but not yet logged in. Fewer
than half of the forms that have been logged in have been processed to
date, and only a very small percentage of the forms that have been
processed have been found valid and been paid. In addition, in light
of substantial questions that have been raised concerning the validity
of many of these matrix claims, the federal court overseeing the
nationwide settlement has ordered that 100% of the matrix claims be
audited for eligibility for awards under the settlement. That 100%
audit process remains in its earliest stages; the Company expects
that, as a result of the audit process, only a fraction of the actual
claim forms submitted will result in a payment.
With respect to claims outside of the settlement, the Company has
resolved the claims of all but a small percentage of the "initial" opt
outs (i.e., those individuals who exercised their right to opt out of
the settlement class) and continues to work toward resolving the rest.
In regard to those class members who seek to exercise a "downstream"
opt out right provided by the settlement, based on preliminary
estimates, approximately 70,000 intermediate opt out forms were
submitted by May 3, 2003, the applicable deadline for most class
members (other than qualified class members receiving echocardiograms
through the settlement trust after January 3, 2003, who may exercise
intermediate opt out rights within 120 days after the date of their
echocardiogram). The number of class members who have purported to
exercise a back-end opt out right is estimated to be approximately
20,000 and certain additional class members will be entitled to
exercise back-end opt out rights in the future. However, the Company
expects that the number of valid opt outs will be substantially less
than the number of forms submitted. First, there is no estimate at
this time of the percentage of those purported exercise forms that are
valid (i.e., forms that are not duplicative of other filings, that are
not filed on behalf of individuals who have already either received
payments from the settlement trust or settlements from the Company,
and are otherwise not invalid on their face). Second, there is no
estimate at this time of the percentage of the purported opt outs that
satisfy the settlement's medical eligibility requirements. The Company
is vigorously challenging all intermediate and back-end opt out claims
of questionable validity or medical eligibility and the number of such
claims that meet the settlement criteria will not be known for some
time.
10
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Intermediate and back-end opt outs who meet the settlement's criteria
may pursue lawsuits against the Company, but must prove their cases
without relying on verdicts, judgments or factual findings made in
other lawsuits. They also may not seek or recover punitive, exemplary
or multiple damages and may sue only for the valvular condition giving
rise to their opt out right. The Company plans to vigorously defend
such lawsuits.
Based upon the information currently available, the Company believes
that there is no basis to change its reserves to cover the remaining
obligations relating to the diet drug litigation. However, the volume
of opt out and matrix-level claims in the settlement has been higher
than anticipated. Accordingly, in light of the increased uncertainty,
it is possible that additional reserves will be required.
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 will not have
a material adverse effect on the Company's financial position but
could be material to the results of operations or cash flows in one or
more accounting periods.
Note 4. Restructuring Program
In December 2002, the Company recorded a special charge for
restructuring and related asset impairments of $340.8 million to
recognize the costs of closing certain manufacturing facilities and
two research facilities, as well as the elimination of certain
positions at the Company's facilities. The Company recorded its asset
impairments in accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets and its restructuring
charges, including personnel and other costs, in accordance with EITF
No. 94-3, Liability Recognition for Certain Employee Termination
Benefits and Other Costs to Exit an Activity (including Certain Costs
Incurred in a Restructuring).
The restructuring will ultimately result in the elimination of
approximately 3,150 positions worldwide. The reductions in workforce
are permanent and affected all of the Company's segments, including
Corporate. As of June 30, 2003, the Company has initiated the process
of closing certain manufacturing facilities and had eliminated
approximately 2,755 positions. The activity in the restructuring
accruals was as follows:
Personnel Other Closure/
(In thousands) Costs Exit Costs Total
------------------------------------------- --------- -------------- --------
Restructuring accruals at December 31, 2002 $163,700 $73,000 $236,700
Cash expenditures (100,400) (27,300) (127,700)
--------- -------------- --------
Restructuring accruals at June 30, 2003 $63,300 $45,700 $109,000
========= ============== ========
11
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 5. Earnings per Share
The following table sets forth the computations of basic earnings per
share and diluted earnings per share:
Three Months Six Months
Ended June 30, Ended June 30,
---------------------- ------------------------
(In thousands except per share amounts) 2003 2002 2003 2002
--------------------------------------- --------- --------- ---------- ----------
Net income less preferred dividends $864,387 $599,840 $2,142,260 $1,471,750
Denominator:
Weighted average number of common
shares outstanding 1,329,333 1,325,989 1,328,238 1,324,970
--------- --------- ---------- ----------
Basic earnings per share $0.65 $0.45 $1.61 $1.11
========= ========= ========== ==========
Net income $864,405 $599,859 $2,142,287 $1,471,779
Denominator:
Weighted average number of common
shares outstanding 1,329,333 1,325,989 1,328,238 1,324,970
Common stock equivalents of
outstanding stock options and
deferred common stock awards 5,853 10,307 5,068 12,437
--------- --------- ---------- ----------
Total shares 1,335,186 1,336,296 1,333,306 1,337,407
--------- --------- ---------- ----------
Diluted earnings per share $0.65 $0.45 $1.61 $1.10
========= ========= ========== ==========
Diluted earnings per share excluded 86.8 million and 81.0 million
common shares related to options outstanding under the Company's Stock
Incentive Plans at June 30, 2003 and 2002, respectively, as the
exercise price per share of these options was greater than the average
market value, resulting in an antidilutive effect on diluted earnings
per share.
12
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 6. Marketable Securities
The cost, gross unrealized gains and (losses), and fair value of
available-for-sale and held-to-maturity securities by major security
type at June 30, 2003 and December 31, 2002, were as follows:
Gross Gross
(In thousands) Unrealized Unrealized Fair
At June 30, 2003 Cost Gains (Losses) Value
---------------------------------- ---------- ---------- ---------- ----------
Available-for-sale:
U.S. Treasury securities $208,835 $656 $(261) $209,230
Commercial paper 96,719 15 (1) 96,733
Certificates of deposit 21,668 4 - 21,672
Corporate debt securities 182,413 628 (55) 182,986
Other debt securities 9,701 257 - 9,958
Institutional fixed income fund 531,932 6,858 - 538,790
---------- ---------- ---------- ----------
Total available-for-sale 1,051,268 8,418 (317) 1,059,369
---------- ---------- ---------- ----------
Held-to-maturity:
Commercial paper 7,976 - - 7,976
Certificates of deposit 53,450 - - 53,450
Other debt securities 14,993 - - 14,993
---------- ---------- ---------- ----------
Total held-to-maturity 76,419 - - 76,419
---------- ---------- ---------- ----------
$1,127,687 $8,418 $(317) $1,135,788
========== ========== ========== ==========
Gross Gross
(In thousands) Unrealized Unrealized Fair
At December 31, 2002 Cost Gains (Losses) Value
---------------------------------- ---------- ---------- ---------- ----------
Available-for-sale:
U.S. Treasury securities $105,583 $615 $(15) $106,183
Commercial paper 57,397 - - 57,397
Certificates of deposit 29,218 77 - 29,295
Corporate debt securities 214,127 1,202 (388) 214,941
Other debt securities 9,702 150 - 9,852
Institutional fixed income fund 510,574 16,312 - 526,886
---------- ---------- ---------- ----------
Total available-for-sale 926,601 18,356 (403) 944,554
---------- ---------- ---------- ----------
Held-to-maturity:
Time / term deposits 30,002 - - 30,002
U.S. Treasury securities 1,996 - - 1,996
Commercial paper 10,473 - - 10,473
Certificates of deposit 15,251 - - 15,251
Other debt securities 999 - - 999
---------- ---------- ---------- ----------
Total held-to-maturity 58,721 - - 58,721
---------- ---------- ---------- ----------
$985,322 $18,356 $(403) $1,003,275
========== ========== ========== ==========
13
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
The contractual maturities of debt securities classified as
available-for-sale at June 30, 2003 were as follows:
Fair
(In thousands) Cost Value
---------------------------------------- -------- --------
Available-for-sale:
Due within one year $166,351 $166,394
Due after one year through five years 341,283 342,502
Due after five years through 10 years - -
Due after 10 years 11,702 11,683
-------- --------
$519,336 $520,579
======== ========
All held-to-maturity debt securities are due within one year and had
aggregate fair values of $76.4 million at June 30, 2003.
Note 7. Company Data by Segment
The Company has three segments: Pharmaceuticals, Consumer Healthcare
and Corporate. The Company's Pharmaceuticals and Consumer Healthcare
operating segments are strategic business units that are managed
separately because they manufacture, distribute and sell distinct
products and provide services, which require various technologies and
marketing strategies.
Net Revenue
------------------------------------------------------------
Three Months Six Months
Ended June 30, Ended June 30,
(In thousands) -------------------------- --------------------------
Segment 2003 2002 2003 2002
----------------------- ---------- ---------- ---------- ----------
Pharmaceuticals $3,193,471 $3,009,708 $6,350,524 $6,158,752
Consumer Healthcare 553,085 493,140 1,085,089 987,617
---------- ---------- ---------- ----------
Total $3,746,556 $3,502,848 $7,435,613 $7,146,369
========== ========== ========== ==========
Income Before Taxes
------------------------------------------------------------
Three Months Six Months
Ended June 30, Ended June 30,
(In thousands) -------------------------- --------------------------
Segment 2003 2002 2003 2002
----------------------- ---------- ---------- ---------- ----------
Pharmaceuticals(1) $1,083,366 $736,607 $2,027,248 $1,809,815
Consumer Healthcare (2) 149,000 143,457 229,204 302,936
---------- ---------- ---------- ----------
1,232,366 880,064 2,256,452 2,112,751
Corporate (3) (124,154) (108,329) 634,348 (218,854)
---------- ---------- ---------- ----------
Total $1,108,212 $771,735 $2,890,800 $1,893,897
========== ========== ========== ==========
14
WYETH
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
(1) Pharmaceuticals for the 2003 second quarter and first half
included gains of $231,233 as a result of the divestiture of
product rights to ATIVAN, ISORDIL, DIAMOX, ZIAC, ZEBETA, AYGESTIN
and SONATA.
(2) Consumer Healthcare for the 2003 second quarter and first half
included a gain of $34,000 related to the divestiture of ANACIN.
In addition, gains of $40,350 and $73,850 were included in the
2002 second quarter and first half, respectively, related to a
class action settlement regarding price fixing by certain vitamin
suppliers.
(3) Corporate for the 2003 first half included a first quarter gain
of $860,554 relating to the sale of Amgen shares.
Note 8. Sale of Amgen Common Stock Investment
During the first quarter of 2003, the Company completed the sale of
the remaining 31,235,958 shares of Amgen common stock held by the
Company at December 31, 2002. These remaining shares netted proceeds
of $1,579.9 million and resulted in a gain of $860.6 million ($558.7
million after-tax or $0.42 per share-diluted).
15
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Item 2. Results of Operations
Worldwide net revenue for the 2003 second quarter and first half was
7% and 4% higher, respectively, compared with prior year levels. The
increase in worldwide net revenue for the 2003 second quarter and
first half was due primarily to higher worldwide net revenue of both
pharmaceuticals and consumer healthcare. Excluding the impact of
foreign exchange, worldwide net revenue increased 3% for the 2003
second quarter and was flat for the 2003 first half.
The following table sets forth worldwide net revenue results by
operating segment together with the percentage changes from the
comparable period in the prior year:
Net Revenue
----------------------
Three Months
Ended June 30,
($ in millions) ----------------------
Segment 2003 2002 % Increase
------------------------- -------- -------- ----------
Pharmaceuticals $3,193.5 $3,009.7 6%
Consumer Healthcare 553.1 493.1 12%
-------- -------- ----------
Total $3,746.6 $3,502.8 7%
======== ======== ==========
Net Revenue
----------------------
Six Months
Ended June 30,
($ in millions) ----------------------
Segment 2003 2002 % Increase
------------------------- -------- -------- ----------
Pharmaceuticals $6,350.5 $6,158.8 3%
Consumer Healthcare 1,085.1 987.6 10%
-------- -------- ----------
Total $7,435.6 $7,146.4 4%
======== ======== ==========
Pharmaceuticals
Worldwide pharmaceutical net revenue increased 6% for the 2003 second
quarter and 3% for the 2003 first half. Excluding the impact of
foreign exchange, worldwide pharmaceutical net revenue increased 2%
and decreased 1% for the 2003 second quarter and first half,
respectively.
Worldwide human pharmaceutical net revenue increased 6% for the second
quarter as higher sales of PROTONIX (strong prescription volume
growth), EFFEXOR XR (substantial global growth), PREVNAR and ZOSYN
(both reflecting consistent increased manufacturing capability) and
increased alliance revenue were offset, in part, by lower sales of the
PREMARIN family of products and CORDARONE I.V. (market exclusivity
ended October 2002). The lower sales of the PREMARIN family of
products included a $60.0 million reserve recorded by the Company in
the 2003 second quarter for anticipated returns in connection with a
projected shift in prescriptions toward
16
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
the recently approved lower dosage forms of PREMARIN and PREMPRO.
Excluding the impact of foreign exchange, worldwide human
pharmaceutical net revenue increased 2% and decreased 1% for the 2003
second quarter and first half, respectively.
Worldwide animal health product net revenue increased 10% for the 2003
second quarter and 11% for the 2003 first half. The increase in net
revenue was due primarily to higher domestic sales of the Company's
WEST NILE - INNOVATOR, a biological vaccine for horses. Excluding the
impact of foreign exchange, worldwide animal health product net
revenue increased 6% and 8% for the 2003 second quarter and first
half, respectively.
The following table sets forth the significant worldwide human
pharmaceutical and animal health net revenue by product for the three
and six months ended June 30, 2003 compared with the same periods in
the prior year:
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Consumer Healthcare
Worldwide consumer healthcare net revenue increased 12% for the 2003
second quarter and 10% for the 2003 first half due primarily to sales
of ALAVERT (introduced in the 2002 fourth quarter) and higher sales of
other cough/cold/allergy products, ADVIL COLD & SINUS, CALTRATE and
ADVIL. The first half increase was partially offset by lower sales of
CENTRUM products. Excluding the impact of foreign exchange, worldwide
consumer healthcare net revenue increased 8% and 7% for the 2003
second quarter and first half, respectively.
The following table sets forth the significant worldwide consumer
healthcare net revenue by product for the three and six months ended
June 30, 2003 compared with the same periods in the prior year:
Three Months Six Months
Ended June 30, Ended June 30,
(In millions) ----------------- -------------------
Products 2003 2002 2003 2002
--------------------------------- ------ ------ -------- ------
CENTRUM $134.4 $133.4 $254.0 $263.3
ADVIL 99.6 93.3 208.4 203.4
Other cough/cold/allergy products 56.8 50.9 137.6 115.7
CALTRATE 38.7 35.1 68.9 62.5
SOLGAR 26.7 24.6 55.2 53.0
ADVIL COLD & SINUS 27.9 20.9 52.5 40.0
ALAVERT 30.6 - 51.7 -
CHAP STICK 16.0 19.5 39.4 43.5
Other 122.4 115.4 217.4 206.2
------ ------ -------- ------
Total consumer healthcare $553.1 $493.1 $1,085.1 $987.6
====== ====== ======== ======
18
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
The following table sets forth the percentage changes in worldwide net
revenue by operating segment compared with the prior year, including
the effect volume, price and foreign exchange had on these percentage
changes:
% Increase (Decrease) % Increase (Decrease)
Three Months Ended June 30, 2003 Six Months Ended June 30, 2003
--------------------------------------------- ---------------------------------------------
Foreign Total Foreign Total
Volume Price Exchange Net Revenue Volume Price Exchange Net Revenue
------ ----- -------- ----------- ------ ----- -------- -----------
Pharmaceuticals
-------------------
United States (8%) 8% - - (8%) 6% - (2%)
International 3% 3% 11% 17% - 3% 10% 13%
--- --- --- --- --- --- --- ---
Total (4%) 6% 4% 6% (6%) 5% 4% 3%
=== === === === === === === ===
Consumer Healthcare
-------------------
United States 6% 2% - 8% 3% 3% - 6%
International 5% 4% 10% 19% 5% 3% 9% 17%
--- --- --- --- --- --- --- ---
Total 6% 2% 4% 12% 4% 3% 3% 10%
=== === === === === === === ===
Total
-------------------
United States (6%) 7% - 1% (7%) 6% - (1%)
International 3% 3% 11% 17% 1% 3% 10% 14%
--- --- --- --- --- --- --- ---
Total (3%) 6% 4% 7% (4%) 4% 4% 4%
=== === === === === === === ===
Operating Expenses
Cost of goods sold, as a percentage of Net revenue, increased to 27.2%
for the 2003 second quarter compared with 25.3% for the 2002 second
quarter and increased to 26.2% for the 2003 first half compared with
23.6% for the 2002 first half due primarily to higher manufacturing
costs and a less profitable product mix related to lower sales of
higher margin products. The impact of higher manufacturing costs and a
less profitable product mix on gross margin was partially offset by
increased alliance revenue recorded in the 2003 second quarter and
first half net revenue as compared with the 2002 second quarter and
first half net revenue. There are no costs of goods sold relating to
alliance revenue, and therefore any net revenue fluctuations impacted
by alliance revenue will also impact gross margins.
Selling, general and administrative expenses, as a percentage of Net
revenue, decreased to 36.4% for the 2003 second quarter and 35.7% for
the 2003 first half compared with 37.4% for the 2002 second quarter
and 36.1% for the 2002 first half as a result of cost containment
efforts initiated in the second half of 2002 offset, in part, by
higher general expenses related to increased pension expense, general
insurance and other employee benefit expenses.
Research and development expenses decreased 5% for the 2003 second
quarter and increased 1% for the 2003 first half. The 2003 second
quarter decrease was primarily due to reduced spending for operating
expenses, including lower chemical and material costs and salaries,
offset, in part by higher clinical grant spending. Increased research
and
19
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
development spending is expected for the 2003 second half as a result
of the commencement of several Phase III clinical development
programs.
Interest Expense and Other Income
Interest Expense, net for the three and six months ended June 30, 2003
and 2002 consisted of the following:
Three Months Six Months
Ended June 30, Ended June 30,
--------------- -----------------
(In millions) 2003 2002 2003 2002
---------------------------- ----- ----- ------ ------
Interest expense $72.7 $96.2 $143.8 $189.9
Interest income (18.9) (20.4) (38.4) (43.5)
Less: amount capitalized for
capital projects (27.9) (20.2) (52.5) (37.4)
----- ----- ------ ------
Total interest expense, net $25.9 $55.6 $52.9 $109.0
===== ===== ====== ======
Interest expense, net decreased 53% for the 2003 second quarter and
51% for the 2003 first half due primarily to lower weighted average
debt outstanding, compared with prior year levels. Weighted average
debt outstanding during the 2003 second quarter and first half was
$6,938.1 million and $7,176.1 million, respectively, compared with
prior year levels of $10,379.7 million and $10,161.3 million,
respectively. The decrease in interest expense was also affected by
higher capitalized interest resulting from spending for long-term
capital projects in process. These projects include a new bio-pharma
and vaccine manufacturing facility in Ireland, as well as the
expansion of an existing manufacturing facility in Ireland.
Other income, net increased significantly for both the 2003 second
quarter and first half as a result of significant second quarter gains
from the divestiture of certain pharmaceutical and consumer healthcare
products amounting to approximately $265.2 million. The divestitures
included product rights to ATIVAN, ISORDIL, DIAMOX, ZIAC, ZEBETA,
AYGESTIN, ANACIN and SONATA. The sales, profits and net assets of
these divested products, individually or in the aggregate, were not
material to either business segment or the Company's consolidated
financial position or results of operations.
20
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Income Before Taxes
The following table sets forth worldwide income before taxes by
segment together with the percentage changes from the comparable
period in the prior year:
(1) Pharmaceuticals for the 2003 second quarter and first half
included gains of $231.2 as a result of the divestiture of
product rights to ATIVAN, ISORDIL, DIAMOX, ZIAC, ZEBETA, AYGESTIN
and SONATA. Excluding these divestiture gains, Pharmaceuticals
income before taxes increased 16% for the 2003 second quarter and
decreased 1% for the 2003 first half.
(2) Consumer Healthcare for the 2003 second quarter and first half
included a gain of $34.0 related to the divestiture of ANACIN. In
addition, gains of $40.3 and $73.9 in the 2002 second quarter and
first half, respectively, related to a class action settlement
regarding price fixing by certain vitamin suppliers. Excluding
the divestiture and settlement gains, Consumer Healthcare income
before taxes increased 12% for the 2003 second quarter and
decreased 15% for the 2003 first half.
(3) Corporate for the 2003 first half included a first quarter gain
of $860.6 relating to the sale of Amgen shares. Excluding the
gain on the sale of Amgen shares from the 2003 first half
results, Corporate expenses, net increased 3%.
Worldwide pharmaceutical income before taxes increased 47% for the
2003 second quarter and 12% for the 2003 first half due primarily to
higher other income, as a result of gains from the divestiture of
certain products, lower selling, general and administrative expenses
and research and development expenses offset, in part, by lower gross
profit margins earned on worldwide sales of human pharmaceuticals.
Worldwide consumer healthcare income before taxes increased 4% for the
2003 second quarter and decreased 24% for the 2003 first half while
consumer healthcare sales increased 12% and 10% for the 2003 second
quarter and first half, respectively. This difference between sales
growth and the growth of income before taxes for the 2003 second
quarter is primarily attributable to lower gross profit margins earned
on worldwide sales of consumer healthcare products and higher selling,
general and administrative expenses as a result of increased marketing
expenses associated with the launch of ALAVERT and ADVIL ALLERGY
SINUS. The 2003 first half difference was additionally impacted by the
non-recurrence of income received in 2002 in
21
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
connection with a class action settlement gain relating to price
fixing by certain vitamin suppliers.
Corporate expenses, net, increased 15% for the 2003 second quarter and
3% for the 2003 first half, excluding the 2003 first quarter gain of
$860.6 million from the sale of the Company's remaining Amgen shares.
The increase in corporate expenses, net is due primarily to higher
general expenses related to increased pension expense, general
insurance and other employee benefit expenses offset, in part, by
lower interest expense resulting from lower weighted average debt
outstanding as compared with prior year levels.
The effective tax rate remained flat at 22.0% for both the 2003 second
quarter and first half, excluding the 2003 first quarter gain on the
sale of the Company's remaining Amgen shares, compared with 22.3% for
both the 2002 second quarter and first half.
Consolidated Net Income and Diluted Earnings Per Share Results
Net income and diluted earnings per share for the 2003 second quarter
increased to $864.4 million and $0.65 compared with $599.9 million and
$0.45 in the prior year, both increases of 44%. The increases in net
income and diluted earnings per share for the 2003 second quarter were
greater than the growth rate in net revenue due primarily to higher
other income, as a result of gains from the divestiture of certain
pharmaceutical and consumer healthcare products and lower interest
expense, which factors were partially offset by higher costs of goods
sold, as a percentage of net revenue.
Net income and diluted earnings per share each increased 46% for the
2003 first half to $2,142.3 million and $1.61, respectively, compared
with $1,471.8 million and $1.10 in the prior year. The 2003 first half
net income and diluted earnings per share included a first quarter
gain of $860.6 million ($558.7 million after-tax or $0.42 per
share-diluted) related to the sale of the remaining 31,235,958 shares
of the Company's Amgen common stock holdings. Excluding the gain on
the sale of Amgen shares from the 2003 first half results, net income
and diluted earnings per share for the 2003 first half each increased
8% to $1,583.6 million and $1.19 compared with the 2002 first half.
Higher net income for the 2003 first half, excluding the Amgen gain,
was affected by the same items that impacted the 2003 second quarter
results, which included higher other income and lower interest
expense, partially offset by a less profitable product mix and higher
manufacturing costs, as well as higher selling, general and
administrative expenses.
22
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Liquidity, Financial Condition and Capital Resources
Cash flows provided by operating activities totaling $950.4 million
during the 2003 first half were generated primarily by earnings of
$991.6 million (which excludes non-cash gains related to the sale of
the remaining Amgen shares and sales of other assets) and proceeds of
$126.2 million relating to improved collections on outstanding
accounts receivable. Driving the cash outflows were payments of $248.4
million relating to the diet drug litigation and a payment of $535.2
million to the security fund as collateral for the Company's financial
obligations under the diet drug settlement (see Note 3 to the
consolidated condensed financial statements). Additionally, an
increase in inventories of $326.4 million due primarily to production
planning impacted cash outflows.
The Company generated $981.2 million of cash from investing activities
during the 2003 first half due primarily to proceeds received of
$1,579.9 million relating to the sale of the Company's remaining
31,235,958 shares of Amgen common stock. The Company used $1,402.0
million for investments in property, plant and equipment and
marketable securities. The capital expenditures made during the 2003
first half were consistent with the Company's commitment to expand
existing manufacturing and research and development facilities
worldwide, and build new biotechnology facilities.
The Company received proceeds of $1,800.0 million from the issuance of
two tranches of Notes in February 2003 (see Note 2 to the consolidated
condensed financial statements). These proceeds were offset by cash
used for financing activities relating to repayments of commercial
paper and other borrowing transactions totaling $3,356.1 million and
dividend payments of $610.6 million.
At June 30, 2003, the Company had outstanding $6,927.0 million in
total debt. The Company's total debt consisted of commercial paper of
$457.7 million, and notes payable and other debt of $6,469.3 million.
The Company offers its commercial paper in a very liquid market
commensurate with its short-term credit ratings from Moody's (P2), S&P
(A1) and Fitch (F1). Current debt at June 30, 2003, classified as
Loans payable, consisted of $511.8 million of notes payable and other
debt that is due within one year. All of the commercial paper
outstanding at June 30, 2003 was supported by the Company's new credit
facilities, totaling $2,700.0 million, and is classified as Long-term
debt.
Subject to the uncertainty in predicting the outcome of litigation
(see Note 3 to the consolidated condensed financial statements),
management believes that cash flows from operating activities and
existing and prospective financing resources will be adequate to fund
the Company's operations, pay opt out settlement payments and fund the
nationwide class action settlement relating to the REDUX and PONDIMIN
diet drug litigation, pay dividends, maintain the ongoing programs of
capital expenditures, and repay both the principal and interest on its
outstanding obligations, without requiring the disposition of any
significant strategic core assets or businesses.
23
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Certain Factors that May Affect Future Results
Prempro / Premarin - HRT Studies
Two subsets of the Women's Health Initiative (WHI) enrolled a total of
27,000 predominantly healthy postmenopausal women to assess the risks
and benefits of either long-term estrogen replacement therapy (ERT) or
long-term hormone replacement therapy (HRT). The primary endpoint of
the WHI study was coronary heart disease, with invasive breast cancer
as the primary adverse outcome studied. In July 2002, the HRT 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
average of 5.2 years) because, according to the predefined stopping
rule, increased risks of breast cancer and cardiovascular events
exceeded the specified long-term benefits. The study observed an
increased incidence of cardiovascular disease and, over time, breast
cancer among women on HRT compared to those on placebo. The study also
observed a reduction in the incidence of hip, vertebral and other
osteoporotic fractures and of colon cancer among women on HRT compared
to those on placebo. The study did not evaluate the use of HRT for the
treatment of menopausal symptoms, the main indication of the product.
Additional analyses of data from the HRT subset of the WHI study,
including data on stroke, cognition, dementia, and breast cancer
characteristics have been released during 2003, and further analyses
of WHI data are expected to be released in the future.
Sales of PREMPRO and other PREMARIN family products have been and will
continue to be adversely affected by the WHI results. Based on the
most recent available market data, average weekly prescriptions
written for PREMPRO and PREMARIN decreased approximately 72% and 36%,
respectively, compared to the average weekly prescriptions written
during the eight-week period preceding the termination of the study
subset. PREMPRO sales (including PREMPHASE) for the three and six
months ended June 30, 2003 represented approximately 1% and 2%,
respectively, of consolidated net revenue.
24
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
Set forth below are individual product operating results for both
PREMPRO/PREMPHASE and PREMARIN for the three and six months ended
June 30, 2003 and 2002.
Prempro/Premphase
--------------------------------------------
Three Months Six Months
Ended June 30, Ended June 30,
----------------- -----------------
(In millions) 2003 2002 2003 2002
---------------- ------ ------ ------ ------
Net revenue $22.1 $171.5 $165.0 $387.6
Gross profit (*) (8.4) 147.2 115.1 332.9
Premarin
--------------------------------------------
Three Months Six Months
Ended June 30, Ended June 30,
----------------- -----------------
(In millions) 2003 2002 2003 2002
---------------- ------ ------ ------ ------
Net revenue $254.4 $273.9 $514.2 $733.3
Gross profit 223.5 247.0 456.7 676.1
(*) The Company recorded a $60.0 reserve in the 2003 second quarter
for anticipated returns in connection with a projected shift in
prescriptions toward the recently approved lower dosage forms of
PREMARIN and PREMPRO.
Competition
The Company operates in the highly competitive pharmaceutical and
consumer health care industries. PREMARIN, the Company's principal
conjugated estrogens product manufactured from pregnant mare's 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 the Company's net revenue and results of
operations. PREMARIN's natural composition is not subject to patent
protection (although PREMPRO has patent protection). The principal
indications of PREMARIN, PREMPRO and PREMPHASE are to manage the
symptoms of menopause and to prevent osteoporosis, a condition
involving a loss of bone mass in postmenopausal women.
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
than those found in PREMPRO and PREMPHASE, utilizing various forms of
delivery and having one or more of the same indications have also been
introduced. Some companies have attempted to obtain approval for
generic versions of PREMARIN. 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
25
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
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. In June 2003, a competitor company announced that it had filed
an Abbreviated New Drug Application for approval of a generic version
of PREMARIN allegedly made from the same natural source; the Company
cannot predict the timing or outcome of the approval process.
Product Supply
Market demand for ENBREL is strong; however the sales growth had been
constrained by limits on the existing source of supply. In December
2002, the retrofitted Rhode Island facility owned by Amgen was
completed, and manufacturing production was approved by the FDA.
Consequently, manufacturing capacity for ENBREL will significantly
increase in 2003. Market demand is expected to continue to grow, and
additional manufacturing supply is projected to be required. In April
2002, Immunex (prior to being acquired by Amgen) announced it entered
into a manufacturing agreement with Genentech, Inc. to produce ENBREL
beginning in 2004, subject to FDA approval. The current plan for the
longer term includes an additional manufacturing facility, which is
being constructed by the Company in Ireland and expansion of the Rhode
Island facility, both of which are expected to be completed during
2005.
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 Company's Annual Report on Form 10-K for the year
ended December 31, 2002, Quarterly Report on Form 10-Q for the quarter
ended March 31, 2003 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,
DIMETAPP, ROBITUSSIN and PREMPRO. 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.
The estimated costs that the Company expects to pay in these cases are
accrued when the liability is considered probable and the amount can
be reasonably estimated. In many cases, future environmental-related
expenditures cannot be quantified with a reasonable degree of
accuracy. As investigations and cleanups proceed,
environmental-related
26
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
liabilities are reviewed and adjusted as additional information
becomes available. In addition, the Company is self-insured against
ordinary product liability risks and has liability coverage, in excess
of certain limits and subject to certain policy ceilings, from various
insurance carriers. It is the opinion of the Company that any
potential liability that might exceed amounts already accrued will not
have a material adverse effect on the Company's financial position but
could be material to the results of operations or cash flows in one or
more accounting periods.
Cautionary Statements Regarding Forward-Looking Information
The Private Securities Litigation Reform Act of 1995 provides a "safe
harbor" for forward-looking statements. This quarterly report,
including management's discussion and analysis set forth herein, as
well as our annual, quarterly and special reports, proxy statements
and other information filed with the Securities and Exchange
Commission and other written or oral statements made by us or on our
behalf may include forward-looking statements reflecting our current
views at the time these statements were made with respect to future
events and financial performance. These forward-looking statements can
be identified by the 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 future impact of presently known trends, including those with
respect to product performance and competition;
o anticipated developments related to PREMPRO/PREMARIN performance
and ENBREL product supply; and
o expectations regarding the impact of potential litigation
relating to PREMPRO; the nationwide class action settlement
relating to REDUX and PONDIMIN; and additional litigation charges
related to REDUX and PONDIMIN, including those for opt outs from
the national settlement.
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
27
Management's Discussion and Analysis of Financial Condition
and Results of Operations
Three Months and Six Months Ended June 30, 2003
undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future developments or otherwise. Certain factors which could cause
the Company's actual results to differ materially from expected and
historical results are discussed herein and others have been
identified by the Company in Exhibit 99 to the Company's 2002 Annual
Report on Form 10-K, which exhibit is incorporated herein by
reference.
28
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The market risk disclosures appearing on page 65 of the Company's 2002
Annual Report as incorporated by reference in the Form 10-K have not
materially changed from December 31, 2002.
At June 30, 2003, the fair values of the Company's financial
instruments were as follows:
(1) If the value of the U.S. dollar were to increase or decrease by
10%, in relation to all hedged foreign currencies, the net
payable on the forward and option contracts would decrease or
increase by approximately $88.0.
(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 $329.9.
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. Specifically, the fair value of outstanding debt
instruments reflects a current yield valuation based on observed
market prices as of June 30, 2003; the fair value of interest rate
swaps and forward contracts reflects the present value of the future
potential gain or (loss) if settlement were to take place on June 30,
2003; and the fair value of option contracts reflects the present
value of future cash flows if the contracts were settled on June 30,
2003.
Item 4. Controls and Procedures
During the 2003 second quarter, the Company carried out an evaluation,
under the supervision and with the participation of the Company's
management, including the Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of the
Company's disclosure controls and procedures pursuant to Exchange Act
Rule 13a-14. Based upon that evaluation, the Chief Executive Officer
and Chief Financial Officer concluded that the Company's disclosure
controls and procedures are reasonably effective in design and
practice to alert them, in a timely manner, to material information
relating to the Company (including its consolidated subsidiaries)
required to be included in the Company's periodic SEC filings.
Subsequent to the date of that evaluation, there have been no
significant changes in the Company's internal controls or in other
factors that could significantly affect internal controls, nor were
any corrective actions required with regard to significant
deficiencies or material weaknesses.
29
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 are
described in the Company's Annual Report on Form 10-K for the year
ended December 31, 2002 and Quarterly Report on Form 10-Q for the
quarter ended March 31, 2003.
In the litigation involving PREMPRO, the Company's estrogen and
progestin replacement therapy, four additional putative class action
lawsuits have been filed. Alexander, et al., v. Wyeth, No. 03-WM-0160,
U.S.D.C., D. Colo.; Katzman, et al. v. Wyeth, No. L-1285-03, Super.
Ct., Morris Cty., NJ; Leone, et al. v. Wyeth, No. 03CV0588, U.S.D.C.,
S.D.N.Y.; Phelps, et al. v. Wyeth, No. 03-80063, U.S.D.C., S.D. Fla.
Plaintiffs in three of the cases (Alexander, Leone, and Phelps) each
seek to represent a nationwide class of women who have ever ingested
PREMPRO. They generally seek similar relief on behalf of the putative
class: 1) purchase price refunds; 2) medical monitoring expenses; and
3) compensatory and punitive damages. The plaintiffs in the Katzman
case seek to represent a class of New Jersey women who have ingested
the drug and seek purchase price refunds and medical monitoring
expenses on their behalf. In addition to the 20 pending putative class
actions, the Company is defending approximately 100 individual actions
and approximately 25 multi-plaintiff actions in various courts for
personal injuries including breast cancer, stroke and heart disease.
Together with the class actions, these cases assert claims on behalf
of approximately 380 women alleged injured by PREMPRO or PREMARIN.
In the litigation involving alleged injuries as a result of the use of
the NORPLANT SYSTEM, the Company's implantable contraceptive, the
Louisiana Court of Appeals recently affirmed the certification of a
statewide class of NORPLANT users and the Louisiana Supreme Court has
now refused to hear a further appeal by the Company. The matter will
now return to the trial court level for further proceedings. Davis v.
American Home Products Corporation, No. CDC 94-11684, Orleans Parish,
LA.
By final judgment dated August 14, 2002, United States District Judge
Richard A. Schell granted in part and denied in part the Company's
motion for summary judgment in the cases pending before him in the
federal multidistrict NORPLANT litigation. In re: Norplant
Contraceptive Products Liability Litigation, MDL No. 1038, U.S.D.C.,
E.D. Tex. The effect of the ruling was to grant summary judgment
against 2,960 plaintiffs in 710 cases (virtually all of the plaintiffs
asserting claims in the MDL). Eighteen plaintiffs appealed this
judgment to the United States Court of Appeals for the Fifth Circuit.
Seventeen of those appellants subsequently agreed to drop their
appeals and the Fifth Circuit has recently affirmed Judge Schell's
ruling with respect to the remaining appellant.
In the litigation involving the Company's cough/cold products, which
contained the ingredient phenylpropanolamine (PPA), the first trials
of PPA lawsuits against the Company are scheduled to begin in November
and December 2003. Two trials
30
previously scheduled for earlier this year have recently been settled:
Walker, et al. v. Whitehall-Robins, et al., No. 0105-05204, Super.
Ct., Multnomah Cty., OR, and Palmer, et al. v. Eon Labs Manufacturing,
Inc., et al., No. 00-2-15370-8SEA, Super. Ct., King Cty., WA. The
Company is currently defending approximately 1,200 lawsuits on behalf
of approximately 2,200 plaintiffs.
In the litigation alleging that the cumulative effect of 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 in children, an additional
putative class action has been filed since the last Quarterly Report.
Bothwell, et al. v. Abbott Laboratories, et al., No. JCCP 4246, Super.
Ct., Los Angeles Cty., CA was a putative California statewide class
action seeking relief under California's Proposition 65. The Bothwell
case has been dismissed with prejudice, although an appeal of that
dismissal is pending. Six of the other ten previously-reported
putative class actions have also been dismissed without prejudice to
permit plaintiffs to pursue claims under the Vaccine Compensation Act,
one has been dismissed with prejudice because the claims of the class
representatives were barred by the Vaccine Compensation Act's statute
of limitations (Ashton, et al. v. Aventis Pasteur Inc., et al., Class
Action Complaint 004026, Ct. Comm. Pleas, Philadelphia Cty., PA), and
motions to dismiss are pending in the remaining three putative class
actions.
Including the putative class actions, the Company has been served with
approximately 260 thimerosal lawsuits, involving approximately 1,800
named plaintiffs. The Company is also in the process of filing motions
to dismiss in many of the individual cases for failure of the minor
plaintiffs to file in the first instance under the Vaccine
Compensation Act. The Vaccine Compensation Act mandates that vaccine
recipients alleging injury from childhood vaccines first bring a claim
under the Vaccine Compensation Act (the Act). If a claim under the Act
has not been adjudicated within 240 days, the claimant may be released
from proceeding under the Act and may pursue a lawsuit against the
manufacturer. Four claimants who have not elected to participate in
the Omnibus Autism Proceeding currently being conducted under the
auspices of the Act have filed lawsuits against the Company following
the expiration of the 240-day period, and an unknown number of
additional claimants are expected to do likewise.
The Company's Wyeth Medica Ireland (WMI) subsidiary has been served
with a Statement of Claim filed in the High Court, Dublin, Ireland, by
Schuurmans & Van Ginneken (SVG), a Netherlands-based molasses and
liquid storage concern. SVG alleges that WMI conspired with its waste
disposal contractors to improperly dispose of a sugar water process
stream that contained medroxyprogesterone acetate (MPA). SVG seeks
damages in excess of EU115 million for its own alleged direct losses
related to the cleanup of systems and destruction of MPA-contaminated
molasses and alleged losses made against it by various third parties,
including compound feed manufacturers and pig farmers represented by
the German Legal Aid Service. The Company has also recently received a
claim letter on behalf of various Dutch entities, including the Dutch
Association for the Animal Feed Industry, the Dutch Trade Union for
Stock-Breeders, the Central Organization for the Meat Sector, and the
Dutch Union of Traders in Cattle, claiming unspecified losses related
to the alleged MPA contamination.
31
The Company intends to continue to defend all of the foregoing
litigation vigorously.
The Federal Trade Commission has notified the Company that the
Commission has closed its investigation into licensing agreements
involving the Company and other pharmaceutical companies relating to
Recombinant Factor VIII products and concluded that no further action
is warranted at this time.
In connection with the litigation brought by Duramed Pharmaceuticals,
Inc. (which has since been acquired by Barr Laboratories, Inc.)
involving allegations that the Company violated the antitrust laws
through alleged exclusive and "disguised" exclusive contracts with
managed care organizations and pharmacy benefit managers concerning
PREMARIN, the Company and Barr have completed a transaction in which,
inter alia, Barr acquired certain rights to four Company products and
a sublicense to develop and market oral contraceptives using a
compound in development. The sale of the product rights totaled $22.6
million and included DIAMOX, ZIAC, ZEBETA and AYGESTIN. As part of the
transaction, Barr and the Company have terminated the litigation
originally brought by Duramed Pharmaceuticals, Inc. (Duramed
Pharmaceuticals, Inc. v. Wyeth-Ayerst Laboratories, Inc., No.
C-1-00-735, U.S.D.C., S.D. Oh.). On June 11, 2003, the Company and
Barr filed with the court a joint notice of final settlement and
dismissal.
The U.S. Court of Appeals for the Federal Circuit has affirmed the
decision in August 2002 in favor of the Company by the U.S. District
Court for the District of New Jersey that claims 1 and 3 of Schering's
patent claiming a metabolite of loratadine were invalid. Schering
Corp. v. Geneva Pharmaceuticals, Inc., et al., Docket Numbers 02-1545
and 02-1549, U.S.C.A., Fed. Cir. The Company had been sued by Schering
for infringing these patent claims as a result of filing applications
with the FDA seeking to market generic and over-the-counter loratadine
products.
Boston Scientific Scimed v. Cordis (Docket No 03-283, U.S.D.C., Del.)
involves a patent infringement lawsuit brought by Boston Scientific
against Cordis, seeking to enforce a patent on stent coatings against
the Cordis Cypher Sirolimus drug eluting stent. In an earlier filed
action, Cordis had sued Boston Scientific seeking to enforce Cordis'
stent architecture patent. In the respective actions, both Boston
Scientific and Cordis sought a preliminary injunction against the
other. Although the Company is not a party to this litigation, if
Cordis were to be enjoined from selling the Cypher stent, the Company
could lose licensing income. Cordis has advised the Company that it
intends to vigorously defend this litigation.
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 will not have
a material adverse effect on the Company's financial position but
could be material to the results of operations or cash flows in one or
more accounting periods.
32
Item 4. Submission of Matters to a Vote of Security-Holders
(a) The matters described under item 4(c) below were submitted to a
vote of security-holders, through the solicitation of proxies
pursuant to Section 14 under the Securities Exchange Act of 1934,
as amended, at the Annual Meeting of Stockholders held on April
24, 2003 (the Annual Meeting).
(b) Not applicable.
(c) The following describes the matters voted upon at the Annual
Meeting and sets forth the number of votes cast for, against or
withheld and the number of abstentions as to each such matter
(except as provided below, there were no broker non-votes):
(i) Election of directors:
Nominee For Withheld
------- --- --------
Clifford L. Alexander, Jr. 1,066,188,095 36,771,691
Frank A. Bennack, Jr. 1,015,302,311 87,657,475
Richard L. Carrion 1,004,172,369 98,787,417
Robert Essner 1,066,667,027 36,292,759
John D. Feerick 1,016,088,451 86,871,335
John P. Mascotte 1,016,127,398 86,832,388
Mary Lake Polan,M.D.,Ph.D.,M.P.H. 1,066,682,517 36,277,269
Ivan G. Seidenberg 1,053,953,801 49,005,985
Walter V. Shipley 1,054,516,653 48,443,133
John R. Torell III 1,016,384,282 86,575,504
(ii) Ratification of the appointment of PricewaterhouseCoopers
LLP as principal independent public accountants for 2003:
For Against Abstain
--- ------- -------
1,079,517,923 14,369,515 9,095,607
(iii)Adoption of Stockholder Proposal regarding shareholder
approval of "Poison Pills":
For Against Abstain
--- ------- -------
700,342,172 240,376,740 16,907,473
There were 145,356,660 broker non-votes with reference to
this item.
33
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
--------
Exhibit No. Description
----------- -----------
(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.
(b) Reports on Form 8-K
The following Current Reports on Form 8-K were filed by the
Company:
o April 23, 2003 to furnish the Press Release reporting the
Company's earnings results for the 2003 first quarter.
o July 23, 2003 to furnish the Press Release reporting the
Company's earnings results for the 2003 second quarter.
34
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.
Wyeth
(Registrant)
By /s/ Paul J. Jones
--------------------
Paul J. Jones
Vice President and Controller
(Duly Authorized Signatory
and Chief Accounting Officer)
Date: August 8, 2003
35
Exhibit Index
Exhibit No. Description
----------- -----------
(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.
EX-1
Exhibit 12
Wyeth
Computation of Ratio of Earnings to Fixed Charges (3)
(in thousands, except ratio amounts)
Year Ended December 31,
Six Months Ended --------------------------------------------------------------------
June 30, 2003 2002 2001 2000 1999 1998
---------------- ---------- ---------- ----------- ----------- ----------
Earnings
--------
Income (loss) from continuing operations
before federal and foreign taxes $2,890,800 $6,097,245 $2,868,747 $(1,101,040) $(1,907,299) $3,089,936
Add:
Fixed charges 167,975 430,449 439,058 324,887 403,694 371,986
Minority interests 13,205 27,993 20,841 26,784 30,301 620
Distributed equity income 0 0 0 0 0 771
Amortization of capitalized interest 4,360 8,866 2,497 1,917 1,803 1,487
Less:
-----
Equity income 331 20,766 70,372 55,991 2,122 473
Capitalized interest 52,500 88,008 94,257 43,303 15,375 9,497
---------- ---------- ---------- ----------- ----------- ----------
Total earnings (loss) as defined $3,023,509 $6,455,779 $3,166,514 $(846,746) $(1,488,998) $3,454,830
========== ========== ========== =========== =========== ==========
Fixed Charges:
--------------
Interest and amortization of debt expense $91,334 $294,160 $301,145 $238,840 $343,271 $322,970
Capitalized interest 52,500 88,008 94,257 43,303 15,375 9,497
Interest factor of rental expense (1) 24,141 48,281 43,656 42,744 45,048 39,519
---------- ---------- ---------- ----------- ----------- ----------
Total fixed charges as defined $167,975 $430,449 $439,058 $324,887 $403,694 $371,986
========== ========== ========== =========== =========== ==========
Ratio of earnings to fixed charges (2) 18.0 15.0 7.2 - - 9.3
(1) A 1/3 factor was used to compute the portion of rental expenses deemed representative of the interest factor.
(2) The results of operations for the years ended December 31, 2000 and 1999 were inadequate to cover total fixed
charges as defined. The coverage deficiency for the years ended December 31, 2000 and 1999 was $1,171,633 and
$1,892,692, respectively.
(3) Amounts have been restated to reflect the Cyanamid Agricultural Products business as a discontinued operation.
Exhibit 31.1
CERTIFICATION OF DISCLOSURE
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Robert Essner, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Wyeth;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in
light of the circumstances under which such statements were
made, not misleading with respect to the period covered by
this report;
3. Based on my knowledge, the financial statements, and other
financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as
of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are
responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material
information relating to the registrant, including its
consolidated subsidiaries, is made known to us by
others within those entities, particularly during the
period in which this report is being prepared;
(b) Evaluated the effectiveness of the registrant's
disclosure controls and procedures and presented in
this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end
of the period covered by this report based on such
evaluation; and
(c) Disclosed in this report any change in the registrant's
internal control over financial reporting that occurred
during the registrant's most recent fiscal quarter (the
registrant's fourth fiscal quarter in the case of an
annual report) that has materially affected, or is
reasonably likely to materially affect, the
registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrant's
auditors and the audit committee of the registrant's board
of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies and material weaknesses in
the design or operation of internal control over
financial reporting which are reasonably likely to
adversely affect the registrant's ability to record,
process, summarize and report financial information;
and
(b) Any fraud, whether or not material, that involves
management or other employees who have a significant
role in the registrant's internal control over
financial reporting.
Dated: August 8, 2003
By /s/ Robert Essner
---------------------------------------------
Robert Essner
Chairman, President and Chief Executive Officer
Exhibit 31.2
CERTIFICATION OF DISCLOSURE
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Kenneth J. Martin, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Wyeth;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in
light of the circumstances under which such statements were
made, not misleading with respect to the period covered by
this report;
3. Based on my knowledge, the financial statements, and other
financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as
of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are
responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material
information relating to the registrant, including its
consolidated subsidiaries, is made known to us by
others within those entities, particularly during the
period in which this report is being prepared;
(b) Evaluated the effectiveness of the registrant's
disclosure controls and procedures and presented in
this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end
of the period covered by this report based on such
evaluation; and
(c) Disclosed in this report any change in the registrant's
internal control over financial reporting that occurred
during the registrant's most recent fiscal quarter (the
registrant's fourth fiscal quarter in the case of an
annual report) that has materially affected, or is
reasonably likely to materially affect, the
registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrant's
auditors and the audit committee of the registrant's board
of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies and material weaknesses in
the design or operation of internal control over
financial reporting which are reasonably likely to
adversely affect the registrant's ability to record,
process, summarize and report financial information;
and
(b) Any fraud, whether or not material, that involves
management or other employees who have a significant
role in the registrant's internal control over
financial reporting.
Dated: August 8, 2003
By /s/ Kenneth J. Martin
------------------------------------------
Kenneth J. Martin
Executive Vice President and
Chief Financial Officer
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Wyeth (the Company) on Form 10-Q for
the fiscal quarter ended June 30, 2003, as filed with the Securities and
Exchange Commission on August 8, 2003 (the Report), I, Robert Essner, Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as
adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company.
Dated: August 8, 2003
By /s/ Robert Essner
-----------------------------------------------
Robert Essner
Chairman, President and Chief Executive Officer
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Wyeth (the Company) on Form 10-Q for
the fiscal quarter ended June 30, 2003, as filed with the Securities and
Exchange Commission on August 8, 2003 (the Report), I, Kenneth J. Martin, Chief
Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as
adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company.
Dated: August 8, 2003
By /s/ Kenneth J. Martin
------------------------------------------
Kenneth J. Martin
Executive Vice President and
Chief Financial Officer
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