10-K
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For fiscal year ended December 31, 2005 |
Commission file number 1-6571
SCHERING-PLOUGH CORPORATION
(Exact name of registrant as specified in its charter)
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New Jersey |
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22-1918501 |
State or other jurisdiction of
incorporation or organization |
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(I.R.S. Employer
identification No.) |
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2000 Galloping Hill Road, Kenilworth, NJ
(Address of principal executive offices) |
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07033
Zip Code |
Registrant’s telephone number, including area code:
(908) 298-4000
Securities register pursuant to Section 12(b) of the
Act:
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Title of Each Class |
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Name of Each Exchange on Which Registered |
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Common Shares, $.50 par value |
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New York Stock Exchange |
Mandatory Convertible Preferred Stock |
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New York Stock Exchange |
Preferred Share Purchase Rights* |
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New York Stock Exchange |
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* |
At the time of filing, the Rights were not traded separately
from the Common Shares. |
Securities register pursuant to section 12(g) of the
Act:
None.
Indicate if the registrant is a well-known seasoned issuer, as
defined in Rule 405 of the Securities
Act. Yes þ No o
Indicate if the registrant is not required to file reports
pursuant to Section 13 or Section 15(d) of the
Act. Yes o No þ
Indicate 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 the registrant was
required to file such reports), and (2) has been subject to
such filing requirements for the past
90 days. Yes þ No o
Indicate if disclosure of delinquent filers pursuant to
Item 405 of
Regulation S-K
(§229.405 of this chapter) is not contained herein, and
will not be contained, to the best of registrant’s
knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this
Form 10-K or any
amendment to this
Form 10-K. þ
Indicate whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in
Rule 12b-2 of the
Exchange Act.
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Large Accelerated Filer þ |
Accelerated Filer o |
Non-accelerated Filer o |
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Indicate whether the registrant is a shell company (as defined
in Rule 12b-2 of
the
Act). Yes o No þ
State the aggregate market value of the voting and non-voting
common equity held by non-affiliates computed by reference to
the price at which the common shares were last sold, or the
average bid and asked price of such common equity, as of
June 30, 2005 (the last business day of the
registrant’s most recently completed second fiscal
quarter): $28,123,003,392
Common Shares outstanding as of January 31, 2006:
1,479,475,643
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Part of Form 10-K |
Documents Incorporated by Reference |
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Incorporated into |
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Schering-Plough Corporation Proxy Statement for the Annual
Meeting of Shareholders on May 19, 2006 |
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Part III |
TABLE OF CONTENTS
Part I
Overview of the Business
Schering-Plough or the “Company” refers to
Schering-Plough Corporation and its subsidiaries, except as
otherwise indicated by the context. Schering Corporation, a
predecessor company, was incorporated in New York in 1928 and
New Jersey in 1935. The trademarks indicated by CAPITAL LETTERS
in this 10-K are the
property of, licensed to, promoted or distributed by
Schering-Plough Corporation, its subsidiaries or related
companies.
Schering-Plough is a global science-based health care company
with leading prescription, consumer and animal health products.
Through internal research and collaborations with business
partners, Schering-Plough discovers, develops, manufactures and
markets advanced drug therapies to meet important medical needs.
Schering-Plough’s vision is to earn the trust of the
physicians, patients, customers and shareholders that it serves
around the world. Schering-Plough’s worldwide headquarters
is in Kenilworth, New Jersey, and its website is
www.schering-plough.com.
In April 2003, the Board of Directors named Fred Hassan as the
new Chairman of the Board and Chief Executive Officer of
Schering-Plough Corporation. Under his leadership, the six- to
eight-year Action Agenda, a plan directed toward the goals of
stabilizing, repairing and turning around Schering-Plough to
produce long-term value for shareholders, was established and a
new leadership team was recruited.
Segment Information
The new management team reorganized the business from one
managed along geographic lines, with the primary segments being
U.S. and rest-of-world,
to a business organized around its products. Currently,
Schering-Plough has three reportable segments: Prescription
Pharmaceuticals, Consumer Health Care and Animal Health. The
segment sales and profit data that follow are consistent with
Schering-Plough’s current management reporting structure.
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Prescription Pharmaceuticals |
The Prescription Pharmaceuticals segment discovers, develops,
manufactures and markets human pharmaceutical products. Within
the Prescription Pharmaceutical segment there are three customer
groups: Primary Care, Specialty Care and the Cholesterol
Franchise. Principal products in this segment include:
Allergy/ Respiratory: NASONEX, a once-daily,
nasal-inhaled steroid for nasal allergy symptoms, including
congestion, and for the treatment of nasal polyps in patients
18 years of age and older; CLARINEX, a nonsedating
antihistamine for the treatment of allergic rhinitis; FORADIL
AEROLIZER, a long-acting beta2-agonist marketed by
Schering-Plough in the United States for the maintenance
treatment of asthma and chronic obstructive pulmonary disease,
and for the acute prevention of exercise-induced bronchospasm;
and ASMANEX TWISTHALER, an oral dry-powder corticosteroid
inhaler for first-line maintenance treatment of asthma.
Antibiotics: AVELOX, a broad-spectrum fluoroquinolone
antibiotic for certain respiratory and skin infections, and
CIPRO, a broad-spectrum fluoroquinolone antibiotic for certain
respiratory, skin, urinary tract and other infections.
Dermatologicals: ELOCON, a medium-potency topical steroid
cream, lotion and ointment.
Other Disorders: LEVITRA, a phosphodiesterase type 5
inhibitor (PDE5) co-marketed by Schering-Plough in the United
States for the treatment of male erectile dysfunction.
1
Anti-Virals: PEG-INTRON Powder for Injection, the only
pegylated interferon product for chronic hepatitis C
approved for dosing according to patient body weight;
INTRON A Injection for chronic hepatitis B and C and
other antiviral indications; and REBETOL Capsules for use with
PEG-INTRON or INTRON A for chronic hepatitis C.
Anti-Inflammatories: REMICADE, an anti-TNF antibody
marketed by Schering-Plough outside the United States for the
treatment of rheumatoid arthritis, Crohn’s disease,
ankylosing spondylitis, psoriatic arthritis, psoriasis, and as
first-line therapy for the treatment of early rheumatoid
arthritis.
Oncology: TEMODAR Capsules for certain types of brain
tumors, including newly diagnosed glioblastoma multiforme;
CAELYX, a long-circulating pegylated liposomal formulation of
the cancer drug doxorubicin marketed by Schering-Plough outside
the United States for the treatment of certain ovarian cancers,
Kaposi’s sarcoma and metastatic breast cancer; and INTRON A
Injection, marketed for numerous anticancer indications
worldwide, including as adjuvant therapy for malignant melanoma.
Acute Coronary Care: INTEGRILIN Injection, a platelet
receptor GP IIb/ IIIa inhibitor for the treatment of
patients with acute coronary syndrome and those undergoing
percutaneous coronary intervention in the United States, as well
as for the prevention of early myocardial infarction in patients
with acute coronary syndrome in most countries.
Other Disorders: SUBUTEX, a sublingual tablet formulation
of buprenorphine, and SUBOXONE, a sublingual tablet combination
of buprenorphine and naloxone, marketed by Schering-Plough in
certain countries outside the United States for the treatment of
opiate addiction.
ZETIA, a novel cholesterol-absorption inhibitor discovered by
Schering-Plough scientists, for use in combination with statin
drugs or as monotherapy to lower cholesterol.
VYTORIN, a cholesterol-lowering tablet combining the dual action
of ZETIA and Merck & Co., Inc.’s statin Zocor.
The Consumer Health Care segment develops, manufactures and
markets OTC, foot care and sun care products. Principal products
in this segment include:
Over-the-Counter
Products: CLARITIN non-drowsy antihistamines; DRIXORAL cold
and allergy, allergy sinus, flu and nasal decongestant tablets;
AFRIN nasal decongestant spray and CORRECTOL laxative tablets.
Foot Care: DR. SCHOLL’S foot care products; LOTRIMIN
topical antifungal products; and TINACTIN topical antifungal
products and foot and sneaker odor/wetness products.
Sun Care: COPPERTONE sun care lotions, sprays, dry oils
and lip-protection products and sunless tanning products; and
SOLARCAINE sunburn relief products.
The Animal Health segment discovers, develops, manufactures and
markets animal health products. Principal products in this
segment include:
Livestock Products: NUFLOR bovine and swine antibiotic;
BANAMINE bovine and swine anti-inflammatory; and M+PAC swine
pneumonia vaccine.
Poultry Products: PARACOX and COCCIVAC coccidiosis
vaccines for poultry.
2
Companion Animal Products: OTOMAX, a steroid for otitis
in dogs; EXSPOT topical insecticide for dogs; HOMEAGAIN pet
recovery service; and ZUBRIN, an anti-inflammatory/ analgesic
for dogs.
Aquaculture Products: SLICE parasiticide for sea lice in
salmon and AQUAFLOR antibiotic for farm-raised fish.
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Year Ended December 31, | |
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2005 | |
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2004 | |
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2003 | |
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(Dollars in millions) | |
Prescription Pharmaceuticals
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$ |
7,564 |
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$ |
6,417 |
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$ |
6,611 |
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Consumer Health Care
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1,093 |
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1,085 |
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1,026 |
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Animal Health
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851 |
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770 |
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697 |
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Consolidated net sales
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$ |
9,508 |
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$ |
8,272 |
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$ |
8,334 |
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Year Ended December 31, | |
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2005 | |
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2004 | |
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2003 | |
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(Dollars in millions) | |
Prescription Pharmaceuticals
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$ |
733 |
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$ |
13 |
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$ |
513 |
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Consumer Health Care
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235 |
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234 |
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199 |
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Animal Health
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120 |
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88 |
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86 |
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Corporate and other
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(591 |
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(503 |
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(844 |
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Consolidated profit/(loss) before tax
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$ |
497 |
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$ |
(168 |
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$ |
(46 |
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“Corporate and other” includes interest income and
expense, foreign exchange gains and losses, headquarters
expenses, special charges and other miscellaneous items. The
accounting policies used for segment reporting are the same as
those described in Note 1, “Summary of Significant
Accounting Policies”, under Item 8, Financial
Statements and Supplementary Data, in
this 10-K.
In 2005, “Corporate and other” includes special
charges of $294 million, including $28 million of
employee termination costs, $16 million of asset impairment
and other charges, and an increase in litigation reserves by
$250 million resulting in a total reserve of
$500 million representing the Company’s current
estimate to resolve the Massachusetts investigation as well as
the investigations disclosed under “AWP
Investigations” and the state litigation disclosed under
“AWP Litigation” in Note 19, “Legal,
Environmental and Regulatory Matters” in Item 8,
Financial Statements and Supplementary Data. It is estimated
that the charges relate to the reportable segments as follows:
Prescription Pharmaceuticals — $289 million,
Consumer Health Care — $2 million, Animal
Health — $1 million and Corporate and
other — $2 million.
In 2004, “Corporate and other” includes special
charges of $153 million, including $119 million of
employee termination costs, as well as $34 million of asset
impairment and other charges. It is estimated the charges relate
to the reportable segments as follows: Prescription
Pharmaceuticals — $135 million, Consumer Health
Care — $3 million, Animal Health —
$2 million and Corporate and other —
$13 million.
In 2003, “Corporate and other” includes Special
charges of $599 million, including $179 million of
employee termination costs, a $350 million provision to
increase litigation reserves, and $70 million of asset
impairment charges. It is estimated the charges relate to the
reportable segments as follows: Prescription
Pharmaceuticals — $515 million, Consumer Health
Care — $25 million, Animal Health —
$4 million and Corporate and other —
$55 million.
3
See Note 2 “Special Charges” under Item 8,
Financial Statements and Supplementary Data, in
this 10-K for
additional information.
Global Operations
Non-U.S. operations
generate the majority of the Company’s profits and cash
flow.
Non-U.S. activities
are carried out primarily through wholly-owned subsidiaries
wherever market potential is adequate and circumstances permit.
In addition, Schering-Plough is represented in some markets
through licensees or other distribution arrangements. Currently,
Schering-Plough has business operations in more than 120
countries and has approximately 18,900 employees outside the U.S.
Non-U.S. operations
are subject to certain risks that are inherent in conducting
business overseas. These risks include possible nationalization,
expropriation, importation limitations, pricing and
reimbursement restrictions, and other restrictive governmental
actions or economic destabilization. Also, fluctuations in
foreign currency exchange rates can impact
Schering-Plough’s consolidated financial results. For
additional information on global operations, see Item 7,
Management’s Discussion and Analysis of Financial Condition
and Results of Operations and the segment information described
above in this 10-K.
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Net sales by geographic area |
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2005 | |
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2004 | |
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2003 | |
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(Dollars in millions) | |
United States
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$ |
3,589 |
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$ |
3,219 |
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$ |
3,559 |
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Europe and Canada
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4,040 |
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3,595 |
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3,410 |
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Pacific Area and Asia
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995 |
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676 |
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649 |
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Latin America
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884 |
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782 |
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716 |
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Consolidated net sales
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$ |
9,508 |
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$ |
8,272 |
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$ |
8,334 |
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The Company has subsidiaries in more than 50 countries outside
the U.S. No single international country, except for
France, Japan and Italy, accounted for 5 percent or more of
consolidated net sales during the past three years. Net sales
are presented in the geographic area in which the Company’s
customers are located.
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2005 | |
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2004 | |
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2003 | |
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% of | |
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% of | |
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% of | |
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Consolidated | |
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Net | |
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Consolidated | |
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Net | |
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Consolidated | |
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Net Sales | |
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Net Sales | |
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Sales | |
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Net Sales | |
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Sales | |
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Net Sales | |
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(Dollars in millions) | |
Total International net sales
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$ |
5,919 |
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62 |
% |
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$ |
5,053 |
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61 |
% |
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$ |
4,775 |
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57 |
% |
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France
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771 |
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8 |
% |
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729 |
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9 |
% |
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691 |
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8 |
% |
Japan
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687 |
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7 |
% |
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385 |
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5 |
% |
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414 |
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5 |
% |
Italy
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457 |
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5 |
% |
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443 |
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5 |
% |
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436 |
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5 |
% |
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2005 | |
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2004 | |
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2003 | |
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% of | |
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% of | |
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% of | |
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Consolidated | |
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Net | |
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Consolidated | |
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Net | |
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Consolidated | |
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Net Sales | |
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Net Sales | |
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Sales | |
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Net Sales | |
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Sales | |
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Net Sales | |
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(Dollars in millions) | |
McKesson Corporation
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$ |
1,073 |
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11 |
% |
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$ |
868 |
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10 |
% |
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$ |
667 |
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8 |
% |
No single customer, except for McKesson Corporation, a major
pharmaceutical and health care products distributor, accounted
for 10 percent or more of consolidated net sales during the
past three years.
4
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Long-lived assets by geographic location |
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2005 | |
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2004 | |
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2003 | |
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(Dollars in millions) | |
United States
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$ |
2,538 |
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$ |
2,447 |
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$ |
2,507 |
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Singapore
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840 |
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884 |
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828 |
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Ireland
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486 |
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449 |
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444 |
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Puerto Rico
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|
307 |
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298 |
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317 |
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Other
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|
602 |
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|
768 |
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726 |
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Total
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$ |
4,773 |
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$ |
4,846 |
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$ |
4,822 |
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Long-lived assets shown by geographic location are primarily
property.
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Supplemental sales information |
Sales of products comprising 10 percent or more of the
Company’s U.S. or international sales for the year
ended December 31, 2005, were as follows:
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Amount | |
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Percentage | |
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(Dollars in millions) | |
U.S.
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NASONEX
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$ |
447 |
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12 |
% |
OTC CLARITIN
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375 |
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10 |
% |
International
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REMICADE
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$ |
942 |
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16 |
% |
PEG-INTRON
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567 |
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10 |
% |
Schering-Plough net sales do not include sales of VYTORIN and
ZETIA, which are marketed in partnership with Merck, as the
Company accounts for this joint venture under the equity method
of accounting. See Note 3, “Equity Income from
Cholesterol Joint Venture,” under Item 8, Financial
Statements and Supplementary Data, in
this 10-K.
The Company does not disaggregate assets on a segment basis for
internal management reporting and, therefore, such information
is not presented.
Research and Development
Schering-Plough’s research activities are primarily aimed
at discovering and developing new prescription products and
enhancements to existing prescription products of medical and
commercial significance. Company-sponsored research and
development expenditures were $1,865 million,
$1,607 million and $1,469 million in 2005, 2004 and
2003, respectively. Research expenditures represented
approximately 20 percent of consolidated net sales in 2005,
19 percent of consolidated net sales in 2004 and
approximately 18 percent of consolidated net sales in 2003.
Schering-Plough’s research activities are concentrated in
the therapeutic areas of respiratory diseases, inflammatory
diseases, infectious diseases, oncology, cardiovascular and
metabolic diseases, and central nervous system disorders.
Schering-Plough also has substantial efforts directed toward
biotechnology and immunology. Research activities include
expenditures for both internal research efforts and research
collaborations with various partners.
While several pharmaceutical compounds are in varying stages of
development, it cannot be predicted when or if these compounds
will become available for commercial sale. The Company’s
product pipeline lists significant products in development and
is available on the Schering-Plough website at
www.schering-plough.com.
5
Patents, Trademarks and Other Intellectual Property Rights
Overview. Intellectual property protection is critical to
Schering-Plough’s ability to successfully commercialize its
product innovations. Schering-Plough owns, has applied for, or
has licensed rights to, a large number of patents, both in the
U.S. and in other countries, relating to molecules, products,
product uses, formulations, and manufacturing processes. There
is no assurance that the patents Schering-Plough is seeking will
be granted or that the patents Schering-Plough has been granted
would be found valid if challenged. Moreover, patents relating
to particular molecules, products, uses, formulations, or
processes do not preclude other manufacturers from employing
alternative processes or from marketing alternative products or
formulations that might successfully compete with the
Company’s patented products.
Outside the U.S., the standard of intellectual property
protection for pharmaceuticals varies widely. While many
countries have reasonably strong patent laws, other countries
currently provide little or no effective protection for
inventions or other intellectual property rights. Under the
Trade-Related Aspects of Intellectual Property Agreement (TRIPs)
administered by the World Trade Organization (WTO), more than
140 countries have now agreed to provide non-discriminatory
protection for most pharmaceutical inventions and to assure that
adequate and effective rights are available to all patent
owners. It is possible that changes to this agreement will be
made in the future that will diminish or further delay its
implementation in developing countries. It is too soon to assess
how much, if at all, the Company will be impacted commercially
from these changes.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a rapid, sharp and material decline in sales of the formerly
patented product, particularly in the U.S. However, in some
cases the innovator company can obtain additional commercial
benefits through manufacturing trade secrets; later-expiring
patents on processes, uses, or formulations; trademark use; or
exclusivity that may be available under pharmaceutical
regulatory laws.
Schering-Plough’s Intellectual Property Portfolio.
Patent protection for certain Schering-Plough molecules,
products, processes, and uses are important to
Schering-Plough’s business and financial results. For many
of the Company’s products, in addition to patents on the
compound, Schering-Plough holds other patents on manufacturing
processes, formulations, or uses that may extend exclusivity
beyond the expiration of the compound patent.
Schering-Plough’s subsidiaries own (or have licensed rights
under) a number of patents and patent applications, both in the
U.S. and abroad. Patents and patent applications relating to
Schering-Plough’s significant products, including, without
limitation, VYTORIN, ZETIA, REMICADE, NASONEX INTRON A,
PEG-INTRON, TEMODAR and CLARINEX, are of material importance to
Schering-Plough.
Worldwide, Schering-Plough sells all major products under
trademarks that also are material in the aggregate to its
business and financial results. Trademark protection varies
throughout the world, with protection continuing in some
countries as long as the mark is used and in other countries as
long as it is registered. Registrations are normally for fixed
but renewable terms.
Patent Challenges Under the Hatch-Waxman Act. The Drug
Price Competition and Patent Term Restoration Act of 1984,
commonly known as Hatch-Waxman, made a complex set of changes to
both patent and new drug approval laws in the U.S. Before
Hatch-Waxman, no drug could be approved without providing the
U.S. Food and Drug Administration (FDA) complete
safety and efficacy studies, known as a complete New Drug
Application (NDA). Hatch-Waxman authorizes the FDA to approve
generic versions of innovative medicines without such
information upon the filing of an Abbreviated New Drug
Application (ANDA). In an ANDA, the generic manufacturer must
demonstrate only bioequivalence between the generic version and
the NDA-approved drug — not safety and efficacy.
Hatch-Waxman provides for limited patent term restoration to
partially make up for patent term lost during the time an
NDA-approved drug is in regulatory review. NDA-approved drugs
also receive a limited period of data exclusivity which prevents
the approval of ANDA applications for specific time periods
after approval of the NDA-approved drug.
6
Absent a successful patent challenge, the FDA cannot approve an
ANDA until after the innovator’s patents expire. However, a
generic manufacturer may file an ANDA seeking approval after the
expiration of the applicable data exclusivity, and alleging that
one or more of the patents listed in the innovator’s NDA
are invalid or not infringed. This allegation is commonly known
as a Paragraph IV certification. The innovator must then
file suit against the generic manufacturer to protect its
patents. If one or more of the NDA-listed patents are
successfully challenged, the first filer of a Paragraph IV
certification may be entitled to a
180-day period of
market exclusivity over all other generic manufacturers. In
recent years, generic manufacturers have used Paragraph IV
certifications extensively to challenge patents on a wide array
of innovative pharmaceuticals, and it is anticipated that this
trend will continue.
Marketing Activities and Competition
Prescription drugs are introduced and made known to physicians,
pharmacists, hospitals, managed care organizations and buying
groups by trained professional sales representatives, and are
sold to hospitals, certain managed care organizations, wholesale
distributors and retail pharmacists. Prescription products are
also introduced and made known through journal advertising,
direct mail advertising, the distribution of samples to
physicians and through television, radio, internet, print and
other advertising media.
Animal health products are promoted to veterinarians,
distributors and animal producers.
Footcare, OTC and suncare products are sold through wholesale
and retail drug, food chain and mass merchandiser outlets, and
are promoted directly to the consumer through television, radio,
internet, print and other advertising media.
The pharmaceutical industry is highly competitive and includes
other large companies, some significantly larger than
Schering-Plough, with substantial resources for research,
product development, advertising, promotion and field selling
support. There are numerous domestic and international
competitors in this industry. Some of the principal competitive
techniques used by Schering-Plough for its products include
research and development of new and improved products, varied
dosage forms and strengths and switching prescription products
to non-prescription status. In the U.S., many of
Schering-Plough’s products are subject to increasingly
competitive pricing as managed care groups, institutions,
federal and state government entities and agencies and buying
groups seek price discounts and rebates. Governmental and other
pressures toward the dispensing of generic products may
significantly reduce the sales of certain products when they, or
competing products in the same therapeutic category, are no
longer protected by patents or exclusivity available under
pharmaceutical regulatory laws.
Schering-Plough operates primarily in the prescription
pharmaceutical marketplace. However, where appropriate,
Schering-Plough has sought and may in the future seek regulatory
approval to switch prescription products to
over-the-counter
(OTC) status as a means of extending a product’s life
cycle. In this way, the OTC marketplace is another means of
maximizing the return on investments in discovery and
development.
Government Regulation
Each of the Company’s major business segments is subject to
significant regulation in multiple jurisdictions. This section
describes the general regulatory framework. Additional
information about the cost of regulatory compliance and specific
impacts on the Company’s business and financial condition
are described under the heading “Regulatory And Competitive
Environment In Which The Company Operates” in
Management’s Discussion and Analysis later in
this 10-K.
Additional information about other regulatory matters can be
found in Item 3, Legal Matters, Note 18, “Consent
Decree” and Note 19, “Legal, Environmental and
Regulatory Matters,” under Item 8, Financial
Statements and Supplementary Data, in
this 10-K.
In the prescription drug segment, regulations apply at all
phases of the business including:
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regulatory requirements to conduct, and standards for, clinical
trials (for example, requiring the use of Good Clinical
Practices or GCPs) which apply at the research and development
stage; |
7
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regulatory requirements to conduct, and standards for,
post-approval clinical trials; |
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required regulatory approval to begin marketing a new drug or to
market an existing drug product for new indications; |
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regulations prescribing the manner in which drugs are
manufactured, packaged, labeled, advertised, marketed and
distributed; |
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regulations impacting the pricing of drugs; |
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regulatory requirements to assess and report adverse impacts and
side effects of drugs used in clinical trials, as well as
marketed drugs, called “pharmacovigilance;” and |
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the ability of regulatory authorities to remove a product from
the market or recall certain batches of products. |
In the U.S., the national regulation of all phases of the
prescription drug business except pricing is centralized at the
Food and Drug Administration (FDA). The FDA is responsible for
protecting the U.S. public health by assuring the safety,
efficacy, and security of human and veterinary drugs, biological
products, and medical devices. Generally, there is free market
pricing in the U.S., although the Centers for Medicare and
Medicaid Services (CMS) and Medicare Part B and D
include provisions about pricing drugs for the elderly, disabled
and indigent who receive federal prescription benefits. The
Company is also committed to complying with voluntary best
practices of the Pharmaceutical Research and Manufacturers of
America (PhRMA), a trade industry group of which it is a member,
regarding marketing and advertising practices.
In the European Union (EU), including the Company’s key
markets in the United Kingdom, France, Germany and Italy, there
is regulation at the local country level and additional
regulation at the EU level, through the European Medicines
Agency (EMEA). Pharmaceutical products are regulated at both of
these levels through various national, mutual recognition or
centralized regulatory procedures. The EMEA coordinates the
evaluation and supervision of medicinal products throughout the
European Union. There is no pan-EU market pricing system;
however, individual member states have various systems/agencies
that regulate price at a local level.
In Japan, there is regulation through the Pharmaceuticals and
Medical Device Agency (PMDA). The PMDA regulates pharmaceuticals
and medical devices from development through post-marketing use.
The Japanese government regulates the pricing/reimbursement of
pharmaceutical products in Japan through a complicated pricing
process that includes benchmarks with prices in other western
countries such as the United States, Canada and select EU
countries.
As all of the major countries have some influence over pricing,
even with the CMS in the United States, there is increasing
pressure on the pharmaceutical industry to bring products to
market that provide differentiation versus existing products.
This can lead to more expensive and scientifically challenging
clinical trials in order to generate this type of data for new
products versus marketed comparators.
Information About the Merck/ Schering-Plough Joint
Ventures
In May 2000, the Company and Merck & Co., Inc. (Merck)
entered into two separate sets of agreements to jointly develop
and market certain products in the U.S. including
(1) two cholesterol-lowering drugs and (2) an
allergy/asthma drug. In December 2001, the cholesterol
agreements were expanded to include all countries of the world
except Japan. In general, the companies agreed that the
collaborative activities under these agreements would operate in
a virtual joint venture to the maximum degree possible by
relying on the respective infrastructures of the two companies.
These agreements generally provide for equal sharing of
development costs and for co-promotion of approved products by
each company.
8
The cholesterol agreements provide for the Company and Merck to
jointly develop ezetimibe (marketed as ZETIA in the U.S. and
Asia and EZETROL in Europe):
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i. as a once-daily monotherapy; |
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ii. in co-administration with any statin drug, and; |
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iii. as a once-daily fixed-combination tablet of ezetimibe
and simvastatin (Zocor), Merck’s cholesterol-modifying
medicine. This combination medication (ezetimibe/simvastatin) is
marketed as VYTORIN in the U.S. and as INEGY in many
international countries. |
ZETIA/ EZETROL (ezetimibe) and VYTORIN/ INEGY (the
combination of ezetimibe/simvastatin) are approved for use in
the U.S. and have been launched in several international markets.
The Company utilizes the equity method of accounting for the
joint venture. The cholesterol agreements provide for the
sharing of net income/(loss) based upon percentages that vary by
product, sales level and country. In the U.S. market,
Schering-Plough receives a greater share of profits on the first
$300 million of annual ZETIA sales. Above $300 million
of annual ZETIA sales, Merck and Schering-Plough (the Partners)
share profits equally. Schering-Plough’s allocation of
joint venture income is increased by milestones earned. Further,
either Partner’s share of the joint venture’s net
income/(loss) is subject to a reduction if the Partner fails to
perform a specified minimum number of physician details in a
particular country. The Partners agree annually to the minimum
number of physician details by country.
The Partners bear the costs of their own general sales forces
and commercial overhead in marketing joint venture products
around the world. In the U.S., Canada and Puerto Rico, the
cholesterol agreements provide for a reimbursement to each
Partner for physician details that are set on an annual basis.
This reimbursed amount is equal to each Partner’s physician
details multiplied by a contractual fixed fee. Schering-Plough
reports the receipt of this reimbursement as part of equity
income from cholesterol joint venture. This amount does not
represent a reimbursement of specific, incremental, identifiable
costs for the Company’s detailing of the cholesterol
products in these markets. In addition, this reimbursement
amount is not reflective of Schering-Plough’s sales effort
related to the joint venture, as Schering-Plough’s sales
force and related costs associated with the joint venture are
generally estimated to be higher.
Costs of the joint venture that the Partners contractually share
are a portion of manufacturing costs, specifically identified
promotion costs (including
direct-to-consumer
advertising and direct and identifiable
out-of-pocket
promotion) and other agreed-upon costs for specific services
such as market support, market research, market expansion, a
specialty sales force and physician education programs.
Certain specified research and development expenses are
generally shared equally by the Partners.
Due to the virtual nature of the cholesterol joint venture, the
Company incurs substantial costs, such as selling, general and
administrative costs, that are not reflected in equity income
from cholesterol joint venture and are borne by the overall cost
structure of the Company. These costs are reported on their
respective line items in the Statements of Consolidated
Operations. The cholesterol agreements do not provide for any
jointly owned facilities and, as such, products resulting from
the collaboration are manufactured in facilities owned by either
the Company or Merck.
The allergy/asthma agreements provide for the joint development
and marketing by the Partners of a once-daily, fixed-combination
tablet containing CLARITIN and Singulair. Singulair is
Merck’s once-daily leukotriene receptor antagonist for the
treatment of asthma and seasonal allergic rhinitis. In January
2002, the Merck/ Schering-Plough respiratory joint venture
reported on results of Phase III clinical trials of a
fixed-combination tablet containing CLARITIN and Singulair. This
Phase III study did not demonstrate sufficient added
benefits in the treatment of seasonal allergic rhinitis. The
CLARITIN and Singulair combination tablet does not have approval
in any country and remains in clinical development with new
Phase III clinical trials planned.
9
Raw Materials
Raw materials essential to Schering-Plough are available in
adequate quantities from a number of potential suppliers. Energy
is expected to be available to Schering-Plough in sufficient
quantities to meet operating requirements.
Seasonality
Certain of the Company’s products, particularly the
respiratory and suncare categories, are seasonal in nature.
Seasonal patterns do not have a pronounced effect on the
consolidated operations of Schering-Plough.
Environment
To date, compliance with federal, state and local laws regarding
discharge of materials into the environment, or protection of
the environment, have not had a material effect on
Schering-Plough’s capital expenditures, earnings and
competitive position.
Employees
There were approximately 32,600 people employed by
Schering-Plough as of December 31, 2005.
Available Information
Schering-Plough’s 10-Ks, 10-Qs, 8-Ks,
and amendments to those reports, filed with the SEC are
available free of charge, on Schering-Plough’s website, as
soon as reasonably practicable after such materials are
electronically filed with the SEC. Schering-Plough’s
address on the World Wide Web is www.schering-plough.com. Since
Schering-Plough began this practice in the third quarter of
2002, each such report has been available on
Schering-Plough’s website within 24 hours of filing.
Reports filed by Schering-Plough with the SEC may be read and
copied at the SEC’s Public Reference Room at 100 F Street,
NE, Washington, DC 20549. Information on the operation of the
Public Reference Room may be obtained by calling the SEC at
1-800-SEC-0330. The SEC
also maintains an internet site at www.sec.gov that contains
reports, proxy and information statements and other information
regarding issuers that file electronically with the SEC.
The Company’s future operating results and cash flows may
differ materially from the results described in
this 10-K due to
risks and uncertainties related to the Company’s business,
including those discussed below. In addition, these factors
represent risks and uncertainties that could cause actual
results to differ materially from those implied by
forward-looking statements contained in this report.
Key Company products generate a significant amount of the
Company’s profits and cash flows, and any events that
adversely affect the market for its leading products could have
a material and negative impact on results of operations and cash
flows.
The Company’s ability to generate profits and operating
cash flow is dependent upon the increasing profitability of the
Company’s cholesterol franchise, consisting of VYTORIN and
ZETIA. In addition, products such as CLARINEX, PEG-INTRON,
REBETOL, REMICADE, TEMODAR, OTC CLARITIN and NASONEX accounted
for a material portion of 2005 revenues. As a result of the
Company’s dependence on key products, any events that
adversely affect the markets for these products could have a
significant impact on results of operations. These events
include loss of patent protection, increased costs associated
with manufacturing, OTC availability of the Company’s
product or a competitive product, the discovery of previously
unknown side effects, increased competition from the
introduction of new, more effective treatments, and
discontinuation or removal from the market of the product for
any reason.
10
More specifically, the profitability of the Company’s
cholesterol franchise may be adversely affected by the
introduction of generic forms of two competing cholesterol
products that will lose patent protection in 2006. In addition,
generic Flonase (fluticasone propionate) was approved in 2006
and may unfavorably impact the corticosteroid nasal spray market.
Past examples of events in recent years that have adversely
affected the market for leading products include events that
have affected the market for CLARINEX and PEG-INTRON and
REBETOL, particularly in the U.S. CLARINEX continues to
experience intense competition in the prescription
U.S. allergy market after the launch of CLARITIN OTC and a
competing OTC loratadine product in the U.S. in December
2002 and the introduction of generic Allegra
(fexofenadine) in the U.S. in September 2005. In
addition, as a result of the introduction of a competitor’s
product for pegylated interferon and the introduction of generic
ribavirin, the value of PEG-INTRON (pegylated interferon) and
REBETOL (ribavirin) combination therapy for hepatitis has
been severely diminished and earnings and cash flow have been
materially and negatively impacted.
There is a high risk that funds invested in research will not
generate financial returns because the development of novel
drugs requires significant expenditures with a low probability
of success.
There is a high rate of failure inherent in the research to
develop new drugs to treat diseases. As a result, there is a
high risk that funds invested in research programs will not
generate financial returns. This risk profile is compounded by
the fact that this research has a long investment cycle. To
bring a pharmaceutical compound from the discovery phase to
market may take a decade or more and failure can occur at any
point in the process, including later in the process after
significant funds have been invested.
The Company’s success is dependent on the development
and marketing of new products, and uncertainties in the
regulatory and approval process may result in the failure of
products to reach the market.
Products that appear promising in development may fail to reach
market for numerous reasons, including the following:
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findings of ineffectiveness or harmful side effects in clinical
or pre-clinical testing; |
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failure to receive the necessary regulatory approvals, including
delays in the approval of new products and new indications; |
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lack of economic feasibility due to manufacturing costs or other
factors; and |
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preclusion from commercialization by the proprietary rights of
others. |
Intellectual property protection is an important contributor
to the Company’s profitability and as patents covering the
Company’s products expire or if they are found to be
invalid, generic forms of the Company’s products may be
introduced to the market, which may have a material and negative
affect on results of operations.
Intellectual property protection is critical to
Schering-Plough’s ability to successfully commercialize its
products. Upon the expiration or the successful challenge of the
Company’s patents covering a product, competitors may
introduce generic versions of such products, which may include
the Company’s well-
11
established products. Such generic competition could result in
the loss of a significant portion of sales or downward pressures
on the prices at which the Company offers formerly patented
products, particularly in the U.S. Patents and patent
applications relating to Schering-Plough’s significant
products are of material importance to Schering-Plough.
Additionally, certain foreign governments have indicated that
compulsory licenses to patents may be granted in the case of
national emergencies, which could diminish or eliminate sales
and profits from those regions and negatively affect the
Company’s results of operations.
Patent disputes can be costly to prosecute and defend and
adverse judgments could result in damage awards, increased
royalties and other similar payments and decreased sales.
Patent positions can be highly uncertain and patent disputes in
the pharmaceutical industry are not unusual. An adverse result
in a patent dispute involving the Company’s patents may
lead to a loss of market exclusivity and render the
Company’s patents invalid. An adverse result in a patent
dispute involving patents held by a third party may preclude the
commercialization of the Company’s products, force the
Company to obtain licenses in order to continue manufacturing or
marketing the affected products, negatively affect sales of
existing products or result in injunctive relief and payment of
financial remedies. For example, the Company’s product, DR.
SCHOLL’S FREEZE AWAY wart removal product, is currently the
subject of a patent infringement action brought by a third party
company, and an adverse outcome in this action may result in the
Company’s inability to continue manufacturing the product.
Even if the Company is ultimately successful in a particular
dispute, the Company may incur substantial costs in defending
its patents and other intellectual property rights. For example,
a generic manufacturer may file an Abbreviated New Drug
Application seeking approval after the expiration of the
applicable data exclusivity and alleging that one or more of the
patents listed in the innovator’s New Drug Application are
invalid or not infringed. This allegation is commonly known as a
Paragraph IV certification. The innovator then has the
ability to file suit against the generic manufacturer to enforce
its patents. In recent years, generic manufacturers have used
Paragraph IV certifications extensively to challenge
patents on a wide array of innovative pharmaceuticals, and it is
anticipated that this trend will continue. The potential for
litigation regarding Schering-Plough’s intellectual
property rights always exists and may be initiated by third
parties attempting to abridge Schering-Plough’s rights, as
well as by Schering-Plough in protecting its rights.
U.S. and foreign regulations, including those establishing
the Company’s ability to price products, may negatively
affect the Company’s sales and profit margins.
The Company faces increased pricing pressure in the U.S. and
abroad from managed care organizations, institutions and
government agencies and programs that could negatively affect
the Company’s sales and profit margins. For example, the
Medicare Prescription Drug Improvement and Modernization Act of
2003 contains a prescription drug benefit for individuals who
are eligible for Medicare. The prescription drug benefit became
effective on January 1, 2006, and it is anticipated that it
may result in increased purchasing power of those negotiating on
behalf of Medicare recipients.
In addition to legislation concerning price controls, other
trends that could affect the Company’s business include
legislative or regulatory action relating to pharmaceutical
pricing and reimbursement, health care reform initiatives and
drug importation legislation, involuntary approval of medicines
for OTC use, consolidation among customers, and trends toward
managed care and health care costs containment.
As a result of the U.S. government’s efforts to reduce
Medicaid expenses, managed care organizations continue to grow
in influence and the Company faces increased pricing pressure as
managed care organizations continue to seek price discounts with
respect to the Company’s products.
In the international markets, cost control methods including
restrictions on physician prescription levels and patient
reimbursements, emphasis on greater use of generic drugs, and
across the board price cuts may decrease revenues
internationally.
12
There are material pending investigations against the
Company, the outcome of which could include the commencement of
civil and/or criminal proceedings involving the imposition of
substantial fines, penalties and injunctive or administrative
remedies, including exclusion from government reimbursement
programs.
The Company cannot predict with certainty the outcome of the
pending investigations to which it is subject, any of which may
lead to a judgment or settlement involving a significant
monetary award or restrictions on its operations.
The pricing, sales and marketing programs and arrangements, and
related business practices of the Company and other participants
in the health care industry are under increasing scrutiny from
federal and state regulatory, investigative, prosecutorial and
administrative entities. These entities include the Department
of Justice and its U.S. Attorney’s Offices, the Office
of Inspector General of the Department of Health and Human
Services, the FDA, the Federal Trade Commission and various
state Attorneys General offices. Many of the health care laws
under which certain of these governmental entities operate,
including the federal and state anti-kickback statutes and
statutory and common law false claims laws, have been construed
broadly by the courts and permit the government entities to
exercise significant discretion. In the event that any of those
governmental entities believes that wrongdoing has occurred, one
or more of them could institute civil or criminal proceedings,
which, if instituted and resolved unfavorably, could subject the
Company to substantial fines, penalties and injunctive or
administrative remedies, including exclusion from government
reimbursement programs. The Company also cannot predict whether
any investigations will affect its marketing practices or sales.
Any such result could have a material adverse impact on the
Company’s results of operations, cash flows, financial
condition, or its business.
Regardless of the merits or outcomes of these investigations,
government investigations are costly, divert management’s
attention from the Company’s business and may result in
substantial damage to the Company’s reputation. Please
refer to Item 3. Legal Proceedings in this report
for descriptions of these pending investigations.
There are other legal matters in which adverse outcomes could
negatively affect the Company’s business.
Unfavorable outcomes in other pending litigation matters,
including litigation concerning product pricing, securities law
violations, product liability claims, ERISA matters, patent and
intellectual property disputes, and antitrust matters could
preclude the commercialization of products, negatively affect
the profitability of existing products, materially and adversely
affect the Company’s financial condition and results of
operations, or subject the Company to conditions that affect
business operations, such as exclusion from government
reimbursement programs.
Please refer to Item 3. Legal Proceedings in this
report for descriptions of significant pending litigation.
The Company is subject to governmental regulations, and the
failure to comply with, as well as the costs of compliance of,
these regulations may adversely affect the Company’s
financial position and results of operations.
The Company’s manufacturing facilities must meet stringent
regulatory standards and are subject to regular inspections. The
cost of regulatory compliance, including that associated with
compliance failures, can materially affect the Company’s
financial position and results of operations. Failure to comply
with regulations, which include pharmacovigilance reporting
requirements and standards relating to clinical, laboratory and
manufacturing practices, can result in delays in the approval of
drugs, seizure or recalls of drugs, suspension or revocation of
the authority necessary for the production and sale of drugs,
fines and other civil or criminal sanctions.
For example, in May 2002, the Company agreed with the FDA to the
entry of a Consent Decree to resolve issues related to
compliance with current Good Manufacturing Practices at certain
of the Company’s facilities in New Jersey and Puerto Rico.
The Consent Decree work placed significant additional controls
on production and release of products from these sites, which
increased costs and
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slowed production and led to a reduction in the number of
products produced at the sites. Further, the Company’s
research and development operations were negatively impacted by
the Consent Decree because these operations share common
facilities with the manufacturing operations.
The Company also is subject to other regulations, including
environmental, health and safety and labor regulations.
Developments following regulatory approval may decrease
demand for the Company’s products.
Even after a product reaches market, certain developments
following regulatory approval may decrease demand for the
Company’s products, including the following:
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the re-review of products that are already marketed; |
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uncertainties concerning safety labeling changes; and |
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greater scrutiny in advertising and promotion. |
Recently, clinical trials and post-marketing surveillance of
certain marketed drugs of competitors within the industry have
raised safety concerns that have led to recalls, withdrawals or
adverse labeling of marketed products. These situations also
have raised concerns among some prescribers and patients
relating to the safety and efficacy of pharmaceutical products
in general, which have negatively affected the sales of such
products.
In addition, following the wake of recent product withdrawals of
other companies and other significant safety issues, health
authorities such as the FDA, the European Medicines Agency and
the Pharmaceuticals and Medicines Device Agency have increased
their focus on safety, when assessing the benefit/risk balance
of drugs. Some health authorities appear to have become more
cautious when making decisions about approvability of new
products or indications and are re-reviewing select products
which are already marketed, adding further to the uncertainties
in the regulatory processes. There is also greater regulatory
scrutiny, especially in the United States, on advertising and
promotion and in particular
direct-to-consumer
advertising.
If previously unknown side effects are discovered or if there is
an increase in the prevalence of negative publicity regarding
known side effects of any of the Company’s products, it
could significantly reduce demand for the product or may require
the Company to remove the product from the market.
New products and technological advances developed by the
Company’s competitors may negatively affect sales.
The Company operates in a highly competitive industry. Many of
the Company’s competitors have been conducting research and
development in areas both served by the Company’s current
products and by those products the Company is in the process of
developing. Competitive developments that may impact the Company
include technological advances by, patents granted to, and new
products developed by competitors or new and existing generic,
prescription and/or OTC products that compete with products of
Schering-Plough or the Merck/ Schering-Plough Cholesterol
Partnership. In addition, it is possible that doctors, patients
and providers may favor those products offered by competitors
due to safety, efficacy, pricing or reimbursement
characteristics, and as a result the Company will be unable to
maintain its sales for such products.
Because the Company often competes with other companies to
acquire or license products (whether in early stage development
or already approved for commercial sale) that the Company
believes to be clinically or commercially attractive, it may be
difficult for the Company to enter into such transactions.
One aspect of the Company’s business is to acquire or
license rights to develop or sell products from other companies.
It may be challenging to acquire or license products that the
Company believes to be clinically or commercially attractive on
acceptable terms or at all because the Company competes for
these opportunities against companies that often have far
greater financial resources than the Company. The Company’s
prospects may be adversely affected if it is unable to obtain
rights to additional products on acceptable terms.
14
The Company relies on third party relationships for its key
products and changes to the third parties that are outside its
control may impact the business.
The Company relies on third party relationships for many of its
key products. Any time that third parties are involved, there
may be changes to or influences or impact on the third parties
that are outside the control of the Company that may also,
directly or indirectly, impact the Company’s business
operation.
The Company does not have operational or financial control over
these third parties and may only have limited influence, if any,
with respect to the manner in which they conduct their
businesses or behave in their relationships with the Company.
Also, in many cases, these third parties may offer or develop
products that may compete with the Company’s products or
have other conflicting interests relative to the Company.
The Company operates a global business that exposes the
Company to additional risks, and any adverse events could have a
material negative impact on results of operations.
The Company operates in over 120 countries, and
non-U.S. operations
generate the majority of the Company’s profit and cash
flow.
Non-U.S. operations
are subject to certain risks, which are inherent in conducting
business overseas. These risks include possible nationalization,
expropriation, importation limitations, pricing and
reimbursement restrictions, and other restrictive governmental
actions or economic destabilization. Also, fluctuations in
inflation, interest rate, and foreign currency exchange rates
can impact Schering-Plough’s consolidated financial results.
In addition, there may be changes to the Company’s business
and political position if there is instability, disruption or
destruction in a significant geographic region, regardless of
cause, including war, terrorism, riot, civil insurrection or
social unrest; and natural or man-made disasters, including
famine, flood, fire, earthquake, storm or disease.
Insurance coverage for product liability may become
unavailable or cost prohibitive.
The Company maintains insurance coverage with such deductibles
and self-insurance to reflect market conditions (including cost
and availability) existing at the time it is written, and the
relationship of insurance coverage to self-insurance varies
accordingly. However, as a result of increased product liability
claims in the pharmaceutical industry, the availability of third
party insurance may become unavailable or cost prohibitive.
The Company is subject to evolving and complex tax laws,
which may result in additional liabilities that may affect
results of operations.
The Company is subject to evolving and complex tax laws in the
U.S. and in foreign jurisdictions. Significant judgment is
required for determining the Company’s tax liabilities, and
the Company’s tax returns are periodically examined by
various tax authorities. The Company’s U.S. federal
income tax returns for the 1997-2002 period are currently under
audit by the Internal Revenue Service. The Company may be
challenged by the IRS and other tax authorities on positions it
has taken in its income tax returns. Although the Company
believes that its accrual for tax contingencies is adequate for
all open years, based on past experience, interpretations of tax
law, and judgments about potential actions by tax authorities,
due to the complexity of tax contingencies, the ultimate
resolution may result in payments that materially affect
shareholders’ equity, liquidity and/or cash flow.
In addition, the Company may be impacted by changes in tax laws
including tax rate changes, new tax laws and revised tax law
interpretations in domestic and foreign jurisdictions.
15
|
|
Item 1B. |
Unresolved Staff Comments |
None.
Schering-Plough’s corporate headquarters is located in
Kenilworth, New Jersey. Principal research facilities are
located in Kenilworth, Union and Summit, New Jersey; Palo Alto,
California; and Elkhorn, Nebraska. Principal manufacturing
facilities are as follows:
|
|
|
Location |
|
Product Type |
|
|
|
Kenilworth, New Jersey
|
|
Pharmaceuticals, Consumer Products |
Omaha, Nebraska
|
|
Animal Health |
Cleveland, Tennessee
|
|
Consumer Products |
Puerto Rico
|
|
Pharmaceuticals |
Belgium
|
|
Pharmaceuticals |
Ireland
|
|
Pharmaceuticals, Consumer Products, Animal Health |
Mexico
|
|
Pharmaceuticals |
Singapore
|
|
Pharmaceuticals |
The Company anticipates capital expenditures of up to
$300 million over the next several years for a
U.S. pharmaceutical sciences center.
|
|
Item 3. |
Legal Proceedings |
Material pending legal proceedings, other than ordinary routine
litigation incidental to the business, to which Schering-Plough
Corporation or any of its subsidiaries or to which any of their
property is subject, are disclosed below.
Additional information on legal proceedings, including important
financial information, can be found in the Litigation Charges
discussion in Note 2, “Special Charges” and
Note 19, “Legal, Environmental and Regulatory
Matters” contained in Item 8, Financial Statements and
Supplementary Data, and in Item 7, Management’s
Discussion and Analysis of Financial Condition and Results of
Operations in this 10-K.
Patent Matters
As described in “Patents, Trademarks, and Other
Intellectual Property Rights” under Part I, Business
in this 10-K,
intellectual property protection is critical to
Schering-Plough’s ability to successfully commercialize its
product innovations. The potential for litigation regarding
Schering-Plough’s intellectual property rights always
exists and may be initiated by third parties attempting to
abridge Schering-Plough’s rights, as well as by
Schering-Plough in protecting its rights. Patent matters
described below have a potential material effect on the Company.
DR. SCHOLL’S FREEZE AWAY Patent. On
July 26, 2004, OraSure Technologies filed an action in the
U.S. District Court for the Eastern District of
Pennsylvania alleging patent infringement by Schering-Plough
Healthcare Products by its sale of DR. SCHOLL’S FREEZE AWAY
wart removal product. The complaint seeks a permanent injunction
and unspecified damages, including treble damages.
Investigations
Massachusetts Investigation. The
U.S. Attorney’s Office for the District of
Massachusetts is investigating a broad range of the
Company’s sales, marketing and clinical trial practices and
programs along with those of Warrick Pharmaceuticals (Warrick),
the Company’s generic subsidiary. The investigation is
focused on the following alleged practices: providing
remuneration to managed care organizations, physicians and
others to induce the purchase of Schering pharmaceutical
products; off-label marketing of drugs; and submitting false
pharmaceutical pricing information to the government for
16
purposes of calculating rebates required to be paid to the
Medicaid program. The Company is cooperating with this
investigation.
The outcome of this investigation could include the commencement
of civil and/or criminal proceedings involving the imposition of
substantial fines, penalties and injunctive or administrative
remedies, including exclusion from government reimbursement
programs. The Company has recorded a liability of
$500 million related to this investigation as well as the
investigations described below under “AWP
Investigations” and the state litigation described below
under “AWP Litigation.” It is reasonably possible that
a settlement of the investigation could involve amounts
materially in excess of this accrual.
AWP Investigations. The Company continues to
respond to existing and new investigations by the Department of
Health and Human Services, the Department of Justice and several
states into industry and Company practices regarding average
wholesale price (AWP). These investigations relate to whether
the AWP used by pharmaceutical companies for certain drugs
improperly exceeds the average prices paid by providers and, as
a consequence, results in unlawful inflation of certain
government drug reimbursements that are based on AWP. The
Company is cooperating with these investigations. The outcome of
these investigations could include the imposition of substantial
fines, penalties and injunctive or administrative remedies.
NITRO-DUR Investigation. In August 2003, the
Company received a civil investigative subpoena issued by the
Office of Inspector General of the U.S. Department of
Health and Human Services, seeking documents concerning the
Company’s classification of NITRO-DUR for Medicaid rebate
purposes, and the Company’s use of nominal pricing and
bundling of product sales. The Company is cooperating with the
investigation. It appears that the subpoena is one of a number
addressed to pharmaceutical companies concerning an inquiry into
issues relating to the payment of government rebates.
Pricing Matters
AWP Litigation. The Company continues to respond
to existing and new litigation by certain states and private
payors into industry and Company practices regarding average
wholesale price (AWP). These litigations relate to whether the
AWP used by pharmaceutical companies for certain drugs
improperly exceeds the average prices paid by providers and, as
a consequence, results in unlawful inflation of certain
reimbursements for drugs by state programs and private payors
that are based on AWP. The complaints allege violations of
federal and state law, including fraud, Medicaid fraud and
consumer protection violations, among other claims. In the
majority of cases, the plaintiffs are seeking class
certifications. In some cases, classes have been certified. The
outcome of these litigations could include substantial damages,
the imposition of substantial fines, penalties and injunctive or
administrative remedies.
Securities and Class Action Litigation
Federal Securities Litigation. Following the
Company’s announcement that the FDA had been conducting
inspections of the Company’s manufacturing facilities in
New Jersey and Puerto Rico and had issued reports citing
deficiencies concerning compliance with current Good
Manufacturing Practices, several lawsuits were filed against the
Company and certain named officers. These lawsuits allege that
the defendants violated the federal securities law by allegedly
failing to disclose material information and making material
misstatements. Specifically, they allege that the Company failed
to disclose an alleged serious risk that a new drug application
for CLARINEX would be delayed as a result of these manufacturing
issues, and they allege that the Company failed to disclose the
alleged depth and severity of its manufacturing issues. These
complaints were consolidated into one action in the
U.S. District Court for the District of New Jersey, and a
consolidated amended complaint was filed on October 11,
2001, purporting to represent a class of shareholders who
purchased shares of Company stock from May 9, 2000 through
February 15, 2001. The complaint seeks compensatory damages
on behalf of the class. The Court certified the shareholder
class on October 10, 2003. Discovery is ongoing.
Shareholder Derivative Actions. Two lawsuits were
filed in the U.S. District Court for the District of New
Jersey, against the Company, certain officers, directors and a
former director seeking damages on
17
behalf of the Company, including disgorgement of trading profits
made by defendants allegedly obtained on the basis of material
non-public information. The complaints allege a failure to
disclose material information and breach of fiduciary duty by
the directors, relating to the FDA inspections and
investigations into the Company’s pricing practices and
sales, marketing and clinical trials practices. These lawsuits
are shareholder derivative actions that purport to assert claims
on behalf of the Company. The two shareholder derivative actions
pending in the U.S. District Court for the District of New
Jersey were consolidated into one action on August 20,
2001, which is in its very early stages.
Product Liability. The Company previously
disclosed that it was a defendant in putative class action
lawsuits involving alleged claims for personal injuries arising
from the plaintiffs’ ingestion of
phenylpropanolamine-containing cough/cold remedies
(“PPA” products), and other class action lawsuits in
which plaintiffs asserted claims for personal injuries arising
from their use of laxative products and sought a refund of the
purchase price of laxatives they purchased. These lawsuits have
been dismissed or resolved. Any amounts paid to resolve these
matters were immaterial. While no class action lawsuits
currently exist concerning PPA claims, individual lawsuits
involving PPA products are still pending. The Company deems the
pending lawsuits to be immaterial in the aggregate. The Company
also previously disclosed that it was the defendant in
individual lawsuits relating to recalled albuterol/ VANCERIL/
VANCENASE inhalers. These lawsuits have been dismissed or
resolved. Any amounts paid to resolve these lawsuits were
immaterial.
ERISA Litigation. On March 31, 2003, the
Company was served with a putative class action complaint filed
in the U.S. District Court in New Jersey alleging that the
Company, retired Chairman, CEO and President Richard Jay Kogan,
the Company’s Employee Savings Plan (Plan) administrator,
several current and former directors, and certain corporate
officers (Messrs. LaRosa and Moore) breached their
fiduciary obligations to certain participants in the Plan. The
complaint seeks damages in the amount of losses allegedly
suffered by the Plan. The complaint was dismissed on
June 29, 2004. The plaintiffs appealed. On August 19,
2005 the U.S. Court of Appeals for the Third Circuit
reversed the dismissal by the District Court and the matter has
been remanded back to the District Court for further proceedings.
K-DUR Antitrust litigation. K-DUR is
Schering-Plough’s long-acting potassium chloride product
supplement used by cardiac patients. Following the commencement
of the FTC administrative proceeding described below, alleged
class action suits were filed in federal and state courts on
behalf of direct and indirect purchasers of K-DUR against
Schering-Plough, Upsher-Smith and Lederle. These suits claim
violations of federal and state antitrust laws, as well as other
state statutory and common law causes of action. These suits
seek unspecified damages. Discovery is ongoing.
Antitrust Matters
K-DUR. Schering-Plough had settled patent
litigation with Upsher-Smith, Inc. (Upsher-Smith) and ESI
Lederle, Inc. (Lederle), relating to generic versions of K-DUR
for which Lederle and Upsher Smith had filed Abbreviated New
Drug Applications. On April 2, 2001, the FTC started an
administrative proceeding against Schering-Plough, Upsher-Smith
and Lederle alleging anti-competitive effects from those
settlements. The administrative law judge issued a decision that
the patent litigation settlements complied with the law in all
respects and dismissed all claims against the Company. The FTC
Staff appealed that decision to the full Commission. The
Commission reversed the decision of the administrative law
judge, ruling that the settlements did violate the antitrust
laws. The full Commission issued a cease and desist order
imposing various injunctive restraints. The federal court of
appeals set aside that 2003 Commission ruling and vacated the
cease and desist order. On August 29, 2005, the FTC filed a
petition seeking a hearing by the U.S. Supreme Court.
Senate Finance Committee Inquiry
In January 2006, the United States Senate Committee on Finance
followed up on previous requests to the Company with a request
for further information on the Company’s practices relating
to educational and other grants. The Company understands that
the Committee has directed similar
follow-up requests to
18
other pharmaceutical companies. The Company is cooperating with
the Committee and is in the process of responding to its
requests.
Tax Matters
In October 2001, IRS auditors asserted that two interest rate
swaps that the Company entered into with an unrelated party
should be recharacterized as loans from affiliated companies,
resulting in additional tax liability for the 1991 and 1992 tax
years. In September 2004, the Company made payments to the IRS
in the amount of $194 million for income tax and
$279 million for interest. The Company filed refund claims
for the tax and interest with the IRS in December 2004.
Following the IRS’s denial of the Company’s claims for
a refund, the Company filed suit in May 2005 in the
U.S. District Court for the District of New Jersey for
refund of the full amount of the tax and interest. This refund
litigation is currently in the discovery phase. The
Company’s tax reserves were adequate to cover the
above-mentioned payments.
Pending Administrative Obligations
In connection with the settlement of an investigation with the
U.S. Department of Justice and the
U.S. Attorney’s Office for the Eastern District of
Pennsylvania, the Company entered into a five-year corporate
integrity agreement (CIA). As disclosed in Note 18
“Consent Decree,” the Company is subject to
obligations under a Consent Decree with the FDA. Failure to
comply with the obligations under the CIA or the Consent Decree
can result in financial penalties.
For a discussion of pending pharmacovigilance matters resulting
from pharmacovigilance inspections by officials of the British
and French medicines agencies conducted at the request of the
European Agency for the Evaluation of Medicinal Products (EMEA),
refer to “Regulatory and Competitive Environment in Which
the Company Operates” in Management’s Discussion and
Analysis in this 10-K.
Other Matters
Biopharma Contract Dispute. Biopharma S.r.l. filed
a claim in the Civil Court of Rome on July 21, 2004 (docket
no. 57397/2004, 9th Chamber), against certain
Schering-Plough subsidiaries. The complaint alleges that
Schering-Plough did not fulfill its duties under distribution
and supply agreements between Biopharma and a Schering-Plough
subsidiary for distribution by Schering-Plough of generic
products manufactured by Biopharma to hospitals and to
pharmacists in France.
|
|
Item 4. |
Submission of Matters to a Vote of Security Holders |
Not applicable.
19
Executive Officers of the Registrant
Listed below are the executive officers and corporate officers
of the Company. Unless otherwise indicated, each has held the
position indicated for the past five years. Officers serve for
one year and until their successors have been duly appointed.
|
|
|
|
|
|
|
Name |
|
Title |
|
Age | |
|
|
|
|
| |
Robert J. Bertolini*
|
|
Executive Vice President and Chief Financial Officer(1) |
|
|
44 |
|
C. Ron Cheeley*
|
|
Senior Vice President, Global Human Resources(2) |
|
|
55 |
|
Carrie S. Cox*
|
|
Executive Vice President and President, Global Pharmaceuticals(3) |
|
|
48 |
|
William J. Creelman
|
|
Vice President, Tax(4) |
|
|
51 |
|
Douglas J. Gingerella*
|
|
Vice President and Controller(5) |
|
|
47 |
|
Fred Hassan*
|
|
Chairman and Chief Executive Officer(6) |
|
|
60 |
|
Thomas H. Kelly
|
|
Vice President, Corporate Business Development(7) |
|
|
56 |
|
Raul E. Kohan*
|
|
Group Head, Global Specialty Operations, and President, Animal
Health |
|
|
53 |
|
Joseph J. LaRosa
|
|
Vice President, Legal Affairs(8) |
|
|
47 |
|
Ian A.T. McInnes
|
|
Senior Vice President, Global Supply Chain(9) |
|
|
53 |
|
E. Kevin Moore
|
|
Vice President and Treasurer |
|
|
53 |
|
Cecil B. Pickett, Ph.D.*
|
|
Senior Vice President and President, Schering-Plough Research
Institute Division(10) |
|
|
60 |
|
Anne Renahan
|
|
Vice President, Global Internal Audits(11) |
|
|
47 |
|
Thomas J. Sabatino, Jr.*
|
|
Executive Vice President and General Counsel(12) |
|
|
47 |
|
Karl Salnoske
|
|
Vice President and Chief Information Officer(13) |
|
|
52 |
|
Brent Saunders*
|
|
Senior Vice President, Global Compliance and Business
Practices(14) |
|
|
36 |
|
Susan Ellen Wolf
|
|
Corporate Secretary, Associate General Counsel and Vice
President, Corporate Governance(15) |
|
|
51 |
|
|
|
|
|
* |
Officers as defined in
Rule 16a-1(f)
under the Securities Exchange Act of 1934. |
|
|
|
|
(1) |
Mr. Bertolini joined the Company in 2003 as Executive Vice
President and Chief Financial Officer. Mr. Bertolini was a
partner at PricewaterhouseCoopers from 1993 to 2003. |
|
|
(2) |
Mr. Cheeley joined the Company in 2003 as Senior Vice
President, Global Human Resources. Mr. Cheeley was Group
Vice President, Global Compensation and Benefits, Pharmacia
Corporation from 1998 to 2003. |
|
|
(3) |
Ms. Cox joined the Company in 2003 as Executive Vice
President and President, Global Pharmaceuticals. Ms. Cox
was Executive Vice President and President, Global Prescription
Business, Pharmacia Corporation from 1999 to 2003. |
20
|
|
|
|
(4) |
Mr. Creelman joined the Company in 2004 as Vice President,
Tax. Mr. Creelman was Senior Tax Counsel, Pfizer from 2003
to 2004. Mr. Creelman was Assistant Vice
President — International Tax, CIGNA Corporation from
2002 to 2003 and Vice President Tax — U.S., SmithKline
Beecham from 1996 to 2001. |
|
|
(5) |
Mr. Gingerella was named Vice President and Controller in
2004. Mr. Gingerella was Vice President, Corporate Audits
from 1999 to 2004. |
|
|
(6) |
Mr. Hassan joined the Company in 2003 as Chairman of the
Board and Chief Executive Officer. Mr. Hassan was Chairman
of the Board and Chief Executive Officer of Pharmacia
Corporation from 2001 to 2003. |
|
|
(7) |
Mr. Kelly became Vice President, Corporate Business
Development in 2004. Mr. Kelly was Vice President and
Controller from 1991 to 2004. |
|
|
(8) |
Mr. LaRosa became Vice President, Legal Affairs in 2004.
Mr. LaRosa was Staff Vice President, Secretary and
Associate General Counsel from 2001 to 2004. |
|
|
(9) |
Dr. McInnes joined the Company in 2004 as Senior Vice
President, Global Supply Chain. Dr. McInnes was Senior Vice
President, Global Supply Chain, Pharmacia Corporation from 1994
to 2003 and Executive Vice President, Supply Chain, Watson
Pharmaceuticals, Inc. from 2003 to 2004. |
|
|
(10) |
Dr. Pickett was named Senior Vice President in 2004.
Dr. Pickett joined Schering-Plough Research Institute in
1993 as Executive Vice President, Discovery Research,
Schering-Plough Research Institute and in 2002 was named
President of Schering-Plough Research Institute. |
|
(11) |
Ms. Renahan joined the Company in 2004 as Vice President,
Global Internal Audits. Ms. Renahan was Executive Director
and Controller, Eisai Inc. from 1999 to 2004. |
|
(12) |
Mr. Sabatino joined the Company in 2004 as Executive Vice
President and General Counsel. Mr. Sabatino was Senior Vice
President and General Counsel, Baxter International, Inc. from
2001 to 2004. |
|
(13) |
Mr. Salnoske joined the Company in 2004 as Vice President
and Chief Information Officer. Mr. Salnoske was CEO of
Adaptive Trade from 2001 to 2004. |
|
(14) |
Mr. Saunders joined the Company in 2003 as Senior Vice
President, Global Compliance and Business Practices.
Mr. Saunders was a partner at PricewaterhouseCoopers from
2000 to 2003. |
|
(15) |
Ms. Wolf was named Vice President, Corporate Secretary and
Associate General Counsel in 2004. She held various positions in
Schering-Plough’s Law Department from 2002 to 2004. She was
Senior Attorney, Delta Airlines from 2000 to 2002. |
21
Part II
|
|
Item 5. |
Market for Registrant’s Common Equity and Related
Stockholder Matters |
The common share dividends, share price data and the approximate
number of holders of record are set forth under Item 8,
Financial Statements and Supplementary Data, in
this 10-K.
The following table provides information with respect to
purchases by the Company of its common shares during the fourth
quarter of 2005.
ISSUER PURCHASES OF EQUITY SECURITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of | |
|
Maximum Number | |
|
|
|
|
|
|
Shares Purchased as | |
|
of Shares that May | |
|
|
|
|
Average | |
|
Part of Publicly | |
|
Yet Be Purchased | |
|
|
Total Number of | |
|
Price Paid | |
|
Announced Plans or | |
|
Under the Plans or | |
Period |
|
Shares Purchased | |
|
per Share | |
|
Programs | |
|
Programs | |
|
|
| |
|
| |
|
| |
|
| |
October 1, 2005 through October 31, 2005
|
|
|
8,577 |
(1) |
|
$ |
20.49 |
|
|
|
N/A |
|
|
|
N/A |
|
November 1, 2005 through November 30, 2005
|
|
|
1,850 |
(1) |
|
$ |
19.69 |
|
|
|
N/A |
|
|
|
N/A |
|
December 1, 2005 through December 31, 2005
|
|
|
357,331 |
(1) |
|
$ |
19.72 |
|
|
|
N/A |
|
|
|
N/A |
|
Total October 1, 2005 through December 31, 2005
|
|
|
367,758 |
(1) |
|
$ |
19.74 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
(1) |
All of the shares included in the table above were repurchased
pursuant to the Company’s stock incentive program and
represent shares delivered to the Company by option holders for
payment of the exercise price and tax withholding obligations in
connection with stock options and stock awards. |
22
|
|
Item 6. |
Selected Financial Data |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In millions, except per share figures and percentages) | |
Operating Results
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
$ |
10,180 |
|
|
$ |
9,762 |
|
Income/(loss) before income taxes(1)
|
|
|
497 |
|
|
|
(168 |
) |
|
|
(46 |
) |
|
|
2,563 |
|
|
|
2,523 |
|
Net income/(loss)(1)
|
|
|
269 |
|
|
|
(947 |
) |
|
|
(92 |
) |
|
|
1,974 |
|
|
|
1,943 |
|
Net income/(loss) available to common shareholders
|
|
|
183 |
|
|
|
(981 |
) |
|
|
(92 |
) |
|
|
1,974 |
|
|
|
1,943 |
|
Diluted earnings/(loss) per common share(1)
|
|
|
0.12 |
|
|
|
(0.67 |
) |
|
|
(0.06 |
) |
|
|
1.34 |
|
|
|
1.32 |
|
Basic earnings/(loss) per common share(1)
|
|
|
0.12 |
|
|
|
(0.67 |
) |
|
|
(0.06 |
) |
|
|
1.35 |
|
|
|
1.33 |
|
Research and development expenses
|
|
|
1,865 |
|
|
|
1,607 |
|
|
|
1,469 |
|
|
|
1,425 |
|
|
|
1,312 |
|
Depreciation and amortization expenses
|
|
|
486 |
|
|
|
453 |
|
|
|
417 |
|
|
|
372 |
|
|
|
320 |
|
Financial Position and Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, net
|
|
$ |
4,487 |
|
|
$ |
4,593 |
|
|
$ |
4,527 |
|
|
$ |
4,236 |
|
|
$ |
3,814 |
|
Total assets
|
|
|
15,469 |
|
|
|
15,911 |
|
|
|
15,271 |
|
|
|
14,136 |
|
|
|
12,174 |
|
Long-term debt
|
|
|
2,399 |
|
|
|
2,392 |
|
|
|
2,410 |
|
|
|
21 |
|
|
|
112 |
|
Shareholders’ equity
|
|
|
7,387 |
|
|
|
7,556 |
|
|
|
7,337 |
|
|
|
8,142 |
|
|
|
7,125 |
|
Capital expenditures
|
|
|
478 |
|
|
|
489 |
|
|
|
711 |
|
|
|
776 |
|
|
|
759 |
|
Financial Statistics
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) as a percent of net sales
|
|
|
2.8 |
% |
|
|
(11.4 |
)% |
|
|
(1.1 |
)% |
|
|
19.4 |
% |
|
|
19.9 |
% |
Return on average shareholders’ equity
|
|
|
3.6 |
% |
|
|
(12.7 |
)% |
|
|
(1.2 |
)% |
|
|
25.9 |
% |
|
|
29.3 |
% |
Net book value per common share(2)
|
|
$ |
4.77 |
|
|
$ |
4.91 |
|
|
$ |
4.99 |
|
|
$ |
5.55 |
|
|
$ |
4.86 |
|
Other Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends per common share
|
|
$ |
.22 |
|
|
$ |
.22 |
|
|
$ |
.565 |
|
|
$ |
.67 |
|
|
$ |
.62 |
|
Cash dividends on common shares
|
|
|
324 |
|
|
|
324 |
|
|
|
830 |
|
|
|
983 |
|
|
|
911 |
|
Cash dividends on preferred shares
|
|
|
86 |
|
|
|
30 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Average shares outstanding used in calculating diluted
earnings/(loss) per common share
|
|
|
1,484 |
|
|
|
1,472 |
|
|
|
1,469 |
|
|
|
1,470 |
|
|
|
1,470 |
|
Average shares outstanding used in calculating basic
earnings/(loss) per common share
|
|
|
1,476 |
|
|
|
1,472 |
|
|
|
1,469 |
|
|
|
1,466 |
|
|
|
1,463 |
|
Common shares outstanding at year-end
|
|
|
1,479 |
|
|
|
1,474 |
|
|
|
1,471 |
|
|
|
1,468 |
|
|
|
1,465 |
|
|
|
(1) |
2005, 2004, 2003, 2002 and 2001 include Special charges of $294,
$153, $599, $150 and $500, respectively. See Note 2,
“Special Charges,” under Item 8, Financial
Statements and Supplementary Data, in
this 10-K for
additional information. |
|
(2) |
Assumes conversion of all preferred shares into approximately
69 million common shares for 2005 and 65 million
common shares for 2004. |
|
|
Item 7. |
Management’s Discussion and Analysis of Financial
Condition and Results of Operations |
EXECUTIVE SUMMARY
Schering-Plough (the Company) discovers, develops, manufactures
and markets medical therapies and treatments to enhance human
health. The Company also markets leading consumer brands in the
over-the-counter (OTC),
foot care and sun care markets and operates a global animal
health business.
23
As a research-based pharmaceutical company, a core strategy of
Schering-Plough is to invest substantial funds in scientific
research with the goal of creating therapies and treatments with
important medical and commercial value. Consistent with this
core strategy, the Company has been increasing its investment in
research and development, and this trend is expected to continue
at historic levels or greater. Research and development
activities focus on mechanisms to treat serious diseases. There
is a high rate of failure inherent in such research and, as a
result, there is a high risk that the funds invested in research
programs will not generate financial returns. This risk profile
is compounded by the fact that this research has a long
investment cycle. To bring a pharmaceutical compound from the
discovery phase to the commercial phase may take a decade or
more.
There are two sources of new products: products acquired through
acquisition and licensing arrangements, and products in the
Company’s late-stage research pipeline. With respect to
acquisitions and licensing, there are limited opportunities for
obtaining or licensing critical late-stage products, and these
limited opportunities typically require substantial amounts of
funding. The Company competes for these opportunities against
companies often with greater financial resources. Accordingly,
it may be challenging for the Company to acquire or license
critical late-stage products that will have a positive material
financial impact.
The Company supports commercialized products with manufacturing,
sales and marketing efforts. The Company is also moving forward
with additional investments to enhance its infrastructure and
business, including capital expenditures for the development
process, where products are moved from the drug discovery
pipeline to markets, information technology systems, and
post-marketing studies and monitoring.
The Company’s financial situation continues to improve, as
discussed below. The Company’s cholesterol franchise
products, VYTORIN and ZETIA, are the primary drivers of this
improvement. ZETIA is the Company’s novel cholesterol
absorption inhibitor. VYTORIN is the combination of ZETIA and
Zocor, Merck & Co., Inc.’s (Merck) statin
medication. These two products have been launched through a
joint venture between the Company and Merck. ZETIA (ezetimibe),
marketed in Europe as EZETROL, is marketed for use either by
itself or together with statins for the treatment of elevated
cholesterol levels. ZETIA/ EZETROL has been launched in more
than 60 countries. VYTORIN (ezetimibe/simvastatin), marketed as
INEGY internationally, has been launched in over 20 countries,
including the United States.
The Company currently expects its cholesterol franchise to
continue to grow. The financial commitment to compete in the
cholesterol reduction market is shared with Merck and profits
from the sales of VYTORIN and ZETIA are also shared with Merck.
The operating results of the joint venture with Merck are
recorded using the equity method of accounting. Outside of the
joint venture with Merck, in the Japanese market, Bayer
Healthcare will co-market the Company’s
cholesterol-absorption inhibitor, ZETIA, upon approval. Due to a
backlog of new drug applications in Japan, the Company cannot
precisely predict the timing of this approval.
The cholesterol-reduction market is the single largest
pharmaceutical category in the world. VYTORIN and ZETIA are
competing in this market, and on a combined basis, these
products continued to grow in terms of market share during 2005.
As a franchise, the two products together have captured more
than 14 percent of new prescriptions for the
U.S. cholesterol management market (based on January 2006
IMS data). VYTORIN currently ranks as the third-leading
prescription product for treating patients with high cholesterol
(based on new prescriptions). To date, physicians have written
more than 11 million total prescriptions for VYTORIN in the
U.S. ZETIA sales continue to grow even as VYTORIN grows its
market share.
During 2005, the Company’s results of operations and cash
flows were driven significantly by the performance of VYTORIN
and ZETIA. As a result, the Company’s ability to generate
profits is predominantly dependent upon the performance of the
VYTORIN and ZETIA cholesterol franchise, which dependence is
expected to continue for some time. For 2005, equity income from
the cholesterol joint venture was $873 million and net
income available to common shareholders was $183 million.
Additional information regarding the joint venture with Merck is
also included in Note 3, “Equity Income
24
from Cholesterol Joint Venture,” under Item 8,
Financial Statements and Supplementary Data, in
this 10-K.
Although it is expected that operating cash flow, existing cash
and investments, including funds repatriated under the American
Jobs Creation Act of 2004 (AJCA), will fund the Company’s
operations for the near and intermediate term, as discussed in
more detail below, future cash flows are also dependent upon the
performance of VYTORIN and ZETIA. The Company must generate
profits and cash flows to maintain and enhance its
infrastructure and business as discussed above.
Sales of the products may be impacted by the introduction of new
innovative competing treatments and generic versions of existing
products. In this regard, the Company expects that generic forms
of Pravachol and Zocor, two existing well-established
cholesterol-management products, will be introduced in the
U.S. as they lose patent protection beginning in 2006
(generics have been introduced during 2005 in some international
markets). The Company cannot reasonably predict what effect the
introduction of generic forms of cholesterol management products
may have on VYTORIN and ZETIA, although the decisions of
government entities, managed care groups and other groups
concerning formularies and reimbursement policies could
potentially negatively impact the dollar size and/or growth of
the cholesterol management market, including VYTORIN and ZETIA.
A material change in the sales or market share of VYTORIN and
ZETIA would have a significant impact on the Company’s
operations and cash flow.
REMICADE is prescribed for the treatment of rheumatoid
arthritis, early rheumatoid arthritis, psoriatic arthritis,
Crohn’s disease and ankylosing spondylitis, and recently
gained approval in Europe for psoriasis. REMICADE is the
Company’s second largest marketed pharmaceutical product
line (after the cholesterol franchise). This product is licensed
from and manufactured by Centocor, Inc., a Johnson &
Johnson company. The Company has the exclusive marketing rights
to this product outside of the U.S., Japan, China (including
Hong Kong), Taiwan and Indonesia. During the third quarter of
2005, the Company exercised an option under its contract with
Centocor for license rights to develop and commercialize
golimumab, a fully human monoclonal antibody, in the same
territories as REMICADE. Golimumab is currently under
Phase III trials. Centocor believes these rights to
golimumab expire in 2014, while the Company believes these
rights extend beyond 2014. The parties are working together to
move forward with their collaboration on golimumab, and steps
are being taken to resolve the difference of opinion as to the
expiration date.
As is typical in the pharmaceutical industry, the Company
licenses manufacturing, marketing and/or distribution rights to
certain products to others, and also manufactures, markets
and/or distributes products owned by others pursuant to
licensing and joint venture arrangements. Any time that third
parties are involved, there are additional factors relating to
the third party and outside the control of the Company that may
create positive or negative impacts on the Company. VYTORIN,
ZETIA and REMICADE are subject to such arrangements and are key
to the Company’s current business and financial performance.
In addition, any potential strategic alternatives may be
impacted by the change of control provisions in those
arrangements, which could result in VYTORIN and ZETIA being
acquired by Merck or REMICADE reverting back to Centocor. The
change in control provision relating to VYTORIN and ZETIA is
included in the contract with Merck, filed as Exhibit 10(q)
to the
Company’s 10-K,
and the change of control provision relating to REMICADE is
contained in the contract with Centocor, filed as
Exhibit 10(u) to the
Company’s 10-K.
During the period from 2002 to 2004, the Company experienced a
number of negative events that have strained and continue to
strain the Company’s financial resources. While as
explained below, the Company’s overall financial situation
began to improve in 2005, these negative events remain relevant
to understand the Company’s current challenges. These
negative events included, but were not limited to, the following
matters:
|
|
|
|
• |
Entered into a formal Consent Decree with the FDA in 2002 and
agreed to implement a cGMP Work Plan and revalidate
manufacturing processes at certain manufacturing sites in the
U.S. and Puerto Rico. The Company has completed all of the
significant steps of the cGMP Work Plan and validation actions
required by December 31, 2005, under the Consent Decree.
These are subject to certification by an external third party
and review and approval by the FDA. Under the terms of |
25
|
|
|
|
|
the Decree, provided that the FDA has not notified the Company
of a significant violation of FDA law, regulations, or the
Decree in the five year period since the Decree’s entry,
May 2002 through May 2007, the Company may petition the court to
have the Decree dissolved and the FDA will not oppose the
Company’s petition. The Company has incurred significant
costs associated with manufacturing compliance efforts as part
of the Consent Decree. Incremental compliance costs will be
incurred through the completion of the third party certification
and FDA review and approval process. In addition, the Company
has found it necessary to discontinue certain older profitable
products and outsource other products. |
|
|
• |
Switch of CLARITIN in the U.S., beginning in December 2002, from
prescription to OTC status. This switch coupled with private
label competition has resulted in substantially lower overall
sales of this product starting in 2003 as well as lower average
unit selling price for this product and ongoing intense
competition. The Company’s exposure to powerful retail
purchasers has also increased. |
|
|
• |
Market shares and sales levels of certain other Company products
fell significantly and have experienced increased competition.
Some of these products continue to compete in declining or
volatile markets. |
|
|
• |
Investigations into certain of the Company’s sales and
marketing practices by the U.S. Attorney’s Offices in
Massachusetts and Pennsylvania. During 2004, the Company made
payments totaling $294 million to the
U.S. Attorney’s Office for the Eastern District of
Pennsylvania in settlement of that investigation. |
In response to these matters, beginning in April 2003, the Board
of Directors named Fred Hassan as the new Chairman of the Board
and Chief Executive Officer of Schering-Plough Corporation.
Under his leadership, a new leadership team was recruited and a
six- to eight-year, five-phase Action Agenda was formulated with
the goal of stabilizing, repairing and turning around the
Company. In October 2005, the Company announced that it has
entered the third, Turnaround, phase of the Action Agenda. The
beginning of the Turnaround phase had been defined as achieving
three consecutive quarters of sales and earnings growth,
excluding special items.
|
|
|
Current State of the Business |
Net sales in 2005 were $9.5 billion, an increase of
$1.2 billion, or 15 percent, over the 2004 period. The
increase was driven primarily by the growth of REMICADE,
PEG-INTRON, NASONEX, TEMODAR and the Animal Health business, and
the U.S. sales contribution from the antibiotics AVELOX and
CIPRO and other products under the agreement with Bayer that
became effective in October 2004. Foreign exchange contributed
1 percent to the sales increase.
Sales and marketing costs have increased due to the addition of
Bayer sales representatives, increased selling expenses in
Europe to support the continued launches of VYTORIN and ZETIA,
and increased promotional spending, primarily for NASONEX,
ASMANEX and the products under the agreement with Bayer.
The Company had net income available to common shareholders of
$183 million for 2005, compared to a net loss available to
common shareholders of $981 million in 2004. Net income
available to common shareholders for 2005 included a charge to
increase the litigation reserves by $250 million resulting
in a total reserve of $500 million representing the
Company’s current estimate to resolve the Massachusetts
investigation as well as the investigations disclosed under
“AWP Investigations” and the state litigation
disclosed under “AWP Litigation” in Note 19,
“Legal, Environmental and Regulatory Matters,” in
Item 8, Financial Statements and Supplementary Data. In
addition, net income available to common shareholders also
included research and development expense of approximately
$124 million (or $118 million net of tax) for the
license rights to develop and commercialize golimumab. Net loss
available to common shareholders for 2004 included a pre-tax
research and development charge of $80 million for the
license of garenoxacin from Toyama Chemical Company Ltd., tax
expense of $779 million which included a
26
provision for taxes related to the planned repatriation of
unremitted foreign earnings during 2005 under the American Jobs
Creation Act, and a valuation reserve for net deferred tax
assets in the U.S.
Many of the Company’s manufacturing sites operate below
capacity. The Company’s manufacturing sites subject to the
Consent Decree remained open while the Company was performing
its revalidation and cGMP Work Plan obligations under decree.
However, the Consent Decree work placed significant additional
controls on production and release of products from these sites,
which increased costs and slowed production and led to a
reduction in the product mix at the sites. Further, the
Company’s research and development operations were
negatively impacted by the Consent Decree because these
operations share common facilities with the manufacturing
operations. Although certain costs, such as those associated
with third party certifications, will decrease when the
completion of the Work Plan is certified, other financial
impacts will continue, such as the costs of the new processes
that will continue to be used and the reduced product mix and
volumes at the sites.
The Company’s manufacturing cost base is relatively fixed.
Actions on the part of management to significantly reduce the
Company’s manufacturing infrastructure involve complex
issues. In most cases, shifting products between manufacturing
plants can take many years due to construction, revalidation and
registration requirements. Management continues to review the
carrying value of certain manufacturing assets for indications
of impairment. Future events and decisions may lead to asset
impairments and/or related costs.
During 2005, the Company repatriated approximately
$9.4 billion of previously unremitted foreign earnings at a
reduced tax rate as provided by the American Jobs Creation Act
(AJCA). Repatriating funds under the AJCA benefits the Company
in the following ways:
|
|
|
|
• |
The Company’s U.S. operations currently incur
significant negative cash flow. Operating cash flows, existing
cash and investments, including repatriations made during 2005
under the AJCA, are expected to provide the Company with the
ability to fund U.S. cash needs for the near and
intermediate term. The Company will continue to use repatriated
funds for AJCA qualified spending. |
|
|
• |
The U.S. operations during 2005 and 2004 produced
U.S. tax net operating loss (U.S. NOL) carryforwards
of approximately $1.5 billion. Under the AJCA, qualifying
repatriations do not reduce U.S. tax losses. As such, the
Company has both the cash necessary to fund its U.S. cash
needs and the potential benefit of being able to carry forward
U.S. NOLs to reduce future U.S. taxable income. This
potential future benefit could be significant but is dependent
on the Company achieving profitability in the U.S. |
DISCUSSION OF OPERATING RESULTS
A significant portion of net sales is made to major
pharmaceutical and health care product distributors and major
retail chains in the U.S. Consequently, net sales and
quarterly growth comparisons may be affected by fluctuations in
the buying patterns of major distributors, retail chains and
other trade buyers. These fluctuations may result from
seasonality, pricing, wholesaler buying decisions or other
factors.
Consolidated net sales in 2005 totaled $9.5 billion, an
increase of $1.2 billion or 15 percent compared with
2004. Consolidated net sales reflected higher volumes of
REMICADE, PEG-INTRON, NASONEX, TEMODAR and the inclusion of a
full year of sales of AVELOX and CIPRO. In addition, foreign
exchange had a favorable impact of 1 percent.
Consolidated 2004 net sales of $8.3 billion had
decreased $62 million or 1 percent as compared to
2003, primarily reflecting volume declines offset by a favorable
foreign exchange rate impact of 4 percent.
27
Net sales for the years ended December 31, 2005, 2004 and
2003 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Increase (Decrease) | |
|
|
|
|
|
|
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005/2004 | |
|
2004/2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
|
|
|
|
PRESCRIPTION PHARMACEUTICALS
|
|
$ |
7,564 |
|
|
$ |
6,417 |
|
|
$ |
6,611 |
|
|
|
18 |
% |
|
|
(3 |
)% |
|
REMICADE
|
|
|
942 |
|
|
|
746 |
|
|
|
540 |
|
|
|
26 |
|
|
|
38 |
|
|
PEG-INTRON
|
|
|
751 |
|
|
|
563 |
|
|
|
802 |
|
|
|
33 |
|
|
|
(30 |
) |
|
NASONEX
|
|
|
737 |
|
|
|
594 |
|
|
|
500 |
|
|
|
24 |
|
|
|
19 |
|
|
CLARINEX/ AERIUS
|
|
|
646 |
|
|
|
692 |
|
|
|
694 |
|
|
|
(7 |
) |
|
|
0 |
|
|
TEMODAR
|
|
|
588 |
|
|
|
459 |
|
|
|
324 |
|
|
|
28 |
|
|
|
42 |
|
|
CLARITIN Rx(a)
|
|
|
371 |
|
|
|
321 |
|
|
|
328 |
|
|
|
16 |
|
|
|
(2 |
) |
|
REBETOL
|
|
|
331 |
|
|
|
287 |
|
|
|
639 |
|
|
|
15 |
|
|
|
(55 |
) |
|
INTEGRILIN
|
|
|
315 |
|
|
|
325 |
|
|
|
306 |
|
|
|
(3 |
) |
|
|
6 |
|
|
INTRON A
|
|
|
287 |
|
|
|
318 |
|
|
|
409 |
|
|
|
(10 |
) |
|
|
(22 |
) |
|
AVELOX
|
|
|
228 |
|
|
|
44 |
|
|
|
— |
|
|
|
N/M |
|
|
|
N/M |
|
|
SUBUTEX
|
|
|
197 |
|
|
|
185 |
|
|
|
144 |
|
|
|
6 |
|
|
|
29 |
|
|
CAELYX
|
|
|
181 |
|
|
|
150 |
|
|
|
111 |
|
|
|
21 |
|
|
|
35 |
|
|
CIPRO
|
|
|
146 |
|
|
|
43 |
|
|
|
— |
|
|
|
N/M |
|
|
|
N/M |
|
|
ELOCON
|
|
|
144 |
|
|
|
168 |
|
|
|
154 |
|
|
|
(14 |
) |
|
|
9 |
|
|
Other Pharmaceutical
|
|
|
1,700 |
|
|
|
1,522 |
|
|
|
1,660 |
|
|
|
12 |
|
|
|
(8 |
) |
CONSUMER HEALTH CARE
|
|
|
1,093 |
|
|
|
1,085 |
|
|
|
1,026 |
|
|
|
1 |
|
|
|
6 |
|
|
OTC(b)
|
|
|
556 |
|
|
|
578 |
|
|
|
588 |
|
|
|
(4 |
) |
|
|
(2 |
) |
|
Foot Care
|
|
|
333 |
|
|
|
331 |
|
|
|
292 |
|
|
|
1 |
|
|
|
13 |
|
|
Sun Care
|
|
|
204 |
|
|
|
176 |
|
|
|
146 |
|
|
|
16 |
|
|
|
20 |
|
ANIMAL HEALTH
|
|
|
851 |
|
|
|
770 |
|
|
|
697 |
|
|
|
11 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED NET SALES
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
|
15 |
% |
|
|
(1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain prior year amounts have been reclassified to conform to
current year presentation.
N/ M — Not a meaningful percentage.
|
|
|
(a) |
|
Amounts shown include international sales of CLARITIN Rx only. |
|
(b) |
|
Includes OTC CLARITIN of $394, $419, and $432 in 2005, 2004 and
2003, respectively. |
International net sales of REMICADE, for the treatment of
immune-mediated inflammatory disorders such as rheumatoid
arthritis, early rheumatoid arthritis, psoriatic arthritis,
Crohn’s disease, ankylosing spondylitis and plaque
psoriasis, were up $196 million or 26 percent in 2005
to $942 million due to greater demand, expanded indications
and continued market growth. Sales of REMICADE in 2004 were
$746 million, up $206 million or 38 percent
compared with 2003, due to greater medical use and expanded
indications in European markets. In the near future, additional
competitive products for the indications referred to above are
likely to be introduced.
Global net sales of PEG-INTRON Powder for Injection, a pegylated
interferon product for treating hepatitis C, increased
$188 million or 33 percent to $751 million
compared with 2004 due to the December 2004 launch of the
PEG-INTRON and REBETOL combination therapy in Japan. Sales in
Japan benefited from the significant number of patients who were
waiting for approval of PEG-INTRON before beginning treatment
(patient warehousing). Comparisons in 2006 will be unfavorably
impacted by the absence of this patient warehousing and
anticipated government mandated price reductions in Japan. As a
result of these factors, sales may decline materially. Sales of
PEG-INTRON in the U.S. in 2005 have decreased, primarily
reflecting a decline in the overall market. Sales of PEG-INTRON
decreased
28
$239 million or 30 percent to $563 million in
2004, due primarily to loss of market share reflecting the
entrance of a competitor’s new products in the
hepatitis C market in 2003.
Global net sales of NASONEX Nasal Spray, a once-daily
corticosteroid nasal spray for allergies, rose 24 percent
to $737 million in 2005 as the product captured greater
U.S. and international market share versus the 2004 period.
U.S. sales benefited from an increased promotional effort
and the introduction, beginning in January 2005, of a new
scent-free, alcohol-free formulation of NASONEX nasal spray.
2004 sales of NASONEX increased 19 percent versus 2003 to
$594 million primarily due to international sales growth
and favorable prior year trade inventory comparisons in the
U.S., tempered by a decline in U.S. market share. Generic
Flonase (fluticasone propionate) was approved in 2006 and may
unfavorably impact the corticosteroid nasal spray market.
Global net sales of CLARINEX (marketed as AERIUS in many
countries outside the U.S.), for the treatment of seasonal
outdoor allergies and year-round indoor allergies, decreased
$46 million, or 7 percent, versus 2004. Sales in the
U.S. decreased $95 million or 23 percent versus
2004 due to reduced market share in a declining market. In
September 2005, generic Allegra (fexofenadine) was
introduced to the U.S., which will continue to negatively affect
the antihistamine market including CLARINEX. Sales outside the
U.S. increased $49 million or 18 percent to
$321 million in 2005 due primarily to market share gains.
Global net sales of CLARINEX were $692 million in 2004,
essentially flat versus 2003. Sales outside the
U.S. increased 39 percent to $272 million in 2004
due to market share gains and continued conversion from
prescription CLARITIN. U.S. sales decreased 16 percent
to $420 million in 2004 due to the continued contraction in
the U.S. prescription antihistamine market following the
launch of OTC CLARITIN and other branded and non-branded
non-sedating antihistamines coupled with market share declines.
Global net sales of TEMODAR Capsules, a treatment for certain
types of brain tumors, increased $129 million or
28 percent to $588 million in 2005 due to increased
utilization for treating newly diagnosed glioblastoma multiforme
(GBM), which is the most prevalent form of brain cancer. This
new indication was granted U.S. FDA approval in March 2005
and was rapidly adopted by U.S. physicians. In June 2005,
TEMODAR received approval from the European Commission for use
in combination with radiotherapy for GBM patients in 25 member
states as well as in Iceland and Norway. In Japan, TEMODAR was
granted a priority review of the regulatory application to treat
malignant glioma in the 2005 fourth quarter. Sales of TEMODAR
increased $135 million or 42 percent to
$459 million in 2004 due to increased market penetration.
The growth rates for TEMODAR may moderate going forward, as
significant market penetration has already been achieved in the
treatment of GBM, especially in the U.S.
International net sales of prescription CLARITIN increased
$50 million or 16 percent to $371 million in 2005
due to the launch of CLARITIN REDITABS in Japan coupled with an
unusually severe Japanese allergy season that may not recur in
2006. In 2004, international sales of prescription CLARITIN were
$321 million, a decrease of 2 percent compared to 2003
due to continued conversion to CLARINEX.
Global net sales of REBETOL Capsules, for use in combination
with INTRON A or PEG-INTRON for treating hepatitis C,
increased $44 million or 15 percent to
$331 million in 2005 due primarily to the launch of the
PEG-INTRON and REBETOL combination therapy in Japan in December
2004. Sales in Japan benefited from the significant number of
patients who were waiting for approval of PEG-INTRON before
beginning treatment (patient warehousing). Comparisons in 2006
will be unfavorably impacted by the absence of this patient
warehousing and, as a result, sales may decline materially.
REBETOL may also be subject to larger than average government
mandated price reductions in Japan. Sales of REBETOL in 2004
decreased 55 percent to $287 million due to the launch
of generic versions of REBETOL in the U.S. in April 2004
and increased price competition outside the U.S.
Global net sales of INTEGRILIN Injection, a glycoprotein
platelet aggregation inhibitor for the treatment of patients
with acute coronary syndrome, which is sold primarily in the
U.S. by the Company, were $315 million in 2005
compared with $325 million in 2004. While sales of
INTEGRILIN in the U.S. were essentially flat versus 2004,
sales outside the U.S. decreased $8 million,
reflecting the return of
29
European marketing rights to Millennium Pharmaceuticals, Inc.
(Millennium). Sales of INTEGRILIN in 2004 increased
$19 million or 6 percent versus 2003 due to increased
patient utilization.
Effective September 1, 2005, the Company restructured its
INTEGRILIN co-promotion agreement with Millennium. Under the
terms of the restructured agreement, the Company acquired
exclusive U.S. development and commercialization rights to
INTEGRILIN in exchange for an upfront payment of
$36 million and royalties on INTEGRILIN sales. The
restructured agreement calls for minimum royalty payments of
$85 million per year to Millennium for 2006 and 2007.
Global net sales of INTRON A Injection, for chronic hepatitis B
and C and other antiviral and anticancer indications, decreased
10 percent in 2005 to $287 million due to the
conversion to PEG-INTRON in Japan. Sales of INTRON A decreased
22 percent in 2004 to $318 million due primarily to
lower demand.
Net sales of AVELOX, a fluoroquinolone antibiotic for the
treatment of certain respiratory and skin infections, sold
primarily in the U.S. by Schering-Plough as a result of the
Company’s license agreement with Bayer, were
$228 million in 2005. Sales of AVELOX in 2004 represented
the initial three months of sales under the agreement with
Bayer, which was effective October 1, 2004.
International net sales of SUBUTEX Tablets, for the treatment of
opiate addiction, increased 6 percent to $197 million
in 2005 due to increased market penetration. Sales of SUBUTEX
were $185 million in 2004, an increase of 29 percent over
2003 due to increased market penetration. It is expected that
SUBUTEX will encounter generic competition in the near future.
International sales of CAELYX, for the treatment of ovarian
cancer, metastatic breast cancer and Kaposi’s sarcoma,
increased 21 percent to $181 million, reflecting
further adoption of the ovarian cancer and metastatic breast
cancer indications. Sales of CAELYX in 2004 increased
35 percent versus 2003 to $150 million, reflecting
initial adoption of the metastatic breast cancer indication.
Net sales of CIPRO, a fluoroquinolone antibiotic for the
treatment of certain respiratory, skin, urinary tract and other
infections, sold primarily in the U.S. by Schering-Plough
as a result of the Company’s license agreement with Bayer,
were $146 million in 2005. Sales of CIPRO in 2004
represented the initial three months of sales under the
agreement with Bayer.
Global net sales of ELOCON cream, a medium-potency topical
steroid, decreased 14 percent to $144 million,
reflecting generic competition introduced in the
U.S. during the first quarter of 2005. Generic competition
is expected to continue to adversely affect sales of this
product.
Other pharmaceutical net sales include a large number of lower
sales volume prescription pharmaceutical products. Several of
these products are sold in limited markets outside the U.S., and
many are multiple source products no longer protected by
patents. The products include treatments for respiratory,
cardiovascular, dermatological, infectious, oncological and
other diseases.
Global net sales of Consumer Health Care products, which include
OTC, foot care and sun care products, were $1.1 billion in
2005 and 2004. Sales of OTC CLARITIN were $394 million in
2005, a decrease of $25 million or 6 percent from
2004, reflecting the adverse impact on sales of CLARITIN-D due
to restrictions on the retail sale of OTC products containing
pseudoephedrine (PSE) that came into effect during 2005.
Sales of CLARITIN-D may continue to be adversely affected by
both recent and future restrictions on the retail sale of such
products. In addition, OTC CLARITIN continues to face
competition from private label and branded loratadine. Net sales
of sun care products increased $28 million or
16 percent in 2005, primarily due to the launch of new
COPPERTONE CONTINUOUS SPRAY products coupled with a stronger
overall suncare season in the U.S. Net sales of foot care
products increased $2 million or 1 percent in 2005,
due primarily to the new MEMORY FIT and FOR HER INSOLES and
other insole products. Net sales of Consumer Health Care
products in 2004 increased $59 million or 6 percent
compared to 2003, due primarily to the strong performance of
DR. SCHOLL’S FREEZE AWAY and other foot care products.
30
The Company sells numerous non-prescription upper respiratory
products that contain PSE, an FDA-approved ingredient for the
relief of nasal congestion. The Company’s annual North
American sales of non-prescription upper respiratory products
that contain PSE totaled approximately $277 million in
2005, $305 million in 2004 and approximately
$160 million in 2003. These products include all CLARITIN-D
products as well as some DRIXORAL, CORICIDIN and CHLOR-TRIMETON
products. The Company understands that PSE has been used in the
illicit manufacture of methamphetamine, a dangerous and
addictive drug. As of December 31, 2005, 26 states,
Canada and Mexico have enacted regulations concerning the
non-prescription sale of products containing PSE, including
limiting the amount of these products that can be purchased at
one time or requiring that these products be located behind the
pharmacist’s counter, with the stated goal of deterring the
illicit/illegal manufacture of methamphetamine. An additional
12 states have enacted limits on the quantity of PSE any
person can possess. One state has recently enacted legislation
that regulates all PSE products to prescription status. Also,
the U.S. federal government has proposed legislation
placing restrictions on the sale of products containing PSE.
Further, major U.S. retailers that are customers of the
Company have voluntarily placed non-prescription products
containing PSE behind the pharmacy counter at all of their
stores, whether or not required by local law. Sales of
non-prescription PSE products were down $28 million or
approximately 9 percent as compared to 2004. The Company
continues to monitor developments in this area that could have a
further negative impact on operations or financial results. It
should be noted that these regulations do not relate to the sale
of prescription products, such as CLARINEX-D products, that
contain PSE.
Global net sales of Animal Health products increased
11 percent in 2005 to $851 million. The increased
sales reflected strong growth of core brands across most
geographic and species areas, led by products serving the
U.S. cattle market, including NUFLOR, and the vaccine
business. The increased sales were also due in part to better
product supply in the U.S. The sales growth included a
favorable foreign exchange impact of 1 percent. The Company
expects this growth rate to moderate due to increased
competition, including generic products. Global net sales of
Animal Health products increased 10 percent in 2004, which
included a favorable foreign exchange impact of 6 percent.
Certain situations that had a positive impact on sales and net
income in 2005 may not recur in 2006. These include the
favorable effect of foreign exchange, the patient warehousing
benefit to PEG-INTRON and REBETOL related to the launch of
PEG-INTRON in Japan, and an unusually severe allergy season in
Japan that benefited the reported sales of prescription
CLARITIN. Generic Allegra (fexofenadine) was introduced in
the U.S. during 2005, which is expected to have a negative
impact on U.S. CLARINEX sales in 2006. Generic Flonase
(fluticasone propionate) was approved in 2006 and may
unfavorably impact the corticosteroid nasal spray market. The
growth of REMICADE may also be affected by increased
competition. In addition, the Company expects the growth rate
for the Animal Health business to moderate due to increased
competition, including generic products.
31
|
|
|
Costs, Expenses and Equity Income |
A summary of costs, expenses and equity income for the years
ended December 31, 2005, 2004 and 2003 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Increase (Decrease) | |
|
|
|
|
|
|
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005/2004 | |
|
2004/2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
|
|
|
|
Cost of sales
|
|
$ |
3,346 |
|
|
$ |
3,070 |
|
|
$ |
2,833 |
|
|
|
9 |
% |
|
|
8 |
% |
Selling, general and administrative (SG&A)
|
|
|
4,374 |
|
|
|
3,811 |
|
|
|
3,474 |
|
|
|
15 |
% |
|
|
10 |
% |
Research and development (R&D)
|
|
|
1,865 |
|
|
|
1,607 |
|
|
|
1,469 |
|
|
|
16 |
% |
|
|
9 |
% |
Other expense/(income), net
|
|
|
5 |
|
|
|
146 |
|
|
|
59 |
|
|
|
N/M |
|
|
|
N/M |
|
Special charges
|
|
|
294 |
|
|
|
153 |
|
|
|
599 |
|
|
|
N/M |
|
|
|
N/M |
|
Equity income from cholesterol joint venture
|
|
|
(873 |
) |
|
|
(347 |
) |
|
|
(54 |
) |
|
|
N/M |
|
|
|
N/M |
|
N/ M — Not a meaningful percentage
Substantially all the sales of cholesterol products are not
included in the Company’s net sales. The results of these
sales are reflected in equity income from cholesterol joint
venture. In addition, due to the virtual nature of the joint
venture, the Company incurs substantial selling, general and
administrative expenses that are not captured in equity income
but are included in the Company’s Statements of
Consolidated Operations. As a result, the Company’s gross
margin, and ratios of SG&A expenses and R&D expenses as
a percentage of net sales do not reflect the impact of the joint
venture’s operating results.
Gross margin increased in 2005 as compared to 2004 from
62.9 percent to 64.8 percent, primarily due to supply
chain process improvements, increased sales of higher-margin
products and a favorable impact from foreign exchange, partly
offset by higher royalties related to the Bayer products and
beginning September 1, 2005, royalties for INTEGRILIN. The
restructuring of the INTEGRILIN agreement has substantially
offsetting effects, generally increasing cost of sales due to
increased royalties offset by reduced selling, general and
administrative expenses. Gross margin in 2006 will be
unfavorably impacted by a full year of the increased royalties
from this restructured agreement. Gross margin in 2004 decreased
as compared to 2003 from 66.0 percent to 62.9 percent,
primarily due to lower production volumes coupled with increased
spending related to the FDA Consent Decree, other manufacturing
compliance spending and efforts to upgrade the Company’s
global infrastructure. The absence of European LOSEC revenues
and a change in product sales mix, including sales of Bayer
licensed products, contributed to the unfavorable comparison as
well.
|
|
|
Selling, general and administrative |
Selling, general and administrative expenses (SG&A)
increased 15 percent to $4.4 billion in 2005 versus
$3.8 billion in 2004. This increase was primarily due to
the addition in the 2004 fourth quarter of Bayer sales
representatives, increased selling expenses in Europe to support
the continued launch of VYTORIN and ZETIA, and increased
promotional spending, primarily for NASONEX, ASMANEX and the
products under the agreement with Bayer. SG&A expenses
increased 10 percent to $3.8 billion in 2004 from
$3.5 billion in 2003 primarily due to the expansion of the
sales field force, higher employee-related costs and the
unfavorable impact of foreign exchange, partially offset by
lower promotional spending.
Research and development (R&D) spending increased
16 percent to $1.9 billion, representing
19.6 percent of net sales in 2005, and included a
$124 million charge in conjunction with the Company’s
exercise of its rights to develop and commercialize golimumab.
R&D spending for 2004 included an $80 million charge in
conjunction with the license from Toyama Chemical Company Ltd.
for garenoxacin. Generally, changes in R&D spending reflect
the timing of the Company’s funding of both internal
research
32
efforts and research collaborations with various partners to
discover and develop a steady flow of innovative products.
The Company believes it has a strong Early Development pipeline
across a wide-range of therapeutic areas with 14 preclinical/
Phase I compounds in 2005. Additionally, as the later phase
growth-drivers of the pipeline enter Phase III (e.g.,
Thrombin Receptor Antagonist, vicriviroc and HCV protease
inhibitor), the Company anticipates an approximate doubling of
annual patient enrollment in clinical trials over the next
2-4 years versus 2005 levels.
The Company expects R&D spending to increase as compared to
prior years due to the progression of the Company’s
early-stage pipeline and increased clinical trial activity. To
maximize the Company’s chances for the successful
development of new products, the Company began a Development
Excellence initiative in 2005 to build talent and critical mass,
create a uniform level of excellence and deliver on
high-priority programs within R&D.
|
|
|
Other expense/(income), net |
In 2005, Other expense/(income), net, of $5 million was
lower than 2004 as it reflected higher net interest income due
to higher interest rates on cash equivalents and short-term
investments. The increase in Other expense/(income), net, in
2004 versus 2003 was primarily the result of higher net interest
expense due to debt issuances in 2003.
The components of special charges are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Litigation charges
|
|
$ |
250 |
|
|
$ |
— |
|
|
$ |
350 |
|
Employee termination costs
|
|
|
28 |
|
|
|
119 |
|
|
|
179 |
|
Asset impairment and other charges
|
|
|
16 |
|
|
|
34 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
294 |
|
|
$ |
153 |
|
|
$ |
599 |
|
|
|
|
|
|
|
|
|
|
|
In 2005, litigation reserves were increased by
$250 million. This increase resulted in a total reserve of
$500 million for the Massachusetts investigation as well as
the investigations disclosed under “AWP
Investigations” and the state litigation disclosed under
“AWP Litigation” in Note 19, “Legal,
Environmental and Regulatory Matters,” representing the
Company’s current estimate to resolve this matter.
Additional information regarding litigation reserves is also
included in Note 19, “Legal, Environmental and
Regulatory Matters,” under Item 8, Financial
Statements and Supplementary Data, in
this 10-K.
In 2003, litigation reserves were increased by
$350 million, primarily as a result of the investigations
into the Company’s sales and marketing practices.
|
|
|
Employee termination costs |
In August 2003, the Company announced a global workforce
reduction initiative. The first phase of this initiative was a
Voluntary Early Retirement Program (VERP) in the
U.S. Under this program, eligible employees in the
U.S. had until December 15, 2003 to elect early
retirement and receive an enhanced retirement benefit.
Approximately 900 employees elected to retire under the program,
all of which have retired by December 31, 2005. The total
cost of this program was approximately $191 million,
comprised of increased pension costs of $108 million,
increased post-retirement health care costs of $57 million,
vacation payments of $4 million and costs related to
accelerated vesting of stock grants of
33
$22 million. Amounts recognized in 2005, 2004 and 2003 for
this program were $7 million, $20 million and
$164 million, respectively. No additional amounts are
expected to be recognized under this program.
Termination costs not associated with the VERP totaled
$21 million, $99 million and $15 million in 2005,
2004 and 2003, respectively.
The following summarizes the activity in the accounts related to
employee termination costs:
|
|
|
|
|
|
|
Employee | |
|
|
Termination Costs | |
|
|
| |
|
|
(Dollars in millions) | |
Special charges incurred during 2003
|
|
$ |
179 |
|
Credit to retirement benefit plan liability
|
|
|
(144 |
) |
Disbursements
|
|
|
(6 |
) |
|
|
|
|
Special charges liability balance at December 31, 2003
|
|
$ |
29 |
|
|
|
|
|
Special charges incurred during 2004
|
|
$ |
119 |
|
Credit to retirement benefit plan liability
|
|
|
(20 |
) |
Disbursements
|
|
|
(110 |
) |
|
|
|
|
Special charges liability balance at December 31, 2004
|
|
$ |
18 |
|
|
|
|
|
Special charges incurred during 2005
|
|
$ |
28 |
|
Credit to retirement benefit plan liability
|
|
|
(7 |
) |
Disbursements
|
|
|
(35 |
) |
|
|
|
|
Special charges liability balance at December 31, 2005
|
|
$ |
4 |
|
|
|
|
|
|
|
|
Asset impairment and other charges |
For the year ended December 31, 2005, the Company
recognized asset impairment and other charges of
$16 million related primarily to the consolidation of the
Company’s U.S. biotechnology organizations.
The Company recorded asset impairment and other charges of
$34 million in 2004, related primarily to the shutdown of a
small European research and development facility.
Asset impairment and other charges in 2003 were $70 million
and related to the closure of a manufacturing facility in the
United Kingdom, the write-down of production equipment related
to products that were no longer going to be produced at a
manufacturing site operating under the FDA Consent Decree, and
the write-down of a drug license and a sun care trade name for
which expected cash flows did not support the carrying value.
|
|
|
Equity Income from Cholesterol Joint Venture |
Global cholesterol franchise sales, which include sales made by
the Company and the cholesterol joint venture with Merck of
VYTORIN and ZETIA, totaled $2.4 billion, $1.2 billion
and $471 million in 2005, 2004 and 2003, respectively. The
2005 sales comparison benefited from the U.S. launch of
VYTORIN in the second half of 2004. As a franchise, the two
products combined have passed the 14 percent share level of
new prescriptions in the U.S. cholesterol management market
(based on January 2006 IMS data). VYTORIN has been launched in
more than 20 countries, including the U.S. in August 2004.
ZETIA has been approved in more than 70 countries and has been
launched in more than 60 countries.
The Company utilizes the equity method of accounting for the
joint venture. Sharing of income from operations is based upon
percentages that vary by product, sales level and country. The
Company’s allocation of joint venture income is increased
by milestones earned. Merck and Schering-Plough (the Partners)
bear the costs of their own general sales forces and commercial
overhead in marketing joint venture products around the world.
In the U.S., Canada and Puerto Rico, the joint venture
reimburses each Partner for a pre-defined amount of physician
details that are set on an annual basis. The Company
34
reports this reimbursement as part of equity income from the
cholesterol joint venture. This reimbursement does not represent
a reimbursement of specific, incremental and identifiable costs
for the Company’s detailing of the cholesterol products in
these markets. In addition, this reimbursement amount is not
reflective of Schering-Plough’s sales effort related to the
joint venture as Schering-Plough’s sales force and related
costs associated with the joint venture are generally estimated
to be higher.
Costs of the joint venture that the Partners contractually share
are a portion of manufacturing costs, specifically identified
promotion costs (including
direct-to-consumer
advertising and direct and identifiable
out-of-pocket
promotion) and other agreed upon costs for specific services
such as market support, market research, market expansion, a
specialty sales force and physician education programs.
Certain specified research and development expenses are
generally shared equally by the Partners.
Equity income from cholesterol joint venture totaled
$873 million, $347 million and $54 million in
2005, 2004 and 2003, respectively. The 2005 equity income
comparison benefited from the U.S. launch of VYTORIN in the
second half of 2004.
During 2005, 2004 and 2003, the Company recognized milestones
from Merck of $20 million, $7 million and
$20 million, respectively. The $20 million milestone
in 2005 related to certain European approvals of VYTORIN
(ezetimibe/simvastatin) in 2005. The $7 million milestone
in 2004 related to the approval of ezetimibe/simvastatin in
Mexico in 2004. The $20 million milestone in 2003 related
to certain European approvals of ZETIA in 2003. These amounts
are included in equity income.
Under certain other conditions, as specified in the joint
venture agreements with Merck, the Company could earn additional
milestones totaling $105 million.
It should be noted that the Company incurs substantial selling,
general and administrative and other costs, which are not
reflected in equity income from the cholesterol joint venture
and instead are included in the overall cost structure of the
Company.
|
|
|
Provision for Income Taxes |
Tax expense was $228 million, $779 million, and
$46 million in 2005, 2004, and 2003, respectively. The
overall income tax expense in 2005, net of the benefit described
below, primarily related to foreign taxes and does not include
any benefit related to U.S. Net Operating Losses (NOLs).
The Company has established a valuation allowance on net
U.S. deferred tax assets, including the benefit of
U.S. NOLs, as management cannot conclude that it is more
likely than not that the benefit of U.S. net deferred tax
assets can be realized. As of December 31, 2005, the
Company had U.S. NOL carryforwards totaling approximately
$1.5 billion.
The Company’s tax provision for the year ended
December 31, 2005 includes a U.S. federal income tax
benefit of approximately $42 million as a result of an IRS
Notice issued in August 2005. The provisions of this Notice
resulted in a reduction of the previously accrued tax liability
attributable to the AJCA repatriation, and also reduced the 2005
U.S. NOLs carried forward to subsequent years.
The 2005 income tax provision includes a charge of approximately
$260 million related to foreign taxes, $14 million for
state taxes and a benefit of $46 million for
U.S. federal taxes primarily related to the 2005 IRS Notice
mentioned above.
In January 2006, the Internal Revenue Service (IRS) completed
its examination of the Company’s 1993 - 1996 federal
income tax returns. The Company had made a cash payment in the
third quarter of 2005 in the form of a tax deposit of
approximately $239 million in anticipation of the
settlement of the 1993 - 1996 tax examination and to
prevent additional IRS interest charges. This payment fully
satisfied the liability associated with the tax examination and
was consistent with the previously recorded reserves. The IRS is
currently examining the Company’s 1997 - 2002 federal
income tax returns.
35
|
|
|
Net Income/(Loss) Available to Common Shareholders |
Net income available to common shareholders for 2005 includes
the deduction of preferred stock dividends of $86 million
related to the issuance of the 6 percent Mandatory
Convertible Preferred Stock in August 2004. The 2004 net
loss available to common shareholders includes the deduction of
preferred stock dividends of $34 million.
LIQUIDITY AND FINANCIAL RESOURCES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Cash flow from operating activities
|
|
$ |
882 |
|
|
$ |
(154 |
) |
|
$ |
601 |
|
Cash flow from investing activities
|
|
|
(454 |
) |
|
|
(621 |
) |
|
|
(790 |
) |
Cash flow from financing activities
|
|
|
(633 |
) |
|
|
1,534 |
|
|
|
882 |
|
In 2005, cash flow from operating activities on a worldwide
basis approximated cash payments for capital expenditures and
dividends. International operations generate cash in excess of
local cash needs. However, U.S. operations have cash needs
well in excess of cash generated in the U.S. The
U.S. operations must fund dividend payments, the majority
of research and development costs and U.S. capital
expenditures. In years prior to 2003, overall U.S. cash
needs were funded primarily through operations.
Cash requirements during 2005 in the U.S. including
operating cash needs, capital expenditures, tax payments and
dividends on common and preferred shares approximated
$1.1 billion.
In 2005, consolidated operating activities generated
$882 million of cash, compared with a use of
$154 million in 2004. The increase was primarily due to
higher net income and timing of payments of special charges
related to litigation, partially offset by an increase in
accounts receivable due to sales growth, payments to tax
authorities for tax liabilities related to the repatriation of
foreign earnings under the AJCA of approximately
$375 million and tax deposits of $239 million for the
anticipated settlement of certain tax contingencies for the tax
years 1993 through 1996. Tax charges related to the AJCA were
expensed in 2004.
In 2004, operating cash flow was favorably impacted by a
U.S. tax refund of $404 million as a result of loss
carry back. However, cash flow was unfavorably impacted by a
$473 million payment to the U.S. government for a tax
deficiency related to certain transactions in tax years 1991 to
1992 and the payment of $294 million under the settlement
agreement with the U.S. Attorney’s office for the
Eastern District of Pennsylvania.
In 2003, operating activities provided approximately
$601 million of cash. This amount includes the cash flow
benefit from the reduction in accounts receivable following the
end of sales of CLARITIN as a prescription product in the
U.S. This amount also includes a $250 million payment
under the terms of the FDA Consent Decree.
Net cash used for investing activities during 2005 was
$454 million, primarily related to $478 million of
capital expenditures and the purchase of intangible assets of
$51 million, partially offset by proceeds from sales of
property and equipment of $43 million and the net reduction
in short-term investments of $33 million. Net cash used for
investing activities in 2004 was $621 million and included
capital expenditures of $489 million and net purchases of
investments of $264 million, partially offset by cash
proceeds of $118 million from the transfer of license
rights and $7 million from the dispositions of property and
equipment.
Net cash used for financing activities during 2005 was
$633 million, compared to net cash provided by financing
activities of $1.5 billion in 2004. Uses of cash for
financing activities in 2005 include the
36
payment of dividends on common and preferred shares of
$410 million and the repayment of $1.2 billion of
commercial paper borrowings, partially offset by proceeds of
$900 million from bank debt incurred by a foreign
subsidiary related to funding of a portion of the repatriations
under the AJCA during 2005. The net cash provided by financing
activities in 2004 reflected proceeds of $1.4 billion from
the preferred stock issuance and $546 million from the
increase in short-term borrowings, partially offset by the
payment of dividends on common and preferred shares of
$354 million.
As the Company’s financial situation has begun to improve,
the Company is moving forward with additional investments to
enhance its infrastructure and business. This includes expected
capital expenditures of up to $300 million over the next
several years for a pharmaceutical sciences center. This center
will allow the Company to streamline and integrate the
Company’s drug development process, where products are
moved from the drug discovery pipeline to market. There will be
additional related expenditures to upgrade equipment and
staffing for this center.
In 2006, the U.S. operations will continue to generate
negative cash flow. Payments regarding litigation and
investigations could increase cash needs. Operating cash flows,
existing cash and investments, including repatriations made
during 2005 under the AJCA, are expected to provide the Company
with the ability to fund cash needs, including U.S. cash
needs, for the near and intermediate term. Total cash, cash
equivalents and short-term investments less total debt was
approximately $1.9 billion at December 31, 2005.
In August 2004 the Company issued 6 percent mandatory
convertible preferred stock (see Note 14,
“Shareholders Equity,” under Item 8, Financial
Statements and Supplementary Data) and received net proceeds of
$1.4 billion after deducting commissions, discounts and
other underwriting expenses. The proceeds were used to reduce
short-term commercial paper borrowings, pay tax and litigation
settlement amounts and litigation costs, and to fund operating
expenses, shareholder dividends and capital expenditures. The
preferred stock was issued under the Company’s
$2.0 billion shelf registration. As of December 31,
2005, $563 million remains registered and unissued under
the shelf registration.
|
|
|
Borrowings and Credit Facilities |
On November 26, 2003, the Company issued $1.25 billion
aggregate principal amount of 5.3 percent senior unsecured
notes due 2013 and $1.15 billion aggregate principal amount
of 6.5 percent senior unsecured notes due 2033. Proceeds
from this offering of $2.4 billion were used for general
corporate purposes, including repaying commercial paper
outstanding in the U.S. Upon issuance, the notes were rated
A3 by Moody’s Investors Service (Moody’s) and A+ (on
Credit Watch with negative implications) by Standard &
Poor’s (S&P). The interest rates payable on the notes
are subject to adjustment. If the rating assigned to the notes
by either Moody’s or S&P is downgraded below A3 or A-,
respectively, the interest rate payable on that series of notes
would increase. See Note 12, “Short-Term Borrowings,
Long-Term Debt and Other Commitments,” under Item 8,
Financial Statements and Supplementary Data, in
this 10-K, for
additional information.
On July 14, 2004, Moody’s lowered its rating on the
notes to Baa1. Accordingly, the interest payable on each note
increased 25 basis points effective December 1, 2004.
Therefore, on December 1, 2004, the interest rate payable
on the notes due 2013 increased from 5.3 percent to
5.55 percent, and the interest rate payable on the notes
due 2033 increased from 6.5 percent to 6.75 percent.
This adjustment to the interest rate payable on the notes
increased the Company’s interest expense by approximately
$6 million annually.
The Company has a revolving credit facility from a syndicate of
major financial institutions. During March 2005, the Company
negotiated an increase in the bank commitments from
$1.25 billion to $1.5 billion with no changes in the
basic terms of the pre-existing credit facility. Concurrently
with the increase in commitments under this facility, the
Company terminated early a separate $250 million line of
credit which would have matured in May 2006. There was no
outstanding balance under this facility at the time it was
terminated.
37
The existing $1.5 billion credit facility matures in May
2009 and requires the Company to maintain a total debt to total
capital ratio of no more than 60 percent. This credit line
is available for general corporate purposes and is considered as
support to the Company’s commercial paper borrowings.
Borrowings under this credit facility may be drawn by the
U.S. parent company or by its wholly-owned international
subsidiaries when accompanied by a parent guarantee. This
facility does not require compensating balances, however, a
nominal commitment fee is paid. As of December 31, 2005,
$325 million has been drawn under this facility by a
wholly-owned international subsidiary for the purposes of
funding AJCA related repatriations.
In addition to the aforementioned credit facility, the Company
entered into a $575 million credit facility during the
fourth quarter of 2005, all of which was drawn as of
December 31, 2005. This credit facility was utilized by a
wholly-owned international subsidiary to fund repatriations
under the AJCA. This credit facility requires the Company to
maintain a total debt to total capital ratio of no more than
60 percent. These borrowings are payable no later than
November 4, 2008. Any funds borrowed under this facility
which are subsequently repaid may not be re-borrowed.
All credit facility borrowings have been classified as
short-term borrowings as the Company intends to repay these
amounts in the next twelve months.
As of December 31, 2005 and 2004, short-term borrowings,
including the credit facilities mentioned above, totaled
$1.3 billion and $1.6 billion, respectively.
Commercial paper outstanding at December 31, 2005 and 2004
was $298 million and $1.46 billion, respectively. The
weighted-average interest rate for short-term borrowings at
December 31, 2005 and 2004 was 4.7 percent and
2.6 percent respectively.
The Company’s current unsecured senior credit ratings and
outlook are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior Unsecured Credit Ratings |
|
Long-term | |
|
Short-term | |
|
Outlook | |
|
|
| |
|
| |
|
| |
Moody’s Investors Service
|
|
|
Baa1 |
|
|
|
P-2 |
|
|
|
Negative |
|
Standard and Poor’s
|
|
|
A- |
|
|
|
A-2 |
|
|
|
Negative |
|
Fitch Ratings
|
|
|
A- |
|
|
|
F-2 |
|
|
|
Negative |
|
The commercial paper ratings discussed above have not
significantly affected the Company’s ability to issue or
rollover its outstanding commercial paper borrowings at this
time. However, the Company believes the ability of commercial
paper issuers, such as the Company, with one or more short-term
credit ratings of P-2 from Moody’s, A-2 from S&P and/or
F2 from Fitch to issue or rollover outstanding commercial paper
can, at times, be less than that of companies with higher
short-term credit ratings. In addition, the total amount of
commercial paper capacity available to these issuers is
typically less than that of higher-rated companies. The Company
maintains sizable lines of credit with commercial banks, as well
as cash and short-term investments held by U.S. and
international subsidiaries, to serve as alternative sources of
liquidity and to support its commercial paper program.
The Company’s credit ratings could decline below their
current levels. The impact of such decline could reduce the
availability of commercial paper borrowing and would increase
the interest rate on the Company’s short and long-term
debt. As discussed above, the Company believes that existing
cash balances and cash generated from operations will allow the
Company to fund its U.S. cash needs for the near and
intermediate term.
38
Payments due by period under the Company’s known
contractual obligations at December 31, 2005, are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
|
|
Less | |
|
|
|
More | |
|
|
|
|
than | |
|
|
|
than | |
|
|
Total | |
|
1 Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Short-term borrowings and current portion of long-term debt
|
|
$ |
1,278 |
|
|
$ |
1,278 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Long-term debt obligations(1)
|
|
|
2,399 |
|
|
|
— |
|
|
|
2 |
|
|
|
1 |
|
|
|
2,396 |
|
Operating lease obligations
|
|
|
249 |
|
|
|
76 |
|
|
|
108 |
|
|
|
33 |
|
|
|
32 |
|
Purchase obligations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advertising contracts
|
|
|
107 |
|
|
|
107 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Research contracts(2)
|
|
|
161 |
|
|
|
140 |
|
|
|
12 |
|
|
|
7 |
|
|
|
2 |
|
|
Capital expenditure commitments
|
|
|
179 |
|
|
|
175 |
|
|
|
4 |
|
|
|
— |
|
|
|
— |
|
|
Other purchase obligations(3)
|
|
|
829 |
|
|
|
778 |
|
|
|
25 |
|
|
|
9 |
|
|
|
17 |
|
Other obligations(4)
|
|
|
912 |
|
|
|
269 |
|
|
|
170 |
|
|
|
25 |
|
|
|
448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
6,114 |
|
|
$ |
2,823 |
|
|
$ |
321 |
|
|
$ |
75 |
|
|
$ |
2,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Long-term debt obligations include the $1,250 million
aggregate principal amount of 5.55 percent senior,
unsecured notes due 2013 and $1,150 million aggregate
principal amount of 6.75 percent senior, unsecured notes
due 2033 and excludes interest obligations. See Note 12,
“Short-Term Borrowings, Long-Term Debt and Other
Commitments,” under Item 8, Financial Statements and
Supplementary Data, in
this 10-K, for
additional information. |
|
(2) |
Research contracts do not include any potential milestone
payments to be made since such payments are contingent on the
occurrence of certain events. The table also excludes those
research contracts that are cancelable by the Company without
penalty. |
|
(3) |
Other purchase obligations consist of both cancelable and
non-cancelable inventory and expense items. |
|
(4) |
This caption includes obligations, based on undiscounted
amounts, for estimated payments under certain of the
Company’s pension and deferred compensation plans,
preferred stock dividends and other contractual obligations. |
REGULATORY AND COMPETITIVE ENVIRONMENT IN WHICH THE COMPANY
OPERATES
The Company is subject to the jurisdiction of various national,
state and local regulatory agencies. These regulations are
described in more detail in Part I, Item I, Business,
of this 10-K.
Regulatory compliance is complex, as regulatory standards
(including Good Clinical Practices, Good Laboratory Practices
and Good Manufacturing Practices) vary by jurisdiction and are
constantly evolving.
Regulatory compliance is costly. Regulatory compliance also
impacts the timing needed to bring new drugs to market and to
market drugs for new indications. Further, failure to comply
with regulations can result in delays in the approval of drugs,
seizure or recall of drugs, suspension or revocation of the
authority necessary for the production and sale of drugs, fines
and other civil or criminal sanctions.
Regulatory compliance, and the cost of compliance failures, can
have a material impact on the Company’s results of
operations, its cash flows or financial condition.
Since 2002, the Company has been working under a U.S. FDA
Consent Decree to resolve issues involving the Company’s
compliance with current Good Manufacturing Practices (cGMP) at
certain of its
39
manufacturing sites in New Jersey and Puerto Rico. See details
in Note 18, “Consent Decree” under Item 8,
Financial Statements and Supplementary Data, in
this 10-K.
Under the terms of the Consent Decree, the Company made payments
totaling $500 million. As of the end of 2005, the Company
has completed the revalidation programs for bulk active
pharmaceutical ingredients and finished drug products, as well
as all 212 Significant Steps of the cGMP Work Plan, in
accordance with the schedules required by the Consent Decree.
The Company’s completion of the cGMP Work Plan is currently
pending certification by a third party expert, whose
certification is in turn subject to acceptance by the FDA. Under
the terms of the Decree, provided that the FDA has not notified
the Company of a significant violation of FDA law, regulations,
or the Decree in the five year period since the Decree’s
entry, May 2002 through May 2007, the Company may petition the
court to have the Decree dissolved and FDA will not oppose the
Company’s petition.
The Company is subject to pharmacovigilance reporting
requirements in many countries and other jurisdictions,
including the U.S., the European Union (EU) and the EU member
states. The requirements differ from jurisdiction to
jurisdiction, but all include requirements for reporting adverse
events that occur while a patient is using a particular drug, in
order to alert the manufacturer of the drug and the governmental
agency to potential problems.
During 2003, pharmacovigilance inspections by officials of the
British and French medicines agencies conducted at the request
of the European Agency for the Evaluation of Medicinal Products
(EMEA) cited serious deficiencies in reporting processes. The
Company has continued to work on its long-term action plan to
rectify the deficiencies and has provided regular updates to the
EMEA.
During the fourth quarter 2005, local UK and EMEA regulatory
authorities conducted a follow up inspection to assess the
Company’s implementation of its action plan. The inspectors
acknowledged that progress had been made since 2003, but also
continued to note significant concerns with the quality systems
supporting the Company’s pharmacovigilance processes.
Similarly, in a follow up inspection of the Company’s
clinical trial practices in the UK, inspectors identified issues
with respect to the Company’s management of clinical trials
and related pharmacovigilance practices.
The Company intends to continue upgrading skills, processes and
systems in clinical practices and pharmacovigilance. The Company
remains committed to accomplish this work and to invest
significant resources in this area. Further, in February 2006,
the Company announced a 2006 initiative for building clinical
excellence (in trial design, execution and tracking), which will
strengthen the Company’s scientific and compliance rigor on
a global basis.
The Company does not know what action, if any, the EMEA or
national authorities will take in response to the inspections.
Possible actions include further inspections, demands for
improvements in reporting systems, criminal sanctions against
the Company and/or responsible individuals and changes in the
conditions of marketing authorizations for the Company’s
products.
Recently, clinical trials and post-marketing surveillance of
certain marketed drugs of competitors’ within the industry
have raised safety concerns that have led to recalls,
withdrawals or adverse labeling of marketed products. In
addition, these situations have raised concerns among some
prescribers and patients relating to the safety and efficacy of
pharmaceutical products in general. Company personnel have
regular, open dialogue with the FDA and other regulators and
review product labels and other materials on a regular basis and
as new information becomes known.
Following this wake of recent product withdrawals of other
companies and other significant safety issues, health
authorities such as the FDA, the EMEA and the PMDA have
increased their focus on safety, when assessing the benefit/risk
balance of drugs. Some health authorities appear to have become
more cautious when making decisions about approvability of new
products or indications and are re-reviewing select products
which are already marketed, adding further to the uncertainties
in the regulatory processes. There is also greater regulatory
scrutiny, especially in the United States, on advertising and
promotion and in particular
direct-to-consumer
advertising.
40
Similarly, major health authorities, including the FDA, EMEA and
PMDA, have also increased collaboration amongst themselves,
especially with regard to the evaluation of safety and
benefit/risk information. Media attention has also increased. In
the current environment, a health authority regulatory action in
one market, such as a safety labeling change, may have
regulatory, prescribing and marketing implications in other
markets to an extent not previously seen.
Some health authorities, such as the PMDA in Japan, have
publicly acknowledged a significant backlog in workload due to
resource constraints within their agency. This backlog has
caused long regulatory review times for new indications and
products, including the initial approval of ZETIA in Japan, and
has added to the uncertainty in predicting approval timelines in
these markets. While the PMDA has committed to correcting the
backlog, it is expected to continue for the foreseeable future.
In 2005, the FDA issued a Final Rule removing the essential use
designation for albuterol CFC products. The removal of this
designation requires that all CFC albuterol products, including
the Company’s PROVENTIL CFC, be removed from the market no
later than December 31, 2008. This will necessitate a
transition in the marketplace from albuterol CFC
(PROVENTIL) to albuterol HFA (PROVENTIL HFA) no later than
the end of 2008. It is difficult to predict what impact this
transition will have on the albuterol marketplace and the
Company’s products.
These and other uncertainties inherent in government regulatory
approval processes, including, among other things, delays in
approval of new products, formulations or indications, may also
affect the Company’s operations. The effect of regulatory
approval processes on operations cannot be predicted.
The Company has nevertheless achieved a significant number of
important regulatory approvals since 2004, including approvals
for VYTORIN, CLARINEX D-24, CLARINEX REDITABS, CLARINEX D-12 and
new indications for TEMODAR and NASONEX. Other significant
approvals since 2004 include ASMANEX DPI (Dry Powder for
Inhalation) in the United States, NOXAFIL in the EU, PEG-INTRON
in Japan and new indications for REMICADE. The Company also has
a number of significant regulatory submissions filed in major
markets awaiting approval.
As described more specifically in Note 19, “Legal,
Environmental and Regulatory Matters” under Item 8,
Financial Statements and Supplementary Data, in
this 10-K, the
pricing, sales and marketing programs and arrangements, and
related business practices of the Company and other participants
in the health care industry are under increasing scrutiny from
federal and state regulatory, investigative, prosecutorial and
administrative entities. These entities include the Department
of Justice and its U.S. Attorney’s Offices, the Office
of Inspector General of the Department of Health and Human
Services, the FDA, the Federal Trade Commission (FTC) and
various state Attorneys General offices. Many of the health care
laws under which certain of these governmental entities operate,
including the federal and state anti-kickback statutes and
statutory and common law false claims laws, have been construed
broadly by the courts and permit the government entities to
exercise significant discretion. In the event that any of those
governmental entities believes that wrongdoing has occurred, one
or more of them could institute civil or criminal proceedings,
which, if instituted and resolved unfavorably, could subject the
Company to substantial fines, penalties and injunctive or
administrative remedies, including exclusion from government
reimbursement programs. The Company also cannot predict whether
any investigations will affect its marketing practices or sales.
Any such result could have a material adverse impact on the
Company’s results of operations, cash flows, financial
condition, or its business.
In the U.S., many of the Company’s pharmaceutical products
are subject to increasingly competitive pricing as managed care
groups, institutions, government agencies and other groups seek
price discounts. In the U.S. market, the Company and other
pharmaceutical manufacturers are required to provide statutorily
defined rebates to various government agencies in order to
participate in Medicaid, the veterans’ health care program
and other government-funded programs.
In most international markets, the Company operates in an
environment of government mandated cost-containment programs.
Several governments have placed restrictions on physician
prescription levels and patient reimbursements, emphasized
greater use of generic drugs and enacted
across-the-board price
41
cuts as methods to control costs. For example, Japan generally
enacts biennial price reductions and this is expected to occur
again in 2006. Pricing actions will occur in 2006 in certain
major European markets.
Since the Company is unable to predict the final form and timing
of any future domestic or international governmental or other
health care initiatives, including the passage of laws
permitting the importation of pharmaceuticals into the U.S.,
their effect on operations and cash flows cannot be reasonably
estimated. Similarly, the effect on operations and cash flows of
decisions of government entities, managed care groups and other
groups concerning formularies and pharmaceutical reimbursement
policies cannot be reasonably estimated.
The Company cannot predict what net effect the Medicare
prescription drug benefit will have on markets and sales. The
new Medicare Drug Benefit (Medicare Part D), which took
effect January 1, 2006, offers voluntary prescription drug
coverage, subsidized by Medicare, to over 40 million
Medicare beneficiaries through competing private prescription
drug plans (PDPs) and Medicare Advantage (MA) plans. Many
of the Company’s leading drugs are already covered under
Medicare Part B (e.g., TEMODAR, INTEGRILIN and INTRON A).
Medicare Part B provides payment for physician services
which can include prescription drugs administered along with
other physician services. The manner in which drugs are
reimbursed under Medicare Part B may limit the
Company’s ability to offer larger price concessions or make
large price increases on these drugs. Other Schering-Plough
drugs have a relatively small portion of their sales to the
Medicare population (e.g., CLARINEX, the hepatitis C
franchise). The Company could experience expanded utilization of
VYTORIN and ZETIA and new drugs in the Company’s R&D
pipeline. Of greater consequence for the Company may be the
legislation’s impact on pricing, rebates and discounts.
The market for pharmaceutical products is competitive. The
Company’s operations may be affected by technological
advances of competitors, industry consolidation, patents granted
to competitors, competitive combination products, new products
of competitors, new information from clinical trials of marketed
products or post-marketing surveillance and generic competition
as the Company’s products mature. In addition, patent
positions are increasingly being challenged by competitors, and
the outcome can be highly uncertain. An adverse result in a
patent dispute can preclude commercialization of products or
negatively affect sales of existing products. The effect on
operations of competitive factors and patent disputes cannot be
predicted.
2006 OUTLOOK
As it relates to financial performance, the Company anticipates
that sales and profits of its pivotal cholesterol franchise will
continue to grow in 2006.
The Company’s gross margin improved in 2005 as a result of,
among other things, operating efficiencies in its plants and
reduced spending related to the Consent Decree. The improvement
in gross margin is expected to moderate in 2006 and improvements
may be offset by royalty payments to partners.
The Company anticipates that R&D expenses may grow at a
faster rate than net sales in 2006, but will depend on the
timing of studies and the success of Phase II trials now
underway for the Thrombin Receptor Antagonist, the Hepatitis
Protease Inhibitor and the HIV drug vicriviroc.
As the Company moves forward in the Action Agenda, additional
investments are anticipated to enhance the infrastructure in
areas such as clinical development, pharmacovigilance and
information technology.
The risks described in Item 1A. “Risk Factors”
could cause actual results to differ from the expectations
provided in this section.
IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
In November 2004, the FASB issued Statement of Financial
Accounting Standard (SFAS) 151, “Inventory
Costs.” This SFAS requires that abnormal spoilage be
expensed in the period incurred (as
42
opposed to inventoried and amortized to income over inventory
usage) and that fixed production facility overhead costs be
allocated over the normal production level of a facility. The
Company implemented SFAS 151 in the fourth quarter of 2005.
The implementation of this SFAS did not have a material impact
on the Company’s financial statements.
In March 2005, the FASB issued Interpretation No. 47
(FIN 47) for SFAS 143, “Accounting for
Conditional Asset Retirement Obligations,” to clarify the
term “conditional asset retirement obligations,” as
used in SFAS 143. This term refers to a legal obligation to
perform an asset retirement activity in which the timing and/or
method of settlement are conditional on a future event that may
or may not be within the control of the entity. Accordingly, a
company is required to recognize liability for the fair value of
a conditional asset retirement obligation if the fair value of
the liability can be reasonably estimated. This interpretation
is effective no later than the end of fiscal year ending after
December 15, 2005. Retroactive application is not required.
The Company implemented FIN 47 in the fourth quarter of
2005. The implementation of FIN 47 did not have a material
impact on the Company’s financial statements.
In December 2004, the FASB issued SFAS 123 (Revised 2004),
“Share-Based Payment” (SFAS 123R). SFAS 123R
is effective for the Company on January 1, 2006.
SFAS 123R requires companies to recognize compensation
costs related to all share-based transactions as well as
compensation based on the market performance of Company shares
on a fair value basis. The Company will adopt SFAS 123R in
the first quarter of 2006 using the modified prospective method.
The modified prospective method requires the Company to
recognize compensation costs on all share-based grants made on
or after January 1, 2006 as well as the unrecognized cost
of unvested awards at the date of adoption. Upon adoption of
SFAS 123R, the Company will recognize share-based
compensation costs over the service period, which is the earlier
of the employees’ retirement eligibility date or the stated
vesting period of the award. For grants issued to retirement
eligible employees prior to the adoption of SFAS 123R, the
Company will recognize compensation costs over the stated
vesting period with acceleration of any unrecognized
compensation costs upon the retirement of the employee.
SFAS 123R also amends SFAS No. 95,
“Statement of Cash Flows,” to require that excess tax
benefits that had been reflected as operating cash flows be
reflected as financing cash flows.
Note 1, “Summary of Significant Accounting
Policies”, under Item 8, Financial Statements and
Supplementary Data, in
this 10-K presents
pro forma disclosures reflecting the effect on net income/(loss)
as if stock based compensation had been applied under the
SFAS 123, “Accounting for Stock-Based
Compensation,” fair value method. As a result of the
adoption of SFAS 123R, the Company’s 2006 compensation
expense for stock options and deferred stock units is expected
to be consistent with 2005 pro forma amounts but could be lower
based on the timing and number of individual grants, the
Company’s stock price and other assumptions necessary to
estimate fair value.
In addition, the Company has two compensation plans that will be
accounted for under SFAS 123R as liability-based plans. The
ultimate cash payout of these liability-based plans will be
based on the Company’s stock price performance as compared
to the stock price performance of its peer group. This change in
accounting required by SFAS 123R will result in a
cumulative effect of $26 million in income at
January 1, 2006, in order to recognize the difference
between the Company’s previously accrued liability as
reported under Accounting Principles Board (APB) Opinion
Number 25 and the fair value of the liability for these
plans. Future operating results will be impacted by the
fluctuation in the fair value of the liability under these
plans, which is required to be remeasured at each reporting date.
CRITICAL ACCOUNTING POLICIES
The following accounting policies are considered significant
because changes to certain judgments and assumptions inherent in
these policies could affect the Company’s financial
statements:
|
|
|
|
• |
Revenue Recognition |
|
|
• |
Rebates, Discounts and Returns |
|
|
• |
Provision for Income Taxes |
43
|
|
|
|
• |
Impairment of Intangible Assets and Property |
|
|
• |
Accounting for Pensions and Post-retirement Benefit Plans |
|
|
• |
Accounting for Legal and Regulatory Matters |
The Company’s pharmaceutical products are sold to direct
purchasers (e.g., wholesalers, retailers and certain health
maintenance organizations). Price discounts and rebates on such
sales are paid to federal and state agencies as well as to
indirect purchasers and other market participants (e.g., managed
care organizations that indemnify beneficiaries of health plans
for their pharmaceutical costs and pharmacy benefit managers).
The Company recognizes revenue when title and risk of loss pass
to the purchaser and when reliable estimates of the following
can be determined:
|
|
|
i. commercial discount and rebate arrangements; |
|
|
ii. rebate obligations under certain federal and state
governmental programs and; |
|
|
iii. sales returns in the normal course of business. |
When recognizing revenue, the Company estimates and records the
applicable commercial and governmental discounts and rebates as
well as sales returns that have been or are expected to be
granted or made for products sold during the period. These
amounts are deducted from sales for that period. Estimates
recorded in prior periods are re-evaluated as part of this
process. If reliable estimates of these items cannot be made,
the Company defers the recognition of revenue.
Revenue recognition for new products is based on specific facts
and circumstances including estimated acceptance rates from
established products with similar marketing characteristics.
Absent the ability to make reliable estimates of rebates,
discounts and returns, the Company would defer revenue
recognition.
Product discounts granted are based on the terms of arrangements
with wholesalers, managed-care organizations and government
purchasers as well as market conditions, including prices
charged by competitors. Rebates are estimated based on sales
terms, historical experience, trend analysis and projected
market conditions in the various markets served. The Company
evaluates market conditions for products or groups of products
primarily through the analysis of third party demand and market
research data as well as internally generated information. Data
and information provided by purchasers and obtained from third
parties are subject to inherent limitations as to their accuracy
and validity.
Sales returns are generally estimated and recorded based on
historical sales and returns information, analysis of recent
wholesale purchase information, consideration of stocking levels
at wholesalers and forecasted demand amounts. Products that
exhibit unusual sales or return patterns due to dating,
competition or other marketing matters are specifically
investigated and analyzed as part of the formulation of return
reserves.
During 2004, the Company entered into agreements with the major
U.S. pharmaceutical wholesalers. These agreements deal with
a number of commercial issues, such as product returns, timing
of payment, processing of chargebacks and the quantity of
inventory held by these wholesalers. With respect to the
quantity of inventory held by these wholesalers, these
agreements provide a financial disincentive for these
wholesalers to acquire quantities of product in excess of what
is necessary to meet current patient demand. Through the use of
this monitoring and the above noted agreements, the Company
expects to avoid situations where the Company’s shipments
of product are not reflective of current demand.
|
|
|
Rebates, Discounts and Returns |
Rebate accruals for federal and state governmental programs were
$144 million at December 31, 2005 and
$155 million at December 31, 2004. Commercial
discounts and other rebate accruals were
44
$378 million at December 31, 2005, and
$382 million at December 31, 2004. These and other
rebate accruals are established in the period the related
revenue was recognized resulting in a reduction to sales and the
establishment of liabilities, which are included in total
current liabilities.
In the case of the governmental rebate programs, the
Company’s payments involve interpretations of relevant
statutes and regulations. These interpretations are subject to
challenges and changes in interpretive guidance by governmental
authorities. The result of such a challenge or change could
affect whether the estimated governmental rebate amounts are
ultimately sufficient to satisfy the Company’s obligations.
Additional information on governmental inquiries focused in part
on the calculation of rebates is contained in Note 19,
“Legal, Environmental and Regulatory Matters,” under
Item 8, Financial Statements and Supplementary Data, in
this 10-K. In
addition, it is possible that, as a result of governmental
challenges or changes in interpretive guidance, actual rebates
could materially exceed amounts accrued.
The following summarizes the activity in the accounts related to
accrued rebates, sales returns and discounts:
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
Year Ended | |
|
|
December 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
Accrued Rebates/ Returns/ Discounts, Beginning of Period
|
|
$ |
537 |
|
|
$ |
594 |
|
Provision for Rebates
|
|
|
479 |
|
|
|
486 |
|
Payments
|
|
|
(495 |
) |
|
|
(524 |
) |
|
|
|
|
|
|
|
|
|
|
(16 |
) |
|
|
(38 |
) |
|
|
|
|
|
|
|
Provision for Returns
|
|
|
116 |
|
|
|
277 |
|
Returns
|
|
|
(167 |
) |
|
|
(321 |
) |
|
|
|
|
|
|
|
|
|
|
(51 |
) |
|
|
(44 |
) |
|
|
|
|
|
|
|
Provision for Discounts
|
|
|
459 |
|
|
|
294 |
|
Discounts granted
|
|
|
(407 |
) |
|
|
(269 |
) |
|
|
|
|
|
|
|
|
|
|
52 |
|
|
|
25 |
|
|
|
|
|
|
|
|
Accrued Rebates/ Returns/ Discounts, End of Period
|
|
$ |
522 |
|
|
$ |
537 |
|
|
|
|
|
|
|
|
Management makes estimates and uses assumptions in recording the
above accruals. Actual amounts paid in the current period were
consistent with those previously estimated. Certain prior year
amounts have been conformed to reflect the current year
presentation.
|
|
|
Provision for Income Taxes |
As of December 31, 2005, taxes have not been provided on
approximately $3.1 billion of undistributed earnings of
international subsidiaries as the Company considers these
earnings permanently reinvested in its international
subsidiaries.
The Company’s potential tax exposures result from the
varying application of statutes, regulations and interpretations
and include exposures on intercompany terms of cross border
arrangements and utilization of cash held by foreign
subsidiaries (investment in U.S. property). Although the
Company’s cross border arrangements between affiliates are
based upon internationally accepted standards, tax authorities
in various jurisdictions may disagree with and subsequently
challenge the amount of profits taxed in their country. It is
reasonably possible that the ultimate resolution of any tax
matters could materially affect shareholders’ equity,
liquidity and/or cash flows.
The Company believes that its accrual for tax contingencies is
adequate for all open years, based on past experience,
interpretations of tax law, and judgments about potential
actions by taxing authorities. The Company accrues liabilities
for identified tax contingencies that result from tax positions
taken that could be challenged by tax authorities. While the
Company believes that its tax reserves reflect the probable
45
outcome of identified tax contingencies, it is reasonably
possible that the ultimate resolution of any tax matters may be
materially greater or less than the amount accrued.
The Company records a valuation allowance to reduce its deferred
tax assets to the amount that is more likely than not to be
realized. The Company has considered ongoing prudent and
feasible tax planning strategies in assessing the need for a
valuation allowance. In the event the Company were to determine
that it would be able to realize all or an additional portion of
its net deferred tax assets, an adjustment to the valuation
allowance would increase income in the period such determination
is made. Likewise, should the Company subsequently determine
that it would not be able to realize all or an additional
portion of its remaining net deferred tax asset in the future,
an adjustment to the deferred tax asset would be charged to
income in the period such determination was made.
|
|
|
Impairment of Intangible Assets and Property |
Intangible assets representing the capitalized costs of
purchased goodwill, patents, licenses and other forms of
intellectual property totaled $569 million at
December 31, 2005. Annual amortization expense in each of
the next five years is estimated to be approximately
$50 million per year based on the intangible assets
recorded as of December 31, 2005. The value of these assets
is subject to continuing scientific, medical and marketplace
uncertainty. For example, if a marketed pharmaceutical product
were to be withdrawn from the market for safety reasons or if
marketing of a product could only occur with pronounced
warnings, amounts capitalized for such a product may need to be
reduced due to impairment. Events giving rise to impairment are
an inherent risk in the pharmaceutical industry and cannot be
predicted. Management regularly reviews intangible assets for
possible impairment.
Many of the Company’s manufacturing sites operate below
capacity. Overall costs of operating manufacturing sites have
significantly increased due to the Consent Decree and other
compliance activities. The Company’s manufacturing cost
base is relatively fixed. Actions on the part of management to
significantly reduce the Company’s manufacturing
infrastructure involve complex issues. In most cases, shifting
products between manufacturing plants can take many years due to
construction, revalidation and registration requirements.
Management continues to review the carrying value of certain
manufacturing assets for indications of impairment. Future
events and decisions may lead to asset impairments and/or
related costs.
|
|
|
Accounting for Pension and Post-retirement Benefit
Plans |
Pension and other post-retirement benefit plan information for
financial reporting purposes is calculated using actuarial
assumptions. The Company assesses its pension and other
post-retirement benefit plan assumptions on a regular basis. In
evaluating these assumptions, the Company considers many factors
including evaluation of the discount rate, expected rate of
return on plan assets, healthcare cost trend rate, retirement
age assumption, the Company’s historical assumptions
compared with actual results and analysis of current market
conditions and asset allocations (see Note 6,
“Retirement Plans and Other Post-retirement Benefits,”
under Item 8, Financial Statements and Supplementary Data,
in this 10-K, for
additional information).
Discount rates used for pension and other post-retirement
benefit plan calculations are evaluated annually and modified to
reflect the prevailing market rate at the measurement date of a
high-quality fixed income debt instrument portfolio that would
provide the future cash flows needed to pay the benefits
included in the benefit obligations as they come due. In
countries where debt instruments are thinly traded, estimates
are based on available market rates.
Actuarial assumptions are based upon management’s best
estimates and judgment. An increase of 50 basis points in
the discount rate assumption, with other assumptions held
constant, would have an estimated $21 million favorable
impact on net pension and post-retirement benefit cost. An
increase of 50 basis points in the expected rate of return
assumption, with other assumptions held constant, would have an
estimated $8 million favorable impact on net pension and
post-retirement benefit cost.
46
The expected rates of return for the pension and other
post-retirement benefit plans represent the average rates of
return to be earned on plan assets over the period during which
the benefits included in the benefit obligation are to be paid.
In developing the expected rate of return, the Company
determines expected returns for each of the major asset classes,
principally equities, fixed income and real estate. The return
expectations for these asset classes are based on assumptions
for economic growth and inflation, which are supported by long
term historical data as well as the Company’s actual
experience of return on plan assets. The expected portfolio
performance also reflects the contribution of active management
as appropriate.
Unrecognized net loss amounts reflect experience differentials
primarily relating to differences between expected and actual
returns on plan assets as well as the effects of changes in
actuarial assumptions. Expected returns are based primarily on a
calculated market-related value of assets. Under this
methodology, asset gains/losses resulting from actual returns
that differ from the Company’s expected returns for the
majority of the assets are realized in the market-related value
of assets ratably over a five-year period. Total unrecognized
net loss amounts in excess of certain thresholds are amortized
into net pension and other post-retirement benefit cost over the
average remaining service life of employees.
The targeted investment portfolio of the Company’s
U.S. pension plan is allocated 65 percent to equities,
28 percent to fixed income investments and 7 percent
to real estate. The targeted investment portfolio of the
Company’s U.S. other post-retirement benefit plans is
allocated 70 percent to equities and 30 percent to
fixed income investments. The portfolios’ equity weightings
are consistent with the long-term nature of the plans’
benefit obligations. For
non-U.S. pension
plans, the targeted investment portfolio varies based on the
duration of pension liabilities and local governmental rules and
regulations.
Substantially all investments in equities and fixed income are
valued based on quoted public market values. All investments in
real estate are valued based on periodic appraisals.
|
|
|
Accounting for Legal and Regulatory Matters |
Management judgments and estimates are required in the
accounting for legal and regulatory matters on an ongoing basis
including insurance coverages. The Company reviews the status of
all claims, investigations and legal proceedings on an ongoing
basis. From time to time, the Company may settle or otherwise
resolve these matters on terms and conditions management
believes are in the best interests of the Company. Resolution of
any or all claims, investigations and legal proceedings,
individually or in the aggregate, could have a material adverse
effect on the Company’s results of operations, cash flows
or financial condition.
MARKET RISK DISCLOSURE
The Company is exposed to market risk primarily from changes in
foreign currency exchange rates and, to a lesser extent, from
interest rates and equity prices. The following describes the
nature of these risks.
|
|
|
Foreign Currency Exchange Risk |
The Company has subsidiaries in more than 50 countries. In 2005,
sales outside the U.S. accounted for approximately
62 percent of global sales. Virtually all these sales were
denominated in currencies of the local country. As such, the
Company’s reported profits and cash flows are exposed to
changing exchange rates.
To date, management has not deemed it cost effective to engage
in a formula-based program of hedging the profits and cash flows
of international operations using derivative financial
instruments. Because the Company’s international
subsidiaries purchase significant quantities of inventory
payable in U.S. dollars, managing the level of inventory
and related payables and the rate of inventory turnover provides
a level of protection against adverse changes in exchange rates.
The risk of adverse exchange rate change is also mitigated by
the fact that the Company’s international operations are
widespread.
47
In addition, at any point in time, the Company’s
international subsidiaries hold financial assets and liabilities
that are denominated in currencies other than U.S. dollars.
These financial assets and liabilities consist primarily of
short-term, third party and intercompany, receivables and
payables. Changes in exchange rates affect the translated value
of these financial assets and liabilities. Gains or losses that
arise from translation do not affect net income.
On occasion, the Company has used derivatives to hedge specific
short-term risk situations involving foreign currency exposures.
However, these derivative transactions have not been material.
|
|
|
Interest Rate and Equity Price Risk |
Financial assets exposed to changes in interest rates and/or
equity prices are primarily cash equivalents, short-term
investments and the debt and equity securities held in
non-qualified trusts for employee benefits. These assets totaled
$5.7 billion at December 31, 2005. For cash
equivalents and short-term investments, a 10 percent
decrease in interest rates would decrease interest income by
approximately $15 million. For securities held in
non-qualified trusts, due to the long-term nature of the
liabilities that these trust assets will fund, the
Company’s exposure to market risk is deemed to be low.
Financial obligations exposed to variability in interest rates
are primarily short-term borrowings. The Company maintains an
investment portfolio in excess of the amount of borrowings.
Accordingly, the Company has mitigated its exposure for changes
in interest rates relating to its financial obligations.
The Company has long-term debt outstanding, on which a
10 percent decrease in interest rates would increase the
fair value of the debt by approximately $120 million.
However, the Company does not expect to refund this debt.
Disclosure Notice
|
|
|
Cautionary Statements Under the Private Securities
Litigation Reform Act of 1995 |
Management’s Discussion and Analysis of Financial Condition
and Results of Operations and other sections of this report and
other written reports and oral statements made from time to time
by the Company may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements do not relate strictly to historical
or current facts and are based on current expectations or
forecasts of future events. You can identify these
forward-looking statements by their use of words such as
“anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,”
“project,” “intend,” “plan,”
“potential,” “will,” and other similar words
and terms. In particular, forward-looking statements include
statements relating to future actions, ability to access the
capital markets, prospective products or product approvals,
timing and conditions of regulatory approvals, patent and other
intellectual property protection, future performance or results
of current and anticipated products, sales efforts, research and
development programs, estimates of rebates, discounts and
returns, expenses and programs to reduce expenses, the cost of
and savings from reductions in work force, the outcome of
contingencies such as litigation and investigations, growth
strategy and financial results.
Any or all forward-looking statements here or in other
publications may turn out to be wrong. There are no guarantees
about the Company’s financial and operational performance
or the performance of the Company’s stock. The Company does
not assume the obligation to update any forward-looking
statement. Many factors could cause actual results to differ
from the Company’s forward-looking statements. These
factors include inaccurate assumptions and a broad variety of
other risks and uncertainties, including some that are known and
some that are not. Although it is not possible to predict or
identify all such factors, we refer you to Item 1A. Risk
Factors of this report, which we incorporate herein by
reference, for identification of important factors with respect
to these risks and uncertainties.
|
|
Item 7A. |
Quantitative and Qualitative Disclosures about Market
Risk |
See the Market Risk Disclosures as set forth in Item 7,
Management’s Discussion and Analysis of Financial Condition
and Results of Operations, in this
10-K.
48
|
|
Item 8. |
Financial Statements and Supplementary Data |
Index to Financial Statements
49
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
STATEMENTS OF CONSOLIDATED OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Amounts in millions, except | |
|
|
per share figures) | |
Net sales
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
3,346 |
|
|
|
3,070 |
|
|
|
2,833 |
|
Selling, general and administrative
|
|
|
4,374 |
|
|
|
3,811 |
|
|
|
3,474 |
|
Research and development
|
|
|
1,865 |
|
|
|
1,607 |
|
|
|
1,469 |
|
Other expense/(income), net
|
|
|
5 |
|
|
|
146 |
|
|
|
59 |
|
Special charges
|
|
|
294 |
|
|
|
153 |
|
|
|
599 |
|
Equity income from cholesterol joint venture
|
|
|
(873 |
) |
|
|
(347 |
) |
|
|
(54 |
) |
|
|
|
|
|
|
|
|
|
|
Income/(loss) before income taxes
|
|
|
497 |
|
|
|
(168 |
) |
|
|
(46 |
) |
Income tax expense
|
|
|
228 |
|
|
|
779 |
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss)
|
|
$ |
269 |
|
|
$ |
(947 |
) |
|
$ |
(92 |
) |
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends
|
|
|
86 |
|
|
|
34 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) available to common shareholders
|
|
$ |
183 |
|
|
$ |
(981 |
) |
|
$ |
(92 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted earnings/(loss) per common share
|
|
$ |
0.12 |
|
|
$ |
(0.67 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
Basic earnings/(loss) per common share
|
|
$ |
0.12 |
|
|
$ |
(0.67 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
Dividends per common share
|
|
$ |
0.22 |
|
|
$ |
0.22 |
|
|
$ |
0.565 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
50
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
STATEMENTS OF CONSOLIDATED CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Amounts in millions) | |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss)
|
|
$ |
269 |
|
|
$ |
(947 |
) |
|
$ |
(92 |
) |
Adjustments to reconcile net income/(loss) to net cash provided
by/(used for) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments to U.S. taxing authorities
|
|
|
(239 |
) |
|
|
(473 |
) |
|
|
— |
|
|
Tax refunds from U.S. loss carryback
|
|
|
57 |
|
|
|
404 |
|
|
|
— |
|
|
Special charges
|
|
|
265 |
|
|
|
(265 |
) |
|
|
593 |
|
|
Depreciation and amortization
|
|
|
486 |
|
|
|
453 |
|
|
|
417 |
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(209 |
) |
|
|
(7 |
) |
|
|
603 |
|
|
Inventories
|
|
|
(92 |
) |
|
|
92 |
|
|
|
(152 |
) |
|
Prepaid expenses and other assets
|
|
|
168 |
|
|
|
174 |
|
|
|
(259 |
) |
|
Accounts payable and other liabilities
|
|
|
241 |
|
|
|
174 |
|
|
|
(668 |
) |
|
Income taxes payable
|
|
|
(64 |
) |
|
|
241 |
|
|
|
159 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used for) operating activities
|
|
|
882 |
|
|
|
(154 |
) |
|
|
601 |
|
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(478 |
) |
|
|
(489 |
) |
|
|
(711 |
) |
Dispositions of property and equipment
|
|
|
43 |
|
|
|
7 |
|
|
|
10 |
|
Proceeds from transfer of license
|
|
|
— |
|
|
|
118 |
|
|
|
— |
|
Purchases of investments
|
|
|
(2,608 |
) |
|
|
(2,852 |
) |
|
|
(2,169 |
) |
Reduction of investments
|
|
|
2,641 |
|
|
|
2,588 |
|
|
|
2,063 |
|
Other, net
|
|
|
(52 |
) |
|
|
7 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used for investing activities
|
|
|
(454 |
) |
|
|
(621 |
) |
|
|
(790 |
) |
|
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid to common shareholders
|
|
|
(324 |
) |
|
|
(324 |
) |
|
|
(830 |
) |
Cash dividends paid to preferred shareholders
|
|
|
(86 |
) |
|
|
(30 |
) |
|
|
— |
|
Proceeds from preferred stock issuance, net
|
|
|
— |
|
|
|
1,394 |
|
|
|
— |
|
Short-term borrowings
|
|
|
900 |
|
|
|
546 |
|
|
|
— |
|
Payments of short-term borrowings
|
|
|
(1,183 |
) |
|
|
— |
|
|
|
(399 |
) |
Issuance of long-term debt
|
|
|
— |
|
|
|
— |
|
|
|
2,369 |
|
Reductions of long-term debt
|
|
|
— |
|
|
|
(18 |
) |
|
|
— |
|
Other, net
|
|
|
60 |
|
|
|
(34 |
) |
|
|
(258 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash (used for) provided by financing activities
|
|
|
(633 |
) |
|
|
1,534 |
|
|
|
882 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
(12 |
) |
|
|
7 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(217 |
) |
|
|
766 |
|
|
|
697 |
|
Cash and cash equivalents, beginning of year
|
|
|
4,984 |
|
|
|
4,218 |
|
|
|
3,521 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of year
|
|
$ |
4,767 |
|
|
$ |
4,984 |
|
|
$ |
4,218 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest, net of amounts capitalized
|
|
$ |
159 |
|
|
$ |
166 |
|
|
$ |
46 |
|
Cash paid (refunded) for income taxes (see Note 5)
|
|
|
592 |
|
|
|
(144 |
) |
|
|
196 |
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
51
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
At December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Amounts in millions, | |
|
|
except per | |
|
|
share figures) | |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
4,767 |
|
|
$ |
4,984 |
|
Short-term investments
|
|
|
818 |
|
|
|
851 |
|
Accounts receivable, less allowances: 2005, $211; 2004, $173
|
|
|
1,479 |
|
|
|
1,407 |
|
Inventories
|
|
|
1,605 |
|
|
|
1,580 |
|
Deferred income taxes
|
|
|
294 |
|
|
|
309 |
|
Prepaid expenses and other current assets
|
|
|
769 |
|
|
|
872 |
|
|
|
|
|
|
|
|
Total current assets
|
|
|
9,732 |
|
|
|
10,003 |
|
Property, at cost:
|
|
|
|
|
|
|
|
|
Land
|
|
|
67 |
|
|
|
79 |
|
Buildings and improvements
|
|
|
3,238 |
|
|
|
3,198 |
|
Equipment
|
|
|
3,131 |
|
|
|
2,999 |
|
Construction in progress
|
|
|
761 |
|
|
|
809 |
|
|
|
|
|
|
|
|
Total
|
|
|
7,197 |
|
|
|
7,085 |
|
Less accumulated depreciation
|
|
|
2,710 |
|
|
|
2,492 |
|
|
|
|
|
|
|
|
Property, net
|
|
|
4,487 |
|
|
|
4,593 |
|
Goodwill
|
|
|
204 |
|
|
|
209 |
|
Other intangible assets, net
|
|
|
365 |
|
|
|
371 |
|
Other assets
|
|
|
681 |
|
|
|
735 |
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
15,469 |
|
|
$ |
15,911 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
Current Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
1,078 |
|
|
$ |
978 |
|
Short-term borrowings and current portion of long-term debt
|
|
|
1,278 |
|
|
|
1,569 |
|
U.S., foreign and state income taxes
|
|
|
213 |
|
|
|
896 |
|
Accrued compensation
|
|
|
632 |
|
|
|
443 |
|
Other accrued liabilities
|
|
|
1,458 |
|
|
|
1,280 |
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
4,659 |
|
|
|
5,166 |
|
Long-term Liabilities:
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
2,399 |
|
|
|
2,392 |
|
Deferred income taxes
|
|
|
117 |
|
|
|
111 |
|
Other long-term liabilities
|
|
|
907 |
|
|
|
686 |
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
3,423 |
|
|
|
3,189 |
|
Commitments and contingent liabilities (Note 19)
|
|
|
|
|
|
|
|
|
Shareholders’ Equity:
|
|
|
|
|
|
|
|
|
Mandatory convertible preferred shares — $1 par
value; issued: 29; $50 per share face value
|
|
|
1,438 |
|
|
|
1,438 |
|
Common shares — authorized shares: 2,400,
$.50 par value; issued: 2,030
|
|
|
1,015 |
|
|
|
1,015 |
|
Paid-in capital
|
|
|
1,416 |
|
|
|
1,234 |
|
Retained earnings
|
|
|
9,472 |
|
|
|
9,613 |
|
Accumulated other comprehensive income
|
|
|
(516 |
) |
|
|
(300 |
) |
|
|
|
|
|
|
|
Total
|
|
|
12,825 |
|
|
|
13,000 |
|
Less treasury shares: 2005, 550; 2004, 555; at cost
|
|
|
5,438 |
|
|
|
5,444 |
|
|
|
|
|
|
|
|
Total shareholders’ equity
|
|
|
7,387 |
|
|
|
7,556 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders’ equity
|
|
$ |
15,469 |
|
|
$ |
15,911 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
52
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
STATEMENTS OF CONSOLIDATED SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
Mandatory | |
|
|
|
|
|
|
|
|
|
Other | |
|
Total | |
|
|
Convertible | |
|
|
|
|
|
|
|
|
|
Compre- | |
|
Share- | |
|
|
Preferred | |
|
Common | |
|
Paid-in | |
|
Retained | |
|
Treasury | |
|
hensive | |
|
holders’ | |
|
|
Shares | |
|
Shares | |
|
Capital | |
|
Earnings | |
|
Shares | |
|
Income | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Amounts in millions) | |
Balance January 1, 2003
|
|
|
— |
|
|
$ |
1,015 |
|
|
$ |
1,203 |
|
|
$ |
11,840 |
|
|
$ |
(5,439 |
) |
|
$ |
(477 |
) |
|
$ |
8,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(92 |
) |
|
|
|
|
|
|
|
|
|
|
(92 |
) |
Foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
218 |
|
|
|
218 |
|
Minimum pension liability, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(178 |
) |
|
|
(178 |
) |
Unrealized gain on investments available for sale, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
13 |
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends on common shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(830 |
) |
|
|
|
|
|
|
|
|
|
|
(830 |
) |
Stock incentive plans and other
|
|
|
— |
|
|
|
— |
|
|
|
69 |
|
|
|
— |
|
|
|
(3 |
) |
|
|
— |
|
|
|
66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2003
|
|
|
— |
|
|
|
1,015 |
|
|
|
1,272 |
|
|
|
10,918 |
|
|
|
(5,442 |
) |
|
|
(426 |
) |
|
|
7,337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(947 |
) |
|
|
|
|
|
|
|
|
|
|
(947 |
) |
Foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107 |
|
|
|
107 |
|
Minimum pension liability, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14 |
|
|
|
14 |
|
Unrealized gain on investments available for sale, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(821 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of preferred stock
|
|
|
1,438 |
|
|
|
|
|
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,394 |
|
Cash dividends on common shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(324 |
) |
|
|
|
|
|
|
|
|
|
|
(324 |
) |
Dividends on preferred shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
(34 |
) |
Stock incentive plans and other
|
|
|
— |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
|
|
(2 |
) |
|
|
— |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2004
|
|
$ |
1,438 |
|
|
$ |
1,015 |
|
|
$ |
1,234 |
|
|
$ |
9,613 |
|
|
$ |
(5,444 |
) |
|
$ |
(300 |
) |
|
$ |
7,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
269 |
|
|
|
|
|
|
|
|
|
|
|
269 |
|
Foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(160 |
) |
|
|
(160 |
) |
Minimum pension liability, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(56 |
) |
|
|
(56 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends on common shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(324 |
) |
|
|
|
|
|
|
|
|
|
|
(324 |
) |
Dividends on preferred shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86 |
) |
|
|
|
|
|
|
|
|
|
|
(86 |
) |
Stock incentive plans and other
|
|
|
— |
|
|
|
— |
|
|
|
182 |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
|
|
188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2005
|
|
$ |
1,438 |
|
|
$ |
1,015 |
|
|
$ |
1,416 |
|
|
$ |
9,472 |
|
|
$ |
(5,438 |
) |
|
$ |
(516 |
) |
|
$ |
7,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
53
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
1. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Schering-Plough (the Company) discovers, develops, manufactures
and markets medical therapies and treatments to enhance human
health. The Company also markets leading consumer brands in the
over-the-counter (OTC),
foot care and sun care markets and operates a global animal
health business.
|
|
|
Principles of Consolidation |
The consolidated financial statements include Schering-Plough
Corporation and its subsidiaries (the Company). Intercompany
balances and transactions are eliminated. Certain prior year
amounts have been reclassified to conform to the current year
presentation.
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to
make estimates and use assumptions that affect certain reported
amounts and disclosures. Actual amounts may differ.
|
|
|
Equity Method of Accounting |
The Company accounts for its share of activity from the Merck/
Schering-Plough cholesterol joint venture (the Partnership or
the joint venture) with Merck & Co., Inc. (Merck) using
the equity method of accounting as the Company has significant
influence over the joint venture’s operating and financial
policies. Accordingly, the Company’s share of earnings in
the joint venture is included in consolidated net income/(loss).
Revenue from the sales of VYTORIN and ZETIA are recognized by
the joint venture when title and risk of loss has passed to the
customer. Equity income from the joint venture excludes any
profit arising from transactions between the Company and the
joint venture until such time as there is an underlying profit
realized by the joint venture in a transaction with a party
other than the Company or Merck. See Note 3, “Equity
Income From Cholesterol Joint Venture” for information
regarding this joint venture.
|
|
|
Cash and Cash Equivalents |
Cash and cash equivalents include operating cash and highly
liquid investments with original maturities of three months or
less.
Short-term investments are carried at their fair value and are
classified as available for sale. These investments consist of
time deposits, certificates of deposit and commercial paper with
maturities of less than a year.
Inventories are valued at the lower of cost or market. Cost is
determined by using the
last-in, first-out
(LIFO) method for a substantial portion of inventories
located in the U.S. The cost of all other inventories is
determined by the
first-in, first-out
method (FIFO).
|
|
|
Depreciation of Property and Equipment |
Depreciation is provided over the estimated useful lives of the
properties, generally by use of the straight-line method.
54
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
Useful lives of property are generally as follows:
|
|
|
|
|
Asset Category |
|
Years | |
|
|
| |
Buildings
|
|
|
50 |
|
Building Improvements
|
|
|
25 |
|
Equipment
|
|
|
3 - 15 |
|
The Company reviews the carrying value of property and equipment
for indications of impairment in accordance with Statement of
Financial Accounting Standard (SFAS) 144, “Accounting
for the Impairment and Disposal of Long-Lived Assets.”
Depreciation expense was $362 million, $340 million
and $304 million in 2005, 2004 and 2003, respectively.
|
|
|
Foreign Currency Translation |
The net assets of most of the Company’s international
subsidiaries are translated into U.S. dollars using current
exchange rates. The U.S. dollar effects that arise from
translating the net assets of these subsidiaries at changing
rates are recorded in the foreign currency translation account,
which is included in other comprehensive income. For the
remaining international subsidiaries, non-monetary assets and
liabilities are translated using historical rates, while
monetary assets and liabilities are translated at current rates,
with the U.S. dollar effects of rate changes included in
income.
Exchange gains and losses arising from translating intercompany
balances of a long-term investment nature are recorded in the
foreign currency translation account. Transactional exchange
gains and losses are included in income.
The Company’s pharmaceutical products are sold to direct
purchasers (e.g., wholesalers, retailers and certain health
maintenance organizations). Price discounts and rebates on such
sales are paid to federal and state agencies as well as to
indirect purchasers and other market participants (e.g., managed
care organizations that indemnify beneficiaries of health plans
for their pharmaceutical costs and pharmacy benefit managers).
The Company recognizes revenue when title and risk of loss pass
to the purchaser and when reliable estimates of the following
can be determined:
|
|
|
i. commercial discount and rebate arrangements; |
|
|
ii. rebate obligations under certain federal and state
governmental programs; and |
|
|
iii. sales returns in the normal course of business. |
When recognizing revenue the Company estimates and records the
applicable commercial and governmental discounts and rebates as
well as sales returns that have been or are expected to be
granted or made for products sold during the period. These
amounts are deducted from sales for that period. Estimates
recorded in prior periods are reevaluated as part of this
process. If reliable estimates of these items cannot be made,
the Company defers the recognition of revenue.
|
|
|
Earnings Per Common Share |
In 2005, diluted earnings per common share is computed by
dividing income available to common shareholders by the sum of
the weighted average number of common shares outstanding plus
the dilutive effect of shares issuable through deferred stock
units and the exercise of stock options. The impact of the
55
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
conversion of mandatory convertible preferred shares has been
excluded from this calculation since including these securities
in the earnings per share calculation would be antidilutive.
In 2004, diluted loss per common share excludes the effect of
shares issuable through deferred stock units, the exercise of
stock options and the impact of the conversion of mandatory
convertible preferred shares because including these securities
in the earnings per share calculation would be antidilutive as
it would result in a lower loss per share.
In 2003, diluted loss per common share excludes the effect of
shares issuable through deferred stock units and through the
exercise of stock options because including these securities
would be antidilutive.
For all periods presented, basic earnings/(loss) per common
share is computed by dividing income/(loss) available to common
shareholders by the weighted average number of common shares
outstanding.
|
|
|
Goodwill and Other Intangible Assets |
SFAS 142, “Goodwill and Other Intangible Assets,”
requires that intangible assets acquired either individually or
with a group of other assets be initially recognized and
measured based on fair value. An intangible with a finite life
is amortized over its useful life, while an intangible with an
indefinite life, including goodwill, is not amortized.
The Company evaluates goodwill for impairment using a
fair-value-based test. If goodwill is determined to be impaired,
it is written down to its estimated fair value. The
Company’s goodwill is primarily related to the Animal
Health business.
Deferred income taxes are recognized for the future tax effects
of temporary differences between the financial and income tax
reporting basis of the Company’s assets and liabilities
based on enacted tax laws and rates.
|
|
|
Accounting for Stock-Based Compensation |
Through December 31, 2005, the Company accounted for its
stock-based compensation arrangements using the intrinsic value
method. No stock-based employee compensation cost is reflected
in net income/(loss), other than for the Company’s deferred
stock units and performance plans, as stock options granted
under all other plans had an exercise price equal to the market
value of the underlying common stock on the date of grant.
In December 2004, the FASB issued SFAS 123 (Revised 2004)
“Share-Based Payment” (SFAS 123R). SFAS 123R
is effective for the Company on January 1, 2006.
SFAS 123R requires companies to recognize compensation
costs related to all share-based transactions and compensation
based on the market performance of the Company’s shares
determined on a fair value basis. The Company will adopt
SFAS 123R in the first quarter of 2006 using the modified
prospective method. The modified prospective method requires the
Company to recognize compensation costs on all share-based
grants made on or after January 1, 2006 as well as the
unrecognized cost of unvested awards at the date of adoption.
Upon adoption of SFAS 123R, the Company will recognize
share-based compensation costs over the service period, which is
the earlier of the employees retirement eligibility date or the
stated vesting period of the award. For grants issued to
retirement eligible employees prior to the adoption of
SFAS 123R, the Company will recognize compensation costs
over the stated vesting period with acceleration of any
unrecognized compensation costs upon the retirement of the
employee. SFAS 123R also amends SFAS No. 95,
“Statement of Cash Flows,” to require that excess tax
benefits that had been reflected as operating cash flows be
reflected as financing cash flows.
56
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
In addition, the Company has two compensation plans that will be
accounted for under SFAS 123R as liability-based plans. The
ultimate cash payout of these liability-based plans will be
based on the Company’s stock price performance as compared
to the stock price performance of its peer group. This change in
accounting required by SFAS 123R will result in a
cumulative effect of $26 million in income at
January 1, 2006, in order to recognize the difference
between the Company’s previously accrued liability as
reported under Accounting Principles Board (APB) Opinion
number 25, “Accounting for Stock Issued to
Employees”, and the fair value of the liability for these
plans. Future operating results will be impacted by the
fluctuation in the fair value of the liability under these
plans, which is required to be remeasured at each reporting date.
The following table reconciles net income/(loss) available to
common shareholders and basic/diluted earnings/(loss) per common
share, as reported, to pro forma net income/(loss) available to
common shareholders and basic/diluted earnings/(loss) per common
share, as if the Company had expensed the grant-date fair value
of both stock options and deferred stock units as permitted by
SFAS 123, “Accounting for Stock-Based
Compensation.”
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions, | |
|
|
except per share data) | |
Net income/(loss) available to common shareholders, as reported
|
|
$ |
183 |
|
|
$ |
(981 |
) |
|
$ |
(92 |
) |
Add back: Expense included in reported net income for deferred
stock units, net of tax in 2003
|
|
|
89 |
|
|
|
59 |
|
|
|
66 |
|
Deduct: Pro forma expense as if both stock options and deferred
stock units were charged against net income/(loss) available to
common shareholders in accordance with SFAS 123, net of
tax in 2003
|
|
|
(177 |
) |
|
|
(160 |
) |
|
|
(143 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net income/(loss) available to common shareholders
using the fair value method
|
|
$ |
95 |
|
|
$ |
(1,082 |
) |
|
$ |
(169 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted earnings/(loss) per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings/(loss) per common share, as reported
|
|
$ |
0.12 |
|
|
$ |
(0.67 |
) |
|
$ |
(0.06 |
) |
|
Pro forma diluted earnings/(loss) per common share using the
fair value method
|
|
|
0.06 |
|
|
|
(0.74 |
) |
|
|
(0.12 |
) |
Basic earnings/(loss) per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings/(loss) per common share, as reported
|
|
$ |
0.12 |
|
|
$ |
(0.67 |
) |
|
$ |
(0.06 |
) |
|
Pro forma basic earnings/(loss) per common share using the fair
value method
|
|
|
0.06 |
|
|
|
(0.74 |
) |
|
|
(0.12 |
) |
The weighted-average fair value of options granted in 2005, 2004
and 2003 was $7.04, $6.15 and $5.29, respectively. These fair
values were estimated using the Black-Scholes option-pricing
model, based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Dividend yield
|
|
|
1.7 |
% |
|
|
1.7 |
% |
|
|
1.4 |
% |
Volatility
|
|
|
32 |
% |
|
|
33 |
% |
|
|
34 |
% |
Risk-free interest rate
|
|
|
4.1 |
% |
|
|
3.9 |
% |
|
|
2.9 |
% |
Expected term of options (in years)
|
|
|
7 |
|
|
|
7 |
|
|
|
5 |
|
|
|
|
Impact of Other Recently Issued Accounting
Pronouncements |
In November 2004, the FASB issued SFAS 151, “Inventory
Costs.” This SFAS requires that abnormal spoilage be
expensed in the period incurred (as opposed to inventoried and
amortized to income
57
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
over inventory usage) and that fixed production facility
overhead costs be allocated over the normal production level of
a facility. The Company implemented SFAS 151 in the fourth
quarter of 2005. The implementation of this SFAS did not have a
material impact on the Company’s financial statements.
In March 2005, the FASB issued Interpretation No. 47
(FIN 47) for SFAS 143, “Accounting for
Conditional Asset Retirement Obligations,” to clarify the
term “conditional asset retirement obligations,” as
used in SFAS 143. This term refers to a legal obligation to
perform an asset retirement activity in which the timing and/or
method of settlement are conditional on a future event that may
or may not be within the control of the entity. Accordingly, a
company is required to recognize liability for the fair value of
a conditional asset retirement obligation if the fair value of
the liability can be reasonably estimated. This interpretation
is effective no later than the end of fiscal year ending after
December 15, 2005. Retroactive application is not required.
The Company implemented FIN 47 in the fourth quarter of
2005. The implementation of FIN 47 did not have a material
impact on the Company’s financial statements.
The components of special charges for the year ended
December 31 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Litigation charges
|
|
$ |
250 |
|
|
$ |
— |
|
|
$ |
350 |
|
Employee termination costs
|
|
|
28 |
|
|
|
119 |
|
|
|
179 |
|
Asset impairment and related charges
|
|
|
16 |
|
|
|
34 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
294 |
|
|
$ |
153 |
|
|
$ |
599 |
|
|
|
|
|
|
|
|
|
|
|
During 2005, litigation reserves were increased by
$250 million resulting in a total reserve of
$500 million for the Massachusetts investigation as well as
the investigations disclosed under “AWP
Investigations” and the state litigation disclosed under
“AWP Litigation” in Note 19, “Legal,
Environmental and Regulatory Matters.”
In 2003, litigation reserves were increased by $350 million
primarily as a result of the investigations into the
Company’s sales and marketing practices (see Note 19,
“Legal, Environmental and Regulatory Matters,” for
additional information).
|
|
|
Employee Termination Costs |
In August 2003, the Company announced a global workforce
reduction initiative. The first phase of this initiative was a
Voluntary Early Retirement Program (VERP) in the
U.S. Under this program, eligible employees in the
U.S. had until December 15, 2003 to elect early
retirement and receive an enhanced retirement benefit.
Approximately 900 employees elected to retire under the program,
all of which have retired by December 31, 2005. The total
cost of this program was approximately $191 million,
comprised of increased pension costs of $108 million,
increased post-retirement health care costs of $57 million,
vacation payments of $4 million and costs related to
accelerated vesting of stock grants of $22 million. Amounts
recognized relating to this program during the years ended
December 31, 2005, 2004 and 2003 were $7 million,
$20 million and $164 million, respectively.
Employee termination costs not associated with the VERP totaled
$21 million, $99 million and $15 million in 2005,
2004 and 2003, respectively.
58
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The following summarizes the activity in the accounts related to
employee termination costs:
|
|
|
|
|
|
|
Employee | |
|
|
Termination | |
|
|
Costs | |
|
|
| |
|
|
(Dollars | |
|
|
in millions) | |
Special charges incurred during 2003
|
|
$ |
179 |
|
Credit to retirement benefit plan liability
|
|
|
(144 |
) |
Disbursements
|
|
|
(6 |
) |
|
|
|
|
Special charges liability balance at December 31, 2003
|
|
$ |
29 |
|
|
|
|
|
Special charges incurred during 2004
|
|
$ |
119 |
|
Credit to retirement benefit plan liability
|
|
|
(20 |
) |
Disbursements
|
|
|
(110 |
) |
|
|
|
|
Special charges liability balance at December 31, 2004
|
|
$ |
18 |
|
|
|
|
|
Special charges incurred during 2005
|
|
$ |
28 |
|
Credit to retirement benefit plan liability
|
|
|
(7 |
) |
Disbursements
|
|
|
(35 |
) |
|
|
|
|
Special charges liability balance at December 31, 2005
|
|
$ |
4 |
|
|
|
|
|
|
|
|
Asset Impairment and Other Charges |
Asset impairment charges have been recognized in accordance with
SFAS 142, “Goodwill and Other Intangible Assets”
and SFAS 144, “Accounting for the Impairment or
Disposal of Long-Lived Assets.”
For the year ended December 31, 2005, the Company
recognized asset impairment and other charges of
$16 million related primarily to the consolidation of the
Company’s U.S. biotechnology organizations.
For the year ended December 31, 2004, the Company
recognized asset impairment charges of $27 million based on
discounted cash flows, and other charges of $7 million
related primarily to the shutdown of a small European research
and development facility.
For the year ended December 31, 2003, the Company
recognized asset impairment charges related to the following:
|
|
|
|
• |
Asset impairment charges totaling $26 million were
recognized based on discounted cash flow analysis related to the
facilities and equipment at two of the Company’s
manufacturing sites. |
|
|
• |
An asset impairment charge of $27 million based on
discounted cash flows was recognized related to the intangible
asset for a licensed cancer therapy drug that was sold in
countries outside the U.S. |
|
|
• |
An impairment charge of $17 million related to the trade
name of the Company’s high-end sun care brand was
recognized based on discounted cash flows. |
|
|
3. |
EQUITY INCOME FROM CHOLESTEROL JOINT VENTURE |
In May 2000, the Company and Merck & Co., Inc. (Merck)
entered into two separate sets of agreements to jointly develop
and market certain products in the U.S. including
(1) two cholesterol-lowering drugs and (2) an
allergy/asthma drug. In December 2001, the cholesterol
agreements were expanded to include all countries of the world
except Japan. In general, the companies agreed that the
collaborative activities under these agreements would operate in
a virtual joint venture to the maximum degree possible by
relying on the respective infrastructures of the two companies.
These agreements
59
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
generally provide for equal sharing of development costs and for
co-promotion of approved products by each company.
The cholesterol agreements provide for the Company and Merck to
jointly develop ezetimibe (marketed as ZETIA in the U.S. and
Asia and EZETROL in Europe):
|
|
|
i. as a once-daily monotherapy; |
|
|
ii. in co-administration with any statin drug, and; |
|
|
iii. as a once-daily fixed-combination tablet of ezetimibe
and simvastatin (Zocor), Merck’s cholesterol-modifying
medicine. This combination medication (ezetimibe/simvastatin) is
marketed as VYTORIN in the U.S. and as INEGY in many
international countries. |
ZETIA/ EZETROL (ezetimibe) and VYTORIN/ INEGY (the
combination of ezetimibe/simvastatin) are approved for use in
the U.S. and have been launched in several international markets.
The Company utilizes the equity method of accounting in
recording its share of activity from the Merck/ Schering-Plough
cholesterol joint venture. As such, the Company’s net sales
do not include the sales of the joint venture. The cholesterol
joint venture agreements provide for the sharing of operating
income generated by the joint venture based upon percentages
that vary by product, sales level and country. In the
U.S. market, the Company receives a greater share of
profits on the first $300 million of annual ZETIA sales.
Above $300 million of annual ZETIA sales, Merck and
Schering-Plough (the Partners) generally share profits equally.
Schering-Plough’s allocation of the joint venture income is
increased by milestones recognized. Further, either
Partner’s share of the joint venture’s income from
operations is subject to a reduction if the Partner fails to
perform a specified minimum number of physician details in a
particular country. The Partners agree annually to the minimum
number of physician details by country.
The Partners bear the costs of their own general sales forces
and commercial overhead in marketing joint venture products
around the world. In the U.S., Canada, and Puerto Rico, the
cholesterol agreements provide for a reimbursement to each
Partner for physician details that are set on an annual basis.
This reimbursed amount is equal to each Partner’s physician
details multiplied by a contractual fixed fee. Schering-Plough
reports this reimbursement as part of equity income from the
cholesterol joint venture. This amount does not represent a
reimbursement of specific, incremental and identifiable costs
for the Company’s detailing of the cholesterol products in
these markets. In addition, this reimbursement amount is not
reflective of the Company’s sales effort related to the
joint venture as the Company’s sales force and related
costs associated with the joint venture are generally estimated
to be higher.
For the year ended December 31, 2005, the Company
recognized milestones of $20 million. These milestones
related to certain European approvals of VYTORIN
(ezetimibe/simvastatin) in 2005. During 2004, the Company
recognized a milestone of $7 million related to the
approval of ezetimibe/simvastatin in Mexico during 2004. During
2003, the Company recognized milestones of $20 million
related to certain European approvals of ZETIA in 2003.
Under certain other conditions, as specified in the joint
venture agreements with Merck, the Company could earn additional
milestones totaling $105 million.
Costs of the joint venture that the Partners contractually share
are a portion of manufacturing costs, specifically identified
promotion costs (including
direct-to-consumer
advertising and direct and identifiable
out-of-pocket
promotion) and other agreed upon costs for specific services
such as market support, market research, market expansion, a
specialty sales force and physician education programs.
Certain specified research and development expenses are
generally shared equally by the Partners.
60
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The following information provides a summary of the components
of the Company’s equity income from the cholesterol joint
venture for the year ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Schering-Plough’s share of net income/(loss) (including
milestones of $20, $7 and $20 in 2005, 2004 and 2003,
respectively)
|
|
$ |
689 |
|
|
$ |
244 |
|
|
$ |
(11 |
) |
Reimbursement to Schering-Plough for physician details
|
|
|
194 |
|
|
|
121 |
|
|
|
68 |
|
Elimination of intercompany profit and other, net
|
|
|
(10 |
) |
|
|
(18 |
) |
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total equity income from cholesterol joint venture
|
|
$ |
873 |
|
|
$ |
347 |
|
|
$ |
54 |
|
|
|
|
|
|
|
|
|
|
|
Equity income from the joint venture excludes any profit arising
from transactions between the Company and the joint venture
until such time as there is an underlying profit realized by the
joint venture in a transaction with a party other than the
Company or Merck.
Due to the virtual nature of the cholesterol joint venture, the
Company incurs substantial costs, such as selling, general and
administrative costs, that are not reflected in equity income
and are borne by the overall cost structure of the Company.
These costs are reported on their respective line items in the
Statements of Consolidated Operations. The cholesterol
agreements do not provide for any jointly owned facilities and,
as such, products resulting from the joint venture are
manufactured in facilities owned by either the Company or Merck.
The allergy/asthma agreements provide for the joint development
and marketing by the Partners of a once-daily, fixed-combination
tablet containing CLARITIN and Singulair. Singulair is
Merck’s once-daily leukotriene receptor antagonist for the
treatment of asthma and seasonal allergic rhinitis. In January
2002, the Merck/ Schering-Plough respiratory joint venture
reported on results of Phase III clinical trials of a
fixed-combination tablet containing CLARITIN and Singulair. This
Phase III study did not demonstrate sufficient added
benefits in the treatment of seasonal allergic rhinitis. The
CLARITIN and Singulair combination tablet does not have approval
in any country and remains in clinical development with new
Phase III clinical trials planned.
|
|
4. |
OTHER EXPENSE/(INCOME), NET |
The components of other expense/(income), net are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Interest cost incurred
|
|
$ |
177 |
|
|
$ |
188 |
|
|
$ |
92 |
|
Less: amount capitalized on construction
|
|
|
(14 |
) |
|
|
(20 |
) |
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
163 |
|
|
|
168 |
|
|
|
81 |
|
Interest income
|
|
|
(176 |
) |
|
|
(80 |
) |
|
|
(57 |
) |
Foreign exchange losses
|
|
|
8 |
|
|
|
5 |
|
|
|
1 |
|
Other, net
|
|
|
10 |
|
|
|
53 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
Total other expense/(income), net
|
|
$ |
5 |
|
|
$ |
146 |
|
|
$ |
59 |
|
|
|
|
|
|
|
|
|
|
|
61
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The components of consolidated income/(loss) before income taxes
for the years ended December 31 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
United States
|
|
$ |
(1,436 |
) |
|
$ |
(1,548 |
) |
|
$ |
(1,169 |
) |
Foreign
|
|
|
1,933 |
|
|
|
1,380 |
|
|
|
1,123 |
|
|
|
|
|
|
|
|
|
|
|
Total income/(loss) before income taxes
|
|
$ |
497 |
|
|
$ |
(168 |
) |
|
$ |
(46 |
) |
|
|
|
|
|
|
|
|
|
|
Income from the cholesterol joint venture is included in the
above table based on the jurisdiction in which the income is
earned.
The components of income tax expense for the years ended
December 31 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal | |
|
State | |
|
Foreign | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
(46 |
) |
|
$ |
23 |
|
|
$ |
227 |
|
|
$ |
204 |
|
Deferred
|
|
|
— |
|
|
|
(9 |
) |
|
|
33 |
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
(46 |
) |
|
$ |
14 |
|
|
$ |
260 |
|
|
$ |
228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
365 |
|
|
$ |
24 |
|
|
$ |
182 |
|
|
$ |
571 |
|
Deferred
|
|
|
240 |
|
|
|
(14 |
) |
|
|
(18 |
) |
|
|
208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
605 |
|
|
$ |
10 |
|
|
$ |
164 |
|
|
$ |
779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
(299 |
) |
|
$ |
21 |
|
|
$ |
187 |
|
|
$ |
(91 |
) |
Deferred
|
|
|
126 |
|
|
|
— |
|
|
|
11 |
|
|
|
137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
(173 |
) |
|
$ |
21 |
|
|
$ |
198 |
|
|
$ |
46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company’s tax provision for the year ended
December 31, 2005 includes a U.S. federal income tax
benefit of approximately $42 million as a result of an IRS
Notice issued in August 2005. The provisions of this Notice
resulted in a reduction of the previously accrued tax liability
attributable to the American Jobs Creation Act
(AJCA) repatriation, and also reduced the 2005
U.S. Net Operating Loss (NOL) carried forward to
subsequent years.
In the fourth quarter of 2004, the Company made the decision to
repatriate approximately $9.4 billion under the provisions
of the AJCA, which was the maximum amount of foreign earnings
that qualified for the reduced tax rate of 5.25 percent.
The intended repatriation of earnings resulted in a
U.S. federal tax liability of approximately
$417 million and a state income tax liability of
approximately $6 million, which was recorded in the 2004
income tax expense. During 2005, the Company repatriated
approximately $9.4 billion in accordance with its planned
repatriation under the AJCA. The Company will continue to use
the repatriated funds for qualified spending.
Prior to the AJCA, the Company’s intent was to permanently
reinvest all unremitted earnings of its international
subsidiaries, and except for the amounts repatriated under the
AJCA, the Company maintains its intent to permanently reinvest
earnings of its international subsidiaries. The Company has not
provided deferred taxes on approximately $3.1 billion of
undistributed foreign earnings as of December 31, 2005.
Determining the tax liability that would arise if these earnings
were remitted is not practicable. That
62
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
liability would depend on a number of factors, including the
amount of the earnings distributed and whether the
U.S. operations were generating taxable profits or losses.
In the fourth quarter of 2004, due to changes in tax planning
strategies triggered by the Company’s intent to repatriate
earnings under the AJCA, management was no longer able to
conclude that it was more likely than not that it would realize
the benefit of its net U.S. deferred tax assets, including
any benefit related to its U.S. NOLs. Therefore, in
general, the Company established a valuation allowance on its
net U.S. deferred tax asset at December 31, 2004. The
Company continues to maintain a valuation allowance for its net
U.S. deferred tax asset at December 31, 2005.
Deferred income taxes are provided for temporary differences
between the financial reporting basis and the tax basis of the
Company’s assets and liabilities. The Company’s
deferred tax assets result principally from the recording of
certain items that currently are not deductible for tax purposes
and net operating loss and other tax credit carryforwards. The
Company’s deferred tax liabilities principally result from
the use of accelerated depreciation for tax purposes.
The components of the Company’s deferred tax assets and
liabilities at December 31, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating losses (NOLs) and other tax credit carryforwards
|
|
$ |
865 |
|
|
$ |
324 |
|
|
Postretirement and other employee benefits
|
|
|
275 |
|
|
|
281 |
|
|
Inventory related
|
|
|
170 |
|
|
|
190 |
|
|
Sales return reserves
|
|
|
149 |
|
|
|
153 |
|
|
Litigation accruals
|
|
|
126 |
|
|
|
103 |
|
|
Other
|
|
|
223 |
|
|
|
145 |
|
|
|
|
|
|
|
|
Total deferred tax assets:
|
|
$ |
1,808 |
|
|
$ |
1,196 |
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
$ |
(310 |
) |
|
$ |
(333 |
) |
|
Inventory valuation
|
|
|
(26 |
) |
|
|
(63 |
) |
|
Other
|
|
|
(89 |
) |
|
|
(166 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities:
|
|
$ |
(425 |
) |
|
$ |
(562 |
) |
|
|
|
|
|
|
|
Deferred tax valuation allowance
|
|
$ |
(1,143 |
) |
|
$ |
(406 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$ |
240 |
|
|
$ |
228 |
|
|
|
|
|
|
|
|
The change in the valuation allowance from 2004 to 2005 is
primarily due to the increase in the U.S. NOL.
Deferred taxes for net operating losses and other carryforwards
principally relate to U.S. NOLs, Research and Development
(R&D) tax credits, U.S. foreign tax credits and Federal
Alternative Minimum Tax (AMT) credit carryforwards. At
December 31, 2005, the Company had approximately
$1.5 billion of U.S. NOLs for income tax purposes that
are available to offset future U.S. taxable income. These
U.S. NOLs will expire in varying amounts in 2024 and 2025,
if unused. At December 31, 2005, the Company had
approximately $66 million of R&D tax credits
carryforwards that will expire between 2022 and 2025;
$155 million of foreign tax credit carryforwards that will
expire between 2011 and 2015; and $44 million of AMT tax
credit carryforwards that have an indefinite life. Approximately
$300 million and $1.5 billion of the U.S. NOLs
generated in 2004 and 2003, respectively, were eligible for
carryback benefits under a provision of the U.S. tax law.
In accordance with this provision, the Company was able to
63
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
recoup previous U.S. taxes paid, which resulted in income
tax benefits of $52 million and $452 million for 2004
and 2003, respectively.
The difference between income taxes based on the
U.S. statutory tax rate and the Company’s income tax
expense for the years ending December 31 was due to the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Income tax expense/(benefit) at U.S. statutory rate
|
|
$ |
174 |
|
|
$ |
(59 |
) |
|
$ |
(16 |
) |
Increase/(decrease) in taxes resulting from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lower rates in other jurisdictions, net
|
|
|
(417 |
) |
|
|
(319 |
) |
|
|
(308 |
) |
|
Federal (benefit) tax on repatriated foreign earnings under the
Act, net of credits
|
|
|
(42 |
) |
|
|
417 |
|
|
|
— |
|
|
U.S. NOLs for which no tax benefit was recorded
|
|
|
437 |
|
|
|
384 |
|
|
|
— |
|
|
Provision for valuation allowance of net U.S. deferred tax
assets
|
|
|
— |
|
|
|
240 |
|
|
|
— |
|
|
Non-deductible litigation reserves
|
|
|
— |
|
|
|
— |
|
|
|
123 |
|
|
Reserves for tax litigation
|
|
|
— |
|
|
|
— |
|
|
|
200 |
|
|
Research tax credit
|
|
|
— |
|
|
|
— |
|
|
|
(13 |
) |
|
State income tax
|
|
|
14 |
|
|
|
10 |
|
|
|
13 |
|
|
Permanent differences
|
|
|
66 |
|
|
|
98 |
|
|
|
28 |
|
|
All other, net
|
|
|
(4 |
) |
|
|
8 |
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
Income tax at effective tax rate
|
|
$ |
228 |
|
|
$ |
779 |
|
|
$ |
46 |
|
|
|
|
|
|
|
|
|
|
|
The lower tax rates in other jurisdictions in 2005, 2004 and
2003, net, are primarily attributable to the Company’s
manufacturing subsidiaries in Puerto Rico, Singapore and
Ireland, which operate under various incentive tax grants that
begin to expire in 2011. Overall income tax expense primarily
relates to foreign taxes and does not include any benefit
related to U.S. NOLs.
Net consolidated income tax payments/(refunds), exclusive of
payments related to the tax examinations and litigation
discussed below, during 2005, 2004 and 2003 were
$592 million, $(144) million and $196 million,
respectively.
In January 2006, the Internal Revenue Service (IRS) completed
its examination of the Company’s
1993-1996 federal
income tax returns. The Company had made a cash payment in the
third quarter of 2005 in the form of a tax deposit of
approximately $239 million in anticipation of the
settlement of the
1993-1996 tax
examination and to prevent additional IRS interest charges. This
payment fully satisfied the liability associated with the tax
examination and was consistent with the previously recorded
reserves. The IRS is currently examining the Company’s
1997-2002 federal income tax returns.
The Company’s potential tax exposures result from the
varying application of statutes, regulations and interpretations
and include exposures on intercompany terms of cross border
arrangements and utilization of cash held by foreign
subsidiaries (investment in U.S. property). Although the
Company’s cross border arrangements between affiliates are
based upon internationally accepted standards, tax authorities
in various jurisdictions may disagree with and subsequently
challenge the amount of profits taxed in their country. It is
reasonably possible that the ultimate resolution of any tax
matters could materially affect shareholders’ equity,
liquidity and/or cash flows.
The Company believes that its accrual for tax contingencies is
adequate for all open years, based on past experience,
interpretations of tax law, and judgments about potential
actions by taxing authorities. The Company accrues liabilities
for identified tax contingencies that result from tax positions
taken that could be challenged by tax authorities. While the
Company believes that its tax reserves reflect the
64
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
probable outcome of identified tax contingencies, it is
reasonably possible that the ultimate resolution of any tax
matters may be materially greater or less than the amount
accrued.
In October 2001, IRS auditors asserted that two interest rate
swaps that the Company entered into with an unrelated party
should be recharacterized as loans from affiliated companies,
resulting in additional tax liability for the 1991 and 1992 tax
years. In September 2004, the Company made payments to the IRS
in the amount of $194 million for income tax and
$279 million for interest. The Company filed refund claims
for the tax and interest with the IRS in December 2004.
Following the IRS’s denial of the Company’s claims for
a refund, the Company filed suit in May 2005 in the
U.S. District Court for the District of New Jersey for
refund of the full amount of the tax and interest. This refund
litigation is currently in the discovery phase. The
Company’s tax reserves were adequate to cover the above
mentioned payments.
|
|
6. |
RETIREMENT PLANS AND OTHER POST-RETIREMENT BENEFITS |
The Company has defined benefit pension plans covering eligible
employees in the U.S. and certain foreign countries. For the
U.S. plan, benefits for normal retirement are primarily
based upon the participant’s average final earnings, years
of service and Social Security income, and are modified for
early retirement. Death and disability benefits are also
available under the plan. Benefits become fully vested after
five years of service. The plan provides for the continued
accrual of credited service for employees who opt to postpone
retirement and remain employed with the Company after reaching
the normal retirement age.
Non-U.S. pension
plans offer benefits that are competitive with local market
conditions.
In addition, the Company provides post-retirement medical and
life insurance benefits to its eligible U.S. retirees and
their dependents through its post-retirement benefit plans.
The measurement date for the majority of the plans’
liabilities is December 31. The net pension and other
post-retirement benefit costs totaled $165 million in 2005
as compared to $155 million in 2004 and $181 million
in 2003.
The consolidated weighted average assumptions used to determine
benefit obligations at December 31 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Post- | |
|
|
Retirement | |
|
retirement | |
|
|
Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
Discount rate
|
|
|
5.3% |
|
|
|
5.6% |
|
|
|
5.7% |
|
|
|
6.0% |
|
Rate of increase in future compensation
|
|
|
3.8% |
|
|
|
3.9% |
|
|
|
N/A |
|
|
|
N/A |
|
The assumptions above are used to develop the benefit
obligations at year-end.
The consolidated weighted average assumptions used to determine
net benefit costs for the years ended December 31 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Post-retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Discount rate
|
|
|
5.6% |
|
|
|
5.7% |
|
|
|
6.3% |
|
|
|
6.0% |
|
|
|
6.0% |
|
|
|
6.7% |
|
Long-term expected rate of return on plan assets
|
|
|
7.5% |
|
|
|
7.6% |
|
|
|
8.5% |
|
|
|
7.5% |
|
|
|
7.5% |
|
|
|
8.0% |
|
Rate of increase in future compensation
|
|
|
3.9% |
|
|
|
3.9% |
|
|
|
3.9% |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
65
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The assumptions used to determine net periodic benefit costs for
each year are established at the end of each previous year while
the assumptions used to determine benefit obligations are
established at each year-end. The net periodic benefit costs and
the actuarial present value of the benefit obligations are based
on actuarial assumptions that are determined annually based on
an evaluation of long-term trends, as well as market conditions,
that may have an impact on the cost of providing retirement
benefits.
The long-term expected rates of return on plan assets are
derived from return assumptions determined for each of the major
asset classes: equities, fixed income and real estate, on a
proportional basis. The return expectations for each of these
asset classes are based largely on assumptions about economic
growth and inflation, which are supported by long-term
historical data.
The weighted average assumed healthcare cost trend rate used for
post-retirement measurement purposes is 9.1 percent for
2006, trending down to 4.8 percent by 2013. A one percent
increase in the assumed healthcare cost trend rate would
increase combined post-retirement service and interest cost by
$8 million and the post-retirement benefit obligation by
$65 million. A one percent decrease in the assumed health
care cost trend rate would decrease combined post-retirement
service and interest cost by $6 million and the
post-retirement benefit obligation by $51 million.
Average retirement age is assumed based on the annual rates of
retirement experienced by the Company.
|
|
|
Components of Net Periodic Benefit Costs |
The components of net pension and other post-retirement benefits
expense were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Post-retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Service cost
|
|
$ |
102 |
|
|
$ |
91 |
|
|
$ |
71 |
|
|
$ |
15 |
|
|
$ |
13 |
|
|
$ |
9 |
|
Interest cost
|
|
|
106 |
|
|
|
102 |
|
|
|
85 |
|
|
|
24 |
|
|
|
22 |
|
|
|
18 |
|
Expected return on plan assets
|
|
|
(112 |
) |
|
|
(115 |
) |
|
|
(118 |
) |
|
|
(15 |
) |
|
|
(16 |
) |
|
|
(18 |
) |
Amortization, net
|
|
|
31 |
|
|
|
27 |
|
|
|
(1 |
) |
|
|
2 |
|
|
|
2 |
|
|
|
— |
|
Termination benefits(1)
|
|
|
7 |
|
|
|
18 |
|
|
|
70 |
|
|
|
1 |
|
|
|
2 |
|
|
|
9 |
|
Curtailment(1)
|
|
|
— |
|
|
|
— |
|
|
|
8 |
|
|
|
— |
|
|
|
— |
|
|
|
46 |
|
Settlement(1)
|
|
|
4 |
|
|
|
9 |
|
|
|
2 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net pension and other post-retirement benefits expense
|
|
$ |
138 |
|
|
$ |
132 |
|
|
$ |
117 |
|
|
$ |
27 |
|
|
$ |
23 |
|
|
$ |
64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Termination benefits, curtailment and settlement costs primarily
relate to the matters discussed in Note 2, “Special
Charges.” |
66
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
|
|
|
Benefit Obligations and Funded Status |
The components of the changes in the benefit obligations were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other | |
|
|
|
|
Post-retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Benefit obligations at beginning of year
|
|
$ |
1,995 |
|
|
$ |
1,822 |
|
|
$ |
409 |
|
|
$ |
431 |
|
|
Service cost
|
|
|
102 |
|
|
|
91 |
|
|
|
15 |
|
|
|
13 |
|
|
Interest cost
|
|
|
106 |
|
|
|
102 |
|
|
|
24 |
|
|
|
22 |
|
|
Participant contributions
|
|
|
4 |
|
|
|
6 |
|
|
|
1 |
|
|
|
1 |
|
|
Effects of exchange rate changes
|
|
|
(59 |
) |
|
|
41 |
|
|
|
— |
|
|
|
— |
|
|
Benefits paid
|
|
|
(91 |
) |
|
|
(119 |
) |
|
|
(23 |
) |
|
|
(21 |
) |
|
Acquisitions/ plan transfers
|
|
|
5 |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
|
Actuarial losses/(gains) (including assumption change)
|
|
|
91 |
|
|
|
39 |
|
|
|
38 |
|
|
|
(4 |
) |
|
Plan amendments
|
|
|
— |
|
|
|
8 |
|
|
|
(19 |
) |
|
|
(33 |
) |
|
Termination benefits(1)
|
|
|
2 |
|
|
|
6 |
|
|
|
— |
|
|
|
— |
|
|
Curtailment(1)
|
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit obligations at end of year
|
|
$ |
2,155 |
|
|
$ |
1,995 |
|
|
$ |
451 |
|
|
$ |
409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit obligations of over-funded plans
|
|
$ |
84 |
|
|
$ |
16 |
|
|
$ |
— |
|
|
$ |
— |
|
Benefit obligations of under-funded plans
|
|
|
2,071 |
|
|
|
1,979 |
|
|
|
451 |
|
|
|
409 |
|
|
|
(1) |
Termination benefits and Curtailment costs primarily relate to
the matters discussed in Note 2, “Special
Charges.” |
The components of the changes in plan assets were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Post- | |
|
|
|
|
retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Fair value of plan assets, primarily stocks and bonds, at
beginning of year
|
|
$ |
1,429 |
|
|
$ |
1,319 |
|
|
$ |
197 |
|
|
$ |
200 |
|
|
Actual gain (loss) on plan assets
|
|
|
122 |
|
|
|
113 |
|
|
|
9 |
|
|
|
17 |
|
|
Contributions
|
|
|
27 |
|
|
|
82 |
|
|
|
2 |
|
|
|
1 |
|
|
Acquisitions/ plan transfers
|
|
|
1 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Effects of exchange rate changes
|
|
|
(47 |
) |
|
|
34 |
|
|
|
— |
|
|
|
— |
|
|
Benefits paid
|
|
|
(91 |
) |
|
|
(119 |
) |
|
|
(23 |
) |
|
|
(21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of plan assets at end of year
|
|
$ |
1,441 |
|
|
$ |
1,429 |
|
|
$ |
185 |
|
|
$ |
197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plan assets of over-funded plans
|
|
$ |
96 |
|
|
$ |
18 |
|
|
$ |
— |
|
|
$ |
— |
|
Plan assets of under-funded plans
|
|
|
1,345 |
|
|
|
1,411 |
|
|
|
185 |
|
|
|
197 |
|
In addition to the plan assets indicated above, at
December 31, 2005 and 2004, securities investments of
$70 million and $71 million, respectively, were held
in a non-qualified trust designated to provide pension benefits
for certain under-funded plans.
At December 31, 2005 and 2004, the accumulated benefit
obligations (ABO) for the retirement plans were
$1,844 million and $1,672 million, respectively. The
aggregated accumulated benefit obligations and
67
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
fair values of plan assets for retirement plans with accumulated
benefit obligations in excess of plan assets were
$1,671 million and $1,232 million, respectively, at
December 31, 2005, and $1,331 million and
$1,029 million, respectively, at December 31, 2004.
In accordance with FASB Staff Position 106-2, Accounting and
Disclosure Requirements Related to the Medicare Prescription
Drug, Improvement and Modernization Act of 2003 (the Medicare
Act), the Company began accounting for the effect of the federal
subsidy under the Medicare Act in the third quarter of 2004. As
a result, the Company’s accumulated other post-retirement
benefit obligation was reduced by $48 million, and the
Company’s net other post-retirement benefits expense was
reduced by $7 million during 2004. The reduction in the
other post-retirement benefits expense consists of reductions in
service cost, interest cost and net amortization of
$2 million, $3 million and $2 million,
respectively.
The following is a reconciliation of the funded status of the
plans to the net asset/(liability):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other | |
|
|
|
|
Post-retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Benefit obligations in excess of plan assets
|
|
$ |
(714 |
) |
|
$ |
(566 |
) |
|
$ |
(266 |
) |
|
$ |
(212 |
) |
Post measurement date contributions
|
|
|
4 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Unrecognized prior service costs
|
|
|
69 |
|
|
|
78 |
|
|
|
(48 |
) |
|
|
(2 |
) |
Unrecognized net actuarial loss
|
|
|
669 |
|
|
|
636 |
|
|
|
203 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net asset/(liability) at end of year
|
|
$ |
28 |
|
|
$ |
148 |
|
|
$ |
(111 |
) |
|
$ |
(81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The unrecognized actuarial gains or losses primarily represent
the cumulative difference between the actuarial assumptions and
the actual returns from plan assets, changes in discount rates
and plans’ experience. At December 31, 2005, the
Company has an unrecognized net actuarial loss of
$669 million for the retirement plans and $203 million
for the post-retirement benefit plans. Total unrecognized net
loss amounts in excess of certain thresholds are amortized into
net pension and other post-retirement benefit cost over the
average remaining service life of employees.
The components of the net asset/(liability) were recorded in the
consolidated balance sheet as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other | |
|
|
|
|
Post-retirement | |
|
|
Retirement Plans | |
|
Benefits | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Prepaid benefit cost
|
|
$ |
51 |
|
|
$ |
124 |
|
|
$ |
— |
|
|
$ |
— |
|
Accrued benefit cost
|
|
|
(439 |
) |
|
|
(312 |
) |
|
|
(111 |
) |
|
|
(81 |
) |
Intangible assets
|
|
|
61 |
|
|
|
49 |
|
|
|
— |
|
|
|
— |
|
Accumulated other comprehensive income
|
|
|
355 |
|
|
|
287 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net asset/(liability) at end of year
|
|
$ |
28 |
|
|
$ |
148 |
|
|
$ |
(111 |
) |
|
$ |
(81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2005 and 2004, the Company’s
additional minimum pension liability was $416 million and
$335 million, respectively, primarily related to domestic
retirement plans. This resulted in an adjustment to accumulated
other comprehensive income/(loss), net of tax, of
$56 million and $(14) million in 2005 and 2004,
respectively.
68
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
|
|
|
Plan Assets at Fair Value |
The asset allocation for the consolidated retirement plans at
December 31, 2005 and 2004, and the target allocation for
2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of | |
|
|
|
|
Plan Assets at | |
|
|
Target | |
|
December 31, | |
|
|
Allocation | |
|
| |
Asset Category |
|
2006 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
Equity Securities
|
|
|
59% |
|
|
|
62% |
|
|
|
60% |
|
Debt Securities
|
|
|
36 |
|
|
|
32 |
|
|
|
33 |
|
Real Estate
|
|
|
5 |
|
|
|
6 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
100% |
|
|
|
100% |
|
|
|
100% |
|
|
|
|
|
|
|
|
|
|
|
The asset allocation for the post-retirement benefit trusts at
December 31, 2005 and 2004, and the target allocation for
2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of | |
|
|
|
|
Plan Assets at | |
|
|
Target | |
|
December 31, | |
|
|
Allocation | |
|
| |
Asset Category |
|
2006 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
Equity Securities
|
|
|
70% |
|
|
|
72% |
|
|
|
74% |
|
Debt Securities
|
|
|
30 |
|
|
|
28 |
|
|
|
26 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
100% |
|
|
|
100% |
|
|
|
100% |
|
|
|
|
|
|
|
|
|
|
|
The Company’s investments related to these plans are
broadly diversified, consisting primarily of equities and fixed
income securities, with an objective of generating long-term
investment returns that are consistent with an acceptable level
of overall portfolio market value risk. The assets are
periodically rebalanced back to the target allocations.
|
|
|
Estimated Future Benefit Payments |
The following benefit payments, which reflect expected future
service, as appropriate, are expected to be paid:
|
|
|
|
|
|
|
|
|
|
|
|
|
Other | |
|
|
Retirement | |
|
Post-retirement | |
|
|
Plans | |
|
Benefits(1) | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
2006
|
|
$ |
96 |
|
|
$ |
23 |
|
2007
|
|
|
88 |
|
|
|
24 |
|
2008
|
|
|
89 |
|
|
|
26 |
|
2009
|
|
|
95 |
|
|
|
27 |
|
2010
|
|
|
99 |
|
|
|
28 |
|
Years 2011-2015
|
|
|
630 |
|
|
|
158 |
|
|
|
(1) |
Expected benefit payments have not been reduced for expected
subsidy payments under the Medicare Act of $2 million,
$3 million, $3 million, $3 million,
$3 million, and $21 million in 2006, 2007, 2008, 2009,
2010, and 2011-2015, respectively. |
The Company’s practice is to fund qualified pension plans
at least at sufficient amounts to meet the minimum requirements
set forth in applicable laws.
69
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The Company expects to contribute approximately
$100 million to its retirement plans during 2006, including
about $50 million to its U.S. Retirement Plan. The
contribution in the U.S. may change based on the outcome of
pending funding reform legislation.
|
|
|
Defined Contribution Plans |
In 2003, the Company had a defined contribution profit-sharing
plan covering substantially all of its full-time domestic
employees who have completed one year of service. The annual
contribution was determined by a formula based on the
Company’s income, shareholders’ equity and
participants’ compensation.. There was no profit sharing
contribution in 2003 as determined by the formula described
above. The Company no longer makes contributions to this plan.
Beginning in 2004, the Company makes contributions to an
existing defined contribution savings plan equal to three
percent of eligible employee earnings, plus a matching of up to
two percent of eligible employee earnings based on employee
contributions to this plan. The total Company contributions to
this plan in 2005 and 2004 were $58 million and
$48 million, respectively.
|
|
7. |
EARNINGS PER COMMON SHARE |
The following table reconciles the components of the basic and
diluted earnings/(loss) per share computations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars and shares in millions) | |
EPS Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss)
|
|
$ |
269 |
|
|
$ |
(947 |
) |
|
$ |
(92 |
) |
Less: Preferred stock dividends
|
|
|
86 |
|
|
|
34 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) available to common shareholders
|
|
$ |
183 |
|
|
$ |
(981 |
) |
|
$ |
(92 |
) |
|
|
|
|
|
|
|
|
|
|
EPS Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Average shares outstanding for basic EPS
|
|
|
1,476 |
|
|
|
1,472 |
|
|
|
1,469 |
|
Dilutive effect of options and deferred stock units
|
|
|
8 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Average shares outstanding for diluted EPS
|
|
|
1,484 |
|
|
|
1,472 |
|
|
|
1,469 |
|
|
|
|
|
|
|
|
|
|
|
The equivalent common shares issuable under the Company’s
stock incentive plans which were excluded from the computation
of diluted EPS because their effect would have been antidilutive
were 39 million, 89 million and 77 million,
respectively, for the years ended December 31, 2005, 2004
and 2003, respectively. Also, for the years ended
December 31, 2005 and 2004, 69 million and
27 million common shares, respectively, obtainable upon
conversion of the Company’s 6 percent Mandatory
Convertible Preferred Stock were excluded from the computation
of diluted earnings per share because their effect would have
been antidilutive.
|
|
8. |
COMPREHENSIVE INCOME/(LOSS) |
The components of accumulated other comprehensive income/(loss)
at December 31 were:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
Foreign currency translation adjustment
|
|
$ |
(291 |
) |
|
$ |
(131 |
) |
Minimum pension liability, net of tax
|
|
|
(238 |
) |
|
|
(182 |
) |
Unrealized gain on investments available for sale, net of tax
|
|
|
13 |
|
|
|
13 |
|
|
|
|
|
|
|
|
Total
|
|
$ |
(516 |
) |
|
$ |
(300 |
) |
|
|
|
|
|
|
|
70
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
Gross unrealized pre-tax gains on investments in 2005 and 2004
were $0 and $5 million, respectively; unrealized losses
were immaterial.
Inventories consisted of the following at December 31:
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
Finished products
|
|
$ |
665 |
|
|
$ |
630 |
|
Goods in process
|
|
|
614 |
|
|
|
651 |
|
Raw materials and supplies
|
|
|
326 |
|
|
|
299 |
|
|
|
|
|
|
|
|
|
Total inventories
|
|
$ |
1,605 |
|
|
$ |
1,580 |
|
|
|
|
|
|
|
|
Inventories valued on a
last-in, first-out
basis comprised approximately 19 percent of total
inventories at December 31, 2005 and 2004. The estimated
replacement cost of total inventories at December 31, 2005
and 2004 was $1,652 million and $1,624 million,
respectively.
|
|
10. |
OTHER INTANGIBLE ASSETS |
The components of other intangible assets, net are as follows at
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
Gross | |
|
|
|
Gross | |
|
|
|
|
Carrying | |
|
Accumulated | |
|
|
|
Carrying | |
|
Accumulated | |
|
|
|
|
Amount | |
|
Amortization | |
|
Net | |
|
Amount | |
|
Amortization | |
|
Net | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Patents and licenses
|
|
$ |
579 |
|
|
$ |
329 |
|
|
$ |
250 |
|
|
$ |
558 |
|
|
$ |
287 |
|
|
$ |
271 |
|
Trademarks and other
|
|
|
166 |
|
|
|
51 |
|
|
|
115 |
|
|
|
144 |
|
|
|
44 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other intangible assets
|
|
$ |
745 |
|
|
$ |
380 |
|
|
$ |
365 |
|
|
$ |
702 |
|
|
$ |
331 |
|
|
$ |
371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in other are pension assets of $61 million and
$49 million for 2005 and 2004, respectively.
Patents, licenses and trademarks are amortized on the
straight-line method over their respective useful lives. The
residual value of intangible assets is estimated to be zero.
During 2005, the Company recorded $11 million in base
technology intangibles related to the acquisition of
NeoGenesis’ assets. This amount is being amortized over
five years.
During 2005, the Company restructured its INTEGRILIN
co-promotion agreement with Millennium Pharmaceuticals, Inc.
(Millennium). As a result, $36 million has been included in
intangible assets and is being amortized over approximately nine
years.
Included in intangible assets is approximately $120 million
related to the license and co-promotion agreements with Bayer.
These amounts are being amortized over the effective useful
lives of the agreements ranging from seven to 14 years.
See Note 11, “Product Licenses and Acquisitions,”
for additional information on the above transactions.
During 2004, the net carrying amount of patents and licenses was
reduced by approximately $118 million as a result of
Bristol-Myers Squibb’s reacquisition of co-promotion rights
of TEQUIN in the U.S.
Amortization expense related to other intangible assets in 2005,
2004 and 2003 was $49 million, $42 million, and
$55 million, respectively. All intangible assets are
reviewed to determine their
71
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
recoverability by comparing their carrying values to their
expected undiscounted future cash flows when events or
circumstances warrant such a review.
|
|
11. |
PRODUCT LICENSES & ACQUISITIONS |
On February 14, 2005, the Company acquired most of the
assets of NeoGenesis Pharmaceuticals for approximately
$18 million, of which $11 million was recorded as an
intangible asset related to base technology. NeoGenesis applies
novel screening and chemistry technologies to discover new drug
candidates.
In August 2005, the Company announced that it exercised its
right to develop and commercialize with Centocor, Inc.
(Centocor), golimumab, a fully human monoclonal antibody being
developed as a therapy for the treatment of rheumatoid arthritis
and other immune-mediated inflammatory diseases. Pursuant to the
exercise, the Company receives exclusive worldwide marketing
rights to golimumab, excluding the U.S., Japan, China (including
Hong Kong), Taiwan, and Indonesia. In exchange for its rights
under this agreement, the Company made an upfront payment in the
amount of $124 million to Centocor before a tax benefit of
$6 million. This payment has been expensed and reported in
Research and development for the year ended December 31,
2005, in the Statements of Consolidated Operations. The Company
is sharing development costs with Centocor.
Effective September 1, 2005, the Company restructured its
INTEGRILIN co-promotion agreement with Millennium. Under the
terms of the restructured agreement, the Company acquired
exclusive U.S. development and commercialization rights to
INTEGRILIN in exchange for an upfront payment of
$36 million and royalties on INTEGRILIN sales. The Company
has agreed to pay minimum royalties of $85 million per year
to Millennium for 2006 and 2007. The Company also purchased
existing INTEGRILIN inventory from Millennium. The
$36 million upfront payment has been capitalized and
included in other intangible assets.
During 2004, the Company entered into a collaboration and
license agreement with Toyama Chemical Co. Ltd (Toyama). Under
the terms of the agreement, the Company has acquired the
exclusive worldwide rights, excluding Japan, Korea and China, to
develop, use and sell garenoxacin for all human and veterinary
uses (excluding topical ophthalmic applications). Garenoxacin is
Toyama’s quinolone antibacterial agent currently under
regulatory review in the U.S. In connection with the
execution of the agreement, the Company incurred a charge in the
second quarter of 2004 for an up-front fee of $80 million
to Toyama. This amount has been expensed and reported in
Research and development for the year ended December 31,
2004, in the Statements of Consolidated Operations.
During 2004, the Company entered into a strategic agreement with
Bayer intended to enhance the Company’s pharmaceutical
resources. Under the terms of this agreement, the Company has
exclusive rights in the U.S. and Puerto Rico to market, sell and
distribute the AVELOX and CIPRO antibiotics for all uses
(excluding certain topical formulations for administration to
the eye or ear). The Company pays Bayer royalties generally in
excess of 50 percent of these products based on sales.
Under the agreement, the Company also undertook Bayer’s
U.S. commercialization activities for the erectile
dysfunction medicine LEVITRA under Bayer’s co-promotion
agreement with GlaxoSmithKline PLC. In the Japanese market,
Bayer will co-market the Company’s cholesterol-absorption
inhibitor ZETIA, when it is approved. The Company has received
and recorded deferred revenue of $120 million related to
the sale of ZETIA co-promotion rights to Bayer. This deferred
revenue will begin to be recognized upon regulatory approval in
Japan. ZETIA is currently under regulatory review in Japan.
Under certain circumstances, if ZETIA does not receive
regulatory/marketing approval in Japan by a certain date, this
amount will be required to be repaid to Bayer.
The agreement with Bayer potentially restricts the Company from
marketing products in the U.S. that would compete with any
of the products under the agreement. As a result, the Company
expects that it
72
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
will sublicense rights to garenoxacin, the quinolone
antibacterial agent that the Company licensed from Toyama in
2004.
|
|
12. |
SHORT-TERM BORROWINGS, LONG-TERM DEBT AND OTHER
COMMITMENTS |
|
|
|
Short and Long-Term Borrowings |
In general, short-term borrowings consist of bank loans and
commercial paper issued in the U.S. Short-term borrowings
at December 31, 2005 and 2004 totaled $1.3 billion and
$1.6 billion, respectively. Included in short-term
borrowings is commercial paper outstanding at December 31,
2005 and 2004 of $298 million and $1.5 billion,
respectively. The weighted average interest rate for short-term
borrowings at December 31, 2005 and 2004 was
4.7 percent and 2.6 percent respectively.
On November 26, 2003, the Company issued $1.25 billion
aggregate principal amount of 5.3 percent senior unsecured
notes due 2013 and $1.15 billion aggregate principal amount
of 6.5 percent senior unsecured notes due 2033. Interest is
payable semi-annually. The net proceeds from this offering were
$2.37 billion. Upon issuance, the notes were rated A3 by
Moody’s Investors Service, Inc. (Moody’s), and A+ by
Standard & Poor’s Rating Services (S&P). The
interest rates payable on the notes are subject to adjustment as
follows: if the rating assigned to a particular series of notes
by either Moody’s or S&P changes to a rating set forth
below, the interest rate payable on that series of notes will be
the initial interest rate (5.3 percent for the notes due
2013 and 6.5 percent for the notes due 2033) plus the
additional interest rate set forth below by Moody’s and
S&P:
|
|
|
|
|
|
|
|
|
Additional Interest Rate |
|
Moody’s Rating | |
|
S&P Rating | |
|
|
| |
|
| |
0.25%
|
|
|
Baa1 |
|
|
|
BBB+ |
|
0.50%
|
|
|
Baa2 |
|
|
|
BBB |
|
0.75%
|
|
|
Baa3 |
|
|
|
BBB- |
|
1.00%
|
|
|
Ba1 or below |
|
|
|
BB+ or below |
|
In no event will the interest rate for any of the notes increase
by more than 2 percent above the initial coupon rates of
5.3 percent and 6.5 percent, respectively. If either
Moody’s or S&P subsequently upgrades its ratings, the
interest rates will be correspondingly reduced, but not below
5.3 percent or 6.5 percent, respectively. Furthermore,
the interest rate payable on a particular series of notes will
return to 5.3 percent and 6.5 percent, respectively,
and the rate adjustment provisions will permanently cease to
apply if, following a downgrade by either Moody’s or
S&P below A3 or A-, respectively, the notes are subsequently
rated above Baa1 by Moody’s and BBB+ by S&P.
On July 14, 2004, Moody’s lowered its rating of the
notes to Baa1 and, accordingly, the interest payable on each
note increased by 25 basis points, effective
December 1, 2004. Therefore, effective on December 1,
2004, the interest rate payable on the notes due 2013 increased
from 5.3 percent to 5.55 percent, and the interest
rate payable on the notes due 2033 increased from
6.5 percent to 6.75 percent. At December 31,
2005, the notes were rated Baa1 by Moody’s and A- by
S&P.
The notes are redeemable in whole or in part, at the
Company’s option at any time, at a redemption price equal
to the greater of (1) 100 percent of the principal
amount of such notes and (2) the sum of the present values
of the remaining scheduled payments of principal and interest
discounted using the rate of Treasury Notes with comparable
remaining terms plus 25 basis points for the 2013 notes or
35 basis points for the 2033 notes.
The Company has a revolving credit facility from a syndicate of
major financial institutions. During March 2005, the Company
negotiated an increase in the commitment under this facility
from $1.25 billion to $1.5 billion with no changes in
the basic terms of the pre-existing credit facility.
Concurrently with the
73
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
increase in commitments under this facility, the Company
terminated early a separate $250 million line of credit
which would have matured in May 2006. There was no outstanding
balance under this facility at the time it was terminated. The
existing $1.5 billion credit facility matures in May 2009
and requires the Company to maintain a total debt to capital
ratio of no more than 60 percent. This credit line is
available for general corporate purposes and management
considers this facility as support to the Company’s
commercial paper borrowings. Borrowings under the credit
facility may be drawn by the U.S. parent company or by its
wholly-owned international subsidiaries when accompanied by a
parent guarantee. This facility does not require compensating
balances, however, a nominal commitment fee is paid. As of
December 31, 2005, $325 million has been drawn down
under this facility by a wholly-owned international subsidiary
to fund AJCA repatriations.
In addition to the aforementioned credit facility, the Company
entered into a $575 million credit facility during the
fourth quarter of 2005, all of which was drawn as of
December 31, 2005. This credit facility was utilized by a
wholly-owned international subsidiary to fund repatriations
under the AJCA. This credit facility requires the Company to
maintain a total debt to total capital ratio of no more than
60 percent. These borrowings are payable no later than
November 4, 2008. Any funds borrowed under this facility
which are subsequently repaid may not be re-borrowed.
All credit facility borrowings have been classified as
short-term borrowings as the Company intends to repay these
amounts in the next twelve months.
In addition, the Company’s international subsidiaries had
approximately $173 million available in unused lines of
credit from various financial institutions at December 31,
2005.
Total rent expense amounted to $110 million in 2005,
$100 million in 2004, and $91 million in 2003. Future
annual minimum rental commitments on non-cancelable operating
leases as of December 31, 2005, are as follows: 2006,
$76 million; 2007, $63 million; 2008,
$45 million; 2009, $21 million; 2010,
$12 million; with aggregate minimum lease obligations of
$32 million due thereafter.
As of December 31, 2005, capital lease obligations of
$1 million and $6 million are included in current
portion of long-term debt and long-term debt, respectively.
As of December 31, 2005, the Company has commitments
totaling $175 million related to capital expenditures to be
made in 2006.
|
|
13. |
FINANCIAL INSTRUMENTS |
SFAS 133, “Derivative Instruments and Financial
Hedging Activities,” as amended, requires all derivatives
to be recorded on the balance sheet at fair value. This
accounting standard also provides that the effective portion of
qualifying cash flow hedges be recognized in income when the
hedged item affects income; that changes in the fair value of
derivatives that qualify as fair value hedges, along with the
change in the fair value of the hedged risk, be recognized as
they occur; and that changes in the fair value of derivatives
that do not qualify for hedge treatment, as well as the
ineffective portion of qualifying hedges, be recognized in
income as they occur.
|
|
|
Risks, Policy and Objectives |
The Company is exposed to market risk, primarily from changes in
foreign currency exchange rates and, to a lesser extent, from
interest rate and equity price changes. From time to time, the
Company will hedge selective foreign currency risks with
derivatives. Currently, management has not deemed it cost
effective to engage in a formula-based program of hedging the
profits and cash flows of international operations using
derivative financial instruments. Because the Company’s
international subsidiaries purchase significant quantities of
inventory payable in U.S. dollars, managing the level of
inventory and
74
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
related payables and the rate of inventory turnover can provide
a natural level of protection against adverse changes in
exchange rates. Furthermore, the risk of adverse exchange rate
change is somewhat mitigated by the fact that the Company’s
international operations are widespread. On a limited basis, the
Company will hedge selective foreign currency contract exposures
to mitigate exchange rate risks.
The Company mitigates credit risk on derivative instruments by
dealing only with counterparties considered to be financially
sound. Accordingly, the Company does not anticipate loss for
non-performance. The Company does not enter into derivative
instruments to generate trading profits.
The table below presents the carrying values and estimated fair
values for certain of the Company’s financial instruments
at December 31. Estimated fair values were determined based
on market prices, where available, or dealer quotes. The
carrying values of all other financial instruments, including
cash and cash equivalents, approximated their estimated fair
values at December 31, 2005 and 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
Carrying | |
|
Estimated | |
|
Carrying | |
|
Estimated | |
|
|
Value | |
|
Fair Value | |
|
Value | |
|
Fair Value | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments
|
|
$ |
818 |
|
|
$ |
818 |
|
|
$ |
851 |
|
|
$ |
851 |
|
Long-term investments
|
|
|
144 |
|
|
|
147 |
|
|
|
153 |
|
|
|
157 |
|
|
LIABILITIES: |
Short-term borrowings and current portion of long-term debt
|
|
$ |
1,278 |
|
|
$ |
1,278 |
|
|
$ |
1,569 |
|
|
$ |
1,569 |
|
Long-term debt
|
|
|
2,399 |
|
|
|
2,583 |
|
|
|
2,392 |
|
|
|
2,600 |
|
Long-term investments, which are included in other non-current
assets, primarily consist of debt and equity securities held in
non-qualified trusts to fund long-term employee benefit
obligations, which are included as liabilities in the
Consolidated Balance Sheets. These assets can only be used to
fund the related liabilities.
|
|
|
Interest Rate Swap Contract |
Prior to March 2005, the Company had an interest rate swap
arrangement in effect with a counterparty bank. The arrangement
utilized two long-term interest rate swap contracts, one between
a foreign-based subsidiary of the Company and a bank and the
other between a U.S. subsidiary of the Company and the same
bank. The two contracts had equal and offsetting terms and were
covered by a master netting arrangement. The contract involving
the foreign-based subsidiary permitted the subsidiary to prepay
a portion of its future obligation to the bank, and the contract
involving the U.S. subsidiary permitted the bank to prepay
a portion of its future obligation to the U.S. subsidiary.
Prepayments totaling $1.9 billion were made under both
contracts as of December 31, 2004.
The terms of the swap contracts, as amended, called for a phased
termination of the swaps based on an agreed repayment schedule
that was to begin no later than March 31, 2005. Termination
would require the Company and the counterparty each to repay all
prepayments pursuant to the agreed repayment schedule. The
Company, at its option, was allowed to accelerate the
termination of the arrangement and associated scheduled
repayments for a nominal fee.
On February 28, 2005, the Company’s foreign-based
subsidiary and U.S. subsidiary each gave notice to the
counterparty of their intent to terminate the arrangement. On
March 21, 2005, the Company terminated these swap
agreements and all associated repayments were made by the
respective obligors.
75
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
The termination of this arrangement did not have a material
impact on the Company’s Statement of Consolidated
Operations.
The Company has authorized 50,000,000 shares of preferred
stock that consists of: 12,000,000 preferred shares designated
as Series A Junior Participating Preferred Stock,
28,750,000 preferred shares designated as 6 percent
Mandatory Convertible Preferred Stock, and 9,250,000 preferred
shares whose designations have not yet been determined.
|
|
6 |
percent Mandatory Convertible Preferred Stock and Shelf
Registration |
On August 10, 2004, the Company issued
28,750,000 shares of 6 percent Mandatory Convertible
Preferred Stock (the Preferred Stock) with a face value of
$1.44 billion. Net proceeds to the Company were
$1.4 billion after deducting commissions, discounts and
other underwriting expenses. The Preferred Stock will
automatically convert into between 2.2451 and 2.7840 common
shares of the Company depending on the average closing price of
the Company’s common shares over a period immediately
preceding the mandatory conversion date of September 14,
2007, as defined in the prospectus. The preferred shareholders
may elect to convert at any time prior to September 14,
2007, at the minimum conversion ratio of 2.2451 common shares
per share of the Preferred Stock. Additionally, if at any time
prior to the mandatory conversion date, the closing price of the
Company’s common shares exceeds $33.41 (for at least 20
trading days within a period of 30 consecutive trading days),
the Company may elect to cause the conversion of all, but not
less than all, of the Preferred Stock then outstanding at the
same minimum conversion ratio of 2.2451 common shares for each
preferred share.
The Preferred Stock accrues dividends at an annual rate of
6 percent on shares outstanding. The dividends are
cumulative from the date of issuance and, to the extent the
Company is legally permitted to pay dividends and the Board of
Directors declares a dividend payable, the Company will pay
dividends on each dividend payment date. The dividend payment
dates are March 15, June 15, September 15 and
December 15, with the first dividend having been paid on
December 15, 2004.
As of December 31, 2005, the Company has the ability to
issue $563 million (principal amount) of securities under a
currently effective Securities and Exchange Commission
(SEC) shelf registration.
A summary of treasury share transactions for the years ended
December 31 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Shares in millions) | |
Share balance at January 1
|
|
|
555 |
|
|
|
559 |
|
|
|
562 |
|
Shares issued under stock incentive plans
|
|
|
(5 |
) |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
Share balance at December 31
|
|
|
550 |
|
|
|
555 |
|
|
|
559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Share Purchase Rights |
The Company has Preferred Share Purchase Rights outstanding that
are attached to and presently only trade with the Company’s
common shares and are not exercisable. The rights will become
exercisable only if a person or group acquires 20 percent
or more of the Company’s common stock or announces a tender
offer that, if completed, would result in ownership by a person
or group of 20 percent or more of the Company’s common
stock. Should a person or group acquire 20 percent or more
of the Company’s outstanding common stock through a merger
or other business combination transaction, each right will
76
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
entitle its holder (other than such acquirer) to purchase common
shares of Schering-Plough having a market value of twice the
exercise price of the right. The exercise price of the rights is
$100.
Following the acquisition by a person or group of beneficial
ownership of 20 percent or more but less than
50 percent of the Company’s common stock, the Board of
Directors may call for the exchange of the rights (other than
rights owned by such acquirer), in whole or in part, at an
exchange ratio of one common share or one two-hundredth of a
share of Series A Junior Participating Preferred Stock per
right. Also, prior to the acquisition by a person or group of
beneficial ownership of 20 percent or more of the
Company’s common stock, the rights are redeemable for
$.005 per right at the option of the Board of Directors.
The rights will expire on July 10, 2007, unless earlier
redeemed or exchanged. The Board of Directors is also authorized
to reduce the 20 percent thresholds referred to above to
not less than the greater of (i) the sum of
.001 percent and the largest percentage of the outstanding
shares of common stock then known to the Company to be
beneficially owned by any person or group of affiliated or
associated persons and (ii) 10 percent, except that,
following the acquisition by a person or group of beneficial
ownership of 20 percent or more of the Company’s
common stock, no such reduction may adversely affect the
interests of the holders of the rights.
|
|
15. |
STOCK INCENTIVE PLANS |
Under the terms of the Company’s 2002 Stock Incentive Plan,
which was approved by the Company’s shareholders,
72 million of the Company’s common shares may be
granted as stock options or awarded as deferred stock units to
officers and certain employees of the Company through December
2007. As of December 31, 2005, 11 million options and
deferred stock units remain available for future year grants
under the 2002 Stock Incentive Plan. Option exercise prices
equal the market price of the common shares at their grant
dates. Options expire no later than 10 years after the date
of grant. Options granted in 2005 and 2004 generally had a
three-year vesting term, while those granted in 2003 and prior
generally had a one-year vesting term. Other option grants vest
over longer periods ranging from three to nine years. Deferred
stock units are payable in an equivalent number of common
shares; the shares are distributable in a single installment or
in three or five equal annual installments generally commencing
three years from the date of the award.
The following table summarizes stock option activity over the
past three years under the current and prior plans. These
incentive plans are approved by the Company’s shareholders.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
Number | |
|
Average | |
|
Number | |
|
Average | |
|
Number | |
|
Average | |
|
|
of | |
|
Exercise | |
|
of | |
|
Exercise | |
|
of | |
|
Exercise | |
|
|
Options | |
|
Price | |
|
Options | |
|
Price | |
|
Options | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Number of options in millions) | |
Outstanding at January 1
|
|
|
79 |
|
|
$ |
27.43 |
|
|
|
71 |
|
|
$ |
30.15 |
|
|
|
54 |
|
|
$ |
35.40 |
|
|
Granted
|
|
|
12 |
|
|
|
19.58 |
|
|
|
19 |
|
|
|
18.12 |
|
|
|
23 |
|
|
|
17.57 |
|
|
Exercised
|
|
|
(4 |
) |
|
|
14.58 |
|
|
|
(2 |
) |
|
|
12.12 |
|
|
|
(1 |
) |
|
|
9.40 |
|
|
Canceled or expired
|
|
|
(5 |
) |
|
|
29.45 |
|
|
|
(9 |
) |
|
|
32.37 |
|
|
|
(5 |
) |
|
|
33.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31
|
|
|
82 |
|
|
$ |
27.00 |
|
|
|
79 |
|
|
$ |
27.43 |
|
|
|
71 |
|
|
$ |
30.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31
|
|
|
54 |
|
|
$ |
31.03 |
|
|
|
50 |
|
|
$ |
32.07 |
|
|
|
43 |
|
|
$ |
34.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
Summarized information about stock options outstanding and
exercisable at December 31, 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding | |
|
|
|
|
|
|
|
|
|
|
Weighted- | |
|
|
|
|
|
|
|
|
|
|
Average | |
|
Weighted- | |
|
|
|
Weighted- | |
|
|
Number | |
|
Remaining | |
|
Average | |
|
Exercisable | |
|
Average | |
|
|
of | |
|
Term in | |
|
Exercise | |
|
Number of | |
|
Exercise | |
Exercise Price Range |
|
Options | |
|
Years | |
|
Price | |
|
Options | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Number of options in millions) | |
Under $20
|
|
|
41 |
|
|
|
6.9 |
|
|
$ |
17.81 |
|
|
|
24 |
|
|
$ |
17.74 |
|
$20 to $30
|
|
|
10 |
|
|
|
9.2 |
|
|
|
20.83 |
|
|
|
— |
|
|
|
23.70 |
|
$30 to $40
|
|
|
16 |
|
|
|
4.2 |
|
|
|
36.57 |
|
|
|
15 |
|
|
|
36.59 |
|
Over $40
|
|
|
15 |
|
|
|
4.3 |
|
|
|
46.37 |
|
|
|
15 |
|
|
|
46.33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82 |
|
|
|
|
|
|
|
|
|
|
|
54 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2005, 2004 and 2003, the Company awarded deferred stock units
totaling 7.3 million units, 3.4 million units, and
3.2 million units, respectively. The weighted average fair
values of the deferred stock units granted in 2005, 2004 and
2003 were $20.65, $18.11 and $17.59, respectively.
The Company maintains insurance coverage with such deductibles
and self-insurance as management believes adequate for its needs
under current circumstances. Such coverage reflects market
conditions (including cost and availability) existing at the
time it is written, and the relationship of insurance coverage
to self-insurance varies accordingly. As a result of recent
external events, the availability of insurance has become more
restrictive. Management considers the impact of these changes as
it continually assesses the best way to provide for its
insurance needs in the future. The Company self-insures a
substantial proportion of risk as it relates to products’
liability.
The Company has three reportable segments: Prescription
Pharmaceuticals, Consumer Health Care and Animal Health. The
segment sales and profit data that follow are consistent with
the Company’s current management reporting structure. The
Prescription Pharmaceuticals segment discovers, develops,
manufactures and markets human pharmaceutical products. The
Consumer Health Care segment develops, manufactures and markets
over-the-counter, foot
care and sun care products, primarily in the U.S. The Animal
Health segment discovers, develops, manufactures and markets
animal health products.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Prescription Pharmaceuticals
|
|
$ |
7,564 |
|
|
$ |
6,417 |
|
|
$ |
6,611 |
|
Consumer Health Care
|
|
|
1,093 |
|
|
|
1,085 |
|
|
|
1,026 |
|
Animal Health
|
|
|
851 |
|
|
|
770 |
|
|
|
697 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated net sales
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
|
|
|
|
|
|
|
|
|
78
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Prescription Pharmaceuticals
|
|
$ |
733 |
|
|
$ |
13 |
|
|
$ |
513 |
|
Consumer Health Care
|
|
|
235 |
|
|
|
234 |
|
|
|
199 |
|
Animal Health
|
|
|
120 |
|
|
|
88 |
|
|
|
86 |
|
Corporate and other
|
|
|
(591 |
) |
|
|
(503 |
) |
|
|
(844 |
) |
|
|
|
|
|
|
|
|
|
|
Consolidated profit/(loss) before tax
|
|
$ |
497 |
|
|
$ |
(168 |
) |
|
$ |
(46 |
) |
|
|
|
|
|
|
|
|
|
|
“Corporate and other” includes interest income and
expense, foreign exchange gains and losses, headquarters
expenses, special charges and other miscellaneous items. The
accounting policies used for segment reporting are the same as
those described in Note 1, “Summary of Significant
Accounting Policies.”
In 2005, “Corporate and other” includes special
charges of $294 million, including $28 million of
employee termination costs, $16 million of asset impairment
and other charges, and an increase in litigation reserves by
$250 million resulting in a total reserve of
$500 million representing the Company’s current
estimate to resolve the Massachusetts investigation as well as
the investigations disclosed under “AWP
Investigations” and the state litigation disclosed under
“AWP Litigation” in Note 19, “Legal,
Environmental and Regulatory Matters.” It is estimated that
the charges relate to the reportable segments as follows:
Prescription Pharmaceuticals — $289 million,
Consumer Health Care — $2 million, Animal
Health — $1 million and Corporate and
other — $2 million.
In 2004, “Corporate and other” includes special
charges of $153 million, including $119 million of
employee termination costs, as well as $27 million of asset
impairment charges and $7 million of closure costs
primarily related to the exit from a small European research and
development facility. It is estimated the charges relate to the
reportable segments as follows: Prescription
Pharmaceuticals — $135 million, Consumer Health
Care — $3 million, Animal Health —
$2 million and Corporate and other —
$13 million.
In 2003, “Corporate and other” includes special
charges of $599 million, including $179 million of
employee termination costs, a $350 million provision to
increase litigation reserves, and $70 million of asset
impairment charges. It is estimated that the charges relate to
the reportable segments as follows: Prescription
Pharmaceuticals — $515 million, Consumer Health
Care — $25 million, Animal Health —
$4 million and Corporate and other —
$55 million.
79
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
Net Sales by Major
Product:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
PRESCRIPTION PHARMACEUTICALS
|
|
$ |
7,564 |
|
|
$ |
6,417 |
|
|
$ |
6,611 |
|
|
REMICADE
|
|
|
942 |
|
|
|
746 |
|
|
|
540 |
|
|
PEG-INTRON
|
|
|
751 |
|
|
|
563 |
|
|
|
802 |
|
|
NASONEX
|
|
|
737 |
|
|
|
594 |
|
|
|
500 |
|
|
CLARINEX/ AERIUS
|
|
|
646 |
|
|
|
692 |
|
|
|
694 |
|
|
TEMODAR
|
|
|
588 |
|
|
|
459 |
|
|
|
324 |
|
|
CLARITIN Rx
|
|
|
371 |
|
|
|
321 |
|
|
|
328 |
|
|
REBETOL
|
|
|
331 |
|
|
|
287 |
|
|
|
639 |
|
|
INTEGRILIN
|
|
|
315 |
|
|
|
325 |
|
|
|
306 |
|
|
INTRON A
|
|
|
287 |
|
|
|
318 |
|
|
|
409 |
|
|
AVELOX
|
|
|
228 |
|
|
|
44 |
|
|
|
— |
|
|
SUBUTEX
|
|
|
197 |
|
|
|
185 |
|
|
|
144 |
|
|
CAELYX
|
|
|
181 |
|
|
|
150 |
|
|
|
111 |
|
|
CIPRO
|
|
|
146 |
|
|
|
43 |
|
|
|
— |
|
|
ELOCON
|
|
|
144 |
|
|
|
168 |
|
|
|
154 |
|
|
Other Pharmaceutical
|
|
|
1,700 |
|
|
|
1,522 |
|
|
|
1,660 |
|
CONSUMER HEALTH CARE
|
|
|
1,093 |
|
|
|
1,085 |
|
|
|
1,026 |
|
|
OTC (includes OTC CLARITIN sales in 2005, 2004, and 2003 of
$394, $419, and $432, respectively)
|
|
|
556 |
|
|
|
578 |
|
|
|
588 |
|
|
Foot Care
|
|
|
333 |
|
|
|
331 |
|
|
|
292 |
|
|
Sun Care
|
|
|
204 |
|
|
|
176 |
|
|
|
146 |
|
ANIMAL HEALTH
|
|
|
851 |
|
|
|
770 |
|
|
|
697 |
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED NET SALES
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
|
|
|
|
|
|
|
|
|
Net Sales by Geographic
Area:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
United States
|
|
$ |
3,589 |
|
|
$ |
3,219 |
|
|
$ |
3,559 |
|
Europe and Canada
|
|
|
4,040 |
|
|
|
3,595 |
|
|
|
3,410 |
|
Pacific Area and Asia
|
|
|
995 |
|
|
|
676 |
|
|
|
649 |
|
Latin America
|
|
|
884 |
|
|
|
782 |
|
|
|
716 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated net sales
|
|
$ |
9,508 |
|
|
$ |
8,272 |
|
|
$ |
8,334 |
|
|
|
|
|
|
|
|
|
|
|
The Company has subsidiaries in more than 50 countries outside
the U.S. No single foreign country, except for France,
Italy and Japan, accounted for 5 percent or more of
consolidated net sales during the
80
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
past three years. Net sales are presented in the geographic area
in which the Company’s customers are located.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
% of | |
|
|
|
% of | |
|
|
|
% of | |
|
|
|
|
Consolidated | |
|
|
|
Consolidated | |
|
|
|
Consolidated | |
|
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
Total International net sales
|
|
$ |
5,919 |
|
|
|
62 |
% |
|
$ |
5,053 |
|
|
|
61 |
% |
|
$ |
4,775 |
|
|
|
57 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
France
|
|
|
771 |
|
|
|
8 |
% |
|
|
729 |
|
|
|
9 |
% |
|
|
691 |
|
|
|
8 |
% |
Japan
|
|
|
687 |
|
|
|
7 |
% |
|
|
385 |
|
|
|
5 |
% |
|
|
414 |
|
|
|
5 |
% |
Italy
|
|
|
457 |
|
|
|
5 |
% |
|
|
443 |
|
|
|
5 |
% |
|
|
436 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
% of | |
|
|
|
% of | |
|
|
|
% of | |
|
|
|
|
Consolidated | |
|
|
|
Consolidated | |
|
|
|
Consolidated | |
|
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
Net Sales | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
McKesson Corporation
|
|
$ |
1,073 |
|
|
|
11 |
% |
|
$ |
868 |
|
|
|
10 |
% |
|
$ |
667 |
|
|
|
8 |
% |
No single customer, except for McKesson Corporation, a major
pharmaceutical and health care products distributor, accounted
for 10 percent or more of consolidated net sales during the
past three years.
|
|
|
Long-lived Assets by Geographic Location: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
United States
|
|
$ |
2,538 |
|
|
$ |
2,447 |
|
|
$ |
2,507 |
|
Singapore
|
|
|
840 |
|
|
|
884 |
|
|
|
828 |
|
Ireland
|
|
|
486 |
|
|
|
449 |
|
|
|
444 |
|
Puerto Rico
|
|
|
307 |
|
|
|
298 |
|
|
|
317 |
|
Other
|
|
|
602 |
|
|
|
768 |
|
|
|
726 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
4,773 |
|
|
$ |
4,846 |
|
|
$ |
4,822 |
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets shown by geographic location are primarily
property.
|
|
|
Supplemental sales information: |
Sales of products comprising 10 percent or more of the
Company’s U.S. or international sales for the year
ended December 31, 2005, were as follows:
|
|
|
|
|
|
|
|
|
|
|
Amount | |
|
Percentage | |
|
|
| |
|
| |
|
|
(Dollars in millions) | |
U.S.
|
|
|
|
|
|
|
|
|
NASONEX
|
|
$ |
447 |
|
|
|
12% |
|
OTC CLARITIN
|
|
|
375 |
|
|
|
10% |
|
International
|
|
|
|
|
|
|
|
|
REMICADE
|
|
$ |
942 |
|
|
|
16% |
|
PEG-INTRON
|
|
|
567 |
|
|
|
10% |
|
81
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
Schering-Plough’s net sales do not include sales of VYTORIN
and ZETIA that are marketed in partnership with Merck, as the
Company accounts for this joint venture under the equity method
of accounting. See Note 3, “Equity Income From
Cholesterol Joint Venture.”
The Company does not disaggregate assets on a segment basis for
internal management reporting and, therefore, such information
is not presented.
In May 2002, the Company agreed with the FDA to the entry of a
Consent Decree to resolve issues related to compliance with
current Good Manufacturing Practices (cGMP) at certain of the
Company’s facilities in New Jersey and Puerto Rico (the
“Consent Decree” or the “Decree”).
In summary, the Decree required the Company to make payments
totaling $500 million in two equal installments of
$250 million, which were paid in 2002 and 2003. In
addition, the Decree required the Company to complete
revalidation programs for manufacturing processes used to
produce bulk active pharmaceutical ingredients and finished drug
products at the covered facilities, as well as to implement a
comprehensive cGMP Work Plan for each such facility. The Decree
required the foregoing to be completed in accordance with strict
schedules, and provided for possible imposition of additional
payments in the event the Company did not adhere to the approved
schedules. Final completion of the work was made subject to
certification by independent experts, whose certifications were
in turn made subject to FDA acceptance.
As of September 30, 2005, the Company had completed the
revalidation and third party certification of the bulk active
pharmaceutical ingredients. As of December 31, 2005, the
Company had completed the revalidation and third party
certification of the finished drug products. The Company also
completed all 212 Significant Steps of the cGMP Work Plan by
December 31, 2005. All of these requirements were completed
in accordance with the schedules required by the Decree.
Under the terms of the Decree, provided that the FDA has not
notified the Company of a significant violation of FDA law,
regulations, or the Decree in the five year period since the
Decree’s entry, May 2002 through May 2007, the Company may
petition the court to have the Decree dissolved and the FDA will
not oppose the Company’s petition.
Although the Company has reported to the FDA that it has
completed both the revalidation programs and the cGMP Work Plan,
third party certification of the Work Plan is still pending. It
is possible that the third party expert may not certify the
completion of a Work Plan Significant Step or that the FDA may
disagree with the expert’s certification. In such an event,
it is possible that FDA may assess additional payments as
permitted under the Decree, and as described in more detail
below.
In general, the cGMP Work Plan contained 212 Significant Steps
whose timely and satisfactory completion are subject to payments
of $15 thousand per business day for each deadline missed. These
payments may not exceed $25 million for 2002, and
$50 million for each of the years 2003, 2004 and 2005.
These payments are subject to an overall cap of
$175 million. The Company would expense any such additional
payments assessed under the Decree if and when incurred.
|
|
19. |
LEGAL, ENVIRONMENTAL AND REGULATORY MATTERS |
The Company is involved in various claims, investigations and
legal proceedings.
The Company records a liability for contingencies when it is
probable that a liability has been incurred and the amount can
be reasonably estimated. The Company adjusts its liabilities for
contingencies to reflect the current best estimate of probable
loss or minimum liability as the case may be. Where no best
estimate is determinable the company records the minimum amount
within the most probable range
82
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
of its liability. Expected insurance recoveries have not been
considered in determining the amounts of recorded liabilities
for environmental-related matters.
If the Company believes that a loss contingency is reasonably
possible, rather than probable, or the amount of loss cannot be
estimated, no liability is recorded. However, where a liability
is reasonably possible, disclosure of the loss contingency is
made.
The Company reviews the status of all claims, investigations and
legal proceedings on an ongoing basis, including related
insurance coverages. From time to time, the Company may settle
or otherwise resolve these matters on terms and conditions
management believes are in the best interests of the Company.
Resolution of any or all claims, investigations and legal
proceedings, individually or in the aggregate, could have a
material adverse effect on the Company’s results of
operations, cash flows or financial condition.
Resolution (including settlements) of matters of the types set
forth in the remainder of this Note, and in particular under
Investigations, frequently involve fines and penalties of an
amount that would be material to its results of operations, cash
flows or financial condition. Resolution of such matters may
also involve injunctive or administrative remedies that would
adversely impact the business such as exclusion from government
reimbursement programs, which in turn would have a material
adverse impact on the business, future financial condition, cash
flows or the results of operations. There are no assurances that
the Company will prevail in any of the matters discussed in the
remainder of this Note, that settlements can be reached on
acceptable terms (including the scope of the release provided
and the absence of injunctive or administrative remedies that
would adversely impact the business such as exclusion from
government reimbursement programs) or in amounts that do not
exceed the amounts reserved. Even if an acceptable settlement
were to be reached, there can be no assurance that further
investigations or litigations will not be commenced raising
similar issues, potentially exposing the Company to additional
material liabilities. The outcome of the matters discussed below
under Investigations could include the commencement of civil
and/or criminal proceedings involving the imposition of
substantial fines, penalties and injunctive or administrative
remedies, including exclusion from government reimbursement
programs. Total liabilities reserved reflect an estimate (and in
the case of the Investigations, a current estimate of the
liability), and any final settlement or adjudication of any of
these matters could possibly be less than, or could materially
exceed the liabilities recorded in the financial statements and
could have a material adverse impact on the Company’s
financial condition, cash flows or operations. Further, the
Company cannot predict the timing of the resolution of these
matters or their outcomes.
Except for the matters discussed in the remainder of this Note,
the recorded liabilities for contingencies at December 31,
2005, and the related expenses incurred during the year ended
December 31, 2005, were not material. In the opinion of
management, based on the advice of legal counsel, the ultimate
outcome of these matters, except matters discussed in the
remainder of this Note, will not have a material impact on the
Company’s results of operations, cash flows or financial
condition.
DR. SCHOLL’S FREEZE AWAY Patent. On
July 26, 2004, OraSure Technologies filed an action in the
U.S. District Court for the Eastern District of
Pennsylvania alleging patent infringement by Schering-Plough
HealthCare Products by its sale of DR. SCHOLL’S FREEZE AWAY
wart removal product. The complaint seeks a permanent injunction
and unspecified damages, including treble damages.
Massachusetts Investigation. The
U.S. Attorney’s Office for the District of
Massachusetts is investigating a broad range of the
Company’s sales, marketing and clinical trial practices and
programs along with those of Warrick Pharmaceuticals (Warrick),
the Company’s generic subsidiary. The investigation is
focused on the following alleged practices: providing
remuneration to managed care
83
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
organizations, physicians and others to induce the purchase of
Schering pharmaceutical products; off-label marketing of drugs;
and submitting false pharmaceutical pricing information to the
government for purposes of calculating rebates required to be
paid to the Medicaid program. The Company is cooperating with
this investigation.
The outcome of this investigation could include the commencement
of civil and/or criminal proceedings involving the imposition of
substantial fines, penalties and injunctive or administrative
remedies, including exclusion from government reimbursement
programs. The Company has recorded a liability of
$500 million related to this investigation as well as the
investigations described below under “AWP
Investigations” and the state litigation described below
under “AWP Litigation.” If the Company is not able to
reach a settlement at the current estimate, the resolution of
this matter could have a material adverse impact on the
Company’s results of operations (beyond what has been
reflected to date if the Company is not able to reach a
settlement at the current estimate), cash flows, financial
condition and/or its business.
AWP Investigations. The Company continues to respond to
existing and new investigations by the Department of Health and
Human Services, the Department of Justice and several states
into industry and Company practices regarding average wholesale
price (AWP). These investigations relate to whether the AWP used
by pharmaceutical companies for certain drugs improperly exceeds
the average prices paid by providers and, as a consequence,
results in unlawful inflation of certain government drug
reimbursements that are based on AWP. The Company is cooperating
with these investigations. The outcome of these investigations
could include the imposition of substantial fines, penalties and
injunctive or administrative remedies.
NITRO-DUR Investigation. In August 2003, the Company
received a civil investigative subpoena issued by the Office of
Inspector General of the U.S. Department of Health and
Human Services, seeking documents concerning the Company’s
classification of NITRO-DUR for Medicaid rebate purposes, and
the Company’s use of nominal pricing and bundling of
product sales. The Company is cooperating with the
investigation. It appears that the subpoena is one of a number
addressed to pharmaceutical companies concerning an inquiry into
issues relating to the payment of government rebates.
AWP Litigation. The Company continues to respond to
existing and new litigation by certain states and private payors
into industry and Company practices regarding average wholesale
price (AWP). These litigations relate to whether the AWP used by
pharmaceutical companies for certain drugs improperly exceeds
the average prices paid by providers and, as a consequence,
results in unlawful inflation of certain reimbursements for
drugs by state programs and private payors that are based on
AWP. The complaints allege violations of federal and state law,
including fraud, Medicaid fraud and consumer protection
violations, among other claims. In the majority of cases, the
plaintiffs are seeking class certifications. In some cases,
classes have been certified. The outcome of these litigations
could include substantial damages, the imposition of substantial
fines, penalties and injunctive or administrative remedies.
|
|
|
Securities and Class Action Litigation |
Federal Securities Litigation. Following the
Company’s announcement that the FDA had been conducting
inspections of the Company’s manufacturing facilities in
New Jersey and Puerto Rico and had issued reports citing
deficiencies concerning compliance with current Good
Manufacturing Practices, several lawsuits were filed against the
Company and certain named officers. These lawsuits allege that
the defendants violated the federal securities law by allegedly
failing to disclose material information and making material
misstatements. Specifically, they allege that the Company failed
to disclose an alleged serious risk that a new drug application
for CLARINEX would be delayed as a result of these manufacturing
issues, and they allege that the Company failed to disclose the
alleged depth and severity of
84
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
its manufacturing issues. These complaints were consolidated
into one action in the U.S. District Court for the District
of New Jersey, and a consolidated amended complaint was filed on
October 11, 2001, purporting to represent a class of
shareholders who purchased shares of Company stock from
May 9, 2000 through February 15, 2001. The complaint
seeks compensatory damages on behalf of the class. The Court
certified the shareholder class on October 10, 2003.
Discovery is ongoing.
Shareholder Derivative Actions. Two lawsuits were filed
in the U.S. District Court for the District of New Jersey,
against the Company, certain officers, directors and a former
director seeking damages on behalf of the Company, including
disgorgement of trading profits made by defendants allegedly
obtained on the basis of material non-public information. The
complaints allege a failure to disclose material information and
breach of fiduciary duty by the directors, relating to the FDA
inspections and investigations into the Company’s pricing
practices and sales, marketing and clinical trials practices.
These lawsuits are shareholder derivative actions that purport
to assert claims on behalf of the Company. The two shareholder
derivative actions pending in the U.S. District Court for
the District of New Jersey were consolidated into one action on
August 20, 2001, which is in its very early stages.
Product Liability. The Company previously disclosed that
it was a defendant in putative class action lawsuits involving
alleged claims for personal injuries arising from the
plaintiffs’ ingestion of phenylpropanolamine-containing
cough/cold remedies (“PPA” products), and other class
action lawsuits in which plaintiffs asserted claims for personal
injuries arising from their use of laxative products and sought
a refund of the purchase price of laxatives they purchased.
These lawsuits have been dismissed or resolved. Any amounts paid
to resolve these matters were immaterial. While no class action
lawsuits currently exist concerning PPA claims, individual
lawsuits involving PPA products are still pending. The Company
deems the pending lawsuits to be immaterial in the aggregate.
The Company also previously disclosed that it was the defendant
in individual lawsuits relating to recalled albuterol/ VANCERIL/
VANCENASE inhalers. These lawsuits have been dismissed or
resolved. Any amounts paid to resolve these lawsuits were
immaterial.
ERISA Litigation. On March 31, 2003, the Company was
served with a putative class action complaint filed in the
U.S. District Court in New Jersey alleging that the
Company, retired Chairman, CEO and President Richard Jay Kogan,
the Company’s Employee Savings Plan (Plan) administrator,
several current and former directors, and certain corporate
officers (Messrs. LaRosa and Moore) breached their
fiduciary obligations to certain participants in the Plan. The
complaint seeks damages in the amount of losses allegedly
suffered by the Plan. The complaint was dismissed on
June 29, 2004. The plaintiffs appealed. On August 19,
2005 the U.S. Court of Appeals for the Third Circuit
reversed the dismissal by the District Court and the matter has
been remanded back to the District Court for further proceedings.
K-DUR Antitrust Litigation. K-DUR is
Schering-Plough’s long-acting potassium chloride product
supplement used by cardiac patients. Following the commencement
of the FTC administrative proceeding described below, alleged
class action suits were filed in federal and state courts on
behalf of direct and indirect purchasers of K-DUR against
Schering-Plough, Upsher-Smith and Lederle. These suits claim
violations of federal and state antitrust laws, as well as other
state statutory and common law causes of action. These suits
seek unspecified damages. Discovery is ongoing.
K-DUR. Schering-Plough had settled patent litigation with
Upsher-Smith, Inc. (Upsher-Smith) and ESI Lederle, Inc.
(Lederle), which had related to generic versions of K-DUR for
which Lederle and Upsher Smith had filed Abbreviated New Drug
Applications (ANDAs). On April 2, 2001, the FTC started an
administrative proceeding against Schering-Plough, Upsher-Smith
and Lederle alleging anti-competitive effects from those
settlements. The administrative law judge issued a decision that
the patent litigation settlements complied with the law in all
respects and dismissed all claims against the Company. The FTC
Staff appealed that decision to the full Commission. The full
Commission reversed the decision
85
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS —
(Continued)
of the administrative law judge ruling that the settlements did
violate the antitrust laws. The full Commission issued a cease
and desist order imposing various injunctive restraints. The
federal court of appeals set aside the Commission ruling and
vacated the cease and desist order. On August 29, 2005, the
FTC filed a petition seeking a hearing by the U.S. Supreme
Court.
|
|
|
Pending Administrative Obligations |
In connection with the settlement of an investigation with the
U.S. Department of Justice and the
U.S. Attorney’s Office for the Eastern District of
Pennsylvania, the Company entered into a five-year corporate
integrity agreement (CIA). As disclosed in Note 18
“Consent Decree,” the Company is subject to
obligations under a Consent Decree with the FDA. Failure to
comply with the obligations under the CIA or the Consent Decree
can result in financial penalties.
Other Matters
Biopharma Contract Dispute. Biopharma S.r.l. filed a
claim in the Civil Court of Rome on July 21, 2004 (docket
No. 57397/2004, 9th Chamber) against certain
Schering-Plough subsidiaries. The Complaint alleges that the
Company did not fulfill its duties under distribution and supply
agreements between Biopharma and a Schering-Plough subsidiary
for distribution by Schering-Plough of generic products
manufactured by Biopharma to hospitals and to pharmacists in
France.
In October 2001, IRS auditors asserted that two interest rate
swaps that the Company entered into with an unrelated party
should be recharacterized as loans from affiliated companies,
resulting in additional tax liability for the 1991 and 1992 tax
years. In September 2004, the Company made payments to the IRS
in the amount of $194 million for income tax and
$279 million for interest. The Company filed refund claims
for the tax and interest with the IRS in December 2004.
Following the IRS’s denial of the Company’s claims for
a refund, the Company filed suit in May 2005 in the
U.S. District Court for the District of New Jersey for
refund of the full amount of the tax and interest. This refund
litigation is currently in the discovery phase. The
Company’s tax reserves were adequate to cover the above
mentioned payments.
The Company has responsibilities for environmental cleanup under
various state, local and federal laws, including the
Comprehensive Environmental Response, Compensation and Liability
Act, commonly known as Superfund. At several Superfund sites (or
equivalent sites under state law), the Company is alleged to be
a potentially responsible party (PRP). The Company believes that
it is remote at this time that there is any material liability
in relation to such sites. The Company estimates its obligations
for cleanup costs for Superfund sites based on information
obtained from the federal Environmental Protection Agency (EPA),
an equivalent state agency and/or studies prepared by
independent engineers, and on the probable costs to be paid by
other PRPs. The Company records a liability for environmental
assessments and/or cleanup when it is probable a loss has been
incurred and the amount can be reasonably estimated.
86
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Schering-Plough
Corporation
We have audited the accompanying consolidated balance sheets of
Schering-Plough Corporation and subsidiaries (the
“Company”) as of December 31, 2005 and 2004, and
the related consolidated statements of operations,
shareholders’ equity, and cash flows for each of the three
years in the period ended December 31, 2005. Our audits
also included the financial statement schedule listed at
Item 15. These financial statements and financial statement
schedule are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these
financial statements and financial statement schedule based on
our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, such consolidated financial statements present
fairly, in all material respects, the financial position of
Schering-Plough Corporation and subsidiaries as of
December 31, 2005 and 2004, and the results of their
operations and their cash flows for each of the three years in
the period ended December 31, 2005, in conformity with
accounting principles generally accepted in the United States of
America. Also, in our opinion, such financial statement
schedule, when considered in relation to the basic consolidated
financial statements taken as a whole, presents fairly, in all
material respects, the information set forth therein.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of the Company’s internal control over
financial reporting as of December 31, 2005, based on the
criteria established in Internal Control —
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated
February 28, 2006 expressed an unqualified opinion on
management’s assessment of the effectiveness of the
Company’s internal control over financial reporting and an
unqualified opinion on the effectiveness of the Company’s
internal control over financial reporting.
/s/ Deloitte &
Touche LLP
Parsippany, New Jersey
February 28, 2006
87
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
QUARTERLY DATA (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
| |
|
|
March 31 | |
|
June 30 | |
|
September 30 | |
|
December 31 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions, except per share figures) | |
|
|
Net sales
|
|
$ |
2,369 |
|
|
$ |
1,963 |
|
|
$ |
2,532 |
|
|
$ |
2,147 |
|
|
$ |
2,284 |
|
|
$ |
1,978 |
|
|
$ |
2,324 |
|
|
$ |
2,184 |
|
Cost of sales
|
|
|
889 |
|
|
|
740 |
|
|
|
867 |
|
|
|
790 |
|
|
|
775 |
|
|
|
711 |
|
|
|
815 |
|
|
|
829 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
1,480 |
|
|
|
1,223 |
|
|
|
1,665 |
|
|
|
1,357 |
|
|
|
1,509 |
|
|
|
1,267 |
|
|
|
1,509 |
|
|
|
1,355 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
1,081 |
|
|
|
914 |
|
|
|
1,116 |
|
|
|
979 |
|
|
|
1,064 |
|
|
|
892 |
|
|
|
1,114 |
|
|
|
1,026 |
|
Research and development
|
|
|
384 |
|
|
|
372 |
|
|
|
442 |
|
|
|
451 |
|
|
|
566 |
|
|
|
378 |
|
|
|
474 |
|
|
|
406 |
|
Other expense/(income), net
|
|
|
17 |
|
|
|
36 |
|
|
|
(8 |
) |
|
|
43 |
|
|
|
— |
|
|
|
34 |
|
|
|
(5 |
) |
|
|
33 |
|
Special charges
|
|
|
27 |
|
|
|
70 |
|
|
|
259 |
|
|
|
42 |
|
|
|
6 |
|
|
|
26 |
|
|
|
2 |
|
|
|
15 |
|
Equity (income)/loss from cholesterol joint venture
|
|
|
(220 |
) |
|
|
(78 |
) |
|
|
(170 |
) |
|
|
(77 |
) |
|
|
(215 |
) |
|
|
(95 |
) |
|
|
(268 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) before income taxes
|
|
|
191 |
|
|
|
(91 |
) |
|
|
26 |
|
|
|
(81 |
) |
|
|
88 |
|
|
|
32 |
|
|
|
192 |
|
|
|
(27 |
) |
Income tax expense/(benefit)
|
|
|
64 |
|
|
|
(18 |
) |
|
|
74 |
|
|
|
(16 |
) |
|
|
23 |
|
|
|
6 |
|
|
|
66 |
|
|
|
807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss)
|
|
$ |
127 |
|
|
$ |
(73 |
) |
|
$ |
(48 |
) |
|
$ |
(65 |
) |
|
$ |
65 |
|
|
$ |
26 |
|
|
$ |
126 |
|
|
$ |
(834 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on preferred shares
|
|
|
22 |
|
|
|
— |
|
|
|
22 |
|
|
|
— |
|
|
|
22 |
|
|
|
12 |
|
|
|
22 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) available to common shareholders
|
|
$ |
105 |
|
|
$ |
(73 |
) |
|
$ |
(70 |
) |
|
$ |
(65 |
) |
|
$ |
43 |
|
|
$ |
14 |
|
|
$ |
104 |
|
|
$ |
(856 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings/(loss) per common share
|
|
$ |
.07 |
|
|
$ |
(.05 |
) |
|
$ |
(.05 |
) |
|
$ |
(.04 |
) |
|
$ |
.03 |
|
|
$ |
.01 |
|
|
$ |
.07 |
|
|
$ |
(.58 |
) |
Basic earnings/(loss) per common share
|
|
|
.07 |
|
|
|
(.05 |
) |
|
|
(.05 |
) |
|
|
(.04 |
) |
|
|
.03 |
|
|
|
.01 |
|
|
|
.07 |
|
|
$ |
(.58 |
) |
Dividends per common share
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
|
|
.055 |
|
Common share prices:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
21.41 |
|
|
|
18.97 |
|
|
|
20.94 |
|
|
|
18.70 |
|
|
|
22.45 |
|
|
|
19.98 |
|
|
|
21.76 |
|
|
|
21.12 |
|
|
Low
|
|
|
17.68 |
|
|
|
15.96 |
|
|
|
17.89 |
|
|
|
16.10 |
|
|
|
18.48 |
|
|
|
17.55 |
|
|
|
19.05 |
|
|
|
16.72 |
|
Average shares outstanding for diluted EPS (in millions)
|
|
|
1,480 |
|
|
|
1,471 |
|
|
|
1,476 |
|
|
|
1,472 |
|
|
|
1,487 |
|
|
|
1,475 |
|
|
|
1,487 |
|
|
|
1,473 |
|
Average shares outstanding for basic EPS (in millions)
|
|
|
1,474 |
|
|
|
1,471 |
|
|
|
1,476 |
|
|
|
1,472 |
|
|
|
1,477 |
|
|
|
1,472 |
|
|
|
1,478 |
|
|
|
1,473 |
|
See Note 2, “Special Charges” to the Consolidated
Financial Statements for additional information relating to
Special charges.
The Company’s common shares are listed and principally
traded on the New York Stock Exchange. The approximate number of
holders of record of common shares as of January 31, 2006
was 37,000.
88
|
|
Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
Not applicable.
|
|
Item 9A. |
Controls and Procedures |
Management, including the chief executive officer and the chief
financial officer, has evaluated the Company’s disclosure
controls and procedures as of the end of the period covered by
this 10-K and has
concluded that the Company’s disclosure controls and
procedures are effective. They also concluded that there were no
changes in the Company’s internal control over financial
reporting that occurred during the Company’s most recent
fiscal quarter that have materially affected, or are reasonably
likely to materially affect, the Company’s internal control
over financial reporting.
As part of the changing business environment in which the
Company operates, the Company is replacing and upgrading a
number of information systems. This process will be ongoing for
several years. In connection with these changes, as part of the
Company’s management of both internal control over
financial reporting and disclosure controls and procedures,
management has concluded that the new systems are at least as
effective with respect to those controls as the prior systems.
Examples of changes in information systems that occurred during
2005 are the replacement of the Company’s order entry and
accounts receivable information systems within its
U.S. prescription pharmaceutical business, and the Medicaid
management system.
Management’s Report on Internal Control over Financial
Reporting
The Management of Schering-Plough Corporation is responsible for
establishing and maintaining adequate internal control over
financial reporting. Schering-Plough’s internal control
system is designed to provide reasonable assurance to the
Company’s Management and Board of Directors regarding the
preparation and fair presentation of published financial
statements.
All internal control systems, no matter how well designed, have
inherent limitations. Therefore, even those systems determined
to be effective can provide only reasonable assurance with
respect to financial statement preparation and presentation.
Schering-Plough’s Management assessed the effectiveness of
the Company’s internal control over financial reporting as
of December 31, 2005. In making this assessment, Management
used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in
Internal Control — Integrated Framework. Based
on its assessment Management believes that, as of
December 31, 2005, the Company’s internal control over
financial reporting is effective.
Schering-Plough’s independent auditors, Deloitte &
Touche LLP, have issued an attestation report on
Management’s assessment of the Company’s internal
control over financial reporting. Their report follows.
89
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Schering-Plough
Corporation
We have audited management’s assessment, included in the
accompanying Management’s Report on Internal Control over
Financial Reporting, that Schering-Plough Corporation and
subsidiaries (the “Company”) maintained effective
internal control over financial reporting as of
December 31, 2005, based on criteria established in
Internal Control — Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission. The Company’s management is responsible for
maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control
over financial reporting. Our responsibility is to express an
opinion on management’s assessment and an opinion on the
effectiveness of the Company’s internal control over
financial reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
management’s assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinions.
A company’s internal control over financial reporting is a
process designed by, or under the supervision of, the
company’s principal executive and principal financial
officers, or persons performing similar functions, and effected
by the company’s board of directors, management, and other
personnel to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A company’s
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
company’s assets that could have a material effect on the
financial statements.
Because of the inherent limitations of internal control over
financial reporting, including the possibility of collusion or
improper management override of controls, material misstatements
due to error or fraud may not be prevented or detected on a
timely basis. Also, projections of any evaluation of the
effectiveness of the internal control over financial reporting
to future periods are subject to the risk that the controls may
become inadequate because of changes in conditions, or that the
degree of compliance with the policies or procedures may
deteriorate.
In our opinion, management’s assessment that the Company
maintained effective internal control over financial reporting
as of December 31, 2005, is fairly stated, in all material
respects, based on the criteria established in Internal
Control — Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway
Commission. Also in our opinion, the Company maintained, in all
material respects, effective internal control over financial
reporting as of December 31, 2005, based on the criteria
established in Internal Control — Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission.
90
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated financial statements and financial statement
schedule as of and for the year ended December 31, 2005 of
the Company and our report dated February 28, 2006
expressed an unqualified opinion on those financial statements
and financial statement schedule.
/s/ Deloitte &
Touche LLP
Parsippany, New Jersey
February 28, 2006
91
Part III
|
|
Item 10. |
Directors and Executive Officers of the Registrant |
Information concerning Directors and nominees for Directors is
incorporated by reference to “Proposal One: Election
of Directors” in the Company’s Proxy Statement for the
Annual Meeting of Shareholders on May 19, 2006.
Information concerning executive officers is included in
Part I of this filing under the caption “Executive
Officers of the Registrant.”
Information concerning the audit committee financial expert is
incorporated by reference to “Audit Committee Report”
in the Company’s Proxy Statement for the Annual Meeting of
Shareholders on May 19, 2006.
Information concerning the Standards of Global Business
Practices is incorporated by reference to “Corporate
Governance Materials” in the Company’s Proxy Statement
for the Annual Meeting of Shareholders on May 19, 2006.
|
|
Item 11. |
Executive Compensation |
Executive compensation is incorporated by reference to
“Executive Compensation” in the Company’s Proxy
Statement for the Annual Meeting of Shareholders on May 19,
2006.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
Information concerning security ownership of certain beneficial
owners and management is incorporated by reference to
“Stock Ownership” in the Company’s Proxy
Statement for the Annual Meeting of Shareholders on May 19,
2006.
Equity Compensation Plan Information — The following
information relates to plans under which equity securities of
the Company may be issued to employees or Directors. The Company
has no plans under which equity securities may be issued to
non-employees (except that under the 2002 Stock Incentive Plan
and predecessor plans, certain stock options may be transferable
to family members of the employee-optionee or related trusts).
92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Column A | |
|
Column B | |
|
Column C | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
Number of | |
|
|
|
|
|
|
securities | |
|
|
|
|
|
|
remaining | |
|
|
|
|
|
|
available for | |
|
|
Number of securities | |
|
|
|
future issuance | |
|
|
to be issued | |
|
Weighted-average | |
|
under equity | |
|
|
upon exercise of | |
|
exercise price of | |
|
compensation | |
|
|
outstanding | |
|
outstanding | |
|
plans (excluding | |
|
|
options, warrants | |
|
options, | |
|
securities reflected | |
Plan Category |
|
and rights | |
|
warrants and rights | |
|
in Column A) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders 2002
Stock Incentive Plan and Predecessor Plans
|
|
|
82,483,524 |
|
|
$ |
27.00 |
|
|
|
11,163,695 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors Stock Award Plan*
|
|
|
N/A |
|
|
|
N/A |
|
|
|
544,008 |
|
|
Schering-Plough (Ireland) Approved Profit Sharing Scheme**
|
|
|
N/A |
|
|
|
N/A |
|
|
|
** |
|
Non-plan inducement awards not approved by security holders
|
|
|
300,000 restricted shares |
*** |
|
|
N/A |
|
|
|
0 |
|
Total
|
|
|
|
|
|
|
|
|
|
|
11,707,703 |
|
|
|
|
|
* |
The Plan provides an annual grant of 3,000 shares of common
stock to each non-employee director. Directors may defer awards
into stock units that pay out in shares of common stock when the
deferral period ends. |
|
|
|
|
** |
The Plan permits eligible employees who work for
Schering-Plough’s Irish subsidiaries to enjoy tax
advantages by having some or all of their Christmas bonus and
between 1 percent and 5 percent of their pay passed to
a trustee. The trustee purchases shares of common stock in the
open market and allocates the shares to the employees’
accounts. No more than Euro 12,700 may be deferred in a year by
an employee. Employees may not sell or withdraw shares allocated
to their accounts for two to three years. |
|
|
*** |
Represents restricted shares awarded pursuant to Restricted
Shares Agreements outside of any equity compensation plan
adopted by the Company. Mr. Hassan was awarded 200,000
restricted shares upon the commencement of his employment in
April 2003. Ms. Cox was awarded 100,000 restricted shares
upon the commencement of her employment in May 2003. Both awards
of restricted shares vest upon the third anniversary of the
award date. Such non-plan awards were authorized by the
Compensation Committee of the Board but have not been approved
by the stockholders of the Company. |
|
|
Item 13. |
Certain Relationships and Related Transactions |
Information concerning certain relationships and related
transactions is incorporated by reference to “Certain
Transactions” in the Company’s Proxy Statement for the
Annual Meeting of Shareholders on May 19, 2006.
|
|
Item 14. |
Principal Accountant Fees and Services |
Information concerning principal accountant fees and services is
incorporated by reference to “Proposal Two: Ratify the
Designation of Deloitte & Touche LLP to Audit
Schering-Plough’s Books and Accounts for 2006” in the
Company’s Proxy Statement for the Annual Meeting of
Shareholders on May 19, 2006.
93
Part IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules |
(a) The following documents are filed as part of this report
(1) Financial Statements: The financial statements are set
forth under Item 8 of
this 10-K
(2) Financial Statement Schedules:
Merck/Schering-Plough Cholesterol Partnership Combined
Financial Statements
|
|
|
|
|
Index |
|
Page | |
|
|
| |
Combined Statements of Net Sales and Contractual Expenses for
the Years Ended December 31, 2005, 2004 and 2003 (Unaudited)
|
|
|
102 |
|
Combined Balance Sheets at December 31, 2005 and 2004
|
|
|
103 |
|
Combined Statements of Cash Flows for the Years Ended
December 31, 2005, 2004 and 2003 (Unaudited)
|
|
|
104 |
|
Combined Statements of Partners’ Capital for the Years
Ended December 31, 2005, 2004 and 2003 (Unaudited)
|
|
|
105 |
|
Notes to Combined Financial Statements for the Years Ended
December 31, 2005, 2004 and 2003 (Unaudited)
|
|
|
106 |
|
Independent Auditors’ Report
|
|
|
111 |
|
Schedule II — Valuation and Qualifying
Accounts
|
|
|
112 |
|
Schedules other than those listed above have been omitted
because they are not applicable or not required.
94
(3) Index to Exhibits:
Unless otherwise indicated, all exhibits are part of Commission
File Number 1-6571.
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Description |
|
Location |
| |
|
|
|
|
|
3(a) |
|
|
Restated Certificate of Incorporation. |
|
Incorporated by reference to Exhibit 3(i) to the
Company’s 10-Q for the period ended September 30,
2004. |
|
|
3(b) |
|
|
Amended and Restated By-laws. |
|
Incorporated by reference to Exhibit 3.2 to the
Company’s 8-K filed June 28, 2005. |
|
|
4(a) |
|
|
Rights Agreement between the Company and the Bank of New York
dated June 24, 1997. |
|
Incorporated by reference to Exhibit 1 to the
Company’s 8-A filed on June 30, 1997. |
|
|
4(b) |
|
|
Form of Participation Rights Agreement between the Company and
the Chase Manhattan Bank (National Association) as Trustee. |
|
Incorporated by reference to Exhibit 4.6 to the
Company’s Registration Statement on Form S-4,
Amendment No. 1, filed December 29, 1995. File
No. 33-65107. |
|
|
4(c)(i) |
|
|
Indenture, dated November 26, 2003, between the Company and
The Bank of New York as Trustee. |
|
Incorporated by reference to Exhibit 4.1 to the
Company’s 8-K filed November 28, 2003. |
|
|
4(c)(ii) |
|
|
First Supplemental Indenture (including Form of Note), dated
November 26, 2003. |
|
Incorporated by reference to Exhibit 4.2 to the
Company’s 8-K filed November 28, 2003. |
|
|
4(c)(iii) |
|
|
Second Supplemental Indenture (including Form of Note), dated
November 26, 2003. |
|
Incorporated by reference to Exhibit 4.3 to the
Company’s 8-K filed November 28, 2003. |
|
|
4(c)(iv) |
|
|
5.30% Global Senior Note, due 2013. |
|
Incorporated by reference to Exhibit 4(c)(iv) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
4(c)(v) |
|
|
6.50% Global Senior Note, due 2033. |
|
Incorporated by reference to Exhibit 4(c)(v) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
10(a) |
|
|
Executive Incentive Plan (as amended and restated to
October 1, 2000).* |
|
Incorporated by reference to Exhibit 10(a)(i) to the
Company’s 10-K for the year ended December 31,
2000. |
|
|
10(b)(i) |
|
|
1992 Stock Incentive Plan (as amended).* |
|
Incorporated by reference to Exhibit 10(d) to the
Company’s 10-K for the year ended December 31,
1992. |
|
|
10(b)(ii) |
|
|
1992 Stock Incentive Plan (as amended to December 11,
1995).* |
|
Incorporated by reference to Exhibit 10(d) to the
Company’s 10-K for the year ended December 31,
1995. |
|
|
10(b)(iii) |
|
|
Amendment to the 1992 Stock Incentive Plan (effective
February 25, 2003).* |
|
Incorporated by reference to Exhibit 10(b) to the
Company’s 10-K for the year ended December 31,
2002. |
95
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Description |
|
Location |
| |
|
|
|
|
|
10(c)(i) |
|
|
1997 Stock Incentive Plan.* |
|
Incorporated by reference to Exhibit 10 to the
Company’s 10-Q for the period ended September 30,
1997. |
|
|
10(c)(ii) |
|
|
Amendment to 1997 Stock Incentive Plan (effective
February 22, 1999).* |
|
Incorporated by reference to Exhibit 10(a) to the
Company’s 10-Q for the period ended March 31,
1999. |
|
|
10(c)(iii) |
|
|
Amendment to the 1997 Stock Incentive Plan (effective
February 25, 2003).* |
|
Incorporated by reference to Exhibit 10(c) to the
Company’s 10-K for the year ended December 31,
2002. |
|
|
10(d) |
|
|
2002 Stock Incentive Plan (as amended to February 25,
2003).* |
|
Incorporated by reference to Exhibit 10(d) to the
Company’s 10-K for the year ended December 31,
2002. |
|
|
10(e)(i) |
|
|
Employment Agreement dated as of April 20, 2003 between
Fred Hassan and the Company.* |
|
Incorporated by reference to Exhibit 99.2 to the
Company’s 8-K filed April 21, 2003. |
|
|
10(e)(ii) |
|
|
Employment Agreement dated as of May 12, 2003 between
Carrie Cox and the Company.* |
|
Incorporated by reference to Exhibit 99.6 to
Company’s 8-K filed May 13, 2003. |
|
|
10(e)(iii) |
|
|
Letter agreement dated November 4, 2003 between Robert
Bertolini and the Company.* |
|
Incorporated by reference to Exhibit 10(e)(iii) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
10(e)(iv) |
|
|
Employment Agreement effective upon a change of control dated as
of November 17, 2003 between Robert Bertolini and
Schering-Plough Corporation.* |
|
Incorporated by reference to Exhibit 10(e)(iv) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
10(e)(v) |
|
|
Letter agreement dated March 11, 2004 between Thomas J.
Sabatino, Jr. and the Company.* |
|
Incorporated by reference to Exhibit 10 to the
Company’s 10-Q for the period ended March 31,
2004. |
|
|
10(e)(vi) |
|
|
Form of employment agreement effective upon a change of control
between the Company and certain executives for new agreements
beginning in June 2004.* |
|
Incorporated by reference to Exhibit 10(e)(vi) to the
Company’s 10-K for the year ended December 31,
2004. |
|
|
10(e)(vii)(1) |
|
|
Form of employment agreement between the Company and its
executive officers effective upon a change of control.* |
|
Incorporated by reference to Exhibit 10(e)(iv) to the
Company’s 10-K for the year ended December 31,
1994. |
|
|
10(e)(vii)(2) |
|
|
Form of amendment to employment agreement between the Company
and its executive officers effective upon a change of control.* |
|
Incorporated by reference to Exhibit 10(a) to the
Company’s 10-Q for the period ended September 30,
1999. |
|
|
10(e)(vii)(3) |
|
|
Forms of amendment to employment agreement between the Company
and its executive officers effective upon a change of control
effective January 1, 2002.* |
|
Incorporated by reference to Exhibits 10(e)(ii)(A)
and (B) to the Company’s 10-K for the year ended
December 31, 2001. |
96
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Description |
|
Location |
| |
|
|
|
|
|
10(e)(vii)(4) |
|
|
Form of employment agreement between the Company and its
executive officers effective upon a change of control
incorporating all prior amendments through January 1, 2002
and for new agreements effective beginning January 1, 2002.* |
|
Incorporated by reference to Exhibit 10(e)(ii)(C) to the
Company’s 10-K for the year ended December 31,
2001. |
|
|
10(e)(xi) |
|
|
Severance Benefit Plan (as amended and restated effective
December 17, 2004 with amendments through April 18,
2005).* |
|
Incorporated by reference to Exhibit 10(e)(xi) to the
Company’s 10-Q for the period ended March 31,
2005. |
|
|
10(e)(xii) |
|
|
Savings Advantage Plan (as amended and restated as of
January 1, 2005).* |
|
Attached. |
|
|
10(f)(i) |
|
|
Amended and Restated Directors Deferred Compensation Plan (as
amended to October 26, 1999) and Trust related thereto.* |
|
Incorporated by reference to Exhibit 10(b) to the
Company’s 10-Q for the period ended September 30,
1999. |
|
|
10(f)(ii) |
|
|
Amended and Restated Defined Contribution Trust.* |
|
Incorporated by reference to Exhibit 10(a)(ii) to the
Company’s 10-K for the year ended December 31,
2000. |
|
|
10(g)(i) |
|
|
Supplemental Executive Retirement Plan (amended and restated to
February 24, 1998).* |
|
Incorporated by reference to Exhibit 10(e) to the
Company’s 10-Q for the period ended March 31,
1998. |
|
|
10(g)(ii) |
|
|
Amendment to Supplemental Executive Retirement Plan (effective
November 1, 1998).* |
|
Incorporated by reference to Exhibit 10(a) to the
Company’s 10-Q for the period ended September 30,
1998. |
|
|
10(g)(iii) |
|
|
Second Amendment to Supplemental Executive Retirement Plan
(effective as of October 1, 2000).* |
|
Incorporated by reference to Exhibit 10(g) to the
Company’s 10-K for the year ended December 31,
2000. |
|
|
10(g)(iv) |
|
|
Amended and Restated SERP Rabbi Trust Agreement.* |
|
Incorporated by reference to Exhibit 10(g) to the
Company’s 10-K for the year ended December 31,
1998. |
|
|
10(h) |
|
|
Directors Stock Award Plan (amended and restated through
February 25, 2003).* |
|
Incorporated by reference to Exhibit 10(h) to the
Company’s 10-K for the year ended December 31,
2002. |
|
|
10(i) |
|
|
Deferred Compensation Plan (as amended and restated to
October 1, 2000).* |
|
Incorporated by reference to Exhibit 10(i) to the
Company’s 10-K for the year ended December 31,
2000. |
|
|
10(k)(i) |
|
|
Form of Split Dollar Agreement and related Collateral Assignment
between the Company and its Executive Officers.* |
|
Incorporated by reference to Exhibit 10(l) to the
Company’s 10-K for the year ended December 31,
1997. |
|
|
10(k)(ii) |
|
|
Form of Amendment to Split Dollar Agreement and related
Collateral Assignment between the Company and its Executive
Officers.* |
|
Incorporated by reference to Exhibit 10(g) to the
Company’s 10-Q for the period ended March 31,
1998. |
97
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Description |
|
Location |
| |
|
|
|
|
|
10(l) |
|
|
Retirement Benefits Equalization Plan (as amended and restated
as of January 1, 2005).* |
|
Attached. |
|
|
10(m) |
|
|
Operations Management Team Incentive Plan.* |
|
Incorporated by reference to Exhibit 10(m) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
10(n) |
|
|
Cash Long-Term Incentive Plan (as amended and restated effective
January 24, 2005).* |
|
Incorporated by reference to Exhibit 10(n) to the
Company’s 10-K for the year ended December 31,
2004. |
|
|
10(o) |
|
|
Long-Term Performance Share Unit Incentive Plan (as amended and
restated effective January 24, 2005).* |
|
Incorporated by reference to Exhibit 10(o) to the
Company’s 10-K for the year ended December 31,
2004. |
|
|
10(p) |
|
|
Transformational Performance Contingent Shares Program.* |
|
Incorporated by reference to Exhibit 10(p) to the
Company’s 10-K for the year ended December 31,
2003. |
|
|
10(q) |
|
|
Cholesterol Governance Agreement, dated as of May 22, 2000,
by and among the Company, Merck & Co., Inc. and the
other parties signatory thereto.† |
|
Incorporated by reference to Exhibit 99.2 to the
Company’s 8-K dated October 21, 2002. |
|
|
10(r) |
|
|
First Amendment to the Cholesterol Governance Agreement, dated
as of December 18, 2001, by and among the Company,
Merck & Co., Inc. and the other parties signatory
thereto.† |
|
Incorporated by reference to Exhibit 99.3 to the
Company’s 8-K filed October 21, 2002. |
|
|
10(s) |
|
|
Master Agreement, dated as of December 18, 2001, by and
among the Company, Merck & Co., Inc. and the other
parties signatory thereto.† |
|
Incorporated by reference to Exhibit 99.4 to the
Company’s 8-K filed October 21, 2002. |
|
|
10.2(t) |
|
|
Letter Agreement dated April 14, 2003 relating to Consent
Decree. |
|
Incorporated by reference to Exhibit 99.3 to the
Company’s 10-Q for the period ended March 31,
2003. |
|
|
10(u) |
|
|
Distribution agreement between the Company and Centocor, Inc.,
dated April 3, 1998. † |
|
Incorporated by reference to Exhibit 10(u) to the
Company’s Amended 10-K for the year ended
December 31, 2003, filed May 3, 2004. |
|
|
10(v) |
|
|
Amended and Restated Directors’ Deferred Stock Equivalency
Program. |
|
Incorporated by reference to Exhibit 10(d) to the
Company’s 10-Q for the period ended September 30,
1999. |
|
|
10(w) |
|
|
Summary of Director Compensation. |
|
Incorporated by reference to Exhibit 10(w) to the
Company’s 10-K for the year ended December 31,
2004. |
|
|
12 |
|
|
Computation of Ratio of Earnings to Fixed Charges. |
|
Attached. |
98
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Description |
|
Location |
| |
|
|
|
|
|
14 |
|
|
Standards of Global Business Practices (covers all employees,
including Senior Financial Officers). |
|
Incorporated by reference to Exhibit 14 to the
Company’s 8-K filed September 30, 2004. |
|
|
21 |
|
|
Subsidiaries of the registrant. |
|
Attached. |
|
|
23.1 |
|
|
Consent of Independent Registered Public Accounting Firm. |
|
Attached. |
|
|
23.2 |
|
|
Independent Auditor’s Consent. |
|
Attached. |
|
|
24 |
|
|
Power of attorney. |
|
Attached. |
|
|
31.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
Chairman of the Board and Chief Executive Officer. |
|
Attached. |
|
|
31.2 |
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for
Executive Vice President and Chief Financial Officer. |
|
Attached. |
|
|
32.1 |
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certification for
Chairman of the Board and Chief Executive Officer. |
|
Attached. |
|
|
32.2 |
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certification for
Executive Vice President and Chief Financial Officer. |
|
Attached. |
|
|
* |
Compensatory plan, contract or arrangement. |
|
|
† |
Certain portions of the exhibit have been omitted pursuant to a
request for confidential treatment. The non-public information
has been filed separately with the Securities and Exchange
Commission pursuant to rule
24b-2 under the
Securities Exchange Act of 1934, as amended. |
Copies of the above exhibits will be furnished upon request.
99
SIGNATURES
Pursuant to the requirements of Section 13 or 15
(d) 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.
|
|
|
SCHERING-PLOUGH CORPORATION |
|
(Registrant) |
|
|
|
|
By |
/s/ DOUGLAS J. GINGERELLA |
|
|
|
|
|
Douglas J. Gingerella |
|
Vice President and Controller |
|
(Duly Authorized Officer |
|
and Chief Accounting Officer) |
Date: February 28, 2006
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the
date indicated.
|
|
|
|
|
|
/s/ FRED HASSAN
Fred Hassan |
|
Chairman of the Board and Chief Executive Officer |
|
/s/ ROBERT J. BERTOLINI
Robert J. Bertolini |
|
Executive Vice President and Chief Financial Officer |
|
/s/ DOUGLAS J.
GINGERELLA
Douglas J. Gingerella |
|
Vice President and Controller |
|
*
Hans W. Becherer |
|
Director |
|
*
Thomas J. Colligan |
|
Director |
|
*
C. Robert Kidder |
|
Director |
|
*
Philip Leder, M.D. |
|
Director |
|
*
Eugene R. McGrath |
|
Director |
|
*
Carl E. Mundy, Jr. |
|
Director |
|
*
Richard de J. Osborne |
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Director |
100
|
|
|
|
|
|
*
Patricia F. Russo |
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Director |
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*
Kathryn C. Turner |
|
Director |
|
*
Robert F. W. van Oordt |
|
Director |
|
*
Arthur F. Weinbach |
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Director |
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*By |
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/s/ Douglas J. Gingerella
Douglas J. Gingerella
Attorney-in-fact |
|
|
Date: February 28, 2006
101
Merck/ Schering-Plough Cholesterol Partnership
Combined Statements of Net Sales and Contractual Expenses
Years Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
|
($ in millions) | |
Net sales
|
|
$ |
2,425 |
|
|
$ |
1,214 |
|
|
$ |
475 |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
93 |
|
|
|
74 |
|
|
|
24 |
|
Selling, general and administrative
|
|
|
945 |
|
|
|
634 |
|
|
|
396 |
|
Research and development
|
|
|
134 |
|
|
|
138 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,172 |
|
|
|
846 |
|
|
|
595 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
$ |
1,253 |
|
|
$ |
368 |
|
|
$ |
(120 |
) |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these combined
financial statements.
102
Merck/ Schering-Plough Cholesterol Partnership
Combined Balance Sheets
December 31,
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
($ in millions) | |
ASSETS |
Cash and cash equivalents
|
|
$ |
40 |
|
|
$ |
47 |
|
Accounts receivable, net
|
|
|
230 |
|
|
|
184 |
|
Inventories
|
|
|
75 |
|
|
|
64 |
|
Prepaid expenses and other assets
|
|
|
4 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
349 |
|
|
$ |
296 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND PARTNERS’ DEFICIT |
Accounts payable
|
|
$ |
62 |
|
|
$ |
35 |
|
Payable to Schering-Plough, net
|
|
|
156 |
|
|
|
111 |
|
Payable to Merck, net
|
|
|
123 |
|
|
|
159 |
|
Rebates payable
|
|
|
120 |
|
|
|
35 |
|
Accrued expenses and other liabilities
|
|
|
24 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
485 |
|
|
|
362 |
|
Commitments and Contingent Liabilities (notes 3 and 5)
|
|
|
|
|
|
|
|
|
Partners’ capital (deficit)
|
|
|
(136 |
) |
|
|
(66 |
) |
|
|
|
|
|
|
|
|
Total liabilities and Partners’ capital (deficit)
|
|
$ |
349 |
|
|
$ |
296 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these combined
financial statements.
103
Merck/ Schering-Plough Cholesterol Partnership
Combined Statements of Cash Flows
Years Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
|
($ in millions) | |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
$ |
1,253 |
|
|
$ |
368 |
|
|
$ |
(120 |
) |
|
Adjustments to reconcile income (loss) from operations to net
cash provided by (used for) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(46 |
) |
|
|
(121 |
) |
|
|
(35 |
) |
|
|
Inventories
|
|
|
(11 |
) |
|
|
(41 |
) |
|
|
4 |
|
|
|
Prepaid expenses and other assets
|
|
|
(3 |
) |
|
|
16 |
|
|
|
(15 |
) |
|
|
Accounts payable
|
|
|
27 |
|
|
|
24 |
|
|
|
(3 |
) |
|
|
Rebates payable
|
|
|
85 |
|
|
|
22 |
|
|
|
13 |
|
|
|
Accrued expenses and other liabilities
|
|
|
2 |
|
|
|
14 |
|
|
|
4 |
|
|
|
Payables to Merck and Schering-Plough, net
|
|
|
9 |
|
|
|
114 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used for) operating activities
|
|
|
1,316 |
|
|
|
396 |
|
|
|
(149 |
) |
|
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributions from Partners
|
|
|
710 |
|
|
|
473 |
|
|
|
1,092 |
|
|
Distributions to Partners
|
|
|
(2,033 |
) |
|
|
(855 |
) |
|
|
(926 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used for) provided by financing activities
|
|
|
(1,323 |
) |
|
|
(382 |
) |
|
|
166 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease)/increase in cash and cash equivalents
|
|
|
(7 |
) |
|
|
14 |
|
|
|
17 |
|
Cash and cash equivalents, beginning of period
|
|
|
47 |
|
|
|
33 |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$ |
40 |
|
|
$ |
47 |
|
|
$ |
33 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these combined
financial statements.
104
Merck/ Schering-Plough Cholesterol Partnership
Combined Statements of Partners’ Capital (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schering- | |
|
|
|
|
|
|
Plough | |
|
Merck | |
|
Total | |
|
|
| |
|
| |
|
| |
|
|
($ in millions) | |
Balance, January 1, 2003 (unaudited)
|
|
$ |
(41 |
) |
|
$ |
(57 |
) |
|
$ |
(98 |
) |
Contributions from Partners (unaudited)
|
|
|
514 |
|
|
|
578 |
|
|
|
1,092 |
|
Loss from operations (unaudited)
|
|
|
(14 |
) |
|
|
(106 |
) |
|
|
(120 |
) |
Distributions to Partners (unaudited)
|
|
|
(463 |
) |
|
|
(463 |
) |
|
|
(926 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2003 (unaudited)
|
|
|
(4 |
) |
|
|
(48 |
) |
|
|
(52 |
) |
Contributions from Partners
|
|
|
243 |
|
|
|
230 |
|
|
|
473 |
|
Income from operations
|
|
|
244 |
|
|
|
124 |
|
|
|
368 |
|
Distributions to Partners
|
|
|
(427 |
) |
|
|
(428 |
) |
|
|
(855 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2004
|
|
|
56 |
|
|
|
(122 |
) |
|
|
(66 |
) |
Contributions from Partners
|
|
|
330 |
|
|
|
380 |
|
|
|
710 |
|
Income from operations
|
|
|
689 |
|
|
|
564 |
|
|
|
1,253 |
|
Distributions to Partners
|
|
|
(1,042 |
) |
|
|
(991 |
) |
|
|
(2,033 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2005
|
|
$ |
33 |
|
|
$ |
(169 |
) |
|
$ |
(136 |
) |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these combined
financial statements.
105
Merck/ Schering-Plough Cholesterol Partnership
Notes to Combined Financial Statements
|
|
1. |
Description of Business and Basis of Presentation |
In May 2000, Merck & Co., Inc. (“Merck”) and
Schering-Plough Corporation (“Schering-Plough”)
(collectively “Management” or the
“Partners”) entered into agreements to jointly develop
and market in the United States, Schering-Plough’s then
experimental cholesterol absorption inhibitor ezetimibe
(marketed today in the United States as ZETIA and as EZETROL in
most other countries) (the “Agreements”) and certain
respiratory products. The cholesterol collaboration is formally
referred to as the Merck/ Schering-Plough Cholesterol
Partnership (the “Partnership”). In December 2001, the
Agreements were expanded to include all countries of the world
except Japan. The Agreements provide for ezetimibe to be
developed and marketed in the following forms:
|
|
|
|
• |
Ezetimibe, a once daily non-statin cholesterol-reducing medicine
used alone or co-administered with any statin drug, and |
|
|
• |
Ezetimibe and simvastatin (Merck’s existing ZOCOR statin
cholesterol-modifying medicine) combined into one tablet
(marketed today in the United States as VYTORIN and as INEGY in
most other countries). |
VYTORIN and ZETIA were approved by the U.S. FDA in July
2004 and October 2002, respectively, and have been launched in
more than 20 and 60 countries, respectively. Together, these
products, whether marketed as VYTORIN, ZETIA or under other
trademarks locally, are referred to as the “Cholesterol
Products.”
Under the Agreements, the Partners established jointly-owned,
limited purpose legal entities in Canada, Puerto Rico, and the
United States through which to carry out the contractual
activities of the Partnership in these countries. An additional
jointly-owned, limited purpose legal entity was established in
Singapore to own the rights to the intellectual property of the
Partnership and to fund and oversee research and development and
manufacturing activities of the Partnership and certain
respiratory products. In all other markets except Latin America,
subsidiaries of Merck or Schering-Plough perform marketing
activities for Cholesterol Products under contract with the
Partnership. These legal entity and subsidiary operations are
collectively referred to as the “Combined Companies.”
In Latin America, the Partnership sells directly to
Schering-Plough and Merck’s Latin American subsidiaries and
Schering-Plough and Merck compete against one another in the
cholesterol market. Consequently, selling, promotion and
distribution activities for the Cholesterol Products within
Latin America are not included in the Combined Companies.
The Partnership is substantially reliant on the infrastructures
of Merck and Schering-Plough. There are a limited number of
employees of the legal entities of the Partnership and most
activities are performed by employees of either Merck or
Schering-Plough under service agreements with the Partnership.
Profits, which are shared by the Partners under differing
arrangements in countries around the world, are defined as net
sales minus (1) agreed upon manufacturing costs and
expenses incurred by the Partners and invoiced to the
Partnership, (2) direct promotion expenses incurred by the
Partners and invoiced to the Partnership, (3) expenses for
a limited specialty sales force incurred by the Partners and
invoiced to the Partnership and certain amounts for sales force
physician detailing of the Cholesterol Products in the United
States, Puerto Rico and Canada, (4) administration expenses
based on a percentage of Cholesterol Product net sales, which
are invoiced by one of the Partners, and (5) other costs
and expenses incurred by the Partners that were not contemplated
when the Agreements were entered into but that were subsequently
agreed to by both Partners. Agreed upon research and development
expenses incurred by the Partners and invoiced to the
Partnership are shared equally by the Partners, after adjusting
for special allocations in the nature of milestone payments due
to one of the Partners.
106
Merck/ Schering-Plough Cholesterol Partnership
Notes to Combined Financial
Statements — (Continued)
The accompanying combined balance sheets and combined statements
of net sales and contractual expenses, cash flows and
partners’ capital (deficit) include the cholesterol
and respiratory-related activities of the Combined Companies.
The respiratory-related activities primarily pertain to clinical
development work, the spending for which is not material to the
income (loss) from operations reported in 2005, 2004 and 2003
(unaudited). Interpartnership balances and profits are
eliminated.
Net sales include the net sales of the Cholesterol Products sold
by the Combined Companies. Expenses include amounts that Merck
and Schering-Plough have contractually agreed to directly
invoice to the Partnership, or are shared through the
contractual profit sharing arrangements between the Partners
described above.
The accompanying combined financial statements were prepared for
the purpose of complying with certain rules and regulations of
the Securities and Exchange Commission, and reflect the
activities of the Partnership based on the contractual
agreements between the Partners. Such combined financial
statements include only the expenses agreed by the Partners to
be shared or included in the calculation of profits under the
contractual agreements of the Partnership, and are not intended
to be a complete presentation of all of the costs and expenses
that would be incurred by a stand-alone pharmaceutical company
for the discovery, development, manufacture, distribution and
marketing of pharmaceutical products.
Under the Agreements, certain activities are charged to the
Partnership by the Partners based on contractually agreed upon
allocations of Partner-incurred expenses as described below. In
the opinion of Management, any allocations of expenses described
below were made on a basis that reasonably reflects the actual
level of support provided. All other expenses are expenses of
the Partners and accordingly, are reflected in each
Partner’s respective expense line items in their separate
consolidated financial statements. Future results of operations,
financial position, and cash flows could differ materially from
the historical results presented herein.
As described above, the profit sharing arrangements under the
Agreements provide that only certain Partner-incurred costs and
expenses be invoiced to the Partnership by the Partners and
therefore become part of the profit calculation. The following
paragraphs list the typical categories of costs and expenses
that are generally incurred in the discovery, development,
manufacture, distribution and marketing of the Cholesterol
Products and provide a description of how such costs and
expenses are treated in the accompanying combined statements of
net sales and contractual expenses, and in determining profits
under the contractual agreements.
|
|
|
|
• |
Manufacturing costs and expenses — All contractually
agreed upon manufacturing plant costs and expenses incurred by
the Partners related to the manufacture of the Partnership
products are included as “Cost of sales” in the
accompanying combined statements of net sales and contractual
expenses, including direct production costs, certain production
variances, expenses for plant services and administration,
warehousing, distribution, materials management, technical
services, quality control, and asset utilization. “Cost of
sales” in 2005 includes certain interpartnership
adjustments totaling $14 million that relate to prior
years. The adjustments, which lowered 2005 cost of sales, are
not material to the current year or individual prior years’
results of operations and do not impact the Partners’
current and prior year equity income amounts. All other
manufacturing costs and expenses incurred by the Partners not
agreed to be included in the determination of profits under the
contractual agreements are not invoiced to the Partnership and
therefore are excluded from the accompanying combined financial
statements. These costs and expenses include but are not limited
to yield gains and losses in excess of jointly agreed upon yield
rates and excess/idle capacity of manufacturing plant assets. |
107
Merck/ Schering-Plough Cholesterol Partnership
Notes to Combined Financial
Statements — (Continued)
|
|
|
|
• |
Direct promotion expenses — Direct promotion
represents direct and identifiable
out-of-pocket expenses
incurred by the Partners on behalf of the Partnership, including
but not limited to contractually agreed upon expenses related to
market research, detailing aids, agency fees,
direct-to-consumer
advertising, meetings and symposia, trade programs, launch
meetings, special sales force incentive programs and product
samples. All such contractually agreed upon expenses are
included in “Selling, general and administrative” in
the accompanying combined statements of net sales and
contractual expenses. All other promotion expenses incurred by
the Partners not agreed to be included in the determination of
profits under the contractual agreements are not invoiced to the
Partnership and therefore are excluded from the accompanying
combined financial statements. |
|
|
• |
Selling expenses — In the United States, Canada and
Puerto Rico, the general sales forces of the Partners provide a
majority of the physician detail activity at an agreed upon
amount which is included in “Selling, general and
administrative” in the accompanying combined statements of
net sales and contractual expenses. The agreed upon costs of a
limited specialty sales force for the United States market that
calls on opinion leaders in the field of cholesterol medicine
are also included in “Selling, general and
administrative.” All other selling expenses incurred by the
Partners not agreed to be included in the determination of
profits under the contractual agreements are not invoiced to the
Partnership and therefore are excluded from the accompanying
combined financial statements. These expenses include the total
costs of the general sales forces of the Partners detailing the
Cholesterol Products in most countries outside of the United
States, Canada and Puerto Rico. |
|
|
• |
Administrative expenses — Administrative support is
primarily provided by one of the Partners. The contractually
agreed upon expenses for support are determined based on a
percentage of Cholesterol Product sales. Such amounts are
included in “Selling, general and administrative” in
the accompanying combined statements of net sales and
contractual expenses. Selected contractually agreed upon direct
costs of employees of the Partners for support services and
out-of-pocket expenses
incurred by the Partners on behalf of the Partnership are also
included in “Selling, general and administrative.” All
other expenses incurred by the Partners not agreed to be
included in the determination of profits under the contractual
agreements are not invoiced to the Partnership and therefore are
excluded from the accompanying combined financial statements.
These expenses include, but are not limited to, certain
U.S. managed care services, Partners’ subsidiary
management in most international markets, and other indirect
expenses such as corporate overhead and interest. |
|
|
• |
Research and development (“R&D”)
expense — R&D activities are performed by the
Partners and agreed upon costs and expenses are invoiced to the
Partnership. These agreed upon expenses generally represent an
allocation of each Partner’s estimate of full time
equivalents devoted to the research and development of the
cholesterol and respiratory products and include grants and
other third-party expenses. These contractually agreed upon
allocated costs are included as “Research and
development” in the accompanying combined statements of net
sales and contractual expenses. All other R&D costs that are
incurred by the Partners but are not jointly agreed upon are not
invoiced to the Partnership and therefore are excluded from the
accompanying combined financial statements. |
|
|
2. |
Summary of Significant Accounting Policies |
|
|
|
Principles of Combination |
The accompanying combined balance sheets and combined statements
of net sales and contractual expenses, cash flows and
partners’ capital (deficit) include the cholesterol
and respiratory-related activities of the Combined Companies.
Interpartnership balances and profits are eliminated.
108
Merck/ Schering-Plough Cholesterol Partnership
Notes to Combined Financial
Statements — (Continued)
The combined financial statements are prepared based on
contractual agreements between the Partners, as described above,
and include certain amounts that are based on Management’s
best estimates and judgments. Estimates are used in determining
such items as provisions for sales discounts and returns.
Because of the uncertainty inherent in such estimates, actual
results may differ from these estimates.
|
|
|
Foreign Currency Translation |
The United States dollar is the functional currency for the
Partnership’s foreign operations.
|
|
|
Cash and Cash Equivalents |
Cash equivalents are comprised of certain highly liquid
investments with original maturities of less than three months.
Substantially all inventories are valued at the lower of first
in, first out cost or market.
Intangible assets consist of licenses, trademarks and trade
names owned by the Partnership. These intangible assets have
been recorded at the Partners’ historical cost at the date
of contribution at a nominal value.
|
|
|
Revenue Recognition, Rebates, Returns and
Allowances |
Revenues from sales of Cholesterol Products are recognized when
title and risk of loss pass to the customer. Recognition of
revenue also requires reasonable assurance of collection of
sales proceeds and completion of all performance obligations. In
the United States, sales discounts are issued to customers as
direct discounts at the
point-of-sale or
indirectly through an intermediary wholesale purchaser, known as
chargebacks, or indirectly in the form of rebates. Additionally,
sales are generally made with a limited right of return under
certain conditions. Revenues are recorded net of provisions for
sales discounts and returns for which reliable estimates can be
made at the time of sale. Reserves for chargebacks, discounts
and returns and allowances are reflected as a direct reduction
to accounts receivable and amounted to $23 million and
$6 million at December 31, 2005 and 2004,
respectively. Accruals for rebates are reflected as
“Rebates payable”, shown separately in the combined
balance sheets.
No provision has been made for federal, foreign or state income
taxes as taxable income or losses of the Partnership are
allocated to the Partners and included in each Partners’
income tax return.
|
|
|
Concentrations of Credit Risk |
The Partnership’s concentrations of credit risk consist
primarily of accounts receivable. Four customers represented, in
aggregate, approximately 83% of the Partnership’s
“Accounts receivable, net” at December 31, 2005.
Bad debts for the years ended December 31, 2005, 2004 and
2003 (unaudited) have been minimal. The Partnership does
not normally require collateral or other security to support
credit sales. In 2005, 2004 and 2003 (unaudited), the
Partnership derived approximately 81%, 83% and 88%,
respectively, of its combined net sales from the United States.
109
Merck/ Schering-Plough Cholesterol Partnership
Notes to Combined Financial
Statements — (Continued)
Inventories at December 31 consisted of:
|
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|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(Dollars in | |
|
|
Millions) | |
Finished goods
|
|
$ |
37 |
|
|
$ |
31 |
|
Raw materials and work in process
|
|
|
38 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
$ |
75 |
|
|
$ |
64 |
|
|
|
|
|
|
|
|
The Partnership has entered into long-term agreements with the
Partners for the supply of active pharmaceutical ingredients
(API) and for the formulation and packaging of the
Cholesterol Products at an agreed upon cost. In connection with
these supply agreements, the Partnership has entered into
capacity agreements under which the Partnership has committed to
take a specified annual minimum supply of API and formulated
tablets or pay a penalty. These capacity agreements are in
effect for a period of seven years following the first full year
of production by one of the Partners and expire beginning in
2011. The Partnership has met its commitments under the capacity
agreements through December 31, 2005.
|
|
4. |
Related Party Transactions |
The Partnership purchases substantially all of its goods and
services, including pharmaceutical product, manufacturing
services, sales force services, administrative services and
R&D services, from its Partners. Summarized information
about related party balances is as follows:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
December 31, 2004 | |
|
|
| |
|
| |
|
|
Schering- | |
|
|
|
Schering- | |
|
|
|
|
Plough | |
|
Merck | |
|
Total | |
|
Plough | |
|
Merck | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in Millions) | |
Receivables
|
|
$ |
5 |
|
|
$ |
241 |
|
|
$ |
246 |
|
|
$ |
4 |
|
|
$ |
120 |
|
|
$ |
124 |
|
Payables
|
|
|
161 |
|
|
|
364 |
|
|
|
525 |
|
|
|
115 |
|
|
|
279 |
|
|
|
394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payables, net
|
|
$ |
156 |
|
|
$ |
123 |
|
|
$ |
279 |
|
|
$ |
111 |
|
|
$ |
159 |
|
|
$ |
270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, promotion and administrative services provided to the
Partnership by the Partners and included in “Selling,
general and administrative” in the accompanying combined
statements of net sales and contractual expenses for years 2005,
2004 and 2003 amounted to $463 million, $290 million
and $180 million (unaudited), respectively. Selling expense
includes reimbursements made to Schering-Plough and Merck for
physician details of $194 million and $178 million,
respectively, in 2005, $121 million and $99 million,
respectively, in 2004 and $70 million to each Partner in
2003 (unaudited). Administrative expense includes reimbursements
made to Merck pursuant to administrative services and
partnership agreements of $13 million in 2005,
$2 million in 2004 and $.9 million in 2003 (unaudited).
In Latin America, the Partners compete with one another in the
cholesterol market and thereby sell products separately. The
Partnership sells Cholesterol Products to the Partners for this
purpose and these sales are included in “Net sales” at
their invoiced price in the accompanying combined statements of
net sales and contractual expenses. Net sales to Merck and
Schering-Plough’s Latin American subsidiaries were
$36 million, $42 million, and $9 million
(unaudited), in 2005, 2004 and 2003, respectively.
The Partnership maintains insurance coverage with deductibles
and self-insurance as Management believes is cost beneficial.
The Partnership self-insures all of its risk as it relates to
product liability and accrues an estimate of product liability
claims incurred but not reported.
110
INDEPENDENT AUDITORS’ REPORT
The Partners of the Merck/ Schering-Plough Cholesterol
Partnership
We have audited the accompanying combined balance sheets of the
Merck/ Schering-Plough Cholesterol Partnership as of
December 31, 2005 and 2004, as described in Note 1,
and the related combined statements of net sales and contractual
expenses, partners’ capital (deficit) and cash flows,
as described in Note 1, for the years then ended. These
financial statements are the responsibility of the management of
Merck & Co., Inc. and Schering-Plough Corporation,
collectively “Management” or “the Partners”.
Our responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with auditing standards
generally accepted in the United States of America. Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes consideration
of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Partnership’s internal control
over financial reporting. Accordingly, we express no such
opinion. An audit also includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
The accompanying statements were prepared for the purpose of
complying with certain rules and regulations of the Securities
and Exchange Commission and, as described in Note 1, are
not intended to be a complete presentation of the financial
position, results of operations or cash flows of all of the
activities of a stand-alone pharmaceutical company involved in
the discovery, development, manufacture, distribution and
marketing of pharmaceutical products.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the combined financial
position of the Merck/ Schering-Plough Cholesterol Partnership,
as described in Note 1, as of December 31, 2005 and
2004, and the combined results of its net sales and contractual
expenses and its combined cash flows, as described in
Note 1, for the years then ended in conformity with
accounting principles generally accepted in the United States of
America.
/s/ Deloitte &
Touche LLP
Parsippany, New Jersey
February 28, 2006
111
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
SCHEDULE II. VALUATION AND QUALIFYING ACCOUNTS
For the Years Ended December 31, 2005, 2004 and 2003
Valuation and qualifying accounts deducted from assets to which
they apply:
Allowances for accounts receivable:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve for | |
|
Reserve | |
|
Reserve | |
|
|
|
|
Doubtful | |
|
for Cash | |
|
for Claims | |
|
|
|
|
Accounts | |
|
Discounts | |
|
and Other | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in millions) | |
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning of year
|
|
$ |
67 |
|
|
$ |
25 |
|
|
$ |
81 |
|
|
$ |
173 |
|
Additions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to costs and expenses
|
|
|
14 |
|
|
|
138 |
|
|
|
271 |
|
|
|
423 |
|
Deductions from reserves
|
|
|
(25 |
) |
|
|
(131 |
) |
|
|
(225 |
) |
|
|
(381 |
) |
Effects of foreign exchange
|
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
$ |
54 |
|
|
$ |
31 |
|
|
$ |
126 |
|
|
$ |
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning of year
|
|
$ |
60 |
|
|
$ |
22 |
|
|
$ |
35 |
|
|
$ |
117 |
|
Additions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to costs and expenses
|
|
|
16 |
|
|
|
105 |
|
|
|
159 |
|
|
|
280 |
|
Deductions from reserves
|
|
|
(11 |
) |
|
|
(103 |
) |
|
|
(114 |
) |
|
|
(228 |
) |
Effects of foreign exchange
|
|
|
2 |
|
|
|
1 |
|
|
|
1 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
$ |
67 |
|
|
$ |
25 |
|
|
$ |
81 |
|
|
$ |
173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning of year
|
|
$ |
68 |
|
|
$ |
39 |
|
|
$ |
27 |
|
|
$ |
134 |
|
Additions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to costs and expenses
|
|
|
18 |
|
|
|
112 |
|
|
|
40 |
|
|
|
170 |
|
Deductions from reserves
|
|
|
(29 |
) |
|
|
(131 |
) |
|
|
(34 |
) |
|
|
(194 |
) |
Effects of foreign exchange
|
|
|
3 |
|
|
|
2 |
|
|
|
2 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
$ |
60 |
|
|
$ |
22 |
|
|
$ |
35 |
|
|
$ |
117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112