(Dollars in millions, except per share figures) Change
Net sales $ 9,815 $ 9,116 8%
Income before income taxes 3,188 2,795 14%
Net income 2,423 2,110 15%
Diluted earnings per common share 1.64 1.42 15%
Research and development $ 1,333 $ 1,191 12%
Capital expenditures 763 543 40%
Return on average shareholders’ equity 42.9% 46.0%
Total assets $ 10,805 $ 9,375
Shareholders’ equity 6,119 5,165
Cash dividends per common share $ .545 $ .485
Number of employees 28,100 26,500
Average shares outstanding for diluted EPS (in millions) 1,476 1,486
DILUTED EARNINGS PER
COMMON SHARE NET INCOME DIVIDENDS PER COMMON SHARE
dollars dollars in millions dollars
96 97 98 00
99 96 97 98 00
99 96 97 98 00
01 financial highlights 02 letter to shareholders 04 worldwide pharmaceuticals and research
14 sales by major therapeutic categories 15 financial section 37 directors and officers 37 investor information
S C H E R I N G - P L O U G H C O R P O R AT I O N 0 1
letter to shareholders
For the 15th consecutive year, Schering-Plough in 2000 recorded MARKETING ACHIEVEMENTS Worldwide pharmaceutical sales in
double-digit growth in diluted earnings per share, which rose 15 2000 grew 8 percent to $8.3 billion. Leading pharmaceutical sales
percent to $1.64 from $1.42 in the prior year. Net income totaled for the year was our CLARITIN line of nonsedating antihistamines,
$2.4 billion versus $2.1 billion in 1999. Worldwide sales for the year the largest selling in the world. Worldwide sales of CLARITIN increased
were up 8 percent to $9.8 billion. Excluding foreign exchange, sales 13 percent to $3.0 billion.
rose 10 percent. Growth was paced by worldwide pharmaceuticals,
Building on the strength of the CLARITIN franchise in world allergy
which contributed 85 percent of total Company sales.
markets is expected to be CLARINEX (desloratadine), a new once-daily
Schering-Plough recorded other notable achievements during nonsedating antihistamine. In January 2001, the product gained
the year. We gained marketing approvals for eight major products European Union (EU) approval for the treatment of seasonal allergies,
or indications in the United States or internationally. We filed and it also received a U.S. approvable letter. Schering-Plough
14 regulatory applications for major products or indications. We is working to expand its global allergy/respiratory franchise with
strengthened our research and development programs by entering NASONEX, a nasal-inhaled steroid for allergies, and ASMANEX, an
into eight research collaborations and recommending that five new orally inhaled steroid for asthma. In 2000, NASONEX continued to
compounds advance into development. gain market share in the United States and major international
markets. ASMANEX has been approved for use in eight international
ADVANCES IN RESEARCH Schering-Plough’s record of success countries, including Canada.
proceeds from a tradition of growth through research, as evidenced
by steadily increasing expenditures for research and development. Our alpha interferon franchise for treating various cancers and
In 2000, R&D spending rose 12 percent to $1.3 billion. viral diseases was a major contributor in 2000, with worldwide
sales increasing 21 percent to $1.4 billion. The product line consists
Targeting specific therapeutic areas, Schering-Plough has built a of INTRON A; REBETRON Combination Therapy, containing REBETOL
strong in-house organization to generate promising drug candidates Capsules and INTRON A Injection; and PEG-INTRON, a longer-acting
and critically assess external opportunities. We actively seek to expand form of INTRON A. REBETRON Combination Therapy is the current stan-
our pipeline through licensing agreements for new compounds and dard of care for treating hepatitis C, a serious disease affecting some
advanced research technologies. 10 million people in major world markets. PEG-INTRON was approved
in May in the EU and in January 2001 in the United States to treat
An important collaboration was announced in May, when we entered
hepatitis C. In December, the EU’s regulatory agency recommended
into two partnerships with Merck & Co., Inc. One partnership is
approval of the combination use of PEG-INTRON and REBETOL for
seeking to develop for the U.S. market a once-daily fixed-combination
hepatitis C. This combination is expected to become the new stan-
tablet of ezetimibe, the Company’s novel cholesterol absorption
dard of care. A U.S. application for the combination use was submit-
inhibitor, and Merck’s cholesterol-management medicine Zocor, as
ted in February 2001.
well as use of ezetimibe as monotherapy and co-administered with
other statins. The other partnership is pursuing development in Schering-Plough is increasing its presence in the areas of cancer and
the United States of a once-daily fixed-combination tablet containing inflammatory diseases. Sales of TEMODAR, a brain cancer treatment,
our nonsedating antihistamine CLARITIN and Merck’s leukotriene topped $100 million for the first time in 2000. In June, REMICADE,
receptor antagonist Singulair for treating allergic rhinitis and asthma. an anti-inflammatory agent, received EU marketing authorization for
combination use in treating rheumatoid arthritis, with an expanded
indication approved in February 2001. The product is licensed for
0 2 S C H E R I N G - P L O U G H C O R P O R AT I O N
RICHARD JAY KOGAN (LEFT) AND RAUL E. CESAN
marketing in most non-U.S. countries from Centocor, Inc., a unit FDA regarding the quality and reliability of our manufacturing systems
of Johnson & Johnson. and controls.
In cardiovasculars, INTEGRILIN Injection, a platelet aggregation We continue to strive to conduct all aspects of our business
inhibitor, has become the most widely used GP IIb/IIIa inhibitor according to the highest ethical standards and in compliance with
in the United States. Through a licensing agreement with COR all applicable laws and regulations. We believe that our products
Therapeutics, Inc., Schering-Plough co-markets INTEGRILIN in the deliver quality and value to patients and the medical community,
United States and markets the product in Europe. and that we have priced them responsibly. The Company recognizes
its obligations to be a good corporate citizen and seeks to fulfill
Contributing to Schering-Plough’s success in 2000 were our animal those responsibilities. Philanthropic contributions in 2000 totaled
health and consumer products business units. Animal health sales $6.0 million, including those from the Schering-Plough
totaled $720 million. Our DR. SCHOLL’S line of foot care products Foundation and direct or in-kind corporate gifts.
and the COPPERTONE and BAIN DE SOLEIL sun care lines together
hold well-established No. 1 positions in their North American We are pleased to welcome David H. Komansky, chairman and chief
markets. The Company’s over-the-counter products include some executive officer of Merrill Lynch & Co., Inc., who was elected to the
of the best-known U.S. brands. Board of Directors effective November 1, 2000.
CORPORATE DEVELOPMENTS Schering-Plough’s capital investments At year-end, Hugh A. D’Andrade, vice chairman and chief
totaled $763 million in 2000. A $450 million expansion of our administrative officer, retired from his corporate and Board positions.
Singapore manufacturing facilities was initiated in December 2000. In Mr. D’Andrade has been an integral part of Schering-Plough’s
July, Schering-Plough announced an agreement to purchase progress for nearly 20 years and a valued member of our leadership
Novartis Pharmaceuticals Corporation’s research and office facility team. We are grateful to him for his many contributions.
in Summit, N.J. This past fall we opened a new world headquarters
Schering-Plough demonstrated in 2000 that we have the expertise,
at our Kenilworth, N.J. campus.
resources and drive to compete and succeed in the global
The Board of Directors in April 2000 authorized Schering-Plough’s pharmaceutical marketplace. We are confident our strengths will
17th increase in the quarterly dividend since 1986, raising enable us to build on that record in the years ahead.
the quarterly payment by 12 percent to 14 cents per share.
A $1.5 billion share repurchase program begun in April 2000
was 33 percent complete by year-end 2000. Since 1983, the
Company has bought back the equivalent of 789 million shares
at a cost of approximately $5.9 billion. RICHARD JAY KOGAN
Chairman and Chief Executive Officer
Schering-Plough in February 2001 reported on U.S. manufacturing
process and control issues, critical findings from facility inspections
by the U.S. Food and Drug Administration (FDA) and the negative
impact these issues are expected to have on our 2001 financial results.
For details see page 19. We are taking full responsibility for resolving RAUL E. CESAN
these matters in a timely manner and securing the confidence of the President and Chief Operating Officer
February 16, 2001
S C H E R I N G - P L O U G H C O R P O R AT I O N 0 3
allergy and respiratory
Schering-Plough’s success in the worldwide pharmaceutical The Company’s next-generation
marketplace stems from its commitment to innovative research allergy treatment, CLARINEX
and effective execution of global marketing programs. (desloratadine), is a new once-
Building on strong and growing daily nonsedating antihistamine
Consolidated worldwide sales rose 8 percent in 2000, led by product lines, allergy/respiratory for the treatment of seasonal
Schering-Plough’s global pharmaceuticals business. U.S. sales rose is Schering-Plough’s largest allergic rhinitis (SAR). In
9 percent and international sales grew 6 percent, with pharmaceutical therapeutic product category. January 2001, the European
products generating 85 percent of total sales. Also contributing were Worldwide sales increased Union (EU) granted marketing
the Company’s global animal health business and its consumer lines 9 percent to $4.2 billion authorization for desloratadine
of foot care, over-the-counter and sun care products. in 2000. 5 mg tablets for the treatment
of SAR in adults and children
The United States, as the world’s largest pharmaceutical market, Schering-Plough is establishing
12 years of age and older. A
historically has produced the majority of Schering-Plough’s sales. a global allergy/respiratory fran-
highly potent H1 receptor
While the Company expects this country to remain its largest market, chise with new and established
antagonist, desloratadine taken
it also foresees major growth opportunities in international markets, products that are steadily
once daily provides 24-hour
notably in Europe. In that region, Schering-Plough has new products, producing higher sales in most
relief from nasal and non-nasal
both on the market and undergoing regulatory review, in therapeutic major markets. The Company
symptoms of SAR and, in clini-
areas where the Company has not previously competed. holds the leading position in the
cal trials, significantly reduced
U.S. allergy/respiratory market
total symptom scores associat-
Helping fuel this growth has been the steady expansion of the and is embarking on a major
ed with seasonal allergies.
Company’s sales force, both internationally and in the United States. drive to extend that position
The sales force has grown to approximately 12,400 worldwide, with on a worldwide basis. A U.S. approvable letter for
about 4,700 in the United States and 7,700 internationally.
the 5 mg tablet formulation of
The Company’s strong U.S.
CLARINEX was issued in January
Schering-Plough’s research and development efforts focus position has been led by sales of
2001. Regulatory applications
on therapeutic areas where there are opportunities to achieve the CLARITIN (loratadine) family
have been submitted in the EU
significant medical advances. Research targets include allergic and of nonsedating antihistamine
and the United States for other
inflammatory disorders, infectious diseases, oncology, cardiovascular products. Worldwide CLARITIN
CLARINEX formulations and
disease and central nervous system disorders. In 2000, five discovery sales increased by 13 percent in
indications, including a rapidly
compounds were recommended to advance into clinical development. 2000 to $3.0 billion, with $2.6
disintegrating tablet, a twice-daily
billion generated in the United
The Company has systematically integrated new technologies into version with a decongestant
States. Decongestant formula-
its drug discovery and development programs. These technologies and a pediatric syrup formula-
tions represented 27 percent of
include genomics, combinatorial chemistry, automated high-through- tion, and for use in treating
CLARITIN sales, or $817 million.
put screening and structure-based drug design. Schering-Plough chronic idiopathic urticaria (CIU),
also actively supplements in-house research efforts by licensing or hives of unknown cause.
potential new therapies and research technologies. R&D investments
in 2000 rose 12 percent to $1.3 billion.
0 4 S C H E R I N G - P L O U G H C O R P O R AT I O N
REVIEWING PLANS FOR CLARINEX (LEFT PHOTO), A NEW ONCE-DAILY NONSEDATING ANTIHISTAMINE, ARE MARKETING TEAM MEMBERS, FROM LEFT,
GRETA KELLER, DIRECTOR; JAMES ROBINSON, DIRECTOR; AND LUIS SALMUN, M.D., DIRECTOR. REAGENTS AND BUFFERS (RIGHT PHOTO) ARE USED TO PURIFY
PROTEINS BY SCIENTISTS SEARCHING FOR NEW THERAPEUTIC ENTITIES.
The success of CLARITIN has In August 2000, the FDA An important part of approved in the United States
been due to its unique combi- granted CLARITIN six months of Schering-Plough’s drive to for the prevention of nasal
nation of benefits. A once-daily, additional marketing exclusivity, expand its global allergy/ symptoms of SAR in adults and
nonsedating antihistamine, covering all five formulations respiratory franchise is NASONEX children as young as age 12.
CLARITIN provides safe and of the product, as a result of (mometasone furoate monohy- The Company holds a U.S.
effective relief from seasonal the Company’s having conducted drate), a potent, once-daily nasal patent that is set to expire in
allergies with flexible and con- pediatric clinical trials. The spray for allergies. Sold in 57 2017 for mometasone furoate
venient dosing. In major world six-month period of marketing countries, the product offers a monohydrate, the active ingre-
markets, the product is available exclusivity is added to the rapid onset of action, favorable dient in NASONEX.
in as many as five formulations. expiration dates of all patents side-effect profile and low
In the EU, NASONEX is marketed
These include CLARITIN Tablets, covering CLARITIN. systemic absorption.
for use in children 6 to 11 years
a once-daily antihistamine;
Schering-Plough owns or has Worldwide sales of NASONEX of age for the once-daily treat-
CLARITIN-D 24 Hour (loratadine/
licensed several loratadine- increased 60 percent in 2000 ment of symptoms of seasonal
related patents. The loratadine to $415 million. NASONEX allergic or perennial allergic
Extended Release Tablets,
compound patent in the United continues to capture U.S. rhinitis. In France, NASONEX is
a once-daily version with a
States is set to expire in market share formerly held by indicated for use in children as
decongestant; CLARITIN-D 12
June 2002 and the compound VANCENASE (beclomethasone young as age 3. The product
Hour, a twice-daily version with
patent for desloratadine in dipropionate), the Company’s holds the No. 2 position in the
a decongestant; CLARITIN Syrup,
April 2004. A fluoroloratadine predecessor nasal-inhaled world nasal-inhaled steroid
a syrup formulation for children;
patent is due to expire in 2008, steroid. Combined worldwide market and leading positions in
and CLARITIN REDITABS, a
and a formulation patent for sales of NASONEX and VANCENASE several major markets in the
once-daily product in a rapidly
CLARITIN-D 24 Hour is due to rose 24 percent to $590 million EU and Latin America.
expire in 2012. in 2000. At year-end, the
Asthma affects millions of
Based on the results of pediatric two products held a 33 percent
The Company also has licensed people worldwide and represents
trials, the U.S. Food and share of the U.S. nasal-inhaled
from Sepracor Inc. patent rights a growing public health concern in
Drug Administration (FDA) in steroid category.
covering certain uses of major world markets, particularly
December approved broader
desloratadine that expire in In the United States, NASONEX given its increased incidence in
product labeling for CLARITIN
2014. In August 2000, a U.S. is marketed for the treatment pediatric populations.
Syrup to include children 2 to
formulation patent covering of nasal symptoms of seasonal
5 years old for the relief of nasal
desloratadine-related products and perennial allergic rhinitis
and non-nasal symptoms of SAR
was issued to Schering-Plough in children as young as 3 years
and the treatment of CIU.
that expires in 2019. of age. NASONEX is the only drug
CLARITIN Syrup is the only
in its class to be indicated for
children as young as age 3, and
approved for children as young
the only nasal-inhaled steroid
as age 2.
S C H E R I N G - P L O U G H C O R P O R AT I O N 0 5
DISCUSSING NEW RESPIRATORY THERAPIES (LEFT PHOTO) ARE GARY MCWALTERS, SENIOR PRODUCT MANAGER, AND LINDA ARMSTRONG, M.D., DIRECTOR, CLINICAL
RESEARCH, ALLERGY. CARMINE GIANNETTA, PROCESS DEVELOPMENT SPECIALIST (RIGHT PHOTO), MONITORS A 30-LITER CELL CULTURE BIOREACTOR AT A COMPANY
FACILITY IN UNION, N.J.
ASMANEX (mometasone furoate), in the United States. A In May 2000, the Company antibody to the cytokine
an orally inhaled steroid, is the Company subsidiary, Warrick formed a partnership with interleukin-5 (IL-5). Anti-IL-5
Company’s next-generation Pharmaceuticals, markets Merck & Co., Inc. to develop is designed to block the
treatment for asthma. ASMANEX generic albuterol products. and market in the United migration of inflammatory
TWISTHALER, a dry powder inhaled States a once-daily fixed- eosinophils to the lungs, thus
PRODUCTS IN DEVELOPMENT
formulation, has received combination tablet containing offering promise as a long-acting
Building upon its 50-year history
regulatory approvals in eight CLARITIN and Singulair asthma treatment.
as a leader in developing
countries, including Canada. (montelukast sodium) for the
therapies for allergy and An early stage collaborative
ASMANEX uses a state-of-the-art treatment of allergic rhinitis
asthma, Schering-Plough is effort with Chiroscience Group
delivery device designed to and asthma. Singulair is
pursuing new and more plc (merged with Celltech Group
offer a simplified inhalation Merck’s once-daily leukotriene
effective therapies to prevent plc) has identified a potent and
delivery system powered by the receptor antagonist for the
or block the body’s allergic highly selective oral inhibitor of
patient’s own inhalation and free treatment of asthma. A CLARITIN/
and immunological responses. the phosphodiesterase type 4
of any chlorofluorocarbon (CFC) Singulair fixed-combination
(PDE 4) enzyme, a component
propellants. Under regulatory tablet may have the potential
In December 2000, the of the body’s inflammatory
review in the United States, to treat seasonal allergies by
Company submitted marketing response mechanism. Such
ASMANEX may offer improved blocking two key mediators of
applications to the FDA for three inhibitors may be effective as
pharmacological benefits, low inflammation in the respiratory
new CLARINEX formulations: a oral treatments for asthma and
systemic absorption and the tract (histamine and
fixed combination of deslorata- other inflammatory diseases.
convenience of once-daily dos- leukotrienes). The combination
dine and the decongestant The compound is in early
ing. A U.S. approvable letter therapy is in Phase III studies
pseudoephedrine sulfate as a phase studies.
was received in October 1999. for the treatment of SAR.
twice-daily treatment of SAR in
adults and children 12 years of Through a new collaboration
The Company’s other asthma A metered-dose, CFC-free
age and older; a syrup form for and licensing agreement, the
products include VANCERIL (non-chlorofluorocarbon)
the treatment of SAR and CIU Company is working with Texas
(beclomethasone dipropionate), inhaled version of ASMANEX is
in patients as young as 2 years Biotechnology Corporation to
an orally inhaled steroid for in Phase III studies for the
of age; and a rapidly disintegrat- discover, develop and commer-
asthma, with 2000 sales of treatment of asthma.
ing tablet formulation. A U.S. cialize VLA-4 antagonists, a
$127 million, down 29 percent
regulatory application is also In pursuing new methods to new class of compounds being
due primarily to manufacturing
pending for CLARINEX in treating prevent or block allergic and studied as possible treatments
issues; and PROVENTIL and other
CIU. EU applications for treating immunologic responses, for asthma.
albuterol products, with sales of
CIU and for the syrup form were Schering-Plough researchers
$197 million, down 21 percent
filed in January 2001. Phase II are conducting Phase II clinical
due to manufacturing issues and
and Phase III studies for various studies with a monoclonal
continued generic competition
line extensions are ongoing.
0 6 S C H E R I N G - P L O U G H C O R P O R AT I O N
RESEARCH SCIENTISTS, FROM LEFT, BIRENDRA PRAMANIK, PH.D., AND YAN-HUI LIU, PH.D., USE MASS SPECTROMETERS TO CHARACTERIZE THE STRUCTURE OF
SMALL MOLECULES AND PROTEINS IN THE EARLY DRUG DISCOVERY PROCESS. PHOTO AT RIGHT SHOWS A DETAILED VIEW OF A MASS SPECTROMETER.
An expanded research agreement expand, creating a major stage liver disease is the most leading cause of chronic liver
with Genome Therapeutics Corp. franchise for the Company and frequent indication for liver disease and the most common
(GTC) enables Schering-Plough driving sales higher. transplantation among adults. reason for liver transplants in
to use GTC’s high-throughput Europe, where some 5 million
Schering-Plough’s research A major advance in the treat-
positional cloning, bioinformatics people are estimated to be
into the use of INTRON A to treat ment of hepatitis C came in
and genomics sequencing chronically infected.
hepatitis C has led to the June 1998 with the U.S. intro-
capabilities to identify asthma-
Company’s becoming the world duction of Schering-Plough’s In October, the United
susceptibility genes that may be
leader in discovering and REBETRON Combination Therapy, Kingdom’s National Institute
useful in the development of
developing new therapies for containing REBETOL (ribavirin) for Clinical Excellence (NICE)
novel asthma therapies.
the disease, one of the most Capsules and INTRON A Injection. issued clinical guidance
prevalent worldwide public This combination therapy recommending the combination
health threats. This serious quickly became the worldwide use of interferon alpha and
anti-infective and disease affects as many as standard of care for treating the ribavirin for the treatment of
anticancer 10 million people in major disease. Schering-Plough has moderate to severe hepatitis C.
world markets, including about exclusive rights to market oral
The next advance in treating
MARKETED PRODUCTS 4 million in the United States. ribavirin for hepatitis C in all
Fueled by growth in U.S. and hepatitis C is expected to be the
Despite the seriousness of the major world markets through a
major international markets, the combination use of PEG-INTRON
disease, only about 10 to licensing agreement with ICN
Company’s anti-infective/anti- (peginterferon alfa-2b) with
15 percent of patients with Pharmaceuticals, Inc. In
cancer product group achieved REBETOL. PEG-INTRON is a longer-
hepatitis C have been treated. November 2000, an application
16 percent higher sales in acting form of INTRON A that
was submitted to the U.S. Food
2000 to total $2.0 billion. According to the Centers for uses proprietary PEG technology
and Drug Administration (FDA)
Disease Control and Prevention, developed by Enzon, Inc.
seeking approval to market
The anticancer/antiviral agent approximately 70 percent of REBETOL separately for use in
INTRON A (interferon alfa-2b Use of PEG-INTRON as
U.S. patients infected with combination with INTRON A for the
recombinant) Injection is the once-weekly monotherapy to
hepatitis C go on to develop treatment of chronic hepatitis C.
world’s largest-selling alpha treat chronic hepatitis C was
chronic liver disease. Hepatitis C
interferon and has been the approved in the EU in May
infection contributes to the In the European Union (EU),
foundation for Schering-Plough’s and in the United States in
deaths of an estimated 8,000 to the use of REBETOL Capsules
success in this product category. January 2001, making it
10,000 Americans each year, in combination with interferon
The broad medical utility of the first pegylated interferon
and the toll is expected to triple alfa-2b injection (marketed
alpha interferon, used as approved for marketing in
by the year 2010, exceeding the as INTRON A in certain EU
monotherapy, in combination the world. In clinical studies,
number of annual deaths due countries) has gained rapid,
with other agents and most once-weekly administration of
to AIDS. The American Liver widespread acceptance among
recently in a longer-acting PEG-INTRON has been shown to
Foundation has reported that physicians treating hepatitis C
formulation, has continued to be significantly more effective
hepatitis C-associated end- patients. The disease is the
S C H E R I N G - P L O U G H C O R P O R AT I O N 0 7
CONFERRING WITH A PATIENT (LEFT PHOTO) ABOUT TREATMENT OF CHRONIC HEPATITIS C IS DR. CHRISTINA MONDORF IN FRANKFURT, GERMANY. PEG-INTRON
IS APPROVED FOR TREATING CHRONIC HEPATITIS C IN THE UNITED STATES AND THE EUROPEAN UNION. X-RAY CRYSTALLOGRAPHY (RIGHT PHOTO) CAN
ACCELERATE DRUG DISCOVERY BY PROVIDING 3-D STRUCTURES OF POTENTIAL DRUG MOLECULES BOUND TO THEIR PROTEIN TARGETS.
in treating hepatitis C than on health care systems if not service, is available to for refractory anaplastic astro-
INTRON A, with a similar safety properly treated. hepatitis B and hepatitis C cytoma, making it the first new
profile and the convenience patients in the United States. chemotherapy agent for this
INTRON A is also approved
of less-frequent dosing. type of brain tumor approved in
for several cancer indications, A new program under develop- the United States in 20 years.
In December 2000, the including use as an adjuvant ment is geared to patients who Schering-Plough has exclusive
EU’s Committee for Proprietary treatment to surgery in patients have been diagnosed with worldwide rights to market temo-
Medicinal Products (CPMP) with malignant melanoma. hepatitis C but are not yet on zolomide through a licensing
recommended approval of the Results of a study presented in any therapy. A personalized agreement with Cancer Research
combination use of PEG-INTRON October at the 25th Congress nurse counselor provides Campaign Technology, Ltd.
and REBETOL Capsules for of the European Society of education about the disease,
treating both relapsed and Medical Oncology confirmed including transmission and Schering-Plough entered into
naïve (previously untreated) the significant and consistent risk factors. The Company also a co-promotion agreement in
adult hepatitis C patients. The efficacy of INTRON A in high-risk offers CROSSING BRIDGES, a March 2000 with Bristol-Myers
CPMP recommendation serves melanoma patients. patient-support program Squibb Company to co-promote
as the basis for a European designed to help malignant TEQUIN (gatifloxacin), a
A multidose injection pen
Commission approval, which melanoma patients adhere to broad-spectrum fluoroquinolone
delivery system, which offers
typically follows three to four their INTRON A dosing regimen. antibiotic. The product is co-
six pre-measured injections
months later. A U.S. application marketed by the two companies
in a compact and easy-to-use The anticancer product
for the combination use was in the United States for the
delivery system, has been widely TEMODAR (temozolomide) has
submitted in February 2001 treatment of community-acquired
accepted by patients who gained increasing use as a
with a request for priority review. respiratory infections.
administer INTRON A at home. treatment for two serious and
Combined worldwide sales of aggressive types of malignant REMICADE (infliximab), a novel
Schering-Plough is committed
INTRON A, REBETRON Combination brain cancer. Sales of TEMODAR anti-TNF antibody, has been
to helping patients gain access
Therapy and PEG-INTRON were $121 million for the year, marketed internationally since
to medicines proven to be safe
increased 21 percent to $1.4 surpassing the $100 million 1999 for the treatment of
and effective at affordable
billion in 2000. The higher sales mark for the first time. Crohn’s disease, a chronic and
prices. Its COMMITMENT TO CARE
sales reflected the significant An oral cytotoxic, alkylating debilitating disorder of the
patient-assistance program is
treatment advance afforded by agent, the product is approved gastrointestinal tract that often
designed to ensure that no
REBETRON Combination Therapy in the EU for the treatment of occurs in young adults and can
patient is denied access to
and the increased recognition by patients with glioblastoma seriously diminish a patient’s
the Company’s oncology and
the public, medical community multiforme showing progression quality of life.
and governments of the or recurrence after standard
because of an inability to pay.
seriousness of the disease and therapy and for anaplastic
Schering-Plough’s BE IN CHARGE
its potential financial impact astrocytoma. The product
program, a patient-counseling gained U.S. approval in 1999
0 8 S C H E R I N G - P L O U G H C O R P O R AT I O N
SCIENTISTS USE COMPUTER-ASSISTED DRUG DESIGN (LEFT PHOTO) TO VISUALIZE AND MANIPULATE MOLECULAR MODELS OF POTENTIAL NEW DRUGS. SENIOR SCIENTISTS
LI XIAO, PH.D. (LEFT), AND JOSE DUCA, PH.D., ANALYZE THE STRUCTURE OF A POTENTIAL ANTICANCER AGENT. A ROBOTIC LIQUID HANDLING SYSTEM
(RIGHT PHOTO) IS USED TO DETERMINE THE SOLUBILITY OF NEW COMPOUNDS.
In June 2000, REMICADE with can occur and lead to permanent The oral chemotherapy agent
PRODUCTS IN DEVELOPMENT
methotrexate received EU disability. Schering-Plough has Schering-Plough has targeted TEMODAR is the lead compound
marketing authorization for international marketing rights, the fields of cancer, infectious in a new class of compounds
the reduction of the signs excluding Japan and parts of diseases and immunology known as imidazotetrazines. The
and symptoms of rheumatoid the Far East, for REMICADE from as areas of major focus for product, approved for treating
arthritis (RA) in patients Centocor, Inc., a Johnson & its research efforts. The certain brain cancers, is in
with active disease when the Johnson subsidiary. Company’s success is evident Phase II development for treating
response to other available in its growing portfolio of new various solid tumors. Studies are
Other cancer therapies
treatments has been inadequate. and innovative compounds in exploring different dosing regi-
include ETHYOL (amifostine), a
REMICADE not only has been development and products mens and its use in combination
cytoprotective agent licensed for
shown to relieve RA symptoms, launched in global markets. with other chemotherapy agents.
international marketing from
but also has demonstrated a
MedImmune, Inc., and CAELYX PEG-INTRON, a longer-acting In development for malignant
reduction in the rate of joint
(pegylated liposomal doxorubicin formulation of INTRON A, is melanoma is MELACINE, a ther-
damage in some patients, as
HCl), a long-circulating pegylated among the Company’s potential apeutic vaccine developed by
verified by X-ray results. In
liposomal formulation of the new therapies for treating various Corixa Corporation, which is in
January 2001, the EU’s
cancer drug doxorubicin. CAELYX cancers. The product is in Phase III studies as monotherapy
regulatory agency approved
received EU marketing approval Phase III clinical trials for for Stage II malignant melanoma
a broader RA indication
in October for the treatment chronic myelogenous leukemia and in combination with
for REMICADE, including the
of advanced ovarian cancer and malignant melanoma, and INTRON A for Stage IV of the
improvement in physical func-
in women who have failed a in early phase studies for a vari- disease. Schering-Plough has
tion in patients and a reduction
first-line platinum-based ety of solid tumors. PEG-INTRON exclusive worldwide marketing
in the rate of the progression
chemotherapy regimen. Canadian uses Enzon, Inc.’s proprietary rights to this agent from Corixa.
of joint damage.
approval was granted in January drug-delivery system.
Seeking to gain expanded
In Europe, an estimated 2001. Schering-Plough has
Approved as once-weekly indications for marketed
2.5 million people – mostly exclusive international marketing
monotherapy for the treatment products, the Company is
women – are affected by RA, rights to CAELYX, except in Japan
of hepatitis C, PEG-INTRON is conducting Phase III studies
which is a chronic and often and certain other countries,
under U.S. and EU regulatory of CAELYX in breast cancer.
painful disease characterized through a distribution agreement
review in combination with
by inflammation of the joints. with ALZA Corporation.
A farnesyl protein transferase
REBETOL for the treatment
As the disease progresses, ALZA markets the product in
(FPT) inhibitor from
of chronic hepatitis C. The
joints become swollen, inflamed, the United States under the
EU’s CPMP in December
painful and stiff. When trade name Doxil.
Institute is in Phase II trials
recommended approval for
inflammation persists or does
as an oral therapy for several
this combination use.
not respond well to treatment,
solid tumors. Research is
destruction of nearby cartilage,
focused on inhibiting the
bone, tendons and ligaments
S C H E R I N G - P L O U G H C O R P O R AT I O N 0 9
SCHERING-PLOUGH AND MERCK & CO., INC. (LEFT PHOTO) IN MAY 2000 FORMED PARTNERSHIPS TO DEVELOP AND MARKET NEW PRODUCTS IN THE U.S. CHOLESTEROL-
MANAGEMENT AND RESPIRATORY MARKETS. PICTURED ARE, FROM LEFT, RATNAKAR MITRA, SCHERING-PLOUGH VICE PRESIDENT AND GENERAL MANAGER OF THE
RESPIRATORY PARTNERSHIP, AND ROBERT MCMAHON, MERCK VICE PRESIDENT AND GENERAL MANAGER OF THE CHOLESTEROL PARTNERSHIP. PHOTO AT RIGHT
DEPICTS A VIEW INSIDE SCHERING-PLOUGH’S NEW WORLD HEADQUARTERS IN KENILWORTH, N.J.
action of the enzyme FPT, Also known to play a critical of novel target genes in two a platelet receptor glycoprotein
which is involved in the growth role in virus infection and medically important fungal (GP) IIb/IIIa inhibitor for treating
of solid tumors, including those transmission are chemokine pathogens, Candida albicans cardiovascular patients with
of the bladder and lung, and receptors expressed on the and Aspergillus fumigatus. In acute coronary syndromes.
in chronic myelogenous surface of immune cells. A the area of antibacterial
INTEGRILIN, which helps prevent
leukemia. small molecule CCR5 receptor research, Company scientists
platelets from binding to
antagonist identified by have identified novel target
Schering-Plough continues to fibrinogen and forming blood
Schering-Plough researchers is genes in gram-negative and
explore the potential of gene clots, has become the
in early phase development as gram-positive bacteria. These
therapy to treat various diseases. most widely used GP IIb/IIIa
an oral agent for treating HIV. findings may lead to the identi-
Phase II studies with p53 inhibitor in the United States.
fication of novel drug targets for
tumor suppressor gene therapy Approved for the treatment of Worldwide sales increased
for treating ovarian cancer are Crohn’s disease and rheumatoid sharply to $172 million in
ongoing. Further research in arthritis, REMICADE is in Phase In May 2000, the Company 2000, driven by increased
this area is being conducted at III studies as a treatment discontinued the clinical U.S. market penetration due
Canji, Inc., the Company’s cen- for early rheumatoid arthritis. development of ZIRACIN to positive results of a major
ter for gene therapy discovery. (evernimicin), an intravenous clinical trial named ESPRIT.
TENOVIL (interleukin-10), a antibiotic for treating drug- Interim results were first
Schering-Plough research into cytokine cloned and expressed resistant bacterial infections. reported in February 2000, with
new hepatitis C treatments at DNAX Research Institute, six-month results reported in
has involved determining the is in Phase II trials for hepatic January 2001. The ESPRIT trial
molecular structure of all fibrosis, a serious liver disorder, demonstrated a statistically
identified key enzymes of and in early phase development significant 35 percent reduction
the hepatitis C virus (HCV). for various inflammatory in the combined incidence of
Company scientists have disorders and viral diseases. death or heart attack over the six
identified the structure of an months following intracoronary
In Phase III studies for treating presence in the worldwide
enzyme complex that is stent implantation in patients
serious opportunistic fungal cardiovascular marketplace
essential to replication of HCV. receiving a stent and INTEGRILIN
infections is posaconazole, a is expanding through internal
Protease and helicase activities as compared to those patients
highly potent antifungal agent. development programs and
of NS3, a multifunctional receiving a stent and placebo.
Schering-Plough’s activities strategic licensing agreements.
HCV protein, are required for Launched in the United States
in antifungal research include Sales for the cardiovascular
viral maturation and replication. in 1998, INTEGRILIN has
an agreement with Genome product group increased
These unique, virally encoded the broadest U.S. labeling in
Therapeutics Corp., which has 11 percent to $746 million
enzymes are essential in its class.
resulted in the identification, in 2000, driven by positive
the life cycle of HCV and
using proprietary genomic physician acceptance of
constitute promising targets
technologies, of a large number INTEGRILIN (eptifibatide) Injection,
for drug intervention.
1 0 S C H E R I N G - P L O U G H C O R P O R AT I O N
A PROTEIN SEQUENCER (LEFT PHOTO) IS USED TO IDENTIFY PURIFIED PROTEINS IN THE DRUG DISCOVERY PROCESS. INTEGRILIN, A PLATELET-CLOTTING INHIBITOR
(RIGHT PHOTO), IS THE MOST WIDELY USED DRUG IN ITS CLASS IN THE UNITED STATES. CARDIOLOGIST SABINO TORRE, M.D. (LEFT) AND DAVID PEARSALL, MEDICAL
CENTER SPECIALIST, KEY ACUTE CORONARY SYNDROMES, CONFER IN A CATHETERIZATION LAB AT SAINT BARNABAS MEDICAL CENTER IN LIVINGSTON, N.J.
In the European Union (EU), Sales of K-DUR, a sustained- An ezetimibe/Zocor fixed-com- A collaborative effort with
INTEGRILIN is marketed for the release potassium chloride bination tablet has the potential AtheroGenics, Inc. is seeking to
prevention of early myocardial supplement, rose 16 percent to achieve higher levels of cho- develop and commercialize
infarction in patients with to $290 million in 2000. lesterol reduction through two drugs for the treatment and pre-
acute coronary syndromes who Sales of IMDUR (isosorbide complementary mechanisms vention of restenosis in patients
are managed medically and/or mononitrate), a once-daily, of action while maintaining a following PCI. AGI-1067 has
with percutaneous coronary long-acting oral nitrate for good safety profile. been identified as the first in a
intervention (PCI), also known angina, declined in 2000 to promising new class of orally
Ezetimibe, a product of
as angioplasty. $120 million due to continued delivered compounds known as
generic competition. A vascular protectants. The agent
Schering-Plough, through a research efforts, has been
Company subsidiary, Warrick is in early phase development
licensing agreement with COR shown in clinical studies to
Pharmaceuticals, markets a for the prevention of athero-
Therapeutics, Inc., markets selectively inhibit the body’s
generic version. sclerosis and restenosis.
INTEGRILIN in Europe and ability to absorb cholesterol in
co-markets the product with the intestine without interfering
PRODUCTS IN DEVELOPMENT
COR in the United States. Schering-Plough’s cardiovascu- with the absorption of other
lar research program illustrates fat-soluble nutrients. Statins,
Complementing INTEGRILIN how external licensing agree- such as Zocor, act primarily
marketing efforts is a three-way MARKETED PRODUCTS
ments and collaborations can by inhibiting the production
collaboration with COR and Schering-Plough is well
help realize the potential of of cholesterol in the liver.
Genentech, Inc., announced in established as a leader in
novel therapies. Ezetimibe is in Phase III trials
January 2001, to co-promote world dermatological markets
as monotherapy and as a co-
INTEGRILIN, TNKASE In May 2000, the Company through nearly five decades
administered agent with statins.
(tenecteplase) and ACTIVASE formed a partnership with of research discoveries
(alteplase, recombinant). Merck & Co., Inc. to develop and INTEGRILIN is in Phase II and product innovations.
TNKASE and ACTIVASE are market in the United States studies as a treatment for Worldwide sales of the
Genentech’s market-leading ezetimibe, Schering-Plough’s acute myocardial infarction. dermatological product group
fibrinolytic therapies for the cholesterol absorption were $680 million in 2000,
treatment of acute myocardial inhibitor, in three ways: as a approximately the same as
infarction. The agreement once-daily fixed-combination the prior year.
is expected to expand the tablet with Zocor (simvastatin),
promotion of INTEGRILIN into Merck’s cholesterol-management
thousands of additional medicine; as a once-daily
is the most-prescribed topical
hospitals nationwide. monotherapy; and in co-
administration with statins.
S C H E R I N G - P L O U G H C O R P O R AT I O N 1 1
DISCUSSING EARLY PHASE CLINICAL DATA (LEFT PHOTO) OF AN ANTI-INFECTIVE COMPOUND ARE, FROM LEFT, BAHIGE BAROUDY, PH.D., DIRECTOR, ANTIVIRAL THERAPY,
AND KATHLEEN COX, PH.D., SENIOR PRINCIPAL SCIENTIST. PHOTO AT RIGHT WAS TAKEN IN A SCHERING-PLOUGH RESEARCH LABORATORY IN KENILWORTH, N.J.
central nervous system
antifungal/anti-inflammatory To better focus its U.S. In early phase development is
and other disorders
cream in the United States, marketing resources on core an antagonist of the M2 subtype
with a market share therapeutic areas, of the muscarinic acetylcholine
approaching 60 percent. The Schering-Plough in 2000 receptor. This M2 antagonist
Worldwide sales for the
product line was expanded ended its 1998 agreement has the potential for enhancing
Company’s other pharmaceuti-
in December 2000 with U.S. with Novo Nordisk to memory function and may be
cal product category were
approval of a lotion formulation co-promote PRANDIN useful in the symptomatic treat-
$716 million in 2000.
of LOTRISONE. In 2000, (repaglinide), an oral ment of dementia associated
worldwide sales decreased antidiabetic agent for the with Alzheimer’s disease.
Schering-Plough has exclusive
2 percent to $192 million. treatment of Type 2 diabetes,
worldwide rights, excluding In January 2000, the Company
and a range of other insulin
Japan, Taiwan and Korea, to
Available in 64 countries, extended its collaboration with
products and devices.
market a line of buprenorphine
ELOCON (mometasone furoate) the University of Toronto to
hydrochloride products for
holds the leading worldwide develop drugs to prevent and
PRODUCTS IN DEVELOPMENT
opiate addiction through a
position among branded, Building on the Company’s treat Alzheimer’s disease.
distribution agreement with
medium-potency topical strengths in chemical Efforts are focused on the
Reckitt & Colman plc. These
steroids. Worldwide sales of synthesis and molecular function of presenilin genes as
products include SUBUTEX, a
ELOCON increased 2 percent biology, research efforts are possible tools for drug devel-
sublingual tablet formulation of
in 2000 to $171 million. progressing to discover and opment.
buprenorphine, and SUBOXONE, develop medications that
Also contributing to 2000 a sublingual tablet combination can treat cognitive disorders
dermatological sales were of buprenorphine and naloxone. and degenerative nervous
Schering-Plough’s DIPROLENE SUBUTEX is marketed in system diseases.
and DIPROSONE (betamethasone select international countries,
dipropionate) lines including the United Kingdom, Ecopipam, a potent D1/D5
Sales for Schering-Plough’s
of high-potency topical Germany and France, for the dopamine receptor antagonist,
animal health business rose
steroids, with combined sales treatment of opiate addiction. is in Phase II studies as a
7 percent in 2000 to $720
of $176 million. potential obesity-management
In the United States, both million, including revenues
therapy. Preclinical data suggest
anti-addiction treatments are from the June acquisition of
that the compound could
under regulatory review and the animal health business of
reduce food craving in patients
have received approvable letters Takeda Chemical Industries,
undergoing diet restrictions in
from the U.S. Food and Drug Ltd. in Japan. Despite chal-
a weight-loss program.
Administration. lenging market conditions,
higher sales for the year and
ranks sixth largest in world
animal health markets.
1 2 S C H E R I N G - P L O U G H C O R P O R AT I O N
VETERINARIAN KEITH WALL, D.V.M., TECHNICAL SERVICES MANAGER, SCHERING-PLOUGH ANIMAL HEALTH, IS PICTURED (LEFT PHOTO) AT HIS FARM IN NEW JERSEY.
INNOVATIVE MARKETING EFFORTS (RIGHT PHOTO) SUPPORT THE DR. SCHOLL’S LINE OF FOOT CARE PRODUCTS. PICTURED ARE, FROM LEFT, SUE FULTON, SENIOR PRODUCT
MANAGER, DR. SCHOLL’S, AND CLOVER BERGMANN, VICE PRESIDENT, MARKETING, SCHERING-PLOUGH HEALTHCARE PRODUCTS.
foot care otc products sun care
Higher sales were led by NUFLOR
(florfenicol), a broad-spectrum
MARKETED PRODUCTS MARKETED PRODUCTS MARKETED PRODUCTS
antibiotic used to treat bovine
Led by the DR. SCHOLL’S Sales of over-the-counter (OTC) Schering-Plough maintained
respiratory disease, a serious
brand, Schering-Plough’s products declined 4 percent in its No. 1 position in the U.S.
condition that can have a
sales of foot care products in 2000 to $202 million, primarily sun care category in 2000.
significant economic impact
2000 grew 5 percent to due to the December 1999
on cattle producers. In 2000,
Sales of sun care products
$348 million. The Company divestiture of the PAAS product
NUFLOR sales increased
increased 8 percent to
strengthened its position as line of decorating kits.
18 percent to $93 million. In
$199 million in 2000,
the U.S. market leader with
March 2000, a subcutaneous
The AFRIN brand maintained its driven by strong sales of the
new product offerings and
claim for NUFLOR was approved
leadership position in the nasal BAIN DE SOLEIL line acquired
in the European Union; market-
spray category, supported by in 1999 from Pfizer Inc.
ing for that indication began
Foot care sales were driven the launch of three “No Drip”
in the second half of the year. Also contributing to sales
by the introduction of several sprays – AFRIN No Drip Severe
were four new COPPERTONE KIDS
new products, including Congestion Nasal Spray, AFRIN
WACKY FOAM products and a
DR. SCHOLL’S ADVANTAGE Sport No Drip Sinus Nasal Spray and
line of WATER BABIES sprays,
Insoles, designed to help AFRIN No Drip Extra Moisturizing
clotrimazole), a three-way
which was the No. 1-selling
athletes improve performance, Nasal Spray.
treatment for acute and
new sun care product in 2000.
and DR. SCHOLL’S ADVANTAGE
chronic ear infections in dogs,
CORICIDIN HBP continued to
Work Insoles, clinically proven
was launched in early 2000
outperform sales growth in the
to reduce lower back pain.
in major European markets,
cough/cold category, benefiting
Other innovative DR. SCHOLL’S
including Germany, Spain
from its targeted positioning
products launched in 2000
for consumers with high
include MAGNA-ENERGY Insoles.
blood pressure. The 2000
Also contributing to 2000
LOTRIMIN AF and TINACTIN introduction of CORICIDIN
results were other established
antifungal products maintained Maximum Strength Flu helped
lines of animal health products.
their No. 1 and No. 2 positions, the brand achieve significant
Sales increased for swine
respectively, in unit sales sales growth.
biologicals, reflecting the
during the year, supported by
Company’s leading position
product introductions and a
in that market and its ability to
strong marketing campaign.
offer the only effective product
against a strain of swine flu
prevalent in the United States
S C H E R I N G - P L O U G H C O R P O R AT I O N 1 3
major therapeutic categories
S C H E R I N G – P L O U G H C O R P O R AT I O N 2 0 0 0 S A L E S dollars in millions
PHARMACEUTICALS CONSOLIDATED $9,815
P H A R M A C E U T I C A L T H E R A P E U T I C C AT E G O R I E S 2 0 0 0 S A L E S dollars in millions
ALLERGY AND RESPIRATORY TOTAL PHARMACEUTICALS $8,346
ANTI-INFECTIVE AND ANTICANCER
NET SALES RESEARCH AND DEVELOPMENT C A P I TA L E X P E N D I T U R E S
dollars in millions dollars in millions dollars in millions
96 97 98 00 96 97 98 00 96 97 98 00
99 99 99
1 4 S C H E R I N G - P L O U G H C O R P O R AT I O N
16 management’s discussion and analysis of operations and financial condition
21 statements of consolidated income
21 statements of consolidated cash flows
22 consolidated balance sheets
23 statements of consolidated shareholders’ equity
24 notes to consolidated financial statements
34 report by management
34 independent auditors’ report
35 quarterly data
36 six-year selected financial & statistical data
S C H E R I N G - P L O U G H C O R P O R AT I O N 1 5