SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
AUGUST 21, 2003
Date of Report (Date of Earliest Event Reported)
SCHERING-PLOUGH CORPORATION
(Exact name of registrant as specified in its charter)
NEW JERSEY 1-6571 22-1918501
(State or other (Commission File Number) (IRS Employer
jurisdiction Identification Number)
of incorporation)
2000 GALLOPING HILL ROAD
KENILWORTH, NJ 07033
(Address of principal executive offices, including Zip Code)
(908) 298-4000
(Registrant's telephone number, including area code)
ITEM 5. OTHER EVENTS AND REGULATION FD DISCLOSURE
Item 5 of the 8-K transmitted for filing by Schering-Plough on August 21,
2003 with a filing date of August 22, 2003 is hereby amended to include the
following sentence at the end of Item 5:
All references in this 8-K and the Exhibits to "the 8-K filed
August 21, 2003" mean "the 8-K transmitted for filing on August
21, 2003 with a filing date of August 22, 2003 (as amended)."
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DISCLOSURE NOTICE
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS (CAUTIONARY STATEMENTS
UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995).
This 8-K, including each Exhibit, and other written and oral statements made
from time to time by Schering-Plough may contain "forward-looking statements"
within the meaning of the Securities Litigation Reform Act of 1995.
Forward-looking statements relate to expectations or forecasts of future
events. They use words such as "anticipate," "believe," "could," "estimate,"
"expect," "forecast," "project," "intend," "plan," "potential," "will," and
other words and terms of similar meaning in connection with a discussion of
potential future events, circumstances or future operating or financial
performance. You can also identify forward-looking statements by the fact
that they do not relate strictly to historical or current facts.
In particular, forward-looking statements include statements relating to
future actions, prospective products, the status of product approvals, future
performance or results of current and anticipated products, sales efforts,
development programs, expenses and our programs to reduce expenses, the
number of employees accepting Schering-Plough's planned voluntary early
retirement program and the cost of and savings from that program, the outcome
of contingencies such as litigation and investigations, growth strategy and
financial results.
Any or all of our forward-looking statements here or in other publications
may turn out to be wrong. Our actual results may vary materially, and there
are no guarantees about the performance of Schering-Plough stock.
Schering-Plough does not assume the obligation to update any forward-looking
statement.
You should carefully consider any forward-looking statement and should
understand that many factors could cause actual results to differ from
Schering-Plough'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, they may include the
following:
o A significant portion of net sales are made to major pharmaceutical and
health care products distributors and major retail chains in the United
States. 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.
o Competitive factors, including technological advances attained by
competitors, patents granted to competitors, new products of
competitors coming to the market, new indications for competitive
products or generic prescription or OTC competition as
Schering-Plough's products mature and patents expire on products.
o Increased pricing pressure both in the United States and abroad from
managed care organizations, institutions and government agencies and
programs. In the United States, among other developments, consolidation
among customers may increase pricing pressures and may result in
various customers having greater influence over prescription decisions
through formulary decisions and other policies.
o Government laws and regulations (and changes in laws and regulations)
affecting domestic and international operations and the enforcement
thereof including, among other laws and regulations, those resulting
from healthcare reform initiatives and Medicare drug benefit and drug
importation legislation in the United States at the state and federal
level and in other countries, as well as laws and regulations relating
to trade, antitrust, monetary and fiscal policies, taxes, price
controls and possible nationalization.
o Patent positions can be highly uncertain and patent disputes are not
unusual. An adverse result in a patent dispute can preclude
commercialization of products or negatively impact sales of existing
products or result in injunctive relief and payment of financial
remedies.
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o Uncertainties of the FDA approval process and the regulatory approval
processes of non-U.S. countries, including, without limitation, delays
in approval of new products.
o Failure to meet Good Manufacturing Practices established by the FDA and
other governmental authorities can result in delays in the approval of
products, release of products, seizure or recall of products,
suspension or revocation of the authority necessary for the production
and sale of products, fines and other civil or criminal sanctions. The
resolution of manufacturing issues with the FDA discussed in this
report are subject to substantial risks and uncertainties. These risks
and uncertainties, including the timing, scope and duration of a
resolution of the manufacturing issues, will depend on the ability of
Schering-Plough to assure the FDA of the quality and reliability of its
manufacturing systems and controls, and the extent of remedial and
prospective obligations undertaken by Schering-Plough.
o Difficulties in product development. Pharmaceutical product development
is highly uncertain. Products that appear promising in development may
fail to reach market for numerous reasons. They may be found to be
ineffective or to have harmful side effects in clinical or pre-clinical
testing, they may fail to receive the necessary regulatory approvals,
they may turn out not to be economically feasible because of
manufacturing costs or other factors or they may be precluded from
commercialization by the proprietary rights of others.
o Efficacy or safety concerns with respect to marketed products, whether
or not scientifically justified, leading to recalls, withdrawals or
declining sales.
o Major products such as CLARITIN, CLARINEX, INTRON A, PEG-INTRON,
REBETOL Capsules and NASONEX accounted for a material portion of
Schering-Plough's 2002 revenues. If any major product were to become
subject to a problem such as loss of patent protection, OTC
availability (as indicated above for CLARITIN and its current and
potential OTC competition), previously unknown side effects; if a new,
more effective treatment should be introduced; or if the product is
discontinued for any reason, the impact on revenues could be
significant. Further such information about important new products such
as ZETIA or other important products in our pipeline may impact future
revenues.
o Legal factors, including product liability claims and other litigation,
government investigations, patent disputes with competitors and
environmental concerns, any of which could preclude commercialization
of products or negatively affect the profitability of existing
products.
o Economic factors over which Schering-Plough has no control, including
changes in inflation, interest rates and foreign currency exchange
rates.
o Instability, disruption or destruction in a geographic region important
to us - due to the location of our manufacturing facilities,
distribution facilities or customers - regardless of cause, including
war, terrorism, riot, civil insurrection or social unrest; and natural
or man-made disasters, including famine, flood, fire, earthquake and
storm.
o Changes in tax laws including changes related to taxation of foreign
earnings.
o Changes in accounting standards promulgated by the American Institute
of Certified Public Accountants, the Financial Accounting Standards
Board or the Securities and Exchange Commission that would require a
significant change to Schering-Plough's accounting practices.
For further details and a discussion of these and other risks and
uncertainties, see Schering-Plough's Securities and Exchange Commission (SEC)
filings, including Schering-Plough's 2003 Second Quarter 10-Q filed with the
Commission on July 31, 2003 and future SEC filings.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits. The following exhibits are filed with this 8-K:
99.1 Press Release titled "Schering-Plough CEO Fred Hassan Completes First 100
Days `360 Degree Review;' Announces Key Measures to Set Foundation for
Turnaround" issued August 21, 2003*
99.2 Letter to Shareholders dated August 21, 2003*
99.3 Message to Employees from Fred Hassan, Chairman of the Board and CEO,
dated August 21, 2003*
99.4 Memo to Employees from Executive Management Team regarding Value
Enhancement Initiative dated August 21, 2003*
99.5 Letter to Employees from C. Ron Cheeley, Senior Vice President of
Global Human Resources, regarding Voluntary Early Retirement Program dated
August 21, 2003*
99.6 Frequently Asked Questions and Answers, FAQs, dated August 21, 2003*
* Previously filed.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Schering-Plough Corporation
By: /s/ Thomas H. Kelly
----------------------------
Thomas H. Kelly
Vice President and Controller
Date: August 22, 2003
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Exhibit Index
The following exhibits are filed with this 8-K:
99.1 Press Release titled "Schering-Plough CEO Fred Hassan Completes First 100
Days `360 Degree Review;' Announces Key Measures to Set Foundation for
Turnaround" issued August 21, 2003*
99.2 Letter to Shareholders dated August 21, 2003*
99.3 Message to Employees from Fred Hassan, Chairman of the Board and CEO,
dated August 21, 2003*
99.4 Memo to Employees from Executive Management Team regarding Value
Enhancement Initiative dated August 21, 2003*
99.5 Letter to Employees from C. Ron Cheeley, Senior Vice President of
Global Human Resources, regarding Voluntary Early Retirement Program dated
August 21, 2003*
99.6 Frequently Asked Questions and Answers, FAQs, dated August 21, 2003*
* Previously filed.
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