UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
OCTOBER 21, 2004
Date of Report (Date of Earliest Event Reported)
SCHERING-PLOUGH CORPORATION
(Exact name of registrant as specified in its charter)
NEW JERSEY
(State or other jurisdiction of incorporation)
1-6571
(Commission File Number)
22-1918501
(IRS Employer
Identification Number)
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)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
ITEM 2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
Schering-Plough today issued a press release titled "Schering-Plough Reports
Financial Results for 2004 Third Quarter" and provided additional supplemental
financial data. The press release is attached to this 8-K as Exhibit 99.1. The
supplemental financial data is attached to this 8-K as Exhibit 99.2.
ITEM 7.01 REGULATION FD DISCLOSURE.
Schering-Plough issued a press release titled "Schering-Plough Reports Financial
Results for 2004 Third Quarter" on October 21, 2004, and the press release is
attached to this 8-K as Exhibit 99.1. Schering-Plough also issued related
supplemental data, which is attached to this 8-K as Exhibit 99.2.
Disclosure Notice for Forward Looking Statements
Cautionary Factors That May Affect Future Results (Cautionary Statements Under
the Private Securities Litigation Reform Act of 1995)
This 8-K, including each exhibit, the comments of Schering-Plough officers
during our earnings teleconference/webcast on October 21, 2004 at 8:00 am (EDT),
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
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, ability to access the capital markets, prospective products, the status
of product approvals, future performance or results of current and anticipated
products, sales efforts, development programs, 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. Actual results may vary materially, and there are no guarantees
about Schering-Plough's financial and operational performance or the performance
of Schering-Plough stock. Schering-Plough does not assume the obligation to
update any forward-looking statement.
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:
- 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.
- 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, and
generic, prescription and/or OTC products that compete with products of
Schering-Plough or the Merck/Schering-Plough Pharmaceuticals joint venture
(such as competition from OTC statins, like the one approved for use in
the U.K. for which impact in the cholesterol reduction market is not yet
known).
- 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.
- The potential impact of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003; possible other U.S. legislation or regulatory
action affecting, among other things, pharmaceutical pricing and
reimbursement, including Medicaid and Medicare, involuntary approval of
prescription medicines for over-the-counter use; and other health care
reform initiatives and drug importation legislation. Legislation or
regulations in markets outside the U.S. affecting product pricing,
reimbursement or access. Laws and regulations relating to trade,
antitrust, monetary and fiscal policies, taxes, price controls and
possible nationalization.
- 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.
- Uncertainties of the FDA approval process and the regulatory approval and
review processes in other countries, including, without limitation, delays
in approval of new products.
- 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 Schering-Plough's 10-Ks,
10-Qs and 8-Ks 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.
- 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.
- Efficacy or safety concerns with respect to marketed products, whether or
not scientifically justified, leading to recalls, withdrawals or declining
sales.
- Major products such as CLARITIN, CLARINEX, INTRON A, PEG-INTRON, REBETOL
Capsules, REMICADE and NASONEX accounted for a material portion of
Schering-Plough's 2003 revenues. If any major product were to become
subject to a problem such as loss of patent protection, OTC availability
of the Company's product or
a competitive product (as has been disclosed for CLARITIN and its current
and potential OTC competition), previously unknown side effects; if a new,
more effective treatment should be introduced; generic availability of
competitive products; or if the product is discontinued for any reason,
the impact on revenues could be significant. Also, such information about
important new products, such as ZETIA and VYTORIN, or important products
in our pipeline, may impact future revenues. Further, the launch of
VYTORIN may negatively impact sales of ZETIA.
- Unfavorable outcomes of government (local and federal, domestic and
international) investigations, litigation about product pricing, product
liability claims, other litigation and environmental concerns could
preclude commercialization of products, negatively affect the
profitability of existing products, materially and adversely impact
Schering-Plough's financial condition and results of operations, or
contain conditions that impact business operations, such as exclusion from
government reimbursement programs.
- Economic factors over which Schering-Plough has no control, including
changes in inflation, interest rates and foreign currency exchange rates.
- Instability, disruption or destruction in a significant geographic region
- due to the location of 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, storm or disease.
- Changes in tax laws including changes related to taxation of foreign
earnings.
- Changes in accounting standards promulgated by the American Institute of
Certified Public Accountants, the Financial Accounting Standards Board,
the SEC, or the Public Company Accounting Oversight Board that would
require a significant change to Schering-Plough's accounting practices.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
The following exhibits are filed with this 8-K:
99.1 Press release titled "Schering-Plough Reports Financial Results for 2004
Third Quarter"
99.2 Supplemental Financial Data
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/ Douglas J. Gingerella
---------------------------
Douglas J. Gingerella
Vice President and Controller
Date: October 21, 2004
Exhibit Index
The following exhibits are filed with this 8-K:
99.1 Press release titled "Schering-Plough Reports Financial Results for 2004
Third Quarter"
99.2 Supplemental Financial Data