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
Date of Report (Date of earliest event reported): April 21, 2005
SCHERING-PLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
New Jersey 1-6571 22-1918501
(State or Other Jurisdiction of (Commission File Number) (IRS Employer
Incorporation) Identification
Number)
2000 Galloping Hill Road
Kenilworth, NJ 07033
(Address of Principal Executive Office)
Registrant's telephone number, including area code: (908) 298-4000
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 2005 First Quarter" and provided additional supplemental
financial data. The press release is furnished as Exhibit 99.1 to this 8-K. The
supplemental financial data is furnished as Exhibit 99.2 to this 8-K.
ITEM 8.01 OTHER EVENTS.
Disclosure Notice for Forward Looking Statements
This 8-K, including each exhibit, the comments of Schering-Plough officers
during our earnings teleconference/webcast on April 21, 2005 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, 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. 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
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.
- 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 new and existing generic, prescription and/or OTC
products that compete with products of Schering-Plough or the
Merck/Schering-Plough Cholesterol Partnership (such as competition
from OTC statins, like the one approved for use in the U.K., the
impact of which in the cholesterol reduction market is not yet
known).
- Increased pricing pressure both in the U.S. and abroad from managed
care organizations, institutions and government agencies and
programs. In the U.S., 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 in the regulatory and approval processes in the U.S.
and other countries, including delays in the approval of new
products and new indications and uncertainties in the FDA's approval
process; and uncertainties concerning regulatory decisions regarding
labeling and other matters.
- Failure to meet current 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.
- Post-marketing issues. Once a product is approved and marketed,
clinical trials of marketed products or post-marketing surveillance
may raise efficacy or safety concerns. Whether or not scientifically
justified, this new information could lead to recalls, withdrawals
or adverse labeling of marketed products, which may negatively
impact sales. Concerns of prescribers or patients relating to the
safety or efficacy of Schering-Plough products, or other companies'
products or pharmaceutical products generally, may also negatively
impact sales.
- Major products such as CLARITIN, CLARINEX, INTRON A, PEG-INTRON,
REBETOL Capsules, REMICADE, TEMODAR and NASONEX accounted for a
material portion of Schering-Plough's 2004 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, sales 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 and auditing 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 furnished pursuant to Item 2.02 with this 8-K:
99.1 Press release dated April 21, 2005 titled "Schering-Plough Reports
Financial Results for 2005 First Quarter" (furnished pursuant to Item 2.02)
99.2 Supplemental Financial Data (furnished pursuant to Item 2.02)
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: April 21, 2005
Exhibit Index
The following exhibits are furnished with this 8-K:
99.1 Press release dated April 21, 2005 titled "Schering-Plough Reports
Financial Results for 2005 First Quarter" (furnished pursuant to Item 2.02)
99.2 Supplemental Financial Data (furnished pursuant to Item 2.02)