8-K
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): February 12, 2008
SCHERINGPLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
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New Jersey
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1-6571
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22-1918501 |
(State or Other Jurisdiction of
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(Commission File Number)
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(IRS Employer |
Incorporation)
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Identification Number) |
2000 Galloping Hill Road
Kenilworth, NJ 07033
(Address of Principal Executive Office)
Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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ITEM 2.02 |
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RESULTS OF OPERATIONS AND FINANCIAL CONDITION. |
Schering-Plough today issued a press release titled Schering-Plough Reports Financial Results for
2007 Fourth Quarter, Full Year 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
Risk Factors
Below are updated risk factors relating to Schering-Plough and its business. Schering-Ploughs
future operating results and cash flows may differ materially from the actual results due to risks
and uncertainties related to Schering-Ploughs 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 8-K, including each
exhibit, the comments of Schering-Plough officers during the earnings teleconference/webcast on
February 12, 2008, beginning at 8 a.m. (EST), and other written reports and oral statements made
from time to time by Schering-Plough.
Key Schering-Plough products generate a significant amount of Schering-Ploughs profits and
cash flows, and any events that adversely affect the markets for its leading products could have a
material and negative impact on results of operations and cash flows.
Schering-Ploughs
ability to generate profits and operating cash flow depends largely upon the continued profitability of Schering-Ploughs cholesterol franchise, consisting of VYTORIN
and ZETIA. In addition, other key products such as REMICADE, NASONEX, PEGINTRON, TEMODAR, CLARINEX,
and AVELOX account for a material portion of revenues. As a result of Schering-Ploughs dependence
on key products, any events that adversely affects 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, generic or OTC availability of Schering-Ploughs 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.
For example, the profitability of Schering-Ploughs cholesterol franchise may be adversely
affected by competition from multiple generic cholesterol products. The FDA has held a public
meeting to solicit comment on making certain prescription drugs available behind-the-counter
without a prescription and continues to study this scenario. Although the FDA did not indicate
what drugs might be included this category, if the FDA approved behind-the-counter sales of
products that compete with products of Schering-Plough or the Merck/Schering-Plough cholesterol
joint venture, such competition could have an adverse result on sales and profitability.
Negative publicity surrounding the
release of top line results from the ENHANCE study may also
negatively affect the cholesterol franchise. That study was a randomized 24 month trial
comparing simvastatin (Zocor) 80 mg with simvastatin 80 mg plus
ezetimibe (ZETIA) 10 mg in patients with familial
hypercholesterolemia. The study did not show any statistically
significant difference in carotid intima media thickness between
subjects in the two treatment arms.
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.
Schering-Ploughs
success is dependent on the successful development and marketing of new
products, which are subject to substantial risks.
Products that appear promising in development may fail to reach market for numerous reasons,
including the following:
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findings of ineffectiveness, superior safety or efficacy of competing products,
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 for innovation is an important contributor to
Schering-Ploughs profitability. Generic forms of Schering-Ploughs products may be introduced to
the market as a result of the expiration of patents covering Schering-Ploughs products, a
successful challenge to Schering-Ploughs patents, or the at-risk launch of a generic version of a
Schering-Plough product, which may have a material and negative effect on results of operations.
Intellectual property protection is critical to Schering-Ploughs ability to successfully
commercialize its products. U.S. patents relating to Schering-Ploughs significant products are of
material importance to Schering-Plough. Upon the expiration or the successful challenge of
Schering-Ploughs patents covering a product, competitors may introduce lower-priced generic or
similar branded versions of that product, which may include Schering-Ploughs well-established
products.
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 innovators New Drug Application are invalid, not infringed or unenforceable. 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. 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. In recent years, some generic
manufacturers have launched generic versions of products before the ultimate resolution of patent
litigation (commonly known as at-risk product launches). Generic entry may result in the loss of
a significant portion of sales or downward pressures on the prices at which Schering-Plough offers
formerly patented products. Please refer to Legal Proceedings in Schering-Ploughs 10-K and
10-Qs for descriptions of pending intellectual property litigation.
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 Schering-Ploughs results of operations. Further,
recent court decisions relating to other companies patents in the U.S., potential U.S. legislation
relating to patent reform, as well as regulatory initiatives may result in further erosion of
intellectual property protection.
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 Schering-Ploughs patents, or the
patents of its collaborators, may lead to a determination by a court that the patent is not
infringed, invalid, and/or unenforceable. Such an adverse determination could lead to a loss of
market exclusivity. An adverse result in a patent dispute involving patents held by a third party
may lead to a determination by a court that the patent is infringed, valid, and enforceable. Such
an adverse determination may preclude the commercialization of Schering-Ploughs products through
injunctive relief, and/or may lead to significant financial damages for past and ongoing
infringement. Due to the uncertainty surrounding patent litigation, parties may settle patent
disputes by obtaining a license under mutually agreeable terms in order to decrease risk of an
interruption in manufacturing and/or marketing of its products.
The potential for litigation regarding Schering-Ploughs intellectual property rights always
exists and may be initiated by third parties attempting to abridge Schering-Ploughs rights. Even
if Schering-Plough is ultimately successful in a particular dispute, Schering-Plough may incur
substantial costs in defending its patents and other intellectual property rights.
Multi-jurisdictional regulations, including those establishing Schering-Ploughs ability to
price products, may negatively affect Schering-Ploughs sales and profit margins.
Schering-Plough faces increased pricing pressure globally from managed care organizations,
institutions and government agencies and programs that could negatively affect Schering-Ploughs
sales and profit margins. For example, in the U.S., 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 is resulting in
increased use of generics and increased purchasing power of those negotiating on behalf of Medicare
recipients.
In addition to legislation concerning price controls, other trends that could affect
Schering-Ploughs 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. Increasingly, market approval or reimbursement of
products may be impacted by health technology assessments, which seek to condition approval or
reimbursement on an assessment of the impact of health technologies on the healthcare system.
In the U.S., as a result of the governments efforts to reduce Medicaid expenses, managed care
organizations continue to grow in influence, and Schering-Plough faces increased pricing pressure
as managed care organizations continue to seek price discounts with respect to Schering-Ploughs
products.
In other countries, many governmental agencies strictly control, directly or indirectly, the
prices at which pharmaceutical products are sold. In these 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.
Through the acquisition of Organon BioSciences, Schering-Plough acquired marketed products and
pipeline projects in therapeutic areas not currently covered by Schering-Ploughs existing marketed
products portfolio and pipeline projects, including womens health and fertility, anesthesia, and
neuroscience, each of which carry unique risks and uncertainties which could have a negative impact
on future results of operations.
With
its acquisition of Organon BioSciences, Schering-Plough acquired products in additional therapeutic areas.
Each therapeutic area presents a different risk profile, including different benefits and safety
issues that must be balanced by Schering-Plough and the regulators as various R&D and marketing
decisions are made; unique product liability risks; different patient and prescriber priorities;
and different societal pressures. While adding new therapeutic areas may strengthen the business by
increasing sales and profits; making the combined company more relevant to patients and
prescribers; and diversifying enterprise risk across more areas, such positives may not outweigh
the additional risk in a particular therapeutic area or could result in unanticipated costs that
could be material.
Market forces continue to evolve and can impact Schering-Ploughs ability to sell products or
the price Schering-Plough can charge for products.
A number of intermediaries are involved between drug manufacturers, such as Schering-Plough,
and patients who use the drugs. These intermediaries impact the patients ability, and their
prescribers ability, to choose and pay for a particular drug. These intermediaries include health
care providers, such as hospitals and clinics; payors and their representatives, such as employers,
insurers, managed care organizations and governments; and others in the supply chain, such as
pharmacists and wholesalers. Examples include: payors that require a patient to first fail on a
generic drug before reimbursing for a more
effective, branded product that is more expensive; hospitals that stock and administer only a
generic product to in-patients; managed care organizations that may penalize doctors who prescribe
outside approved formularies which may not include branded products when a generic is available;
and pharmacists who receive a higher profit when they dispense a generic drug over a branded drug.
Further, the intermediaries are not required to routinely provide
transparent data to patients comparing the effectiveness of generic and branded products or to
disclose their own economic benefits that are tied to steering patients toward, or requiring
patients to use, generic products rather than branded products.
Government investigations against Schering-Plough could lead to 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, which could
give rise to other investigations or litigation by government entities or private parties.
Schering-Plough cannot predict whether future or pending investigations to which it may become
subject would 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
Schering-Plough 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. Attorneys 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 resolved unfavorably, could subject Schering-Plough to substantial
fines, penalties and injunctive or administrative remedies, including exclusion from government
reimbursement programs. In addition, an adverse outcome to a government investigation could prompt
other government entities to commence investigations of Schering-Plough or cause those entities or
private parties to bring civil claims against it. Schering-Plough also cannot predict whether any
investigations will affect its marketing practices or sales. Any such result could have a material
adverse impact on Schering-Ploughs results of operations, cash flows, financial condition, or its
business.
Congress
and certain states have initiated investigations into the timing and disclosure of the ENHANCE clinical
trial and related events, as well as the timing of certain stock sales by one executive officer,
Carrie Cox.
Regardless of the merits or outcomes of any investigations, government investigations are
costly, divert managements attention from Schering-Ploughs business and may result in substantial
damage to Schering-Ploughs reputation.
There are other legal matters in which adverse outcomes could negatively affect
Schering-Ploughs business.
Unfavorable outcomes in other pending litigation matters (including recently initiated
litigation relating to the timing and disclosure of the ENHANCE clinical trial), or in future
litigation, 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 and could subject Schering-Plough to substantial fines, penalties and injunctive or
administrative remedies, including exclusion from government reimbursement programs. Any such
result could materially and adversely affect Schering-Ploughs results of operations, cash flows,
financial condition, or its business.
Please refer to Legal Proceedings in Schering-Ploughs 10-K and 10-Qs for descriptions of
significant pending litigation.
Schering-Plough is subject to governmental regulations, and the failure to comply with, as
well as the costs of compliance of, these regulations may adversely affect Schering-Ploughs
financial position and results of operations.
Schering-Ploughs manufacturing facilities and clinical/research practices 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 Schering-Ploughs
financial position, cash flows 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.
Schering-Plough also is subject to other regulations, including environmental, health and
safety, and labor regulations.
Developments following regulatory approval may
adversely affect sales of Schering-Ploughs products.
Even after a product reaches market, certain developments following regulatory approval,
including results in post-marketing Phase IV trials, may decrease demand for Schering-Ploughs
products, including the following:
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the re-review of products that are already marketed; |
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new scientific information and evolution of scientific theories; |
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the recall or loss of marketing approval 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. |
In the past several years, 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 that are already marketed, adding further to the uncertainties in the regulatory
processes. There is also greater regulatory scrutiny, especially in the U.S., 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 Schering-Ploughs products, it could
significantly reduce demand for the product or may require Schering-Plough to remove the product
from the market. Further, in the current environment in which all pharmaceutical companies operate,
Schering-Plough is at risk for product liability claims for its products.
New products and technological advances developed by Schering-Ploughs competitors may
negatively affect sales.
Schering-Plough operates in a highly competitive industry. Schering-Plough competes with a
large number of multinational pharmaceutical companies, biotechnology companies and generic
pharmaceutical companies. Many of Schering-Ploughs competitors have been conducting research and
development in areas served both by Schering-Ploughs current products and by those products
Schering-Plough is in the process of developing. Competitive developments that may impact
Schering-Plough 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 joint venture. 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 Schering-Plough
will be unable to maintain its sales for such products.
Competition from third parties may make it difficult for Schering-Plough to acquire or license
new products or product candidates (regardless of stage of development) or to enter into such
transactions on terms that permit Schering-Plough to generate a positive financial impact.
Schering-Plough depends on acquisition and in-licensing arrangements as a source for new
products. Opportunities for obtaining or licensing new products are limited, however, and securing
rights to them typically requires substantial amounts of funding or substantial resource
commitments. Schering-Plough competes for these opportunities against many other companies and
third parties that have greater financial resources and greater ability to make other resource
commitments. Schering-Plough may not be able to acquire or license new products, which could
adversely impact Schering-Plough and its prospects. Schering-Plough may also have difficulty
acquiring or licensing new products on acceptable terms. To secure rights to new products,
Schering-Plough may have to make substantial financial or other resource commitments that could
limit its ability to produce a positive financial impact from such transactions.
Schering-Plough relies on third-party relationships for its key products, and the conduct and
changing circumstances of such third parties may adversely impact the business.
Schering-Plough has several relationships with third parties on which Schering-Plough depends
for many of its key products. Very often these third parties compete with Schering-Plough or have
interests that are not aligned with the interests of Schering-Plough. Notwithstanding any contracts
Schering-Plough has with these third parties, Schering-Plough may not be able to control or
influence the conduct of these parties, or the circumstances that affect them, either of which
could adversely impact Schering-Plough.
The relationships are long-standing and, as the third partys work and Schering-Ploughs work
evolves, priorities and alignments also change. At times new issues develop that were not
anticipated at the time contracts were negotiated. These new issues, and related uncertainties in
the contracts, also can adversely impact Schering-Plough.
Schering-Ploughs global operations expose Schering-Plough to additional risks, and any
adverse event could have a material negative impact on results of operations.
Schering-Plough operates in more than 120 countries, and the majority of Schering-Ploughs
profit and cash flow is generated from international operations. Acquisitions, such as the recently
completed purchase of Organon BioSciences, further expanded the size, scale and scope of its global
operations. Risks inherent in conducting a global business include:
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changes in medical reimbursement policies and programs and pricing restrictions
in key markets; |
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multiple regulatory requirements that could restrict Schering-Ploughs ability
to manufacture and sell its products in key markets; |
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trade protection measures and import or export licensing requirements; |
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diminished protection of intellectual property in some countries; and |
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possible nationalization and expropriation. |
In addition, there may be changes to Schering-Ploughs 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.
The integration of the businesses of Schering-Plough and Organon BioSciences to create a
combined company is a complex process and may be subject to unforeseen developments, which could
impact anticipated cost savings from synergies, expected accretion to earnings and results of
future operations.
As the two companies are combined, the workforces of Schering-Plough and Organon BioSciences
will continue to face uncertainties until the completion of the integration phase. Although
substantial efforts are being made to complete the integration phase as quickly as possible, it is
difficult to predict how long the integration phase will last.
The workforces of both companies are learning to use new processes as work is integrated and
streamlined. Further, for those employees of the new combined company who have not in the past
worked for a U.S.-based global company, the applicable regulatory requirements are different in a
number of respects. While substantial efforts are being made to facilitate smooth execution of
integration including thorough training and transparent and
motivational employee communications -
there may be an increased risk of slower execution of various work processes, repeated execution to
achieve quality standards and reputational harm in the event of a compliance failure with new and
complex regulatory requirements, even if such a failure were inadvertent. Any such events could
have an adverse impact on anticipated cost savings from synergies, anticipated accretion to
earnings from the transaction and the results of future operations.
The acquisition of Organon BioSciences expanded Schering-Ploughs animal health business
worldwide, which increases the risk that negative events in the animal health industry could have a
negative impact on future results of operations.
Through the acquisition of Organon BioSciences animal health businesses, Schering-Ploughs
global animal health business is now a more significant business segment. The combined companys
future sales of key animal health products could be adversely impacted by a number of risk factors
including certain that are specific to the animal health business. For example, the outbreak of
disease carried by animals, such as Bovine Spongiform Encephalopathy (BSE) or mad cow disease,
could lead to their widespread death and precautionary destruction as well as the reduced
consumption and demand for animals, which could adversely impact Schering-Ploughs results of
operations. Also, the outbreak of any highly contagious diseases near Schering-Ploughs main
production sites could require Schering-Plough to immediately halt production of vaccines at such sites or force
Schering-Plough to incur substantial expenses in procuring raw materials or vaccines elsewhere. As the animal
health segment of Schering-Ploughs business becomes more significant, the impact of any such
events on future results of operations would also become more significant.
The acquisition of Organon BioSciences increased Schering-Ploughs biologics human and animal
health product offerings, including animal health vaccines. Biologics carry unique risks and
uncertainties, which could have a negative impact on future results of operations.
The successful development, testing, manufacturing and commercialization of biologics,
particularly human and animal health vaccines, is a long, expensive and uncertain process. There
are unique risks and uncertainties with biologics, including:
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There may be limited access to and supply of normal and diseased tissue samples,
cell lines, pathogens, bacteria, viral strains and other biological materials. In
addition, government regulations in multiple jurisdictions such as the U.S. and
European states within the E.U., could result in restricted access to, or transport or
use of, such materials. If Schering-Plough loses access to sufficient sources of such
materials, or if tighter restrictions are imposed on the use of such materials,
Schering-Plough may not be able to conduct research activities as planned and may
incur additional development costs. |
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The development, manufacturing and marketing of biologics are subject to regulation
by the FDA, the European Medicines Agency and other regulatory bodies. These
regulations are often more complex and extensive than the regulations applicable to
other pharmaceutical products. For example, in the U.S., a Biologics License
Application, including both preclinical and clinical trial data and extensive data
regarding the manufacturing procedures, is required for human vaccine candidates and
FDA approval for the release of each manufactured lot. |
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Manufacturing biologics, especially in large quantities, is sometimes complex and
may require the use of innovative technologies to handle living micro-organisms.
Manufacturing biologics requires facilities specifically designed for and validated
for this purpose, and sophisticated quality assurance and quality control procedures
are necessary. Slight deviations anywhere in the manufacturing process, including
filling, labeling, packaging, storage and shipping and quality control and testing,
may result in lot failures, product recalls or spoilage. |
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Biologics are frequently costly to manufacture because production ingredients are
derived from living animal or plant material, and most biologics cannot be made
synthetically. In particular, keeping up with the demand for vaccines may be difficult
due to the complexity of producing vaccines. |
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The use of biologically derived ingredients can lead to allegations of harm,
including infections or allergic reactions, or closure of product facilities due to
possible contamination. Any of these events could result in substantial costs. |
Schering-Plough is exposed to market risk from fluctuations in currency exchange rates and
interest rates.
Schering-Plough
operates in multiple jurisdictions and, as such, virtually all sales are
denominated in currencies of the local jurisdiction. Additionally, Schering-Plough has entered and
will enter into acquisition, licensing, borrowings or other financial transactions that may give
rise to currency and interest rate exposure. Since Schering-Plough cannot, with certainty, foresee
and mitigate against such adverse fluctuations, fluctuations in currency exchange rates and
interest rates could negatively affect Schering-Ploughs results of operations and/or cash flows.
In order to mitigate against the adverse impact of these market fluctuations, Schering-Plough
will from time to time enter into hedging agreements. While hedging agreements, such as currency
options and interest rate swaps, limit some of the exposure to exchange rate and interest rate
fluctuations, such attempts to mitigate these risks are costly and not always successful.
Insurance coverage for product liability may be limited, cost prohibitive or unavailable.
Schering-Plough 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. For certain products,
third-party insurance may be cost prohibitive, available on limited terms or unavailable.
Schering-Plough is subject to evolving and complex tax laws, which may result in additional
liabilities that may affect results of operations.
Schering-Plough is subject to evolving and complex tax laws in its jurisdictions. Significant
judgment is required for determining Schering-Ploughs tax liabilities, and Schering-Ploughs tax
returns are periodically examined by various tax authorities. Schering-Ploughs 1997-2006 tax
returns remain open for examination by the IRS. Schering-Plough may be challenged by the IRS and
other tax authorities on positions it has taken in its income tax returns. Although Schering-Plough
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 of any tax matters may result
in payments greater or less than amounts accrued.
With
the acquisition of OBSs Organon (human pharmaceutical) and Intervet (animal health)
businesses, the main tax risks are correspondingly centered in the Netherlands, where management,
intellectual property, and beneficial rights as well as product liability have been predominantly
centered. The tax position for both Organon and Intervet in the
Netherlands has been closed through 2005. The period post 2005 up to the
acquisition date is subject to tax indemnity
issued to Schering-Plough by OBSs former parent company, Akzo
Nobel, under the Share Purchase
Agreement, executed November 19, 2007. See Exhibit 10.1 to Schering-Ploughs 8-K filed October 2,
2007.
In addition, Schering-Plough may be impacted by changes in tax laws including tax rate
changes, changes to the laws related to the remittance of foreign earnings, new tax laws and
revised tax law interpretations in domestic and foreign jurisdictions.
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ITEM 9.01 |
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FINANCIAL STATEMENTS AND EXHIBITS. |
(d) Exhibits
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99.1 |
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Press release dated February 12, 2008 titled Schering-Plough Reports Financial Results for
2007 Fourth Quarter, Full Year |
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99.2 |
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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.
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Schering-Plough Corporation |
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By: /s/ Steven H. Koehler |
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Vice President and Controller |
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Date: February 12, 2008 |
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Exhibit Index
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Exhibit Number |
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Description |
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99.1 |
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Press release dated February 12, 2008 titled
Schering-Plough Reports Financial Results for 2007 Fourth
Quarter, Full Year |
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99.2 |
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Supplemental Financial Data |