-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Svjb0aAzvvucCpqx3pWR5h3bwrlsq36VQc2QYHl+z1K8Xr86GhZ9Uu2ZWQPhyq9L DuahavPnljwuzwIt3jCSgg== 0000950123-08-001466.txt : 20080212 0000950123-08-001466.hdr.sgml : 20080212 20080212072144 ACCESSION NUMBER: 0000950123-08-001466 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080212 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080212 DATE AS OF CHANGE: 20080212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCHERING PLOUGH CORP CENTRAL INDEX KEY: 0000310158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221918501 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 08595697 BUSINESS ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 BUSINESS PHONE: 9082984000 MAIL ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 8-K 1 y48349e8vk.htm FORM 8-K 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
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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   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 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-Plough’s future operating results and cash flows may differ materially from the actual results due to risks and uncertainties related to Schering-Plough’s 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-Plough’s 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-Plough’s ability to generate profits and operating cash flow depends largely upon the continued profitability of Schering-Plough’s 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-Plough’s 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-Plough’s 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-Plough’s 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-Plough’s 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:

 


 

    findings of ineffectiveness, superior safety or efficacy of competing products, or harmful side effects in clinical or pre-clinical testing;
 
    failure to receive the necessary regulatory approvals, including delays in the approval of new products and new indications;
 
    lack of economic feasibility due to manufacturing costs or other factors; and
 
    preclusion from commercialization by the proprietary rights of others.
     Intellectual property protection for innovation is an important contributor to Schering-Plough’s profitability. Generic forms of Schering-Plough’s products may be introduced to the market as a result of the expiration of patents covering Schering-Plough’s products, a successful challenge to Schering-Plough’s 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-Plough’s ability to successfully commercialize its products. U.S. patents relating to Schering-Plough’s significant products are of material importance to Schering-Plough. Upon the expiration or the successful challenge of Schering-Plough’s patents covering a product, competitors may introduce lower-priced generic or similar branded versions of that product, which may include Schering-Plough’s 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 innovator’s 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-Plough’s 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-Plough’s 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-Plough’s 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-Plough’s 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-Plough’s intellectual property rights always exists and may be initiated by third parties attempting to abridge Schering-Plough’s 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-Plough’s ability to price products, may negatively affect Schering-Plough’s 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-Plough’s 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-Plough’s 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 government’s 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-Plough’s 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-Plough’s existing marketed products portfolio and pipeline projects, including women’s 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-Plough’s 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 patient’s 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. Attorney’s 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-Plough’s 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 management’s attention from Schering-Plough’s business and may result in substantial damage to Schering-Plough’s reputation.
     There are other legal matters in which adverse outcomes could negatively affect Schering-Plough’s 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-Plough’s results of operations, cash flows, financial condition, or its business.

 


 

     Please refer to “Legal Proceedings” in Schering-Plough’s 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-Plough’s financial position and results of operations.
     Schering-Plough’s 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-Plough’s 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-Plough’s 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-Plough’s products, including the following:
    the re-review of products that are already marketed;
 
    new scientific information and evolution of scientific theories;
 
    the recall or loss of marketing approval of products that are already marketed;
 
    uncertainties concerning safety labeling changes; and
 
    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-Plough’s 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-Plough’s 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-Plough’s competitors have been conducting research and development in areas served both by Schering-Plough’s 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 party’s work and Schering-Plough’s 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-Plough’s 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-Plough’s 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:
    changes in medical reimbursement policies and programs and pricing restrictions in key markets;
 
    multiple regulatory requirements that could restrict Schering-Plough’s ability to manufacture and sell its products in key markets;

 


 

    trade protection measures and import or export licensing requirements;
 
    diminished protection of intellectual property in some countries; and
 
    possible nationalization and expropriation.
     In addition, there may be changes to Schering-Plough’s 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-Plough’s 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-Plough’s global animal health business is now a more significant business segment. The combined company’s 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-Plough’s results of operations. Also, the outbreak of any highly contagious diseases near Schering-Plough’s 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-Plough’s 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-Plough’s 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:
    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.
 
    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.
 
    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.
 
    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.
 
    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-Plough’s 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-Plough’s tax liabilities, and Schering-Plough’s tax returns are periodically examined by various tax authorities. Schering-Plough’s 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 OBS’s 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 OBS’s former parent company, Akzo Nobel, under the Share Purchase Agreement, executed November 19, 2007. See Exhibit 10.1 to Schering-Plough’s 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.

 


 

ITEM 9.01   FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits
         
       
 
  99.1    
Press release dated February 12, 2008 titled “Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year”
       
 
  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/  Steven H. Koehler
   
 
Steven H. Koehler
   
Vice President and Controller
   
 
   
Date: February 12, 2008
   

 


 

Exhibit Index
         
Exhibit Number   Description
       
 
  99.1    
Press release dated February 12, 2008 titled “Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year”
       
 
  99.2    
Supplemental Financial Data

 

EX-99.1 2 y48349exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

Exhibit 99.1
         
FOR RELEASE: IMMEDIATELY
  Media Contact:   Steve Galpin, Jr.
 
      (908) 298-7415
 
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SCHERING-PLOUGH REPORTS FINANCIAL RESULTS
FOR 2007 FOURTH QUARTER, FULL YEAR
Company Records Strong Performance in 2007 and Notes Achievements over 4-year Period,
Progressing with Integration of Organon BioSciences, Preparing for Challenges of 2008
KENILWORTH, N.J., Feb. 12, 2008 — Schering-Plough Corporation (NYSE: SGP) today reported financial results for the 2007 fourth quarter and full year, and commented on its ongoing integration of Organon BioSciences N.V. (OBS), which was acquired in November 2007 and includes the Organon human health business and Intervet animal health business.
          “Schering-Plough delivered another strong performance in both the fourth quarter and full year of 2007,” said Fred Hassan, chairman and CEO. “We continued the remarkable transformation that began in 2003. On track with our Action Agenda, we grew the top line, built greater diversity in our business portfolio, improved our financial strength and cash flows, and established R&D as an engine for future growth. Our acquisition of Organon BioSciences was a substantial strategic achievement. Today, we are a much stronger and more diverse company than ever before, and we are better positioned to deal with the new challenges confronting us in 2008.”
          For the 2007 fourth quarter on a GAAP basis, due to purchase accounting adjustments, Schering-Plough reported a net loss available to common shareholders of $3.4 billion or $2.08 per common share. Earnings per common share for the 2007 fourth quarter would have been 27 cents, excluding purchase accounting adjustments and acquisition-related items for the OBS acquisition (closed Nov. 19, 2007) and other specified items (see table below on page 13). For the 2006 fourth quarter, Schering-Plough reported net income of $182 million or 12 cents per common share on a GAAP basis and 17 cents per common share when excluding other specified items.
          GAAP net sales for the 2007 fourth quarter totaled $3.7 billion as compared to $2.7 billion in the fourth quarter of 2006. Adjusted net sales (GAAP net sales plus an assumed 50 percent of global cholesterol joint venture net sales — see table below on page 19 and hereinafter referred to as “adjusted sales”) would have totaled $4.4 billion. Schering-Plough does not


 

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record sales of its cholesterol joint venture with Merck & Co., Inc. (Merck), as the venture is accounted for under the equity method.
          The 2007 full year was significant for many important achievements:
    Completing the acquisition of Organon BioSciences N.V. for approximately 11 billion euro, thus adding new categories — women’s health and anesthesia/psychiatry — and making Schering-Plough one of the world’s leading animal health companies;
 
    Growing cholesterol franchise sales to $5.2 billion in 2007, with U.S. sales up 26 percent and international sales up 70 percent;
 
    Growing sales by double digits in each major customer segment — Prescription Pharmaceuticals, Consumer Health Care and Animal Health;
 
    Gaining strength in global markets, with sales in international markets representing more than 60 percent of total GAAP net sales;
 
    Continuing to expand the company’s businesses with new products and indications while extending its presence in fast-growing emerging markets, such as China, Brazil and Russia;
 
    Strengthening the research pipeline with new compounds and by advancing development to Phase III of such agents as a thrombin receptor antagonist (TRA) for atherothrombosis and vicriviroc for HIV; both are among the company’s four compounds designated “fast track” by the U.S. Food and Drug Administration (FDA); and
 
    Filing regulatory submissions for important new agents and indications, which now include sugammadex and asenapine from Organon.
          “Schering-Plough now has four full years of accomplishments since we began this transformation,” said Hassan. “In that time, we also brought a new culture to the company — focused on meeting the needs of our customers and patients, and founded on a commitment to quality, compliance and business integrity.”
          Hassan continued: “As we begin 2008, new challenges have emerged, especially the initial reaction to the ENHANCE trial. We and our joint venture partner Merck acted with integrity and good faith with respect to that trial. We stand behind VYTORIN and ZETIA, behind the validity of the science, and behind our commitment to doing what’s right for patients and physicians.”
          The company noted that the pharmaceutical industry continues to be subject to ever-more critical scrutiny, where events can be mischaracterized and drive amplified reactions. The company believes that new scientific data are best presented and discussed at appropriate scientific and medical forums.


 

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          Medical experts and health advisory groups have long recognized high LDL cholesterol as a significant cardiovascular risk factor and recommended increasingly aggressive treatment of high cholesterol for certain patients. While it is too early to tell the impact of the ENHANCE trial results on the cholesterol business, lowering LDL cholesterol, along with healthy diet and lifestyle changes, remains the cornerstone of lipid treatment for patients at risk for heart disease. Clinical studies have demonstrated that VYTORIN lowered patients’ LDL cholesterol more than rosuvastatin, atorvastatin and simvastatin at the doses studied and was able to get more patients to their goal.
OBS Integration
The company reviewed progress in the integration of OBS since the transaction closed in November 2007.
          “The strategic soundness of this combination is clear and the benefits are becoming increasingly evident,” said Hassan. “We broaden our human therapeutic product lines to reach important new customers and patients, strengthen our R&D pipeline and capabilities, and gain greater balance and diversification with a world-class animal health business.” He noted that the integration of OBS is progressing well. An over-arching integration plan is in place, and the company is on track to deliver on it.
          The company reiterated that it is still targeting the same accretion and synergy targets as stated when the OBS acquisition was announced March 12, 2007: that the OBS transaction is anticipated to be accretive to Schering-Plough’s stand-alone earnings per share by about 10 cents in the first full year, excluding purchase-accounting adjustments and acquisition-related costs; and annual synergies of $500 million are expected to be achieved by three years from the date of closing.
Fourth Quarter 2007 Results
For the 2007 fourth quarter, due to purchase accounting adjustments, Schering-Plough reported a net loss available to common shareholders of $3.4 billion or $2.08 per common share on a GAAP basis. Earnings per common share for the 2007 fourth quarter would have been 27 cents, excluding purchase accounting adjustments and acquisition-related items for the OBS acquisition and other specified items. For the 2006 fourth quarter, Schering-Plough reported net


 

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income available to common shareholders of $182 million or 12 cents per common share on a GAAP basis and 17 cents per common share excluding other specified items.
          GAAP net sales for the 2007 fourth quarter totaled $3.7 billion, up 41 percent, as compared to the fourth quarter of 2006. Sales for the quarter included $626 million of OBS net sales related to the period subsequent to the acquisition closing date. In addition, the sales growth, on a GAAP basis, reflects a 7 percent favorable impact from foreign exchange.
          Global cholesterol joint venture net sales, which include VYTORIN and ZETIA, totaled $1.4 billion in the 2007 fourth quarter. Schering-Plough does not record sales of its cholesterol joint venture with Merck as the venture is accounted for under the equity method. Including an adjustment of an assumed 50 percent of the global cholesterol joint venture net sales, Schering-Plough’s adjusted sales for the 2007 fourth quarter would have been $4.4 billion.
          Overall, Schering-Plough shares in approximately 50 percent of the profits of the joint venture with Merck, although there are different profit-sharing arrangements for the cholesterol products in countries around the world. Schering-Plough records its share of the income from operations in “Equity income,” which totaled $566 million in the 2007 fourth quarter, an increase of 40 percent versus $403 million in the fourth quarter of 2006. Schering-Plough noted that it incurs substantial costs such as selling, general and administrative costs that are not reflected in “Equity income” and are borne by its overall cost structure.
          There is a separate co-marketing agreement with Bayer for ZETIA in Japan, where the product was launched in June 2007.
          Sales of Global Pharmaceuticals for the 2007 fourth quarter totaled $3.0 billion. Included in the fourth quarter of 2007 are $409 million of net sales related to Organon, the OBS human health business.
          Sales of REMICADE increased 35 percent to $455 million in the fourth quarter of 2007 due to continued market growth and expanded use across indications. REMICADE is a treatment for inflammatory diseases that Schering-Plough markets in countries outside the United States (except in Japan and certain other Asian markets) for rheumatoid arthritis, early rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, pediatric Crohn’s disease and ulcerative colitis.
          Global sales of NASONEX, an inhaled nasal corticosteroid for allergies, rose 7 percent to $271 million versus the 2006 period, due to increased sales in international markets, partially offset by a decline in sales in the United States.


 

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          Sales of PEGINTRON for hepatitis C increased 15 percent to $239 million in the 2007 fourth quarter due to higher sales in Latin America and emerging markets across Europe, and tempered by lower sales in Japan and the United States.
          Sales of TEMODAR, a treatment for certain types of brain tumors, grew 23 percent to $234 million due to increased sales across geographic regions, including Japan, where the product was launched in September 2006.
          Sales of OBS human pharmaceutical products for the period Nov. 19 through Dec. 31, 2007, include $57 million for FOLLISTIM, a fertility treatment, and $45 million for NUVARING, a contraceptive product.
          Global sales of CLARINEX, a nonsedating antihistamine, in the fourth quarter of 2007 were $174 million, up 6 percent as compared to sales of $164 million in the fourth quarter of 2006. Higher sales of CLARINEX in international markets were partially offset by lower sales in the United States. International sales of prescription CLARITIN were $93 million in the fourth quarter of 2007, a 19 percent increase compared to sales of $78 million in the fourth quarter of 2006.
          Sales of the antibiotic AVELOX were up 12 percent to $115 million, as a result of increased market share. The growth rate for AVELOX in the 2007 fourth quarter was affected by lower demand as a result of a mild U.S. respiratory infection season.
          Consumer Health Care sales were $254 million in the 2007 fourth quarter, up 24 percent versus the 2006 period. The increase was primarily due to sales of MIRALAX, which was launched in February 2007 as the first Rx-to-OTC switch in the laxative category in more than 30 years, and higher sales of OTC CLARITIN.
          Animal Health sales totaled $507 million in the 2007 fourth quarter. Sales for the quarter included $217 million related to Intervet, the OBS animal health business. Sales benefited from the inclusion of OBS sales and solid growth in all geographic areas, led by the cattle and companion animal product lines, coupled with a positive impact from foreign currency exchange rates. With the Intervet business, there was also significant growth in sales of vaccine products in the fourth quarter. On a combined basis, the animal health business is one of the leading companies in the vaccine segment.
          Schering-Plough does not record sales of its cholesterol joint venture and incurs substantial costs such as selling, general and administrative costs that are not reflected in “Equity income” and are borne by the overall cost structure of Schering-Plough. As a result, Schering-Plough’s gross margin and ratios of selling, general and


 

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administrative (SG&A) expenses and R&D expenses as a percentage of sales do not reflect the benefit of the impact of the cholesterol joint venture’s operating results.
          Schering-Plough’s gross margin on a GAAP basis was unfavorably affected by purchase accounting adjustments and as a result was 57.9 percent for the 2007 fourth quarter as compared to 65.5 percent in the 2006 period. The gross margin percentage excluding purchase accounting adjustments and other specified items decreased to 66.7 percent for the fourth quarter of 2007 as compared to 67.2 percent for the fourth quarter of 2006.
          SG&A expenses were $1.6 billion in the fourth quarter of 2007 versus $1.3 billion in the prior-year period. SG&A in the fourth quarter of 2007 increased primarily due to the impact of the inclusion of SG&A expenses from OBS and increased promotional spending.
          Research and development spending for the 2007 fourth quarter increased to $855 million compared to $631 million in the fourth quarter of 2006. The increase in R&D expenses was due to the inclusion of OBS expenses, higher spending for clinical trials and related activities, and investments to build greater breadth and capacity to support Schering-Plough’s expanding R&D pipeline.
          Acquired in-process research and development, a charge related to the purchase accounting of the OBS acquisition, totaled $3.8 billion for the fourth quarter of 2007.
Full-Year 2007 Results
For the full-year 2007, Schering-Plough reported a net loss available to common shareholders of $1.6 billion or $1.04 per common share on a GAAP basis due to purchase accounting adjustments. Earnings per common share would have been $1.37, excluding purchase accounting adjustments, acquisition-related items and other specified items (see table below on page 15). For the full-year 2006, Schering-Plough reported net income of $1.1 billion or 71 cents per common share on a GAAP basis and 87 cents per common share excluding other specified items.
          Schering-Plough reported full-year 2007 GAAP net sales of $12.7 billion, a 20 percent increase, compared to $10.6 billion in 2006. Full-year 2007 net sales included $626 million of OBS net sales related to the period subsequent to the acquisition. In addition, the sales growth reflects a 4 percent favorable impact from foreign exchange. Schering-Plough’s adjusted sales for 2007 totaled $15.2 billion, an increase of $2.7 billion as compared to $12.5 billion on an adjusted basis in 2006.


 

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          On a GAAP basis, Schering-Plough’s gross margin was 65.3 percent in 2007 as compared to 65.1 percent in 2006. The gross margin percentage excluding purchase accounting adjustments and other specified items increased to 67.9 percent in 2007 as compared to 66.5 percent in 2006, due primarily to realized cost savings in 2007 from manufacturing streamlining activities during 2006.
          Selling, general and administrative expenses were $5.5 billion for the 2007 full year. Research and development spending for 2007 totaled $2.9 billion. Full-year 2007 results include results of operations for OBS for the period subsequent to the acquisition. Acquired in-process research and development, a charge related to the purchase accounting of the OBS acquisition, totaled $3.8 billion for 2007. Equity income in 2007 totaled $2.0 billion, an increase of 40 percent compared to 2006.
Recent Developments
The company also offered the following summary of recent significant developments that have previously been announced, including:
    Reported on results from two Phase II studies in patients with vascular disease showing that TRA, a novel oral thrombin receptor antagonist, does not increase the rate of major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy. (Announced Oct. 22, 2007)
 
    Reported long-term follow-up results with the European Organization for the Research and Treatment of Cancer Phase III trial that showed the combination of TEMODAR (temozolomide) Capsules and radiation therapy significantly prolonged survival in patients with glioblastoma multiforme. (Announced Oct. 30, 2007)
 
    Reported that the U.S. District Court for the District of Massachusetts found no liability for Warrick Pharmaceuticals, the company’s generic subsidiary, in a class action lawsuit regarding average wholesale prices for prescription products. (Announced Nov. 5, 2007)
 
    Gained European Commission approval of PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin) combination therapy for retreating adult patients with chronic hepatitis C whose prior treatment did not result in a sustained response. (Announced Nov. 15, 2007)


 

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    Completed the acquisition of Organon BioSciences N.V. (Announced Nov. 19, 2007)
 
    Merck/Schering-Plough Pharmaceuticals announced that an independent panel of clinical and biostatistics experts had been convened to offer advice about the prospective analysis of the ENHANCE trial. (Announced Nov. 19, 2007)
 
    Reported on new study results that demonstrated that asenapine was more effective than placebo and well tolerated in treating patients with acute schizophrenia. (Announced Dec. 17, 2007)
 
    Announced with Centocor, Inc., revision of a 1998 distribution agreement regarding the development, commercialization and distribution of both REMICADE (infliximab) and golimumab. (Announced Dec. 21, 2007)
 
    Received priority review status from FDA for the company’s New Drug Application for sugammadex, an agent specifically designed to reverse the effects of certain muscle relaxants used in surgery. Also announced filing of an NDA with the Japanese Ministry of Health, Labor and Welfare. (Announced Jan. 2, 2008, and Jan. 17, 2008, respectively)
 
    Merck/Schering-Plough Pharmaceuticals announced the primary endpoint and other results of the ENHANCE trial. Merck/Schering-Plough has submitted an abstract on the ENHANCE trial for presentation at the American College of Cardiology meeting, which will be held in March 2008. (Announced Jan. 14, 2008)
 
    Reported top-line results of the IDEAL study, showing that sustained virologic response was similar for the two leading combination therapies for hepatitis C, and that fewer patients treated with both PEGINTRON regimens relapsed after the end of treatment compared to those receiving Pegasys and Copegus. (Announced Jan. 14, 2008)
 
    Announced that Schering-Plough Chairman/CEO Fred Hassan intends to make an open market purchase of $2 million of Schering-Plough Common Shares with personal funds. (Announced Jan. 18, 2008)
 
    With Merck, issued a release strongly objecting to mischaracterizations of the ENHANCE trial. (Announced Jan. 25, 2008)
 
    Announced FDA acceptance for review of the Peg-IFN (peginterferon alfa-2b) supplemental Biologics License Application, granted Priority Review status for the adjuvant treatment of patients with Stage III melanoma. (Announced Jan. 31, 2008)
 
    Reported that the antifungal agent NOXAFIL (posaconazole) Oral Suspension had received an A-1 recommendation (highest rating) for the prevention of invasive


 

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      Aspergillus infections in certain high-risk patients in the latest Treatment of Aspergillosis Clinical Practice Guidelines of the Infectious Diseases Society of America. (Announced Jan. 31, 2008)
 
    Gained FDA approval of ASMANEX TWISTHALER (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age. (Announced Feb. 4, 2008)
 
    Announced final results of a Phase II clinical study showing that vicriviroc, an investigational CCR5 antagonist, demonstrated potent and sustained viral suppression through 48 weeks of therapy in treatment-experienced HIV-infected patients, when administered once-daily as a single tablet in combination with an optimized ritonavir-boosted protease inhibitor-containing antiretroviral regimen. (Announced Feb. 6, 2008)
Fourth Quarter 2007 Conference Call and Webcast
Schering-Plough will conduct a conference call today at 8 a.m. (EST) to review the 2007 fourth quarter and full-year results. To listen live to the call, dial 1-877-565-9664 or 1-706-634-5003 and enter conference ID #26183610. A replay of the call will be available beginning later today through 5 p.m. on March 11. To listen to the replay, dial 1-800-642-1687 or 1-706-645-9291 and enter the conference ID #26183610. A live audio webcast of the conference call also will be available by going to the Investor Relations section of the Schering-Plough corporate Web site, www.schering-plough.com, and clicking on the “Presentations/Webcasts” link. A replay of the webcast will be available starting on Feb. 12 through 5 p.m. on March 11.
DISCLOSURE NOTICE: The information in this press release, the comments of Schering-Plough officers during the earnings teleconference/webcast on Feb. 12, 2008, beginning at 8 a.m. (EST), 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 Private Securities Litigation Reform Act of 1995. Forward-looking statements do not relate strictly to historical or current facts and are based on current expectations or forecasts of future events. You can identify these forward-looking statements by their use of words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “project,” “intend,” “plan,” “potential,” “will,” and other similar words and terms. In particular, forward-looking statements include statements relating to the company’s plans; its strategies; its progress under the Action Agenda


 

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and anticipated timing regarding future performance of the Action Agenda; business prospects; anticipated growth; timing and conditions of regulatory approvals and expected synergies related to the Organon BioSciences acquisition; prospective products or product approvals; trends in performance; anticipated timing of clinical trials and its impact on R&D spending; anticipated exclusivity periods; actions to enhance clinical, R&D, manufacturing and post-marketing systems; and the potential of certain products including VYTORIN and ZETIA and trending in the cholesterol market. Actual results may vary materially from the company’s forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. A number of risks and uncertainties could cause results to differ materially from forward-looking statements, including, among other uncertainties, market viability of the company’s (and the cholesterol joint venture’s) marketed and pipeline products; market forces; economic factors such as interest rate and exchange rate fluctuations; the outcome of contingencies such as litigation and investigations including litigation and investigations relating to the ENHANCE clinical trial; product availability; patent and other intellectual property protection; current and future branded, generic or over-the-counter competition; the regulatory process (including product approvals, labeling and post-marketing actions); scientific developments relating to marketed products or pipeline projects; and media and societal reaction to such developments. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Item 8.01 of the company’s 8-K filed today.
          Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company’s ongoing transformation. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
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SCHERING-PLOUGH CORPORATION
U.S. GAAP report for the fourth quarter ended December 31 (unaudited):
(Amounts in millions, except per share figures)
                                 
    Fourth Quarter     Full Year  
    2007     2006     2007     2006  
Net sales 1/
  $ 3,724     $ 2,650     $ 12,690     $ 10,594  
Cost of sales 2/
    1,566       915       4,405       3,697  
Selling, general and administrative
    1,634       1,250       5,468       4,718  
Research and development 3/
    855       631       2,926       2,188  
Acquired in-process research and development 4/
    3,754             3,754        
Other income, net 5/
    (231 )     (46 )     (683 )     (135 )
Special and acquisition related charges 6/
    52       12       84       102  
Equity income
    (566 )     (403 )     (2,049 )     (1,459 )
 
                       
 
                               
(Loss)/income before income taxes
    (3,340 )     291       (1,215 )     1,483  
Income tax (benefit)/expense
    (14 )     87       258        362  
 
                       
Net (loss)/income before cumulative effect of a change in accounting principle
  $ (3,326 )   $ 204     $ (1,473 )   $ 1,121  
 
                       
Cumulative effect of a change in accounting principle, net of tax 7/
                      (22 )
 
                       
Net (loss)/income
  $ (3,326 )   $ 204     $ (1,473 )   $ 1,143  
 
                       
 
                               
Preferred stock dividends
    38       22       118       86  
 
                       
Net (loss)/income available to common shareholders
  $ (3,364 )   $ 182     $ (1,591 )   $ 1,057  
 
                       
 
                               
Diluted earnings per common share:
                               
(Loss)/earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ (2.08 )   $ 0.12     $ (1.04 )   $ 0.69  
Cumulative effect of a change in accounting principle, net of tax 7/
                      0.02  
 
                       
Diluted (loss)/earnings per common share
  $ (2.08 )   $ 0.12     $ (1.04 )   $ 0.71  
 
                       
 
                               
Average common shares outstanding – diluted
    1,621       1,497       1,536       1,491  
 
    The company incurs substantial costs related to the cholesterol joint venture, such as selling, general and administrative costs, that are not reflected in the “Equity income” and are borne by the overall cost structure of Schering-Plough.
 
1/   Net sales for the three and twelve months ended December 31, 2007, both include $626 million of Organon BioSciences (OBS) net sales for the period November 19, 2007 to December 31, 2007.
 
2/   Cost of sales for the three and twelve months ended December 31, 2007 both include purchase accounting adjustments of $326 million related to the acquisition of OBS. Cost of sales for the three and twelve months ended December 31, 2006 include $45 million and $146 million, respectively, related to the manufacturing changes announced June 1, 2006.
 
3/   Research and development for the three and twelve months ended December 31, 2007 include $21 million and $197 million related to upfront R&D payments. Research and development for the three and twelve months ended December 31, 2006 both include $15 million related to an upfront R&D payment.
 
4/   Acquired in-process research and development for the three and twelve months ended December 31, 2007 both include a charge of $3.8 billion in connection with the acquisition of OBS.


 

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5/   Included in other income, net for the three months ended December 31, 2007 are $255 million of acquisition-related gains on currency-related items. Included in other income, net for the twelve months ended December 31, 2007 are $537 million of acquisition-related net gains on currency-related and interest rate-related items.
 
6/   Special and acquisition related charges for the three and twelve months ended December 31, 2007 reflect $52 million and $84 million, respectively, related to the acquisition of OBS. Special and acquisition related charges for the three and twelve months ended December 31, 2006 are $12 million and $102 million, respectively, reflecting charges related to the manufacturing changes announced June 1, 2006.
 
7/   In the first quarter of 2006, Schering-Plough adopted the provisions of SFAS 123R. As a result of this adoption, Schering-Plough recognized a non-recurring cumulative effect adjustment of $22 million of income associated with Schering-Plough’s liability-based compensation plans.


 

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SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Common Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
To supplement its consolidated financial statements presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), Schering-Plough is providing the supplemental financial information below and on the following pages to reflect “As Reconciled” amounts related to Net (loss)/ income available to common shareholders and diluted (loss)/earnings per common share. “As Reconciled” amounts exclude the effects of purchase accounting adjustments, acquisition related items and other specified charges or benefits.
“As Reconciled” amounts related to Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share are non-U.S. GAAP measures used by management in evaluating the performance of Schering-Plough’s overall business. The effects of purchase accounting adjustments, acquisition related items and other specified charges or benefits have been excluded from net (loss)/income available to common shareholders and diluted (loss)/earnings per common share as management of Schering-Plough does not consider these charges to be indicative of continuing operating results. Schering-Plough believes that these “As Reconciled” performance measures contribute to a more complete understanding by investors of the overall results of the company and enhances investor understanding of items that impact the comparability of results between fiscal periods. Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share, as reported, are required to be presented under U.S. GAAP.
                                         
    Three months ended December 31, 2007  
            Purchase     Acquisition-     Other        
    As     Accounting     Related     Specified     As  
    Reported     Adjustments     Items     Items     Reconciled  
     
Net sales
  $ 3,724     $     $     $     $ 3,724  
Cost of sales
    1,566       (326 )                 1,240  
Selling, general and administrative
    1,634                         1,634  
Research and development
    855                   (21 )     834  
Acquired in-process research and development
    3,754       (3,754 )                  
Other (income)/expense, net
    (231 )           255             24  
Special and acquisition related charges
    52             (52 )            
Equity income
    (566 )                       (566 )
 
                             
 
                                       
(Loss)/income before income taxes
    (3,340 )     4,080       (203 )     21       558  
Income tax (benefit)/expense
    (14 )     89       2       1       78  
 
                             
Net (loss)/income before cumulative effect of a change in accounting principle
  $ (3,326 )   $ 3,991     $ (205 )   $ 20     $ 480  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
                                       
Net (loss)/income
  $ (3,326 )   $ 3,991     $ (205 )   $ 20     $ 480  
 
                             
 
Preferred stock dividends
    38                         38  
 
                             
Net (loss)/income available to common shareholders
  $ (3,364 )   $ 3,991     $ (205 )   $ 20     $ 442  
 
                             
 
                                       
Diluted (loss)/earnings per common share:
                                       
(Loss)/earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ (2.08 )                           $ 0.27  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted (loss)/earnings per common share
  $ (2.08 )                           $ 0.27  
 
                                   
Average common shares outstanding-diluted
    1,621                               1,648  


 

- 14 -

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net Income Available to Common Shareholders
and Reported Diluted Earnings Per Common Share to As Reconciled Amounts for Net Income
Available to Common Shareholders and Diluted Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Three months ended December 31, 2006  
            Purchase     Acquisition-     Other        
    As     Accounting     Related     Specified     As  
    Reported     Adjustments     Items     Items     Reconciled  
     
Net sales
  $ 2,650     $     $     $     $ 2,650  
Cost of sales
    915                   (45 )     870  
Selling, general and administrative
    1,250                         1,250  
Research and development
    631                   (15 )     616  
Acquired in-process research and development
                             
Other income, net
    (46 )                       (46 )
Special and acquisition related charges
    12                   (12 )      
Equity income
    (403 )                       (403 )
 
                             
 
                                       
Income before income taxes
    291                   72       363  
Income tax expense
    87                         87  
 
                             
Net income before cumulative effect of a change in accounting principle
  $ 204     $     $     $ 72     $ 276  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
                                       
Net income
  $ 204     $     $     $ 72     $ 276  
 
                             
 
                                       
Preferred stock dividends
    22                         22  
 
                             
Net income available to common shareholders
  $ 182     $     $     $ 72     $ 254  
 
                             
 
                                       
Diluted earnings per common share:
                                       
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.12                             $ 0.17  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted earnings per common share
  $ 0.12                             $ 0.17  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,497                               1,497  


 

- 15 -

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net/(Loss) Income Available to Common Shareholders
and Reported Diluted/(Loss) Earnings Per Common Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Twelve months ended December 31, 2007  
            Purchase     Acquisition-     Other        
    As     Accounting     Related     Specified     As  
    Reported     Adjustments     Items     Items     Reconciled  
     
Net sales
  $ 12,690     $     $     $     $ 12,690  
Cost of sales
    4,405       (326                 4,079  
Selling, general and administrative
    5,468                         5,468  
Research and development
    2,926                   (197 )     2,729  
Acquired in-process research and development
    3,754       (3,754)                    
Other (income)/expense, net
    (683           537             (146
Special and acquisition related charges
    84             (84            
Equity income
    (2,049                       (2,049
 
                             
 
                                       
(Loss)/income before income taxes
    (1,215     4,080       (453     197       2,609  
Income tax expense
    258       89       2       1       350  
 
                             
Net (loss)/income before cumulative effect of a change in accounting principle
  $ (1,473   $ 3,991     $ (455   $ 196     $ 2,259  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
Net (loss)/income
  $ (1,473   $ 3,991     $ (455   $ 196     $ 2,259  
 
                             
 
                                       
Preferred stock dividends
    118                         118  
 
                             
Net (loss)/income available to common shareholders
  $ (1,591   $ 3,991     $ (455   $ 196     $ 2,141  
 
                             
 
                                       
Diluted (loss)/earnings per common share:
                                       
(Loss)/earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ (1.04                           $ 1.37  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted (loss)/earnings per common share
  $ (1.04                           $ 1.37  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,536                               1,607  


 

- 16 -

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net Income Available to Common Shareholders
and Reported Diluted Earnings Per Common Share to As Reconciled Amounts for Net Income
Available to Common Shareholders and Diluted Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Twelve months ended December 31, 2006  
            Purchase     Acquisition-     Other        
    As     Accounting     Related     Specified     As  
    Reported     Adjustments     Items     Items     Reconciled  
     
Net sales
  $ 10,594     $     $     $     $ 10,594  
Cost of sales
    3,697                   (146 )     3,551  
Selling, general and administrative
    4,718                         4,718  
Research and development
    2,188                   (15 )     2,173  
Acquired in-process research and development
                             
Other income, net
    (135 )                       (135 )
Special and acquisition related charges
    102                   (102 )      
Equity income
    (1,459 )                       (1,459 )
 
                             
 
                                       
Income before income taxes
    1,483                   263       1,746  
Income tax expense
    362                         362  
 
                             
Net income before cumulative effect of a change in accounting principle
  $ 1,121     $     $     $ 263     $ 1,384  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
    (22 )                 22        
 
                             
 
                                       
Net income
  $ 1,143     $     $     $ 241     $ 1,384  
 
                             
 
                                       
Preferred stock dividends
    86                         86  
 
                             
Net income available to common shareholders
  $ 1,057     $     $     $ 241     $ 1,298  
 
                             
 
                                       
Diluted earnings per common share:
                                       
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.69                             $ 0.87  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
    0.02                                
 
                                   
 
                                       
Diluted earnings per common share
  $ 0.71                             $ 0.87  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,491                               1,491  


 

- 17 -

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported (Loss)/Diluted Earnings Per Common Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
“As Reconciled” amounts related to Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share reflect the following adjustments:
(Amounts in Millions)
                                 
    Fourth Quarter     Twelve Months  
    2007     2006     2007     2006  
Purchase accounting adjustments:
                               
Amortization of intangibles in connection with the acquisition of Organon BioSciences (a)
  $ 65     $     $ 65     $  
Depreciation related to the fair value adjustment of fixed assets related to the acquisition of Organon BioSciences (a)
    3             3        
Charge related to the fair value adjustment to inventory related to the acquisition of Organon BioSciences (a)
    258             258        
Acquired IPR&D related to the acquisition of Organon BioSciences (b)
    3,754             3,754        
 
                       
Total purchase accounting adjustments, pre-tax
    4,080             4,080        
Income tax benefit
    89             89        
 
                       
Total purchase accounting adjustments
  $ 3,991     $     $ 3,991     $  
 
                       
 
                               
Acquisition-related items:
                               
Acquisition-related (gains)/losses on currency-related and interest-related items (c)
  $ (255 )   $     $ (537 )   $  
Integration-related activities (d)
    52             84        
 
                       
Total acquisition-related items, pre-tax
    (203 )           (453 )      
Income tax benefit
    2             2        
 
                       
Total acquisition-related items
  $ (205 )         $ (455 )      
 
                       
 
                               
Other specified items:
                               
Manufacturing changes announced June 1, 2006 (e)
  $     $ 57     $     $ 248  
Upfront R&D payments (b)
    21       15       197       15  
Change in accounting principle (f)
                      (22 )
 
                       
Total other specified items, pre-tax
    21       72       197       241  
Income tax benefit
    1             1        
 
                       
Total other specified items
  $ 20     $ 72     $ 196     $ 241  
 
                       
 
                               
Total purchase accounting adjustments, acquisition-related items and other specified items
  $ 3,806     $ 72     $ 3,732     $ 241  
 
                       
 
(a)   Included in cost of sales
 
(b)   Included in research and development
 
(c)   Included in other (income)/expense, net
 
(d)   Included in special and acquisition-related charges
 
(e)   Included in cost of sales and special and acquisition-related charges
 
(f)   Included in cumulative effect in change in accounting principle, net


 

- 18 -

SCHERING-PLOUGH CORPORATION
Report for the period ended December 31 (unaudited):
GAAP Net Sales by Key Product
                                                 
    Fourth Quarter     Full Year  
(Dollars in millions)   2007     2006     %     2007     2006     %  
GLOBAL PHARMACEUTICALS a/
  $ 2,963     $ 2,211       34 %    $ 10,173     $ 8,561       19 %
REMICADE
    455       337       35     1,648       1,240       33
NASONEX
    271       253       7     1,092       944       16 %
PEGINTRON
    239       208       15     911       837       9
TEMODAR
    234       189       23     861       703       22
CLARINEX / AERIUS
    174       164       6     799       722       11
CLARITIN RX
    93       78       19     391       356       10
AVELOX
    115       103       12     384       304       26
INTEGRILIN
    91       85       7     332       329       1
REBETOL
    71       75       (6 %)      277       311       (11 %) 
CAELYX
    66       49       33     257       206       25
INTRON A
    57       57             233       237       (2 %)
SUBUTEX / SUBOXONE
    57       51       11     220       203       8
PROVENTIL / ALBUTEROL CFC
    41       55       (25 %)      207       203       2
ASMANEX
    41       36       16     162       103       57
ELOCON
    37       33       10     156       141       11
FORADIL
    25       28       (11 %)      102       94       8 %
NOXAFIL
    29       10       N/M       89       19       N/M  
FOLLISTIM c/
    57             N/M       57             N/M  
NUVARING c/
    45             N/M       45             N/M  
REMERON c/
    33             N/M       33             N/M  
ZEMURON c/
    25             N/M       25             N/M  
LIVIAL c/
    24             N/M       24             N/M  
CERAZETTE c/
    20             N/M       20             N/M  
MARVELON c/
    20             N/M       20             N/M  
MERCILON c/
    18             N/M       18             N/M  
IMPLANON c/
    15             N/M       15             N/M  
Other Pharmaceuticals
    610       400       53     1,795       1,609       12
 
                                               
 
                                         
CONSUMER HEALTH CARE
    254       205       24 %      1,266       1,123       13 % 
OTC
    161       118       37     682       558       22
OTC CLARITIN
    94       72       30     462       390       18
Foot Care
    74       73       1     345       343       1
Sun Care
    19       14       38     239       222       8
 
                                               
ANIMAL HEALTH b/
    507       234       117 %      1,251        910       37 % 
 
                                     
 
                                               
CONSOLIDATED GAAP NET SALES
  $ 3,724     $ 2,650       41 %    $ 12,690     $ 10,594       20 % 
 
                                     
 
a/   Global Pharmaceuticals net sales for both the three and twelve months ended December 31, 2007, include $409 million from Organon, the human health business of Organon BioSciences. Sales of Organon are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
b/   Animal Health net sales for both the three and twelve months ended December 31, 2007, include $217 million from Intervet, the animal health business of Organon BioSciences. Sales of Intervet are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
c/   Products acquired in OBS acquisition reflect net sales for the period from November 19, 2007 through year-end.
 
NOTE:   Additional information about U.S. and international sales for specific products is available by calling the company or visiting the Investor Relations Web site at http://ir.schering-plough.com.


 

- 19 -

SCHERING-PLOUGH CORPORATION
Reconciliation of Non-U.S. GAAP Financial Measures
Adjusted net sales, defined as net sales plus an assumed 50 percent of global cholesterol joint venture net sales.
                                 
    Three months ended December 31  
    (unaudited)  
(Dollars in millions)   2007     2006     %          
     
Net sales, as reported a/
  $ 3,724     $ 2,650       41%      
 
                               
50 percent of cholesterol joint venture net sales b/
    722        541       33%           
     
 
                               
Adjusted net sales b/
  $ 4,446     $ 3,191       39%           
     
                                 
    Twelve months ended December 31  
    (unaudited)  
(Dollars in millions)   2007     2006     %          
     
Net sales, as reported a/
  $ 12,690     $ 10,594       20%      
 
                               
50 percent of cholesterol joint venture net sales b/
    2,559       1,915       34%           
     
 
                               
Adjusted net sales
  $ 15,249     $ 12,509       22%           
     
 
a/   Net sales for the three and twelve months ended December 31, 2007, both include $626 million recorded as a result of the Organon BioSciences acquisition on November 19, 2007 through year-end.
 
b/   Total net sales of the cholesterol joint venture for the three months ended December 31, 2007 and 2006 were $1.4 billion and $1.1 billion, respectively. Total net sales of the cholesterol joint venture for the twelve months ended December 31, 2007 and 2006 were $5.1 billion and $3.8 billion, respectively.
 
Schering-Plough net sales growth for the three and twelve months ended December 31, 2007 reflects a favorable foreign exchange impact of 7% and 4%, respectively.
NOTE: Adjusted net sales, defined as net sales plus an assumed 50 percent of global cholesterol joint venture net sales, is a non-U.S. GAAP measure used by management in evaluating the performance of the Schering-Plough’s overall business. Schering-Plough believes that this performance measure contributes to a more complete understanding by investors of the overall results of the company. Schering-Plough provides this information to supplement the reader’s understanding of the importance to the company of its share of results from the operations of the cholesterol joint venture. Net sales (excluding the cholesterol joint venture net sales) is required to be presented under U.S. GAAP. The cholesterol joint venture’s net sales are included as a component of income from operations in the calculation of Schering-Plough’s “Equity income.” Net sales of the cholesterol joint venture do not include net sales of cholesterol products in non-joint venture territories.
# # #

 

EX-99.2 3 y48349exv99w2.htm EX-99.2: SUPPLEMENTAL FINANCIAL DATA EX-99.2
 

Exhibit 99.2
SCHERING-PLOUGH CORPORATION
STATEMENTS OF CONSOLIDATED OPERATIONS
(U.S. GAAP and As Reconciled)
(Amounts in Millions, except Per Share Figures)
(Unaudited)
                                                                                                   
    2007     2006     2007     2006               2007     2006     2007     2006      
    4th Qtr     4th Qtr     4th Qtr     4th Qtr     4th Qtr vs.     Full Year     Full Year     Full Year     Full Year      
    U.S.     U.S.     * As     * As     4th Qtr     U.S.     U.S.     * As     * As      
    GAAP     GAAP     Reconciled     Reconciled     As     GAAP     GAAP     Reconciled     Reconciled     2007 vs. 2006
    $     $     $     $     Reconciled     $     $     $     $     As Reconciled
                                                           
Net sales
    3,724         2,650         3,724         2,650         41       12,690         10,594         12,690         10,594         20
 
                                                                                                 
Cost of sales
    1,566         915         1,240         870         43       4,405         3,697         4,079         3,551         15
                                                           
Gross profit
    2,158         1,735         2,484         1,780         40       8,285         6,897         8,611         7,043         22
 
                                                                                                 
Selling, general and administrative
    1,634         1,250         1,634         1,250         31       5,468         4,718         5,468         4,718         16
Research and development
    855         631         834         616         35       2,926         2,188         2,729         2,173         26
Acquired in-process research and development
    3,754                                 *         3,754                                 *  
Other income, net
    (231       (46 )       24         (46 )       *         (683       (135 )       (146       (135 )       8
Special and acquisition related charges
    52         12                         *         84         102                         *  
Equity income
    (566       (403 )       (566)         (403 )       40       (2,049       (1,459 )       (2,049       (1,459 )       40
                                                           
Income/(loss) before income taxes
    (3,340       291         558         363         54       (1,215       1,483         2,609         1,746         49
 
                                                                                                 
Income tax expense/(benefit)
    (14       87         78         87         *         258         362         350         362         *  
                                                           
Net income/(loss) before cumulative effect of a change in accounting principle
    (3,326       204         480         276         74       (1,473       1,121         2,259         1,384         63
 
                                                                                                 
Cumulative effect of a change in accounting principle, net of tax
                                    *                 (22 )                       *  
                                                           
Net income/(loss)
    (3,326       204         480         276         74       (1,473       1,143         2,259         1,384         63
                                                           
Preferred stock dividends
    38         22         38         22         73       118         86         118         86         37
 
                                                                                                 
Net income/(loss) available to common shareholders
    (3,364       182         442         254         74       (1,591       1,057         2,141         1,298         65
                                                           
 
                                                                                                 
Diluted earnings/(loss) per common share:
                                                                                                 
Earnings/(loss) available to common shareholders before cumulative effect of a change in accounting principle
    (2.08       0.12         0.27         0.17         59       (1.04       0.69         1.37         0.87         57
Cumulative effect of a change in accounting principle, net of tax
                                                    0.02                          
                                                           
Diluted earnings/(loss) per common share
    (2.08       0.12         0.27         0.17         59       (1.04       0.71         1.37         0.87         57
                                                           
 
                                                                                                 
Avg. shares outstanding- diluted
    1,621         1,497         1,648         1,497                 1,536         1,491         1,607         1,491          
                                                           
 
                                                                                                 
 
 
 
 
                                                                   
Ratios to net sales
                                                                                                 
 
                                                                                                 
Net sales
    100.0       100.0 %       100.0       100.0 %                 100.0       100.0 %       100.0       100.0 %          
 
                                                                                                 
Cost of sales
    42.1       34.5 %       33.3       32.8 %                 34.7       34.9 %       32.1       33.5 %          
 
                                                                                                 
Gross margin
    57.9       65.5 %       66.7       67.2 %                 65.3       65.1 %       67.9       66.5 %          
 
                                                                                                 
Selling, general and administrative
    43.9       47.2 %       43.9       47.2 %                 43.1       44.5 %       43.1       44.5 %          
 
                                                                                                 
Research and development
    23.0       23.8 %       22.4       23.2 %                 23.1       20.6 %       21.5       20.5 %          
 
                                                                                                 
Income/(loss) before income taxes
    (89.7 %)        11.0 %       15.0       13.7 %                 (9.6 %)        14.0 %       20.6       16.5 %          
 
                                                                                                 
Net income/(loss)
    (89.3 %)        7.7 %       12.9       10.4 %                 (11.6 %)        10.8 %       17.8       13.1 %          
                                                                   
*   “As Reconciled” to exclude purchase accounting adjustments, acquisition-related items and other specified items. See Non-GAAP Reconciliation tables posted on the Schering-Plough website at www.Schering-Plough.com under “Investor Relations/Financial Highlights”
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 1


 

SCHERING-PLOUGH CORPORATION
STATEMENTS OF CONSOLIDATED OPERATIONS
(U.S. GAAP)
(Amounts in Millions, except Per Share Figures)
(Unaudited)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Net sales 1/
    2,975       3,178       2,812         3,724         12,690         2,551       2,818       2,574         2,650         10,594         41       20
 
                                                                                                             
Cost of sales 2/
    937       977       925         1,566         4,405         893       1,004       885         915         3,697         71       19
                                               
Gross profit
    2,038       2,201       1,887         2,158          8,285          1,658       1,814       1,689         1,735         6,897         24 %       20 %
 
                                                                                                             
Selling, general and administrative
    1,213       1,358       1,262         1,634         5,468         1,086       1,224       1,158         1,250         4,718         31       16
Research and development 3/
    707       696       669         855         2,926         481       539       536         631         2,188         35       34
Acquired in-process research and development 4/
                        3,754         3,754                                             *         *  
Other income, net 5/
    (48 )     (16 )     (390 )       (231 )       (683       (34 )     (19 )     (37 )       (46 )       (135 )       *         *  
Special and acquisition related charges 6/
    1       11       20         52         84               80       10         12         102         *         *  
Equity income
    (487 )     (490 )     (506 )       (566       (2,049       (311 )     (355 )     (390 )       (403 )       (1,459 )       40       40%  
                                               
Income/(loss)before income taxes
    652       642       832         (3,340       (1,215       436       345       412         291         1,483         *         *  
 
                                                                                                             
Income tax expense/(benefit)7/
    87       103       82         (14       258         86       86       103         87         362         *         *  
                                               
Net income/(loss) before cumulative effect of a change in accounting principle
    565       539       750         (3,326       (1,473       350       259       309         204         1,121         *         *  
 
                                                                                                             
Cumulative effect of a change in accounting principle, net of tax
                                        (22 )                           (22 )       *         *  
                                               
Net income/(loss)
    565       539       750         (3,326       (1,473       372       259       309         204         1,143         *         *  
                                               
Preferred stock dividends
    22       22       37         38         118         22       22       22         22         86         *         *  
Net income/(loss) available to common shareholders
    543       517       713         (3,364       (1,591       350       237       287         182         1,057         *         *  
                                               
 
                                                                                                             
Diluted earnings/(loss) per common share:
                                                                                                             
Earnings/(loss) available to common shareholders before cumulative effect of a change in accounting principle
    0.36       0.34       0.45         (2.08       (1.04       0.22       0.16       0.19         0.12         0.69                      
Cumulative effect of a change in accounting principle, net of tax
                                        0.02                             0.02                      
                                               
Diluted earnings/(loss) per common share
    0.36       0.34       0.45         (2.08       (1.04       0.24       0.16       0.19         0.12         0.71                      
                                               
 
                                                                                                             
Avg. shares outstanding- diluted
    1,571       1,587       1,622         1,621         1,536         1,486       1,489       1,492         1,497         1,491                      
Actual shares outstanding
    1,489       1,496       1,620         1,621         1,621         1,481       1,481       1,483         1,487         1,487                      
                                               
 
                                                                                                 
 
 
 
 
                                                       
Ratios to net sales
                                                                                                             
Net sales
    100.0 %     100.0 %     100.0 %       100.0       100.0       100.0 %     100.0 %     100.0 %       100.0 %       100.0 %                    
Cost of sales
    31.5 %     30.7 %     32.9 %       42.1       34.7       35.0 %     35.6 %     34.4 %       34.5 %       34.9 %                    
Gross margin
    68.5 %     69.3 %     67.1 %       57.9       65.3       65.0 %     64.4 %     65.6 %       65.5 %       65.1 %                    
Selling, general and administrative
    40.8 %     42.7 %     44.9 %       43.9       43.1       42.6 %     43.4 %     45.0 %       47.2 %       44.5 %                    
Research and development
    23.8 %     21.9 %     23.8 %       23.0       23.1       18.8 %     19.1 %     20.8 %       23.8 %       20.6 %                    
Income/(loss) before income taxes
    21.9 %     20.2 %     29.6 %       (89.7 %)        (9.6 %)        17.1 %     12.2 %     16.0 %       11.0 %       14.0 %                    
Net income/(loss)
    19.0 %     17.0 %     26.7 %       (89.3 %)        (11.6 %)        14.6 %     9.2 %     12.0 %       7.7 %       10.8 %                    
                                                       
 
*   Not a meaningful percentage
 
Note: The Company incurs substantial costs, such as selling, general and administrative costs, that are not reflected in “Equity income” and are borne by the overall cost structure of Schering-Plough.
 
1/   Net sales for the three and twelve months ended December 31, 2007, both include $626 million of Organon BioSciences (OBS) net sales as of the November 19, 2007 close of the acquisition through year-end.
 
2/   Cost of sales for the three and twelve months ended December 31, 2007 both include purchase accounting adjustments of $326 million related to the acquisition of OBS. Included in cost of sales for the three and twelve months ended December 31, 2006 is $45 million and $146 million, respectively, related to the manufacturing changes announced June 1, 2006.
 
3/   Research and development for the three months ended December 31, 2007 includes $21 million related to an upfront R&D payment. Research and development for the twelve months ended December 31, 2007 includes $197 million related to upfront R&D payments. Included in research and development for the three and twelve months ended December 31, 2006 is a $15 million payment for licensing of a product.
 
4/   Acquired in-process research and development for the three and twelve months ended December 31, 2007 both include a charge of $3.8 billion in connection with the acquisition of OBS.
 
5/   Included in other income, net for the three months ended December 31, 2007 are $255 million of acquisition-related gains on currency-related items. Included in other income, net for the twelve months ended December 31, 2007 are $537 million of acquisition-related net gains on currency-related and interest rate-related items.
 
6/   Special and acquisition related charges for the three and twelve months ended December 31, 2007, reflects $52 million and $84 million, respectively, related to the acquisition of OBS. Special and acquisition related charges of $102 million for the twelve months ended December 31, 2006 include severance and fixed asset write-offs related to the manufacturing changes in June 2006.
 
7/   Tax expense or benefit for all periods presented primarily relates to foreign taxes as the Company did not recognize the benefit of U.S. tax operating losses.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 2


 

SCHERING-PLOUGH CORPORATION
ANALYSIS OF NET SALES AND ADJUSTED NET SALES
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Cholesterol Joint Venture:
    1,150       1,248       1,277         1,443         5,119         778       958       1,010         1,082         3,829         33%         34%  
U.S.
    897       958       969         1,071         3,894         634       784       820         852         3,091         26%         26%  
International
    253       290       308         372         1,225         144       174       190         230         738         62%         66%  
                                           
 
                                                                                                             
50% of Cholesterol Joint Venture:
    575       624       639         722         2,559         389       479       505         541         1,915         33%         34%  
                                           
 
                                                                                                             
                                           
Prescription Pharma (1):
    2,398       2,520       2,291         2,963         10,173         2,032       2,230       2,087         2,211         8,561         34%         19%  
U.S.
    802       771       709         855         3,138         656       718       733         800         2,908         7%         8%  
International
    1,596       1,749       1,582         2,108         7,035         1,376       1,512       1,354         1,411         5,653         49%         24%  
                                           
 
                                                                                                             
                                           
Consumer Health Care
    345       394       273         254         1,266         311       349       259         205         1,123         24%         13%  
                                           
 
                                                                                                             
                                           
Animal Health (2):
    232       264       248         507         1,251         208       239       228         234         910         117%         37%  
U.S.
    58       58       63         99         278         57       62       72         50         240         98%         16%  
International
    174       206       185         408         973         151       177       156         184         670         121%         45%  
                                           
 
                                                                                                             
Consolidated GAAP Net Sales:
    2,975       3,178       2,812         3,724         12,690         2,551       2,818       2,574         2,650         10,594         41%         20%  
 
                                                                                                             
U.S.
    1,179       1,195       1,028         1,194         4,597         999       1,103       1,047         1,043         4,192         15%         10%  
International
    1,796       1,983       1,784         2,530         8,093         1,552       1,715       1,527         1,607         6,402         57%         26%  
                                           
 
                                                                                                             
                                           
Adjusted Net Sales:
    3,550       3,802       3,451         4,446         15,249         2,940       3,297       3,079         3,191         12,509         39%         22%  
                                           
 
(1)   Prescription Pharma for both the fourth quarter and full year 2007 include sales of Organon, the human health business of Organon BioSciences, of $84 million in the U.S. and $325 million Internationally. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
(2)   Animal Health for both the fourth quarter and full year 2007 include sales of Intervet, the animal health business of Organon BioSciences, of $35 million in the U.S. and $182 million Internationally. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
NOTE: As Schering-Plough integrates systems during 2008 separate sales information for Organon and Intervet is not expected to be presented separately.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 3


 

SCHERING-PLOUGH CORPORATION
CHOLESTEROL FRANCHISE NET SALES
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Global ZETIA: 1/
    544       605       606         680         2,436         415       474       501         535         1,925         27%         27%  
U.S.
    408       424       443         489         1,764         315       363       389         405         1,472         21%         20%  
International
    136       181       163         191         672         100       111       112         130         453         47%         48%  
 
                                                                                                             
Global VYTORIN: 1/
    616       683       684         778         2,761         371       491       517         554         1,933         40%         43%  
U.S.
    489       534       526         582         2,130         319       421       431         448         1,619         30%         32%  
International
    127       149       158         196         631         52       70       86         106         314         85%         101%  
 
                                                                                                             
Global Cholesterol: 1/
    1,160       1,288       1,290         1,458         5,197         786       965       1,018         1,089         3,858         34%         35%  
U.S.
    897       958       969         1,071         3,894         634       784       820         852         3,091         26%         26%  
International
    263       330       321         387         1,303         152       181       198         237         767         64%         70%  
1/ Substantially all sales of cholesterol products are not included in Schering-Plough’s net sales. Global franchise sales include sales under the Merck/Schering-Plough joint venture, plus any sales that are not part of the joint venture, such as Schering-Plough sales of cholesterol products in Latin America and Japan. In Japan, Schering-Plough co-markets Zetia with Bayer HealthCare. Zetia was launched in Japan in June 2007. In the fourth quarter of 2007 and 2006, sales in non-joint venture territories of the cholesterol franchise totaled $15 million and $7 million, respectively. For the twelve months of 2007 and 2006, sales in non-joint venture territories of the cholesterol franchise totaled $78 million and $29 million, respectively.
The results of the operation of the joint venture are reflected in equity income. As a result, Schering-Plough’s gross margin and ratios of selling, general and administrative expenses and R&D expenses as a percentage of sales do not reflect the benefit of the impact of the cholesterol joint venture’s operating results.
Schering-Plough utilizes the equity method of accounting for the joint venture. The cholesterol agreements provide for the sharing of operating income based upon percentages that vary by product, sales level and country. In the U.S. market, Schering-Plough receives a greater share of profits on the first $300 million of annual ZETIA sales. Above $300 million of annual ZETIA sales, the companies share profits equally. Schering-Plough’s allocation of joint venture income is increased by milestones earned. Further, either company’s share of the joint venture’s operating income is subject to a reduction if either company fails to perform a specified minimum number of physician details in a particular country. The companies agree annually to the minimum number of physician details by country.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 4


 

SCHERING-PLOUGH CORPORATION
PRESCRIPTION PHARMACEUTICAL SALES — KEY PRODUCT NET SALES
(Dollars in Millions)
                                                                                         
    Global Prescription Pharma     U.S.     International
    2007     2006               2007     2006               2007     2006      
    4th     4th     4th Qtr     4th     4th     4th Qtr     4th     4th     4th Qtr
    Qtr.     Qtr.     vs     Qtr.     Qtr.     vs     Qtr.     Qtr.     vs
    $     $     4th Qtr     $     $     4th Qtr     $     $     4th Qtr
                                                     
Prescription Pharma:
    2,963         2,211         34 %       855         800         7 %       2,108         1,411         49 %
 
                                                                                       
Remicade
    455         337         35 %                               455         337         35 %
Nasonex
    271         253         7 %       162         171         (5 %)       109         82         33
PegIntron
    239         208         15 %       42         49         (14 %)       197         159         25
Temodar
    234         189         23       83         74         12 %       151         115         31 %
Clarinex / Aerius
    174         164         6 %       82         94         (12 %)       92         70         30 %
Claritin rx
    93         78         19                               93         78         19
avelox
    115         103         12 %       115         103         12 %                        
Integrilin
    91         85         7 %       85         81         6 %       6         4         29 %
Rebetol
    71         75         (6 %)       1         2         (55 %)       70         73         (4 %)
Caelyx
    66         49         33 %                               66         49         33 %
Intron A
    57         57                 28         29         (4 %)       29         28         3 %
Subutex / Suboxone
    57         51         11 %                               57         51         11 %
Proventil / Albuterol cfc
    41         55         (25 %)       41         55         (25 %)                        
Asmanex
    41         36         16 %       38         33         17 %       3         3          
Elocon
    37         33         10 %                                     39         32         21 %
Foradil
    25         28         (11 %)       24         27         (10 %)       1         1          
Noxafil
    29         10         N/M         10         3         N/M         19         7         N/M  
Follistim (2)
    57                 N/M         14                 N/M         43                 N/M  
Nuvaring (2)
    45                 N/M         26                 N/M         19                 N/M  
Remeron (2)
    33                 N/M         2                 N/M         31                 N/M  
Zemuron (2)
    25                 N/M         10                 N/M         15                 N/M  
Livial (2)
    24                 N/M                         N/M         24                 N/M  
Cerazette (2)
    20                 N/M                         N/M         20                 N/M  
MARVELON (2)
    20                 N/M         2                 N/M         18                 N/M  
Mercilon (2)
    18                 N/M                         N/M         18                 N/M  
Implanon (2)
    15                 N/M         3                 N/M         12                 N/M  
 
(1)   Prescription Pharma for the fourth quarter includes sales of Organon, the human health business of Organon BioSciences, of $84 million in the U.S. and $325 million Internationally. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
(2)   Products acquired in OBS acquisition reflect net sales for the period from November 19, 2007 through year-end.
NOTE: As Schering-Plough integrates systems during 2008 separate sales information for Organon is not expected to be presented separately.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 5


 

SCHERING-PLOUGH CORPORATION
GLOBAL PRESCRIPTION PHARMACEUTICAL SALES — KEY PRODUCT NET SALES
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Global Prescription Pharma (1):
    2,398       2,520       2,291         2,963         10,173         2,032       2,230       2,087         2,211         8,561         34%         19%  
 
                                                                                                             
Remicade
    373       394       426         455         1,648         278       307       317         337         1,240         35%         33%  
Nasonex
    284       295       242         271         1,092         229       242       221         253         944         7%         16%  
PegIntron
    217       234       221         239         911         196       226       206         208         837         15%         9%  
Temodar
    196       216       215         234         861         163       171       179         189         703         23%         22%  
Clarinex / Aerius
    204       250       171         174         799         160       226       171         164         722         6%         11%  
Claritin rx
    112       102       83         93         391         101       104       74         78         356         19%         10%  
Avelox
    115       75       78         115         384         80       58       63         103         304         12%         26%  
Integrilin
    84       78       78         91         332         80       82       82         85         329         7%         1%  
Rebetol
    71       74       60         71         277         78       86       72         75         311         (6%)         (11%)  
Caelyx
    62       65       64         66         257         51       53       52         49         206         33%         25%  
Intron A
    60       55       61         57         233         60       64       57         57         237                 (2%)  
Subutex / Suboxone
    56       52       55         57         220         48       53       51         51         203         11%         8%  
Proventil / Albuterol cfc
    53       61       52         41         207         41       63       45         55         203         (25%)         2%  
Asmanex
    43       42       36         41         162         20       20       28         36         103         16%         57%  
Elocon
    36       43       40         37         156         34       38       36         33         141         10%         11%  
Foradil
    26       26       25         25         102         21       23       22         28         94         (11%)         8%  
Noxafil
    16       20       24         29         89         2       3       6         10         19         N/M         N/M  
Follistim (2)
                        57         57                                             N/M         N/M  
Nuvaring (2)
                        45         45                                             N/M         N/M  
Remeron (2)
                        33         33                                             N/M         N/M  
Zemuron (2)
                        25         25                                             N/M         N/M  
Livial (2)
                        24         24                                             N/M         N/M  
Cerazette (2)
                        20         20                                             N/M         N/M  
Marvelon (2)
                        20         20                                             N/M         N/M  
Mercilon (2)
                        18         18                                             N/M         N/M  
Implanon (2)
                        15         15                                             N/M         N/M  
 
(1)   Global Prescription Pharma for both the fourth quarter and full year 2007 include sales of Organon, the human health business of Organon BioSciences, of $84 million in the U.S. and $325 million Internationally. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
(2)   Products acquired in OBS acquisition reflect net sales for the period from November 19, 2007 through year-end .
NOTE: As Schering-Plough integrates systems during 2008 separate sales information for Organon is not expected to be presented separately.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 6


 

SCHERING-PLOUGH CORPORATION
U.S. PHARMACEUTICAL SALES — KEY PRODUCT NET SALES
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Total U.S. Pharma (1):
    802       771       709         855         3,138         656       718       733         800         2,908         7       8%  
 
                                                                                                         
Nasonex
    177       175       153         162         667         144       144       153         171         611         (5 %)        9 %
PegIntron
    49       46       46         42         183         43       57       51         49         201         (14 %)        (9 %) 
Temodar
    74       79       79         83         315         67       72       72         74         286         12       10
Clarinex / Aerius
    91       106       83         82         362         70       97       98         94         358         (12 %)        1
Avelox
    115       75       78         115         384         80       58       63         103         304         12       26
Integrilin
    80       73       73         85         312         76       78       78         81         312         6        
Intron a
    31       28       29         28         117         30       33       28         29         120         (4 %)        (3 %) 
Proventil / Albuterol cfc
    53       61       52         41         207         41       63       45         55         203         (25 %)        2
Asmanex
    40       39       34         38         152         18       18       26         33         94         17       61
Foradil
    25       25       24         24         98         20       22       22         27         91         (10 %)        8
Noxafil
    6       7       8         10         31                     2         3         4         N/M         N/M  
Follistim (2)
                        14         14                                             N/M         N/M  
Nuvaring (2)
                        26         26                                             N/M         N/M  
Remeron (2)
                        2         2                                             N/M         N/M  
Zemuron (2)
                        10         10                                             N/M         N/M  
Marvelon (2)
                        2         2                                             N/M         N/M  
Implanon (2)
                        3         3                                             N/M         N/M  
 
(1)   U.S. Pharma for both the fourth quarter and full year 2007 include sales of Organon, the human health business of Organon BioSciences, of $84 million. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
(2)   Products acquired in OBS acquisition reflect net sales for the period from November 19, 2007 through year-end.
NOTE: As Schering-Plough integrates systems during 2008 separate sales information for Organon is not expected to be presented separately.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 7


 

SCHERING-PLOUGH CORPORATION
INTERNATIONAL PHARMACEUTICAL SALES — KEY PRODUCT NET SALES
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Total International Pharma (1):
    1,596       1,749       1,582         2,108         7,035         1,376       1,512       1,354         1,411         5,653         49%         24%  
 
                                                                                                             
Remicade
    373       394       426         455         1,648         278       307       317         337         1,240         35%         33%  
Nasonex
    107       120       89         109         425         85       98       68         82         333         33%         28%  
PegIntron
    168       188       175         197         728         153       169       155         159         636         25%         14%  
Temodar
    122       137       136         151         546         96       99       107         115         417         31%         31%  
Clarinex / Aerius
    113       144       88         92         437         90       129       73         70         364         30%         20%  
Claritin Rx
    112       102       83         93         391         101       104       74         78         356         19%         10%  
Integrilin
    4       5       5         6         20         4       4       4         4         17         29%         17%  
Rebetol
    71       73       59         70         273         76       84       72         73         306         (4%)         (11%)  
Caelyx
    62       65       64         66         257         51       53       52         49         206         33%         25%  
Intron A
    29       27       32         29         116         30       31       29         28         117         3%         (1%)  
Subutex / Suboxone
    56       52       55         57         220         48       53       51         51         203         11%         8%  
Asmanex
    3       3       2         3         10         2       2       2         3         9                 14%  
Elocon
    36       43       40         39         158         34       37       35         32         138         21%         14%  
Noxafil
    10       13       16         19         58         2       3       4         7         15         N/M         N/M  
Follistim (2)
                        43         43                                             N/M         N/M  
Nuvaring (2)
                        19         19                                             N/M         N/M  
Remeron (2)
                        31         31                                             N/M         N/M  
Zemuron (2)
                        15         15                                             N/M         N/M  
Livial (2)
                        24         24                                             N/M         N/M  
Cerazette (2)
                        20         20                                             N/M         N/M  
Marvelon (2)
                        18         18                                             N/M         N/M  
Mercilon (2)
                        18         18                                             N/M         N/M  
Implanon (2)
                        12         12                                             N/M         N/M  
 
(1)   International Pharma for both the fourth quarter and full year 2007 include sales of Organon, the human health business of Organon BioSciences, of $325 million. Sales of Organon BioSciences are reflected as of the closing date of the acquisition on November 19, 2007 through year-end.
 
(2)   Products acquired in OBS acquisition reflect net sales for the period from November 19, 2007 through year-end.
NOTE: As Schering-Plough integrates systems during 2008 separate sales information for Organon is not expected to be presented separately.
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 8


 

SCHERING-PLOUGH CORPORATION
GLOBAL CONSUMER HEALTH CARE
NET SALES ANALYSIS
(Dollars in Millions)
                                                                                                               
    2007     2006            
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full     4th Qtr     12 Mos.
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year     vs     vs
    $   $   $     $     $     $   $   $     $     $     4th Qtr     12 Mos.
                                               
Global Health Care:
    345       394       273         254         1,266         311       349       259         205         1,123         24       13
 
                                                                                                             
OTC:
    177       182       162         161         682         153       149       138         118         558         37       22
OTC Claritin
    127       137       104         94         462         111       111       95         72         390         30       18
Other OTC
    50       45       58         67         220         42       38       43         46         168         47       31
Foot Care
    78       102       92         74         345         83       96       92         73         343         1       1
Sun Care
    90       110       19         19         239         75       104       29         14         222         38       8
All figures rounded. Totals may not add due to rounding. Percentages based on unrounded figures.

Page 9


 

SCHERING-PLOUGH CORPORATION
CONSOLIDATED OPERATIONS DATA
(Dollars in Millions)
(Unaudited)
                                                                                           
    2007     2006
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full
    Qtr.   Qtr.   Qtr.     Qtr.(1)     Year(1)     Qtr.   Qtr.   Qtr.     Qtr.     Year
    $   $   $     $     $     $   $   $     $     $
                                   
Geographic net sales
                                                                                         
U.S.
    1,179       1,195       1,028         1,194         4,597         999       1,103       1,047         1,043         4,192  
Europe and Canada
    1,215       1,343       1,199         1,743         5,500         1,046       1,206       1,044         1,107         4,403  
Latin America
    311       327       324         398         1,359         260       248       233         249         990  
Asia Pacific
    270       313       261         389         1,234         246       261       250         251         1,009  
 
                                                                                         
Consolidated net sales
    2,975       3,178       2,812         3,724          12,690         2,551       2,818       2,574         2,650         10,594  
 
                                                                                         
                                                                                           
    2007     2006
    1st   2nd   3rd     4th     Full     1st   2nd   3rd     4th     Full
    Qtr.   Qtr.   Qtr.     Qtr.     Year     Qtr.   Qtr.   Qtr.     Qtr.     Year
    $   $   $     $     $     $   $   $     $     $
                                   
Other income, net
                                                                                         
Interest income
    (82 )     (86 )     (117 )       (112 )       (395       (68 )     (69 )     (77 )       (83 )       (297 )
Interest expense
    37       39       45         125         245         46       45       40         41         172  
Acquisition-related (gains)/losses on currency-related and interest rate-related items (2)
    (3 )     35       (314 )       (255       (537 )                                    
Foreign exchange (gains)/losses
          (3 )     (4 )       3         (3 )             5               (4 )       2  
Other (income)/expense
          (1 )             8         7         (12 )                           (12 )
 
                                                                                         
 
                                                                                         
Total — Other income, net
    (48 )     (16 )     (390 )       (231 )       (683 )       (34 )     (19 )     (37 )       (46 )       (135 )
 
                                                                                         
 
    All figures rounded. Totals may not add due to rounding.
 
(1)   Fourth quarter and full year 2007 includes sales of Organon BioSciences which was acquired on November 19, 2007
 
(2)   Included in acquisition-related (gains)/losses in currency-related and interest rate-related items are gains from foreign currency options in the amount of $221 and $510 for the three and twelve months ended December 31, 2007, respectively.
Alex Kelly           908-298-7450
Robyn Brown          908-298-7417

Page 10


 

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amount in Millions, except per share figures)
To supplement its consolidated financial statements presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), Schering-Plough is providing the supplemental financial information to reflect “As Reconciled” amounts related to Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share. “As Reconciled” amounts exclude the effects of purchase accounting adjustments, acquisition-related items and other specified items.
“As Reconciled” amounts related to Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share are non-U.S. GAAP measures used by management in evaluating the performance of Schering-Plough’s overall business. The effects of purchase accounting adjustments, acquisition-related items and other specified items have been excluded from net (loss)/income available to common shareholders and diluted (loss)/earnings per common share as management of Schering-Plough does not consider these charges to be indicative of continuing operating results. Schering-Plough believes that these “As Reconciled” performance measures contribute to a more complete understanding by investors of the overall results of the company and enhances investor understanding of items that impact the comparability of results between fiscal periods. Net (loss)/income available to common shareholders and diluted (loss)/earnings per common share, as reported, are required to be presented under U.S. GAAP.
                                         
    Three months ended December 31, 2007  
            Purchase             Other        
    As     Accounting     Acquisition-     Specified     As Reconciled  
    Reported     Adjustments     Related Items     Items     (1)  
     
Net sales
  $ 3,724     $     $     $     $ 3,724  
Cost of sales
    1,566       (326 )                 1,240  
Selling, general and administrative
    1,634                         1,634  
Research and development
    855                   (21 )     834  
Acquired in-process research and development
    3,754       (3,754 )                  
 
                                       
Other (income)/expense, net
    (231           255             24  
Special and acquisition related charges
    52             (52 )            
Equity income
     (566 )                       (566 )
 
                             
 
                                       
(Loss)/income before income taxes
    (3,340 )     4,080       (203 )     21       558  
Income tax (benefit)/expense
    (14 )     89       2       1       78  
 
                             
Net (loss)/income before cumulative effect of a change in accounting principle
  $ (3,326 )   $ 3,991     $ (205 )   $ 20     $ 480  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
                                       
Net (loss)/income
  $ (3,326 )   $ 3,991     $ (205 )   $ 20     $ 480  
 
                             
 
                                       
Preferred stock dividends
    38                         38  
 
                             
Net (loss)/income available to common shareholders
  $ (3,364 )   $ 3,991     $ (205 )   $ 20     $ 442  
 
                             
 
                                       
Diluted (loss)/earnings per common share:
                                       
 
                                       
(Loss)/earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ (2.08 )                           $ 0.27  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted (loss)/earnings per common share
  $ (2.08 )                           $ 0.27  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,621                               1,648  
 
(1)   “As Reconciled” to exclude purchase accounting adjustments, acquisition-related items and other specified items.

Page 11


 

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Three months ended December 31, 2006  
            Purchase             Other        
    As     Accounting     Acquisition-     Specified     As Reconciled  
    Reported     Adjustments     Related Items     Items     (1)  
     
Net sales
  $ 2,650     $     $     $     $ 2,650  
Cost of sales
    915                   (45 )     870  
Selling, general and administrative
    1,250                         1,250  
Research and development
    631                   (15 )     616  
Acquired in-process research and development
                             
 
                                       
Other income, net
    (46 )                       (46 )
Special and acquisition related charges
    12                   (12 )      
Equity income
    (403 )                       (403 )
 
                             
 
                                       
Income before income taxes
    291                   72       363  
Income tax expense
    87                         87  
 
                             
Net income before cumulative effect of a change in accounting principle
  $ 204     $     $     $ 72     $ 276  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
                                       
Net income
  $ 204     $     $     $ 72     $ 276  
 
                             
 
                                       
Preferred stock dividends
    22                         22  
 
                             
Net income available to common shareholders
  $ 182     $     $     $ 72     $ 254  
 
                             
 
                                       
Diluted earnings per common share:
                                       
 
                                       
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.12                             $ 0.17  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted earnings per common share
  $ 0.12                             $ 0.17  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,497                               1,497  
 
(1)   “As Reconciled” to exclude purchase accounting adjustments, acquisition-related items and other specified items.

Page 12


 

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Twelve months ended December 31, 2007  
            Purchase             Other        
    As     Accounting     Acquisition-     Specified     As Reconciled  
    Reported     Adjustments     Related Items     Items     (1)  
     
Net sales
  $ 12,690     $     $     $     $ 12,690  
Cost of sales
    4,405       (326 )                 4,079  
Selling, general and administrative
    5,468                         5,468  
Research and development
    2,926                   (197 )     2,729  
Acquired in-process research and development
    3,754       (3,754 )                  
 
                                       
Other (income)/expense, net
    (683 )           537             (146 )
Special and acquisition related charges
    84             (84 )            
Equity income
    (2,049 )                       (2,049 )
 
                             
 
                                       
(Loss)/income before income taxes
    (1,215 )     4,080       (453 )     197       2,609  
Income tax expense
    258       89       2       1       350  
 
                             
Net (loss)/income before cumulative effect of a change in accounting principle
  $ (1,473 )   $ 3,991     $ (455 )   $ 196     $ 2,259  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                             
 
                             
 
                                       
Net (loss)/income
  $ (1,473 )   $ 3,991     $ (455 )   $ 196     $ 2,259  
 
                             
 
                                       
Preferred stock dividends
    118                         118  
 
                             
Net (loss)/income available to common shareholders
  $ (1,591 )   $ 3,991     $ (455 )   $ 196     $ 2,141  
 
                             
 
                                       
Diluted (loss)/earnings per common share:
                                       
 
                                       
(Loss)/earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ (1.04 )                           $ 1.37  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
                                   
 
                                   
 
                                       
Diluted (loss)/earnings per common share
  $ (1.04 )                           $ 1.37  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,536                               1,607  
 
(1)   “As Reconciled” to exclude purchase accounting adjustments, acquisition-related items and other specified items.

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SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
                                         
    Twelve months ended December 31, 2006  
            Purchase             Other        
    As     Accounting     Acquisition-     Specified     As Reconciled  
    Reported     Adjustments     Related Items     Items     (1)  
     
Net sales
  $ 10,594     $     $     $     $ 10,594  
Cost of sales
    3,697                   (146 )     3,551  
Selling, general and administrative
    4,718                         4,718  
Research and development
    2,188                   (15 )     2,173  
Acquired in-process research and development
                             
Other income, net
    (135 )                       (135 )
Special and acquisition related charges
    102                   (102 )      
Equity income
    (1,459 )                       (1,459 )
 
                             
 
                                       
Income before income taxes
    1,483                   263       1,746  
Income tax expense
    362                         362  
 
                             
Net income before cumulative effect of a change in accounting principle
  $ 1,121     $     $     $ 263     $ 1,384  
 
                             
 
                                       
Cumulative effect of a change in accounting principle, net of tax
    (22 )                 22        
 
                             
 
                                       
Net income
  $ 1,143     $     $     $ 241     $ 1,384  
 
                             
 
                                       
Preferred stock dividends
    86                         86  
 
                             
Net income available to common shareholders
  $ 1,057     $     $     $ 241     $ 1,298  
 
                             
 
                                       
Diluted earnings per common share:
                                       
 
                                       
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.69                             $ 0.87  
 
                                       
Cumulative effect of a change in accounting principle, net of tax
    0.02                                
 
                                   
 
                                       
Diluted earnings per common share
  $ 0.71                             $ 0.87  
 
                                   
 
                                       
Average common shares outstanding-diluted
    1,491                               1,491  
 
(1)   “As Reconciled” to exclude purchase accounting adjustments, acquisition-related items and other specified items.

Page 14


 

SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net (Loss)/Income Available to Common Shareholders
and Reported Diluted (Loss)/Earnings Per Share to As Reconciled Amounts for Net (Loss)/Income
Available to Common Shareholders and Diluted (Loss)/Earnings per Common Share (unaudited)
(Amounts in Millions, except per share figures)
“As Reconciled” amounts related to Net (loss)/income available to common shareholders and diluted (loss) earnings per common share reflect the following adjustments:
                                 
    Fourth Quarter     Twelve Months  
(Amounts in millions)   2007     2006     2007     2006  
Purchase accounting adjustments:
                               
Amortization of intangibles in connection with the acquisition of Organon BioSciences (a)
  $ 65     $     $ 65     $  
Depreciation related to the fair value adjustment of fixed assets related to the acquisition of Organon BioSciences (a)
    3             3        
Charge related to the fair value adjustment to inventory related to the acquisition of Organon BioSciences (a)
    258             258        
Acquired IPR&D related to the Organon BioSciences acquisition (b)
    3,754             3,754        
 
                       
Total purchase accounting adjustments, pre-tax
    4,080             4,080        
Income tax benefit
    89             89        
 
                       
Total purchase accounting adjustments
  $ 3,991     $     $ 3,991     $  
 
                               
Acquisition-related items:
                               
Acquisition-related (gains)/losses on currency-related and interest-related items (c)
  $ (255   $     $ (537   $  
Integration-related activities (d)
    52             84        
 
                       
Total acquisition-related items, pre-tax
    (203           (453      
Income tax benefit
    2             2        
 
                       
Total acquisition-related items
  $ (205   $     $ (455   $  
 
                               
Other specified items:
                               
Manufacturing changes announced June 1, 2006 (e)
  $     $ 57     $     $ 248  
Upfront R&D payments (b)
    21       15       197       15  
Change in accounting principle (f)
                      (22 )
 
                       
Total other significant items, pre-tax
    21       72       197       241  
Income tax benefit
    1             1        
 
                       
Total other specified items
  $ 20     $ 72     $ 196     $ 241  
 
                               
Total purchase accounting adjustments, acquisition-related items and other specified items
  $ 3,806     $ 72     $ 3,732     $ 241  
 
                       
 
(a)   Included in cost of sales
 
(b)   Included in research and development
 
(c)   Included in other (income)/expense, net
 
(d)   Included in special and acquisition-related charges
 
(e)   Included in cost of sales and special and acquisition-related charges
 
(f)   Included in cumulative effect in change in accounting principle, net

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