-----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, EHNWY5zcm98W0MwxgPatijiLRaeRWnnlchkl1jgkAYLQfId/di47VMiV+61nxpVv zxvW0RDdv4N8CjPKFgm6Jg== 0000310158-01-500010.txt : 20010814 0000310158-01-500010.hdr.sgml : 20010814 ACCESSION NUMBER: 0000310158-01-500010 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20010630 FILED AS OF DATE: 20010813 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: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 1707506 BUSINESS ADDRESS: STREET 1: ONE GIRALDA FARMS CITY: MADISON STATE: NJ ZIP: 07940-1000 BUSINESS PHONE: 9738227000 10-Q 1 finalqbody.htm FINAL 10Q BODY UNITED STATES SECURITIES AND EXCHANGE COMMISSION

FORM 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549


QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934


For the quarterly period ended June 30, 2001



COMMISSION FILE NUMBER 1-6571



SCHERING-PLOUGH CORPORATION



Incorporated in New Jersey

22-1918501

2000 Galloping Hill Road

(I.R.S. Employer Identification No.)

Kenilworth, N.J. 07033

(908) 298-4000

 

(telephone number)

   



Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months,
and (2) has been subject to such filing requirements for the past 90 days.

YES    X       NO




Common Shares Outstanding as of July 31, 2001: 1,463,534,577

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements



SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
STATEMENTS OF CONSOLIDATED INCOME

(UNAUDITED)
(Amounts in millions, except per share figures)

 

Three months

Ended

       June 30,        

 

Six months

Ended

       June 30,       

   
   
 

   2001 

 2000 

 

 2001 

 2000 

           
           

Net sales

$ 2,630 

$ 2,626 

 

$ 4,949 

$ 5,015 

Costs and Expenses:

         

 Cost of sales

535 

489 

 

1,005 

946 

 Selling, general and administrative

967 

977 

 

1,819 

1,818 

 Research and development

334 

345 

 

624 

635 

 Other income, net

     (29)

     (19)

 

     (55)

     (44)

 

  1,807 

  1,792 

 

  3,393 

  3,355 

Income before income taxes

823 

834 

 

  1,556 

  1,660 

Income taxes

    189 

    200 

 

    358 

    398 

Net income

$   634 

$   634 

 

$ 1,198 

$ 1,262 

           

Diluted earnings per common share

$    .43 

$    .43 

 

$    .81 

$    .85 

           

Basic earnings per common share

$    .43 

$    .43 

 

$    .82 

$    .86 

           

Dividends per common share

$    .16 

$    .14 

 

$    .30 

$   .265 

           

 

See notes to consolidated financial statements.

 

 

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in millions, except per share figures
)

 

June 30,

 

December 31,

 

2001

 

2000

       

Assets

     

Cash and cash equivalents

$  2,560 

 

$  2,397 

  Accounts receivable, net

1,614 

 

1,413 

  Inventories

975 

 

951 

  Prepaid expenses, deferred income

     

    taxes and other current assets

983 

 

959 

       Total current assets

6,132 

 

5,720 

  Property, plant and equipment

5,174 

 

4,927 

  Less accumulated depreciation

1,657 

 

1,565 

        Property, net

3,517 

 

3,362 

  Intangible assets, net

632 

 

627 

  Other assets

1,129 

 

1,096 

 

$ 11,410 

 

$ 10,805 

       

Liabilities and Shareholders' Equity

     

  Accounts payable

$  1,036 

 

$  1,031 

  Short-term borrowings and current
    portion of long-term debt


879 

 


994 

  Other accrued liabilities

1,636 

 

1,620 

        Total current liabilities

3,551 

 

3,645 

  Long-term liabilities

1,031 

 

1,041 

  Shareholders' Equity:

     

    Preferred shares - $1 par value;

     

      issued: none

 

    Common shares - $.50 par value;

     

      issued:  2,030

1,015 

 

1,015 

     Paid-in capital

1,015 

 

974 

     Retained earnings

10,575 

 

9,817 

     Accumulated other comprehensive income

(373)

(318)

           Total

12,232 

 

11,488 

     Less treasury shares: 2001 - 566 shares;

2000 - 567 shares, at cost

5,404 

 

5,369 

        Total shareholders' equity

6,828 

 

6,119 

 

$ 11,410 

 

$ 10,805 

See notes to consolidated financial statements.

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
STATEMENTS OF CONSOLIDATED CASH FLOWS
FOR THE SIX MONTHS ENDED JUNE 30,
(UNAUDITED)
(Amounts in millions)

 

2001

 

2000

       

Operating Activities:

     

  Net Income

$ 1,198 

 

$ 1,262 

  Depreciation and amortization

159 

 

148 

  Accounts receivable

(246)

 

(400)

  Inventories

(39)

 

(4)

  Prepaid expenses and other assets

(78)

 

(41)

  Accounts payable and other liabilities

57 

 

163 

  Net cash provided by operating activities

1,051 

 

1,128 

  

     

Investing Activities:

     

  Capital expenditures

(301)

 

(252)

  Purchases of investments

(47)

 

(50)

  Reduction of investments

14 

 

12 

  Other, net

11 

 

(45)

  Net cash used for investing activities

(323)

 

(335)

       

Financing Activities:

     

  Cash dividends paid to common shareholders

(441)

 

(390)

  Common shares repurchased

(34)

 

(445)

  Net change in short-term borrowings

(110)

 

139 

  Other, net

23 

 

69 

  Net cash used for financing activities

(562)

 

(627)

       

Effect of exchange rates on cash and

     

  cash equivalents

(3)

 

(3)

Net increase in cash and cash equivalents

163 

 

163 

Cash and cash equivalents, beginning

     

  of period

2,397 

 

1,876 

Cash and cash equivalents, end of period

$ 2,560 

 

$ 2,039 

       

     

See notes to consolidated financial statements.

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

 

Basis of Presentation

The unaudited financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission for reporting on Form 10-Q. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. Certain prior year amounts have been reclassified to conform to the current year presentation. The statements should be read in conjunction with the accounting policies and notes to consolidated financial statements included in the Company's 2000 Annual Report on Form 10-K.

In the opinion of management, the financial statements reflect all adjustments necessary for a fair statement of the operations for the interim periods presented.

Recently Issued Accounting Standards

In July 2001, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 141, "Business Combinations" and SFAS No. 142, "Goodwill and Other Intangible Assets". SFAS No. 141 will require all business combinations initiated after June 30, 2001 to be accounted for using the purchase method of accounting, thereby eliminating the pooling-of-interests method. SFAS No. 142 will eliminate the amortization of goodwill after January 1, 2002 and will require periodic testing of goodwill for impairment. If goodwill is deemed impaired, it will be written down to its estimated fair value. The impact of adoption of SFAS No. 142 will not be material to the Company's Consolidated Financial Statements.

Financial Instruments

Effective January 1, 2001, the Company adopted SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities." The Company makes limited use of derivative financial instruments and, as a result, the effect of adoption was not material.

SFAS No. 133, as amended, requires all derivatives to be recorded on the balance sheet at fair value. The effective portion of qualifying cash flow hedges are recognized in income when the hedged item affects income. Changes in the fair value of derivatives that qualify as fair value hedges, along with the change in the fair value of the hedged risk, are recognized in income as they occur. Changes in the fair value of derivatives that do not qualify for hedge treatment, as well as the ineffective portion of qualifying hedges, are recognized in income as they occur.

Risks, policy and objectives - The Company is exposed to market risk primarily from changes in foreign currency exchange rates and, to a lesser extent, from interest rate and equity price changes. In general, such market risks are not material to the Company.

To date, management has not deemed it cost-effective to engage in a formula-based program of hedging the profits and cash flows of foreign operations using derivative financial instruments. Because the Company's foreign subsidiaries purchase significant quantities of inventory payable in U.S. dollars, managing the level of inventory and related payables and the rate of inventory turnover provides a level of protection against adverse changes in exchange rates. In addition, the risk of adverse exchange rate change is mitigated by the fact that the Company's foreign operations are widespread. From time to time, the Company will hedge selective foreign currency risks with derivatives.

In addition, the Company uses derivative instruments to hedge the fair value of certain equity investments and, on a limited basis, the Company will hedge selective exposures to interest rate risks.

Interest Rate Hedges - During 1999, the Company purchased a $200 million variable rate, three-month time deposit. The Company intends to roll over this time deposit every three months until November 2003. To hedge the variable rate risk, the Company has entered into an interest rate swap that matures in November 2003. Under the swap the Company receives a fixed rate of approximately 5.6% and pays a variable rate. This swap is designated as a cash flow hedge with the effective portion of the swap deferred until the transaction being hedged is recorded into earnings. The amount of hedge ineffectiveness and the impact on comprehensive income and accumulated other comprehensive income in the quarter and six months ended June 30, 2001 was not material to the Company's financial statements. The amount of the gain or loss expected to be reclassified to earnings within the next twelve months is not material to the Company's financial statements.

In addition, the Company had utilized interest rate swaps as part of its international cash management strategy. These swaps are not designated as hedging instruments and, accordingly, the changes in fair value are recorded in earnings.

Equity Security Price Hedges - Equity investments acquired in connection with in-licensing agreements are subject to market price risk. The Company has hedged certain of these investments with equity swaps. These swaps are designated as fair value hedges. The amount of hedge ineffectiveness and the amount excluded from the assessment of effectiveness in the quarter and six months ended June 30, 2001 were not material. Gains and losses on these equity swaps are recorded in other, net.

Earnings Per Common Share

The shares used to calculate basic and diluted earnings per common share are reconciled as follows (number of shares in millions):

 

 

Three Months

Ended

June 30,

Six Months

Ended

June 30,

 

2001

2000

2001

2000

         

Average shares outstanding for basic earnings per share

1,463

1,464

1,463

1,467

Dilutive effect of options and deferred stock units

7

12

8

11

Average shares outstanding for diluted earnings per share

1,470

1,476

1,471

1,478

As of June 30, 2001, there were 24 million options outstanding with exercise prices higher than the average price of the Company's common stock. Accordingly, these options are not included in the dilutive effects indicated above.

Comprehensive Income

Total comprehensive income for the three months ended June 30, 2001 and 2000 was $633 million and $603 million, respectively. Total comprehensive income for the six months ended June 30, 2001 and 2000 was $1,143 million and $1,205 million, respectively.

Inventories

Inventories consisted of:

 

June 30,

December 31,

(Amounts in millions)

2001

2000

     

   Finished products

$ 347      

$ 459      

   Goods in process

316      

261      

   Raw materials and supplies

  312      

  231      

     Total inventories

$ 975      

$ 951      

Lines of Credit

The Company has recently renegotiated its $1 billion committed, multi-currency unsecured revolving credit facility into two unsecured revolving credit facilities from a syndicate of financial institutions totaling $1 billion. Under one facility, up to $500 million can be drawn down through May 2002, with repayment due by May 2003. Under a second multi-currency facility, an additional $500 million can be drawn down through the maturity date of May 2006. These facilities are available for general corporate purposes and are considered as support for the Company's commercial paper borrowings. These facilities do not require compensating balances; however, a nominal commitment fee is paid. At June 30, 2001, no funds had been drawn down under these facilities. In addition, the Company's foreign subsidiaries have approximately $300 million available in unused lines of credit from various financial institutions at June 30, 2001.

Legal and Environmental Matters

The Company has responsibilities for environmental cleanup under various state, local and federal laws, including the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund. At several Superfund sites (or equivalent sites under state law), the Company is alleged to be a potentially responsible party (PRP). The Company estimates its obligations for cleanup costs for Superfund sites based on information obtained from the federal Environmental Protection Agency, an equivalent state agency and/or studies prepared by independent engineers, and on the probable costs to be paid by other PRPs. The Company records a liability for environmental assessments and/or cleanup when it is probable a loss has been incurred and the amount can be estimated reasonably.

The Company is also involved in various other claims and legal proceedings of a nature considered normal to its business, including product liability cases. The estimated costs the Company expects to pay in these cases are accrued when the liability is considered probable and the amount can be estimated reasonably. Consistent with trends in the pharmaceutical industry, the Company is self-insured for certain events.

The recorded liabilities for the above matters at June 30, 2001 and the related expenses incurred during the six months ended June 30, 2001 were not material. Expected insurance recoveries have not been considered in determining the costs for environmental-related liabilities. Management believes that, except for the matters discussed in the following paragraphs, it is remote that any material liability in excess of the amounts accrued will be incurred.

Residents in the vicinity of a publicly owned waste-water treatment plant in Barceloneta, Puerto Rico, have filed two lawsuits against the plant operator and numerous companies that discharge into the plant, including a subsidiary of the Company, for damages and injunctive relief relating to odors coming from the plant and connecting sewers. One of these lawsuits is a class action claiming damages of $600 million. Both lawsuits are in the very early stages of discovery, and it is not possible to predict the outcome.

The Company is a defendant in approximately 100 antitrust actions commenced (starting in 1993) in state and federal courts by independent retail pharmacies, chain retail pharmacies and consumers. The plaintiffs allege price discrimination and/or conspiracy between the Company and other defendants to restrain trade by jointly refusing to sell prescription drugs at discounted prices to the plaintiffs.

One of the federal cases was a class action on behalf of approximately two-thirds of all retail pharmacies in the United States and alleged a price-fixing conspiracy. The Company, in February 1996, agreed to settle the federal class action for a total of $22 million, which has been paid in full. The United States District Court in Illinois approved the settlement of the federal class action in June 1996. In June 1997, the Seventh Circuit Court of Appeals dismissed all appeals from that settlement, and it is not subject to further review. The defendants that did not settle the class action proceeded to trial in September 1998. The trial ended in November 1998 with a directed verdict in the defendants' favor.

In April 1997, certain of the plaintiffs in the federal class action commenced another purported class action in the United States District Court in Illinois against the Company and the other defendants who settled the previous federal class action. The complaint alleges that the defendants conspired not to implement the settlement commitments following the settlement discussed above. The District Court has denied the plaintiffs' motion for a preliminary injunction hearing.

The Company has settled all the state retailer actions, except Alabama. The settlement in principal of the California retailer action occurred during March 2001. The settlement amounts were not material to the Company. In June 1999, the Alabama Supreme Court reversed the denial of a motion for judgment on the pleadings in the Alabama retailer case. The court held that the Alabama antitrust law did not apply to conspiracies alleged to be in interstate commerce. Based on that ruling, the Alabama retailer case has been dismissed. Subsequently, the District Attorney for the First Judicial Circuit filed a complaint on behalf of Alabama consumers under the State's Deceptive Trade Practices Act.

The Company has settled or otherwise disposed of all the state consumer cases. The settlement amounts were not material to the Company.

Plaintiffs in these antitrust actions generally seek treble damages in an unspecified amount and an injunction against the allegedly unlawful conduct.

The Company believes all the antitrust actions are without merit and is defending itself vigorously.

In March 1996, the Company was notified that the United States Federal Trade Commission (FTC) was investigating whether the Company, along with other pharmaceutical companies, conspired to fix prescription drug prices. In June 2001, the Company was informed that the FTC had closed this investigation without any charges being brought.

In October 1999, the Company received a subpoena from the U.S. Attorney's Office for the Eastern District of Pennsylvania, pursuant to the Health Insurance Portability and Accountability Act of 1996, concerning the Company's contracts with pharmacy benefit managers (PBMs) and managed care organizations to provide disease management services in connection with the marketing of its pharmaceutical products. It appears that the subpoena is one of a number addressed to industry participants as part of an inquiry into, among other things, pharmaceutical marketing practices. The government's inquiry appears to focus on whether the Company's disease management and other marketing programs and arrangements comply with federal health care laws and whether the value of its disease management programs and other marketing programs and arrangements should have been included in the calculation of rebates to the government. The Company is cooperating in the investigation. It is not possible to predict the outcome of the investigation, which could include the imposition of fines, penalties and injunctive or administrative remedies, nor can the Company predict whether the investigation will affect its marketing practices or sales.

In February 1998, Geneva Pharmaceuticals, Inc. (Geneva) submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking to market a generic form of CLARITIN in the United States several years before the expiration of the Company's patents. Geneva has alleged that certain of the Company's U.S. CLARITIN patents are invalid and unenforceable. The CLARITIN patents are material to the Company's business. In March 1998, the Company filed suit in federal court seeking a ruling that Geneva's ANDA submission constitutes willful infringement of the Company's patents and that its challenge to the Company's patents is without merit. The Company believes that it should prevail in the suit. However, as with any litigation, there can be no assurance that the Company will prevail.

During 1999, Copley Pharmaceutical, Inc., Teva Pharmaceuticals, Inc., Novex Pharma and Zenith Goldline Pharmaceuticals individually notified the Company that each had submitted an ANDA to the FDA seeking to market certain generic forms of CLARITIN in the United States before the expiration of certain of the Company's patents, including the compound patents for loratadine and desloratadine. In 2000, Andrx Pharmaceuticals, L.L.C., Mylan Pharmaceuticals Inc., ESI Lederle, Inc. (Lederle) and Impax Laboratories, Inc. made similar submissions. In 2001, Alpharma USPD Inc., Ranbaxy Pharmaceuticals, Inc., Taro Pharmaceuticals USA, Inc., and Genpharm Incorporated have made similar submissions. Each has alleged that one or more of those patents are invalid and unenforceable. In each case, the Company has filed suit in federal court seeking a ruling that the applicable ANDA submission and proposed marketing of a generic product constitute willful infringement of the Compa ny's patent and that the challenge to the patent is without merit. The Company believes that it should prevail in these suits. However, as with any litigation, there can be no assurance that the Company will prevail.

In January 2000, Hoffmann-La Roche Inc. (Roche) filed actions against the Company in the United States District Court in New Jersey, France and Germany alleging that the Company's PEG-INTRON (peginterferon alfa-2b) infringes Roche's patents on certain pegylated interferons. In August 2001, the Company and Roche entered into a licensing agreement that settles all patent disputes relative to the two companies' respective peginterferon products. The agreement provides for each company to manufacture and market worldwide its separate peginterferon products free from liability for infringement under the other's existing patent rights. Under the agreement, the Company and Roche will seek court dismissal of all patent litigation in the United States and Europe involving the two companies' respective peginterferon products.

The Company is responding to investigations by the Department of Health and Human Services, the Department of Justice and certain states into certain industry and Company practices regarding average wholesale price (AWP). These investigations include a Department of Justice review of the merits of a federal action filed by a private entity on behalf of the United States in the United States District Court for the Southern District of Florida, as well as an investigation by the United States Attorney's Office for the District of Massachusetts, regarding, inter alia, whether the AWP set by pharmaceutical companies for certain drugs improperly exceeds the average prices paid by dispensers and, as a consequence, results in unlawful inflation of certain government drug reimbursements that are based on AWP. The U.S. Attorney's Office for the District of Massachusetts is also investigating whether the Company's sales of a product that was repackaged for sale by a managed care organization shoul d have been included in the Company's Medicaid best price calculations. In March 2001, the Company received a subpoena from the Massachusetts Attorney General's office seeking documents concerning the use of AWP and other pricing and/or marketing practices. The Company is cooperating with these investigations. It is not possible to predict the outcome of these investigations, which could include the imposition of fines, penalties and injunctive or administrative remedies.

During the third quarter of 2000, the Company's generic subsidiary, Warrick Pharmaceuticals, was sued by the state of Texas. The lawsuit alleges that Warrick supplied the state with false reports of wholesale prices, which caused the state to pay Medicaid claims on prescriptions of Warrick's albuterol sulfate solution at a higher than justified level. The state seeks damages of $54 million against Warrick, including treble damages and penalties. It is not possible to predict the outcome of the litigation, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

On April 2, 2001, the FTC started an administrative proceeding against the Company, Upsher-Smith, Inc. (Upsher-Smith) and Lederle. The complaint alleges anti-competitive effects from the settlement of patent lawsuits between the Company and Lederle and the Company and Upsher-Smith. The lawsuits that were settled related to generic versions of K-DUR, the Company's long-acting potassium chloride product, which was the subject of Abbreviated New Drug Applications filed by Lederle and Upsher-Smith. The litigation is in its early stages. The Company believes that its actions have been lawful and proper, and intends to defend itself vigorously. However, it is not possible to predict the outcome of the investigation, which could result in the imposition of injunctive or administrative remedies.

Following the commencement of the FTC administrative proceeding, alleged class action suits were filed on behalf of direct and indirect purchasers of K-DUR against the Company, Upsher-Smith and Lederle in federal and state courts. These suits all allege essentially the same facts and claim violations of federal and state antitrust laws, as well as other state statutory and/or common law causes of action. The Company believes that it has substantial defenses and intends to defend itself vigorously.

In January 2000, a jury found that the Company's PRIME PACâ PRRS (Porcine Respiratory and Reproductive Syndrome) vaccine infringed a patent owned by Boehringer Ingelheim Vetmedica, Inc. An injunction was issued in August 2000 barring further sales of the Company's vaccine. The Company has filed post-trial motions, currently pending, for either a reversal of the jury's verdict or a new trial. The Company believes it should prevail, either through the post-trial motions or on appeal. However, as with any litigation, there can be no assurance that the Company will prevail.

On February 15, 2001, the Company stated in a press release that the FDA has been conducting inspections of the Company's manufacturing facilities in New Jersey and Puerto Rico and has issued reports citing deficiencies concerning compliance with current Good Manufacturing Practices, primarily relating to production processes, controls and procedures. The next day, February 16, 2001, a lawsuit was filed in the United States District Court for the District of New Jersey against the Company and certain named officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Additional lawsuits of the same tenor followed, and others may be filed. The plaintiffs in the suits purport to represent classes of shareholders who purchased shares of Company stock between dates as early as March 2, 2000 and February 15, 2001, the date of the press release. In May 2001, a lawsuit was filed in the United States District Court for the District of New Jersey against the Company and certain named officers alleging substantially the same violations of the Securities Exchange Act of 1934 as alleged in the putative class actions described above in this paragraph, as well as alleging violations of Section 11 of the Securities Act of 1933 and failure to disclose information which is the subject matter of the FTC administrative proceeding described above. The plaintiff in this suit purports to represent a class of shareholders who purchased shares of Company stock between July 25, 2000 and March 30, 2001, the last business day before the Company issued a press release relating to the FTC administrative proceeding. Each of these lawsuits is in the very early stages. The Company believes that it has substantial defenses and intends to defend the suits vigorously.

In addition to the lawsuits described in the immediately preceding paragraph, two lawsuits were filed in the United States District Court for the District of New Jersey and two lawsuits were filed in New Jersey state court against the Company (as a nominal defendant) and certain officers, directors and a former director seeking damages on behalf of the Company including disgorgement of trading profits made by defendants allegedly obtained on the basis of material inside information. The complaints in each of those four lawsuits relate to the issues described in the Company's February 15, 2001, press release, and allege a failure to disclose material information and breach of fiduciary duty by the directors. One of the federal court lawsuits also includes allegations related to the investigations by the U. S. Attorney's Offices for the Eastern District of Pennsylvania and the District of Massachusetts, the FTC's administrative proceeding against the Company, and the lawsuit by the State of Texas against Warrick, all of which are described above. Each of these lawsuits is a shareholder derivative action that purports to assert claims on behalf of the Company, but as to which no demand was made on the Board of Directors and no decision has been made on whether the Company can or should pursue such claims. Each of these lawsuits is in the very early stages.

The Company is a party to an arbitration commenced in August 2001 by Biogen, Inc. relating to Biogen's claims that the Company owes U.S. alpha interferon royalty payments to Biogen for a period of time that the Company does not believe such royalties are owed, and to preempt future royalty disputes. Biogen's claims relate to the Company's sale of INTRON A and PEG-INTRON. The Company believes that Biogen's claims are without merit and will defend itself vigorously. However, as with any arbitration, there can be no assurance that the Company will prevail.

On August 9, 2001, the Prescription Access Litigation (PAL) project, a Boston-based group formed in 2001 to litigate against drug companies, issued a press release stating that PAL members filed a lawsuit in New Jersey state court against the Company. As of August 10, 2001 (the last business day before filing this report), the Company had not been served with a complaint in this case. According to the press release, the suit, which PAL purports to be a class action, alleges, among other things, that the Company's direct-to-consumer advertising falsely depicts the benefits of CLARITIN in violation of the New Jersey Consumer Fraud Act. Based on the reports it has received, the Company believes that the claims are without merit and will defend itself vigorously. However, as with any litigation, there can be no assurance that the Company will prevail.

 

 

 

INDEPENDENT ACCOUNTANTS' REPORT

To the Shareholders and Board of Directors of

Schering-Plough Corporation:

We have reviewed the accompanying condensed consolidated balance sheet of Schering-Plough Corporation and subsidiaries (the "Corporation") as of June 30, 2001, and the related statements of consolidated income for the three-month and six-month periods ended June 30, 2001 and 2000, and cash flows for the six-month period ended June 30, 2001 and 2000. These financial statements are the responsibility of the Corporation's management.

We conducted our review in accordance with standards established by the American Institute of Certified Public Accountants. A review of interim financial information consists principally of applying analytical procedures to financial data and of making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with auditing standards generally accepted in the United States of America, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.

Based on our review, we are not aware of any material modifications that should be made to such condensed consolidated financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.

We have previously audited, in accordance with auditing standards generally accepted in the United States of America, the consolidated balance sheet of Schering-Plough Corporation and subsidiaries as of December 31, 2000, and the related statements of consolidated income, shareholders' equity, and cash flows for the year then ended (not presented herein); and in our report dated February 16, 2001, we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of December 31, 2000 is fairly stated, in all material respects, in relation to the consolidated balance sheet from which it has been derived.

/s/Deloitte & Touche LLP

Parsippany, New Jersey

August 13, 2001

 

 

 

 

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Results of Operations - three and six months ended June 30, 2001 compared with the corresponding periods in 2000.

Net Sales

Consolidated net sales for the second quarter totaled $2.6 billion, and were essentially unchanged compared with the same period in 2000. For the six months, net sales decreased $66 million or 1 percent versus 2000. Excluding the effect of foreign currency exchange rate fluctuations, consolidated net sales increased 3 percent in the quarter and 1 percent in the first six months, impacted by volume growth of 1 percent in the second quarter and volume declines of 2 percent for the first six months of 2001. Net sales in the United States decreased 3 percent versus the second quarter of 2000 and 5 percent for the six-month period. U.S. sales were negatively impacted in both periods by the manufacturing issues discussed below, and by changes in trade inventory levels. International sales advanced 7 percent (14 percent excluding exchange) versus the second quarter of 2000. For the six-month period, international sales grew 6 percent (12 percent excluding exchange).

Net sales by major therapeutic category for the second quarter and six months were as follows ($ in millions):

 

               
 

      Second Quarter      

 

      Six Months      

 

2001

2000

%

 

2001

2000

%

Allergy & Respiratory

$1,244

$1,216 

 

$2,171

$2,172 

Anti-infective & Anticancer

510

508 

 

1,035

1,000 

Cardiovasculars

134

168 

(20)

 

 297

351 

(15)

Dermatologicals

176

170 

 

318

342 

(7)

Other Pharmaceuticals

164

174 

(6)

 

 355

383 

(7)

Animal Health

171

173 

(1)

 

 324

330 

(2)

Foot Care

97

100 

(3)

 

 176

190 

(7)

Over-the-Counter (OTC)

42

45 

(5)

 

98

87 

12 

Sun Care

 92

72 

28 

 

175

160 

10 

Consolidated net sales

$    2,630

$2,626 

$  4,949

$5,015 

(1)

Worldwide net sales of allergy and respiratory products increased 2 percent in the quarter and were unchanged versus the six-month period of 2000. Worldwide net sales of the CLARITIN line of nonsedating antihistamines totaled $925 million for the quarter, up $28 million or 3 percent, and totaled $1,643 million, up $81 million or 5 percent for the first six months of 2001, as compared with the corresponding periods in 2000. The increase in the CLARITIN line in both periods was due primarily to continued expansion in the U.S. antihistamine market and the international launch of CLARINEX, tempered by U.S. market share declines and changes in U.S. trade inventory levels. CLARITIN demand is expected to remain strong, however, reported U.S. CLARITIN sales for the third quarter of 2001 may be below third quarter 2000 U.S. CLARITIN sales due to reductions in trade inventory levels. The impact of any such sales decrease is expected to be offset by sales increases of other products coupled with lower expense levels. Sales of NASONEX, a once-daily corticosteroid for seasonal allergic rhinitis, increased $62 million or 51 percent in the quarter and $72 million or 36 percent for the six-month period, due to expansion in the U.S. nasal-inhaled steroid market and increases in market share as it continues to capture share from VANCENASE. NASONEX sales also benefited from increases in U.S. trade inventory levels and strength in most major international markets. Sales of VANCENASE allergy products decreased $56 million and $109 million, for the quarter and six-month periods, respectively, and VANCERIL, an orally inhaled steroid for asthma, declined $5 million or 17 percent and $30 million or 47 percent, in the quarter and six-month periods respectively, both primarily due to manufacturing issues.

Net sales of worldwide anti-infective and anticancer products were unchanged in the quarter versus the prior year and increased 3 percent year-to-date. Sales in both periods benefited from higher international sales of REMICADE, marketed for Crohn's disease and rheumatoid arthritis, and worldwide sales of TEMODAR, a chemotherapy agent for treating certain types of brain tumors. Sales of REMICADE were up $24 million in the second quarter and $43 million year-to-date, and sales of TEMODAR rose $14 million or 46 percent in the quarter and $36 million or 69 percent in the first six months, reflecting increased utilization. Worldwide sales of the INTRON A franchise, consisting of INTRON A, PEG-INTRON, a longer-acting form of INTRON A (as monotherapy for treating hepatitis C and, internationally, in combination with REBETOL Capsules) and REBETRON Combination Therapy, containing REBETOL Capsules and INTRON A Injection, totaled $315 million in the quarter, down $46 million or 13 percent from the second quarter of 2000, and totaled $641 million, down $56 million or 8 percent year-to-date. The decrease in INTRON A franchise sales in both periods reflects U.S. trade inventory changes as well as a decline in the hepatitis C market attributable to anticipated approval of newer therapies.

Worldwide net sales of cardiovascular products decreased 20 percent in the second quarter and 15 percent year-to-date due to lower sales in the United States. Sales of K-DUR, a sustained-release potassium supplement decreased $35 million or 64 percent in the quarter and $38 million or 29 percent year-to-date, due to trade inventory reductions and manufacturing issues. Sales of IMDUR, an oral nitrate for angina, declined $15 million or 46 percent in the quarter and $29 million or 43 percent year-to-date, due to continued generic competition. The decrease was tempered by higher sales of INTEGRILIN, a platelet aggregation inhibitor for the treatment of patients with acute coronary syndromes, up $25 million or 60 percent in the quarter and $35 million or 51 percent in the first six months, due to increased utilization.

Dermatological products' worldwide net sales increased 4 percent in the second quarter but decreased 7 percent in the first six months. Sales of LOTRISONE, a topical antifungal/anti-inflammatory, declined $38 million or 38 percent in the first six months due to U.S. trade inventory reductions of LOTRISONE cream related to the recent introduction of LOTRISONE lotion.

Worldwide sales of animal health products decreased 1 percent in the second quarter and 2 percent year-to-date. The decline in sales in both periods was due to manufacturing issues in the United States, coupled with the impact of bovine spongiform encephalopathy (BSE or Mad Cow disease) and foot and mouth disease (FMD) in Europe. These decreases were tempered by the June 2000 acquisition of the animal health business of Takeda Chemical Industries, Ltd. in Japan.

Net sales of foot care products decreased 3 percent in the quarter and 7 percent year-to-date, mainly due to increasing competition.

OTC product sales decreased 5 percent in the second quarter of 2001 but grew 12 percent year-to-date. Sales growth was led by higher sales of cough and cold products.

Sales of sun care products were up 28 percent in the second quarter and 10 percent for the first six months of 2001. Growth was due to higher sales in Japan and the success of new sunless products in the United States.

Costs and Expenses

Cost of sales as a percentage of sales increased to 20.3 percent in both the quarter and first six months of 2001 from 18.6 percent in the second quarter of 2000 and 18.9 percent in the first six months of 2000. The increase was primarily due to costs associated with the manufacturing issues described in Additional Factors Influencing Operations below and unfavorable foreign exchange impacts, tempered by lower royalties paid by the Company.

Selling, general and administrative expenses represented 36.8 percent of sales in the second quarter of 2001 compared with 37.2 percent last year. For the six-month period the ratio increased to 36.8 percent from 36.2 percent last year. The decrease in this ratio in the second quarter reflects lower promotional spending. The increase in this ratio in the first six months was primarily due to lower sales.

Research and development spending decreased 3 percent in the second quarter of 2001, representing 12.7 percent of sales in 2001 and 13.1 percent in 2000. For the first six months of 2001, spending decreased 2 percent and represented 12.6 percent of sales versus 12.7 percent in 2000. R&D spending reflects the timing of the Company's funding of both internal research efforts and research collaborations with various partners to discover and develop a steady flow of innovative products.

The effective tax rate was 23.0 percent in the three and six month periods of 2001 and 24.0 percent in both periods of 2000. The decrease was primarily due to increased sales of products manufactured in jurisdictions with lower tax rates.

Diluted earnings per common share were unchanged in the second quarter at $.43 in 2001 and 2000 and declined 5 percent to $.81 from $.85 for the six-month period. Excluding the impact of exchange rate fluctuations, diluted earnings per common share increased 2 percent in the second quarter and decreased 1 percent in the first six months. Basic earnings per common share were unchanged in the quarter versus the prior period and declined 5 percent year-to-date.

Additional Factors Influencing Operations

In the United States, many of the Company's pharmaceutical products are subject to increasingly competitive pricing as managed care groups, institutions, government agencies and other buying groups seek price discounts. In most international markets, the Company operates in an environment of government-mandated cost-containment programs. In the U.S. market, the Company and other pharmaceutical manufacturers are required to provide statutorily defined rebates to various government agencies in order to participate in Medicaid, the veterans health care program and other government-funded programs. Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs, imposed supplemental rebates and enacted across-the-board price cuts as methods to control costs.

Since the Company is unable to predict the final form and timing of any future domestic and international governmental or other health care initiatives, their effect on operations and cash flows cannot be reasonably estimated. Similarly, the effect on operations and cash flows of decisions of government entities, managed care groups and other buying groups concerning formularies, pharmaceutical reimbursement policies and availability of the Company's pharmaceutical products cannot be reasonably estimated.

A significant portion of net sales are made to major pharmaceutical and health care products distributors and major retail chains in the United States. Consequently, net sales and quarterly growth comparisons may be affected by fluctuations in the buying patterns of major distributors, retail chains and other trade buyers. These fluctuations may result from seasonality, pricing, wholesaler buying decisions or other factors.

The market for pharmaceutical products is competitive. The Company's operations may be affected by technological advances of competitors, industry consolidation, patents granted to competitors, new products of competitors and generic competition as the Company's products mature. In addition, patent positions are increasingly being challenged by competitors, and the outcome can be highly uncertain. An adverse result in a patent dispute can preclude commercialization of products or negatively affect sales of existing products. The effect on operations of competitive factors and patent disputes cannot be predicted.

As noted in the "Legal and Environmental Matters" footnote included in the financial statements to this report and in Part II, Item 1, Legal Proceedings to this report, the Company has sued thirteen generic drug manufacturers that are seeking to market certain forms of generic loratadine prior to the expiration of certain of the Company's U.S. patents, including the compound patents for loratadine and desloratadine. In each case, the Company has filed suit in federal court seeking a ruling that the applicable ANDA submission and proposed marketing of a generic product constitute willful infringement of the Company's patent and that the challenge to the patent is without merit. The compound patent for loratadine is set to expire on June 19, 2002. U.S. market exclusivity for CLARITIN was extended by the FDA to December 19, 2002 because the Company conducted pediatric clinical trials at the request of the FDA. The compound patent for desloratadine is set to expire on April 21, 2004 . If the Company does not prevail in those suits, it is reasonably possible that generic forms of loratadine could enter the market as early as December 20, 2002. There are two generic manufacturers claiming that the loratadine compound patent is invalid and/or unenforceable. If either prevails on those contentions, it is possible the generic loratadine could be available before December 20, 2002. The Company believes that it is unlikely generic loratadine would be available before December 20, 2002. Further, as described below in this section, on May 11, 2001 a joint advisory committee to the FDA has recommended that loratadine and two other second generation antihistamines have safety profiles acceptable for OTC marketing. Based in part on that recommendation, the FDA may consider whether it can require a switch of loratadine from prescription to OTC status with or without the consent of the Company.

The Company expects that its pending NDAs for CLARINEX (desloratadine) Tablets will be approved when GMP deficiencies have been resolved. CLARINEX is the Company's next generation nonsedating antihistamine (NSA) allergy treatment. The ability of the Company to capture and maintain market share for its NSA products in the U.S. market will depend on a number of factors, including the date of the U.S. launch of CLARINEX, additional entrants in the market for allergy treatments, clinical differentiation of CLARINEX from other allergy treatments and the perception of the extent of such differentiation in the marketplace, the pricing differentials that may exist among CLARITIN, CLARINEX, other allergy treatments and generic loratadine tablets upon their introduction in the market which could be substantial, the date of launch of generic loratadine tablets, the erosion rate of CLARITIN market share upon the entry of generic loratadine tablets and whether or not the FDA switches CLARITIN and one or both of the other branded second generation antihistamines from prescription to OTC status. Management believes that the introduction of generic loratadine and/or the switch of CLARITIN to OTC status is likely to result in a substantial decline in CLARITIN sales in the United States, which in all formulations accounted for 33 percent of the Company's consolidated worldwide sales in the first six months of 2001. Further, in light of the factors listed in the third sentence of this paragraph, management believes that either of those events would likely have a material adverse effect on the Company's results of operations and growth prospects for an indeterminate period of time. Additional information regarding government regulation and cautionary factors that may affect future results is provided in Part I, Item I, Business, in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, which is incorporated herein by reference.

Uncertainties inherent in government regulatory approval processes, including, among other things, delays in approval of new products, formulations or indications, may also affect the Company's operations. The effect on operations of regulatory approval processes cannot be predicted.

The Company is subject to the jurisdiction of various national, state and local regulatory agencies and is, therefore, subject to potential administrative actions. Of particular importance is the Food and Drug Administration (FDA) in the United States. It has jurisdiction over all the Company's businesses and administers requirements covering the testing, safety, effectiveness, approval, manufacturing, labeling and marketing of the Company's products. From time to time, agencies, including the FDA, may require the Company to address various manufacturing, advertising, labeling or other regulatory issues, such as those noted below relating to the Company's current manufacturing issues. Failure to comply with governmental regulations can result in delays in the release of products, seizure or recall of products, suspension or revocation of the authority necessary for the production and sale of products, discontinuance of products, fines and other civil or criminal sanctions. Any such re sult could have a material adverse effect on the Company, its financial position or its results of operations. Additional information regarding government regulation and cautionary factors that may affect future results is provided in Part I, Item I, Business, in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, which is incorporated by reference herein.

On May 11, 2001, the FDA held a joint meeting of its Nonprescription Drugs Advisory Committee and its Pulmonary-Allergy Drugs Advisory Committee to consider a citizens' petition filed with the FDA by a health insurance company requesting that loratadine and two other antihistamines marketed by other companies be switched from prescription to over-the-counter (OTC) status. The panel voted 19-4 in a non-binding recommendation that loratadine has a safety profile acceptable for OTC marketing. The panel also had serious concerns regarding appropriate OTC labeling. Additional issues on the lack of use studies as well as patient access were also noted. The Company opposed the petition which it maintains would force patients to self-diagnose, self-treat and pay the entire cost of their allergy medications, thus raising serious questions about quality of care and costs for patients. Further, the Company believes that there are significant legal and public policy issue s that would be raised if the FDA were to require an OTC switch without drug-sponsor support. However, the ultimate resolution of the citizens' petition cannot be predicted, and a final resolution mandating an OTC switch of loratadine would likely have a material adverse effect on the Company, its financial position or its results of operations.

In February 2001, the Company reported that manufacturing process and control issues have led to reduced sales of certain products in the U.S. marketplace, with the result that first quarter and full-year 2001 sales and earnings will be lower than expected. The extent of this impact will depend upon the timing and nature of a resolution of the manufacturing issues. The Company said that the FDA has been conducting inspections of the Company's manufacturing facilities in New Jersey and Puerto Rico, and has issued reports citing deficiencies concerning compliance with current Good Manufacturing Practices (GMPs), primarily relating to production processes, controls and procedures.

In April 2001, the Company reported on its efforts to complete a new, comprehensive GMP Work Plan that takes a broad, systemic approach that will encompass all FDA-regulated manufacturing sites and address six key areas: quality assurance, facilities and equipment, materials management, production, laboratories, and packaging and labeling. That GMP Work Plan was submitted to the FDA on May 1, 2001. In June 2001, the Company reported that the FDA had completed additional inspections at the Company's New Jersey and Puerto Rico manufacturing facilities and had issued new inspection reports which cited some continuing and some additional GMP deficiencies. Among the issues affecting the Company's ability to manufacture and ship certain pharmaceutical products has been the temporary interruption of some production lines to install system upgrades and further enhance compliance, and other technical production and equipment qualification issues.

As part of its effort to improve manufacturing and quality-control functions, the Company will continue to invest in new equipment, process and system improvements. In addition, the Company is making extensive improvements to its operations, including:

  • In quality control and production, some 500 people will be added to strengthen these areas. The Company is about half-way to this goal and has recruited a number of senior level executives from outside the Company;
  • In the area of equipment requalification and revalidation, the Company has recruited highly qualified executives, scientists and consultants to improve revalidation studies and set up a validation review board to oversee the requalification of manufacturing equipment and the revalidation of processes and support systems;
  • In certain production areas where appropriate, equipment and manufacturing lines are being upgraded, notably in aerosol production and tablet manufacturing;
  • In global quality control, improved electronic document management and laboratory information systems are being installed; and
  • A GMP Review Board has been formed, which includes three prominent former FDA officials. This Board is overseeing progress on the Company's cGMP compliance efforts and providing periodic reports to the FDA.

While the Company has taken extensive measures intended to enhance its manufacturing processes and controls, the Company notes that, although improvements are required, it believes that progress has been made.

Under certain circumstances, the Company may deem it advisable to initiate product recalls. In the first half of 2001, the Company initiated voluntary recalls of batches of several human and animal health products. The cost of the recalls did not have a significant impact on the financial results of the Company.

As described in part in each of the note entitled Legal and Environmental Matters above, in Item 1, Legal Proceedings, of Part II of this report, and in Part I, Item 1, Business, in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, which is incorporated by reference herein, the pricing, marketing programs and arrangements and related business practices of the Company 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, the Office of Inspector General of the Department of Health and Human Services, the FDA, the FTC 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 c laims" 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 instituted and resolved unfavorably, could subject the Company to fines, penalties, and administrative remedies, including exclusion from government reimbursement programs. Any such result could have a material adverse effect on the Company, its financial position or its results of operations.

Liquidity and financial resources - six months ended June 30, 2001

Net income generated from operations continues to be the Company's major source of funds to finance working capital, shareholder dividends, common share repurchases and capital expenditures. Cash provided by operating activities was $1,051 million for the first six months of 2001, a decrease of $77 million from 2000. This change was due to the decrease in net income, as well as the timing of receipts and disbursements.

Cash was also used in the first six months to fund capital expenditures of $301 million. The Company anticipates that capital expenditures will exceed $750 million in 2001.

In the first six months of 2001, cash was used to repurchase shares for $34 million. In February 2000, the Board of Directors authorized the repurchase of $1.5 billion of the Company's common shares. As of June 30, 2001, this program was approximately 36 percent complete. The Company suspended its repurchase activity in the first quarter and intends to restart that program when it deems it prudent to do so. Cash was also used to pay shareholder dividends of $441 million in the first six months of 2001. In April 2001, the Board of Directors increased the quarterly dividend by 14 percent to $.16 from $.14 per common share.

The Company's liquidity and financial resources continue to be sufficient to meet its operating needs.

Recently Issued Accounting Standards

In July 2001, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 141, "Business Combinations" and SFAS No. 142, "Goodwill and Other Intangible Assets". SFAS No. 141 will require all business combinations initiated after June 30, 2001 to be accounted for using the purchase method of accounting, thereby eliminating the pooling-of-interests method. SFAS No. 142 will eliminate the amortization of goodwill after January 1, 2002 and will require periodic testing of goodwill for impairment. If goodwill is deemed impaired, it will be written down to its estimated fair value. The impact of adoption of SFAS No. 142 will not be material to the Company's Consolidated Financial Statements.

Cautionary Factors That May Affect Future Results

Management's discussion and analysis set forth above contains certain forward-looking statements, including statements regarding the Company's financial position and results of operations. These forward-looking statements are based on current expectations. Certain factors have been identified by the Company in Item 1 of the Company's December 31, 2000, Form 10-K filed with the Securities and Exchange Commission, and under Additional Factors Influencing Operations above, which could cause the Company's actual results to differ materially from expected and historical results. Item 1 from the Form 10-K is incorporated by reference herein.

Item 3. Market Risk Disclosures

As discussed in the 2000 Annual Report to Shareholders, the Company's exposure to market risk from changes in foreign currency exchange rates and interest rates, in general, is not material.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, as amended by the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2001, is incorporated by reference.

The Company is a party to an arbitration commenced in August 2001 by Biogen, Inc. relating to Biogen's claims that the Company owes U.S. alpha interferon royalty payments to Biogen for a period of time that the Company does not believe such royalties are owed, and to preempt future royalty disputes. Biogen's claims relate to the Company's sale of INTRON A and PEG-INTRON. The Company believes that Biogen's claims are without merit and will defend itself vigorously. However, as with any arbitration, there can be no assurance that the Company will prevail.

On August 9, 2001, the Prescription Access Litigation (PAL) project, a Boston-based group formed in 2001 to litigate against drug companies, issued a press release stating that PAL members filed a lawsuit in New Jersey state court against the Company. As of August 10, 2001 (the last business day before filing this report), the Company had not been served with a complaint in this case. According to the press release, the suit, which PAL purports to be a class action, alleges, among other things, that the Company's direct-to-consumer advertising falsely depicts the benefits of CLARITIN in violation of the New Jersey Consumer Fraud Act. Based on the reports it has received, the Company believes that the claims are without merit and will defend itself vigorously. However, as with any litigation, there can be no assurance that the Company will prevail.

Reference is made to the twelfth paragraph of Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, relating to an investigation commenced by the Federal Trade Commission (FTC) in March 1996 into whether the Company, along with other pharmaceutical companies, conspired to fix prescription drug prices. In June 2001, the Company was informed that the FTC had closed this investigation without any charges being brought.

Reference is made to the fifteenth paragraph of Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, as amended by the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2001, relating to CLARITIN patent litigation. Ranbaxy Pharmaceuticals, Inc., Taro Pharmaceuticals USA, Inc. and Genpharm Incorporated notified the Company that each had submitted an ANDA to the FDA seeking to market certain generic forms of CLARITIN in the United States before the expiration of certain of the Company's patents. In each case, the Company has filed suit in federal court seeking a ruling that the applicable ANDA submission and proposed marketing of a generic product constitute willful infringement of the Company's patent and that the challenge to the patent is without merit. The Company believes that it should prevail in these suits. However, as with any litigation, there can be no assurance that the Compa ny will prevail.

Reference is made to the sixteenth paragraph of Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, relating to litigation filed against the Company by Hoffmann-La Roche Inc. (Roche) in the United States and Europe concerning Roche's patents on certain pegylated interferons. In August 2001, the Company and Roche entered into a licensing agreement that settles all patent disputes relative to the two companies' respective peginterferon products. The agreement provides for each company to manufacture and market worldwide its separate peginterferon products free from liability for infringement under the other's existing patent rights. Under the agreement, the Company and Roche will seek court dismissal of all patent litigation in the United States and Europe involving the two companies' respective peginterferon products.

Reference is made to the second paragraph of Item I, Legal Proceedings, of Part II of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2001, relating to alleged class action suits filed on behalf of direct and indirect purchasers of K-DUR against the Company, Upsher-Smith and Lederle. Those alleged class actions were filed in federal and state courts. These suits all allege essentially the same facts and claim violations of federal and state antitrust laws, as well as other state statutory and/or common law causes of action. The Company believes that it has substantial defenses and intends to defend itself vigorously.

Reference is made to the fourth paragraph of Item I, Legal Proceedings, of Part II of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2001, relating to lawsuits against the Company (as nominal defendant) and certain officers, directors and a former director seeking damages on behalf of the Company including disgorgement of trading profits made by defendants allegedly on the basis of material inside information. Two lawsuits were filed in the United States District Court for the District of New Jersey and two lawsuits were filed in New Jersey state court. One of the federal court lawsuits also includes allegations relating the investigations by the U.S. Attorney's Offices for the Eastern District of Pennsylvania and the District of Massachusetts (both of which are described in Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000), the FTC's administrative proceeding against th e Company (described in Item I, Legal Proceedings, of Part II of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2001) and the lawsuit by the State of Texas against Warrick (described in Item 3, Legal Proceedings, of Part I of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2000).

 

Item 6. Exhibits and Reports on Form 8-K

a) Exhibits - The following Exhibits are filed with this document:

Exhibit Number

 


Description

15

-

Awareness letter

99(a)

-

Press Release dated February 15, 2001 - Schering-Plough Reports on Manufacturing Issues and FDA Inspections of U.S. Facilities, comments on Earnings Impact

99(b)

-

Press Release dated April 17, 2001 - Schering-Plough Reports Sales, Earnings for 2001 First Quarter

99(c)

-

Press Release dated April 24, 2001 - Schering-Plough Annual Meeting Highlights Worldwide Performance, Commitment to Resolving Manufacturing Issues

99(d)

-

Press Release dated June 22, 2001 - Schering-Plough Provides Update on Manufacturing Issues and FDA Inspections of U.S. Manufacturing Facilities

99(e)

 

Press Release dated June 27, 2001 - Schering-Plough Announces Cesan Resignation

99(f)

-

Press Release dated June 28, 2001 - Schering-Plough Reviews Pharmaceutical Research and Business Progress

99(g)

-

Press Release dated June 28, 2001 - Schering-Plough Reports Expected 2001 Second Quarter Earnings Per Share

99(h)

-

Press Release dated July 25, 2001 - Schering-Plough Reports Sales, Earnings for 2001 Second Quarter, First Half

  1. Reports on Form 8-K:

No report was filed during the three months ended June 30, 2001.

 

SIGNATURE(S)

 

 

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 thereunto duly authorized.

 

Schering-Plough Corporation

 

(Registrant)

   

Date    August 13, 2001

/s/Thomas H. Kelly

 

Thomas H. Kelly
Vice President and Controller

 

(Duly Authorized Officer and Chief Accounting Officer)

EX-15 3 exhibit15.htm EXHIBIT 15 Exhibit 15

Exhibit 15

August 13, 2001

To the Shareholders and Board of Directors of
Schering-Plough Corporation:

We have made a review, in accordance with standards established by the American Institute of Certified Public Accountants, of the unaudited interim financial information of Schering-Plough Corporation and subsidiaries for the periods ended June 30, 2001 and 2000, as indicated in our report dated August 13, 2001; because we did not perform an audit, we expressed no opinion on that information.

We are aware that our report referred to above, which is included in your Quarterly Report on Form 10-Q for the quarter ended June 30, 2001, is incorporated by reference in Registration Statements No. 2-83963, No. 33-19013, No. 33-50606, No. 333-30331 and No. 333-87077 on Form S-8, Registration Statement No. 333-853 on Form S-3, Post Effective Amendment No. 1 to Registration Statement No. 2-84723 on Form S-8, Post Effective Amendment No. 1 to Registration Statement No. 2-80012 on Form S-3, Post Effective Amendment No. 1 to Registration Statement No. 2-77740 on Form S-3 and Registration Statements No. 333-12909 and No. 333-30355 on Form S-3.

We also are aware that the aforementioned report, pursuant to Rule 436(c) under the Securities Act of 1933, is not considered a part of the Registration Statement prepared or certified by an accountant or a report prepared or certified by an accountant within the meaning of Sections 7 and 11 of that Act.

 

/s/Deloitte & Touche LLP

Parsippany, New Jersey

EX-99 4 exhibit99a.htm exhibit99a

Exhibit 99(a)

SCHERING-PLOUGH REPORTS ON MANUFACTURING ISSUES AND FDA INSPECTIONS
OF U.S. FACILITIES, COMMENTS ON EARNINGS IMPACT

KENILWORTH, N.J., Feb. 15, 2001 - Schering-Plough Corporation (NYSE: SGP) today reported that manufacturing process and control issues have led to reduced sales of certain products in the U.S. marketplace, with the result that first quarter and full-year 2001 sales and earnings will be lower than expected.

The company said the U.S. Food and Drug Administration (FDA) has been conducting inspections of the company's manufacturing facilities in New Jersey and Puerto Rico, and has issued reports citing deficiencies concerning compliance with current Good Manufacturing Practices (GMPs), primarily relating to production processes, controls and procedures.

Schering-Plough is confident that all prescription and OTC products currently in the marketplace are safe and effective, and that the needs of patients will be met.

"Our highest priority is - and always has been - the well-being of patients who use our products," said Richard Jay Kogan, chairman and chief executive officer. "I am taking full responsibility for resolving these matters in a timely manner and securing FDA's confidence in the quality and reliability of our manufacturing systems and controls. The management of this company is committed to accomplishing this and putting Schering-Plough back on the solid growth track that has been our hallmark."

Schering-Plough anticipates that first quarter 2001 diluted earnings per share will be lower by as much as 15 percent versus the 42 cents per share reported for the same period last year. Some factors affecting first quarter results also are expected to negatively affect earnings for the full year 2001, although the extent of this impact will depend upon the timing and nature of a resolution of the manufacturing issues. The company has not previously made an earnings projection for 2001.

Schering-Plough said among the issues affecting its ability to manufacture and ship certain pharmaceutical products has been the temporary interruption of some production lines to install system upgrades and further enhance compliance, and other technical production and equipment qualification issues.

After the company experienced manufacturing problems in the fall of 1999 involving aerosol inhaler products, Schering-Plough undertook a broad review of manufacturing systems and procedures with the help of outside consultants. From this, Schering-Plough developed a GMP action plan applicable to all manufacturing sites regulated by FDA. The company had designed and was implementing improvements under that plan when FDA initiated the recent general GMP inspections of Schering-Plough's New Jersey and Puerto Rico manufacturing facilities. While Schering-Plough has taken extensive measures intended to enhance its manufacturing processes and controls, the company notes that FDA's inspection reports and its own internal reviews indicate that improvements are required.

As part of its effort to improve manufacturing and quality-control functions, the company has committed to spend more than $50 million in new equipment, process and system improvements. In addition, the company has increased the number of personnel dedicated to quality control and compliance. By year-end 2001, the company will have increased the number of authorized quality-related positions at its FDA-regulated sites by 30 percent since 1999. The company has also initiated major organizational changes in its manufacturing and quality control operations, appointing a new senior vice president of technical operations and creating a quality unit headed by a new senior vice president. In addition, new senior managers in manufacturing have been brought in from outside the company.

Schering-Plough also reported that FDA has advised the company that GMP deficiencies cited in facility inspection reports must be resolved prior to granting approval of the company's pending New Drug Application (NDA) for CLARINEX™ (desloratadine) Tablets. In response to a Jan. 19, 2001 "approvable" letter for CLARINEX, Schering-Plough has submitted revised product labeling as requested by FDA and there are no outstanding scientific or clinical issues that would affect approval of the product. Schering-Plough said it is ready to launch CLARINEX into the U.S. market upon approval. The company noted that it continues to market CLARITINÒ (loratadine), the nation's largest-selling nonsedating antihistamine.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements concerning the expected impact on the company's first-quarter and full-year 2001 sales and earnings from the manufacturing process and control issues described herein, the company's efforts going forward to resolve the GMP issues identified by FDA at certain of the company's manufacturing facilities, remedies FDA may seek with respect to those issues, the expected need for and cost of any additional remedial actions the company may take, and the pendency of the company's NDA for CLARINEX which remains subject to FDA approval. The reader of this release should understand that the resolution of these issues with FDA, as well as the potential impact of those issues on the company's first-quarter and full-year 2001 sales and earnings, are subject to substantial risks and uncertainties. Many factors could cause actual results to differ materially from the company's forward-looking statements, including that t he timing, scope and duration of a resolution of the manufacturing issues will depend on the ability of the company to assure FDA of the quality and reliability of its manufacturing systems and controls, and the extent of remedial and prospective obligations undertaken by the company. Other risk factors include that the FDA approval process is uncertain and can cause delays in approval of new products, and that any failure to meet good manufacturing practices established by FDA can result in delays in the release of products, seizure or recall of products, suspension or revocation of the authority necessary for the production and sale of products, fines and other civil or criminal sanctions. In addition to the risks and uncertainties relating to the company's manufacturing deficiencies, the company's forward-looking statements relating to, among other things, sales and earnings, may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, trade buying patterns, patent positions and litigation, among other things. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 1999 annual report on Form 10-K.

Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 5 exhibit99b.htm Earnings for 1st Quarter 2001

Exhibit 99(b)

SCHERING-PLOUGH REPORTS SALES, EARNINGS
FOR 2001 FIRST QUARTER

2001 First Quarter Diluted Earnings Per Share Down 10% to 38 cents

KENILWORTH, N.J., April 17, 2001 - Schering-Plough Corporation (NYSE: SGP) today reported that first quarter 2001 diluted earnings per share declined 10 percent to 38 cents on net income of $564 million versus 42 cents per share on net income of $628 million in 2000. First quarter 2001 sales of $2.3 billion were 3 percent lower than last year's $2.4 billion. Excluding exchange, first quarter sales decreased 1 percent.

The company had projected in a Feb. 15, 2001, press release reporting on manufacturing process and control issues and facility inspections by the U.S. Food and Drug Administration (FDA) that first quarter sales and earnings would be lower than expected. In the release, the company stated that first quarter 2001 diluted earnings per share would be lower by as much as 15 percent versus the prior year's first quarter.

"Schering-Plough is moving aggressively and deliberately to resolve the manufacturing issues that affected our performance in the first quarter," said Richard Jay Kogan, chairman and chief executive officer. "We have responded to the FDA's facility inspection reports, continue to work on completing our Good Manufacturing Practices (GMP) initiatives, have undertaken major organizational changes in manufacturing and control operations, and are developing a comprehensive plan that will incorporate the initiatives already begun and establish systems for sustaining GMP compliance throughout the organization. Further, we have retained consultants to assist in designing, implementing and auditing these improvements," he said.

In the 2001 first quarter, worldwide pharmaceutical sales totaled $1.9 billion, down 3 percent (down 1 percent when foreign exchange is excluded). Lower sales for the first quarter 2001 were recorded in all of the major therapeutic categories except anti-infective/anticancer, where higher sales were achieved. Worldwide sales of the CLARITIN (loratadine) nonsedating antihistamine line, the world's No. 1 antihistamine, grew 8 percent to $718 million. First quarter 2001 worldwide sales of NASONEX (mometasone furoate monohydrate) Nasal Spray, a once-daily nasal-inhaled steroid for allergies, increased 13 percent to $92 million. Combined sales of the anti-infective/anticancer agent INTRON A (interferon alfa-2b); PEG-INTRON (peginterferon alfa-2b), a longer-acting form of INTRON A; and REBETRON Combination Therapy containing INTRON A and REBETOL (ribavirin, USP) Capsules, totaled $326 million, down 3 percent versus the comparable year-ago period.

Also contributing to first quarter worldwide sales were TEMODAR (temozolomide), for treating certain types of brain tumors, with sales of $43 million; INTEGRILIN (eptifibatide) Injection, a glycoprotein platelet aggregation inhibitor for the treatment of patients with acute coronary syndromes, up 38 percent to $38 million; and REMICADE (infliximab), for the treatment of rheumatoid arthritis and Crohn's disease, with higher sales of $27 million.

U.S. pharmaceutical sales in the 2001 first quarter totaled $1.2 billion, down 8 percent versus the 2000 period. In allergy/respiratory, first quarter 2001 U.S. sales of the CLARITIN line were $610 million, up 11 percent, with growth benefiting from an expanding antihistamine market. Domestic sales of NASONEX increased 2 percent to $63 million in the first quarter 2001. Sales of the VANCERIL (beclomethasone dipropionate) line of orally inhaled steroids for asthma and of VANCENASE (beclomethasone dipropionate) Nasal Spray, the company's predecessor nasal-inhaled steroid for allergies, were down sharply due to manufacturing issues. In anti-infective/anticancer, U.S. combined sales of INTRON A, PEG-INTRON and REBETRON Combination Therapy totaled $187 million, down 4 percent, reflecting a slowing in the hepatitis C market attributable to the anticipated approval of newer therapies. Sales of dermatologicals, including LOTRISONE (clotrimazole and betamethasone dipropionate), a topical antifungal/anti - -inflammatory, were down due to changes in the timing of trade buying. Reflecting increased utilization, first quarter domestic sales of TEMODAR rose to $26 million and, in cardiovasculars, sales of INTEGRILIN increased 30 percent to $34 million.

International pharmaceutical sales in the 2001 first quarter increased 4 percent (up 11 percent when foreign exchange is excluded) to $783 million. International sales were led by, in allergy/respiratory, NASONEX, with sales of $29 million, up 52 percent; and, in anti-infective/anticancer, TEMODAR, with sales of $17 million, up 58 percent, and REMICADE. International combined sales of INTRON A (including combination therapy with REBETOL and PEG-INTRON) totaled $139 million, down 2 percent versus the comparable 2000 period.

First quarter sales of animal health products were down 2 percent (up 2 percent when foreign exchange is excluded). Sales of Schering-Plough's foot care and sun care product categories were down versus the comparable 2000 period. Sales of over-the-counter (OTC) products were up versus the comparable 2000 period.

"Schering-Plough remains a strong and highly effective organization, as reflected in the success of our marketing programs and advances in our research pipeline," added Kogan. "We have a proven ability to overcome challenges and achieve our objectives, and we look forward to growing our business and rewarding the confidence of our shareholders."

DISCLOSURE NOTICE: In addition to historical information, this press release includes certain "forward-looking" statements relating to the company's business prospects and the expected impact on the company of the manufacturing process and control issues described in more detail in the company's Feb. 15, 2001, press release. The reader of this release should understand that the resolution of those manufacturing issues, as well as the potential impact of those issues on the company's full-year 2001 sales and earnings, are subject to substantial risks and uncertainties, and that those issues could cause actual results to differ materially from the company's forward-looking statements. For a full description of those risks and uncertainties, the reader of this release is encouraged to read the Disclosure Notice in the company's Feb. 15, 2001, press release, which is available on the company's Web site at www.schering-plough.com. In addition to the risks and uncertainties relating to the company's manufacturi ng deficiencies, the company's forward-looking statements relating to, among other things, business prospects and research pipeline may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, trade buying patterns, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

SCHERING-PLOUGH CORPORATION
Report for the quarter ended March 31 (unaudited):

(Amounts in millions, except per share figures)

 

 

First Quarter

% Change

 

 

2001

 

2000

 

 

 

 

 

 

 

Net Sales

 

$

 2,319

 

$

2,389

(3)

 

 

 

 

 

 

Costs and Expenses:

 

 

 

 

 

 

Cost of Sales

 

470

 

457

3

 

Selling, General

 

 

 

 

 

 

 

and Administrative

 

 

852

 

841

1

 

Research and Development

 

289

 

290

--

 

Other, Net

 

(25)

 

(25)

--

 

 

 

 

 

 

 

1,586 

 

1,563

1

 

 

 

 

 

 

Income Before Income Taxes

 

733

 

826

(11)

Income Taxes

 

169

 

198

(15)

 

 

 

 

 

 

Net Income

 

$

564

 

$

628

(10)

 

 

 

 

 

 

Diluted Earnings Per Common Share

 

$

 0.38

 

$

0.42

(10)

 

 

 

 

 

 

Effective Tax Rate

 

 23.0%

 

24.0%

 

 

 

 

 

 

 

Average Common Shares

 

 

 

 

 

Outstanding - Diluted

 

1,472

 

1,479

 

 

 

Actual Number of Common Shares

 

1,463 

 

1,464

 

 

Outstanding at March 31

Excluding exchange, diluted earnings per share for the first quarter decreased 5 percent.

 

Net Sales by Major Product:
(Dollars in millions)

 

 

First Quarter

 

 

2001

 

2000

 

%

 

 

 

 

 

 

 

ALLERGY & RESPIRATORY

 

$

927

 

$

956

 

(3)

           Claritin

 

 

718

 

 

665

 

8

           Nasonex

 

 

92

 

 

81

 

13

           Vancenase

 

 

3

 

 

56

 

(94)

           Proventil

 

 

40

 

 

44

 

(9)

           Vanceril

 

 

11

 

 

37

 

(69)

 

 

 

 

 

 

 

 

 

ANTI-INFECTIVE & ANTICANCER

 

525

 

492

 

7

           Eulexin

 

29

 

37

 

(21)

           Intron A/Rebetron/PEG

 

326

 

336

 

(3)

           Remicade

 

27

 

8

 

N/M

           Temodar

 

43

 

21

 

N/M

 

 

 

 

 

 

 

CARDIOVASCULARS

 

164

 

183

 

(11)

           Imdur

 

21

 

35

 

(41)

           Integrilin

 

38

 

28

 

38

           K-Dur

 

74

 

78

 

(5)

           Nitro-Dur

 

26

 

35

 

(26)

 

 

 

 

 

 

 

DERMATOLOGICALS

 

142

 

172

 

(17)

           Elocon

 

53

 

44

 

19

           Lotrisone

 

12

 

50

 

(75)

 

 

 

 

 

 

 

OTHER PHARMACEUTICALS

 

191

 

209

 

(9)

 

 

 

 

WORLDWIDE PHARMACEUTICALS

 

 1,949

 

2,012

 

(3)

 

 

 

 

 

 

 

ANIMAL HEALTH

 

153

 

156

 

(2)

FOOT CARE

 

79

 

90

 

(13)

OTC

 

56

 

43

 

31

SUN CARE

 

82

 

88

 

(6)

 

 

 

CONSOLIDATED NET SALES

 

$

2,319

 

$

2,389

 

(3)

N/M - not a meaningful percentage

NOTE: Additional information about U.S. and international sales for specific products is available by calling the company or visiting the corporate Web site at www.schering-plough.com.

 

EX-99 6 exhibit99c.htm Exhibit 99(c)

Exhibit 99(c)

 

SCHERING-PLOUGH ANNUAL MEETING
HIGHLIGHTS WORLDWIDE PERFORMANCE,
COMMITMENT TO RESOLVING MANUFACTURING ISSUES

KENILWORTH, N.J., April 24, 2001 - Schering-Plough Corporation (NYSE: SGP) is moving deliberately and methodically to address manufacturing issues and improve quality systems on a global basis, the company reported at its annual meeting with shareholders here today.

In his remarks to shareholders, Richard Jay Kogan, chairman and chief executive officer, said the company has given itself three benchmarks in addressing these issues: first, to secure the confidence of the U.S. Food and Drug Administration (FDA) concerning its manufacturing systems and controls; second, to assure that Schering-Plough has a culture and a system that will sustain compliance throughout the organization; and third, to reward shareholders with results.

"Schering-Plough is a strong company, with a proud history and a promising future," Kogan told shareholders. "From 1995 through last year, we nearly doubled sales, more than doubled earnings per share and more than doubled our annual investments in research and development," he continued.

Kogan today also reported that the company's Board of Directors authorized a 14 percent increase in the quarterly dividend, from 14 cents to 16 cents per share, marking the 18th increase in the dividend since 1986. Kogan said the Board's action "reflects our confidence in the financial strength of the company and our commitment to reward shareholders."

While 2000 was another successful year for Schering-Plough, Kogan observed that this is not a "normal time" for the company, acknowledging that "now we've run into some difficulties." Referring to the manufacturing issues, he said, "We are working through them and I am confident we will come out of this with our fundamental strengths intact, wiser and as competitive as ever."

Schering-Plough on Feb. 15, 2001, reported that the FDA had conducted inspections of the company's manufacturing facilities in New Jersey and Puerto Rico, and had issued reports citing deficiencies concerning compliance with current Good Manufacturing Practices (GMPs), primarily relating to production processes, controls and procedures. Schering-Plough also reported that FDA has advised the company that GMP deficiencies cited in facility inspection reports must be resolved prior to granting approval of the company's pending New Drug Application (NDA) for CLARINEX™ (desloratadine) Tablets, a new nonsedating antihistamine.

"CLARINEX has been judged approvable by FDA, and there are no other scientific or clinical issues remaining. So as soon as we can satisfy FDA on the manufacturing issues, we expect to see the product approved and launched rapidly into the U.S. market. We are already marketing the product in several European countries," Kogan said.

On an immediate basis, the company is addressing the issues cited in the FDA's inspection reports and dedicating the appropriate resources, including personnel, equipment and training.

"We are working to complete the GMP initiatives begun in 1999 and are in the process of completing a new comprehensive GMP work plan," Kogan told the audience. "This plan takes a broad, systemic approach that will encompass all FDA-regulated manufacturing sites and address six key areas: quality assurance, facilities and equipment, materials management, production, laboratories, and packaging and labeling," he said.

"We are increasing the number of people dedicated to quality control and compliance," Kogan noted. "From 1999 to the end of this year, we expect to have increased the number of authorized quality-related positions at our FDA-regulated sites by 30 percent. I believe we have the right organizational structure and the right people to assure and sustain a culture of compliance to meet FDA expectations on a systematic, company-wide basis," he added.

"I am determined to put Schering-Plough back on a solid growth track," Kogan told shareholders. "I know this is what you expect from your company's management, and that is what we intend to deliver."

In reviewing the company's 2000 performance, Kogan said Schering-Plough's progress was marked by several major accomplishments:

  • Sales for the year reached $9.8 billion, up 8 percent, and earnings per share rose 14 percent to $1.64.
  • Research and development programs made important progress, as evidenced by the five discovery compounds that were recommended to go into clinical development in 2000.
  • In U.S. and leading world markets, the company received eight marketing approvals for major products or indications and filed 14 major regulatory applications.
  • Ezetimibe, a novel cholesterol absorption inhibitor and product of internal research efforts, is in development for U.S. marketing through a partnership with Merck & Co., Inc. Ezetimibe development is focused on its use in a once-daily fixed-combination tablet with Zocor® (simvastatin), Merck's cholesterol-management drug; as a once-daily monotherapy; and in co-administration with statins. Results of Phase III monotherapy and co-administration studies are expected to be presented at major medical meetings this year.
  • PEG-INTRON™, a longer-acting form of INTRON® A alpha interferon, has been launched in the United States and the European Union (EU) for the treatment of hepatitis C.
  • PEG-INTRON and REBETOL® combination therapy, expected to become a new standard of care for hepatitis C, was approved in the EU in March 2001 and has been granted priority review status by FDA in the United States.


"Schering-Plough has a long history of discovering and developing important products," Kogan reminded the audience. "The company has grown and our shareholders have prospered because Schering-Plough has steadily brought to market innovative drugs that address unmet medical needs and represent real therapeutic advances," he said.

"Schering-Plough has not lost sight of that objective. Even as we direct resources to address the various manufacturing issues, our scientists are conducting world-class research, and our marketing and sales teams are as fully engaged and effective as ever," Kogan said.

Kogan concluded his remarks by saying, "Schering-Plough has proven time and again that it is a capable, "can do" company. We are putting good plans in place; we know how to get things done; and we are doing them. We have the opportunity to come out of this difficult period as a stronger company, more competitive and better able to reward you -our shareholders."

In other business at the annual meeting, shareholders elected Kogan, David H. Komansky, Eugene R. McGrath, Donald L. Miller and Richard de J. Osborne for three-year terms on the Board of Directors. Shareholders also ratified the designation of Deloitte & Touche LLP as auditors for 2001. A shareholder proposal concerning pharmaceutical pricing was not adopted.

DISCLOSURE NOTICE: In addition to historical information, this press release includes certain "forward-looking" statements relating to the company's business prospects and the expected impact on the company of the manufacturing process and control issues described in more detail in the company's Feb. 15, 2001, press release. The reader of this release should understand that the resolution of those manufacturing issues, as well as the potential impact of those issues on the company's full-year 2001 sales and earnings, are subject to substantial risks and uncertainties, and that those issues could cause actual results to differ materially from the company's forward-looking statements. For a full description of those risks and uncertainties, the reader of this release is encouraged to read the Disclosure Notice in the company's Feb. 15, 2001, press release, which is available on the company's Web site at www.schering-plough.com. In addition to the risks and uncertainties relating to the company's manufacturing deficiencies, the company's forward-looking statements relating to, among other things, business prospects and research pipeline, may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, trade buying patterns, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K.

Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 7 exhibit99d.htm SCHERING-PLOUGH PROVIDES UPDATE ON MANUFACTURING ISSUES

Exhibit 99(d)

SCHERING-PLOUGH PROVIDES UPDATE ON MANUFACTURING ISSUES
AND FDA INSPECTIONS OF U.S. MANUFACTURING FACILITIES

KENILWORTH, N.J., June 22, 2001 -Schering-Plough Corporation (NYSE: SGP) today reported that the U.S. Food and Drug Administration (FDA) has completed inspections conducted during May and June at the company's manufacturing facilities in Kenilworth and Union, New Jersey, and Las Piedras and Manati, Puerto Rico, and has issued new inspection reports (Form FDA-483), which cited some continuing and some additional deficiencies concerning compliance with current Good Manufacturing Practices (cGMP). Depending on when the Form FDA-483 was received, Schering-Plough has either responded to or is in the process of responding to these observations and is continuing to discuss these matters with FDA. The company cannot predict the outcome of these issues or the timing of any resolution.

These most recent FDA inspections follow general cGMP inspections conducted at the company's New Jersey and Puerto Rico facilities in late 2000 and early 2001. As reported by Schering-Plough on February 15, 2001, FDA had conducted inspections of these facilities and had issued

Form FDA-483s citing cGMP deficiencies, primarily relating to production processes, controls and procedures. In late 2000 and early 2001, the company submitted written responses to FDA's inspection reports.

In the months since FDA's initial inspections of the New Jersey and Puerto Rico facilities, Schering-Plough believes it has moved aggressively and deliberately in an effort to resolve these manufacturing issues. The company also believes that progress has been made, but recognizes that additional work remains to be done.

On May 1, 2001, Schering-Plough submitted to FDA a comprehensive cGMP Work Plan designed to take a broad, systemic approach to all aspects of manufacturing and serve as a blueprint for quality and compliance initiatives.

Also on May 1 and continuing into June, FDA conducted reinspections of the company's New Jersey and Puerto Rico manufacturing facilities, and subsequently issued new inspection reports. Schering-Plough has either responded to or is in the process of responding to these observations.

In its response letter to FDA on one site's observations, the company emphasized that it takes each of the observations very seriously. Schering-Plough noted in its letter that the Form FDA-483 observations are not meant to reflect (because that is not their purpose):

    • The major changes that have been made in the entire Schering-Plough corporate structure;
    • The substantial resources devoted to keeping the company's cGMP commitments to FDA;
    • The large amount of cGMP work being undertaken; and
    • The deep resolve of the company to continue this progress until its commitments are
      fully met.


Schering-Plough believes that the manufacturing issues identified by FDA will be addressed in the cGMP Work Plan now being implemented. The plan encompasses all FDA-regulated manufacturing sites, consolidates all ongoing cGMP actions and addresses six key areas: quality assurance, facilities and equipment, materials management, production, laboratories, and packaging and labeling. The plan covers all product lines and takes a uniform approach to quality, production and maintenance at all FDA-regulated manufacturing sites.

Under this plan, Schering-Plough has undertaken major structural and organizational changes.
A new Worldwide Quality Operations unit has been formed and given the authority and independence to address quality issues throughout the company. This unit is responsible for all quality-related issues, including technology transfer, validation, investigation, change authorization policies and other quality-related procedures, protocols and documentation. The Quality function at all FDA-regulated sites reports directly to this new unit.

In order to address its manufacturing issues, the company is making extensive improvements to its operations, including:

    • In quality control and production, some 500 people will be added to strengthen these areas. The company is about half-way to this goal, and has recruited a number of senior level executives from outside the company;
    • In the area of equipment requalification and revalidation, the company has recruited highly qualified executives, scientists and consultants to improve revalidation studies and set up a validation review board to oversee the requalification of manufacturing equipment and the revalidation of processes and support systems;
    • In certain production areas where appropriate, equipment and manufacturing lines are being upgraded, notably in aerosol production and tablet manufacturing;
    • In global quality control, improved electronic document management and laboratory information systems are being installed; and
    • A GMP Review Board has been formed, which includes three prominent former FDA officials. This Board is overseeing progress on the company's cGMP compliance efforts and providing periodic reports to FDA.


DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating to the company's plans and activities designed to resolve cGMP deficiencies identified by FDA in its inspections of the company's New Jersey and Puerto Rico manufacturing facilities. The resolution of the issues with FDA is subject to substantial risks and uncertainties. Many factors could cause actual results to differ materially from the company's forward-looking statements, including that the timing, scope and duration of a resolution of the manufacturing and cGMP issues will depend on the ability of the company to assure FDA of the quality and reliability of its manufacturing systems and controls, and the extent of remedial and prospective obligations undertaken by the company. Other risk factors include that any failure to meet cGMP can result in delays in the release of products, seizure or recall of products, suspension or revocation of the authority necessary for the production and sale of products, fines and other civil or criminal sanctions. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K and subsequent quarterly report on Form 10-Q.

Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 8 exhibit99e.htm Exhibit 99(e)

Exhibit 99(e)

SCHERING-PLOUGH ANNOUNCES CESAN RESIGNATION

KENILWORTH, N.J., June 27, 2001 -Richard Jay Kogan, chairman and chief executive officer of Schering-Plough Corporation (NYSE: SGP), today reported that Raul E. Cesan has resigned as president and chief operating officer, effective July 15, 2001. Cesan also resigned from Schering-Plough's Board of Directors.

"We understand his decision and respect it," said Kogan. "We are all grateful to Raul for his many contributions to Schering-Plough. His many accomplishments are not overshadowed by the company's current challenges.

"As I have said publicly, I am committed to delivering on the company's quality and compliance objectives and getting Schering-Plough back on its growth track.

"Our priorities and our objectives will not be interrupted by this change. Senior management will absorb his responsibilities," concluded Kogan.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 9 exhibit99f.htm Exhibit 99(f)

Exhibit 99(f)

SCHERING-PLOUGH REVIEWS
PHARMACEUTICAL RESEARCH AND BUSINESS PROGRESS

NEW YORK, N.Y., June 28, 2001 -Richard Jay Kogan, chairman and chief executive officer of Schering-Plough Corporation (NYSE: SGP), today reviewed highlights of the company's pharmaceutical business and research progress, and discussed efforts to address ongoing manufacturing issues at a meeting with analysts and portfolio managers.

Also presenting at the meeting were Jonathan R. Spicehandler, M.D., president of Schering-Plough Research Institute, who spoke on ezetimibe, the company's cholesterol absorption inhibitor in development; Robert J. Spiegel, M.D., senior vice president, medical affairs and chief medical officer, who provided an overview of Schering-Plough's leadership role in discovering and developing new therapies for the treatment of hepatitis C; and Roch Doliveux, president, Schering-Plough International, who reviewed Schering-Plough's business opportunities in international pharmaceutical markets.

Commenting on the manufacturing issues, Kogan said the company is "engaged in a major effort to resolve these issues, meet the expectations of the Food and Drug Administration (FDA), and put in place the people, systems and equipment to assure sustained compliance." These manufacturing process and control issues were previously reported by the company on February 15 and updated in a June 22 press release.

In reviewing the company's business operations and research activities, Kogan said that pharmaceuticals make up 85 percent of total sales, with the largest product groups being allergy/respiratory, anti-infective/anticancer and cardiovascular. The company's animal health and consumer product lines represent about 15 percent of total sales. While the U.S. market has recently been the source of most of the company's growth, Kogan said, "Now we are entering a period when our major international markets should generate significantly higher sales."

Schering-Plough's largest therapeutic category is allergy/respiratory, led by the nonsedating antihistamine CLARITIN® (loratadine), the world's largest-selling antihistamine. Sales increased to $3 billion in 2000, reflecting growth in world allergy markets. Commenting on recent FDA and congressional hearings about proposals to take CLARITIN and other second-generation prescription antihistamines over-the-counter, Kogan said, "We believe CLARITIN should remain a prescription product. We think this is the best setting for the patient and for the health care system."

Kogan said the successor product is CLARINEX® (desloratadine), a new once-daily nonsedating antihistamine approved in 28 countries, including the European Union (EU). In addition to the tablet form, marketing applications have been filed for various line extensions. In the United States, approval of CLARINEX remains subject to a successful resolution of the manufacturing issues. Kogan noted that the FDA has designated CLARINEX as approvable; there are no other scientific or clinical issues remaining; "and we will launch it as soon as it's approved."

Schering-Plough has several other opportunities in the respiratory area. He cited one of two partnerships with Merck & Co., Inc., announced in May 2000. The respiratory partnership is working on developing a once-daily, fixed-combination tablet containing Schering-Plough's CLARITIN and Merck's Singulair® (montelukast sodium), a once-daily leukotriene receptor antagonist for asthma, for the treatment of allergic rhinitis. The combination therapy has the potential to compete in a U.S. allergy market valued at more than $5 billion.

Kogan also highlighted NASONEX® (mometasone furoate monohydrate), a potent,

once-daily nasal spray for allergies. Sold in 60 countries, NASONEX is the company's first nasal steroid to be marketed on a global basis. With worldwide sales up 60 percent in 2000 to $415 million, NASONEX has captured the No. 2 position in the world nasal-inhaled steroid market.

ASMANEX® (mometasone furoate), a next-generation inhaled steroid for asthma, also "would mark the first time we have a product in this therapeutic class to market on a worldwide basis." ASMANEX is approved in 11 countries and in April received UK approval, marking the first step in the EU mutual recognition procedure. In the United States, the FDA has designated ASMANEX as approvable. The company plans to launch the product on a global basis.

In the anti-infective/anticancer area, Kogan reviewed positive developments for the company's interferon franchise, including the anticancer/antiviral agent INTRON® A (interferon alfa-2b, recombinant); REBETRON Combination Therapy, containing REBETOL® (ribavirin) Capsules and INTRON A Injection; and PEG-INTRON™ (peginterferon alfa-2b), a longer-acting form of INTRON A and the world's first pegylated interferon on the market. "No other company has done more to develop and introduce new treatments for hepatitis C than Schering-Plough," observed Kogan.

Reviewing other products in the anti-infective/anticancer category, Kogan highlighted REMICADE® (infliximab), an anti-inflammatory marketed internationally for the treatment of Crohn's disease and rheumatoid arthritis, which has the potential to be a major factor in what may become a billion-dollar market in Europe; TEQUIN(gatifloxacin), a new broad-spectrum antibiotic for respiratory infections co-promoted in the United States with Bristol-Myers Squibb; TEMODAR® (temozolomide), an oral agent approved in the EU and United States for treating certain types of brain cancer; and CAELYX®, a long-circulating form of doxorubicin (a widely used cancer drug), approved to treat advanced ovarian cancer last fall in the EU and this year in Canada.

Kogan also reviewed research efforts in the anticancer area, including a farnesyl protein transferase (FPT) inhibitor in Phase II studies for treating various solid tumors. The FPT inhibitor is a member of a new class of "smart" targeted anticancer agents that inhibits a specific cancer cell pathway.

In cardiovasculars, he discussed INTEGRILIN® (eptifibatide), a platelet aggregation inhibitor for cardiovascular patients with certain acute coronary syndromes and those undergoing percutaneous coronary intervention. "In the United States, INTEGRILIN has the broadest labeling and has become the country's most widely used product in its class," he said. COR Therapeutics, Inc. and Schering-Plough are worldwide partners for INTEGRILIN.

"A great commercial opportunity in our late-stage pipeline is ezetimibe, a cholesterol absorption inhibitor and a product of Schering-Plough's research efforts," said Kogan. Ezetimibe forms the basis of the company's cholesterol-management partnership with Merck to develop and market in the United States the compound three ways: as a once-daily monotherapy; co-administered with other statins; and as a once-daily, fixed combination tablet with Zocor® (simvastatin), Merck's cholesterol-management medicine.

Kogan noted that the partnerships are owned 50/50 by Schering-Plough and Merck, with profits and costs shared equally, except for more generous early profit terms for Schering-Plough for ezetimibe monotherapy. Commenting on the partnership, Kogan said, "We are a year into this now, and I am very pleased with how these partnerships are working, with the excellent people involved, and the progress that has been achieved."

Kogan said that the company has been making good progress in its research programs. "In 2000, we received eight major approvals, filed 14 major regulatory applications, and recommended that five compounds advance from basic research to development," he said. "This year we expect to recommend six compounds. We are moving closer to achieving our goal of recommending 10 compounds advance into development annually." With 2000 R&D spending of $1.3 billion, Kogan projected that 2001 R&D expenditures would be around $1.4 billion.

Dr. Spicehandler presented a review of the medical attributes and development program for ezetimibe. Ezetimibe is a member of a new novel class of oral lipid-lowering agents that selectively inhibit cholesterol absorption in the intestine. Statins, such as Zocor, act primarily to inhibit the production of cholesterol in the liver.

Dr. Spicehandler reviewed previously reported results from a Phase III monotherapy study with ezetimibe and Phase II studies of ezetimibe co-administered with statins. Results of the studies showed that ezetimibe reduced low-density lipoprotein cholesterol (LDL-C) by about 18 percent as monotherapy and achieved a similar 18 percent additive effect when co-administered with statins. Dr. Spicehandler said co-administration of ezetimibe with a statin may have the potential to help more patients achieve their cholesterol goals.

Dr. Spiegel provided an overview of Schering-Plough's leadership role in discovering and developing new therapies for the treatment of hepatitis C, a serious disease affecting more than 11 million people in developed countries, including 4 million Americans, 5 million Europeans and 2 million Japanese.

Dr. Spiegel provided a historical look at treatment advances developed by Schering-Plough, beginning with the 1991 U.S. approval of INTRON A for chronic hepatitis C. He noted that in the last 10 years Schering-Plough has developed innovative therapies that have significantly improved clinical outcomes with each advance. He reviewed the clinical development of REBETRON Combination Therapy, which produces a three-fold increase in sustained response rates compared with INTRON A monotherapy, and the development of PEG-INTRON, which offers patients the convenience of once-weekly injections. He said PEG-INTRON/REBETOL combination therapy can raise the sustained viral response rate for all hepatitis C genotypes to 54 percent and, in particular, can significantly improve response rates in the poor prognosis genotype 1 patients. He noted that the PEG-INTRON/REBETOL combination therapy, approved in the EU and under priority review in the United States, represents the new standard of care for the treatment of hepatitis C.

Roch Doliveux discussed growth opportunities for Schering-Plough in international pharmaceutical markets, particularly in Europe and Japan. He noted that among the top 20 pharmaceutical companies, Schering-Plough is the second-fastest growing in the international marketplace and the fastest-growing company in Europe.

In Latin America, Schering-Plough is the market leader in key therapeutic areas, including allergy/respiratory, anti-infective/anticancer and dermatologicals, said Doliveux. In reviewing product sales in Europe, Doliveux said growth was being driven by INTRON A and REBETOL, REMICADE, TEMODAR, NASONEX and CLARINEX. Doliveux said CLARINEX has already become the leading nonsedating antihistamine in Germany. NASONEX is the leading nasal-inhaled steroid in Italy, France and Germany, and the fastest-growing product in its therapy class. In anti-infectives/anticancer, he said

PEG-INTRON/REBETOL combination therapy was launched in major European markets in the second quarter for the treatment of hepatitis C. He also noted that REMICADE has been launched in all major European markets for rheumatoid arthritis. Doliveux said that there is "significant potential for growth" in the European and Canadian markets as more patients obtain treatment for conditions such as rheumatoid arthritis, hepatitis C and brain cancer.

Doliveux said, "Schering-Plough is poised for aggressive growth in Japan," benefiting from increased market penetration for INTRON A, especially for treating hepatitis C, and anticipated major new product launches. He said the company filed an application in April in Japan for the combination use of INTRON A with REBETOL for hepatitis C, which has been granted priority review. Also in Japan, a marketing application was filed in January for CLARITIN for the treatment of chronic idiopathic urticaria.

Reviewing the company's manufacturing issues, Kogan summarized events since the February 15 announcement and as detailed in the June 22 press release. "We are working through our priorities, believe we are making progress, but there is still much to do," he said. Kogan reminded the audience of the powers of the FDA, particularly if it is not satisfied with the corrective actions the company has taken or proposed.

Kogan reported that more than $60 million has already been spent on quality-related and validation projects, primarily in New Jersey and Puerto Rico, and that the company has committed significant additional funds. He also said the manufacturing issues have affected a number of areas, including the company's current $1.5 billion share repurchase program. That program was suspended in February 2001 as "we believed it would be prudent to stop until these issues were clarified." He added, "It was 36 percent complete at the time and we will get back into the market when we believe it is appropriate."

In concluding his remarks on the state of the business, Kogan said, "I have outlined what I believe is an outstanding portfolio of current and future growth drivers for the company. We have a strong position in the U.S. market and the potential for significantly higher sales in international markets. We have also, through internal research and collaborative agreements, created opportunities for new franchises and substantial future growth."

A Webcast of this meeting in a live audio format with slides is available via the Schering-Plough corporate Web site, www.schering-plough.com. An audio replay of the meeting is available via the Schering-Plough corporate Web site starting at approximately 2 p.m. on June 28 through 5 p.m. on July 27.

DISCLOSURE STATEMENT: The information in this press release includes certain "forward-looking" statements relating to the company's business prospects and the expected impact on the company of the manufacturing process and control and current Good Manufacturing Practices (GMP) issues identified by the FDA, the company's efforts going forward to resolve those issues, remedies the FDA may seek with respect to those issues, the expected need for and cost of any additional remedial actions the company may take, and the pendency of the company's NDA for CLARINEX, which remains subject to FDA approval. The resolution of the issues with the FDA, as well as the potential impact of those issues on the company's second-quarter and full-year 2001 sales and earnings, are subject to substantial risks and uncertainties. Many factors could cause actual results to differ materially from the company's forward-looking statements, including that the timing, scope and duration of a resolution of the manufacturing process and co ntrol and GMP issues will depend on the ability of the company to assure FDA of the quality and reliability of its manufacturing systems and controls, and the extent of remedial and prospective obligations undertaken by the company. Other risk factors include that the FDA approval process is uncertain and can cause delays in approval of new products, and that any failure to meet GMPs can result in delays in the release of products, seizure or recall of products, suspension or revocation of the authority necessary for the production and sale of products, fines and other civil or criminal sanctions. In addition, the forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, generic competition, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, trade buying patterns, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K and subsequent quarterly report on Form 10-Q.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 10 exhibit99g.htm Exhibit 99(g)

Exhibit 99(g)

SCHERING-PLOUGH REPORTS EXPECTED
2001 SECOND QUARTER EARNINGS PER SHARE

NEW YORK, N.Y., June 28, 2001 -Richard Jay Kogan, chairman and chief executive officer of Schering-Plough Corporation (NYSE: SGP), today reported that earnings per share for the 2001 second quarter are expected to be 43 cents, which is flat compared with the 43 cents recorded in the 2000 period. Schering-Plough is scheduled to issue its full earnings report on the 2001 second quarter on July 25, 2001.

Commenting on earnings guidance, Kogan said that, "For now and the rest of 2001, we will be taking a quarter-by-quarter approach, providing periodic updates as the year progresses."

Earlier today and as reported in a separate press release, Kogan reviewed highlights of the company's pharmaceutical business and provided an update on manufacturing issues. He concluded his remarks today saying, "Going forward, my priorities are straightforward: To achieve our quality and compliance objectives, and get Schering-Plough back on a solid growth track. I am committed to delivering on these and determined that these manufacturing issues will get resolved."

An audio replay of the meeting, which was Webcast in a live audio format with slides, is available via the Schering-Plough corporate Web site, www.schering-plough.com, starting at approximately 2 p.m. on June 28 through 5 p.m. on July 27.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating to the company's business prospects and the expected impact on the company of the manufacturing process and control issues described in more detail in the company's Feb. 15, 2001, and June 22, 2001, press releases. The resolution of those manufacturing issues, as well as the potential impact of those issues on the company's second-quarter and full-year 2001 sales and earnings, are subject to substantial risks and uncertainties, and those issues could cause actual results to differ materially from the forward looking statements. A full description of those risks and uncertainties is included in the company's Feb. 15, 2001, and June 22, 2001, press releases, which are available on the company's Web site at www.schering-plough.com. In addition, the forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, generic competition, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, trade buying patterns, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K and subsequent quarterly report on Form 10-Q.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

EX-99 11 exhibit99h.htm Exhibit 99(h)

Exhibit 99(h)

SCHERING-PLOUGH REPORTS SALES, EARNINGS
FOR 2001 SECOND QUARTER, FIRST HALF

2001 Second Quarter Diluted Earnings Per Share 43 Cents

KENILWORTH, N.J., July 25, 2001 -Schering-Plough Corporation (NYSE: SGP) today reported financial results for the 2001 second quarter and first half. Diluted earnings per share for the 2001 second quarter were 43 cents (as estimated in a June 28, 2001, press release) on net income of $634 million, which is flat compared with 43 cents on net income of $634 million in the 2000 second quarter. Second quarter 2001 sales of $2.6 billion were also flat compared with last year. Excluding exchange, second quarter sales increased 3 percent.

Diluted earnings per share for the 2001 first half decreased 5 percent to 81 cents on net income of $1.2 billion versus 85 cents on net income of $1.3 billion in 2000. First half 2001 sales of $4.9 billion were 1 percent lower than the $5.0 billion recorded in 2000. Excluding exchange, 2001 first half sales increased 1 percent.

"Worldwide pharmaceutical sales for the second quarter included strong demand for a number of the company's newer products," said Richard Jay Kogan, chairman and chief executive officer. "We also continue to see good growth in our international markets, driven by higher sales in the allergy/respiratory and anti-infective/anticancer product categories." Commenting on previously reported manufacturing issues, he said, "We have made progress toward resolving these manufacturing issues and I remain committed to getting Schering-Plough back on a solid growth track."

2001 SECOND QUARTER RESULTS

In the 2001 second quarter, worldwide pharmaceutical sales totaled $2.2 billion, with growth flat compared with the 2000 period (up 2 percent when foreign exchange is excluded). Higher sales for the 2001 second quarter were recorded in the allergy/respiratory and dermatologicals categories. Worldwide sales of the CLARITIN (loratadine) nonsedating antihistamine line, the world's No. 1 antihistamine, grew 3 percent to $925 million. Second quarter 2001 worldwide sales of NASONEX (mometasone furoate monohydrate) Nasal Spray, a once-daily nasal spray for allergies, increased 51 percent to $183 million. Sales of the anti-infective/anticancer INTRON A franchise totaled $315 million, down 13 percent versus the comparable year-ago period. The franchise includes INTRON A (interferon alfa-2b); PEG-INTRON (peginterferon alfa-2b), a longer-acting form of INTRON A (as monotherapy for treating hepatitis C and, internationally, in combination with REBETOL (ribavirin, USP) Capsules); and REBETRON Combination Therapy c ontaining INTRON A and REBETOL.

Second quarter worldwide sales of TEMODAR (temozolomide), for treating certain types of brain tumors, were $44 million, up 46 percent. Sales of INTEGRILIN (eptifibatide) Injection, a glycoprotein platelet aggregation inhibitor for the treatment of patients with acute coronary syndromes, totaled $67 million, up 60 percent, and sales of REMICADE (infliximab), for the treatment of rheumatoid arthritis and Crohn's disease, were $36 million.

U.S. pharmaceutical sales in the 2001 second quarter totaled $1.4 billion, down 4 percent versus the 2000 period, with sales affected by manufacturing issues and changes in the timing of trade buying, tempered by increased demand for certain products. In allergy/respiratory, second quarter 2001 U.S. sales of the CLARITIN line were $782 million, up 2 percent. Domestic sales of NASONEX increased 56 percent to $145 million in the 2001 second quarter. In anti-infective/anticancer, U.S. sales of the INTRON A franchise totaled $147 million, down 32 percent. Second quarter domestic sales of TEMODAR rose to $26 million, up 55 percent. Sales of cardiovascular products in the 2001 second quarter were down 24 percent due to continued generic competition for IMDUR (isosorbide mononitrate), a once-daily, long-acting oral nitrate for angina, and lower sales of K-DUR® (potassium chloride USP), a sustained-release potassium supplement. Domestic sales of INTEGRILIN increased 58 percent to $61 million.

International pharmaceutical sales in the 2001 second quarter increased 6 percent (up 13 percent when foreign exchange is excluded) to $833 million. In allergy/respiratory, combined international sales of CLARITIN and CLARINEX (desloratadine), a non-sedating antihistamine, were $143 million, up 9 percent, and sales of NASONEX were $37 million, up 35 percent. In anti-infective/anticancer, sales of the INTRON A franchise totaled $169 million, up 16 percent versus the comparable 2000 period, benefiting from the March 2001 European Union approval of PEG-INTRON and REBETOL combination therapy for the treatment of chronic hepatitis C. Also contributing to second quarter international sales were TEMODAR, with sales of $18 million, up 34 percent, and REMICADE.

Second quarter sales of animal health products were down 1 percent (up 3 percent when foreign exchange is excluded). Sales of Schering-Plough's foot care products decreased 3 percent and over-the-counter (OTC) products were down 5 percent versus the comparable 2000 period. Sales of sun care products were up 28 percent versus the 2000 period.

2001 FIRST HALF RESULTS

Worldwide pharmaceutical sales in the 2001 first half decreased 2 percent (up 1 percent when foreign exchange is excluded) to $4.2 billion.

Sales of domestic pharmaceuticals totaled $2.6 billion, down 6 percent versus the 2000 first half, with sales affected by manufacturing issues and changes in the timing of trade buying, tempered by increased demand for certain products. The sales decline was due to lower sales of VANCENASE and the VANCERIL (beclomethasone dipropionate) line of orally inhaled steroids for asthma; lower sales of K-DUR, and lower sales of the INTRON A franchise. Also contributing to lower sales in the 2001 first half were LOTRISONE (clotrimazole and betamethasone dipropionate), a topical antifungal/anti-inflammatory, and IMDUR, which declined due to continued generic competition. The overall sales decline for U.S. pharmaceuticals was moderated by higher sales of CLARITIN, NASONEX, TEMODAR and INTEGRILIN.

International pharmaceutical sales for the period rose 5 percent (up 12 percent when foreign exchange is excluded) and totaled $1.6 billion. Higher sales were led by NASONEX, the INTRON A franchise, REMICADE and TEMODAR.

Sales of animal health products decreased 2 percent in the 2001 first half (up 2 percent when foreign exchange is excluded) and totaled $324 million. Sales of Schering-Plough's foot care products decreased 7 percent versus the prior year. Sales of OTC products were up 12 percent compared with the prior period. Schering-Plough's sun care products were up 10 percent in the 2001 first half versus the prior year.

DISCLOSURE NOTICE: In addition to historical information, this press release includes certain "forward-looking" statements relating to the company's business prospects and the expected impact on the company of the manufacturing process and control and current Good Manufacturing Practices (GMP) issues identified by the FDA, the company's efforts going forward to resolve those issues, remedies the FDA may seek with respect to those issues, the expected need for and cost of any additional remedial actions the company may take and the pendency of the company's New Drug Applications (NDA) for CLARINEX, which remain subject to FDA approval. The reader of this release should understand that the resolution of the issues with the FDA, as well as the potential impact of those issues on the company's full-year 2001 sales and earnings, are subject to substantial risks and uncertainties, and those issues could cause actual results to differ materially from the company's forward-looking statements. Many factors could c ause actual results to differ materially from the company's forward-looking statements, including that the timing, scope and duration of a resolution of the manufacturing process and control and GMP issues will depend on the ability of the company to assure FDA of the quality and reliability of its manufacturing systems and controls, and the extent of remedial and prospective obligations undertaken by the company. Other risk factors include that the FDA approval process is uncertain and can cause delays in the release of products, seizure or recall of products, suspension or revocation of the authority necessary for the production and sale of products, fines and other civil or criminal sanctions. In addition to the risks and uncertainties relating to the company's manufacturing deficiencies, the forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, current and future branded and generic competition for the company's product s, federal and state regulations and legislation, the regulatory process for new products and indications, new manufacturing issues that may arise, timing of trade buying, exchange rate fluctuations, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K and subsequent quarterly report on Form 10-Q.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

SCHERING-PLOUGH CORPORATION
Report for the second quarter ended June 30 (unaudited):
(Amounts in millions, except per share figures)

 

Second Quarter

 

% Change

 

 

2001

 

2000

 

 

 

 

 

 

 

 

 

Net Sales

 

$

2,630

 

$

2,626

 

--

 

 

 

 

 

 

 

Costs and Expenses:

 

 

 

 

 

 

 

Cost of Sales

 

535

 

489

 

9

 

Selling, General

 

 

 

 

 

 

 

 

and Administrative

 

 

967

 

977

 

(1)

 

Research and Development

 

334

 

345

 

(3)

 

Other, Net

 

(29)

 

(19)

 

53

 

 

 

1,807

 

1,792

 

1

 

 

 

 

 

 

 

Income Before Income Taxes

 

823

 

834

 

(1)

Income Taxes

 

189

 

200

 

(5)

Net Income

 

$

634

 

$

634

 

--

 

 

 

 

 

 

 

 

Diluted Earnings Per Common Share

 

$

0.43

 

$

0.43

 

--

 

 

 

 

 

 

 

Effective Tax Rate

 

23.0%

 

24.0%

 

 

 

 

 

 

 

 

 

Average Number of Common Shares Outstanding- Diluted

 

1,470

 

1,476

 

 

 

 

 

 

 

 

 

 

 

 

Actual Number of Common Shares Outstanding at June 30

 

 

1,463

 

 

1,465

 

 

 

 

 

 

 

 

 

 

 

 

Excluding exchange, diluted earnings per share for the second quarter increased 2 percent.

SCHERING-PLOUGH CORPORATION
Report for the six months ended June 30 (unaudited):
(Amounts in millions, except per share figures)

Six Months

% Change

2001

2000

Net Sales

$

4,949

$

5,015

(1)

Costs and Expenses:

Cost of Sales

1,005

946

6

Selling, General

and Administrative

1,819

1,818

--

Research and Development

624

635

(2)

Other, Net

(55)

(44)

27

3,393

3,355

1

Income Before Income Taxes

1,556

1,660

(6)

Income Taxes

358

398

(10)

Net Income

$

1,198

$

1,262

(5)

Diluted Earnings Per Common Share

$

0.81

$

0.85

(5)

Effective Tax Rate

23.0%

24.0%

Average Number of Common Shares Outstanding- Diluted

1,471

1,478

Actual Number of Common Shares Outstanding at June 30

1,463

1,465

Excluding exchange, diluted earnings per share for the first half of 2001 decreased 1 percent.

Net Sales by Major Product:
(Dollars in millions)

 

Second Quarter

 

 

2001

 

2000

 

%

 

 

 

 

 

 

 

ALLERGY & RESPIRATORY

 

$

1,244

 

$

1,216

 

2

Claritin

 

 

925

 

 

897

 

3

Nasonex

 

 

183

 

 

121

 

51

Vancenase

 

 

(2)

 

 

54

 

N/M

Proventil

 

 

66

 

 

55

 

21

Vanceril

 

 

22

 

 

27

 

(17)

 

 

 

 

 

 

 

 

 

ANTI-INFECTIVE & ANTICANCER

 

510

 

508

 

--

Eulexin

 

19

 

26

 

(25)

Intron A franchise*

 

315

 

361

 

(13)

Remicade

 

36

 

12

 

N/M

Temodar

 

44

 

30

 

46

 

 

 

 

 

 

 

CARDIOVASCULARS

 

134

 

168

 

(20)

Imdur

 

18

 

33

 

(46)

Integrilin

 

67

 

42

 

60

K-Dur

 

19

 

54

 

(64)

Nitro-Dur

 

29

 

32

 

(8)

 

 

 

 

 

 

 

DERMATOLOGICALS

 

176

 

170

 

4

Elocon

 

51

 

44

 

15

Lotrisone

 

48

 

48

 

1

 

 

 

 

 

 

 

OTHER PHARMACEUTICALS

 

164

 

174

 

(6)

 

 

 

 

WORLDWIDE PHARMACEUTICALS

 

2,228

 

2,236

 

--

 

 

 

 

 

 

 

ANIMAL HEALTH

 

171

 

173

 

(1)

FOOT CARE

 

97

 

100

 

(3)

OTC

 

42

 

45

 

(5)

SUN CARE

 

92

 

72

 

28

 

 

 

CONSOLIDATED NET SALES

 

$

2,630

 

$

2,626

 

--

N/M - not a meaningful percentage.

* The Intron A franchise includes INTRON A, PEG-INTRON (monotherapy for treating hepatitis C and, internationally, in combination with REBETOL), and REBETRON Combination Therapy.

NOTE: Additional information about U.S. and international sales for specific products is available by calling the company or visiting the corporate Web site at www.schering-plough.com.

Net Sales by Major Product:
(Dollars in millions)

 

Six Months

 

 

2001

 

2000

 

%

 

 

 

 

 

 

 

ALLERGY & RESPIRATORY

 

$

2,171

 

$

2,172

 

--

Claritin

 

 

1,643

 

 

1,562

 

5

Nasonex

 

 

274

 

 

202

 

36

Vancenase

 

 

1

 

 

110

 

(99)

Proventil

 

 

106

 

 

99

 

7

Vanceril

 

 

34

 

 

64

 

(47)

 

 

 

 

 

 

 

 

 

ANTI-INFECTIVE & ANTICANCER

 

1,035

 

1,000

 

3

Eulexin

 

49

 

63

 

(23)

Intron A franchise*

 

641

 

697

 

(8)

Remicade

 

63

 

20

 

N/M

Temodar

 

87

 

51

 

69

 

 

 

 

 

 

 

CARDIOVASCULARS

 

297

 

351

 

(15)

Imdur

 

39

 

68

 

(43)

Integrilin

 

105

 

70

 

51

K-Dur

 

94

 

132

 

(29)

Nitro-Dur

 

55

 

67

 

(17)

 

 

 

 

 

 

 

DERMATOLOGICALS

 

318

 

342

 

(7)

Elocon

 

103

 

88

 

17

Lotrisone

 

60

 

98

 

(38)

 

 

 

 

 

 

 

OTHER PHARMACEUTICALS

 

355

 

383

 

(7)

 

 

 

 

WORLDWIDE PHARMACEUTICALS

 

4,176

 

4,248

 

(2)

 

 

 

 

 

 

 

ANIMAL HEALTH

 

324

 

330

 

(2)

FOOT CARE

 

176

 

190

 

(7)

OTC

 

98

 

87

 

12

SUN CARE

 

175

 

160

 

10

 

 

 

CONSOLIDATED NET SALES

 

$

4,949

 

$

5,015

 

(1)

N/M - not a meaningful percentage.

* The Intron A franchise includes INTRON A, PEG-INTRON (monotherapy for treating hepatitis C and, internationally, in combination with REBETOL), and REBETRON Combination Therapy.

Note: Additional information about U.S. and international sales for specific products is available by calling the company or visiting the corporate Web site at www.schering-plough.com.

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