SCHERING PLOUGH CORP
10-Q, 2000-11-13
PHARMACEUTICAL PREPARATIONS
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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 September 30, 2000

 

 

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)

   

Former Address:

 

One Giralda Farms

 

Madison, NJ 07940

 
   

 

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 October 31, 2000: 1,462,036,425

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

      September 30        

 

Nine months

Ended

    September 30       

   
   
 

   2000 

 1999 

 

 2000 

 1999 

           
           

Net sales

$ 2,394 

$ 2,236 

 

$ 7,442 

$ 6,873 

Costs and expenses:

         

 Cost of sales

468 

438 

 

1,414 

1,342 

 Selling, general and administrative

839 

814 

 

2,690 

2,571 

 Research and development

340 

305 

 

975 

864 

 Other income, net

(30)

(7)

 

(74)

(29)

 

1,617 

1,550 

 

5,005 

4,748 

Income before income taxes

777 

   686 

 

2,437 

 2,125 

Income taxes

186 

168 

 

585 

521 

Net income

$ 591 

$ 518 

 

$ 1,852 

$ 1,604 

           

Diluted earnings per common share

$ .40 

$ .35 

 

$ 1.25 

$ 1.08 

           

Basic earnings per common share

$ .40 

$ .35 

 

$ 1.26 

$ 1.09 

           

Dividends per common share

$ .14 

$ .125 

 

$ .405  

$ .36 

           

 

See notes to consolidated financial statements.

 

 

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(Amounts in millions, except per share figures)

 

September 30,

 

December 31,

 

2000

 

1999

       

Assets

     

Cash and cash equivalents

$ 2,181 

 

$ 1,876 

  Accounts receivable, net

1,202 

 

1,022 

  Inventories

934 

 

958 

  Prepaid expenses, deferred income

     

    taxes and other current assets

1,072 

 

1,053 

       Total current assets

5,389 

 

4,909 

  Property, plant and equipment

4,672 

 

4,386 

  Less accumulated depreciation

1,546 

 

1,447 

        Property, plant and equipment, net

3,126 

 

2,939 

  Intangible assets, net

657 

 

588 

  Other assets

1,055 

 

939 

 

$10,227 

 

$ 9,375 

       

Liabilities and Shareholders' Equity

     

  Accounts payable

$ 1,039 

 

$ 1,065 

  Short-term borrowings

715 

 

728 

  Other accrued liabilities

1,700 

 

1,416 

        Total current liabilities

3,454 

 

3,209 

  Long-term liabilities

968 

 

1,001 

  Shareholders' Equity

     

    Preferred shares - $1 par value;

     

      Issued: none

 

    Common shares - $.50 par value;

     

      Issued: 2,030  

1,015 

 

1,015 

     Paid-in capital

796 

 

675 

     Retained earnings

9,452 

 

8,196 

     Accumulated other comprehensive           income

(327)

(233)

           Total

10,936 

 

9,653 

     Less treasury shares: 2000 - 568 shares

1999 - 558 shares, at cost

5,131 

 

4,488 

        Total shareholders' equity

5,805 

 

5,165 

 

$10,227 

 

$ 9,375 

See notes to consolidated financial statements.

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

STATEMENTS OF CONSOLIDATED CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30,

(UNAUDITED)

(Amounts in millions)

 

2000

 

1999

       

Operating Activities:

     

  Net Income

$ 1,852 

 

$ 1,604 

  Depreciation and amortization

224 

 

193 

  Accounts receivable

(214)

 

(393)

  Inventories

(3)

 

(146)

  Prepaid expenses and other assets

(130)

 

(122)

  Accounts payable and other liabilities

270 

 

280 

  Net cash provided by operating activities

1,999 

 

1,416 

  

     

Investing Activities:

     

  Capital expenditures

(436)

 

(338)

  Purchases of investments

(99)

 

(288)

  Reduction of investments

43 

 

204 

  Purchase of business, net of cash acquired

(48)

 

  Other, net

 3 

 

  Net cash used for investing activities

(537)

 

(420)

       

Financing Activities:

     

  Dividends paid to common shareholders

(596)

 

(532)

  Common shares repurchased

(644)

 

(475)

  Short-term borrowings, net

 (1)

 

152 

  Other, primarily equity proceeds

89 

 

267 

  Net cash used for financing activities

(1,152)

 

(588)

       

Effect of exchange rates on cash and

     

  cash equivalents

(5)

 

(2)

Net increase in cash and cash equivalents

305 

 

406 

Cash and cash equivalents, beginning

 

   

  of period

1,876 

 

1,259 

Cash and cash equivalents, end of period

$2,181 

 

$1,665 

       

     

See notes to consolidated financial statements.

 

 

SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

(Amounts in millions, except per share figures)

 

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 1999 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.

New Accounting Standards

In May 2000, the Emerging Issues Task Force (EITF) reached a concensus on EITF Issue No. 00-14, "Accounting for Certain Sales Incentives". EITF Issue No. 00-14 addresses the income statement classification of certain sales incentives and will require the Company to reclassify the cost of certain sales incentives from Selling, general and administrative expenses to Net sales. The Company is currently determining the amount of sales incentives that will require reclassification; however, the Company believes the amounts will be immaterial. The Company will implement EITF Issue No. 00-14 in the fourth quarter of 2000. Certain prior period financial statements will also require reclassification for comparability purposes. The adoption of EITF Issue No. 00-14 will have no effect on net income.

In June 1998, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 133, "Accounting for Derivative Instruments and Hedging Activities". SFAS No. 133, as amended by SFAS Nos. 137 and 138, is required to be adopted no later than January 1, 2001. Accordingly, the Company plans to adopt the new standard at that time. Based on the Company's current limited use of derivative financial instruments, the adoption of this statement is not expected to materially impact the Company's Consolidated Financial Statements.

Joint Venture Acquisition

On June 25, 2000, the Company acquired a majority interest in a joint venture with Takeda Chemical Industries, Ltd. to develop and market animal health products in Japan. The cost of the acquisition was approximately $48.

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

September 30,

Nine Months

Ended

September 30

 

2000

1999

2000

1999

         

Average shares outstanding for basic earnings per share

1,463

1,469

1,466

1,470

Dilutive effect of options and deferred stock units

11

15

11

17

Average shares outstanding for diluted earnings per share

1,474

1,484

1,477

1,487

As of September 30, 2000, there were approximately 17 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 September 30, 2000 and 1999 was $554 and $532, respectively. Total comprehensive income for the nine months ended September 30, 2000 and 1999 was $1,759 and $1,580, respectively.

Inventories

Inventories consisted of:

September 30,

December 31,

 

2000

1999

     

   Finished products

$ 401       

$ 437      

   Goods in process

256       

267      

   Raw materials and supplies

277       

  254      

     Total inventories

$ 934       

$ 958      

     

 

 

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 reasonably be estimated.

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 reasonably be estimated. Consistent with trends in the pharmaceutical industry, the Company is self-insured for certain events.

The recorded liabilities for the above matters at September 30, 2000 and the related expenses incurred during the nine months ended September 30, 2000, 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. 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 more than 110 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 is a class action on behalf of approximately two-thirds of all retail pharmacies in the United States and alleges a price-fixing conspiracy. The Company agreed to settle the federal class action for a total of $22, which has been paid in full. The settlement provides, among other things, that the Company shall not refuse to grant discounts on brand-name prescription drugs to a retailer based solely on its status as a retailer and that, to the extent a retailer can demonstrate its ability to affect market share of a Company brand-name prescription drug in the same manner as a managed care organization with which the retailer competes, it will be entitled to negotiate similar incentives subject to the rights, obligations, exemptions and defenses of the Robinson-Patman Act and other laws and regulations. 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 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 of the state retailer actions, except California and Alabama. The settlement amounts were not material to the Company. In addition, 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.

The Company has settled all of the state consumer cases, except Alabama, North Dakota, South Dakota, West Virginia and New Mexico. The settlement amounts were not material to the Company. While the initial Alabama consumer case was dismissed by the trial court based on the Alabama Supreme Court decision discussed above, the District Attorney for the First Judicial Circuit has filed a complaint on behalf of Alabama consumers under the State's Deceptive Trade Practices Act.

In May 1998, the Company settled six of the federal antitrust cases brought by 26 food and drug chain retailers and several independent retail stores. Plaintiffs in these cases comprise collectively approximately one-fifth of the prescription drug retail market. Also in 1999, the Company settled federal antitrust cases brought by independent pharmacists and small pharmacy chains comprising about 2 percent of the prescription drug retail market. 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) is investigating whether the Company, along with other pharmaceutical companies, conspired to fix prescription drug prices. The investigation is ongoing. The Company believes that its actions have been lawful and proper and is cooperating in the investigation. However, it is not possible to predict the outcome of the investigation, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

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 including PBMs, managed care organizations and manufacturers as a part of an inquiry into, among other things, marketing practices. The government's inquiry appears to focus on whether the Company's disease management and other marketing programs comply with federal health care laws and whether the value of its disease management programs should have been included in the calculation of rebates to the government. The Company believes that its disease management and other marketing programs have been designed to comply with the law and that its rebate calculations have properly excluded the value of its disease management programs. The Company is cooperating in the investigation. However, 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, and in 2000 Andrx Pharmaceuticals, L.L.C. (Andrx), Mylan Pharmaceuticals, Inc. and American Home Products, et.al., made separate, 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 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 Company will prevail.

In January 2000, Hoffmann-La Roche Inc. filed actions against the Company in United States District Court in New Jersey and in France alleging that the Company's PEG-INTRON (peginterferon alfa-2b) infringes Hoffmann-La Roche Inc.'s patents on certain pegylated interferons. 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.

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's claim against Warrick, with trebling of damages and penalties, amounts to approximately $54. The Company believes that the actions of Warrick have been lawful and proper and is cooperating in the investigations. However, 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.

There are investigations by the Department of Health and Human Services, Department of Justice and certain states into certain industry and Company practices, including the setting of average wholesale prices (AWP) and the repackaging of products purchased in bulk by a managed care organization. The Company believes that its actions have been lawful and proper and is cooperating in the investigations. However, it is not possible to predict the outcome of the investigations, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

The FTC has initiated an investigation of possible anti-competitive effects of the settlement of patent lawsuits between the Company and ESI Lederle, Inc. (Lederle) and the Company and Upsher-Smith, Inc. (Upsher-Smith), the lawsuits that were settled related to generic versions of K-DUR, the Company's long-acting potassium chloride product that were the subject of Abbreviated New Drug Applications filed by Lederle and Upsher-Smith. The investigation is ongoing. The Company believes that its actions have been lawful and proper and is cooperating in the investigation. However, it is not possible to predict the outcome of the investigation, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

 

 

 

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 September 30, 2000, and the related condensed consolidated statements of income for the three-month and nine-month periods ended September 30, 2000 and 1999, and cash flows for the nine-month period ended September 30, 2000 and 1999. 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, 1999, and the related consolidated statements of income, shareholders' equity, and cash flows for the year then ended (not presented herein); and in our report dated February 11, 2000, 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, 1999 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

November 7, 2000

 

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

Results of Operations - three and nine months ended September 30, 2000 compared with the corresponding periods in 1999.

Net Sales

Consolidated net sales for the third quarter totaled $2.4 billion, an increase of $158 million or 7 percent compared with the same period in 1999. For the nine months, net sales rose $569 million or 8 percent over 1999. Excluding the effect of foreign currency exchange rate fluctuations, consolidated net sales grew 9 percent in the quarter and 10 percent for the nine-month period. Based on the current weakness of most major European currencies, exchange rate fluctuations are expected to continue having a negative impact on year-to-year sales comparisons. Net sales in the United States increased 4 percent versus the third quarter of 1999 and advanced 13 percent internationally (19 percent excluding exchange). For the nine-month period, net sales in the United States grew 8 percent and increased 9 percent internationally (14 percent excluding exchange).

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

 

               
 

      Third Quarter      

 

      Nine Months      

 

2000

1999

%

 

2000

1999

%

Allergy & Respiratory

$1,042 

$ 980 

6

 

$3,215 

$2,970 

8

Anti-infective & Anticancer

506 

413 

23

 

1,507 

1,243 

21

Dermatologicals

198 

186 

7

 

540 

497 

9

Cardiovasculars

169 

161 

5

 

519 

493 

5

Other Pharmaceuticals

143 

171 

(17)

 

535 

576 

(7)

Animal Health

176 

161 

9

 

508 

486 

4

Foot Care

95 

93 

3

 

293 

276 

6

Over-the-Counter (OTC)

59 

60 

(1)

 

151 

165 

(8)

Sun Care

11 

(47)

 

174 

167 

5

Consolidated net sales

$2,394 

$2,236 

7

$7,442 

$6,873 

8

Worldwide net sales of allergy and respiratory products advanced 6 percent in the quarter and 8 percent for the nine-month period. The increase was led by continued growth for the CLARITIN line of nonsedating antihistamines. Worldwide net sales of the CLARITIN brand totaled $787 million, up 10 percent for the quarter, and $2,349 million, up 12 percent for the first nine months of 2000, as compared with the corresponding periods in 1999. The increase in the CLARITIN brand was due primarily to continued expansion in the U.S. antihistamine market, tempered by market share declines. Franchise sales of nasal inhaled steroid products, which include NASONEX, a once-daily corticosteroid for allergic rhinitis and VANCENASE allergy products, increased 29 percent in the quarter and year-to-date. This growth was due to overall nasal inhaled steroid market expansion and market share increases in the United States for NASONEX, which continues to capture market share from VANCENASE. The launch of NASONEX in several international markets also benefited sales. Sales of VANCERIL, an orally inhaled steroid for asthma, declined $19 million and $55 million for the quarter and nine-month periods, respectively, due to manufacturing issues and branded competition. U.S. sales of the PROVENTIL (albuterol) line of asthma products declined $15 million in the quarter and $48 million year-to-date as compared with the corresponding periods of 1999 due to manufacturing issues and continued generic competition.

Net sales of worldwide anti-infective and anticancer products increased 23 percent in the quarter and 21 percent year-to-date. Growth in both periods was led by combined worldwide sales of INTRON A (interferon alfa-2b) and REBETRON Combination Therapy containing REBETOL (ribavirin) Capsules and INTRON A Injection, which totaled $338 million in the quarter, up 24 percent from the corresponding period of 1999 and totaled $1,036 million year-to-date, up 26 percent from 1999. Sales of these products grew because of increased use in the treatment of chronic hepatitis C including the launch of REBETOL in most major European markets. The U.S. and international launches of TEMODAR, a chemotherapy agent for treating certain types of brain tumors, and the international launch of REMICADE, marketed for Crohn's disease and for the treatment of rheumatoid arthritis, also contributed to the increase in this therapeutic category's sales in both periods.

Dermatological products' worldwide net sales increased 7 percent in the third quarter and 9 percent year-to-date due to modest market share increases coupled with expansion in the topical steroid market in the United States.

Worldwide net sales of cardiovascular products increased 5 percent in the quarter and for the first nine months of 2000. The third quarter and nine months of 2000 benefited from higher sales of INTEGRILIN, a platelet aggregation inhibitor for the treatment of acute coronary syndromes, due to increased market penetration. Sales of IMDUR, an oral nitrate for angina, decreased in both periods due to continued generic competition.

Worldwide sales of animal health products increased 9 percent in the quarter and 4 percent year-to-date. Growth in both periods was primarily due to the June 2000 acquisition of a majority interest in a joint venture with Takeda Chemical Industries, Ltd. in Japan.

Net sales of foot care products increased 3 percent in the quarter and 6 percent year-to-date driven by higher sales of DR. SCHOLL'S insoles, reflecting new product introductions.

OTC product sales declined 1 percent in the third quarter of 2000 and 8 percent year-to-date. The decrease in the first nine months of 2000 was due mainly to the fourth quarter 1999 sale of the PAAS product line.

Sales of sun care products, including the newly acquired BAIN DE SOLEIL product line, were down in the third quarter but grew 5 percent year-to-date.

Costs and Expenses

Cost of sales as a percentage of sales was unchanged versus the prior quarter at 19.6 percent in the third quarter of 2000 and decreased to 19.0 percent for the first nine months of 2000 from 19.5 percent in the first nine months of 1999. The decrease was primarily due to favorable sales mix and foreign exchange impacts.

Selling, general and administrative expenses represented 35.0 percent of sales in the third quarter of 2000, a decrease from 36.4 percent last year. For the nine-month period, the ratio decreased to 36.1 percent from 37.4 percent last year. The decrease in this ratio in both periods was the result of sales growth outpacing promotional spending. The Company continued to expand the sales forces in major international markets to support the launches of new products and growth of current product lines.

Research and development spending rose 12 percent in the third quarter, representing 14.2 percent of sales compared with 13.6 percent in 1999. For the first nine months of 2000, spending grew 13 percent and represented 13.1 percent of sales in 2000 versus 12.6 percent in 1999. The higher spending reflects the Company's funding of both internal research efforts and research collaborations with various partners to develop a steady flow of innovative products.

Income before income taxes increased 13 percent for the quarter and 15 percent for the first nine months compared with the corresponding periods of 1999, and represented 32.5 percent of sales for the third quarter of 2000 versus 30.7 percent last year and 32.7 percent of sales for the first nine months of 2000 versus 30.9 percent last year.

The effective tax rate was 24.0 percent in the three and nine-month periods of 2000 and 24.5 percent in both periods of 1999. The decrease was primarily due to increased sales of products manufactured in jurisdictions with lower tax rates.

Diluted earnings per common share advanced 14 percent in the third quarter to $.40 from $.35 in 1999 and grew 16 percent to $1.25 from $1.08 for the nine-month period. Foreign currency exchange rate changes had no impact on diluted earnings per common share for the third quarter or first nine months of 2000. Basic earnings per common share advanced 14 percent in the quarter and 16 percent in the nine-month period.

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. Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and enacted across-the-board price cuts as methods of cost control.

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 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.

Uncertainties inherent in government regulatory approval processes, including, among other things, delays in approval of new products, 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. Failure to comply with governmental regulations or other manufacturing issues 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.

From time to time, the Company has received Warning Letters from the FDA pertaining to various manufacturing issues. Among these, the Company has received a Warning Letter from the FDA relating specifically to manufacturing issues identified during FDA inspections of the Company's aerosol products (albuterol and VANCERIL) manufacturing facilities in New Jersey. The Company is implementing remedial actions at these facilities. The Company has met with the FDA on several occasions to apprise the agency of the scope and status of these activities. The Company cannot predict whether its remedial actions will resolve the FDA's concerns, whether the FDA will take any further action or the effect of this matter on the Company's operations.

Under certain circumstances, the Company may deem it advisable to initiate product recalls. In 1999, the Company voluntarily chose to initiate several recalls, including a recall of certain shipments of albuterol and VANCERIL manufactured at its New Jersey facilities. In the first quarter of 2000, the Company voluntarily expanded the recall to include shipments manufactured prior to September 30, 1999. The cost of the recall did not have a significant impact on the financial results of the Company.

Liquidity and financial resources - nine months ended September 30, 2000

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 $1,999 million for the first nine months of 2000, an increase of $583 million from 1999. This change is primarily due to an increase in net income and a reduction in the amount invested in working capital compared to 1999. This reduction was primarily due to year-to-year changes in the timing of cash receipts.

Cash was also used in the first nine months to fund capital expenditures of $436 million. The Company anticipates that capital expenditures will exceed $750 million in 2000. This amount includes the cost of the purchase of the Summit, New Jersey research and office facility.

In the first nine months of 2000, cash was used to repurchase shares for $644 million. In March 2000, the Board of Directors authorized the repurchase of $1.5 billion of the Company's common shares. As of September 30, 2000, this program was approximately 19 percent complete. Cash was also used to pay shareholder dividends of $596 million in the first nine months of 2000. In April 2000, the Board of Directors increased the quarterly dividend by 12 percent to $.14 from $.125 per common share.

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

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, 1999, Form 10-K filed with the Securities and Exchange Commission, 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 1999 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, 1999, as amended by the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2000 and June 30, 2000, respectively, is incorporated by reference.

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's claim against Warrick, with trebling of damages and penalties, amounts to approximately $54 million. The Company believes that the actions of Warrick have been lawful and proper and is cooperating in the investigations. However, 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.

There are investigations by the Department of Health and Human Services, Department of Justice and certain states into certain industry and Company practices, including the setting of average wholesale prices (AWP) and the repackaging of products purchased in bulk by a managed care organization. The Company believes that its actions have been lawful and proper and is cooperating in the investigations. However, it is not possible to predict the outcome of the investigations, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

The second paragraph of Item 1, Legal Proceedings, of Part II of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2000 is hereby deleted and replaced with the following paragraph:

The FTC has initiated an investigation of possible anti-competitive effects of the settlement of patent lawsuits between the Company and ESI Lederle, Inc. (Lederle) and the Company and Upsher-Smith, Inc. (Upsher-Smith), the lawsuits that were settled related to generic versions of K-DUR, the Company's long-acting potassium chloride product that were the subject of Abbreviated New Drug Applications filed by Lederle and Upsher-Smith. The investigation is ongoing. The Company believes that its actions have been lawful and proper and is cooperating in the investigation. However, it is not possible to predict the outcome of the investigation, which could result in the imposition of fines, penalties and injunctive or administrative remedies.

 

 

 

 

 

Item 6. Exhibits and Reports on Form 8-K

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

Exhibit

Number

 

Description

15

27

99

  • Awareness letter
  • Financial Data Schedule
  • Company statement relating to forward looking information.

 

  1. Reports on Form 8-K:

No report was filed during the three months ended September 30, 2000.

 

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    November 13, 2000

/s/Thomas H. Kelly

 

Thomas H. Kelly

Vice President and Controller

 

Exhibit 15

November 7, 2000

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 September 30, 2000 and 1999, as indicated in our report dated November 7, 2000; 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 September 30, 2000, 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

 

 

Exhibit 99

 

Company statement relating to forward looking information from press release by the Company dated October 3, 2000

(Filed pursuant to Rule 175).

 

 

"Schering-Plough reiterated its previously stated earnings projection for 2000, saying that diluted earnings per share are expected to be in line with the current consensus of analysts' estimates of $1.64, as compiled by four investor services (First Call, I/B/E/S, Nelson and Zacks). The earnings projection for the 2000 fiscal year, ending December 31, would represent a 15 percent increase from the $1.42 in diluted earnings per share reported for 1999. The Company also said the percent increases in earnings per share for the 2000 third and fourth quarters versus the 1999 periods are expected to be comparable to the percent increase for the 2000 full year versus 1999."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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