SCHERING PLOUGH CORP
10-Q, 2000-08-09
PHARMACEUTICAL PREPARATIONS
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2000

 

 

COMMISSION FILE NUMBER 1-6571

 

 

SCHERING-PLOUGH CORPORATION

 

 

Incorporated in New Jersey

22-1918501

One Giralda Farms

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

Madison, N.J. 07940-1000

(973) 822-7000

 

(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 June 30, 2000: 1,464,932,783

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         

   
   
 

   2000 

 1999 

 

 2000 

 1999 

           
           

Net sales

$  2,642 

$  2,451 

 

$  5,048 

$ 4,637 

Costs and Expenses:

         

 Cost of sales

489 

472 

 

946 

904 

 Selling, general and administrative

993 

963 

 

1,851 

1,757 

 Research and development

345 

297 

 

635 

559 

 Other income, net

     (19)

        (7)

 

      (44)

      (22)

 

  1,808 

   1,725 

 

   3,388 

   3,198 

Income before income taxes

834 

      726 

 

   1,660 

   1,439 

Income taxes

     200 

     179 

 

     398 

     353 

Net income

$   634 

$   547 

 

$ 1,262 

$ 1,086 

           

Diluted earnings per common share

$    .43 

$    .37 

 

$    .85 

$    .73 

           

Basic earnings per common share

$    .43 

$    .37 

 

$    .86 

$    .74 

           

Dividends per common share

$    .14 

$  .125 

 

$   .265 

$  .235 

           

 

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,

 

2000

 

1999

       

Assets

     

Cash and cash equivalents

$ 2,039 

 

$ 1,876 

  Accounts receivable, net

1,416 

 

1,022 

  Inventories

951 

 

958 

  Prepaid expenses, deferred income

     

    taxes and other current assets

1,066 

 

1,053 

       Total current assets

5,472 

 

4,909 

  Property, plant and equipment

4,544 

 

4,386 

  Less accumulated depreciation

1,515 

 

1,447 

        Property, net

3,029 

 

2,939 

  Intangible assets, net

623 

 

588 

  Other assets

999 

 

939 

 

$10,123 

 

$ 9,375 

       

Liabilities and Shareholders' Equity

     

  Accounts payable

$ 996 

 

$ 1,065 

  Short-term borrowings

857 

 

728 

  Other accrued liabilities

1,683 

 

1,416 

        Total current liabilities

3,536 

 

3,209 

  Long-term liabilities

964 

 

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

762 

 

675 

     Retained earnings

9,068 

 

8,196 

     Accumulated other comprehensive income

(290)

(233)

           Total

10,555 

 

9,653 

     Less treasury shares: 2000 - 565 shares;

1999 - 558 shares, at cost

4,932 

 

4,488 

        Total shareholders' equity

5,623 

 

5,165 

 

$ 10,123 

 

$ 9,375 

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)

 

2000

 

1999

       

Operating Activities:

     

  Net Income

$ 1,262 

 

$ 1,086 

  Depreciation and amortization

148 

 

121 

  Accounts receivable

(400)

 

(352)

  Inventories

(4)

 

(49)

  Prepaid expenses and other assets

(41)

 

(84)

  Accounts payable and other liabilities

131 

 

45 

  Net cash provided by operating activities

1,096 

 

767 

  

     

Investing Activities:

     

  Capital expenditures

(252)

 

(201)

  Purchases of investments

(50)

 

(257)

  Reduction of investments

12 

 

213 

  Purchase of business, net of cash acquired

(48)

 

  Other, net

 

(2)

  Net cash used for investing activities

(335)

 

(247)

       

Financing Activities:

     

  Dividends paid to common shareholders

(390)

 

(347)

  Common shares repurchased

(445)

 

(425)

  Short-term borrowings, net

139 

 

204 

  Other, primarily equity proceeds

101 

 

314 

  Net cash used for financing activities

(595)

 

(254)

       

Effect of exchange rates on cash and

     

  cash equivalents

(3)

 

(2)

Net increase in cash and cash equivalents

163 

 

264 

Cash and cash equivalents, beginning

     

  of period

1,876 

 

1,259 

Cash and cash equivalents, end of period

$ 2,039 

 

$ 1,523 

       

     

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.

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 June 30,

Six Months

Ended June 30

 

2000

1999

2000

1999

         

Average shares outstanding for basic earnings per share

1,464

1,470 

1,467

1,471 

Dilutive effect of options and deferred stock units

12

16 

11

17 

Average shares outstanding for diluted earnings per share

1,476

1,486 

1,478

1,488 

As of June 30, 2000, there were 9 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, 2000 and 1999 was $603 and $549, respectively. Total comprehensive income for the six months ended June 30, 2000 and 1999 was $1,205 and $1,048, respectively.

Inventories

Inventories consisted of:

June 30,

December 31,

 

2000

1999

     

   Finished products

$ 382      

$ 437      

   Goods in process

287      

267      

   Raw materials and supplies

  282      

  254      

     Total inventories

$ 951      

$ 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 June 30, 2000 and the related expenses incurred during the three months ended June 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, Hoffman-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 Hoffman-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.

The FTC has initiated an investigation of possible anticompetitive effects of the settlement of a patent litigation between the Company and ESI Lederle, Inc. (Lederle) relating to Lederle's generic version of K-DUR, the Company's long acting potassium chloride product. 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 as of June 30, 2000, and the related condensed consolidated statements of income for the three-month and six-month periods then ended and cash flows for the six-month period then ended. 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 generally accepted auditing standards, 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 modification 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.

/s/Deloitte & Touche LLP

Parsippany, New Jersey

July 24, 2000

 

 

 

 

 

 

 

 

 

 

 

 

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

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

Net Sales

Consolidated net sales for the second quarter totaled $2.6 billion, an increase of $191 million or 8 percent compared with the same period in 1999. For the six months, net sales rose $411 million or 9 percent over 1999. Excluding the effect of foreign currency exchange rate fluctuations, consolidated net sales grew 10 percent in the quarter and 11 percent for the six-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 8 percent versus the second quarter of 1999 and advanced 8 percent internationally (14 percent excluding exchange). For the six-month period, net sales in the United States grew 10 percent and increased 7 percent internationally (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      

 

2000

1999

%

 

2000

1999

%

Allergy & Respiratory

$1,216 

$1,124 

 

$2,172 

$1,990 

Anti-infective & Anticancer

508 

408 

25 

 

1,000 

830 

21 

Dermatologicals

170 

160 

 

342 

311 

10 

Cardiovasculars

168 

172 

(2)

 

351 

332 

Other Pharmaceuticals

178 

201 

(11)

 

392 

405 

(3)

Animal Health

174 

172 

 

332 

325 

Foot Care

105 

100 

 

198 

183 

Over-the-Counter (OTC)

46 

43 

 

92 

105 

(12)

Sun Care

77 

71 

 

169 

156 

Consolidated net sales

$2,642 

$2,451 

$5,048 

$4,637 

Worldwide net sales of allergy and respiratory products advanced 8 percent in the quarter and 9 percent for the six-month period. The increase was led by continued growth for the CLARITIN line of nonsedating antihistamines. Worldwide net sales of the CLARITIN brand totaled $897 million, up 9 percent for the quarter, and $1,562 million, up 13 percent for the first half 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 32 percent in the quarter and 29 percent 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 $17 million and $36 million for the quarter and six-month periods, respectively, due to manufacturing issues and branded competition. U.S. sales of the PROVENTIL (albuterol) line of asthma products declined $12 million in the quarter and $33 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 25 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 $361 million in the quarter, up 31 percent from the corresponding period of 1999 and totaled $697 million year-to-date, up 27 percent from 1999. Sales of these products grew because of increased use in the treatment of chronic hepatitis C coupled with 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 third quarter 1999 international launch of REMICADE, marketed for Crohn's disease, also contributed to the increase in this therapeutic category's sales in both periods.

Dermatological products' worldwide net sales increased 6 percent in the second quarter and 10 percent year-to-date due to modest market share increases coupled with expansion in the topical steroid markets in the United States.

Worldwide net sales of cardiovascular products decreased 2 percent in the quarter but increased 6 percent for the first half of 2000. The second quarter and six 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.

Net sales of foot care products increased 4 percent in the quarter and 8 percent year-to-date driven by higher sales of DR. SCHOLL'S insoles, reflecting new product introductions.

 

 

OTC product sales increased 8 percent in the second quarter of 2000 but declined 12 percent year-to-date. The growth in the quarter was led by higher sales of certain cough and cold products. The decrease in the first six 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 up 8 percent in the second quarter and year-to-date periods.

Costs and Expenses

Cost of sales as a percentage of sales decreased to 18.5 percent in the quarter and 18.7 percent for the first six months from 19.3 percent in the second quarter of 1999 and 19.5 percent in the first half of 1999. The decrease was primarily due to favorable sales mix and foreign exchange impacts.

Selling, general and administrative expenses represented 37.6 percent of sales in the second quarter of 2000, a decrease from 39.3 percent last year. For the six-month period, the ratio decreased to 36.7 percent from 37.9 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 16 percent in the second quarter, representing 13.1 percent of sales compared with 12.1 percent in 1999. For the first half of 2000, spending grew 13 percent and represented 12.6 percent of sales in 2000 versus 12.1 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 15 percent for the quarter and six months compared with the corresponding periods of 1999, and represented 31.6 percent of sales for the second quarter of 2000 versus 29.6 percent last year and 32.9 percent of sales for the first half of 2000 versus 31.0 percent last year.

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

Diluted earnings per common share advanced 16 percent in the second quarter to $.43 from $.37 in 1999 and grew 16 percent to $.85 from $.73 for the six-month period. Foreign currency exchange rate changes had no impact on diluted earnings per common share for the second quarter or first half of 2000. Basic earnings per common share advanced 16 percent in the quarter and six-month periods.

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 - six months ended June 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 $1,096 million for the first six months of 2000, an increase of $329 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 due to year-to-year changes in the timing of receipts and disbursements.

Cash was also used in the first six months to fund capital expenditures of $252 million. The Company anticipates that capital expenditures will exceed $750 million in 2000. This amount includes the cost of the planned purchase of the Summit, New Jersey research and office facility.

In the first six months of 2000, cash was used to repurchase shares for $445 million. In March 2000, the Board of Directors authorized the repurchase of $1.5 billion of the Company's common shares. As of June 30, 2000, this program was approximately 6 percent complete. Cash was also used to pay shareholder dividends of $390 million in the first half 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 report on Form 10-Q for the quarter ended March 31, 2000, is incorporated by reference.

Reference is made to the seventh paragraph of Item 3, Legal Proceedings, of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1999, relating to state consumer antitrust cases. During the second quarter of 2000, the Alabama consumer case was dismissed by the trial court. 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.

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, 1999, as amended by the Company's Form 10-Q for the quarter ended March 31, 2000, relating to CLARITIN patent litigation. The Company has filed suit against Mylan. Also, American Home Products, et.al., submitted an ANDA in May 2000 concerning CLARITIN Redi-tabs. The Company has filed a 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 American Home Products' challenge to the Company's patent is without merit. The Company believes that it should prevail in this suit. However, as with any litigation, there can be no assurance that the Company will prevail.

 

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 June 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    August 9, 2000

/s/Thomas H. Kelly

 

Thomas H. Kelly

Vice President and Controller

 

Exhibit 15

August 9, 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 June 30, 2000 and 1999, as indicated in our report dated July 24, 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 June 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 July 25, 2000

(Filed pursuant to Rule 175).

 

 

Mr. Richard Jay Kogan, Chairman and Chief Executive Officer, commenting on the Company's business results, stated, "Schering-Plough's earnings per share for the year would be in line with the current consensus of analysts' estimates of $1.64."

 

 

 

 

 

 

 

 



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