10-Q 1 0001.txt FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) [ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2000 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 000-12477 AMGEN INC. (Exact name of registrant as specified in its charter) Delaware 95-3540776 ------------------------------- ------------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, Thousand Oaks, California 91320-1799 -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (805) 447-1000 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 (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No As of June 30, 2000, the registrant had 1,028,267,140 shares of Common Stock, $0.0001 par value, outstanding. AMGEN INC. INDEX Page No. PART I FINANCIAL INFORMATION Item 1. Financial Statements................................... 3 Condensed Consolidated Statements of Operations - three and six months ended June 30, 2000 and 1999.................................. 4 Condensed Consolidated Balance Sheets - June 30, 2000 and December 31, 1999........................... 5 Condensed Consolidated Statements of Cash Flows - six months ended June 30, 2000 and 1999.................................. 6 Notes to Condensed Consolidated Financial Statements.................................................... 7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations............................................ 14 PART II OTHER INFORMATION Item 1. Legal Proceedings..................................... 20 Item 4. Submission of Matters to a Vote of Security Holders...................................... 21 Item 5. Other Information..................................... 22 Item 6. Exhibits and Reports on Form 8-K...................... 22 Signatures..................................................... 23 Index to Exhibits.............................................. 24 2 PART I - FINANCIAL INFORMATION Item 1. Financial Statements The information in this report for the three and six months ended June 30, 2000 and 1999 is unaudited but includes all adjustments (consisting only of normal recurring accruals, unless otherwise indicated) which Amgen Inc. ("Amgen" or the "Company") considers necessary for a fair presentation of the results of operations for those periods. The condensed consolidated financial statements should be read in conjunction with the Company's financial statements and the notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 1999. Interim results are not necessarily indicative of results for the full fiscal year. 3
AMGEN INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2000 1999 2000 1999 -------------- --------------- ---------------- -------------- Revenues: Product sales $ 806.8 $ 737.9 $1,504.4 $1,426.2 Corporate partner revenues 61.1 49.0 135.3 76.0 Royalty income 46.5 33.6 88.8 63.8 -------------- --------------- ---------------- -------------- Total revenues 914.4 820.5 1,728.5 1,566.0 -------------- --------------- ---------------- -------------- Operating expenses: Cost of sales 101.7 98.8 187.4 191.2 Research and development 202.8 194.1 392.6 382.1 Selling, general and administrative 205.1 157.2 374.8 290.1 Loss of affiliates, net 4.9 9.2 21.3 12.0 -------------- --------------- ---------------- -------------- Total operating expenses 514.5 459.3 976.1 875.4 -------------- --------------- ---------------- -------------- Operating income 399.9 361.2 752.4 690.6 Other income (expense): Interest and other income 43.2 24.5 79.6 43.0 Interest expense, net (3.4) (3.3) (7.6) (5.5) -------------- --------------- ---------------- -------------- Total other income 39.8 21.2 72.0 37.5 -------------- --------------- ---------------- -------------- Income before income taxes 439.7 382.4 824.4 728.1 Provision for income taxes 137.1 114.8 255.6 213.3 -------------- --------------- ---------------- -------------- Net income $ 302.6 $ 267.6 $ 568.8 $ 514.8 ============== =============== ================ ============== Earnings per share: Basic $ 0.29 $ 0.26 $ 0.55 $ 0.50 Diluted $ 0.28 $ 0.25 $ 0.52 $ 0.48 Shares used in calculation of earnings per share: Basic 1,027.5 1,021.1 1,025.4 1,022.3 Diluted 1,083.3 1,073.8 1,084.6 1,077.4 See accompanying notes.
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AMGEN INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In millions, except per share data) (Unaudited) June 30, December 31, 2000 1999 ---------------- ----------------- ASSETS ------ Current assets: Cash and cash equivalents $ 136.2 $ 130.9 Marketable securities 1,484.9 1,202.1 Trade receivables, net 312.3 412.2 Inventories 272.6 184.3 Other current assets 176.6 135.8 ---------------- ----------------- Total current assets 2,382.6 2,065.3 ---------------- ----------------- Property, plant and equipment at cost, net 1,638.5 1,553.6 Investments in affiliated companies 120.9 132.8 Other equity investments 238.4 129.7 Other assets 162.8 196.2 ---------------- ----------------- $4,543.2 $4,077.6 ================ ================= LIABILITIES AND STOCKHOLDERS' EQUITY ------------------------------------ Current liabilities: Accounts payable $ 120.1 $ 83.4 Commercial paper 99.7 99.5 Accrued liabilities 616.1 648.2 ---------------- ----------------- Total current liabilities 835.9 831.1 Long-term debt 223.0 223.0 Contingencies Stockholders' equity: Preferred stock; $0.0001 par value; 5.0 shares authorized; none issued or outstanding - - Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding - 1,028.3 shares in 2000 and 1,017.9 shares in 1999 2,409.1 2,072.3 Retained earnings 1,049.7 966.0 Accumulated other comprehensive income (loss) 25.5 (14.8) ---------------- ----------------- Total stockholders' equity 3,484.3 3,023.5 ---------------- ----------------- $4,543.2 $4,077.6 ================ ================= See accompanying notes.
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AMGEN INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In millions) (Unaudited) Six Months Ended June 30, 2000 1999 ------------- -------------- Cash flows from operating activities: Net income $ 568.8 $ 514.8 Depreciation and amortization 103.8 89.2 Gain on equity investments (30.2) - Loss of affiliates, net 21.3 12.0 Cash provided by (used in): Trade receivables, net 99.9 (43.7) Inventories (88.3) (11.0) Other current assets (23.6) 3.7 Accounts payable 36.7 22.4 Accrued liabilities (32.1) (22.3) ------------- -------------- Net cash provided by operating activities 656.3 565.1 ------------- -------------- Cash flows from investing activities: Purchases of property, plant and equipment (188.7) (147.0) Proceeds from maturities of marketable securities - 10.5 Proceeds from sales of marketable securities 337.7 373.3 Purchases of marketable securities (619.4) (494.0) Other (11.6) (2.0) -------------- -------------- Net cash used in investing activities (482.0) (259.2) -------------- -------------- Cash flows from financing activities: Repayment of long-term debt - (6.0) Net proceeds from issuance of common stock upon the exercise of employee stock options in connection with an employee stock purchase plan 175.5 131.6 Tax benefits related to employee stock options 161.2 66.9 Repurchases of common stock (485.1) (470.7) Other (20.6) (29.2) ------------- -------------- Net cash used in financing activities (169.0) (307.4) ------------- -------------- Increase (decrease) in cash and cash equivalents 5.3 (1.5) Cash and cash equivalents at beginning of period 130.9 201.1 ------------- -------------- Cash and cash equivalents at end of period $ 136.2 $ 199.6 ============= ============== See accompanying notes.
6 AMGEN INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS June 30, 2000 1. Summary of significant accounting policies Business Amgen Inc. ("Amgen" or the "Company") is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as well as affiliated companies for which the Company has a controlling financial interest and exercises control over their operations ("majority controlled affiliates"). All material intercompany transactions and balances have been eliminated in consolidation. Investments in affiliated companies which are 50% or less owned and where the Company exercises significant influence over operations are accounted for using the equity method. All other equity investments are accounted for under the cost method. The caption "Loss of affiliates, net" includes Amgen's equity in the operating results of affiliated companies and the minority interest others hold in the operating results of Amgen's majority controlled affiliates. Inventories Inventories are stated at the lower of cost or market. Cost is determined in a manner which approximates the first-in, first-out (FIFO) method. Inventories consist of currently marketed products and product candidates which the Company expects to commercialize. The inventory balance of such product candidates totaled $75.3 million and $20.3 million as of June 30, 2000 and December 31, 1999, respectively. Inventories are shown net of applicable reserves and allowances. Inventories consist of the following (in millions): June 30, December 31, 2000 1999 ---------------- ---------------- Raw materials $ 45.4 $ 37.5 Work in process 178.6 96.6 Finished goods 48.6 50.2 ---------------- ---------------- $272.6 $184.3 ================ ================ 7 Product sales Product sales primarily consist of sales from EPOGEN(R) (Epoetin alfa) and NEUPOGEN(R) (Filgrastim). The Company has the exclusive right to sell Epoetin alfa for dialysis, diagnostics and all non-human uses in the United States. The Company sells Epoetin alfa under the brand name EPOGEN(R). Amgen has granted to Ortho Pharmaceutical Corporation (which has assigned its rights under the product license agreement to Ortho Biotech, Inc.), a subsidiary of Johnson & Johnson ("Johnson & Johnson"), a license relating to Epoetin alfa for sales in the United States for all human uses except dialysis and diagnostics. Pursuant to this license, Amgen does not recognize product sales it makes into the exclusive market of Johnson & Johnson and does recognize the product sales made by Johnson & Johnson into Amgen's exclusive market. Sales in Amgen's exclusive market and adjustments thereto are derived from Company shipments and from third-party data on shipments to end users and their usage (see Note 6, "Contingencies - Johnson & Johnson arbitrations"). Sales of the Company's other products are recognized when shipped and title has passed. Foreign currency transactions The Company has a program to manage foreign currency risk. As part of this program, it has purchased foreign currency option and forward contracts to hedge against possible reductions in values of certain anticipated foreign currency cash flows generally over the next 12 months, primarily resulting from its sales in Europe. At June 30, 2000, the Company had option and forward contracts to exchange foreign currencies for U.S. dollars of $21.6 million and $45.4 million, respectively, all having maturities of seven months or less. The option contracts, which have only nominal intrinsic value at the time of purchase, are designated as effective hedges of anticipated foreign currency transactions for financial reporting purposes and accordingly, the net gains on such contracts are deferred and recognized in the same period as the hedged transactions. The forward contracts do not qualify as hedges for financial reporting purposes and accordingly, are marked-to-market. Net gains on option contracts (including option contracts for hedged transactions whose occurrence are no longer probable) and changes in market values of forward contracts are reflected in "Interest and other income". The deferred premiums on option contracts and fair values of forward contracts are included in "Other current assets". The Company has additional foreign currency forward contracts to hedge exposures to foreign currency fluctuations of certain assets and liabilities denominated in foreign currencies. At June 30, 2000, the Company had forward contracts to exchange foreign currencies for U.S. dollars of $46.3 million, all having maturities of less than one month. These contracts are designated as effective hedges and accordingly, gains and losses on these forward contracts are recognized in the same period the offsetting gains and losses of hedged assets and liabilities are realized and recognized. The fair values of the forward contracts are included in the corresponding 8 captions of the hedged assets and liabilities. Gains and losses on forward contracts, to the extent they differ in amount from the hedged assets and liabilities, are included in "Interest and other income". Employee stock option and stock purchase plans The Company's employee stock option and stock purchase plans are accounted for under Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees". Earnings per share Basic earnings per share is based upon the weighted-average number of common shares outstanding. Diluted earnings per share is based upon the weighted-average number of common shares and dilutive potential common shares outstanding. Potential common shares are outstanding options under the Company's employee stock option plans and potential issuances of stock under the employee stock purchase plan which are included under the treasury stock method. The following table sets forth the computation for basic and diluted earnings per share (in millions, except per share information):
Three Months Ended Six Months Ended June 30, June 30, 2000 1999 2000 1999 ------------- ------------- ------------- ------------- Numerator for basic and diluted earnings per share - net income $302.6 $267.6 $568.8 $514.8 ============= ============= ============= ============= Denominator: Denominator for basic earnings per share - weighted-average shares 1,027.5 1,021.1 1,025.4 1,022.3 Effect of dilutive securities - employee stock options and stock issuances under the employee stock purchase plan 55.8 52.7 59.2 55.1 ------------- ------------- ------------- ------------- Denominator for diluted earnings per share - adjusted weighted- average shares 1,083.3 1,073.8 1,084.6 1,077.4 ============= ============= ============= ============= Basic earnings per share $ 0.29 $ 0.26 $ 0.55 $ 0.50 Diluted earnings per share $ 0.28 $ 0.25 $ 0.52 $ 0.48
Recent accounting pronouncements In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133 ("SFAS 133"), "Accounting for Derivative Instruments and Hedging Activities". SFAS 133 establishes accounting and reporting standards requiring that all derivatives be recorded in the balance sheet as either an asset or liability measured at fair value and that changes in fair 9 value be recognized currently in earnings, unless specific hedge accounting criteria are met. The Company is required to adopt SFAS 133, as amended, in the first quarter of 2001 and is currently evaluating the effect that such adoption may have on its results of operations and financial position. In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 ("SAB 101"), "Revenue Recognition in Financial Statements". SAB 101 provides guidance on applying generally accepted accounting principles to revenue recognition issues in financial statements. The Company is required to adopt SAB 101 in the fourth quarter of 2000. Management does not expect the adoption of SAB 101 to have a material effect on the Company's results of operations or financial position. Use of estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results may differ from those estimates. Basis of presentation The financial information for the three and six months ended June 30, 2000 and 1999 is unaudited but includes all adjustments (consisting only of normal recurring accruals, unless otherwise indicated) which the Company considers necessary for a fair presentation of the results of operations for these periods. Interim results are not necessarily indicative of results for the full fiscal year. Reclassification Certain prior year amounts have been reclassified to conform to the current year presentation. 2. Debt As of June 30, 2000, the Company had $223 million of unsecured long-term debt securities outstanding. These unsecured long-term debt securities consisted of: 1) $100 million of debt securities that bear interest at a fixed rate of 6.5% and mature in 2007 that were issued in December 1997 under a $500 million debt shelf registration (the "Shelf"), 2) $100 million of debt securities that bear interest at a fixed rate of 8.1% and mature in 2097 and 3) $23 million of debt securities that bear interest at a fixed rate of 6.2% and mature in 2003. Under the Shelf, all of the remaining $400 million of debt securities available for issuance may be offered under the Company's medium-term note program from time to time with terms to be determined by market conditions. The Company has a commercial paper program which provides for unsecured short-term borrowings up to an aggregate of $200 million. 10 As of June 30, 2000, commercial paper with a face amount of $100 million was outstanding. These borrowings had maturities of less than one month and had effective interest rates averaging 6.0%. The Company also has an unsecured $150 million credit facility that expires on May 28, 2003. This credit facility supports the Company's commercial paper program. As of June 30, 2000, no amounts were outstanding under this line of credit. 3. Income taxes The provision for income taxes consists of the following (in millions):
Three Months Ended Six Months Ended June 30, June 30, 2000 1999 2000 1999 ------------- ------------ ------------- ------------ Federal (including U.S. possessions) $126.1 $105.9 $235.0 $196.6 State 11.0 8.9 20.6 16.7 ------------- ------------ ------------- ------------ $137.1 $114.8 $255.6 $213.3 ============= ============ ============= ============
The Company's effective tax rate for the three and six months ended June 30, 2000 was 31.2% and 31.0%, respectively, compared with 30.0% and 29.3% for the same periods last year. The higher effective tax rates in the current year are primarily due to an increase in the current year's expected pretax income without corresponding increases in the tax benefits associated with the Company's Puerto Rico operations and research and experimentation credits. 4. Stockholders' equity During the six months ended June 30, 2000, the Company repurchased 7.6 million shares of its common stock at a total cost of $485.1 million under its common stock repurchase program. In October 1999, the Board of Directors authorized the Company to repurchase up to $2 billion of common stock through December 31, 2000, replacing the remaining amount authorized in October 1998. The amount the Company spends on and the number of shares repurchased each quarter varies based on a variety of factors, including the stock price and blackout periods in which the Company is restricted from repurchasing shares. At June 30, 2000, $1,163.1 million of this authorization remained. Stock repurchased under the program is retired. On May 11, 2000, the Company's stockholders approved an increase in the number of authorized shares of common stock from 1,500,000,000 to 2,750,000,000. 11 5. Comprehensive income During the three and six months ended June 30, 2000, total comprehensive income was $291.0 million and $609.2 million, respectively. During the three and six months ended June 30, 1999, total comprehensive income was $260.7 million and $495.4 million, respectively. The Company's other comprehensive income/loss is comprised of unrealized gains and losses on the Company's available-for-sale securities and foreign currency translation adjustments. 6. Contingencies Johnson & Johnson arbitrations In September 1985, the Company granted Johnson & Johnson's affiliate, Ortho Pharmaceutical Corporation, a license relating to certain patented technology and know-how of the Company to sell a genetically engineered form of recombinant human erythropoietin, called Epoetin alfa, throughout the United States for all human uses except dialysis and diagnostics. A number of disputes have arisen between Amgen and Johnson & Johnson as to their respective rights and obligations under the various agreements between them, including the agreement granting the license (the "License Agreement"). A dispute between Amgen and Johnson & Johnson that has been the subject of an arbitration proceeding relates to the audit methodology currently employed by the Company to account for Epoetin alfa sales. The Company and Johnson & Johnson are required to compensate each other for Epoetin alfa sales that either party makes into the other party's exclusive market, sometimes described as "spillover" sales. The Company has established and is employing an audit methodology to measure each party's spillover sales and to allocate the net profits from those sales to the appropriate party. The arbitrator in this matter (the "Arbitrator") issued an opinion adopting the Company's audit methodology with certain adjustments and, subsequently, issued his final order confirming that the Company was the successful party in the arbitration. Pursuant to the final order in the arbitration, an independent panel was formed principally (i) to address ongoing challenges to the survey results for the years 1995 through 1999 and (ii) to refine the procedures for measuring the erythropoietin market as may be necessary. Johnson & Johnson has brought challenges under this procedure to certain survey results for certain periods. As a result of decisions made by this independent panel regarding certain of these challenges as well as other reduced uncertainties, the Company has reduced amounts previously provided for potential spillover liabilities by $49 million in the third quarter of 1999 and $23 million in the fourth quarter of 1998. Because the Arbitrator ruled that the Company was the successful party in the arbitration, Johnson & Johnson was ordered to pay to the Company all costs and expenses, including reasonable attorneys' fees, that the Company incurred in the arbitration as well as one-half of the audit costs. The Company submitted a bill for such costs and expenses incurred over an eight-year period in 12 the amount of approximately $110 million. Johnson & Johnson contested substantially all such costs and expenses. In addition, on October 26, 1998, Johnson & Johnson filed a petition in the Circuit Court of Cook County, Illinois (the "Illinois Lawsuit") seeking to vacate or modify the Arbitrator's award to the Company of all costs and expenses, including reasonable attorney's fees and costs, that the Company incurred in the arbitration. On January 26, 2000, the Arbitrator ruled that the Company is entitled to recover approximately $78 million of its costs and expenses from Johnson & Johnson. On July 5, 2000, the Company and Johnson & Johnson entered into a Settlement Agreement and Mutual Release which provides that (i) the Company, as the successful party in the arbitration, will receive from Johnson & Johnson $78 million for costs and expenses, including reasonable attorneys' fees that the Company incurred in the arbitration as well as one-half of the audit costs, (ii) the Company will pay to Johnson & Johnson $10 million in full and final satisfaction of a dispute as to the remaining amount due to Johnson & Johnson for the 1991-1994 spillover award and (iii) Johnson & Johnson will voluntarily dismiss with prejudice the Illinois Lawsuit. On July 17, 2000, the Arbitrator issued a final order awarding the Company $78 million in costs and expenses, including reasonable attorneys' fees that the Company incurred in the arbitration as well as one-half of the audit costs. The Company will recognize the $78 million benefit of this award in the third quarter of 2000. On July 24, 2000, the Illinois Lawsuit was dismissed with prejudice. The Company has filed a demand in the arbitration to terminate Johnson & Johnson's rights under the License Agreement and to recover damages for breach of the License Agreement based on the Company's claim that Johnson & Johnson has intentionally sold PROCRIT(R) (the brand name under which Johnson & Johnson sells Epoetin alfa) into the Company's exclusive dialysis market. Pursuant to the Arbitrator's ruling, discovery has commenced. Both the Company and Johnson & Johnson filed motions for summary judgment which were argued in January 2000. On March 10, 2000, the Arbitrator denied both motions for summary judgment. A trial date has been set for February 2001. The Company is unable to predict at this time the outcome of its demand for termination of the License Agreement or when it will be resolved. While it is not possible to predict accurately or determine the eventual outcome of the above described legal matters or various other legal proceedings (including patent disputes) involving Amgen, the Company believes that the outcome of these proceedings will not have a material adverse effect on its annual financial statements. 13 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources The Company had cash, cash equivalents and marketable securities of $1,621.1 million at June 30, 2000, compared with $1,333.0 million at December 31, 1999. Cash provided by operating activities has been and is expected to continue to be the Company's primary source of funds. During the six months ended June 30, 2000, operations provided $656.3 million of cash compared with $565.1 million during the same period last year. Capital expenditures totaled $188.7 million for the six months ended June 30, 2000, compared with $147.0 million for the same period a year ago. The Company anticipates spending approximately $450 million to $550 million in 2000 on capital projects and equipment to expand the Company's global operations. The Company receives cash from the exercise of employee stock options and proceeds from the sale of stock by Amgen pursuant to the employee stock purchase plan. During the six months ended June 30, 2000, employee stock option exercises, their related tax benefits and proceeds from the sale of stock by Amgen pursuant to the employee stock purchase plan provided $336.7 million of cash compared with $198.5 million for the same period last year. Proceeds from the exercise of employee stock options and their related tax benefits will vary from period to period based upon, among other factors, fluctuations in the market value of the Company's stock relative to the exercise price of such options. The Company has a stock repurchase program primarily to reduce the dilutive effect of its employee stock option and stock purchase plans. During the six months ended June 30, 2000, the Company purchased 7.6 million shares of its common stock at a cost of $485.1 million compared with 13.9 million shares purchased at a cost of $470.7 million during the same period last year. In October 1999, the Board of Directors authorized the Company to repurchase up to $2 billion of common stock through December 31, 2000, replacing the remaining amount authorized in October 1998. The amount the Company spends on and the number of shares repurchased each quarter varies based on a variety of factors, including the stock price and blackout periods in which the Company is restricted from repurchasing shares. As of June 30, 2000, $1,163.1 million was available for stock repurchases. To provide for financial flexibility and increased liquidity, the Company has established several sources of debt financing. As of June 30, 2000, the Company had $223 million of unsecured long-term debt securities outstanding. These unsecured long-term debt securities consisted of: 1) $100 million of debt securities that bear interest at a fixed rate of 6.5% and mature in 2007 that were issued in December 1997 under a $500 million debt shelf registration (the "Shelf"), 2) $100 million of debt securities that bear interest at a fixed rate of 8.1% and mature in 2097 and 3) $23 million of debt securities that bear interest at a fixed rate of 6.2% and mature in 14 2003. Under the Shelf, all of the remaining $400 million of debt securities available for issuance may be offered under the Company's medium-term note program from time to time with terms to be determined by market conditions. The Company's sources of debt financing also include a commercial paper program which provides for unsecured short-term borrowings up to an aggregate face amount of $200 million. As of June 30, 2000, commercial paper with a face amount of $100 million was outstanding. These borrowings had maturities of less than one month and had effective interest rates averaging 6.0%. In addition, the Company has an unsecured $150 million credit facility that expires on May 28, 2003. This credit facility supports the Company's commercial paper program. As of June 30, 2000, no amounts were outstanding under this line of credit. The primary objectives for the Company's investment portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return to the Company, consistent with these two objectives. The Company's investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company invests its excess cash in securities with varying maturities to meet projected cash needs. The Company believes that existing funds, cash generated from operations and existing sources of debt financing are adequate to satisfy its working capital and capital expenditure requirements for the foreseeable future, as well as to support its stock repurchase program. However, the Company may raise additional capital from time to time. Results of Operations Product sales Product sales were $806.8 million and $1,504.4 million during the three and six months ended June 30, 2000, respectively. These amounts represent increases of $68.9 million and $78.2 million or 9% and 5%, respectively, over the same periods last year. Quarterly product sales are influenced by a number of factors, including underlying demand, wholesaler inventory management practices and foreign exchange effects. EPOGEN(R) (Epoetin alfa) EPOGEN(R) sales were $493.0 million and $933.4 million for the three and six months ended June 30, 2000, respectively. These amounts represent increases of $65.0 million and $110.5 million or 15% and 13%, respectively, over the same periods last year. These increases were primarily due to higher demand. Sales in the first six months of 2000 were adversely impacted by year 2000-related sales to wholesalers in the fourth quarter of 1999 for which the Company provided extended payment terms and, the Company believes, 15 by dialysis provider inventory drawdowns in 2000 of additional 1999 year-end stockpiling. The Company also believes that some of this dialysis provider stockpiling may have been due to year 2000 concerns and year-end contract expirations. NEUPOGEN(R) (Filgrastim) Worldwide NEUPOGEN(R) sales for the three months ended June 30, 2000 were $309.7 million, an increase of $6.2 million or 2% over the same period last year. For the six months ended June 30, 2000, worldwide NEUPOGEN(R) sales were $559.7 million, a decrease of $30.8 million or 5% from the same period last year. During the second quarter of 2000, NEUPOGEN(R) sales were adversely impacted by several factors, including foreign exchange effects and continued low inventory levels at major wholesalers. The Company believes that NEUPOGEN(R) demand also softened in the second quarter of 2000 and grew at a mid-single digit rate, which includes the effect of higher prices in the U.S. The Company believes this softness in demand was due in part to the realignment of the oncology sales force. NEUPOGEN(R) sales in the first six months of 2000 were adversely impacted primarily by year 2000-related sales to wholesalers in the fourth quarter of 1999 for which the Company provided extended payment terms and, the Company believes, by additional wholesaler inventory drawdowns in 2000. In addition, NEUPOGEN(R) sales in the first six months of 2000 were also adversely impacted by the stronger U.S. dollar. These decreases were partially offset by higher demand, which includes the effect of higher prices in the U.S. Other product sales Other product sales primarily consist of INFERGEN(R) (Interferon alfacon- 1). INFERGEN(R) sales were $3.8 million and $10.7 million for the three and six months ended June 30, 2000, respectively. These amounts represent decreases of $2.5 million and $1.9 million or 40% and 15%, respectively, from the same periods last year. INFERGEN(R) was launched in October 1997 for the treatment of chronic hepatitis C virus infection. There are existing treatments, including combination therapy, for this infection against which INFERGEN(R) competes. The Company cannot predict the extent to which it will maintain its share or further penetrate this market. Corporate partner revenues During the three and six months ended June 30, 2000, corporate partner revenues increased $12.1 million and $59.3 million, or 25% and 78%, respectively, compared with the same periods last year. These increases were primarily due to amounts earned from Kirin-Amgen, Inc. related to the NESP development program. 16 Cost of sales Cost of sales as a percentage of product sales was 12.6% and 12.5% for the three and six months ended June 30, 2000, respectively, compared with 13.4% for both of the same periods last year. These decreases as a percentage of product sales were due in part to increased manufacturing efficiencies. Research and development During the three and six months ended June 30, 2000, research and development expenses increased $8.7 million and $10.5 million, or 4% and 3%, respectively, compared with the same periods last year. Research and development expenses increased primarily due to higher staff-related costs necessary to support ongoing product development activities and higher clinical trial costs. These increases were substantially offset by a reduction in clinical manufacturing and product licensing costs. Selling, general and administrative During the three and six months ended June 30, 2000, selling, general and administrative ("SG&A") expenses increased $47.9 million and $84.7 million, or 30% and 29%, respectively, compared with the same periods last year. SG&A expenses increased primarily due to higher staff-related costs and outside marketing expenses as the Company continues to support its existing products and prepares for anticipated new product launches. Interest and other income During the three and six months ended June 30, 2000, interest and other income increased $18.7 million and $36.6 million, or 76% and 85%, respectively, compared with the same periods last year. These increases were primarily due to gains realized on the sale of certain equity securities in the Company's portfolio. Income taxes The Company's effective tax rate for the three and six months ended June 30, 2000 was 31.2% and 31.0%, respectively, compared with 30.0% and 29.3% for the same periods last year. The higher effective tax rates in the current year are primarily due to an increase in the current year's expected pretax income without corresponding increases in the tax benefits associated with the Company's Puerto Rico operations and research and experimentation credits. Foreign currency transactions The Company has a program to manage certain portions of its exposure to fluctuations in foreign currency exchange rates arising from international operations. The Company generally hedges the receivables and payables with foreign currency forward contracts, which typically mature within one to three months. The Company uses foreign currency option and forward contracts which generally expire within 12 months to hedge certain anticipated future sales and 17 expenses. At June 30, 2000, outstanding foreign currency option and forward contracts totaled $21.6 million and $91.7 million, respectively. Financial Outlook The Company expects the EPOGEN(R) sales growth rate in 2000 to be in the low teens. As average hematocrits have risen, the rate of demand growth has slowed and the Company expects this trend to continue in the future. Patients receiving treatment for end stage renal disease are covered primarily under medical programs provided by the federal government. Therefore, EPOGEN(R) sales may also be affected by future changes in reimbursement rates or a change in the basis for reimbursement by the federal government. In their fiscal year 2001 budget, the Clinton administration has proposed a Medicare cost savings plan which includes a provision for cutting Medicare reimbursement of EPOGEN(R) by 10%. This proposal will be addressed during the federal government's fiscal year 2001 budget process. The Company believes the proposal, if enacted, would primarily affect dialysis providers that use EPOGEN(R) and it is difficult to predict its impact on Amgen. Assuming that foreign exchange rates for the U.S. dollar remain at levels existing at June 30, 2000, the Company expects NEUPOGEN(R) sales in 2000 to be approximately the same as in 1999. The Company believes that there may be a trend in some cancer settings towards the use of chemotherapy treatments that are less myelosuppressive. Chemotherapy treatments that are less myelosuppressive may require less NEUPOGEN(R). Future NEUPOGEN(R) sales growth is dependent primarily upon further penetration of existing markets and the effects of competitive products. NEUPOGEN(R) usage is expected to continue to be affected by cost containment pressures from governments and private insurers on health care providers worldwide. In addition, reported NEUPOGEN(R) sales will continue to be affected by changes in foreign currency exchange rates. In both domestic and foreign markets, sales of NEUPOGEN(R) are dependent, in part, on the availability of reimbursement from third party payors such as governments (for example, Medicare and Medicaid programs in the U.S.) and private insurance plans. Therefore, NEUPOGEN(R) sales may also be affected by future changes in reimbursement rates or changes in the bases for reimbursement. In their fiscal year 2001 budget, the Clinton administration has proposed a reduction in the basis upon which Medicare reimburses for outpatient prescription drugs from the current 95% of average wholesale price ("AWP") to 83% of AWP. This proposal would impact reimbursement of NEUPOGEN(R). The Company believes the proposal, if enacted, would primarily affect customers that use NEUPOGEN(R) and it is difficult to predict its impact on Amgen. INFERGEN(R) (Interferon alfacon-1) was launched in October 1997 for the treatment of chronic hepatitis C virus infection. There are existing treatments, including combination therapy, for this infection against which INFERGEN(R) competes. The Company cannot 18 predict the extent to which it will maintain its share or further penetrate this market. In 2000, SG&A expenses are expected to significantly increase as the Company continues to support its existing products and prepares for anticipated new product launches. Excluding a legal award benefit of $78 million to be recorded in the third quarter of 2000 (see Note 6 to the Condensed Consolidated Financial Statements), Amgen expects earnings per share for 2000 to be in the range of $1.06 to $1.08. Estimates of future product sales, operating expenses and earnings per share are necessarily speculative in nature and are difficult to predict with accuracy. Except for the historical information contained herein, the matters discussed herein are by their nature forward-looking. Investors are cautioned that forward-looking statements or projections made by the Company, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Reference is made in particular to forward-looking statements regarding product sales, earnings per share and expenses. Amgen operates in a rapidly changing environment that involves a number of risks, some of which are beyond the Company's control. Future operating results and the Company's stock price may be affected by a number of factors, including, without limitation: (i) the results of preclinical and clinical trials; (ii) regulatory approvals of product candidates, new indications and manufacturing facilities; (iii) reimbursement for Amgen's products by governments and private payors; (iv) health care guidelines and policies relating to Amgen's products; (v) intellectual property matters (patents) and the results of litigation; (vi) competition; (vii) fluctuations in operating results and (viii) rapid growth of the Company. These factors and others are discussed herein and in the sections appearing in "Item 1. Business - Factors That May Affect Amgen" in the Company's Annual Report on Form 10-K for the year ended December 31, 1999 which sections are incorporated herein by reference and filed as an exhibit hereto. Legal Matters The Company is engaged in arbitration proceedings with one of its licensees. For a discussion of these matters, see Note 6 to the Condensed Consolidated Financial Statements. 19 PART II - OTHER INFORMATION Item 1. LEGAL PROCEEDINGS Legal proceedings are reported in the Company's Annual Report on Form 10-K for the year ended December 31, 1999, with material developments since that report described in the Company's Form 10-Q for the quarter ended March 31, 2000, and below. While it is not possible to predict accurately or to determine the eventual outcome of these matters, the Company believes that the outcome of these proceedings will not have a material adverse effect on the annual financial statements of the Company. Transkaryotic Therapies and Aventis S.A. litigation On May 15, 2000, trial began in the United States District Court in Boston, Massachusetts (the "Court") and is ongoing. On June 9, 2000, the Court granted Transkaryotic Therapies, Inc.'s ("TKT") and Hoechst Marion Roussel, Inc.'s ("HMR" - now Aventis S.A., together with TKT, the "Defendants") motion for non- infringement of U.S. Patent No. 5,618,698 (the "'698 Patent"), removing the '698 Patent from this action. The Court also held that, although the Defendants' erythropoietin product does not literally fall within the scope of U.S. Patent No. 5,621,080 (the "'080 Patent"), such product may infringe if it is found to be equivalent to the product claimed by the '080 Patent. Additionally, the Court denied the Defendants' motion for non-infringement of U.S. Patent No. 5,547,933 (the "'933 Patent"). On July 21, 2000, the Court granted Amgen's motion for judgment on the Defendants' defenses of invalidity based upon anticipation and obviousness. The issues of infringement of the '933 Patent, the '080 Patent and U.S. Patent No. 5,756,349 remain to be decided by the Court as well as the other validity and inequitable conduct defenses raised by the Defendants. Securities litigation The class action complaint filed against the Company and certain of its current and former officers in the California Superior Court for the County of Ventura was dismissed with prejudice on May 31, 2000. Johnson & Johnson arbitrations The Company is engaged in arbitration proceedings with one of its licensees. See Note 6 to the Condensed Consolidated Financial Statements, "Contingencies-Johnson & Johnson arbitrations". 20 Item 4. Submission of Matters to a Vote of Security Holders (a) The Company held its Annual Meeting of Stockholders on May 11, 2000. (b) Omitted pursuant to Instruction 3 to Item 4 of Form 10-Q. (c) The four matters voted upon at the meeting were: (i) to elect three directors to a three year term of office expiring at the Annual Meeting of Stockholders in the year 2003; (ii) to approve an amendment to the Company's Restated Certificate of Incorporation, as amended, to increase the authorized number of shares of Common Stock from 1,500,000,000 shares to 2,750,000,000 shares ("Proposal Two"); (iii) to approve an amendment to the Company's Amended and Restated Employee Stock Purchase Plan to extend the term of such plan indefinitely ("Proposal Three"); and (iv) to ratify the selection of Ernst & Young LLP as independent auditors of the Company for the year ending December 31, 2000 ("Proposal Four"). (i) With respect to each of the nominees for director, Gordon M. Binder, received 902,615,275 shares in favor and 5,938,887 shares were withheld, Fredrick W. Gluck received 847,729,463 shares in favor and 60,824,699 shares were withheld and Franklin P. Johnson, Jr. received 902,666,186 shares in favor and 5,887,976 shares were withheld, and there were no abstentions or broker non-votes. All nominees were declared to have been elected as directors to hold office until the Annual Meeting of Stockholders in the year 2003. (ii) With respect to Proposal Two, 840,847,018 shares were in favor, 63,282,003 shares were against, 4,424,308 shares abstained and there were 833 broker non-votes. Proposal Two was declared to have been approved. (iii) With respect to Proposal Three, 878,301,243 shares were in favor, 24,001,076 shares were against, 6,209,340 shares abstained and there were 42,503 broker non-votes. Proposal Three was declared to have been approved. (iv) With respect to Proposal Four, 903,214,912 shares were in favor, 1,694,599 shares were against, 3,644,649 shares abstained and there were 2 broker non-votes. Proposal Four was declared to have been approved. (d) Not applicable. 21 Item 5. Other Information The Company's 2001 Annual Meeting of Stockholders will be held on May 17, 2001. Item 6. Exhibits and Reports on Form 8-K (a) Reference is made to the Index to Exhibits included herein. (b) Reports on Form 8-K - none 22 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Amgen Inc. (Registrant) Date: 8/1/00 By: /s/ Kathryn E. Falberg ---------------- ------------------------------------ Kathryn E. Falberg Senior Vice President, Finance and Chief Financial Officer Date: 8/1/00 By: /s/ Barry D. Schehr ---------------- ------------------------------------ Barry D. Schehr Vice President, Financial Operations, and Chief Accounting Officer 23 AMGEN INC. INDEX TO EXHIBITS Exhibit No. Description 3.1 Restated Certificate of Incorporation as amended. (14) 3.2 Amended and Restated Bylaws. (22) 3.3* Certificate of Amendment of Restated Certificate of Incorporation. 3.4* Certificate of Amendment of Certificate of Designations of Series A Junior Participating Preferred Stock. 4.1 Indenture dated January 1, 1992 between the Company and Citibank N.A., as trustee. (6) 4.2 First Supplement to Indenture, dated February 26, 1997 between the Company and Citibank N.A., as trustee. (11) 4.3 Officer's Certificate pursuant to Sections 2.1 and 2.3 of the Indenture, as supplemented, establishing a series of securities "8- 1/8% Debentures due April 1, 2097." (13) 4.4 8-1/8% Debentures due April 1, 2097. (13) 4.5 Form of stock certificate for the common stock, par value $.0001 of the Company. (14) 4.6 Officer's Certificate pursuant to Sections 2.1 and 2.3 of the Indenture, dated as of January 1, 1992, as supplemented by the First supplemental Indenture, dated as of February 26, 1997, each between the Company and Citibank, N.A., as Trustee, establishing a series of securities entitled "6.50% Notes Due December 1, 2007". (16) 4.7 6.50% Notes Due December 1, 2007 described in Exhibit 4.6. (16) 4.8 Corporate Commercial Paper - Master Note between and among Amgen Inc., as Issuer, Cede & Co., as nominee of The Depository Trust Company and Citibank, N.A. as Paying Agent. (19) 10.1 Company's Amended and Restated 1991 Equity Incentive Plan. (22) 10.2 Sixth Amendment to the Company's Amended and Restated Retirement and Savings Plan as amended and restated April 1, 1996. (21) 10.3 Shareholder's Agreement of Kirin-Amgen, Inc., dated May 11, 1984, between the Company and Kirin Brewery Company, Limited (with certain confidential information deleted therefrom). (1) 10.4* Amendment Nos. 1, 2, and 3, dated March 19, 1985, July 29, 1985 and December 19, 1985, respectively, to the Shareholder's Agreement of Kirin-Amgen, Inc., dated May 11, 1984. 10.5* Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated, September 30, 1985 between the Company and Ortho Pharmaceutical Corporation. 24 10.6* Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated September 30, 1985 between Kirin-Amgen, Inc. and Ortho Pharmaceutical Corporation. 10.7* Company's Amended and Restated Employee Stock Purchase Plan. 10.8 Research, Development Technology Disclosure and License Agreement PPO, dated January 20, 1986, by and between the Company and Kirin Brewery Co., Ltd. (2) 10.9 Amendment Nos. 4 and 5, dated October 16, 1986 (effective July 1, 1986) and December 6, 1986 (effective July 1, 1986), respectively, to the Shareholders Agreement of Kirin-Amgen, Inc. dated May 11, 1984 (with certain confidential information deleted therefrom). (3) 10.10 Assignment and License Agreement, dated October 16, 1986, between the Company and Kirin-Amgen, Inc. (with certain confidential information deleted therefrom). (3) 10.11 G-CSF European License Agreement, dated December 30, 1986, between Kirin-Amgen, Inc. and the Company (with certain confidential information deleted therefrom). (3) 10.12 Research and Development Technology Disclosure and License Agreement: GM-CSF, dated March 31, 1987, between Kirin Brewery Company, Limited and the Company (with certain confidential information deleted therefrom). (3) 10.13 Company's Amended and Restated 1988 Stock Option Plan. (9) 10.14 Company's Amended and Restated Retirement and Savings Plan. (9) 10.15 Amendment, dated June 30, 1988, to Research, Development, Technology Disclosure and License Agreement: GM-CSF dated March 31, 1987, between Kirin Brewery Company, Limited and the Company. (4) 10.16 Agreement on G-CSF in Certain European Countries, dated January 1, 1989, between Amgen Inc. and F. Hoffmann-La Roche & Co. Limited Company (with certain confidential information deleted therefrom). (5) 10.17 Partnership Purchase Agreement, dated March 12, 1993, between the Company, Amgen Clinical Partners, L.P., Amgen Development Corporation, the Class A limited partners and the Class B limited partner. (7) 10.18 Amgen Inc. Supplemental Retirement Plan (As Amended and Restated Effective November 1, 1999). (23) 10.19* First Amendment to Amgen Inc. Change of Control Severance Plan. 10.20 Amended and Restated Amgen Performance Based Management Incentive Plan. (22) 10.21 Credit Agreement, dated as of May 28, 1998, among Amgen Inc., the Borrowing Subsidiaries named therein, the Banks named therein, Citibank, N.A., as Issuing Bank, and Citicorp USA, Inc., as Administrative Agent. (20) 10.22 Promissory Note of Mr. George A. Vandeman, dated December 15, 1995. (8) 10.23 Promissory Note of Mr. George A. Vandeman, dated December 15, 1995. (8) 10.24 Agreement between Amgen Inc. and Dr. N. Kirby Alton, dated October 11, 1999. (23) 25 10.25 Amendment No. 1 to the Company's Amended and Restated Retirement and Savings Plan. (9) 10.26 Seventh Amendment to the Amgen Retirement and Savings Plan as Amended and Restated effective April 1, 1996. (22) 10.27 Amendment Number 2 to the Company's Amended and Restated Retirement and Savings Plan dated April 1, 1996. (12) 10.28 Amgen Inc. Change of Control Severance Plan effective as of October 20, 1998. (21) 10.29 Preferred Share Rights Agreement, dated February 18, 1997, between Amgen Inc. and American Stock Transfer and Trust Company, Rights Agent. (10) 10.30 First Amendment, effective January 1, 1998, to the Company's Amended and Restated Employee Stock Purchase Plan. (15) 10.31 Third Amendment, effective January 1, 1997, to the Company's Amended and Restated Retirement and Savings Plan dated April 1, 1996. (15) 10.32 Agreement between Amgen Inc. and Dr. Fabrizio Bonanni, dated March 3, 1999. (23) 10.33 Promissory Note of Ms. Kathryn E. Falberg, dated April 7, 1995. (17) 10.34 Promissory Note of Mr. Edward F. Garnett, dated July 18, 1997. (17) 10.35 Fourth Amendment to the Company's Amended and Restated Retirement and Savings Plan as amended and restated effective April 1, 1996. (17) 10.36 Fifth Amendment to the Company's Amended and Restated Retirement and Savings Plan as amended and restated effective April 1, 1996. (17) 10.37 Company's Amended and Restated 1987 Directors' Stock Option Plan. (12) 10.38 Amended and Restated Agreement on G-CSF in the EU between Amgen Inc. and F. Hoffmann-La Roche Ltd (with certain confidential information deleted therefrom). (19) 10.39 Collaboration and License Agreement, dated December 15, 1997, between the Company, GPI NIL Holdings, Inc. and Guilford Pharmaceuticals Inc. (with certain confidential information deleted therefrom). (18) 10.40 Promissory Note of Dr. Fabrizio Bonanni, dated August 7, 1999. (23) 10.41 Promissory Note of Dr. Fabrizio Bonanni, dated October 29, 1999. (23) 10.42 Agreement between Amgen Inc. and Dr. Lawrence M. Souza, Ph.D., dated March 6, 2000. (24) 10.43* Agreement between Amgen Inc. and Mr. Gordon M. Binder, dated May 10, 2000. 27* Financial Data Schedule. 99* Sections appearing under the heading "Item 1. Business - Factors That May Affect Amgen" in the Company's Annual Report on Form 10-K for the year ended December 31, 1999. ---------------- * Filed herewith. 26 (1) Filed as an exhibit to the Annual Report on Form 10-K for the year ended March 31, 1984 on June 26, 1984 and incorporated herein by reference. (2) Filed as an exhibit to Amendment No. 1 to Form S-1 Registration Statement (Registration No. 33-3069) on March 11, 1986 and incorporated herein by reference. (3) Filed as an exhibit to the Form 10-K Annual Report for the year ended March 31, 1987 on May 18, 1987 and incorporated herein by reference. (4) Filed as an exhibit to Form 8 amending the Quarterly Report on Form 10-Q for the quarter ended June 30, 1988 on August 25, 1988 and incorporated herein by reference. (5) Filed as an exhibit to the Form 8 dated November 8, 1989, amending the Annual Report on Form 10-K for the year ended March 31, 1989 on June 28, 1989 and incorporated herein by reference. (6) Filed as an exhibit to Form S-3 Registration Statement dated December 19, 1991 and incorporated herein by reference. (7) Filed as an exhibit to the Form 8-A dated March 31, 1993 and incorporated herein by reference. (8) Filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 1995 on March 29, 1996 and incorporated herein by reference. (9) Filed as an exhibit to the Form 10-Q for the quarter ended September 30, 1996 on November 5, 1996 and incorporated herein by reference. (10) Filed as an exhibit to the Form 8-K Current Report dated February 18, 1997 on February 28, 1997 and incorporated herein by reference. (11) Filed as an exhibit to the Form 8-K Current Report dated March 14, 1997 on March 14, 1997 and incorporated herein by reference. (12) Filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 1996 on March 24, 1997 and incorporated herein by reference. (13) Filed as an exhibit to the Form 8-K Current Report dated April 8, 1997 on April 8, 1997 and incorporated herein by reference. (14) Filed as an exhibit to the Form 10-Q for the quarter ended March 31, 1997 on May 13, 1997 and incorporated herein by reference. (15) Filed as an exhibit to the Form 10-Q for the quarter ended June 30, 1997 on August 12, 1997 and incorporated herein by reference. (16) Filed as an exhibit to the Form 8-K Current Report dated and filed on December 5, 1997 and incorporated herein by reference. (17) Filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 1997 on March 24, 1998 and incorporated herein by reference. (18) Filed as Exhibit 10.40 to the Guilford Pharmaceuticals Inc. Form 10-K for the year ended December 31, 1997 on March 27, 1998 and incorporated herein by reference. (19) Filed as an exhibit to the Form 10-Q for the quarter ended March 31, 1998 on May 13, 1998 and incorporated herein by reference. 27 (20) Filed as an exhibit to the Form 10-Q for the quarter ended June 30, 1998 on August 14, 1998 and incorporated herein by reference. (21) Filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 1998 on March 16, 1999 and incorporated herein by reference. (22) Filed as an exhibit to the Form 10-Q for the quarter ended June 30, 1999 on August 3, 1999 and incorporated herein by reference. (23) Filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 1999 on March 7, 2000 and incorporated herein by reference. (24) Filed as an exhibit to the Form 10-Q for the quarter ended March 31, 2000 on April 27, 2000 and incorporated herein by reference. 28