- -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- FORM 10-Q SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (MARK ONE) /X/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 1999 OR / / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ______________ Commission File Number: 0-12798 __CHIRON CORPORATION__ (Exact name of registrant as specified in its charter) DELAWARE 94-2754624 -------- --------- (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 4560 HORTON STREET, EMERYVILLE, CALIFORNIA 94608 (Address of principal executive offices) (Zip code) (510) 655-8730 (Registrant's telephone number, including area code) NOT APPLICABLE (Former name, former address and former fiscal year, if changed since last report) 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 ______ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. TITLE OF CLASS OUTSTANDING AT OCTOBER 31, 1999 Common Stock, $0.01 par value 181,650,478 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- CHIRON CORPORATION TABLE OF CONTENTS PAGE NO. PART I. FINANCIAL INFORMATION -------- ITEM 1. FINANCIAL STATEMENTS Condensed Consolidated Balance Sheets as of September 30, 1999 and December 31, 1998............... 3 Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 1999 and 1998................................................... 4 Condensed Consolidated Statements of Comprehensive Income for the three and nine months ended September 30, 1999 and 1998............................ 5 Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 1999 and 1998.......... 6 Notes to Condensed Consolidated Financial Statements.... 7 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS..................... 16 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK............................................. 28 PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS................................. 28 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.................. 29 SIGNATURES.................................................. 31 2 ITEM 1. FINANCIAL STATEMENTS CHIRON CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE DATA) SEPTEMBER 30, DECEMBER 31, 1999 1998 -------------- ------------- (UNAUDITED) ASSETS Current assets: Cash and cash equivalents................................. $ 205,768 $ 513,315 Short-term investments in marketable debt securities...... 699,612 716,619 ---------- ---------- Total cash and short-term investments................... 905,380 1,229,934 Accounts receivable, net.................................. 197,419 167,588 Inventories............................................... 95,149 79,862 Other current assets...................................... 78,086 153,558 ---------- ---------- Total current assets.................................... 1,276,034 1,630,942 Noncurrent investments in marketable debt securities........ 647,631 360,069 Property, plant, equipment, and leasehold improvements, at cost: Land and buildings........................................ 143,022 141,452 Laboratory, production, and office equipment.............. 310,612 236,803 Leasehold improvements.................................... 69,226 84,607 Construction-in-progress.................................. 27,998 38,321 ---------- ---------- 550,858 501,183 Less accumulated depreciation and amortization............ (232,396) (198,102) ---------- ---------- Net property, plant, equipment, and leasehold improvements.......................................... 318,462 303,081 Purchased technology, net................................... 12,518 14,753 Other intangible assets, net................................ 146,973 167,534 Investments in equity securities and affiliated companies... 35,794 27,456 Other assets................................................ 37,156 20,429 ---------- ---------- $2,474,568 $2,524,264 ========== ========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable.......................................... $ 44,562 $ 44,833 Accrued compensation and related expenses................. 46,739 40,727 Short-term borrowings and current portion of long-term debt.................................................... 24,123 17,554 Note payable to Novartis.................................. 66,830 63,945 Current portion of unearned revenue....................... 36,413 41,893 Taxes payable............................................. 31,919 180,536 Other current liabilities................................. 120,606 167,947 ---------- ---------- Total current liabilities............................... 371,192 557,435 Long-term debt.............................................. 350,736 338,158 Other noncurrent liabilities................................ 65,497 82,869 ---------- ---------- Total liabilities....................................... 787,425 978,462 ---------- ---------- Commitments and contingencies (Note 6) Stockholders' equity: Common stock.............................................. 1,819 1,799 Additional paid-in capital................................ 2,039,149 1,979,615 Accumulated deficit....................................... (331,599) (437,873) Accumulated other comprehensive (loss) income............. (7,351) 2,261 Treasury stock, at cost (432,712 shares).................. (14,875) -- ---------- ---------- Total stockholders' equity.............................. 1,687,143 1,545,802 ---------- ---------- $2,474,568 $2,524,264 ========== ========== THE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS ARE AN INTEGRAL PART OF THIS STATEMENT. 3 CHIRON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (IN THOUSANDS, EXCEPT PER SHARE DATA) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------------- ------------------------- 1999 1998 1999 1998 ----------- ----------- ----------- ----------- Revenues: Product sales, net.......................... $ 114,006 $ 112,813 $ 308,295 $ 278,091 Equity in earnings of unconsolidated joint businesses................................ 23,297 21,255 58,431 51,493 Collaborative agreement revenues............ 18,442 24,278 59,603 73,110 Royalty and license fee revenues............ 36,524 49,756 96,292 81,325 Other revenues.............................. 12,107 7,868 46,425 28,128 ----------- ----------- ----------- ----------- Total revenues............................ 204,376 215,970 569,046 512,147 ----------- ----------- ----------- ----------- Operating expenses: Cost of sales............................... 53,580 51,063 138,215 124,462 Research and development.................... 75,473 67,348 216,732 196,238 Selling, general, and administrative........ 41,802 40,745 128,617 103,533 Write-off of purchased in-process technologies.............................. -- -- -- 1,645 Restructuring and reorganization charges (Note 3).................................. (1,290) 6,401 2,062 11,339 Other operating expenses.................... 2,471 3,179 7,164 8,142 ----------- ----------- ----------- ----------- Total operating expenses.................. 172,036 168,736 492,790 445,359 ----------- ----------- ----------- ----------- Income from operations........................ 32,340 47,234 76,256 66,788 Gain on sale of assets........................ -- 1,510 -- 7,751 Interest expense.............................. (6,158) (6,009) (17,866) (18,638) Other income, net............................. 19,685 5,035 63,061 21,196 ----------- ----------- ----------- ----------- Income from continuing operations before income taxes................................ 45,867 47,770 121,451 77,097 Provision for income taxes.................... 826 13,856 18,938 15,539 ----------- ----------- ----------- ----------- Income from continuing operations............. 45,041 33,914 102,513 61,558 ----------- ----------- ----------- ----------- Discontinued operations (Note 2): Income (loss) from discontinued operations................................ -- 5,001 -- (8,107) Gain on disposal of discontinued operations................................ 23,288 45,520 26,297 110,852 ----------- ----------- ----------- ----------- Net income.................................... $ 68,329 $ 84,435 $ 128,810 $ 164,303 =========== =========== =========== =========== Basic earnings per share (Note 1): Income from continuing operations........... $ 0.25 $ 0.19 $ 0.57 $ 0.35 =========== =========== =========== =========== Net income.................................. $ 0.38 $ 0.47 $ 0.71 $ 0.93 =========== =========== =========== =========== Diluted earnings per share (Note 1): Income from continuing operations........... $ 0.24 $ 0.19 $ 0.55 $ 0.34 =========== =========== =========== =========== Net income.................................. $ 0.36 $ 0.47 $ 0.69 $ 0.91 =========== =========== =========== =========== THE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS ARE AN INTEGRAL PART OF THIS STATEMENT. 4 CHIRON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (UNAUDITED) (IN THOUSANDS) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------------- ------------------------- 1999 1998 1999 1998 ----------- ----------- ----------- ----------- Net income.................................... $ 68,329 $ 84,435 $ 128,810 $ 164,303 ----------- ----------- ----------- ----------- Other comprehensive income (loss): Foreign currency translation adjustment: Change in foreign currency translation adjustment during the period............ 6,236 7,893 (13,500) 6,910 Plus: reclassification adjustment for loss included in discontinued operations..... -- -- -- 2,087 ----------- ----------- ----------- ----------- Net foreign currency translation adjustment.............................. 6,236 7,893 (13,500) 8,997 ----------- ----------- ----------- ----------- Unrealized gains (losses) from investments: Unrealized holding gains (losses) arising during the period......................... 880 (2,375) 4,793 (8,744) Reclassification adjustment for net losses (gains) included in net income net of tax benefit (provision) of $26 and $311 for the three months ended September 30, 1999 and 1998, respectively, and ($531) and ($253) for the nine months ended September 30, 1999 and 1998, respectively.............................. 86 553 (905) (448) ----------- ----------- ----------- ----------- Net unrealized gains (losses) from investments............................... 966 (1,822) 3,888 (9,192) ----------- ----------- ----------- ----------- Other comprehensive income (loss)............. 7,202 6,071 (9,612) (195) ----------- ----------- ----------- ----------- Comprehensive income.......................... $ 75,531 $ 90,506 $ 119,198 $ 164,108 =========== =========== =========== =========== THE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS ARE AN INTEGRAL PART OF THIS STATEMENT. 5 CHIRON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (IN THOUSANDS) NINE MONTHS ENDED SEPTEMBER 30, ------------------------- 1999 1998 ----------- ----------- Net cash (used in) provided by operating activities......... $ (37,092) $ 85,766 ----------- ----------- Cash flows from investing activities: Purchases of investments in marketable debt securities.... (1,130,974) (371,343) Proceeds from sale and maturity of investments in marketable debt securities.............................. 867,365 192,406 Capital expenditures...................................... (55,742) (82,480) Proceeds from disposal of discontinued operations......... 46,912 298,939 Proceeds from sale of assets.............................. -- 38,312 Business acquired, net of cash acquired................... -- (54,770) Purchases of investments in equity securities and affiliated companies.................................... -- (6,000) Other, net................................................ (11,108) (23,314) ----------- ----------- Net cash used in investing activities................... (283,547) (8,250) ----------- ----------- Cash flows from financing activities: Net proceeds from (repayment of) short-term borrowings.... 7,934 (129,800) Proceeds from issuance of debt............................ 8,114 -- Repayment of debt and capital leases...................... (1,987) (1,693) Proceeds from issuance of common stock.................... 31,683 35,962 Proceeds from reissuance of treasury stock................ 36,408 -- Payments to acquire treasury stock........................ (69,060) -- ----------- ----------- Net cash provided by (used in) financing activities..... 13,092 (95,531) ----------- ----------- Net decrease in cash and cash equivalents............... (307,547) (18,015) Cash and cash equivalents at beginning of the period........ 513,315 98,483 ----------- ----------- Cash and cash equivalents at end of the period.............. $ 205,768 $ 80,468 =========== =========== THE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS ARE AN INTEGRAL PART OF THIS STATEMENT. 6 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 1999 (UNAUDITED) NOTE 1--THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BASIS OF PRESENTATION The information presented in the accompanying Condensed Consolidated Financial Statements at September 30, 1999, and for the three and nine months ended September 30, 1999 and 1998, is unaudited, but includes all normal recurring adjustments which the management of Chiron Corporation ("Chiron" or the "Company") believes to be necessary for fair presentation of the periods presented. For the three and nine months ended September 30, 1999, the Company's results include a $2.0 million and $8.4 million reduction, respectively, in other operating expenses resulting from a change in estimated tax accruals related to certain employee payments recorded in 1995 in connection with the Novartis transaction. For the three and nine months ended September 30, 1999, the Company's results also include a $23.3 million and $26.3 million adjustment, respectively, to the gain on disposal of discontinued operations resulting from net tax benefits of adjustments to the sales price of Chiron Diagnostics, the disposal of most of the Claremont facility and adjustments to certain deductions and credits based on the filing of the Company's 1998 income tax returns, as well as changes in estimated accruals created at the time of disposal. For the three and nine months ended September 30, 1998, the Company's results include a $3.3 million and $9.3 million reduction, respectively, in cost of sales due to a change in estimated property tax accruals created in prior periods. For the nine months ended September 30, 1998, the Company's results include a $3.6 million reduction in restructuring and reorganization charges due to a revised estimate of property and other tax-related accruals recorded in 1995 in connection with the idling of the Puerto Rico facility and a $2.0 million reduction in selling, general, and administrative expenses due to changes in estimated accruals created in prior periods. During the second quarter of 1999, the Company completed the implementation of an integrated information system. As a result, certain previously reported amounts have been reclassified to conform with the current period presentation. The condensed consolidated balance sheet amounts at December 31, 1998 have been derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. This information should be read in conjunction with Chiron's audited consolidated financial statements for the year ended January 3, 1999, which are included in the Annual Report on Form 10-K filed by the Company with the Securities and Exchange Commission. In the first quarter of 1998, Chiron completed the sale of its ophthalmics business ("Chiron Vision") to Bausch & Lomb Incorporated ("B&L"), and in the fourth quarter of 1998, Chiron completed the sale of its IN VITRO diagnostics business ("Chiron Diagnostics") to Bayer Corporation ("Bayer") (see Note 2). The accompanying Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 1998 reflect the after-tax results of Chiron Diagnostics as discontinued operations. On March 31, 1998, in an acquisition accounted for under the purchase method of accounting, Chiron acquired the remaining 51% interest in Chiron Behring GmbH & Co ("Chiron Behring"), not previously owned, from Hoechst AG. Beginning in the second quarter of 1998, the results of Chiron Behring were consolidated with those of the Company. Prior to January 1999, the results of Chiron's Italian subsidiary ("Chiron S.p.A.") were reported on a one-month lag. In the first quarter of 1999, the results of Chiron S.p.A. were brought current. As a result, during the first quarter of 1999, the Company recorded a loss of approximately $5.2 million for the month of December 1998 as a component of "Accumulated deficit" in the accompanying Condensed Consolidated Balance Sheets. 7 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 1--THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) FISCAL YEAR Effective with the beginning of fiscal year 1999, the Company changed its fiscal year from a 52 or 53-week year ending on the Sunday nearest the last day in December to coincide with a calendar year ending on December 31. In 1998, the Company's fiscal year was a 53-week year ending on January 3, 1999 and the third fiscal quarter was a 13-week period ending on September 27, 1998. For presentation purposes, the 1998 dates used in the condensed consolidated financial statements and notes refer to the fiscal month-end. INVENTORIES Inventories are stated at the lower of cost or market using the moving weighted-average cost method as of September 30, 1999. For the period ending December 31, 1998, vaccine inventories were valued using the last-in, first-out ("LIFO") method. In the second quarter of 1999, the Company changed its inventory valuation methodology for vaccine inventories from LIFO to the moving weighted-average cost method. The effect of this change in methodology was not material to the financial statements. Inventories consist of the following (in thousands): SEPTEMBER 30, DECEMBER 31, 1999 1998 -------------- ------------- Finished goods.......................................... $19,036 $12,301 Work-in-process......................................... 58,765 54,333 Raw materials........................................... 17,348 13,228 ------- ------- $95,149 $79,862 ======= ======= INCOME TAXES The 1999 estimated annual tax provision is expected to be approximately 27% of pretax income from continuing operations, prior to the recognition of deferred tax assets through a reduction in the valuation allowance associated with such assets. The actual tax provision for the three and nine months ended September 30, 1999 includes the reduction in the state deferred tax asset valuation allowance of $9.1 million and $14.4 million, respectively. The valuation allowance was reduced because management believes that it is more likely than not that the deferred tax assets to which the valuation allowance related will be realized. In addition, in the third quarter of 1999, the Company recorded as additional paid-in capital approximately $27.9 million resulting from the tax benefits related to the Company's stock option plans. Income tax expense for the nine months ended September 30, 1998 was based on actual year-to-date effective tax rate on pretax income from continuing operations of approximately 20%, after taking into account federal deferred tax assets recognized through a reduction in the valuation allowance associated with such assets. The actual 1998 annual effective tax rate of 20% reflects the deferred tax assets that were recognized during the second half of 1998 through a reduction in the valuation allowance associated with such assets. PER SHARE DATA 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. Dilutive potential common shares could result from (i) the assumed exercise of outstanding stock options, warrants, and equivalents, which are included under the treasury-stock method; 8 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 1--THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) (ii) performance units to the extent that dilutive shares are assumed issuable; and (iii) convertible debentures, which are included under the if-converted method. The following table sets forth the computation for basic and diluted earnings per share on income from continuing operations (in thousands, except per share data): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------- ------------------- 1999 1998 1999 1998 -------- -------- -------- -------- Income (Numerator): Income from continuing operations available to common stockholders........................................ $ 45,041 $ 33,914 $102,513 $ 61,558 Plus: Interest on 1.9% convertible debentures, net of taxes............................................... 1,936 -- 1,936 -- -------- -------- -------- -------- Income available to common stockholders, plus assumed conversions......................................... $ 46,977 $ 33,914 $104,449 $ 61,558 -------- -------- -------- -------- Shares (Denominator): Weighted-average common shares outstanding............ 181,419 177,820 181,160 177,086 Effect of dilutive securities: Options and equivalents............................. 4,686 1,937 3,948 2,447 Warrants............................................ 319 135 265 170 1.9% convertible debentures......................... 8,785 -- 2,928 -- -------- -------- -------- -------- Weighted-average common shares outstanding, plus assumed conversions................................. 195,209 179,892 188,301 179,703 -------- -------- -------- -------- Basic earnings per share................................ $ 0.25 $ 0.19 $ 0.57 $ 0.35 ======== ======== ======== ======== Diluted earnings per share.............................. $ 0.24 $ 0.19 $ 0.55 $ 0.34 ======== ======== ======== ======== 9 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 1--THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) The following table sets forth the computation of basic and diluted earnings per share on net income (in thousands, except per share data): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------- ------------------- 1999 1998 1999 1998 -------- -------- -------- -------- Income (Numerator): Net income available to common stockholders........... $ 68,329 $ 84,435 $128,810 $164,303 Plus: Interest on 1.9% convertible debentures, net of taxes............................................... 1,936 -- 1,936 -- -------- -------- -------- -------- Income available to common stockholders, plus assumed conversions......................................... $ 70,265 $ 84,435 $130,746 $164,303 -------- -------- -------- -------- Shares (Denominator): Weighted-average common shares outstanding............ 181,419 177,820 181,160 177,086 Effect of dilutive securities: Options and equivalents............................. 4,686 1,937 3,948 2,447 Warrants............................................ 319 135 265 170 1.9% convertible debentures......................... 8,785 -- 2,928 -- -------- -------- -------- -------- Weighted-average common shares outstanding, plus assumed conversions................................. 195,209 179,892 188,301 179,703 -------- -------- -------- -------- Basic earnings per share................................ $ 0.38 $ 0.47 $ 0.71 $ 0.93 ======== ======== ======== ======== Diluted earnings per share.............................. $ 0.36 $ 0.47 $ 0.69 $ 0.91 ======== ======== ======== ======== For the three months ended September 30, 1999 and 1998, options to purchase 1,950,000 and 14,717,000 shares, respectively, and for the nine months ended September 30, 1999 and 1998, options to purchase 6,121,000 and 13,821,000 shares, respectively, with exercise prices greater than the average market price of common stock, were excluded from the respective computations of diluted earnings per share as their inclusion would be antidilutive. Also excluded from the computations of dilutive earnings per share were 3,240,000 and 12,026,000 shares for the three and nine months ended September 30, 1999 and the three and nine months ended September 30, 1998, respectively, of common stock issuable upon conversion of the Company's convertible subordinated debentures as the interest, net of tax, per common share obtainable on conversion exceeds basic earnings per share. TREASURY STOCK Treasury stock is stated at cost. Gains on reissuance of treasury stock are credited to additional paid-in capital. Losses on reissuance of treasury stock are charged to additional paid-in capital to the extent of available net gains on reissuance of treasury stock. Otherwise, losses are charged to accumulated deficit. For the three and nine months ended September 30, 1999, the Company charged losses of $17.3 million to accumulated deficit. 10 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 2--DISCONTINUED OPERATIONS On December 29, 1997, Chiron completed the sale of all of the outstanding capital stock of Chiron Vision to B&L for approximately $300.0 million in cash, subject to certain post-closing adjustments. The sale was completed under the terms of a Stock Purchase Agreement (the "B&L Agreement"), dated as of October 21, 1997, between Chiron and B&L. Chiron Vision's cash and cash equivalents totaling $2.7 million, certain Chiron Vision real estate assets (the "real estate assets") with a carrying value of $25.1 million and Chiron Vision's future noncancelable operating lease costs totaling $1.1 million were retained by the Company upon the completion of the sale. The Company has provided customary indemnities under the terms of the B&L Agreement. For a period of three years following the completion of the sale, Chiron Vision has the right to use a portion of the real estate assets, which were occupied at closing, on a rent-free basis. As of September 30, 1999 and December 31, 1998, the real estate assets, which represent all of the remaining net assets of Chiron's discontinued operations, are recorded in the accompanying Condensed Consolidated Balance Sheets as "Other current assets". In July 1999, the Company sold a portion of these real estate assets and recognized a gain of $4.8 million, which includes a net income tax benefit of $2.9 million related to cumulative differences in the basis of the assets sold. On November 30, 1998, Chiron completed the sale of its IN VITRO diagnostics business to Bayer for $1,013.8 million in cash, subject to certain post-closing adjustments. The sale was completed under the terms of a Stock Purchase Agreement (the "Bayer Agreement"), dated as of September 17, 1998, between Chiron and Bayer. The results of operations for Chiron Diagnostics are reported as a discontinued operation for the three and nine months ended September 30, 1998 in the accompanying Condensed Consolidated Statements of Operations. Chiron has provided customary indemnities under the terms of the Bayer Agreement. For the three and nine months ended September 30, 1998, Chiron Diagnostics recognized total revenues of $134.6 million and $412.8 million, respectively. For the three and nine months ended September 30, 1998, "Income (loss) from discontinued operations" are reported net of income tax provisions of less than $0.1 million and $3.0 million, respectively. For the three months ended September 30, 1999 and 1998, and for the nine months ended September 30, 1999 and 1998, "Gain on disposal of discontinued operations" includes the sale of the real estate assets and income tax benefits of $15.3 million, $45.5 million, $16.0 million and $14.3 million, respectively. For the three months ended September 30, 1999, basic and diluted earnings per share from discontinued operations was $0.13 and $0.12, respectively. For the three months ended September 30, 1998, basic and diluted earnings per share from discontinued operations was $0.28. For the nine months ended September 30, 1999, basic and diluted earnings per share from discontinued operations was $0.14. For the nine months ended September 30, 1998, basic and diluted earnings per share from discontinued operations was $0.58 and $0.57, respectively. NOTE 3--RESTRUCTURING AND REORGANIZATION CHARGES In 1999 and 1998, the Company recorded restructuring and reorganization charges related to the integration of its worldwide vaccines operations, the closure of its Puerto Rico and St. Louis facilities and the ongoing rationalization of its business operations. The integration of its worldwide vaccines operations consisted of termination and other employee-related costs recognized in connection with the elimination of 28 positions in the Company's Italian manufacturing facility and facility-related costs. The closure of its Puerto Rico and St. Louis, Missouri facilities and the ongoing rationalization of its business operations consisted of termination and 11 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 3--RESTRUCTURING AND REORGANIZATION CHARGES (CONTINUED) other employee-related costs recognized in connection with the elimination of 400 positions in manufacturing, research and development, sales, marketing, and other administrative functions, and facility-related costs. In the nine months ended September 30, 1999, the Company recorded restructuring and reorganization charges of $2.1 million, which included a benefit of $1.3 million recorded in the third quarter of 1999 and a charge of $3.4 million recorded in the first quarter of 1999. The benefit of $1.3 million related to revised estimates of property and other tax-related accruals recorded in connection with the idling of the St. Louis facility, as well as revised estimates of termination and other employee-related costs recorded in connection with the elimination of 400 positions. As of September 30, 1999, 301 of these 400 positions had been eliminated. The charge of $3.4 million related to termination and other employee-related costs recognized in connection with the elimination of 28 positions at the Company's Italian manufacturing facility. As of September 30, 1999, 20 of these 28 positions had been eliminated. In the nine months ended September 30, 1998, the Company recorded restructuring and reorganization charges of $11.3 million, of which $6.4 million was recognized in the third quarter of 1998, related to the integration of its worldwide vaccines operations, closure of its Puerto Rico and St. Louis facilities and the ongoing rationalization of its business operations. The current status of the accrued restructuring and reorganization charges is summarized as follows (in thousands): AMOUNT AMOUNT OF AMOUNT OF UTILIZED AMOUNT TO ACCRUAL AT TOTAL TOTAL THROUGH BE UTILIZED DECEMBER 31, RESTRUCTURING RESTRUCTURING SEPTEMBER 30, IN FUTURE 1998 CHARGE BENEFIT 1999 PERIODS ------------- ------------- ------------- -------------- ----------- Employee-related costs............... $15,390 $2,826 $ (832) $10,803 $6,581 Other facility-related costs......... 3,931 1,099 (1,031) 1,789 2,210 ------- ------ ------- ------- ------ 19,321 3,925 (1,863) 12,592 8,791 Discontinued operations.............. 4,475 -- -- 3,789 686 ------- ------ ------- ------- ------ $23,796 $3,925 $(1,863) $16,381 $9,477 ======= ====== ======= ======= ====== The liabilities related to restructuring and reorganization charges are expected to be substantially settled within 12 months of accruing the related charges. NOTE 4--AGREEMENT WITH HOECHST AG Effective July 1, 1996, Chiron purchased a 49% interest in the human vaccine business of Behringwerke AG, a subsidiary of Hoechst AG. The total acquisition price, which was paid in cash, was approximately $120.0 million, including costs directly related to the acquisition. Of the acquisition price, approximately $97.0 million was allocated to various intangible assets such as goodwill, trademarks, and patents, and is being amortized on a straight-line basis over lives ranging from five to 20 years. From July 1, 1996 through March 31, 1998 (period of joint ownership), Chiron and Hoechst AG operated the vaccine business as a joint venture under the name Chiron Behring GmbH & Co. Chiron accounted for its 49% interest under the equity method and recognized revenues of $2.4 million as a component of "Equity in earnings of unconsolidated joint businesses" in the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 1998. 12 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 4--AGREEMENT WITH HOECHST AG (CONTINUED) In the second quarter of 1998, in an acquisition accounted for under the purchase method of accounting, Chiron acquired the remaining 51% interest in Chiron Behring from Hoechst AG. The purchase price of approximately $113.1 million, including acquisition costs, was allocated to the acquired assets and liabilities assumed based upon their estimated fair value on the date of acquisition. In connection with the acquisition, liabilities assumed were as follows (in thousands): Cash acquired............................................... $ 57,119 Fair value of all other assets acquired..................... 206,922 Carrying value of original investment in Chiron Behring..... (117,157) Cash paid................................................... (111,889) Acquisition costs........................................... (1,180) --------- Liabilities assumed......................................... $ 33,815 ========= At the time of acquisition, Chiron expensed $1.6 million of purchased in-process technologies. Other purchased intangible assets of approximately $135.0 million, including goodwill, trademarks, patents, and customer list, are being amortized over their estimated useful lives of four to 17 years on a straight-line basis. Chiron Behring's operating results were included in Chiron's consolidated operating results beginning in the second quarter of 1998. The following unaudited pro forma information presents the results of continuing operations of Chiron and Chiron Behring for the nine months ended September 30, 1998 with pro forma adjustments as if Chiron's acquisition of the remaining 51% interest in Chiron Behring had been consummated as of January 1, 1998. The pro forma information does not purport to be indicative of what would have occurred had the acquisition been made as of that date or of results that may occur in the future. The unaudited pro forma information is as follows (in thousands, except per share data): NINE MONTHS ENDED SEPTEMBER 30, 1998 ------------------- Total revenues.............................................. $546,108 Income from continuing operations........................... $ 79,227 Pro forma earnings per share from continuing operations: Basic..................................................... $ 0.45 Diluted................................................... $ 0.44 NOTE 5--SEGMENT INFORMATION Chiron is organized based on the products and services that it offers. Under this organizational structure, the Company has the following three reportable segments: (i) biopharmaceuticals, (ii) vaccines, and (iii) blood testing. The biopharmaceuticals segment consists of products and services related to therapeutics, with an emphasis on oncology, serious infectious diseases, and cardiovascular diseases as well as the development and acquisition of technologies related to recombinant proteins, gene therapy, small molecules and genomics. The vaccines segment consists principally of products and services related to adult and pediatric vaccines sold primarily in Germany and Italy, and also sold in other international markets. The blood testing segment consists of an alliance with Gen-Probe Incorporated ("Gen-Probe") and Chiron's one-half interest in the pretax operating earnings of its joint business with Ortho-Clinical Diagnostics, Inc. ("Ortho"), a Johnson & Johnson company. Chiron's alliance with Gen-Probe is focused on developing and selling products using nucleic acid 13 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 5--SEGMENT INFORMATION (CONTINUED) testing ("NAT") to screen blood and plasma for infection by viruses. Chiron's joint business with Ortho sells a line of immunodiagnostic tests, other than nucleic acid tests, required to screen blood for hepatitis viruses and retroviruses, and provides supplemental tests and microplate-based instrument systems to automate test performance and data collection. Certain revenues and expenses, particularly Novartis research and development funding, certain royalty revenues, and unallocated corporate expenses, are not viewed by management as belonging to any one reportable segment. As a result, these items have been aggregated into an "Other" segment, as permitted by Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information" ("SFAS 131"). The accounting policies of the Company's reportable segments are the same as those described in Note 1--The Company and Summary of Significant Accounting Policies. Chiron evaluates the performance of its segments based on each segment's income (loss) from continuing operations, excluding certain special items, such as the write-off of purchased in-process technologies and restructuring and reorganization charges, which are shown as reconciling items in the table below. The following segment information excludes all significant intersegment transactions as these transactions are eliminated for management reporting purposes (in thousands): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------- ------------------- 1999 1998 1999 1998 -------- -------- -------- -------- REVENUES Biopharmaceuticals, includes equity in earnings of unconsolidated joint businesses of $33 and $0 for the three and nine months ended September 30, 1998, respectively............................................. $ 59,921 $ 69,773 $215,576 $222,868 Vaccines, includes equity in earnings of unconsolidated joint businesses of $319 and ($485) for the three months ended September 30, 1999 and 1998, respectively, and $963 and $304 for the nine months ended September 30, 1999 and 1998, respectively....................................... 84,692 72,217 188,873 142,295 Blood testing, includes equity in earnings of unconsolidated joint businesses of $22,978 and $21,707 for the three months ended September 30, 1999 and 1998, respectively, and $57,468 and $51,189 for the nine months ended September 30, 1999 and 1998, respectively.......... 32,943 28,302 83,594 69,706 Other...................................................... 26,820 45,678 81,003 77,278 -------- -------- -------- -------- Total revenues............................................. $204,376 $215,970 $569,046 $512,147 ======== ======== ======== ======== 14 CHIRON CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) SEPTEMBER 30, 1999 (UNAUDITED) NOTE 5--SEGMENT INFORMATION (CONTINUED) The following segment information excludes all significant intersegment transactions as these transactions are eliminated for management reporting purposes (in thousands): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------- ------------------- 1999 1998 1999 1998 -------- -------- -------- -------- INCOME FROM CONTINUING OPERATIONS Biopharmaceuticals........................................ $(22,941) $10,306 $(27,708) $ 23,953 Vaccines.................................................. 13,187 (719) (3,093) (35,758) Blood testing............................................. 21,167 19,555 47,765 47,889 Other..................................................... 19,637 24,493 61,354 43,688 -------- ------- -------- -------- Segment income from operations.......................... 31,050 53,635 78,318 79,772 Operating income (expense) reconciling items: Write-off of purchased in-process technologies.......... -- -- -- (1,645) Restructuring and reorganization charges................ 1,290 (6,401) (2,062) (11,339) -------- ------- -------- -------- Income from operations.................................... 32,340 47,234 76,256 66,788 Gain on sale of assets.................................. -- 1,510 -- 7,751 Interest expense........................................ (6,158) (6,009) (17,866) (18,638) Other income, net....................................... 19,685 5,035 63,061 21,196 -------- ------- -------- -------- Income from continuing operations before income taxes..... $ 45,867 $47,770 $121,451 $ 77,097 ======== ======= ======== ======== NOTE 6--CONTINGENCIES The Company is party to various claims, investigations, and legal proceedings arising in the ordinary course of business. These claims, investigations, and legal proceedings relate to intellectual property rights, contractual rights and obligations, employment matters, claims of product liability, and other issues. While there is no assurance that an adverse determination of any of such matters could not have a material adverse impact in any future period, management does not believe, based upon information known to it, that the final resolution of any of these matters will have a material adverse effect upon the Company's consolidated financial position and annual results of operations and cash flows. NOTE 7--SUBSEQUENT EVENTS In February 1999, the Company's Board of Directors authorized the repurchase of up to 2.5 million shares of Chiron common stock from time to time on the open market to offset the dilution associated with the operation of the Company's stock option and employee stock purchase plans and the granting of share rights. Effective October 7, 1999, the Company's Board of Directors approved a 4.0 million share increase, thereby bringing the total number of shares authorized for repurchase to 6.5 million shares. On November 1, 1999, the Company entered into a patent and license agreement. Under this agreement, the Company will pay $12.5 million, consisting of $5.0 million in cash and $7.5 million as a forgiveable note payable to the licensor, in licensing fees. In addition, the Company may make total payments of $12.0 million if certain development objectives are met. 15 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW THIS QUARTERLY REPORT ON FORM 10-Q CONTAINS FORWARD-LOOKING STATEMENTS. THESE INCLUDE STATEMENTS CONCERNING PLANS, OBJECTIVES, GOALS, STRATEGIES, FUTURE EVENTS OR PERFORMANCE, AND ALL OTHER STATEMENTS WHICH ARE OTHER THAN STATEMENTS OF HISTORICAL FACT, INCLUDING, WITHOUT LIMITATION, STATEMENTS CONTAINING WORDS SUCH AS "BELIEVES", "ANTICIPATES", "EXPECTS", "ESTIMATES", "PROJECTS", "WILL", "MAY", "MIGHT", AND WORDS OF A SIMILAR NATURE. THE FORWARD-LOOKING STATEMENTS CONTAINED IN THIS REPORT REFLECT MANAGEMENT'S CURRENT BELIEFS AND EXPECTATIONS ON THE DATE OF THIS REPORT. ACTUAL RESULTS, PERFORMANCE OR OUTCOMES MAY DIFFER MATERIALLY FROM THOSE EXPRESSED IN THE FORWARD-LOOKING STATEMENTS. SOME OF THE IMPORTANT FACTORS WHICH, IN THE VIEW OF CHIRON CORPORATION ("CHIRON" OR THE "COMPANY"), COULD CAUSE ACTUAL RESULTS TO DIFFER ARE DISCUSSED UNDER THE CAPTION "FACTORS THAT MAY AFFECT FUTURE RESULTS." THE COMPANY UNDERTAKES NO OBLIGATION TO PUBLICLY ANNOUNCE ANY REVISIONS TO THESE FORWARD-LOOKING STATEMENTS TO REFLECT FACTS OR CIRCUMSTANCES OF WHICH MANAGEMENT BECOMES AWARE AFTER THE DATE THEREOF. THE DISCUSSION BELOW SHOULD BE READ IN CONJUNCTION WITH PART I, ITEM 1,"FINANCIAL STATEMENTS", OF THIS QUARTERLY REPORT ON FORM 10-Q AND PART II, ITEMS 7, 7A, AND 8, "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS", "QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK", AND "FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA", RESPECTIVELY, OF THE COMPANY'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED JANUARY 3, 1999. Chiron is a biotechnology company that participates in three global healthcare businesses: biopharmaceuticals, vaccines, and blood testing. The biopharmaceuticals segment consists of products and services related to therapeutics, with an emphasis on oncology, serious infectious diseases, and cardiovascular diseases as well as the development and acquisition of technologies related to recombinant proteins, gene therapy, small molecules and genomics. The vaccines segment consists principally of adult and pediatric vaccines sold primarily in Germany and Italy, and also sold in other international markets. The blood testing segment consists of an alliance with Gen-Probe Incorporated ("Gen-Probe") and Chiron's one-half interest in the pretax operating earnings of its joint business with Ortho-Clinical Diagnostics, Inc. ("Ortho"), a Johnson & Johnson company. Chiron's alliance with Gen-Probe is focused on developing and selling products using nucleic acid testing ("NAT") to screen blood and plasma for infection by viruses. Chiron's joint business with Ortho sells a line of immunodiagnostic tests, other than nucleic acid tests, required to screen blood for hepatitis viruses and retroviruses, and provides supplemental tests and microplate-based instrument systems to automate test performance and data collection. On December 29, 1997, Chiron completed the sale of its ophthalmics business ("Chiron Vision") to Bausch & Lomb Incorporated ("B&L") and on November 30, 1998, Chiron completed the sale of its IN VITRO diagnostics business ("Chiron Diagnostics") to Bayer Corporation ("Bayer"). The Company's Condensed Consolidated Statements of Operations reflect the after-tax results of Chiron Diagnostics as discontinued operations for the three and nine months ended September 30, 1998. On March 31, 1998, in an acquisition accounted for under the purchase method of accounting, Chiron acquired the remaining 51% interest in Chiron Behring GmbH & Co ("Chiron Behring") from Hoechst AG. Beginning in the second quarter of 1998, the results of Chiron Behring were consolidated with those of the Company. RESULTS OF OPERATIONS REVENUES BIOPHARMACEUTICAL PRODUCT SALES For the three months ended September 30, 1999 and 1998, product sales from the biopharmaceuticals segment were $36.6 million and $46.8 million, respectively. For the nine months ended September 30, 1999 and 1998, biopharmaceutical product sales were $134.6 million and $144.1 million, respectively. In 1999 and 1998, biopharmaceutical product sales consisted principally of Proleukin-Registered Trademark-(aldesleukin, interleukin-2), Betaseron-Registered Trademark- (interferon beta-1b) and PDGF (recombinant human platelet-derived growth factor -rhPDGF-BB). 16 PROLEUKIN-REGISTERED TRADEMARK- Chiron sells Proleukin-Registered Trademark- directly in the U.S. and certain international markets. For the three months ended September 30, 1999 and 1998, sales of Proleukin-Registered Trademark- were $18.7 million and $22.3 million, respectively. For the nine months ended September 30, 1999 and 1998, sales of Proleukin-Registered Trademark- were $81.8 million and $66.2 million, respectively. Management believes that the third quarter 1999 decrease in Proleukin-Registered Trademark- product sales as compared with 1998 is primarily due to a shift in purchases by distributors from the third quarter 1999 to the second quarter 1999 in anticipation of the July 1999 price increase. Impacting the year-to-date increase in Proleukin-Registered Trademark- product sales are continued volume growth in existing indications, price increases which occurred during the period, and expansion into additional countries. The Company continues to pursue the use of Proleukin-Registered Trademark- for additional indications, including human immunodeficiency virus ("HIV"). The Company also anticipates further geographic expansion of Proleukin-Registered Trademark- into additional countries. BETASERON-REGISTERED TRADEMARK- Chiron manufactures Betaseron-Registered Trademark- for Berlex Laboratories, Inc. ("Berlex") and its parent company, Schering AG of Germany. Chiron earns a partial payment for Betaseron-Registered Trademark- upon shipment to Berlex and Schering AG and a subsequent additional payment upon sales by Berlex and Schering AG. Accordingly, Chiron's revenues from Betaseron-Registered Trademark- tend to fluctuate based upon the inventory management practices of Berlex and Schering AG. For the three months ended September 30, 1999 and 1998, revenues from Betaseron-Registered Trademark- were $17.9 million and $15.3 million, respectively. For the nine months ended September 30, 1999 and 1998, revenues from Betaseron-Registered Trademark- were $46.5 million and $46.6 million, respectively. Management believes that the increase in Betaseron-Registered Trademark- revenues in the third quarter 1999 as compared with the third quarter 1998 is primarily related to the approval of Betaseron-Registered Trademark- for secondary progressive multiple sclerosis in Europe, Canada and Australia in 1999. PDGF Chiron manufactures PDGF for Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson ("J&J") company. PDGF is the active ingredient in Regranex-Registered Trademark-(becaplermin) Gel, a treatment for diabetic foot ulcers. Regranex-Registered Trademark- Gel was approved by the FDA in December 1997 and was launched commercially in early 1998. Sales of PDGF to J&J decreased $9.8 million from the three months ended September 30, 1998 to the three months ended September 30, 1999 and $27.2 million from the nine months ended September 30, 1998 to the nine months ended September 30, 1999. The third quarter 1999 and year-to-date activity in PDGF sales are primarily related to a lack of orders from J&J in 1999 and an increase in the product returns allowance in the third quarter 1999. The increase to the product returns allowance is primarily due to additional historical return information, now that PDGF has been in the commercial market for over 12 months. As Regranex-Registered Trademark- is the first product of its kind, the Company believes it will take time for the market to fully develop. In addition, Chiron's sales of PDGF will tend to fluctuate based upon the inventory management practices of J&J. Regranex-Registered Trademark- Gel was recently approved for use in the treatment of diabetic foot ulcers in Canada and Europe. However, even with these approvals, Chiron's sales to date have largely filled J&J's initial inventory requirements for product launch, and as a result, no significant sales of PDGF to J&J are expected until the second quarter of 2000. VACCINE PRODUCT SALES Chiron sells pediatric and adult vaccines in Germany, Italy, other international markets, and in the U.S. Certain of the Company's vaccine products, particularly its flu vaccine, are seasonal and typically have higher sales in the third quarter of the year. For the three months ended September 30, 1999 and 1998, vaccine product sales were $70.6 million and $60.7 million, respectively. The increase in product sales for the three months ended September 30, 1999 as compared with the same period in 1998 is primarily due to the change in timing of reporting the results of the Company's Italian subsidiary. Historically, the results of the Company's Italian subsidiary were reported on a one-month lag; however, during the first quarter 1999, the Company eliminated the lag such that these results are now reported on a current basis. As a result of this change, the Company recorded a significant amount of flu vaccine sales during the third quarter 1999, which were historically recorded during the fourth quarter. For the nine months ended September 30, 1999 and 1998, vaccine product sales were $153.8 million and $119.1 million, respectively. The increase in sales for the nine months ended September 30, 1999 as compared with the same period in 1998 is primarily due to the change in timing of reporting the results of the Company's Italian subsidiary (see above) and Chiron's acquisition of the remaining 51% interest in, and consolidation of, Chiron Behring during the second quarter of 1998. Also affecting vaccine product sales for the nine months ended September 30, 1999 was a one-time $4.2 million sale of adult influenza vaccine to Argentina in the first quarter 1999. 17 In August 1999, Chiron filed an application for approval to market Menjugate-TM-, its vaccine against meningococcal meningitis caused by the bacterium N. MENINGITIDIS serogroup C, in the United Kingdom. The Company has received orders for Menjugate-TM- shipments, which are scheduled to begin in March 2000. These orders are subject to final approval by the United Kingdom's Medicines Control Agency ("MCA"). There can be no assurance as to the receipt of regulatory approval or the timing of any such regulatory approval. BLOOD TESTING PRODUCT SALES During the second quarter 1999, the Company began recognizing revenues for sales of its nucleic acid tests that are used to screen blood and plasma under an investigational new drug ("IND") application in the U.S. Product sales related to these tests were $2.0 million and $3.9 million for the three and nine months ended September 30, 1999, respectively. As with any new product, there can be no assurance that healthcare providers will adopt the Company's nucleic acid testing technology. In addition, sales of the Company's nucleic acid tests may be affected by the presence of a competitive product, the availability of reimbursement from the government and government regulations relating to the pricing of healthcare products. EQUITY IN EARNINGS OF UNCONSOLIDATED JOINT BUSINESSES For the three months ended September 30, 1999 and 1998, Chiron recognized equity in earnings of unconsolidated joint businesses of $23.3 million and $21.3 million, respectively. For the nine months ended September 30, 1999 and 1998, Chiron recognized equity in earnings of unconsolidated joint businesses of $58.4 million and $51.5 million, respectively. In 1999, equity in earnings of unconsolidated joint businesses consisted substantially of revenues generated by Chiron's joint business with Ortho. In 1998, equity in earnings of unconsolidated joint businesses also included one quarter of earnings from Chiron's 49% share of the after-tax operating results of Chiron Behring. CHIRON-ORTHO JOINT BUSINESS For the three months ended September 30, 1999 and 1998, Chiron's earnings from its joint business with Ortho were $23.0 million and $21.7 million, respectively. For the nine months ended September 30, 1999 and 1998, these earnings were $57.5 million and $51.2 million, respectively. The overall fluctuations in earnings from the joint business are primarily due to certain adjustments made during the first quarters of 1999 and 1998. In the first quarter 1999, an annual inventory adjustment resulted in a charge of $0.7 million as compared with a charge of $4.1 million recognized in the first quarter 1998. Also contributing to the increase in earnings in 1999 as compared with 1998, were higher foreign affiliate profits and a first-quarter 1998 one-time contract termination fee. CHIRON BEHRING On July 1, 1996, Chiron acquired a 49% interest in Chiron Behring. On March 31, 1998, Chiron acquired the remaining 51% interest in Chiron Behring (refer to Note 4 of "Notes to Condensed Consolidated Financial Statements"). From July 1, 1996 through the first quarter 1998, equity in earnings of unconsolidated joint businesses included Chiron's 49% share of the after-tax operating results of Chiron Behring. Chiron's share of earnings from the joint business, including amortization of intangibles, was $2.4 million for the three months ended March 31, 1998. Beginning in the second quarter 1998, Chiron Behring's results were consolidated with those of the Company. COLLABORATIVE AGREEMENT REVENUES Chiron recognizes collaborative agreement revenues for fees received for research services as they are performed and fees received upon the achievement of specified milestones. For the three months ended September 30, 1999 and 1998, Chiron recognized collaborative agreement revenues of $18.4 million and $24.3 million, respectively. For the nine months ended September 30, 1999 and 1998, collaborative agreement revenues were $59.6 million and $73.1 million, respectively. The decrease in collaborative agreement revenues in 1999 as compared with 1998 is partially due to a contractual decrease in payments received by the Company under a November 1996 consent agreement between Chiron, Novartis AG ("Novartis"), and the Federal Trade Commission related to the Herpes Simplex Virus-thymidine kinase (HSV-tk) gene in the field of gene therapy (for more information, refer to the Company's Annual Report on Form 10-K for the year ended January 3, 1999). The remaining decrease is primarily due to an agreement with Novartis, under which Novartis agreed to provide research funding for certain projects through 1999 (for more information, refer to the Company's Annual Report on Form 10-K for the year ended January 3, 1999). In September 1999, Chiron and Novartis determined to amend this agreement. This amendment will increase the aggregate maximum amount of funding provided by Novartis from $250.0 million to $265.0 million. Under this agreement, for the three months ended 18 September 30, 1999 and 1998, Chiron recognized collaborative agreement revenues of $10.0 million and $15.6 million, respectively. For the nine months ended September 30, 1999 and 1998, revenues recognized under this agreement were $39.0 million and $47.2 million, respectively. Collaborative agreement revenues tend to fluctuate based on the amount of research services performed, the status of projects under collaboration, and the achievement of milestones. Due to the nature of the Company's collaborative agreement revenues, results in any one period are not necessarily indicative of results to be achieved in the future. The Company's ability to generate additional collaborative agreement revenues may depend, in part, on its ability to initiate and maintain relationships with potential and current collaborative partners. There can be no assurance that such relationships will be established or that current collaborative agreement revenues will not decline. In particular, the research funding agreement with Novartis (see above) expires by its terms on December 31, 1999, and there can be no assurance that new relationships will be established. ROYALTY AND LICENSE FEE REVENUES The Company receives royalties and license fees for products or technologies that are marketed, distributed, or used by third parties. For the three months ended September 30, 1999 and 1998, Chiron recognized royalty and license fee revenues of $36.5 million and $49.8 million, respectively. For the nine months ended September 30, 1999 and 1998, royalty and license fee revenues were $96.3 million and $81.3 million, respectively. The increase in royalty and license fee revenues in 1999 as compared with 1998 is primarily due to a cross-license agreement with Bayer whereby Chiron agreed to grant to Bayer rights under certain Chiron patents, including rights under patents relating to HIV and hepatitis C virus. In exchange for these rights, Bayer paid to Chiron a license fee of $100.0 million, which is refundable in decreasing amounts over a period of three years. During the three and nine months ended September 30, 1999, Chiron recognized license fee revenues of $10.0 million and $30.0 million, respectively, which represent the portions of the $100.0 million payment that became nonrefundable during the periods. For the three months ended September 30, 1999, other items contributing to royalty and license fee revenues were $7.3 million of royalties generated from Schering AG's European sales of Betaferon-Registered Trademark- and $5.8 million of royalties related to Chiron's vaccine products. For the nine months ended September 30, 1999, other items contributing to royalty and license fee revenues were $21.4 million of royalties generated from Schering AG's European sales of Betaferon-Registered Trademark-, $9.9 million of royalties related to insulin products, and $15.4 million related to vaccine products. In the third quarter 1998, Chiron recognized $24.0 million related to a license fee received from SmithKline Beecham to use certain human vaccine product technologies. In the first quarter 1998, Chiron recognized $5.0 million related to a license fee received from Pharmacia & Upjohn Company to research, develop, manufacture, and commercialize therapeutic products for the treatment of hepatitis C virus in humans. Royalty and license fee revenues may fluctuate based on the nature of the related agreements and the timing of receipt of license fees. Results in any one period are not necessarily indicative of results to be achieved in the future. In addition, the Company's ability to generate additional royalty and license fee revenues may depend, in part, on its ability to market and capitalize on its technologies. There can be no assurance that the Company will be able to do so or that future royalty and license fee revenue will not decline. OTHER REVENUES For the three months ended September 30, 1999 and 1998, Chiron recognized other revenues of $12.1 million and $7.9 million, respectively. For the nine months ended September 30, 1999 and 1998, these revenues were $46.4 million and $28.1 million, respectively. Contributing to the increase in other revenues were contract manufacturing revenues which increased to $2.2 million in the third quarter 1999 from $0.1 million in the comparable period in 1998 as a result of a new contract manufacturing agreement. Also included in other revenues during the third quarters 1999 and 1998 were approximately $6.8 million and $5.9 million, respectively, of commission revenues received on sales of hepatitis B products and immunoglobulin products. For the nine months ended September 30, 1999, other revenues primarily consisted of a $9.7 million milestone payment related to the FDA's approval of DepoCyt-Registered Trademark- in April 1999, $10.7 million related to contract manufacturing and $18.0 million related to commission revenues. For the nine months ended September 30, 1998, other revenues primarily consisted of $9.8 million of revenues related to Aredia-Registered Trademark- (pamidronate disodium for injection) recognized under an arrangement which terminated in April 1998, pursuant to which Chiron promoted Aredia-Registered Trademark- on behalf of Novartis, and $12.2 million of commission revenues. 19 In October 1999, SkyePharma, Inc. ("SkyePharma"), the manufacturer of DepoCyt-Registered Trademark-, discovered two DepoCyt-Registered Trademark- lots that did not meet manufacturing specifications and, as a result, recalled all DepoCyt-Registered Trademark- vials from these lots. The commercial supply of this product is on hold while the Company and SkyePharma investigate the cause. Management of the Company does not believe that this event will have a material impact on the results of operations for fiscal year 1999. The impact of this event on future shipments of DepoCyt-Registered Trademark- is not yet known. The Company's other revenues may fluctuate due to the nature of the revenues recognized and the timing of events giving rise to these revenues. There can be no guarantee that the Company will be successful in obtaining additional revenues or that these revenues will not decline. COSTS AND EXPENSES GROSS PROFIT For the three months ended September 30, 1999 and 1998, gross profit as a percentage of net product sales was 53% and 55%, respectively. For each of the nine months ended September 30, 1999 and 1998, gross profit as a percentage of net product sales was 55%. In the third quarter 1999, Chiron recognized a $2.7 million reduction in sales related to the PDGF product returns allowance. Excluding this reduction, gross profit as a percentage of sales would have been 54% for the three months ended September 30, 1999. In the third quarter 1998, Chiron recognized a $3.3 million reduction in cost of goods sold related to a change in estimated property tax accruals created in prior periods. Excluding this reduction, gross profit as a percentage of net product sales would have been 53% for the three months ended September 30, 1998. Also impacting Chiron's gross profit for the nine months ended September 30, 1998 was a $6.0 million reduction in cost of goods sold related to a change in estimated property tax accruals created in prior periods. Excluding this reduction, gross profit as a percentage of net product sales would have been 53% for the nine months ended September 30, 1998. The increase in gross profit margins in the third quarter 1999 as compared to the third quarter 1998 is primarily related to a significant improvement in vaccine product gross profit due to manufacturing efficiencies resulting from increased production and a favorable mix of vaccine product sales. The increase in gross profit margins during the nine months ended September 30, 1999 as compared to the nine months ended September 30, 1998 is primarily related to (i) a slight increase in sales of biopharmaceutical products as a percentage of sales and biopharmaceutical product gross profit; and (ii) a significant improvement in vaccine product gross profit due to manufacturing efficiencies resulting from increased production and a favorable mix of vaccine product sales. The Company's gross profit percentages may fluctuate significantly in future periods as the Company's product mix continues to evolve. RESEARCH AND DEVELOPMENT For the three months ended September 30, 1999 and 1998, Chiron recognized research and development expenses of $75.5 million and $67.3 million, respectively. For the nine months ended September 30, 1999 and 1998, Chiron's research and development expenses were $216.7 million and $196.2 million, respectively. The Company's research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of clinical trial-related activities. The increase in research and development spending in 1999 as compared with 1998 was due, in part, to $2.6 million and $3.0 million milestone payments made during the third and second quarters of 1999, respectively, related to the Company's collaboration agreement with Medivir AB. Also contributing to the increase in research and development expense was the furtherance of the Company's clinical trials related to Proleukin-Registered Trademark- for HIV, Insulin-Like Growth Factor-1 ("IGF-1") for osteoarthritis, Fibroblast Growth Factor ("FGF") for coronary artery disease and Tissue Factor Pathway Inhibitor ("TFPI") for sepsis. In November 1999, Chiron entered into a patent and license agreement relating to FGF. Under this agreement, the Company will pay $12.5 million, consisting of $5.0 million in cash and $7.5 million as a forgiveable note payable, in licensing fees to Scios, Inc. In addition, Chiron may make total payments of $12.0 million if certain development objectives are met. SELLING, GENERAL, AND ADMINISTRATIVE For the three months ended September 30, 1999 and 1998, Chiron recognized selling, general, and administrative ("SG&A") expenses of $41.8 million and $40.7 million, respectively. For the nine months ended September 30, 1999 and 1998, Chiron recognized SG&A expenses of 20 $128.6 million and $103.5 million, respectively. The increase in SG&A expenses in 1999 as compared with 1998 is primarily due to the acquisition and consolidation of Chiron Behring, which contributed $10.2 million to SG&A expenses. SG&A expenses also increased as a result of the Company's worldwide implementation of its integrated information system in April 1999, the launch of DepoCyt-Registered Trademark- and the nucleic acid testing segment of its blood testing business, and certain patent defense legal costs. OTHER OPERATING EXPENSES In the nine months ended September 30, 1999, the Company recorded restructuring and reorganization charges of $2.1 million, which included a benefit of $1.3 million recorded in the third quarter 1999 and a charge of $3.4 million recorded in the first quarter 1999. The benefit of $1.3 million related to revised estimates of property and other tax-related accruals recorded in connection with the idling of the St. Louis facility, as well as revised estimates of termination and other employee-related costs recorded in connection with the elimination of 400 positions. As of September 30, 1999, 301 of these 400 positions had been eliminated. The charge of $3.4 million related to termination and other employee-related costs recognized in connection with the elimination of 28 positions at the Company's Italian manufacturing facility. As of September 30, 1999, 20 of these 28 positions had been eliminated. In the nine months ended September 30, 1998, the Company recorded restructuring and reorganization charges of $11.3 million, of which $6.4 million was recognized in the third quarter 1998, related to the integration of its worldwide vaccines operations, closure of its Puerto Rico and St. Louis facilities and the ongoing rationalization of its business operations. During the three and nine months ended September 30, 1999, Chiron recognized a reduction in other operating expenses of $2.0 million and $8.4 million, respectively, resulting from a change in estimated tax accruals related to certain employee payments recorded in 1995 under a series of agreements between Chiron and Novartis (for more information, refer to the Company's Annual Report on Form 10-K for the year ended January 3, 1999). NON-OPERATING INCOME AND EXPENSE Other income, net, primarily consists of interest and investment income on the Company's cash and investment balances and other non-operating gains and losses. For the three months ended September 30, 1999 and 1998, Chiron recognized interest and investment income of $20.2 million and $5.7 million, respectively. For the nine months ended September 30, 1999 and 1998, interest and investment income totaled $60.9 million and $20.0 million, respectively. The increase in interest and investment income in 1999 as compared with 1998 is primarily due to higher average cash and investment balances attributable to the net cash proceeds received from the sale of Chiron Diagnostics in November 1998. Interest expense remained fairly constant at $6.2 million and $6.0 million for the three months ended September 30, 1999 and 1998, respectively, and $17.9 million and $18.6 million for the nine months ended September 30, 1999 and 1998, respectively. INCOME TAXES The 1999 estimated annual tax provision is expected to be approximately 27% of pretax income from continuing operations, prior to the recognition of deferred tax assets through a reduction in the valuation allowance associated with such assets. The actual tax provision for the three and nine months ended September 30, 1999 includes the reduction in the state deferred tax asset valuation allowance of $9.1 million and $14.4 million, respectively. The valuation allowance was reduced because management believes that it is more likely than not that the deferred tax assets to which the valuation allowance related will be realized. NEW ACCOUNTING STANDARD In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133"), which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. In June 1999, SFAS 133 was amended by SFAS No. 137, "Accounting for Derivative Instruments and Hedging Activities--Deferral of the Effective Date of SFAS 133". As a result of this amendment, SFAS 133 shall be effective for all fiscal quarters of all fiscal years beginning after June 15, 2000. 21 In accordance with SFAS 133, an entity is required to recognize all derivatives as either assets or liabilities in the statement of financial position and measure those instruments at fair value. SFAS 133 requires that changes in the derivative's fair value be recognized currently in earnings unless specific hedge accounting criteria are met. Special accounting for qualifying hedges allows a derivative's gains and losses to offset related results on the hedged item in the income statement, and requires that a company formally document, designate, and assess the effectiveness of transactions that receive hedge accounting. The Company is currently evaluating the effect that implementation of SFAS 133 will have on its results of operations and financial position and anticipates that it will implement SFAS 133 during the first fiscal quarter of 2001. LIQUIDITY AND CAPITAL RESOURCES Chiron's capital requirements have generally been funded from operations, cash and investments on hand, debt borrowings, issuance of common stock, and off-balance sheet financing. Chiron's cash and investments in marketable debt securities, which totaled $1.6 billion at September 30, 1999, are invested in a diversified portfolio of investment grade financial instruments, including money market instruments, corporate notes and bonds, government or government agency securities, and other debt securities. By policy, the amount of credit exposure to any one institution is limited; however, these investments are generally not collateralized and primarily mature within three years. SOURCES AND USES OF CASH Chiron had cash and cash equivalents of $205.8 million and $80.5 million at September 30, 1999 and 1998, respectively. Through the nine months ended September 30, 1999, net cash used in operating activities was $37.1 million as compared with net cash provided by operating activities of $85.8 million in 1998. Through the nine months ended September 30, 1999, the Company paid $179.7 million in estimated taxes primarily related to the sale of the Company's IN VITRO diagnostics business. This use of cash was partially offset by $54.0 million in federal and state tax refunds received and net income of $128.8 million for the nine months ended September 30, 1999. Through the nine months ended September 30, 1999, net cash used in investing activities consisted of purchases of investments in marketable debt securities of $1.1 billion, capital expenditures of $55.7 million, and other uses of cash of $11.1 million. Partially offsetting these uses of cash were proceeds from the sale and maturity of investments in marketable debt securities of $867.4 million and proceeds from disposal of discontinued operations of $46.9 million. Through the nine months ended September 30, 1999, net cash provided by financing activities primarily consisted of $68.1 million from the issuance of common stock and the reissuance of treasury stock related to stock option exercises, $7.9 million related to short-term borrowings and $8.1 million in proceeds from the issuance of long-term debt. This was partially offset by $2.0 million related to the repayment of debt and capital leases and $69.1 million related to the acquisition of treasury stock. In February 1999, the Company's Board of Directors authorized the repurchase of up to 2.5 million shares of Chiron common stock from time to time on the open market to offset the dilution associated with the operation of the Company's stock option and employee stock purchase plans and the granting of share rights. In October 1999, the Board of Directors approved a 4.0 million share increase, thereby bringing the total number of shares authorized for repurchase to 6.5 million shares. As of September 30, 1999, 2.5 million shares had been repurchased. The Company is currently evaluating a number of business development opportunities. To the extent that the Company is successful in reaching agreements with third parties, these transactions may involve the expenditure of a significant amount of the Company's current investment portfolio. BORROWING ARRANGEMENTS Under a revolving, committed, unsecured credit agreement with a major financial institution, Chiron can borrow up to $100.0 million in the U.S. This credit facility is guaranteed by Novartis under a November 1994 Investment Agreement, provides various interest rate options, and matures in February 2003. There were no 22 borrowings outstanding under this credit facility at September 30, 1999. Chiron also has credit facilities outside the U.S. which allow for total borrowings of $63.1 million. Under these credit facilities, $22.7 million of borrowings were outstanding at September 30, 1999. In September 1999, Chiron and Novartis determined to amend the November 1994 Investment Agreement. This amendment will reduce the maximum amount of Chiron obligations that Novartis will guarantee from $725.0 million to $702.5 million. YEAR 2000 Chiron is dependent on a number of computer systems and applications to conduct its business. In the past, many computer programs were written using two digits rather than four to identify the relevant year. These programs may not be able to distinguish between 21st and 20th century dates (for example, "00" may be read as the year 1900 when the year 2000 is intended). This could result in significant system failures or miscalculations. Accordingly, the Company has developed a comprehensive risk-based plan designed to make its computer hardware and communication systems, software applications, and facilities and other non-information technology-related functions Year 2000 compliant. The plan covers three phases including (i) planning, (ii) assessment, and (iii) implementation. The Company has completed the planning and assessment phases and has substantially completed the implementation phase. With regard to the Company's computer hardware and communication systems, Chiron has completed its initial technology refresh program which was developed in conjunction with International Business Machines, Inc. ("IBM") to update and standardize the Company's computer hardware and communication systems. In the third quarter 1999, the Company continued its technology refresh program, which it will complete in November 1999. With regard to the Company's software applications, the Company has identified critical and non-critical software applications and has remediated all mission critical and substantially all non-critical applications in all material respects. Certain non-critical user specific applications based on compliant software platforms are in testing and will be completed in November 1999. With regard to the Company's key facilities and other non-information technology-related functions, including research, manufacturing, and inventory management practices, the Company has completed its remediation plans for its critical systems and substantially completed its remediation plans for its non-critical systems. Some non-critical embedded systems remediation has been rescheduled to November 1999 due to manufacturing schedules and vendor changes. The Company has a facility in Amsterdam, The Netherlands, which is currently being marketed for sale. Due to the Company's manufacturing requirements, the Company plans to operate this facility until the end of 1999, at which time, the Company intends to complete certain upgrades within its embedded systems. The Company believes that it will be able to sell the facility in its current state and does not consider this facility to be a significant Year 2000 risk. The Company is using both internal and external resources to prepare for the Year 2000. Although the Company believes that it should be able to substantially complete the implementation of critical internal aspects of its Year 2000 plan prior to the commencement of the Year 2000, even with substantial completion of internal remediation plans, the Company's customers, suppliers, and distributors also present risk of their own Year 2000 compliance over which the Company has no control. The Company has surveyed and assessed its critical suppliers and other external relationships to determine the extent to which the Company may be vulnerable to such parties' failure to resolve their own Year 2000 issues. Where practicable, the Company is attempting to mitigate its risks with respect to the failure of these entities to be Year 2000 compliant and has prepared contingency plans accordingly. The Company cannot reasonably estimate the effect, if any, from the failure of such parties to be Year 2000 compliant. However, the Company believes that its contingency plans will substantially mitigate all significant risks resulting from such parties' failure to resolve their Year 2000 issues. The SEC has requested that companies disclose the most likely worst case scenario that could occur as a result of the Year 2000. The Company believes that its most likely worst case scenario would be delays in product shipments due to a complete or partial manufacturing shutdown. To address the manufacturing shutdown scenario, the Company plans, among other things, to increase its inventory and re-prioritize staff assignments, as needed, but does not believe that such a scenario is likely to occur. 23 In addition to the Company's remediation efforts, the Company is also implementing contingency plans and preparing for the year-end rollover and leap year. The Company's contingency plans include, among other things, the implementation of specific plans to ensure that the necessary precautions are taken to prevent and/ or address an unexpected system failure. The Company has scheduled contingency plan drills for November and December 1999. The Company also intends to increase certain raw material and finished goods inventories to mitigate external and internal risks. The Company's plans also include placing teams in all critical locations to monitor and protect critical systems during the year-end rollover period. The Company intends to monitor its computer hardware and communication systems, software applications, and facilities and other non-information technology-related functions for Year 2000 issues through March 2000. The Company may incur significant costs in preparing for the Year 2000. Costs associated with preparing for the Year 2000 are not expected to exceed $4.0 million, and include costs related to contingency plans, which may not require execution. The costs related to the technology refresh program and the integrated information system are not included in the above estimates as Year 2000 compliance is incidental to the operational benefits expected to be derived from these programs. As of September 30, 1999, total costs incurred to date have been funded through operations and approximate $2.7 million. The Company anticipates funding its remaining Year 2000 expenditures with cash on hand and cash generated through operations. EURO CONVERSION On January 1, 1999, eleven European Union member countries established fixed conversion rates between their existing currencies ("legacy currencies") and one common currency, the Euro. The Euro is currently traded on currency exchanges and can be used in business transactions. The Company believes that its financial systems are Euro-ready in all material respects. However, the Company is still in the process of evaluating the effect, if any, that the Euro may have on its product pricing and gross profit percentages. FACTORS THAT MAY AFFECT FUTURE RESULTS As a biotechnology company, Chiron is engaged in a rapidly evolving and often unpredictable business. The forward-looking statements contained in this Report and in other periodic reports, press releases and other statements issued by the Company from time to time reflect management's current beliefs and expectations concerning objectives, plans, strategies, future performance, and other future events. The following discussion highlights some of the factors, many of which are beyond the Company's control, which could cause actual results to differ. PROMISING TECHNOLOGIES ULTIMATELY MAY NOT PROVE SUCCESSFUL The Company focuses its research and development activities on areas in which it has particular strengths, and on technologies that appear promising. These technologies often are on the "cutting edge" of modern science. As a result, the outcome of any research or development program is highly uncertain. Only a very small fraction of such programs ultimately result in commercial products or even product candidates. Product candidates that initially appear promising often fail to yield successful products. In many cases, preclinical or clinical studies will show that a product candidate is not efficacious (that is, it does not have the intended therapeutic or prophylactic effect), or that it raises safety concerns or has other side effects which outweigh the intended benefit. Success in preclinical or early clinical trials (which generally focus on safety issues) may not translate into success in large-scale clinical trials (which are designed to show efficacy), often for reasons that are not fully understood. And even after a product is approved and launched, general usage or post-marketing studies may identify safety or other previously unknown problems with the product which may result in regulatory approvals being suspended, limited to narrow indications, or revoked, or which may otherwise prevent successful commercialization. 24 REGULATORY APPROVALS The Company is required to obtain and maintain regulatory approval in order to market most of its products. Generally, these approvals are on a product-by-product and country-by-country basis, and, in the case of therapeutic products, a separate approval is required for each therapeutic indication. See Item 1, "Business--Government Regulation" in the Company's Annual Report on Form 10-K for the year ended January 3, 1999. Product candidates that appear promising based on early, and even large-scale, clinical trials may not receive regulatory approval. The results of clinical trials often are susceptible to varying interpretations that may delay, limit or prevent approval or result in the need for post-marketing studies. MANUFACTURING Most of the Company's products are biologics. Manufacturing biologic products is complex. Unlike chemical pharmaceuticals, a biologic product generally cannot be sufficiently characterized (in terms of its physical and chemical properties) to rely on assaying of the finished product alone to ensure that the product will perform in the intended manner. Accordingly, it is essential to be able to both validate and control the manufacturing process: that is, to show that the process works, and that the product is made strictly and consistently in compliance with that process. Slight deviations in the manufacturing process may result in unacceptable changes in the products that may result in lot failures. Manufacturing processes which are used to produce the (smaller) quantities of material needed for research and development purposes may not be successfully scaled up to allow production of commercial quantities at reasonable cost or at all. All of these difficulties are compounded when dealing with novel biologic products that require novel manufacturing processes. Accordingly, manufacturing is subject to extensive government regulation. Even minor changes in the manufacturing process require regulatory approval, which, in turn, may require further clinical studies. PATENTS HELD BY THIRD PARTIES MAY DELAY OR PREVENT COMMERCIALIZATION Third parties, including competitors, have patents and patent applications in the U.S. and other significant markets that may be useful or necessary for the manufacture, use, or sale of certain of the Company's products and products in development. It is likely that third parties will obtain other such patents in the future. Certain of these patents may be sufficiently broad to prevent or delay Chiron from manufacturing or marketing products important to the Company's current and future business. The scope, validity, and enforceability of such patents, if granted, the extent to which Chiron may wish or need to obtain licenses to such patents, and the cost and availability of such licenses cannot be accurately predicted. If Chiron does not obtain such licenses, products may be withdrawn from the market or delays could be encountered in market introduction while an attempt is made to design around such patents. Alternatively, Chiron could find that the development, manufacture, or sale of such products is foreclosed. Chiron could also incur substantial costs in challenging the validity and scope of such patents. PRODUCT ACCEPTANCE The Company may experience difficulties in launching new products, many of which are novel products based on technologies that are unfamiliar to the healthcare community. There can be no assurance that healthcare providers and patients will accept such products. In addition, government agencies as well as private organizations involved in healthcare from time to time publish guidelines or recommendations to healthcare providers and patients. Such guidelines or recommendations can be very influential, and may adversely affect the usage of the Company's products directly (for example, by recommending a decreased dosage of the Company's product in conjunction with a concomitant therapy) or indirectly (for example, by recommending a competitive product over the Company's product). COMPETITION Chiron operates in a highly competitive environment, and the competition is expected to increase. Competitors include large pharmaceutical, chemical and blood testing companies, as well as biotechnology companies. Some of these competitors, particularly large pharmaceutical and blood testing companies, have greater resources than the Company. Accordingly, even if the Company is successful in launching a product, it 25 may find that a competitive product dominates the market for any number of reasons, including the possibility that the competitor may have launched its product first; the competitor may have greater marketing capabilities; or the competitive product may have therapeutic or other advantages. The technologies applied by the Company and its competitors are rapidly evolving, and new developments frequently result in price competition and product obsolescence. CHIRON'S PATENTS MAY NOT PREVENT COMPETITION OR GENERATE REVENUES Chiron seeks to obtain patents on its inventions. Without the protection of patents, competitors may be able to use the Company's inventions to manufacture and market competing products without being required to undertake the lengthy and expensive development efforts made by Chiron and without having to pay royalties or otherwise compensate Chiron for the use of the invention. There can be no assurance that patents and patent applications owned or licensed to Chiron will provide substantial protection. Important legal questions remain to be resolved as to the extent and scope of available patent protection for biotechnology products and processes in the U.S. and other important markets. It is not known how many of the Company's pending patent applications will be granted, or the effective coverage of those that are granted. In the U.S. and other important markets, the issuance of a patent is neither conclusive as to its validity nor the enforceable scope of its claims. The Company has engaged in significant litigation to determine the scope and validity of certain of its patents and expects to continue to do so in the future. Even if the Company is successful in obtaining and defending patents, there can be no assurance that these patents will provide substantial protection. The length of time necessary to successfully resolve patent litigation may allow infringers to gain significant market advantage. Third parties may be able to design around the patents and develop competitive products that do not use the inventions covered by the patents. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, the third party's product is needed to meet a threat to public health or safety in that country, or the patent owner has failed to "work" the invention in that country, or the third party has patented improvements) and most countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may be limited to monetary relief and may be unable to enjoin infringement, which could materially diminish the value of the patent. AVAILABILITY OF REIMBURSEMENT; GOVERNMENT AND OTHER PRESSURES ON PRICING In the U.S. and other significant markets, sales of the Company's products may be affected by the availability of reimbursement from the government or other third parties, such as insurance companies. It is difficult to predict the reimbursement status of newly approved, novel biotechnology products, and current reimbursement policies for existing products may change. In certain foreign markets, governments have issued regulations relating to the pricing and profitability of pharmaceutical companies. There have been proposals in the U.S. (at both the federal and state level) to implement such controls. The growth of managed care in the U.S. also has placed pressure on the pricing of healthcare products. These pressures can be expected to continue. COSTS ASSOCIATED WITH REFOCUSING AND EXPANDING THE BUSINESS The Company is refocusing its efforts on its core businesses and on improving operational efficiencies. In addition, management expects to grow the business in areas in which the Company can be most competitive, either through in-licensing, collaborations, or acquisitions of products or companies. In connection with these efforts, the Company may incur significant charges, costs, and expenses which could impact the Company's profitability, including impairment losses, restructuring charges, the write-off of purchased in-process technology, transaction-related expenses, costs associated with integrating new businesses, and the cost of amortizing goodwill and other intangibles. 26 OTHER NEW PRODUCTS AND SOURCES OF REVENUE Many products in the Company's current pipeline are in relatively early stages of research or development. The Company's ability to grow earnings in the near-to medium-term may depend, in part, on its ability to initiate and maintain other revenue generating relationships with third parties, such as licenses to certain of the Company's technologies, and on its ability to identify and successfully acquire rights to later-stage products from third parties. There can be no assurance that such other sources of revenue will be established. INTEREST RATE AND FOREIGN CURRENCY EXCHANGE RATE FLUCTUATIONS In 1998, the Company sold certain businesses for cash, including its IN VITRO diagnostics and ophthalmics businesses, and as a result has significant cash balances and short-term investments. The Company's financial results therefore are sensitive to interest rate fluctuations in the U.S. In addition, the Company sells products in many countries throughout the world, and its financial results could be significantly affected by fluctuations in foreign currency exchange rates or by weak economic conditions in foreign markets. COLLABORATION PARTNERS An important part of the Company's business strategy depends upon collaborations with third parties, including research collaborations and joint efforts to develop and commercialize new products. As circumstances change, the Company and its corporate partners may develop conflicting priorities or other conflicts of interest. The Company may experience significant delays and incur significant expenses in resolving these conflicts and may not be able to resolve these matters on acceptable terms. Even without conflicts of interest, the parties may differ in their views as to how best to realize the value associated with a current product or a product in development. In some cases, the corporate partner may have responsibility for formulating and implementing key strategic or operational plans. Decisions by corporate partners on key clinical, regulatory, marketing (including pricing), inventory management, and other issues may prevent successful commercialization of the product or otherwise impact the Company's profitability. STOCK PRICE VOLATILITY The price of the Company's stock, like that of other biotechnology companies, is subject to significant volatility. Any number of events, both internal and external to the Company, may affect the stock price. These include, without limitation, results of clinical trials conducted by the Company or by its competitors; announcements by the Company or its competitors regarding product development efforts, including the status of regulatory approval applications; the outcome of legal proceedings, including claims filed by the Company against third parties to enforce its patents and claims filed by third parties against the Company relating to patents held by the third parties; the launch of competing products; the resolution of (or failure to resolve) disputes with collaboration partners; corporate restructuring by the Company; licensing activities by the Company; and the acquisition or sale by the Company of products, products in development, or businesses. In connection with its research and development collaborations, from time to time the Company invests in equity securities of its corporate partners. The price of these securities also is subject to significant volatility and may be affected by, among other things, the types of events that affect the Company's stock. Changes in the market price of these securities may impact the Company's profitability. TAX The Company is taxable principally in the U.S., Germany, Italy, and The Netherlands. All of these jurisdictions have in the past and may in the future make changes to their corporate tax rates and other tax laws, which could increase the Company's tax provision in the future. The Company has negotiated a number of rulings regarding income and other taxes that are subject to periodic review and renewal. If such rulings are not renewed or are substantially modified, taxes payable in particular jurisdictions could increase. While the Company believes that all material tax liabilities are properly reflected in its balance sheet, the Company is presently under audit in several jurisdictions, and there can be no assurance that Chiron will prevail in all cases in the event the taxing authorities disagree with its interpretations of the tax law. In addition, the Company has assumed liabilities for all income taxes incurred prior to the sales of its former subsidiaries, Chiron Vision 27 Corporation (subject to certain limitations) and Chiron Diagnostics Corporation. Future levels of research and development spending, capital investment, and export sales will impact the Company's entitlement to related tax credits and benefits which have the effect of lowering its effective tax rate. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK MARKET RISK MANAGEMENT The Company's cash flow and earnings are subject to fluctuations due to changes in foreign currency exchange rates, interest rates, and fair value of equity securities held. The Company attempts to limit its exposure to some or all of these market risks through the use of various financial instruments. There were no significant changes in the Company's market risk exposures through the nine months ended September 30, 1999. For further discussion of the Company's market risk exposures, refer to Part II, Item 7A, "Quantitative and Qualitative Disclosures About Market Risk" in Chiron's Annual Report on Form 10-K for the fiscal year ended January 3, 1999. PART II ITEM 1. LEGAL PROCEEDINGS The Company is party to certain lawsuits and legal proceedings, which are described in Part I, Item 3, "Legal Proceedings," of the Company's Annual Report on Form 10-K for the year ended January 3, 1999, in Part II, Item 1, "Legal Proceedings", of the Company's Quarterly Reports on Form 10-Q for the periods ended March 31, 1999 and June 30, 1999. The following is a description of material developments during the period covered by this Quarterly Report and should be read in conjunction with the Annual Report on Form 10-K and the first and second Quarterly Reports on Form 10-Q. CONNAUGHT LABORATORIES, LIMITED Chiron is involved in lawsuits in Italy and certain other countries with Connaught Laboratories Limited ("Connaught") relating to TriAcelluvax-TM-, the Company's diptheria/tetanus/acellullar pertussis vaccine. Litigation in Milan, Italy relating to the Italian counterpart of Connaught's European Patent 0 527 753 is currently pending. On October 6, 1999, Connaught filed suit against Chiron in the Milan court alleging infringement of its European Patent Number 322,115 (the "'115 patent"). The '115 patent contains claims relating to pertussis toxin mutants. Connaught seeks a declaration of infringement of the Italian counterpart to the '115 patent and seeks damages and injunctive relief to prevent the manufacture and sale in Italy of Chiron's vaccines, Acelluvax-TM-, Acelluvax DTP-TM-, and Triacelluvax-TM-. FEDERAL EXPRESS On September 3, 1999, Federal Express Corporation ("Federal Express") filed suit in the Supreme Court of the State of New York, County of Orange against Perseptive Biosystems, Inc, Perkin-Elmer Corporation, PE Biosystems Group, and PE Corporation (together, the "PE Defendants") and Chiron. The matter has been removed to the United States District Court for the Southern District of New York. The Federal Express complaint relates to a fire that allegedly destroyed a Federal Express aircraft and the majority of its cargo in September 1996. Federal Express claims breach of contract, negligence and product liability with regard to equipment owned and shipped by Chiron and designed, manufactured, packaged and prepared for shipping by the PE Defendants and seeks damages, interest, costs and fees. Federal Express alleges that improper packing and shipping procedures were a proximate cause of the destruction of the plane. The National Transportation Safety Board, an agency of the federal government, had previously investigated the circumstances surrounding the incident and issued a letter of no determination as to the cause of the fire. It is not known when nor on what basis this litigation will be concluded. F. HOFFMANN-LAROCHE AG Chiron is involved in certain lawsuits in the United States, The Netherlands, Japan, Germany, and other countries with F. Hoffmann-LaRoche AG and several of its affiliated companies concerning infringement and/or validity of certain patents related to HCV and HIV technology. 28 In January 1998, Chiron initiated an action against F. Hoffmann-LaRoche AG and several of its affiliated companies (collectively, "Roche") in the United States District Court for the Northern District of California. The Company asserted that Roche's manufacture and sale of Amplicor HCV Test and Amplicor HCV Monitor Test constituted infringement of Chiron's U.S. Patent Nos. 5,712,088 (the "'088 patent"), 5,714,596 (the "'596 patent"), and 5,863,719 (the "'719 patent"). The action sought damages, injunctive relief, and a declaratory judgment that Chiron is the sole and exclusive owner of the patents in suit. The parties' cross-motions for summary judgment on Roche defenses based upon prior licenses were resolved in Chiron's favor in June 1999. In October 1999, Roche filed counterclaims against Chiron which challenge the validity and enforceability of the patents in suit. Roche also seeks to recover treble damages and an injunction against Chiron for alleged breaches of state and federal antitrust statutes relating to Chiron's HCV licensing practices. Roche has appealed the injunction granted by the Regional Court in Dusseldorf, Germany against manufacture or sale by Roche of HCV immunoassay kits. A suit filed in October 1998 by Roche AG against Chiron and Ortho is pending in the Federal Court of Australia, New South Wales District Registry, and is seeking revocation of Australian patent number 624105, relating to HCV technology. In May 1999, Chiron and Gen-Probe, Incorporated ("Gen-Probe") initiated action in the Tribunal of Milan, Italy, against Roche AG and several of its European affiliates (together, "Roche"). The lawsuit seeks a cross-border declaration that Gen-Probe's Transcription Mediated Amplification System ("TMA") which is used in Chiron/Gen-Probe blood screening kits, does not infringe Roche's European Patent 0 505 012 (the "'012 patent") which relates to PCR technology. The plaintiffs also seek an assessment of the '012 patent and a declaration of nullity of the Italian counterpart of the '012 patent. It is not known when nor on what basis these matters will be concluded. ORTHO DIAGNOSTIC SYSTEMS, INC. On March 31, 1999, Chiron filed a lawsuit against Ortho Diagnostic Systems, Inc. in the United States District Court for the Northern District of California. The suit concerns certain issues relating to the conduct of the parties' joint business and seeks to compel arbitration of those issues. On November 1, 1999, the Court entered judgment in Chiron's favor, ordering Ortho to submit the underlying issues to arbitration. It is not known when nor on what basis this matter will be concluded. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K. (a) Exhibits EXHIBIT NUMBER EXHIBIT - --------------------- ------- 3.01 Restated Certificate of Incorporation of the Registrant, as filed with the Office of the Secretary of State of Delaware on August 17, 1987, incorporated by reference to Exhibit 3.01 of the Registrant's report on Form 10-K for fiscal year 1996. 3.02 Certificate of Amendment of Restated Certificate of Incorporation of the Registrant, as filed with the Office of the Secretary of State of Delaware on December 12, 1991, incorporated by reference to Exhibit 3.02 of the Registrant's report on Form 10-K for fiscal year 1996. 3.03 Certificate of Amendment of Restated Certificate of Incorporation of the Registrant, as filed with the Office of the Secretary of State of Delaware on May 22, 1996, incorporated by reference to Exhibit 3.04 of the Registrant's report on Form 10-Q for the period ended June 30, 1996. 3.04 Bylaws of the Registrant, as amended, incorporated by reference to Exhibit 3.04 to the Registrant's report on Form 10-Q for the period ended June 30, 1999. 29 EXHIBIT NUMBER EXHIBIT - --------------------- ------- 4.01 Indenture, dated as of May 21, 1987, between Cetus Corporation and Bankers Trust Company, Trustee (initially filed as Exhibit 4.01 to the Registrant's report on Form 10-Q for the period ended September 30, 1994), incorporated by reference to Exhibit 4.01 of the Registrant's report on Form 10-Q for the period ended June 30, 1999. 4.02 First Supplemental Indenture, dated as of December 12, 1991, by and among the Registrant, Cetus Corporation, and Bankers Trust Company, incorporated by reference to Exhibit 4.02 of the Registrant's report on Form 10-K for fiscal year 1997. 4.03 Second Supplemental Indenture, dated as of March 25, 1996, by and among the Registrant, Cetus Oncology Corporation (formerly Cetus Corporation), and Bankers Trust Company, incorporated by reference to Exhibit 4.03 of the Registrant's report on Form 10-Q for the period ended June 30, 1996. 4.04 Indenture, dated as of November 15, 1993, between the Registrant and The First National Bank of Boston, as Trustee (initially filed as Exhibit 4.03 of the Registrant's report on Form 10-K for fiscal year 1993), incorporated by reference to Exhibit 4.04 of the Registrant's report on Form 10-K for fiscal year 1998. 10.306 HCV Probe License and Option Agreement dated September 26, 1999, between Abbott Laboratories, an Illinois corporation, and the Registrant. (Certain information has been omitted from the Agreement and filed separately with the Securities and Exchange Commission pursuant to a request by Registrant for confidential treatment pursuant to Rule 24b-2. The omitted confidential information has been identified by the following statement "Confidential Treatment Requested".) 10.614 Letter Agreement dated May 28, 1999 between the Registrant and Paul J. Hastings, as supplemented by Promissory Note dated July 20, 1999, executed by Mr. Hastings.* 10.707 Amendment dated as of January 3, 1995 among Ciba-Geigy Limited, Ciba-Geigy Corporation, Ciba Biotech Partnership, Inc. and the Registrant (initially filed as Exhibit 10.61 of the Registrant's current report on Form 8-K dated January 4, 1995). 10.708 Supplemental Agreement dated as of January 3, 1995 among Ciba-Geigy Limited, Ciba-Geigy Corporation, Ciba Biotech Partnership, Inc. and the Registrant (initially filed as Exhibit 10.61 of the Registrant's current report on Form 8-K dated January 4, 1995). 10.709 Amendment with Respect to Employee Stock Option Arrangements dated as of January 3, 1995 among Ciba-Geigy Limited, Ciba-Geigy Corporation, Ciba Biotech Partnership, Inc. and the Registrant (initially filed as Exhibit 10.62 of the Registrant's current report on Form 8-K dated January 4, 1995).* 10.716 Letter Agreement dated September 30, 1999, between Novartis Corporation and the Registrant. (Certain information has been omitted from the Agreement and filed separately with the Securities and Exchange Commission pursuant to a request by Registrant for confidential treatment pursuant to Rule 24b-2. The omitted confidential information has been identified by the following statement: "Confidential Treatment Requested".) 27 Financial Data Schedule for the Nine Months ended September 30, 1999. 27.1 Financial Data Schedule for the Nine Months ended September 27, 1998. (b) Reports on Form 8-K None. - ------------------------ * Management contract, compensatory plan or arrangement. 30 CHIRON CORPORATION SEPTEMBER 30, 1999 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. CHIRON CORPORATION DATE: November 12, 1999 BY: /s/ SEAN P. LANCE -------------------------------------- Sean P. Lance Chairman; Chief Executive Officer DATE: November 12, 1999 BY: /s/ JAMES R. SULAT -------------------------------------- James R. Sulat Vice President; Chief Financial Officer DATE: November 12, 1999 BY: /s/ DAVID V. SMITH -------------------------------------- David V. Smith Vice President; Controller and Principal Accounting Officer 31