UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF ----- THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1999 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 1-4448 BAXTER INTERNATIONAL INC. ------------------------ (Exact name of registrant as specified in its charter) Delaware 36-0781620 ------------------------------- ------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Baxter Parkway, Deerfield, Illinois 60015-4633 - ---------------------------------------- ---------- (Address of principal executive offices) (Zip Code) (847) 948-2000 -------------- (Registrant's telephone number, including area code) 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 ----- ----- The number of shares of the registrant's Common Stock, par value $1.00 per share, outstanding as of August 6, 1999, the latest practicable date, was 291,143,216 shares. BAXTER INTERNATIONAL INC. FORM 10-Q For the quarterly period ended June 30, 1999 TABLE OF CONTENTS Page Number ----------- Part I. FINANCIAL INFORMATION - ------------------------------- Item 1. Financial Statements Condensed Consolidated Statements of Income...................... 2 Condensed Consolidated Balance Sheets............................ 3 Condensed Consolidated Statements of Cash Flows.................. 4 Notes to Condensed Consolidated Financial Statements............. 5 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations........................................13 Review by Independent Public Accountants......................................22 Report of Independent Accountants.............................................23 Part II. OTHER INFORMATION - --------------------------- Item 1. Legal Proceedings...................................................24 Item 4. Submission of Matters to a Vote of Security Holders.................27 Item 6. Exhibits and Reports on Form 8-K....................................27 Signature.....................................................................28 Exhibits......................................................................29 PART I. FINANCIAL INFORMATION Item 1. Financial Statements Baxter International Inc. and Subsidiaries Condensed Consolidated Statements of Income (unaudited) (in millions, except per share data) Three months ended Six months ended June 30, June 30, 1999 1998 1999 1998 ------------------ ------------------ Operations Net sales $1,560 $1,419 $3,022 $2,675 Costs and expenses Cost of goods sold 870 765 1,707 1,458 Marketing and administrative expenses 319 306 623 563 Research and development expenses 84 84 159 158 In-process research and development -- 116 -- 116 Interest, net 22 33 46 64 Goodwill amortization 4 5 9 9 Other expense 6 6 6 4 - -------------------------------------------------------------------------------------------------------------- Total costs and expenses 1,305 1,315 2,550 2,372 - -------------------------------------------------------------------------------------------------------------- Income from continuing operations before income taxes and cumulative effect of accounting change 255 104 472 303 Income tax expense 66 52 121 103 - -------------------------------------------------------------------------------------------------------------- Income from continuing operations before cumulative effect of accounting change 189 52 351 200 Income from discontinued operation, net of applicable income tax expense of $6 and $10 in 1999 and $4 and $8 in 1998 18 11 34 27 - -------------------------------------------------------------------------------------------------------------- Income before cumulative effect of accounting change 207 63 385 227 Cumulative effect of accounting change, net of income tax benefit of $7 -- -- (27) -- - -------------------------------------------------------------------------------------------------------------- Net income $ 207 $ 63 $ 358 $ 227 - -------------------------------------------------------------------------------------------------------------- Earnings per basic common share Continuing operations, before cumulative effect of accounting change $ .65 $ .18 $ 1.21 $ .71 Discontinued operation .06 .04 .12 .10 Cumulative effect of accounting change -- -- (.09) -- - -------------------------------------------------------------------------------------------------------------- Net income $ .71 $ .22 $ 1.24 $ .81 ============================================================================================================== Earnings per diluted common share Continuing operations, before cumulative effect of accounting change $ .64 $ .18 $ 1.19 $ .70 Discontinued operation .06 .04 .12 .09 Cumulative effect of accounting change -- -- (.09) -- - -------------------------------------------------------------------------------------------------------------- Net income $ .70 $ .22 $ 1.22 $ .79 ============================================================================================================== Weighted average number of common shares outstanding: Basic 290 283 289 282 ============================================================================================================== Diluted 295 288 294 287 ============================================================================================================== The accompanying notes are an integral part of these condensed consolidated financial statements. 2 Baxter International Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in millions, except shares) ==================================================================================================================== June 30, December 31, 1999 1998 (unaudited) ----------------------------------- Current assets Cash and equivalents $ 723 $ 709 Accounts receivable 1,581 1,588 Notes and other current receivables 153 329 Inventories 1,397 1,324 Short-term deferred income taxes 387 467 Prepaid expenses 246 234 --------------------------------------------------------------------------------------------------- Total current assets 4,487 4,651 - -------------------------------------------------------------------------------------------------------------------- Property, At cost 4,945 4,989 plant and Accumulated depreciation and amortization (2,297) (2,316) Equipment --------------------------------------------------------------------------------------------------- Net property, plant and equipment 2,648 2,673 - -------------------------------------------------------------------------------------------------------------------- Other assets Goodwill and other intangibles 1,734 1,817 Insurance receivables 393 378 Other 637 566 --------------------------------------------------------------------------------------------------- Total other assets 2,764 2,761 - -------------------------------------------------------------------------------------------------------------------- Total assets $ 9,899 $10,085 ==================================================================================================================== Current Notes payable to banks $ 123 $ 156 liabilities Current maturities of long-term debt and lease obligations 110 115 Accounts payable and accrued liabilities 1,786 2,181 Income taxes payable 578 536 --------------------------------------------------------------------------------------------------- Total current liabilities 2,597 2,988 - -------------------------------------------------------------------------------------------------------------------- Long-term debt and lease obligations 2,907 3,096 - -------------------------------------------------------------------------------------------------------------------- Long-term deferred income taxes 440 505 - -------------------------------------------------------------------------------------------------------------------- Long-term litigation liabilities 334 246 - -------------------------------------------------------------------------------------------------------------------- Other long-term liabilities 402 411 - -------------------------------------------------------------------------------------------------------------------- Stockholders' Common stock, $1 par value, authorized 350,000,000 equity shares, issued 294,363,251 shares in 1999 and 291,248,251 shares in 1998 294 291 Additional contributed capital 2,249 2,064 Retained earnings 1,145 990 Common stock in treasury, at cost, 2,479,526 shares in 1999 and 4,919,141 shares in 1998 (132) (210) Accumulated other comprehensive income (337) (296) --------------------------------------------------------------------------------------------------- Total stockholders' equity 3,219 2,839 - -------------------------------------------------------------------------------------------------------------------- Total liabilities and stockholders' equity $ 9,899 $10,085 ==================================================================================================================== The accompanying notes are an integral part of these condensed consolidated financial statements. 3 Baxter International Inc. and Subsidiaries Condensed Consolidated Statements of Cash Flows (unaudited) (in millions) ====================================================================================================================== Six months ended June 30, (brackets denote cash outflows) 1999 1998 ------------------------------- Cash flows Net income $ 358 $ 227 from Adjustments operations Depreciation and amortization 227 211 Deferred income taxes 16 66 Cumulative effect of accounting change 34 -- In-process research and development -- 116 Other 8 3 Changes in balance sheet items Accounts receivable 5 (116) Inventories (104) (136) Accounts payable and other accrued liabilities (143) (142) Net litigation payments and other (155) (138) ----------------------------------------------------------------------------------------------------- Cash flows from operations 246 91 - ---------------------------------------------------------------------------------------------------------------------- Cash flows Capital expenditures (248) (221) from investing Acquisitions, net of cash received, activities and investments in affiliates (57) (239) Divestitures and other asset dispositions 6 -- ----------------------------------------------------------------------------------------------------- Investment activities, net (299) (460) - ---------------------------------------------------------------------------------------------------------------------- Cash flows Issuances of debt and lease obligations 268 879 from financing Redemptions of debt and lease obligations (375) (117) activities Increase (decrease) in debt with maturities of three months or less, net 122 (310) Common stock cash dividends (169) (165) Stock issued under Shared Investment Plan 198 -- Stock issued under employee benefit plans 67 57 ----------------------------------------------------------------------------------------------------- Financing activities, net 111 344 - ---------------------------------------------------------------------------------------------------------------------- Effect of currency exchange rate changes on cash and equivalents (44) (12) - ---------------------------------------------------------------------------------------------------------------------- Increase (decrease) in cash and equivalents 14 (37) Cash and equivalents at beginning of period 709 465 - ---------------------------------------------------------------------------------------------------------------------- Cash and equivalents at end of period $ 723 $ 428 ====================================================================================================================== The accompanying notes are an integral part of these condensed consolidated financial statements. 4 Baxter International Inc. and Subsidiaries Notes to Condensed Consolidated Financial Statements (unaudited) 1. FINANCIAL INFORMATION - ------------------------- The unaudited interim condensed consolidated financial statements of Baxter International Inc. and its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles (GAAP) have been condensed or omitted. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in the company's 1998 Annual Report to Stockholders. In the opinion of management, the interim condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim period are not necessarily indicative of the results of operations to be expected for the full year. Certain reclassifications have been made to conform the 1998 financial statements to the 1999 presentation. Basis of consolidation - ---------------------- Prior to fiscal 1999, all operations outside the United States and its territories had been included in the consolidated financial statements on the basis of fiscal years ending November 30 in order to facilitate timely consolidation. In conjunction with the implementation of new financial systems, this one-month lag was eliminated as of the beginning of fiscal 1999 for certain of these international operations, and the December 1998 results of operations for these entities were recorded directly to retained earnings. This change does not have a material impact on the consolidated financial statements. Start-up costs - -------------- Effective at the beginning of 1999, the company adopted AICPA Statement of Position (SOP) 98-5, "Reporting on the Costs of Start-up Activities." This SOP requires that, at the date of adoption, costs of start-up and organization activities previously capitalized be expensed and reported as a cumulative effect of a change in accounting principle, and requires that such costs subsequent to adoption be expensed as incurred. The after-tax cumulative effect of this accounting change was $27 million. Excluding the initial effect of adopting this standard, management does not anticipate that the new SOP will have a material impact on future results of operations. Comprehensive income - -------------------- Total comprehensive income was $226 million and $49 million for the three months ended June 30, 1999 and 1998, respectively, and was $283 million and $172 million for the six months ended June 30, 1999 and 1998, respectively. 5 2. DISCONTINUED OPERATION - -------------------------- On July 11, 1999, the board of directors of Baxter International Inc. approved a plan to spin off its cardiovascular business to Baxter stockholders. Management expects that shares of the new cardiovascular company will be distributed to Baxter stockholders (the distribution) in the first six months of 2000 and that the spin-off will be tax-free. The distribution will result in the cardiovascular business operating as an independent entity with publicly traded common stock. The creation of a separately traded, publicly held company will enable Baxter and the new company to devote more management time, attention and investments directly to the core strategies of each business. The spin-off is expected to provide both companies with more financial flexibility and accelerate the speed of innovation. The new cardiovascular company will manufacture, market and sell a comprehensive line of therapies and services to treat late-stage heart disease and vascular disorders. Products manufactured by the company will include heart valve replacement and repair products, critical-care monitoring devices, cardiopulmonary products, heart-assist systems and other products. The company will also provide services to hospitals for cardiovascular surgery and special procedures. The following unaudited selected income statement data for the cardiovascular business is presented for informational purposes only and does not necessarily reflect what the results of operations would have been had the business operated as a stand-alone entity. - --------------------------------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, June 30, (in millions) 1999 1998 1999 1998 - --------------------------------------------------------------------------------------------------------------------------- Operations Net sales $ 233 $ 227 $ 456 $ 439 Costs and expenses Cost of goods sold 115 118 227 231 Marketing and administrative expenses 60 55 118 105 Research and development expenses 13 15 25 27 Interest, net 9 10 20 21 Goodwill amortization 9 9 17 17 Other expense 3 5 5 3 - --------------------------------------------------------------------------------------------------------------------------- Total costs and expenses 209 212 412 404 - --------------------------------------------------------------------------------------------------------------------------- Income before income taxes $ 24 $ 15 $ 44 $ 35 =========================================================================================================================== Income before interest, taxes, depreciation and amortization (EBITDA) $ 55 $ 47 $ 109 $ 100 =========================================================================================================================== The following unaudited selected balance sheet data for the cardiovascular business is presented for informational purposes only. The data is presented on an historical management basis and does not reflect certain adjustments necessary to present the financial position of the business on a stand-alone basis. - --------------------------------------------------------------------------------------------------- June 30, December 31, (in millions, on a management basis) 1999 1998 - --------------------------------------------------------------------------------------------------- Net current assets $ 221 $ 206 Net noncurrent assets 1,049 1,048 - --------------------------------------------------------------------------------------------------- Total net assets $1,270 $1,254 =================================================================================================== As a result of the board's approval of the distribution, the company's condensed consolidated income statement and related notes have been adjusted and restated to reflect the results of operations of the cardiovascular business as a discontinued operation. Management is in the process of analyzing and making decisions regarding assets and liabilities related to the cardiovascular business as well as the capitalization of the business. Therefore, the condensed consolidated balance sheet and condensed consolidated statement of cash flows and related notes have not yet been adjusted and restated to reflect the cardiovascular business as a discontinued operation. Such adjustments and restatements are expected to be 6 made in the latter part of 1999. It is expected that through the issuance of new third-party debt, a portion of Baxter's existing debt will be indirectly assumed by the new cardiovascular company. The amount of debt will be determined when the capital structure for the new company is finalized. 3. EARNINGS PER SHARE - ---------------------- The numerator for both basic and diluted earnings per share (EPS) is income from continuing operations before cumulative effect of accounting change, income from discontinued operation, cumulative effect of accounting change or net income, as applicable. The denominator for basic EPS is the weighted-average number of common shares outstanding during the period. The following is a reconciliation of the shares (denominator) of the basic and diluted per-share computations: - --------------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, June 30, (in millions) 1999 1998 1999 1998 - --------------------------------------------------------------------------------------------------------- Basic EPS shares 290 283 289 282 - --------------------------------------------------------------------------------------------------------- Effect of dilutive securities Employee stock options 4 4 5 4 Employee stock purchase plans and equity forward agreements 1 1 0 1 - --------------------------------------------------------------------------------------------------------- Diluted EPS shares 295 288 294 287 ========================================================================================================= 4. COMMON STOCK - ---------------- Shared Investment Plan - ---------------------- In connection with a newly implemented Shared Investment Plan, the company received approximately $198 million in cash in May 1999 from 142 of Baxter's senior managers, who in the aggregate voluntarily purchased approximately 3.1 million shares of the company's common stock. This plan, which is similar to one implemented in 1994, directly aligns management and shareholder interests. The Baxter managers used full-recourse personal bank loans to purchase the stock at the May 3, 1999 closing price of $63.625. Baxter has agreed to guarantee repayment to the banks in the event of default by a participant in the plan. Equity Forward Agreements - ------------------------- During the first and second quarters of 1999, the company entered into forward agreements with independent third parties related to approximately 2.7 million and 3.8 million shares, respectively, of its common stock. The purpose of the agreements is to attempt to partially offset the dilutive effect of stock issuances under the company's employee stock option plans. The forward agreements require the company to purchase its common stock from the counterparties on specified future dates and at specified prices. The company can, at its option, require settlement of the agreements with shares of its common stock or, in some cases, cash, in lieu of physical settlement. Agreements related to approximately 2.8 million shares mature in 2000 at exercise prices ranging from $68 to $71 per share. Agreements related to approximately 3.7 million shares mature in 2002 at exercise prices ranging from $74 to $81 per share. The company may, at its option, terminate these agreements at any time before maturity. 7 In conjunction with its stock repurchase program, during the third quarter of 1999 the company terminated one of the agreements prior to original maturity date, delivering approximately $32.7 million in cash to the counterparty for 500,000 shares of Baxter common stock. 5. ACQUISITIONS - ----------------- All acquisitions during the six months ended June 30, 1999 and 1998 were accounted for under the purchase method. Results of operations of acquired companies are included in the company's results of operations as of the respective acquisition dates. The purchase price of each acquisition was allocated to the net assets acquired based on estimates of their fair values at the date of the acquisition. The excess of the purchase price over the fair values of the net tangible assets and liabilities acquired was allocated to goodwill and other intangible assets, and is being amortized on a straight-line basis over periods ranging from 10 to 40 years. As further discussed below, a portion of the purchase price for one of the acquisitions was allocated to in- process research and development (IPR&D) which, under GAAP, was immediately expensed. Excluding the IPR&D charge, had the 1999 and 1998 acquisitions taken place on January 1 of 1999 or 1998, net sales, net income and earnings per share would not have been materially different from the reported amounts. Somatogen, Inc. - --------------- In May 1998, the company acquired Somatogen, Inc. (Somatogen), a developer of recombinant hemoglobin-based technology. The purchase price was approximately $206 million and was principally settled with approximately 3.5 million shares of Baxter International Inc. common stock. In addition, Somatogen shareholders are entitled to a contingent deferred cash payment of up to $2.00 per Somatogen share, or approximately $42 million, based on a percentage of sales of certain future products through the year 2007. Approximately $116 million of the purchase price was allocated to IPR&D, and immediately expensed, as discussed above. The amount allocated to IPR&D was determined on the basis of an independent appraisal using the income approach, which measures the value of an asset by the present value of its future economic benefits. Estimated cash flows were discounted to their present values at rates of return that incorporate the risk- free rate, the expected rate of inflation, and risks associated with the particular projects, including their stages of completion. Projected revenue and cost assumptions were determined based upon the company's historical experience and industry trends and averages. Somatogen was a development-stage company, developing oxygen-carrying therapeutics. No revenue had ever been generated from commercial product sales. The development of oxygen-carrying therapeutics is a strategic priority to Baxter. At the time of the acquisition of Somatogen, Baxter was in final-stage (Phase III) clinical trials with its HemAssist(R) (DCLHb) product. Baxter acquired Somatogen to advance the development of new generations of recombinant oxygen-carrying technology-based products with enhanced attributes. Subsequent to the date of the acquisition, Baxter decided to end its HemAssist (DCLHb) program and focus on Somatogen's next-generation program. Material net cash inflows relating to Somatogen's IPR&D were forecasted in the valuation to begin in 2004. Estimated research and development costs to be incurred prior to 2004 total approximately $100 million. A discount rate of 22 percent was used in the valuation. 8 Pharmaceutical Products Division of the BOC Group - ------------------------------------------------- In April 1998, the company acquired the Pharmaceutical Products Division of the BOC Group's Ohmeda health-care business, a manufacturer of gases and drugs used for general and local anesthesia, for approximately $91 million. The fair value of the identifiable net assets acquired exceeded the purchase price by approximately $149 million. Such excess was allocated to reduce the values assigned to noncurrent assets in determining their fair values. Bieffe Medital S.p.A. - --------------------- In early 1998, the company acquired Bieffe Medital S.p.A., a manufacturer of dialysis and intravenous solutions and containers, for approximately $188 million. Approximately $124 million and $15 million of the purchase price was allocated to goodwill and other intangibles, respectively. 6. INVENTORIES - --------------- Inventories consisted of the following: - -------------------------------------------------------------------------------------- June 30, December 31, 1999 1998 (in millions) (unaudited) - -------------------------------------------------------------------------------------- Raw materials $ 329 $ 315 Work in process 272 262 Finished products 796 747 - -------------------------------------------------------------------------------------- Total inventories $1,397 $1,324 ====================================================================================== 7. EXIT AND OTHER REORGANIZATION PROGRAMS - ------------------------------------------ In September 1998, the company decided to end the clinical development of the Blood Therapies' segment's first-generation oxygen-carrying therapeutic called HemAssist(R) (DCLHb) and focus on the next-generation program. While the first- generation program was based on human hemoglobin, the next-generation program is based on genetically engineered hemoglobin molecules. The company also decided to exit certain non-strategic investments, primarily in Asia, and reorganize certain other activities, principally in the Blood Therapies and I.V. Systems/Medical Products segments. As a result of these decisions, the company recorded a $131 million pretax charge primarily for asset writedowns and employee severance, of which approximately $38 million related to employee severance resulting from the elimination of approximately 400 positions worldwide. Approximately 330 positions have been eliminated to date and approximately $19 million of reserves are remaining at June 30, 1999, of which approximately $6 million pertain to employee-related costs. The majority of the asset writedowns relate to assets located in a manufacturing facility in Neuchatel, Switzerland, that were used solely in the development and manufacture of HemAssist(R) (DCLHb), and have no alternative future use. In 1999, the company has begun modifications to this manufacturing facility, which was designed to manufacture a human hemoglobin product, to produce another biopharmaceutical product. Such alternate production is expected to commence at the Neuchatel facility in the next two to four years. In September 1995, the company recorded a restructuring charge of $103 million primarily to eliminate excess plant capacity and reduce manufacturing costs. The charge predominantly 9 related to the closure of the intravenous-solutions plant and warehouse in Carolina, Puerto Rico. As of year-end 1998, production and warehousing had been consolidated into other facilities. The remaining reserves were utilized during the first quarter of 1999 as employee severance was paid and other wind-down activities were completed. Approximately 1,200 positions were eliminated in Puerto Rico. Certain positions, primarily direct labor, were added to other facilities to support the increased production levels at those sites. 8. LEGAL PROCEEDINGS - -------------------- Refer to "Part II - Item 1. Legal Proceedings" below for the status of lawsuits and claims involving the company. 9. INTEREST, NET - ---------------- Net interest expense consisted of the following (unaudited): - ----------------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, June 30, (in millions) 1999 1998 1999 1998 - ----------------------------------------------------------------------------------------------------------- Interest expense $39 $49 $80 $102 Interest income (8) (6) (14) (17) - ----------------------------------------------------------------------------------------------------------- Interest, net $31 $43 $66 $85 =========================================================================================================== Allocated to discontinued operation $ 9 $10 $20 $21 =========================================================================================================== Allocated to continuing operations $22 $33 $46 $64 =========================================================================================================== The allocation of interest to continuing operations and the discontinued operation was based on estimated relative net assets of these operations. 10. SEGMENT INFORMATION - ----------------------- The company operates in three segments, each of which are strategic businesses that are managed separately because each business develops, manufactures and sells distinct products and services. The segments and a description of their businesses are as follows: I.V. Systems/Medical Products: technologies and systems to provide intravenous fluid and drug delivery; Blood Therapies: biopharmaceutical and blood-collection and separation products and technologies; and Renal: products and services to treat end-stage kidney disease. As discussed in Note 2 above, the company plans to spin off its cardiovascular business to Baxter stockholders. Income statement information for the cardiovascular business, which is substantially the same as the former CardioVascular segment, is now being reflected in the condensed consolidated income statement as a discontinued operation. Certain items are maintained at corporate headquarters (Corporate) and are not allocated to the segments. They primarily include most of the company's debt and cash and equivalents and related net interest expense, corporate headquarters costs, certain non-strategic investments and nonrecurring gains and losses, deferred income taxes, hedging activities, and certain litigation liabilities and related insurance receivables. 10 Financial information for the company's segments for the three and six months ended June 30 is as follows: I.V. Systems/ Medical Blood Products Therapies Renal Other Total - -------------------------------------------------------------------------------- For the three months ended - -------------------------- June 30, - -------- 1999 - ---- Net sales $ 604 $ 543 $413 -- $1,560 Pretax income 99 117 79 ($40) 255 1998 - ---- Net sales $ 572 $ 477 $370 -- $1,419 Pretax income 98 109 65 ($168) 104 For the six months ended - ------------------------ June 30, - -------- 1999 - ---- Net sales $1,154 $1,055 $813 -- $3,022 Pretax income 169 217 149 ($63) 472 1998 - ---- Net sales $1,073 $ 887 $715 -- $2,675 Pretax income 169 195 133 ($194) 303 - -------------------------------------------------------------------------------- The following are reconciliations of total segment amounts to amounts per the condensed consolidated financial statements: Three Months Ended June 30, --------------- 1999 1998 - --------------------------------------------------------------------------- Pretax income - ------------ Total pretax income from segments $295 $ 272 Unallocated amounts Interest expense, net (22) (33) In-process research and development -- (116) Other Corporate items (18) (19) ---- ----- Income from continuing operations before income taxes and cumulative effect of accounting change $255 $ 104 - --------------------------------------------------------------------------- 11 Six Months Ended June 30, --------------- 1999 1998 - -------------------------------------------------------------------------- Pretax income - ------------- Total pretax income from segments $ 535 $ 497 Unallocated amounts Interest expense, net (46) (64) In-process research and development -- (116) Other Corporate items (17) (14) --------------- Income from continuing operations before income taxes and cumulative effect of accounting change $ 472 $ 303 - -------------------------------------------------------------------------- 12 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Baxter International Inc.'s (the company or Baxter) 1998 Annual Report to Stockholders ("Annual Report") contains management's discussion and analysis of financial condition and results of operations for the year ended December 31, 1998. In the Annual Report, management outlined its key financial objectives for 1999. The objectives, which are summarized below, were established based on total company results prior to the July 1999 announcement of the plan to spin off the cardiovascular business as a distribution to stockholders. Refer to Note 2 to the Condensed Consolidated Financial Statements for further information regarding the planned spin-off. Accordingly, the results presented below reflect the combined results of both continuing and discontinued operations. RESULTS THROUGH FULL YEAR 1999 OBJECTIVES JUNE 30, 1999 - -------------------------------------------------------------------------------------------------------------- . Increase net sales approximately 10 . Net sales during the six months ended percent. June 30, 1999 increased 12 percent. - -------------------------------------------------------------------------------------------------------------- . Grow net earnings in the low double . Excluding the cumulative effect of a change in digits. accounting principle in 1999 and the in-process research and development charge in 1998, net income for the first half of the year increased approximately 12 percent. - -------------------------------------------------------------------------------------------------------------- . Generate $500 million in operational cash . The company generated operational cash flow of flow, after investing approximately $1 $144 million during the six months ended June 30, billion in capital improvements and 1999. The total of capital expenditures and research research and development. and development expenses for the six months ended June 30, 1999 was $432 million. - -------------------------------------------------------------------------------------------------------------- 13 RESULTS OF OPERATIONS - --------------------- The following management discussion and analysis pertains to continuing operations, unless otherwise noted. NET SALES TRENDS - --------------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, Percent June 30, Percent (in millions) 1999 1998 Increase 1999 1998 Increase - --------------------------------------------------------------------------------------------------------- International $ 858 $ 793 8% $1,663 $1,475 13% United States 702 626 12% 1,359 1,200 13% - --------------------------------------------------------------------------------------------------------- Total net sales $1,560 $1,419 10% $3,022 $2,675 13% ========================================================================================================= Refer to Note 10 to the Condensed Consolidated Financial Statements for a summary of net sales by segment. Blood Therapies Sales in the Blood Therapies segment increased 14 percent and 19 percent for the three- and six-month periods ended June 30, 1999, respectively. Strong demand for the segment's therapeutic proteins, especially Recombinate Antihemophilic Factor (recombinant), generated significant worldwide growth. Due to the company's recent increase in manufacturing capacity and the strong demand for Recombinate, sales growth for this product was unusually strong in 1999, especially during the first quarter. While sales for the rest of the year are expected to continue to remain strong, management expects that growth rates in the third and fourth quarters of 1999 will be lower than in the first half of the year. Domestic sales of the segment's plasma-based products also contributed strongly to the sales growth for both the quarter and year-to-date period, as the supply constraints that impacted the entire factor concentrates industry in 1998 have eased somewhat in 1999. Renal The Renal segment generated sales growth of 12 percent and 14 percent during the three and six months ended June 30, 1999, respectively. International sales were particularly strong in both the quarter and year-to-date period, with significant growth generated from the segment's Renal Therapy Services (RTS) business, which operates dialysis clinics in partnership with local physicians and hospitals in international markets. While RTS sales are expected to remain strong, management expects that growth rates in the third and fourth quarters of 1999 will be less than in the first half of the year due to a reduction in acquisition-related growth. Domestically, the Renal Management Services (RMS) business, which is a renal-disease management organization, contributed to the sales growth rate for both the three- and six-month periods ended June 30, 1999. The base business, which consists of products for hemodialysis and peritoneal dialysis, also generated solid sales growth during the first half of the year. I.V. Systems/Medical Products The I.V. Systems/Medical Products segment generated 6 percent and 8 percent sales growth during the three and six months ended June 30, 1999, respectively. The April 1998 acquisition of the Pharmaceutical Products Division of The BOC Group's Ohmeda health-care business (Ohmeda), a domestic manufacturer of inhalants and drugs used for general and local 14 anesthesia, was a significant contributor to sales growth, especially for the six-month period ended June 30, 1999. The recent introductions of the Colleague(R) single-channel and triple-channel volumetric infusion pumps, and increased penetration and new product introductions in emerging markets also contributed to sales growth for both the quarter and year-to-date period. Partially offsetting these factors were the effects of competitive pricing and cost pressures from health-care providers in certain markets. The following table shows key ratios of certain income statement items as a percent of sales: GROSS MARGIN AND EXPENSE RATIOS - ----------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, June 30, 1999 1998 (Decrease) 1999 1998 (Decrease) - ----------------------------------------------------------------------------------------------------- Gross profit margin 44.2% 46.1% (1.9 pts) 43.5% 45.5% (2.0 pts) Marketing and administrative expenses 20.4% 21.6% (1.2 pts) 20.6% 21.0% (0.4 pts) - ----------------------------------------------------------------------------------------------------- The gross profit margin decreased for both the quarter and year-to-date period primarily due to a less favorable product and services mix. The decrease in the margin in the year-to-date period was also due to the recognition of unfavorable manufacturing variances. These variances relate to increased investments in 1998 in the Blood Therapies segment's safety and quality systems in response to heightened FDA regulatory activity. Marketing and administrative expenses decreased as a percent of sales for both the three-month and six-month periods ended June 30, 1999 as the company effectively leveraged expenses as a result of strong sales, particularly in the Blood Therapies and Renal segments. Partially offsetting this leveraging effect was an increase in the ratio in the year-to-date period due to the acquisition of Ohmeda. Management expects to decrease the expense ratio during the second half of the year as it focuses on cost control across all business units, integrates recent acquisitions and implements the reorganization programs discussed below. RESEARCH AND DEVELOPMENT - ---------------------------------------------------------------------------------------------------- Three months ended Six months ended June 30, Percent June 30, Percent (in millions) 1999 1998 Increase 1999 1998 Increase - ---------------------------------------------------------------------------------------------------- Research and development expenses $84 $84 0% $159 $158 1% As a percent of sales 5% 6% 5% 6% - ---------------------------------------------------------------------------------------------------- Research and development (R&D) expenses above exclude the in-process R&D charge recorded in 1998 relating to the acquisition of Somatogen, Inc. (Somatogen). Refer to Note 5 to the Condensed Consolidated Financial Statements for further information regarding this charge. R&D expenses decreased as a percentage of sales in 1999 as compared to 1998, primarily due to the September 1998 decision to end the clinical development of the company's first-generation oxygen- carrying therapeutic called HemAssist(R)(DCLHb). Management expects the growth rate in R&D expenses will increase in the future as the company focuses on the next-generation oxygen-carrying therapeutics program within its Blood Therapies segment, as well as on other R&D initiatives across its three segments. 15 EXIT AND OTHER REORGANIZATION PROGRAMS Refer to Note 7 to the Condensed Consolidated Financial Statements for a discussion of the company's charges, utilization of the reserves and headcount reductions to date. Management believes remaining restructuring reserves are adequate to complete the actions contemplated by the programs. Future cash expenditures will be funded by cash generated from operations. The 1998 program is in process and principally relates to the decision to end the clinical development of HemAssist (DCHLb), as discussed above, as well as the decision to exit certain non-strategic investments, primarily in Asia, and reorganize certain other activities. The 1995 program has been completed. The plant closures and consolidations in Puerto Rico lower manufacturing costs and help mitigate any future exposure to gross margin erosion arising from pricing pressures, primarily in the United States. OTHER INCOME AND EXPENSE Net interest expense decreased for the three- and six-month periods ended June 30, 1999 as compared to the prior-year periods principally due to the impact of a higher level of foreign currency denominated debt, which bears a lower average interest rate, and, in the second quarter, due to the cash proceeds from the Shared Investment Plan, which is further discussed in Note 4 to the Condensed Consolidated Financial Statements. PRETAX INCOME Refer to Note 10 to the Condensed Consolidated Financial Statements for a summary of financial results by segment. Blood Therapies The pretax income growth of 7 percent and 11 percent for the three and six months ended June 30, 1999, respectively, was driven by the strong sales for the quarter, a reduction in R&D expenses due to the termination of the HemAssist (DCLHb) program, leveraging of marketing and administrative expenses, and fluctuations in currency exchange rates. As discussed above, the gross profit margin for the Blood Therapies segment declined in the year-to-date period primarily due to the recognition of unfavorable manufacturing variances. Additionally, the blood-collection businesses generated lower profits in 1999 principally as a result of a less favorable mix of sales, pricing pressures due to competition and continued regulatory activity in the industry, which has affected certain of the segment's customers. Renal Pretax income increased approximately 22 percent and 12 percent for the quarter and year-to-date period, respectively. Strong sales growth for the quarter and the effect of currency exchange rate fluctuations were partially offset by a less favorable product and services mix, and increased investments in the business. I.V. Systems/Medical Products Pretax income increased 1 percent for three months and was flat for the six months ended June 30, 1999, respectively, as compared to the prior year periods. This growth in profitability was principally due to the acquisition of Ohmeda in April 1998, partially offset by the effect of currency exchange rate fluctuations. 16 INCOME TAXES FROM CONTINUING OPERATIONS Excluding the in-process research and development charge in the second quarter of 1998, the effective income tax rate was 26 percent and 26 percent for the three- and six-month periods ended June 30, 1999, compared to 24 percent and 25 percent for the three- and six-month periods ended June 30, 1998. The increase in the effective income tax rate for both periods was due to a larger portion of the company's earnings being generated in higher tax jurisdictions. DISCONTINUED OPERATION Income from the discontinued operation increased by $7 million in both the quarter and year-to-date period ended June 30, 1999, resulting in growth of 64 percent and 26 percent, respectively. These results reflect the favorable effect of currency exchange rate fluctuations, growth in the higher-margin tissue heart valves and valve-repair product lines and reduced R&D spending, partially offset by reduced profits in certain other product and service lines due to pricing and competitive pressures, loss of a distribution agreement and a reduction in the number of open-heart surgical procedures. CHANGE IN ACCOUNTING PRINCIPLE In the first quarter of 1999, the company recorded a $27 million after-tax charge for the cumulative effect of a change in accounting principle. The charge related to the adoption of AICPA Statement of Position (SOP) 98-5, "Reporting on the Costs of Start-up Activities." Excluding the initial effect of adopting this standard, management does not anticipate that the new SOP will have a material impact on future results of operations. LIQUIDITY AND CAPITAL RESOURCES - ------------------------------- Management assesses the company's liquidity in terms of its overall ability to mobilize cash to support ongoing business levels and to fund its growth. Management uses an internal performance measure called operational cash flow that evaluates each operating business and geographic region on all aspects of cash flow under its direct control. The following table reconciles cash flow provided by operations, as determined by generally accepted accounting principles, to operational cash flow: - ----------------------------------------------------------------------------- Six months ended June 30, (in millions) 1999 1998 - ----------------------------------------------------------------------------- Cash flow from operations per the company's Condensed Consolidated Statements of Cash Flows $ 246 $ 91 Capital expenditures (248) (221) Net interest after tax 34 51 Other, including mammary implant litigation 112 84 - ----------------------------------------------------------------------------- Operational cash flow $ 144 $ 5 ============================================================================= Approximately $30 million of the total net cash flows used for acquisitions and investments in affiliates for the six months ended June 30, 1999 related to a contingent purchase price payment pertaining to the 1997 acquisition of Immuno International AG. Refer 17 to "Part II Item 1. Legal Proceedings" for further information. Approximately $114 million of the total net cash flows used for acquisitions and investments in affiliates for the six months ended June 30, 1998 related to the acquisition of Bieffe Medital S.p.A., with most of the remaining amount related to the acquisition of Ohmeda. Refer to Note 5 to the Condensed Consolidated Financial Statements for further information regarding these acquisitions. The company's net-debt-to-capital ratio was 42.9 percent and 48.4 percent at June 30, 1999 and December 31, 1998, respectively. The decrease in the ratio was primarily due to the $198 million cash inflow from the Shared Investment Plan, which is discussed in Note 4 to the Condensed Consolidated Financial Statements, cash flows from ongoing operations and favorable currency exchange rate fluctuations. In addition, due principally to favorable fluctuations in currency exchange rates, the total market value of the company's foreign exchange contracts has increased significantly from that disclosed in the Annual Report. As authorized by the board of directors, the company repurchases its stock to optimize its capital structure depending upon its operational cash flows, net debt level and current market conditions. In November 1995, the board of directors authorized the repurchase of up to $500 million over a period of several years, of which $267 million was repurchased as of December 31, 1996. No shares were repurchased between the end of 1996 and the end of the second quarter of 1999. As the company's net-debt-to-capital ratio is now in the targeted low-to-mid 40 percent range, management resumed the share repurchase program in the third quarter of 1999. During July, 1999 the company repurchased approximately 1.1 million shares of its stock at a net cost of approximately $71 million. The company intends to fund its short-term and long-term obligations as they mature by issuing additional debt or through cash flow from operations. The company believes it has lines of credit adequate to support ongoing operational requirements. Beyond that, the company believes it has sufficient financial flexibility to attract long-term capital on acceptable terms as may be needed to support its growth objectives. See "Part II - Item 1. Legal Proceedings" for a discussion of the company's legal contingencies and related insurance coverage with respect to cases and claims relating to the company's plasma-based therapies and mammary implants manufactured by the Heyer-Schulte division of American Hospital Supply Corporation, as well as other matters. Upon resolution of any of these matters, the company may incur charges in excess of presently established reserves. While such future charges could have a material adverse impact on the company's net income or cash flows in the period in which they are recorded or paid, management believes that the outcomes of these actions, individually or in the aggregate, will not have a material adverse effect on the company's consolidated financial position. YEAR 2000 - --------- The company has developed, and is implementing, a comprehensive program to address Year 2000 issues pertaining to both information technology (IT) and non- IT systems. The program is monitored by a steering committee comprised of senior management in key functional areas, which periodically reports to the audit committee of the board of directors as to the program's status. The program consists of identification, compliance and post-implementation phases and considers the effect of the Year 2000 on the company's internal systems, customers, products 18 and services, and manufacturing systems, as well as on its suppliers and other critical business partners. The current status of these areas of scope vary within the post-implementation phase. The company has been upgrading, replacing or modifying non-compliant internal systems. All major systems are expected to be Year 2000 compliant, based on a phased implementation plan, by the end of the third quarter of 1999. To date, the company has achieved all significant milestones relating to this initiative, with approximately 85 percent of major system implementations complete as of the end of the second quarter of 1999, and with the remainder scheduled for completion by the end of the third quarter of 1999. The total cost to upgrade or replace IT systems that would not have been Year 2000 ready is estimated to be approximately $145 million. More than 75 percent of this total has been expended to date, with the remainder to be substantially expended by the end of 1999. None of the company's systems are being upgraded or replaced solely to address Year 2000 issues, although in some cases the timing of the system upgrades and replacements was accelerated. Compliance checking of products has been completed and fewer than 20 products were identified to have Year 2000 issues. Approximately 80 percent of product modifications and replacements have been completed as of June 30, 1999. The remaining modifications and replacements are expected to be completed by the end of 1999. The company's Year 2000 customer website includes a complete list of the company's electronic medical products, frequent and detailed updates regarding the status of Year 2000 affected products, a product supply requirements policy addressing Year 2000 supply chain issues, and other information regarding the company's Year 2000 program. The company is actively addressing systems in its manufacturing plants and other facilities. All remediation decisions for critical items were complete at the end of 1998. Over 95 percent of the required changes for critical and non- critical date-dependent items have been implemented as of the end of the second quarter of 1999, consistent with management's expectations. The remainder of the required changes are expected to be completed by the end of 1999. In addition, the company has been communicating with critical suppliers and other business partners to determine the extent to which any Year 2000 issues affecting such third parties will affect the company. Such communications have included solicitation of written responses to questionnaires and follow-up meetings as needed. To date, the company has achieved a response rate in excess of 90 percent from critical supplier questionnaires. Such communications are ongoing and are expected to continue through the end of 1999, with action plans developed and implemented as necessary. Based upon the company's current estimates, and information available at this time, incremental out-of-pocket costs of the Year 2000 program, which are required to be expensed as incurred, have been and are expected to be immaterial to the company's financial results. A large part of the Year 2000 effort has been accomplished through the redeployment of existing resources. The cost of such redeployment or of internal management time has not been specifically quantified. However, no critical projects of the company have been deferred due to the Year 2000 program. Management of the company believes that its program will be effective to resolve the Year 2000 issue in a timely manner. The company has, however, begun contingency planning to address any situations that may arise in which the readiness of the company's internal technology or 19 that of third parties is not reasonably expected to be adequate, and where practical alternatives are available. The company has been assessing the viability of the entire supply chain and is in the process of finalizing any necessary and feasible contingency plans accordingly. Current contingency planning centers on human resource issues, inventory management, and the development of a rapid response capability and monitoring process for critical communications during the transition into the Year 2000. To accumulate ongoing input into the contingency planning process, the company is meeting regularly with key health-care industry leaders, contacting customs officials and monitoring the Year 2000 status of key customers, distributors and suppliers. Key company management and other critical resources have been identified to be available during the transition into the Year 2000 to address any business needs and communicate as needed with employees, customers, suppliers and other business partners. Management does not believe there has been or will be a significant disruption to the company's business due to the Year 2000 remediation effort. However, there can be no assurance that the company's Year 2000 program or the programs of critical business partners will be successful. Any failure to adequately address the Year 2000 issue could significantly disrupt the company's operations and possibly lead to litigation against the company. The costs and expenses associated with any such failure or litigation, or with any disruptions in the economy in general as a result of the Year 2000, are not presently estimable, but could have a material adverse effect on the company's business and results of operations. FORWARD-LOOKING INFORMATION - --------------------------- The matters discussed in this section that are not historical facts include forward-looking statements. These statements are based on the company's current expectations and involve numerous risks and uncertainties. Some of these risks and uncertainties are factors that affect all international businesses, while some are specific to the company and the health-care arenas in which it operates. The factors below in some cases have affected and could affect the company's actual results, causing results to differ, and possibly differ materially, from those expressed in any such forward-looking statements. These factors include technological advances in the medical field, unforeseen information technology issues related to the company or third parties, economic conditions, demand and market acceptance risks for new and existing products, technologies and health-care services, the impact of competitive products and pricing, manufacturing capacity, new plant start-ups, global regulatory, trade and tax policies, continued price competition, product development risks, including technological difficulties, ability to enforce patents and unforeseen commercialization and regulatory factors. In particular, the company, as well as other companies in its industry, is experiencing increased regulatory activity by the U.S. Food and Drug Administration with respect to its plasma- based biologicals and its complaint-handling systems. Currency fluctuations are also a significant variable for global companies, especially fluctuations in local currencies where hedging opportunities are unreasonably expensive, or altogether unavailable. If the United States dollar strengthens against most foreign currencies, the company's growth rates in its sales and net earnings will be negatively impacted. Management believes that its expectations with respect to forward-looking statements are based upon reasonable assumptions within the bounds of its knowledge of the company's business and operations, but there can be no assurance that the actual results or performance 20 of the company will conform to any future results or performance expressed or implied by such forward-looking statements. NEW ACCOUNTING STANDARD - ----------------------- In June 1998, the FASB issued Statement No. 133, "Accounting for Derivative Instruments and Hedging Activities" (Statement No. 133) which was to be effective for all fiscal quarters of fiscal years beginning after June 15, 1999. In June 1999, the FASB issued Statement No. 137, "Accounting for Derivative Instruments and Hedging Activities-Deferral of the Effective Date of FASB Statement No. 133" (Statement No. 137). Statement No. 137 deferred the effective date of Statement No. 133 to all fiscal quarters of fiscal years beginning after June 15, 2000. Statement No. 133 requires that all derivatives be recorded in the balance sheet as either assets or liabilities and be measured at fair value. If certain conditions are met, a derivative may be specifically designated as (i) a hedge of a recognized asset or liability or an unrecognized firm commitment, (ii) a hedge of the exposure to variable cash flows of a forecasted transaction, or (iii) a hedge of the foreign currency exposure of a net investment in a foreign operation, an unrecognized firm commitment, an available-for-sale security, or a foreign-currency-denominated forecasted transaction. The accounting for changes in the fair value of a derivative depends on the intended use of the derivative and the resulting designation. Management is in the process of evaluating this standard and has not yet determined the future impact on the company's consolidated financial statements. 21 Review by Independent Public Accountants - ---------------------------------------- Reviews of the interim condensed consolidated financial information included in this Quarterly Report on Form 10-Q for the three months and six months ended June 30, 1999 and 1998 have been performed by PricewaterhouseCoopers LLP, the company's independent public accountants. Their report on the interim condensed consolidated financial information follows. There have been no material adjustments or disclosures proposed by PricewaterhouseCoopers LLP, which have not been reflected in the interim condensed consolidated financial information. This report is not considered a report within the meaning of Sections 7 and 11 of the Securities Act of 1933 and therefore, the independent accountants' liability under Section 11 does not extend to it. 22 Report of Independent Accountants --------------------------------- To the Board of Directors and Stockholders of Baxter International Inc. We have reviewed the accompanying condensed consolidated balance sheet as of June 30, 1999 and the related condensed consolidated statements of income for the three-month and six-month periods ended June 30, 1999 and 1998, and condensed consolidated statements of cash flows for the six-month periods ended June 30, 1999 and 1998 of Baxter International Inc. and its subsidiaries. This interim financial information is the responsibility of the company's management. We conducted our review in accordance with standards established by the American Institute of Certified Public Accountants. A review of interim financial information consists principally of applying analytical procedures to financial data and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with generally accepted auditing standards, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion. Based on our review, we are not aware of any material modifications that should be made to the accompanying interim financial information for it to be in conformity with generally accepted accounting principles. We previously audited, in accordance with generally accepted auditing standards, the consolidated balance sheet as of December 31, 1998, and the related consolidated statements of income, cash flows and stockholders' equity for the year then ended (not presented herein), and in our report dated February 5, 1999 we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet information as of December 31, 1998, is fairly stated in all material respects in relation to the consolidated balance sheet from which it has been derived. /s/ PricewaterhouseCoopers LLP Chicago, Illinois August 16, 1999 23 PART II. OTHER INFORMATION Baxter International Inc. and Subsidiaries Item 1. Legal Proceedings Baxter International Inc. (Baxter or the company) and certain of its subsidiaries are named as defendants in a number of lawsuits, claims and proceedings, including product liability claims involving products now or formerly manufactured or sold by the company or by companies that were acquired by the company. The most significant of these are reported in the company's Annual Report on Form 10-K for the year ended December 31, 1998, and material developments in such matters for the quarter ended June 30, 1999 are described below. Upon resolution of any such matters, Baxter may incur charges in excess of presently established reserves. While such a future charge could have a material adverse impact on the company's net income and net cash flows in the period in which it is recorded or paid, management believes that no such charge would have a material adverse effect on Baxter's consolidated financial position. Mammary Implant Litigation - -------------------------- As previously reported in the company's Annual Report on Form 10-K, the company, together with certain of its subsidiaries, is currently a defendant in various courts in a number of lawsuits brought by individuals, all seeking damages for injuries of various types allegedly caused by silicone mammary implants formerly manufactured by the Heyer-Schulte division of American Hospital Supply Corporation (AHSC). AHSC, which was acquired by the company in 1985, divested its Heyer-Schulte division in 1984. It is not known how many of these claims and lawsuits involve products manufactured and sold by Heyer-Schulte, as opposed to other manufacturers. On December 1, 1998, a panel of independent medical experts appointed by a federal judge announced their findings that reported medical studies contained no clear evidence of a connection between silicone mammary implants and traditional or atypical systemic diseases. In June 1999 a similar conclusion was announced by a committee of independent medical experts from the Institute of Medicine, an arm of the National Academy of Sciences. As of June 30, 1999, Baxter, together with certain of its subsidiaries, had been named as a defendant or co-defendant in 4,447 lawsuits and 136 claims relating to mammary implants, brought by approximately 11,899 plaintiffs, of which 9,640 are implant plaintiffs and the remainder are consortium or second-generation plaintiffs. Of those plaintiffs, 4,687 currently are included in the Lindsey class action revised settlement described below, which accounts for 1,896 of the pending lawsuits against the company. Additionally, 4,765 plaintiffs have opted out of the revised settlement (representing 2,500 pending lawsuits), and the status of the remaining plaintiffs with pending lawsuits is unknown. Some of the opt-out plaintiffs filed their cases naming multiple defendants and without product identification; thus, not all of the opt-out plaintiffs will have viable claims against the company. As of June 30, 1999, 1,585 of the opt-out plaintiffs had confirmed Heyer-Schulte mammary implant product identification. Furthermore, during the first two quarters of 1999, Baxter obtained dismissals, or agreements for dismissals, with respect to 1,992 plaintiffs. In addition to the individual suits against the company, a class action on behalf of all women with silicone mammary implants is pending in the United States District Court (U.S.D.C.) for the Northern District of Alabama involving most manufacturers of such implants, including Baxter, 24 as successor to AHSC (Lindsey, et al., v. Dow Corning, et al., U.S.D.C., N. Dist. Ala., CV 94-P-11558-S). The class action was certified for settlement purposes only by the court on September 1, 1994, and the settlement terms were subsequently revised and approved on December 22, 1995 (the revised settlement). All appeals directly challenging the revised settlement have been dismissed. In addition to the Lindsey class action, the company also has been named in 12 other purported class actions in various state and provincial courts, only one of which is certified. Plasma-Based Therapies Litigation - --------------------------------- As previously reported in the company's Annual Report on Form 10-K, Baxter currently is a defendant in a number of claims and lawsuits brought by individuals who have hemophilia, all seeking damages for injuries allegedly caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma (factor concentrates) processed by the company from the late 1970s to the mid-1980s. The typical case or claim alleges that the individual was infected with the HIV virus by factor concentrates, which contained the HIV virus. None of these cases involves factor concentrates currently processed by the company. As of June 30, 1999, Baxter had been named in 269 lawsuits and 441 claims in the United States, Canada, Ireland, Italy, Taiwan, Japan, Germany and the Netherlands. The U.S.D.C. for the Northern District of Illinois has approved a settlement of all U.S. federal court factor concentrates cases. As of June 30, 1999, approximately 6,500 claimant groups had been found eligible to participate in the settlement, and approximately 350 claimants had opted out of the settlement. Approximately 6,075 of the claimant groups had received payments as of June 30, 1999, and payments are expected to continue through the third quarter of 1999 as releases are received from the remaining claimant groups. The company also has been named in four purported class actions. None of these class actions has been certified. In Japan, Baxter is a defendant, along with the Japanese government and four other co-defendants, in factor concentrates cases in Osaka, Tokyo, Nagoya, Tohoku, Fukuoka, Sapporo and Kumamoto. As of June 30, 1999, the cases involved 1,308 plaintiffs, of whom 1,296 have settled their claims. In addition, Immuno International AG (Immuno), a company Baxter acquired in 1997, has unsettled claims for damages for injuries allegedly caused by its plasma-based therapies. The typical claim alleges that the individual with hemophilia was infected with HIV by factor concentrates containing the HIV virus. Additionally, Immuno faces multiple claims stemming from its vaccines and other biologically derived therapies. A portion of the liability and defense costs related to these claims will be covered by insurance, subject to exclusions, conditions, policy limits and other factors. In addition, pursuant to the original stock purchase agreement between the company and Immuno, approximately 84 million Swiss francs (or approximately $61 million at year-end) of the purchase price was withheld to cover these contingent liabilities. In April 1999, the stock purchase agreement between the company and Immuno was amended to revise the holdback amount from 84 million Swiss francs to 26 million Swiss francs in consideration for an April 1999 payment by the company of 29 million Swiss francs to Immuno as additional purchase price. As previously reported in the company's Annual Report on Form 10-K, Baxter is currently a defendant in a number of claims and lawsuits brought by individuals who infused the company's 25 Gammagard(R) IVIG (intravenous immunoglobulin), all of whom are seeking damages for hepatitis C infections allegedly caused by infusing Gammagard(R) IVIG. As of June 30, 1999, Baxter was a defendant in 43 lawsuits and 54 claims in the United States, Denmark, France, Germany, Italy, Spain and the United Kingdom. Three suits currently pending in the United States have been filed as purported class actions but only one has been certified. Other Litigation - ---------------- As of September 30, 1996, the date of the spin-off of Allegiance Corporation (Allegiance) from Baxter, Allegiance assumed the defense of litigation involving claims related to Allegiance's businesses, including certain claims of alleged personal injuries as a result of exposure to natural rubber latex gloves. Allegiance has not been named in most of this litigation but will be defending and indemnifying Baxter pursuant to certain contractual obligations for all expenses and potential liabilities associated with claims pertaining to latex gloves. As of June 30, 1999, the company had been named as a defendant in 435 lawsuits, including the following purported class action: Swartz v. Baxter Healthcare Corporation, et al. Court of Common Pleas, Jefferson County, PA, 656- 1997 C.D. 26 Item 4. Submission of Matters to a Vote of Security Holders The company's annual meeting of stockholders was held on May 4, 1999 for the purpose of electing directors, approving the appointment of auditors, and voting on the other proposal listed below. Proxies for the meeting were solicited pursuant to Section 14(a) of the Securities Exchange Act of 1934 and there was no solicitation in opposition to management's solicitation. Each of management's nominees for directors as listed in the proxy statement were elected with the number of votes set forth below: - ------------------------------------------------------------------- Number of Votes -------------------------------- Abstained/ In Favor Withheld -------------------------------- Martha R. Ingram 230,446,118 16,995,367 Harry M. Jansen Kraemer, Jr. 230,494,999 16,946,486 Fred L. Turner 230,305,310 17,136,175 The results of other matters voted upon at the annual meeting are as follows: - ------------------------------------------------------------------------------------------------ Number of Votes ------------------------------------------- In Favor Against Abstained ------------------------------------------- PricewaterhouseCoopers LLP as independent accountants for the company for 1999 246,406,410 332,094 702,981 Defeat of the stockholder proposal relating to cumulative voting in the election of directors 70,230,594 134,640,810 19,189,534 - ------------------------------------------------------------------------------------------------ Item 6. Exhibits and Reports on Form 8-K. (a) Exhibits Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index hereto. (b) Reports on Form 8-K A report on Form 8-K was filed on July 12, 1999, which reported under "Item 5 -- Other Events" a press release which announced a planned spin-off by Baxter International Inc. of its cardiovascular business to Baxter shareholders. In addition, the report noted that, during a conference call with analysts on the topic, Harry M. Jansen Kraemer, Jr., President and Chief Executive Officer of Baxter International Inc., reaffirmed that the company expects to meet its previously announced financial commitments for the second quarter of 1999. 27 Signature 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. BAXTER INTERNATIONAL INC. ------------------------- (Registrant) /s/ Brian P. Anderson Date: August 16, 1999 By: _________________________ Brian P. Anderson Senior Vice President and Chief Financial Officer (Chief Accounting Officer) 28 EXHIBITS FILED WITH SECURITIES AND EXCHANGE COMMISSION - -------------------------------------------------------------------------------- Number Description of Exhibit - -------- ---------------------- 10.1 Baxter International Inc. 1999 Shared Investment Plan................. 12 Computation of Ratio of Earnings to Fixed Charges..................... 15 Letter Re Unaudited Interim Financial Information..................... 27 Financial Data Schedule............................................... (All other exhibits have been omitted because they are not applicable or not required.) 29