UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (X) Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the third quarter period ended May 31, 1998 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 0-20212 ARROW INTERNATIONAL, INC. ------------------------- (Exact name of registrant as specified in its charter) Pennsylvania 23-1969991 ------------ ---------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 3000 Bernville Road, Reading, Pennsylvania 19605 - ------------------------------------------- ----- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (610) 378-0131 -------------- 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. Class Shares outstanding at July 13, 1998 ----- ----------------------------------- Common Stock, No Par Value 23,224,321 ARROW INTERNATIONAL, INC. Form 10-Q Index Page ---- PART I. FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets at May 31, 1998 and August 31, 1997 3-4 Consolidated Statements of Income 5-6 Consolidated Statements of Cash Flows 7-8 Notes to Consolidated Financial Statements 9-12 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 13-19 PART II. OTHER INFORMATION Item 5. Other Events 20 Item 6. Exhibits and Reports on Form 8-K 20 Signature 21 Exhibit Index 22 -2- PART I - FINANCIAL INFORMATION Item 1. Financial Statements ARROW INTERNATIONAL, INC. CONSOLIDATED BALANCE SHEETS (All Dollar Amounts in Thousands) May 31, August 31, 1998 1997 --------- ----------- (unaudited) (unaudited) ASSETS Current assets: Cash and cash equivalents $ 4,242 $ 6,276 Accounts receivable, net 64,593 60,801 Inventories 68,372 57,334 Prepaid expenses and other 13,534 8,729 Deferred income taxes 3,173 2,833 --------- --------- Total current assets 153,914 135,973 --------- --------- Property, plant and equipment: Total property, plant and equipment 180,529 171,067 Less accumulated depreciation (69,381) (60,474) ---------- --------- Property, plant and equipment, net 111,148 110,593 ========== ========= Other assets: Goodwill, net 47,065 48,720 Intangible and other assets, net 33,289 24,430 Deferred income taxes 109 657 ---------- --------- Total other assets 80,463 73,807 ---------- --------- Total assets $ 345,525 $ 320,373 ========== ========= See accompanying notes to consolidated financial statements. Continued -3- ARROW INTERNATIONAL, INC. CONSOLIDATED BALANCE SHEETS, Continued (All Dollar Amounts in Thousands) May 31, August 31, 1998 1997 ----------- ----------- (unaudited) (unaudited) LIABILITIES Current liabilities: Current maturities of long-term debt $ 1,498 $ 2,675 Notes payable 20,946 21,978 Accounts payable 9,463 9,983 Accrued liabilities 6,773 6,856 Accrued compensation 7,155 9,945 Accrued income taxes 6,021 3,076 ----------- ---------- Total current liabilities 51,856 54,513 Long-term debt 11,567 12,043 Accrued postretirement benefit obligation 8,919 7,900 Commitments and contingencies SHAREHOLDERS' EQUITY Preferred Stock, no par value; 5,000,000 shares authorized; none issued - - Common Stock, no par value; 50,000,000 shares authorized; issued 26,478,813 shares 45,603 45,603 Retained earnings 243,349 216,173 Less cost of treasury stock: 3,254,492 and 3,252,687 shares of Common Stock, respectively (8,427) (8,374) Unearned compensation (90) (239) Cumulative translation adjustment (5,266) (5,088) Unrealized holding loss on securities, net of tax (1,986) (2,158) -------- -------- Total shareholders' equity 273,183 245,917 -------- -------- Total liabilities and shareholders' equity $ 345,525 $ 320,373 ========= ========= See accompanying notes to consolidated financial statements. -4- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF INCOME (unaudited) (All Dollar Amounts in Thousands, Except Per Share Data) For the Three Months Ended May 31, 1998 1997 ---------- ---------- Net sales $ 65,735 $ 62,107 Cost of goods sold 28,499 27,900 --------- --------- Gross profit 37,236 34,207 Operating expenses: Research, development and engineering 4,799 4,090 Selling, general and administrative 16,291 14,366 -------- -------- Operating income 16,146 15,751 Other expenses (income): Interest expense, net of amounts capitalized 261 186 Interest income (56) (211) Other, net 394 338 -------- ------- Other expenses, net 599 313 -------- ------- Income before income taxes 15,547 15,438 Provision for income taxes 5,830 5,944 -------- ------- Net income $ 9,717 $ 9,494 ======== ======= Basic earnings per common share $ .42 $ .41 ======== ======= Diluted earnings per common share $ .42 $ .41 ======== ======= Cash dividends per common share $ .050 $ .045 ======== ======= Weighted average shares outstanding 23,224,422 23,226,428 ========== ========== See accompanying notes to consolidated financial statements. -5- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF INCOME (unaudited) (All Dollar Amounts in Thousands, Except Per Share Data) For the Nine Months Ended May 31, 1998 1997 --------- --------- Net sales $ 196,274 $ 183,262 Cost of goods sold 86,190 83,283 --------- --------- Gross profit 110,084 99,979 Operating expenses: Research, development and engineering 13,286 11,891 Selling, general and administrative 46,936 42,663 --------- --------- Operating income 49,862 45,425 --------- --------- Other expenses (income): Interest expense, net of amounts capitalized 570 780 Interest income (366) (642) Other, net 790 1,324 --------- -------- Other expenses, net 994 1,462 --------- -------- Income before income taxes 48,868 43,963 Provision for income taxes 18,326 16,926 --------- -------- Net income $ 30,542 $ 27,037 ========= ======== Basic earnings per common share $ 1.32 $ 1.17 ========= ========= Diluted earnings per common share $ 1.32 $ 1.17 ========= ========= Cash dividends per common share $ .145 $ .130 ========= ========= Weighted average shares outstanding 23,224,960 23,227,390 ========== ========== See accompanying notes to consolidated financial statements. -6- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (All Dollar Amounts in Thousands) For the Nine Months Ended May 31, 1998 1997 ----------- ---------- Cash flows from operating activities: Net income $ 30,542 $ 27,037 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation 8,798 8,447 Amortization of intangible assets 3,092 2,910 Amortization of unearned compensation 134 151 Deferred income taxes 209 (882) Other 882 2,655 Changes in operating assets and liabilities: Accounts receivable (4,953) (9,367) Inventories (10,227) (5,847) Prepaid expenses and other (4,843) (3,786) Accounts payable and accrued liabilities 25 2,930 Accrued compensation (2,785) 527 Accrued income taxes 2,921 640 --------- -------- Total adjustments (6,747) (1,622) --------- -------- Net cash provided by operating activities 23,795 25,415 Cash flows from investing activities: Capital expenditures (9,243) (12,703) Increase in intangible and other assets (3,746) (1,203) Cash paid for businesses acquired (7,321) 0 -------- -------- Net cash used in investing activities (20,310) (13,906) Cash flows from financing activities: Decrease in notes payable (578) (4,695) Principal payments of long-term debt (1,558) (4,952) Dividends paid (3,251) (3,020) Purchase of treasury stock (38) (32) -------- -------- Net cash used in financing activities (5,425) (12,699) Effect of exchange rate changes on cash and cash equivalents (94) (329) Net change in cash and cash equivalents (2,034) (1,519) Cash and cash equivalents at beginning of year 6,276 4,807 --------- -------- Cash and cash equivalents at end of period $ 4,242 $ 3,288 ========= ======== See accompanying notes to consolidated financial statements Continued -7- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS, Continued (unaudited) (All Dollar Amounts in Thousands) For the Nine Months Ended May 31, 1998 1997 -------- --------- Supplemental disclosure of cash flow information: Cash paid during the year for: Interest (net of amounts capitalized) $ 570 $ 780 Income taxes $ 15,000 $ 15,110 See accompanying notes to consolidated financial statements -8- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (unaudited) (All Dollar Amounts in Thousands, Except Per Share Data) Note 1 - Basis of Presentation These unaudited consolidated financial statements include all adjustments, consisting only of normal recurring accruals, which management considers necessary for a fair presentation of the Company's consolidated financial position, results of operations, and cash flows for the interim periods presented. Results for the interim period are not necessarily indicative of results for the entire year. Note 2 - Inventories Inventories are summarized as follows: May 31, August 31, 1998 1997 --------- --------- Finished goods $ 23,259 $ 20,718 Semi-finished goods 18,079 13,906 Work-in-process 9,832 9,900 Raw materials 17,202 12,810 --------- --------- $ 68,372 $ 57,334 ========= ========= Note 3 - Commitments and Contingencies The Company is a party to certain legal actions arising in the ordinary course of its business. Based upon information presently available to the Company, the Company believes it has adequate legal defenses or insurance coverage for these actions and that the ultimate outcome of these actions would not have a material adverse effect on the Company's financial position or results of operations. Continued -9- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (unaudited) (All Dollar Amounts in Thousands, Except Per Share Data) Note 4 - Related Party Transactions During the nine months ended May 31, 1998, the Company assumed certain pension and retirement health care benefit obligations of Arrow Precision Products, Inc. ("Precision"), which is related to the Company through common ownership, to former employees of Precision who are currently, or previously were, employed by the Company in exchange for the transfer by Precision to the Company of appropriate assets to satisfy such obligations. Consequently, Precision's two pension plans, both of which were overfunded as of August 31, 1997, were merged with the Company's pension plans covering comparable employees. The Company paid Precision $2,975, the amount by which the value of Precision's pension plan assets exceeded the actuarially determined present value of Precision's pension plan obligations. This payment was offset by the payment by Precision to the Company of $757, the actuarially determined present value of Precision's retirement heath care obligations to former Precision employees who are currently, or previously were, employed by the Company. In addition, Precision transferred to the Company, with no payment by either party to the other, its rights and responsibilities under a split dollar life insurance policy covering the former Chief Operating Officer of Precision. During fiscal 1997, certain of the Company facilities, personnel and services were utilized by Precision. Effective August 29, 1997, such utilization ended when Precision Medical Products, Inc., the wholly owned and remaining operating subsidiary of Precision, was acquired by a company formed by certain management employees of Precision. The Company charged Precision $110 and $330 for certain facilities, personnel and services utilized by Precision during the three months and nine months ended May 31, 1997, respectively. The Company made purchases from Precision amounting to $338 and $1,029 for the three months and nine months ended May 31, 1997, respectively. In addition, the Company made payments on behalf of Precision related to certain costs incurred by Precision for which the Company was reimbursed, amounting to $162 and $609 during the three months and nine months ended May 31, 1997, respectively. Continued -10- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (unaudited) Note 5 - Accounting Policies The effect of exchange rate changes on cash and cash equivalents have been reclassified and stated as a separate category in the consolidated statements of Cash Flows for the nine months ended May 31, 1998. Prior periods have been restated to reflect this change. Note 6 - New Accounting Standards On June 15, 1998, the Financial Accounting Standards Board issued FAS No. 133, Accounting for Derivative Instruments and Hedging Activities (FAS 133). FAS 133 establishes new procedures for accounting for derivatives and hedging activities and supersedes and amends a number of existing standards. FAS 133 is effective for fiscal years beginning after June 15, 1999, but earlier application is permitted as of the beginning of any fiscal quarter subsequent to June 15, 1998. Although the Company has not fully completed its evaluation of the impact of this new standard, the Company does not anticipate that the adoption of this new standard will have a material effect on the Company's consolidated financial statements. On April 3, 1998, the Accounting Standards Executive Committee of the American Institute of Certified Public Accountants (AICPA) issued Statement of Position (SOP) 98-5, "Reporting on the Costs of Start-up Activities". SOP 98-5 provides guidance on the financial reporting of start-up costs and organization costs. It requires costs of start-up activities and organization costs to be expensed as incurred. The standard is effective for financial statements for fiscal years beginning after December 15, 1998. Earlier application is encouraged. The Company does not anticipate that the adoption of this new standard will have a material effect on the Company's consolidated financial statements. On March 4, 1998, the Accounting Standards Executive Committee of the AICPA issued Statement of Position (SOP) 98- 1 "Accounting for the Costs of Computer Software Development or Obtained for Internal Use". The SOP provided guidance on accounting for the costs of computer software developed or obtained for internal use. The SOP is effective for financial statements for fiscal years beginning after December 15, 1998, but earlier application is encouraged. The Company does not anticipate that adoption of this new standard will have a material effect on the Company's consolidated financial statements. Continued -11- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (unaudited) Note 6 - New Accounting Standards, Continued During February 1998, the FASB issued SFAS No. 132, "Employers' Disclosures about Pension and Other Postretirement Benefits". SFAS No. 132 does not change the measurement or recognition of those plans. It standardizes the disclosure requirements for pensions and other postretirement benefits, requires additional information on changes in the benefit obligations and fair values of plan assets, and eliminates certain disclosures that are no longer as useful. The statement is effective for fiscal years beginning after December 15, 1997, but earlier application is encouraged. The adoption of SFAS No. 132 is not expected to have any impact on the Company's results of operations, financial position or cash flows. -12- ARROW INTERNATIONAL, INC. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations The following discussion includes certain forward-looking statements. Such forward-looking statements are subject to a number of factors, including material risks, uncertainties and contingencies, which could cause actual results to differ materially from the forward-looking statements. For a discussion of important factors that could cause actual results to differ materially from the forward-looking statements, see Exhibit 99.1 to this Report and the Company's periodic reports and other documents filed with the Securities and Exchange Commission. Results of Operations Three Months Ended May 31, 1998 Compared to Three Months Ended May 31, 1997 Net sales for the three months ended May 31, 1998 increased by $3.6 million, or 5.8%, to $65.7 million from $62.1 million in the same period last year. Net sales represent gross sales invoiced to customers, plus royalty income, less certain related charges, including freight costs, discounts, returns and other allowances. This increase was due primarily to increased shipments of intra-aortic balloon ("IAB") products, percutaneous thrombolytic devices ("PTD"), and implantable drug infusion pumps. Sales of critical care products, including royalty income, increased 3.4% to $54.3 million from $52.5 million in the comparable prior period, due primarily to increased shipments of PTD's. Cardiac care (formerly interventional procedure) product sales increased to $11.5 million from $9.6 million, an increase of 19.3% over the comparable prior period, due primarily to higher sales of IAB products. International sales increased by $.3 million, or 1.3%, to 22.9 million, representing 34.9% of net sales for the three months ended May 31, 1998, compared to 36.5% of net sales in the comparable period of fiscal 1997, principally as a result of higher sales of IAB products. The increased strength of the U.S. dollar, relative to currencies in countries where the Company operates direct sales subsidiaries, reduced net sales for the period by $1.0 million. Gross profit increased 8.9% to $37.2 million in the three months ended May 31, 1998 from $34.2 million in the same period of fiscal 1997. As a percentage of net sales, gross profit increased to 56.6% during the three months ended May 31, 1998 from 55.1% in the comparable period of fiscal 1997, due principally to a more profitable product mix and improved manufacturing costs resulting from increased production at the Company's international manufacturing facilities. -13- ARROW INTERNATIONAL, INC. Research, development and engineering expenses increased by 17.3% to $4.8 million in the three months ended May 31, 1998 from $4.1 million in the comparable prior period, primarily as a result of increased spending related to research, product development, process development and clinical trial activities. As a percentage of net sales, these expenses increased in the third quarter of fiscal 1998 to 7.3%, compared to 6.6% in the same period in fiscal 1997. Current research and development programs include additional applications for the PTD, pullback atherectomy catheters for treating coronary artery disease, microwave ablation catheters for the treatment of heart arrythmias and a fully implantable Left Ventricular Assist Device. Selling, general and administrative expenses increased by 13.4% to $16.3 million in the three months ended May 31, 1998 from $14.4 million in the comparable prior period of fiscal 1997. Selling, general and administrative expenses increased as a percentage of net sales to 24.8% in the third quarter of fiscal 1998 from 23.1% in the comparable period of fiscal 1997. This increase was due primarily to increased U.S. sales and marketing expenses and increased expenses in Japan to implement direct sales of IAB products. Principally due to the above factors, operating income increased in the third quarter of fiscal 1998 by 2.5% to $16.1 million from $15.8 million in the comparable period of fiscal 1997. Other expenses (income), net, increased to $0.6 million during the third quarter of fiscal 1998 from $0.3 million in the comparable prior period. Other expenses (income), net, consist principally of interest expense and gains and losses on foreign exchange transactions associated with the Company's direct sales subsidiaries. As a result of the factors discussed above, income before income taxes increased by 0.7% to $15.5 million in the third quarter of fiscal 1998 from $15.4 million in the comparable prior period. For the third quarter of fiscal 1998, the Company's effective tax rate was 37.5%, a decrease from 38.5% in fiscal 1997, principally as a result of a reduction in tax accruals for certain state and international jurisdictions. Net income in the third quarter of fiscal 1998 increased by 2.3% to $9.7 million from $9.5 million in the comparable prior period. As a percentage of net sales, net income represented 14.8% in the three months ended May 31, 1998, compared to 15.3% in the comparable period of fiscal 1997. Basic and diluted earnings per common share were $.42 in the three month period ended May 31, 1998, an increase of 2.4%, or $0.01 per share, from $.41 -14- ARROW INTERNATIONAL, INC. per share in the comparable prior period. Weighted average common shares outstanding decreased to 23,224,422 in the third quarter of fiscal 1998 from 23,226,428 in the comparable prior period. Nine Months Ended May 31, 1998 Compared to Nine Months Ended May 31, 1997 Net sales for the nine months ended May 31, 1998 increased by $13.0 million, or 7.1%, to $196.3 million from $183.3 million in the same period last year. This increase was due primarily to an increase in unit sales of the Company's central venous catheter products, as well as increased shipments of IAB products, PTD's and implantable drug infusion pumps. Sales of critical care products, including royalty income, increased 6.4% to $164.8 million from $154.9 million in the comparable prior period, due primarily to increased shipments of central venous catheters, PTD's and implantable drug infusion pumps. Cardiac care (formerly interventional procedure) product sales increased to $31.4 million from $28.4 million, an increase of 10.7% over the comparable prior period, due primarily to higher sales of IAB products. International sales increased by $2.9 million, or 4.4%, to $68.8 million, representing 35.0% of net sales for the nine months ended May 31, 1998, compared to 36.0% of net sales in the comparable period of fiscal 1997, principally as a result of increased sales of central venous catheters and IAB products. The increased strength of the U.S. dollar, relative to currencies in countries where the Company operates direct sales subsidiaries, reduced net sales for the nine month period ended May 31, 1998 by $4.0 million. Gross profit increased 10.1% to $110.1 million in the nine months ended May 31, 1998, compared to $100.0 million in the same period of fiscal 1997. As a percentage of net sales, gross profit increased to 56.1% during the nine months ended May 31, 1998 from 54.6% in the comparable period of fiscal 1997, due principally to a more profitable product mix and improved manufacturing costs resulting from increased production at the Company's international manufacturing facilities. Research, development and engineering expenses increased by 11.7% to $13.3 million in the nine months ended May 31, 1998 from $11.9 million in the comparable prior period. As a percentage of net sales, these expenses increased in the first nine months of fiscal 1998 to 6.8%, compared to 6.5% in the same period in fiscal 1997, primarily as a result of increased spending related to research, product development, process development and clinical trial activities. Current research and development programs include additional applications for the PTD, pullback atherectomy catheters for treating coronary artery disease, microwave ablation catheters for the treatment of heart arrythmias and a fully implantable Left Ventricular Assist Device. -15- ARROW INTERNATIONAL, INC. Selling, general and administrative expenses increased by 10.0% to $46.9 million in the nine months ended May 31, 1998 from $42.7 million in the comparable prior period and increased as a percentage of net sales to 23.9% in the first nine months of fiscal 1998 from 23.3% in the comparable period of fiscal 1997. The increase was due primarily to increased U.S. sales and marketing expenses and increased expenses in Japan to implement direct sales of IAB products. Principally due to the above factors, operating income increased in the first nine months of fiscal 1998 by 9.8% to $49.9 million from $45.4 million in the comparable period of fiscal 1997. Other expenses (income), net, decreased to $1.0 million in the first nine months of fiscal 1998 from $1.5 million in the comparable prior period. Other expenses (income), net, consist principally of interest expense and foreign exchange gains and losses associated with the Company's direct sales subsidiaries. As a result of the factors discussed above, income before income taxes increased in the first nine months of fiscal 1998 by 11.2% to $48.9 million from $44.0 million in the comparable prior period. For the first nine months of fiscal 1998, the Company's effective income tax rate was 37.5%, a decrease from 38.5% in fiscal 1997, principally as a result of a reduction in tax accruals for certain state and international jurisdictions. Net income increased 13.0% to $30.5 million in the nine months ended May 31, 1998 from $27.0 million in the comparable prior period. As a percentage of net sales, net income represented 15.6% during the nine months ended May 31, 1998 compared to 14.8% in the comparable period of fiscal 1997. Basic and diluted earnings per common share were $1.32 in the nine month period ended May 31, 1998, an increase of 12.8%, or $0.15 per share, from $1.17 per share in the comparable prior period. Weighted average common shares outstanding decreased to 23,224,960 from 23,227,390 in the comparable prior period. -16- ARROW INTERNATIONAL, INC. Liquidity and Capital Resources For the nine months ended May 31, 1998, net cash provided by operations was $23.8 million, a decrease of $1.6 million from the same period in the prior year. Accounts receivable, exclusive of the impact of changes in foreign exchange rates, increased by $5.0 million in the nine months ended May 31, 1998, compared to a $6.6 million increase in the same period of fiscal 1997. Accounts receivable, measured in day sales outstanding during the period, increased to 90 days at May 31, 1998 from 84 days at May 31, 1997, due principally to an increase in the collection period for the Company's international sales. Inventories, exclusive of the impact of changes in foreign exchange rates, increased by $10.2 million in the nine months ended May 31, 1998, compared to a $5.8 million increase in the same period of fiscal year 1997, principally to support increased production at the Company's international manufacturing facilities. Net cash used in the Company's investing activities increased to $20.3 million in the nine months ended May 31, 1998 from $13.9 million in the comparable period of fiscal 1997, principally as a result of the acquisition in November 1997, for $7.3 million, of certain assets of the Cardiac Assist Division of Boston Scientific Corporation. Financing activities used $5.4 million in the nine month period ended May 31, 1998, whereas such activities used $12.7 million in the comparable period of fiscal 1997, changing principally as a result of a reduction in repayments of long-term debt and in borrowings under the Company's revolving credit facilities. As of May 31, 1998, the Company had U.S. bank credit facilities providing a total of $50.0 million in revolving credit for general business purposes, of which $34.2 million remained unused. In addition, certain of the Company's foreign subsidiaries have revolving credit facilities totaling the U.S. dollar equivalent of $11.3 million, of which $5.2 million remained unused as of May 31, 1998. Combined borrowings under these facilities decreased $0.1 million during the nine month period ended May 31, 1998. As a partial hedge against adverse fluctuations in exchange rates, the Company periodically enters into foreign currency exchange contracts with certain major financial institutions. By their nature, all such contracts involve risk, including the risk of nonperformance by counterparties. Accordingly, losses relating to these contracts could have a material adverse effect upon the Company's business, financial condition and results of operations. Based upon the Company's knowledge of the financial condition of the counterparties to its existing forward contracts, the Company believes that it does not have any material exposure to any individual counterparty. The Company's policy prohibits the use of derivative instruments for trading purposes. -17- ARROW INTERNATIONAL, INC. During the nine month periods ended May 31, 1998 and 1997, the percentage of the Company's sales invoiced in currencies other than U.S. dollars was 24.6% and 24.7%, respectively. As of May 31, 1998, outstanding foreign currency exchange contracts totaling the U.S. dollar equivalent of $9.2 million mature at various dates through December 1998. The Company expects to continue to utilize foreign currency exchange contracts to manage its exposure, although there can be no assurance that the Company's effort in this regard will be successful. Based upon its present plans, the Company believes that operating cash flow and available credit resources will be adequate to repay current portions of long-term debt, to finance currently planned capital expenditures and to meet the currently foreseeable liquidity needs of the Company. During the periods discussed above, the overall effects of inflation and seasonality on the Company's business were not significant. The Company recognizes the need to ensure its operations will not be adversely impacted by Year 2000 software failures. Software failures due to processing errors potentially arising from calculations using a 21st Century date are a known risk. The Company is addressing this risk to the availability and integrity of its financial systems and the reliability of its operational systems. Based upon a review of its technology and software, the Company has concluded that there are no material issues regarding its Year 2000 compliance that will not be resolved through normal software upgrades and replacements that will be made through 1999. While the Company believes its efforts to address its Year 2000 concerns are adequate and will not require material additional expenditures by the Company, there can be no guarantee that the systems of other companies on which the Company's systems and operations rely, will be converted on a timely basis and will not have a material adverse effect on the Company. -18- ARROW INTERNATIONAL, INC. New Accounting Standards On June 15, 1998, the Financial Accounting Standards Board issued FAS No. 133, Accounting for Derivative Instruments and Hedging Activities (FAS 133 or the "Statement"). FAS 133 establishes new procedures for accounting for derivatives and hedging activities and supersedes and amends a number of existing standards. FAS 133 is effective for fiscal years beginning after June 15, 1999, but earlier application is permitted as of the beginning of any fiscal quarter subsequent to June 15, 1998. Although the Company has not fully completed its evaluation of the impact of this new standard, we do not anticipate the adoption of this new standard will have a material effect on the Company's consolidated financial statements. On April 3, 1998, the Accounting Standards Executive Committee of the AICPA issued Statement of Position (SOP) 98- 5, "Reporting on the Costs of Start-up Activities". SOP 98-5 provides guidance on the financial reporting of start-up costs and organization costs. It requires costs of start-up activities and organization costs to be expensed as incurred. The standard is effective for financial statements for fiscal years beginning after December 15, 1998. Earlier application is encouraged. The Company does not anticipate the adoption of this new standard will have a material effect on the Company's consolidated financial statements. On March 4, 1998, the Accounting Standards Executive Committee of the AICPA issued Statement of Position (SOP) 98- 1 "Accounting for the Costs of Computer Software Development or Obtained for Internal Use". The SOP provided guidance on accounting for the costs of computer software developed or obtained for internal use. The SOP is effective for financial statements for fiscal years beginning after December 15, 1998, but earlier application is enouraged. The Company does not anticipate the adoption of this new standard to have a material effect on the Company's consolidated financial statements. During February 1998, the FASB issued SFAS No. 132, "Employers' Disclosures about Pension and Other Postretirement Benefits". SFAS No. 132 does not change the measurement or recognition of those plans. It standardizes the disclosure requirements for pensions and other postretirement benefits, requires additional information on changes in the benefit obligations and fair values of plan assets, and eliminates certain disclosures that are no longer as useful. The statement is effective for fiscal years beginning after December 15, 1997, but earlier application is encouraged. The adoption of SFAS No. 132 is not expected to have any impact on the Company's results of operations, financial position or cash flows. -19- ARROW INTERNATIONAL, INC. PART II. OTHER INFORMATION Item 5. Other Events. The Securities and Exchange Commission (the "SEC") has amended recently its rule 14a-4, which governs the use by the Company of discretionary voting authority with respect to certain shareholder proposals. SEC Rule 14a-4(c)(1) provides that, if the proponent of a shareholder proposal fails to notify the Company at least 45 days prior to the month and day of mailing the prior year's proxy statement, the proxies of the Company's management would be permitted to use their discretionary authority at the Company's next annual meeting of shareholders if the proposal were raised at the meeting without any discussion of the matter in the proxy statement. In order to provide shareholders with notice of the deadline for the submission of such proposals for the Company's 1999 Annual Meeting of Shareholders, the Company hereby notifies all shareholders of the Company that after November 1, 1998 any shareholder proposal submitted outside the process of SEC Rule 14a-8 will be considered untimely for purposes of SEC Rules 14a-4 and 14a-5(e). Item 6. Exhibits and Reports on Form 8-K (a) Exhibits The following exhibits will be filed as part of this Form 10-Q: Exhibit 27 Financial Data Schedule Exhibit 99.1 Cautionary Statement for Purposes of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 (b) Reports on Form 8-K No reports on Form 8-K were filed during the quarter ended May 31, 1998. -20- ARROW INTERNATIONAL, INC. 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. ARROW INTERNATIONAL, INC. (Registrant) Date: July 14, 1998 By: /s/ John H. Broadbent, Jr. --------------------------- (signature) John H. Broadbent, Jr. Vice President-Finance and Treasurer (Principal Financial Officer and Chief Accounting Officer) -21- EXHIBIT INDEX Exhibit Description Number of Exhibit Method of Filing - ------ ----------- ---------------- 27 *Financial Data Schedule EDGAR 99.1 Cautionary Statement for Pages 23-27 of this report Purposes of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 *Not deemed filed for purposes of Section 11 of the Securities Act of 1933, Section 18 of the Securities Exchange Act of 1934 and Section 323 of the Trust Indenture Act of 1939, or otherwise subject to the liabilities of such sections and not deemed part of any registration statement to which such exhibit relates. -22- EXHIBIT 99.1 CAUTIONARY STATEMENT FOR PURPOSES OF THE SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 From time to time, in both written reports and in oral statements by the Company's senior management, expectations and other statements are expressed regarding future performance of the Company. These forward-looking statements are inherently uncertain and investors must recognize that events could turn out to be different than such expectations and statements. Key factors impacting current and future performance are discussed in the Company's Annual Report on Form 10-K for its fiscal year ended August 31, 1997 and other filings with the Securities and Exchange Commission (the "Commission"). In addition to such information in the Company's Annual Report on Form 10- K and its other filings with the Commission, the following risk factors should be considered in evaluating the Company and its business, as well as in reviewing forward-looking statements contained in the Company's periodic reports filed with the Commission and in oral statements made by the Company's senior management. The Company's actual results could differ materially from such forward-looking statements due to material risks, uncertainties and contingencies, including, without limitation, those set forth below. Stringent Government Regulation The Company's products are subject to extensive regulation by the Food and Drug Administration (the "FDA") and, in some jurisdictions, by state and foreign governmental authorities. In particular, the Company must obtain specific clearance or approval from the FDA before it can market new products or certain modified products in the United States. With the exception of one product, the Company has, to date, obtained FDA marketing clearance only through the 510(k) premarket notification process. Certain products under development and future product applications, however, will require approval through the more rigorous Premarket Approval application ("PMA") process. The process of obtaining such clearances or approvals can be time consuming and expensive, and there can be no assurance that all clearances or approvals sought by the Company will be granted or that FDA review will not involve delays adversely affecting the marketing and sale of the Company's products. The Company is required to adhere to applicable regulations setting forth current Good Manufacturing Practices ("GMP") which require that the Company manufacture its products and maintain its records in a prescribed manner with respect to manufacturing, testing and control activities. In addition, the Company is required to comply with FDA requirements for labeling and promotion of its products. Failure to comply with applicable federal, state or foreign laws or regulations could subject the Company to enforcement action, including product -23- seizures, recalls, withdrawal of clearances or approvals, and civil and criminal penalties, any one or more of which could have a material adverse effect on the Company. Medical device laws and regulations with similar substantive and enforcement provisions are also in effect in many of the foreign countries where the Company does business. Federal, state and foreign laws and regulations regarding the manufacture and sale of medical devices are subject to future changes. No assurance can be given that such changes will not have a material adverse effect on the Company. Significant Competition and Continual Technological Change The markets for medical devices are highly competitive. The Company currently competes with many companies in the development and marketing of catheters and related medical devices. Some of the Company's competitors have access to greater financial and other resources than the Company. Furthermore, the markets for medical devices are characterized by rapid product development and technological change. The present or future products of the Company could be rendered obsolete or uneconomical by technological advances by one or more of the Company's current or future competitors. The Company's future success will depend upon its ability to develop new products and technology to remain competitive with other developers of catheters and related medical devices. The Company's business strategy emphasizes the continued development and commercialization of new products and the enhancement of existing products for the critical care and cardiac care markets. There can be no assurance that the Company will be able to continue to successfully develop new products and to enhance existing products, to manufacture these products in a commercially viable manner, to obtain required regulatory approvals or to gain satisfactory market acceptance for such products. Cost Pressures on Medical Technology and Proposed Health Care Reform The Company's products are purchased principally by hospitals, hospital networks and hospital buying groups. Although the Company's products are used primarily for non- optional medical procedures, the Company believes that the overall escalating cost of medical products and services has led and will continue to lead to increased pressures upon the health care industry to reduce the cost or usage of certain products and services, which has included and will continue to include those of the Company. In the United States, these cost pressures are leading to increased emphasis on the price and cost-effectiveness of any treatment regimen and medical device. In addition, third party payors, such as governmental programs, private insurance plans and managed care plans, which are billed by hospitals for such health care services, are increasingly negotiating the prices charged for medical products and services and may deny reimbursement if they determine that a device was not used in -24- accordance with cost-effective treatment methods as determined by the payor, was experimental, unnecessary or used for an unapproved indication. In international markets, reimbursement systems vary significantly by country. Many international markets have government managed health care systems that control reimbursement for certain medical devices and procedures and, in most such markets, there also are private insurance systems, which impose similar cost restraints. There can be no assurance that hospital purchasing decisions or government or private third party reimbursement policies in the United States or in international markets will not adversely affect the profitability of the Company's products. In recent years, several comprehensive health care reform proposals have been introduced in the U.S. Congress. While none of these proposals have to date been adopted, the intent of these proposals was, generally, to expand health care coverage for the uninsured and reduce the rate of growth of total health care expenditures. In addition, certain states have made significant changes to their Medicaid programs and have adopted various measures to limit costs. Implementation of government health care reform and other private sector efforts to control costs may limit the price of, or the level at which reimbursement is provided for, the Company's products. Similar initiatives to limit the growth of health care costs, including price regulation, are also under way in several other countries in which the Company does business. The Company anticipates that Congress, state legislatures, foreign governments and the private sector will continue to review and assess alternative health care delivery and payment systems. The Company cannot predict what additional legislation or regulation, if any, relating to the health care industry may be enacted in the future or what impact the adoption of any federal, state or foreign health care reform, private sector reform or market forces may have on its business. No assurance can be given that any such reforms will not have a material adverse effect on the medical device industry in general, or the Company in particular. Dependence on Patents and Proprietary Rights The Company owns numerous U.S. and foreign patents and has several U.S. and foreign patent applications pending. The Company also has exclusive license rights to certain patents held by third parties. These patents relate to aspects of the technology used in certain of the Company's products. From time to time, the Company is subject to legal actions involving patent and other intellectual property claims. Successful litigation against the Company regarding its patents or infringement by the Company of the patent rights of others could have a material adverse effect on the Company. In addition, there can be no assurance that pending patent applications will result in issued patents or that patents issued to or licensed-in by the Company will not be challenged or circumvented by competitors or found to be valid or sufficiently broad to protect -25- the Company's technology or to provide it with any competitive advantage. The Company also relies on trade secrets and proprietary technology that it seeks to protect, in part, through confidentiality agreements with employees, consultants and other parties. There can be no assurance that these agreements will not be breached, that the Company will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to the Company's trade secrets. There has been substantial litigation regarding patent and other intellectual property rights in the medical devices industry. Historically, litigation has been necessary to enforce certain patent and trademark rights held by the Company. Future litigation may be necessary to enforce patent and other intellectual property rights belonging to the Company, to protect trade secrets or know- how owned by the Company or to defend the Company against claimed infringement of the rights of others and to determine the scope and validity of the proprietary rights of the Company and others. Any such litigation could result in substantial cost to and diversion of effort by the Company. Adverse determinations in any such litigation could subject the Company to significant liabilities to third parties, could require the Company to seek licenses from third parties and could prevent the Company from manufacturing, selling or using certain of its products, any of which could have a material adverse effect on the Company's business, financial condition and results of operations. Risks Associated with International Operations The Company generates significant sales outside the United States and is subject to risks generally associated with international operations, such as unexpected changes in regulatory requirements, tariffs, customs, duties and other trade barriers, difficulties in staffing and managing foreign operations, longer payment cycles, problems in collecting accounts receivable, political risks, fluctuations in currency exchange rates, foreign exchange controls which restrict or prohibit repatriation of funds, technology export and import restrictions or prohibitions, delays from customs brokers or government agencies and potentially adverse tax consequences resulting from operating in multiple jurisdictions with different tax laws, which could materially adversely impact the success of the Company's international operations. As its revenues from its international operations increase, an increasing portion of the Company's revenues and expenses may be denominated in currencies other than U.S. dollars, and changes in exchange rates could have a greater effect on the Company's results of operations. There can be no assurance that such factors will not have a material adverse effect on the Company's future operations and, consequently, on the Company's business, results of operations and financial condition. In addition, there can be no assurance that laws or administrative practices relating to regulation of medical devices, taxation, foreign exchange or other matters of countries within which the Company operates will not change. Any such change could have a material adverse effect on the Company's business, financial condition and results of operations. -26- Potential Product Liability The Company's business exposes it to potential product liability risks, which are inherent in the testing, and marketing of catheters and related medical devices. The Company's products are often used in intensive care settings with seriously ill patients. In addition, many of the medical devices manufactured and sold by the Company are designed to be implanted in the human body for long periods of time and component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks with respect to these or other products manufactured or sold by the Company could result in an unsafe condition or injury to, or death of, the patient. The occurrence of such a problem could result in product liability claims and/or a recall of, or safety alert relating to, one or more of the Company's products. There can be no assurance that the product liability insurance maintained by the Company will be available or sufficient to satisfy all claims made against it or that the Company will be able to obtain insurance in the future at satisfactory rates or in adequate amounts. Product liability claims or product recalls in the future, regardless of their ultimate outcome, could result in costly litigation and could have a material adverse effect on the Company's business or reputation or on its ability to attract and retain customers for its products. Risks Associated with Derivative Financial Instruments As a partial hedge against adverse fluctuations in exchange rates, the Company periodically enters into foreign currency exchange contracts with certain major financial institutions. By their nature, all such contracts involve risk, including the risk of nonperformance by counterparties. Accordingly, losses relating to these contracts could have a material adverse effect upon the Company's business, financial condition and results of operations. The Company's policy prohibits the use of derivative instruments for speculative purposes. Dependence on Key Management The Company's success depends upon the continued contributions of key members of its senior management team, certain of whom have been with the Company since its inception in 1975. Accordingly, loss of the services of one or more of these key members of management could have a material adverse effect on the business of the Company. None of these individuals has an employment agreement with the Company. -27-