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 first quarter period ended November 30, 1999 or ( ) Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from ________ to ________ Commission File Number 0-20212 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.) 2400 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 January 13, 2000 _____ ______________________________________ Common Stock, No Par Value 22,548,343 ARROW INTERNATIONAL, INC. Form 10-Q Index Page ____ [S] [C] PART I. FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets at November 30, 1999 and August 31, 1999 3-4 Consolidated Statements of Income 5 Consolidated Statements of Cash Flows 6-7 Consolidated Statements of Comprehensive Income 8 Notes to Consolidated Financial Statements 9-12 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 13-17 Item 3. Quantitative and Qualitative Disclosures About Market Risk 18 PART II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K 19 Signature 20 Exhibit Index 21 -2- PART I - FINANCIAL INFORMATION Item 1. Financial Statements ARROW INTERNATIONAL, INC. CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) November 30, August 31, 1999 1999 ___________ __________ ASSETS Current assets: Cash and cash equivalents $ 7,689 $ 3,939 Accounts receivable, net 69,828 70,467 Inventories 75,929 74,809 Prepaid expenses and other 15,707 15,394 Deferred income taxes 2,018 2,018 __________ __________ Total current assets 171,171 166,627 ========== ========== Property, plant and equipment: Total property plant and equipment 210,823 204,939 Less accumulated depreciation (91,633) (88,005) __________ __________ 119,190 116,934 ========== ========== Goodwill, net 40,003 35,698 Intangible and other assets, net 36,781 33,487 Deferred income taxes 4,899 4,738 __________ __________ Total other assets 81,683 73,923 __________ __________ Total assets $ 372,044 $ 357,484 ========== ========== See accompanying notes to consolidated financial statements Continued -3- ARROW INTERNATIONAL, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share amounts) (Unaudited) November 30, August 31, 1999 1999 ____________ __________ LIABILITIES Current liabilities: Current maturities of long-term debt $ 486 $ 470 Notes payable 44,651 32,802 Accounts payable 8,304 10,028 Cash overdrafts - 394 Accrued liabilities 9,220 8,707 Accrued compensation 6,649 6,223 Accrued income taxes 5,173 102 ____________ __________ Total current liabilities 74,483 58,726 Long-term debt 10,894 11,105 Accrued postretirement benefit obligation 9,587 9,486 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 45,661 45,661 Retained earnings 258,902 250,931 Less treasury stock at cost: 3,733,270 and 3,420,970 shares, respectively (21,322) (12,618) Accumulated other comprehensive expense (6,161) (5,807) __________ __________ Total shareholders' equity 277,080 278,167 __________ __________ Total liabilities and shareholders' equity $ 372,044 $ 357,484 ========== ========== See accompanying notes to consolidated financial statements -4- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF INCOME (In thousands, except share and per share amounts) (Unaudited) For the Three Months Ended __________________________ November 30, November 30, 1999 1998 ____________ ____________ Net sales $ 76,717 $ 68,085 Cost of goods sold 35,337 31,036 ____________ ____________ Gross profit 41,380 37,049 Operating expenses: Research, development and engineering 5,371 5,311 Selling, general and administrative 18,243 16,855 Special charge 3,320 - ____________ ____________ Operating income 14,446 14,883 ____________ ____________ Other expenses (income): Interest expense, net of amounts capitalized 463 222 Interest income (149) (91) Other, net 160 (1,223) ____________ ____________ Other expenses (income), net 474 (1,092) ____________ ____________ Income before income taxes 13,972 15,975 Provision for income taxes 4,750 5,831 ____________ ____________ Net income $ 9,222 $ 10,144 ============ ============ Basic and diluted earnings per common share $ .40 $ .44 ============ ============ Cash dividends per common share $ .055 $ .05 ============ ============ Weighted average shares outstanding 22,899,232 23,224,780 ============ ============ See accompanying notes to consolidated financial statements -5- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) For the Three Months Ended November 30, November 30, 1999 1998 ____________ ____________ Cash flows from operating activities: Net income $ 9,222 $ 10,144 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation 3,838 3,280 Special charge 3,320 - Amortization of intangible assets and goodwill 1,246 763 Amortization of unearned compensation - 44 Deferred income taxes (161) (171) Unrealized holding loss on securities 149 171 Other 81 81 Changes in operating assets and liabilities: Accounts receivable 1,649 1,437 Inventories (861) (1,684) Prepaid expenses and other (455) 45 Accounts payable and accrued liabilities (2,470) (2,643) Accrued compensation 432 (320) Accrued income taxes 5,023 3,164 ___________ __________ Total adjustments 11,791 4,167 ___________ __________ Net cash provided by operating activities 21,013 14,311 ___________ __________ Cash flows from investing activities: Capital expenditures (6,266) (4,071) (Increase) decrease in intangible and other assets (1,036) 416 Cash paid for businesses acquired, net (10,595) - ___________ __________ Net cash used in investing activities (17,897) (3,655) ___________ __________ Cash flows from financing activities: Increase (decrease) in notes payable 11,247 (4,931) Principal payments of long-term debt (235) (461) Increase (decrease) in book overdrafts (394) 80 Dividends paid (1,251) (1,161) Purchase of treasury stock (8,703) (2) ___________ __________ Net cash provided by (used) in financing activities 664 (6,475) ___________ __________ Effect of exchange rate changes on cash and cash equivalents (30) 233 Net change in cash and cash equivalents 3,750 4,414 Cash and cash equivalents at beginning of year 3,939 4,652 ___________ __________ Cash and cash equivalents at end of period $ 7,689 $ 9,066 =========== ========== See accompanying notes to consolidated financial statements Continued -6- <\PAGE> ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS, Continued (In thousands) (Unaudited) For the Three Months Ended ___________________________ November 30, November 30, 1999 1998 ___________ ___________ Supplemental disclosure of cash flow information: Cash paid during the period for: Interest (net of amounts capitalized) $ 463 $ 222 Income taxes $ 903 $ 2,829 Supplemental schedule of non-cash investing and financing activities: Estimated fair value of assets acquired, net of cash acquired $ 12,913 $ - Cash paid for assets, net of cash acquired of $460 10,595 - ___________ ____________ Liabilities assumed $ 2,318 $ - =========== ============ Cash paid for business acquired: Working capital $ (317) $ - Property, plant and equipment 66 - Goodwill, intangible assets and in-process research and development 11,306 - ___________ ____________ $ 11,055 $ - =========== ============ See accompanying notes to consolidated financial statements -7- ARROW INTERNATIONAL, INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (In thousands) (Unaudited) For the Three Months Ended ____________________________ November 30, November 30, 1999 1998 _____________ ____________ Net income $ 9,222 $ 10,144 Other comprehensive income (expense): Currency translation adjustments (143) 2,008 Unrealized holding loss on securities, net of tax ($149 and $171, respectively) (211) (259) _____________ ____________ Other comprehensive income (expense) (354) 1,749 _____________ ____________ Total comprehensive income $ 8,868 $ 11,893 ============= ============ See accompanying notes to consolidated financial statements -8- <\PAGE> ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (In thousands, except per share amounts) (Unaudited) 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 periods are not necessarily indicative of results for the entire year. Such statements are presented in accordance with the requirements of Form 10-Q and do not include all disclosures normally required by generally accepted accounting principles or those normally made on Form 10-K. Note 2 - Inventories: Inventories are summarized as follows: November 30, August 31, 1999 1999 ___________ __________ Finished goods $ 29,494 $ 31,779 Semi-finished goods 14,285 12,654 Work-in-process 11,037 10,528 Raw materials 21,113 19,848 __________ __________ $ 75,929 $ 74,809 ========== ========== 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 business, financial position or results of operations. Note 4 - Related Party Transactions: During the three months ended November 30, 1998, the Company charged Arrow Precision Products, Inc. ("Precision"), which is related to the Company through common ownership, $6 relating to the utilization of certain of the Company's personnel. No such charges were incurred during the three months ended November 30, 1999. The Company had a net receivable from Precision amounting to $375 at November 30, 1998 and no net balance at November 30, 1999. Continued <\PAGE> -9- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (In thousands, except per share amounts) (Unaudited) Note 4 - Related Party Transactions: (Continued) During the three months ended November 30, 1999 and 1998, the Company made purchases amounting to $24 and $10, respectively, from Precision Medical Products, Inc., ("PMP"), a former subsidiary of Precision currently owned by certain former management employees of Arrow Precision Products, Inc., including T. Jerome Holleran, who serves as PMP's Chairman and Chief Executive Officer and as Secretary and a Director of the Company. In addition, the Company provided certain computer related services to PMP for $3 during the three months ended November 30, 1998 but provided no such services during the same period in 1999. Note 5 - Accounting Policies: Certain prior period information has been reclassified for comparative purposes. Note 6 - Business Acquisitions: On September 1, 1999, the Company completed the acquisition of Sometec, S.A., a French development company that has recently developed a non-invasive esophageal ultrasound probe that continuously measures descending aortic blood flow, for $11.1 million. The acquisition has been accounted for using the purchase method of accounting. The allocation of the purchase price was prepared on a preliminary basis pending completion of the valuation. The excess of the purchase price over the estimated fair value of the net assets acquired of approximately $3.8 million is being amortized over a period of 20 years. Intangible assets acquired are being amortized over a period of 10 years. The results of operations of this business are included in the Company's consolidated financial statements from the date of acquisition. Proforma amounts are not presented as this acquisition has no material effect on the Company's results of operations or financial condition. Note 7 - Special Charge: In the first quarter of fiscal 2000, the Company recorded a non- cash pre-tax special charge of $3,320 ($2,191 after tax or $.10 per basic and diluted common share) related primarily to a write-down for the in-process research and development acquired in Continued <\PAGE> -10- ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (In thousands, except per share amounts) (Unaudited) Note 7 - Special Charge: (Continued) connection with the Company's recent acquisition of Sometec, S.A. (see footnote 6). The technology acquired is a compact monitoring device that measures and monitors the descending aortic blood flow during anesthesia and intensive care. The device provides real-time aortic blood flow (a measurement of cardiac output) by using both pulsed Doppler for measuring blood velocity and M-mode ultrasound to accurately measure the aortic diameter. The monitoring system consists of four main components: the main console (monitor), a transesophagael probe, a disposable jacket and an articulated probe holder. The monitor provides the physician with a continuous display of a patient's hemodynamic profile, including aortic blood flow, heart rate, stroke volume, peak velocity, acceleration, left ventricular ejection time and systemic vascular resistance. To facilitate use of this device, a disposable jacket, containing an acoustic get, is placed over the probe utilizing a special vacuum mounting tool supplied with the jacket. The Company believes that the speed and ease of use of this new noninvasive measurement technique has the potential of establishing cardiac output as a frequently used physician tool with value similar to blood pressure, EKG and pulse oximetry measurements. In accordance with SFAS No. 2, "Accounting for Research and Development Costs" and FIN No. 4, "Applicability of SFAS No. 2 to business combinations accounted for by the Purchase Method", these costs were charged to expense at the date of consummation of the acquisition. The value assigned to purchase Sometec in-process technology was based on a valuation prepared by an independent third-party appraisal company. Each of the technologies under development at the date of acquisition was reviewed for technological feasibility, stage of completeness at the acquisition date, and scheduled release dates of products employing the technology to determine whether the technology was complete or under development. At the acquisition date, the research and development project was estimated to be 75% complete. Incomplete development efforts at the time of acquisition included improved portability, software development and development of the disposable sheath. The valuation was based on the estimated cash flows resulting from commercially viable products discounted to present value using a risk adjusted after tax discount rate of 22%. The research and development costs and the net cash inflows from these projects are expected to commence within a year of the acquisition date. However, while the Company believes these projects will be completed as planned, the Company cannot assure you that they will be completed on schedule or once completed, that the new products resulting from these projects will be successfully introduced into the marketplace. The Company does not anticipate material adverse changes from historical pricing, margins and expense levels as a result of the introduction of the new technologies related to the projects. -11- <\PAGE> ARROW INTERNATIONAL, INC. Notes to Consolidated Financial Statements (In thousands, except per share amounts) (Unaudited) Note 8 - Segment Reporting: In the fourth quarter of fiscal 1999, the Company adopted SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information". SFAS No. 131 changes the way the Company reports information about its operating segments to the "management approach". The management approach is based on the way management organizes the segments within the enterprise for making operating decisions and assessing performance. The Company operates as a single reportable segment. Restatement of disclosures for prior years have been made for comparative purposes. The Company operates in four main geographic regions, therefore, information by product category and geographic areas is presented below. The following table provides quarterly information about the Company's sales by product category: Quarter ending Quarter ending November 30, 1999 November 30, 1998 _________________ __________________ Critical Cardiac Critical Cardiac Care Care Care Care _________ ________ _________ ________ Sales to external customers $ 63,900 $ 12,800 $ 56,100 $ 12,000 The following tables present quarterly information about geographic areas: Quarter ending November 30, 1999 ______________________________________________________________ United Asia and Other States Africa Europe Foreign Eliminations Consolidated ______ ________ ______ _______ ____________ ____________ Sales to unaffiliated customers $ 57,992 $ 9,348 $ 7,293 $ 2,084 $ - $ 76,717 Long-lived assets $249,669 $ 3,263 $ 30,689 $ 2,108 $ (89,755) $195,974 Quarter ending November 30, 1998 ______________________________________________________________ United Asia and Other States Africa Europe Foreign Eliminations Consolidated ______ ________ ______ _______ ____________ ____________ Sales to unaffiliated customers $ 52,406 $ 7,133 $ 6,817 $ 1,729 $ - $ 68,085 Long-lived assets $211,940 $ 1,605 $28,491 $ 1,770 $(75,281) $168,525 -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 November 30, 1999 Compared to Three Months Ended November 30, 1998 Net sales for the first quarter of fiscal 2000 ended November 30, 1999 increased 12.7% to $76.7 million, compared with $68.1 million in the same period last year. Net sales represent gross sales invoiced to customers, less certain related charges, including freight costs, discounts, returns and other allowances. Sales of critical care products increased 13.9% to $63.9 million from $56.1 million in the comparable prior year period due primarily to additional unit shipments of central venous catheters, including increased shipments of ARROWg+ard Blue (Registration Mark) antiseptic surface treated catheter products, special catheters, percutaneous thrombolytic devices ("PTDs") and drug infusion pumps. Sales of cardiac care products increased to $12.8 million from $12.0 million, an increase of 6.7% from the comparable fiscal 1999 period, principally as a result of increased sales of intra-aortic balloon ("IAB") pump and catheter products. International sales increased by 13.6% to $26.7 million from $23.5 million in the same prior year period and represented 34.8% of net sales, compared to 34.4% in the comparable fiscal 1999 period, principally as a result of increased sales of central venous catheters and IAB pump and catheter products. The increased strength of the U.S. dollar, relative to currencies in countries where the Company operates direct sales subsidiaries, increased net sales for the quarter by $0.3 million. Gross profit increased 11.7% to $41.4 million in the first quarter of the current fiscal year compared to $37.0 million in the same period of fiscal 1999. As a percentage of net sales, gross profit decreased to 53.9% during the three months ended November 30, 1999 from 54.4% in the comparable prior year period, due to product and distribution mix. Research, development and engineering expenses increased by 1.1% to $5.4 million in the first quarter of fiscal 2000 from $5.3 million in the comparable prior year period. As a percentage of net sales, these expenses decreased in the first quarter of fiscal 2000 to 7.0%, compared to 7.8% in the same period in fiscal 1999. -13- <\PAGE> ARROW INTERNATIONAL, INC. Selling, general and administrative expenses increased by 8.2% to $18.2 million during the first quarter of fiscal 2000 from $16.9 million in the same period of fiscal 1999 and decreased as a percentage of net sales to 23.8% in the first quarter of fiscal 2000 from 24.8% in the comparable period of fiscal 1999. The increase was due primarily to additional expenses related to the acquisition of the cardiac assist division of C.R. Bard, Inc. in the second quarter of fiscal 1999 offset by the Company's cost containment efforts. In the first quarter of fiscal 2000, the Company recorded a non- cash pre-tax special charge of $3,320 ($2,191 after tax or $.10 per basic and diluted common share) related primarily to a write- down for the in-process research and development acquired in connection with the Company's recent acquisition of Sometec, S.A. (see footnote 6). The technology acquired is a compact monitoring device that measures and monitors the descending aortic blood flow during anesthesia and intensive care. The device provides real-time aortic blood flow (a measurement of cardiac output) by using both pulsed Doppler for measuring blood velocity and M-mode ultrasound to accurately measure the aortic diameter. The monitoring system consists of four main components: the main console (monitor), a transesophagael probe, a disposable jacket and an articulated probe holder. The monitor provides the physician with a continuous display of a patient's hemodynamic profile, including aortic blood flow, heart rate, stroke volume, peak velocity, acceleration, left ventricular ejection time and systemic vascular resistance. To facilitate use of this device, a disposable jacket, containing an acoustic get, is placed over the probe utilizing a special vacuum mounting tool supplied with the jacket. The Company believes that the speed and ease of use of this new noninvasive measurement technique has the potential of establishing cardiac output as a frequently used physician tool with value similar to blood pressure, EKG and pulse oximetry measurements. In accordance with SFAS No. 2, "Accounting for Research and Development Costs" and FIN No. 4, "Applicability of SFAS No. 2 to business combinations accounted for by the Purchase Method", these costs were charged to expense at the date of consummation of the acquisition. The value assigned to purchase Sometec in-process technology was based on a valuation prepared by an independent third-party appraisal company. Each of the technologies under development at the date of acquisition was reviewed for technological feasibility, stage of completeness at the acquisition date, and scheduled release dates of products employing the technology to determine whether the technology was complete or under development. At the acquisition date, the research and development project was estimated to be 75% complete. Incomplete development efforts at the time of acquisition included improved portability, software development and development of the disposable sheath. The valuation was based on the estimated cash flows resulting from commercially viable products discounted to present value using a risk adjusted after tax discount rate of 22%. The research and development costs and the net cash inflows from these projects are expected to commence within a year of the acquisition date. However, while the Company believes these projects will be completed as planned, the Company cannot assure you that they will be completed on schedule or once completed, that the new products resulting from these projects will be successfully introduced into the marketplace. The Company does not anticipate material adverse changes from historical pricing, margins and expense levels as a result of the introduction of the new technologies related to the projects. <\PAGE> -14- ARROW INTERNATIONAL, INC. Principally due to the above factors, operating income decreased in the first quarter of fiscal 2000 by 3.0% to $14.4 million from $14.9 million in the comparable prior year period. Other expenses (income), net, decreased to $0.5 million of expense during the first quarter of fiscal 2000 from $1.1 million of income in the comparable prior year 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 decreased during the first quarter of fiscal 2000 by 12.5% to $14.0 million from $16.0 million in the comparable prior year period. For the first quarter of fiscal 2000, the Company's effective income tax rate was 34.0%, a decrease from 36.5% in the same period of fiscal 1999, principally as a result of the recent completion of tax examinations through August 31, 1998. Net income decreased 9.1% to $9.2 million from $10.1 million in the comparable fiscal 1999 period. As a percentage of net sales, net income represented 12.0% during the three months ended November 30, 1999, compared to 14.8% in the comparable prior year period. Basic and diluted earnings per common share were $.40 and $.44 in the first quarters of fiscal 2000 and 1999, respectively. Weighted average common shares outstanding decreased to 22,899,232 in the first quarter of fiscal 2000 from 23,224,780 in the comparable prior year period as a result of the Company's previously announced share repurchase program, which remains in effect. Liquidity and Capital Resources For the three months ended November 30, 1999, net cash provided by operations was $21.0 million, an increase of $6.7 million from the same period in the prior year, due to higher net income, before a non-cash pre-tax special charge of $3,320 ($2,191 after tax or $.10 per basic and diluted common share in the first quarter of fiscal 2000), and to the timing of the payment of income taxes. Accounts receivable, net of the allowance for doubtful accounts, decreased by $.6 million in the three months ended November 30, 1999, compared to a $1.0 million increase in the same period in fiscal 1999. Accounts receivable, measured in average days sales outstanding during the period, was 83 days at November 30, 1999 and 86 days at November 30, 1998. Net cash used in the Company's investing activities increased to $17.9 million in the three months ended November 30, 1999 from $3.7 million for the same period in fiscal 1999, due primarily to the Company's acquisition of Sometec S.A.. Financing activities provided $0.7 million of net cash in the three months ended November 30, 1999, compared to using $6.5 million in the same period in fiscal 1999, <\PAGE> -15- ARROW INTERNATIONAL, INC. primarily as a result of increased borrowing related to the Company's acquisition of Sometec S.A. and increased use of cash to purchase shares of its common stock in the open market in connection with the Company's previously announced share repurchase program. As of November 30, 1999, the Company has expended $8.7 million to fund repurchases of 312,300 shares of its common stock pursuant to this program. As of November 30, 1999, the Company had U.S. bank credit facilities providing a total of $65.0 million in available revolving credit for general business purposes, of which $30.0 million remained unused. In addition, certain of the Company's foreign subsidiaries had revolving credit facilities totaling the U.S. dollar equivalent of $25.0 million, of which $15.3 million remained unused as of November 30, 1999. Combined borrowings under these facilities increased $11.9 million and decreased $5.0 million during the three months ended November 30, 1999 and 1998, respectively. During the three month periods ended November 30, 1999 and 1998, the percentage of the Company's sales invoiced in currencies other than U.S. dollars was 24.4% and 23.0%, respectively. 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 speculative purposes. As of November 30, 1999, outstanding foreign currency exchange contracts totaling the U.S. dollar equivalent of $10.2 million mature at various dates through March 2000. 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 its working capital, 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. <\PAGE> -16- ARROW INTERNATIONAL, INC. The Company expended an aggregate of approximately $1.7 million and devoted in excess of 1,200 man-days in internal resources in fiscal 1998 and 1999 and the first quarter of fiscal 2000 to achieve its objective of ensuring that the Company's products, business systems and support services to customers would continue to operate satisfactorily on and after January 1, 2000. The Company has described in detail its efforts to address the Year 2000 problem as it may have related to its business operations and regulation by the Food and Drug Administration in its Annual Report on Form 10-K for its fiscal year ended August 31, 1999 and in its other filings with the Securities and Exchange Commission. Subsequent to the end of the Company's first quarter of fiscal 2000, the calendar changed to the year 2000. The business and operations of the Company experienced no material adverse effects from the date change, nor has the Company been notified of any disruptions or failures in the systems of any of its suppliers or customers. There is an ongoing risk that Year 2000 related problems could still occur and the Company will continue to evaluate these risks; however, the Company believes that the Year 2000 issue will not pose any significant operational problems for the Company. -17- ARROW INTERNATIONAL, INC. Item 3. Quantitative and Qualitative Disclosures About Market Risk: Financial Instruments: During the three month period ended November 30, 1999 and 1998, the percentage of the Company's sales invoiced in currencies other than U.S. dollars was 24.4% and 23.0%, respectively. In addition, a small part of the Company's cost of goods sold is denominated in foreign currencies. The Company enters into foreign currency forward contracts, which are derivative financial instruments, with major financial institutions to reduce the effect of these foreign currency risk exposures, primarily on U.S. dollar cash inflows resulting from the collection of intercompany receivables denominated in foreign currencies. Such transactions occur throughout the year and are probable, but not firmly committed. Forward contracts are marked to market each accounting period, and the resulting gains or losses on these contracts are recorded in Other Income / Expense of the Company's consolidated statements of income. Realized gains and losses on these contracts are offset by the assets, liabilities and transactions being hedged. The Company does not use financial instruments for trading or speculative purposes. 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 efforts in this regard will be successful. Operations of the Company are also exposed to, in the normal course of business, fluctuations in interest rates. This interest rate risk exposure results from changes in short-term U.S. dollar interest rates. The Company does not expect the impact of interest rate volatility to be significant. The Company's exposure to credit risk consists principally of trade receivables. Hospitals and international dealers account for a substantial portion of trade receivables and collateral is generally not required. The risk associated with this concentration is limited due to the Company's on-going credit review procedures. At November 30, 1999, the Company had forward exchange contracts to sell foreign currencies which mature at various dates through March 2000. The following table identifies forward exchange contracts to sell foreign currencies at November 30, 1999 and August 31, 1999 as follows: November 30, 1999 August 31, 1999 Notional Fair Market Notional Fair Market Amounts Value Amounts Value _________ __________ _________ _________ Foreign currency: (U.S. Dollar Equivalents) Japanese yen $ 4,473 $ 4,678 $ 5,698 $ 5,855 Canadian dollars 1,591 1,595 1,115 1,108 Greek drachmas 1,809 1,842 1,571 1,603 Mexican peso 1,537 1,589 1,012 1,064 African rand 795 809 1,270 1,314 ________ ________ ________ ________ $10,205 $10,513 $10,666 $10,944 ======== ======== ======== ======== -18- ARROW INTERNATIONAL, INC. PART II. OTHER INFORMATION 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 November 30, 1999. *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. -19- 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: January 14, 2000 By: /s/ Frederick J. Hirt __________________________ (signature) Frederick J. Hirt Vice President-Finance and Treasurer (Principal Financial Officer and Chief Accounting Officer) -20- EXHIBIT INDEX Exhibit Description Number of Exhibit Method of Filing _______ ___________ ________________ 27 *Financial Data Schedule EDGAR 99.1 Cautionary Statement for Page 22-26 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. -21- 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 our senior management, expectations and other statements are expressed regarding our future performance. 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 our current and future performance are discussed in our Annual Report on Form 10-K for our fiscal year ended August 31, 1999 and other filings with the Securities and Exchange Commission (the "Commission"). In addition to such information in our Annual Report on Form 10-K and our other filings with the Commission, investors should consider the following risk factors in evaluating us and our business, as well as in reviewing forward- looking statements contained in our periodic reports filed with the Commission and in oral statements made by our senior management. Our 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 Our products are subject to extensive regulation by the Food and Drug Administration (the "FDA") and, in some jurisdictions, by state, local and foreign governmental authorities. In particular, we must obtain specific clearance or approval from the FDA before we can market new products or certain modified products in the United States. With the exception of one product, we have, to date, obtained FDA marketing clearance for our products only through the 510(k) premarket notification process. Certain of our products under development and future applications, however, will require approval through the more vigorous Premarket Approval application ("PMA") process. The process of obtaining such clearances or approvals can be time consuming and expensive. We cannot assure you that the FDA will grant all clearances or approvals sought by us or that FDA review will not involve delays adversely affecting the marketing and sale of our products. We are also required to adhere to applicable regulations setting forth current Good Manufacturing Practices ("GMP") which require that we manufacture our products and maintain our records in a prescribed manner with respect to manufacturing, testing and control activities. In addition, we are required to comply with FDA requirements for labeling and promotion of our products. Failure to comply with applicable federal, state, local or foreign laws or regulations could subject us to enforcement action, including product 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 our business, financial condition and results of operations. Many of the foreign countries where we conduct business have adopted medical device laws and regulations with similar substantive and enforcement provisions. Federal, state, local and foreign laws and regulations regarding the development, manufacture and sale of medical devices are subject to future changes. We cannot assure you that such changes will not have a material adverse effect on our business, financial condition and results of operations. -22- Significant Competition and Continual Technological Change The markets for medical devices are highly competitive. We currently compete with many companies in the development and marketing of catheters and related medical devices. Some of our competitors have access to greater financial and other resources than us. Furthermore, the markets for medical devices are characterized by rapid product development and technological change. Technological advances by one or more of our current or future competitors could render our present or future products obsolete or uneconomical. Our future success will depend upon our ability to develop new products and technology to remain competitive with other developers of catheters and related medical devices. Our 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. We cannot assure you that we 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 our products. Cost Pressures on Medical Technology and Proposed Health Care Reform Our products are purchased principally by hospitals, hospital networks and hospital buying groups. Although our products are used primarily for non-optional medical procedures, we believe 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. 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 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. We cannot assure you 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 our 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 <\PAGE> -23- 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 expand coverage and limit costs. Implementation of government health care reform and other efforts to control costs may limit the price of, or the level at which reimbursement is provided for, our products. Several foreign countries have recently considered, and in some countries adopted, similar reforms to limit the growth of health care costs, including price regulation. We anticipate that Congress, state legislatures, foreign governments and the private sector will continue to review and assess alternative health care delivery and payment systems. We 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 our business. We cannot assure you that any such reforms will not have a material adverse effect on the medical device industry in general, or on our business, in particular. Dependence on Patents and Proprietary Rights We own numerous U.S. and foreign patents and have several U.S. and foreign patent applications pending. We also have exclusive license rights to certain patents held by third parties. These patents relate to aspects of the technology used in certain of our products. From time to time, we are subject to legal actions involving patent and other intellectual property claims. Successful litigation against us regarding our patents or infringement of the patent rights of others could have a material adverse effect on our business, financial condition and results of operations. In addition, we cannot assure you that pending patent applications will result in issued patents or that patents issued to or licensed-in by us will not be challenged or circumvented by competitors or found to be valid or sufficiently broad to protect our technology or to provide it with any competitive advantage. We also rely on trade secrets and proprietary technology that we seek to protect, in part, through confidentiality agreements with employees, consultants and other parties. We cannot assure you that these agreements will not be breached, that we 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 our 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 us. Future litigation may be necessary to enforce patent and other intellectual property rights belonging to us, to protect our trade secrets or other know-how owned by us, or to defend ourself against claimed infringement of the rights of others and to determine the scope and validity of our and others' proprietary rights. Any such litigation could result in substantial cost to and diversion of effort by us. Adverse determinations in any such litigation could subject us to significant liabilities to third parties, require us to seek licenses from third parties and prevent us from manufacturing, selling or using certain of our products, any one or more of which could have a material adverse effect on our business, financial condition and results of operations. <\PAGE> -24- Risks Associated with International Operations We generate significant sales outside the United States and are 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, any one or more of which could materially adversely impact the success of our international operations. As our revenues from international operations increase, an increasing portion of our revenues and expenses will be denominated in currencies other than U.S. dollars and, consequently, changes in exchange rates could have a greater effect on our future operations. We cannot assure you that such factors will not have a material adverse effect on our business, financial condition and results of operations. In addition, we cannot assure you that laws or administrative practices relating to regulation of medical devices, taxation, foreign exchange or other matters of countries within which we operate will not change. Any such change could also have a material adverse effect on our business, financial condition and results of operations. Potential Product Liability Our business exposes us to potential product liability risks which are inherent in the testing and marketing of catheters and related medical devices. Our products are often used in intensive care settings with seriously ill patients. In addition, many of the medical devices manufactured and sold by us 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 us 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 our products. We cannot assure you that the product liability insurance maintained by us will be available or sufficient to satisfy all claims made against us or that we 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 our business or reputation or on our ability to attract and retain customers for our products. Risks Associated with Derivative Financial Instruments As a partial hedge against adverse fluctuations in exchange rates, we periodically enter into foreign currency exchange contracts with certain major financial institutions. By their nature, all such contracts involve risk, including the risk of -25- nonperformance by counterparties. Accordingly, losses relating to these contracts could have a material adverse effect upon our business, financial condition and results of operations. Our policy prohibits the use of derivative instruments for speculative purposes. Dependence on Key Management Our success depends upon the continued contributions of key members of our senior management team, certain of whom have been with us since our 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 our business. None of these individuals has an employment agreement with us. <\PAGE> -26-