1 ================================================================================ U.S. Securities and Exchange Commission Washington, D.C. 20549 --------------- FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2001 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 0-15963 INVIVO CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 77-0115161 (State or other jurisdiction (IRS Employer Identification No.) Of incorporation) 4900 HOPYARD RD. SUITE 210, PLEASANTON, CALIFORNIA 94588 (Address of principal executive offices) (Zip Code) TELEPHONE: (925) 468-7600 (Registrant's telephone number) --------------- Indicate by check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] The number of shares outstanding of the issuer's Common Stock, par value $.01 per share, at March 31, 2001 was 4,423,249 shares. ================================================================================ 2 PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS INVIVO CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (UNAUDITED) MARCH 31, JUNE 30, 2001 2000 ----------- ----------- ASSETS Current assets: Cash and cash equivalents $ 1,060,600 969,800 Short term investments 9,408,200 6,817,600 Trade receivables, net 13,977,200 14,656,600 Inventories 10,245,100 10,132,000 Deferred income taxes 1,110,000 1,343,000 Prepaid expenses and other current assets 915,800 407,200 ----------- ----------- Total current assets 36,716,900 34,326,200 Property and equipment, net 6,141,700 6,139,600 Intangible assets 7,474,700 8,439,700 Other assets 262,900 570,500 ----------- ----------- $50,596,200 49,476,000 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,967,800 2,725,600 Accrued expenses 3,097,700 3,381,100 Current portion of long-term debt and bank borrowings 142,700 142,700 Income taxes payable 1,251,200 1,347,200 ----------- ----------- Total current liabilities 6,459,400 7,596,600 Long-term debt, excluding current portion 1,277,100 1,392,900 Deferred income taxes 123,000 118,000 Other liabilities -- 52,000 ----------- ----------- Total liabilities 7,859,500 9,159,500 ----------- ----------- Stockholders' equity: Common stock 44,200 43,600 Additional paid-in capital 26,440,500 26,257,300 Retained earnings 16,252,000 14,041,800 Accumulated other comprehensive loss -- (26,200) ----------- ----------- Total stockholders' equity 42,736,700 40,316,500 ----------- ----------- Commitments and contingencies $50,596,200 49,476,000 =========== =========== See accompanying notes to consolidated financial statements. 2 3 INVIVO CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF INCOME (UNAUDITED) THREE MONTHS ENDED NINE MONTHS ENDED MARCH 31, MARCH 31, ------------------------------- ------------------------------- 2001 2000 2001 2000 ------------ ------------ ------------ ------------ Sales $ 13,800,900 $ 13,232,300 39,508,100 39,123,800 Cost of goods sold 7,088,700 6,854,000 20,242,100 20,110,600 ------------ ------------ ------------ ------------ Gross profit 6,712,200 6,378,300 19,266,000 19,013,200 ------------ ------------ ------------ ------------ Operating expenses: Selling, general and administrative 5,008,700 4,274,300 13,586,200 12,049,300 Research and experimental 883,700 800,800 2,376,300 2,213,000 ------------ ------------ ------------ ------------ Total operating expenses 5,892,400 5,075,100 15,962,500 14,262,300 ------------ ------------ ------------ ------------ Income from operations 819,800 1,303,200 3,303,500 4,750,900 Other income (expense): Interest income 109,500 77,200 324,000 282,900 Interest expense (27,900) (34,600) (92,100) (99,200) Loss on sale of G.C. Industries (600,500) -- (600,500) -- Other, net 439,100 415,500 439,100 417,200 ------------ ------------ ------------ ------------ Income before income taxes 740,000 1,761,300 3,374,000 5,351,800 Income tax expense 255,100 598,700 1,163,800 1,819,600 ------------ ------------ ------------ ------------ Net income $ 484,900 $ 1,162,600 2,210,200 3,532,200 ============ ============ ============ ============ Basic net income per common share $ .11 $ .27 .50 .82 ============ ============ ============ ============ Weighted average common Shares outstanding (basic) 4,410,438 4,362,999 4,394,965 4,317,588 ============ ============ ============ ============ Diluted net income per common Share $ .11 $ .26 .49 .78 ============ ============ ============ ============ Weighted average common Shares outstanding (diluted) 4,463,154 4,497,405 4,475,657 4,506,697 ============ ============ ============ ============ See accompanying notes to consolidated financial statements. 3 4 INVIVO CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) NINE MONTHS ENDED MARCH 31, 2001 AND 2000 2001 2000 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net income $ 2,210,200 $ 3,532,200 Adjustments to reconcile net income to Cash provided by operating activities: Depreciation and amortization 1,138,200 916,700 Loss on sale of G.C. Industries 600,500 -- Write-off of note receivable 203,600 Deferred income taxes 238,000 -- Change in operating assets and liabilities: Trade receivables 594,100 (1,609,800) Inventories (174,700) (1,388,200) Prepaid expenses and other current assets (508,600) (332,300) Accrued expenses (402,700) (692,600) Accounts payable (757,800) 9,000 Income taxes payable (96,000) 405,700 ----------- ----------- Net cash provided by operating activities 3,044,800 840,700 ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: (Purchase) sale of short-term investments (2,564,400) 1,483,900 Proceeds from sale of G.C. Industries 664,000 -- Capital expenditures (1,172,400) (1,827,900) Other assets 50,800 (3,200) ----------- ----------- Net cash (used in) investing activities (3,022,000) (347,200) ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of common stock 183,800 179,700 Bank borrowings, net -- (78,400) Principal payments under long-term debt and other liabilities (115,800) (37,400) ----------- ----------- Net cash provided by financing activities 68,000 63,900 ----------- ----------- Net increase in cash and cash equivalents 90,800 557,400 Cash and cash equivalents at beginning of period 969,800 207,800 ----------- ----------- Cash and cash equivalents at end of period $ 1,060,600 $ 765,200 =========== =========== Supplemental disclosures of cash flow information: Cash paid during the period for: Income taxes $ 1,018,600 $ 1,478,400 =========== =========== Interest $ 92,100 $ 99,200 =========== =========== See accompanying notes to consolidated financial statements. 4 5 INVIVO CORPORATION NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS 1. GENERAL The unaudited consolidated financial statements reflect, in the opinion of management, all adjustments necessary to present fairly the financial position and results of operations as of the end of and for the periods indicated. Interim results are not necessarily indicative of results for a full year. The financial statements and notes are presented as permitted by Form 10-Q, and do not contain certain information included in the Company's annual consolidated financial statements and notes. 2. SEGMENT INFORMATION The method for determining what information to report is based on the way that management organizes the operating segments within the Company for making operating decisions and assessing financial performance. The Company's chief operating decision-maker is considered to be the Chief Executive Officer (CEO). The CEO reviews financial information presented on a consolidated basis accompanied by information by business segment. The Company operates in two business segments: (i) patient safety monitoring, which designs, manufactures, and markets monitoring systems that measure and display vital signs of patients in medical settings; and (ii) safety and industrial instrumentation, which is engaged in the design, manufacture, and marketing of sensor-based instruments for safety and industrial process control applications. These segments are managed separately because of different customers and products that require different business strategies. The Company evaluates the operating performance of its segments based on net sales and income from operations. Summarized financial information concerning the Company's business segments is shown in the following table. The "Corporate" column includes general and administrative and corporate-related expenses not allocated to reportable segments (in thousands). SAFETY AND PATIENT SAFETY INDUSTRIAL MONITORING INSTRUMENTATION CORPORATE TOTAL -------------- --------------- --------- -------- For the three months ended March 31, 2001 Net sales ........................... $ 9,153 4,648 -- 13,801 Income from operations .............. 905 578 (663) 820 Depreciation and amortization ....... 263 79 15 357 For the three months ended March 31, 2000 Net sales ........................... $ 8,350 4,882 -- 13,232 Income from operations .............. 972 764 (433) 1,303 Depreciation and amortization ....... 144 113 13 270 For the nine months ended March 31, 2001 Net sales ........................... $ 25,617 13,891 -- 39,508 Income from operations .............. 2,873 1,771 (1,340) 3,304 Depreciation and amortization ....... 790 307 41 1138 Total assets at March 31, 2001 .......... 28,750 10,679 11,167 50,596 For the nine months ended March 31, 2000 Net sales ........................... $ 24,401 14,723 -- 39,124 Income from operations .............. 3,445 2,430 (1,124) 4,751 Depreciation and amortization ....... 591 290 36 917 Total assets at March 31, 2000 .......... 28,898 9,747 9,467 48,112 5 6 3. DEBT AND BANK BORROWINGS The Company's bank line of credit of $1,000,000 was renewed at the same terms on December 1, 2000 and expires on December 1, 2001. The Company's revolving bank line of credit is collateralized by the Company's accounts receivable, inventory, and equipment. At March 31, 2001, $1,000,000 was available under the line of credit. 4. COMPREHENSIVE INCOME The components of comprehensive income, net of tax, are as follows: Three Months Ended Nine Months Ended Mar. 31, 2001 Mar. 31, 2000 Mar. 31, 2001 Mar. 31, 2000 ------------- ------------- ------------- ------------- Net Income 484,900 1,162,600 2,210,200 3,532,200 Change in unrealized gain (loss) on Short Term Investments -- (77,800) 26,200 152,900 ---------- ---------- ---------- ---------- Comprehensive income 484,900 1,084,800 2,236,400 3,685,100 ========== ========== ========== ========== ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS RESULTS OF OPERATIONS THREE AND NINE MONTH PERIODS ENDED MARCH 31, 2001 AND 2000 Sales Sales of $13,800,900 for the third quarter ended March 31, 2001 increased 4.3% as compared to sales of $13,232,300 for the third quarter ended March 31, 2000. Sales for the nine months ended March 31, 2001 increased 1.0% to $39,508,100 compared with $39,123,800 for the comparable period last year. Sales at the Company's patient safety monitoring business increased 9.6% in the third quarter as compared to year earlier sales. Continued growth in sales of the Company's MRI vital signs monitor offset a decrease in "Millennia" product sales as the general monitoring market continued to experience slowing market conditions. The sales increase at the patient safety monitoring business for the third quarter of fiscal 2001 was offset by a sales decline at the Company's safety and industrial instrumentation segment as the Company's non-contact infrared temperature products continued to experience competitive pricing pressures and difficult market conditions. The Company's pressure sensing devices and oxygen monitoring products also experienced sales declines. An increase in sales at the Company's gas detection product line for the three and nine month periods ended March 31, 2001 partially offset the other sales declines in the safety and industrial segment. For the nine months ended March 31, 2001, the sales increase at the patient safety monitoring business slightly offset the sales decline in the industrial instrumentation segment. Gross Profit The gross profit margin increased slightly for the three and nine month periods ended March 31, 2001 to 48.6% and 48.8% from 48.2% and 48.6%, respectively, from the previous fiscal periods. The increase was attributable to an increase in patient safety monitoring business as a percentage of total revenue, the effect of which offset the deteriorating gross margins of the non-contact infrared industrial products due to price discounting and the impact of decreased sales at the other safety and industrial instrumentation product lines relative to fixed cost of sale components. 6 7 Operating Expenses Selling, general and administrative expenses for the three and nine month periods ended March 31, 2001 increased 17.2% or $734,400 and 12.8% or $1,536,900, respectively, from the previous fiscal periods. Selling, general and administrative expenses were 36.3% and 34.4% of sales for the three and nine month periods ended March 31, 2001 compared with 32.3% and 30.8%, respectively, for the comparable periods in fiscal 2000. The increase in these expenditures in aggregate and as a percentage of sales for the three and nine month periods ended March 31, 2001 was primarily due to higher administrative and selling expenses at the Company's patient safety monitoring business along with the write-off of the remaining balance on a note receivable of $203,600, net of a deferred gain of $52,000, from the sale of a product line in fiscal 1996. The Company believes that the note receivable is not collectable based on the recent non-performance of the buyer and the effect of the current economic downturn on the product line's market. The increase in selling, general and administrative expenses at the patient safety monitoring business was in anticipation of higher sales volume for the three and nine month periods than was actually achieved. The increase in selling expenses was also due to higher sales commission expenses and higher international selling expenses as the Company established a U.K. subsidiary in the first quarter of fiscal 2001. Research and experimental expenses were 6.4% and 6.0% of sales for the three and nine month periods ended March 31, 2001 compared to 6.1% and 5.7% for the comparable periods in fiscal 2000. The increase in the third quarter as compared to the prior year period was due to a portion of the expenditures related to equipment for the production of the Company's proprietary anesthetic agent module for the "Millennia" being capitalized in the second and third quarters of fiscal 2000. The Company plans to continue its efforts in developing new products and enhancing its existing ones and expects future aggregate research and experimental expenditures to be consistent with the second quarter of fiscal 2001 levels. Other Income and Expense Interest income was $109,500 for the third quarter of fiscal 2001 as compared to $77,200 for the prior year period. The increase was largely due to the higher balances on the Company's short-term investments. Interest expense remained stable at $27,900 in the third quarter of fiscal 2001. On March 2, 2001, the Company sold G.C. Industries, a gas permeation device business, for $664,000 in cash. The asset sale resulted in a loss of $600,500. G.C. Industries was a part of the safety and industrial segment and represented approximately 1% of the Company's annual sales. Other income, net for the third quarter of fiscal 2001 of $439,100 included a gain of $450,000 on the settlement of a patent infringement lawsuit brought by the Company against a competitor in the MRI monitoring market. Other income, net for the three months ended March 30, 2000 included a $415,500 gain on the sale of short-term investments. Provision for Income Taxes The effective tax rate for the nine months ended March 31, 2001 was 34.5% as compared to 34.0% for the prior year period. LIQUIDITY AND CAPITAL RESOURCES Working capital at March 31, 2001 increased to $30,257,500 from $26,729,600 at June 30, 2000. Net cash provided by operating activities was $2,789,200 for the nine months ended March 31, 2001 compared with $840,700 used by operating activities for the nine months ended March 31, 2000. This increase was largely the result of changes in operating assets and liabilities, particularly accounts receivable and deferred income taxes. Capital expenditures were $1,172,400 for the first nine months of fiscal 2001 compared to $1,827,900 for the prior year period. Capital expenditures were primarily related to information system software enhancements and additional demonstration equipment for the direct sales force at the Company's patient safety monitoring business and leasehold improvements and manufacturing equipment at the Company's new facility for the oxygen monitoring business. The Company believes that its cash resources and cash flow from operations are adequate to meet its anticipated cash needs for working capital and capital expenditures throughout fiscal 2001. As the Company did not foresee any near term borrowing 7 8 requirements coupled with the fees associated with maintaining a bank line of credit, the Company elected to decrease its bank line of credit from $7,500,000 to $1,000,000 in May of 2000. The line of credit was renewed at the same terms for one year on December 1, 2000. The Company's revolving bank line of credit is collateralized by the Company's accounts receivable, inventory, and equipment. At March 31, 2001, $1,000,000 was available under the line of credit. The Company will continue to explore opportunities for the possible acquisitions of technologies or businesses, which may require the Company to seek additional financing. RECENT ACCOUNTING PRONOUNCEMENTS SAB 101 In December 1999, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin NO. 101 (SAB 101), Revenue Recognition in Financial Statements as amended by SAB 101A, which provides guidance on the recognition, presentation, and disclosure of revenue in financial statements filed with the SEC. SAB 101 outlines the basic criteria that must be met to recognize revenue and provides guidance for disclosures related to revenue recognition policies. In June 2000, the SEC issued SAB 101B which deferred the effective date of SAB 101 until the last quarter of fiscal years beginning after December 15, 1999. The Company adopted SAB 101 for the quarter ended March 31, 2001. The adoption of SAB 101 did not have a material effect on the Company's consolidated financial position or results of operations. NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements regarding the Company's plans, expectations, estimates and beliefs. Actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The Company is not obligated to update or revise these forward-looking statements to reflect new events or circumstances. Factors that could cause actual results, events or circumstances to differ from forward-looking statements made in this report include those set forth in the following "Risk Factors" section. RISK FACTORS Risks Relating to the Company's Business: THE COMPANY IS DEPENDENT ON A CONCENTRATED LINE OF PRODUCTS The Company's future financial performance will be largely dependent on its patient monitor product line, which includes a limited number of products. The Company expects its Omni-Trak 3150 MRI patient monitor and its Millennia portable patient monitor to have a substantial impact on revenue growth. In the MRI monitoring market, the success of its Omni-Trak 3150 is heavily dependent on the continued acceptance of MRI technology as a diagnostic tool. In the general patient monitoring market, the Company's Millennia monitor is heavily dependent on its ability to penetrate an already competitive market. In addition, the recent consolidation in the medical care provider market has resulted in a number of very large purchasers of medical devices. These large purchasers may prefer to establish relationships with medical device manufacturers who are larger than the Company and that have broad and diverse product lines. The failure of the Company's products to continue to gain market acceptance or a continued consolidation of the medical care provider market could have a material adverse effect on its business and results of operations. 8 9 THE COMPANY FACES INCREASED LEVELS OF COMPETITION The Company has encountered and will continue to encounter significant competition in the sale of its products. The Company's general patient monitoring competitors include a number of large multinational corporations. Some of these competitors may be able to adapt more quickly to new or emerging technologies and changes in customer requirements, or to devote greater resources to the development, promotion and sale of their products than the Company can. In the MRI patient monitoring market, the Company has enjoyed a significant first-to-market advantage over its competitors. However, competitors have introduced products designed to compete with its MRI vital signs monitoring products. In addition, as the market for MRI vital signs monitoring products expands it may attract competitors with greater resources. Additionally, competition may increase if new companies enter the Company's markets or if existing competitors expand their product lines or intensify efforts within existing product lines. The introduction of competitive products may result in a decrease in the Company's market share and in a decrease in the prices at which the Company is able to sell its products. The Company's market share could also be adversely affected by increasing concentration in the medical care provider market. Any decrease in the Company's market share or decrease in the prices at which the Company is able to sell its products could have a material adverse effect on its business and results of operations. THE COMPANY'S FINANCIAL RESULTS MAY FLUCTUATE The Company's financial results may fluctuate significantly from period to period because of a variety of factors, many of which is beyond its control. These factors include: - increased competition - changes in the Company's pricing policies and those of its competitors - changes in the Company's operating expenses or capital expenditures - timing and market acceptance of new and upgraded product introductions by the Company and its competitors - seasonal fluctuations in the demand for the Company's products - introduction of alternative technologies by the Company and its competitors - effect of potential acquisitions - other general economic factors Fluctuations caused by these and other factors could have a material adverse effect on the Company's business and results of operations. THE COMPANY IS SUBJECT TO A SIGNIFICANT RISK OF NEW LAWS RELATED TO HEALTH CARE Changes in the law or new interpretations of existing laws may have a significant effect on the Company's costs of doing business and the amount of reimbursement the Company receives from both government and third-party payors. In addition, economic forces, regulatory influences and political initiatives are subjecting the health care industry to fundamental changes. Health care reform proposals have been formulated by the current administration and by members of Congress. Federal, state and local government representatives are likely to continue to review and assess alternative health care delivery systems and payment methods. The Company expects ongoing public debate on these issues. Any of these efforts or reforms could have a material adverse affect on the Company's business and results of operations. 9 10 THE COMPANY'S BUSINESS IS SUBJECT TO TECHNOLOGICAL CHANGE AND INTRODUCTION OF NEW PRODUCTS Technological change, evolving industry standards and new product introductions and enhancements characterize the markets for the Company's products. Many of the Company's products and products under development are technologically innovative, and therefore require significant planning, design, development and testing. These activities require the Company to make significant capital commitments and investments. In addition, industry standards may change on short notice and new products and technologies may render existing products and technologies uncompetitive. Additionally, the products that the Company is currently developing, and those that the Company develops in the future, may not be technologically feasible or accepted by the marketplace or they may not be completed in an acceptable time frame. Any increased capital investments or loss in sales due to technological change could have a material adverse effect on the Company's business and results of operations. THE COMPANY CURRENTLY IS INVOLVED IN A LEGAL PROCEEDING The Company's medical device subsidiary, Invivo Research, was one of two third-party defendants named in a lawsuit in June of 1994 by Southern Nevada Surgical Center and Surgex Southern Nevada, Inc. in Nevada State District Court. The underlying action in this matter stemmed from an incident involving a surgical patient undergoing a procedure at the Southern Nevada Surgical Center. The patient suffered a serious permanent brain injury. A lawsuit was filed on behalf of the patient against the surgical center and the anesthesiologist who monitored the patient. The defendants in that action made a substantial settlement to the patient. Southern Nevada Surgical Center ("SNSC") and Surgex were seeking indemnity and contribution of approximately $14 million from the manufacturer of the anesthetic gas machine and Invivo Research, which manufactured the vital signs monitor used in this procedure. SNSC and Surgex alleged that both the anesthetic gas machine and the vital signs monitor were defective. The Company believes that the vital signs monitor operated properly and was properly designed for its intended function. On August 18, 1999, the Nevada District Court granted the Company's Motion to Dismiss for Failure to Prosecute. The Order granted dismissal of the SNSC and Surgex contribution claims, without prejudice, based upon Nevada law that provides that an action must be brought to trial within five years of the date of the filing of the original action. The dismissal is being appealed. In April of 1997, the plaintiff's insurer, CNA, filed an action with identical causes in the same Nevada State Court. This second action was removed by the Company to U.S. District Court. The action by CNA was dismissed by the District Court on January 19, 2000. The dismissal is being appealed. Any judgment against the Company that exceeds the amount that its insurer is required to pay could have a material adverse effect on its business and results of operations. THE COMPANY FACES PRODUCT LIABILITY AND PRODUCT RECALL RISKS With respect to all of its products, and particularly its medical devices, the Company faces the risk of potentially large product liability claims. The malfunction or misuse of its products could potentially result in serious harm to a patient. In addition, the Company may be required to indemnify its distributors and customers for similar claims made against them. Claims could be made against the Company even if its products did not contribute to the injury that was sustained. Frequently, the Company's products are used with products developed by other manufacturers. Even if its products are not the cause of the injury, the Company may not be able to prove that some other product malfunction or human error caused a claimant's injury. The Company has had product liability claims made against it in the past and may have further claims made against it in the future. While the Company is insured for certain product liability claims, not all claims will be covered and the level of its insurance may not be sufficient to protect us from the full amount of a successful claim. In addition, the Company may not be able to obtain adequate amounts of insurance at an acceptable cost. Claims made against the Company that are not insured, or that exceed the amount of the Company's coverage, could have a material adverse effect on its business and results of operations. 10 11 Similarly, the Company's products are subject to the potential of being recalled by government agencies for actual or potential deficiencies or problems. Any such recall would likely be expensive and would have a material adverse effect on the Company's business and results of operations. THE COMPANY FACES INCREASED RISKS OF INTERNATIONAL OPERATIONS International sales have accounted for over 20% of the Company's sales for each of the past three years and may increase over time. International sales are subject to a number of risks, including the following: - fluctuations in exchange rates may affect the demand for products and services the Company provides in foreign markets - adverse changes in local economic conditions, such as those recently occurring in Asian and South American countries, could depress the demand for the Company's products - agreements may be difficult to enforce and receivables difficult to collect through a foreign country's legal system - foreign customers may have longer payment cycles - foreign countries may impose additional withholding taxes or otherwise tax the Company's foreign income, impose tariffs, or adopt other restrictions on foreign trade - U.S. export licenses may be difficult to obtain - the protection of intellectual property in foreign countries may be more difficult to enforce Any of these factors could have a material adverse impact on the Company's business and results of operations. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The Company's sales are primarily denominated in U.S. dollars and as a result, the Company has relatively little exposure to foreign currency exchange risk with respect to its sales. The Company does not currently hedge against foreign currency rate fluctuations. The effect of an immediate 10% change in exchange rates would not have a material impact on the Company's future operating results or cash flows. PART II - OTHER INFORMATION ITEM 1: LEGAL PROCEEDINGS: Not Applicable. ITEM 2: CHANGES IN SECURITIES: Not Applicable. ITEM 3: DEFAULTS UPON SENIOR SECURITIES: Not Applicable. ITEM 4: SUBMISSION OF MATTERS TO A VOTE OF SECURITIES HOLDERS: Not Applicable 11 12 ITEM 5: OTHER INFORMATION: Not Applicable. ITEM 6: EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibit No. Description of Exhibit ----------- ---------------------- Exhibit 10.20 First Amendment to Lease between Principal Life Insurance Company and Invivo Corporation dated February 26, 2001 Exhibit 10.21 Lease between Arcadia Management Services and Invivo Corporation dated November 29, 2000 Exhibit 11.1 Statement of Computation of Net Income Per Share (b) Reports on Form 8-K: None. 12 13 SIGNATURES In accordance with requirements of the Exchange Act, the Registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized. INVIVO CORPORATION Date: May 15, 2001 By: /s/ JOHN F. GLENN ------------------------------- Vice President-Finance and Chief Financial Officer (Principal Financial and Accounting Officer) 13