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 SEPTEMBER 30, 1999 COMMISSION FILE NO. 0-18602 ATS MEDICAL, INC. (Exact name of registrant as specified in its charter) MINNESOTA 41-1595629 (state or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 3905 ANNAPOLIS LANE, SUITE 105 55447 MINNEAPOLIS, MINNESOTA (Zip Code) (Address of principal executive offices) Registrant's telephone number, including area code: (612) 553-7736 Former name, if changed since last report: N/A Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes __X__ No _____ The number of shares outstanding of each of the registrant's classes of common stock as of November 1, 1999 was: Common Stock $.01 par value 17,884,253 shares ATS MEDICAL, INC. INDEX PART I. FINANCIAL INFORMATION PAGE Item 1. Statements of Financial Position - 3 September 30, 1999 (unaudited) and December 31, 1998 Statements of Operations - 4 Three Months and Nine Months Ended September 30, 1999 and 1998 (unaudited) Statements of Cash Flows - 5 Nine Months Ended September 30, 1999 and 1998 (unaudited) Notes to Financial Statements 6 Item 2. Management's Discussion and Analysis of 7 Financial Condition and Results of Operations Item 3. Quantitative and Qualitative Disclosures About 14 Market Risk PART II. OTHER INFORMATION 15 Signatures 16 Item 1 Financial Statements ATS MEDICAL, INC. CONSOLIDATED CONDENSED STATEMENTS OF FINANCIAL POSITION SEPTEMBER 30, DECEMBER 31, 1999 1998 ---------------------------------- (Unaudited) (Note) ASSETS Current assets: Cash & cash equivalents $ 6,914,943 $ 7,754,077 Short-term investments 9,511,595 12,852,885 ---------------------------------- 16,426,538 20,606,962 Accounts receivable, less allowance of $200,000 in 1999 and $185,000 in 1998 6,382,436 5,820,699 Inventories 36,311,187 29,954,718 Prepaid expenses 326,892 458,663 ---------------------------------- Total current assets 59,447,053 56,841,042 Furniture, machinery and equipment 2,532,104 2,596,311 Less accumulated depreciation 1,602,740 1,393,527 ---------------------------------- 929,364 1,202,784 Other assets 398,068 387,550 ---------------------------------- Total assets $ 60,774,485 $ 58,431,376 ================================== LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,302,952 $ 2,355,443 Accrued payroll and expenses 329,705 256,358 ---------------------------------- Total current liabilities 2,632,657 2,611,801 Long-term debt 0 0 Shareholders' equity: Common Stock, $.01 par value: Authorized 40,000,000 shares; Issued and outstanding 17,871,503 & 17,824,137 at September 30, 1999 and Dec 31, 1998, respectively 178,715 178,241 Additional paid-in capital 71,448,685 71,249,846 Stock subscriptions receivable 0 0 Accumulated other comprehensive income 43,494 43,799 Accumulated deficit (13,529,066) (15,652,311) ---------------------------------- Total shareholders' equity 58,141,828 55,819,575 ---------------------------------- Total liabilities and shareholders' equity $ 60,774,485 $ 58,431,376 ================================== Note: The balance sheet at December 31, 1998 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. See notes to condensed financial statements. ATS MEDICAL, INC. CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS (Unaudited) Three months ended September 30, Nine months ended September 30, 1999 1998 1999 1998 ------------ ------------- ------------ ------------ Net sales $ 4,258,127 $ 4,138,721 $ 13,170,277 $ 12,953,042 Less cost of goods sold 2,639,250 2,593,159 8,124,129 8,048,109 ------------ ------------ ------------ ------------ Gross profit 1,618,877 1,545,562 5,046,148 4,904,933 Expenses: Research, development and engineering 335,485 355,462 952,202 1,096,218 Selling, general and administrative 852,358 827,812 2,677,975 2,650,014 ------------ ------------ ------------ ------------ Total expenses 1,187,843 1,183,274 3,630,177 3,746,232 ------------ ------------ ------------ ------------ Operating income 431,034 362,288 1,415,971 1,158,701 Interest income 224,682 344,951 707,275 1,042,713 ------------ ------------ ------------ ------------ Net income $ 655,716 $ 707,239 $ 2,123,246 $ 2,201,414 ============ ============ ============ ============ Net income per share: Basic $ 0.04 $ 0.04 $ 0.12 $ 0.12 Diluted $ 0.04 $ 0.04 $ 0.12 $ 0.12 Weighted average number of shares outstanding: Basic 17,867,803 17,777,790 17,849,877 17,722,858 Diluted 18,459,324 18,107,666 18,320,618 18,153,622 ATS MEDICAL, INC. CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) NINE MONTHS ENDED SEPTEMBER 30, 1999 1998 ------------ ------------ OPERATING ACTIVITIES Net income $ 2,123,246 $ 2,201,414 Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 215,966 196,090 Loss on disposal of equipment 186,037 1,420 Changes in operating assets and liabilities: Accounts receivable (561,737) (1,625,426) Prepaid expenses 131,771 48,796 Other assets (10,518) (11,549) Inventories (6,356,469) (3,750,305) Accounts payable and accrued expenses 20,856 1,739,580 ------------ ------------ Net cash used in operating activities (4,250,848) (1,199,980) INVESTING ACTIVITIES Purchase of marketable securities (8,906,182) (16,737,404) Sale of marketable securities 12,247,472 23,372,536 Purchases of property, plant and equipment (128,583) (356,298) ------------ ------------ Net cash provided by investing activities 3,212,707 6,278,834 FINANCING ACTIVITIES Net proceeds from sale of common stock 199,312 (576,106) ------------ ------------ Net cash provided by financing activities 199,312 (576,106) Effect of exchange rate changes on cash (305) 5,230 ------------ ------------ Increase (decrease) in cash and cash equivalents (839,134) 4,507,978 Cash and cash equivalents at beginning of period 7,754,077 4,568,332 ------------ ------------ Cash and cash equivalents at end of period $ 6,914,943 $ 9,076,310 ============ ============ ATS MEDICAL, INC. NOTES TO FINANCIAL STATEMENTS (UNAUDITED) September 30, 1999 Note A - BASIS OF PRESENTATION The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month and nine-month periods ended September 30, 1999 are not necessarily indicative of the results that may be expected for the year ended December 31, 1999. ITEM 2 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ATS Medical, Inc. (the "Company") is engaged in the manufacturing and marketing of a pyrolytic carbon bileaflet mechanical heart valve. The Company sells the ATS Open Pivot TM valve (the "ATS Valve" or the "Valve") in international markets and is conducting a clinical study in the United States and Canada for the purpose of obtaining regulatory approval. RESULTS OF OPERATIONS Net sales for the quarter ended September 30, 1999 increased 2.9% to $4,258,127,compared to $4,138,721 for the quarter ended September 30, 1998. Unit sales increased 11% in 1999 compared to 1998. The continued volatility in foreign exchange rates, the pressure from hospital administrators for lower prices and the willingness of competitors to reduce prices put pressure on revenue growth and margins. This pressure, which is expected to continue for the remainder of 1999, caused the average selling price of the Valve to decrease for the quarter ended September 30, 1999 compared to the quarter ended September 30, 1998. Net sales for the nine months ended September 30, 1999 totaled $13,170,277 which represented a 1.7% increase over the net sales of $12,953,042 reported for the nine months ended September 30, 1998. Unit sales for the first nine months of 1999 increased 4.9% compared to the first nine months of 1998. The Company sells to independent distributors with assigned territories (generally a specific country or region) who in turn sell the Valve to hospitals or clinics. The Company sells in U.S. dollars, so currency risk is borne by the distributor. As the dollar increases in value against the distributor's local currency, the cost of the Valve increases for the distributor even though ATS does not change the selling price. For the nine months ended September 30, 1999 the Company's sales efforts were challenged by significant price competition from other valve manufacturers and the increased strength of the U.S. dollar relative to almost all foreign currencies. During 1999 and 1998 the Company was selling Valves in most developed countries and several lesser-developed countries ("LDC's"). Since January 1997, the Company has been conducting a clinical study of the Valve at fifteen hospitals in the United States. During the study, Valves are provided to the hospitals at prices designed to recover some of the costs of the clinical study. On August 3, 1999 the Company submitted a PreMarket Approval Application ("PMA") to the U.S. Food and Drug Administration ("FDA"). The FDA will review the information included in the application and if it demonstrates the safety and effectiveness of the Valve, the FDA will allow the Company to market the Valve in the United States. Although it is not possible to predict how long this process may take in this case, it often takes from nine months to over one year. Cost of sales for the three months ended September 30,1999 totaled $2,639,250 or 62% of sales compared to $2,593,159 or 62.7% of sales for the three months ended September 30, 1998. Cost of goods sold totaled $8,124,129 or 61.7% of sales for the first nine months of 1999 compared to $8,048,109 or 62.1% for the first nine months of 1998. Beginning in January, 1999 the Company increased production/assembly levels of the Valve. During the first nine months of 1999 the Company assembled 142% more Valves than in the first nine months of 1998. The increased levels are in excess of the Company's current sales levels and are in anticipation of eventual FDA PreMarket approval of the Valve. The benefit of increased production volumes is increased absorption of overhead costs leading to slightly lower cost of goods sold. However, unless the Company is able to increase sales following FDA approval, it would not be practical to continue to assemble Valves at these levels. While the price of the carbon components contained in the Valves sold in the first quarter of 1999 were 6% lower as compared to the cost of carbon components contained in the Valves sold in the first quarter of 1998, the price of components sold for most of the second and third quarter 1999 were 3% higher than the cost of components contained in the Valves sold in the second and third quarter 1998. Based upon the Company's internal sales projections, the price of the carbon contained in Valves sold in the remainder of 1999 is expected to be 3% higher than in 1998. The Company purchases pyrolytic carbon components for the Valve from CarboMedics, Inc. ("CMI"). Approximately 80% of the total cost of a valve is contained in the cost of the carbon components. The price of the components is set under a multi-year supply agreement between the Company and CMI. The price was established in 1990, and varies according to annual volume and is adjusted annually according to increases in the U.S. Department of Labor Employment Cost Index. The Company uses the first-in first-out ("FIFO") method of accounting for inventory. Gross profit totaled $1,618,877 for the quarter ended September 30, 1999 or 38% of sales, compared to gross profit of $1,545,562 or 37.3% of sales for the quarter ended September 30, 1998. Gross profit totaled $5,046,148 for the first nine months of 1999 or 38.3% of sales compared to $4,904,933 for the nine months ended September 30, 1998 or 37.9% of sales. Although the average selling price per unit decreased in the first nine months of 1999 compared to 1998, the average cost per unit sold decreased even more, improving gross margin. Research, development and engineering expenses totaled $335,485 for the quarter ended September 30, 1999 versus $355,462 for the quarter ended September 30, 1998. The major portion of the decrease is related to the costs associated with the Company's U.S. clinical study. Approximately 27% and 25% of research and development expenses for the quarters ended September 30, 1999 and 1998, respectively, were for testing and outside consulting services related to the Valve. The Company began human implants in the United States under an Investigational Device Exemption ("IDE") in January 1997. The Company sells the Valves to the hospitals involved in the study and the cost of the Valve is eligible for reimbursement by Medicare and most private pay insurance companies. The Company is responsible for reimbursing the hospital for certain additional tests and procedures required by the clinical protocol. The estimated total cost of follow-up is accrued at the time of the sale as research and development expense. Selling, general and administrative expenses totaled $852,358 for the three months ended September 30, 1999, a $24,546 increase from $827,812 reported for the three months ended September 30, 1998. Selling, general and administrative expenses totaled $2,677,975 for the first nine months of 1999 compared to $2,650,014 for the first nine months of 1998. The Company had 88 employees at September 30, 1999 compared to 72 employees at September 30, 1998. The absorption of labor into inventory offset the increased payroll expenses. For the quarter ended September 30, 1999 the Company accrued 50% less for incentive compensation than in the quarter ended September 30, 1998. Interest income totaled $224,682 for the quarter ended September 30, 1999 compared to $344,951 for the quarter ended September 30, 1998. The decrease in interest income in 1999 was the result of lower average investable cash balances during 1999 and lower interest rates. Cash on hand at September 30, 1999 is less than the amount on hand at December 31, 1998. Interest income in 1999 is expected to be approximately 50% less than in 1998. The Company is investing cash in carbon and the completion of a large quantity of Valves in anticipation of the market release of the Valve in the United States. Net income totaled $655,716 for the quarter ended September 30,1999 compared to $707,239 for the quarter ended September 30, 1998. Net income for the first nine months of 1999 totaled $2,123,246 compared to $2,201,414 for the first nine months of 1998. The increases in operating income for the quarter and first nine months of 1999 as compared to 1998 were more than offset by the decreases in interest income. The Company has accumulated approximately $15 million of net operating loss carryforwards for U.S. tax purposes. The Company believes that its ability to fully utilize the existing net operating loss carryforwards will be restricted to approximately $3 million per year. Although the Company can offset a significant portion of pretax income with the net operating losses from prior years the Company is subject to alternative minimum taxes and accrued $50,234 to cover state and federal income taxes for the nine months ended September 30, 1999. LIQUIDITY AND CAPITAL RESOURCES Cash, cash equivalents and marketable securities decreased by $4,180,424 from $20,606,962 at December 31, 1998 to $16,426,538 at September 30, 1999. Inventory purchases and the pay-down in accounts payable caused the Company to have negative cash flow from operations. During 1999 the Company is obligated to purchase $14.4 million of components in accordance with the terms of its long-term supply agreement with CMI (the "Supply Agreement"). The Company is obligated to purchase $18.6 million of components in the year 2000. These minimum purchases under the Supply Agreement are not tied to sales of the Company's Valve and the Company does not expect sales of the Valve to exceed the minimum purchase requirements under the Supply Agreement until the Valve is approved for sale in the United States. After the Company purchases the minimum required Valves under the Supply Agreement for the year 2000, the Company will be obligated under the Supply Agreement only to buy what it sells through year 2007. Accounts receivable increased from $5,820,699 at December 31, 1998 to $6,382,436 at September 30, 1999. Most of the Company's sales have been to customers in international markets and while the Company attempts to set standard 60 day terms for accounts receivable, competitive pressures and geographical economic situations have caused the Company to selectively extend the terms for payment. At December 31, 1998 and September 30, 1999, the account balance for one customer was 26% and 27.8%, respectively, of outstanding receivables. The Company has done business with this customer since 1992 and the size of the receivable, while substantial, is consistent with the growth of business in this market and in line with the size of the customer's overall business. Current liabilities increased slightly from $2,611,801 at December 31, 1998 to $2,632,657 at September 30, 1999. The majority is in accounts payable and is related to the amount owing to CarboMedics, Inc. under the Supply Agreement. Based upon the Company's current rate of sales, its expected obligations under the Supply Agreement and its expected expenses, the Company anticipates that existing cash, cash equivalents and short-term investments will be sufficient to satisfy its capital requirements through 2000. Beyond 2000 the Company should be cash flow positive or at worst cash flow neutral barring a significant change in the Company's business plan. The Company does not use derivatives and therefore does not face market risk from currency or interest rate changes on these types of instruments. There would be no impact on the Company's operations from interest rate changes on debt instruments since the Company has not used debt to finance its operations. Assuming that interest rates on investment grade securities were to decrease by 10%, the Company's annual interest income would decrease by approximately $100,000 based on the level of investable funds available to the Company at December 31, 1998. YEAR 2000 SITUATION The "Year 2000 Problem" refers to a complex set of problems which may arise when computer hardware or software is unable to distinguish between 21st century dates and 20th century dates because the date code fields have been abbreviated into two digits, i.e. 00. This problem could result in system failures or miscalculations causing disruptions of business operations (including, among other things, a temporary inability to process transactions, send invoices or engage in other similar business activities). As a result, many companies' computer systems and software will need to be upgraded or replaced in order to comply with Year 2000 requirements. The potential global impact of the Year 2000 problem is not known, and, if not corrected in a timely manner, could affect the Company and the U.S. and world economy generally. The Company's products, including the ATS Medical heart valve, do not contain any electronics or software and therefore will not be affected by the "Year 2000 Problem". The Company's internal financial, manufacturing and other computer systems are being reviewed to assess and remediate Year 2000 problems. The Company's assessment of internal systems includes its information technology ("IT") as well as non-IT systems (systems which contain embedded technology and are used in manufacturing or process control equipment containing microprocessors or other similar circuitry). As a result of this review the Company determined that some of its equipment and software needed to be upgraded or replaced. During 1998 the Company spent approximately $59,000 on hardware and software some of which was necessary to eliminate potential Year 2000 problems. During the first nine months of 1999 the Company purchased $58,268 of computer equipment and software. The Company's 1999 budget for hardware and software is $164,528 including the replacement or upgrade of personal computers, workstations and software which are not currently Year 2000 compliant. Shortly after the close of the quarter ended March 31, 1999 the Company took delivery on custom measuring equipment. The primary purpose of this equipment was to improve processing of the Company's products but it also contained Year 2000 compliant software. Vendor personnel installed and attempted to debug the equipment and software. The equipment was not able to perform up to specification. During the quarter ended June 30, 1999, the Company expensed the $186,000 prepaid in 1998. Since substantially all of this hardware and software is being purchased from large, industry-leading vendors (i.e. Compaq, Lotus, and Microsoft), the Company will rely on vendor certification and internal tests to determine Year 2000 compliance as opposed to hiring consultants to perform reviews. Such certifications and tests were obtained or completed by the end of the second quarter 1999. In addition, during the first quarter of 1999 the Company has requested assurances from its major suppliers that they are addressing the Year 2000 problem and that products purchased by the Company from such suppliers will function properly in the Year 2000. The Company has a significant inventory of product components on hand, however, certain key components for the Valve are available from a single supplier and a protracted Year 2000 problem for this vendor could have an adverse impact on the Company. Contacts have been made with the Company's major customers. These contacts with the Company's suppliers and customers are intended to help mitigate the possible external impact of the Year 2000 problem. However, it is impossible to fully assess the potential consequences in the event service interruption from suppliers occur or in the event that there are disruptions in such infrastructure areas as utilities, communications, transportation, banking and government. The total estimated cost for resolving the Company's Year 2000 issues is approximately $223,500, of which approximately $169,000 has been spent through September 30, 1999. The total cost estimate includes the cost of replacing non-compliant systems as a remediation cost in cases where the Company has accelerated plans to replace such systems. Estimates of Year 2000 costs are based on numerous assumptions, and there can be no assurance that the estimates are correct or that actual costs will not be materially greater than anticipated. Based upon its assessments to date, the Company believes it will not experience any material disruption in its operations as a result of Year 2000 problems to internal financial, manufacturing and other process control systems, or in its interface with major customers and suppliers. However, if major suppliers, including those providing component parts, electricity, communications and transportation services, experience difficulties resulting in disruption of critical supplies or services to the Company, a shutdown of the Company's operations could occur for the duration of the disruption. The Company has developed contingency plans to help provide continuity of normal business operations in the event that problem scenarios arise. Assuming no major disruption in service from critical third party providers, the Company believes that it will be able to manage the Year 2000 transition without any material effect on the Company's results of operations or financial position. There can be no assurance, however, that unexpected difficulties will not arise and, if so, that the Company will be able to timely develop and implement an effective contingency plan. THE SINGLE EUROPEAN CURRENCY A significant portion of the Company's sales occur in Europe. Effective January 1, 1999 various European countries began utilizing a single currency, the "Euro". From January 1999 through December 2001, merchants will be encouraged to discontinue using local country currencies and begin using the Euro to transact business. Beginning in 2002, it will be required that business in the European Community be conducted using the Euro. The Company sells to all of its customers in U.S. Dollars and does not expect to have accounting system issues relative to currency translation. The Company's selling prices are similar to most of its European distributors and therefore should not cause significant disruption whether in dollars or Euros. Europe is a very important market for the Company's Valve. Disruption or loss of a portion of the Company's European business could have a material and adverse impact on the Company's financial position. The Euro has declined in value relative to the dollar by 10% from its introduction January 1, 1999 to September 30, 1999. The Company sells in U.S. Dollars so the price of the Valve to Distributors in countries covered by the Euro has in effect increased by 10%. Transactionally the introduction of the Euro has not been a problem for the Company and its European distributors, but economically the weakness in the Euro has put pressure on the Company's pricing. CAUTIONARY STATEMENT PURSUANT TO THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 The Private Securities Litigation Reform Act of 1995 (the "Act") provides a "safe harbor" for forward-looking statements to encourage companies to provide prospective information about their business, so long as those statements are identified as forward-looking and are accompanied by meaningful cautionary statements identifying important factors that could cause actual results to differ materially from those discussed in the statement. ATS Medical, Inc. desires to take advantage of the safe harbor provisions with respect to any forward-looking statements it may make in this filing, other filings with the Securities and Exchange Commission and any public oral statements or written releases. The words or phrases "will likely," "is expected," "will continue," "is anticipated," "estimate," "projected," "forecast," or similar expressions are intended to identify forward-looking statements within the meaning of the Act. Such statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. In accordance with the Act, the Company identifies the following important general factors which if altered from the current status could cause the Company's actual results to differ from those described in any forward-looking statements: the continued acceptance of the Company's mechanical heart Valve in international markets, the acceptance by the U.S. FDA of the Company's regulatory submissions, the continued performance of the Company's mechanical heart valve without structural failure, the actions of the Company's competitors including pricing changes and new product introductions, the continued performance of the Company's independent distributors in selling the Valve, the actions of the Company's supplier of pyrolytic carbon components for the Valve and the effect of the Year 2000 problem on the Company, its suppliers and its customers. This list is not exhaustive, and the Company may supplement this list in any future filing or in connection with the making of any specific forward-looking statement. ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The Company does not use derivatives and therefore does not face market risk from currency or interest rate changes on these types of instruments. There would be no impact on the Company's operations from interest rate changes on debt instruments since the Company has not used debt to finance its operations. Assuming that interest rates on investment grade securities were to decrease by 10%; the Company's annual interest income would decrease by approximately $100,000 based on the level of investable funds available to the Company at December 31, 1998. PART II. OTHER INFORMATION Item 1. Legal Proceedings None Item 2. Changes in Securities None Item 3. Defaults Upon Senior Securities None Item 4. Submission of Matters to a Vote of Security Holders None Item 5. Other Information None Item 6. Exhibits and Reports on Form 8-K (a) Exhibits Number Description ------ ----------- 27.1 Financial Data Schedule (b) Reports on Form 8-K None SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Date: November 5, 1999 ATS MEDICAL, INC. By: /s/ John H. Jungbauer ------------------------------------- John H. Jungbauer, Vice President/CFO (Principal Financial Officer and Authorized Signatory) EXHIBIT INDEX Number Description ------ ----------- 27.1 Financial Data Schedule