SECURITIES AND EXCHANGE COMMISSION Washington, DC Form 10-Q (Mark One) X Quarterly Report Pursuant to Section 13 or 15(d) of the Securities ------- Exchange Act of 1934 For the quarterly period ended September 30, 2000 ------------------ 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: 0-28748 --------- CLOSURE MEDICAL CORPORATION ------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 56-1959623 - ----------------------- ------------------- (State or other (I.R.S. Employer jurisdiction Identification No.) of incorporation or organization) 5250 Greens Dairy Road, Raleigh, North Carolina 27616 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) (919) 876-7800 ----------------------- (Registrant's telephone number, including area code) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. X Yes _______ No _______ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Class Outstanding at November 7, 2000 ----- ------------------------------- Common Stock, par value $0.01 per share 13,413,491 CLOSURE MEDICAL CORPORATION INDEX Page Number ----------- PART I: FINANCIAL INFORMATION Item 1. Financial Statements Balance Sheets as of September 30, 2000 (unaudited) and December 31, 1999............................... 3 Statements of Operations (unaudited) for the three months ended September 30, 2000 and 1999 and for the nine months ended September 30, 2000 and 1999....... 4 Statements of Cash Flows (unaudited) for the nine months ended September 30, 2000 and 1999............ 5 Notes to Condensed Financial Statements (unaudited).. 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.................................. 8 Item 3. Quantitative and Qualitative Disclosure about Market Risk........................... 12 PART II: OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K............ 13 2 PART I - FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS CLOSURE MEDICAL CORPORATION BALANCE SHEETS (IN THOUSANDS, EXCEPT PER SHARE DATA) SEPTEMBER 30, DECEMBER 31, 2000 1999 ---- ---- (UNAUDITED) ASSETS Cash and cash equivalents $ 180 $ 508 Short-term investments 7,919 9,299 Restricted investments 1,588 1,515 Accounts receivable, net 1,381 732 Inventories 730 591 Prepaid expenses 131 326 -------------- ------------ Total current assets 11,929 12,971 Restricted investments 1,294 1,292 Furniture, fixtures and equipment, net 6,983 7,351 Intangible assets, net 1,234 897 -------------- ------------ Total assets $ 21,440 $ 22,511 ============== ============ LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable $ 1,281 $ 1,110 Accrued expenses 1,366 794 Deferred revenue 227 443 Capital lease obligations 311 279 Current portion of long-term debt 600 600 -------------- ------------ Total current liabilities 3,785 3,226 Deferred revenue 505 505 Capital lease obligations less current portion 417 655 Long-term debt less current portion 1,036 1,500 -------------- ------------ Total liabilities 5,743 5,886 -------------- ------------ Commitments and Contingencies - - Preferred Stock, $.01 par value. Authorized 2,000 shares; none issued or outstanding - - Common Stock, $.01 par value. Authorized 35,000 shares; issued and outstanding 13,411 and 13,347 shares, respectively 134 133 Additional paid-in capital 47,443 46,940 Accumulated deficit (31,880) (30,375) Deferred compensation on stock options - (73) -------------- ------------ Total stockholders' equity 15,697 16,625 -------------- ------------ Total liabilities and stockholders' equity $ 21,440 $ 22,511 ============== ============ The accompanying notes are an integral part of these condensed financial statements. 3 CLOSURE MEDICAL CORPORATION STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, SEPTEMBER 30, SEPTEMBER 30, 2000 1999 2000 1999 ---- ---- ---- ---- Product sales $ 3,565 $ 2,732 $ 9,302 $10,826 Cost of products sold 950 1,093 2,746 3,789 ------- ------- ------- ------- Gross profit 2,615 1,639 6,556 7,037 ------- ------- ------- ------- Research, development and regulatory affairs expenses 1,439 1,633 4,505 5,083 General and administrative expenses 1,544 1,341 3,925 4,099 ------- ------- ------- ------- Total operating expenses 2,983 2,974 8,430 9,182 ------- ------- ------- ------- Income (loss) from operations (368) (1,335) (1,874) (2,145) Interest expense (59) (84) (180) (270) Investment and interest income 184 215 549 661 ------- ------- ------- ------- Net income (loss) $ (243) $(1,204) $(1,505) $(1,754) ======= ======= ======= ======= Shares used in computation of net income (loss) per common share: Basic 13,407 13,333 13,380 13,317 ======= ======= ======= ======= Diluted 13,407 13,333 13,380 13,317 ======= ======= ======= ======= Net income (loss) per common share: Basic $ (0.02) $ (0.09) $ (0.11) $ (0.13) ======= ======= ======= ======= Diluted $ (0.02) $ (0.09) $ (0.11) $ (0.13) ======= ======= ======= ======= The accompanying notes are an integral part of these condensed financial statements. 4 CLOSURE MEDICAL CORPORATION STATEMENTS OF CASH FLOWS (UNAUDITED) (IN THOUSANDS) NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, 2000 1999 ---- ---- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (1,505) $ (1,754) Adjustments to reconcile net loss to net cash used by operating activities: Depreciation and amortization expense 696 705 Amortization of deferred compensation on stock options 73 228 Net loss on disposals of fixed assets 12 303 Change in accounts receivable (649) 48 Change in inventories (139) 475 Change in prepaid expenses 195 (144) Change in accounts payable and accrued expenses 743 (965) Change in deferred revenue (216) (625) --------- --------- Net cash provided (used) by operating activities (790) (1,729) --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of furniture, fixtures and equipment (329) (1,042) Investment in intangible assets (348) (258) Purchases of investments (4,377) (4,495) Proceeds from the sale of investments 5,682 7,700 --------- --------- Net cash provided (used) by investing activities 628 1,905 --------- --------- CASH FLOWS FROM FINANCING ACTIVITIES: Repayment of debt (464) (400) Net proceeds from exercise of stock options 504 538 Payments under capital lease obligations (206) (181) --------- --------- Net cash provided (used) by financing activities (166) (43) --------- --------- Increase (decrease) in cash and cash equivalents (328) 133 Cash and cash equivalents at beginning of period 508 824 --------- --------- Cash and cash equivalents at end of period $ 180 $ 957 ========= ========= The accompanying notes are an integral part of these condensed financial statements. 5 CLOSURE MEDICAL CORPORATION CONDENSED NOTES TO FINANCIAL STATEMENTS (Unaudited) 1. Organization and Operations Closure Medical Corporation ("Closure" or the "Company") develops, manufactures and commercializes medical tissue adhesive products based on its proprietary cyanoacrylate technology for use in wound closure in humans and animals. On September 30, 1996, the Company sold 2,550,000 shares of Common Stock in its initial public offering ("IPO"). On April 2, 1997, the Company completed a follow-on public offering selling 1,025,000 shares of Common Stock. The net proceeds from the IPO and follow-on public offering of approximately $17.9 million and $12.0 million, respectively, have been and will continue to be used primarily for capital expenditures related to office space and manufacturing facilities, laboratories, research and development, including clinical trials, working capital and general corporate purposes. 2. Significant Accounting Policies The significant accounting policies followed by the Company for interim financial reporting are consistent with the accounting policies followed for annual financial reporting. These unaudited financial statements have been prepared in accordance with Rule 10-01 of Regulation S-X, and in management's opinion, all adjustments of a normal recurring nature necessary for a fair presentation have been included. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements and should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 1999 included in the Company's Annual Report on Form 10-K for the year ended December 31, 1999. The results of operations for the three and nine month periods ended September 30, 2000 are not necessarily indicative of the results to be expected for the full year ending December 31, 2000. Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133"), was issued in June 1998. SFAS 133, as amended by SFAS 137, is effective for financial statements for fiscal years beginning after June 15, 2000. The Company will adopt SFAS 133 on or before the effective date. It is not anticipated that this standard will have a material impact on the results of operations or financial position of the Company. In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements,"("SAB 101"), which provides guidance on the recognition, presentation, and disclosures of revenue in financial statements filed with the SEC. SAB 101, as amended by SAB 101A and SAB 101B, outlines the basic criteria that must be met to recognize revenue and provides guidance for disclosures related to revenue recognition policies. SAB 101B delays the implementation date of SAB 101 until no later than the fourth fiscal quarter of fiscal years beginning after December 15, 1999. Upon adoption of SAB 101 in the fourth quarter of fiscal 2000, the Company estimates that it will record a cumulative adjustment of approximately $2,656,000 related to license and product development revenues received under the 1996 supply and distribution agreement with Ethicon Inc., a subsidiary of Johnson & Johnson. SAB 101 requires that these revenues be recorded as deferred revenue and recognized over the Company's remaining commitment period through the first quarter of 2004. 3. Taxes No federal or state income tax provision has been provided for income tax purposes, as the Company does not expect to have a tax liability for the year ending December 31, 2000. Additionally, the deferred tax asset that might be recorded as a result of net operating losses under Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes," has been offset by a related valuation allowance because realization of the asset is not likely. Accordingly, no benefit has been recorded. 6 CLOSURE MEDICAL CORPORATION CONDENSED NOTES TO FINANCIAL STATEMENTS (Unaudited) 4. Inventories Inventories consisted of the following (in thousands): September 30, December 31, 2000 1999 ---- ---- Packaging $ 181 $148 Raw materials 69 45 Work-in-process 354 283 Finished goods 126 115 ----- ---- $ 730 $591 ===== ==== 5. Net Income (Loss) Per Share Basic net income (loss) per common share is computed using the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per common share is computed using the weighted average number of shares of common and common equivalent shares outstanding during the period. Common equivalent shares consist of stock options using the treasury stock method and are excluded from the computation if their effect is antidilutive. 7 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION ACT OF 1995 The following discussion should be read in conjunction with the unaudited financial statements and notes thereto included in Part I--Item 1 of this Form 10-Q and the audited financial statements and notes thereto and Management's Discussion and Analysis of Financial Condition and Results of Operations for the year ended December 31, 1999 contained in the Company's Annual Report on Form 10-K for the year ended December 31, 1999. This report and the documents incorporated by reference herein contain "forward- looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this report and the documents incorporated herein by reference, the words "anticipate," "believe," "estimate," and similar expressions are generally intended to identify forward-looking statements. These forward-looking statements include, among others, the statements in Management's Discussion and Analysis about the following: . the Company's expectations with respect to increases in operating expenses; . expectations with respect to increases in research and development and general and administrative expenses in order to develop new products, manufacture commercial quantities of products and fund additional clinical trials; . expectations with respect to the development, manufacturing and approval of new products; . expectations with respect to incurring additional capital expenditures to expand its manufacturing capabilities; . expectations with respect to generating revenue or becoming profitable on a sustained basis; . the Company's ability to enter into additional marketing agreements and the ability of its existing marketing partners to successfully commercialize products incorporating the Company's technologies; . the sufficiency of the Company's existing cash and cash equivalents and investments to finance its capital requirements for 12 months; . expected losses in 2000 and subsequent years; and . expectations with respect to future capital requirements. There are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements including, but not limited to, the following: . a decline in the level of demand for the Company's products; . developments by competitors; . the Company's inability to obtain regulatory clearances; . general economic conditions and specifically, conditions in the health care industry; . the Company's ability to protect its proprietary products, know-how and manufacturing processes; 8 . the Company's inability to obtain adequate supply of raw materials; . the failure to enter into definitive marketing agreements; . unanticipated cash requirements to support current operations or research and development; and . the Company's ability to attract and retain key personnel. These and other risks and uncertainties affecting the Company are discussed in greater detail in this report and in other filings by the Company with the Securities and Exchange Commission. OVERVIEW Since its inception in May 1990, the Company has been developing, manufacturing and commercializing medical tissue adhesive products for use in wound closure in humans and animals. The Company's products are based on its proprietary cyanoacrylate technology, and a substantial portion of the Company's historical expenses have consisted of research and development and clinical trial expenses. Through September 25, 1996, the effective date of the Company's initial public offering, the Company had funded its operations with cash borrowed from Sharpoint Development Corporation ("Sharpoint"), sales of Octyldent(R) and Nexaband(R) products, and license and product development revenues from marketing partners. On September 30, 1996, the Company completed its initial public offering, issuing 2,550,000 shares of Common Stock and generating net proceeds of approximately $17.9 million. On April 2, 1997, the Company completed a follow-on public offering, issuing 1,025,000 shares of Common Stock and generating net proceeds of approximately $12.0 million. The Company has also funded its operations through sales of DERMABOND(R) Topical Skin Adhesive ("DERMABOND(R) adhesive") after the product received its CE Mark and U.S. Food and Drug Administration ("FDA") approval in August 1997 and August 1998, respectively. The Company has been unprofitable since its inception and has incurred net losses in each year, including a net loss of approximately $2.5 million for the year ended December 31, 1999. The Company anticipates that its recurring operating expenses will increase for the next several years, as it expects its research and development and general and administrative expenses to increase in order to develop new products, manufacture commercial quantities of products and fund additional clinical trials. The Company also expects to incur additional capital expenditures to expand its manufacturing capabilities. The Company expects to incur a loss in 2000 and may incur losses in subsequent years, although the amount of future net losses and time required by the Company to reach profitability are highly uncertain. The Company's ability to generate significant revenue and become profitable will depend on its success in commercializing DERMABOND(R) adhesive, expanding its manufacturing capabilities, developing new products, entering into additional marketing agreements and on the ability of its marketing partners to successfully commercialize products incorporating the Company's technologies. The Company may never generate significant revenue or become profitable on a sustained basis, if at all. On August 28, 1998, the Company was granted approval from the FDA of its premarket approval application to market DERMABOND(R) adhesive in the United States. DERMABOND(R) adhesive, which is used to replace sutures, staples and adhesive strips for closing certain topical incisions and lacerations, is the first such product to be approved by the FDA for the U.S. market. In March 1996, Closure licensed exclusive worldwide marketing and distribution rights for DERMABOND(R) adhesive to Ethicon, Inc. ("Ethicon"), a subsidiary of Johnson & Johnson. In August 1997, Closure received CE Mark approval allowing the Company to ship DERMABOND(R) adhesive to Ethicon to support its launch in European Union countries. DERMABOND(R) adhesive is currently marketed by Ethicon in the U.S. and approximately 35 countries outside the U.S., including Japan. 9 On July 27, 1999, the Company was awarded its first United States Patent relevant to DERMABOND(R) adhesive. The invention covered in this patent capitalizes on the ability of the Company's adhesive technology to be manipulated in a manner that enhances product performance by controlling the setting time and extending the shelf-life of the material. The award of the patent increases royalty revenue on sales of DERMABOND(R) adhesive in the United States under the supply and distribution agreement with Ethicon. On September 2, 1999, the Company received clearance from the FDA to market SOOTHE-N-SEAL(TM) canker sore relief in the United States. SOOTHE-N-SEAL(TM) adhesive, which is used to provide relief of pain associated with oral ulcers, is the first such product to be approved by the FDA for the over-the-counter United States consumer market. The Company is currently in discussions for a marketing distribution agreement for SOOTHE-N-SEAL(TM) adhesive. The Company has developed LIQUIDERM(TM) liquid adhesive bandage for the treatment of minor cuts and abrasions. The results of the preclinical studies, performed in July and August 1999, for the liquid adhesive bandage indicated that the product compared favorably to air-dried wounds and wounds covered with commercial adhesive bandages. As a result of this preclinical study, the Company conducted a definitive multi-center, 162-patient study which was completed in June 2000. In the multi-center study, LIQUIDERM(TM) liquid adhesive bandage was found to: (i) stay on wounds better and longer than traditional adhesive bandages, (ii) seal wounds from dirt and germs, (iii) minimize pain better than adhesive bandages, (iv) stop bleeding of minor cuts and abrasions, and (v) require only one application per treatment. The Company will seek marketing clearance for LIQUIDERM(TM) adhesive through submission of a 510(k) premarket notification which was filed August 1, 2000 with the FDA. The Company is currently in discussions for a marketing distribution agreement for LIQUIDERM(TM) adhesive. RESULTS OF OPERATIONS Product sales were $3.6 million for the three months ended September 30, 2000, compared to $2.7 million for the three months ended September 30, 1999. The increase in third quarter revenues was primarily a result of increased sales of DERMABOND(R) adhesive. For the nine months ended September 30, 2000, product sales were $9.3 million compared to $10.8 million for the same period of 1999. The decrease in revenues from the 1999 period reflects pipeline fill for an operating room launch during the first half of 1999 of DERMABOND(R) adhesive by Ethicon. Cost of products sold was $950,000 for the three months ended September 30, 2000 compared to $1.1 million for the same period of 1999. Cost of products sold as a percentage of product sales decreased to 27% for the three months ended September 30, 2000 compared to 40% during the same period of 1999. This decrease is primarily related to a reduction in manufacturing expenses, increased product yields and increased plant utilization. For the nine months ended September 30, 2000, cost of products sold was $2.7 million compared to $3.8 million for the same period of 1999. Cost of products sold as a percentage of product sales decreased to 30% in the nine months ended September 30, 2000, compared to 35% during the same period of 1999. Although DERMABOND(R) adhesive unit sales decreased during the nine month period ended September 30, 2000, compared to the same period in 1999, an increased gross margin percentage for the 2000 period was achieved primarily as a result of significant reductions in manufacturing expenses and an increase in product yields. Operating expenses were $3.0 million for the three months ended September 30, 2000 and September 30, 1999. Although operating expenses remained constant from quarter to quarter, research, development and regulatory affairs expenses decreased by $194,000 whereas general and administrative expenses increased by $203,000. The decrease in research, development and regulatory affairs was primarily attributable to less clinical trial expenses and outside professional services during the 1999 period as opposed to an increase in general and administrative expenses which was due to non-recurring professional services during the 2000 period. For the nine months ended September 30, 2000 and September 30, 1999, operating expenses were $8.4 million and $9.2 million, respectively. The decrease was primarily attributable to a decline in outside professional services for research and development and the reduction of personnel. 10 Although the Company experienced decreased expenses related to research and development, it expects these expenses will increase in the future as the Company expands its pipeline and related development efforts and clinical trials for potential new products. Interest expense was $59,000 for the three months ended September 30, 2000, compared to $84,000 for the three months ended September 30, 1999. For the nine months ended September 30, 2000 and September 30, 1999, interest expense was $180,000 and $270,000, respectively. This decrease was primarily the result of the continued reduction of the Company's term loan balance and capital lease obligations through monthly principal payments. Investment and interest income was $184,000 for the three months ended September 30, 2000, compared to $215,000 for the same period of 1999. For the nine months ended September 30, 2000 and September 30, 1999, investment and interest income was $549,000 and $661,000, respectively. This decrease was primarily attributed to interest earned from lower average cash and investment balances. LIQUIDITY AND CAPITAL RESOURCES The Company has financed its operations to date primarily through the sale of equity securities, borrowings from Sharpoint and other lenders, license and product development revenues and product sales. Through September 30, 2000, the Company has raised approximately $30.0 million from equity financings. During 1997 and 1998, the Company entered into and received approximately $4.5 million from a new lease line and term loan. In May 1999, the term loan principal balance of $2.5 million was refinanced under similar terms of the original agreement for an additional 24 months. In May 2000, the Company renewed for a period of one year its $3.0 million line of credit for working capital purposes. As of September 30, 2000, there were no borrowings against the line of credit. At September 30, 2000, net working capital was approximately $8.1 million versus net working capital of $9.7 million available at December 31, 1999. This decrease was primarily attributable to cash and cash equivalents used to fund the Company's operations as well as cash used for the repayments of its term loan and capital lease obligations. At September 30, 2000, the Company's cash and cash equivalents and investments were $11.0 million compared to $12.6 million at December 31, 1999. The Company had $2.4 million in debt and capital lease obligations at September 30, 2000, reflecting a $670,000 decrease over the December 31, 1999 debt and capital lease obligations. These decreases represent monthly principal payments on these obligations. Net cash provided by investing activities was $628,000 for the nine months ended September 30, 2000 compared to $1.9 million for the same period in 1999. During the nine months ended September 30, 2000 and September 30, 1999, cash was provided by the sale of investments offset by purchases of investments and other long-term assets. Net cash used by financing activities was $166,000 and $43,000 for the nine months ended September 30, 2000 and September 30, 1999, respectively. The Company's primary financing activities during the nine months ended September 30, 2000 and September 30, 1999 were the repayments of its term loan and capital lease obligations offset by employee stock option exercises. The Company believes that existing cash and cash equivalents and investments, which totaled approximately $11.0 million at September 30, 2000, will be sufficient to finance its capital requirements for 12 months. In May 2000, the Company renewed for a period of one year its $3.0 million line of credit for working capital purposes. The Company expects to incur a loss in 2000 and may incur losses in subsequent years, although the amount of future net losses and time required by the Company to reach profitability are highly uncertain. The Company anticipates that its recurring operating expenses will increase for the next several years, as it expects its research and development and general and administrative expenses to increase in order to develop new products, manufacture commercial quantities of products and fund additional clinical trials. The Company also expects to incur additional capital expenditures to expand its manufacturing capabilities. 11 The Company's future capital requirements, however, will depend on numerous factors, including (i) the Company's ability to manufacture and successfully commercialize its lead product, DERMABOND(R) adhesive, (ii) the progress of its research and product development programs for future nonabsorbable and absorbable products, including clinical studies, (iii) the effectiveness of product commercialization activities and marketing agreements for the Company's future products, including additional scale-up of manufacturing capability in anticipation of product commercialization and development and progress of sales and marketing efforts, (iv) the ability of the Company to maintain existing marketing agreements, including its agreement with Ethicon for DERMABOND(R) adhesive, and establish and maintain new marketing agreements, (v) the costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights and complying with regulatory requirements, (vi) the effect of competing technological and market developments, (vii) timely receipt of regulatory clearances and approvals and (viii) general economic conditions. The Company may be required to seek additional capital to finance its operations in the future. If the Company's currently available funds and internally generated cash flow are not sufficient to satisfy its financing needs, the Company will be required to seek additional funding through bank borrowings and additional public or private sales of its securities, including equity securities, or through other arrangements with marketing partners. Other than the Company's equipment financing line of credit, term loan, and working capital line of credit, the Company has no credit facility or other committed sources of capital. There can be no assurance that additional funds, if required, will be available to the Company on favorable terms, if at all. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK INTEREST RATE SENSITIVITY The Company is subject to interest rate risk on its investment portfolio which consists primarily of high quality short-term money market funds, commercial paper and corporate bonds with an average maturity of less than one year. The Company mitigates default risk by investing in what it believes are safe and high credit quality securities and by monitoring the credit rating of investment issuers. The portfolio includes only marketable securities with active secondary or resale markets to ensure portfolio liquidity and there are limitations regarding average and individual duration of investments. These available-for- sale securities are subject to interest rate risk and will decrease in value if market interest rates increase. At September 30, 2000, the Company's total portfolio consisted of approximately $11.0 million of investments, the majority of which had average maturities within one year. Additionally, the Company generally has the ability to hold fixed income investments to maturity. Therefore, the Company does not expect its results of operations or cash flows to be materially affected due to a sudden change in interest rates. FOREIGN CURRENCY EXCHANGE RISK The Company's international sales and related royalties of DERMABOND(R) adhesive are based on sales in foreign currencies, but payable in U.S. dollars, and thus may be adversely affected by fluctuations in currency exchange rates. Additionally, fluctuations in currency exchange rates may adversely affect demand for the Company's products by increasing the price of the Company's products in the currency of the countries in which the products are sold. 12 PART II-OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K. (a) Exhibits. 27 Financial Data Schedule. (b) Reports on Form 8-K. None. 13 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. CLOSURE MEDICAL CORPORATION Date: November 14, 2000 By: /s/ ROBERT V. TONI ----------------------------------- Robert V. Toni President and Chief Executive Officer Date: November 14, 2000 By: /s/ BENNY WARD ----------------------------- Benny Ward Vice President and Chief Financial Officer EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION - ------ ----------- 27 Financial Data Schedule.