UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q |X| Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the quarterly period ended September 30, 1999. |_| Transition period pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____________ to ______________. 0-20727 ------- (Commission File Number) Novoste Corporation ------------------- (Exact Name of Registrant as Specified in Its Charter) Florida 59-2787476 ------- ---------- (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 3890 Steve Reynolds Blvd., Norcross, GA 30093 --------------------------------------- ----- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone, including area code: (770) 717-0904 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 requirements for the past 90 days. (Item 1) Yes |X| No |_| (Item 2) Yes |X| No |_| As of October 22, 1999 there were 14,169,851 shares of the Registrant's Common Stock outstanding. Exhibit Index on page: 25 NOVOSTE CORPORATION FORM 10-Q INDEX PART I. FINANCIAL INFORMATION PAGE NO. -------- Item 1. Consolidated Financial Statements Consolidated Balance Sheets as of September 30, 1999 (unaudited) and December 31, 1998 3 Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 1999 and 1998 4 Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 1999 and 1998 5 Notes to Unaudited Consolidated Financial Statements 6-7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 8-21 Item 3. Quantitative and Qualitative Disclosures About Market Risk 22 PART II. OTHER INFORMATION Item 5. Other Information 23 Item 6. Exhibits and Reports on Form 8-K 23 SIGNATURES 24 EXHIBIT INDEX 25 2 NOVOSTE CORPORATION CONSOLIDATED BALANCE SHEETS September 30, December 31, 1999 1998 ------------- ------------ (unaudited) Assets Current assets: Cash and cash equivalents $ 8,179,574 $ 2,352,517 Short-term investments 40,429,175 23,695,451 Accounts receivable 1,039,223 8,775 Inventory 2,349,514 537,351 Prepaid expenses 410,698 168,142 ------------- ------------ Total current assets 52,408,184 26,762,236 ------------- ------------ Property and equipment, net 3,197,354 2,327,467 License agreements, net 115,893 126,121 Other assets 254,192 266,408 ------------- ------------ $ 55,975,623 $ 29,482,232 ============= ============ Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 1,806,709 $ 1,059,591 Accrued expenses and taxes withheld 4,284,450 3,905,548 ------------- ------------ Total current liabilities 6,091,159 4,965,139 ------------- ------------ Shareholders' equity: Preferred stock, $.01 par value, 5,000,000 shares authorized; no shares issued and outstanding -- -- Common stock, $.01 par value, 25,000,000 shares authorized; 14,175,255 and 10,704,817 shares issued, respectively 141,753 107,048 Additional paid-in capital 127,908,972 77,022,814 Accumulated deficit (75,847,546) (52,281,002) ------------- ------------ 52,203,179 24,848,860 Less treasury stock, 5,780 shares of common stock at cost (23,840) (23,840) Unearned compensation (2,294,875) (307,927) ------------- ------------ Total shareholders' equity 49,884,464 24,517,093 ------------- ------------ $ 55,975,623 $ 29,482,232 ============= ============ See accompanying notes. 3 NOVOSTE CORPORATION UNAUDITED CONDENSED STATEMENTS OF OPERATIONS Three months ended Nine months ended September 30, September 30, 1999 1998 1999 1998 ------------------------------- ------------------------------- Net revenue $ 566,872 $ -- $ 1,204,699 $ -- Cost of sales 539,777 -- 1,216,943 -- ------------ ------------ ------------ ------------ Gross Margin 27,095 -- (12,244) -- ------------ ------------ ------------ ------------ Operating Expenses Research and development 6,115,556 5,685,268 17,950,943 13,597,906 Sales and marketing 1,678,437 832,230 4,519,703 1,703,656 General and administrative 917,379 799,805 2,731,284 1,852,670 ------------ ------------ ------------ ------------ Total operating expenses 8,711,372 7,317,303 25,201,930 17,154,232 ------------ ------------ ------------ ------------ Loss from operations (8,684,277) (7,317,303) (25,214,174) (17,154,232) ------------ ------------ ------------ ------------ Interest income 618,007 511,560 1,647,630 1,724,647 ------------ ------------ ------------ ------------ Net loss $ (8,066,270) $ (6,805,743) $(23,566,544) $(15,429,585) ============ ============ ============ ============ Net loss per share $ (0.57) $ (0.64) $ (1.79) $ (1.47) ============ ============ ============ ============ Weighted average shares outstanding 14,134,862 10,601,916 13,170,928 10,483,965 ============ ============ ============ ============ See accompanying notes. 4 NOVOSTE CORPORATION UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS For the nine months ended September 30, 1999 1998 ------------ ------------ Cash flows from operating activities Net loss $(23,566,544) $(15,429,585) Adjustments to reconcile net loss to net cash used by operating activities: Depreciation and amortization 691,546 392,536 Issuance of stock for services or compensation 348,723 741,740 Amortization of deferred compensation 566,177 -- Changes in assets and liabilities: Accounts receivable (1,030,448) -- Inventory (1,812,163) (236,430) Prepaid expenses (242,555) (117,526) Accounts payable 747,118 680,528 Accrued expenses and taxes withheld 378,902 766,600 Other 12,215 (195,602) ------------ ------------ Net cash used by operations (23,907,029) (13,397,739) ------------ ------------ Cash flows from investing activities Maturity (purchase) of short-term investments (16,733,724) 1,581,704 Purchase of property and equipment, net (1,551,206) (1,645,075) ------------ ------------ Net cash (used) provided by investing activities (18,284,930) (63,371) ------------ ------------ Cash flows from financing activities Proceeds from issuance of common stock 48,019,016 934,469 ------------ ------------ Net cash provided by financing activities 48,019,016 934,469 ------------ ------------ Net increase in cash and cash equivalents 5,827,057 (12,526,641) Cash and cash equivalents at beginning of period 2,352,517 35,993,933 ------------ ------------ Cash and cash equivalents at end of period $ 8,179,574 $ 23,467,292 ============ ============ See accompanying notes. 5 NOVOSTE CORPORATION NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS September 30, 1999 Note 1. Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and in accordance with instructions to Article 10 of Regulation S-X. Accordingly, such consolidated financial statements do not include all of the information and disclosures 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. The operating results of the interim periods presented are not necessarily indicative of the results to be achieved for the year ending December 31, 1999. The accompanying consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 1998 included in the Company's 1998 Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC"). The consolidated financial statements include the accounts of Novoste Corporation and its wholly-owned subsidiaries incorporated in August 1998 in The Netherlands, in December 1998 in Belgium and February 1999 in Germany. Significant intercompany transactions and accounts have been eliminated. Note 2. Inventories Inventories are stated at the lower of cost or market. Inventories are comprised of the following at September 30, 1999: September 30, 1999 December 31, 1998 ------------------ ----------------- Finished Goods $ 1,804,089 $ 382,424 Work in Process 42,968 -- Raw Materials 502,457 154,927 ------------------ ----------------- Total $ 2,349,514 $ 537,351 ================== ================= Note 3. Net Loss Per Share The basic and diluted loss per share is computed based on the weighted average number of common shares outstanding. Common equivalent shares are not included in the per share calculations where the effect of their inclusion would be antidilutive. Note 4. Cash Equivalents and Investments Cash equivalents are comprised of certain highly liquid investments with maturities of less than three months at the time of their acquisition. In addition to cash equivalents, we have investments in commercial paper that are classified as short-term (mature in more than 90 days but less than one year). Management determines the appropriate classification of debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Debt securities are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Investments held-to-maturity are carried at amortized cost, adjusted for the amortization or accretion of premiums or discounts without recognition of gains or losses that are deemed to be temporary. Premiums and discounts are amortized or accreted over the life of the related instrument as an adjustment to yield 6 using the straight-line method, which approximates the effective interest method. Interest income is recognized when earned. Marketable equity securities and debt securities not classified as held-to-maturity are classified as available-for-sale. Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in a separate component of shareholders' equity, if significant. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in investment income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in investment income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in investment income. At September 30, 1999 fair value approximated net book value for all short-term investments. Note 5. Revenue Recognition Revenues from sales of products are recognized at the time of shipment with allowances provided for estimated returns, warranty costs and doubtful accounts. Note 6. Consulting Agreements On May 13, 1999 the Company granted stock options to the members of its Clinical Advisory Board. These options were priced at the fair market value on the date of grant and the related consulting expense will be recognized over the one-year vesting period. Note 7. Follow-on Equity Offering On March 19, 1999 the Company completed a follow-on equity offering (the "Offering") of 2,400,000 newly issued shares of its common stock at a public offering price of $20 per share. On March 24, 1999 the Company issued an additional 160,000 shares of common stock pursuant to the exercise of the underwriters' over-allotment option. Net proceeds to the Company after the exercise of the underwriters' over-allotment option and all related expenses approximated $47.5 million. 7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Forward Looking Information The statements contained in this Form 10-Q that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events and financial performance, but are subject to many uncertainties and risks which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward-looking statements. Some of these risks are discussed below in the section "Certain Factors That May Impact Future Operations." Additional risk factors are discussed in our prospectus dated March 15, 1999 under the caption "Risk Factors" beginning on page 9 and other reports filed by the Company from time to time on Forms 10-K, 10-Q and 8-K. The Company does not undertake any obligation to update or revise any forward-looking statement, made by it or on its behalf, whether as a result of new information, future events, or otherwise. Overview Novoste commenced operations as a medical device company in May 1992. Since 1994, we have devoted substantially all of our efforts to developing the Beta-CathTM System, an intraluminal beta radiation catheter delivery system designed to reduce the frequency of restenosis subsequent to percutaneous transluminal coronary angioplasty ("PTCA") as well as other interventional procedures. For the period since our capitalization through December 31, 1998 we earned minimal non-recurring revenues and experienced significant losses in each period. The Company commenced the active marketing of the Beta-CathTM System in Europe in January 1999. At September 30, 1999 we had an accumulated deficit of approximately $75.8 million. We expect to continue to incur significant operating losses through at least 2000 as we conduct clinical trials, seek regulatory approval or clearance for our products, continue research and development projects, expand our sales and marketing efforts in contemplation of product introduction and market development, and increase our administrative activities to support our growth. The clinical trials may not demonstrate the safety and efficacy of the Beta-Cath System. Additionally, we may not obtain necessary approvals for the Beta-Cath System from the FDA, the State of Georgia Department of Natural Resources or other state or foreign governmental agencies. Our research and development efforts may not be successfully completed. We may not successfully introduce the Beta-Cath System or attract any significant level of market acceptance for the Beta-Cath System or any other product we develop. We may never achieve significant revenues from sales of our Beta-Cath System and we may never achieve or sustain profitability. Clinical Trials We are currently conducting two pivotal clinical trials, the Beta-Cath System Trial and the START Trial as well as several other trials. The pivotal trials are intended to support a pre-market approval application to the FDA to market our device in the United States to reduce the incidence of coronary restenosis following PTCA, stent placement and the treatment of "in-stent" restenosis. The Beta-Cath System Trial. On July 30, 1997 we initiated our Beta-Cath System Trial, a randomized, triple-masked, placebo-controlled, multicenter human clinical trial under an investigational device 8 exemption granted by the FDA. The Beta-Cath System Trial seeks to determine the clinical safety and effectiveness of the Beta-Cath System in reducing coronary restenosis following PTCA or stent placement. We initially targeted enrollment for approximately 1,100 patients in the trial at up to 55 clinical sites located in the United States. The protocol contemplated that patients would be divided into two approximately equal subgroups, one receiving PTCA alone and one receiving coronary stents in addition to PTCA. Patients in each subgroup of the trial received, determined on a random basis, either vascular brachytherapy through the Beta-Cath System using a 30mm radiation source train or no vascular brachytherapy through a placebo version of the Beta-Cath System. In both subgroups, patients who received the beta radiation received dosages of 14 gray for vessels ranging from 2.70 to 3.35mm and 18 gray for vessels ranging from 3.36 to 4.00mm. The protocol provides for telephone follow-up with patients 30 days after treatment for PTCA patients and monthly for newly stented patients up to the eighth month, and a follow-up angiogram eight months after the initial treatment regardless of the treatment. The primary endpoint of the trial is target vessel revascularization ("TVR"), the incidence of an additional revascularization procedure in the vessel originally treated within eight months. Other endpoints of the trial include angiographic restenosis, late loss index, and the incidence of major adverse cardiac events. As is typical for patients undergoing stent placement, the patients in the stent placement subgroup of the Beta-Cath System Trial received anti-platelet therapy to prevent stent thrombosis, a condition which can lead to acute closure of the treated artery. Stent thrombosis typically occurs within 30 days of treatment in a small percentage of patients receiving stent placement. There were incidences of stent thrombosis reported in the Beta-Cath System Trial. These patients developed the condition later following their treatment than is normally observed. As a result, in November 1998 we modified the Trial protocol for the stent placement subgroup to extend the anti-platelet therapy from two weeks to 60 days following stent placement and to provide for additional follow-up contact with these patients in the second, third and fourth months after treatment. On April 27, 1999 we announced approval of our intention to increase patient enrollment in the stent placement subgroup of the Trial and to extend the anti-platelet therapy to a minimum of 90 days following stent placement. These changes were made based upon a recommendation made by the Data Safety and Monitoring Board (DSMB) at its March 1999 meeting. The DSMB is an independent committee of clinicians and statisticians that has responsibility for review of the study protocol and clinical events at regular intervals during patient enrollment into the Trial. Based on its review of the available data set, including the incidence of major adverse cardiac events, the DSMB proposed these changes to ensure sufficient data to evaluate the safety and effectiveness of the Beta-Cath System with the revised anti-platelet therapy protocol. We completed enrollment in the PTCA subgroup in July 1999 and enrollment in the stent placement subgroup with the extended antiplatelet therapy in September 1999. Enrollment in the Trial was stopped on September 30, 1999 after having enrolled a total of 1,456 patients at 58 clinical sites, principally located in the United States. A follow-up angiogram eight months after the initial treatment will be performed to observe the treated artery. The angiogram will be analyzed to determine if there has been an incidence of restenosis and to measure late loss index. The START Trial. On September 21, 1998 we initiated the "STents And Radiation Therapy Trial" or START Trial, a randomized, triple-masked, placebo-controlled, multicenter human clinical trial, under an investigational device exemption granted by the FDA. The primary endpoint of this trial is target vessel revascularization within eight months of treatment. The START Trial seeks to determine the safety and effectiveness of the Beta-Cath System in treating "in-stent" restenosis. We divided patients into two approximately equal subgroups, one receiving vascular brachytherapy through the Beta-Cath System using a 30mm radiation source train and the other receiving no vascular brachytherapy through a placebo version of the Beta-Cath System. Patients who received the beta radiation received dosages of 16 gray for vessels ranging from 2.70 to 3.35mm and 20 gray for vessels ranging from 3.36 to 4.00mm, slightly higher doses than those used in our Beta-Cath System Trial because of radiation shielding from stents 9 previously implanted in a procedure unrelated to this trial. Although the START Trial protocol does not contemplate the placement of new stents, we believe that approximately 20% of the enrolled patients received new stents. We surpassed our targeted enrollment of 386 patients, and enrollment in this trial was completed as of April 30, 1999. A total of 476 patients were enrolled at 51 sites, located principally in the United States. A follow-up angiogram eight months after the initial treatment will be performed to observe the treated artery. The angiogram will be analyzed to determine if there has been an incidence of restenosis and to measure late loss index. We do not anticipate FDA approval to market the Beta-Cath System in the United States for any indication any earlier than one year after the FDA accepts our application for filing. Assuming the START Trial yields positive results, we expect that our application seeking approval to market the Beta-Cath System in the United States to treat "in-stent" restenosis will be submitted to the FDA first and will be based upon the enrollment of 476 patients in that Trial. The START 40 Trial. In addition, on June 22, 1999 we initiated the START 40 Trial. This multicenter clinical trial has a targeted enrollment of 200 patients who will receive vascular brachytherapy using a 40 mm active radiation source train. The START 40 Trial has an identical clinical design to the START Trial and, therefore, we will use the START Trial's control group in analyzing the clinical data from the START 40 Trial. The purpose of this trial is to gain regulatory approval for the longer, 40mm radiation source train. Enrollment in this trial of the planned 200 patients was completed on October 22, 1999. BRIE Trial. We are currently conducting a 180 patient multicenter, non-randomized registry trial in Europe, known as the BRIE trial. This registry started in July 1998 and is intended to enhance market acceptance of the Beta-Cath System among physicians and to collect additional clinical data to support reimbursement approvals. As of October 22, 1999, 171 patients had been enrolled at nine sites. We reported interim clinical results on August 31, 1999 for the first 90 patients who returned for angiographic follow-up. These patients were all enrolled prior to the aforementioned extension of anti-platelet therapy to a minimum of 90 days. The independent core lab provided the following data: PTCA Stent Total Subgroup Subgroup Population ----------------------------------------------------------------------------- NUMBER OF LESIONS 36 62 98 Restenosis - Initial Obstructed Segment(1) 8% 16% 13% Late Loss Index 3% 17% 12% ----------------------------------------------------------------------------- (1) For purposes of the interim analysis, the core lab approximated the target lesion by analyzing the "initial obstructed segment" of the artery, a 5mm or 10mm segment containing the minimum lumen diameter (MLD). Restenosis was calculated using the MLD of this segment as compared to the interpolated reference vessel diameter at follow-up. The core lab also provided angiographic data on a broader vessel segment (beyond the target lesion) to determine if there were cases where the radiation source train did not adequately cover the arterial segment revascularized by balloon angioplasty or stent placement, a concept known as "geographic miss". Geographic miss often reduces the effectiveness of radiation because the target tissue is insufficiently dosed. This broader variable of Target Vessel Restenosis was measured with and without late coronary occlusion, an event observed in earlier vascular brachytherapy trials in a small percentage of stent patients, before the need for extended anti-platelet therapy (APT) was understood. None of the patients included in the interim BRIE data analysis received an extended APT regimen due to the timing of their 10 enrollment. The broader data set is as follows: PTCA Stent Total Subgroup Subgroup Population ----------------------------------------------------------------------------- Number of Lesions 36 62 98 Target Vessel Restenosis 19% 35% 30% Excluding Late Occlusions 17% 29% 24% ----------------------------------------------------------------------------- Results of Operations Net loss for the three months ended September 30, 1999 was $8,066,270, or ($.57) per share, as compared to $6,805,743 or ($.64) per share, for the three months ended September 30, 1998. Net loss for the nine months ended September 30, 1999 was $23,566,544 or ($1.79) per share as compared to $15,429,585 or ($1.47) per share for the year earlier period. The increase in net loss for the three and nine months ended September 30, 1999 compared to the year earlier period was primarily due to increased research and development spending related to the company's clinical trials and product development activities and increased sales and marketing spending related to the commercial launch of the Beta-Cath System in Europe. Net Sales. Net sales of $566,872 were recognized in the three months ended September 30, 1999. Net sales of $1,204,699 were recognized for the nine months ended September 30, 1999. No revenues were earned for the three and nine months ended September 30, 1998. The Company expects net sales to increase in the future as direct distribution is expanded in Europe, and if and when the Beta-Cath System is approved by the FDA and launched commercially in the U.S. Cost of Sales. Cost of sales of $539,777 were incurred in the three months ended September 30, 1999 and $1,216,943 for the nine months ended September 30, 1999. No cost of sales were incurred for the three and nine months ended September 30, 1998. The Company expects cost of sales to closely approximate sales for the year ended 1999 as the Company ramps up both its European production and sales activities. Research and Development Expenses. Research and development expenses increased 8% to $6,115,556 for the three months ended September 30, 1999 from $5,685,268 for the three months ended September 30, 1998. For the nine months ended September 30, 1999 research and development expenses increased 32% to $17,950,943 from $13,597,906 for the same period in 1998. These increases were primarily the result of patient enrollment and follow-up costs in the Company's clinical trials, the cost of supplying the Beta-Cath System to clinical sites, and costs related to the ongoing development of the Beta-Cath System. Sales and Marketing Expenses. Sales and marketing expenses increased 202% to $1,678,437 for the three months ended September 30, 1999 from $832,230 for the three months ended September 30, 1998. For the nine months ended September 30, 1999 sales and marketing expenses increased 265% to $4,519,703 from $1,703,656 for the same period in 1998. These increases were primarily the result of higher personnel, trade show, consulting and promotional literature costs associated with marketing the Company's product on a direct basis in Europe. The Company expects sales and marketing expenses to increase significantly in the future as direct distribution is expanded in Europe, and if and when the Beta-Cath System is approved by the FDA and launched commercially in the U.S. General and Administrative Expenses. General and administrative expenses increased 15% to $917,379 for the three months ended September 30, 1999 from $799,805 for the three months ended September 30, 1998. For the nine months ended September 30, 1999 general and administrative expenses increased 47% to $2,731,284 from $1,852,670 for the same period in 1998. This increase for the three and nine month periods was primarily the result of additional management personnel and higher salaries. The Company 11 expects general and administrative expenses to increase in the future in support of a higher level of operations. Interest Income. Net interest income increased 21% to $618,007 for the three months ended September 30, 1999 from $511,560 for the three months ended September 30, 1998. For the nine months ended September 30, 1999 interest income decreased 5% to $1,647,630 from $1,724,647. The increase in interest income for the quarter was primarily due to the increase in average cash equivalent and short-term investment balances arising from the follow-on public offering completed in March 1999. Liquidity and Capital Resources During the nine months ended September 30, 1999 and 1998 the Company used cash to fund operations of $23.9 million and $13.4 million, respectively. The increase in cash used in operations was due primarily to increased research and development activities and the expansion of sales and marketing activities in Europe. At September 30, 1999 the Company had commitments to purchase $3.2 million in inventory components of the Beta-Cath System over the next year. In addition, on October 14, 1999 the Company signed a development and manufacturing supply agreement with AEA Technologies QSA GmbH for a second source of radioisotope supply and for the development of a smaller diameter source. This agreement provides for the construction of a production line over the period October 1, 1999 to February 2001. The cost of this production line is estimated at $4,000,000 and will be paid by the Company as construction progresses. Because of the development, manufacturing scale-up and commercialization of the Beta-Cath System, Novoste's future cash needs for operating and investing activities are anticipated to be higher than historical levels subject to the factors discussed below. On March 19, 1999 the Company completed a follow-on public offering of 2,400,000 newly issued shares of its common stock at a public offering price of $20 per share. On March 24, 1999 the Company issued an additional 160,000 shares of common stock pursuant to the exercise of the underwriters' over-allotment option. Net proceeds to the Company after the exercise of the underwriters' over-allotment option and all related expenses totaled $47.5 million. The Company's principal source of liquidity at September 30, 1999 consisted of cash, cash equivalents and short-term investments of $48.6 million. The Company did not have any credit lines available or outstanding borrowings at September 30, 1999. The Company anticipates that its operating losses will continue through at least 2000 as it expends substantial resources in funding clinical trials in support of regulatory approvals, and continues to expand research and development and sales and marketing activities. We believe that our existing capital resources will be sufficient to fund the company through the end of 2000, but those resources may prove insufficient. We cannot assure that additional financing, if required, will be available on satisfactory terms, or at all. However, the Company's future liquidity and capital requirements will depend upon numerous factors, including, among others: the progress of the Company's clinical research and product development programs; the receipt of and the time required to obtain regulatory clearances and approvals; the resources required to gain approvals; the resources the Company devotes to the development, manufacture and marketing of its products; the resources required to hire and develop a direct sales force in the United States and in the larger markets of Europe, develop distributors internationally, and to expand manufacturing capacity; and market acceptance and demand for its products. Additional capital may be required to launch the Beta-Cath System in the United States. Novoste may in the future seek to raise additional funds through bank facilities, debt or equity offerings or other sources of capital. There can be no assurance that additional financing, if required, will be available on satisfactory terms, or at all. 12 Impact of Year 2000 We have completed the process of evaluating the potential impact of what is commonly referred to as the year 2000 issue, concerning the inability of certain computer systems to properly recognize and process dates starting with the year 2000 and beyond. We are taking steps to ensure that our business systems software and equipment will continue to function properly after December 31, 1999. In doing so, we have established a team, which is working directly with management to (1) assess and test all internal information systems and other systems that may be affected by the year 2000 date change; (2) assess and test our products that may be affected by the year 2000 date change; (3) communicate with third parties that supply our products to ensure they are addressing the year 2000 issue; and (4) compose a contingency and disaster recovery plan to ensure resolution of problems that may arise as a result of the year 2000 date change. As of September 30, 1999 items (1), (2), (3) and (4) above are complete. Because the Company is relying on information provided to it by third parties to assess the Year 2000 readiness of such vendors, the Company cannot provide assurances that all of its critical vendors are or will be Year 2000 ready. As a contingency, the Company has increased safety stock levels on its critical component inventory. The Beta-Cath System does not contain any real time clocks and therefore the device itself does not present any year 2000 issues. With respect to our internal business systems, an assessment of equipment and software was started in September 1998. In addition, in anticipation of in-house manufacturing, we purchased a complete manufacturing software package in January 1998 that includes integrated financial modules that replace our previous financial software program. The contract for the purchase of the new software package requires year 2000 compliance. We have completed testing to determine that our internal systems are year 2000 compliant. All internal systems critical to the Company's overall business have been inventoried and evaluated. As of September 30, 1999, 90% of the Company's internal systems have been determined to be year 2000 compliant or where upgraded and are now year 2000 compliant. The remaining 10% of the Company's internal systems are ether slated for obsolescence by or before December 31, 1999 or will be upgraded by October 31, 1999. We have and will continue to devote the necessary resources to resolve all significant year 2000 issues in a timely manner. Based upon current estimates, we expect capital expenditures of approximately $100,000 will be necessary to achieve year 2000 compliance. As of September 30, 1999 the Company has expended approximately $60,000 for year 2000 compliance. Regardless of the year 2000 compliance of our systems and products, we may be adversely affected by disruptions in the operations of the enterprises with which we interact. These business enterprises include suppliers, clinical research organizations, corporate partners, both domestic and international, government agencies, hospitals, physicians and other third parties. We cannot reasonably predict the impact on our operations and financial condition if any such businesses are adversely affected by the year 2000 issue. Statements made herein about the implementation of various phases of our year 2000 program, the costs expected to be associated with that program and the results we expect to achieve constitute forward-looking information. There are many uncertainties involved in the year 2000 issue and the following important factors, among others, could affect the impact of the year 2000 issue: (1) the inherent uncertainty of the costs and timing of achieving compliance on the wide variety of systems used by us, (2) the reliance on the efforts of vendors, customers, government agencies and other third parties beyond our control to achieve adequate compliance and avoid disruption of our business in early 2000 and (3) the 13 uncertainty of the ultimate costs and consequences of any unanticipated disruption of our business resulting from the failure of one of our applications or of a third party's systems. CERTAIN FACTORS THAT MAY IMPACT FUTURE OPERATIONS Dependence On The Successful Development And Commercialization Of The Beta-Cath System We have not yet successfully commercialized any product in the United States and only started to sell the Beta-Cath System in Europe in December 1998. We anticipate that for the foreseeable future we will be solely dependent on the successful development and commercialization of the Beta-Cath System. Failure to commercialize the Beta-Cath System would have a material adverse effect on our business, financial condition and results of operations. The Beta-Cath System will require further development and clinical testing, as well as regulatory approval, before we can market it in the United States. Our development efforts and clinical testing may not be successful. Commercialization of the Beta-Cath System in Europe is subject to certain additional risks. Physicians in Europe are generally less receptive to and slower to adopt new medical devices and technologies than physicians in the United States due to various factors. These factors include the influence of national health care policies and reimbursement strategies of health care payors and the frequent absence of pivotal human clinical trial results at the time a manufacturer qualifies to apply the CE marking to a new medical device and commences sale of the device. We may never achieve significant revenue from sales in Europe or ever achieve or sustain profitability in our European operations. Limited Operating History; History Of Losses And Expectation Of Future Losses Through At Least The Year 2000 We have a limited history of operations. Since our inception in May 1992, we have been primarily engaged in developing and testing our Beta-Cath System. We have generated only limited revenue and do not have experience in manufacturing, marketing or selling our products in quantities necessary for achieving profitability. At September 30, 1999 we had accumulated a deficit of approximately $75.8 million since our inception in 1992. The commercialization of the Beta-Cath System and other new products, if any, will require substantial additional development, clinical, regulatory, manufacturing, sales and marketing and other expenditures. We expect our operating losses to continue through at least 2000 as we continue to expand our product development, clinical trials and marketing efforts. We may never commercialize the Beta-Cath System, or any other product, or achieve or sustain profitability. Clinical Testing Of Beta-Cath System; No Assurance Of Its Safety And Effectiveness The safety and effectiveness of the Beta-Cath System has not been determined in a placebo-controlled, pivotal trial. We are currently conducting two multi-center human clinical trials of the Beta-Cath System to determine its safety and effectiveness. At September 30, 1999 we completed enrollment in both the PTCA and stent placement subgroup of the Beta-Cath System Trial and had enrolled a total of 1,456 patients at 58 clinical sites. We completed enrollment in the START Trial in April 1999, having enrolled 476 patients at 51 sites, principally located in the United States. As is typical for patients receiving stent placement, the patients in the stent placement subgroup of the Beta-Cath System Trial receive anti-platelet therapy to prevent stent thrombosis, a condition which can 14 lead to acute closure of the treated artery. Stent thrombosis typically occurs within 30 days of treatment in a small percentage of patients receiving stent placement. There were incidences of stent thrombosis reported in the Beta-Cath System Trial. These patients developed the condition later following their treatment than is normally observed. As a result, in November 1998, we modified the Trial protocol for the stent placement subgroup to extend the anti-platelet therapy from two weeks to 60 days following stent placement and to provide for additional follow-up contact with these patients in the second, third and fourth months after treatment. On April 27, 1999 we announced approval of our intention to increase patient enrollment in the stent placement subgroup of the Trial by up to 300 more patients and to extend the anti-platelet therapy to a minimum of 90 days following stent placement. These changes were made based upon a recommendation made by the Data Safety and Monitoring Board (DSMB) at its March 1999 meeting. Based on its review of the available data set, including the incidence of major adverse cardiac events, the DSMB proposed these changes to ensure sufficient data to evaluate the safety and effectiveness of the Beta-Cath System with the revised anti-platelet therapy protocol. Both of our current pivotal trials require follow-up examinations with patients after eight months. It is only after analysis of a statistically significant number of patients in one of these trials that we would apply for the regulatory approvals required to commence marketing the Beta-Cath System in the United States. Various factors, including performing follow-up examinations on patients, could delay completion of either trial for an indeterminate amount of time. The data from these trials, if completed, may not demonstrate the safety and effectiveness of the Beta-Cath System and may not be adequate to support our application to the FDA for pre-market approval. In particular, we cannot be sure that the incidence of stent thrombosis seen in the Beta-Cath System Trial will be resolved by the protocol modification. If the Beta-Cath System does not prove to be safe and effective in clinical trials, our business, financial condition and results of operations will be materially adversely affected. In addition, the clinical trials may identify significant technical or other obstacles to obtaining necessary regulatory approvals. Because vascular brachytherapy in human coronary arteries is a relatively new treatment, the long-term effects on patients are not known and likely will not be known for several years. As a result, even if our current clinical trials indicate the Beta-Cath System is safe and effective over an eight-month period, we cannot be sure that the Beta-Cath System will be safe and effective over the long term. No Assurance of Regulatory Approvals United States Pre-Market Approvals. We will not be able to commence marketing or commercial sales of the Beta-Cath System in the United States unless we receive pre-market approval from the FDA. We do not expect to submit a pre-market approval application until the second quarter of 2000 at the earliest, following analysis of a statistically significant number of patients in the START Trial. We do not anticipate FDA approval to market the Beta-Cath System in the United States for any indication any earlier than one year after the FDA accepts our application for filing. Assuming the START Trial yields positive results, we expect that our application seeking approval to market the Beta-Cath System in the United States to treat "in-stent" restenosis will be submitted to the FDA first and will be based upon the enrollment of 476 patients in that Trial. The FDA could require that we submit results from our Beta-Cath System Trial prior to considering our initial application for approval of our device in treating "in-stent" restenosis. Instead of filing an additional, separate application, we may amend our initial application relating to "in-stent" restenosis to seek pre-market approval of the Beta-Cath System for use following PTCA and stent placement based upon the results of the Beta-Cath System Trial. If we file such an amendment, the FDA would restart the statutory review period for our initial application as of the date of the filing of the amendment. This would cause a delay in obtaining FDA approval. Moreover, if either Trial does not yield positive results, the FDA's consideration of any application we have submitted could be adversely affected; any such application could be refused filing for substantive review, or if filed, 15 could be subject to requests for substantial amounts of additional information, or ultimately could be denied approval. The FDA may request additional data or require that we conduct further clinical trials, either of which could delay or preclude our receipt of pre-market approval as well as require significant additional expenditures. Such a delay or failure to receive pre-market approval would have a material adverse effect on our business, financial condition and results of operations and could result in cessation of our operations. Even if we receive approval based on the results of the START Trial, we will be limited to marketing the Beta-Cath System for use with patients who are being treated for "in-stent" restenosis in a single coronary artery. In order to market the Beta-Cath System for a broader range of patients, we will seek to expand the indications for which the Beta-Cath System can be marketed to include patients receiving PTCA or stent placement. Even if we receive approval based on the results of the Beta-Cath System Trial, we would be limited to marketing the Beta-Cath System for use with patients who are being treated for one lesion in a single coronary artery following PTCA or stent placement. In order to market the Beta-Cath System for use with a broader range of patients, we will likely be required to demonstrate to the FDA through additional clinical trials that the Beta-Cath System is safe and effective in treating a broader range of indications and the FDA must approve a pre-market approval application, application amendment or application supplement covering the broader range of indications for the device. Foreign Pre-Market Approvals. Sales of the Beta-Cath System outside the United States are subject to regulatory requirements that vary widely from country to country but generally include pre-marketing governmental approval. The time required to obtain approval for sale in foreign countries may be longer or shorter than required for FDA approval, and the requirements for the conduct of clinical trials, marketing authorization, pricing and reimbursement differ from those in the United States. Moreover, the export of medical devices from the United States must be in compliance with FDA regulations. In August 1998 we qualified to apply CE marking to the Beta-Cath System, a requirement necessary to sell our device in most of Western Europe. We are subject to continuing audit and reporting requirements related to this marking. We may be delayed or precluded from marketing the Beta-Cath System in other foreign countries. Foreign pre-market and other regulatory approvals of the Beta-Cath System, if granted, may include significant limitations on the indicated uses for which the device may be marketed. Approvals to Use, Handle and Transfer Radioactive Materials. Our business involves the import, manufacture, transfer, use and disposal of Strontium 90 (Strontium/Yttrium), the beta-emitting radioisotope utilized in the Beta-Cath System's radiation source train. Accordingly, manufacture, distribution, use and disposal of the radioactive material used in the Beta-Cath System in the United States will be subject to federal, state and/or local laws and regulations relating to the use and handling of radioactive materials. Specifically, we must obtain approval from the State of Georgia Department of Natural Resources to commercially distribute our radiation sources to licensed recipients in the United States. In addition, we must also comply with NRC, Georgia and United States Department of Transportation regulations on the labeling and packaging requirements for shipment of radiation sources to hospitals or other users of the Beta-Cath System. Further, hospitals and/or physicians in the United States may be required to amend their radiation licenses to hold, handle and use Strontium 90 prior to receiving and using our Beta-Cath System. The distribution and use of the Beta-Cath System outside the United States is subject to radiation regulatory requirements that vary from country to country and sometimes vary within a given country. Generally, each country has a national regulatory agency responsible for regulating the safe practice and use of radiation in its jurisdiction. In addition, each hospital desiring to use the Beta-Cath System is generally required to amend its license to store, handle and receive the Strontium 90 sources in our device. Generally, these licenses are specific to the amount and type of radioactivity utilized. In addition, 16 generally the use of a radiation source by a physician, either for a diagnostic or therapeutic application, also requires a license, which again is specific to the isotope and the clinical application. Obtaining any of the foregoing radiation-related approvals and licenses can be complicated and time consuming. If we or any hospital or physician is significantly delayed in obtaining any of the foregoing approvals or any of those approvals are not obtained, our business, financial condition and results of operations could be materially adversely affected. Risk Of Inadequate Funding We anticipate that our losses will continue through at least the year 2000 as we expend substantial resources to fund clinical trials in support of regulatory approvals, continue development of the Beta-Cath System and launch our product first in Europe and then in the United States. Our future liquidity and capital requirements will depend upon numerous factors. We believe that our existing capital resources will be sufficient to fund the company through the end of 2000, but those resources may prove insufficient. Additional capital may be required to launch the Beta-Cath System in the United States. We may in the future seek to raise additional funds through bank facilities, debt or equity offerings or other sources of capital. We cannot assure that additional financing, if required, will be available on satisfactory terms, or at all. Rapid Technological Change And Intense Competition Competition in the medical device industry, and specifically the markets for cardiovascular devices, is intense and characterized by extensive research and development efforts and rapidly advancing technology. New developments in technology could render vascular brachytherapy generally or the Beta-Cath System in particular noncompetitive or obsolete. Vascular brachytherapy may compete with other treatment methods designed to improve outcomes from coronary artery procedures that are well established in the medical community, such as coronary stents. Stents are the predominant treatment currently utilized to reduce the incidence of coronary restenosis following PTCA and were used in approximately 60% of all PTCA procedures performed worldwide in 1998. Manufacturers of stents include Johnson & Johnson/Cordis, Medtronic, Inc., Guidant Corporation and Boston Scientific Corporation. Stent manufacturers often sell many products used in the cardiac catheterization labs, commonly referred to as cath labs, and as discussed below certain of these companies are developing vascular brachytherapy devices. Other devices under development that use vascular brachytherapy include: o a radioactive-tipped guidewire; o a radioactive stent; and o a radioactive fluid-filled balloon. The most advanced competitive approach may be represented by the radioactive guidewire, as we are aware that Johnson & Johnson/Cordis and Guidant are investigating this general type of device in the pivotal clinical trial stage in the United States. Many of our competitors and potential competitors have substantially greater capital resources than we do and also have greater resources and expertise in the areas of research and development, obtaining regulatory approvals, manufacturing and marketing. We cannot assure you that competitors and potential competitors will not succeed in developing, marketing and distributing technologies and products that are more effective than those we will develop and market or that would render our Beta-Cath System obsolete or noncompetitive. Additionally, many of the 17 competitors have the capability to bundle a wide variety of products in sales to cath labs. We may be unable to compete effectively against such competitors and other potential competitors in terms of manufacturing, marketing and sales. Any product we develop that gains regulatory clearance or approval will have to compete for market acceptance and market share. An important factor in such competition may be the timing of market introduction of competitive products. Accordingly, we expect the relative speed with which we can develop products, gain regulatory approval and reimbursement acceptance and supply commercial quantities of the product to the market to be an important competitive factor. One of our competitors, Johnson & Johnson/Cordis, has recently submitted a pre-market approval application to the FDA for its gamma-emitting vascular brachytherapy device. Other manufacturers may be the first to market a vascular brachytherapy system to reduce the incidence of restenosis in the United States. We may also not be the first to market a beta-emitting vascular brachytherapy system in the United States or be able to market such a system effectively. Limitations On Third-Party Reimbursement For The Beta-Cath System The Beta-Cath System, where approved for commercial sale, will be sold primarily to hospitals. Hospitals and physicians bill various third-party payors, such as government health programs, private health insurance plans, managed care organizations and other similar programs, for the health care services provided to their patients. If and when we receive FDA approval to market the Beta-Cath System in the United States, third-party payors may not cover procedures using the Beta-Cath System or, if covered, third-party payors may place certain restrictions on the circumstances in which coverage will be available. In addition, payors may deny reimbursement if they determine a product was not used in accordance with established payor protocol regarding cost-effective treatment methods or was used for an unapproved indication. Third-party payors are increasingly challenging the prices charged for medical products and services and, in some instances, have put pressure on medical device suppliers and health care providers to lower their prices. We are unable to predict what changes third-party health care payors will make in their reimbursement methodologies. Third-party payors or health care providers may not consider the Beta-Cath System cost-effective and may not reimburse for its usage or, if they do, may reimburse at levels that adversely affect its market acceptance and our ability to sell the Beta-Cath System on a profitable basis. The cost of health care has risen significantly over the past decade, and legislators, regulators, third-party payors and health care providers have made and may continue to make proposals to curb these costs. Failure by hospitals and physicians to obtain reimbursement from third-party payors, changes in third-party payors' policies toward reimbursement for the Beta-Cath System or legislative action could have a material adverse effect on our business, financial condition and results of operations. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. Many international markets have government managed health care systems that control reimbursement for new devices and procedures. In most markets there are private insurance systems as well as government managed systems. Reimbursement for our products may not be available in international markets under either government or private reimbursement systems. Uncertainty Of Market Acceptance Of Vascular Brachytherapy And The Beta-Cath System Even if we obtain regulatory approvals and reimbursement from third party payors for the use of the Beta-Cath System, our device may not gain any significant degree of market acceptance among physicians and 18 patients. Vascular brachytherapy is a new treatment method and has not been used to any significant extent by physicians outside the context of clinical trials. We believe that physicians' acceptance of vascular brachytherapy generally and the Beta-Cath System in particular will be essential for our operations and we may not obtain this acceptance. Even if we establish clinical efficacy of the Beta-Cath System, cardiologists, radiation oncologists and other physicians may elect not to recommend vascular brachytherapy generally or the Beta-Cath System in particular. Even if recommended, physicians may not utilize the Beta-Cath System in a sufficient number of procedures to generate significant revenues or to enable us to operate profitably. In addition, market acceptance of our device could be hindered because using the Beta-Cath System currently requires the participation not only of an interventional cardiologist, but also a radiation oncologist appropriately credentialed to administer our beta radiation source train. Uncertainty Regarding Our Issued Patent, Pending Patent Applications And Other Matters On November 4, 1997 we received United States Patent No. 5,683,345 on the Beta-Cath System and on May 4, 1999 we received United States Patent No. 5,899,882. United States Patent Nos. 5,683,345 and 5,899,882 may not offer any protection to us. It may also be reexamined, invalidated or circumvented. In addition, claims under our other pending applications may not be allowed, or if allowed, may not offer any protection or may be reexamined, invalidated or circumvented. Competitors may have or obtain patents that will prevent, limit or interfere with our ability to make, use or sell our products in either the United States or international markets. We received a letter from NeoCardia, L.L.C., dated July 7, 1995, in which NeoCardia notified us that it is the exclusive licensee of United States Patent No. 5,199,939, or the Dake patent, and requested that we confirm that our products did not infringe the claims of the Dake patent. On August 22, 1995 our patent counsel responded on our behalf that we did not infringe the Dake patent. The United States Patent and Trademark Office later reexamined the Dake patent. In the reexamination proceeding some of the patent claims were amended and new claims were added. We have concluded, based upon advice of patent counsel, that our Beta-Cath System would not infringe any claim of the Dake patent as reexamined. In May 1997 Guidant acquired NeoCardia together with the rights under the Dake patent. Guidant is attempting to develop and commercialize products that may compete with the Beta-Cath System and has significantly greater capital resources than the company. Guidant may sue for patent infringement in an attempt to obtain damages from us and/or injunctive relief restraining us from commercializing the Beta-Cath System in the United States. If Guidant were successful in any such litigation, we might be required to obtain a license from Guidant under the Dake patent to market the Beta-Cath System in the United States, if such license were available, or be prohibited from selling the Beta-Cath System in the United States. Any of these actions could have a material adverse effect on our business, financial condition and results of operations, or could result in cessation of our business. We have two versions of our delivery catheter: a "rapid exchange" catheter and an "over the wire" catheter. As a result of certain United States patents held by other medical device manufacturers covering "rapid exchange" catheters, we currently intend to sell the "over the wire" version of our delivery catheter in the United States. If further investigation reveals that we may sell a "rapid exchange" version in the United States without infringing the valid patent rights of others, we might decide to do so in the future. However, we cannot assure that we will be able to sell a "rapid exchange" version in the United States without a license of third party patent rights or that such a license would be available to us on favorable terms or at all. 19 The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights. Companies in the medical device industry have employed intellectual property litigation to gain a competitive advantage. There can be no assurance that we will not become subject to patent-infringement claims or litigation or interference proceedings declared by the United States Patent and Trademark Office to determine the priority of inventions. The defense and prosecution of intellectual property suits, or interference proceedings and related legal and administrative proceedings are both costly and time-consuming. Litigation may be necessary to enforce our patents, to protect our trade secrets or know-how or to determine the enforceability, scope and validity of the proprietary rights of others. Any litigation or interference proceedings will result in substantial expense to us and significant diversion of effort by our technical and management personnel. An adverse determination in litigation or interference proceedings to which we may become a party could subject us to significant liabilities to third parties, require us to seek licenses from third parties, require us to redesign our products or processes to avoid infringement or prevent us from selling our products in certain markets, if at all. Although patent and intellectual property disputes regarding medical devices have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and could include significant ongoing royalties. Furthermore, there can be no assurance that the necessary licenses would be available to us on satisfactory terms, if at all, or that we could redesign our products or processes to avoid infringement. Any adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products, which would have a material adverse effect on our business, financial condition and results of operations. Dependence On Single Vendor To Supply Radioisotopes To date, we have obtained all our beta radiation isotope requirements from a single supplier, Bebig Isotopentechnik und Umweltdiagnostik GmbH, a German corporation. Our supply agreement with Bebig has an initial term ending in November 2000. During the term, we have agreed not to purchase more than 30% of our annual radioisotope requirements from any supplier other than Bebig. Our business, results of operations and financial condition could be materially adversely affected by Bebig's failure to provide us with beta isotopes on a timely basis during the term of the agreement. On October 14, 1999 the Company signed a development and manufacturing supply agreement with AEA Technologies QSA GmbH for a second source of radioactive supply and for the development of a smaller diameter source. The agreement provides for the construction of a production line which is expected to be finished in February 2001. The development of the smaller diameter source may not be successfully completed, the new production line may not be completed on time and on budget, and the smaller diameter source may not be manufacturable in commercial quantities. Limited Manufacturing Experience; Scale-Up Risk To date, we have not yet successfully commercialized the Beta-Cath System, and our manufacturing activities have consisted of producing small quantities of our products for use in clinical trials and our initial product launch in Europe. To achieve profitability, the Beta-Cath System must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs. Production in commercial quantities will require us to expand our manufacturing capabilities and to hire and train additional personnel. We have no experience in manufacturing our products in commercial quantities. We may encounter difficulties in scaling up production, including problems involving production yields, quality control and assurance, component supply and shortages of qualified personnel. Difficulties encountered in manufacturing scale up could have a material adverse effect on our business, financial condition and results of operations. We cannot assure that future manufacturing difficulties, which could have a material adverse effect on our business, financial condition and results of operations, will not occur. 20 Price Volatility And Fluctuations In Operating Results The market price of our common stock could decline below the public offering price. Specific factors relating to our business or broad market fluctuations may materially adversely affect the market price of our common stock. The trading price of our common stock could be subject to wide fluctuations in response to quarter-to-quarter variations in operating results, announcements of technological innovations, new products or clinical data announced by us or our competitors, governmental regulatory action, developments with respect to patents or proprietary rights, general conditions in the medical device or cardiovascular device industries, changes in earnings estimates by securities analysts, or other events or factors, many of which are beyond our control. In addition, the stock market has experienced extreme price and volume fluctuations, which have particularly affected the market prices of many medical device companies and which have often been unrelated to the operating performance of such companies. Our revenue or operating results in future quarters may be below the expectations of securities analysts and investors. In such an event, the price of our common stock would likely decline, perhaps substantially. During the twelve month period ended September 30, 1999, the closing price of our common stock ranged from a high of $30.25 per share to a low of $11.00 per share and ended that period at $17.84 per share. In addition, our results of operations may fluctuate significantly from quarter to quarter and will depend upon numerous factors, including product development efforts, actions relating to regulatory and reimbursement matters, progress and costs related to clinical trials, the extent to which our products gain market acceptance, and competition. These factors may cause the price of our stock to fluctuate, perhaps substantially. 21 Item 3. Quantitative And Qualitative Disclosures About Market Risk Interest Rate Risk The Company's cash equivalents and short-term investments are subject to market risk, primarily interest-rate and credit risk. The Company's investments are managed by outside professional managers within investment guidelines set by the Company. Such guidelines include security type, credit quality and maturity and are intended to limit market risk by restricting the Company's investments to high credit quality securities with relatively short-term maturities. The table below presents principal amounts and related weighted average interest rates by year of maturity for the Company's investment portfolio. All investments mature, by policy, in one year or less. Fair Value (in thousands) 1999 2000 2001 2002 2003 Total 9/30/99 - ------------------------------------------------------------------------------------------------------- Assets: Cash equivalents Fixed rate $8,180 $-- $-- $-- $-- $8,180 $8,180 Average interest rate 5.25% Held to Maturity investments Fixed rate 11,810 28,619 -- -- -- 40,429 40,429 Average interest rate 4.95% 5.55% Total investments Securities 19,990 28,619 -- -- -- 48,609 48,609 Average interest rate 5.12% 5.55% Foreign Currency Risk International revenues from the Company's foreign direct sales and distributor sales comprised 100% of total revenues for the three and nine month periods ending September 30, 1999. With the exception of the Australian and New Zealand distributors, sales are denominated in Euros. The Company experienced an immaterial amount of transaction gains and losses through the three and nine month periods ending September 30, 1999. The Company is also exposed to foreign exchange rate fluctuations as the financial results of its Belgian, German, and Holland subsidiaries are translated into U.S. dollars in consolidation. As exchange rates vary, these results, when translated, may vary from expectations and adversely impact overall expected profitability. The net effect of foreign exchange rate fluctuations on the Company during the three and nine month periods ending September 30, 1999 was not material. 22 PART II. OTHER INFORMATION Item 5. Other Information In September 1999, Dr. Raoul Bonan completed his leave of absence and returned to clinical practice at the Montreal Heart Institute. He will continue to serve as the Company's Medical Director and Vice President of Clinical Affairs on a part time basis through August 31, 2000. Item 6. Exhibits and Reports on Form 8-K 10.23 Modifications to Employment Agreement with Dr. Raoul Bonan, July 1, 1999. 10.24 Further modifications to Employment Agreement with Dr. Raoul Bonan, August 11, 1999. *10.25 Development and Manufacturing Agreement between AEA Technology-QSA, GmbH and Novoste Corporation. 27 Financial data schedule *Portions have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. (b) The Company did not file any reports on Form 8-K during the three months ended September 30, 1999. 23 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 hereunto duly authorized. NOVOSTE CORPORATION October 31, 1999 /s/ William A. Hawkins - ---------------- --------------------------------- Date William A. Hawkins President & Chief Executive Officer October 31, 1999 /s/ David N. Gill - ---------------- --------------------------------- Date David N. Gill Vice President - Finance, Chief Operating Officer and Chief Financial Officer (Principal Financial & Accounting Officer) 24 EXHIBIT INDEX Exhibit Number Exhibit Description - ------ ------------------- 10.23 Modifications to Employment Agreement with Dr. Raoul Bonan, July 1, 1999. 10.24 Further modifications to Employment Agreement with Dr. Raoul Bonan, August 11, 1999. *10.25 Development and Manufacturing Agreement between AEA Technology-QSA, GmbH and Novoste Corporation. 27 Financial data schedule *Portions have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. 25