SECURITIES AND EXCHANGE COMMISSION

FORM 10-Q

September 30, 2004

Commission file number 0-19711

The Spectranetics Corporation

96 Talamine Court
Colorado Springs, Colorado 80907
(719) 633-8333
(Address of principal executive offices and telephone number)

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 shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.      Yes þ No o

Indicate by check mark whether the Registrant is an accelerated filer.      Yes o No þ

As of November 11, 2004 there were 25,341,633 outstanding shares of Common Stock.

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Table of Contents

Part I—FINANCIAL INFORMATION

Item 1. Financial Statements

THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(In Thousands, Except Share Amounts)
(Unaudited)

See accompanying unaudited notes to condensed consolidated financial statements.

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THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Income
(In Thousands, Except Percentages, Share and Per Share Amounts)
(Unaudited)

See accompanying unaudited notes to condensed consolidated financial statements.

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THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows (In Thousands)
(Unaudited)

See accompanying unaudited notes to condensed consolidated financial statements.

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Item 1. Unaudited Notes to Condensed Consolidated Financial Statements

(1) General

     We develop, manufacture, market and distribute single-use medical devices used in minimally invasive procedures within the vascular system in conjunction with our proprietary excimer laser system. Excimer laser technology delivers comparatively cool ultraviolet light in short, controlled energy pulses to ablate or remove tissue. Our excimer laser system includes the CVX-300® laser unit and various fiber-optic delivery devices, including disposable catheters and sheaths. Our excimer laser system is the only excimer laser system approved in the United States and Europe for use in multiple, minimally invasive cardiovascular applications. Our excimer laser system is used in complex atherectomy procedures to open clogged or obstructed arteries in the coronary and peripheral vascular system. It is also used to remove lead wires from patients with implanted pacemakers or cardioverter defibrillators, which are electronic devices that regulate the heartbeat. On April 29, 2004, we received 510(k) clearance from the Food and Drug Administration (“FDA”) for our CliRpath® laser catheters which are indicated for use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions are not crossable with a guidewire.

     The accompanying consolidated financial statements include the accounts of The Spectranetics Corporation, a Delaware corporation, and its wholly owned subsidiary, Spectranetics International, B.V. (collectively, the Company). All intercompany balances and transactions have been eliminated in consolidation.

     We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America. As such, management is required to make certain estimates, judgments and assumptions based upon the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. Significant items subject to estimates and assumptions include the carrying amount of property and equipment, intangible assets, valuation allowances for receivables, inventories, and deferred income tax assets; and accrued warranty and royalty expenses. Actual results could differ from those estimates.

     The information included in the accompanying condensed consolidated interim financial statements is unaudited and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s latest Annual Report on Form 10-K. In the opinion of management, all adjustments necessary for a fair presentation of the assets, liabilities and results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the entire year.

(2) Stock-Based Compensation

     The Company accounts for its stock-based compensation plans for employees in accordance with the provisions of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and related interpretations. As such, compensation expense is recorded on the date of grant only if the current market price of the underlying stock exceeds the exercise price. No compensation cost has been recognized for stock option grants to employees in the accompanying financial statements as all options granted had an exercise price equal to or above the market value of the underlying common stock on the date of grant. Under FASB Statement No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), and FASB Statement No. 148, Accounting for Stock-Based Compensation – Transition and Disclosure, an amendment of SFAS No. 123 (SFAS No. 148), entities are permitted to recognize as expense

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the fair value of all stock-based awards on the date of grant over the vesting period. Alternatively, SFAS No. 123, as amended, also allows entities to continue to apply the provisions of APB 25 and provide pro forma earnings (loss) and pro forma earnings (loss) per share disclosures for employee stock option grants as if the fair-value-based method defined in SFAS No. 123, as amended, had been applied. The Company has elected to continue to apply the provisions of APB 25 and provide the pro forma disclosures required by SFAS No. 123, as amended.

     The Company accounts for nonemployee stock-based awards in accordance with SFAS No. 123 and related interpretations.

     The following table illustrates the effect on net income (loss) and net income (loss) per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation for the three months and nine months ended September 30, 2004 and 2003 (in thousands, except per share amounts):

     The per share weighted-average fair value of stock options granted during the third quarter of 2004 and 2003 was $4.36 and $2.18, respectively, using the Black-Scholes option pricing model. The per share weighted-average fair value of stock options granted during the nine months ended September 30, 2004 and 2003 was $4.30 and $2.16, respectively, using the Black-Scholes option pricing model. The Company used the following weighted average assumptions in determining the fair value of options granted during the three months and nine months ended September 30, 2004 and 2003:

(3) Net Income Per Share

     The Company calculates net income per share under the provisions of Statement of Financial Accounting Standards No. 128, Earnings Per Share (SFAS 128). Under SFAS 128, basic earnings per share is computed by dividing net income by the weighted average number of common shares outstanding. Shares issued during the period and shares reacquired during the period are weighted for

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the portion of the period that they were outstanding. Diluted earnings per share is computed in a manner consistent with that of basic earnings per share while giving effect to all potentially dilutive common shares outstanding during the period using the treasury stock method.

     For the three months ended September 30, 2004 and September 30, 2003, 439,953 and 880,231 stock options, respectively, were excluded from the computation of diluted earnings per share due to their antidilutive effect. For the nine months ended September 30, 2004 and 2003, respectively, 676,748 and 1,352,120 stock options were excluded from the computation due to their antidilutive effect. A summary of the net income per share calculation is shown below (in thousands, except per share amounts):

(4) Inventories

     Inventories consist of the following:

(5) Deferred Revenue

     Deferred revenue was $1,855,000 and $1,741,000 at September 30, 2004 and December 31, 2003, respectively. These amounts relate to payments in advance for various product maintenance contracts in which revenue is initially deferred and recognized over the life of the contract, which is generally one year, and to deferred revenue associated with service provided to our customers during the warranty period after the sale of equipment. Additional information relating to the deferral of revenue associated with the warranty provided upon sale of equipment is included in Footnote 9, “Revenue Recognition”.

(6) Restricted Cash

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     Restricted cash in the amount of $1,133,000 at December 31, 2003 consisted of an escrow fund established pursuant to a dispute with a licensor of certain patents of the Company. The dispute was settled in the fourth quarter of 2003, and the funds were released to the Company during the quarter ended March 31, 2004, resulting in a zero balance at September 30, 2004.

(7) Segment and Geographic Reporting

     An operating segment is a component of an enterprise whose operating results are regularly reviewed by the enterprise’s chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance. The primary performance measure used by management is net income or loss. The Company operates in one distinct line of business consisting of developing, manufacturing, marketing and distributing a proprietary excimer laser system for the treatment of certain coronary and vascular conditions. The Company has identified two reportable geographic segments within this line of business: (1) U.S. Medical and (2) Europe Medical. U.S. Medical and Europe Medical offer the same products and services but operate in different geographic regions and have different distribution networks. Additional information regarding each reportable segment is shown below.

U. S. Medical

     Products offered by this reportable segment include an excimer laser unit (“equipment”), fiber-optic delivery devices (“disposables”), and the service of the excimer laser unit (“service”). The Company is subject to product approvals from the FDA. At September 30, 2004, FDA-approved products were used in multiple cardiovascular procedures, including coronary atherectomy as well as the removal of non-functioning leads from pacemakers and cardiac defibrillators. On April 29, 2004, the Company received 510(k) clearance from the FDA to treat patients suffering from total occlusions (blockages) not crossable with a guidewire in their leg arteries. This segment’s customers are primarily located in the United States; however, the geographic areas served by this segment also include Canada, Mexico, South America, the Pacific Rim and Australia.

     U.S. Medical is also corporate headquarters for the Company. Accordingly, research and development as well as corporate administrative functions are performed within this reportable segment. As of September 30, 2004 and 2003, cost allocations of these functions to Europe Medical have not been performed.

     Manufacturing activities are performed primarily within the U.S. Medical segment. Revenue associated with intersegment product transfers to Europe Medical was $352,000 and $402,000 for the three months ended September 30, 2004 and 2003, respectively, and $1,062,000 and $1,043,000 for the nine months ended September 30, 2004 and 2003, respectively. Revenue is based upon transfer prices, which provide for intersegment profit that is eliminated upon consolidation.

Europe Medical

     The Europe Medical segment is a marketing and sales subsidiary located in the Netherlands that serves all of Europe as well as the Middle East. Products offered by this reportable segment are the same as U.S. Medical products. The Company has received CE mark approval for products that relate to four applications of excimer laser technology – coronary atherectomy, in-stent restenosis, lead removal, and peripheral angioplasty to clear blockages in leg arteries.

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     Summary financial information relating to reportable segment operations is shown below. Intersegment transfers as well as intercompany assets and liabilities are excluded from the information provided (in thousands):

(8) Income Taxes

     At December 31, 2003, the Company had net operating loss carryforwards for United States federal income tax purposes of approximately $53 million, which are available to offset future federal taxable income, if any, and expire at varying dates from 2004 through 2022. The annual use of the net operating loss carryforwards is limited under Section 382 of the Internal Revenue Code of 1986 (the “Code”).

     An alternative minimum tax credit carryforward of $298,000 is available to offset future regular tax liabilities and has no expiration date. The Company also has research and experimentation tax credit carryforwards at December 31, 2003, for federal income tax purposes of approximately $3 million, which are available to reduce future federal income taxes, if any, and expire at varying dates through 2023. The annual use of portions of the research and experimentation credit carryforwards is also limited under Section 382 of the Code.

     The Company has calculated a potential net deferred tax asset of approximately $40.0 million as of December 31, 2003, which includes U.S. net operating losses, foreign net operating losses, research and experimentation tax credit carryforwards and several other timing differences. The Company has recorded a valuation allowance equal to the net deferred tax asset at December 31, 2003 due to the uncertainty of realization. The Company reviews its deferred tax assets on an ongoing basis for realizability. While the Company has generated net income in recent quarters, the Company believes there currently is not enough positive evidence to support a conclusion that it is more likely than not that

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it will utilize some or all of its deferred tax assets.

When the Company determines there is enough positive evidence to support a conclusion that it is more likely than not that it will realize some or all of its deferred tax asset, the Company will reduce the valuation allowance which will result in an increase to net income in the period in which such determination is made. Specific factors that would support a conclusion that a portion of our deferred tax asset is realizable include, but are not limited to, continuing net income, our ability to grow revenue on a sequential quarterly basis, achievement of projected sales of our recently FDA-approved CliRpath product line, and our outlook for future taxable income. If a determination is made that a portion of our deferred tax asset will be realized through future taxable income, the Company will reverse a portion of its valuation allowance, which will be recorded as a reduction of income tax expense during the quarter the determination is made. If the specific factors outlined above occur, the Company expects to reverse some or all of its deferred tax valuation allowance in the fourth quarter of 2004.

(9) Revenue Recognition

     As a result of adopting EITF 00-21, Revenue Arrangements with Multiple Deliverables, which was effective July 1, 2003, the Company’s revenue recognition policy for the sale of laser equipment was modified. The primary impact of this guidance is to treat service provided during the one-year warranty period as a separate unit of accounting. The residual method of revenue recognition is used to allocate the sales price to equipment revenue and deferred service revenue. As such, the fair value of this service is separated from equipment revenue and is deferred and recognized as revenue on a straight-line basis over the warranty period. Equipment revenue is recognized upon completion of all contractual obligations in the sales contract, which includes installation of the laser system and physician training and when collection is reasonably assured. Prior to July 1, 2003, revenue for the sale of laser equipment was recognized upon shipment. For the three and nine months ended September 30, 2004, $108,000 and $202,000, respectively, of revenue associated with services to be performed during the warranty period was deferred. For the three and nine months ended September 30, 2004, revenue recognized from deferred service revenue was $109,000 and $269,000, respectively. The balance of deferred service revenue at September 30, 2004 is $280,000 and will be recorded as revenue on a straight-line basis over the remaining warranty period.

Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition

Forward-Looking Statements

     This report contains 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. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. For a description of such risks and uncertainties, which could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the risk factors below. Readers are urged to carefully review and consider the various disclosures made in this report and in our other reports filed with the SEC that attempt to advise interested parties of certain risks and factors that may affect our business. This analysis should be read in conjunction with our consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Form 10-K, filed on March 30, 2004. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events.

Corporate Overview

     We develop, manufacture, market and service an excimer laser unit and fiber optic delivery system for minimally invasive surgical procedures within the vascular system. Our CVX-300® excimer

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy and removal of faulty pacemaker and defibrillator leads. On April 29, 2004, we received 510(k) clearance from the FDA for use of our CVX-300 excimer laser in treatment of patients suffering from total occlusions (blockages) in the legs not crossable with a guidewire. Our laser system is typically used adjunctively with balloon catheters and cardiovascular stents. We compete with alternative technologies including mechanical atherectomy and thrombectomy devices.

     Our strategy is to develop additional applications for our excimer laser system, gather and develop clinical data for publication in peer-reviewed journals, increase utilization of our FDA-approved products, and expand our installed base of laser systems. We plan to remain focused on profitability, however there are no assurances that we will continue to be profitable in the future.

     In 1993, the FDA approved for commercialization our CVX-300 laser system and the first generation of our fiber optic coronary atherectomy catheters. Several improvements and additions to our coronary atherectomy product line have been made since 1993 and have been approved for commercialization by the FDA. In 1997, we secured FDA approval to use our excimer laser system for removal of pacemaker and defibrillator leads, and we secured FDA approval in 2001 to market certain products for use in restenosed (clogged) stents (thin steel mesh tubes used to support the walls of coronary arteries) as a pretreatment prior to brachytherapy (radiation therapy).

     On April 29, 2004, we received 510(k) clearance from the FDA for our CliRpath excimer laser catheters which are indicated for use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease when total obstructions are not crossable with a guidewire. The data submitted to the FDA showed that the limb salvage rate (no major amputations) among the 47 patients treated was 95% for those patients surviving six months following the procedure. There was no difference in serious adverse events as compared with the entire set of patients treated in the LACI (Laser Angioplasty for Critical Limb Ischemia) trial.

     We are currently exploring the use of our technology to treat blockages caused by the formation of thrombus (blood clots) and are gathering clinical data for laser-based treatment of saphenous vein grafts (heart bypass grafts that develop blockages), peripheral vascular disease and acute myocardial infarction (AMI, or heart attack). Enrollment in the CORAL trial for a laser-based treatment of saphenous vein grafts is currently slower than expected. Management is currently evaluating alternatives associated with the completion of this clinical trial. We are currently FDA-approved to treat saphenous vein grafts so the clinical data from this trial, if successful, will be used for marketing the clinical advantages of our technology. Our peripheral trial is called DELTA and is a pilot study on a new catheter designed to create larger lumens (holes) within the superficial femoral artery. This 25-patient study is expected to be completed by the end of the year. We began the clinical research associated with the laser-based treatment of AMI in the second quarter of 2004 and expect to complete enrollment in this 80-patient study in early 2005. It is likely that further clinical research, potentially in the form of a randomized clinical trial, beyond this 80-patient study will be required to generate a new indication from the FDA.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

Results of Operations

The following table summarizes key supplemental financial information for the last 5 quarters.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

Three Months Ended September 30, 2004, Compared with Three Months Ended September 30, 2003

     Revenue for the third quarter of 2004 was $8,934,000, up 29 percent, as compared with $6,901,000 in the third quarter of 2003. The increase is due to a 36 percent increase in equipment revenue, a 28 percent increase in disposable product revenue and a 32 percent increase in service and other revenue.

     Increased laser unit sales and a slight increase in the average selling price of the laser systems are the primary contributors to the growth in equipment revenue compared with the prior year quarter. The Company sold (either an outright sale from inventory or a sale conversion from evaluation or rental programs) seven laser units in the third quarter of 2004 compared with five laser units sold in the third quarter of 2003. Our installed base of excimer laser systems increased by 10 to 404 excimer laser systems (301 in the United States) during the third quarter of 2004, compared with eight net placements (systems sold, rented or provided for evaluation) during the third quarter of 2003.

     Disposable products revenue, which consists of single-use catheter products, was $6,579,000 during the third quarter of 2004 compared with $5,139,000 last year, an increase of 28 percent. This increase is due to a 21 percent increase in revenue from lead removal products and a 36 percent increase in atherectomy catheter revenue. A net increase of approximately three percent in sales prices for most disposable products went into effect as of April 2004, which accounted for a portion of the increase. The growth in atherectomy revenue is primarily due to the launch of our CLiRpath product line, which is used to treat total occlusions in the legs that cannot be crossed with a guidewire. Sales of the new, larger diameter CliRpath catheters were $1,113,000 during the three months ended September 30, 2004. Increases in Quick-Cross and Point 9 product line sales also contributed to the increase in atherectomy catheter revenue. These increases were partially offset by a decrease in sales of our rapid exchange, or Vitesse, product line. Atherectomy revenue growth from current levels will depend on our ability to increase market acceptance of our CliRpath product line, stopping the continuing declines within our Vitesse product line, and success of our ongoing clinical research and product development within the coronary and peripheral atherectomy markets.

     We continue to believe our lead removal revenue is increasing primarily as a result of the increase in use of implantable cardioverter defibrillators (ICD), devices that regulate heart rhythm. When an ICD is implanted, it often replaces a pacemaker. In these cases, the old pacemaker leads are likely to be removed to avoid potential electrical interference with the new ICD leads.

     Service revenue and other revenue in the third quarter of 2004 was $1,343,000 compared with $1,017,000 during the same quarter last year. The change is attributable to an increased installed base of excimer laser systems and better conversion rates to accounts with service contracts.

     Gross margin increased to 76 percent during the three months ended September 30, 2004 from 72 percent for the third quarter of 2003. This increase was due primarily to manufacturing efficiencies realized as a result of the higher volume of catheters produced and sold during the current year quarter.

     Operating expenses rose 37 percent to $6,389,000 in the three months ended September 30, 2004 from $4,651,000 in the same period of 2003. This increase is mainly due to a 30 percent increase in selling, general and administrative expenses and a 69 percent increase in research development and other technology expenses relative to the prior year period.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     Selling, general and administrative expenses were $4,838,000 for the three months ended September 30, 2004, a 30 percent increase from the prior year period expenses of $3,735,000. The increase is primarily due to:

•

Marketing and selling expenses increased $673,000 in the quarter compared with last year’s quarter primarily as a result of the following:

•

Approximately $100,000 relates to personnel-related expenses associated with an increase of six additional employees in our U.S. field sales force compared with last year and $290,000 relates primarily to higher commissions as a result of increased revenue compared with the prior year.

•

Approximately $100,000 relates to increased costs of our foreign operations. Of this amount, approximately $37,000 is associated with the strengthening euro in relation to the U.S. dollar. An increase of one additional employee in the European field sales force also contributed to the increase over the prior year period.

•

Approximately $150,000 relates to increased marketing costs, including conventions and promotional materials related to the CLiRpath launch.

•

General and administrative expenses increased approximately $430,000 in the quarter compared with last year. The primary reasons for the growth in general and administrative expenses are increased personnel costs of $80,000 associated with additional employees, $250,000 increased incentive-based compensation for Company-wide personnel, $50,000 increase for consulting services related to Sarbanes-Oxley compliance, and $155,000 increase for legal and audit expenses. These increased costs were partially offset by decreases of $120,000 in other general and administrative costs.

     Research, development and other technology expenses increased 69 percent to $1,551,000 for the third quarter of 2004 from $916,000 in the third quarter of 2003. Costs included within research, development and other technology expenses are research and development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors. Research and development costs increased approximately $280,000 in 2004 primarily as a result of two additional employees and increased costs related to engineering projects. Royalties increased approximately $250,000 from the prior year quarter primarily as a result of increased royalty-bearing revenue. Increased spending for clinical research studying the use of our technology to treat acute myocardial infarction (heart attack) and saphenous vein grafts and the costs of compiling data related to lead failure attributed to the $108,000 growth in clinical studies costs as compared with the prior year period. We have begun clinical research studying the use of our technology to treat thrombus-laden lesions in saphenous vein grafts (CORAL), acute myocardial infarction (Extended FAMILI) and peripheral vascular disease (DELTA). We anticipate completion of Extended FAMILI and DELTA patient enrollment by the end of 2004 or early 2005. We have enrolled 100 patients to date in the CORAL study and will now enter Phase II of the study to evaluate the combination of the laser with distal protection in highly diseased saphenous vein grafts.

     Interest income increased 65 percent in the third quarter of 2004 to $56,000 due to higher yields on an increased balance of interest-bearing securities, which consist primarily of cash equivalents, short-term government bonds, and corporate bonds.

     Net income for the three months ended September 30, 2004 was $479,000, compared with net income of $357,000 in the same quarter last year.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     The functional currency of Spectranetics International B.V. is the euro. All revenue and expenses are translated to U.S. dollars in the consolidated statements of operations using weighted average exchange rates during the period. Fluctuation in euro currency rates during the three months ended September 30, 2004, as compared with the three months ended September 30, 2003, caused an increase of less than one percent in consolidated revenue and operating expenses.

Nine Months Ended September 30, 2004 Compared with Nine Months Ended September 30, 2003

     Revenue for the nine months ended September 30, 2004 increased 24 percent to $25,378,000 from revenue of $20,423,000 for the nine months ended September 30, 2003. The increase is due to a 23 percent increase in disposable products revenue, an 11 percent increase in equipment revenue and a 42 percent increase in service and other revenue.

     The increase in disposable products revenue, which consists of single-use catheter products, is attributable to 34 percent increase in atherectomy revenue and a 12 percent increase in lead removal products revenue. A net increase of approximately three percent in sales prices for most disposable products went into effect as of April 2004, which accounted for a portion of the increase. Revenue of $2,101,000 from the sale of new, larger diameter CLiRpath catheters, which we received 510(k) clearance on April 29, 2004, contributed to the increase in atherectomy revenue. The CLiRpath product line consists of catheters used for the treatment of total occlusions in the legs which are not crossable with a guidewire. Increases in Quick-Cross and Point 9 product line sales also contributed to the increase in atherectomy catheter revenue. These increases were partially offset by a decrease in sales of our rapid exchange, or Vitesse, product line. We believe our lead removal business continues to benefit from the expansion of patients eligible for inplantable cardioverter defibrillators (ICD), a device that regulates heart rhythm. When an ICD is implanted, it often replaces a pacemaker. In these cases, the old pacemaker leads are likely to be removed to avoid potential electrical interference with the new ICD leads.

     For the nine months ended September 30, 2004, our installed base of excimer laser systems increased by 21 to 404 excimer laser systems (301 in the United States) compared with 16 net placements during the nine months ended September 30, 2003. The equipment revenue increase is primarily due to increased equipment rental revenue. The Company sold (either an outright sale from inventory or a sale conversion from evaluation or rental programs) 14 laser units during the first nine months of 2004, compared with 15 units during the same period of 2003.

     Service and other revenue of $3,996,000 during the nine months ended September 30, 2004 increased 42 percent from $2,816,000 in the nine months ended September 30, 2003. An increase in the installed base of laser systems and an increase in the number of laser systems under service agreements are the primary reasons for the change from prior year amounts.

     Gross margin increased to 75 percent during the nine months ended September 30, 2003, from 71 percent for the nine months ended September 30, 2003. This increase was due primarily to disposable products manufacturing efficiencies resulting from higher production volumes and improved average selling prices on laser system sales.

     Operating expenses increased 28 percent in the nine months ended September 30, 2004 to $18,107,000, compared with $14,179,000 for the nine months ended September 30, 2003.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     Selling, general and administrative expenses increased 24 percent to $14,209,000 for the nine months ended September 30, 2004 from $11,431,000 in the nine months ended September 30, 2003. This increase is due to:

•

Marketing and selling expenses increased $1,808,000 compared with last year as a result of the following:

•		Approximately $375,000 relates to personnel-related expenses associated with an increase of six additional employees in our field sales force this year and $600,000 relates to higher commissions as a result of increased revenue compared with the prior year period and incentives related to the launch of the CliRpath product line.
•		Approximately $360,000 relates to increased costs of our foreign operations. Of this amount, $150,000 is associated with the strengthening euro in relation to the U.S. dollar. An increase of one additional employee in the European field sales force also contributed to the increase over the prior year period.
•		Approximately $360,000 relates to increased marketing costs, including conventions and promotional materials related to the launch of the CliRpath product line.
•		Approximately $110,000 relates to an increase in depreciation charges compared with last year resulting from an increase in the number of lasers placed for evaluation.

•

General and administrative expenses increased approximately $970,000 compared with last year primarily as a result of the following:

•		Approximately $560,000 relates to personnel-related expenses associated with additional employees and increased accrued incentive compensation based on financial performance in relation to financial targets set at the beginning of 2004.
•		Approximately $150,000 relates to consulting costs associated with Sarbanes-Oxley compliance.
•		Approximately $230,000 relates to increased legal fees.

     Research, development and other technology expenses of $3,898,000 for the nine months ended September 30, 2004 increased 42 percent from $2,748,000 for the same period of 2003. Costs included within research, development and other technology expenses are research and development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors. Royalty costs increased $414,000 from the prior year due to increased royalty-bearing revenue. Research and development costs increased $269,000 primarily as a result of increased personnel and recruiting costs related to two additional employees. The additional increase from the prior year amount is primarily due to a $453,000 increase in clinical studies costs as a result of the costs of clinical research for the treatment of saphenous vein grafts and acute myocardial infarction (heart attack). We have begun clinical research studying the use of our technology to treat thrombus-laden lesions in saphenous vein grafts (CORAL), acute myocardial infarction (Extended FAMILI) and peripheral vascular disease (DELTA). We anticipate completion of Extended FAMILI and DELTA patient enrollment by the end of 2004 or early 2005. We have enrolled 100 patients to date in the CORAL study and will now enter Phase II of the study to evaluate the combination of the laser with distal protection in highly diseased saphenous vein grafts.

     Interest income for the nine months ended September 30, 2004 was $152,000, an increase of $10,000 from the prior year period.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     Net income for the nine months ended September 30, 2004 was $1,015,000, compared with $551,000 for the nine months ended September 30, 2003.

     The functional currency of Spectranetics International B.V. is the euro. All revenue and expenses are translated to U.S. dollars in the consolidated statements of operations using weighted average exchange rates during the period. Fluctuation in euro currency rates during the nine months ended September 30, 2004, as compared with the nine months ended September 30, 2003, caused an increase in consolidated revenue and operating expenses of one percent.

Income Taxes

     At December 31, 2003, the Company had net operating loss carryforwards for United States federal income tax purposes of approximately $53 million, which are available to offset future federal taxable income, if any, and expire at varying dates from 2004 throught 2022. The annual use of the net operating loss carryforwards is limited under Section 382 of the Internal Revenue Code of 1986 (the “Code”).

     An alternative minimum tax credit carryforward of $298,000 is available to offset future regular tax liabilities and has no expiration date. The Company also has research and experimentation tax credit carryforwards at December 31, 2003, for federal income tax purposes of approximately $3 million, which are available to reduce future federal income taxes, if any, and expire at varying dates through 2023. The annual use of portions of the research and experimentation credit carryforwards is also limited under Section 382 of the Code.

     The Company has calculated a potential net deferred tax asset of approximately $40.0 million as of December 31, 2003, which includes U.S. net operating losses, foreign net operating losses, research and experimentation tax credit carryforwards and several other timing differences. The Company has recorded a valuation allowance equal to the net deferred tax asset at December 31, 2003 due to the uncertainty of realization. The Company reviews its deferred tax assets on an ongoing basis for realizability. While the Company has generated net income in recent quarters, the Company believes there currently is not enough positive evidence to support a conclusion that it is more likely than not that it will utilize some or all of its deferred tax assets. When the Company determines there is enough positive evidence to support a conclusion that it is more likely than not that it will realize some or all of its deferred tax asset, the Company will reduce the valuation allowance which will result in an increase to net income in the period in which such determination is made. Specific factors that would support a conclusion that a portion of our deferred tax asset is realizable includes, but is not limited to, strengthening net income, our ability to grow revenue on a sequential quarterly basis, increased sales of our recently FDA-approved CliRpath product line from current levels, and our outlook for future taxable income. If a determination is made that a portion of our deferred tax asset will be realized through future taxable income, it will be recorded as a reduction of income tax expense during the quarter the determination is made.

Liquidity and Capital Resources

     Cash and cash equivalents as of September 30, 2004 were $2,794,000, a decrease of $8,487,000 from $11,281,000 at December 31, 2003. The primary reason for the decrease is due to the net purchase of $11,414,000 of investment securities and capital expenditures totaling $351,000. This decrease was

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

offset by the reclassification back to operating cash of $1,133,000 which was previously classified as restricted cash and held in an escrow account during a dispute with a license holder as a result of the settlement of that matter in the fourth quarter of 2003. Proceeds from the exercise of stock options and employee stock purchases also offset the decrease in cash as discussed above, and were $1,616,000 and $447,000, respectively, during the nine months ended September 30, 2004.

     Cash provided by operating activities of $107,000 for the nine months ended September 30, 2004 consisted primarily of the following:

•		Net income of $1,015,000 for the nine months ended September 30, 2004 plus non-cash expenses of $1,188,000, which consist of depreciation and amortization of $1,166,000 and the fair value of options granted for consulting services of $22,000.
•		Accounts payable and accrued liabilities increased $939,000 primarily due to increased payroll related accruals of $585,000, a $637,000 increase in royalty accruals and a $89,000 increase in accrued clinical studies costs, partially offset by a decrease in accounts payable of $386,000.
•		Deferred revenue and other liabilities increased $118,000, primarily as a result of sales of service agreements for our excimer laser systems.

The above sources of cash provided by operating activities were offset by the following uses for the nine months ended September 30, 2004:

•		An increase in accounts receivable of $1,390,000 due to increased revenue compared with the prior year period.
•		An increase in other assets and prepaid expenses and other current assets of $433,000, primarily due to payments of annual premiums for corporate insurance and prepayment of health insurance premiums.
•		An increase in inventory and equipment held for rental or loan of $1,330,000, primarily as a result of the Company’s ongoing program to facilitate placements of new laser systems through evaluation or rental programs. The Company intends to continue to increase its installed base through evaluation and rental programs offered to our customers.

     The table below presents the change in receivables and inventory in relative terms, through the presentation of financial ratios. Days sales outstanding are calculated by dividing the ending accounts receivable balance, net of reserves for sales returns and doutful accounts, by the average daily sales for the third quarter. Inventory turns are calculated by dividing annualized cost of sales for the third quarter by ending inventory.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     Cash used by investing activities of $10,632,000 for the nine months ended September 30, 2004 was due to net purchases of investment securities totaling $11,414,000 and capital expenditures of $351,000. These purchases were partially offset by the reclassification of restricted cash of $1,133,000 to operating cash.

     Cash provided by financing activities was $2,063,000, comprised of proceeds from the sale of common stock to employees or former employees as a result of exercises of stock options and stock issuances under our employee stock purchase plan. At September 30, 2004, there was no debt or capital lease obligations.

     At September 30, 2004, and December 31, 2003, we had placed a number of laser systems on rental and loan programs. A total of $6,551,000 and $5,843,000 was recorded as equipment held for rental or loan at September 30, 2004 and December 31, 2003, respectively, and is being depreciated over three to five years. The net book value of this equipment was $3,408,000 and $3,052,000 at September 30, 2004 and December 31, 2003, respectively.

     We currently use two placement programs in addition to the sale of laser systems:

(1)		Evergreen rental program – This rental program was introduced in July 1999. Rental revenue under this program varies on a sliding scale depending on the customer’s purchases of disposable products each month. Rental revenue is invoiced on a monthly basis and revenue is recognized upon invoicing. The laser unit is transferred to the equipment held for rental or loan account upon shipment, and depreciation expense is recorded within cost of revenue based upon a three- to five-year expected life of the unit. We also offer a stright monthly rental program and tere are a small number of hospitals that pay $3000-$5000 per month under this program. As of September 30, 2004, 46 laser units were in place under the rental programs.
(2)		Evaluation programs – We “loan” laser systems to institutions for use over a short period of time, usually three to six months. The loan of the equipment is to create awareness of our products and their capabilities, and no revenue is earned or recognized in connection with the placement of a loaned laser (although sales of disposable products result from the laser placement). The laser unit is transferred to the equipment held for rental or loan account upon shipment, and depreciation expense is recorded within selling, general and administrative expense based on a three- to five-year expected life of the unit. As of September 30, 2004, 42 laser units were in place under the evaluation program in the United States.

     We believe our liquidity and capital resources as of September 30, 2004 are sufficient to meet our operating and capital requirements through at least the next twelve months. In the event we need additional financing for the operation of our business, we will consider additional public or private financing. Factors influencing the availability of additional financing include our progress in our current clinical trials, investor perception of our prospects and the general condition of the financial markets. We cannot assure you that our existing cash and cash equivalents will be adequate or that additional financing will be available when needed or that, if available, this financing will be obtained on terms favorable to us or our shareholders.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America. As such, we are required to make certain estimates, judgments and assumptions that we believe are reasonable based upon the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. Significant items subject to estimates and assumptions include the carrying amount of property and equipment, intangible assets, valuation allowances for receivables, inventories, and deferred income tax assets; and accrued warranty and royalty expenses. Actual results could differ from those estimates.

     Our critical accounting policies and estimates are included in our Form 10-K, filed with the SEC on March 30, 2004.

RISK FACTORS

     We Have a History of Losses and May Not Be Able to Maintain Profitability. We incurred losses from operations since our inception in June 1984 until the second quarter of 2001, and we incurred net losses in the first and second quarters of 2002. At September 30, 2004, we had accumulated $75.3 million in net losses since inception. We expect that our research, development and clinical trial activities and regulatory approvals, together with future selling, general and administrative activities and the costs associated with launching our products for additional indications will result in significant expenses for the foreseeable future. Although we have been profitable for nine consecutive quarters, no assurance can be given that we will be able to maintain profitability in the future.

     Increases in our Stock Price are Largely Dependent on our Ability to Grow Revenues. Revenue growth from current levels depends largely on our ability to successfully launch our recently introduced CliRpath product line targeted at total occlusions (blockages) in the legs. The success of this launch will require increased re-order rates from existing customers and adoption by new customers. Beyond the initial CliRpath product line launch, new products will need to be developed and FDA-approved to sustain revenue growth within the peripheral market.

     Regulatory Compliance Is Expensive and Can Often Be Denied or Significantly Delayed. The industry in which we compete is subject to extensive regulation by the FDA and comparable state and foreign agencies. Complying with these regulations is costly and time consuming. International regulatory approval processes may take longer than the FDA approval process. If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspensions or revocations of approvals, seizures or recalls of products, operating restrictions, criminal prosecutions and other penalties. We may be unable to obtain future regulatory approval in a timely manner, or at all, if existing regulations are changed or new regulations are adopted. For example, the FDA approval process for the use of excimer laser technology in clearing blocked arteries in the leg took longer than we anticipated due to requests for additional clinical data and changes in regulatory requirements.

     Failures in Clinical Trials May Hurt Our Business and Our Stock Price. All of Spectranetics’ potential products are subject to extensive regulation and will require approval from the FDA and other regulatory agencies prior to commercial sale. The results from pre-clinical testing and early clinical trials may not be predictive of results obtained in large clinical trials. Companies in the medical device industry have suffered significant setbacks in various stages of clinical trials, even in advanced clinical trials, after apparently promising results had been obtained in earlier trials.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     The development of safe and effective products is uncertain and subject to numerous risks. The product development process may take several years, depending on the type, complexity, novelty and intended use of the product. Larger competitors are able to offer larger financial incentives to their customers to support their clinical trials. Enrollment in our clinical trials may be adversely affected by clinical trials financed by our larger competitors. Product candidates that may appear to be promising in development may not reach the market for a number of reasons.

     Product candidates may:

•		be found ineffective;
•		take longer to progress through clinical trials than had been anticipated; or
•		require additional clinical data and testing.

     Our Small Sales and Marketing Team May Be Unable To Compete With Our Larger Competitors or To Reach All Potential Customers. Many of our competitors have larger sales and marketing operations than we do. This allows those competitors to spend more time with potential customers and to focus on a larger number of potential customers, which gives them a significant advantage over our team in making sales.

     Our Products May Not Achieve Market Acceptance. Excimer laser technology competes with more established therapies for restoring circulation to clogged or obstructed arteries such as balloon angioplasty and stent implantation. Market acceptance of the excimer laser system depends on our ability to provide adequate clinical and economic data that shows the clinical efficacy and cost effectiveness of, and patient benefits from, excimer laser atherectomy and lead removal.

     We May Be Unable To Compete Successfully With Bigger Companies in Our Highly Competitive Industry. Our primary competitors are manufacturers of products used in competing therapies within the coronary and peripheral atherectomy markets, such as:

•		bypass surgery (coronary and peripheral);
•		atherectomy and thrombectomy, using mechanical methods to remove arterial blockages (coronary and peripheral);
•		amputation (peripheral); and
•		balloon angioplasty (peripheral);

     We also compete with companies marketing lead extraction devices or removal methods, such as mechanical sheaths. In the lead removal market, we compete worldwide with lead removal devices manufactured by Cook Vascular Inc. and we compete in Europe with devices manufactured by VascoMed. Although balloon angioplasty and stents are used extensively in the coronary vascular system, we do not compete directly with these products. Rather, our laser technology is most often used as an adjunctive treatment to balloon angioplasty and stents.

     Almost all of our competitors have substantially greater financial, manufacturing, marketing and technical resources than we do. Larger competitors have a broader product line, which enables them to offer customers bundled purchase contracts and quantity discounts. We expect competition to intensify.

     We believe that the primary competitive factors in the interventional cardiovascular market are:

•

the ability to treat a variety of lesions safely and effectively;

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

•		the impact of managed care practices, related reimbursement to the health care provider, and procedure costs;
•		ease of use;
•		size and effectiveness of sales forces; and
•		research and development capabilities.

     Manufacturers of atherectomy or thrombectomy devices include Boston Scientific, Guidant, Possis Medical, Inc., Fox Hollow Technologies, Lumend, and Intraluminal Therapeutics.

     Laser placement is a barrier to accessing patient cases for which our disposable products may be suited. Many competing products do not require an up-front investment in the form of a capital equipment purchase, lease, or rental.

     Failure of Third Parties To Reimburse Medical Providers for Our Products May Reduce Our Sales. We sell our CVX-300 laser unit primarily to hospitals, which then bill third-party payers such as government programs and private insurance plans, for the services the hospitals provide using the CVX-300 laser unit. Unlike balloon angioplasty, laser atherectomy requires the purchase or lease of expensive capital equipment. In some circumstances, the amount reimbursed to a hospital for procedures involving our products may not be adequate to cover a hospital’s costs. We do not believe that reimbursement has materially adversely affected our business to date, but continued cost containment measures by third-party payers could hurt our business in the future.

     In addition, the FDA has required that the label for the CVX-300 laser unit state that adjunctive balloon angioplasty was performed together with laser atherectomy in most of the procedures we submitted to the FDA for pre-market approval. Adjunctive balloon angioplasty requires the purchase of a balloon catheter in addition to the laser catheter. While all approved procedures using the excimer laser system are reimbursable, some third-party payers attempt to deny reimbursement for procedures they believe are duplicative, such as adjunctive balloon angioplasty performed together with laser atherectomy. Third-party payers may also attempt to deny reimbursement if they determine that a device used in a procedure was experimental, was used for a non-approved indication, or was not used in accordance with established pay protocols regarding cost-effective treatment methods. Hospitals that have experienced reimbursement problems or expect to experience reimbursement problems may not purchase our excimer laser systems.

     Technological Change May Result in Our Products Becoming Obsolete. We derive substantially all of our revenue from the sale or lease of the CVX-300 laser unit, related disposable devices and service. Technological progress or new developments in our industry could adversely affect sales of our products. Many companies, some of which have substantially greater resources than we do, are engaged in research and development for the treatment and prevention of coronary artery disease and peripheral vascular disease. These include pharmaceutical approaches as well as development of new or improved angioplasty, atherectomy, thrombectomy or other devices. Our products could be rendered obsolete as a result of future innovations in the treatment of vascular disease.

     Our European Operations May Not Be Successful or May Not Be Able To Achieve Revenue Growth. In January 2001 we established a distributor relationship in Germany, and now utilize distributors throughout most of Europe. The sales and marketing efforts on our behalf by distributors in Europe could fail to attain long-term success.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     We Are Exposed to the Problems That Come From Having International Operations. For the nine months ended September 30, 2004, our revenue from international operations represented 10 percent of consolidated revenue. Changes in overseas economic conditions, war, currency exchange rates, foreign tax laws or tariffs or other trade regulations could adversely affect our ability to market our products in these and other countries. The new product approval process in foreign countries is often complex and lengthy. For example, the reimbursement approval process in Japan has taken longer than anticipated due to the complexity of this process. As we expand our international operations, we expect our sales and expenses denominated in foreign currencies to expand.

     We Have Important Sole Source Suppliers and May Be Unable To Replace Them if They Stop Supplying Us. We purchase certain components of our CVX-300 laser unit from several sole source suppliers. We do not have guaranteed commitments from these suppliers and order products through purchase orders placed with these suppliers from time to time. While we believe that we could obtain replacement components from alternative suppliers, we may be unable to do so.

     Potential Product Liability Claims and Insufficient Insurance Coverage May Hurt Our Business and Stock Price. We are subject to risk of product liability claims. We maintain product liability insurance with coverage and aggregate maximum amounts of $5,000,000. The coverage limits of our insurance policies may be inadequate, and insurance coverage with acceptable terms could be unavailable in the future.

     Our Patents and Proprietary Rights May Be Proved Invalid, Which Would Enable Competitors To Copy Our Products; We May Infringe Other Companies’ Rights. We hold patents and licenses to use patented technology, and have patent applications pending. Any patents we have applied for may not be granted. In addition, our patents may not be sufficiently broad to protect our technology or to give us any competitive advantage. Our patents could be challenged as invalid or circumvented by competitors. In addition, the laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States. We do not have patents in many foreign countries. We could be adversely affected if any of our licensors terminate our licenses to use patented technology. We have received inquiries from two of our licensors regarding the level of past royalty payments and have engaged in discussions with them regarding their inquiries. The disagreements over past royalty payments center on the treatment of certain service-based revenue, including repair and maintenance, and physician and clinical training services. We believe these services are beyond the scope of the license agreements. We have accrued costs of $1.8 million associated with the resolution of these matters, which represents our best estimate of costs to resolve the matter if service-based revenue is ultimately deemed to be included in the calculation. One of these matters has been referred to arbitration proceedings, and we will vigorously defend our position that royalties are not owed on the service-based revenues in dispute.

     There may be patents and patent applications owned by others relating to laser and fiber-optic technologies, which, if determined to be valid and enforceable, may be infringed by Spectranetics. Holders of certain patents, including holders of patents involving the use of lasers in the body, may contact us and request that we enter into license agreements for the underlying technology. For example, we have been made aware of a patent issued to Dr. Peter Rentrop for a certain catheter with a diameter of less than 0.9 millimeters and are currently involved in litigation regarding this patent. See Part II, Item 1 - Legal Proceedings for further discussion of this litigation. We cannot guarantee a patent holder will not file a lawsuit against us and prevail. If we decide that we need to license technology, we may be unable to obtain these licenses on favorable terms or at all. We may not be able to develop or otherwise obtain alternative technology.

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Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition (cont’d)

     Litigation concerning patents and proprietary rights is time-consuming, expensive, unpredictable and could divert the efforts of our management. An adverse ruling could subject us to significant liability, require us to seek licenses and restrict our ability to manufacture and sell our products.

     Our Stock Price May Continue To Be Volatile. The market price of our common stock, similar to other small-cap medical device companies, has been, and is likely to continue to be, highly volatile. The following factors may significantly affect the market price of our common stock:

•		fluctuations in operating results;
•		announcements of technological innovations or new products by Spectranetics or our competitors;
•		governmental regulation;
•		developments with respect to patents or proprietary rights;
•		public concern regarding the safety of products developed by Spectranetics or others;
•		the initiation or cessation in coverage of our common stock, or changes in ratings of our common stock, by securities analysts;
•		past or future management changes;
•		litigation;
•		general market conditions; and
•		financing of future operations through additional issuances of equity securities, which may result in dilution to existing stockholders and falling stock prices.

     Protections Against Unsolicited Takeovers in Our Rights Plan, Charter and Bylaws May Reduce or Eliminate Our Stockholders’ Ability To Resell Their Shares at a Premium Over Market Price. We have a stockholders’ rights plan that may prevent an unsolicited change of control of Spectranetics. The rights plan may adversely affect the market price of our common stock or the ability of stockholders to participate in a transaction in which they might otherwise receive a premium for their shares. Under the rights plan, rights to purchase preferred stock in certain circumstances have been issued to holders of outstanding shares of common stock, and rights will be issued in the future for any newly issued common stock. Holders of the preferred stock are entitled to certain dividend, voting and liquidation rights that could make it more difficult for a third party to acquire Spectranetics. No preferred stock has been issued under the stockholders’ rights plan.

     Our charter and bylaws contain provisions relating to issuance of preferred stock, special meetings of stockholders and amendments of the bylaws that could have the effect of delaying, deferring or preventing an unsolicited change in the control of Spectranetics. Our Board of Directors is elected for staggered three-year terms, which prevents stockholders from electing all directors at each annual meeting and may have the effect of delaying or deferring a change in control.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

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     We are exposed to a variety of risks, including changes in interest rates affecting the return on our investments and foreign currency fluctuations. Our exposure to market rate risk for changes in interest rates relate primarily to our investment portfolio. We attempt to place our investments with high quality issuers and, by policy, limit the amount of credit exposure to any one issuer and do not use derivative financial instruments in our investment portfolio. We maintain an investment portfolio of various issuers, types and maturities, which consist of both fixed and variable rate financial instruments. Marketable securities are classified as available-for-sale, and consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as a separate component in stockholders’ equity, net of applicable taxes. At any time, sharp changes in interest rates can affect the value of our investment portfolio and its interest earnings. Currently, we do not hedge these interest rate exposures. Since our investment securities have maturities that are generally less than one year and never more than two years, we do not expect interest rate fluctuations to have a significant impact on the fair value of our investment securities. As of September 30, 2004, the unrealized loss on our investment securities was approximately $16,000.

     Our exposure to foreign currency fluctuations is primarily related to sales of our products in Europe, which are denominated in the euro. Changes in the exchange rate between the euro and the U. S. dollar could adversely affect our revenue and net income. Exposure to foreign currency exchange rate risk may increase over time as our business evolves and our products continue to be introduced into international markets. Currently, we do not hedge against any foreign currencies and, as a result, could incur unanticipated gains or losses. Fluctuation in euro currency rates during the nine months ended September 30, 2004 as compared with the nine months ended September 30, 2003, caused an increase in consolidated revenue and operating expenses of one percent.

Item 4. Controls and Procedures

     We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

     As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision of and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

     There has been no change in our internal controls over financial reporting during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

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Part II—OTHER INFORMATION

Item 1. Legal Proceedings

     In July, 2003, Spectranetics filed a complaint in the United States District Court for the District of Colorado against Dr. Peter Rentrop, which Spectranetics amended in September, 2003, seeking declaratory relief that (1) Spectranetics’ products do not infringe any claims of Dr. Rentrop’s United States Patent No. 6,440,125 (the “’125 patent”); (2) the claims of the ‘125 patent are invalid and unenforceable; and (3) in the event that the Court finds that the claims of the patent to be valid and enforceable, that Spectranetics is, through its employees, a joint owner of any invention claimed in the ’125 patent. Spectranetics also brought claims against Dr. Rentrop for damages based upon Dr. Rentrop’s (1) misappropriation of Spectranetics’ trade secrets; (2) breach of the parties’ Confidentiality Agreement; and (3) wrongful taking of Spectranetics’ confidential and proprietary information.

     On January 6, 2004, the United States Patent and Trademark Office issued to Dr Rentrop a continuation patent to the ‘125 patent, United States Patent No. 6,673,064 (the “’064 patent”). On the same day, Dr. Rentrop filed in the United States District Court for the Southern District of New York, a complaint for patent infringement against Spectranetics, under the ‘064 patent (the “New York case”).

     On January 26, 2004, the Court in Colorado granted Dr. Rentrop’s Motion to Dismiss the Amended Complaint on the basis that the Court lacked personal jurisdiction over Dr. Rentrop, a resident of New York. Spectranetics decided to forgo appealing that decision, thus, there no longer is any case pending in Colorado.

     On March 9, 2004, Spectranetics filed its Answer, Affirmative Defenses and Counterclaims against Dr. Rentrop in the New York case. Spectranetics’ claim is that, in connection with consultation services provided to Spectranetics by Dr. Rentrop, Spectranetics provided Dr. Rentrop with confidential and proprietary information concerning certain of Spectranetics’ laser catheter technology. Spectranetics claims that rather than keeping such information confidential as required by agreement with Spectranetics, Dr. Rentrop used the information to file patent applications associated with the ‘125 and ‘064 patents, which incorporate and claim inventions to which Spectranetics’ personnel contributed significantly and materially, if not exclusively, thus entitling Spectranetics’ personnel to designation at least as co-inventors. Spectranetics also seeks declaratory judgments of non infringement, invalidity and unenforceability of the patents-in-suit, and has alleged counterclaims against Dr. Rentrop for breach of confidentiality agreement, misappropriation of trade secrets, and conversion. The discovery phase of this case is nearly complete and a trial date has not yet been set

     On June 24, 2004, the Court of Appeal of Amsterdam rejected an appeal made by Spectranetics International, B.V. (Spectranetics BV), on a judgment awarded to Cardiomedica S.p.A. (Cardiomedica), an Italian company, by the District Court of Amsterdam. Cardiomedica originally filed the suit in July 1999, and the lower court’s judgment was rendered on April 3, 2002. The Court of Appeal of Amsterdam affirmed the lower court’s opinion that an exclusive distributor agreement for the Italian market was entered into between the parties for the three-year period ending December 31, 2001, and that Cardiomedica may exercise its right to compensation from Spectranetics BV for its loss of profits during such three-year period. The appellate court awarded Cardiomedica the costs of the appeal, which approximated $20,000, and has referred the case back to the lower court for determination of the loss of profits. Cardiomedica asserts lost profits of approximately $1,500,000, which is based on their estimate of potential profits during the three-year period. Spectranetics BV estimates that the lost profits to Cardiomedica totaled $129,000 for the three-year period, with such estimate being based on actual profits earned in the Italian market during the period by Spectranetics B.V.’s actual distributor. We intend to

Page 26

vigorously defend the calculation of lost profits. The total of the court costs awarded and our calculated estimated lost profits have been included in accrued liabilities as of September 30, 2004.

     On or about August 30, 2004, SurModics filed a lawsuit against Spectranetics in the United States District Court for the District of Minnesota, alleging that Spectranetics underpaid royalties for the period since January 2001 under a license agreement with SurModics. SurModics claims that Spectranetics took improper deductions from royalty-bearing revenue, resulting in alleged underpayment. Spectranetics disagrees with SurModics’ allegations and intends to defend itself vigorously. The parties have agreed to an extension of Spectranetics’ formal answer in the proceedings while settlement discussions continue.

     The Company is involved in other legal proceedings in the normal course of business and does not expect them to have a material adverse effect on our business.

Items 2-5. Not applicable

Item 6. Exhibits

Exhibits.

31.1(a) Rule 13(a)-14(a)/15d-14(a) Certification.

31.1(b) Rule 13(a)-14(a)/15d-14(a) Certification.

32.1(a) Section 1350 Certification.

32.1(b) Section 1350 Certification

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.

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Index to Exhibits

31.1(a) Rule 13(a)-14(a)/15d-14(a) Certification.

31.1(b) Rule 13(a)-14(a)/15d-14(a) Certification.

32.1(a) Section 1350 Certification.

32.1(b) Section 1350 Certification

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