-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, S+sbmzRBsn37md1v4Xs2YyApamjlP9UJPZH9MS+c/g5fbR0YSDGTSrQmx0v3NArm mDJTYq14wgGZvHK5ycgLiQ== 0000950134-05-009646.txt : 20050510 0000950134-05-009646.hdr.sgml : 20050510 20050510154551 ACCESSION NUMBER: 0000950134-05-009646 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20050331 FILED AS OF DATE: 20050510 DATE AS OF CHANGE: 20050510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRANETICS CORP CENTRAL INDEX KEY: 0000789132 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 840997049 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-19711 FILM NUMBER: 05816485 BUSINESS ADDRESS: STREET 1: 96 TALAMINE COURT CITY: COLORADO SPRING STATE: CO ZIP: 80907 BUSINESS PHONE: 7196338333 MAIL ADDRESS: STREET 1: 96 TALAMINE COURT CITY: COLORADO SPRINGS STATE: CO ZIP: 80907 FORMER COMPANY: FORMER CONFORMED NAME: THE SPECTRANETICS CORP DATE OF NAME CHANGE: 19900510 10-Q 1 d25231e10vq.htm FORM 10-Q e10vq
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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

þ    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED

March 31, 2005

o    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM                      TO                     

Commission file number 0-19711

The Spectranetics Corporation

(Exact name of Registrant as specified in its charter)
     
Delaware   84-0997049
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer Identification No.)

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 ¨

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

As of May 5, 2005 there were 25,778,542 outstanding shares of Common Stock.

 
 

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Part I—FINANCIAL INFORMATION
Item 1. Financial Statements
Item 1. Unaudited Notes to Condensed Consolidated Financial Statements
Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Part II—OTHER INFORMATION
Item 1. Legal Proceedings
Item 5. Other Information
Item 6. Exhibits
SIGNATURES
EXHIBIT INDEX
Consulting Agreement
Settlement and Amendment to License Agreement
Rule 13a-14(a)/15d-14(a) Certification
Rule 13a-14(a)/15d-14(a) Certification
Section 1350 Certification
Section 1350 Certification


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Part I—FINANCIAL INFORMATION

Item 1. Financial Statements

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

                 
    March 31, 2005     December 31, 2004  
Assets:
               
Current assets:
               
Cash and cash equivalents
  $ 2,571     $ 4,004  
Investment securities available for sale
    7,956       9,963  
Trade accounts receivable, net of allowances of $200 and $239, respectively
    6,288       6,456  
Inventories, net
    2,657       1,782  
Deferred income taxes, net
    77       88  
Prepaid expenses and other current assets
    794       835  
 
           
Total current assets
    20,343       23,128  
Property, plant and equipment, net of accumulated depreciation of $9,876 and $10,183, respectively
    5,726       4,362  
Goodwill, net
    308       308  
Other intangible assets, net
    106       124  
Long-term deferred income taxes, net
    1,481       1,527  
Other assets
    125       146  
Long-term investment securities available for sale
    5,414       3,443  
 
           
Total Assets
  $ 33,503     $ 33,038  
 
           
Liabilities and Shareholders’ Equity:
               
Current liabilities:
               
Accounts payable and accrued liabilities
  $ 7,152     $ 7,499  
Deferred revenue
    1,788       1,967  
 
           
Total current liabilities
    8,940       9,466  
Deferred revenue, net of current portion
    39       56  
Other long-term liabilities
    24       27  
 
           
Total liabilities
    9,003       9,549  
 
           
Shareholders’ Equity:
               
Preferred stock, $.001 par value authorized 5,000,000 shares; none issued
           
Common stock, $.001 par value authorized 60,000,000 shares; issued and outstanding 25,758,078 and 25,377,939 shares, respectively
    26       25  
Additional paid-in capital
    97,872       96,823  
Accumulated other comprehensive income (loss)
    (64 )     50  
Accumulated deficit
    (73,334 )     (73,409 )
 
           
Total shareholders’ equity
    24,500       23,489  
 
           
Total Liabilities and Shareholders’ Equity
  $ 33,503     $ 33,038  
 
           

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 (Loss)
(In Thousands, Except Percentages, Share and Per Share Amounts)
(Unaudited)

                 
    Three Months Ended March 31,  
    2005     2004  
Revenue
  $ 9,053     $ 7,787  
Cost of revenue
    2,176       2,131  
 
           
Gross margin
    6,877       5,656  
 
           
Gross margin %
    76 %     73 %
Operating expenses:
               
Selling, general and administrative
    5,384       4,410  
Research, development and other technology
    1,465       1,119  
 
           
Total operating expenses
    6,849       5,529  
 
           
Operating income
    28       127  
Other income:
               
Interest income
    99       27  
Other, net
    5       2  
 
           
Total other income
    104       29  
 
           
Income before income taxes
    132       156  
Income tax expense
    (57 )     (21 )
 
           
Net income
    75       135  
Other comprehensive income (loss):
               
Foreign currency translation
    (78 )     (28 )
Unrealized loss on investment securities
    (36 )      
 
           
Comprehensive income (loss)
  $ (39 )   $ 107  
 
           
 
               
Net income per share – basic and diluted
  $ 0.00     $ 0.01  
 
           
 
               
Weighted average shares outstanding:
               
Basic
    25,663,217       24,655,299  
 
           
Diluted
    27,640,550       26,584,163  
 
           

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)

                 
    Three Months Ended March 31,  
    2005     2004  
Cash flows from operating activities:
               
Net income
  $ 75     $ 135  
Adjustments to reconcile net income to net cash used by operating activities:
               
Depreciation and amortization
    398       397  
Fair value of options granted for consulting services
    3       12  
Deferred income taxes
    57        
Net change in operating assets and liabilities
    (1,544 )     (587 )
 
           
Net cash used by operating activities
    (1,011 )     (43 )
 
           
Cash flows from investing activities:
               
Capital expenditures
    (1,421 )     (84 )
Sales of investment securities
    2,001        
Purchases of investment securities
    (2,001 )      
Net change in restricted cash
          1,133  
 
           
Net cash provided (used) by investing activities
    (1,421 )     1,049  
 
           
Cash flows from financing activities:
               
Proceeds from sale of common stock
    1,048       691  
 
           
Net cash provided by financing activities
    1,048       691  
 
           
Effect of exchange rate changes on cash
    (49 )     (30 )
 
           
Net increase (decrease) in cash and cash equivalents
    (1,433 )     1,667  
Cash and cash equivalents at beginning of period
    4,004       11,281  
 
           
Cash and cash equivalents at end of period
  $ 2,571     $ 12,948  
 
           
 
               
Supplemental disclosures of cash flow information —
               
 
               
Cash paid for taxes
  $ 9     $ 25  
 
           

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 design, manufacture, market and distribute single-use medical devices used in minimally invasive surgical 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 blockages. 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. In April 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 condensed 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 condensed 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 such 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 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

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(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 ended March 31, 2005 and 2004 (in thousands, except per share amounts):

                 
    Three months ended  
    March 31,  
    2005     2004  
Net income, as reported
  $ 75     $ 135  
Deduct: Total stock-based employee compensation expense attributable to Common stock options determined under fair value based method, net of related tax effects
    (160 )     (120 )
     
Pro forma net income (loss)
  $ (85 )   $ 15  
     
Net income per share – basic and diluted, as reported
  $ 0.00     $ 0.01  
Net income (loss) per share – basic and diluted, pro forma
    (0.00 )     0.00  

     The per share weighted-average fair value of stock options granted during the first quarter of 2005 and 2004 was $5.29 and $4.05, respectively, on the date of grant 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 ended March 31, 2005 and 2004:

                 
    Three months ended  
    March 31,  
    2005     2004  
Expected life (years)
    5.59       5.40  
Risk-free interest rate
    4.17 %     2.78 %
Expected volatility
    156.8 %     118.6 %
Expected dividend yield
  None   None

(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 the portion of the period that they were outstanding. Diluted earnings per share are 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 March 31, 2005 and 2004, 637,292 and 1,038,392 stock options, respectively, were excluded from the computation of diluted earnings per share due to their antidilutive

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effect. A summary of the net income per share calculation is shown below (in thousands, except per share amounts):

                 
    Three months ended  
    March 31,  
    2005     2004  
Net income
  $ 75     $ 135  
 
           
 
               
Common shares outstanding:
               
Historical common shares outstanding at beginning of period
    25,378       24,452  
Weighted average common shares issued
    285       203  
 
           
Weighted average common shares outstanding – basic
    25,663       24,655  
Effect of dilution from stock options
    1,978       1,929  
 
           
Weighted average common shares outstanding – diluted
    27,641       26,584  
 
           
 
               
Net income per share – basic and diluted
  $ 0.00     $ 0.01  
 
           

(4) Inventories

     Inventories consist of the following (in thousands):

                 
    March 31, 2005     December 31, 2004  
Raw materials
  $ 837     $ 411  
Work in process
    880       351  
Finished goods
    975       1,049  
Less reserve for obsolescence
    (35 )     (29 )
 
           
 
  $ 2,657     $ 1,782  
 
           

(5) Property, Plant and Equipment

     Property, plant and equipment consist of the following (in thousands):

                 
    March 31, 2005     December 31, 2004  
Land
  $ 270     $  
Building
    1,080        
Manufacturing equipment and computers
    5,798       6,283  
Leasehold improvements
    1,014       1,014  
Equipment held for rental or loan
    7,258       7,064  
Furniture and fixtures
    182       184  
Less accumulated depreciation
    (9,876 )     (10,183 )
 
           
 
  $ 5,726     $ 4,362  
 
           

     On March 29, 2005, the Company acquired the building and land which houses its manufacturing facilities for $1,350,000 in cash. The purchase price was allocated between land and building based on the relative fair value of the assets acquired.

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     Property and equipment are recorded at cost. Repairs and maintenance costs are expensed as incurred. Equipment acquired under capital leases is recorded at the present value of minimum lease payments at the inception of the lease.

     Depreciation is calculated using the straight-line method over the estimated useful lives of the assets of three to five years for manufacturing equipment, computers, and furniture and fixtures. Equipment held for rental or loan is depreciated using the straight-line method over three to five years. Equipment acquired under capital leases and leasehold improvements are amortized using the straight-line method over the shorter of the lease term or estimated useful life of the asset. The building is depreciated using the straight-line method over its remaining estimated useful life of 20 years.

(6) Deferred Revenue

     Deferred revenue was $1,827,000 and $2,023,000 at March 31, 2005 and December 31, 2004, respectively. These amounts primarily 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”.

(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, which is the development, manufacture, marketing and distribution of 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 March 31, 2005, FDA-approved products were used in multiple vascular procedures, including coronary and peripheral atherectomy as well as the removal of nonfunctioning leads from pacemakers and cardiac defibrillators. In April 2004, the Company received 510(k) clearance from the FDA to sell fiber-optic delivery devices for the treatment of 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 March 31, 2005 and 2004, cost allocations of these functions to Europe Medical have not been performed.

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     Manufacturing activities are performed primarily within the U.S. Medical segment. Revenue associated with intersegment transfers to Europe Medical was $507,000 and $456,000 for the three months ended March 31, 2005 and 2004, 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 Europe as well as the Middle East. Products offered by this reportable segment are the same as those offered by U.S. Medical. 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 atherectomy to clear blockages in leg arteries.

     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):

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Revenue:
               
U.S. Medical
  $ 7,925     $ 7,086  
Europe Medical
    1,128       701  
 
           
Total revenue
  $ 9,053     $ 7,787  
 
           
                 
    Three Months Ended  
    March 31,  
    2005     2004  
Segment net income (loss):
               
U.S. Medical
  $ (88 )   $ 185  
Europe Medical
    163       (50 )
 
           
Total net income
  $ 75     $ 135  
 
           
                 
    March 31,     December 31,  
    2005     2004  
Segment assets:
               
U.S. Medical
  $ 30,906     $ 29,786  
Europe Medical
    2,597       3,252  
 
           
Total assets
  $ 33,503     $ 33,038  
 
           

(8) Income Taxes

     The Company accounts for income taxes pursuant to Statement of Financial Accounting Standards No. 109, Accounting for Income Taxes, which requires the use of the asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future

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tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards.

     A valuation allowance is required to the extent it is more likely than not that a deferred tax asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.

     In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the projected future taxable income, and tax planning strategies in making this assessment. In 2004, based upon the level of historical income and projections for future income, management determined it is more likely than not a portion of the deferred tax assets will be recoverable. As of March 31, 2005, the net deferred tax asset totaled $1,558,000.

     Income tax expense (benefit) attributable to income before income taxes consists of the following (in thousands):

                 
    Three months ended  
    March 31,  
    2005     2004  
Current:
               
Federal
  $     $  
State
          21  
Foreign
           
 
           
 
          21  
 
           
Deferred:
               
Federal
    74        
State
    10        
Foreign
    (27 )      
 
           
 
    57        
 
           
Income tax expense
  $ 57     $ 21  
 
           

(9) Revenue Recognition

     Revenue from the sale of the Company’s disposable products is recognized when products are shipped to the customer and title transfers. Revenue from the sale of excimer laser systems is recognized after completion of contractual obligations, which generally include delivery and installation of the systems and in some cases completion of physician training. The Company’s field service engineers are responsible for installation of each laser and participation in the training program at each site. The Company generally provides a one-year warranty on laser sales, which includes parts, labor and replacement gas. Upon expiration of the warranty period, the Company offers similar service to its customers under service contracts or on a fee-for-service basis. Revenue allocated to service contracts is initially recorded as deferred revenue and recognized over the related service contract period, which is

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generally one year. Revenue from fee-for-service arrangements is recognized upon completion of the related service.

     The Company adopted Emerging Issues Task Force Bulletin (EITF) 00-21, Revenue Arrangements with Multiple Deliverables, on July 1, 2003, which resulted in a modification of the Company’s revenue recognition policy for the sale of a laser. The primary impact of the adoption of EITF No. 00-21 is to treat service provided during the one-year warranty period as a separate unit of accounting. As such, the fair value of this service is deferred and recognized as revenue on a straight-line basis over the related warranty period and warranty costs are expensed in the period they are incurred. Revenue allocated to the laser element is recognized upon completion of all contractual obligations in the sales contract, which generally includes delivery and installation of the laser system and in some cases completion of physician training. Deferred revenue associated with service to be performed during the warranty period totaled $229,000 and $302,000 as of March 31, 2005 and December 31, 2004, respectively.

     The Company offers two laser system placement programs, which are described below, in addition to the sale of laser systems:

     Evergreen rental program — Rental revenue under this program varies on a sliding scale depending on the customer’s catheter purchases 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 sales based upon a three- to five-year expected life of the unit. As of March 31, 2005, 52 laser units were in place under the Evergreen program.

     Evaluation programs — The Company “loans” 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 the Company’s 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 upon a three- to five-year expected life of the unit. As of March 31, 2005, 85 laser units were in place under the evaluation program.

(10) Commitments and Contingencies

     In August 2004, one of the Company’s licensors filed a lawsuit against the Company alleging that the Company underpaid royalties since January 2001 under a license agreement with the licensor. The licensor claimed that the Company took improper deductions from royalty-bearing revenue, resulting in an underpayment of the license fee. In February 2005, the Company settled its dispute with the licensor and executed an amendment to the license agreement that incorporated such settlement. Under the terms of the amendment, which has a noncancelable term of four years, the Company agreed to pay the licensor $275,000 in back royalties. Such amount was included in accrued liabilities at December 31, 2004 and paid in February 2005. Additionally, the license was converted to non-exclusive and the royalty rate for products sold using the associated technology was reduced effective October 1, 2004. The Company also agreed to increase its minimum quarterly royalty payment to $50,000 from $25,000 beginning July 1, 2005.

     The Company has a disagreement with another licensor regarding the level of past royalty payments since inception of a license agreement that was executed in October 2000. The disagreement over past royalty payments centers on the treatment of certain service-based revenue, including repair and maintenance, and physician and clinical training services. Management believes that these are beyond the scope of the license agreement. In August 2004, the licensor commenced arbitration proceedings as provided for under the license agreement, and a resolution to the matter is anticipated in mid to late 2005. The Company has accrued costs of approximately $1,826,000 associated with the resolution of this matter as of March 31, 2005, which represents management’s best estimate of costs to resolve the matter. Management intends to vigorously defend its position in such arbitration proceedings.

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     On June 24, 2004, the Court of Appeal of Amsterdam rejected an appeal made by the Company on a judgment awarded to an Italian distributor (the Distributor) by the District Court of Amsterdam. The Distributor originally filed suit in July 1999, and the lower court’s judgment was rendered in April 2002. The Court of Appeal of Amsterdam affirmed the lower court’s opinion than an exclusive distributor agreement for the Italian market was entered between the parties for the three-year period ending December 31, 2001, and that the Distributor may exercise its right to compensation from the Company for its loss of profits during such three-year period. The appellate court awarded the Distributor the costs of the appeal and has referred the case back to the lower court for determination of the loss of profits. The Distributor asserts lost profits of approximately $1,500,000, which is based on their estimate of potential profits during the three-year period. The Company estimates that the lost profits to the Distributor for the period, plus estimated interest and awarded court costs, totaled approximately $260,000. Such amount was included in accrued liabilities at March 31, 2005. The Company intends to vigorously defend the calculation of lost profits.

     The Company is involved in various other claims and legal actions arising in the ordinary course of business, which, in the opinion of management, the ultimate disposition of such matters will not have a material adverse effect on the Company’s consolidated financial position, results of operations, or liquidity.

(11) Related Party Transaction

     In February 2005, the Company entered into an agreement with a director of the Company whereby the director agreed to provide training services to outside physicians on behalf of the Company. The total to be paid under the agreement, which expires on December 31, 2005, is $75,000. During the first quarter of 2005, the total amount incurred for training services provided by the director totaled $18,750.

(12) Reclassifications

     Certain amounts from prior condensed financial statements have been reclassified to conform with the March 31, 2005 presentation.


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 31, 2005. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events.

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

Corporate Overview

     We develop, manufacture, market and distribute single-use medical devices used in minimally invasive surgical procedures within the vascular system in conjunction with our proprietary excimer laser system. Excimer laser technology delivers comparatively cool ultraviolet energy 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. Our laser system is typically used adjunctively with balloon catheters and cardiovascular stents. We compete with alternative technologies including mechanical atherectomy and thrombectomy devices. In April 2004, we obtained 510(k) marketing clearance from the Food and Drug Administration (FDA) for a laser-based treatment of total occlusions (blockages) in the legs not crossable with a guidewire. Some of the patients with total occlusions in the leg suffer from critical limb ischemia (CLI), a debilitating condition that begins with resting leg pain and often leads to tissue loss or amputation as a result of a lack of blood flow to the legs.

     Although 88% of our revenue was derived in the United States for the three months ended March 31, 2005, we also have regulatory approval to market our products in two key international markets. In Europe, we have the required approvals to market our products for the same indications that are approved in the United States. We have also received approval to market certain coronary atherectomy products in Japan, and are seeking additional approvals there for our newer coronary, peripheral and lead removal products. In 2003, we appointed a new distributor, DVx Japan, who is assisting us in pursuing reimbursement approval. We currently expect reimbursement approval in 2006, although there are no assurances that reimbursement will be received then, if at all. We do not expect significant revenue increases in Japan until reimbursement is received.

     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).

     In April 2004, we received 510(k) marketing 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) and acute myocardial infarction (AMI, or heart attack). The CORAL trial, which is being conducted in the U.S., is a study of the use of laser atherectomy to treat

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

blockages within sapheneous vein grafts. We enrolled almost 100 patients in 18 hospitals, with 2/3 of the patients having lesions where distal protection could not be used due to lesion location or inability to place the filter. The primary endpoint for the CORAL trial is a measurement of the complication rates, known as major adverse cardiac events (MACE). The MACE rates from the CORAL trial will be compared to MACE rates associated with the SAFER trial sponsored by Medtronic, which measured MACE rates using distal protection devices. The goal of this trial is to demonstrate the safety and efficacy of the laser in relation to distal protection devices, which are widely used and were proven to reduce MACE rates in the SAFER clinical trial. We had hoped to match the previously published complication rates of 10% with distal protection versus the complication rates of 17% using balloon and stents alone. Based on our analysis of the data which is not yet complete, it appears that we didn’t meet our endpoint in this pilot study as our complication rates were similar to balloon and stents and higher than distal protection. We believe that our patients may have had more difficult lesions, which could influence the final clinical outcomes. We are currently working with the core lab to finalize the statistical analysis and determine our next steps. Our investigators remain convinced that using the laser in the treatment of saphenous vein grafts, either alone when distal protection cannot be deployed or in combination when it can, will reduce complication rates.

     The Extended FAMILI trial is a feasibility trial that will benchmark quantitative endpoints common in other AMI trials, such as myocardial blush scores and the reduction in infarct size for the subset of patients. Enrollment in the trial has been slow but is expected to be completed by the end of the second quarter. We expect to have the 30-day follow-up and analysis complete in the third quarter. After completion of the data analysis, a decision will be made whether to pursue a pivotal, randomized trial that, if commenced, may take two to three years to complete.

     We are also considering the initiation of additional clinical research during 2005 focused on the treatment of peripheral vascular disease and chronic total occlusions in the coronary vascular system.

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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.

                                         
    2004     2005  
(000’s, except per share amounts)   1st Qtr     2nd Qtr     3rd Qtr     4th Qtr     1st Qtr  
                                         
Laser Revenue:
                                       
Equipment sales
  $ 438     $ 398     $ 665     $ 930     $ 416  
Rental fees
    323       336       347       335       367  
 
                             
Total laser revenue
    761       734       1,012       1,265       783  
 
                                       
Disposable Products Revenue:
                                       
Atherectomy revenue
    3,075       3,474       3,366       3,605       3,373  
Lead removal revenue
    2,638       3,109       3,213       3,177       3,433  
 
                             
Total disposable products revenue
    5,713       6,583       6,579       6,782       6,806  
 
                                       
Service and other revenue
    1,313       1,340       1,343       1,283       1,464  
 
                                       
Total revenue
    7,787       8,657       8,934       9,330       9,053  
 
                                       
Net income
    135       401       479       1,937       75  
Net income per share:
                                       
Basic
    0.01       0.02       0.02       0.08       0.00  
Diluted
    0.01       0.01       0.02       0.07       0.00  
 
                                       
Net cash provided by (used in) operating activities
    (43 )     228       (78 )     1,069       (1,011 )
Total cash and investment securities-current and non-current
    14,948       15,963       16,189       17,410       15,941  
 
                                       
Laser sales summary:
                                       
Laser sales from inventory
    1       1       3       3       2  
Laser sales from evaluation/rental units
    2       3       4       4       1  
 
                             
Total laser sales
    3       4       7       7       3  
 
                                       
Worldwide Installed Base Summary:
                                       
Laser sales from inventory
    1       1       3       3       2  
Rental placements
    0       0       0       1       1  
Evaluation placements
    6       8       9       15       16  
 
                             
Laser placements during quarter
    7       9       12       19       19  
Buy-backs/returns during quarter
    (2 )     (3 )     (2 )     (6 )     (7 )
 
                             
Net laser placements during quarter
    5       6       10       13       12  
Total lasers placed at end of quarter
    388       394       404       417       429  

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

Three Months Ended March 31, 2005, Compared with Three Months Ended March 31, 2004

     Revenue for the first quarter of 2005 was $9,053,000, up 16 percent as compared with $7,787,000 in the first quarter of 2004. The increase is due to a 19 percent increase in disposable product revenue, a three percent increase in equipment revenue, and a 12 percent increase in service and other revenue.

     The increase in disposable product revenue was almost entirely due to unit volume increases; however, a small price increase initiated in April 2004 across most of our disposable products contributed to a portion of the revenue growth in the first quarter of 2005 compared to the first quarter of 2004.

     We separate our disposable products revenue into two separate categories – atherectomy and lead removal. For the three months ended March 31, 2005, our atherectomy revenue totaled $3,373,000 (50% of our disposable product revenue) and our lead removal revenue totaled $3,433,000 (50% of our disposable product revenue). For the three months ended March 31, 2004, our atherectomy revenue totaled $3,075,000 (54% of our disposable product revenue) and our lead removal revenue totaled $2,638,000 (46% of our disposable product revenue). Atherectomy revenue, which includes products used in both the coronary and peripheral vascular system, grew 10% in the first quarter of 2005 as compared with the first quarter of 2004. Atherectomy revenue growth was primarily due to the launch of our CliRpath product line in May 2004, following the April 2004 FDA clearance to market these products to treat total occlusions in the legs that are not crossable with a guidewire. The FDA clearance covered catheter sizes ranging from .9 millimeters in diameter to 2.5 millimeters in diameter. Most of these catheters were marketed for coronary use prior to the FDA clearance; however, the catheters with a diameter from 2.0 to 2.5 millimeters were new products not previously marketed. These new catheters accounted for $987,000 of revenue for the first quarter of 2005 which accounted for the revenue growth within the atherectomy product line. Atherectomy revenue growth from current levels will depend on our ability to increase market acceptance of our CliRpath product line, and future success of our ongoing clinical research and product development within the coronary and peripheral atherectomy markets.

     Lead removal revenue grew 30% for the three month period ended March 31, 2005 as compared with the same three month period in 2004. We continue to believe our lead removal revenue is increasing primarily as a result of the increase in the 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. Recent clinical studies (MADIT and ScD-Heft) have expanded the patient population that may benefit from defibrillator implants. The results of the MADIT clinical trial became available in 2003 and ScD-Heft clinical trials were made public in February 2004. Growth in the implantable defibrillator market may accelerate, depending on the establishment of referral patients to electrophysiologists for this expanded patient pool and the additional reimbursement recently established for the hospitals and electrophysiologists who treat these patients. Generally, growth in the implantable defibrillator market contributes to growth in our lead removal business. Although we expect our lead removal business to continue to grow, there can be no assurances to that effect. The current standard of care in this market is to cap leads and leave them in the body rather than lead removal. We have initiated programs to examine the costs and frequency of complication associated with abandoned leads, but there are no assurances that these programs will be successful or will change the current standard of care.

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

     Laser equipment revenue was $783,000 and $761,000 for the three months ended March 31, 2005 and 2004, respectively. We sold 3 laser units (either an outright sale from inventory or a sale conversion from evaluation or rental programs) during each three month period, which accounts for the comparable laser sales revenue of $416,000 in the first quarter of 2005 and $438,000 in the first quarter of 2004. Rental revenue increased 14% during the three month period ended March 31, 2005, from $323,000 in the first quarter of 2004 to $367,000 in the first quarter of 2005. This increase is consistent with the increase in our installed rental base of laser systems.

     Service revenue and other revenue in the first quarter of 2005 was $1,464,000 compared with $1,313,000 during the same quarter last year. The change is attributable to an increased installed base of excimer laser systems.

     Gross margin increased to 76 percent during the three months ended March 31, 2005 from 73 percent for the first quarter of 2004. 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. Increased selling prices of disposable products, as discussed previously, also contributed to the improved gross margin.

     Operating expenses rose 24 percent to $6,849,000 in the three months ended March 31, 2005 from $5,529,000 in the same period of 2004. This increase is mainly due to a 22 percent increase in selling, general and administrative expenses and a 31 percent increase in research development and other technology expenses relative to the prior year period.

     Selling, general and administrative expenses were $5,384,000 for the three months ended March 31, 2005, as compared to the prior year period expenses of $4,410,000. The increase is primarily due to:

  •   Marketing and selling expenses increased $600,000 in the quarter compared with last year’s quarter primarily as a result of the following:

  •   Increased personnel-related costs of approximately $83,000 associated with the staffing of 9 additional employees within our clinical sales and training organization in the first quarter of 2005 as compared to the first quarter of 2004. These costs include salaries and related taxes, recruiting, and travel costs.
 
  •   Increased commissions of approximately $224,000, which is mainly due to the increase in revenue and additional employees.
 
  •   Increased marketing communication costs of approximately $57,000 which is mainly due to increased marketing literature for the promotion of the CliRpath product line.
 
  •   Increased convention, meeting and education costs of approximately $124,000, primarily the result of attendance at an increasing number of tradeshows and conventions, combined with additional physician training costs incurred primarily in peer-to-peer clinical training sessions, including a pilot training program focused on peripheral interventions, attended by approximately 40 physicians during the quarter.
 
  •   Increased depreciation costs of $48,000 associated with a higher number of evaluation systems in place at March 31, 2005 compared with 2004. Refer to the “Liquidity and Capital Resources” section of this report for a further discussion of these programs.
 
  •   Increased costs of approximately $59,000 associated with the operations of Spectranetics International B.V., our wholly-owned subsidiary located in The Netherlands that serves the European market. Approximately $41,000 is associated with the strengthening euro in relation to the U.S. dollar. The remaining increase is due to increased personnel-related costs.

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

  •   General and administrative expenses increased approximately $385,000 in the quarter compared with last year, primarily the result of the following:

  •   Increased legal fees of $160,000, primarily due to the legal proceedings associated with the Rentrop lawsuit. Legal matters are discussed within Part II, Item 1 — Legal Proceedings within this report.
 
  •   Increased audit and other fees totaling $225,000 due to the compliance requirements of the Sarbanes-Oxley legislation, specifically related to testing of our internal control system over financial reporting.

     Research, development and other technology expenses increased 31 percent to $1,465,000 for the first quarter of 2005 from $1,119,000 in the first quarter of 2004. 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. The increase is primarily due to:

  •   Increased royalty expenses of $16,000 as a result of higher revenues offset by a slight reduction of the royalty rate due to the expiration of certain patents underlying the licensed technology.
 
  •   Increased personnel-related costs of approximately $90,000 due to the hiring of additional engineering staff for the development of new catheter products.
 
  •   Increased product development costs of $208,000, related primarily to peripheral products.
 
  •   Increased clinical data costs of $75,000 primarily related to the advancement of clinical research focused on laser-based treatment of heart attacks, complications associated with capped pacemaker or defibrillator leads, and saphenous vein grafts.

     Interest income increased to $99,000 in the first quarter of 2005 as compared to $27,000 in 2004 due to higher yields on an increased balance of interest-bearing securities, which consist primarily of cash equivalents, and U.S. Treasury and agency notes. The higher yields are consistent with the overall change in the interest rate environment between the first quarter of 2004 and the first quarter of 2005.

     Net income for the three months ended March 31, 2005 was $75,000, compared with net income of $135,000 in the same quarter last year.

     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 March 31, 2005, as compared with the three months ended March 31, 2004, caused an increase of less than one percent in consolidated revenue and operating expenses.

Income Taxes

     The Company accounts for income taxes pursuant to Statement of Financial Accounting Standards No. 109, Accounting for Income Taxes, which requires the use of the asset and liability method

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

of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards.

     A valuation allowance is required to the extent it is more likely than not that a deferred tax asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.

     In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the projected future taxable income, and tax planning strategies in making this assessment. In 2004, based upon the level of historical income and projections for future income, management determined it is more likely than not a portion of the deferred tax assets will be recoverable. As of March 31, 2005, the net deferred tax asset totaled $1,558,000.

Liquidity and Capital Resources

     Cash, cash equivalents, and current and long-term investments in marketable securities as of March 31, 2005 were $15,941,000, a decrease of $1,469,000 from $17,410,000 at December 31, 2004. The primary reason for the decrease is due to the purchase of the building and land in March 2005 that houses our manufacturing facilities for $1,350,000. In addition, $275,000 was paid to a licensor in February 2005 for back royalties associated with an amendment to the license agreement with the licensor. The payment of the back royalties is discussed in Part II, Item 1 — Legal Proceedings within this report.

     Cash used by operating activities of $1,011,000 for the three months ended March 31, 2005 consisted primarily of the following:

  •   Increased inventories of $859,000, primarily the result of higher stocking levels to meet the anticipated increase in laser demand.
 
  •   Increase in equipment held for rental or loan of $349,000 as a result of expanding placement activity of our laser systems through evaluation or rental programs.
 
  •   Accounts payable and accrued liabilities decreased $321,000, primarily due to a decrease in royalty accruals of $161,000, a decrease in employee related accruals of $810,000, and a $58,000 decrease in other accruals, partially offset by an increase in accounts payable of $708,000.

     The above uses of cash by operating activities was offset by the following sources for the three months ended March 31, 2005:

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

  •   Net income of $75,000 for the three months ended March 31, 2005, plus non-cash expenses of $458,000, which consist of depreciation and amortization of $398,000, the fair value of options granted for consulting services of $3,000, and the recognition of deferred taxes of $57,000.
 
  •   A decrease in accounts receivable of $118,000, mainly due to a collection of a large past-due receivable by our foreign subsidiary.

     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 doubtful accounts, by the average daily sales for the first quarter. Inventory turns are calculated by dividing annualized cost of sales for the first quarter by ending inventory.

                 
    March 31, 2005     December 31, 2004  
Days Sales Outstanding
    63       61  
Inventory Turns
    3.3       4.9  

     The reduction in inventory turns is primarily due to the increase in inventory as of March 31, 2005 that was necessitated in order to meet the increased demand for our laser systems.

     For the three months ended March 31, 2005, cash used by investing activities was $1,421,000, primarily due to the purchase of the building and land that houses our manufacturing facilities for $1,350,000 and other capital expenditures of $71,000.

     Cash provided by financing activities for the three month period ended March 31, 2005 was $1,048,000, comprised entirely of proceeds from the sale of common stock to employees and former employees as a result of exercises of stock options and stock issuances under our employee stock purchase plan. At March 31, 2005, there was no debt or capital lease obligations.

     At March 31, 2005, and December 31, 2004, we had placed a number of laser systems on rental and loan programs. A total of $7,258,000 and $7,064,000 was recorded as equipment held for rental or loan at March 31, 2005 and December 31, 2004, respectively, and is being depreciated over three to five years, depending on whether the laser system is new or manufactured. The net book value of this equipment was $3,712,000 and $3,681,000 at March 31, 2005 and December 31, 2004, respectively.

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

  (1)   Evergreen rental program – Rental revenue under this program varies on a sliding scale depending on the customer’s catheter purchases 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 sales based upon a three- to five-year expected life of the unit. We also offer a straight monthly rental program and there are a small number of hospitals that pay $3000-$5000 per month under this program. As of March 31, 2005, 52 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

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

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 March 31, 2005, 85 laser units were in place under the evaluation program. These laser systems contribute to revenue immediately through the sales of disposable products to customers that have acquired a laser system under an evaluation program. During the three months ended March 31, 2005 and 2004, one customer and two customers, respectively, elected to purchase their evaluation laser systems, which accounted for a total of $119,000 and $267,000 of equipment revenue, respectively.

     We believe our liquidity and capital resources as of March 31, 2005 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 our shareholders or us.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

     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 31, 2005.

New Accounting Pronouncements

     In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payments (“Statement 123R”). Statement 123R, which is a revision of Statement 123 and supersedes APB Opinion No. 25, establishes standards for the accounting for transactions in which an entity exchanges its equity instruments for goods or services, primarily focusing on transactions in which an entity obtains employee services. Statement 123R also requires companies to measure the cost of employee services received in exchange for an award of equity instruments (such as stock options and restricted stock) based on the grant-date fair value of the award, and to recognize that cost over the period during which the employee is required to provide service (usually the vesting period of the award). Statement 123R also requires companies to measure the cost of employee services received in exchange for an award of liability instruments (such as stock appreciation rights) based on the current fair value of the award, and to remeasure the fair value of the award at each reporting date.

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

     Public companies are required to adopt Statement 123R as of the beginning of the first interim period that begins after December 15, 2005 (extended from the previous date of June 15, 2005). The provisions of Statement 123R will affect our accounting for all awards granted, modified, repurchased or cancelled after January 1, 2006. Our accounting for awards granted, but not vested, prior to January 1, 2006 will also be impacted. The provisions of Statement 123R allow companies to adopt the standard on a prospective basis or to restate all periods for which Statement 123 was effective. We expect to adopt Statement 123R on a prospective basis, and our financial statements for periods that begin after December 15, 2005 will include pro forma information as though the standard had been adopted for all periods presented.

     While we have not yet fully quantified the impact of adopting Statement 123R, we believe that such adoption could have a significant impact on our operating income and net earnings in the future. For the three months ended March 31, 2005 and 2004, pro forma compensation expense, net of tax, related to equity instruments was $160,000 and $120,000, respectively. These amounts were disclosed, but not recorded, in the financial statements for the three months ended March 31, 2005 and 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 March 31, 2005, we had accumulated $73.3 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. In addition, we expect the adoption of Statement 123R for periods that begin after December 15, 2005 will result in significant compensation expense in future periods. Although we have demonstrated profitability for eleven 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 penetrate the peripheral atherectomy market with 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. Additional clinical data and new products to treat coronary artery disease will likely be necessary to grow revenue within the coronary 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.

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

     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.

     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. Additionally, our field service organization consists primarily of individuals with extensive clinical experience within hospital catheterization labs; however, their sales experience is limited. We are providing sales training and, as we add new field sales employees, will attempt to recruit candidates with more sales experience. However, there are no assurances that our sales training and recruiting will improve productivity within our field sales organization. Further, there may be more turnover within the field sales organization relative to past history as a result of our transition towards a higher level of sales skills.

     Our Products May Not Achieve Market Acceptance. Excimer laser technology is generally used adjunctively 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 incremental clinical and economic data that shows the clinical efficacy and cost effectiveness of, and patient benefits from, excimer laser atherectomy used with balloon angioplasty and stent implantation.

     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).

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

     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. We believe we are the lead removal market leader and are focusing our efforts on growing the market for the removal of pacemaker and defibrillator leads.

     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;
 
  •   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 or other atherectomy devices, laser atherectomy requires the acquisition of 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 our coronary products states 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.

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

     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.

     We Are Exposed to the Problems That Come From Having International Operations. For the three months ended March 31, 2005, our revenue from international operations represented 12 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.

     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

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

less than 0.9 millimeters and are currently involved in litigation regarding this patent. See Part II, Item 1 — Legal Proceedings herein 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.

     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.

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

     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 March 31, 2005, the unrealized loss on our investment securities was approximately $101,000.

     As of March 31, 2005, we had cash and cash equivalents of $2.6 million, and current and long-term investment securities of $13.4 million. Overall average duration to maturity for all cash and investment securities is less than one year with 60% of the portfolio under one year and the remaining 40% between one and two years. At March 31, 2005, the investment securities consisted of government or government agency securities.

     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. For the three months ended March 31, 2005, and 2004, approximately $62,000 and $102,000, respectively, of increased revenue and $41,000 and $75,000, respectively, of increased operating expenses were the result of exchange rate fluctuations of the U.S. dollar in relation to the euro. Accordingly, the net impact of exchange rate fluctuations on consolidated net income for the three months ended March 31, 2005 and 2004 was an increase in net income of $21,000 and $27,000, respectively.

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.

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     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.

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 complete and a trial date has been set for September 2005.

     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

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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 for the period, plus estimated interest and awarded court costs, totaled $260,000 for the three-year period, and such amount is included in accrued liabilities at March 31, 2005. We intend to vigorously defend the calculation of lost profits.

     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 an alleged underpayment. In February 2005, Spectranetics settled its dispute with SurModics and executed an amendment to the license agreement that incorporated such settlement. Under the terms of the amendment, which has a noncancelable term of four years, Spectranetics agreed to pay SurModics $275,000 in back royalties. Such amount was included in accrued liabilities at December 31, 2004 and paid in February 2005. Additionally, the license was converted to nonexclusive and the royalty rate for products sold using the associated technology was reduced effective October 1, 2004. Spectranetics also agreed to increase its minimum quarterly royalty payment to $50,000 from $25,000 beginning July 1, 2005.

     Spectranetics has a disagreement with another licensor regarding the level of past royalty payments since inception of a license agreement that was executed in October 2000. The disagreement over past royalty payments centers on the treatment of certain service-based revenue, including repair and maintenance, and physician and clinical training services. We believe that these are beyond the scope of the license agreement. In August 2004, the licensor commenced arbitration proceedings as provided for under the license agreement, and a resolution to the matter in anticipated in mid to late 2005. Spectranetics has accrued costs of approximately $1,826,000 associated with the resolution of this matter as of March 31, 2005, which represents our best estimate of costs to resolve the matter. Management intends to vigorously defend its position in such arbitration proceedings.

     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 2-4. Not applicable

Item 5. Other Information

     As discussed in Note 11 of the unaudited notes to the condensed consolidated financial statements, in February 2005, the Company entered into an agreement with a Dr. Craig Walker, a director of the Company, whereby Dr. Walker agreed to provide training services to outside physicians on behalf of the Company. The total to be paid under the agreement to Dr. Walker is $75,000. The agreement expires on December 31, 2005.

     As discussed in Part II, Item 1 – Legal Proceedings, in February 2005, the Company settled its dispute with SurModics and executed an amendment to the license agreement that incorporated such settlement. Under the terms of the amendment, which has a noncancelable term of four years, the Company agreed to pay SurModics $275,000 in back royalties. Additionally, the license was converted to nonexclusive and the royalty rate for products sold was reduced effective October 1, 2004. The Company also agreed to increase its minimum quarterly royalty payment to $50,000 from $25,000 beginning July 1, 2005.

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Item 6. Exhibits

     Exhibits.

10.36 Consulting Agreement dated February 14, 2005 between the Company and Dr. Craig Walker.

10.37 Settlement and Amendment to License Agreement executed in February 2005 and effective October 1, 2004 between the Company and SurModics, Inc. (confidential treatment has been requested for portions of this agreement).

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.

         
    The Spectranetics Corporation
    (Registrant)
 
       
May 10, 2005
           By: /s/ John G. Schulte
       
             John G. Schulte
             President and Chief Executive Officer
 
       
May 10, 2005
           By: /s/ Guy A. Childs
       
           Guy A. Childs
           Vice President Finance, Chief Financial Officer

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EXHIBIT INDEX

10.36 Consulting Agreement dated February 14, 2005 between the Company and Dr. Craig Walker.

10.37 Settlement and Amendment to License Agreement executed in February 2005 and effective October 1, 2004 between the Company and SurModics, Inc. (confidential treatment has been requested for portions of this agreement).

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

 

EX-10.36 2 d25231exv10w36.htm CONSULTING AGREEMENT exv10w36
 

EXHIBIT 10.36

[Spectranetics letterhead]

February 14, 2005

Cardiovascular Institute of the South
2730 Ambassador Caffery Parkway
P.O. Box 61160
Lafayette, LA 70596-1160

Dear Craig and David:

I am writing to follow up on the conversations that we have had on number of occasions over the past several months regarding the Peripheral Vascular Training “Gloves On” courses that you operate through the Cardiovascular Institute of the South. I appreciate the opportunity you have afforded Spectranetics to interface with cardiologists, vascular surgeons and radiologists during these courses through a secondary sponsorship. I certainly believe that providing the exposure to the laser during these peripheral training courses adds value to Spectranetics. Your ability to showcase the proper applications for the laser in the treatment of both peripheral vascular disease, in particular critical limb ischemia, as well as, coronary artery disease is very impactful.

We have followed up with a number of physicians who have participated in these “Gloves On” courses during 2004. We have testimonials of the effectiveness of our technology. Many of these physicians return to their hospitals and begin practicing laser atherectomy or request a laser to initiate this program. We appreciate the opportunity to follow up immediately with the participants of your course to help them establish a laser program. We try to “strike while the iron hot”.

In keeping with my commitment to renew on our agreement on training, I would like to extend to you our interest in continuing to train physicians through “Gloves On” courses. I understand that you will have approximately 70 courses in 2005. We would like to continue the training provided directly by both of you in each of these scheduled courses. We would also like to consider scheduling a dedicated Spectranetics customer course for this fall, for several leading interventionalists and vascular surgeons, to learn the special techniques and protocols that you teach.

Spectranetics will continue to be a major participant at the New Cardiovascular Horizon course in New Orleans. We would also like to continue having you both present at programs around the country such as teaching hospital grand rounds, etc. We will also hope that you will continue to develop white papers, peer reviewed abstracts and journal articles based on your outstanding work with the excimer laser.

 


 

Cardiovascular Institute of the South
February 14, 2005
Page 2

I also recognize that there is an appropriate compensation that should be in place to keep Spectranetics active in the “Gloves On” program. I have discussed this with you in light of our past agreements, within the confines of our budgets and in the environment of new regulatory guidance provided by the AdvaMed code of ethics and the Sarbanes-Oxley legislation.

In keeping with all of our interests, we would therefore like to extend our financial agreement for the training of the attendees of the “Gloves On” courses scheduled for 2005. We have budgeted $75,000 for each of you for the year of 2005. This represents $18,750 per quarter.

We recognize this represents a significant opportunity for us to work together to appropriately train our customers. It is the single largest investment that we make in our training and a very large percentage of our total training investment. We look forward to working with you and ask that you individually confirm your agreement to this offer in the signatory space below. If you have any questions, please do not hesitate to contact me. I look forward to our most productive year ever together.

With warm regards,

/s/ John Schulte

John Schulte

     
   /s/ David Allie, MD
     /s/ Craig Walker, MD
 
   
Dr. David Allie
  Dr. Craig Walker

 

EX-10.37 3 d25231exv10w37.htm SETTLEMENT AND AMENDMENT TO LICENSE AGREEMENT exv10w37
 

EXHIBIT 10.37

Confidential Treatment Requested

Settlement and Amendment to License Agreement

This Settlement and Amendment to License Agreement (the “Agreement”), effective October 1, 2004 (the “Effective Date”), is by and between SurModics, Inc. (successor in interest to Bio-Metric Systems, Inc.), a Minnesota corporation, which has an office at 9924 West 74th Street, Eden Prairie, MN 55344 (hereinafter referred to as SURMODICS), and Spectranetics Corporation, a Delaware corporation, which has an office at 96 Talamine Court, Colorado Springs, CO 80907 (hereinafter referred to as SPECTRANETICS).

WHEREAS, SURMODICS and SPECTRANETICS are parties to a certain Vascular Laser Angioplasty Catheter License Agreement, dated April 7, 1992 as amended (the “License”);

WHEREAS, the parties desire to resolve facts and matters alleged in the pending litigation titled SurModics, Inc. v. Spectranetics Corporation, Civil File No. 04-3963 ADM/AJB on the terms and conditions set forth in this Agreement, which includes amending the License; and

WHEREAS, SPECTRANETICS desires to add new rights to the License under SURMODICS’ know-how and patent rights.

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below and for other good and valuable consideration of which receipt is acknowledged, the parties agree as follows:

Part A: Settlement of Dispute

1.   Effective Date
 
    Effective October 1, 2004, the License is amended and shall be governed by the terms and conditions set forth in this Agreement.
 
2.   Amounts Owing
 
    In settlement of amounts which SURMODICS claims to be owing to SURMODICS under the License through September 30, 2004, SPECTRANETICS shall pay SURMODICS $275,000 by wire transfer on the date on which SPECTRANETICS signs this Agreement, as set forth on the signature page hereof.
 
3.   Spectranetics’ Representation
 
    SPECTRANETICS represents that it has disclosed all past due royalties to SURMODICS claimed to be owed and that no other past royalties or payment of any kind are due SURMODICS prior to September 30, 2004.


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

1


 

Confidential Treatment Requested

4.   Stipulation of Dismissal
 
    Upon SPECTRANETICS’ payment of the amount set forth in section 2 above, counsel for SURMODICS shall promptly execute and file with the United States District Court for the District of Minnesota all papers that are necessary to effectuate a dismissal, with prejudice, of the claims asserted by SURMODICS against SPECTRANETICS in the matter of SurModics, Inc. v. Spectranetics Corporation, Civil File No. 04-3963 ADM/AJB.
 
5.   SurModics’ Limited Release
 
    For the consideration recited herein, including the amended License terms included in this Agreement and SPECTRANETICS’ payment of the amount set forth in section 2 above, SURMODICS and its successors, assigns, attorneys, agents, executors and representatives hereby release and forever discharge SPECTRANETICS and its past, present and future successors, assigns, attorneys, agents, executors, officers, directors, and representatives from any and all claims, demands, obligations, losses, causes of action, costs, expenses, attorneys’ fees, liabilities and indemnities, whether known or unknown, relating to the facts and matters alleged in the matter of SurModics, Inc. v. Spectranetics Corporation, Civil File No. 04-3963 ADM/AJB.
 
6.   Spectranetics’ Limited Release
 
    For the consideration recited herein, including the amended License terms included in this Agreement, SPECTRANETICS and its successors, assigns, attorneys, agents, executors and representatives hereby release and forever discharge SURMODICS and its past, present and future successors, assigns, attorneys, agents, executors, officers, directors, and representatives from any and all claims, demands, obligations, losses, causes of action, costs, expenses, attorneys’ fees, liabilities and indemnities, whether known or unknown, relating to the facts and matters alleged in the matter of SurModics, Inc. v. Spectranetics Corporation, Civil File No. 04-3963 ADM/AJB.

Part B: Amendment to License Agreement

1.   Section 1(b) of the License is amended in its entirety to read as follows:
 
    “Patent Rights” means the patents identified in Attachment A hereof, together with all foreign counterparts, divisions, and continuation applications based thereon, any patent issuing on any of said applications, and any reissues or extensions based on any of such patents.
 
2.   Section 1(c) of the License (entitled Improvement Patents), is deleted in its entirety.
 
3.   Section 1(d) of the License is amended in its entirety to read as follows:


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

2


 

Confidential Treatment Requested

    “Licensed Products” means each of the separately sold Licensed Products specifically described in Attachments B1 and B2 and which:

i. but for the license granted herein the manufacture, use, or sale would infringe (or a surface treatment process employed to produce a product or a reagent used in such process would infringe), any claim of Patent Rights, or

ii. are produced through the use of SURMODICS’ Know-how.

4.   Section 1(h) of the License is amended in its entirety to read as follows:
 
    “Net Sales” means the total actual billing for sales of Licensed Products, less the following deductions where they are applicable with respect to such billings and when separately shown on invoices:

i. discounts actually allowed and taken specific to Licensed Products;

ii. any customs duties, taxes, or other governmental excise or charge upon or measured by the production, sale, transportation, delivery, or use of Licensed Product and actually invoiced and paid by SPECTRANETICS;

iii. amounts allowed or credited on rejections or returns of Licensed Products;

iv. transportation charges prepaid or allowed for Licensed Products; and

v. sales commissions paid to employees of SPECTRANETICS for sales of Licensed Products, such commissions not to exceed six percent (6%) of actual invoiced amounts of Licensed Products.

    The total deductions (the sum of the deductions (i)-(v) above), from total actual billings for sales of Licensed Products shall not exceed [*****] of such actual billings for sales of Licensed Products. Except as expressly provided in subsections (i)-(v) above, no deductions from sales of Licensed Products shall apply.
 
    Notwithstanding the above, if any Licensed Product is sold both separately and as a kit with an integral part of a combination product containing one or more integral components or service in addition to that Licensed Product, then Net Sales of that Licensed Product resulting from sales of that combination product will be calculated by multiplying the Net Sales for the combination product as calculated above by the fraction A/B, where A is the invoice price of the Licensed Product as sold separately and B is the invoice price of the combination product. For example, the foregoing mechanism will apply to Licensed Products sold as an integral part of a combination product that includes SPECTRANETICS’ depreciation, repair, and


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

3


 

Confidential Treatment Requested

    maintenance of a laser system so long as (i) Licensed Products are sold both separately and as an integral part of a combination system, and (ii) SPECTRANETICS’ reports (under section 5(a) herein), the average selling prices for (a) the separately sold Licensed Products, and (b) the combination product (or products), that includes Licensed Product. Conversely, the foregoing mechanism shall not apply to Licensed Products that are sold as part of a kit but are not and have never been separately sold (in which case, Net Sales of Licensed Product will be determined based solely on the sales price of the combination product that includes the Licensed Product).
 
5.   Section 1(j) of the License is amended in its entirety to read as follows:
 
    A Licensed Product shall be considered sold when it is shipped or when it is invoiced, whichever is earlier. To assure SURMODICS the full royalty payment contemplated in this Agreement, SPECTRANETICS agrees that if any Licensed Product is sold to an Affiliate for purposes of resale, Earned Royalties for that Licensed Product shall be computed upon the selling price at which such Licensed Product would ordinarily be sold to a non-Affiliate, rather than on the selling price of SPECTRANETICS to the Affiliate.
 
6.   Section 2 of the License is amended in its entirety to read as follows:
 
    License Subject to the conditions and limitations provided in this Agreement, SURMODICS grants SPECTRANETICS a worldwide non-exclusive license under SURMODICS’ Patent Rights and Know-how to make, have made for it, use, and sell Licensed Products. The license granted herein is expressly limited to the specific Licensed Products defined herein, and does not include the right to sublicense except to an Affiliate. Subject to the limited license granted herein, SURMODICS shall retain all rights to the Patent Rights and Know-how.
 
7.   Section 4 of the License is amended in its entirety to read as follows:
 
    Royalties SPECTRANETICS shall pay SURMODICS a royalty for the Patent Rights and Know-how licensed under Attachment B1 and Attachment B2, such royalty will be the greater of (a) the earned royalty set forth for each such Attachment, and (b) the minimum royalty obligation set forth in such Attachment.
 
8.   Section 5(a) of the License is amended in its entirety to read as follows:
 
    During the term of this Agreement, SPECTRANETICS will make written reports and payments to SURMODICS for each license granted in Attachments B1 and B2 within thirty (30) days after the last day of each calendar quarter ending March 31, June 30, September 30, and December 31. Such quarterly written reports shall include an itemized account by SPECTRANETICS’ product tradename and model number (in the form of Exhibit 1 attached to this Agreement), of (i) unit volumes


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

4


 

Confidential Treatment Requested

    and average selling prices of Licensed Product sales, (ii) the applicable earned royalty, (iii) the permitted deductions from sales of Licensed Product set forth in Paragraph 1(h), and (iv) Net Sales. Each such report shall also include corrections of error in prior royalty payments, data, and calculations used by SPECTRANETICS to determine such payments for each of the licenses corresponding to Attachments B1 and B2. Each report shall be accompanied by payment in full of the royalty due SURMODICS for that quarter. The December 31 quarterly report shall also include a nonbinding summary forecast of projected sales of Licensed Products and a nonbinding forecast of reagent usage for the next calendar year. SPECTRANETICS reports shall be considered Confidential Information.
 
9.   The following section 5(f) is added to the License:
 
    If any amount owing SURMODICS is not paid when due, each unpaid amount shall bear interest after its due date at the monthly rate of one/twelfth of the sum of the then-existing prime interest rate plus two percent (2%). In any future lawsuit for recovery, if it prevails, SURMODICS shall be entitled to recover all of its reasonable costs and expenses incurred in any action to collect amounts owing, including attorneys’ fees.
 
10.   Section 8(c) of the License is amended in its entirety to read as follows:
 
    Regardless to the extent, if any, to which Licensed Products are or become covered or continue to be covered by any valid patent of Patent Rights, regardless of which any valid patents of Patent Rights actually issue, and regardless of the provisions of Paragraph 8(b), the Earned Royalty percentages set out in Paragraph 4 of this Agreement shall never be reduced by more than fifty percent (50%). Prior to January 1, 2020, the provisions of Paragraphs 8(b) shall not apply to SPECTRANETICS’ payment of Quarterly Minimum Royalties as provided in Paragraph 4. Beginning January 1, 2020, SPECTRANETICS’ Quarterly Minimum Royalty obligation to SURMODICS will be reduced by fifty percent (50%) if the Licensed Products described in Attachments B1 and B2 are no longer covered by a claim of Patent Rights.

11. Attachment A of the License is amended in its entirety to read as set forth in Attachment A attached to this Agreement.

12. Attachments B1 and B2 are added to the License as set forth in Attachments B1 and B2 attached to this Agreement.

13. Exhibit 1 is added to the License as set forth in Exhibit 1 attached to this Agreement.


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

5


 

Confidential Treatment Requested

Part C: Full Force and Effect

Except as amended by this Agreement, the License is unchanged and remains in full force and effect.

IN WITNESS WHEREOF, the parties hereto execute this Agreement by their duly authorized employees.

     
  Accepted by:
    Accepted by:
  SurModics, Inc.
    Spectranetics Corporation
 
   
  /s/ Bruce J. Barclay
    /s/ Guy A. Childs
 
   
  Signature
    Signature
 
   
  Bruce J. Barclay
    Guy A. Childs
 
   
  Printed Name
    Printed Name
 
   
  President/COO
    Chief Financial Officer
 
   
  Title
    Title
 
   
  February 17, 2005
    February 16, 2005
 
   
  Date
    Date


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

6


 

Confidential Treatment Requested

Attachment A

SurModics, Inc. U.S. Patents

     
1.
  METHOD OF IMPROVING THE BIOCOMPATIBILITY OF SOLID SURFACES
  U.S. Patent No. 4,973,493 issued 11/27/1990
 
   
2.
  BIOCOMPATIBLE COATINGS FOR SOLID SURFACES
  U.S. Patent No. 4,979,959 issued 12/25/1990
 
   
3.
  PREPARATION OF POLYMERIC SURFACES VIA COVALENTLY ATTACHING POLYMERS
  U.S. Patent No. 5,002,582 issued 3/26/1991
 
   
4.
  BIOCOMPATIBLE DEVICE WITH COVALENTLY BONDED BIOCOMPATIBLE AGENT
  U.S. Patent No. 5,263,992 issued 11/23/1993
 
   
5.
  RESTRAINED MULTIFUNCTIONAL REAGENT FOR SURFACE MODIFICATION
  U.S. Patent No. 5,414,075 issued 5/9/1995
 
   
6.
  SUBSTRATE SURFACE PREPARATION
  U.S. Patent No. 5,512,329 issued 4/30/1996
 
   
7.
  RESTRAINED MULTIFUNCTIONAL REAGENT FOR SURFACE MODIFICATION
  U.S. Patent No. 5,637,460 issued 6/10/1997
 
   
8.
  PHOTOACTIVATABLE CROSS-LINKING AGENTS CONTAINING CHARGED GROUPS FOR WATER SOLUBILITY
  U.S. Patent No. 6,077,698 issued 06/20/2000
 
   
9.
  SURFACE COATING AGENTS
  U.S. Patent No. 6,278,018 B1 issued 08/21/2001
 
   
10.
  SURFACE COATING AGENTS
  U.S. Patent No. 6,603,040 B1 issued 8/5/2003
 
   
11.
  SILANE COATING COMPOSITION
  U.S. Patent No. 6,706,408 B2 issued 3/16/2004


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

7


 

Confidential Treatment Requested

Attachment B1
Laser Angioplasty Catheters

1.   MEDICAL PRODUCTS
 
    “Medical Products” means excimer laser angioplasty catheters specifically adapted for coronary and peripheral use. Medical Products includes SPECTRANETICS’ chronic total occlusion laser angioplasty catheters.
 
2.   LICENSED PRODUCT
 
    “Licensed Products” means Medical Products that are surface-treated with photoreactive polyvinylpyrrolidone copolymer, non-photoreactive polyvinylpyrrolidone, photoreactive polyacrylamide copolymer, one or more of the photoreactive crosslinking agents known to the parties as [*****], a compound for promoting polymer-to-metal adhesion known to the parties as [*****], or any combination of these compounds, for the purpose of providing a lubricious surface to the Medical Products.
 
3.   GRANT OF LICENSE
 
    The license granted under this Attachment B1 is non-exclusive. The license granted in this Attachment B1 is non-cancelable by SPECTRANETICS during the period from the Effective Date through June 30, 2009.
 
4.   ROYALTY PAYMENTS
 
    SPECTRANETICS shall pay SURMODICS a royalty for the Patent Rights and Know-how license granted in this Attachment B1, which will be the greater of Paragraphs 4(a) and 4(b) as follows:
 
    a. Earned Royalties of [*****] on Net Sales ($U.S.) of Attachment B1 Licensed Products sold in each calendar quarter.
 
    b. Quarterly Minimum Royalties for all Attachment B1 and B2 Licensed Products during the periods specified as follows:

           
           
 


Quarterly Minimum Royalty Period
    SPECTRANETICS’ Attachment
B1 & B2 Quarterly Minimum
Royalty Obligation
 
           
 
Each calendar quarter during the period
       
 
from the Effective Date to June 30, 2005
    $25,000 per calendar quarter  
           
 
For the calendar quarter beginning July 1,
       
 
2005 and each calendar quarter thereafter
    $50,000 per calendar quarter  
           

    SPECTRANETICS’ Quarterly Minimum Royalty Obligation set forth in the table above shall survive expiration or termination of the licenses granted under this Agreement until June 30, 2009. For the calendar quarter that begins on July 1, 2009


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

8


 

Confidential Treatment Requested

    and for each calendar quarter thereafter, SPECTRANETICS’ $50,000 Quarterly Minimum Royalty Obligation shall remain in effect unless and until the licenses under both Attachments B1 and B2 expire or are terminated, (subject to Paragraph 8(c)).
 
5.   PERFORMANCE
 
    If there are four (4) consecutive quarters after June 30, 2009 in which SPECTRANETICS fails to generate Earned Royalties under Paragraph 4 of this Attachment B1, then SURMODICS may terminate this Attachment B1 license upon thirty (30) days written notice.

This Space Intentionally Left Blank


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

9


 

Confidential Treatment Requested

Attachment B2
Non-Laser Functioning Catheters and Guidewires
for use with Spectranetics Laser Therapy Systems

1.   MEDICAL PRODUCTS
 
    “Medical Products” means the following Spectranetics-labeled non-laser functioning catheters and guidewires for SPECTRANETICS’ laser therapy system that are specifically designed and labeled for use solely with laser angioplasty catheters: (i) [*****], (ii) support catheters, (iii) cardiac lead locking device, and (iv) [*****]. Medical Products does not include catheters for (i) infusion of diagnostic, therapeutic, or embolic agents in the neurovascular region, or (ii) insertion of therapeutic embolic devices in the neurovascular region. Medical Products does not include catheters used to deliver stents of any type.
 
2.   LICENSED PRODUCT
 
    “Licensed Products” means Medical Products that are surface-treated with photoreactive polyvinylpyrrolidone copolymer, non-photoreactive polyvinylpyrrolidone, photoreactive polyacrylamide copolymer, one or more of the photoreactive crosslinking agents known to the parties as [******], a compound for promoting polymer-to-metal adhesion known to the parties as [*****], or any combination of these compounds, for the purpose of providing a lubricious surface to the Medical Products.
 
3.   GRANT OF LICENSE
 
    The license granted under this Attachment B2 is non-exclusive.
 
4.   ROYALTY PAYMENTS
 
    SPECTRANETICS shall pay SURMODICS a royalty for the Patent Rights and Know-how license granted in this Attachment B2, which will be the greater of Paragraphs 4(a) and 4(b) as follows:
 
    a. Earned Royalties of [*****] on Net Sales ($U.S.) of Attachment B2 Licensed Products sold in each calendar quarter.
 
    b. Quarterly Minimum Royalties for all Attachment B1 and B2 Licensed Products during the periods specified as follows:

           
           
 


Quarterly Minimum Royalty Period
    SPECTRANETICS’ Attachment
B1 & B2 Quarterly Minimum
Royalty Obligation
 
           
 
Each calendar quarter during the period
       
 
from the Effective Date to June 30, 2005
    $25,000 per calendar quarter  
           
 
For the calendar quarter beginning July 1,
       
 
2005 and each calendar quarter thereafter
    $50,000 per calendar quarter  
           


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

10


 

Confidential Treatment Requested

    SPECTRANETICS’ Quarterly Minimum Royalty Obligation set forth in the table above shall survive expiration or termination of the licenses granted under this Agreement until June 30, 2009. For the calendar quarter that begins on July 1, 2009 and for each calendar quarter thereafter, SPECTRANETICS’ $50,000 Quarterly Minimum Royalty Obligation shall remain in effect unless and until the licenses under both Attachments B1 and B2 expire or are terminated, (subject to Paragraph 8(c)).
 
5.   PERFORMANCE
 
    If there are four (4) consecutive quarters after June 30, 2009 in which SPECTRANETICS fails to generate Earned Royalties under Paragraph 4 of this Attachment B2, then SURMODICS may terminate this Attachment B2 license upon thirty (30) days written notice.

This Space Intentionally Left Blank


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

11


 

Confidential Treatment Requested

Spectranetics
SurModics Royalty Report

*****Confidential portions of the material have been omitted and filed separately
with the Securities and Exchange Commission.


*****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission.

12

EX-31.(A) 4 d25231exv31wxay.htm RULE 13A-14(A)/15D-14(A) CERTIFICATION exv31wxay
 

Exhibit 31(a)

Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, John G. Schulte, certify that:

1. I have reviewed this quarterly report on Form 10-Q of The Spectranetics Corporation;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

     a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

     b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

     a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

     b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 10, 2005

     
  /s/John G. Schulte
   
  John G. Schulte
  Chief Executive Officer

EX-31.(B) 5 d25231exv31wxby.htm RULE 13A-14(A)/15D-14(A) CERTIFICATION exv31wxby
 

Exhibit 31(b)

Certification of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Guy A. Childs, certify that:

1. I have reviewed this quarterly report on Form 10-Q of The Spectranetics Corporation;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

  a)   designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b)   designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c)   evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
  d)   disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 10, 2005

     
  /s/ Guy A. Childs
   
  Guy A. Childs
  Chief Financial Officer

EX-32.(A) 6 d25231exv32wxay.htm SECTION 1350 CERTIFICATION exv32wxay
 

Exhibit 32.1(a)

Certification of Chief Executive Officer

          Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of The Spectranetics Corporation (the “Company”) hereby certifies, to such officer’s knowledge, that:

     (i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2005 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

     (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

     
Dated: May 10, 2005
  /s/ John G. Schulte
   
  John G. Schulte
President, Chief Executive Officer

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

EX-32.(B) 7 d25231exv32wxby.htm SECTION 1350 CERTIFICATION exv32wxby
 

Exhibit 32.1(b)

Certification of Chief Financial Officer

          Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of The Spectranetics Corporation (the “Company”) hereby certifies, to such officer’s knowledge, that:

     (i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2005 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

     (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

     
Dated: May 10, 2005
  /s/ Guy A. Childs
   
  Guy A. Childs
Vice President, Chief Financial Officer

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

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