-----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, IBPgnAmopPyjurWKmOzWPkvLGMggHxmW1peDWv7V/TV0dZECmgA4+hPNSwRTEgiB bufLEcqNM56sABUwlIplTg== 0001445305-10-001297.txt : 20101108 0001445305-10-001297.hdr.sgml : 20101108 20101108155105 ACCESSION NUMBER: 0001445305-10-001297 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20100930 FILED AS OF DATE: 20101108 DATE AS OF CHANGE: 20101108 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: 101172337 BUSINESS ADDRESS: STREET 1: 9965 FEDERAL DRIVE CITY: COLORADO SPRINGS STATE: CO ZIP: 80921 BUSINESS PHONE: 7196338333 MAIL ADDRESS: STREET 1: 9965 FEDERAL DRIVE CITY: COLORADO SPRINGS STATE: CO ZIP: 80921 FORMER COMPANY: FORMER CONFORMED NAME: THE SPECTRANETICS CORP DATE OF NAME CHANGE: 19900510 10-Q 1 spectranetics10q9302010.htm 10-Q SEPTEMBER 30, 2010 WebFilings | EDGAR view
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
 
x    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 FOR THE QUARTERLY PERIOD ENDED
 
September 30, 2010
 
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.)
9965 Federal Drive
Colorado Springs, Colorado 80921
(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 peri od that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes x No o
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes o No o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o
Accelerated filer x
Non-accelerated filer o
Smaller reporting company o
(Do not check if a smaller reporting company)
 
 
Indicate by check mark whether the regist rant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o No x
 
As of November 3, 2010 there were 33,167,532 outstanding shares of Common Stock. 
 


TABLE OF CONTENTS
 < /font>
 
 

ii


Part I—FINANCIAL INFORMATION
Item 1.       Financial Statements
 
THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(In Thousands, Except Share and Per Share Amounts)
 
September 30, 2010
 
December 31, 2009
 
(unaudited)
 
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
25,666
 
 
$
19,010
 
Restricted cash
 
 
817
 
Investment securities available for sale
761
 
 
43
 
Trade accounts receivable, less allowance for doubtful accounts and sales returns of $766 and $948, respectively
16,274
 
 
16,328
 
Inventories, net
9,343
 
 
8,462
 
Deferred income taxes, current portion, net
210
 
 
1,406
 
Prepaid expenses and other current assets
2,065
 
 
2,054
 
Total current assets
54,319
 
 
48,120
 
Property and equipment, net
29,078
 
 
31,475
 
Long-term investment securities available for sale
4,372
 
 
9,800
 
Deferred income taxes, non-current portion, net
 
 
5,079
 
Goodwill
5,569
 
 
5,569
 
Other intangible assets, net
371
 
 
586
 
Other assets
44
 
 
54
 
Total assets
$
93,753
 
 
$
100,683
 
 
 
 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
1,597
 
 
$
1,514
 
Accrued liabilities
16,166
 
 
11,291
 
Deferred revenue
2,385
 
 
2,357
 
Tot al current liabilities
20,148
 
 
15,162
 
Accrued liabilities, net of current portion
603
 
 
593
 
Total liabilities
20,751
 
 
15,755
 
Commitments and contingencies (Note 11)
 
 
 
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 33,128,035 and 33,064,217 shares, respectively
33
 
 
33
 
Additional paid-in capital
170,798
 
 
168,792
 
Accumulated other comprehensive (loss) income
(336
)
 
20
 
Accumulated deficit
(97,493
)
 
(83,917
)
Total shareholders’ equity
73,002
 
 
84,928
 
Total liabilities and shareholders’ equity
$
93,753
 
 
$
100,683
 
 
The accompanying notes are an integral part of the condensed consolidated financial statements.

1


THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(In Thousands, Except Share and Per Share Amounts)
(Unaudited)
 
< /tr>
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Revenue
$
29,577
 
 
$
28,841
 
 
$
88,612
 
 
$
85,176
 
Cost of products sold
8,486
 
 
7,951
 
 
25,393
 
 
24,497
 
Gross profit
21,091
 
 
20,890
 
 
63,219
 
 
60,679
 
Operating expenses:
 
 
 
 
 
 
 
Selling, general and administrative
15,963
 
 
16,706
 
 
51,436
 
 
52,089
 
Research, development and other technology
3,577
 
 
3,637
 
 
10,884
 
 
10,973
 
Federal investigation legal and accrued indemnification costs
6,527
 
 
602
 
 
6,820
 
 
2,957
 
Litigation settlement
 
 
1,090
 
 
 
 
1,090
 
Discontinuation costs —Safe-Cross® product line
 
 
1,075
 
 
 
 
1,075
 
Asset impairment charge
939
 
 
 
939
 
 
Employee termination and lease abandonment costs
664
 
 
366
 
 
664
 
 
536
 
Total operating expenses
27,670
 
 
23,476
 
 
70,743
 
 
68,720
 
Operating loss
(6,579
)
 
(2,586
)
 
(7,524
)
 
(8,041
)
Other income (expense):
 
 
 
 
 
 
 
Interest income, net
36
 
 
94
 
 
181
 
 
345
 
Other, net
(21
)
 
 
 
(21
)
 
(37
)
Total other income
15
 
 
94
 
 
160
 
 
308
 
Loss before income taxes
(6,564
)
 
(2,492
)
 
(7,364
)
 
(7,733
)
Income tax (expense) benefit
(6,145
)
 
 
 
(6,212
)
 
102
 
Net loss
$
(12,709
)
 
$
(2,492
)
 
$
(13,576
)
 
$
(7,631
)
Loss per share — basic and diluted
$
(0.38
)
 
$
(0.08
)
 
$
(0.41
)
 
$
(0.24
)
Weighted average common shares outstanding — basic and diluted
33,122,742
 
 
32,662,566
< font style="font-family:inherit;font-size:10pt;"> 
 
33,094,133
 
 
32,345,484
 
 
The accompanying notes are an integral part of the condensed consolidated financial statements.
  
 

2


THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In Thousands)
(Unaudited)
 
 
Nine Months Ended September 30,
 
2010
 
2009
Cash flows from operating activities:
 
 
 
Net loss
$
(13,576
)
 
$
(7,631
)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
 
 
 
Depreciation and amortization
7,484
 
 
7,357
 
Stock-based compensation expense
1,932
 
 
2,203
 
Provision for excess and obsolete inventories
236
 
 
290
 
Accrued indemnification costs
6,500
 
 
 
Deferred income taxes
6,110
 
 
(167
)
Asset impairment charge
939
 
&nb sp;
 
Discontinuation costs—Safe-Cross® product line, non-cash portion
 
 
750
 
Net change in operating assets and liabilities
(5,275
)
 
(3,712
)
Net cash provided by (used in) operating activities
4,350
 
 
(910
)
Cash flows from investing activities:
 
 
 
Proceeds from sale, redemption or maturity of investment securities
5,416
 
 
4,600
 
Purchases of investment securities
(760
)
 
 
Capital expenditures
(3,164
)
 
(2,790
)
Additional purchase price – Kensey Nash milestone payment
 
 
(1,500
)
Purchase of intangible assets
 
 
(205
)
Decrease in restricted cash
817
 
 
633
 
Net cash provided by investing activities
2,309
 
 
738
 
Cash flows from financing activities:
 
 
 
Proceeds from the exercise of stock options and employee stock purchase plan
74
 
 
1,966
 
Net cash provided by financing activities
74
 
 
1,966
 
Effec t of exchange rate changes on cash
(77
)
 
97
 
Net increase in cash and cash equivalents
6,656
 
 
1,891
 
Cash and cash equivalents at beginning of period
19,010
 
 
16,113
 
Cash and cash equivalents at end of period
$
25,666
 
 
$
18,004
 
Supplemental disclosures of cash flow information
 
 
 
Cash paid for taxes
$
132
 
 
$
115
 
Supplemental disclosure of non-cash investing and financing activities:
 
 
 
Reclassification of goodwill to property and equipment
$
 
 
$
223
 
 
The accompanying notes are an integral part of the condensed consolidated financial statements.
 
 
 

3

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

 
NOTE 1 — GENERAL
 
The accompanying condensed consolidated financial statements include the accounts of The Spectranetics Corporation, a Delaware corporation, its wholly-owned subsidiary, Spectranetics International, B.V., and its wholly-owned subsidiary, Spectranetics Deutschland GmbH (collectively, the Company). All intercompany balances and transactions have been eliminated in consolidation.
 
The Company develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system.  The Company’s products are sold in 40 countries throughout the world and are used to treat arterial blockages in the heart and legs as well as the removal of problematic pacemaker and defibrillator leads.  Approximately 60% of the Company’s disposable product revenue is from products used in connection with its proprietary excimer laser system, the CVX-300®. As of September 30, 2010, over 900 Spectranetics excimer laser systems were placed in hospitals worldwide.  The Company’s single-use laser catheters contain up to 250 small diameter, flexible optical fibers that can access difficult to reach peripheral and coronary anatomy and produce evenly distributed laser energy at the tip of the catheter for uniform ablation. The Company believes that its excimer laser system is the only laser system approved in the United States, Europe, Japa n and Canada for use in multiple, minimally invasive cardiovascular procedures.
 
The Company’s Vascular Intervention business unit includes a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.  The Company’s Lead Management business unit includes excimer laser sheaths and cardiac lead management accessories for the removal of problematic pacemaker and defibrillator cardiac leads.
 
The Company prepares its condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (US GAAP). 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 the Company’s investments in auction rate securities; the carrying amount of property and equipment, intangible assets and goodwill; valuation allowances and reserves for receivables, inventories and deferred income tax assets; stock-based compensa tion; accrued indemnification costs; and loss contingencies, including those related to litigation. 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 Annual Report on Form 10-K for the year ended December 31, 2009. In the opinion of management, all adjustments necessary for a fair presentation of the assets, liabilities and results of operations for the i nterim periods presented have been reflected herein and are of a normal, recurring nature. The results of operations for interim periods are not necessarily indicative of the results to be expected for the entire year. 
 
 
NOTE 2 — NEW ACCOUNTING STANDARDS
 
In October 2009, an update was ma de to ASC 605, Revenue Recognition — Multiple Deliverable Revenue Arrangements. This update establishes a selling price hierarchy for determining the selling price of a deliverable. It also replaces references to “fair value” with “selling price” to distinguish from the fair value measurements required under the Fair Value Measurements and Disclosures guidance, eliminates the use of the residual method for allocation, and expands the ongoing disclosure requirements. This update is effective for the Company beginning January 1, 2011, and can be applied prospectively or retrospectively. Management is currently evaluating the effect that adoption of this update will have, if any, on the Company’s consolidated fi nancial position and results of operations when it becomes effective in 2011.
 

4

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

In January 2010, the FASB issued guidance that requires reporting entities to make new disclosures about recurring or nonrecurring fair-value measurements including significant transfers into and out of Level 1 and Level 2 fair value measurements and information on purchases, sales, issuances, and settlements on a gross basis in the reconciliation of Level 3 fair value measurements. The guidance became effective for the Company with the reporting period beginning January 1, 2010, except for the Level 3 reconciliation disclosures that are effective for interim and ann ual periods beginning after December 15, 2010. Adoption of this new guidance did not have a material impact on the Company’s consolidated financial statements and management believes that adoption of the Level 3 reconciliation disclosures will not have a material impact on the Company's consolidated financial statements.
 
NOTE 3 — INVESTMENT SECURITIES
 
Investment securities consisted of the following (in thousands):
 
September 30, 2010
 
December 31, 2009
Current investments:
 
 
 
Certificates of deposit
$
761
 
 
$
43
 
Total current investments
761
 
 
43
 
Non-current investments:
 
 
 
Auction rate securities
4,372
 
 
9,800
 
Restricted investment:
 
 
 
Certificate of deposit
 
 
717
 
 
 
 
 
Total investment securities
$
5,133
 
 
$
10,560
 
 
The Company adopted the provisions of ASC 820, Fair Value Measurements and Disclosures, which defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements for financial instruments effective January 1, 2008. The framework requires the valuation of investments using a three tiered approach in the valuation of investments. Fair value measurement must be classified and disclosed in one of the following three categories:
 
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
 
Level 2: Quoted prices for similar assets or liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;
 
Level 3: Prices or valuation techniques that require inputs that are both signi ficant to the fair value measurement and unobservable (i.e. supported by little or no market activity).
 
The following table represents the fair value measurement of the Company’s investments using each of the valuation approaches as applied to each class of security (in thousands):
< /table>
 

5

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

The Company’s investments in certificates of deposit are stated at cost as their carrying value approximates fair value because of their short maturities.
 
The underlying assets of the auction rate securities (ARS) the Company holds are student loans, of which 100% are guaranteed by the U.S. government under the Federal Family Education Loan Program (FFELP ).  At September 30, 2010, the Company held $4.8 million (par value) of principal invested in two ARS issues, both of which have AAA credit ratings with Moody’s and Fitch bond rating services.  ARS are collateralized long-term debt instruments that historically have provided liquidity through a Dutch auction process that reset the applicable interest rate at pre-determined intervals, typically every 7, 28, 35 or 49 days. Beginning in February 2008, auctions failed for the Company’s holdings because sell orders exceeded buy orders. The funds associated with these failed auctions will not be accessible until the issuer calls the security, a successful auction occurs, a buyer is found outside of the auction process, or the security matures. This has resulted in an illiquid asset for the Company, even though the Company continues to earn interest on these securities according to their stated terms. Although the Company has sold four of its ARS positions in recent months, there is no assurance that it will find buyers for the remaining two securities at an acceptable price. Because of this lack of liquidity, the balance of the Company’s auction rate securities continues to be classified as a long-term asset at September 30, 2010.
 
In March 2010, the Company sold one of its ARS positions at 90% of par for cash proceeds of $2.7 million.  The proceeds were equal to the carrying value of this security at the time of sale; accordingly, no gain or loss was recorded within the Company’s financial statements during the nine months ended September 30, 2010. In September 2010, the Company sold another ARS position at 85.5% of par for cash proceeds of $2.3 million. The carrying value of this security was approximately 86% of par at the time of sale; therefore, a realized loss of $12,250 was recorded during the three months ended September 30, 2010, included in “other income (expense)” in the Company's consolidated statements of operations.
 
As of September 30, 2010, the unrealized loss on our auction rate securities was approximately $0.4 million, reducing the par value of the securities of $4.8 million to their fair value of $4.4 million, or approximately 91% of par. The unrealized loss was recorded in earnings in the fourth quarter of 2009 as an other-than-temporary impairment, and the reduction in fair value was deemed necessary due to the impact on the valuation of these securities of the global financial crisis and the continued failure of auctions of these securities since February 2008.  No further reduction of fair value was deemed to have occurred in the first nine months of 2010.
 
The fair value of the Company’s ARS at September 30, 2010 is based on a pricing model prepared by an independent consultant and is classified as a Level 3 pricing category. The Company utilized a discounted cash flow model to estimate the current fair market value for each of the securities it owns as there was no significant recent activity in the secondary markets in these types of securities. This model used unique inputs for each security including discount rate, interest rate currently being paid and estimated date to liquidation. The discount rates ranged from 3.3% to 8.4%.  In order to calculate the discount rate, the Company estimated the expected yield on an average high grade municipal bond.  In the Company’s view, high grade municipal bonds are the most closely comparable security to the ARS contained in its portfolio because they have similar credit quality and are government-backed, as is the Company’s ARS portfolio (through the FFELP program). The Company utilized forecasts for the 3-month LIBOR based on the forecasted data from “Wolters Kluwer - Blue Chip Financial Forecasts,” then estimated the spread between the 3-month LIBOR and a high-grade municipal bond to be 200 basis points, based on current and historical market data. Because the Company is currently unable to withdraw from the securities, it also added a 100 basis points illiquidity premium to the discount rate. 
 
The estimated liquidation dates used in the valuation analysis were 3 years from December 31, 2009.  At December 31, 2009, the Company also performed a sensitivity analysis in the valuation of its ARS using an estimated date to liquidation of plus or minus one year and a discount rate of plus or minus 50 basis points.  The sensitivity analysis with these parameters calculated a valuation ranging from 86% to 96% of par.  The Company believes that its current valuation of $4.4 million is a reasonable measure of fair value of the securities.
 
To date, the Company has collected all interest payable on outstanding ARS when due and expects to continue to do so in the future.  Related to one of the issues it continues to hold, the Company has also received, at par, partial redemptions totaling $1.2 million since 2008, of which $200,000 and $100,000 was redeemed in the first and second quarters of 2010, respectively. 

6

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CO NSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

While the auction failures limit the Company’s ability to liquidate these investments, management believes that the ARS illiquidity will have no significant impact on its ability to fund ongoing operations. If uncertainties in the credit and capital markets continue, if these markets deteriorate further or if there are any further rating downgrades on any investments in the Company’s ARS portfolio, the market value of the Company’s investment portfolio may decline further. This could negatively affect the Company’s financial position, results of operations and liquidity.< /font>
 
For those financial instruments with significant Level 3 inputs, the following table summarizes the activity for the period (in thousands): 
 
 
 
Fair Value Measurements at Reporting Date Using
 
Balance at
September 30,
 2010
 
Quoted Prices in
Active Markets for
Identical Assets
 (Level 1)
 
Significant Other
Observable Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Auction Rate Securities
$
4,372
 
 
$
 
 
$
 
 
$
4,372
 
Certificates of Deposit
761
 
 
761
 
 
 
 
 
Total
$
5,133
 
 
$
761
 
 
$
 
 
$
4,372
 
 
Fair Value Measurements Using
Significant Unobservable
Inputs (Level 3)
 
Auction Rate Securities
Beginning balance at January 1, 2010
$
9,800
 
Transfers in to Level 3
 
Total realized/unrealized losses
 
Realized losses: included in earnings
(12
)
Other-than-temporary im pairment: included in earnings
 
Redemptions (at par)
(450
)
Sales
(4,966
)
Ending balance at September 30, 2010
$
4,372
 
 
 
The amount of total losses for the period included in earnings attributable to the change in unrealized losses relating to assets still held at September 30, 2010
$
 
 
All realized gains or losses related to financial instruments whose fair value is determined based on Level 3 inputs are included in other income. As of September 30, 2010, the Company had no unrealized losses on investment securiti es that were deemed to be temporarily impaired.
 
At September 30, 2010 and December 31, 2009 the Company’s total unrealized losses on investment securities totaled $0.4 million and $1.1 million, respectively.
 
 
NOTE 4 — COMPOSITION OF CERTAIN FINANCIAL STATEMENT ITEMS
 
Trade accounts receivable—allowance for doubtful accounts and sales returns
 
The Company’s allowance for doubtful accounts and sales return s decreased from $948,000 at December 31, 2009 to $766,000 at September 30, 2010.  The significant decrease was due primarily to the write-off of previously reserved receivables for customers in bankruptcy proceedings.
 

7

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

Inventories
 
Inventories consisted of the following (in thousands): 
 
September 30, 2010
 
December 31, 2009
Raw materials
$
2,853
 
 
$
2,676
 
Work in process
2,047
 
 
1,825
 
Finished goods
5,191
 
 
4,341
 
Less: Inventory reserve
(748
)
 
(380
)
 
$
9,343
 
 
$
8,462
 
 
The increase in the inventory reserve from December 31, 2009 to September& nbsp;30, 2010 was primarily due to a $0.2 million reserve for inventory related to the Company’s QuickCat™ product which was subject to a voluntary recall in July 2010.  Additional provisions for excess inventory were also recorded for specific raw materials and finished goods based on the Company’s quarterly analysis of quantities on hand to recent sales activity.
 
Property and Equipment
 
Property and equipment, net, consisted of the following (in thousands): 
 
September 30, 2010
 
December 31, 2009
Equipment held for rental or loan
$
34,144
 
 
$
32,703
 
Manufacturing equipment and computers
19,560
 
 
18,158
 
Leasehold improvements
< /td>
4,458
 
 
4,253
 
Furniture and fixtures
1,642
 
 
1,558
 
Building and improvements
1,245
 
< div style="overflow:hidden;font-size:10pt;"> 
1,264
 
Land
270
 
 
270
 
Less: accumulated depreciation and amortization
(32,241
)
 
(26,731
)
 
$
29,078
 
 
$
31,475
 
 
In September 2010, the Company wrote off a sterilizer system that was not yet placed in service. The total amount of the write-off was $0.9 million and was recorded as an “Asset impairment charge” in the consolidated statement of operations. During the assembly and construction of the sterilizer asset, the Environmental Protection Agency issued a ruling that phases out one of the gases used to operate the sterilizer, which effectively limited the cost-effectiveness and useful life of the asset.
 
Deferred Revenue
 
Deferred revenue was $2.4 million at September 30, 2010 and December 31, 2009. These amounts primarily relate to pay ments 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 the Company’s customers during the warranty period after the sale of equipment.
 

8

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

Accrued Liabilities
 
Acc rued liabilities consisted of the following (in thousands): 
 
September 30, 2010
 
December 31, 2009
Accrued indemnification costs
$
6,500
 
 
$
 
Accrued payroll and employee related expenses
5,227
 
 
6,389
 
Accrued royalty expense
792
 
 
821
 
Accrued sales and value added taxes
662
 
 
823
 
Deferred rent
550
 
 
494
 
Employee stock purchase plan liability
186
 
 
 
Accrued clinical study expense
159
 
 
216
 
Accrued l itigation-related expenses
118
 
 
257
 
Other accrued expenses
2,575
 
 
2,884
 
Less: long-term portion
(603
)
 
(593
)
Accrued liabilities: current portion
$
16,166
 
 
$
11,291
 
 
Following the indictment in the third quarter of 2010 of three former employees with whom the Company has indemnification obligations, the Company accrued a $6.5 million charge to record its estimated liability related thereto. See Note 11, “Commitments and Contingencies,” for further discussion of these costs.
 
 
NOTE 5 — STOCK-BASED COMPENSATION
 
The Company maintains stock option plans which provide for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units and stock appreciation rights. The plans provide that incentive stock options be granted with exercise prices not less than the fair market value at the date of grant. Options granted through September 30, 2010 generally vest over three to four years and expire ten years from the date of grant. Options granted to the Board of Directors generally vest over three years from date of grant and expire ten years from the date of grant. Restricted stock awards granted to the Board of Directors generally vest over one year. Restricted stock units granted to certain officers of the Company generally vest over four years . At September 30, 2010, there were 1.5 million shares available for future issuance under these plans.  The Company’s policy is to issue new shares upon the exercise of stock options and the vesting of restricted stock units.
 
Following a comprehensive review of the Company’s compensation programs, the compensation committee of the Board of Directors initiated an annual equity grant program with the primary goa l of employee retention.  Pursuant to this annual equity grant program, on June 1, 2010, the compensation committee approved the issuance of options to purchase 602,875 shares of common stock and 60,000 restricted stock units to certain of the Company’s officers and employees.
 
Valuation and Expense Information
 
Stock-based compensation expense recognized for the three months ended September 30, 2010 and 2009 was $722,000 and $814,000, respectively, and for the nine months ended September 30, 2010 and 2009 was $1.9 million and $2.2 million, respectively.  This expense consisted of compensation expense related to (1) employee stock options based on the value of share-based payment awards vested during the period, (2) restricted stock awards issued to certain of the Company’s directors in 2009 and 2010, ( 3) restricted stock units issued to certain of the Company’s officers in the second quarter of 2010, and (4) the estimated value to be realized by employees related to shares expected to be issued under the Company's employee stock purchase plan. Stock-based compensation expense is recognized based on awards ultimately expected to vest and is reduced for estimated forfeitures. The Company recognizes compensation cost for these awards on a straight-line basis over the service period.  Cash received from the exercise of options and, in 2009, for the purchase of shares through the employee stock purchase plan was $74,000 and $2.0 million for the nine months ended September 30, 2010 and 2009, respectively.

9

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

 
For all options which are not subject to a market condition, the fair value of each share option award is estimated on the date of grant using the Black-Scholes pricing model based on assumptions noted in the following table. The Company’s employee stock options have various restrictions including vesting provisions and restrictions on transfers and hedging, among others, and are often exercised prior to their contractual maturity. Expected volatilities used in the fair value estimate are based on the historical volatility of the Company’s stock. The Company uses historical data to estimate share option exercises, expected term and employee departure behavior used in the Black-Scholes pricing model. The risk-free rate for periods within the contractual term of the share option is based on the U.S. Treasury yield in effect at the time of grant. The following is a summary of the assumptions used and the weighted average grant-date fair value of the stock options granted during the three and nine months ended September 30, 2010 and 2009, respectively, using the Black-Scholes pricing model:
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Expected life (years)
5.99
 
 
5.95
 
 
5.98
 
 
5.98
 
Risk-free interest rate
1.28
%
 
2.32
%
 
1.79
%
 
2.14
%
Expected volatility
65.87
%
 
74.18
%
 
66.20
%
 
< /td>
74.37
%
Expected dividend yield
None
 
 
None
 
 
None
 
 
None
 
Weighted averag e grant date fair value of options granted during the period
$
3.02
 
 
$
3.31
 
 
$
3.46
 
 
$
2.82
< /td>
 
 
The following table summarizes stock option activity during the nine months ended September 30, 2010
 
Shares
 
Weighted
 Average
 Exercise Price
 
Weighted Avg.
 Remaining
 Contractual Term
 (In Years)
 
Aggregate Intrinsic
 Value
Options outstanding at January 1, 2010
3,825,688
 
 
$
5.10
 
 
 
 
 
Granted
699,375
 
 
5.73
 
 
 
 
 
Exercised
(35,125
)
 
3.17
 
 
 
 
 
Canceled
(437,608
)
 
5.05
 
 
 
 
 
Options outstanding at September 30, 2010
4,052,330
 
 
$
5.23
 
 
6.42
 
 
$
5,741,958
 
Options exercisable at September 30, 2010
1,916,829
 
 
$
6.34
 
 
3.94
 
 
$
2,324,440
 
 
The aggregate intrinsic value in the preceding table represents the total pre-tax intrinsic value, based on the Company’s closing stock price of $5.42 on September 30, 2010, which would have been received by the option holders had all option holders exercised their options as of that date. The total number of in-the-money options exercisable as of September 30, 2010 was approximately 1.0 million.  The total intrinsic value of options exercised during the nine months ended September 30, 2010 and 2009 was $0.1 million and $1.7 million, respectively.
 
The following table summarizes restricted stock award activity during the nine months ended September 30, 2010
 
Shares
 
Weighted Average
 Grant-Date Fair Value
Restricted stock awards outstanding at January 1, 2010
50,000
 
 
$
4.15
 
Awarded
34,000
 
 
5.22
 
Vested/Released
(50,000
)
 
4.15
 
Awards outstanding at September 30, 2010
34,000
 
 
$
5.22
 
 

10

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

The following table summarizes restricted stock unit activity during the nine months ended September 30, 2010
 
Shares
 
Weighted Average
 Grant-Date Fair Value
Restricted stock units outstanding at January 1, 2010
 
 
$
 
Awarded
60,000
 
 
5.76
 
Vested/Released
 
 
 
Units outstanding at September 30, 2010
60,000
 
 
$
5.76
 
 
As of September 30, 2010 there was $4.6 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Company’s stock option and restricted stock plans . This cost is based on an assumed future forfeiture rate of approximately 12.89% per year for Company employees and is expected to be recognized over a weighted-average period of approximately 2.9 years.
 
Employee Stock Purchase Plan
 
In June 2010, shareholders approved the Spectranetics Corporation 2010 Employee Stock Purchase Plan (ESPP).  The ESPP provides for the sale of up to 300,000 shares of common stock to eligible employees, limited to the lesser of 2,500 shares per employee per six-month period or a fair market value of $25,000 per employee per calendar year. Stock purchased under the ESPP will be restricted from sale for one year following the date of purchase. Stock can be purchased from amounts accumulated through payroll deductions during each six-month period, starting July 1, 2010, and the ultimate purchase price is equal to 85% of the lower of the fair market value of the Company’s common stock at the beginning or end of the respective six-month offering period.  This discount does not exceed the maximum discount rate permitted for plans of this type under Section 423 of the Internal Revenue Code of 1986, as amended.  The ESPP is compensatory for financial reporting purposes.
 
The fair value of the July offering under the ESPP was determined on the date of grant using the Black-Scholes option-pricing model. The expected term of six months was based upon the offering period of the ESPP. Expected volatility was determined based on the historical volatility from daily share price observations for the Company's stock covering a period commensurate with the expected term of the ESPP. The risk-free interest rate is based on the six-month U.S. Treasury daily yield rate. The expected dividend yield is based on the Company's historical practice of electing not to pay dividends to its stockholders. For the three months ended September 30, 2010, the Company recognized $48,000 of compensation expense related to its ESPP.
 
 

11

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

NOTE 6 — NET LOSS PER SHARE
 
Basic loss per share is computed by dividing net loss 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 net loss per share is the same as basic net loss per share for the three and nine months ended September 30, 2010 and 2009, as shares issuable upon the exercise of stock options were anti-dilutive as a result of the net losses incurred for those periods.  As a result, all of the stock options outstanding to purchase 3.9 million and 4.1 million weighted average shares at September 30, 2010 and 2009, respectively, were excluded from the diluted net loss per share calculation for those periods because their inclusion would have been anti-dilutive.
&nb sp;
A summary of the net loss per share calculation is shown below (in thousands, except per share amounts):
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Net loss
$
(12,709
)
 
$
(2,492
)
 
$
(13,576
)
 
$
(7,631
)
Common shares outstanding:
 
 
 
 
 
 
 
Historical common shares outstanding at beginning of period
33,119
 
 
32,354
 
 
33,064
 
 
32,037
 
Weighted average common shares issued
4
 
 
309
 
 
30
 
 
308
 
Weighted average common shares outstanding — basic
33,123
 
 
32,663
 
 
33,094
 
 
32,345
 
Effect of dilution — stock options
 
 
 
 
 
 
 
Weighted average common shares outstanding — diluted
33,123
 
 
32,663
 
 
33,094
 
 
32,345
 
Net loss per share — basic
$
(0.38
< /td>
)
 
$
(0.08
)
 
$
(0.41
)
 
$
(0.24
)
Net loss per share — diluted
$
(0.38
)
 
$
(0.08
)
 
$
(0.41
)
 
$
(0.24
)
 
 
NOTE 7 — COMPREHENSIVE LOSS
 
Comprehensive loss includes foreign currency translation gains and losses and unrealized gains and losses on the Company’s investment securities that are classified as available for sale securities. The difference between net loss and comprehensive loss for each of these periods is as follows (in thousands): 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Net loss
$
(12,709
)
 
$
(2,492
)
 
$
(13,576
)
 
$
(7,631
)
Other comprehensive loss:
 
 
 
 
 
 
 
Foreign currency translation gain (loss)
537
 
 
207
 
 
(313
)
 
294
 
Unrealized loss on investment securities
 
 
(2
)
 
(43
)
 
(21
)
Comprehensive loss
$
(12,172
)
 
$
(2,287
)
 
$
(13,932
)
 
$
(7,358
)
 
Total accumulated other comprehensive loss and its components were as follows (in thousands): 
 
Foreign currency
translation loss
 
Unrealized gain (loss)
on investment
securities
 
Accumulated Other
Comprehensive
Gain (Loss)
Beginning balance, January 1, 2010
$
(23
)
 
$
43
 
 
$
20
 
Current period change
(313
)
 
(43
)
 
(356
)
Ending balance, September 30, 2010
$
(336
)
 
$
 
 
$
(336
)

12

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

 
 
NOTE 8 — SEGMENT REPORTING
 
The Company operates in one distinct line of business consisting of developing, manufacturing, marketing and distributing a proprietary excimer laser system and disposable products for the treatment of certain coronary and vascular conditions.
 
Within this line of business, the Company has identified two reporta ble segments, which were identified on a geographic basis: (1) U.S. Medical and (2) International Medical. U.S. Medical and International Medical offer the same products and services but operate in different geographic regions, have different distribution networks and different regulatory environments. Within U.S. Medical, the Company aggregates its two business units, Vascular Intervention and Lead Management, based on their similar economic, operational and regulatory characteristics, consistent with the authoritative guidance on segment reporting.
 
Additional information regarding each reportable segment is shown below.
 
U. S. Medical
 
Products offered by this reportable segment include fiber-optic delivery devices and other non-fiber-optic products (disposables), an excimer laser system (equipment), and the service of the excimer laser system (service). The Company is subject to product approvals from the Food and Drug Administration (FDA). At September 30, 2010, FDA-approved products were used in multiple vascular procedures, including coronary and peripheral atherectomy, aspiration and thrombectomy and the removal of infected, defective or abandoned cardiac lead wires from patients with pacemakers and cardiac defibrillators. This segment’s customers are primarily located in the United States and Canada.
 
U.S. Medical is also corporate headquarters for the Company. All manufacturing, research and development as well as corporate administrative functions are performed within this reportable segment. As of September 30, 2010 and 2009, cost allocations of these functions to International Medical have not been performed, since International Medical operates primarily as a distributor of Spectranetics products.
 
Manufacturing activities are performed entirely within the U.S. Medical segment. Revenue associated with intersegment product transfers to International Medical was $1.0 million and $1.3 mill ion for the three months ended September 30, 2010 and 2009, respectively, and $2.9 million and $4.2 million for the nine months ended September 30, 2010 and 2009, respectively.  Revenue is based upon transfer prices, which provide for intersegment profit that is eliminated upon consolidation.
 
International Medical
 
The International Medica l segment headquarters is located in the Netherlands, and serves Europe as well as the Middle East, Latin America (including Puerto Rico), Japan and the Pacific Rim. Products offered by this reportable segment are substantially the same as those offered by U.S. Medical.  The International Medical segment is engaged primarily in distribution activities, with no manufacturing or product development functions.
 
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):
 

13

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited )
 

 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Revenue:
< /td>
 
 
 
 
 
 
 
U.S. Medical:
 
 
 
 
 
 
Disposable products:
 
 
 
 
 
 
 
Vascular Intervention
$
12,942
 
 
$
13,343
 
 
$
40,553
 
 
$
40,911
 
Lead Management
8,704
 
 
8,101
 
 
25,332
 
 
22,105
 
Service and other, net of provision for sales returns
2,089
 
 
1,844
 
 
6,105
 
 
5,966
 
Equipment sales and rentals
1,716
 
 
1,237
 
 
4,299
 
 
3,585
 
Subtotal
25,451
 
 
24,525
 
 
76,289
 
 
72,567
 
International Medical:
 
 
 
 
 
 
 
Disposable products:
 
 
 
 
 
 
 
Vascular Intervention
1,627
 
 
2,086
 
 
5,608
 
 
5,825
 
Lead Management
1,913
 
 
1,738
 
 
5,233
 
 
4,680
 
Service and other, net of provision for sales returns
236
 
 
348
 
 
823
 
 
900
 
Equipment sales and rentals
350
 
 
144
 
 
659
 
 
1,204
 
Subtotal
4,126
 
 
4,316
 
 
12,323
 
 
< div style="text-align:right;font-size:10pt;">12,609
 
Total revenue
$
29,577
 
 
$
28,841
 
 
$
88,612
 
 
$
85,176
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2010
 
2009
 
2010
 
2009
Segment operating income (loss):
 
 
 
 
 
 
 
U.S. Medical
$
(7,127
)
 
$
(3,678
)
 
$
(8,99 1
)
 
$
(10,015
)
International Medical
548
 
 
1,092
 
 
1,467
 
 
1,974
 
Total operating loss
$
(6,579
)
 
$
(2,586
)
 
$
(7,524
)
 
$
(8,041
)
 
 
September 30, 2010
 
December 31, 2009
 
 
 
 
 
 
Segment assets:
 
 
 
 
 
U.S. Medical
$
83,516
 
 
$
88,883
 
 
 
International Medical
10,237
 
 
11,800
 
 
 
Total assets
$
93,753
 
 
$
100,683
 
 
 
 
In the first nine months of 2010 and 2009, no individual customer represented 10% or more of consolidated revenue.  There were no individual countries, other than the United States, that represented at least 10% of consolidated revenue in the first nine months of 2010 or 2009.
 
NOTE 9 — INCOME TAXES
 
Under ASC 740-270, Income Taxes—Interim Reporting, the Company is required to adjust its effective tax rate each quarter to be consistent with the estimated annual effective tax rate.  The Company is also required to record the tax impact of certain discrete items, unusual or infrequently occurring, including changes in judgment about valuation allowances and effects of changes in tax laws or rates, in the interim period in which they occur.
 

14

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

In the third quarter of 2010, the Company evaluated its net deferred tax assets for recoverability and considered the relative impact of negative and positive evidence, including historical losses and projections of future taxable income. Due to recent events, primarily related to the third quarter indictment of former employees, the related $6.5 million accrual for indemnification costs for the employees, and the possibility that such costs could exceed the estimated accrual, the Company concluded that it no longer meets the accounting criteria for recognizing a portion of its deferred tax asset; that is, estimated future taxable inco me and certain tax planning strategies no longer constitute sufficient positive evidence to conclude that it is more likely than not that its net deferred tax assets would be realizable in the foreseeable future. Therefore, during the three months ended September 30, 2010, the Company increased, to 100%, its valuation allowance against its U.S. deferred tax asset. The effect of the valuation allowance adjustment was to increase the Company's provision for income taxes by $6.1 million for the three and nine months ended September 30, 2010, resulting in a tax provision of approximately $6.2 million on its loss before taxes of approximately $7.4 million. Income tax expense includes approximately $35,000 and $102,000, comprised of state and foreign income taxes payable, for the three and nine months ended September 30, 2010, respectively. The Company has a foreign deferred tax asset of $210,000 related to net operating losses in the Netherlands that the Company expects to utilize against taxable income in the Netherlands prior to their expiration at the end of 2011.
 
 
NOTE 10 — RELATED PARTY TRANSACTIONS
 
During the three and nine months ended September 30, 2010, the Company paid $35,000 and $89,000, respectively, to a director of the Company under an agreement whereby the director provides training services to outside physicians on behalf of the Company.  During the three and nine months ended September 30, 2010, the Company also paid $24,000 and $75,000, respectively, to a director of the Company for royalties based on the sale of the Company’s products that use inventions claimed by a patent purchased from the director in 2007.
 
 
NOTE 11 — COMMITMENTS AND CONTINGENCIES
 
Indemnification of former officers and employees
 
The Company is generally obligated to indemnify its present and former directors, officers and employees against certain losses and to advance their reasonable legal defense expenses including in connection with the federal investigation. The Company maintains insurance for claims of this nature, which does not apply in all such circumstances, may be denied or may not be adequate to cover the legal costs or any settlement or judgment in connection with those proceedings.
 
The indictment in August 2010 of three former employees with whom the Company has indemnification obligations significantly increased the likelihood that the former employees' future defense costs will be substantial and ongoing, and that the Company's indemnification obligations to these employees will exceed the limits of its insurance coverage. Therefore, at September 30, 2010, the Company accrued a $6.5 million charge reflecting the low end of its estimate of the range of its contingent liability under the indemnification obligations. The Company currently estimates that the legal fees in this matter could range from $6.5 million to $11.5 million through trial and that these costs are expected to be paid over the course of the court proceedings. The estimate was developed with the assistance of outside legal counsel familiar with court proceedings similar in nature to the proceedings related to the Company’s indemnif ication obligations. The actual expenses may be higher or lower than the estimate depending upon final resolution of the matter. As of September 30, 2010, the Company has not paid any of the accrued legal fees and costs, and the balance of the accrued liability as of September 30, 2010 was $6.5 million.
 
Litigation
 
The Company is from time to time subject to, and is presently involved in, various pending or threatened legal actions and proceedings , including those that arise in the ordinary course of its business. Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. The Company records a liability in its consolidated financial statements for costs related to claims, settlements and judgments, where management has assessed that a loss is probable and an amount can be reasonably estimated. The Company’s significant legal

15

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

proceedings are discussed below. It is not possible to predict the outcome for the legal proceedings discussed below, and the costs associated with such proceedings could have a material adverse effect on the Company’s consolidated results of operations, financial position or cash flows of a future period.
 
Federal Investigation
 
On December 29, 2009, the Company announced that it had reached a resolution with the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) of the United States Department of Health and Human Services regarding a federal investigation which had commenced on September 4, 2008.
 
As part of the resolution, in December 2009 the Company entered into a Non-Prosecution Agreement with the DOJ, a civil Settlement Agreement with the DOJ and the OIG, and a five-year Corporate Integrity Agreement with the OIG.
 
There were no criminal charges against the Company.  As part of the Settlement Agreement, the Company also expressly denied the contentions of the United States, except those specifically included in the Non-Prosecution Agreement, and there was no admission of wrongdoing by the Company.  The Company remains fully eligible to participate in all federal healt hcare programs.
 
During the nine months ended September 30, 2010 and 2009, the Company incurred legal and other costs related to the federal investigation, excluding the accrued indemnification obligations discussed above, of $0.3 million and $3.0 million, respectively. 
 
Securities Class Actions
 
Several securities class action lawsuits were filed against the company and certain of its executives in 2008.  In 2009, these cases were consolidated into one case styled as In re Spectranetics Corporation Securities Litigation, Case No. 08-2049 in the United States District Court for the District of Colorado, and a group of investors identified as the Spectranetics Investor Group was appointed lead plaintiff.
 
On August 4, 2009, the Spectranetics Investor Group filed its consolidated class action complaint, naming the Company, John Schulte, Guy Childs, Jonathan McGuire, Emile Geisenheimer, and Craig Walker as defendants.  The consolidated complaint asserts claims under the Securities Exchange Act of 1934 alleging that the defendants either failed to disclose, made false and misleading statements, and/or participated in a common plan, scheme and unlawful co urse of conduct involving, among other things, improper marketing, promoting and testing its products and the products of third parties for unapproved uses; payments to medical personnel in connection with these uses; withholding data from the FDA; the lack of effective regulatory compliance controls and adequate internal and financial controls; and materially inflating the Company’s financial results as a result of this conduct.  Lead Plaintiff seeks class certification, compensatory damages, legal fees and such other relief as the court may deem proper.  The defendants moved to dismiss the consolidated class action complaint on September 18, 2009.  Various motions were subsequently filed opposing and supporting the dismissal and the Court has deemed these motions moot in light of the settlement discussed below.
 
Stockholder Derivative Actions
 
Several stockholder derivative actions were filed in 2008 and 2009 against Emile Geisenheimer, David Blackburn, Guy Childs, R. John Fletcher, Martin Hart, Joseph Ruggio, John Schulte and Craig Walker (the “Individual Defendants”), and the Company as a nominal defendant in the United States District Court for the District of Colorado and the District Court of El Paso County, Colorado.  These actions were ultimately c onsolidated into one action styled as Kopp v. Geisenheimer, Case No. 08-2102 in the United States District Court for the District of Colorado.  The lawsuits allege that the Individual Defendants breached their fiduciary duties, grossly mismanaged the Company, wasted corporate assets, abused their control and were unjustly enriched, as indicated by, among other things, the FDA and ICE investigation; the Company’s stock price decline following disclosure of such investigation; the Company’s receipt of an inquiry from the Securities and Exchange Commission; and the suit against the Company by its former Director of Marketing alleging the Company marketed, promoted and tested its

16

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

products for unapproved uses.  Plaintiff seeks damages, equitable and/or injunctive relief, restitution and disgorgement of profits, costs and disbursements of the action, and other relief deemed proper. See discussion of the proposed settlement below.
 
Settlement
 
On June 22, 2010, the Company announced that it had agreed in principle to settle both the securities class action litigation and the sto ckholder derivative case. Under the proposed class action settlement, the claims against Spectranetics and its officers and directors will be dismissed with prejudice and released in exchange for a cash payment of $8.5 million to be funded by Spectranetics’ insurers. On September 7, 2010, the parties submitted a formal Stipulation of Settlement to the court. The court issued an order preliminarily approving the settlement and approving the form and manner of notice on September 13, 2010 and set a final approval hearing for January 21, 2011.
 
Under the proposed derivative settlement, plaintiffs (on their own behalf and derivatively on behalf of Spectranetics) will dismiss the stockholder derivative case with prejudice and release their c laims in exchange for formalizing certain corporate governance procedures and payment of attorneys fees of $350,000. On September 16, 2010, the plaintiffs submitted a formal Stipulation of Settlement to the court. The settlement remains subject to preliminary and final approval by the court.
 
The Company and the individual defendants have steadfastly maintained that the claims raised in the class action litigation and stockholder derivative case were without merit, and have vigorously contested those claims. As part of the settlements, the Company and the individual defendants continue to deny any liability or wrongdoing under the securities laws.
 
Vagle v. The Spectranetics Corporation
 
On May 28, 2010, three Spectranetics stockholders filed an individual lawsuit in the United States District Court for the District of Colorado (Vagle et al. v. The Spectranetics Corp. et al.) asserting various federal and state claims arising out of the same facts alleged in the securities class action against Spectranetics and certain of its cu rrent and former officers and directors. Two of the three stockholders who brought this case had previously moved unsuccessfully to be appointed as lead plaintiff in the securities class action where they claimed a loss of $1.27 million.  Plaintiffs seek compensatory damages, expenses, treble damages, punitive damages, and such other relief as the court deems proper. 
 
Cardiomedica
 
The Company has been engaged in a dispute with Ca rdiomedica S.p.A. (Cardiomedica), an Italian company, over the existence of a distribution agreement between Cardiomedica and Spectranetics. Cardiomedica originally filed the suit in July 1999. The lower court’s judgment was rendered on April 3, 2002. In June 2004, 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 B.V. 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 referred the case back to the lower court for determination of the loss of profits. Cardiomedica had asserted lost profits of approximately 1.3 million euros, which was based on their estimate of potential profits during the three-year period. In December 2006, the court made an interim judgment which narrowed the scope of Cardiomedica’s claim from their original claim of lost profits associated with 10 hospitals down to lost profits on two hospitals during the period from 1999 to 2001. On July 1, 2009, the Court issued a ruling in favor of Cardiomedica for an amount equal to $0.6 million, which includes a judgment for lost profits, interest thereon, and certain costs assessed by the Court related to the proceedings.  Such amount was paid in July 2009.
 
On September 14, 2009, Cardiomedica appealed the ruling of the District Court, seeking additional damages of 1.4 million euros, consistent with its initial claim for damages at the outset of the lawsuit.&nbs p; An oral hearing, with the possibility of witnesses being presented, is scheduled for November 30, 2010. The Company intends to vigorously defend itself against this appeal.
 

17

THE SPECTRANETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 

Kenneth Fox
 
The Company and its Dutch subsidiary are defendants in a lawsuit brought in the District Court of Utrecht, the Netherlands (“the Dutch District Court”) by Kenneth Fox. M r. Fox is an inventor named on patents licensed to Spectranetics under a license agreement assigned to Interlase LP. In this action, Mr. Fox claims an interest in royalties payable under the license and seeks alleged back royalties of approximately $2.2 million. However, in an earlier interpleader action, the United States District Court for the Eastern District of Virginia, Alexandria Division, has already decided that any royalties owing under the license should be paid to a Special Receiver for Interlase. The Company has made all such payments. The United States District Court has also twice held Mr. Fox in contempt of the Court’s permanent injunction that bars him from filing actions like the pending action in the Netherlands, and the Court has ordered Mr. Fox to dismiss the Dutch action and to pay the Company’s costs and expenses. Mr. Fox has not yet complied with the United States District Court’s contempt orders. In August 2006, the Dutch District Court ruled that it does not have jurisdiction over The Spectranetics Corporation (U.S. corporation) and that proceedings would move forward on the basis of jurisdiction over Spectranetics B.V. only, which the Company believed significantly narrowed the scope of the claim. Mr. Fox appealed the Dutch District Court’s jurisdiction decision.  In April 2008, the Dutch Court of Appeal in Amsterdam ruled that the Dutch District Court does have jurisdiction over Spectranetics U.S., and the Court of Appeal referred the matter back to the Dutch District Court for further proceedings and decision involving both companies.
 
On August 19, 2009, Mr. Fox filed his final statement of rejoinder in the Dutch trial cou rt. The pleadings before the Dutch Court at the trial stage are now complete.  On February 1, 2010, a hearing on the pleadings was held before a panel of three judges. On June 9, 2010, the Dutch Court issued its ruling, followed by a decision that dismissed Mr. Fox’s claims against both The Spectranetics Corporation and Spectranetics B.V.  The Court also awarded the Company a nominal amount as attorney’s fees.  On September 7, 2010, Mr. Fox filed and served a Notice of Appeal to the Court of Appeals. Under Dutch law, the appeal entitles Mr. Fox to a new trial on the merits, though still taking into evidence the record that is already in the Dutch court system.
 
The Company intends to vigorously defend against Mr. Fox’s claims in this appeal.
 
Other
 
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 its business.
 
 
Kensey Nash milestone payments
 
On May 30, 2008, the Company acquired the endovascular product lines of Kensey Nash Corporation (KNC) for approximately $10.7 million in cash. Under the terms of the agreements between the two companies, the Company agreed to pay KNC an additional $14 million based on product development, regulatory and sales milestones.
Of the $14 million, up to $8 million is payable based on various product development and regulatory milestones associated with the acquired products. As of September 30, 2010, the Company has paid $2.5 million of the product development and regulatory milestones. The first milestone payment of $1.0 million, related to the development of a next-generation version of the Safe-Cross RF CTO system, was made in October 2008. The second milestone payment of $1.5 million, related to obtaining CE mark approval for the next-generation ThromCat device, was made in June 2009. These payments were recorded as additional goodwill. Most of the remaining product development and regulatory milestone payments will be payable over the next one to two years and are generally tied to product development and FDA approvals for the ThromCat device.
The sales milestone payment of $6 million is payable once cumulative sales of the acquired products reach $20 million. As of September 30, 2010, cumulative sales of the acquired products totaled $13.8 million.
 

18


Item 2.       Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
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 included in our Annual Report on Form 10-K for the year ended December 31, 2009, filed on March 15, 2010.  Readers are urged to carefully review and consider the various disclosur es made in this report and in our other reports filed with the SEC that 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 2009 Form 10-K.  Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events.
 
Corporate Overview
 
We develop, manufacture, market and distribute single-use medical devices used in minimally invasive procedures within the cardiovascular system. Our products are sold in 40 countries throughout the world and are used to treat arterial blockages in the heart and legs as well as the removal of problematic pacemaker and defibrillator leads. Approximately 60% of our disposable product revenue is from products used in connection with our proprietary excimer laser system, the CVX-300®.  Our sing le-use laser catheters contain up to 250 small diameter, flexible optical fibers that can access difficult to reach peripheral and coronary anatomy and produce evenly distributed laser energy at the tip of the catheter for more uniform ablation. We believe that our excimer laser system is the only laser system approved in the United States, Europe, Japan and Canada for use in multiple, minimally invasive cardiovascular procedures.
 
Our Vascular Intervention business unit includes a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. We also market aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facil itate crossing of coronary and peripheral arterial blockages. Our Lead Management business unit includes excimer laser sheaths and cardiac lead management accessories for the removal of problematic pacemaker and defibrillator cardiac leads.
 
Recent Developments
 
New product introductions
 
In January 2010, we received clearance from the FDA to market the redesigned Turbo-Tandem™, a single-use, disposable device indicated for atherectomy of infrainguinal (leg) arteries. The Turbo-Tandem system is comprised of two integrated devices, a 7French laser guide catheter integrated with a 2.0 mm equivalent laser catheter. The Turbo-Tandem is designed to create larger lumens to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries, restoring blood flow to the lower extremities. The angled ramp at the tip of the guide catheter allows the physician circumferential guidance and positioning of the laser catheter within the vessel, and push-button control greatly simplifies use of the Turbo-Tandem for repeated passes through t he vessel. In the third quarter of 2009, we initiated a limited market release of the first version of the Turbo-Tandem which was cleared by the FDA in July 2009.  Based on physician feedback during the limited market release, we decided to make certain changes to the design of the product before the full commercial launch.  We commenced the commercial launch of the redesigned Turbo-Tandem throughout the United States in March 2010 and achieved $3.5 million in sales of this product during the first nine months of 2010.
 
Pending clinical indications
 
On June 10, 2010 we announced the initiation of a multi-center, randomized trial for in-stent restenosis (ISR) (ISR RCT) in the United States. The ISR RCT study will compare laser ablation followed by adjunctive balloon angioplasty with balloon angioplasty alone, using our Turbo-Tandem and Turbo Elite® laser ablation devices. On July 14, 2010, we submitted a Pre-IDE package to the FDA that outlines our plans for conducting this ISR RCT study and followed that submission on July 16, 2010

19

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

with a Pre-IDE for a planned ISR animal study.  Meetings were held with the FDA to discuss the animal study in September 2010, allowing Spectranetics to continue pursuit of submitting an IDE, which is currently targeted for the first or second quarter of 2011, following completion of the bench testing and animal study required by the FDA. A decision whether to continue enrollments in the PATENT clinical trial, which was originally designed as a feasibility trial, will be made once the FDA has completed its review of our Pre-IDE submission for the ISR RCT study. Until then, enrollments will continue in PATENT, which currently has 73 patients enrolled in five centers in Germany. There can be no assurances that we will receive clearance from the FDA for the treatment of ISR.
 
We also plan to support a pilot study evaluating the use of laser ablation followed by a paclitaxel-coated angioplasty balloon (PTX PTA) compared with the use of PTX PTA alone in the treatment of in-stent lesions in above-the-knee arteries. This pilot study, Photoablation Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions (PHOTOPAC), is not intended to be used to gain an indication in the U.S. for the use of PTX PTA with laser, but to determine whether the use of laser with PTX PTA provides a benefit over PTX PTA alone and to provide data for potential future studies. The planned enrollment for the PHOTOPAC trial is 50 patients, which will be followed for up to one year following the procedure. Our support of the PHOTOPAC trial will be in the form of an unrestricted research grant and will be conducted at up to four sites in Germany. W e expect this trial to commence in either the fourth quarter of 2010 or the first quarter of 2011.
 
QuickCat™ Recall
 
On July 1, 2010, we initiated a voluntary recall of specific lots of our QuickCat thrombus extraction catheter. The FDA was informed of this action and communication to various Competent Authorities (regulatory bodies outside of the United States) occurred. While we received and confirmed customer complaints on this issue, no adverse events were reported to us. The occurrence of this issue was very low and could result in a blocked guidewire lumen that restricts the loading of the thrombus extraction catheter onto the guidewire prior to insertion of the catheter into the patient. We replaced all affected units and production volumes were increased so that, as of July 31, we had substantially completed all product replacements. The costs related to this recall were approximately $300,000, which was recorded within cost of products sold during the quarter ended June 30, 2010.
 
Reimbursement in Japan
 
On July 20, 2010, we announced that the Ministry of Health, Labor and Welfare in Japan has approved product reimbursement to hospitals for the Spectranetics Laser Sheath (SLS® II), which is used for the removal of problematic pacemaker and defibrillator cardiac leads. Through our distribution partner, DVx Inc., the initial phase of the product launch has commenced and is focused on establishing a limited number of lead extraction training centers in Japan.  The SLS II is our first product to have both regulatory and reimbursement approval in Japan.
 
Indictment of former employees and related accrued indemnification costs
 
The indictment in August 2010 of three former employees with whom we have indemnification obligations significantly increased the likelihood that the former employees' future defense costs will be substantial and ongoing, and that our indemnification obligations to these employees will exceed the limits of our insurance coverage. Therefore, at September 30, 2010, we accrued a $6.5 million charge reflecting the low end of our estimate of the range of our contingent liability under the indemnification obligations. We currently estimate that the legal fees in this matter could range from $6.5 million to $11.5 million through trial and that these costs are expected to be paid over the course of the court proceedings. We developed the estimate with the assistance of outside legal counsel familiar with court proceedings similar in nature to the proceedings related to our indemnification obligations. The actual expenses may be higher or lower than the estimate depending upon final resolution of the matter. As of September 30, 2010, we have not paid any of the accrued legal fees and costs, and the balance of the accrued liability as of September 30, 2010 was $6.5 million. See Note 11, “Commitments and Contingencies” to the condensed consolidated financial statements included in this report for further discussion of this matter.
&nbs p;

20

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

Results of Operations
 
Financial Results by Geographical Segment
 
Our two reporting segments consist of United States Medical, which includes the United States and Canada, and International Medical, which includes Europe, the Middle East, Asia Pacific, Latin America and Puerto Rico. United States Medical also includes all costs for our corporate hea dquarters, research and development, and corporate administrative functions. The International Medical segment is engaged primarily in distribution activities, with no manufacturing or product development functions. As of September 30, 2010 and 2009, cost allocations of these functions to International Medical have not been performed.
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
(in thousands)
 
2010
 
2009
 
2010
 
2009
Revenue
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
United States
 
$
25,451
 
 
86
%
 
$
24,525
 
 
85
%
 
$
76,289
 
 
86
%
 
$
72,567
 
 
85
%
International
 
4,126
 
 
14
 
 
4,316
 
 
15
 
 
12,323
 
 
14
 
 
12,609
 
 
15
 
Total revenue
 
$
29,577
 
 
100
%
 
$
28,841
 
 
100
%
 
$
88,612
 
 
100
%
 
$
85,176
 
 
100
%
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
(in thousands)
 
2010
 
2009
& nbsp;
2010
 
2009
Net (loss) income
 
 
 
 
 
 
 
 
United States
 
$
(13,162
)
 
$
(3,350
)
 
$
(14,780
)
 
$
(9,327
)
International
& nbsp;
453
 
 
858
 
 
1,204
 
 
1,696
 
Total net loss
 
$
(12,709
)
 
$
(2,492
)
 
$
(13,576
)
 
$
(7,631
)
 

21

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

Selected Consolidated Statements of Operations Data
 
The following table presents Consolidated Statements of Operations data for the three months ended September 30, 2010 and September 30, 2009 based on the percentage of revenue for each line item, as well as the dollar and percentage change of each of the items.
 
Three Months Ended September 30, 2010 Compared with Three Months Ended September 30, 2009  
 
Three Months Ended September 30,
 
 
 
 
(in thousands, except for percentages and
laser placements)
2010
 
% of
rev (1)
 
2009
 
% o f
rev (1)
 
$ change
2010-2009
 
% change
2010-2009
Revenue
 
 
 
 
 
 
 
 
 
 
 
Disposable products revenue:
 
 
 
 
 
 
 
 
 
 
 
Vascular Intervention
$
14,569
 
 
49
 %
 
$
15,429
 
 
53
 %
 
$
(860
)
 
(6
)%
Lead Management
10,617
 
 
36
 
 
9,839
 
 < /font>
34
 
 
778
 
 
8
 
Total disposable products revenue
25,186
 
 
85
  ;
 
25,268
 
 
88
 
 
(82
)
 
(0
)
Service and other revenue
2,325
 
 
8
 
 
2,192
 
 
8
 
 
133
 
 
6
 
Laser equipment revenue:
 
 
 
 
 
 
 
 
 
 
 
Equipment sales
799
 
 
3
 
 
150
 
 
1
 
 
649
 
 
433
 
Rental fees
1,267
 
 
4
 
 
1,231
 
 
4
 
 
36
 
 
3
 
Total laser equipment revenue
2,066
 
 
7
 
 
1,381
 
 
5
 
 
685
 
 
50
 
Total revenue
29,577
 
 
100
 
 
28,841
 
 
100
 
 
736
 
 
3
 
Gross profit
21,091
 
 
71
 
 
20,890
 
 
72
 
 
201
 
 
1
 
Operating expenses
 
 
 
 
 
 
 
 
 
 
 
Selling, general and administrative
15,963
 
 
54
 
 
16,706
 
 
58
 
 
(743
)
 
(4
)
Research, development and other technology
3,577
 
 
12
 
 
3,637
 
 
13
 
 
(60
)
 
(2
)
Federal investigation legal and accrued indemnification costs
6,527
 
 
22
 
 
602
 
 
2
 
 
5,925
 
 
984
 
Litigation settlement
 
 
 
 
1,090
 
 
4
 
 
(1,090
)
 
(100
)
Discont inuation costs--Safe-Cross® product line
 
 
 
 
1,075
 
 
4
 
 
(1,075
)
 
(100
)
Asset impairment charge
939
 
 
3
 
 
 
 
 
 
939
 
 
 
Employee termination and lease abandonment costs
664
 
 
2
 
 
366
 
 
1
 
 
298
 
 
81
 
Total operating expenses
27,670
 
 
94
 
 
23,476
 
 
81
 
 
4,194
 
 
18
 
Operating loss
(6,579
)
 
(22
)
 
(2,586
)
 
(9
)
 
(3,993
)
 
154
 
Other income (expense)
 
 
 
 
 
 
 
 
 
 
 
Interest income, net
36
 
 
 
 
94
 
 
 
 
(58
)
 
(62
)
Other expense, net
(21
)
 
 
 
 
 
< div style="text-align:left;"> 
 
(21
)
 
 
Loss before income taxes
(6,564
)
 
(22
)
 
(2,492
)
 
(9
)
 
(4,072
)
 
163
 
Income tax expense
(6,145
)
 
(21
)
 
 
 
 
 
(6,145
)
 
 
Net loss
$
(12,709
)
 
(43
)%
 
$
(2,492
)
 
(9
)%
 
$
(10,217
)
 
410
 %
 
 
 
 
 
 
 
 
 
 
 
 
Worldwide installed base of laser systems
934
 
 
 
 
889
 
 
 
 
45
 
 
 
___________________________________
 
(1) Percentage amounts may not add due to rounding.
 

22

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

 
Revenue for the three months ended September 30, 2010 was $29.6 million, a 3% increase as compared to $28.8 million for the quarter ended September 30, 2009.  This increase is mainly due to increased Lead Management (LM) disposables revenue and increased equipment revenue, offset by a decline in Vascular Intervention (VI) disposab les revenue compared to the year-ago quarter. Our product mix changed slightly year-over-year, with 85% of revenue coming from disposables in the third quarter of 2010 compared with 88% from disposables in the third quarter of 2009.  Service and other revenue remained stable at 8% of total revenue in the third quarter of 2010 and 2009. Revenue from laser equipment sales and rentals increased to 7% of total revenue in the third quarter of 2010 compared to 5% of total revenue in the third quarter of 2009
 
VI disposables revenue, which includes products used in both the peripheral and coronary vascular systems, decreased 6% to $14.6 million in the third quarter of 2010 as compared with $15.4 million in the third quarter of 2009 .  VI sales include three product categories — atherectomy, which decreased 6%; crossing solutions, which remained flat; and thrombectomy, which decreased 19%, all compared with the third quarter of 2009.  The year-over-year decrease in atherectomy revenue was due primarily to weakness in our Turbo Elite® product line, as a result of a challenging economic environment, disruption associated with the elimination and realignment of certain sales territories and ongoing competitiv e product pressures. These decreases were partially offset by sales of our Turbo-Tandem product which was launched in March 2010, which generated revenue of $1.1 million in the third quarter of 2010, compared with $0.4 million in the third quarter of 2009 during the limited release period. Crossing solutions product sales have remained flat in light of the introduction by competitors of alternative crossing solutions products towards the end of 2009. We believe the decline in thrombectomy revenue is partially due to ordering patterns adversely impacted as a result of the QuickCat recall announced in July 2010.
< font style="font-family:inherit;font-size:10pt;"> 
LM revenue grew 8% for the three months ended September 30, 2010 as compared with the 2009 third quarter.  We continue to believe our LM revenue is increasing primarily as a result of: (1) our expanded sales organiz ation, which was initially established in 2008, (2) clinical data supporting the safety and efficacy of removing problematic pacemaker and defibrillator leads, including results from the four-year Lead Extraction in Contemporary Settings (LExICon) study published in the February 9, 2010 issue of the Journal of the American College of Cardiology, and (3) expanded guidelines set forth by the Heart Rhythm Society for lead extractions. We estimate that the majority of replaced pacemaker or defibrillator leads are capped and left in the body.  We have established a dedicated Lead Management sales organization to increase awareness of potential complications associated with leaving abandoned or non-functioning leads in the body, in addition to other market development activities.
 
Laser equipment revenue was $2.1 million and $1.4 million for the three months ended September 30, 2010 and 2009, respectively.  We sold six laser systems in the third quarter of 2010 as compared to two laser systems in the same period of the prior year, which increased our laser equipment sales revenue more than fourfold year over year.  Rental revenue increased 3% during the second quarter of 2010 as compared to the prior year period.  This increase is due primarily to the increase in our installed rental base of laser systems, which increased to 452 at September 30, 2010 from 406 at September 30, 2009, as well as our focus on converting under-performing Cap-Free (fee per procedure) lasers to straight rentals.  Service and other revenue increased 6% at $2.3 million in the third quarter of 2010 compared to $2.2 million in the third quarter of 2009.
 
We placed 24 laser systems with new customers during the quarter ended September 30, 2010 compared with 30 during the third quarter of last year.  Of those new laser placements, 6 laser systems were transfers from the existing installed base during the third quarter of 2010 compared with 17 transfers during the third quarter of 2009.  In recent quarters, we have placed more focus on redeploying laser systems from hospitals wit h low laser-based catheter utilization to hospitals where we believe utilization will be higher, in order to increase productivity per laser system.  Both our focus on redeploying laser systems and our emphasis on increasing sales to existing accounts have resulted in fewer net new placements as compared to year-ago periods, which was anticipated.  This brings our worldwide installed base of laser systems to 934 (722 in the U.S.) at September 30, 2010
 
On a geographic basis, revenue in the United States was $25.5 million during the quarter ended September 30, 2010, an increase of 4% from the prior year third quarter.  International revenue totaled $4.1 million, a decrease of 4% from the third quarter of 2009.  The decrease in international revenue was primarily due to fluctuations in foreign currency exchange rates year over year.
 

23

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

 
Gross margin for the third quarter of 2010 was 71.3%, down from 72.4% in the third quarter of 2009.  The decrease was primarily due to the change in product mix, with an increase in lower-margin laser equipment sales driving overall margins downward.
 
Operating expenses
 
Operating expenses of $27.7 million in the third quarter of 2010 increased 18% from $23.5 million in the third quarter of 2009.  Operating expenses for the third quarter of 2010 and 2009 included a number of special items, which are separately disclosed components within operating expenses in our statement of operations, further described below . In the third quarter of 2010, these special items totaled $8.1 million compared to $3.1 million in the third quarter of 2009.< /font>
 
Operating expenses represented 94% of total revenue in the third quarter of 2010 as compared to 81% of total revenue in the third quarter of 2009.  Excluding the special items described below, operating expenses were 66% of revenue in the third quarter of 2010 compared to 71% of revenue in the third quarter of 2009. Over the past twelve months, our focus on productivity and expense management activities, along with the elimination of certain positions within the Company to streamline operations, have contributed to the reduction in operating expenses as a percentage of revenue as compared with last year's third quarter, excluding the special items described below.
 
Selling, general and administrative. Selling, general and administrative (SG&A) expenses decreased 4% compared to the year ago quarter due to our continued focus on expense management.  SG&A expenses represented 54% of revenue in the third quarter of 2010 compared to 58% of revenue in the third quarter of 2009. General and administrative expenses decreased 10%, primarily due to year-over-year decreases in legal fees and stock based compensation expense. Marketing and selling expenses de creased 3% year-over-year, due to the timing of certain conventions and lower headcount in 2010 compared with 2009.
 
Research and development. Research, development and other technology expenses of $3.6 million for the third quarter of 2010 decreased 2% compared with the third quarter of 2009. Costs included within research, development and other technology expenses are product development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors.  Fluctuations in these costs are as follows:
 
•    
Product development costs decreased slightly compared to the third quarter of 2009, due to the completion of the Turbo-Tandem design improvement project, with lower product development costs partially offset by higher costs in product-related regulatory costs.
 
•    
Clinical studies expense decreased by approximately $0.1 million due to the conclusion of several studies that were ongoing in the prior year.  We expect these costs to increase upon initiation of the randomized clinical trial to treat ISR, which is subject to approval by the FDA.
 
•    
Royalty expenses increased by approximately $0.1 million due to higher sales of products incorporating technology that we license as well as a higher royalty rate on certain products.
 
Federal investigation legal and accrued indemnification costs. In the third quarter of 2010, three former employees with whom we have indemnification obligations were indicted on charges related to the subjects of the federal investigation, which significantly increased the likelihood that the former employees' future defense costs will be substantial and ongoing, and that our indemnification obligations to these employees will exceed the limits of our insurance coverage. Therefore, at September 30, 2010, we recorded a $6.5 million charge to accrue the low end of our estimate of the range of our contingent liability under the indemnification obligations. We currently estimate that the legal fees in this matter could range from $6.5 million to $11.5 million through trial and that these costs are expected to be paid over the course of the court proceedings. We developed the estimate with the assis tance of outside legal counsel familiar with court proceedings similar in nature to the proceedings related to our indemnification obligations. The actual expenses may be higher or lower than the estimate depending upon final resolution of the matter. See Note 11, “Commitments and Contingencies” to the condensed consolidated financial statements included in this report for further discussion of this matter. In the third quarter of 2009, legal costs related to the federal investigation totaled approximately $0.6 million.

24

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

 
Litigation settlement. The $1.1 million represent royalties related to a patent license agreement, which was executed and paid in December 2009.
 
Discontinuation costs—Safe-Cross product line. In the third quarter of 2009, we decided to discontinue the marketing and sales of the Safe-Cross product line, which was acquired from KNC in May 2008. The $1.1 million charge includes a patent impairment charge in the amount of $0. 2 million, impairment of long-lived assets in the amount of $0.4 million, inventory write-offs of $0.2 million and an amount in consideration of estimated remaining obligations to KNC and customers of $0.3 million.
 
Asset impairment charge. In the third quarter of 2010, we wrote off a capital project in process which is now no longer expected to be complet ed and utilized, due to a recent EPA ruling which effectively limited the useful life of the asset.
 
Employee termination and lease abandonment costs. In the third quarter of 2010, we terminated 14 employees, primarily within the Vascular Intervention sales organization, as a result of a strategic re-alignment of certain sales territories designed to improve sales productivity. As a result, we recorded severance obligations totaling $0.7 million in the third quarter of 2010.
 
In the third quarter of 2009, we eliminated certain positions in order to streamline operations. As a result, we recorded severance obligations totaling $240,000. In addition, we recorded a charge for remaining lease obligations in the amount of $126,000 for a portion of a leased facility that is no longer being utilized.
 
Interest income
 Interest income decreased 62% to $36,000 in the third quarter of 2010 from $94,000 in the third quarter of 2009. The decrease in interest income in 2010 is due primarily to a lower investment portfolio balance and to lower interest rates on our invested balances.
Other expense, net
&nb sp;Other expense, net in the third quarter of 2010 included a $12,500 loss on the sale of one of our auction rate security positions. The carrying value of the security was recorded at approximately 86% of par, and we sold it at 85.5% of par, generating a small realized loss on the sale.
 Loss before income taxes
 The pre-tax loss for the three months ended September 30, 2010 was $6.6 million, compared with a pre-tax loss of $2.5 million for the three months ended September 30, 2009. The current period results included $8.1 million of special items and the prior year third quarter results included $3.1 million of special items, as described above.
 Income taxes
 During the three months ended September 30, 2010, we increased to 100% our valuation allowance against our U.S. deferred tax asset. The effect of the valuation allowance adjustment was to increase the Company's provision for income taxes by $6.1 million for the three months ended September 30, 2010. Recent events, primarily the third quar ter indictment of former employees, the related $6.5 million accrual for indemnification costs for these employees, and the possibility that such costs could exceed the estimated accrual, caused us to conclude that we no longer meet the accounting criteria for recognizing a portion of our deferred tax asset. See Note 9, “Income Taxes” to our condensed consolidated financial statements for further discussion. Income tax expense in the third quarter of 2010 also included approximately $35,000 comprised of state and foreign income taxes payable.
 Net loss
 We recorded a net loss for the three month s ended September 30, 2010 of $12.7 million, or $(0.38) per share, compared with a net loss of $2.5 million, or $(0.08) per share, in the three months ended September 30, 2009< /font>.
 

25

 
Item 2.       Management’s Disc ussion and Analysis of Financial Condition and Results of Operations (Cont'd)

Functional currency
 
The functional currency of Spectranetics International B.V. and Spectranetics Deutschland GmbH 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 currency rates during the three months ended September  ;30, 2010 as compared with the prior year period caused a decrease in consolidated revenue of approximately $0.3 million and a decrease in consolidated operating expenses of approximately $0.2 million.
 

26

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

Selected Consolidated Statements of Operations Data
 
The following table presents Consolidated Statements of Operations data for the nine months ended September 30, 2010 and September 30, 2009 based on the percentage of revenue for each line item, as well as the dollar and percentage change of each of the items.
 
Nine Months Ended September 30, 2010 Compared with Nine Months Ended September 30, 2009
 
 
 
Nine Months Ended September 30,
 
 
 
 
(in thousands, except for percentages and
laser placements)
 
2010
 
% of
rev (1)
 
2009
 
% of
rev (1)
 
$ change
2010-2009
 
% change
2010-2009
Revenue
 
 
 
 
 
 
 
 
 
 
 
 
Disposable products revenue:
 
 
 
 
 
 
 
 
 
 
 
 
Vascular in tervention
 
$
46,161
 
 
52
 %
 
$
46,736
 
 
55
 %
 
$
(575
)
 
(1
)%
Lead management
 
30,565
 
 
34
 
 
26,785
 
 
< /td>
31
 
 
3,780
 
 
14
 
Total disposable products revenue
 
76,726
 
 
87
 
 
73,521
 
 
86
 
 
3,205
 
 
4
 
Service and other revenue
 
6,928
 
 
8
 
 
6,866
 
 
8
 
 
62
 
 
1
 
Laser equipment revenue:
 
 
 
 
 
 
 
 
 
 
 
 
Equipment sales
 
1,112
 
 
1
 
 
1,345
 
 
2
 
 
(233
)
 
(17
)
Rental fees
 
3,846
 
 
4
 
 
3,444
 
 
4
 
 
402
 
 
12
 
Total laser equipment revenue
 
4,958
 
 
6
 
 
4,789
 
 
6
 
 
169
 
 
4
 
Total revenue
 
88,612
 
 
100
 
 
85,176
 
 
100
 
 
3,436
 
 
4
 
Gross profit
 
63,219
 
 
71
 
 
60,679
 
 
71
 
 
2,540
 
 
4
 
Operating expenses
 
 
 
 
 
 
 
 
 
 
 
 
Selling, general and administrative
 
51,436
 
 
58
 
 
52,089
 
 
61
 
 
(653
)
 
(1
)
Research, development and other technology
 
10,884
 
 
12
  ;
 
10,973
 
 
13
 
 
(89
)
 
(1
)
Federal investigation legal and accrued indemnification costs
 
6,820
 
 
8
 
 
2,957
 
 
3
 
 
3,863
 
 
131
 
Asset impairment charge
 
 
 
 
 
1,090
 
 
1
 
 
(1,090
)
 
(100
)
Dicontinuation costs —Safe-Cross® product line
 
 
 
 
 
1,075
 
 
1
 
 
(1,075
)
 
(100
)
Asset impairment charge
 
939
 
 
1
 
 
 
 
 
 
939
 
 
 
Employee termination and lease abandonment costs
 
664
 
 
1
 
 
536
 
 
1
 
 
128
 
 
24
 
Total operating expenses
 
70,743
 
 
80
 
 
68,720
 
 
81
 
 
2,023
 
 
3
 
Operating loss
 
(7,524
)
 
(8
)
 
(8,041
)
 
(9
)
 
517
 
 
(6
)
Other income (expense)
 
 
 
 
 
 
 
 
 
 
 
 
Interest income, net
 
181
 
 
 
 
345
 
 
 
 
(164
)
 
(48
)
Other expense, net
 
< /td>
(21
)
 
 
 
(37
)
 
 
 
16
 
 
(43
)
Loss before income taxes
 
(7,364
)
 
(8
)
 
(7,733
)
 
(9
)
 
369
 
 
(5
)
Income tax (expense) benefit
 
(6,212
)
 
(7
)
 
102
 
 
 
 
(6,314
)
 
(6,190
)
Net loss
 
$
(13,576
)
 
(15
)%
 
$
(7,631
)
 
(9
)%
 
$
(5,945
)
 
78
 %
 
 
 
 
 
 
 
 
 
 
 
 
 
Worldwide installed base of laser systems
 
934
 
 
 
 
889
 
 
 
 
45
 
 
 
___________________________________
 
(1) Percentage amounts may not add due to rounding.

27

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

 
Revenue for the nine months ended September 30, 2010 was $8 8.6 million, a 4% increase as compared to $85.2 million for the nine months ended September 30, 2009.  This increase is mainly due to increased Lead Management (LM) disposables revenue and increased equipment rental revenue, offset by a decline in Vascular Intervention (VI) disposables revenue compared to the year-ago period. Our product mix changed slightl y year-over-year, with 87% of revenue coming from disposables in the first nine months of 2010 compared with 86% from disposables in the first nine months of 2009.  Service and other revenue remained stable at 8% of total revenue in the first nine months of 2010 and 2009, and revenue from laser equipment sales and rentals also remained stable at 6% of total revenue in the first nine months of 2010 and 2009
 
VI revenue, which includes products used in both the peripheral and coronary vascular systems, decreased 1% in the first nine months of 2010 as compared with the first nine months of 2009.  VI sales include three product categories — atherectomy, which remained flat; crossing solutions, which decreased 2%; and thrombectomy, which decreased 6%, all compared with the first nine months of 2009.  The lack of growth in atherectomy revenue was due primarily to a decrease in sales of our Turbo Elite products, as a result of a challenging economic environment, disruption associated with the elimination and realignment of certain sales territories and ongoing competitive product pressures. These declines were partially offset by sales of our Turbo-Tandem product which was launched in March 2010, which generated revenue of $3.5 million in the first nine months of the year. We believe the decrease in crossing solutions product sales is primarily due to the competitive environment, with the introduction by competitors of alternative crossing solutions products towards the end of 2009. We believe the decline in thrombectomy revenue is partially due to ordering patterns adversely impacted as a result of the QuickCat recall announced in July 2010.
 
LM revenue grew 14% for the nine months ended September& nbsp;30, 2010 as compared with the first nine months of 2009.  We continue to believe our LM revenue is increasing primarily as a result of: (1) our expanded sales organization, which was initially established in 2008, (2) clinical data supporting the safety and efficacy of removing problematic pacemaker and defibrillator leads, including results from the four-year Lead Extraction in Contemporary Settings (LExICon) study published in the February 9, 2010 issue of the Journal of the American College of Cardiology, an d (3) expanded guidelines set forth by the Heart Rhythm Society for lead extractions.
 
Laser equipment revenue was $5.0 million and $4.8 million for the nine months ended September 30, 2010 and 2009, respectively.  Rental revenue increased 12% during the first nine months of 2010 as compared to the prior year period.  This increase is due primarily to the increase in our installed rental base of laser systems, which increased to 452 at September 30, 2010 from 406 at September 30, 2009, as well as our focus on converting under-performing Cap-Free (fee per procedure) lasers to straight rentals.  We sold eight laser systems in the first nine months of 2010 and eight in the same period of the prior year; however, our average sales price of laser systems decreased slightly in 2010 compared to the prior year primarily due to the mix of new vs. remanufactured systems sales.  Service and other revenue increased 1%, and was $6.9 million in the first nine months of 2010 and 2009.
 
We placed 62 laser systems with new customers during the nine months ended September 30, 2010 compared with 94 during the first nine months of last year.  Of those new laser placements, 30 laser systems were transfers from the existing installed base during the first nine months of 2010 compared with 55 transfers during the first nine months of 2009.  In recent quarters, we have placed more focus on redeploying laser systems from hospitals with low laser-based catheter utilization to hospitals where we believe utilization will be higher, in order to increase productivity per laser system.  Both our focus on redeploying laser systems and our emphasis on increasing sales to existing accounts have resulted in fewer net new placements as compared to year-ago periods, which was anticipated.  This brings our worldwide installed base of laser systems to 934 (722 in the U.S.) at September 30, 2010.
 
On a geographic basis, revenue in the United States was $76.3 million during the nine months ended September 30, 2010, an increase of 5% from the first nine months of the prior year.  International revenue totaled $12.3 million, a decrease of 2% from the first nine months of 2009.  The decrease in international revenue was primarily due to fluctuations in foreign currency exchange rates year over year. A decrease in laser equipment sales revenue, with two laser system sales in the first nine months of 2010 compared to five international laser system sale s in the prior year, was partially offset by increases in equipment rental revenue, which increased 20%. For international disposables revenue, LM revenue increased 12% while VI revenue decreased 4%; service revenue decreased 9%, all compared to the first nine months of 2009.

28

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

 
Gross margin for the first nine months of 2010 was 71.3%, up from 71.2% in the first nine months of 2009.  The increase in gross margin was primarily due to favorable product mix, as the year-over-year revenue increase was primarily in higher margin disposable products. Cost of products sold in the first nine months of 2010 included the impact of the voluntary product recall and related expenses for product replacement of the QuickCat catheter. Of the total $300,000 charge, $180,000 was related to the costs associated with the return and replacement of product and $120,000 was related to the disposal and write-off of inventory, both of which were recorded as cost of products sold.
 
Operating expenses
 
Operating expenses of $70.7 million in the first nine months of 2010 increased by 3% from $68.7 million in the first nine months of 2009.  Operating expenses for the first nine months of 2010 and 2009 included a number of special items, which are separately disclosed components within operating expenses in our statement of operations, further de scribed below. In the first nine months of 2010, these special items totaled $8.4 million compared to $5.7 million in the first nine months of 2009.
 
Operating expenses represented 80% of total revenue in the first nine months of 2010 as compared with 81% of total revenue in the first nine months of 2009.  Excluding the special items described below, operating expenses were 70% and 74% of revenue in the first nine months of 2010 and 2009, respectively. Over the past twelve months, our focus on productivity and expense management activities, along with the elimination of certain positions within the Company to streamline operations, have contributed to the reduction in operating expenses as a percentage of revenue as compared with the prior year.
 
Selling, general and administrative. Year-over-year fluctuations in selling, general and administrative expenses included:
 
•    
Marketing and selling expenses were essentially flat year-over-year, with decreases in U.S. field sales and marketing costs offset by increases in international sales and marketing, due to an increase in staffing within our international sales organization.
 
•    
General and administrative expenses decreased 5%, with year-over-year decreases in regulatory compliance outside consulting costs partially offset by increases in personnel and other miscellaneous expenses.
 
Research and development. Research, development and other technology expenses decreased 1% year over year, and were $10.9 million for the first nine months of 2010 and 2009. Costs included within research, development and other technology expenses are product development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors.  Fluctuations in these costs are as follows:
 
•    
Product development and related regulatory costs increased approximately $0.2 million compared to the first nine months of 2009 primarily related to an increase in outside consulting costs to support our regulatory affairs activities.
 
•    
Clinical studies expense decreased by approximately $0.5 million due to the conclusion of several studies that were ongoing in the prior year. We expect these costs to increase upon initiation of the randomized clinical trial to treat ISR, which is subject to approval by the FDA.
 
•    
Royalty expenses increased by approximately $0.3 million due to higher sales of products incorporating technology that we license as well as a higher royalty rate on certain products.
 
Federal investigation legal and accrued indemnification costs. In the third quarter of 2010, three former employees with whom we have indemnification obligations were indicted on charges related to the subjects of the federal investigation, which significantly increased the likelihood that the former employees’ future defense costs will be substantial and ongoing, and that our indemnification obligations to these employees will exceed the limits of our insurance coverage. Therefore, at Sep tember 30, 2010, we recorded a $6.5 million charge to accrue the low end of our estimate of the range of our contingent liability under the indemnification obligations. We currently estimate that the legal fees in this matter could range from $6.5 million to $11.5 million through trial and that these costs are expected to be paid over the course of the court proceedings. We developed the estimate with the assistance of outside legal counsel familiar with court proceedings similar in nature to the proceedings related

29

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

to our indemnification obligations. The actual expenses may be higher or lower than the estimate depending upon final resolution of the matter. See Note 11, “Commitments and Contingencies” to the condensed consolidated financial statements included in this report for further discussion of this matter. In the first nine months of 2009, legal costs related to the federal investigation totaled approximately $3.0 million.
 
Litigation settlement. The $1.1 million in 2009 represent royalties related to a patent license agreement, which was executed and paid in December 2009.
 
Discontinuation costs—Safe-Cross product line. In the third quarter of 2009, we decided to discontinue the marketing and sales of the Safe-Cross product line, which was acquired from KNC in May 2008. The $1.1 million charge includes a patent impairment charge in the amount of $0.2 million, impairment of long-lived assets in the amount of $0.4 million, inventory write-offs of $0.2 million, and $0.3 million of estimated remaining obligations to KNC and customers.
 
Asset impairment charge. In the third quarter of 2010, we wrote off a capital project in process which is now no longer expected to be completed and utilized, due to a recent EPA ruling which effectively limited the useful life of the asset.
 
Employee termination and lease abandonment costs. In the third quarter of 2010, we terminated 14 employees, primarily within the Vascular Intervention sales organization, as a result of a strategic re-alignment of certain sales territories designed to improve sales productivity. As a result, we recorded severance obligations totaling $0.7 million in the third quarter of 2010.
 
In the second and third quarters of 2009, we eliminated certain positions in order to streamline operations. As a result, we recorded severance obligations totaling $410,000 for the nine months ended September 30, 2009. In addition, we recorded a charge for remaining lease obligations in the amount of $126,000 for a portion of a leased facility that is no longer being utilized.
 
Interest income
 
Interest income decreased 48% to $181,000 in the first nine months of 2010 from $345,000 in the firs t nine months of 2009. The decrease in interest income in 2010 is due primarily to a lower investment portfolio balance and to lower interest rates on our invested balances.
 
Other expense, net
 
Other expense, net in the first nine months of 2010 included a $12,500 loss on the sale of one of our auction rate security positions. The carrying value of the security was recorded at approximately 86% of par, and we sold it at 85.5% of par, generating a small realized loss on the sale.
 
Loss before income taxes
 
Pre-tax loss for the nine months ended September 30, 2010 was $7.4 million, compared with a pre-tax loss of $7.7 million for the nine months ended September 30, 2009. The current period results included $8.4 million of special items and the prior year period results included $5.7 million of special items, as described above.
 
Income taxes
 
During the three months ended September 30, 2010, we increased to 100% our valuation allowance against our U.S. deferred tax asset. The effect of the valuation allowance adjustment was to increase the Company's provision for income taxes by $6.1 million for the nine months ended September 30, 2010. Recent events, primarily t he third quarter indictment of former employees, the related $6.5 million accrual for indemnification costs for these employees, and the possibility that such costs could exceed the estimated accrual, caused us to conclude that we no longer meet the accounting criteria for recognizing a portion of our deferred tax asset. See Note 9, “Income Taxes” to our condensed consolidated financial statements for further discussion. Income tax expense also included approximately $102,000 comprised of state and foreign income taxes payable for the nine months ended September 30, 2010.

30

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

 
Net loss
 
We recorded a net loss for the nine months ended September 30, 2010 of $13.6 million, or $(0.41) per share, compared with a net loss of $7.6 million, or $(0.24) per share, in the nine months ended September 30, 2009.
 
Functional currency
 
The functional currency of Spectranetics International B.V. and Spectranetics Deutschland GmbH 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 currency rates during the nine months ended September 30, 2010 as compared with the prior year period caused a decrease in consolidated revenue of approximately $220,000 and a decrease in consolidated operating expenses of approximately $160,000.
 
 
 
Liquidity and Capital Resources
 
As of September 30, 2010, we had cash, cash equivalents and current investment securities available for sale of $26.4 million, up $7.3 million from December 31, 2009.
 
As of September 30, 2010, we had long-term investment securities of $4.4 million, a decrease of $5.4 million from $9.8 million at December 31, 2009.  Long-term investment securities at September 30, 2010 consisted of certain auction rate securities (ARS) acquired in Jan uary 2008 which we have not been able to liquidate at an acceptable price.  We sold one of these securities at 90% of par in the first quarter of 2010, for cash proceeds of $2.7 million.  We sold a second security at 85.5% of par in the third quarter of 2010, for cash proceeds of $2.3 million. We also received redemptions of $200,000 and $100,000 on one of the issues of ARS that we continue to hold, at par, in the first and second quarters of 2010, respectively. See further discussion of our ARS in Note 3, “Investment Securities,” to our condensed consolidated financial statements included in this report.
 
If uncertainties in the credit and capital markets continue, if these markets deteriorate further or if we experience rating downgrades on any investments in our portfolio, including our ARS, the market value of our investment portfolio may decline further. This would negatively affect our financial position, results of operations and liquidity.
 
Our future liquidity and capital requirements will be influenced by numerous factors, including any future operating losses, the level and timing of future sales and expenditures, the results and sc ope of ongoing research and product development programs, working capital to support our sales growth, receipt of and time required to obtain regulatory clearances and approvals, sales and marketing programs, acceptance of our products in the marketplace, competing technologies, market and regulatory developments, acquisitions, the future course of pending and threatened litigation and the cost of indemnification obligations with former employees. We believe that our cash and cash equivalents and anticipated funds from operations will be sufficient to meet our liquidity requirements through at least the next twelve months. However, there is no assurance that additional funding will not be needed or sought prior to such time. In the event that we require additional working capital to fund future operations and any future acquisitions, we may enter into credit and financing arrangements with one or more independent institutional lenders, sell shares of our common stock or other equity securities, or sell debt securities. There is no assurance that any financing transaction will be available on terms acceptable to us, or at all, or that any financing transaction will not be dilutive to our current stockholders.
 
Operating Activities. For the nine months ended September 30, 2010, cash provided by operating activities totaled $4.4 million.  The primary sources and uses of cash were the following:
 
(1)    
Excluding approximately $16.7 million of non-cash expenses and the $6.5 million of accrued indemnification costs which did not impact cash in the third quarter of 2010, our net loss of $13.6 million yielded $9.6 million of cash from our operating results, prior to changes in our working capital. Non-cash expenses included $7.5 million of

31

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

depreciation and amortization, $1.9 million of stock-based compensation, $0.2 million of provision for excess and obsolete inventories, $0.9 million of asset impairment charge and $6.1 million of an increase in the valuation allowance against our deferred tax assets.
 
(2)    
The net decrease in operating assets and liabilities of approximately $5.3 million was due primarily to the following:
 
•    
An increase in equipment held for rental or loan of $2.9 million as a result of placement activity of our laser systems through our rental and evaluation programs;
 
•    
An increase in inventories of $1.0 million due primarily to an increase in disposables production related to new product introductions a nd a higher number of lasers in finished goods inventory at September 30, 2010 as compared to year-end;
 
•    
A decrease in accounts payable and accrued liabilities (excluding the accrued indemnification costs) of approximately $1.4 million, due primarily to the payment of year-end accrued commissions and bonuses and the timing of vendor payments.
 
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 quarter.  Inventory turns are calculated by dividing annualized cost of sales for the quarter by ending inventory.  ;
 
September 30, 2010
 
December 31, 2009
Days Sales Outstanding
50
 
 
50
 
Inventory Turns
3.6
 
 
4.1
 
 
Investing Activities. For the nine months ended September 30, 2010, cash provided by investing activities was $2.3 million, consisting of proceeds from the sale and partial redemption of auction rate securities of $5.4 million, offset by capital expenditures of $3.2 million.  In the first quarter of 2010, restricted cash that had previously been held in an escrow fund for a litigation matter had its restriction released, and this cash was invested in a short-term certificate of deposit.  The capital expenditures included manufacturing equipment upgrades and replacements as well as additional capital items for research and development projects and additional computer equipment and software purchases.
&nb sp;
Financing Activities. Cash provided by financing activities for the nine months ended September 30, 2010 was $74,000, comprised entirely of proceeds from the sale of common stock to employees and former employees as a result of exercises of stock options.
 
At September 30, 2010, we had no significant debt or capital lease obligations.
 
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
 
We prepare our condensed 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 our investments in auction rate securities; the carrying amount of property and equipment, goodwill and intangible assets; valuation allowances and reserves for receivables, inventories and deferred income tax assets; stock-based compensation; and loss contingencies, including those related to litigation and indemni fication obligations. Actual results could differ from those estimates.
 
Our critical accounting policies and estimates are included in our 2009 Annual Report on Form 10-K, filed with the SEC on March 15, 2010.  During the first nine months of 2010, there were no significant ch anges to the critical accounting policies we disclosed in our 2009 Form 10-K. 

32


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 relates 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. Aside from our auction rate securities, our current surplus cash is primarily invested in money market accounts and short-term certificates of deposit. Marketable securities are classified as available-for-sale, and consequently, are recorded on the balance sheet at fair value with temporary 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.
 
At September 30, 2010, we had $0.8 million of investment securities available for sale that are classified as current on our balance sheet.  Since these investments have maturities of less than one year, we do not expect interest rate fluctuations to have a significant impact on their fair values.
 
We also hold $4.4 million in auction rate securities, classified as long-term on our balance sheet as of September&nbs p;30, 2010, and changes in interest rates and other assumptions in the valuation of these securities may have a significant impact on their valuation.  The underlying assets of the auction rate securities we hold are student loans which are guaranteed by the U.S. government under the Federal Family Education Loan Program. Beginning in February 2008, auctions failed for our holdings because sell orders exceeded buy orders. The funds associated with these failed auctions will not be accessible until the issuer calls the security, a successful auction occurs, a buyer is found outside of the auction process, or the security matures.
 
As of September 30, 2010, the unrealized loss on our auction rate securities was approximately $0.4 million, reducing the par value of the securities of $4.8 million to their fair value of $4.4 million, or approximately 91% of par. The unrealized loss was recorded in earnings in the fourth quarter of 2009 as an other-than-temporary impairment. At December 31, 2009, we also performed a sensitivity analysis in the valuation of our auction rate s ecurities using an estimated date to liquidation of plus or minus one year and a discount rate of plus or minus 50 basis points.  The sensitivity analysis with these parameters calculated a valuation ranging from 86% to 96% of par.
 
Our exposure to foreign currency fluctuations is primarily related to sales of our products in Europe, which are denominated primarily 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 c urrencies and, as a result, could incur unanticipated gains or losses.  For the three months ended September 30, 2010, approximately $0.3 million of decreased revenue and approximately $0.2 million of decreased operating expenses were the result of exchange rate fluctuations of the U.S. dollar in relation to the euro and other European currencies as compared to the prior year period.  Accordingly, the net impact of exchange rate fluctuations on the consolidated net loss for the three months ended September 30, 2010 was a decrease in net income of approximately $0.1 million as compared to the prior year.

33


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 principal executive and principal financial officers, or persons performing similar functions, 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 co ntrols 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 principal executive and principal financial officers, or persons performing similar functions, of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2010.  Based on the foregoing, our principal executive and principal financial officers, or persons performing similar functions, concluded that our disclosure controls and procedures were e ffective at the reasonable assurance level.
 
There has been no change in our internal control over financial reporting during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 
 

34


Part II—OTHER INFORMATION
 
Item 1.   Legal Proceedings
 
For a discussion of the Company’s legal proceedings, please refer to Note 11, “Commitments and Contingencies” of the condensed consolidated financial statements included in Part I, Item 1 of this report.
 
Item 1A.   Risk Factors
 
There have been no material changes in our risk factors from those disclosed in Part I, Item 1A, of the Company’s 2009 Annual Report on Form 10-K, and Part II, Item 1A of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
 
Item 6.           Exhibits
 
3.2
Restated Bylaws of The Spectranetics Corporation.
 
 
10.1
Stipulation of Settlement (In re Spectranetics Corporation Securities Litigation, Case No. 08-cv-2048-REB-KLM), incorporated by reference to exhibit previously filed by the Company with its Current Report on Form 8-K filed on September 13, 2010.
 
 
10.2
Stipulation of Settlement (Kopp v. Geisenheimer, Case No. 08-cv-2102-REB-MJW), incorporated by reference to exhibit previously filed by the Company with its Current Report on Form 8-K filed on September 21, 2010.
 
 
31.1
Rule 13(a)-14(a)/15d-14(a) Certification of principal executive officer.
 
 
31.2
Rule 13(a)-14(a)/15d-14(a) Certification of Chief Financial Officer.
 
 
32.1
Section 1350 Certification of principal executive officer.
 
 
32.2
Section 1350 Certification of Chief Financial Officer.
 

35

< br>
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)
 
 
 
 
 
 
 
November 8, 2010
 
/s/ Guy A. Childs
 
 
Guy A. Childs
 
 
Chief Financial Officer
 
 
(Duly Authorized Officer and
 
 
Principal Financial Officer)
 
 

36
EX-3.2 2 spectraneticsex3209302010.htm EXHIBIT 3.2 RESTATED BYLAWS OF THE SPECTRANETICS CORP. WebFilings | EDGAR view
 

Exhibit 3.2
 
RESTATED BYLAWS
OF
THE SPECTRANETICS CORPORATION
 
ARTICLE I
Stockholders
 
Section 1.1. Annual Meetings. An annual meeting of stockholders shall be held for the election of directors at such date, time and place, either within or without the State of Delaware, as may be designated by resolution of the Board of Directors from time to time. Any other proper business may be transacted at the an nual meeting.
 
Section 1.2. Special Meetings. Special meetings of stockholders for any purpose or purposes may be called at any time by the Board of Directors, or by a committee of the Board of Directors which has been duly designated by the Board of Directors and whose powers and authority, as expressly provided in a resolution of the Board of Directors, include the power to call such meetings, but such special meetings may not be called by any other person or persons, except as may otherwise be specifically provided in the Certificate of Incorporation.
 
Section 1.3 Notice of Stockholder Business and Nominations.
 
(A) Annual Meetings of Stockholders. (1) Nominations of persons for election to the Board of Directors of the Corporation and the proposal of business to be considered by t he stockholders may be made at an annual meeting of stockholders only (a) pursuant to the Corporation's notice of meeting (or any supplement thereto), (b) by or at the direction of the Board of Directors or (c) by any stockholder of the Corporation who was a stockholder of record of the Corporation at the time the notice provided for in this Section 1.3 is delivered to the Secretary of the Corporation, who is entitled to vote at the meeting and who complies with the notice procedures set forth in this Section 1.3.
 
(2) For nominations or other business to be properly brought before an annual meeting by a stockholder pursuant to clause (c) of paragraph (A)(1) of this Section 1.3, the stockholder must have given timely notice thereof i n writing to the Secretary of the Corporation and any such proposed business other than the nominations of persons for election to the Board of Directors must constitute a proper matter for stockholder action. To be timely, a stockholder's notice shall be delivered to the Secretary at the principal executive offices of the Corporation not later than the close of business on the sixtieth day nor earlier than the close of business on the ninetieth day prior to the first anniversary of the preceding year's annual meeting (provided, however, that in the event that the date of the annual meeting is more than thirty days before or after the date of the first anniversary of the preceding year's annual meeting, notice by the stockholder to be timely must be so received not earlier than the close of business on the ninetieth day prior to such annual meeting and not later than the close of business on the later of the sixtieth day prior to such annual meeting or the tenth day following the day on which public announce ment of the date of such meeting is first made by the Corporation). In no event shall the public announcement of an adjournment or postponement of an annual meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice as described above. Such stockholder's notice shall set forth: (a) as to each person whom the stockholder proposes to nominate for election as a director (i) all information relating to such person that is required to be disclosed in solicitations of proxies for election of directors in an election contest, or is otherwise required,

 
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in each case pursuant to and in accordance with Regulation 14A under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and (ii) such person's written consent to being named in the proxy statement as a nominee and to serving as a director if elected; (b) as to any other business that the stockholder proposes to bring before the meeting, a brief description of the business desired to be brought before the meeting, the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the By-laws of the Corporation, the language of the proposed amendment), the reasons for conducting such business at the meeting and any material interest in such business of such stockholder and the beneficial owner, if any, on whose behalf the proposal is made; and (c) as to the stockholder giving the notic e and the beneficial owner, if any, on whose behalf the nomination or proposal is made (i) the name and address of such stockholder, as they appear on the Corporation's books, and of such beneficial owner, (ii) the class and number of shares of capital stock of the Corporation which are owned beneficially and of record by such stockholder and such beneficial owner, (iii) a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to propose such business or nomination, and (iv) a representation whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends (a) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation's outstanding capital stock required to approve or adopt the proposal or elect the nominee and/or (b) otherwise to solicit proxies from stockholders in support of such proposal or nomination. The foregoing notice requirements shall be deemed satisfied by a stockholder if the stockholder has notified the Corporation of his or her intention to present a proposal at an annual meeting in compliance with Rule 14a-8 (or any successor thereof) promulgated under the Exchange Act and such stockholder's proposal has been included in a proxy statement that has been prepared by the Corporation to solicit proxies for such annual meeting. The Corporation may require any proposed nominee to furnish such other information as it may reasonably require to determine the eligibility of such proposed nominee to serve as a director of the Corporation.
 
(3) Notwithstanding anything in the second sentence of paragraph (A)(2) of this Section 1.3 to the contrary, in the event that the number of directors to be elected to the Board of Directors of the Corporation at an annual meeting is increased and there is no public announcement by the Corporation naming the nominees for the additional directorships at least one hundred days prior to the first anniversary of the preceding year's annual meeting, a stockholder's notice required by this Section 1.3 shall also be considered timely, but only with respect to nominees for the additional directorships, if it shall be delivered to the Secretary at the principal executive offices of the Corporation not later than the close of business on the tenth day following the day on which such public announcement is first made by the Corporation.
 
(B) Special Meetings of Stockholders. Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the Corporation's notice of meeting. Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be elected pursuant to the Corporation's notice of meeting (1) by or at the direction of the Board of Directors or (2) provided that the Board of Directors has determined that directors shall be elected at such meeting, by any stockholder of the Corporation who is a stockholder of record at the time the notice provided for in this Section 1.3 is delivered to the Secretary of the Corporation, who is entitled to vote at the meeting and upon such election and who complies with the notice procedures set forth in this Section 1.3. In the ev ent the Corporation calls a special meeting of stockholders for the purpose of electing one or more directors to the Board of Directors, any such stockholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the Corporation's notice of meeting, if the stockholder's notice required by paragraph (A)(2) of this Section 1.3 shall be delivered to the Secretary at the principal executive offices of the Corporation not earlier than the close of business on the ninetieth day prior to such special meeting and not later than the close of business

 
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on the later of the sixtieth day prior to such special meeting or the tenth day following the day on which public announcement is first made of the date of the special meeting and of the nominees proposed by the Board of Directors to be elected at such meeting. In no event shall the public announcement of an adjournment or postponement of a special meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice as described above.
 
(C) General. (1) Only such persons who are nominated in accordance with the procedures set forth in this Section 1.3 shall be eligible to be elected at an annual or special meeting of stockholders of the Corporation to serve as directors and only such business shall be conducted at a meeting of stockholders as shall have been brought before the meeting in accordance with the procedures set forth in this Section 1.3. Except as otherwise provided by law, the chairman of the meeting shall have the power and duty (a) to determine whether a nomination or any business proposed to be brought before the meeting was made or proposed, as the case may be, in accordance with the procedures set forth in this Section 1.3 (including whether the stockholder or beneficial owner, if any, on whose behalf the nomination or proposal is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such stockholder's nominee or proposal in compliance with such stoc kholder's representation as required by clause (A)(2)(c)(iv) of this Section 1.3) and (b) if any proposed nomination or business was not made or proposed in compliance with this Section 1.3, to declare that such nomination shall be disregarded or that such proposed business shall not be transacted. Notwithstanding the foregoing provisions of this Section 1.3, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual or special meeting of stockholders of the Corporation to present a nomination or business, such nomination shall be disregarded and such proposed business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the Corporation.
 
(2) For purposes of this Section 1.3, "public announcement" shall include disclosure in a press release reported by the Dow Jones News Service, Associated Press or comparable national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.
 
(3) Notwithstanding the foregoing provisions of this Section 1.3, a stockholder shall also comply with all applicable requirements of the Exchange Act and the rules and regulations thereunder with respect to the matters set forth in this Section 1.3. Nothing in this Section 1.3 shall be deemed to affect any rights (a) of stockholders to request inclusion of proposals in the Corporation's proxy statement pursuant to Rule 14a-8 under the Exchange Act or (b) of the holders of any series of Preferred Stock to elect directors pursuant to any applicable provisions of the certificate of incorporation.
 
Section 1.4. Adjournments. Any meeting of stockholders, annual or special, may adjourn from time to time to reconvene at the same or some other place, and notice need not be given of any such adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the corporation may transact any business which might have been tra nsacted at the original meeting. If the adjournment is for more than thirty days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
 
Section 1.5. Quorum. Except as otherwise provided by law, the Certificate of Incorporation or these Bylaws, at each meeting of stockholders the presence in person or by proxy of the holders of shares of stock having a majority of the votes which could be cast by the holders of all outstanding shares of stock entitled to vote at the meeting shall be necessary and sufficient to constitute a quorum. In the absence of a quorum,

 
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the stockholders so present may, by majority vote, adjourn the meeting from time to time in the manner provided in Section 1.4 of these Bylaws until a quorum shall attend. Shares of its own stock belonging to the corporation or to another corporation, if a majority of the shares entitled to vote in the election of directors of such other corporation is held, directly or indirectly, by the corpo ration, shall neither be entitled to vote nor be counted for quorum purposes; provided, however, that the foregoing shall not limit the right of the corporation to vote stock, including but not limited to its own stock, held by it in a fiduciary capacity.
 
Section 1.6. Organization. Meetings of stockholders shall be presided over by the Chairman of the Board, if any, or in his absence by the Vice Chairman of the Board, if any, or in his absence by the President, or in his absence by a Vice President, or in the absence of the foregoing persons, by a chairman designed by the Board of Directors, or in the absence of such designation, by a chairman chosen at the meeting.
 
Section 1.7. Voting Proxies. Except as otherwise provided by the Certificate of Incorporation, each stockholder shall be entitled to one vote for each share of stock held by him which has voting power upon the matter in question. Each stockholder entitled to vote at a meeting of stockholders may authorize another person or persons to act for him by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. A duly executed proxy shall be irrevocable i f it states that it is irrevocable and if, and only as long as, it is coupled with an interest sufficient in law to support an irrevocable power. A stockholder may revoke any proxy which is not irrevocable by attending the meeting and voting in person or by filing an instrument in writing revoking the proxy or another duly executed proxy bearing a later date with the Secretary of the corporation. Voting at meetings of stockholders need not be by written ballot and need not be conducted by inspectors of election unless so determined by the holders of shares of stock having a majority of the votes which could be cast by the holders of all outstanding shares of stock entitled to vote thereon which are present in person or by proxy at such meeting. All elections of directors shall be determined by a plurality of the votes of the shares present in person or represented by proxy at the meeting and entitled to vote, and except as otherwise required by law, the Certificate of Incorporation or these By-Laws, all oth er matters shall be determined by the affirmative vote of the majority of shares present in person or represented by proxy at the meeting and entitled to vote.
 
Section 1.8. Fixing Date for Determination of Stockholders of Record. In order that the corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or to express consent to corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors and which record date: (1) in the case of determination of stockholders entitled to vote at any meeting of stockholders or adjournment thereof, shall, unless otherwise required by law, not be more than sixty nor less than ten days before the date of such meeting; (2) in the case of determination of stockholders entitled to express consent to corporate action in writing without a meeting, shall not be more than ten days from the date upon which the resolution fixing the record date is adopted by the Board of Directors; and (3) in the case of any other action, shall not be more than sixty days prior to such other action. If no record date is fixed: (1) the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held; (2) the record date for determining stockholders entitled to express consent to corporate action in writing without a meeting when no prior action of the Board of Directors is required by law, shall be the first date on which a signed written consent setting forth the action taken or proposed to be taken is delivered to the corporation in accordance with applicable law, or, if

 
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prior action by the Board of Directors is required by law, shall be at the close of business on the day on which the Board of Directors adopts the resolution taking such prior action; and (3) the record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.
 
Section 1.9. List of Stockholders Entitled to Vote. The Secretary or Treasurer shall prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten days prior to the meeting, either at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held. The list shall also be produced and kept at the time and place of the meeting during the whole time thereof and may be inspected by any stockholder who is pr esent. Upon the willful neglect or refusal of the directors to produce such a list at any meeting for the election of directors, they shall be ineligible for election to any office at such meeting. The stock ledger shall be the only evidence as to who are the stockholders entitled to examine the stock ledger, the list of stockholders or the books of the corporation, or to vote in person or by proxy at any meeting of stockholders.
 
Section 1.10. Action By Consent of Stockholders. Unless otherwise restricted by the Certificate of Incorporation, any action required or permitted to be taken at any an nual or special meeting of the stockholders may be taken without a meeting, without prior notice and without a vote, if a consent in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing.
 
ARTICLE II
Board of Directors
 
Section 2.1. Number; Qualifications. The Board of Directors shall consist of one or more members, the number thereof to be determined from time to time as set forth in the Certificate of Incorporation. Directors need not be stockholders.
 
Section 2.2. Election; Resignation; Removal; Vacancies. The Board of Directors shall initially consist of the persons named as directors in the Certificate of Incorporation, and each director so elected shall hold office until the first annual meeting of stockholders or until his successor is elected and qualified. At the first annual meeting of stockholders and at each annual meeting thereafter, the stockholders shall elect directors each of whom shall hold office for a term of one year or until his successor is elected and qualified. Any director may resign at any time upon written notice to the corporation. Any newly created directorship or any vacancy occurring in the Board of Directors for any cause may be filled by the procedures set forth in the Certificate of Incorporation, and each director so elected shall hold office until the expiration of the term of office of the director whom he has replaced or until his succes sor is elected and qualified.
 

 
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Section 2.3. Regular Meetings. Regular meetings of the Board of Directors may be held at such places within or without the State of Delaware and at such times as the Board of D irectors may from time to time determine, and if so determined, notices thereof need not be given.
 
Section 2.4. Special Meetings. Special meetings of the Board of Directors may be held at any time or place within or without the State of Delaware whenever called by the President, any Vice President, the Secretary, or by any member of the Board of Directors. Notice of a special meeting of the Board of Directors shall be given by the person or persons calling the meeting at least twenty-four hours before the special meeting.
 
Section 2.5. Telephonic Meetings Permitted. Members of the Board of Directors, or any committee designed by the Board of Directors, may participate in a meeting thereof by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting pursuant to this bylaw shall constitute presence in person at such meeting.
 
Section 2.6. Quorum; Vote Required for Action. At all meetings of the Board of Directors, a majority of the whole Board of Directors shall constitute a quorum for the transaction of business. Except in cases in which the Certificate of Incorporation or these Bylaws otherwise provide, the vote of a majority of the directors present at a meeting at which a quorum is present shall be the act of the Board of Directors.
 
Section 2.7. Organization. Meetings of the Board of Directors shall be presided over by the Chairman of the Board, if any, or in his absence by the Vice Chairman of the Board, if any, or in his absence by the President, or in their absence, by a chairman chosen at the meeting. The Secretary of the Board of Directors shall act as secretary of the meeting, but in his absence, the chairman of the meeting may appoint any person to act as secretary of the meeting.
 
Section 2.8. Informal Action by Directors. Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, any action required or perm itted to be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken without a meeting if all members of the Board of Directors or such committee, as the case may be, consent thereto in writing, and the writing or writings are filed with the minutes of proceedings of the Board of Directors or such committee.
 
 
ARTICLE III
Committees
 
Section 3.1. Committees. The Board of Directors may, by resolution passed by a majority of the whole Board of Directors, designate one or more committees, each committee to consist of two or more of the directors of the corporation. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee, the members thereof present at any meeting and not disqualified from voting, whether or not they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in place of any such absent or disqualified member. Any such committee, to the extent permitted by l aw and to the extent provided in the resolution of the Board of Directors, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation, and may authorize the seal of the corporation to be affixed to all papers which may require it.
 

 
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Section 3.2. Committee Rules. Unless the Board of Directors otherwise provides, each committee designated by the Board of Directors may make, alter and repeal rules for the conduct of its business. In the absence of such rules, each committee shall conduct its business in the same manner as the Board of Directors conducts its business pursuant to Article II of these Bylaws.
 
ARTICLE IV
Officers
 
Section 4.1. Executive Officers; Election; Qualifications; Term of Office; Resignation; Removal; Vacancies. The Board of Directors shall elect a President and Secretary, and it may, if it so determines, choose a Chairman of the Board and a Vice Chairman of the Board from among its members. The Board of Directors may also choose one or more Vice Presidents, one or more Assistant Secretaries, a Treasurer and one or more Assistant Treasurers. Each such officer shall hold office until the first meeting of the Board of Directors after the annual meeting of stockholders next succeeding his election, and until his successor is elected and qualified or until his earlier resignation or remova l. Any officer may resign at any time upon written notice to the corporation. The Board of Directors may remove any officer with or without cause at any time, but such removal shall be without prejudice to the contractual rights of such officer, if any, with the corporation. Any number of offices may be held by the same person. Any vacancy occurring in any office of the corporation by death, resignation, removal or otherwise may be filled for the unexpired portion of the term by the Board of Directors at any regular or special meeting.
 
Section 4.2. Powers and Duties of Executive Officers. The of ficers of the corporation shall have such powers and duties in the management of the corporation as may be prescribed by the Board of Directors and, to the extent not so provided, as generally pertain to their respective offices, subject to the control of the Board of Directors. The Board of Directors may require any officer, agent or employee to give security for the faithful performance of his duties.
 
ARTICLE V
Stock
 
Section 5.1. Certificates. Every holder of stock shall be entitled to have a certificate signed by or in the name of the corporation by the Chairman or Vice Chairman of the Board of Directors, if any, or the President or a Vice President, and by the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary, of the corporation, certifying the number of shares owned by him in the corporation. Any of or all the signatures on the certificate may be a facsimile. In case any officer, transfer agent, or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he were such officer, transfer agent, or registrar at the date of issue.
 
Section 5.2. Lost, Stolen or Destroyed Stock Certificates; Issuance of New Certificates. The corporation may issue a new certificate of stock in the place of any certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the corporation may require the owner of the lost, stolen or destroyed certificate, or his legal representative, to give the corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any su ch certificate or the issuance of such new certificate.
 

 
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ARTICLE VI
Indemnification
 
Section 6.1. Right to Indemnification. The corporation shall indemnify and hold harmless, to the fullest extent permitted by applicable law as it presently exists or may hereafter be amended, any person who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative (a “proceeding”) by reason of the fact that he, or a person for whom he is the legal representative, is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust, enter prise or non-profit entity, including service with respect to employee benefit plans, against all liability and loss suffered and expenses reasonably incurred by such person. The corporation shall be required to indemnify a person in connection with a proceeding initiated by such person only if the proceeding was authorized by the Board of Directors of the corporation.
 
Section 6.2. Prepayment of Expenses. The corporation shall pay the expenses incurred in defending any proceeding in advance of its final disposition, provided, however, that the payment of expenses incurred by a director or office r in advance of the final disposition of the proceeding shall be made only upon receipt of an undertaking by the director or officer to repay all amounts advanced if it should be ultimately determined that the director or officer is not entitled to be indemnified under this Article or otherwise.
 
Section 6.3. Claims. If a claim for indemnification or payment of expenses under this Article is not paid in full within sixty days after a written claim therefor has been received by the corporation, the claimant may file suit to recover the unpaid amount of such claim and, if successful in whole or in part, shall be entitled to be paid the expense of prosecuting such claim. In any such action the corporation shall have the burden of providing that the claimant was not entitled to the requested indemnification or payment of expenses under applicable law.
 
Section 6.4. Non-Exclusivity of Rights. The rights conferred on any person by this Article VI shall not be exclusive of any other rights which such person may have or hereafter acquire under any statute, provision of the Certificate of Incorporation, these Bylaws, agreement, vote of stockholders or disinterested directors or otherwise.
 
Section 6.5. Other Indemnification. The corporation's obligation, if any, to indemnify any person who was or is serving at its request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, enterprise or non-profit entity shall be reduced by any amount such person may collect as indemnification from such other corporation, partnership, joint venture, trust, enterprise or non-profit enterprise.
 
Section 6.6. Amendment or Repeal. Any repeal or modification of the foregoing provisions of this Article VI shall not adversely affect any right or protection hereunder of any person in respect to any act or omission occurring prior to the time of such repeal or modification.
 

 
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ARTICLE VII
Miscellaneous
 
Section 7.1. Fiscal Year. The fiscal year of the corporation shall be determined by resolution of the Board of Directors.
 
Section 7.2. Seal. The corporate seal shall have the name of the corporation inscribed thereon and shall be in such form as may be approved from time to time by the Board of Directors.
 
Section 7.3. Waiver of Notice of Meetings of Stockholders, Directors and Committees. Any written waiver of notice, signed b y the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of any regular or special meeting of the stockholders, directors or members of a committee of directors need be specified in any written waiver of notice.
 
Section 7.4. Interested Directors; Quorum. No contract or transaction between the corporation and one or more of its directors or officers, or between the corporation and any other corporation, partnership, association, or other organization in which one or more of its directors or officers are directors or officers, or have a financial interest, shall be void or voidable solely for this reason, or solely because the director or officer is present at or participates in the meeting of the Board of Directors or committee thereof which authorizes the contract or transaction, or solely because his or their votes are counted for such purposes, if: (1) the material facts as to his relationship or interest and as to the contract or transaction are disclosed or are known to the Board of Directors or the committee, and the Board of Directors or committee in good faith authorizes the contract or transaction by the affirmative votes of a majority of the disinterested directors, even though the di sinterested directors be less than a quorum; or (2) the material facts as to his relationship or interest and as to the contract or transaction are disclosed or are known to the stockholders entitled to vote thereon, and the contract or transaction is specifically approved in good faith by vote of the stockholders; or (3) the contract or transaction is fair as to the corporation as of the time it is authorized, approved or ratified, by the Board of Directors, a committee thereof, or the stockholders. Common or interested directors may be counted in determining the presence of a quorum at a meeting of the Board of Directors or of a committee which authorizes the contract or transaction.
 
Section 7.5. Form of Records. Any records maintained by the corporation in the regular courses of its business, including its stock ledger, books of account, and minute books, may be kept on, or be in the form of, punch cards, magnetic tape, photographs, microphotographs, or any other information storage device, provided that the records so kept can be converted into clearly legible form within a reasonable time. The corporation shall so convert any records so kept upon the request of any person entitled to inspect the same.
 
Section 7.6 Amendment of Bylaws. These Bylaws may be altered or repealed, and new bylaws made, by the Board of Directors, but the stockholders may make additional bylaws and may alter and repeal any bylaws whether adopted by them or otherwise.
 

 
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EX-31.1 3 spectraneticsex31109302010.htm EXHIBIT 31.1 WebFilings | EDGAR view
 

Exhibit 31.1
Certification of principal executive officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 
I, Guy A. Childs, certify that:< /div>
 
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.        I am 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)    
< div style="line-height:120%;text-align:left;font-size:10pt;">designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me 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 my 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 my 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 c ontrol 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.        I have disclosed, based on my 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.
 
< td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;">
November 8, 2010
 
 
/s/ Guy A. Childs
 
Guy A. Childs
 
principal executive officer
 

 
EX-31.2 4 spectraneticsex31209302010.htm EXHIBIT 31.2 WebFilings | EDGAR view
 

Exhibit 31.2
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.        I am 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 ove r 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 my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly du ring 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 my 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 ac counting principles;
 
c)    
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report my 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.        I have disclosed, based on my 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 r ole in the registrant's internal control over financial reporting.
  
November 8, 2010
 
 
/s/ Guy A. Childs
 
Guy A. Childs
 
Chief Financial Officer
 

 
EX-32.1 5 spectraneticsex32109302010.htm EXHIBIT 32.1 WebFilings | EDGAR view
 

Exhibit 32.1
Certification of principal 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 September 30, 2010 (th e “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 materi al respects, the financial condition and results of operations of the Company.
 
November 8, 2010
/s/ Guy A. Chil ds
 
Guy A. Childs
 
principal 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-32.2 6 spectraneticsex32209302010.htm EXHIBIT 32.2 WebFilings | EDGAR view
 

Exhibit 32.2
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 September 30, 2010 (the &ldq uo;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 res pects, the financial condition and results of operations of the Company.
 
November 8, 2010
/s/ Guy A. Childs
 
Guy A. Childs
 
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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