SECURITIES AND EXCHANGE COMMISSION
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 |
June 30, 2003
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
Delaware | 84-0997049 | |
(State or other jurisdiction of | (I.R.S. Employer Identification No.) | |
incorporation or organization) |
96 Talamine Court
Colorado Springs, Colorado 80907
(719) 633-8333
(Address of principal executive offices and telephone number)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the Registrant is an accelerated filer. Yes o No x
As of August 11, 2003 there were 24,368,224 outstanding shares of Common Stock.
Page 1
Part IFINANCIAL INFORMATION
Item 1. Financial Statements
THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(In Thousands, Except Share Amounts)
(Unaudited)
June 30, 2003 | December 31, 2002 | |||||||||
Assets: |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 8,780 | $ | 2,767 | ||||||
Investment securities available for sale |
3,528 | 8,663 | ||||||||
Trade accounts receivable, net of allowances |
3,715 | 4,042 | ||||||||
Inventories |
2,249 | 2,125 | ||||||||
Prepaid expenses and other current assets |
1,016 | 676 | ||||||||
Total current assets |
19,288 | 18,273 | ||||||||
Net equipment and leasehold improvements |
3,537 | 3,478 | ||||||||
Intangible assets, net |
649 | 771 | ||||||||
Other assets |
280 | 191 | ||||||||
Restricted cash |
1,124 | 1,123 | ||||||||
Total Assets |
$ | 24,878 | $ | 23,836 | ||||||
Liabilities and Shareholders Equity: |
||||||||||
Current liabilities: |
||||||||||
Accounts payable and accrued liabilities |
$ | 6,437 | $ | 6,619 | ||||||
Deferred revenue |
1,306 | 1,064 | ||||||||
Debt |
64 | 79 | ||||||||
Capital lease obligations |
| 3 | ||||||||
Total current liabilities |
7,807 | 7,765 | ||||||||
Other long-term liabilities |
205 | 216 | ||||||||
Total liabilities |
8,012 | 7,981 | ||||||||
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
24,296,420 and 23,877,744 shares, respectively |
24 | 24 | ||||||||
Additional paid-in capital |
94,106 | 93,393 | ||||||||
Accumulated other comprehensive loss |
(168 | ) | (272 | ) | ||||||
Accumulated deficit |
(77,096 | ) | (77,290 | ) | ||||||
Total shareholders equity |
16,866 | 15,855 | ||||||||
Total Liabilities and Shareholders Equity |
$ | 24,878 | $ | 23,836 | ||||||
See accompanying unaudited notes to condensed consolidated financial statements.
Page 2
Item 1. Financial Statements (contd)
THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(In Thousands, Except Percentages, Share and Per Share Amounts)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||||
Revenue |
$ | 6,545 | $ | 6,463 | $ | 13,522 | $ | 13,522 | |||||||||||
Cost of revenue |
1,791 | 2,029 | 3,899 | 4,297 | |||||||||||||||
Gross margin |
4,754 | 4,434 | 9,623 | 9,225 | |||||||||||||||
Gross margin % |
73 | % | 69 | % | 71 | % | 68 | % | |||||||||||
Operating expenses: |
|||||||||||||||||||
Selling, general and administrative |
3,858 | 3,716 | 7,728 | 7,417 | |||||||||||||||
Research, development and other technology |
908 | 1,242 | 1,832 | 2,435 | |||||||||||||||
Proxy contest,settlement obligations and
reorganization costs |
(32 | ) | 1,837 | (32 | ) | 1,837 | |||||||||||||
Total operating expenses |
4,734 | 6,795 | 9,528 | 11,689 | |||||||||||||||
Operating income (loss) |
20 | (2,361 | ) | 95 | (2,464 | ) | |||||||||||||
Other income (expense): |
|||||||||||||||||||
Interest expense |
| (37 | ) | (1 | ) | (74 | ) | ||||||||||||
Interest income |
40 | 142 | 108 | 246 | |||||||||||||||
Other, net |
(7 | ) | (3 | ) | (8 | ) | 16 | ||||||||||||
Total other income |
33 | 102 | 99 | 188 | |||||||||||||||
Net income (loss) |
$ | 53 | $ | (2,259 | ) | $ | 194 | $ | (2,276 | ) | |||||||||
Other comprehensive income (loss): |
|||||||||||||||||||
Foreign currency translation |
58 | 78 | 69 | 70 | |||||||||||||||
Unrealized gain (loss) on investment securities |
56 | 30 | 35 | (44 | ) | ||||||||||||||
Comprehensive income (loss) |
$ | 167 | $ | (2,151 | ) | $ | 298 | $ | (2,250 | ) | |||||||||
Net income (loss) per share basic and diluted |
$ | 0.00 | $ | (0.09 | ) | $ | 0.01 | $ | (0.10 | ) | |||||||||
Weighted average common shares outstanding: |
|||||||||||||||||||
Basic |
24,224,898 | 23,806,077 | 24,104,541 | 23,740,538 | |||||||||||||||
Diluted |
25,058,834 | 23,806,077 | 24,988,895 | 23,740,538 | |||||||||||||||
See accompanying unaudited notes to condensed consolidated financial statements.
Page 3
Item 1. Financial Statements (contd)
THE SPECTRANETICS CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows (In Thousands)
(Unaudited)
Six Months Ended June 30, | |||||||||||
2003 | 2002 | ||||||||||
Cash flows from operating activities: |
|||||||||||
Net income (loss) |
$ | 194 | $ | (2,276 | ) | ||||||
Adjustments to reconcile net income (loss) to net cash used
by operating activities: |
|||||||||||
Depreciation and amortization |
771 | 863 | |||||||||
Options granted for consulting services |
29 | 72 | |||||||||
Net change in operating assets and liabilities |
(621 | ) | 1,818 | ||||||||
Net cash provided by operating activities |
373 | 477 | |||||||||
Cash flows from investing activities: |
|||||||||||
Capital expenditures |
(253 | ) | (114 | ) | |||||||
Proceeds from maturity of investment securities, net |
5,170 | 1,015 | |||||||||
Net cash provided by investing activities |
4,917 | 901 | |||||||||
Cash flows from financing activities: |
|||||||||||
Proceeds from sale of common stock |
684 | 500 | |||||||||
Principal payments on long-term debt and
capital leases obligations |
(23 | ) | (129 | ) | |||||||
Net cash provided by financing activities |
661 | 371 | |||||||||
Effect of exchange rate changes on cash |
62 | 83 | |||||||||
Net increase in cash and cash equivalents |
6,013 | 1,832 | |||||||||
Cash and cash equivalents at beginning of period |
2,767 | 3,093 | |||||||||
Cash and cash equivalents at end of period |
$ | 8,780 | $ | 4,925 | |||||||
Supplemental disclosures of cash flow information
cash paid for interest |
$ | 2 | $ | 78 | |||||||
See accompanying unaudited notes to condensed consolidated financial statements.
Page 4
Item 1. Notes to Financial Statements
(1) General
We develop, manufacture, market and distribute single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with our proprietary excimer laser system. Excimer laser technology delivers comparatively cool ultraviolet light in short, controlled energy pulses to ablate or remove tissue. Our excimer laser system includes the CVX-300® laser unit and various fiber-optic delivery devices, including disposable catheters and sheaths. Our excimer laser system is the only excimer laser system approved in the United States and Europe for use in multiple, minimally invasive cardiovascular applications. Our excimer laser system is used in complex atherectomy procedures to open clogged or obstructed arteries in the coronary vascular system. It is also used to remove lead wires from patients with implanted pacemakers or cardioverter defibrillators, which are electronic devices that regulate the heartbeat.
The accompanying consolidated financial statements include the accounts of The Spectranetics Corporation, a Delaware corporation, and its wholly owned subsidiary, Spectranetics International, B.V. (collectively, the Company). All intercompany balances and transactions have been eliminated in consolidation.
We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America. As such, 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. Actual results could differ from those estimates. Significant estimates are used in these financial statements to determine the allowance for doubtful accounts, provision for sales returns, useful lives of depreciable assets, reserve for royalty obligations, inventory reserves, warranty reserves, and the valuation allowance for deferred tax assets and reserves.
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 Companys latest Annual Report on Form 10-K. In the opinion of management, all adjustments necessary for a fair presentation of the assets, liabilities and results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the entire year.
(2) Stock-Based Compensation
The Company accounts for its stock option plan in accordance with the provisions of Accounting Principles Board (APB) Opinion 25, Accounting for Stock Issued to Employees", and related interpretations. As such, compensation expense is recorded on the date of grant only if the current market price of the underlying stock exceeds the exercise price, the intrinsic value method. Under SFAS 123, Accounting for Stock-Based Compensation", entities are permitted to recognize as expense over the vesting period the fair value of all stock-based awards on the date of grant. Alternatively, SFAS 123 also allows entities to continue to apply the provisions of APB Opinion 25 and provide pro forma net income (loss) disclosures for employee stock option grants as if the fair-value-based method defined in SFAS 123 had been applied. The Company has elected to continue to apply the provisions of APB Opinion 25 and provide the pro forma disclosures required by SFAS 123. All stock-based awards to non-employees are accounted for at their fair value in accordance with SFAS 123 and related interpretations.
Page 5
The following table summarizes relevant information as to reported results under the Companys intrinsic value method of accounting for stock awards, with supplemental information as if the fair value recognition provisions of SFAS 123, Accounting for Stock Based Compensation had been applied for the three months and six months ended June 30, 2003 and 2002 (in thousands, except per share amounts):
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||||||
Net income (loss), as reported |
$ | 53 | $ | (2,259 | ) | $ | 194 | $ | (2,276 | ) | ||||||
Deduct: Total stock-based employee
compensation expense attributable to common
stock options determined under fair value
based method |
(228 | ) | (458 | ) | (485 | ) | (941 | ) | ||||||||
Pro forma net loss |
$ | (175 | ) | $ | (2,717 | ) | $ | (291 | ) | $ | (3,217 | ) | ||||
Income (loss) per share basic and diluted,
as reported |
0.00 | (0.09 | ) | 0.01 | (0.10 | ) | ||||||||||
(Loss) per share basic and diluted, pro forma |
(0.01 | ) | (0.11 | ) | (0.01 | ) | (0.14 | ) |
The per share weighted-average fair value of stock options granted during the second quarter of 2003 and 2002 was $2.29 and $1.79, respectively, using the Black-Scholes option pricing model. The per share weighted-average fair value of stock options granted during the six months ended June 30, 2003 and 2002 was $2.16 and $2.47, respectively, using the Black-Scholes option pricing model. The Company used the following weighted average assumptions in determining the fair value of options granted during the three months and six months ended June 30, 2003 and 2002:
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||||||
Expected Life (years) |
5.13 | 6.75 | 5.12 | 6.75 | ||||||||||||
Risk-free interest rate |
2.42 | % | 2.73 | % | 2.71 | % | 2.73 | % | ||||||||
Expected volatility |
90.5 | % | 91.3 | % | 90.8 | % | 91.3 | % | ||||||||
Expected dividend yield |
None | None | None | None |
(3) Net Income (Loss) Per Share
The Company calculates net income (loss) per share under the provisions of Statement of Financial Accounting Standards No. 128, Earnings Per Share (SFAS 128). Under SFAS 128, basic earnings per share is computed by dividing net income (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 earnings per share are computed in a manner consistent with that of basic earnings per share while giving effect to all potentially dilutive common shares outstanding during the period using the treasury stock method.
Diluted net income (loss) per share is the same as basic net income (loss) per share for the three and six months ended June 30, 2002, since potential common stock instruments are anti-dilutive. For the three months ended June 30, 2003 and June 30, 2002, 2,770,658 and 4,699,636 stock options, respectively, were excluded from the computation of diluted earnings per share due to their antidilutive effect. For the six months ended June 30, 2003 and 2002, respectively, 2,655,851 and 4,699,636 stock options were excluded from the computation due to their antidilutive effect. A summary of the net income (loss) per share calculation is shown below (in thousands, except per share amounts):
Page 6
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||||||
Net income (loss) |
$ | 53 | $ | (2,259 | ) | $ | 194 | $ | (2,276 | ) | ||||||
Common shares outstanding: |
||||||||||||||||
Historical common shares outstanding
at beginning of period |
24,131 | 23,800 | 23,878 | 23,600 | ||||||||||||
Weighted average common shares issued |
94 | 6 | 227 | 141 | ||||||||||||
Weighted average common shares
outstanding basic |
24,225 | 23,806 | 24,105 | 23,741 | ||||||||||||
Effect of dilution stock options |
834 | | 884 | | ||||||||||||
Weighted average common shares
outstanding diluted |
25,059 | 23,806 | 24,989 | 23,741 | ||||||||||||
Net income (loss) per share basic and diluted: |
$ | 0.00 | $ | (0.09 | ) | $ | 0.01 | $ | (0.10 | ) | ||||||
(4) Inventories
Inventories consist of the following:
June 30, 2003 | December 31, 2002 | |||||||
(in thousands) | ||||||||
Raw materials |
$ | 286 | $ | 275 | ||||
Work in process |
786 | 398 | ||||||
Finished goods |
1,177 | 1,452 | ||||||
$ | 2,249 | $ | 2,125 | |||||
(5) Deferred Revenue
Deferred revenue in the amounts of $1,306,000 and $1,064,000 at June 30, 2003 and December 31, 2002, respectively, relates primarily to payments in advance for various product maintenance contracts in which revenue is initially deferred and recognized over the life of the contract, which is generally one year.
(6) Restricted Cash
Restricted cash in the amounts of $1,124,000 and $1,123,000 at June 30, 2003 and December 31, 2002, respectively, consists of an escrow fund established pursuant to litigation with a licensor of certain patents. The funds may be disbursed from the escrow account upon the earlier of the resolution of the dispute or two years from November 8, 2002.
(7) Segment and Geographic Reporting
An operating segment is a component of an enterprise whose operating results are regularly reviewed by the enterprises chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance. The primary performance measure used by management is net income or loss. The Company operates in one distinct line of business consisting of developing, manufacturing, marketing and distributing a proprietary excimer laser system for the treatment of certain coronary and vascular conditions. The Company has identified two reportable geographic
Page 7
segments within this line of business: (1) U.S. Medical and (2) Europe Medical. U.S. Medical and Europe Medical offer the same products and services but operate in different geographic regions and have different distribution networks. Additional information regarding each reportable segment is shown below.
U. S. Medical
Products offered by this reportable segment include an excimer laser unit (equipment), fiber-optic delivery devices (disposables), and the service of the excimer laser unit (service). The Company is subject to product approvals from the Food and Drug Administration (FDA). At June 30, 2003, FDA-approved products were used in conjunction with coronary atherectomy as well as the removal of non-functioning leads from pacemakers and cardiac defibrillators. This segments customers are primarily located in the United States; however, the geographic areas served by this segment also include Canada, Mexico, South America, the Pacific Rim and Australia.
U.S. Medical is also corporate headquarters for the Company. Accordingly, research and development as well as corporate administrative functions are performed within this reportable segment. As of June 30, 2003 and 2002, cost allocations of these functions to Europe Medical have not been performed.
Manufacturing activities are performed primarily within the U.S. Medical segment. Revenue associated with intersegment product transfers to Europe Medical was $294,000 and $322,000 for the three months ended June 30, 2003 and 2002, respectively, and $641,000 and $620,000 for the six months ended June 30, 2003 and 2002, respectively. Revenue is based upon transfer prices, which provide for intersegment profit that is eliminated upon consolidation.
Europe Medical
The Europe Medical segment is a marketing and sales subsidiary located in the Netherlands that serves all of Europe as well as the Middle East. Products offered by this reportable segment are the same as U.S. Medical products. The Company has received CE mark approval for products that relate to four applications of excimer laser technology coronary atherectomy, in-stent restenosis, lead removal, and peripheral angioplasty to clear blockages in leg arteries.
Summary financial information relating to reportable segment operations is shown below. Intersegment transfers as well as intercompany assets and liabilities are excluded from the information provided (in thousands):
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
Revenue: | 2003 | 2002 | 2003 | 2002 | |||||||||||||
U.S. Medical |
$ | 5,890 | $ | 5,847 | $ | 12,292 | $ | 12,250 | |||||||||
Europe Medical |
655 | 616 | 1,230 | 1,272 | |||||||||||||
Total revenue |
$ | 6,545 | $ | 6,463 | $ | 13,522 | $ | 13,522 | |||||||||
Segment net | Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
Income (loss): | 2003 | 2002 | 2003 | 2002 | |||||||||||||
U.S. Medical |
$ | 41 | $ | (2,283 | ) | $ | 182 | $ | (2,381 | ) | |||||||
Europe Medical |
12 | 24 | 12 | 105 | |||||||||||||
Total net income (loss) |
$ | 53 | $ | (2,259 | ) | $ | 194 | $ | (2,276 | ) | |||||||
Page 8
June 30, | December 31, | ||||||||
Segment assets: | 2003 | 2002 | |||||||
U.S. Medical |
$ | 22,723 | $ | 21,636 | |||||
Europe Medical |
2,155 | 2,200 | |||||||
Total assets |
$ | 24,878 | $ | 23,836 | |||||
(8) Reorganization Costs
During the three months ended December 31, 2000, reorganization expense primarily associated with the elimination of the direct sales organization in Germany totaled $1,200,000. A rollforward of these costs is summarized below.
Accrued | Accrued | ||||||||||||||||||||||||
costs as of | costs as of | ||||||||||||||||||||||||
December 31, | Payments made: | Adjustments | June 30, | ||||||||||||||||||||||
2000 | 2001 | 2002 | 2003 | 2003 | 2003 | ||||||||||||||||||||
Termination and
severance costs |
$ | 700 | $ | 513 | $ | 107 | $ | 52 | $ | 28 | $ | | |||||||||||||
Legal fees |
150 | 150 | | | | | |||||||||||||||||||
Cancellation of
contracts and
leases |
172 | 168 | | | 4 | | |||||||||||||||||||
Other |
38 | 38 | | | | | |||||||||||||||||||
Total |
$ | 1,060 | $ | 869 | $ | 107 | $ | 52 | $ | 32 | $ | | |||||||||||||
Additional costs of $140,000 relate primarily to a provision for bad debt expense associated with the restructuring as of December 31, 2000. At June 30, 2003, this provision had a zero balance.
The termination and severance costs relate primarily to eight employees within the direct sales organization in Germany. Effective January 1, 2001, a direct sales organization was no longer used in Germany; instead, a distributor has been contracted to continue selling the Companys products in Germany. At June 30, 2003 all reorganizations costs have been paid and the remaining balance of $32,000 was reversed.
(9) Proxy Contest and Settlement Obligation
On April 26, 2002, a stockholder of the Company, Steven W. Sweet, filed a preliminary proxy statement with the SEC in which he nominated two directors for election at the Companys 2002 Annual Meeting, then scheduled to take place on June 4, 2002. On May 3, 2002, all of the executive officers of the Company signed a letter addressed to Mr. Sweet agreeing to vote in favor of Mr. Sweets director nominees. On May 13, 2002, Mr. Sweet, together with Joseph A. Largey, the former President and Chief Executive Officer of the Company, Paul C. Samek, the former Vice President, Finance and Chief Financial Officer of the Company, Lawrence R. McKinley, Sharon L. Sweet, a former employee of the Company and sibling of Steven W. Sweet (collectively, the Sweet Group) and the other executive officers of the Company filed a Schedule 13D with the SEC indicating that they were acting as a group (the 13D Group) in connection with Mr. Sweets proxy solicitation. On May 14, 2002, all of the executive officers of the Company, other than Messrs. Largey and Samek, signed a letter addressed to Mr. Sweet withdrawing from the 13D Group and from Mr. Sweets proxy solicitation group and stating
Page 9
their neutrality with respect to any proposals submitted to the stockholders by the Company or the Sweet Group. Subsequently, Mr. Sweet filed additional proxy materials adding four proposals for consideration at the June 4, 2002 Annual Meeting. On May 15, 2002, the Company announced that it had deferred its 2002 Annual Meeting in order to give the Companys stockholders more time to fully consider recent developments. On May 23, 2002, the Company filed an action in the United States District Court for the District of Delaware against the members of the Sweet Group for violation of federal securities laws.
On June 6, 2002, the Company reached a definitive agreement that resolved disputes among the Company and the members of the Sweet Group. As part of the settlement, the parties agreed to the following:
| The withdrawal by the Sweet Group of its director nominees as well as the other matters it had proposed for the Annual Meeting and agreement to vote at the Annual Meeting for the election of Messrs. Geisenheimer and Schulte, who were incumbent members of the Board of Directors, and the Company dismissed with prejudice the lawsuits filed against the Sweet Group. | ||
| The appointment to the Board of two new directors who are unaffiliated with, and independent of, any of the Companys current directors and the Sweet Group and who are approved in good faith by the Board and Mr. Sweet, which approval shall not by unreasonably withheld. One of the new directors will fill a vacancy on the Board created by the resignation of Mr. Largey, which became effective on June 18, 2002, and the other new director will replace a current member of the Board, who will retire from the Board upon the appointment of a replacement director. Heidrick & Struggles, a nationally recognized executive recruiting firm, has been retained by the Company to assist in identifying the new directors. As of June 30, 2003, one of the two new directors has been appointed and the search is on-going for the open seat. | ||
| The retention by the Company of a nationally recognized consultant to recommend a program for equity incentives, including stock options, for outside directors and to submit the program recommended by the independent consultant to a vote of the stockholders at the Annual Meeting. The recommendations of the consultant were submitted to a shareholder vote and approved at the Annual Shareholders Meeting held on August 5, 2002. |
The resolution also settled all claims between the Company and Messrs. Largey and Samek and Ms. Sweet, each of whom has separated from the Company.
Costs associated with the proxy contest and settlement obligations are shown below (in thousands):
Costs incurred | |||||||||||||||||||||
during the year | Accrued | ||||||||||||||||||||
ended | costs as of | ||||||||||||||||||||
December 31, | Amounts paid | Adjustments | June 30, | ||||||||||||||||||
2002 | 2002 | 2003 | 2003 | 2003 | |||||||||||||||||
Termination and severance costs |
$ | 570 | $ | 336 | $ | 215 | $ | (19 | ) | $ | | ||||||||||
Legal fees reimbursed to Mr
Sweet |
100 | 100 | | | | ||||||||||||||||
Legal fees |
756 | 684 | | (72 | ) | | |||||||||||||||
Public and investor relations |
135 | 106 | | (29 | ) | | |||||||||||||||
Proxy solicitor |
69 | 49 | | (20 | ) | | |||||||||||||||
Other advisory fees |
151 | 147 | | (4 | ) | | |||||||||||||||
Other fees |
| 133 | 11 | 144 | | ||||||||||||||||
Total |
$ | 1,781 | $ | 1,555 | $ | 226 | $ | | $ | | |||||||||||
Page 10
Additional costs of $56,000 relate primarily to costs associated with accelerating the vesting of stock options of the three terminated executives. All settlement costs have been paid at June 30, 2003.
(10) Income Taxes
At December 31, 2002, the Company had net operating loss carryforwards for United States federal income tax purposes of approximately $54 million, which are available to offset future federal taxable income, if any, and expire at varying dates from 2003 through 2022. The annual use of the net operating loss carryforwards is limited under Section 382 of the Internal Revenue Code of 1986.
An alternative minimum tax credit carryforward of $253,000 is available to offset future regular tax liabilities and has no expiration date. The Company also has research and experimentation tax credit carryforwards at December 31, for federal income tax purposes of approximately $3 million, which are available to reduce future federal income taxes, if any, and expire at varying dates through 2022. The annual use of portions of the research and experimentation credit carryforwards is also limited under Section 382.
The Company has calculated a potential net deferred tax asset of $36.1 million as of December 31, 2002. The Company has recorded a valuation allowance equal to the gross deferred tax asset at December 31, 2002 due to the uncertainty of realization. The Company reviews its deferred tax assets on an ongoing basis for realizability. While the Company has generated net income in recent quarters, the Company believes there currently is not enough positive evidence to support a conclusion that it is more likely than not that it will utilize some or all of our deferred tax assets. When the Company determines there is enough positive evidence to support a conclusion that it is more likely than not that it will realize some or all of its deferred tax asset, the Company will reduce the valuation allowance which will result in an increase to net income in the period in which such determination is made. Positive evidence to support a conclusion that our deferred tax asset is realizable includes, but is not limited to, generating net income in consecutive quarters and projections for taxable income sufficient to utilize our deferred tax assets.
(11) Recent Accounting Pronouncements
In December 2002, the Emerging Issues Task Force (EITF) reached a consensus on EITF 00-21, Revenue Arrangements with Multiple Deliverables. The consensus defines the accounting for arrangements that include multiple deliverables and provides guidance on how the arrangement consideration should be measured, whether the arrangement should be divided into separate units of accounting and that the arrangement consideration should be allocated among the separate units of accounting based on their relative fair value, if applicable. Once the arrangement is separated into its units of accounting, applicable revenue recognition should be applied to each separate unit of accounting. Adoption of the provisions of this EITF are required beginning with the Companys third quarter of 2003
The pronouncement is effective July 1, 2003 and the Company currently intends to record an adjustment for the cumulative effect of a change in accounting principle upon adoption. The Company has not finalized the calculation of the adjustment but estimates that it will be in the range of $150,000 $200,000. The primary impact of the new pronouncement will be to treat service provided during the one-year warranty period as a separate unit of accounting. As such, the retail value of this service will be deferred and recognized as revenue on a straight-line basis over the warranty period. Additionally, the Companys revenue recognition policy as it relates to laser equipment sales will be modified so that revenue will be recognized upon completion of installation of the laser system and physician training. Prior to July 1, 2003, revenue for the sale of laser equipment was recognized upon shipment.
Statement of Financial Accounting Standards 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (SFAS 150), was issued in May 2003. It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). Many of those instruments were previously classified as equity. Some of the provisions of SFAS 150 are consistent with the current definition of liabilities in FASB Concepts Statement No. 6,
Page 11
Elements of Financial Statements. The remaining provisions of SFAS 150 are consistent with the Boards proposal to revise that definition to encompass certain obligations that a reporting entity can or must settle by issuing its own equity shares, depending on the nature of the relationship established between the holder and the issuer. SFAS 150 will not affect the Companys financial statements as it does not have issued or outstanding financial instruments of this type.
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition
Forward-Looking Statements
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. For a description of such risks and uncertainties, which could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the risk factors below. Readers are urged to carefully review and consider the various disclosures made in this report and in our other reports filed with the SEC that attempt to advise interested parties of certain risks and factors that may affect our business. This analysis should be read in conjunction with our consolidated financial statements and related notes and Managements Discussion and Analysis of Financial Condition and Results of Operations included in our Form 10-K, filed on March 31, 2003. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events.
Corporate Overview
We develop, manufacture, market and service an excimer laser unit and fiber optic delivery system for minimally invasive surgical procedures within the cardiovascular system. Our CVX-300® excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy and removal of faulty or infected pacemaker and defibrillator leads. Our laser system competes against alternative technologies including balloon catheters, cardiovascular stents and mechanical atherectomy and thrombectomy devices.
In addition to our core business described above, we also manufacture and distribute certain products as an original equipment manufacturer for other medical device companies. Historically, revenue from this business represented less than 2% of consolidated revenue and gross margin has been in the range of $100,000 to $200,000 per year. In past years, revenue within this business was derived primarily from one customer who has moved its business to another supplier. As a result, we do not expect revenue in 2003 to reach prior year amounts.
Our strategy is to develop additional applications for our excimer laser system, increase utilization of our FDA-approved products, and expand our installed base of laser systems. We plan to remain focused on profitability as we work towards the execution of our strategy.
In 1993, the FDA approved for commercialization our CVX-300 laser system and the first generation of our fiber optic coronary atherectomy catheters. Several improvements and additions to our coronary atherectomy product line have been made since 1993 and have been approved for commercialization by the FDA. In 1997, we secured FDA approval to use our excimer laser system for removal of pacemaker and defibrillator leads, and we secured FDA approval in 2001 to market certain products for use in restenosed (clogged) stents (thin steel mesh tubes used to support the walls of coronary arteries) as a pretreatment prior to brachytherapy (radiation therapy).
Page 12
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
We recently completed two FDA-approved clinical trials evaluating the use of our excimer laser system to treat blocked arteries in the upper and lower leg. In January 2003, the data from our LACI (Laser Angioplasty for Critical Limb Ischemia) trial, which deals with blockages in the lower leg, was submitted to the FDA in the form of a Pre-Market Approval (PMA) Supplement. If successful, this trial will result in additional FDA-approved applications in the United States, which is anticipated in late 2003. In December 2002 we completed the one year follow-up phase of our PELA (Peripheral Excimer Laser Angioplasty) trial, which deals with blockages in the upper leg. An analysis of the PELA data failed to show superiority of the use of the laser. We believe the size of the catheters used in the trial adversely affected results and we are currently developing larger catheters with the objective of improving clinical outcomes. We do not currently intend to submit the data from the PELA trial to the FDA requesting marketing clearance.
Results of Operations
The following table summarizes key supplemental financial information for the last 5 quarters.
2002 | 2003 | ||||||||||||||||||||
2nd Qtr | 3rd Qtr | 4th Qtr | 1st Qtr | 2nd Qtr | |||||||||||||||||
Laser sales summary: |
|||||||||||||||||||||
Laser sales from inventory |
2 | 9 | 4 | 2 | 1 | ||||||||||||||||
Laser sales from evaluation/rental units |
3 | 6 | 6 | 6 | 1 | ||||||||||||||||
Total laser sales |
5 | 15 | 10 | 8 | 2 | ||||||||||||||||
Worldwide
laser placements Laser sales from inventory |
2 | 9 | 4 | 2 | 1 | ||||||||||||||||
Rental placements |
0 | 0 | 0 | 2 | 2 | ||||||||||||||||
Evaluation placements |
7 | 7 | 5 | 1 | 9 | ||||||||||||||||
Laser placements during quarter |
9 | 16 | 9 | 5 | 12 | ||||||||||||||||
Buy-backs/returns during quarter |
(5 | ) | (3 | ) | (3 | ) | (4 | ) | (5 | ) | |||||||||||
Net laser placements during quarter |
4 | 13 | 6 | 1 | 7 | ||||||||||||||||
Total lasers placed at end of quarter |
341 | 354 | 360 | 361 | 368 | ||||||||||||||||
(000s, except per share and percentages) |
|||||||||||||||||||||
Laser Revenue: |
|||||||||||||||||||||
Equipment sales |
$ | 461 | $ | 1,245 | $ | 934 | $ | 761 | $ | 182 | |||||||||||
Rental fees |
391 | 329 | 345 | 311 | 260 | ||||||||||||||||
Total |
852 | 1,574 | 1,279 | 1,072 | 442 | ||||||||||||||||
Disposable products revenue |
4,552 | 4,649 | 5,293 | 5,017 | 5,192 | ||||||||||||||||
Service revenue |
963 | 925 | 983 | 929 | 975 | ||||||||||||||||
Provision
for sales returns and other revenues |
96 | 9 | (137 | ) | (41 | ) | (64 | ) | |||||||||||||
Total revenue |
6,463 | 7,157 | 7,418 | 6,977 | 6,545 | ||||||||||||||||
Gross margin (%) |
69 | % | 67 | % | 69 | % | 70 | % | 73 | % | |||||||||||
Selling, general and administrative
expenses |
3,716 | 3,556 | 3,698 | 3,870 | 3,858 | ||||||||||||||||
Research, development and other
technology expenses |
1,242 | 1,096 | 979 | 924 | 908 | ||||||||||||||||
Proxy contest. settlement obligations and
reorganization costs |
1,837 | | | | (32 | ) | |||||||||||||||
Total operating expenses |
6,795 | 4,652 | 4,677 | 4,794 | 4,734 |
Page 13
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
Operating income (loss) |
(2,361 | ) | 142 | 418 | 75 | 20 | ||||||||||||||
Net income (loss) |
(2,259 | ) | 227 | 488 | 141 | 53 | ||||||||||||||
Net income (loss) per share-
basic and diluted |
(0.09 | ) | 0.01 | 0.02 | 0.01 | 0.00 | ||||||||||||||
Net
cash provided (used) by operating activities |
621 | 177 | (1,276 | ) | 202 | 171 |
Three Months Ended June 30, 2003, Compared with Three Months Ended June 30, 2002
Revenue for the second quarter of 2003 was $6,545,000 as compared to $6,463,000 during the second quarter of 2002, an increase of one percent. This increase is due to a 14 percent increase in disposable products revenue partially offset by a 48 percent decrease in equipment revenue.
During the second quarter of 2003 our installed base of excimer laser systems increased by seven to 368 excimer laser systems (268 in the United States). This is a result of 12 placements (sold, rented or provided for evaluation) net of five returns compared with four net placements during the second quarter of 2002. The decrease in equipment revenue is primarily caused by decreased laser unit sales. The Company sold (either an outright sale from inventory or a sale conversion from evaluation or rental programs) two laser units in the second quarter of 2003 compared with five laser units sold in the second quarter of 2002.
Disposable products revenue, which consists of single-use catheter products, increased 14 percent due to a 38 percent increase in lead removal products partially offset by a four percent decrease in atherectomy catheters. We believe our lead removal revenue increased primarily as a result of the increase in use of automatic implantable cardioverter defibrillators (AICD), devices that regulate heart rhythm. When a patient who already has a pacemaker is upgraded to an AICD, the old pacemaker leads are generally removed to avoid potential electrical interference with the new AICD leads. We have clinical data showing that pacemaker and AICD leads can be taken out using our lead removal products with a dramatically higher success rate and with significantly fewer complications compared with traditional mechanical techniques for lead removal. Sales of our coronary laser atherectomy products continue to be negatively impacted by the lack of recent clinical data supporting the use of our products combined with the diminished value of debulking by any atherectomy device, including laser atherectomy, as a result of the advent of bare metal stents and their pervasive use in coronary interventions. We are focusing our efforts on indications where we believe laser atherectomy can demonstrate improved clinical outcomes. We have initiated clinical research studying the use of our technology to treat thrombus-laden lesions, including saphenous vein grafts and acute myocardial infarction (heart attack). Although we believe this clinical data, when available, may contribute to the growth of our atherectomy business, there can be no assurances this will occur.
Service revenue in the second quarter of 2003 increased slightly from the second quarter of 2002.
Gross margin increased to 73 percent during the three months ended June 30, 2003 from 69 percent for the second quarter of 2002. This increase was due primarily to a higher proportion of disposable products revenue in the product mix compared with the same period in 2002. Disposable products revenue generates higher gross margins than equipment revenue.
Operating expenses of $4,766,000, excluding reversal of reorganization expenses of $(32,000), in the second quarter of 2003 decreased four percent from $4,958,000, excluding proxy contest charges and settlement obligations of $1,837,000, in the three months ended June 30, 2002. This is due to a 27 percent decrease in research, development and other technology expenses partially offset by a four percent increase in selling, general and administrative expenses relative to the same period in 2002.
Page 14
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
Selling, general and administrative expenses were $3,858,000 for the three months ended June 30, 2003, a four percent increase from the prior year period. This increase results primarily from a five percent increase in selling expenses. Selling expenses increased $141,000 over the prior year period primarily as a result of increased personnel-related expenses associated with the addition of three employees in our field sales force. General and administrative expenses in the 2003 second quarter are consistent with the prior year period.
Research, development and other technology expenses decreased 27 percent to $908,000 for the second quarter of 2003 from $1,242,000 in the second quarter of 2002. Costs included within research, development and other technology expenses are research and development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors. The decrease is primarily caused by a $186,000 decrease in clinical studies costs as a result of the completion of the LACI and PELA trials during the fourth quarter of 2002. Research and development costs decreased $115,000 during the period primarily as a result of the completion in the third quarter of 2002 of development on the second generation laser sheath used to remove pacemaker and defibrillator leads. We anticipate that research, development and other technology expenses in future quarters may increase from the amounts incurred during the three months ended June 30, 2003. We have begun clinical research studying the use of our technology to treat thrombus-laden lesions in saphenous vein grafts and acute myocardial infarction (heart attack). We are also conducting animal studies to assess our technologys ability to treat ischemic stroke. We anticipate completing these studies by the end of this year and will determine if further clinical research in humans is warranted.
Reorganization costs of $(32,000) for the three months ended June 30, 2003 represent the reversal of the ending balance of the accrual for reorganization costs. Further discussion of these costs is contained in footnote (8) to our financial statements.
Proxy contest charges and settlement obligations for the three months ended June 30, 2002, totaled $1,837,000. See further discussion of these costs contained in footnote (9) to our financial statements.
Interest income decreased 72 percent in the second quarter of 2003 to $40,000 due to lower yields on our interest-bearing securities, which consist primarily of U.S. government and agency obligations with original maturities of less than two years.
Net income for the three months ended June 30, 2003 was $53,000, compared with a net loss of $2,259,000 in the same quarter last year. Excluding proxy contest and settlement obligation charges of $1,837,000, net loss was $422,000 in the second quarter of 2002. Increased gross margins and decreased operating expenses, discussed above, contributed to the net income in the second quarter of 2003.
The functional currency of Spectranetics International B.V. is the euro. All revenue and expenses are translated to U.S. dollars in the consolidated statements of operations using weighted average exchange rates during the period. Fluctuation in euro currency rates during the three months ended June 30, 2003, as compared with the three months ended June 30, 2002, caused an increase in consolidated revenue and operating expenses of two percent and one percent, respectively.
Six Months Ended June 30, 2003 Compared with Six Months Ended June 30, 2002
Revenue for the six months ended June 30, 2003 was $13,522,000, equal to revenue from the six months ended June 30, 2002. An increase of 11 percent in disposable products revenue was offset by a
Page 15
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
32 percent decrease in equipment revenue. Service revenue remained constant with that of the prior year period.
The equipment revenue decrease is primarily due to increased revenue from sales conversions of rental and evaluation units during the first quarter of 2002, which was driven by a $90,000 special price promotion on laser equipment. For the six months ended June 30, 2003, our installed base of excimer laser systems increased by eight to 368 excimer laser systems (268 in the United States). This is a result of 17 placements (sold, rented or provided for evaluation) net of nine returns compared with 14 net placements during the six months ended June 30, 2002.
Sales of lead removal products for the six months ended June 30, 2003 increased 31 percent from the prior year period. The increase was partially offset by a five percent decrease in sales of atherectomy catheters to result in an 11 percent increase in disposable products revenue, which consists of single-use catheter products.
Gross margin increased to 71 percent during the six months ended June 30, 2003, from 68 percent for the six months ended June 30, 2002. This increase was due to a shift in product mix to a higher proportion of disposable products revenue, which generates higher margins than revenue from excimer laser systems.
Operating expenses decreased three percent in the six months ended June 30, 2003 to $9,560,000, excluding the reversal of reorganization expenses of $(32,000), compared with $9,852,000, excluding proxy contest charges and settlement obligations of $1,837,000, for the six months ended June 30, 2002.
Selling, general and administrative expenses increased four percent to $7,728,000 for the six months ended June 30, 2003 from $7,417,000 in the six months ended June 30, 2002. This increase is due to:
| Selling expenses increased approximately $450,000 compared with last year as a result of the following: |
| Approximately $290,000 relates to personnel-related expenses associated with an increase of three additional employees in our field sales force this year. | ||
| Approximately $90,000 relates to increased costs of our foreign operations, primarily associated with the strengthening euro in relation to the U.S. dollar. | ||
| Approximately $140,000 increased marketing costs in preparation for the anticipated launch of LACI products upon receipt of FDA approval offset by $70,000 decreased costs associated with the marketing costs for our coronary and lead removal applications. |
| General and administrative expenses decreased approximately $150,000 compared with last year primarily as a result of reduced personnel-related costs associated with fewer employees compared with the six months ended June 30, 2002. |
Research, development and other technology expenses of $1,832,000 for the six months ended June 30, 2003 decreased 25 percent from $2,435,000 for the six months ended June 30, 2002. Costs included within research, development and other technology expenses are research and development costs, clinical studies costs and royalty costs associated with various license agreements with third-party licensors. The decrease from prior year amounts is primarily due to a $434,000 decrease in clinical studies costs as a result of the completion of the LACI and PELA trials during the fourth quarter of 2002. A $125,000 decrease in research and development expenses associated with the development in 2002 of
Page 16
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
the second generation laser sheath used for our lead removal application and reduced royalties as a result of decreased royalty-bearing revenue also contributed to the decrease from the six months ended June 30, 2002.
Reorganization costs of $(32,000) represent the reversal of the ending balance of the accrual for reorganization costs. Further discussion of these costs is contained in footnote (8) to our financial statements.
Proxy contest charges and settlement obligations in the six months ended June 30, 2002 totaled $1,837,000. See further discussion of these costs contained in footnote (9) to our financial statements.
Interest income decreased in 2003 to $108,000 from $246,000 in 2002 due to lower investment yields within our investment portfolio, which consist primarily of cash equivalents, short-term government bonds and corporate bonds.
Net income for the six months ended June 30, 2003, was $194,000, compared with a net loss of $2,276,000 in 2002. Net loss in 2002, excluding proxy contest charges and settlement obligations, was $439,000.
The functional currency of Spectranetics International B.V. is the euro. All revenue and expenses are translated to U.S. dollars in the consolidated statements of operations using weighted average exchange rates during the period. Fluctuation in euro currency rates during the six months ended June 30, 2003, as compared with the six months ended June 30, 2002, caused a decrease in consolidated revenue and operating expenses of less than two percent.
Liquidity and Capital Resources
As of June 30, 2003, we had cash, cash equivalents and investment securities of $12,308,000, an increase of $878,000 from $11,430,000 at December 31, 2002.
Cash provided by operating activities of $373,000 for the six months ended June 30, 2003 consisted of net income of $194,000 increased by non-cash expenses of $800,000, a $387,000 decrease in accounts receivable, and a $221,000 increase in deferred revenue, offset by a $271,000 reduction in accounts payable and accrued liabilities, an increase of inventory and equipment held for rental or loan of $535,000, an increase of $387,000 in prepaid expenses and other current assets and an increase of $36,000 in other assets.
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 net accounts receivable balance by the average daily sales for the second quarter. Inventory turns are calculated by dividing annualized cost of sales for the second quarter by ending inventory.
June 30, 2003 | December 31, 2002 | |||||||
Days Sales Outstanding |
51 | 49 | ||||||
Inventory Turns |
3.2 | 4.3 |
Page 17
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
Cash provided by investing activities of $4,917,000 for the six months ended June 31, 2003 was due to proceeds of $5,170,000 from the maturity of investment securities partially offset by capital expenditures of $253,000.
Proceeds of $684,000 from the sale of common stock pursuant to exercises of stock options and stock issuances under our employee stock purchase plan offset by $23,000 of principal payments on long-term debt and capital lease obligations resulted in cash provided by financing activities of $661,000 for the six months ended June 30, 2003. Total debt, including capital lease obligations, was $64,000 at June 30, 2003.
At June 30, 2003 and December 31, 2002, we had placed a number of laser systems on rental and loan programs. A total of $5,235,000 and $5,031,000 was recorded as equipment held for rental or loan at June 30, 2003, and December 31, 2002, respectively, and is being depreciated over three to five years.
We currently use two placement programs in addition to the sale of laser systems:
(1) | Evergreen rental program This rental program was introduced in July 1999. Rental revenue under this program varies on a sliding scale depending on the customers purchases of disposable products each month. Rental revenue is invoiced on a monthly basis and revenue is recognized upon invoicing. The laser unit is transferred to the equipment held for rental or loan account upon shipment, and depreciation expense is recorded within cost of revenue based upon a three- to five-year expected life of the unit. As of June 30, 2003, 45 laser units were in place under the evergreen rental program. We also offer a straight monthly rental program and there are a small number of hospitals that pay $3,000-$5,000 per month under this program. | ||
(2) | Evaluation programs We loan a laser system to an institution for use over a short period of time, usually three to six months. The loan of the equipment is to create awareness of our products and their capabilities, and no revenue is earned or recognized in connection with the placement of a loaned laser (although sales of disposable products result from the laser placement). The laser unit is transferred to the equipment held for rental or loan account upon shipment, and depreciation expense is recorded within selling, general and administrative expense based on a three- to five-year expected life of the unit. As of June 30, 2003, 25 laser units were in place under the evaluation program. |
We believe our liquidity and capital resources as of June 30, 2003 are sufficient to meet our operating and capital requirements through at least the next twelve months. In the event we need additional financing for the operation of our business, we will consider additional public or private financing. Factors influencing the availability of additional financing include investor perception of our business prospects and the general condition of the financial markets. We cannot assure you that our existing cash and cash equivalents will be adequate or that additional financing will be available when needed or that, if available, this financing will be obtained on terms favorable to us or our stockholders.
We do not expect our capital requirements to change significantly in 2003 compared with 2002 levels.
Page 18
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
CONVERSION TO THE EURO
On January 1, 2002, Spectranetics International B.V. adopted the euro as its functional currency. The conversion to the euro did not have and is not expected to have a material effect on our consolidated financial results of operations.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America. As such, we are required to make certain estimates, judgments and assumptions that we believe are reasonable based upon the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. Actual results could differ from those estimates. Significant estimates are used in these financial statements to determine the allowance for doubtful accounts provision for sales returns, useful lives of depreciable assets, reserve for royalty obligations, inventory reserves, warranty reserves, and the valuation allowance for deferred tax assets and reserves.
As a result of adopting EITF-0021, Revenue Arrangements with Multiple Deliverables which is effective July 1 2003, our revenue recognition policy for the sale of laser equipment will be modified. The primary impact of the new pronouncement will be to treat service provided during the one-year warranty period as a separate unit of accounting. As such, the retail value of this service will be deferred and recognized as revenue on a straight-line basis over the warranty period. Revenue will be recognized upon completion of installation of the laser system and physician training. Prior to July 1, 20003, revenue for the sale of laser equipment was recognized upon shipment.
Our critical accounting policies and estimates are included in our Form 10-K, filed on March 31, 2003.
RECENT ACCOUNTING PRONOUNCEMENTS
In December 2002, the Emerging Issues Task Force (EITF) reached a consensus on EITF 00-21, Revenue Arrangements with Multiple Deliverables. The consensus defines the accounting for arrangements that include multiple deliverables and provides guidance on how the arrangement consideration should be measured, whether the arrangement should be divided into separate units of accounting and that the arrangement consideration should be allocated among the separate units of accounting based on their relative fair value, if applicable. Once the arrangement is separated into its units of accounting, applicable revenue recognition should be applied to each separate unit of accounting. Adoption of the provisions of this EITF are required beginning with the Companys third quarter of 2003.
The pronouncement is effective July 1, 2003 and the Company currently intends to record an adjustment for the cumulative effect of a change in accounting principle upon adoption. The Company has not finalized the calculation of the adjustment but estimates that it will be an expense in the range of $150,000 $200,000. The primary impact of the new pronouncement will be to treat service provided during the one-year warranty period as a separate unit of accounting. As such, the retail value of this service will be deferred and recognized as revenue on a straight-line basis over the warranty period. Additionally, the Companys revenue recognition policy as it relates to laser equipment sales will be modified so that revenue will be recognized upon completion of installation of the laser system and
Page 19
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
physician training. Prior to July 1, 20003, revenue for the sale of laser equipment was recognized upon shipment.
Statement of Financial Accounting Standards 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (SFAS 150), was issued in May 2003. It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). Many of those instruments were previously classified as equity. Some of the provisions of SFAS 150 are consistent with the current definition of liabilities in FASB Concepts Statement No. 6, Elements of Financial Statements. The remaining provisions of SFAS 150 are consistent with the Boards proposal to revise that definition to encompass certain obligations that a reporting entity can or must settle by issuing its own equity shares, depending on the nature of the relationship established between the holder and the issuer. SFAS 150 will not affect our financial statements as we do not have issued or outstanding financial instruments of this type.
RISK FACTORS
Failures in Clinical Trials May Hurt Our Business and Our Stock Price. All of Spectranetics potential products are subject to extensive regulation and will require approval from the FDA and other regulatory agencies prior to commercial sale. The results from pre-clinical testing and early clinical trials may not be predictive of results obtained in large clinical trials. Companies in the medical device industry have suffered significant setbacks in various stages of clinical trials, even in advanced clinical trials, after apparently promising results had been obtained in earlier trials.
The development of safe and effective products is uncertain and subject to numerous risks. The product development process may take several years, depending on the type, complexity, novelty and intended use of the product. Larger competitors are able to offer larger financial incentives to their customers to support their clinical trials. Enrollment in our clinical trials may be adversely affected by clinical trials financed by our larger competitors. Product candidates that may appear to be promising in development may not reach the market for a number of reasons.
Product candidates may:
| be found ineffective; | ||
| take longer to progress through clinical trials than had been anticipated; or | ||
| require additional clinical data and testing. |
We cannot guarantee that we will gain FDA approval to market the use of our excimer laser system to treat blocked arteries in the lower leg. If we do not receive these FDA approvals, our business will suffer.
We Have a History of Losses and May Not Be Able to Maintain Profitability. We incurred net losses from operations since our inception in June 1984 until the second quarter of 2001, and we incurred net losses in the first and second quarters of 2002. At June 30, 2003, we had accumulated $77 million in net losses since inception. We expect that our research, development and clinical trial activities and regulatory approvals, together with future selling, general and administrative activities and the costs associated with launching our products for additional indications will result in significant expenses for the foreseeable future. No assurance can be given that we will be able to maintain profitability in the future.
Page 20
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
Our Small Sales and Marketing Team May Be Unable To Compete With Our Larger Competitors or To Reach All Potential Customers. Many of our competitors have larger sales and marketing operations than we do. This allows those competitors to spend more time with potential customers and to focus on a larger number of potential customers, which gives them a significant advantage over our team in making sales.
Our Products May Not Achieve Market Acceptance. Excimer laser technology competes with more established therapies for restoring circulation to clogged or obstructed arteries such as balloon angioplasty and stent implantation. Market acceptance of the excimer laser system depends on our ability to provide adequate clinical and economic data that shows the clinical efficacy and cost effectiveness of, and patient benefits from, excimer laser atherectomy and lead removal.
We May Be Unable To Compete Successfully With Bigger Companies in Our Highly Competitive Industry. Our primary competitors in the area of excimer laser coronary angioplasty are manufacturers of products used in competing therapies, such as:
| balloon angioplasty, which uses a balloon to push obstructions out of the way; | ||
| stent implantation; | ||
| open chest bypass surgery; and | ||
| atherectomy and thrombectomy, using mechanical methods to remove arterial blockages. |
We estimate that approximately 80 percent of coronary interventions involve the placement of a stent. The leading stent providers in the United States are SCIMED Life Systems, Inc. (a subsidiary of Boston Scientific Corporation); Cordis Corporation (a subsidiary of Johnson & Johnson Interventional Systems); Guidant Corporation; Medtronic, Inc.; and JOMED N.V. The leading balloon angioplasty manufacturers are SCIMED, Cordis, Guidant and Medtronic. Manufacturers of atherectomy or thrombectomy devices include SCIMED, Guidant and Possis Medical, Inc.
We also compete with companies marketing lead extraction devices or removal methods, such as mechanical sheaths. In the lead removal market, we compete worldwide with lead removal devices manufactured by Cook Vascular Inc. and we compete in Europe with devices manufactured by VascoMed.
Almost all of our competitors have substantially greater financial, manufacturing, marketing and technical resources than we do. Larger competitors have a broader product line, which enables them to offer customers bundled purchase contracts and quantity discounts. We expect competition to intensify.
We believe that the primary competitive factors in the interventional cardiovascular market are:
| the ability to treat a variety of lesions safely and effectively; | ||
| the impact of managed care practices, related reimbursement to the health care provider, and procedure costs; | ||
| ease of use; | ||
| size and effectiveness of sales forces; and | ||
| research and development capabilities. |
Laser placement is a barrier to accessing patient cases for which our disposable products may be suited. Many competing products do not require an up-front investment in the form of a capital equipment purchase, lease, or rental.
Page 21
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
Failure of Third Parties To Reimburse Medical Providers for Our Products May Reduce Our Sales. We sell our CVX-300 laser unit primarily to hospitals, which then bill third-party payers, such as government programs and private insurance plans, for the services the hospitals provide using the CVX-300 laser unit. Unlike balloon angioplasty, laser atherectomy requires the purchase or lease of expensive capital equipment. In some circumstances, the amount reimbursed to a hospital for procedures involving our products may not be adequate to cover a hospitals costs. We do not believe that reimbursement has materially adversely affected our business to date, but continued cost containment measures by third-party payers could hurt our business in the future.
In addition, the FDA has required that the label for the CVX-300 laser unit state that adjunctive balloon angioplasty was performed together with laser atherectomy in most of the procedures we submitted to the FDA for pre-market approval. Adjunctive balloon angioplasty requires the purchase of a balloon catheter in addition to the laser catheter. While all approved procedures using the excimer laser system are reimbursable, some third-party payers attempt to deny reimbursement for procedures they believe are duplicative, such as adjunctive balloon angioplasty performed together with laser atherectomy. Third-party payers may also attempt to deny reimbursement if they determine that a device used in a procedure was experimental, was used for a non-approved indication, or was not used in accordance with established pay protocols regarding cost-effective treatment methods. Hospitals that have experienced reimbursement problems or expect to experience reimbursement problems may not purchase our excimer laser systems.
Technological Change May Result in Our Products Becoming Obsolete. We derive substantially all of our revenue from the sale or lease of the CVX-300 laser unit, related disposable devices and service. Technological progress or new developments in our industry could adversely affect sales of our products. Many companies, some of which have substantially greater resources than we do, are engaged in research and development for the treatment and prevention of coronary artery disease. These include pharmaceutical approaches as well as development of new or improved angioplasty, atherectomy, thrombectomy or other devices. Our products could be rendered obsolete as a result of future innovations in the treatment of vascular disease.
Regulatory Compliance Is Expensive and Can Often Be Denied or Significantly Delayed. The industry in which we compete is subject to extensive regulation by the FDA and comparable state and foreign agencies. Complying with these regulations is costly and time consuming. International regulatory approval processes may take longer than the FDA approval process. If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspensions or revocations of approvals, seizures or recalls of products, operating restrictions, criminal prosecutions and other penalties. We may be unable to obtain future regulatory approval in a timely manner, or at all, if existing regulations are changed or new regulations are adopted. For example, the FDA approval process for the use of excimer laser technology in clearing blocked arteries in the lower leg has taken longer than we anticipated due to requests for additional clinical data and changes in regulatory requirements.
Our European Operations May Not Be Successful or May Not Be Able To Achieve Revenue Growth. In January 2001 we established a distributor relationship in Germany, and now utilize distributors throughout most of Europe. The sales and marketing efforts on our behalf by distributors in Europe could fail to attain long-term success.
We Are Exposed to the Problems That Come From Having International Operations. For the six months ended June 30, 2003, our revenue from international operations represented 10 percent of consolidated revenue. Changes in overseas economic conditions, currency exchange rates, foreign tax laws or tariffs or other trade regulations could adversely affect our ability to market our products in these
Page 22
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
and other countries. As we expand our international operations, we expect our sales and expenses denominated in foreign currencies to expand.
We Have Important Sole Source Suppliers and May Be Unable To Replace Them if They Stop Supplying Us. We purchase certain components of our CVX-300 laser unit from several sole source suppliers. We do not have guaranteed commitments from these suppliers and order products through purchase orders placed with these suppliers from time to time. While we believe that we could obtain replacement components from alternative suppliers, we may be unable to do so.
Potential Product Liability Claims and Insufficient Insurance Coverage May Hurt Our Business and Stock Price. We are subject to risk of product liability claims. We maintain product liability insurance with coverage and aggregate maximum amounts of $5,000,000. The coverage limits of our insurance policies may be inadequate, and insurance coverage with acceptable terms could be unavailable in the future.
Our Patents and Proprietary Rights May Be Proved Invalid, Which Would Enable Competitors To Copy Our Products; We May Infringe Other Companies Rights. We hold patents and licenses to use patented technology, and have patent applications pending. Any patents we have applied for may not be granted. In addition, our patents may not be sufficiently broad to protect our technology or to give us any competitive advantage. Our patents could be challenged as invalid or circumvented by competitors. In addition, the laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States. We do not have patents in many foreign countries. We could be adversely affected if any of our licensors terminates our licenses to use patented technology. Although we have established reserves for royalty payment obligations based on a process of calculating royalty obligations associated with our licensed technology, the process involves management estimates that require judgement and there can be no assurance that these reserves will be adequate. For example, we are currently involved in litigation over royalties payable by us to one of our licensors, Interlase L.P., under an existing license agreement. Interlase has also filed a complaint alleging we infringe certain patents relating to lead removal products and services that are the subject of the same license agreement. There are no assurances we will prevail in these matters.
There may be patents and patent applications owned by others relating to laser and fiber-optic technologies, which, if determined to be valid and enforceable, may be infringed by Spectranetics. Holders of certain patents, including holders of patents involving the use of lasers in the body, may contact us and request that we enter into license agreements for the underlying technology. For example, we have been made aware of a patent issued for a certain catheter with a diameter of less than .9 millimeters. We are in the process of reviewing the patent to determine its validity and enforceability. We cannot guarantee a patent holder will not file a lawsuit against us and prevail. If we decide that we need to license technology, we may be unable to obtain these licenses on favorable terms or at all. We may not be able to develop or otherwise obtain alternative technology.
Litigation concerning patents and proprietary rights is time-consuming, expensive, unpredictable and could divert the efforts of our management. An adverse ruling could subject us to significant liability, require us to seek licenses and restrict our ability to manufacture and sell our products.
Our Stock Price May Continue To Be Volatile. The market price of our common stock, similar to other small-cap medical device companies, has been, and is likely to continue to be, highly volatile. The following factors may significantly affect the market price of our common stock:
| fluctuations in operating results; |
Page 23
Item 2. Managements Discussion and Analysis of Results of Operations and Financial Condition (contd)
| announcements of technological innovations or new products by Spectranetics or our competitors; | ||
| governmental regulation; | ||
| developments with respect to patents or proprietary rights; | ||
| public concern regarding the safety of products developed by Spectranetics or others; | ||
| past or future management changes; | ||
| general market conditions; and | ||
| financing of future operations through additional issuances of equity securities, which may result in dilution to existing stockholders and falling stock prices. |
Protections Against Unsolicited Takeovers in Our Rights Plan, Charter and Bylaws May Reduce or Eliminate Our Stockholders Ability To Resell Their Shares at a Premium Over Market Price. We have a stockholders rights plan that may prevent an unsolicited change of control of Spectranetics. The rights plan may adversely affect the market price of our common stock or the ability of stockholders to participate in a transaction in which they might otherwise receive a premium for their shares. Under the rights plan, rights to purchase preferred stock in certain circumstances have been issued to holders of outstanding shares of common stock, and rights will be issued in the future for any newly issued common stock. Holders of the preferred stock are entitled to certain dividend, voting and liquidation rights that could make it more difficult for a third party to acquire Spectranetics.
Our charter and bylaws contain provisions relating to issuance of preferred stock, special meetings of stockholders and amendments of the bylaws that could have the effect of delaying, deferring or preventing an unsolicited change in the control of Spectranetics. Our Board of Directors is elected for staggered three-year terms, which prevents stockholders from electing all directors at each annual meeting and may have the effect of delaying or deferring a change in control.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our primary market risks include changes in foreign currency exchange rates and interest rates. Market risk is the potential loss arising from adverse changes in market rates and prices, such as foreign currency exchange and interest rates. We do not use financial instruments to any degree to manage these risks. We do not use financial instruments to manage changes in commodity prices, and do not hold or issue financial instruments for trading purposes. The functional currency of Spectranetics International B.V. is the euro. All revenue and expenses are translated to U.S. dollars in the consolidated statements of operations using weighted average exchange rates during the period. Fluctuation in euro currency rates during the six months ended June 30, 2003, as compared with the six months ended June 30, 2002, caused a decrease in consolidated revenue and operating expenses of less than two percent.
Our exposure to market rate risk for changes in interest rates relates primarily to our investment portfolio. We do not use derivative financial instruments in our investment portfolio. We place our investments with high quality issuers and, by policy, limit the amount of credit exposure to any one issuer. We are averse to principal loss and ensure the safety and preservation of our invested funds by limiting default, market and reinvestment risk. We classify our cash equivalents and marketable securities as fixed-rate if the rate of return on such instruments remains fixed over their term. (These fixed-rate investments include U.S. government securities, commercial paper, asset backed securities, and corporate bonds.) Fixed rate securities may have their fair value adversely affected due to a rise in interest rates and we may suffer losses in principal if forced to sell securities that have declined in market value due to a change in interest rates. We classify our cash equivalents and marketable securities as
Page 24
variable-rate if the rate of return on such investments varies based on the change in a predetermined index or set of indices during their term. These variable-rate investments primarily include money market accounts. The Company does not consider the potential losses in future earnings, cash flows and fair values from reasonable near-term changes in exchange rates or interest rates to be material.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision of and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.
Part IIOTHER INFORMATION
Item 1. Legal Proceedings
The Company is involved in a dispute over royalties payable to one of its licensors, Interlase LP, which has been in receivership since September 1998 under the supervision of a state court in Virginia. In addition, because the general partner of Interlase, Lucre Investments, Ltd., filed a voluntary chapter 7 petition on behalf of Interlase in 1999, there is also a pending bankruptcy proceeding in the United States Bankruptcy Court in the Eastern District of Virginia. In October 2002, the licensor completed an audit of the Companys records relating to a license agreement entered into in 1993 and is claiming past royalties due of approximately $1.1 million related to lead removal products as well as certain service revenue. They are also claiming forward royalties on these items for periods subsequent to October 2002. The Company disagrees with the licensors assertion that additional royalties are due and has filed a complaint in the United States District Court in Denver, Colorado seeking a declaratory judgment that: (1) Spectranetics and the products at issue do not infringe patents that are the subjects of the agreement; and (2) Spectranetics does not owe any additional sums as contended by the licensor under the terms of the agreement and the licensor does not have the right to terminate the agreement as a result of its improper claims. No ruling has been made on the filed complaint.
In March 2003, Interlase filed a complaint in the United States District Court for the Eastern District of Virginia claiming Spectranetics is in breach of the same patent license agreement and is infringing the patents that are the subject of the license agreement. In the complaint, Interlase claims an
Page 25
amount in controversy in excess of $1 million, exclusive of interest and costs, in addition to certain other forms of relief, such as treble damages, a declaratory judgment and injunctive relief. The claims for relief all relate to royalties allegedly owed to or due Interlase in the future associated with the same lead removal products and services that are at issue in the United States District Court case in Colorado. The Company believes the claims are not justified and plans to vigorously defend its position.
On May 23, 2003, the United States District Court for Eastern District of Virginia granted Spectranetics' Motion and entered an order transferring the case titled Interlase Partnership v. The Spectranetics Corporation, Civil No. 3:03 CV265, to the United States District Court for the District of Colorado for all proceedings.
The Company is involved in other legal proceedings in the normal course of business and does not expect them to have a material adverse effect on our business.
Items 2-3. Not applicable
Item 4. Submission of Matters to a Vote of Security Holders
The Annual Meeting of Shareholders was held on June 26, 2003.
(1) | The following director was elected for a three-year term to expire at the Companys Annual Meeting of Shareholders in 2006. |
For | Withheld | |||||||
R. John Fletcher |
21,014,375 | 1,094,518 |
Cornelius C. Bond, Jr., Emile J. Geisenheimer, Martin T. Hart, Joseph M. Ruggio, M.D., and John G. Schulte continued their terms of office as directors after the meeting. |
(2) | The appointment of KPMG LLP as independent auditors of the Company for the current fiscal year was ratified: |
In favor: | 22,006,005 | |||
Against: | 61,424 | |||
Abstain: | 41,464 |
Page 26
Item 5. Not Applicable
Item 6. Exhibits and Reports on Form 8-K
(a) | Exhibits. |
10.3(c) Amendment to lease covering a portion of the Companys facilities between the Company and Full Circle Partnership III dated June 3, 2003. | ||
10.33 Asset Purchase Agreement between the Company and LaTIS, Inc. | ||
31(a) Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
31(b) Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
32(a) Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ||
32(b) Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(b) | Reports on Form 8-K. |
On April 17, 2003, pursuant to Securities and Exchange Commission Release No. 33-8216, the Company filed a Current Report on Form 8-K which included as an exhibit a press release dated April 17, 2003, which sets forth our results of operations for the quarter ended March 31, 2003.
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) | ||||||
August 14, 2003 | By: /s/ John G. Schulte | |||||
John G. Schulte | ||||||
President and Chief Executive Officer | ||||||
August 14, 2003 | By: /s/ Guy A. Childs | |||||
Guy A. Childs | ||||||
Vice President Finance, Chief Financial Officer |
Page 27
EXHIBIT INDEX
Exhibit Number | Description | |
10.3(c) | Amendment to lease covering a portion of the Companys facilities between the Company and Full Circle Partnership III dated June 3, 2003. | |
10.33 | Asset Purchase Agreement between the Company and LaTIS, Inc. | |
31(a) | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
31(b) | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32(a) | Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32(b) | Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |