_________________
| [X] | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2005. |
|---|---|
| [ ] | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from ______ to ______ |
| Delaware | 68-0328265 |
| (State or other jurisdiction of | (I.R.S. Employer |
| incorporation or organization) | Identification 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 such 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 |
|---|---|
Indicate by a check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
| Yes X | No |
|---|---|
On May 3, 2005, 31,918,205 shares of the registrant's only class of common stock were outstanding.
| Page | ||
|---|---|---|
| Part I | Financial Information | |
| Item 1 | Condensed Consolidated Financial Statements (Unaudited) | |
| Condensed consolidated balance sheets at March 31, 2005 and December 31, 2004 | 3 | |
| Condensed consolidated statements of operations for the three months ended March 31, 2005 and 2004 | 4 | |
| Condensed consolidated statements of cash flows for the three months ended March 31, 2005 and 2004 | 5 | |
| Notes to condensed consolidated financial statements | 6 | |
| Item 2 | Management's Discussion and Analysis of Financial Condition and Results of Operations | 15 |
| Item 3 | Quantitative and Qualitative Disclosures about Market Risk | 19 |
| Item 4 | Controls and Procedures | 19 |
| Part II | Other Information | |
| Item 4 | 21 | |
| Item 6 | 21 | |
| Signatures | 22 | |
| Exhibit Index | 23 |
2
| March 31, 2005 |
December 31, 2004 | |||||||
|---|---|---|---|---|---|---|---|---|
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,303 | $ | 4,831 | ||||
| Marketable securities available-for-sale, including unrealized losses of $27 and $39 | 11,754 | 16,335 | ||||||
| Accounts receivable, net of allowance for doubtful accounts of $30 and $31 | 549 | 347 | ||||||
| Other receivables | 201 | 233 | ||||||
| Inventories | 4,965 | 3,984 | ||||||
| Other current assets | 517 | 510 | ||||||
| Total current assets | 22,289 | 26,240 | ||||||
| Property and equipment, net | 936 | 689 | ||||||
| Marketable securities available-for-sale, including unrealized losses of $8 and $0 | 1,507 | 750 | ||||||
| Goodwill | 3,602 | 3,602 | ||||||
| Intangibles, net | ||||||||
| 12,777 | 13,129 | |||||||
| Other assets | 103 | 102 | ||||||
| Total Assets | $ | 41,214 | $ | 44,512 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 2,781 | $ | 2,763 | ||||
| Total current liabilities | 2,781 | 2,763 | ||||||
| Accrued compensation | 47 | 198 | ||||||
| Total liabilities | 2,828 | 2,961 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized, no | ||||||||
| shares issued and outstanding | -- | -- | ||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized, 32,405,000 and 32,362,000 | ||||||||
| shares issued and outstanding | ||||||||
| 32 | 32 | |||||||
| Additional paid-in capital | 125,896 | 125,704 | ||||||
| Deferred Compensation | (43) | -- | ||||||
| Accumulated deficit | (86,898 | ) | (83,602 | ) | ||||
| Treasury stock, at cost, 494,700 shares | (661 | ) | (661 | ) | ||||
| Accumulated other comprehensive income | 60 | 78 | ||||||
| Total stockholders' equity | 38,386 | 41,551 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 41,214 | $ | 44,512 | ||||
See accompanying notes
3
| Three Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| March 31, | |||||||||||
| 2005 | 2004 | ||||||||||
| Revenue: | |||||||||||
| Product | $ | 1,354 | $ | 343 | |||||||
| License | 60 | 477 | |||||||||
| Total revenue | 1,414 | 820 | |||||||||
| Cost of product revenue | 643 | 243 | |||||||||
| Gross profit | 771 | 577 | |||||||||
| Operating expenses: | |||||||||||
| Research, development and clinical | 1,359 | 1,444 | |||||||||
| Marketing and sales | 1,378 | 391 | |||||||||
| General and administrative | 1,439 | 776 | |||||||||
| Total operating expenses | 4,176 | 2,611 | |||||||||
| Loss from operations | (3,405 | ) | (2,034 | ) | |||||||
| Other income: | |||||||||||
| Interest income | 109 | 54 | |||||||||
| Other income | -- | 7 | |||||||||
| Total other income | 109 | 61 | |||||||||
| Net loss | ($ 3,296 | ) | ($ 1,973 | ) | |||||||
| Basic and diluted net loss per share | ($ 0.10 | ) | ($ 0.07 | ) | |||||||
| Shares used in computing basic and diluted net loss per share | 31,896 | 29,273 | |||||||||
See accompanying notes
4
| Three Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| March 31, | |||||||||||
| 2005 | 2004 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net loss | ($3,296 | ) | ($ 1,973 | ) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization | 375 | 370 | |||||||||
| Amortization of stock-based compensation | 14 | 131 | |||||||||
| Bad debt expense (recovery) | -- | (6 | ) | ||||||||
| Change in: | |||||||||||
| Trade accounts receivable | (202 | ) | (18 | ) | |||||||
| Inventories | (981 | ) | (74 | ) | |||||||
| Other receivables and other assets | 25 | 270 | |||||||||
| Accounts payable and accrued expenses | (133 | ) | 644 | ||||||||
| Net cash used in operating activities | (4,198 | ) | (656 | ) | |||||||
| Cash flows provided by (used in) investing activities: | |||||||||||
| Purchases of available-for-sale securities | (4,064 | ) | (13,426 | ) | |||||||
| Sales of available-for-sale securities | 7,892 | 5,297 | |||||||||
| Cash paid for property and equipment | (270 | ) | (9 | ) | |||||||
| Net cash provided by (used in) investing activities | 3,558 | (8,138 | ) | ||||||||
| Cash flows provided by financing activities: | |||||||||||
| Proceeds from sale of common stock, net of expenses | -- | 15,389 | |||||||||
| Proceeds from sale of common stock under employee stock purchase plan | 81 | 56 | |||||||||
| Proceeds from exercise of common stock options | 54 | 1,322 | |||||||||
| Net cash provided by financing activities | 135 | 16,767 | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | (23 | ) | 15 | ||||||||
| Net (decrease) increase in cash and cash equivalents | (528 | ) | 7,988 | ||||||||
| Cash and cash equivalents, beginning of period | 4,831 | 4,402 | |||||||||
| Cash and cash equivalents, end of period | $ | 4,303 | $ | 12,390 | |||||||
See accompanying notes
5
The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement of the results of the periods presented have been included. Operating results for the unaudited three-month period ended March 31, 2005 are not necessarily indicative of results that may be expected for the year ending December 31, 2005 or any other period. For further information, including information on significant accounting policies and use of estimates, refer to the consolidated financial statements and footnotes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31, 2004.
For the three months ended March 31, 2005, the Company incurred a net loss of $3,296. As of March 31, 2005, the Company had an accumulated deficit of approximately $86,898. Historically, the Company has relied on the sale and issuance of equity securities to provide a significant portion of funding for its operations. In July 2003 and March 2004, the Company completed two private placements of its common stock, resulting in aggregate net proceeds of $23,744.
At March 31, 2005, the Company had cash, cash equivalents and marketable securities available for sale of $17,564. The Company expects to continue to incur substantial costs and cash outlays in 2005 to support Powerlink System research and development, manufacturing capability development, a facility relocation, and the U.S. market launch of the Powerlink System. While the Company believes that current cash and cash equivalents and marketable securities will be sufficient to meet anticipated cash needs for operations, capital expenditures, and increases in working capital through at least March 31, 2006, given the difficulty of predicting future capital requirements, the Company may be required to seek additional financing to support our operations and the ongoing commercial launch of the Powerlink System. The Company may not be able to obtain such financing on reasonable terms or at all, which would adversely affect the operations of its business.
The Company has elected to follow Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and related interpretations in accounting for its employee stock options because the alternative fair value accounting provided for under Statement of Finanical Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation, and amended by SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, requires use of option valuation models that were not developed for use in valuing employee stock options. Under the provisions of APB 25, the Company recognizes compensation expense only to the extent that the exercise price of the Companys employee stock options is less than the market price of the underlying stock on the date of grant. SFAS No. 123 requires the presentation of pro forma information as if the Company had accounted for its employee stock options granted under the
6
fair value method. The fair value for these options was estimated at the date of grant using the Black-Scholes option-pricing model. The Black-Scholes model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility.
In calculating the pro forma information, the fair value was estimated at the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: risk-free interest rate of 4.2% and 2.3%; a dividend yield of 0% and 0%; volatility of the expected market price of the Companys common stock of 78.0% and 79.0%; and a weighted-average expected life of the options of 5.0 years and 5.0 years for the first quarter of 2005 and 2004, respectively.
For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options vesting period. The Companys pro forma information for the quarters ended March 31, 2005 and 2004 is as follows:
| 2005 | 2004 | |||||||
|---|---|---|---|---|---|---|---|---|
| Net loss, as reported | $ | (3,296 | ) | $ | (1,973 | ) | ||
| Deduct: Total stock-based employee compensation expense determined under fair | ||||||||
| value based method for all awards, net of related tax effects | (319 | ) | (123 | ) | ||||
| Pro forma net loss | $ | (3,615 | ) | $ | (2,096 | ) | ||
| Earnings per share: | ||||||||
| Basic and diluted-as reported | $ | (0.10 | ) | $ | (0.07 | ) | ||
| Basic and diluted-pro forma | $ | (0.11 | ) | $ | (0.07 | ) | ||
The Company accounts for non-employee stock-based awards, in which goods or services are the consideration received for the stock options issued, in accordance with the provisions of SFAS No. 123 and EITF 96-18 Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Compensation expense for non-employee stock-based awards is recognized in accordance with FASB Interpretation 28, Accounting for Stock Appreciation Rights and Other Variable Stock Options or Award Plans, an Interpretation of APB Opinions No. 15 and 25 (FIN 28). The Company records compensation expense based on the then-current fair values of the stock options at each financial reporting date. Compensation recorded during the service period is adjusted in subsequent periods for changes in the stock options fair value until the options vest.
During the quarter ended March 31, 2005, the Company granted Performance Units under its 2004 Performance Compensation Plan (the Performance Plan). Under the Performance Plan, these units are granted at a discount to the fair market value (as defined in the Performance Plan) of the Companys common stock on the grant date (Base Value). The Performance Units vest over three-years; one-third vests at the end of the first year, and the remainder vests ratably on a quarterly basis. The difference between the closing market price of the Companys common stock and the Base Value of the vested Performance Unit will be payable in cash at the first to occur of (a) a change of control (as defined in the Performance Plan), (b) the termination of employment for any reason other
7
than Cause, or (c) upon exercise of the Performance Unit, which cannot occur until eighteen months from the grant date.
The Company granted a total of 140 and 90 Performance Units at a weighted average Base Value of $3.44 and $1.98, during the first quarter of 2005 and 2004, respectively. The total accrued compensation expense as of March 31, 2005 was $562 and there were 488 total Performance Units outstanding. The Company recorded $40 and $49 in the first quarter of 2005 and 2004, respectively, in compensation expense in accordance with FIN 28. The expense was included in marketing and sales expense in the consolidated statements of operations. The Company will record changes in the estimated compensation expense over the vesting period of the Performance Units, and once fully vested, will record the difference between the closing market price of the Companys common stock and the Base Value as compensation expense each period until exercised.
Net income (loss) per common share is computed using the weighted average number of common shares outstanding during the periods presented. Certain options with an exercise price below the average market price for the first quarter of 2005 and 2004 have been excluded from the calculation of diluted earnings per share, as they are anti-dilutive. If anti-dilutive stock options were included for the first quarter of 2005 and 2004, the number of shares used to compute diluted net loss per share would have been increased by approximately 726 shares and 696 shares, respectively. In addition, options to purchase 233 shares and 134 shares, respectively, with an exercise price above the average market price for the first quarter of 2005 and 2004, respectively, were excluded from the computation of diluted loss per share because the effect would also have been anti-dilutive.
8
The Company accounts for its investments pursuant to SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities.
The Company has classified its entire investment portfolio as available-for-sale. Available-for-sale securities are stated at fair value with unrealized gains and losses recorded in accumulated other comprehensive income, net of realized gains and losses. Management evaluates the classification of its securities based on the Companys short-term cash needs. The cost of securities sold is based on the specific identification method. During the first quarter of 2005 and 2004, the Company did not have any realized gains or losses.
The Companys investments in debt securities are diversified among high credit quality securities in accordance with the Companys investment policy. A major financial institution manages the Companys investment portfolio. As of March 31, 2005, $11,754 and $1,507 of the Companys debt securities had contractual maturities more than 90 days and less than one year, and between one to two years, respectively. As of December 31, 2004, $16,335 and $750 of the Companys debt securities had contractual maturities more than 90 days and less than one year, and between one to two years, respectively.
| March 31, 2005 |
December 31, 2004 |
||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gross Unrealized | Gross Unrealized | ||||||||||||||||||||||||||||||||||||||||
| Holding | Fair | Holding | Fair | ||||||||||||||||||||||||||||||||||||||
| Cost |
Loss |
Value |
Cost |
Loss |
Value | ||||||||||||||||||||||||||||||||||||
| U.S. Treasury and other agencies | |||||||||||||||||||||||||||||||||||||||||
| debt securities | $ | 6,457 | $ | (12 | ) | $ | 6,445 | $ | 10,318 | $ | (15 | ) | $ | 10,303 | |||||||||||||||||||||||||||
| Corporate debt securities | 6,839 | (23 | ) | 6,816 | 6,806 | (24 | ) | 6,782 | |||||||||||||||||||||||||||||||||
| $ | 13,296 | $ | (35 | ) | $ | 13,261 | $ | 17,124 | $ | (39 | ) | $ | 17,085 | ||||||||||||||||||||||||||||
Inventories are stated at the lower of cost, determined on a first in, first out basis, or market value. Inventories consist of the following:
| March 31, 2005 |
December 31, 2004 | |||||||
|---|---|---|---|---|---|---|---|---|
| Raw materials | $ | 3,115 | $ | 3,219 | ||||
| Work-in-process | 507 | 236 | ||||||
| Finished goods | 1,343 | 529 | ||||||
| $ | 4,965 | $ | 3,984 | |||||
9
In June 1998, the Company licensed to Guidant Corporation, an international interventional cardiology products company, the right to manufacture and distribute stent delivery products using the Companys Focus technology. The Company receives royalty payments based upon the sale of products by Guidant using the Focus technology. The agreement includes minimum annual royalties of $250 and expires in 2008. During the first quarter of 2005 and 2004, the Company recorded $60 and $412 respectively, in license revenue due on product sales by Guidant. At March 31, 2005 and December 31, 2004, $60 and $100, respectively, due under this agreement are included in other receivables on the condensed consolidated balance sheets.
The Company had product sales based on the locations of the customer by region as follows:
| Three Months | ||||||||
|---|---|---|---|---|---|---|---|---|
| Ended March 31, | ||||||||
| 2005 | 2004 | |||||||
| Europe | $ | 711 | $ | 220 | ||||
| United States | 621 | $ | 100 | |||||
| Other | 22 | 23 | ||||||
| $ | 1,354 | $ | 343 | |||||
During the first quarter of 2005, revenues from Edwards Lifesciences AG and Bolton Medical Distribution S.A. were $504 and $160, which represented 36% and 11% of total revenues, respectively. During the first quarter of 2004, revenues from Bolton Medical Distribution S.A. were $86, which represented 10% of total revenues. No other single customer in the first quarter of 2005 or 2004 represented more than 10% of total revenues.
As of March 31, 2005 and December 31, 2004, accounts receivable from Bolton Medical Distribution S.A. amounted to $134 and $142, respectively. Additionally, as of December 31, 2004, accounts receivable from Edwards Lifesciences and Comesa Polska Sp. amounted to $73 and $35 respectively. No other single customer accounted for more than 10% of the Companys accounts receivable balance at March 31, 2005 or December 31, 2004.
10
The Companys comprehensive loss included the following:
| Three Months | ||||||||
|---|---|---|---|---|---|---|---|---|
| Ended March 31, | ||||||||
| 2005 |
2004 | |||||||
| Net loss | ||||||||