SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_________________
FORM 10-Q
[X] | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2004. |
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[ ] | 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 000-28440
ENDOLOGIX, INC.
(Exact name of Registrant as specified in its charter)
Delaware | 68-0328265 |
(State or other jurisdiction of | (I.R.S. Employer |
incorporation or organization) | Identification Number) |
13900 Alton Parkway, Suite 122, Irvine, California 92618
(Address of principal executive offices)
(949) 595-7200
Registrant's telephone number, including area code
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 |
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Indicate by a check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes | No X |
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On August 2, 2004, the Registrant had outstanding approximately 31,729,000 shares of Common Stock of $.001 par value, which is the Registrant’s only class of Common Stock.
ENDOLOGIX, INC.
Form 10-Q
June 30, 2004
TABLE OF CONTENTS
Page | ||
---|---|---|
Part I | Financial Information | |
Item 1 | Condensed Consolidated Financial Statements (Unaudited) | |
Condensed consolidated balance sheets at December 31, 2003 and June 30, 2004 | 3 | |
Condensed consolidated statements of operations for the three and six months ended June 30, 2003 and 2004 | 4 | |
Condensed consolidated statements of cash flows for the six months ended June 30, 2003 and 2004 | 5 | |
Notes to condensed consolidated financial statements | 6 | |
Item 2 | Management's Discussion and Analysis of Financial Condition and Results of Operations | |
16 | ||
Item 3 | Quantitative and Qualitative Disclosures about Market Risk | 23 |
Item 4 | Controls and Procedures | 23 |
Part II | Other Information | |
Items 1 through 6 | 24 | |
Signatures | 25 | |
Exhibit Index | 26 |
2
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
December 31, 2003 | June 30, 2004 | |||||||
---|---|---|---|---|---|---|---|---|
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,402 | $ | 6,086 | ||||
Marketable securities available-for-sale | 8,166 | 15,312 | ||||||
Accounts receivable, net | 239 | 505 | ||||||
Other receivables | 656 | 442 | ||||||
Inventories | 2,780 | 3,195 | ||||||
Other current assets | 245 | 374 | ||||||
Total current assets | 16,488 | 25,914 | ||||||
Property and equipment, net | 141 | 195 | ||||||
Marketable securities available-for-sale | 211 | 5,054 | ||||||
Goodwill (Note 9) | 3,602 | 3,602 | ||||||
Other intangibles, net of accumulated amortization of $2,224 and $2,927, | ||||||||
respectively (Note 9) | 14,534 | 13,831 | ||||||
Other assets | 367 | 28 | ||||||
Total Assets | $ | 35,343 | $ | 48,624 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 1,468 | $ | 1,858 | ||||
Current liabilities | 1,468 | 1,858 | ||||||
Accrued compensation | -- | 88 | ||||||
Total liabilities | 1,468 | 1,946 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Stockholders' equity: | ||||||||
Convertible preferred stock, $.001 par value; 5,000 shares authorized, no | ||||||||
shares issued and outstanding | -- | -- | ||||||
Common stock, $.001 par value; 50,000 shares authorized, 28,576 and 32,224 | ||||||||
shares issued and outstanding at December 31, 2003 and June 30, 2004, | ||||||||
respectively | 28 | 32 | ||||||
Additional paid-in capital | 108,279 | 125,166 | ||||||
Accumulated deficit | (73,919 | ) | (77,924 | ) | ||||
Treasury stock, at cost, 495 shares at December 31, 2003 and June 30, 2004 | (661 | ) | (661 | ) | ||||
Accumulated other comprehensive income | 148 | 65 | ||||||
Total stockholders' equity | 33,875 | 46,678 | ||||||
Total Liabilities and Stockholders' Equity | $ | 35,343 | $ | 48,624 | ||||
See accompanying notes
3
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
June 30, | June 30, | |||||||||||||
2003 | 2004 | 2003 | 2004 | |||||||||||
Revenue: | ||||||||||||||
Product | $ | 295 | $ | 860 | $ | 785 | $ | 1,203 | ||||||
License | 694 | 342 | 1,366 | 819 | ||||||||||
Total revenue | 989 | 1,202 | 2,151 | 2,022 | ||||||||||
Cost of product revenue | 108 | 415 | 365 | 658 | ||||||||||
Gross profit | 881 | 787 | 1,786 | 1,364 | ||||||||||
Operating expenses: | ||||||||||||||
Research, development and clinical | 1,715 | 1,652 | 3,561 | 3,097 | ||||||||||
Marketing and sales | 154 | 481 | 437 | 872 | ||||||||||
General and administrative | 697 | 753 | 835 | 1,531 | ||||||||||
Minority interest | 1 | -- | (16 | ) | -- | |||||||||
Total operating expenses | 2,567 | 2,886 | 4,817 | 5,500 | ||||||||||
Loss from operations | (1,686 | ) | (2,099 | ) | (3,031 | ) | (4,136 | ) | ||||||
Other income (expense): | ||||||||||||||
Interest income | 46 | 83 | 200 | 137 | ||||||||||
Gain (loss) on sale of assets | (11 | ) | -- | (8 | ) | 3 | ||||||||
Other expense | (2 | ) | (16 | ) | (4 | ) | (9 | ) | ||||||
Total other income | 33 | 67 | 188 | 131 | ||||||||||
Net loss | ($1,653 | ) | ($2,032 | ) | ($2,843 | ) | ($4,005 | ) | ||||||
Basic and diluted net loss per share | ($ 0.07 | ) | ($ 0.06 | ) | ($ 0.12 | ) | ($ 0.13 | ) | ||||||
Shares used in computing basic and diluted net | ||||||||||||||
loss per share | 23,915 | 31,717 | 23,981 | 30,495 | ||||||||||
See accompanying notes
4
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|
2003 | 2004 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | ($2,843 | ) | ($4,005 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 752 | 743 | ||||||
Stock-based compensation | 44 | 79 | ||||||
Bad debt expense (recovery) | (50 | ) | (5 | ) | ||||
Loss on sale of assets | 18 | -- | ||||||
Minority interest in losses of subsidiary | (16 | ) | -- | |||||
Change in: | ||||||||
Trade accounts receivable | 479 | (261 | ) | |||||
Inventories | (129 | ) | (415 | ) | ||||
Other receivables and other assets | 370 | 424 | ||||||
Accounts payable and accrued expenses | (616 | ) | 478 | |||||
Net cash used in operating activities | (1,991 | ) | (2,962 | ) | ||||
Cash flows provided by (used in) investing activities: | ||||||||
Purchases of available-for-sale securities | (728 | ) | (21,096 | ) | ||||
Sales of available-for-sale securities | 3,035 | 9,043 | ||||||
Final distribution to subsidiary minority interest shareholder | (67 | ) | -- | |||||
Capital expenditures for property and equipment | (7 | ) | (95 | ) | ||||
Net cash provided by (used in) investing activities | 2,233 | (12,148 | ) | |||||
Cash flows provided by (used in) financing activities: | ||||||||
Proceeds from sale of common stock, net of expenses | -- | 15,360 | ||||||
Proceeds from sale of common stock under employee stock purchase plan | 35 | 56 | ||||||
Proceeds from exercise of common stock options | -- | 1,396 | ||||||
Purchases of treasury stock | (456 | ) | -- | |||||
Net cash provided by (used in) financing activities | (421 | ) | 16,812 | |||||
Effect of exchange rate changes on cash and cash equivalents | (11 | ) | (18 | ) | ||||
Net (decrease) increase in cash and cash equivalents | (190 | ) | 1,684 | |||||
Cash and cash equivalents, beginning of period | 2,606 | 4,402 | ||||||
Cash and cash equivalents, end of period | $ | 2,416 | $ | 6,086 | ||||
See accompanying notes
5
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
1. Business and Basis of Presentation
Endologix, Inc. (formerly named Radiance Medical Systems, Inc. referred to as “Endologix” or the “Company”) was incorporated in California in March 1992 and reincorporated in Delaware in June 1993. In May 2002, the Company merged with privately held Endologix, Inc., and changed its name to Endologix, Inc.
The Company is engaged in the development, manufacture, sales and marketing of minimally invasive therapies for the treatment of vascular disease. The Company’s primary focus is the development of the Powerlink System®, a catheter-based alternative treatment for abdominal aortic aneurysms, or AAA. AAA is a weakening of the wall of the aorta, the largest artery of the body. Once AAA develops, it continues to enlarge and if left untreated becomes increasingly susceptible to rupture. Prior to the restructuring in September 2001 and the merger in May 2002 (Note 9), the Company was developing proprietary devices to deliver radiation to prevent the recurrence of blockages in arteries following balloon angioplasty, vascular stenting, arterial bypass surgery and other interventional treatments of blockages in coronary and peripheral arteries. The Company also manufactured, licensed and sold angioplasty catheters and stent products primarily through medical device distributors. The Company operates in a single business segment.
For the six months ended June 30, 2004, the Company incurred a net loss of $4,005. As of June 30, 2004, the Company had an accumulated deficit of approximately $77,924. The Company believes that current cash and cash equivalents and marketable securities will be sufficient to meet anticipated cash needs for operating and capital expenditures through at least December 31, 2005. Failure of the market to accept the products, failure to reduce certain discretionary expenditures, if necessary, or unanticipated reductions in royalty revenue could have a material adverse effect on the Company’s ability to achieve the expected cash position through December 31, 2005.
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 presentation have been included. Operating results for the unaudited six-month period ended June 30, 2004 are not necessarily indicative of results that may be expected for the year ending December 31, 2004 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2003.
2. Stock-Based Compensation
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 SFAS No. 123 (“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
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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 Company’s 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 has accounted for its employee stock options granted under the 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: for the second quarter and first six months of 2003, a risk-free interest rate of 2.1%; a dividend yield of 0%; a volatility of the expected market price of the Company’s common stock of 81.0%; and a weighted-average expected life of the options of 5.0 years; and. for the second quarter and first six months of 2004, a risk-free interest rate of 3.5%; a dividend yield of 0%; a volatility of the expected market price of the Company’s common stock of 77.4%; and a weighted-average expected life of the options of 5.0 years.
For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options’ vesting period. The Company’s pro forma information for the quarters ended June 30, 2003 and 2004 is as follows:
2003 | 2004 | |||||||
---|---|---|---|---|---|---|---|---|
Net loss, as reported | $ | (1,653 | ) | $ | (2,032 | ) | ||
Deduct: Total stock-based employee compensation expense determined under fair | ||||||||
value based method for all awards | (44 | ) | (214 | ) | ||||
Pro forma net loss | $ | (1,697 | ) | $ | (2,246 | ) | ||
Net loss per share: | ||||||||
Basic and diluted-as reported | $ | (0.07 | ) | $ | (0.06 | ) | ||
Basic and diluted-pro forma | $ | (0.07 | ) | $ | (0.07 | ) |
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The Company’s pro forma information for the six month periods ended June 30, 2003 and 2004 is as follows:
2003 | 2004 | |||||||
---|---|---|---|---|---|---|---|---|
Net loss, as reported | $ | (2,843 | ) | $ | (4,005 | ) | ||
Deduct: Total stock-based employee compensation | ||||||||
expense determined under fair value based method for | ||||||||
all awards | (122 | ) | (337 | ) | ||||
Pro forma net loss | $ | (2,965 | ) | $ | (4,342 | ) | ||
Net loss per share: | ||||||||
Basic and diluted-as reported | $ | (0.12 | ) | $ | (0.13 | ) | ||
Basic and diluted-pro forma | $ | (0.12 | ) | $ | (0.14 | ) |
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 first six months ended June 30, 2004, 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 average closing market price of the Company’s common stock for the twenty trading days prior to the grant date. The Performance Units vest over three-years; one-third vests at the end of the first year, and the remainder vest ratably on a quarterly basis. The difference between the closing market price of the Company’s common stock and the grant price of the vested Performance Unit will be payable in cash at the first to occur of (a) a Change of Control, (b) the termination of employment for any reason other than Cause, or (c) upon exercise of the Performance Unit, which cannot occur until eighteen months from the grant date.
During the three and six month periods ended June 30, 2004, the Company granted a total of 30 and 120 Performance Units at a weighted average grant price of $2.72 and $2.17, respectively. The total estimated compensation expense as of June 30, 2004 was $321, which was calculated based on the difference between the grant price and the Company’s common stock fair market value on June 30, 2004. The Company recorded $39 and $88 in compensation expense during the three and six month periods ended June 30, 2004, respectively, in accordance with FIN 28, which has been 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.
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3. Net Income (Loss) Per Share
Net income (loss) per common share is computed using the weighted average number of common shares outstanding during the periods presented. Certain options to purchase shares of the Company’s common stock granted under the Company’s stock option plan 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 second quarter of 2003 and 2004, the number of shares used to compute diluted net loss per share would have been increased by approximately 403 shares and 574 shares, respectively. In addition, options to purchase 1,076 shares and 199 shares with an exercise price above the average market price for the second quarter of 2003 and 2004, respectively, were excluded from the computation of diluted loss per share because the effect would have been anti-dilutive.
If anti-dilutive stock options were included for the first six months of 2003 and 2004, the number of shares used to compute diluted net loss per share would have been increased by approximately 303 shares and 642 shares, respectively. In addition, options to purchase 1,076 shares and 155 shares with an exercise price above the average market price for the first six months of 2003 and 2004, respectively, were excluded from the computation of diluted loss per share because the effect would have been anti-dilutive.
4. Inventories
Inventories are stated at the lower of cost, determined on an average cost basis, or market value. Inventories consist of the following:
December 31, 2003 | June 30, 2004 | |||||||
---|---|---|---|---|---|---|---|---|
Raw materials | $ | 1,647 | $ | 2,188 | ||||
Work-in-process | 496 | 336 | ||||||
Finished goods | 637 | 671 | ||||||
$ | 2,780 | $ | 3,195 | |||||
5. Note Receivable
In February 2001, the Company amended the Assets Sale and Purchase agreement with Escalon Medical Corporation (“Escalon”) regarding the payment of royalties. As part of this amended agreement, the Company received a prime (4.00% at June 30, 2004) plus one percent interest bearing note receivable for $718, payable in eleven equal quarterly installments from April 2002 to October 2004, representing the remaining minimum royalties, on a discounted basis, due for 2001 to 2003. Additional royalties above the minimums will be paid under the amended agreement only if related product sales exceed $3,000 annually. The Company recognizes interest income and license revenue under the $718 note receivable when the payment is received, as collection of this note receivable was not reasonably assured. Accordingly, the note receivable and deferred revenue are not recorded on the condensed consolidated balance sheet.
The Company recognized interest income of $6 and $3 in the second quarter of 2003 and 2004, respectively, under this arrangement. The Company recognized $65 in revenue in each of the second quarters of 2003 and 2004 under this arrangement.
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The Company recognized interest income of $13 and $6 in the first six months of 2003 and 2004, respectively, under this arrangement. The Company recognized $130 in revenue in each of the first six months of 2003 and 2004 under this arrangement. The remaining amount due under the Note was $130, exclusive of interest, at June 30, 2004.
6. License Revenue
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 Company’s 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 second quarter of 2003 and 2004, the Company recorded $628 and $274, respectively, in license revenue due on product sales by Guidant. During the first six months of 2003 and 2004, the Company recorded $1,235 and $686, respectively, in license revenue due on product sales by Guidant. At December 31, 2003 and June 30, 2004, $530 and $274, respectively, due under this agreement are included in other receivables on the condensed consolidated balance sheets.
7. Concentrations of Credit Risk and Significant Customers
In May 2004, the Company signed an international distribution agreement with Edwards LifeSciences AG (“Edwards”), an international interventional cardiology products company, granting them the right to distribute our products in certain European markets. During the second quarter and first six months of 2004, the Company recognized product revenue of $383, which represented 45% and 32%, respectively, of total product revenue. As of June 30, 2004, receivables from Edwards amounted to $227, or 45% of total accounts receivable, net of an allowance for bad debt.
8. Comprehensive Loss
The Company’s comprehensive loss included the following:
Three Months Ended | Six Months Ended | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
June 30, | June 30, | |||||||||||||
2003 | 2004 | 2003 | 2004 | |||||||||||
Net loss | $ | (1,653 | ) | $ | (2,032 | ) | $ | (2,843 | ) | $ | (4,005 | ) | ||
Unrealized holding loss arising during the period | (14 | ) | (60 | ) | (29 | ) | (65 | ) | ||||||
Reclassification adjustment for realized losses | ||||||||||||||
included in net loss | 3 | 6 | 9 | 2 | ||||||||||
Unrealized exchange rate gain (loss) | 5 | (39 | ) | (4 | ) | (20 | ) | |||||||
Comprehensive loss | $ | (1,659 | ) | $ | (2,125 | ) | $ | (2,867 | ) | $ | (4,088 | ) | ||
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9. Merger
Reasons for the Merger
In September 2001, the Company decided to search for additional commercial opportunities by evaluating technologies outside of vascular radiation therapy, then the primary operational focus. Positive data had been presented, and was continuing to be presented, from several major medical device companies, on the effectiveness of drug-coated stents to prevent restenosis, or re-blockage of arteries. As a result, the Company believed the market for its radiation catheter would be limited.
In the fourth quarter of 2001, the Company began discussions with Endologix, Inc. (“former Endologix”), a privately held developer and manufacturer of the Powerlink System, an endoluminal stent graft for minimally invasive treatment of abdominal aortic aneurysms. Based on its investigation of the Powerlink System, the Company believed that it was a novel device and that clinical results to date indicated that the Powerlink System had several features and benefits that may provide a better clinical outcome in comparison to devices currently on the market.
The Company believed that the acquisition of former Endologix’s technology would provide the Company with a new and different medical device technology for a promising and potentially lucrative market.
Merger Transaction
In May 2002, the Company acquired all of the capital stock of former Endologix. The Company paid stockholders of former Endologix $0.75 cash for each share of former Endologix common stock, for an aggregate of $8,355, and issued one share of Radiance common stock for each share of former Endologix common stock, for an aggregate of 11,141 shares. The results of former Endologix have been included in the consolidated financial statements since May 2002.
In addition, the Company agreed to pay contingent consideration in the amount of $2,790 in the event pre-market approval, or PMA, is received in the U.S. for the Powerlink System on or before June 30, 2004. PMA approval was not obtained by such date and therefore, such contingent consideration is not payable by the Company.
The acquisition was accounted for as a purchase under SFAS No. 141, “Business Combinations.” In accordance with SFAS No. 141, the Company allocated the purchase price based on the fair value of the assets acquired and liabilities assumed. In the merger, the Company acquired, in addition to the net tangible assets of the business, intangible assets such as the Powerlink and PowerWeb (an earlier version of the Powerlink) technologies, both developed and in-process, the Endologix trade name and Powerlink and PowerWeb trademarks, and goodwill. The Company employed valuation techniques reflecting recent guidelines from the AICPA on approaches and procedures for identifying and allocating the purchase price to assets to be used in research and development activities, including acquired in-process research and development, or IPR&D. To value IPR&D and developed technology, the Company estimated their future net cash flows and discounted them to their present value. To value trademarks and tradenames, the Company estimated the royalties that would have been paid for their use and discounted them to their net present value.
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To determine the proper allocation of purchase price to technology assets, the Company first determined whether technological feasibility had been reached for a particular technology based upon whether it had been approved for sale by the appropriate regulatory body, or, in the absence of regulatory approval, whether there existed any material costs yet to be incurred, material changes to the technology to be completed or material risks of approval for sale. Then, the Company considered whether the technology had any alternative future uses.
If technological feasibility of projects had not been reached and the technology had no alternative future uses, the Company considered the technology to be IPR&D. The IPR&D is comprised of technological development efforts aimed at the discovery of new, technologically advanced knowledge, the conceptual formulation and design of possible alternatives, as well as the testing of process and product cost improvements. Specifically, these technologies included, but were not limited to, research and development efforts towards U.S. commercialization and expansion of the Powerlink product line to include a larger size of the device.
The Company then estimated that it would spend $6,700 to complete the regulatory process for U.S. commercialization of the Powerlink System by mid-2004. The Company also estimated that it would spend $6,600 to complete the research and development and regulatory approval process for a larger size Powerlink System for commercialization in Europe by late 2002, and in the U.S. by mid-2007.
The Company then determined the weighted average stage of completion for IPR&D projects was approximately 60% for U.S. commercialization of the Powerlink System and 33% for the development and commercialization of the larger size of the Powerlink System as of the merger date. The cash flows from revenues forecasted in each period are reduced by related expenses, capital expenditures, the cost of working capital, and an assigned contribution to the core technologies serving as a foundation for the research and development. The discount rates applied to the individual technology’s net cash flows were 40%, based upon the level of risk associated with a particular technology and the current return on investment requirements of the market.
The amount of merger consideration allocated to IPR&D was then determined by estimating the stage of completion of each IPR&D project at the date of the merger, estimating the cash flows for the future research and development, clinical trials and release of products employing these technologies, all as described above, and discounting the net cash flows to their present values. As a result of the foregoing determinations, the Company expensed the portion of the purchase price allocated to IPR&D of $4,501 during the year ended December 31, 2002.
The Company also determined the fair value of developed technology at the merger date to be $14,050, which represents the acquired, aggregate fair value of individually identified technologies that were fully developed at the time of the merger. As with the IPR&D, the developed technology was valued using the income approach and a discount rate of 30%, in context of the business enterprise value of the former Endologix. The Company determined a value of $2,708 for trademarks and tradenames based upon the estimated royalty that would have to be paid for the right to use these assets if they had not been acquired by the Company, and a discount rate of 35%. The residual amount of $3,602 was allocated to goodwill. The trademarks and tradenames have an indefinite life and the developed technology is being amortized over ten years. The Company recognized amortization expense on intangible assets of $351 and $351 during the second quarter of
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2003 and 2004, respectively. The Company recognized amortization expense on intangible assets of $703 and $703 during the first six months of 2003 and 2004, respectively. The amortization expense on intangible assets for the next five years will be $1,405 per year.
Other intangibles consisted of the following:
December 31, 2003 | June 30, 2004 | |||||||
---|---|---|---|---|---|---|---|---|
Developed technology | $ | 14,050 | $ | 14,050 | ||||
Accumulated amortization | (2,224 | ) | (2,927 | ) | ||||
11,826 | 11,123 | |||||||
Trademarks and tradenames | 2,708 | 2,708 | ||||||
Intangible assets, net | $ | 14,534 | $ | 13,831 | ||||
The Company conducted its annual review for impairment of the intangibles at June 30, 2004. Although the Company determined that the assets were not impaired at June 30, 2004, if the Powerlink technology is not approved for sale in the U.S. by the FDA, or the approval is delayed, the intangible assets could be materially impaired.
10. Commitments and Contingencies
Sole-Source, Related-Party Supplier Agreement
In February 1999, the former Endologix agreed to purchase a key component for its Powerlink product from Impra, Inc., a subsidiary of C.R. Bard, Inc., which at the time was a significant shareholder and thus a related party, under a supplier agreement that expires in December 2007, and which then automatically renews for additional one year periods without notice, unless a party provides notice not to renew within thirty days from the expiration of the renewal period. Under the terms of the agreement, the Company has agreed to purchase certain unit quantities of the component, with built in annual quantity increases. In January 2002, the agreement was amended, increasing the minimum quantity purchase requirements for 2002 and thereafter and increasing the prices each year after 2002 according to the general increase in the Consumer Price Index. In the first six months of 2004, the Company purchased $557 of materials towards fulfilling its 2004 purchase commitment. To complete fulfilling its 2004 unit purchase commitment, which the Company estimated to cost approximately $1,357, and to purchase additional inventory in anticipation of receipt of FDA approval to commercially distribute devices using the component, the Company committed to purchasing, and the supplier agreed to provide, approximately $1,793 in components at existing prices during 2004. If the Company receives FDA approval to commercially distribute devices using the component, and it has not received a commitment from the supplier to provide the component at the then current prices, the total price for the component will materially increase. The Company believes that U.S. commercialization could occur during the second half of 2004.
The Company is economically dependent on this vendor as it is the sole source for the key component.
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Manufacturing Equipment Development Agreement
In June 2004, we entered into an agreement under which a third party will develop, install and test manufacturing equipment for the expansion of our manufacturing capability. Over a period not to exceed twenty months we anticipate spending approximately $1,662. The terms of the agreement also provide for estimated milestone payments totaling $520. During the second quarter of 2004, we incurred costs of approximately $75 associated with this capital project. We can terminate the agreement on 15 days notice, and we would be responsible for costs accrued to the date of termination.
Legal Matters
On September 15, 1999, EndoSonics Corporation, which was a wholly-owned subsidiary of Jomed N.V. until July 2003, filed a complaint for declaratory relief in the Superior Court in Orange County, California, claiming that under a May 1997 agreement between the parties, EndoSonics had rights to combine the Company’s Focus balloon technology with an EndoSonics’ ultrasound imaging transducer on the same catheter with a coronary vascular stent. In February 2001 the court ruled in the Company’s favor, ruling that Jomed-EndoSonics had no such rights to include a stent with the Focus balloon and ultrasound imaging transducer. Under the judgment, the Company was entitled to recover approximately $468 of its legal fees and costs it had previously expensed, plus interest. In May 2001, Jomed-EndoSonics appealed the judgment, and in January 2003 the appeals court upheld the judgment in the favor of the Company. In February 2003, the Company agreed to accept payment of the judgment for legal fees and costs of $468, which was recorded as a reduction to general and administrative expenses, and interest due of $94, all of which was collected by March 31, 2003.
In July 2002, the Company terminated its contracts with two of its European distributors of Powerlink products for non-performance. In October 2002, the Company commenced an arbitration proceeding against the distributors to recover delinquent receivables of $376. In response, the distributors filed counterclaims for breach of contract, intentional and negligent misrepresentation and concealment of material facts in which they claim damages of $1,000. In February 2003, the parties agreed to a mutual release of claims made in the arbitration action and signed a new distribution agreement. The European distributors paid $320 to the Company in full settlement of delinquent receivables, net of product returns for $47 and expense reimbursement of $17. The Company also accepted a one-time exchange of products valued at $80.
The Company is a party to ordinary disputes arising in the normal course of business. Management is of the opinion that the outcome of these matters will not have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
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11. Treasury Stock
In July 2002, the board of directors authorized a program for repurchases of the Company’s outstanding common stock of up to $1,500 under certain parameters. During the six months ended June 30, 2003, the Company utilized $457 to repurchase 268 shares of its common stock at a weighted average share price of $1.71 per share. There were no repurchases during the six months ended June 30, 2004.
12. Sale of Stock
On March 10, 2004, the Company announced the completion of its private placement of 3,200 shares of its common stock at a purchase price of $5.10 per share. The Company received aggregate gross proceeds of $16,320 for the newly issued shares of common stock. The proceeds of the private placement, net of issuance costs, amounted to $15,360.
13. Recent Accounting Pronouncements
In December 2003, the FASB issued Interpretation No. 46R, Consolidation of Variable Interest Entities (FIN 46R). FIN 46R requires the application of either FIN 46 or FIN 436R by public entities to all Special Purpose Entities (SPE) created prior to February 1, 2003 as of December 31, 2003 for calendar year-end companies. FIN 46R is applicable to all non-SPEs created prior to February 1, 2003 at the end of the first interim or annual period ending after March 15, 2004. For all entities created subsequent to January 31, 2003, Public Entities were required to apply the provisions of FIN 46. The adoption of FIN 46 and FIN 46R did not have a material impact on the Company’s consolidated financial position, results of operations or cash flows.
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Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We caution stockholders that, in addition to the historical financial information included herein, this Report on Form 10-Q includes “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 that are based on management’s beliefs, as well as on assumptions made by and information currently available to management. All statements other than statements of historical fact included in this Report on Form 10-Q, including without limitation, statements under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and statements located elsewhere herein regarding our financial position and business strategy, may constitute forward-looking statements. In addition, you generally can identify forward-looking statements by the use of forward-looking terminology such as “believes,” “may,” “will,” “expects,” “intends,” “estimates,” “anticipates,” “plans,” “seeks,” or “continues,” or the negative thereof or variations thereon or similar terminology. Such forward-looking statements involve known and unknown risks, including, but not limited to, economic and market conditions, the regulatory environment in which we operate, the availability of third party payor medical reimbursements, competitive activities or other business conditions. We cannot assure you that our actual results, performance or achievements will not differ materially from any future results, performance or achievements expressed or implied from such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations (“Cautionary Statements”) are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2003, but not limited to, those discussed in “Risk Factors.” All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these Cautionary Statements. We disclaim any obligation to update information contained in any forward-looking statement.
Overview
Organizational History
We were formed in 1992, and our common stock began trading publicly in 1996. The current Endologix, Inc. resulted from the May 2002 acquisition of all of the capital stock of a private company, Endologix, Inc., (“former Endologix”), and the subsequent change of our company name from Radiance Medical Systems, Inc. to Endologix, Inc. The terms of the merger are described below under the caption “Merger with Endologix, Inc.” and also Note 9 to the unaudited Condensed Consolidated Financial Statements.
Our Business
Endologix is engaged in the development, manufacture, sales and marketing of minimally invasive therapies for the treatment of vascular disease. Our primary focus is the development of the Powerlink System, a catheter-based alternative treatment to surgery for abdominal aortic aneurysms, or AAA. AAA is a weakening of the wall of the aorta, the largest artery of the body. Once AAA develops, it continues to enlarge and if left untreated becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured abdominal aortic aneurysms is approximately 75%, making it the 13th leading cause of death in the United States.
The Powerlink System is a catheter and endoluminal graft, or ELG system. The self-expanding stainless steel cage is covered by ePTFE, a commonly-used surgical graft material. The
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Powerlink ELG is implanted in the abdominal aorta by gaining access through the femoral artery. Once deployed into its proper position, the blood flow is shunted away from the weakened or “aneurismal” section of the aorta, reducing pressure and the potential for the aorta to rupture. We believe that implantation of the Powerlink System will reduce the mortality and morbidity rates associated with conventional AAA surgery.
We are currently selling the Powerlink System in Europe. We received Ministry of Health (“MOH”) approval to market the Powerlink System in France, which requires regulatory approval separate from the rest of Europe, in the first quarter of 2003 and are seeking reimbursement for the device, which we expect to receive in the second half of 2004. We completed Japanese clinical trials for our AAA technology in November 2001 and have submitted for Japanese MOH approval to commercialize the product. We believe that Japanese MOH review should be completed in the second half of 2004 and will file for reimbursement for the device thereafter. We anticipate approval for reimbursement for the device in Japan and the start of sales there in the second half of 2005.
We completed enrollment in the first quarter of 2003 for the infrarenal arm of our two arm Phase II U.S. clinical trial and filed a pre-market approval, or PMA, application with the FDA in order to market the infrarenal Powerlink System in the United States in January 2004. We anticipate approval for our infrarenal device in the second half of 2004. We will not be able to market the Powerlink system in the United States until our PMA application is approved by the FDA.
We are in the patient enrollment phase for the suprarenal study arm of the Powerlink System. The difference between the infrarenal and suprarenal devices is that the wire stent in the suprarenal device extends above the graft material to allow the physician to anchor the top of the device above the renal arteries without obstructing them. As of June 30, 2004, we have enrolled a total of 81 patients of the targeted 193 total patient enrollment in the suprarenal arm of the study.
Prior to the acquisition of former Endologix and the restructuring that occurred during the third and fourth quarters of 2001 (see below under the caption “Merger with Endologix, Inc.”), we were researching, developing and marketing a radiation therapy catheter for the treatment of blockages in arteries after angioplasty, or restenosis. Prior to that we developed, manufactured and marketed other catheter and stent products for treatment of cardiovascular disease.
Since 1999, our source of revenues shifted gradually from direct sales of catheter and stent products to royalties from licenses of our stent delivery technology. In June 1998, we licensed Guidant Corporation rights to manufacture and distribute products using our Focus technology for the delivery of stents. In exchange, we received milestone payments based upon the transfer of know-how to Guidant, and continue to receive royalty payments based upon the sale of products by Guidant using the Focus technology. The payments under the Guidant license have been the primary source of our existing revenues. See Note 6 to the unaudited Condensed Consolidated Financial Statements for more information on the Guidant agreement.
Following the introduction by Guidant of non-licensed products to replace some licensed products in 2002, and we believe, more importantly, the introduction by Guidant’s competitors of drug-coated stents, which compete with licensed products, in 2003 and 2004, the license royalties we receive have been materially decreasing. Following the acquisition of former Endologix in May 2002, sales of Powerlink System products have somewhat offset reductions in Guidant license royalties. We anticipate that Guidant license royalties will continue to materially decrease during
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2004 and that Powerlink System product sales will become our major, and only material source of revenues in the first half of 2005.
We have experienced an operating loss for each of the last five years and expect to continue to incur annual operating losses through at least December 31, 2005 due especially to spending to build our sales, marketing and distribution capability. Our results of operations have varied significantly from quarter to quarter, and we expect that our results of operations will continue to vary significantly in the future. Our quarterly operating results depend upon several factors, including:
o | the timing and amount of expenses associated with clinical testing and development of the Powerlink system; |
o | the progress and success of clinical trials and regulatory approvals; |
o | varying product sales by Guidant Corporation, our licensee; |
o | our ability to penetrate the markets following regulatory approval; and, |
o | outcomes from future partnering or technology acquisition agreements, if any. |
Merger with former Endologix, Inc.
Reasons for the Merger
In September 2001, as part of a restructuring plan driven by the success of drug-coated stents, we began investigating other medical device technologies for commercialization. In the fourth quarter of 2001, we began discussions with former Endologix, a privately held developer and manufacturer of the Powerlink System. We believed that the Powerlink System was a novel device for treatment of AAA, and that clinical results to date indicated that the Powerlink System had several features and benefits that may provide a better clinical outcome in comparison to devices then on the market. We believed that the acquisition of former Endologix’s technology would provide us with a new and unique medical device technology for a promising and potentially lucrative market.
Merger Transaction
In May 2002, we acquired all of the capital stock of former Endologix. We paid stockholders of former Endologix $0.75 cash for each share of former Endologix common stock, for an aggregate of $8.4 million, and issued one share of our common stock for each share of former Endologix common stock, for an aggregate of 11,140,541 shares.
In addition, we agreed to pay contingent consideration in the amount of $2.8 million in the event pre-market approval, or PMA, is received in the U.S. for the Powerlink System on or before June 30, 2004. PMA approval was not obtained on or before June 30, 2004 and, as such, no contingent consideration is due.
We accounted for the acquisition was accounted for as a purchase under SFAS No. 141, “Business Combinations.” In accordance with SFAS No. 141, we allocated the purchase price based on the fair value of the assets acquired and liabilities assumed. See Note 9 to the unaudited Condensed Consolidated Financial Statements for further description of the accounting for the merger.
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Results of Operations
Comparison of the Three Months Ended June 30, 2004 and 2003
Product Revenue. Product revenue increased 192% to $860,000 in the three months ended June 30, 2004 from $295,000 in the three months ended June 30, 2003. Product revenue increased primarily due to sales to Edwards Lifesciences AG (“Edwards”), one of our European distributors for our Powerlink System, and higher U.S. clinical trial sales.
We are primarily spending our resources on U.S. clinical trials and preparation of a launch in the U.S. of our infrarenal Powerlink system in the second half of 2004. We market in Europe primarily through distributors and, in the second quarter of 2004, we signed an exclusive distribution agreement for certain European markets with Edwards, which included distribution for Germany and France. As a result of this new distribution agreement and the anticipated approval of our infrarenal Powerlink system in the U.S., we believe that product revenue for the remaining six months of the year will be materially higher in 2004 than in the same period of 2003.
License Revenue. License revenue decreased 51% to $342,000 in the three months ended June 30, 2004 from $694,000 in the three months ended June 30, 2003. We believe that the reduction in license revenue is due primarily to the introduction of non-royalty bearing products by Guidant and sales of drug-coated stents, a competing technology, in the U.S. We also believe that license revenue will continue to decrease during 2004 compared with the comparable periods of 2003 due to increasing acceptance of drug-coated stents. The agreement with Guidant expires in 2008, unless terminated sooner, and provides for minimum annual royalties of $250,000.
Cost of Product Revenue. The cost of product revenue increased 284% to $415,000, or 48% of product revenue, in the three months ended June 30, 2004 from $108,000, or 37% of product revenue, in the three months ended June 30, 2003. Cost of product revenue increased due primarily to higher Powerlink sales. During the second quarter of 2003, a $39,000 favorable inventory reserve adjustment lowered the cost of product revenue as a percentage of product revenue.
During the second quarter of 2004, we began significant development efforts to improve and expand on our manufacturing capability. Although we believe that we have sufficient capacity and resources to support the production we are forecasting through June 2005, we plan to develop our manufacturing capability to support our sales plans thereafter. See Liquidity and Capital Resources, below for more information about our manufacturing development projects.
Research, Development and Clinical. Research, development and clinical expenses were $1.7 million in the three months ended June 30, 2004 and June 30, 2003. A reduction of $121,000 in expenditures for clinical studies of our legacy radiation therapy system, the RDX System, was offset by an increase in expenditures for the development of the Powerlink System in the second quarter of 2004.
We are continuing to conduct new product research and development for our Powerlink System product line, anticipate continuing enrollment in the suprarenal arm of our pivotal U.S. clinical trials throughout 2004 and expect to begin enrollment in a third arm of our pivotal U.S. clinical trials for a study of a large diameter cuff in the third quarter of 2004. We believe we will be able to treat a broader patient population, using a large diameter cuff with our Powerlink System stent grafts.
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As a result of the completion of enrollment in the infrarenal arm of our U.S. pivotal clinical trials in the first quarter of 2003, we anticipate that total research and development expenses for the second quarter of 2004 will be somewhat lower than the expenses for the same period of 2003. For the rest of 2004, due to the start up of enrollment in the large diameter cuff trial and expenses to improve our manufacturing capability, we anticipate that the expenses will be comparable or somewhat higher in the second half of 2004 to those in the second half of 2003.
Marketing and Sales. Marketing and sales expenses increased 212% to $481,000 in the three months ended June 30, 2004 from $154,000 in the three months ended June 30, 2003. The increase in costs for second quarter 2004 marketing and sales expenses resulted because of the increase in U.S. sales and marketing staffing in anticipation of a second half 2004 launch of our infrarenal Powerlink System. We anticipate that marketing and sales expenses over the remaining six month period of 2004 will be materially higher than those for the same period of 2003, and will be more than double the expense for the first half of 2004, as we plan to devote more resources to build a U.S. team of five to eight sales persons for an initial, focused launch of our products following FDA approval.
General and Administrative. General and administrative expenses totaled $753,000 in the three months ended June 30, 2004, compared to $697,000 in the three months ended June 30, 2003. An increase in outside service charges primarily from $109,000 in consulting charges for the review of our internal controls over financial reporting, as required under section 404 of the Sarbanes-Oxley Act, in 2004, was offset by a reduction in other outside service costs, including strategic advisor fees, which were incurred in the second quarter of 2003. We anticipate that general and administrative expenses over the remaining six month period of 2004 will be higher than those for the same period of 2003.
Other Income (Expense). Other income increased 103% to $67,000 in the three months ended June 30, 2004, compared to $33,000 in the same period of 2003. The increase in other income for the second quarter of 2004 compared with the same period of 2003 was due primarily to an increase in interest income of $37,000 resulting from a 250% higher average cash balance, including $15.4 million in proceeds from a private offering of common stock in March 2004, somewhat offset by the effect of an average lower interest rate for the invested cash.
Comparison of the Six Months Ended June 30, 2004 and 2003
Product Revenue. Product revenue increased 53% to $1.2 million in the six months ended June 30, 2004 from $785,000 in the six months ended June 30, 2003. Product revenue increased primarily because of sales to Edwards totalling $383,000.
License Revenue. License revenue decreased 40% to $819,000 in the six months ended June 30, 2004 from $1.4 million in the six months ended June 30, 2003. We believe that the reduction in license revenue is due primarily to the introduction of non-royalty bearing products by Guidant and sales of drug-coated stents in the U.S.
Cost of Product Revenue. The cost of product revenue increased 80% to $658,000, or 55% of product revenue, in the six months ended June 30, 2004 from $365,000, or 46% of product revenue, in the six months ended June 30, 2003. Cost of product revenue increased primarily because of an increase in product sales. The increase in cost of product revenue, as a percentage of product revenue was due primarily to an increase in sales to distributors as a percent of total sales, which are typically at a materially lower average price than the average sale price to hospitals.
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Research, Development and Clinical. Research, development and clinical expenses decreased 13% to $3.1 million in the six months ended June 30, 2004 from $3.6 million in the six months ended June 30, 2003. The decrease resulted primarily from a decrease of $445,000 in legacy radiation catheter technology clinical trial costs as the trials were nearly completed in 2003.
Marketing and Sales. Marketing and sales expenses increased 100% to $872,000 in the six months ended June 30, 2004 from $437,000 in the six months ended June 30, 2003. The increase in costs for first six months of 2004 resulted because of the increase in U.S. sales and marketing staffing in anticipation of a second half 2004 launch of our infrarenal Powerlink System.
General and Administrative. General and administrative expenses increased 83% to $1.5 million in the six months ended June 30, 2004 from $835,000 in the six months ended June 30, 2003. The increase in expenses for the first six months of 2004, compared with the same period of 2003, was due primarily to a reimbursement of $468,000 for legal and other expenses as part of a legal settlement in the first quarter of 2003 with Jomed-Endsonics, which is described in Note 10 to the unaudited Condensed Consolidated Financial Statements, and net bad debt recoveries of $50,000, combined with expenses of $109,000 for consulting services related to our review of our internal controls over financial reporting in preparation for our annual certification under Section 404 of the Sarbanes-Oxley Act.
Other Income (Expense). Other income decreased 30% to $131,000 in the six months ended June 30, 2004, compared to $188,000 in the same period of 2003. The decrease in other income for the first six months of 2004 compared with the same period of 2003 was primarily due to a decrease in interest income of $63,000 resulting from interest income of $94,000 from the legal settlement with Jomed-Endosonics, described above, partially offset by the effect of a 132% higher average cash balance, though the average interest rate on investments was lower during the first half of 2004.
Liquidity and Capital Resources
At June 30, 2004, we had cash, cash equivalents and marketable securities available for sale of $26.5 million. We expect to continue to incur substantial costs and cash outlays in 2004 to support Powerlink research and development and manufacturing capability development.
In July 2002, the board of directors authorized a program for repurchases of our outstanding common stock of up to $l.5 million under certain parameters. As of June 30, 2004, we have repurchased an aggregate of 495,000 shares for $661,000, with the last such purchase in the quarter ended June 30, 2003.
In February 1999, the former Endologix agreed to purchase a key component for its Powerlink product from Impra, Inc., a subsidiary of C.R. Bard, Inc. and then a related party, under a supplier agreement that expires in December 2007, and which then automatically renews, on a year by year basis, for additional one year periods without notice, unless a party provides notice not to renew within thirty days from the expiration of the renewal period. Under the terms of the agreement, we have agreed to purchase certain unit quantities of the component, with built in annual quantity increases, or the agreement may be canceled. In January 2002, the agreement was amended to increase the minimum quantity purchase requirements for 2002 and thereafter and increase the prices each year after 2002 according to the general increase in the Consumer Price Index. To fulfill our 2004 unit purchase commitment, which we estimated to cost approximately $1.4 million, and to purchase additional inventory in anticipation of receipt of FDA approval to commercially distribute
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devices using the component, we committed to purchasing, and the supplier agreed to provide, approximately $1.8 million in components at existing prices during 2004. If we receive FDA approval to commercially distribute devices using the component, and we have not received a commitment from the supplier to provide the component at the then current prices, the total price for the component will materially increase. We believe that U.S. commercialization could occur during the second half of 2004.
We are economically dependent on this vendor as it is the sole source for the key component.
For the six months ended June 30, 2004, we incurred a net loss of $4.0 million. As of June 30, 2004, we had an accumulated deficit of approximately $77.9 million. We believe that current cash and cash equivalents and marketable securities will be sufficient to meet anticipated cash needs for operating and capital expenditures through at least December 31, 2005. Failure of the FDA to approve the Powerlink Systems, failure of the market to accept our products, or failure to reduce certain discretionary expenditures, if necessary, could have a material adverse effect on our ability to achieve our intended business objectives.
Our future capital requirements will depend on many factors, including:
o | regulatory and market acceptance of the Powerlink System; |
o | our research and development programs |
o | the scope and results of clinical trials; |
o | the regulatory approval process; |
o | the costs involved in intellectual property rights enforcement or litigation; |
o | competitive products; |
o | the enhancement of manufacturing capacity; |
o | the development of sales and marketing capabilities; |
o | the establishment of collaborative relationships with other parties; and, |
o | the ability to develop technology and to commercialize products. |
In July 2003, we completed a private placement of 4,000,000 shares of our common stock at $2.25 per share, pursuant to which we received aggregate net proceeds of $8.4 million.
In March 2004, we completed a private placement of 3,200,000 shares of our common stock at $5.10 per share, pursuant to which we received aggregate net proceeds of $15.4 million.
In June 2004, we entered into an agreement under which a third party will develop, install and test manufacturing equipment for the expansion of our manufacturing capability. Over a period not to exceed twenty months we anticipate spending approximately $1.7 million. The terms of the agreement also provide for estimated milestone payments totaling $520,000. During the seond quarter of 2004, we incurred costs of approximately $75,000 associated with this capital project. We can terminate the agreement on 15 days notice, and we would be reponsible for costs accrued to the date of termination.
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Accounts Receivable. Trade accounts receivable, net, increased 111% to $505,000 at June 30, 2004 from $239,000 at December 31, 2003. The increase is due primarily to an increase in sales from Edwards, a new European distributor.
Other Receivables. Other receivables decreased 33% to $442,000 at June 30, 2004 from $656,000 at December 31, 2003 due primarily to a $256,000 decrease of the royalty receivable from Guidant. See Comparisons of Quarters Ended June 30, 2004 and 2003 in subsections License Revenue, regarding Guidant royalty revenues, above.
Deferred Income Taxes. Because of our continuing operating losses and the uncertainty of realization of our net, deferred income tax asset, we recorded an offsetting valuation allowance equal to the net, deferred income tax asset.
Accounts Payable and Accrued Expenses. Accounts payable and accrued expenses increased 27% to $1.9 million at June 30, 2004 from $1.5 million at December 31, 2003. The increase is attributable primarily to an increase of $141,000 in purchases from Impra for a key component of our Powerlink System, and increases in various other payables that increased as a result of our preparations for an anticipated launch in the U.S.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our financial instruments include cash and short-term investment grade debt securities. At June 30, 2004 the carrying values of our financial instruments approximated their fair values based on current market prices and rates. It is our policy not to enter into derivative financial instruments. We do not currently have material foreign currency exposure as the majority of our assets are denominated in U.S. currency and our foreign-currency based transactions are not material. Accordingly, we do not have a significant currency exposure at June 30, 2004.
Item 4. CONTROLS AND PROCEDURES
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our “disclosure controls and procedures” as of the end of the period covered by this report, pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures, as of the end of the period covered by this report, were effective in timely alerting them to material information relating to us required to be included in our periodic SEC filings. There has been no change in our internal control over financial reporting during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Part II.
OTHER INFORMATION
Items 1-5. Not applicable
Item 6. Exhibits and Reports on Form 8-K
(a) The following exhibits are filed herewith:
Exhibit 31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
Exhibit 31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
Exhibit 32.1 | Certification of Chief Executive Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
Exhibit 32.2 | Certification of Chief Financial Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(b) Reports on Form 8-K
The Company filed a Current Report on Form 8-K on May 13, 2004 announcing the financial results for the first quarter ended March 31, 2004.
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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 undersigned thereunto duly authorized.
ENDOLOGIX, INC | |
Date: August 6, 2004 | /s/ Paul McCormick _______________________________________________ Chief Executive Officer and Director (Principal Executive Officer) |
Date: August 6, 2004 | /s/ David M. Richards _______________________________________________ Chief Financial Officer and Secretary (Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
The following exhibits are filed herewith:
Exhibit 31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
Exhibit 31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
Exhibit 32.1 | Certification of Chief Executive Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
Exhibit 32.2 | Certification of Chief Financial Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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