During the three months ended March 31, 2008, no single customer accounted for more than 10% of total revenues. During the three months ended March 31, 2007, revenue from LeMaitre Vascular, Inc. included its initial stocking order and was $665, which represented 11% of total revenues. No other single customer in the three month period ended March 31, 2007 accounted for more than 10% of total revenues.
As of March 31, 2008 and December 31, 2007, no single customer accounted for more than 10% of the Company’s accounts receivable balance.
In accordance with SFAS No. 142, “Goodwill and Other Intangible Assets,” goodwill and other intangible assets with indeterminate lives are no longer subject to amortization but are tested for impairment annually or whenever events or changes in circumstances indicate that the asset might be impaired. The Company most recently performed its annual impairment analysis as of June 30, 2007 and will continue to test for impairment annually as of June 30 each year. No impairment was indicated in the last analysis. Intangible assets with finite lives continue to be subject to amortization, and any impairment is determined in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets.”
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(IN THOUSANDS, EXCEPT PER SHARE, PER UNIT, AND NUMBER OF YEARS)
(Continued)
(Unaudited)
The Company recognized amortization expense on intangible assets of $351 and $352 during the three months ended March 31, 2008 and 2007, respectively. Estimated amortization expense for the remainder of 2008 and the five succeeding fiscal years is as follows:
2008 | $ | 1,054 |
2009 | $ | 1,405 |
2010 | $ | 1,405 |
2011 | $ | 1,405 |
2012 | $ | 585 |
12. Commitments and Contingencies
Legal Matters
The Company is a party to ordinary disputes arising in the normal course of business, including an intellectual property infringement claim as well as claims with respect to its employment of former employees of its competitors. 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 flow.
13. Recent Accounting Pronouncements
As of January 1, 2008, the Company has adopted the FASB issued Statement of Financial Accounting Standards No. 157, or SFAS 157, “Fair Value Measurements,” which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. The expanded disclosures in this statement about the use of fair value to measure assets and liabilities should provide users of financial statements with better information about the extent to which fair value is used to measure recognized assets and liabilities, the inputs used to develop the measurements, and the effect of certain measurements on earnings for the period. As of March 1, 2008, the adoption of SFAS 157 had no impact on our consolidated financial statements.
As of January 1, 2008, the Company has adopted the FASB issued Statement of Financial Accounting Standards No. 159, or SFAS 159, “The Fair Value Option for Financial Assets and Financial Liabilities — Including an amendment of FASB Statement No. 115.” SFAS 159 allows for voluntary measurement of financial assets and liabilities as well as certain other items at fair value. Unrealized gains and losses on financial instruments for which the fair value option has been elected are reported in earnings. As of March 31, 2008, the adoption of SFAS 159 had no impact on our consolidated financial statements.
In December 2007, the FASB issued Statement of Financial Accounting Standards No. 141(R), or SFAS 141(R), “Business Combinations (revised - 2007).” SFAS 141(R) is a revision to previously existing guidance on accounting for business combinations. The statement retains the fundamental concept of the purchase method of accounting, and introduces new requirements for the recognition and measurement of assets acquired, liabilities assumed and noncontrolling interests. The statement is effective for fiscal years beginning after December 15, 2008. We do not expect adoption of this standard to have a material impact on our consolidated financial statements.
In December 2007, the FASB issued Statement of Financial Accounting Standards No. 160, or SFAS 160, “Noncontrolling Interests in Consolidated Financial Statements.” The Statement requires that noncontrolling interests be reported as stockholders equity. The Statement also establishes a single method of accounting for changes in a parent’s ownership interest in a subsidiary as long as that ownership change does not result in deconsolidation. SFAS 160 is required to be applied prospectively in 2009, except for the presentation and disclosure requirements which are to be applied retrospectively. The statement is effective for fiscal years beginning after December 15, 2008. We are currently evaluating the impact of SFAS 160 and do not expect a material impact to our consolidated financial statements.
In March 2008, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 161, “Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133” (“SFAS 161”). This new standard requires enhanced disclosures for derivative instruments, including those used in hedging activities. It is effective for fiscal years and interim periods beginning after November 15, 2008. We are currently evaluating the impact of SFAS 161 and do not expect a material impact to our consolidated financial statements.
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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTSOF OPERATIONS
In addition to the historical financial information included herein, thisQuarterly Report on Form 10-Q includes “forward-looking statements” within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities Exchange Act of 1934 that are based on management’s beliefs, as wellas on assumptions made by and information currently available to management.All statements other than statements of historical fact included in thisQuarterly Report on Form 10-Q, including without limitation, statements under“Management’s Discussion and Analysis of Financial Condition and Results ofOperations” and statements located elsewhere herein regarding our financialposition and business strategy, may constitute forward-looking statements. Yougenerally can identify forward-looking statements by the use of forward-lookingterminology such as “believes,” “may,” “will,” “expects,” “intends,”“estimates,” “anticipates,” “plans,” “seeks,” or “continues,” or the negativethereof or variations thereon or similar terminology. Such forward-lookingstatements involve known and unknown risks, including, but not limited to,market acceptance of our sole technology, the Powerlink® System, economic andmarket conditions, the regulatory environment in which we operate, theavailability of third party payor medical reimbursements, competitiveactivities or other business conditions. Our actual results, performance orachievements may differ materially from any future results, performance orachievements expressed or implied from such forward-looking statements.Important factors that could cause actual results to differ materially from ourexpectations are disclosed in our Annual Report on Form 10-K for the year endedDecember 31, 2007, including but not limited to those factors discussed in“Item 1A. Risk Factors.” All subsequent written and oral forward-lookingstatements attributable to us or persons acting on our behalf are expresslyqualified in their entirety by these cautionary statements. We do not undertakeany obligation to update information contained in any forward-lookingstatement.
Overview
Organizational History
We were formed in 1992 as Cardiovascular Dynamics, Inc., 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., which we refer to herein as the former Endologix, and the subsequent change of our company name from Radiance Medical Systems, Inc. to Endologix, Inc.
Our Business
We are engaged in the development, manufacture, sale 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 AAA is approximately 75%, making it a leading cause of death in the United States today.
The Powerlink System is a catheter and endoluminal stent graft, or ELG, system. The self-expanding cobalt chromium alloy stent cage is covered by ePTFE, a commonly-used surgical graft material. The 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. Our clinical trials demonstrate that implantation of our products reduce the mortality and morbidity rates associated with conventional AAA surgery, as well as provide a clinical alternative to many patients that could not undergo conventional surgery. We are currently selling the Powerlink System in the United States, Europe, South America, Japan and in other selected markets.
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In February 2008, we received Shonin approval from the Japanese Ministry of Health. Shonin is equivalent to FDA approval of a PMA application in the United States. We commenced commercial sales to Japan in February 2008 through our distributor.
We also continue to conduct clinical trials for the suprarenal Powerlink System and for other products related to the Powerlink System. As of March 31, 2008, 153 of the required 193 patients have been enrolled for the second arm of the United States Pivotal Phase II clinical trial for the suprarenal Powerlink System. As of July 31, 2007, all of the required 60 patients have been enrolled in a United States Pivotal Phase II clinical trial utilizing a 34 mm proximal cuff in conjunction with a commercial bifurcated Powerlink ELG to treat patients with large aortic necks. As of March 31, 2008, 36 of the required 63 patients have been enrolled in a clinical trial for a 34mm infrarenal bifurcated device, also designed to treat patients with large aortic necks. Currently, only one commercial device supplied by a competitor, is capable of treating aortic necks larger than 26 mm.
We have experienced an operating loss for each of the last five years and expect to continue to incur operating losses for at least the next nine months. Our business is subject to a number of challenges inherent in a company with a single technology such as the difficulty in predicting physician acceptance of our product and the difficulty of planning for the growth of our operations relative to the market demand for our product. Consequently, 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.
Results of Operations
Comparison of the Three Months Ended March 31, 2008 and 2007
Product Revenue. Product revenue increased 33% to $8.3 million in the three months ended March 31, 2008 from $6.3 million in the three months ended March 31, 2007. Domestic sales increased 34% to $6.8 million in the three months ended March 31, 2008 from $5.1 million in the three months ended March 31, 2007. The increase in domestic sales was due to increased productivity of field sales personnel and an increase in territories covered.
International sales increased 30% to $1.5 million in the three months ended March 31, 2008 from $1.1 million for the comparable period in the prior year. This increase was driven by our initial stocking order to Japan, and higher sales to our distributors in Europe and Latin America.
We expect that product revenue will continue to grow, both sequentially and compared to prior year periods. We anticipate that product revenue will be in the range of $39 to $43 million for the year ended December 31, 2008.
License Revenue.License revenue decreased 79% to $12,000 in the three months ended March 31, 2008 from $58,000 for the comparable period in the prior year. This decrease is due to the expiration of the annual minimum royalty provision of the license agreement with Abbott and the royalty payments will cease when the license becomes fully paid up in June 2008.
Cost of Product Revenue. The cost of product revenue decreased 2% to $2.5 million in the three months ended March 31, 2008 from $2.6 million in the three months ended March 31, 2007. Despite an increase in the volume of Powerlink System sales, the cost of product revenue declined by 2%. As a percentage of product revenue, cost of product revenue decreased to 30% in the first quarter of 2008 as compared to 41% in the same period of 2007. Both the dollar and percentage declines in the cost of product revenue were due to increased substitution of in-house produced ePTFE graft material for higher-cost purchased graft material in a portion of the products sold during the period.
We expect gross margin to range from 71% to 75% for the full year of 2008, reflecting the benefit of increased utilization of ePTFE graft material produced in-house, and higher volume.
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Research, Development and Clinical.Research, development and clinical expense decreased 4% to $1.5 million in the three months ended March 31, 2008 as compared to $1.6 million for the three months ended March 31, 2007. We expect that research, development, and clinical expense will remain in the range of $1.5 million to $1.8 million per quarter through 2008.
Marketing and Sales. Marketing and sales expense increased 13% to $5.8 million in the three months ended March 31, 2008 from $5.2 million in the three months ended March 31, 2007. The increase in the first quarter of 2008 resulted primarily from a 15% increase in the size of the domestic sales force which generated a 34% increase in domestic sales between those periods. We anticipate that marketing and sales expense will increase at a decreasing rate over the remainder of the year due to increased production of our tenured sales representatives within their territories.
General and Administrative. General and administrative expense increased 42% to $2.3 million in the three months ended March 31, 2008 from $1.6 million in the three months ended March 31, 2007. Legal expenses increased approximately $446,000 in response to an intellectual property infringement claim and employment matters. While these matters are still ongoing, we believe that Q1 represented the peak in legal expenses for the year and that additional legal fees related to these matters will be modest for the remainder of 2008.We expect general and administration expense to return to the $1.6 to $1.8 million range per quarter through the balance of 2008, notwithstanding any unforeseen legal activity.
Other Income. Other income decreased 68% to $80,000 in the three months ended March 31, 2008, from $248,000 in the same period of 2007. Interest income declined due to lower balances of invested cash and lower yields on invested cash.
Liquidity and Capital Resources
For the three months ended March 31, 2008, we incurred a net loss of $3.7 million. As of March 31, 2008, we had an accumulated deficit of $135.4 million. Historically, we have relied on the sale and issuance of equity securities to provide a significant portion of funding for our operations. Since July 2003, we have completed four financing transactions resulting in net proceeds of approximately $58.0 million.
In February 2007, we entered into a revolving credit facility, whereby we may borrow up to $5.0 million. All outstanding amounts under the credit facility bear interest at a variable rate equal to the lender’s prime rate plus 0.5%, which is payable on a monthly basis. The unused portion is subject to an unused revolving line facility fee, payable quarterly, in arrears, on a calendar year basis, in an amount equal to one quarter of one percent per annum of the average unused portion of the revolving line, as determined by the lender. The credit facility also contains customary covenants regarding the operation of our business and financial covenants relating to ratios of current assets to current liabilities and tangible net worth during any calendar quarter. As of March 31, 2008, we were in compliance with all of these covenants. The amounts outstanding under the credit facility are collateralized by all of our assets with the exception of our intellectual property. All amounts owing under the credit facility will become due and payable on February 21, 2009. As of March 31, 2008, we did not have any outstanding borrowings under this credit facility.
At March 31, 2008, we had cash, cash equivalents, and restricted cash equivalents of $7.8 million. We believe that current cash and cash equivalents, together with cash receipts generated from sales of the Powerlink System and available borrowings under our credit facility, will be sufficient to meet anticipated cash needs for operating and capital expenditures until we achieve positive cash flow on a sustainable basis.
In the event that we are unsuccessful and do require additional funding, we would attempt to raise the required capital through either debt or equity arrangements. We cannot provide any assurance that the required capital would be available on acceptable terms, if at all, or that any financing activity would not be dilutive to our current stockholders. If we were not able to raise additional funds, we would be required to significantly curtail our operations which would have an adverse effect on our financial position, results of operations and cash flows.
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We believe that our future cash and capital requirements may be difficult to predict and will depend on many factors, including:
- continued market acceptance of the Powerlink System;
- our ability to successfully expand our commercial marketing of the Powerlink System;
- the success of our research and development programs for future products;
- the clinical trial and regulatory approval processes for future products;
- the costs involved in intellectual property rights enforcement or litigation;
- the level of hospital reimbursement for ELG procedures and other competitive factors;
- viability of our sole manufacturing facility through unforeseen natural or other disasters;
- our ability to produce and/or purchase an adequate supply of ePTFE, the key raw material for our PowerlinkSystem;
- the establishment of collaborative relationships with other parties.
As of March 31, 2008, inventory decreased 8% to $7.4 million as compared to $8.1 million as of December 31, 2007. The decrease in inventory is primarily due to continued substitution of in-house produced ePTFE graft material for higher cost purchased graft material. In general, our raw material and in-process inventories have an indefinite shelf life, and finished goods have a shelf life of up to three years.
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Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Our financial instruments include cash and cash equivalents. At March 31, 2008, 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 United States currency and our foreign-currency based transactions are not material. Accordingly, we do not have a significant currency exposure at March 31, 2008.
All outstanding amounts under our revolving credit facility bear interest at a variable rate equal to the lender’s prime rate plus 0.5%, which is payable on a monthly basis and which may expose us to market risk due to changes in interest rates. As of March 31, 2008, we had no outstanding amounts under our credit facility and therefore, were not subject to any risk from changes in interest rates.
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, or the Exchange Act. 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 to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our chief executive officer and chief financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
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
Item 6. EXHIBITS
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 Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
|
Exhibit 32.2 | | Certification of Chief Financial Officer Pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
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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 the undersigned thereunto duly authorized.
| ENDOLOGIX, INC. |
|
Date: May 1, 2008 | /s/ Paul McCormick |
| President and Chief Executive Officer |
| (Principal Executive Officer) |
|
Date: May 1, 2008 | /s/ Robert J. Krist |
| 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 Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
|
Exhibit 32.2 | | Certification of Chief Financial Officer Pursuant to Rule 13a-14(b)/15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
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