Fourth Quarter Net Product Sales Increased 22% Over Fourth Quarter 2007
Achieved Fourth Quarter Non-GAAP Adjusted Earnings Per Share of $0.08
Cash and Cash Equivalents Increased by $13.7 Million to $59.7 Million
PLYMOUTH, Minn., Feb. 24 /PRNewswire-FirstCall/ -- ev3 Inc. , a global endovascular device company, today reported financial results for its fiscal fourth quarter and full-year of 2008 and its financial guidance for 2009. Reconciliations of non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found immediately following the detail of net sales by geography later in this release.
ev3’s net sales were $106.1 million in the fourth quarter of 2008, representing a 15% increase over the same quarter of the prior year. Fourth quarter net product sales totaled approximately $105.6 million and increased 22% versus the prior year quarter. Research collaboration revenues were approximately $469 thousand in the fourth quarter of 2008 compared to $6.0 million in the fourth quarter of 2007. By product segment, fourth quarter neurovascular net sales increased by 32%, and peripheral vascular net product sales increased by 18%. On a geographic basis, ev3 U.S. net sales, excluding revenues from the prior Merck research and collaboration agreement, increased approximately 14% over the prior year quarter. International net sales increased 41% over the prior year quarter. Changes in foreign currency exchange rates had a negative impact of approximately $2.7 million on fourth quarter of 2008 net sales compared to the fourth quarter of the prior year.
For the year ended December 31, 2008, ev3’s net sales increased 49% to $422.1 million versus $284.2 million for the year ended December 31, 2007. Atherectomy net sales totaled approximately $88.8 million in 2008 compared to $20.9 million for the period from October 5 to December 31 in 2007 relating to the acquisition of FoxHollow. Changes in foreign currency exchange rates had a positive impact of approximately $5.0 million on full-year 2008 net sales compared to 2007.
Robert Palmisano, president and chief executive officer of ev3 Inc., commented, “Our performance in the fourth quarter reflects continued sales expansion across both our peripheral vascular and neurovascular businesses. Notably, the performance in our neurovascular segment and international business in the fourth quarter underscores the positive progress we continue to make on our global launch activities for our Axium Progressive Coil System and further penetration of our Onyx Liquid Embolic System.”
Palmisano commented further, “In addition, fourth quarter revenues in our peripheral vascular business segment were led by a particularly strong contribution from our core peripheral vascular products. Despite the competitive activity and lack of market growth that we saw in atherectomy throughout 2008, we remain optimistic about the longer term outlook for atherectomy and are committed to improving our execution and productivity under new sales leadership, adding new plaque excision products and developing clinical data to support procedural expansion.”
ev3’s GAAP net loss for the fourth quarter of 2008 increased to $(291.1) million compared to $(107.9) million in the fourth quarter of 2007. The company’s GAAP net loss for the fiscal year ended December 31, 2008 increased to $(335.6) million compared to $(165.7) million for the year ended December 31, 2007. ev3’s net loss per common share for the fourth quarter and fiscal year ended December 31, 2008 was $(2.78) and $(3.22), respectively, compared to $(1.06) in the fourth quarter of 2007 and $(2.37) in the full-year ended December 31, 2007. The fourth quarter of 2008 and full-year net loss include non-cash asset impairment charges related to goodwill and other intangible assets of $288.8 million and $299.3 million, respectively. The fourth quarter of 2007 net loss reflects an acquired in-process research and development charge of $70.7 million and $10.3 million of merger related integration expenses.
For the fourth quarter of 2008, ev3’s non-GAAP adjusted net income was $7.9 million, or $0.08 per diluted share. For the fiscal year ended December 31, 2008, ev3’s non-GAAP adjusted net income was $9.9 million, or $0.09 per diluted share. Non-GAAP adjusted net income and adjusted net earnings per share for the fourth quarter and full-year exclude non-cash amortization expense of $6.8 million and $31.1 million, non-cash stock-based compensation of $3.5 million and $15.2 million, and non-cash asset impairment charges related to goodwill and other intangible assets of $288.8 million and $299.3 million, respectively.
ev3 recorded its second consecutive quarter of positive cash flow with cash and cash equivalents increasing $13.7 million in the fourth quarter of 2008 compared to the end of the third quarter of 2008. Cash and cash equivalents totaled $59.7 million as of the end of fourth quarter of 2008. This increase was primarily due to cash generated by operations.
Palmisano continued, “We continue to emphasize profitability and cash generation as well as positive product sales growth as our prime objectives, so I was very encouraged to see another quarter of solid progress in these areas. We see additional opportunities to drive profitability throughout 2009 by improving our sales execution, increasing margins and optimizing our cost structure. We are confident that we have the right organizational alignment and strategic programs in place to position us for future success.”
An investor presentation summarizing the company’s fourth quarter 2008 results is available at http://ir.ev3.net.
Outlook
ev3 expects fiscal year 2009 net sales to be in the range of $415 to $430 million compared to $402.2 million of product sales in 2008. Net product sales growth on a constant currency basis is expected to be approximately 7% to 10%. Foreign currency exchange rate fluctuations are expected to negatively impact revenue growth by 3% to 4% in 2009. ev3 expects non-GAAP adjusted earnings per share to be in the range of $0.38 to $0.44 per diluted share, an increase of $0.29 to $0.35 over 2008, based on approximately 105.5 million of outstanding shares. ev3’s adjusted net earnings per share guidance excludes estimated amortization expense of approximately $21.8 million and non-cash stock-based compensation of approximately $13.4 million.
The company expects first quarter 2009 net sales to be in the range of $95 to $99 million compared to $95.1 million of net product sales in the first quarter of 2008 and non-GAAP adjusted net earnings per share to be in the range of $(0.03) to $0.00 per diluted share, based on approximately 105.2 million of outstanding shares. ev3’s non-GAAP adjusted net earnings per share excludes estimated amortization expense of approximately $5.9 million and non-cash stock-based compensation of approximately $3.3 million.
Earnings Call Information
ev3 will host a conference call today, February 24, 2009, beginning at 7:30 a.m. Central Time (8:30 a.m. Eastern Time) to review its results of operations for the fourth quarter and full-year of 2008 and future outlook, followed by a question and answer session.
The conference call will be available to interested parties through a live audio webcast at http://ir.ev3.net, where it will be archived and accessible for approximately 12 months. The live dial-in number for the call is 888-679-8034 (U.S.) or 617-213-4847 (International). The participant passcode is 49792760.
If you do not have access to the Internet and want to listen to an audio replay of the conference call, dial 888-286-8010 (U.S.) or 617-801-6888 (International) and enter passcode 62987548. The audio replay will be available beginning at 9:30 a.m. Central Time on Tuesday, February 24, 2009 until Tuesday, March 3, 2009.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of peripheral vascular and neurovascular diseases. ev3’s products are used by endovascular specialists to treat a wide range of peripheral vascular and neurovascular diseases and disorders. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today - peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at www.ev3.net.
ev3, the ev3 logo, FoxHollow, Axium and Onyx are trademarks of ev3 Inc., registered in the U.S. and other countries. All trademarks and trade names referred to in this press release are the property of their respective owners.
Forward-Looking Statements
Statements contained in this press release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as “expect,” “anticipate,” “intend,” “will,” “may,” “believe,” “could,” “continue,” “future,” “estimate,” “outlook,” “guidance,” or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause ev3’s actual results to be materially different than those expressed in or implied by ev3’s forward-looking statements. For ev3, particular uncertainties and risks include, among others, ev3’s future operating results and financial performance, fluctuations in foreign currency exchange rates, the effect of the current global economic crisis, ev3’s ability to implement, fund and achieve sustainable cost savings measures that will better align its operating expenses with its anticipated net sales levels and reallocate resources to better support growth initiatives, the timing of regulatory approvals and introduction of new products, market acceptance of new products, success of clinical testing, availability of third party reimbursement, impact of competitive products and pricing and effect of regulatory actions. More detailed information on these and additional factors that could affect ev3’s actual results are described in ev3’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Except as required by law, ev3 undertakes no obligation to update publicly its forward-looking statements.
Use of Non-GAAP Financial Measures
To supplement ev3’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), ev3 uses certain non-GAAP financial measures in this release. Reconciliations of the non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found in tables later in this release immediately following the detail of net sales by geography. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for ev3’s financial results prepared in accordance with GAAP.
ev3 Inc.
NON-GAAP FINANCIAL MEASURES
To supplement ev3’s consolidated financial statements prepared in accordance with GAAP, ev3 uses certain non-GAAP financial measures in this release. These non-GAAP financial measures include “U.S. net sales, excluding research collaboration revenues,” “non-GAAP adjusted net income (loss),” “non-GAAP adjusted net earnings (loss) per share,” “estimated non-GAAP adjusted net product sales on a constant currency basis,” and “estimated non-GAAP adjusted net earnings (loss) per share.”
Reconciliations of the non-GAAP financial measures used in this release to the most comparable U.S. GAAP measures for the respective periods can be found in the tables below. In addition, an explanation of the manner in which ev3’s management uses these non-GAAP measures to conduct and evaluate its business, the economic substance behind management’s decision to use these non-GAAP measures, the substantive reasons why management believes that these non-GAAP measures provide useful information to investors, the material limitations associated with the use of these non-GAAP measures and the manner in which management compensates for those limitations is included following the reconciliation tables below.
Use and Economic Substance of Non-GAAP Financial Measures Used by ev3 and Usefulness of Such Non-GAAP Financial Measures to Investors
ev3 uses the non-GAAP financial measures described above as supplemental measures of performance and believes these measures facilitate operating performance comparisons from period to period and company to company by factoring out potential differences caused by acquisitions, dispositions, non-recurring, unusual or infrequent charges not related to ev3’s regular, ongoing business, variations in capital structure, tax positions, depreciation, non-cash charges and certain large and unpredictable charges. ev3’s management uses the non-GAAP financial measures used in this release to analyze the underlying trends in ev3’s business, assess the performance of ev3’s core operations, establish operational goals and forecasts that are used in allocating resources and evaluate ev3’s performance period over period and in relation to its competitors’ operating results. Additionally, ev3’s management is evaluated on the basis of some of these non-GAAP financial measures when determining achievement of their incentive compensation performance targets.
ev3 believes that presenting the non-GAAP financial measures used in this release provides investors greater transparency to the information used by ev3’s management for its financial and operational decision-making and allows investors to see ev3’s results “through the eyes” of management. ev3 also believes that providing this information better enables ev3’s investors to understand ev3’s operating performance and evaluate the methodology used by ev3’s management to evaluate and measure such performance. ev3’s management believes that non-GAAP financial measures are useful to investors to evaluate ev3’s performance period over period and in relation to its competitors’ operating results. Because ev3 historically has reported some of these non-GAAP results to the investment community, management also believes that the disclosure of these non-GAAP measures provides consistency in ev3’s financial reporting and facilitates investors’ understanding of ev3’s historic operating trends by providing an additional basis for comparisons to prior periods.
The following is an explanation of each of the items that management excluded from one or more of the non-GAAP financial measures used in this release and the reasons for excluding each of these individual items:
Material Limitations Associated with the Use of Non-GAAP Financial Measures and Manner in which ev3 Compensates for these Limitations
Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for ev3’s financial results prepared in accordance with GAAP. Some of the limitations associated with ev3’s use of these non-GAAP financial measures are:
ev3 compensates for these limitations by relying primarily upon its GAAP results and using non-GAAP financial measures only supplementally. ev3 provides full disclosure of each non-GAAP financial measure ev3 uses and detailed reconciliations of each non-GAAP measure to its most directly comparable GAAP measure. ev3 encourages investors to review these reconciliations. ev3 qualifies its use of non-GAAP financial measures with cautionary statements as to their limitations.
CONTACT: Julie Tracy, Sr. Vice President, Chief Communications Officer of
ev3 Inc., +1-949-680-1375, jtracy@ev3.net
Web site: http://www.ev3.net/
