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Ev3 Inc. 8-K (Events or Changes Between Quarterly Reports) 2009-02-24
Ev3 Inc. 8-K (Events or Changes Between Quarterly Reports) 2009-02-24
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
ev3 Inc.
(Exact name of registrant as specified in its charter)
(763) 398-7000
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
ev3 Inc.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
99.2 Presentation materials posted on the Investor Relations section of www.ev3.net Furnished herewith
Exhibit 99.1
CONTACT INFORMATION:
(EV3 LOGO)
INVESTORS and MEDIA:
Julie Tracy
Sr. Vice President, Chief Communications Officer
ev3 Inc.
(949) 680-1375
jtracy@ev3.net
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
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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.
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.
ev3 Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars in thousands, except per share amounts)
(unaudited)
Operating expenses
Product cost of goods sold (a) 34,405 33,963 136,847 99,879
Research collaboration 404 1,065 6,051 1,065
Sales, general and administrative (a) 53,188 69,895 231,957 195,267
Research and development (a) 10,871 18,949 48,784 48,413
Amortization of intangible assets 6,787 8,390 31,072 20,306
Goodwill and other intangible asset impairment 288,804 — 299,263 —
Loss (gain) on sale or disposal of assets, net 127 10 243 (978)
Acquired in-process research and development — 70,700 — 70,700
Special charges — (1,129) — 19,054
Total operating expenses 394,586 201,843 754,217 453,706
ev3 Inc.
CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except per share amounts)
De ce m be r 31, De ce m be r 31,
2008 2007
(un au dite d)
Assets
Current assets
Cash and cash equivalents $ 59,652 $ 81,060
Short-term investments — 9,744
Accounts receivable, less allowance of $8,098 and $6,783, respectively 72,814 66,170
Inventories 47,687 64,044
Prepaid expenses and other assets 6,005 6,371
Other receivables 965 981
Total current assets 187,123 228,370
Stockholders’ equity
Preferred stock, $0.01 par value, 100,000,000 shares authorized, none issued and outstanding as of
December 31, 2008 and 2007 — —
Common stock, $0.01 par value, 300,000,000 shares authorized, shares issued and outstanding:
105,822,444 shares as of December 31, 2008 and 105,078,769 shares as of December 31, 2007 1,058 1,051
Additional paid in capital 1,756,832 1,739,064
Accumulated deficit (1,116,661) (781,039)
Accumulated other comprehensive loss (688) (595)
Total stockholders’ equity 640,541 958,481
Total liabilities and stockholders’ equity $ 720,664 $ 1,087,106
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ev3 Inc.
SELECTED NET SALES INFORMATION
(Dollars in thousands)
(unaudited)
Neurovascular
Embolic products 21,173 15,552 36% 74,642 56,003 33%
Neuro access and
delivery products 16,343 12,779 28% 57,662 48,448 19%
Total neurovascular 37,516 28,331 32% 132,304 104,451 27%
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.
ev3 Inc.
RECONCILIATION OF U.S. NET SALES TO
NON-GAAP U.S. NET SALES, EXCLUDING RESEARCH COLLABORATION REVENUES
(Dollars in thousands)
(unaudited)
ev3 Inc.
RECONCILIATION OF NET LOSS TO
NON-GAAP ADJUSTED NET INCOME (LOSS)
(Dollars in thousands)
(unaudited)
ev3 Inc.
RECONCILIATION OF NET LOSS PER COMMON SHARE TO
NON-GAAP ADJUSTED NET EARNINGS (LOSS) PER SHARE
(Dollars in thousands)
(unaudited)
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Non-GAAP adjusted net earnings (loss) per diluted share $ 0.08 $ (0.25) $ 0.09 $ (0.91)
Weighted average diluted shares outstanding 104,699,429 101,864,573 104,668,326 69,909,708
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ev3 Inc.
RECONCILIATION OF NET SALES TO
ESTIMATED NON-GAAP ADJUSTED NET PRODUCT SALES ON A CONSTANT CURRENCY BASIS
(Dollars in thousands)
(unaudited)
ev3 Inc.
RECONCILIATION OF ESTIMATED NET EARNINGS (LOSS) PER SHARE TO
ESTIMATED NON-GAAP ADJUSTED NET EARNINGS (LOSS) PER SHARE
(Dollars in thousands)
(unaudited)
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:
• Foreign exchange impact and estimated foreign exchange impact. The impact of foreign exchange rates is highly variable and
difficult to predict. The foreign exchange impact is the impact from foreign exchange rates on current period sales compared to prior
period sales using the prior period’s foreign exchange rates. Estimated foreign exchange impact is the estimated impact of foreign
exchange rates on future net sales compared to current period net sales using estimated future period foreign exchange rates. ev3’s
management believes that in order to properly understand the underlying business trends and performance of ev3’s ongoing
operations, management has found and investors may find it useful to consider the impact of excluding changes in foreign exchange
rates from ev3’s net sales.
• Research collaboration revenue. In the fourth quarter 2007, ev3 acquired FoxHollow Technologies, Inc. (FoxHollow). As a result of
ev3’s FoxHollow acquisition, ev3 was engaged in a research collaboration with Merck & Co., Inc. (Merck). Prior to ev3’s acquisition
of FoxHollow, ev3 did not recognize any research collaboration revenue. This research collaboration was terminated by Merck
effective in July 2008. ev3’s management believes that in order to properly understand underlying business trends in and performance
of ev3’s ongoing operations, management has found and investors may find it useful to consider the impact of excluding research
collaboration revenue from ev3’s net sales.
• Acquired in-process research and development. In the fourth quarter 2007, in connection with the acquisition of FoxHollow, ev3
acquired $70.7 million of in-process research and development projects that had not yet reached technological feasibility and had no
future alternative use. ev3’s management believes that excluding this item from ev3’s non-GAAP results is useful to investors to
understand ev3’s operational performance.
• Goodwill and other intangible asset impairment. In the fourth quarter 2008, ev3 recorded non-cash, asset impairment charges of
$288.8 million to reduce the carrying values of goodwill and other intangible assets, primarily associated with prior acquisitions, to
their estimated fair values. During the second quarter 2008, as a result of the termination of ev3’s research collaboration with Merck,
ev3 recorded an asset impairment charge of $10.5 million to write-off the remaining carrying value of the related Merck intangible asset
that was established at the time of ev3’s acquisition of FoxHollow. In addition to disclosing net income that is determined in
accordance with GAAP, ev3’s management believes that in order to properly understand the underlying business trends and
performance of ev3’s ongoing operations, management has found and investors may find it useful to consider the impact of excluding
the $288.8 million impairment charges
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related to reduce the carrying values of goodwill and other intangible assets recorded by ev3 in the fourth quarter 2008 and the
$10.5 million research collaboration asset impairment charge recorded by ev3 in second quarter 2008.
• Non-cash stock-based compensation. ev3 excludes stock-based compensation expense from its non-GAAP financial measures
primarily because such expense, while constituting an ongoing and recurring expense, is not an expense that requires cash settlement
and is not used by ev3’s management to assess the core profitability of ev3’s business operations. ev3’s management also believes
that excluding this item from ev3’s non-GAAP results is useful to investors to understand the application of SFAS 123R and its
impact on ev3’s operational performance, liquidity and its ability to invest in research and development and fund acquisitions and
capital expenditures and it allows for greater transparency to certain line items in ev3’s financial statements.
• Amortization expense. ev3 excludes amortization expense from its non-GAAP financial measures primarily because such expense,
while constituting an ongoing and recurring expense, is not an expense that requires cash settlement and is not used by ev3’s
management to assess the core profitability of ev3’s business operations. ev3’s management also believes that excluding this item
from ev3’s non-GAAP results is useful to investors to understand ev3’s operational performance, liquidity and its ability to invest in
research and development and fund acquisitions and capital expenditures.
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:
• Items such as amortization expense and stock-based compensation do not directly affect ev3’s cash flow position; however, such
items reflect economic costs to ev3 and are not reflected in ev3’s “non-GAAP adjusted net income (loss)” or “non-GAAP adjusted
net earnings (loss) per share,” and therefore these non-GAAP measures do not reflect the full economic effect of these items.
• Items such as goodwill and other intangible asset impairment do not directly affect ev3’s cash flow position; however, such items
represent a reduction in value of ev3’s assets. The expense associated with this reduction in value is not included in ev3’s “non-
GAAP adjusted net income (loss)” or “non-GAAP adjusted net earnings (loss) per share,” and therefore these non-GAAP measures
do not reflect the full economic effect of the reduction in value of these assets.
• Non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles and therefore other
companies may calculate similarly titled non-GAAP financial measures differently than ev3, limiting the usefulness of those measures
for comparative purposes.
• ev3’s management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP
financial measures ev3 uses.
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.
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Exhibit 99.2
F o r wa r d - L o o k i n g S t a t e m e n t s S t a t e m e n t s c o n t a i n e d i n t h i s p r e s e n t a t i o n t h a t r e l a t e t o f u t u r e , n o t p a s t , e v e n t s a r e f o r wa r d - l o o k i n g s t a t e m e n t s u n d e r t h e P r i v a t e S e c u r i t i e s L i t i g a t i o n Re f o r m Ac t o f 1 9 9 5 . F o r wa r d - l o o k i n g s t a t e m e n t s o f t e n c a n b e i d e n t i f i e d b y wo r d s s u c h a s " e x p e c t , " " a n t i c i p a t e , " " e s t i m a t e s , " " i n t e n d , " " wi l l , " " m a y , " " b e l i e v e , " " c o u l d , " " c o n t i n u e , " " f u t u r e , " " o u t l o o k , " " g u i d a n c e , " t h e n e g a t i v e o f t h e s e wo r d s o r o t h e r wo r d s o f s i m i l a r m e a n i n g a n d t h e u s e o f f u t u r e d a t e s . F o r wa r d - l o o k i n g s t a t e m e n t s b y t h e i r n a t u r e a d d r e s s m a t t e r s t h a t a r e , t o d i f f e r e n t d e g r e e s , u n c e r t a i n . Un c e r t a i n t i e s a n d r i s k s m a y c a u s e e v 3 's a c t u a l r e s u l t s t o be m at er i al l y
d i f f e r e n t t h a n t h o s e e x p r e s s e d i n o r i m p l i e d b y e v 3 's f o r wa r d - l o o k i n g s t a t e m e n t s . F o r e v 3 , p a r t i c u l a r u n c e r t a i n t i e s a n d r i s k s i n c l u d e , a m o n g o t h e r s , e v 3 's f u t u r e o p e r a t i n g r e s u l t s a n d f i n a n c i a l p e r f o r m a n c e , f l u c t u a t i o n s i n f o r e i g n c u r r e n c y e x c h a n g e r a t e s , e v 3 's a b i l i t y t o i m p l e m e n t , f u n d a n d a c h i e v e s u s t a i n a b l e c o s t s a v i n g s m e a s u r e s t h a t wi l l b e t t e r a l i g n i t s o p e r a t i n g e x p e n s e s wi t h i t s a n t i c i p a t e d n e t s a l e s l e v e l s a n d r e a l l o c a t e r e s o u r c e s t o b e t t e r s u p p o r t g r o wt h i n i t i a t i v e s , t h e e f f e c t o f t h e c u r r e n t g l o b a l e c o n o m i c c r i s i s , t h e t i m i n g o f r e g u l a t o r y a p p r o v a l s a n d i n t r o d u c t i o n o f n e w p r o d u c t s , m a r k e t a c c e p t a n c e o f n e w p r o d u c t s , s u c c e s s o f cl i ni cal t es t i ng,
a v a i l a b i l i t y o f t h i r d p a r t y r e i m b u r s e m e n t , i m p a c t o f c o m p e t i t i v e p r o d u c t s a n d p r i c i n g a n d c h a n g e s i n t h e r e g u l a t o r y e n v i r o n m e n t . M o r e d e t a i l e d i n f o r m a t i o n o n t h e s e a n d a d d i t i o n a l f a c t o r s t h a t c o u l d a f f e c t e v 3 's a c t u a l r e s u l t s a r e d e s c r i b e d i n e v 3 's f i l i n g s wi t h t h e S e c u r i t i e s a n d E x c h a n g e Co m m i s s i o n , i n c l u d i n g i t s m o s t r e c e n t a n n u a l r e p o r t o n F o r m 1 0 - K a n d s u b s e q u e n t q u a r t e r l y r e p o r t s o n F o r m 1 0 - Q. E x c e p t a s r e q u i r e d b y l a w, e v 3 u n d e r t a k e s n o o b l i g a t i o n t o u p d a t e p u b l i c l y i t s f o r wa r d - l o o k i n g s t a t e m e n t s .
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Us e o f No n - GAAP F i n a n c i a l M e a s u r e s e v 3 u s e s c e r t a i n n o n - GAAP f i n a n c i a l m eas ur es i n t h i s p r e s e n t a t i o n , i n c l u d i n g " n o n - GAAP a d j u s t e d n e t i n c o m e ( l os s ) , " " n o n - GAAP a d j u s t e d n e t e a r n i n g s ( l o s s ) p e r s h a r e , " " n e t s a l e s , e x c l u d i n g a t h e r e c t o m y and r es ear ch col l abor at i on r evenues , " and " per i pher al vas cul ar net s al es , excl udi ng at her ect om y. " ev3 u s e s n o n - GAAP f i n a n c i a l m e a s u r e s a s s u p p l e m e n t a l m e a s u r e s o f p e r f o r m a n c e a n d b e l i e v e s t h e s e m e a s u r e s pr ovi de us ef ul i nf or m at i on t o i nves t or s i n eval uat i ng our oper at i ons , per i od over per i od. Ho we v e r , n o n - GAAP f i n a n c i a l m eas ur es have l i m i t at i ons as anal yt i cal t ool s , and s houl d not be cons i der ed i n i s ol at i on or as a
s u b s t i t u t e f o r e v 3 's f i n a n c i a l r e s u l t s p r e p a r e d i n a c c o r d a n c e wi t h GAAP . I n addi t i on, i n v e s t o r s s h o u l d n o t e t h a t a n y n o n - GAAP f i n a n c i a l m e a s u r e s ev3 us es m a y n o t b e t h e s a m e n o n - GAAP f i n a n c i a l m e a s u r e s , a n d m a y n o t b e c a l c u l a t e d i n t h e s am e m anner , as t hat of ot her com pani es . W e have pos t ed a r econci l i at i on of our n o n - GAAP f i n a n c i a l m e a s u r e s t o t h e m o s t d i r e c t l y c o m p a r a b l e GAAP f i n a n c i a l m e a s u r e s o n o u r we b s i t e a t www. e v 3 . n e t .
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Ac t u a l Re s u l t s v s . L a s t Qu a r t e r & Ye a r Ag o * F o u r t h q u a r t e r 2 0 0 7 e x c l u d e s F o x Ho l l o w a t h e r e c t o m y s a l e s o f a p p r o x i m a t e l y $ 3 . 9 m i l l i o n f o r t h e f i r s t f o u r d a y s o f t h e q u a r t e r p r i o r t o t h e c o m p l e t i o n o f t h e m e r g e r . * * Al l q u a r t e r s p r e s e n t e d a r e a d j u s t e d f o r a m o r t i z a t i o n a n d n o n - c a s h s t o c k - b a s e d c o m p e n s a t i o n . Q4 2 0 0 8 a n d Q4 2 0 0 7 a r e a l s o a d j u s t e d f o r n o n - c a s h g o o d wi l l a n d o t h e r i n t a n g i b l e a s s e t i m p a i r m e n t c h a r g e s a n d a c q u i r e d I P R& D, r e s p e c t i v e l y . F o r a r econci l i at i on, see o u r we b s i t e a t www. e v 3 . n e t . Q3 2 0 0 8 Ac t u a l Q4 2 0 0 7 Ac t u a l $ 0 0 0 's except E P S Ne t pr oduct sal es Gr o s s pr of i t Gr o s s m ar gi n Ne t Lo s s Ea r n i n g s ( l os s ) per s har e Ad j u s t e d net i ncom e ( l os s ) ** Ad j u s t e d
net ear ni ngs ( l os s ) per s har e** $86, 271 $57, 200 62. 0% $( 107, 867) $( 1. 06) $ ( 2 4 , 9 7 9 ) $ ( 0 . 2 5 ) $ 1 0 0 , 0 1 8 $ 6 8 , 7 4 7 6 4 . 2 % $ 3 , 8 5 0 $ 0 . 0 4 Q4 2 0 0 8 Ac t u a l $ 1 0 5 , 6 5 6 $ ( 2 9 1 , 1 2 0 ) $ ( 2 . 7 8 ) $ 7 , 9 4 8 $ 0 . 0 8 $ 7 1 , 3 1 6 6 7 . 2 % P e r i p h e r a l v a s c u l a r ( P V) P V, e x c l u d i n g a t h e r e c t o m y At h e r e c t o m y * Ne u r o v a s c u l a r ( NV) I n t e r n a t i o n a l Re s e a r c h c o l l a b o r a t i o n % Ch g S e q . % Ch g YOY $ 4 7 , 9 6 4 $20, 176 $37, 516 $39, 465 $469 $45, 894 $20, 992 $33, 132 $36, 577 $7, 011 $37, 056 $20, 884 $28, 331 $28, 058 $5, 957 5% - - 4% 13% 8% NA 2 9 % NA 3 2 % 4 1 % NA 6 % 22% 4% 25% $( 7, 310) $( 0. 07)
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To t a l Q4 '0 8 Re v e n u e Gr o wt h of 15% Q1 Q2 Q3 Q4 Q4 Ea s t 101. 3 107. 7 107 92. 2 106. 1 To t a l W o r l d wi d e ev3 ( $M ) +1 5 % Q1 Q2 Q3 Q4 Q4 Ea s t 34. 8 35. 9 36. 6 28 39. 4 To t a l I nt er nat i onal ( $M ) +4 1 % Q1 Q2 Q3 Q4 Q4 Ea s t 64. 1 70. 8 66. 9 57. 9 68. 1 W o r l d wi d e Pe r i phe r a l Va s c u l a r ( $M ) +1 8 % Q1 Q2 Q3 Q4 Q4 Ea s t 31 30. 7 33. 1 28. 3 37. 5 W o r l d wi d e Ne u r o v a s c u l a r ( $M ) +3 2 % Q4 Q4 Q4 Q4 2007 2008
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Q1 Q2 Q3 Q4 Ea s t 57 38. 7 45. 9 59. 7 2008 Ba l a n c e She e t i s St r e ngt he ni ng Ca s h / Ca s h Eq u i v a l e n t s Ca s h / c a s h equi val ent s i ncr eas ed $13. 7M Q4 '0 8 vs Q3 '0 8 I nvent or y days d o wn 11% i n Q4 '0 8 vs Q3 '0 8 To t a l debt i s m i ni m al at $9. 0M 7
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Fi na nc i a l Sum m a r y: Co n t i n u i n g t o I m p r o v e P e r f o r m a n c e Ne t P r o d u c t S a l e s * $ 8 6 , 2 7 1 $ 9 5 , 0 5 0 $ 1 0 1 , 5 0 9 $ 1 0 0 , 0 1 8 $ 1 0 5 , 6 5 6 Gr o s s P r o f i t $ 5 7 , 2 0 0 $ 6 7 , 6 3 9 $ 7 1 , 5 2 8 $ 6 8 , 7 4 7 $ 7 1 , 3 1 6 Gr o s s M a r g i n 6 2 . 0 % 6 6 . 8 % 6 6 . 4 % 6 4 . 2 % 6 7 . 2 % Ne t L o s s $( 107, 867) $( 9, 770) $( 27, 422) $( 7, 310) $ ( 2 9 1 , 1 2 0 ) Ad j u s t e d n e t E P S ( l o s s ) per di l ut ed s har e* $( 0. 25) $0. 03 $( 0. 05) $0. 04 $0. 08 GAAP E P S ( l o s s ) $( 1. 06) $( 0. 09) $( 0. 26) $( 0. 07) $( 2. 78) Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 $ 0 0 0 's except EP S * Ex c l u d i n g M er ck r esear ch col l abor at i on r evenue of $6M f or Q4 0 7 , $6M f or Q1 0 8 , $6M f or Q2 0 8 , $7M f or Q3 0 8 and $469K f or Q4 0 8 . * * Al l quar t er s pr es ent ed ar e adj us t ed f or am or t i zat i on and non- cas h s t ock-
bas ed com pens at i on. Q4 2 0 0 7 i s a l s o a d j u s t e d f o r a c q u i r e d I P R& D. Q2 2 0 0 8 a n d Q4 2 0 0 8 a r e a l s o a d j u s t e d f o r n o n - c a s h g o o d wi l l a n d o t h e r i n t a n g i b l e a s s e t i m p a i r m e n t c h a r g e s . F o r a r e c o n c i l i a t i o n , s e e o u r we b s i t e a t www. e v 3 . n e t . Ad j u s t e d n e t i n c o m e ( l o s s ) * $ ( 2 4 , 9 7 9 ) $3, 204 $( 5, 130) $3, 850 $7, 948
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Gu i d a n c e - As o f F e b r u a r y 2 4 , 2 0 0 9 E x p e c t F u l l - Ye a r 2009 Pos i t i ve GAAP E P S Re v e n u e s : Q1 2009: $95 t o $99 m i l l i on F u l l - Ye a r 2009: $415 t o $430 m i l l i on Ad j u s t e d EP S ( l o s s ) 1 per di l ut ed s har e: Q1 2009: $( 0. 03) t o $0. 001, 2 F u l l - Ye a r 2009: $0. 38 t o $0. 441, 2 Ad j u s t e d EP S ( l o s s ) gui dance i s bas ed on we i g h t e d aver age di l ut ed s har es out s t andi ng of appr oxi m at el y 105. 2 and 105. 5 m i l l i on f or Q1 0 9 and f ul l - year 2009, r es pect i vel y, and i s adj us t ed t o excl ude t he i m pact of am or t i zat i on expens e and non- cas h s t ock- bas ed com pens at i on. Th e s e ar e f o r wa r d - l o o k i n g n o n - GAAP f i n a n c i a l m eas ur es . For a r econci l i at i on, see our we b s i t e at www. e v 3 . n e t . Q1 0 9 GAAP E P S ( l o s s ) : $( 0. 12) t o
$( 0. 09) ; F u l l - Ye a r 2 0 0 9 GAAP E P S : $ 0 . 0 4 t o $ 0 . 1 0 9
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2008 % of s al es 2007 2009 Go a l Bu s i n e s s M o d e l S t r u c t u r e - S e l e c t P & L I n f o r m a t i o n Sa l e s 100% 100% 100% Gr o s s m ar gi n 66% 65% 70% Se l l i ng, gener al & adm i ni s t r at i ve 55% 69% 49% Ta x e s 0. 4% 0. 3% 1% Re s e a r c h & devel opm ent 12% 17% 12% St oc k- ba s e d com p & am or t i zat i on 11% 11% 9% Ad j u s t e d net i ncom e ( l os s ) * 2. 3% ( 22. 4% ) 10% * Ad j u s t e d net i ncom e ( l os s ) excl udes am or t i zat i on and non- cas h s t ock- bas ed com pens at i on. For t he year ended De c e m b e r 31, 2007, Ad j u s t e d net i ncom e ( l os s ) al so excl udes $70. 7M of Ac q u i r e d I P R& D. For t he year ended De c e m b e r 31, 2008, Ad j u s t e d net i ncl udes ( l os s ) al so excl udes non- cas h g o o d wi l l and ot her i nt angi bl e
as s et i m pai r m ent char ges o f $ 2 9 9 . 3 M . T h e s e a r e n o n - GAAP f i n a n c i a l m e a s u r e s . 1 0
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P a t h wa y t o Pr of i t a bl e Gr o wt h Lo n g - t e r m pr of i t abl e r evenue g r o wt h I m pr ove cos t s t r uct ur e I ncr eas e sal es f or ce pr oduct i vi t y Gr o w i n t e r n a t i o n a l sal es Cl i n i c a l evi dence Ne w p r o d u c t s 1 2 3 4 5
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1. I m pr ove Co s t St r uc t ur e - Co n t i n u i n g Pr ogr e s s Q4 07 Q4 08 Ea s t 0. 76 0. 5 S G& A % of sal es R& D % of sal es Q4 07 Q4 08 Ea s t 0. 21 0. 1 Ad d i t i o n a l r educt i ons i n COGS a n d S G& A p l a n n e d i n 2009 Co n t i n u e d f ocus on i m pr ovi ng m ar gi ns 12
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An n u a l i z e d Ne t Sa l e s Pe r Te r r i t o r y Q4 '0 8 up 15% vs . Q4 '0 7 Ke y Dr i v e r s At h e r e c t o m y Cl i n i c a l Spe c i a l i s t s Co r p o r a t e Ac c o u n t penet r at i on Re f e r r a l M ar ket devel opm ent DE F I NI T I VE c l i n i c a l dat a Ne u r o bus i nes s al r eady > $2M per t er r i t or y 13 Q4 '0 7 Q2 '0 8 Q4 '0 8 Go a l Ea s t 1. 3 1. 5 1. 5 2 2. I ncr eas e Pe r i phe r a l Va s c u l a r Sa l e s For c e Pr oduc t i vi t y i n U. S .
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2003 2004 2005 2006 2007 2008 Ea s t 30 44 62 81 107 147 3. Co n t i n u e St r ong M om ent um i n I nt er nat i onal * Tr a n s l a t e d t o U. S . Do l l a r s at t he appl i cabl e or est i m at ed f or ei gn exchange r at e f or t he per i ods pr es ent ed 14 I nt er nat i onal Re v e n u e * ( $M ) 37% CAGR
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4 . Br o a d Cl i n i c a l T r i a l I n i t i a t i v e s t o S u p p o r t P r o c e d u r e Ad o p t i o n De s i g n e d t o e x p a n d c l i n i c a l e v i d e n c e , s u p p o r t r e g u l a t o r y c l e a r a n c e s a n d e x p a n d p r o d u c t i n d i c a t i o n s Cl i n i c a l Na m e Cl i n i c a l T r i a l De s c r i p t i o n S t u d y T i m e l i n e S W I F T I s c h e m i c s t r oke f l ow r es t or at i on; S a f e t y : De v i c e - r e l a t e d a n d p r o c e d u r e - r e l a t e d s e r i o u s a d v e r s e e v e n t s ; E f f i c a c y : Re v a s c u l a r i z a t i o n m e a s u r e d b y T I M I s c o r e o f 2 o r 3. Be g i n n i n g 2 H 2 0 0 9 1 5 RACE R P o s t - a p p r o v a l s t u d y f o r Ax i u m ( t m ) t o g e n e r a t e c l i n i c a l d a t a . Al s o m ay be us ed f or J apan s ubm i s s i on. En r o l l i n g Cl i n i c a l Na m e Cl i n i c a l Tr i a l De s c r i p t i o n St udy Ti m e l i n e CRE AT E P AS P o s t - a p p r o v a l s t udy f or P ROT E GE ( r ) RX a n d Spi de r FX i n car ot i d
a r t e r i e s . E n r o l l i n g Ne u r o v a s c u l a r Di v i s i o n P e r i p h e r a l Va s c u l a r Di v i s i o n DURABI L I T Y I I I DE s t u d y o f s i n g l e P ROT E GE ( r ) E v e r F l e x ( t m ) S t e n t ( 2 0 - 2 0 0 m m ) i n l o n g S F A l e s i o n s ( 4 - 1 8 c m ) . E n r o l l i n g DE F I NI T I VE ( t m ) Ca + + T o e v a l u a t e S i l v e r Ha wk ( r ) a n d S p i d e r F X( t m ) i n t h e t r e a t m e n t o f l o we r e x t r e m i t y ( S F A/ P o p l i t e a l ) c a l c i f i e d l e s i o n s . E n r o l l i n g DE F I NI T I VE ( t m ) L E P o s t - m a r k e t n o n - r a n d o m i z e d s t u d y of S i l v e r Ha wk ( r ) i n t h e t r eat m ent of f em or opopl i t eal and t i bi al a r t e r i e s . Be g i n n i n g 1 H 2 0 0 9
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'0 7 A '0 8 A '0 9 E E a s t 278 402 430 $278M $402M ~$415- $430M 5. Ne w P r o d u c t s Dr i v i n g Gr o wt h Ke y Dr i v e r s Pr oduc t Re v e n u e Gr o wt h * Gl o b a l P T A Ba l l o o n La u n c h E v e r Cr o s s ( t m ) . 035 Na n o Cr o s s ( t m ) . 014 . . 018 P T A Ba l l o o n i n 2 H '0 9 Ex p a n d e d At h e r e c t o m y To o l k i t Ro c k Ha wk ( t m ) and T u r b o Ha wk ( t m ) P o we r Cr o s s Gu i d e wi r e Suppor t Ca t h e t e r ( chr oni c t ot al occl us i ons ) Pe ne t r a t i on of AXI UM Co i l i n g Sys t e m P GL A a n d Ny l o n i n 1 H '0 9 Ap o l l o De l i v e r y Ca t h e t e r f or On y x Ad d i t i o n a l Ne u r o Ac c e s s Pr oduc t s Sol i t a i r e ( t m ) s t ent pl at f or m f or An e u r y s m Br i d g i n g * Ex c l u d i n g M er ck r esear ch col l abor at i on r evenue of $6. 0M f or 2007 and $19. 9M f or 2008
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Up c o m i n g Pr oduc t La u n c h : Ne w AXI UM ( t m ) M i cr of i l am ent Co i l Sys t e m s En h a n c e d m i cr of i l am ent t echnol ogy cr eat es l at t i ce ef f ect enabl i ng i ncr eas ed acut e occl us i on and packi ng vol um e De s i g n e d t o accel er at e acut e and l ong- t er m heal i ng T wo m i cr of i l am ent ver s i ons : Ax i u m P GL A c o - p o l y m e r and Ax i u m Ny l o n An t i c i p a t e U. S . and Eu r o p e a n l aunch i n 1 H '0 9 Ny l o n P GL A
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Ne x t Ge n e r a t i o n P T A Ba l l o o n s : E v e r Cr o s s . 035 and Na n o Cr o s s . 014 I nnovat i ve bevel ed t i p pr of i l es f or bes t - i n- cl as s l es i on ent r y Br o a d r ange of si zes, i ncl udi ng onl y 200m m l engt h . 035 bal l oon avai l abl e wo r l d wi d e Ac c e s s t o key m ar ket s wi t h s i gni f i cant l y i m pr oved m ar gi ns Ful l gl obal l aunch i n pr ogr es s E v e r Cr o s s Cr o s s T e c ( t m ) Ti p Na n o Cr o s s Be v e l 360° ( t m ) Ti p 18
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W hy I nves t i n ev3 I N S U M M A R Y 19 Br o a d e s t pr oduct of f er i ng i n $ 2 B g r o wi n g gl obal m ar ket l ar ges t pur e- pl ay i n endovas cul ar m ar ket Cl e a r r oadm ap f or s us t ai ned, pr of i t abl e g r o wt h i m pr oved cos t s , pr oduct i vi t y, cl i ni cal evi dence, new pr oduct s Co m p a n y r ef ocus ed i n 2008 t o achi eve f ut ur e pr of i t abi l i t y com pl et ed F o x Ho l l o w i n t e g r a t i o n , devel oped s har per f ocus
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