Full-Year 2009 Revenue and Earnings Guidance Increased
Constant Currency Second Quarter Net Product Sales
Increase 12% to $109.1 million
GAAP Profitability Achieved
Operating Cash Flow of $20.0 million for the Second Quarter
PLYMOUTH, Minn., July 28, 2009 (GLOBE NEWSWIRE) -- ev3 Inc. (Nasdaq:EVVV), a global endovascular device company, today reported financial results for its fiscal second quarter and increased 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 totaled $109.1 million in the second quarter of 2009 versus $107.7 million in the same quarter of the prior year. Second quarter of 2008 net sales included $6.2 million of research collaboration revenues from our former agreement with Merck, which was terminated on July 22, 2008. Second quarter of 2009 net product sales of $109.1 million increased approximately 7% versus the prior year product sales. Excluding approximately $4.5 million of negative impact due to foreign currency exchange rates, net product sales increased 12% versus the prior year quarter.
ev3's GAAP net income for the second quarter of 2009 was $24.0 million, including a tax benefit of $19.0 million resulting from the purchase accounting for the acquisition of Chestnut Medical Technologies, Inc., compared to a net loss of $(27.4) million in the second quarter of 2008. ev3's net earnings per common share for the second quarter of 2009 was $0.23 including $0.18 of tax benefit compared to a net loss of $(0.26) per share in the second quarter of 2008. Without the one-time effect of the tax benefit, net earnings per share would have been $0.05. These results include approximately $1.1 million of one-time transaction expenses associated with the Chestnut acquisition.
Robert Palmisano, president and chief executive officer of ev3 Inc., commented, "We achieved another quarter of solid top line growth, and for the first time in the company's history, we achieved GAAP profitability driven by another significant improvement in our gross margin and continued expense leverage. These results reflect the significant strides the company has made in the first half of 2009 in achieving sales growth across our neurovascular and peripheral vascular segments and expanding our international business. Notably, our atherectomy net sales increased by approximately 21% during the second quarter from the first quarter of 2009 driven by the restructuring activities and strategic programs implemented earlier in the year to improve our U.S. peripheral vascular sales force execution and productivity."
For the second quarter of 2009, ev3's non-GAAP adjusted net income was $14.6 million, or $0.14 per diluted share, compared to an adjusted net loss of $(5.1) million, or $(0.05) per diluted share, in the second quarter of 2008. Non-GAAP adjusted net income and adjusted net earnings per share for the second quarter of 2009 excludes non-cash amortization expense of $5.8 million, non-cash stock-based compensation of $3.6 million, accounting charges resulting from the change in fair value of the future contingent consideration associated with the Chestnut acquisition of approximately $200,000, and a tax benefit of $19.0 million resulting from the purchase accounting for the acquisition of Chestnut.
Cash and cash equivalents totaled $60.4 million as of the end of the second quarter of 2009, a decrease of $6.6 million compared to the end of the first quarter of 2009 as a result of approximately $24.7 million in net cash paid in conjunction with the acquisition of Chestnut, which closed on June 23, 2009. Cash flow from operating activities was positive for the fourth consecutive quarter, totaling $20.0 million in the second quarter of 2009.
Palmisano concluded, "These second quarter results demonstrate the excellent progress we have made to enhance our business processes and improve our operating leverage. We also closed our acquisition of Chestnut during the second quarter, adding a new platform for future revenue and earnings growth that complements our best-in-class neurovascular product portfolio and leverages the strength of our neurovascular sales channel and established customer relationships. As we head into the second half of the year, we will remain focused on achieving revenue growth at or above market growth rates, sustained profitability and cash generation."
Sales Review
By product segment, peripheral vascular net product sales increased 2% versus the prior year quarter and 5% on a constant currency basis. Excluding atherectomy, peripheral vascular sales increased 13% on a constant currency basis. Neurovascular net sales increased 21% versus the prior year quarter and 28% on a constant currency basis. Product sales from recently acquired Chestnut were insignificant.
On a geographic basis, ev3 U.S. net product sales increased approximately 3% versus the prior year quarter. International net sales increased 15% versus the prior year quarter and 28% on a constant currency basis. Changes in foreign currency exchange rates had negative impact of approximately $4.5 million on net sales compared to the second quarter of the prior year.
An investor presentation summarizing the company's second quarter 2009 results is available at http://ir.ev3.net.
Outlook
The Company has increased its fiscal year 2009 net sales guidance to a range of $435 to $445 million, from its previously issued guidance range of $420 to $430 million. The 2009 guidance includes anticipated net sales of $4 to $5 million from the Chestnut acquisition and compares to $402.2 million of product sales in 2008. Net product sales growth on a constant currency basis is expected to be approximately 11% to 13%. Foreign currency exchange rate fluctuations are expected to negatively impact revenue growth by 2% to 3% in 2009. ev3 increased non-GAAP adjusted earnings per share to a range of $0.47 to $0.53 per diluted share from its previously issued guidance range of $0.40 to $0.45 per diluted share, based on approximately 108.6 million of average outstanding shares. ev3's adjusted net earnings per share guidance excludes estimated amortization expense of approximately $24.7 million, inclusive of amortization relating to Chestnut of approximately $3.1 million, non-cash stock-based compensation of approximately $14.3 million, accounting charges relating to the estimated change in fair value of the future contingent consideration associated with the Chestnut acquisition of $4.9 million, vacant leased facilities reserve expense of $3.4 million, gain on the divestiture of non-strategic investment assets of $4.1 million, and a tax benefit of $19.0 million resulting from the purchase accounting for the acquisition of Chestnut.
The company expects third quarter 2009 net sales to be in the range of $109 to $112 million compared to $100.0 million of net product sales in the third quarter of 2008 and non-GAAP adjusted net earnings per share to be in the range of $0.09 to $0.12 per diluted share, based on approximately 111.3 million of average outstanding shares. ev3's non-GAAP adjusted net earnings per share for the third quarter of 2009 excludes estimated amortization expense of approximately $6.5 million, inclusive of amortization relating to Chestnut of approximately $1.4 million, non-cash stock-based compensation of approximately $3.4 million and accounting charges relating to the estimated change in fair value of the future contingent consideration associated with the Chestnut acquisition of $2.3 million.
Earnings Call Information
ev3 will host a conference call today, July 28, 2009, beginning at 7:30 a.m. Central Time (8:30 a.m. Eastern Time) to review its results of operations for the second quarter of 2009 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 888-679-8040 (U.S.) or 617-213-4851 (International). The participant passcode is 31069484.
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 80793229. The audio replay will be available beginning at 10:30 a.m. Central Time on Tuesday, July 28, 2009 until Tuesday, August 4, 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 and flow diversion devices, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at www.ev3.net.
ev3, the ev3 logo, Axium, Onyx, Solitaire, Pipeline and Alligator are trademarks of ev3 Inc. and its subsidiaries, registered in the U.S. and other countries. All other 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars in thousands, except per share amounts)
(unaudited)
For the Three Months
Ended For the Six Months Ended
------------------------ ------------------------
July 5, June 29, July 5, June 29,
2009 2008 2009 2008
----------- ----------- ----------- -----------
Sales
Product sales $ 109,086 $ 101,509 $ 209,481 $ 196,559
Research
collaboration -- 6,208 -- 12,415
----------- ----------- ----------- -----------
Net sales 109,086 107,717 209,481 208,974
Operating expenses:
Product cost of
goods sold(a) 30,478 34,290 61,466 66,260
Research
collaboration -- 1,899 -- 3,547
Sales, general and
administrative(a) 54,961 65,936 110,609 125,764
Research and
development(a) 12,310 14,054 23,888 25,780
Amortization of
intangible assets 5,814 7,941 11,642 16,184
Contingent
consideration 196 -- 196 --
Intangible asset
impairment -- 10,459 -- 10,459
----------- ----------- ----------- -----------
Total operating
expenses 103,759 134,579 207,801 247,994
Income (loss)
from operations 5,327 (26,862) 1,680 (39,020)
Other expense
(income):
Gain on
investments, net (5) (400) (4,072) (400)
Interest expense
(income), net 222 85 435 (356)
Other (income)
expense, net (711) 345 1,497 (2,087)
----------- ----------- ----------- -----------
Income (loss)
before income
taxes 5,821 (26,892) 3,820 (36,177)
Income tax
(benefit) expense (18,168) 530 (18,360) 1,015
----------- ----------- ----------- -----------
Net income
(loss) $ 23,989 $ (27,422) $ 22,180 $ (37,192)
=========== =========== =========== ===========
Earnings per share:
Net income (loss)
per common share:
Basic $ 0.23 $ (0.26) $ 0.21 $ (0.36)
=========== =========== =========== ===========
Diluted $ 0.23 $ (0.26) $ 0.21 $ (0.36)
=========== =========== =========== ===========
Weighted average
common shares
outstanding:
Basic 105,763,801 104,247,782 105,403,406 104,176,206
=========== =========== =========== ===========
Diluted 106,314,906 104,247,782 105,687,023 104,176,206
=========== =========== =========== ===========
(a) Includes
stock-based
compensation
charges of:
Product cost
of goods
sold $ 237 $ 179 $ 481 $ 476
Sales, general
and
administrative 3,016 3,443 6,114 7,036
Research and
development 360 270 728 1,111
----------- ----------- ----------- -----------
$ 3,613 $ 3,892 $ 7,323 $ 8,623
=========== =========== =========== ===========
ev3 Inc.
CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except per share amounts)
July 5, December 31,
2009 2008
------------ ------------
(unaudited)
Assets
Current assets
Cash and cash equivalents $ 60,356 $ 59,652
Accounts receivable, less allowance of
$8,302 and $8,098, respectively 77,178 72,814
Inventories, net 45,455 47,687
Prepaid expenses and other assets 6,597 6,970
------------ ------------
Total current assets 189,586 187,123
Restricted cash 3,438 1,531
Property and equipment, net 27,343 30,681
Goodwill 367,311 315,654
Other intangible assets, net 267,621 185,292
Other assets 615 383
------------ ------------
Total assets $ 855,914 $ 720,664
============ ============
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 19,293 $ 15,657
Accrued compensation and benefits 24,020 29,547
Accrued liabilities 22,788 19,744
Current portion of long-term debt 2,500 2,500
------------ ------------
Total current liabilities 68,601 67,448
Long-term debt 5,208 6,458
Other long-term liabilities 56,182 6,217
------------ ------------
Total liabilities 129,991 80,123
Stockholders' equity
Preferred stock, $0.01 par value,
100,000,000 shares authorized, none
issued and outstanding as of July 5, 2009
and December 31, 2008 -- --
Common stock, $0.01 par value, 300,000,000
shares authorized, shares issued and
outstanding: 112,063,008 shares as of
July 5, 2009 and 105,822,444 shares as of
December 31, 2008 1,121 1,058
Additional paid in capital 1,819,703 1,756,832
Accumulated deficit (1,094,481) (1,116,661)
Accumulated other comprehensive loss (420) (688)
------------ ------------
Total stockholders' equity 725,923 640,541
------------ ------------
Total liabilities and stockholders'
equity $ 855,914 $ 720,664
============ ============
ev3 Inc.
SELECTED NET SALES INFORMATION
(Dollars in thousands, except per share amounts)
(unaudited)
NET SALES BY SEGMENT
For the Three For the Six
Months Ended Months Ended
------------------ ------------------
July 5, June 29, % July 5, June 29, %
2009 2008 change 2009 2008 change
-------- -------- ------ -------- -------- ------
Peripheral
vascular
Atherectomy $ 22,109 $ 24,932 -11% $ 40,417 $ 47,632 -15%
Stents 29,659 27,128 9% 57,833 51,160 13%
Thrombectomy
and embolic
protection 7,914 7,097 12% 15,961 13,052 22%
Procedural
support and
other 12,331 11,633 6% 24,004 23,059 4%
-------- -------- ------ -------- -------- ------
Total
peripheral
vascular 72,013 70,790 2% 138,215 134,903 2%
Neurovascular
Embolic
products 21,644 17,431 24% 41,191 35,295 17%
Neuro access
and delivery
products 15,429 13,288 16% 30,075 26,361 14%
-------- -------- ------ -------- -------- ------
Total
neuro-
vascular 37,073 30,719 21% 71,266 61,656 16%
Research
collaboration -- 6,208 -100% -- 12,415 -100%
-------- -------- ------ -------- -------- ------
Total company $109,086 $107,717 1% $209,481 $208,974 0%
======== ======== ====== ======== ======== ======
NET SALES BY GEOGRAPHY
For the Three For the Six
Months Ended Months Ended
------------------ ------------------
July 5, June 29, % July 5, June 29, %
2009 2008 change 2009 2008 change
-------- -------- ------ -------- -------- ------
United States $ 67,695 $ 71,869 -6% $129,349 $138,321 -6%
International 41,391 35,848 15% 80,132 70,653 13%
-------- -------- ------ -------- -------- ------
Total net
sales $109,086 $107,717 1% $209,481 $208,974 0%
======== ======== ====== ======== ======== ======
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. 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 NET SALES TO
NON-GAAP NET SALES ON A CONSTANT CURRENCY BASIS
(Dollars in thousands, except per share amounts)
(unaudited)
For the Three Months Ended
-----------------------------------
June 29,
July 5, 2009 2008
-------------------------- --------
Foreign
exchange Net
impact sales % change % change
Net as on a Net of net on a
sales, compared constant sales, sales, constant
as to prior currency as as currency
reported period basis reported reported basis
-------- -------- -------- -------- -------- --------
Net product
sales
Peripheral
vascular
Atherectomy $ 22,109 $ 193 $ 22,302 $ 24,932 -11% -11%
Stents 29,659 1,338 30,997 27,128 9% 14%
Thrombectomy
and embolic
protection 7,914 338 8,252 7,097 12% 16%
Procedural
support and
other 12,331 401 12,732 11,633 6% 9%
-------- -------- -------- -------- -------- --------
Total
peripheral
vascular 72,013 2,270 74,283 70,790 2% 5%
Neurovascular
Embolic
products 21,644 1,374 23,018 17,431 24% 32%
Neuro access
and delivery
products 15,429 896 16,325 13,288 16% 23%
-------- -------- -------- -------- -------- --------
Total
neuro-
vascular 37,073 2,270 39,343 30,719 21% 28%
Total net
product sales 109,086 4,540 113,626 101,509 7% 12%
Research
collaboration -- -- -- 6,208 -100% -100%
-------- -------- -------- -------- -------- --------
Total net
sales $109,086 $ 4,540 $113,626 $107,717 1% 5%
======== ======== ======== ======== ======== ========
ev3 Inc.
RECONCILIATION OF PERIPHERAL VASCULAR NET SALES TO NON-GAAP LEGACY
PERIPHERAL VASCULAR NET PRODUCT SALES ON A CONSTANT CURRENCY BASIS AND
NON-GAAP TOTAL LEGACY NET PRODUCT SALES ON A CONSTANT CURRENCY BASIS
(Dollars in thousands)
(unaudited)
For the Three Months Ended
-----------------------------------
June 29,
July 5, 2009 2008
-------------------------- --------
Foreign
exchange Net
impact sales % change % change
Net as on a Net of net on a
sales, compared constant sales, sales, constant
as to prior currency as as currency
reported period basis reported reported basis
-------- -------- -------- -------- -------- --------
Peripheral
vascular
segment net
sales, as
reported $ 72,013 $ 2,270 $ 74,283 $ 70,790 2% 5%
Atherectomy 22,109 193 22,302 24,932 -11% -11%
-------- -------- -------- -------- -------- --------
Legacy
peripheral
vascular net
sales
(non-GAAP) 49,904 2,077 51,981 45,858 9% 13%
Neurovascular
net sales 37,073 2,270 39,343 30,719 21% 28%
-------- -------- -------- -------- -------- --------
Total legacy net
product sales
(non-GAAP) $ 86,977 $ 4,347 $ 91,324 $ 76,577 14% 19%
======== ======== ======== ======== ======== ========
ev3 Inc.
RECONCILIATION OF NET SALES BY GEOGRAPHY TO
NON-GAAP NET SALES BY GEOGRAPHY ON A CONSTANT CURRENCY BASIS
(Dollars in thousands, except per share amounts)
(unaudited)
For the Three Months Ended
-----------------------------------
June 29,
July 5, 2009 2008
-------------------------- --------
Foreign
exchange Net
impact sales % change % change
Net as on a Net of net on a
sales, compared constant sales, sales, constant
as to prior currency as as currency
reported period basis reported reported basis
-------- -------- -------- -------- -------- --------
United States $ 67,695 $ -- $ 67,695 $ 71,869 -6% -6%
International 41,391 4,540 45,931 35,848 15% 28%
-------- -------- -------- -------- -------- --------
Total net
sales $109,086 $ 4,540 $113,626 $107,717 1% 5%
======== ======== ======== ======== ======== ========
ev3 Inc.
RECONCILIATION OF U.S. NET SALES TO
NON-GAAP U.S. NET PRODUCT SALES
(Dollars in thousands)
(unaudited)
For the Three Months Ended For the Six Months Ended
-------------------------- --------------------------
July 5, June 29, % July 5, June 29, %
2009 2008 change 2009 2008 change
-------- -------- ------ -------- -------- ------
U.S. net sales,
as reported $ 67,695 $ 71,869 -6% $129,349 $138,321 -6%
Research
collaboration -- (6,208) -100% -- (12,415) -100%
-------- -------- ------ -------- -------- ------
U.S. net
product sales
(non-GAAP) $ 67,695 $ 65,661 3% $129,349 $125,906 3%
======== ======== ====== ======== ======== ======
ev3 Inc.
RECONCILIATION OF NET INCOME (LOSS) TO
NET INCOME (LOSS), EXCLUDING NON-CASH TAX BENEFIT FROM ACQUISITIONS
AND NON-GAAP ADJUSTED NET INCOME (LOSS)
(Dollars in thousands)
For the Three Months For the Six Months
Ended Ended
----------------------------------------------
July 5, June 29, July 5, June 29,
2009 2008 2009 2008
---------- ---------- ---------- ----------
Net income (loss), as
reported $ 23,989 $ (27,422) $ 22,180 $(37,192)
Non-cash tax benefit
from acquisitions (18,998) -- (18,998) --
---------- ---------- ---------- ----------
Net income (loss),
excluding non-cash
tax benefit from
acquisitions 4,991 (27,422) 3,182 (37,192)
Amortization expense 5,814 7,941 11,642 16,184
Stock-based
compensation 3,613 3,892 7,323 8,623
Contingent
consideration 196 -- 196 --
Intangible asset
impairment -- 10,459 -- 10,459
FoxHollow lease reserve
adjustment -- -- 3,421 --
Realized gain on
investments -- -- (4,081) --
---------- ---------- ---------- ----------
Non-GAAP adjusted net
income (loss) $ 14,614 $ (5,130) $ 21,683 $ (1,926)
========== ========== ========== ==========
ev3 Inc.
RECONCILIATION OF NET INCOME (LOSS) PER COMMON SHARE TO
NET INCOME (LOSS) PER COMMON SHARE,
EXCLUDING NON-CASH TAX BENEFIT FROM ACQUISITIONS AND
NON-GAAP ADJUSTED NET EARNINGS (LOSS) PER SHARE
For the Three Months For the Six Months
Ended Ended
------------------------ ------------------------
July 5, June 29, July 5, June 29,
2009 2008 2009 2008
----------- ----------- ----------- -----------
Net income (loss)
per common share,
as reported $ 0.23 $ (0.26) $ 0.21 $ (0.36)
Non-cash tax
benefit from
acquisitions (0.18) -- (0.18) --
----------- ----------- ----------- -----------
Net income (loss)
per common share,
excluding non-cash
tax benefit
from acquisitions 0.05 (0.26) 0.03 (0.36)
Amortization
expense 0.06 0.07 0.12 0.16
Stock-based
compensation 0.03 0.04 0.07 0.08
Contingent
consideration -- -- -- --
Intangible asset
impairment -- 0.10 -- 0.10
FoxHollow lease
reserve adjustment -- -- 0.03 --
Realized gain on
investment -- -- (0.04) --
----------- ----------- ----------- -----------
Non-GAAP adjusted
net earnings (loss)
per diluted share $ 0.14 $ (0.05) $ 0.21 $ (0.02)
=========== =========== =========== ===========
Weighted average
diluted shares
outstanding 106,314,906 104,247,782 105,687,023 104,176,206
=========== =========== =========== ===========
ev3 Inc.
RECONCILIATION OF ESTIMATED NET SALES TO
ESTIMATED NON-GAAP ADJUSTED NET PRODUCT SALES
ON A CONSTANT CURRENCY BASIS
(Dollars in thousands)
(unaudited)
For the Twelve Months Ended
--------------------------------------------
Dec. 31, Dec. 31, Dec. 31,
2008 2009 2009
Estimate % Estimate %
(Low) change (High) change
-------- -------- ------ -------- ------
Net sales, as reported $422,128 $435,000 NA $445,000 NA
Research collaboration (19,895) -- NA -- NA
-------- -------- --------
Net product sales 402,233 435,000 8% 445,000 11%
Estimated foreign
exchange impact (10,000) -- NA -- NA
-------- -------- --------
Estimated non-GAAP
adjusted net product
sales on a constant
currency basis $392,233 $435,000 11% $445,000 13%
======== ======== ========
ev3 Inc.
RECONCILIATION OF ESTIMATED NET EARNINGS (LOSS) PER SHARE TO
ESTIMATED NON-GAAP ADJUSTED NET EARNINGS PER SHARE
(Dollars in thousands)
(unaudited)
For the Three Months For the Twelve Months
Ended Ended
------------------------ ------------------------
October 4, October 4, December 31, December 31,
2009 2009 2009 2009
Estimate Estimate Estimate Estimate
(Low) (High) (Low) (High)
----------- ----------- ----------- -----------
Estimated net
earnings (loss)
per share $ (0.02) $ 0.01 $ 0.25 $ 0.31
Amortization
expense 0.06 0.06 0.23 0.23
Stock-based
compensation 0.03 0.03 0.13 0.13
Contingent
consideration 0.02 0.02 0.05 0.05
FoxHollow lease
reserve adjustment -- -- 0.03 0.03
Realized gain on
investment -- -- (0.04) (0.04)
Non-cash tax
benefit from
acquisitions -- -- (0.18) (0.18)
----------- ----------- ----------- -----------
Estimated non-GAAP
adjusted net
earnings per
diluted share $ 0.09 $ 0.12 $ 0.47 $ 0.53
=========== =========== =========== ===========
Estimated weighted
average diluted
shares
outstanding 111,300,000 111,300,000 108,600,000 108,600,000
=========== =========== =========== ===========
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 prior 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. * Atherectomy net product sales. In the fourth fiscal quarter 2007, ev3 acquired FoxHollow Technologies, Inc. (FoxHollow). Prior to this acquisition, ev3 did not recognize any atherectomy net sales. In addition to disclosing net sales and growth rates that are determined in accordance with GAAP, ev3's management believes that in order to properly understand underlying business trends in and performance of ev3's legacy peripheral vascular segment business management has found and investors may find it useful to consider the impact of excluding atherectomy net product sales from ev3's peripheral vascular net product sales and ev3's total net product sales. * Research collaboration revenue. 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. * Intangible asset impairment. 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 $10.5 million research collaboration asset impairment charges recorded by ev3 in the second quarter 2008. * FoxHollow lease reserve adjustment. In the first fiscal quarter 2009, ev3 recorded an adjustment to its lease reserve for leases acquired in connection with the FoxHollow acquisition. This reserve adjustment is not indicative of ev3's ongoing operating performance and therefore 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 $3.4 million lease reserve adjustment recorded by ev3 in the first fiscal quarter 2009. * Realized gain on non-strategic investment assets. In the first fiscal quarter 2009, ev3 recorded a gain of $4.1 million on the sale of certain non-strategic investment assets. This gain is a one-time item and is not indicative of ev3's ongoing operating performance and 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 $4.1 million gain on non-strategic investment assets recorded by ev3 in the first fiscal quarter 2009. * Contingent consideration. In the second fiscal quarter 2009, ev3 acquired Chestnut Medical Technologies, Inc. (Chestnut). Under the terms of the agreement and plan of merger with Chestnut, ev3 made an initial closing payment in the amount of $79.4 million. In addition to the initial closing payment, ev3 may be obligated to make an additional milestone payment of up to $75 million if the FDA issues a letter granting pre-market approval for the commercialization of Chestnut's Pipeline Embolization Device in the United States pursuant to an indication to treat intracranial aneurysms on or before December 31, 2012. ev3 remeasures the contingent consideration to fair value at each reporting date until the contingency is resolved. The changes in fair value are recognized in ev3's consolidated statements of operations. 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 excluding the impact of the accounting charge related to contingent consideration of approximately $200,000 recorded by ev3 in the second fiscal quarter 2009. * Non-cash tax benefit from acquisitions. As a result of ev3's acquisition of Chestnut, ev3 recorded a non-cash one-time tax benefit of $19.0 million in the second fiscal quarter 2009. 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 excluding the impact of the tax benefit from the Chestnut acquisition recorded by ev3 in the second fiscal quarter 2009. * 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 the FoxHollow lease reserve adjustment and realized gain on non-strategic investment assets are unusual items that do not reflect ev3's regular business activities. The effect of the lease reserve adjustment and the income associated with the sale of the non-strategic investment assets is not included in ev3's "non- GAAP adjusted net income (loss)" or "non-GAAP adjusted net earnings (loss) per share." However, these items nonetheless involve economic costs that are not reflected in the non-GAAP measures. * 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.